{"id":"cimetidine","rwe":[{"pmid":"41876561","year":"2026","title":"Pseudomonas plecoglossicida disrupts intestinal homeostasis through manipulation of palmitoleic acid microbial metabolism.","finding":"","journal":"NPJ biofilms and microbiomes","studyType":"Clinical Study"},{"pmid":"41824868","year":"2026","title":"Potentially inappropriate medication use in older adult patients living with cancer using the Beers, STOPP, GO-PIM and Chinese criteria: A retrospective cross-sectional study.","finding":"","journal":"Medicine","studyType":"Clinical Study"},{"pmid":"41817965","year":"2026","title":"Toxicity profile of supratherapeutic loperamide: a systematic review and dose-response analysis.","finding":"","journal":"Clinical toxicology (Philadelphia, Pa.)","studyType":"Clinical Study"},{"pmid":"41787256","year":"2026","title":"IL3RA identified as novel biomarker and therapeutic target for ER(+) breast cancer through plasma proteome-wide mendelian randomization and TCGA database analysis.","finding":"","journal":"Clinical proteomics","studyType":"Clinical Study"},{"pmid":"41628910","year":"2026","title":"Unilateral Fractionated Thoracic Irradiation Induces Abscopal Injury in Contralateral Lung through NF-κB Pathway.","finding":"","journal":"Radiation research","studyType":"Clinical Study"}],"_fda":{"id":"0337689b-c5d5-d881-e063-6394a90aaec9","set_id":"01997826-7ca1-473e-bfc9-075b14b58a35","openfda":{"nui":["N0000000151","N0000175784"],"upc":["0362135633905","0362135630300","0362135631901","0362135632908"],"unii":["80061L1WGD"],"route":["ORAL"],"rxcui":["197505","197506","197507","197508"],"spl_id":["0337689b-c5d5-d881-e063-6394a90aaec9"],"brand_name":["CIMETIDINE"],"spl_set_id":["01997826-7ca1-473e-bfc9-075b14b58a35"],"package_ndc":["62135-630-30","62135-631-90","62135-632-90","62135-633-90"],"product_ndc":["62135-630","62135-631","62135-632","62135-633"],"generic_name":["CIMETIDINE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["CIMETIDINE"],"pharm_class_epc":["Histamine-2 Receptor Antagonist [EPC]"],"pharm_class_moa":["Histamine H2 Receptor Antagonists [MoA]"],"manufacturer_name":["Chartwell RX, LLC"],"application_number":["ANDA074329"],"is_original_packager":[true]},"version":"1","overdosage":["OVERDOSAGE Studies in animals indicate that toxic doses are associated with respiratory failure and tachycardia that may be controlled by assisted respiration and the administration of a beta-blocker. Reported acute ingestions orally of up to 20 grams have been associated with transient adverse effects similar to those encountered in normal clinical experience. The usual measures to remove unabsorbed material from the gastrointestinal tract, clinical monitoring, and supportive therapy should be employed. There have been reports of severe CNS symptoms, including unresponsiveness, following ingestion of between 20 and 40 grams of cimetidine, and extremely rare reports following concomitant use of multiple CNS-active medications and ingestion of cimetidine at doses less than 20 grams. An elderly, terminally ill dehydrated patient with organic brain syndrome receiving concomitant antipsychotic agents and 4,800 mg of cimetidine intravenously over a 24-hour period experienced mental deterioration with reversal on discontinuation of cimetidine. There have been two deaths in adults who were reported to have ingested over 40 grams orally on a single occasion."],"description":["DESCRIPTION Cimetidine, USP is a histamine H 2 -receptor antagonist. Chemically it is N\" -cyano- N -methyl- N' -[2-[[(5-methyl-1 H -imidazol-4-yl)methyl]thio]-ethyl]guanidine. Its structural formula is: Cimetidine, USP contains an imidazole ring, and is chemically related to histamine. Cimetidine, USP has a bitter taste and characteristic odor. Solubility Characteristics Cimetidine is soluble in alcohol, slightly soluble in water, very slightly soluble in chloroform and insoluble in ether. Each tablet, for oral administration, contains 200 mg, 300 mg, 400 mg or 800 mg cimetidine, USP. Inactive ingredients are: corn starch, hydroxypropylmethyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, povidone, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide. image description"],"precautions":["PRECAUTIONS General Rare instances of cardiac arrhythmias and hypotension have been reported following the rapid administration of cimetidine hydrochloride injection by intravenous bolus. Symptomatic response to treatment with cimetidine tablets do not preclude the presence of a gastric malignancy. There have been rare reports of transient healing of gastric ulcers despite subsequently documented malignancy. Reversible confusional states (see ADVERSE REACTIONS ) have been observed on occasion, predominantly, but not exclusively, in severely ill patients. Advancing age (50 or more years) and preexisting liver and/or renal disease appear to be contributing factors. In some patients these confusional states have been mild and have not required discontinuation of cimetidine tablets. In cases where discontinuation was judged necessary, the condition usually cleared within 3 to 4 days of drug withdrawal. Drug Interactions Cimetidine tablets, apparently through an effect on certain microsomal enzyme systems, has been reported to reduce the hepatic metabolism of warfarin-type anticoagulants, phenytoin, propranolol, nifedipine, chlordiazepoxide, diazepam, certain tricyclic antidepressants, lidocaine, theophylline, and metronidazole, thereby delaying elimination and increasing blood levels of these drugs. Clinically significant effects have been reported with the warfarin anticoagulants; therefore, close monitoring of prothrombin time is recommended, and adjustment of the anticoagulant dose may be necessary when cimetidine tablets are administered concomitantly. Interaction with phenytoin, lidocaine, and theophylline has also been reported to produce adverse clinical effects. However, a crossover study in healthy subjects receiving either 300 mg 4 times daily or 800 mg at bedtime of cimetidine tablets concomitantly with a 300 mg twice-daily dose of theophylline extended-release tablets demonstrated less alteration in steady-state theophylline peak serum levels with the 800 mg at bedtime regimen, particularly in subjects aged 54 years and older. Data beyond 10 days are not available. (Note: All patients receiving theophylline should be monitored appropriately, regardless of concomitant drug therapy.) Dosage of the drugs mentioned above and other similarly metabolized drugs, particularly those of low therapeutic ratio or in patients with renal and/or hepatic impairment, may require adjustment when starting or stopping the concomitant administration of cimetidine tablets to maintain optimum therapeutic blood levels. Alteration of pH may affect absorption of certain drugs (e.g., ketoconazole). If these products are needed, they should be given at least 2 hours before cimetidine administration. Additional clinical experience may reveal other drugs affected by the concomitant administration of cimetidine tablets. Carcinogenesis, Mutagenesis, Impairment of Fertility In a 24-month toxicity study conducted in rats, at dose levels of 150, 378 and 950 mg/kg/day (approximately 8 to 48 times the recommended human dose), there was a small increase in the incidence of benign Leydig cell tumors in each dose group; when the combined drug-treated groups and control groups were compared, this increase reached statistical significance. In a subsequent 24-month study, there were no differences between the rats receiving 150 mg/kg/day and the untreated controls. However, a statistically significant increase in benign Leydig cell tumor incidence was seen in the rats that received 378 and 950 mg/kg/day. These tumors were common in control groups as well as treated groups and the difference became apparent only in aged rats. Cimetidine has demonstrated a weak antiandrogenic effect. In animal studies this was manifested as reduced prostate and seminal vesicle weights. However, there was no impairment of mating performance or fertility, nor any harm to the fetus in these animals at doses 8 to 48 times the full therapeutic dose of cimetidine tablets, as compared with controls. The cases of gynecomastia seen in patients treated for 1 month or longer may be related to this effect. In human studies, cimetidine tablets have been shown to have no effect on spermatogenesis, sperm count, motility, morphology or in vitro fertilizing capacity. Pregnancy Teratogenic Effects. Pregnancy Category B Reproduction studies have been performed in rats, rabbits and mice at doses up to 40 times the normal human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cimetidine tablets. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers Cimetidine is secreted in human milk and, as a general rule, nursing should not be undertaken while a patient is on a drug. Pediatric Use Clinical experience in children is limited. Therefore, therapy with cimetidine tablets cannot be recommended for children under 16, unless, in the judgement of the physician, anticipated benefits outweigh the potential risks. In very limited experience, doses of 20 to 40 mg/kg/day have been used. Immunocompromised Patients In immunocompromised patients, decreased gastric acidity, including that produced by acid-suppressing agents such as cimetidine, may increase the possibility of a hyperinfection of strongyloidiasis."],"how_supplied":["HOW SUPPLIED Cimetidine Tablets, USP are available containing 200 mg, 300 mg, 400 mg or 800 mg of cimetidine, USP. The 200 mg tablets are white to off white, oval shaped film-coated tablets, debossed with “CE 59” on one side and plain on the other side. They are available as follows: Bottles of 30 tablets NDC 62135-630-30 The 300 mg tablets are white to off white, oval shaped film-coated tablets, debossed with “CE 60” on one side and plain on the other side. They are available as follows: Bottles of 90 tablets NDC 62135-631-90 The 400 mg tablets are white to off white, oval shaped film-coated tablets, debossed with \"CE\" bisect \"61\" on one side and plain on the other side. They are available as follows: Bottles of 90 tablets NDC 62135-632-90 The 800 mg tablets are white to off white, oval shaped film-coated tablets, debossed with \"CE\" bisect \"62'' on one side and plain on the other side. They are available as follows: Bottles of 90 tablets NDC 62135-633-90 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 Revised: 08/2023-01 L71384"],"effective_time":"20230818","adverse_reactions":["ADVERSE REACTIONS Adverse effects reported in patients taking cimetidine tablets are described as follows by body system. Incidence figures of 1 in 100 and greater are generally derived from controlled clinical studies. Gastrointestinal Diarrhea (usually mild) has been reported in approximately 1 in 100 patients. CNS Headaches, ranging from mild to severe, have been reported in 3.5% of 924 patients taking 1,600 mg/day, 2.1% of 2,225 patients taking 800 mg/day and 2.3% of 1,897 patients taking placebo. Dizziness and somnolence (usually mild) have been reported in approximately 1 in 100 patients on either 1,600 mg/day or 800 mg/day. Reversible confusional states, e.g., mental confusion, agitation, psychosis, depression, anxiety, hallucinations, disorientation, have been reported predominantly, but not exclusively, in severely ill patients. They have usually developed within 2 to 3 days of initiation of treatment with cimetidine tablets and have cleared within 3 to 4 days of discontinuation of the drug. Endocrine Gynecomastia has been reported in patients treated for 1 month or longer. In patients being treated for pathological hypersecretory states, this occurred in about 4% of cases while in all others the incidence was 0.3% to 1% in various studies. No evidence of induced endocrine dysfunction was found, and the condition remained unchanged or returned toward normal with continuing treatment with cimetidine tablets. Reversible impotence has been reported in patients with pathological hypersecretory disorders, e.g., Zollinger-Ellison Syndrome, receiving cimetidine tablets, particularly in high doses, for at least 12 months (range 12 to 79 months, mean 38 months). However, in large-scale surveillance studies at regular dosage, the incidence has not exceeded that commonly reported in the general population. Hematologic Decreased white blood cell counts in patients treated with cimetidine tablets (approximately 1 per 100,000 patients), including agranulocytosis (approximately 3 per million patients), have been reported, including a few reports of recurrence on rechallenge. Most of these reports were in patients who had serious concomitant illnesses and received drugs and/or treatment known to produce neutropenia. Thrombocytopenia (approximately 3 per million patients) and, very rarely, cases of pancytopenia or aplastic anemia have also been reported. As with some other H 2 -receptor antagonists, there have been extremely rare reports of immune hemolytic anemia. Hepatobiliary Dose-related increases in serum transaminase have been reported. In most cases they did not progress with continued therapy and returned to normal at the end of therapy. There have been rare reports of cholestatic or mixed cholestatic-hepatocellular effects. These were usually reversible. Because of the predominance of cholestatic features, severe parenchymal injury is considered highly unlikely. However, as in the occasional liver injury with other H 2 -receptor antagonists, in exceedingly rare circumstances fatal outcomes have been reported. There has been reported a single case of biopsy-proven periportal hepatic fibrosis in a patient receiving cimetidine tablets. Rare cases of pancreatitis, which cleared on withdrawal of the drug, have been reported. Hypersensitivity Rare cases of fever and allergic reactions including anaphylaxis and hypersensitivity vasculitis, which cleared on withdrawal of the drug, have been reported. Renal Small, possibly dose-related increases in plasma creatinine, presumably due to competition for renal tubular secretion, are not uncommon and do not signify deteriorating renal function. Rare cases of interstitial nephritis and urinary retention, which cleared on withdrawal of the drug, have been reported. Cardiovascular Rare cases of bradycardia, tachycardia and AV heart block have been reported with H 2 -receptor antagonists. Musculoskeletal There have been rare reports of reversible arthralgia and myalgia; exacerbation of joint symptoms in patients with preexisting arthritis has also been reported. Such symptoms have usually been alleviated by a reduction in the dosage of cimetidine tablets. Rare cases of polymyositis have been reported, but no causal relationship has been established. Integumental Mild rash and, very rarely, cases of severe generalized skin reactions including Stevens-Johnson syndrome, epidermal necrolysis, erythema multiforme, exfoliative dermatitis and generalized exfoliative erythroderma have been reported with H 2 -receptor antagonists. Reversible alopecia has been reported very rarely. Immune Function There have been extremely rare reports of strongyloidiasis hyperinfection in immunocompromised patients. Respiratory A large epidemiological study suggested an increased risk of developing pneumonia in current users of histamine-2-receptor antagonists (H 2 RAs) compared to patients who had stopped H 2 RA treatment, with an observed adjusted relative risk of 1.63 (95% CI, 1.07 to 2.48). However, a causal relationship between use of H 2 RAs and pneumonia has not been established."],"contraindications":["CONTRAINDICATIONS Cimetidine tablets are contraindicated for patients known to have hypersensitivity to the product."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Cimetidine tablets competitively inhibits the action of histamine at the histamine H 2 receptors of the parietal cells and thus is a histamine H 2 -receptor antagonist. Cimetidine is not an anticholinergic agent. Studies have shown that cimetidine tablets inhibit both daytime and nocturnal basal gastric acid secretion. Cimetidine tablets also inhibit gastric acid secretion stimulated by food, histamine, pentagastrin, caffeine and insulin. Antisecretory Activity 1) Acid Secretion Nocturnal An 800 mg oral dose of cimetidine tablets at bedtime reduces mean hourly H+ activity by greater than 85% over an 8-hour period in duodenal ulcer patients, with no effect on daytime acid secretion. A 1,600 mg oral dose of cimetidine tablets at bedtime produces 100% inhibition of mean hourly H+ activity over an 8-hour period in duodenal ulcer patients, but also reduces H+ activity by 35% for an additional 5 hours into the following morning. Cimetidine tablets given as 400 mg twice daily and 300 mg 4 times daily decreases nocturnal acid secretion in a dose-related manner, i.e., 47% to 83% over a 6- to 8-hour period and 54% over a 9-hour period, respectively. Food Stimulated During the first hour after a standard experimental meal, a 300 mg oral dose of cimetidine tablets inhibited gastric acid secretion in duodenal ulcer patients by at least 50%. During the subsequent 2 hours cimetidine tablets inhibited gastric acid secretion by at least 75%. The effect of a 300 mg breakfast dose of cimetidine tablets continued for at least 4 hours and there was partial suppression of the rise in gastric acid secretion following the luncheon meal in duodenal ulcer patients. This suppression of gastric acid output was enhanced and could be maintained by another 300 mg dose of cimetidine tablets given with lunch. In another study, a 300 mg dose of cimetidine tablets given with the meal increased gastric pH as compared with placebo. Table 1. Mean Gastric pH Cimetidine Placebo 1 hour 3.5 2.6 2 hours 3.1 1.6 3 hours 3.8 1.9 4 hours 6.1 2.2 24-Hour Mean H+ Activity Cimetidine tablets dosed at 800 mg at bedtime, 400 mg twice daily, and 300 mg 4 times daily, all provide a similar, moderate (less than 60%) level of 24-hour acid suppression. However, the 800 mg bedtime dose regimen exerts its entire effect on nocturnal acid, and does not affect daytime gastric physiology. Chemically Stimulated Cimetidine tablets administered orally significantly inhibited gastric acid secretion stimulated by betazole (an isomer of histamine), pentagastrin, caffeine and insulin as follows: Table 2. Cimetidine Tablets Inhibition of Stimulated Gastric Acid Secretion Stimulant Stimulant Dose Cimetidine Tablets % Inhibition Betazole 1.5 mg/kg (sc) 300 mg (po) 85% at 2 1/2 hours Pentagastrin 6 mcg/kg/hr (iv) 100 mg/hr (iv) 60% at 1 hour Caffeine 5 mg/kg/hr (iv) 300 mg (po) 100% at 1 hour Insulin 0.03 units/kg/hr (iv) 100 mg/hr (iv) 82% at 1 hour When food and betazole were used to stimulate secretion, inhibition of hydrogen ion concentration usually ranged from 45% to 75% and the inhibition of volume ranged from 30% to 65%. 2) Pepsin 300 mg of cimetidine tablets taken orally reduced total pepsin output as a result of the decrease in volume of gastric juice. 3) Intrinsic Factor Intrinsic factor secretion was studied with betazole as a stimulant. Cimetidine tablets dosed at 300 mg orally inhibited the rise in intrinsic factor concentration produced by betazole, but some intrinsic factor was secreted at all times. Other Lower Esophageal Sphincter Pressure and Gastric Emptying Cimetidine tablets has no effect on lower esophageal sphincter (LES) pressure or the rate of gastric emptying. Pharmacokinetics Cimetidine tablets are rapidly absorbed after oral administration and peak levels occur in 45 to 90 minutes. The half-life of cimetidine tablets is approximately 2 hours. Blood concentrations remain above that required to provide 80% inhibition of basal gastric acid secretion for 4 to 5 hours following a dose of 300 mg. Following parenteral administration, most of the drug is excreted as the parent compound in the urine, the principle route of excretion of cimetidine tablets. After oral administration, the drug is extensively metabolized in which the sulfoxide is the major metabolite. Following a single oral dose, 48% of the drug is recovered from the urine after 24 hours as the parent compound. CLINICAL TRIALS Duodenal Ulcer Cimetidine tablets have been shown to be effective in the treatment of active duodenal ulcer and, at reduced dosage, in maintenance therapy following healing of active ulcers. Active Duodenal Ulcer Cimetidine tablets accelerate the rate of duodenal ulcer healing. Healing rates reported in U.S. and foreign controlled trials with cimetidine tablets are summarized below, beginning with the regimen providing the lowest nocturnal dose. Table 3. Duodenal Ulcer Healing Rates with Various Dosage Regimens of Cimetidine Tablets * Regimen 300 mg 4 times daily 400 mg twice daily 800 mg at bedtime 1600 mg at bedtime Week 4 68% 73% 80% 86% Week 6 80% 80% 89% - Week 8 - 92% 94% - *Averages from controlled clinical trials. A U.S., double-blind, placebo-controlled, dose-ranging study demonstrated that all once-daily at bedtime regimens of cimetidine tablets were superior to placebo in ulcer healing and that 800 mg of cimetidine tablets at bedtime healed 75% of patients at 4 weeks. The healing rate with 800 mg at bedtime was significantly superior to 400 mg at bedtime (66%) and not significantly different from 1600 mg at bedtime (81%). In the U.S. dose-ranging trial, over 80% of patients receiving 800 mg of cimetidine tablets at bedtime experienced nocturnal pain relief after one day. Relief from daytime pain was reported in approximately 70% of patients after 2 days. As with ulcer healing, the 800 mg dose at bedtime was superior to 400 mg at bedtime and not different from 1,600 mg at bedtime. In foreign, double-blind studies with 800 mg of cimetidine tablets at bedtime, 79% to 85% of patients were healed at 4 weeks. While short-term treatment with cimetidine tablets can result in complete healing of the duodenal ulcer, acute therapy will not prevent ulcer recurrence after cimetidine tablets have been discontinued. Some follow-up studies have reported that the rate of recurrence once therapy was discontinued was slightly higher for patients healed on cimetidine tablets than for patients healed on other forms of therapy; however, the patients treated with cimetidine tablets generally had more severe disease. Maintenance Therapy in Duodenal Ulcer Treatment with a reduced dose of cimetidine tablets have been proven effective as maintenance therapy following healing of active duodenal ulcers. In numerous placebo-controlled studies conducted worldwide, the percent of patients with observed ulcers at the end of 1 year’s therapy with 400 mg of cimetidine tablets at bedtime was significantly lower (10% to 45%) than in patients receiving placebo (44% to 70%). Thus, from 55% to 90% of patients were maintained free of observed ulcers at the end of 1 year with 400 mg of cimetidine tablets at bedtime. Factors such as smoking, duration and severity of disease, gender, and genetic traits may contribute to variations in actual percentages. Trials of other anti-ulcer therapy, whether placebo-controlled, positive-controlled or open, have demonstrated a range of results similar to that seen with cimetidine tablets. Active Benign Gastric Ulcer Cimetidine tablets have been shown to be effective in the short-term treatment of active benign gastric ulcer. In a multicenter, double-blind U.S. study, patients with endoscopically confirmed benign gastric ulcer were treated with 300 mg of cimetidine tablets 4 times a day or with placebo for 6 weeks. Patients were limited to those with ulcers ranging from 0.5 to 2.5 cm in size. Endoscopically confirmed healing at 6 weeks was seen in significantly* more patients treated with cimetidine tablets than in patients receiving placebo, as shown below: Table 4. Rate of Endoscopically Confirmed Gastric Ulcer Healing Cimetidine Tablets (300 mg, 4 times daily) Placebo Week 2 14/63 (22%) 7/63 (11%) Total at week 6 43/65 (66%)* 30/67 (45%) *p < 0.05 In a similar multicenter U.S. study of the 800 mg bedtime oral regimen, the endoscopically confirmed healing rates were: Table 5. Rate of Endoscopically Confirmed Gastric Ulcer Healing Cimetidine Tablets (800 mg at bedtime) Placebo Total at week 6 63/83 (76%)* 44/80 (55%) *p = 0.005 Similarly, in worldwide double-blind clinical studies, endoscopically evaluated benign gastric ulcer healing rates were consistently higher with cimetidine tablets than with placebo. Gastroesophageal Reflux Disease In 2 multicenter, double-blind, placebo-controlled studies in patients with gastroesophageal reflux disease (GERD) and endoscopically proven erosions and/or ulcers, cimetidine tablets were significantly more effective than placebo in healing lesions. The endoscopically confirmed healing rates were: Table 6. Rate of Endoscopically Confirmed Healing of Erosions and/or Ulcers Trial Cimetidine Tablets (800 mg twice daily) Cimetidine Tablets (400 mg 4 times daily) Placebo p-Value (800 mg twice daily vs. placebo) 1 Week 6 45% 52% 26% 0.02 Week 12 60% 66% 42% 0.02 2 Week 6 50% 20% <0.01 Week 12 67% 36% <0.01 In these trials cimetidine tablets were superior to placebo by most measures in improving symptoms of day- and night-time heartburn, with many of the differences statistically significant. The 4 times-daily regimen was generally somewhat better than the twice-daily regimen where these were compared. Pathological Hypersecretory Conditions (such as Zollinger-Ellison Syndrome): Cimetidine tablets significantly inhibited gastric acid secretion and reduced occurrence of diarrhea, anorexia, and pain in patients with pathological hypersecretion associated with Zollinger-Ellison Syndrome, systemic mastocytosis, and multiple endocrine adenomas. Use of cimetidine tablets were also followed by healing of intractable ulcers."],"indications_and_usage":["INDICATIONS AND USAGE Cimetidine tablets are indicated in: 1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine tablets at full dosage for longer than 6 to 8 weeks (see DOSAGE AND ADMINISTRATION: Duodenal Ulcer ). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of cimetidine tablets and antacids is not recommended, since antacids have been reported to interfere with the absorption of cimetidine. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment with cimetidine tablets 400 mg at bedtime for periods of up to 5 years. 3. Short-term treatment of active benign gastric ulcer. There is no information concerning usefulness of treatment periods of longer than 8 weeks. 4. Erosive gastroesophageal reflux (GERD). Erosive esophagitis diagnosed by endoscopy. Treatment is indicated for 12 weeks for healing of lesions and control of symptoms. The use of cimetidine tablets beyond 12 weeks has not been established (see DOSAGE AND ADMINISTRATION: GERD ). 5. The treatment of pathological hypersecretory conditions (i.e., Zollinger-Ellison Syndrome, systemic mastocytosis, multiple endocrine adenomas)."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Duodenal Ulcer Active Duodenal Ulcer Clinical studies have indicated that suppression of nocturnal acid is the most important factor in duodenal ulcer healing (see CLINICAL PHARMACOLOGY: Antisecretory Activity: Acid Secretion ). This is supported by recent clinical trials (see CLINICAL TRIALS: Duodenal Ulcer: Active Duodenal Ulcer ). Therefore, there is no apparent rationale, except for familiarity with use, for treating with anything other than a once-daily at bedtime dosage regimen. In a U.S. dose-ranging study of 400 mg at bedtime, 800 mg at bedtime and 1600 mg at bedtime, a continuous dose-response relationship for ulcer healing was demonstrated. However, 800 mg at bedtime is the dose of choice for most patients, as it provides a high healing rate (the difference between 800 mg at bedtime and 1,600 mg at bedtime being small), maximal pain relief, a decreased potential for drug interactions (see PRECAUTIONS: Drug Interactions ) and maximal patient convenience. Patients unhealed at 4 weeks, or those with persistent symptoms, have been shown to benefit from 2 to 4 weeks of continued therapy. It has been shown that patients who both have an endoscopically demonstrated ulcer larger than 1.0 cm and are also heavy smokers (i.e., smoke 1 pack of cigarettes or more per day) are more difficult to heal. There is some evidence which suggests that more rapid healing can be achieved in this subpopulation with 1,600 mg of cimetidine tablets at bedtime. While early pain relief with either 800 mg at bedtime or 1,600 mg at bedtime is equivalent in all patients, 1,600 mg at bedtime provides an appropriate alternative when it is important to ensure healing within 4 weeks for this subpopulation. Alternatively, approximately 94% of all patients will also heal in 8 weeks with 800 mg of cimetidine tablets at bedtime. Other regimens of cimetidine tablets in the United States which have been shown to be effective are: 300 mg 4 times daily, with meals and at bedtime, the original regimen with which U.S. physicians have the most experience, and 400 mg twice daily, in the morning and at bedtime (see CLINICAL TRIALS: Duodenal Ulcer: Active Duodenal Ulcer ). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of cimetidine tablets and antacids is not recommended, since antacids have been reported to interfere with the absorption of cimetidine. While healing with cimetidine tablets often occurs during the first week or two, treatment should be continued for 4 to 6 weeks unless healing has been demonstrated by endoscopic examination. Maintenance Therapy for Duodenal Ulcer In those patients requiring maintenance therapy, the recommended adult oral dose is 400 mg at bedtime. Active Benign Gastric Ulcer The recommended adult oral dosage for short-term treatment of active benign gastric ulcer is 800 mg at bedtime, or 300 mg 4 times a day with meals and at bedtime. Controlled clinical studies were limited to 6 weeks of treatment (see CLINICAL TRIALS ). A dose of 800 mg at bedtime is the preferred regimen for most patients based upon convenience and reduced potential for drug interactions. Symptomatic response to cimetidine tablets does not preclude the presence of a gastric malignancy. It is important to follow gastric ulcer patients to assure rapid progress to complete healing. Erosive Gastroesophageal Reflux Disease (GERD) The recommended adult oral dosage for the treatment of erosive esophagitis that has been diagnosed by endoscopy is 1,600 mg daily in divided doses (800 mg twice daily or 400 mg 4 times daily) for 12 weeks. The use of cimetidine tablets beyond 12 weeks has not been established. Pathological Hypersecretory Conditions (such as Zollinger-Ellison Syndrome) Recommended adult oral dosage: 300 mg 4 times a day with meals and at bedtime. In some patients it may be necessary to administer higher doses more frequently. Doses should be adjusted to individual patient needs, but should not usually exceed 2,400 mg per day and should continue as long as clinically indicated. Dosage Adjustment for Patients with Impaired Renal Function Patients with severely impaired renal function have been treated with cimetidine tablets. However, such usage has been very limited. On the basis of this experience the recommended dosage is 300 mg every 12 hours orally. Should the patient’s condition require, the frequency of dosing may be increased to every 8 hours or even further with caution. In severe renal failure, accumulation may occur and the lowest frequency of dosing compatible with an adequate patient response should be used. When liver impairment is also present, further reductions in dosage may be necessary. Hemodialysis reduces the level of circulating cimetidine tablets. Ideally, the dosage schedule should be adjusted so that the timing of a scheduled dose coincides with the end of hemodialysis."],"spl_product_data_elements":["CIMETIDINE CIMETIDINE STARCH, CORN POVIDONE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 101 MICROCRYSTALLINE CELLULOSE 102 POLYSORBATE 80 POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE SODIUM LAURYL SULFATE WATER CIMETIDINE CIMETIDINE white to off white CE;59 CIMETIDINE CIMETIDINE STARCH, CORN POVIDONE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 101 MICROCRYSTALLINE CELLULOSE 102 POLYSORBATE 80 POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE SODIUM LAURYL SULFATE WATER CIMETIDINE CIMETIDINE white to off white CE;60 CIMETIDINE CIMETIDINE STARCH, CORN POVIDONE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 101 MICROCRYSTALLINE CELLULOSE 102 POLYSORBATE 80 POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE SODIUM LAURYL SULFATE WATER CIMETIDINE CIMETIDINE white to off white CE;61 CIMETIDINE CIMETIDINE STARCH, CORN POVIDONE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 102 POLYSORBATE 80 POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE SODIUM LAURYL SULFATE WATER CIMETIDINE CIMETIDINE white to off white CE;62"],"clinical_pharmacology_table":["<table width=\"60%\" border=\"1\" cellspacing=\"0\" cellpadding=\"0\"><tbody><tr><td align=\"center\" colspan=\"3\" styleCode=\"Botrule Lrule Rrule\"><paragraph><content styleCode=\"bold\">Table 1. Mean Gastric pH</content></paragraph></td></tr><tr><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"/><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>Cimetidine</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>Placebo</paragraph></td></tr><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule\"><paragraph>1 hour</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>3.5</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>2.6</paragraph></td></tr><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule\"><paragraph>2 hours</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>3.1</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>1.6</paragraph></td></tr><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule\"><paragraph>3 hours</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>3.8</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>1.9</paragraph></td></tr><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule\"><paragraph>4 hours</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>6.1</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>2.2</paragraph></td></tr></tbody></table>","<table width=\"80%\" border=\"1\" cellspacing=\"0\" cellpadding=\"0\"><tbody><tr><td align=\"center\" colspan=\"4\" styleCode=\"Botrule Lrule Rrule\"><paragraph><content styleCode=\"bold\">Table 2. Cimetidine Tablets Inhibition of Stimulated Gastric Acid Secretion</content></paragraph></td></tr><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule\"><paragraph>Stimulant</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>Stimulant Dose</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>Cimetidine Tablets</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>% Inhibition</paragraph></td></tr><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule\"><paragraph>Betazole</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>1.5 mg/kg (sc)</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>300 mg (po)</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>85% at 2 1/2 hours</paragraph></td></tr><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule\"><paragraph>Pentagastrin</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>6 mcg/kg/hr (iv)</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>100 mg/hr (iv)</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>60% at 1 hour</paragraph></td></tr><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule\"><paragraph>Caffeine</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>5 mg/kg/hr (iv)</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>300 mg (po)</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>100% at 1 hour</paragraph></td></tr><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule\"><paragraph>Insulin</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>0.03 units/kg/hr (iv)</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>100 mg/hr (iv)</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>82% at 1 hour</paragraph></td></tr></tbody></table>","<table width=\"60%\" border=\"1\" cellspacing=\"0\" cellpadding=\"0\"><tbody><tr><td align=\"center\" colspan=\"5\" styleCode=\"Botrule Lrule Rrule\"><paragraph><content styleCode=\"bold\">Table 3. Duodenal Ulcer Healing Rates with Various Dosage Regimens of Cimetidine Tablets</content><content styleCode=\"bold\">*</content><content styleCode=\"bold\"/></paragraph></td></tr><tr><td align=\"center\" colspan=\"5\" styleCode=\"Botrule Lrule Rrule\"><paragraph/></td></tr><tr><td align=\"center\" styleCode=\"Botrule Lrule Rrule\" valign=\"bottom\"><paragraph>Regimen</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>300 mg</paragraph><paragraph>4 times daily</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>400 mg</paragraph><paragraph>twice daily</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>800 mg</paragraph><paragraph>at bedtime</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>1600 mg</paragraph><paragraph>at bedtime</paragraph></td></tr><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule\"><paragraph>Week 4</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>68%</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>73%</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>80%</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>86%</paragraph></td></tr><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule\"><paragraph>Week 6</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>80%</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>80%</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>89%</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>-</paragraph></td></tr><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule\"><paragraph>Week 8</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>-</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>92%</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>94%</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>-</paragraph></td></tr></tbody></table>","<table width=\"80%\" border=\"1\" cellspacing=\"0\" cellpadding=\"0\"><tbody><tr><td align=\"center\" colspan=\"3\" styleCode=\"Botrule Lrule Rrule\"><paragraph><content styleCode=\"bold\">Table 4. Rate of Endoscopically Confirmed Gastric Ulcer Healing</content></paragraph></td></tr><tr><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"/><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>Cimetidine Tablets</paragraph><paragraph>(300 mg, 4 times daily)</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>Placebo</paragraph></td></tr><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule\"><paragraph>Week 2</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>14/63 (22%)</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>7/63 (11%)</paragraph></td></tr><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule\"><paragraph>Total at week 6</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>43/65 (66%)*</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>30/67 (45%)</paragraph></td></tr></tbody></table>","<table width=\"80%\" border=\"1\" cellspacing=\"0\" cellpadding=\"0\"><tbody><tr><td align=\"center\" colspan=\"3\" styleCode=\"Botrule Lrule Rrule\"><paragraph><content styleCode=\"bold\">Table 5. Rate of Endoscopically Confirmed Gastric Ulcer Healing</content></paragraph></td></tr><tr><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"/><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>Cimetidine Tablets</paragraph><paragraph>(800 mg at bedtime)</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>Placebo</paragraph></td></tr><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule\"><paragraph>Total at week 6</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>63/83 (76%)*</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>44/80 (55%)</paragraph></td></tr></tbody></table>","<table width=\"80%\" border=\"1\" cellspacing=\"0\" cellpadding=\"0\"><tbody><tr><td align=\"center\" colspan=\"6\" styleCode=\"Botrule Lrule Rrule\"><paragraph><content styleCode=\"bold\">Table 6. Rate of Endoscopically Confirmed Healing of Erosions and/or Ulcers</content></paragraph></td></tr><tr><td align=\"center\" styleCode=\"Botrule Lrule Rrule\" valign=\"bottom\"><paragraph>Trial</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"/><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>Cimetidine Tablets</paragraph><paragraph>(800 mg</paragraph><paragraph>twice daily)</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>Cimetidine Tablets</paragraph><paragraph>(400 mg</paragraph><paragraph>4 times daily)</paragraph></td><td styleCode=\"Botrule Lrule Rrule\" valign=\"bottom\"><paragraph>Placebo</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>p-Value</paragraph><paragraph>(800 mg</paragraph><paragraph>twice daily vs.</paragraph><paragraph>placebo)</paragraph></td></tr><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule\"><paragraph>1</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>Week 6</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>45%</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>52%</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>26%</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>0.02</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"/><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>Week 12</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>60%</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>66%</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>42%</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>0.02</paragraph></td></tr><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule\"><paragraph>2</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>Week 6</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>50%</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"/><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>20%</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>&lt;0.01</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"/><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>Week 12</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>67%</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"/><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>36%</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\"><paragraph>&lt;0.01</paragraph></td></tr></tbody></table>"],"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL Cimetidine Tablets, USP 200 mg - NDC 62135-630-30 - 30's Bottle Label Cimetidine Tablets, USP 300 mg - NDC 62135-631-90 - 90's Bottle Label Cimetidine Tablets, USP 400 mg - NDC 62135-632-90 - 90's Bottle Label Cimetidine Tablets, USP 800 mg - NDC 62135-633-90 - 90's Bottle Label Cimetidine Tablets, USP 200 mg - NDC 62135-630-30 - Bottle of 30 tablets Cimetidine Tablets, USP 300 mg - NDC 62135-631-90 - Bottle of 90 tablets Cimetidine Tablets, USP 400 mg - NDC 62135-632-90 - Bottle of 90 tablets Cimetidine Tablets, USP 800 mg - NDC 62135-633-90 - Bottle of 90 tablets"]},"tags":[{"label":"Histamine-2 Receptor Antagonist","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Histamine H2 receptor","category":"target"},{"label":"HRH2","category":"gene"},{"label":"SLC47A1","category":"gene"},{"label":"HTR2A","category":"gene"},{"label":"A02BA01","category":"atc"},{"label":"Topical","category":"route"},{"label":"Oral","category":"route"},{"label":"Cream","category":"form"},{"label":"Gel","category":"form"},{"label":"Solution","category":"form"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Duodenal ulcer disease","category":"indication"},{"label":"Gastric ulcer","category":"indication"},{"label":"Gastroesophageal reflux disease","category":"indication"},{"label":"Heartburn","category":"indication"},{"label":"Indigestion","category":"indication"},{"label":"Maintenance of Healing Duodenal Ulcer","category":"indication"},{"label":"Approved 1970s","category":"decade"},{"label":"Anti-Ulcer Agents","category":"pharmacology"},{"label":"Cytochrome P-450 CYP1A2 Inhibitors","category":"pharmacology"},{"label":"Cytochrome P-450 Enzyme Inhibitors","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Gastrointestinal Agents","category":"pharmacology"},{"label":"Histamine Agents","category":"pharmacology"},{"label":"Histamine Antagonists","category":"pharmacology"},{"label":"Histamine H2 Antagonists","category":"pharmacology"},{"label":"Metabolic Side Effects of Drugs and Substances","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"CHRONIC KIDNEY DISEASE","source":"FDA FAERS","actionTaken":"1316 reports"},{"date":"","signal":"ACUTE KIDNEY INJURY","source":"FDA FAERS","actionTaken":"741 reports"},{"date":"","signal":"RENAL FAILURE","source":"FDA FAERS","actionTaken":"715 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"683 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"603 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"505 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"503 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"484 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"442 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"432 reports"}],"drugInteractions":[{"url":"/drug/choline-theophyllinate","drug":"choline theophyllinate","action":"Avoid combination","effect":"May interact with Oxtriphylline","source":"DrugCentral","drugSlug":"choline-theophyllinate"},{"url":"/drug/cisapride","drug":"cisapride","action":"Avoid combination","effect":"May interact with Cisapride","source":"DrugCentral","drugSlug":"cisapride"},{"url":"/drug/clomipramine","drug":"clomipramine","action":"Monitor closely","effect":"May interact with Clomipramine","source":"DrugCentral","drugSlug":"clomipramine"},{"url":"/drug/clopidogrel","drug":"clopidogrel","action":"Monitor closely","effect":"May interact with Clopidogrel Bisulfate","source":"DrugCentral","drugSlug":"clopidogrel"},{"url":"/drug/clozapine","drug":"clozapine","action":"Monitor closely","effect":"May interact with Clozapine","source":"DrugCentral","drugSlug":"clozapine"},{"url":"/drug/dasatinib","drug":"dasatinib","action":"Monitor closely","effect":"May interact with Dasatinib","source":"DrugCentral","drugSlug":"dasatinib"},{"url":"/drug/dicoumarol","drug":"dicoumarol","action":"Avoid combination","effect":"May interact with Dicumarol","source":"DrugCentral","drugSlug":"dicoumarol"},{"url":"/drug/dofetilide","drug":"dofetilide","action":"Avoid combination","effect":"May interact with Dofetilide","source":"DrugCentral","drugSlug":"dofetilide"},{"url":"/drug/doxepin","drug":"doxepin","action":"Monitor closely","effect":"May interact with Doxepin","source":"DrugCentral","drugSlug":"doxepin"},{"url":"/drug/enoxacin","drug":"enoxacin","action":"Monitor closely","effect":"May interact with Enoxacin","source":"DrugCentral","drugSlug":"enoxacin"},{"url":"/drug/erlotinib","drug":"erlotinib","action":"Monitor closely","effect":"May interact with Erlotinib","source":"DrugCentral","drugSlug":"erlotinib"},{"url":"/drug/estazolam","drug":"estazolam","action":"Monitor closely","effect":"May interact with Estazolam","source":"DrugCentral","drugSlug":"estazolam"},{"url":"/drug/fosphenytoin","drug":"fosphenytoin","action":"Avoid combination","effect":"May interact with Fosphenytoin Sodium","source":"DrugCentral","drugSlug":"fosphenytoin"},{"url":"/drug/imipramine","drug":"imipramine","action":"Monitor closely","effect":"May interact with Imipramine","source":"DrugCentral","drugSlug":"imipramine"},{"url":"/drug/itraconazole","drug":"itraconazole","action":"Monitor closely","effect":"May interact with Itraconazole","source":"DrugCentral","drugSlug":"itraconazole"},{"url":"/drug/ketoconazole","drug":"ketoconazole","action":"Monitor closely","effect":"May interact with Ketoconazole","source":"DrugCentral","drugSlug":"ketoconazole"},{"url":"/drug/metoprolol","drug":"metoprolol","action":"Monitor closely","effect":"May interact with Metoprolol","source":"DrugCentral","drugSlug":"metoprolol"},{"url":"/drug/nifedipine","drug":"nifedipine","action":"Monitor closely","effect":"May interact with Nifedipine","source":"DrugCentral","drugSlug":"nifedipine"},{"url":"/drug/nortriptyline","drug":"nortriptyline","action":"Monitor closely","effect":"May interact with Nortriptyline","source":"DrugCentral","drugSlug":"nortriptyline"},{"url":"/drug/paroxetine","drug":"paroxetine","action":"Monitor closely","effect":"May interact with Paroxetine","source":"DrugCentral","drugSlug":"paroxetine"}],"commonSideEffects":[{"effect":"Headaches","drugRate":"3.5%","severity":"common","_validated":true},{"effect":"Dizziness","drugRate":"reported","severity":"unknown"},{"effect":"Somnolence","drugRate":"reported","severity":"unknown"},{"effect":"Gynecomastia","drugRate":"4%","severity":"common","_validated":true},{"effect":"Reversible impotence","drugRate":"reported","severity":"unknown"},{"effect":"Decreased white blood cell counts","drugRate":"per 100,000 patients","severity":"serious","_validated":true},{"effect":"Agranulocytosis","drugRate":"per million patients","severity":"serious"},{"effect":"Thrombocytopenia","drugRate":"per million patients","severity":"serious"},{"effect":"Pancytopenia or aplastic anemia","drugRate":"reported","severity":"serious"},{"effect":"Immune hemolytic anemia","drugRate":"reported","severity":"serious"},{"effect":"Dose-related increases in serum transaminase","drugRate":"reported","severity":"unknown"},{"effect":"Cholestatic or mixed cholestatic-hepatocellular effects","drugRate":"reported","severity":"unknown"},{"effect":"Periportal hepatic fibrosis","drugRate":"reported","severity":"unknown"},{"effect":"Pancreatitis","drugRate":"reported","severity":"unknown"},{"effect":"Fever","drugRate":"reported","severity":"unknown"},{"effect":"Allergic reactions","drugRate":"reported","severity":"unknown"},{"effect":"Anaphylaxis","drugRate":"reported","severity":"unknown"},{"effect":"Hypersensitivity vasculitis","drugRate":"reported","severity":"unknown"},{"effect":"Bradycardia","drugRate":"reported","severity":"mild"},{"effect":"Tachycardia","drugRate":"reported","severity":"mild"},{"effect":"A-V heart block","drugRate":"reported","severity":"mild"},{"effect":"Reversible arthralgia","drugRate":"reported","severity":"mild"},{"effect":"Myalgia","drugRate":"reported","severity":"mild"},{"effect":"Polymyositis","drugRate":"reported","severity":"mild"},{"effect":"Mild rash","drugRate":"reported","severity":"mild"},{"effect":"Severe generalized skin reactions","drugRate":"reported","severity":"mild"},{"effect":"Stevens-Johnson syndrome","drugRate":"reported","severity":"mild"},{"effect":"Epidermal necrolysis","drugRate":"reported","severity":"mild"},{"effect":"Erythema multiforme","drugRate":"reported","severity":"mild"},{"effect":"Exfoliative dermatitis","drugRate":"reported","severity":"mild"}],"contraindications":["Cimetidine tablets are contraindicated for patients known to have hypersensitivity to the product."],"specialPopulations":{"Pregnancy":"There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.","Paediatric use":"Clinical experience in pediatric patients is limited. Therefore, therapy with cimetidine cannot be recommended for pediatric patients under 16, unless, in the judgement of the physician, anticipated benefits outweigh the potential risks. In very limited experience, doses of 20 to 40 mg/kg/day have been used."}},"trials":[],"aliases":[],"patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.3482/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$127","description":"CIMETIDINE 200 MG TABLET","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=CIMETIDINE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:23:58.684828+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Cimetidine","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:24:13.640396+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:24:10.009570+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:23:57.815096+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CIMETIDINE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:24:12.572784+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:23:37.640539+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:23:37.640577+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:23:37.640584+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:24:14.091851+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Histamine H2 receptor antagonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:24:13.640338+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201051/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:24:13.289097+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:24:40.952542+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA074329","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:23:37.640588+00:00"}},"allNames":"tagamet","offLabel":[],"synonyms":["cimetidine","tagamet","tametin","ulcedin","ulcedine","ulcerex","ulcerfen","cimetidine hydrochloride","cimetidine HCl"],"timeline":[{"date":"1977-08-16","type":"positive","source":"DrugCentral","milestone":"FDA approval"},{"date":"1996-08-21","type":"positive","source":"FDA Orange Book","milestone":"Tagamet Hb approved — 200MG"},{"date":"1999-07-09","type":"positive","source":"FDA Orange Book","milestone":"Tagamet Hb 200 approved — 200MG/20ML"}],"aiSummary":"Tagamet (Cimetidine) is a small molecule Histamine-2 Receptor Antagonist developed by Smith, Kline & French, currently owned by Glaxosmithkline. It targets the histamine H2 receptor to reduce stomach acid production, treating conditions such as duodenal ulcers, gastric ulcers, and gastroesophageal reflux disease. Tagamet was FDA approved in 1977 and is now off-patent with 19 generic manufacturers. Key safety considerations include potential interactions with other medications and effects on the liver. It has a half-life of 2.2 hours and 60% bioavailability.","approvals":[{"date":"1977-08-16","orphan":false,"company":"","regulator":"FDA"}],"brandName":"Tagamet","ecosystem":[{"indication":"Duodenal ulcer disease","otherDrugs":[{"name":"algeldrate","slug":"algeldrate","company":"Sanofi Aventis Us"},{"name":"famotidine","slug":"famotidine","company":"Valeant Pharms North"},{"name":"lansoprazole","slug":"lansoprazole","company":"Takeda Pharms Usa"},{"name":"nizatidine","slug":"nizatidine","company":""}],"globalPrevalence":null},{"indication":"Gastric ulcer","otherDrugs":[{"name":"algeldrate","slug":"algeldrate","company":"Sanofi Aventis Us"},{"name":"famotidine","slug":"famotidine","company":"Valeant Pharms North"},{"name":"lansoprazole","slug":"lansoprazole","company":"Takeda Pharms Usa"},{"name":"mepenzolate","slug":"mepenzolate","company":"Sanofi Aventis Us"}],"globalPrevalence":null},{"indication":"Gastroesophageal reflux disease","otherDrugs":[{"name":"algeldrate","slug":"algeldrate","company":"Sanofi Aventis Us"},{"name":"almasilate","slug":"almasilate","company":""},{"name":"cisapride","slug":"cisapride","company":""},{"name":"dexlansoprazole","slug":"dexlansoprazole","company":"Takeda Pharms Usa"}],"globalPrevalence":null},{"indication":"Heartburn","otherDrugs":[{"name":"algeldrate","slug":"algeldrate","company":"Sanofi Aventis Us"},{"name":"almasilate","slug":"almasilate","company":""},{"name":"famotidine","slug":"famotidine","company":"Valeant Pharms North"},{"name":"magnesium carbonate","slug":"magnesium-carbonate","company":"United Guardian"}],"globalPrevalence":320000000},{"indication":"Indigestion","otherDrugs":[{"name":"algeldrate","slug":"algeldrate","company":"Sanofi Aventis Us"},{"name":"almasilate","slug":"almasilate","company":""},{"name":"bismuth subsalicylate","slug":"bismuth-subsalicylate","company":"Prometheus Labs"},{"name":"calcium carbonate","slug":"calcium-carbonate","company":"Mcneil Cons"}],"globalPrevalence":null},{"indication":"Maintenance of Healing Duodenal Ulcer","otherDrugs":[{"name":"famotidine","slug":"famotidine","company":"Valeant Pharms North"},{"name":"lansoprazole","slug":"lansoprazole","company":"Takeda Pharms Usa"},{"name":"nizatidine","slug":"nizatidine","company":""},{"name":"sucralfate","slug":"sucralfate","company":"Forest Labs Inc"}],"globalPrevalence":null},{"indication":"Multiple endocrine adenomas","otherDrugs":[{"name":"pantoprazole","slug":"pantoprazole","company":"Wyeth Pharms Inc"},{"name":"rabeprazole","slug":"rabeprazole","company":"Eisai Inc"}],"globalPrevalence":null},{"indication":"Systemic mast cell disease","otherDrugs":[{"name":"avapritinib","slug":"avapritinib","company":"Blueprint Medicines"},{"name":"cromoglicic acid","slug":"cromoglicic-acid","company":"King Pharms"},{"name":"imatinib","slug":"imatinib","company":"Novartis"},{"name":"rabeprazole","slug":"rabeprazole","company":"Eisai Inc"}],"globalPrevalence":null}],"mechanism":{"target":"Histamine H2 receptor","novelty":"Follow-on","targets":[{"gene":"HRH2","source":"DrugCentral","target":"Histamine H2 receptor","protein":"Histamine H2 receptor"},{"gene":"SLC47A1","source":"DrugCentral","target":"Multidrug and toxin extrusion protein 1","protein":"Multidrug and toxin extrusion protein 1"},{"gene":"HTR2A","source":"DrugCentral","target":"5-hydroxytryptamine receptor 2A","protein":"5-hydroxytryptamine receptor 2A"},{"gene":"SLC47A2","source":"DrugCentral","target":"Multidrug and toxin extrusion protein 2","protein":"Multidrug and toxin extrusion protein 2"}],"moaClass":"Histamine H2 Receptor Antagonists","modality":"Small Molecule","drugClass":"Histamine-2 Receptor Antagonist [EPC]","explanation":"","oneSentence":"","technicalDetail":"Tagamet competitively inhibits the histamine H2 receptor, reducing gastric acid secretion through a decrease in parietal cell activity and a reduction in the release of histamine from enterochromaffin-like cells."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Cimetidine","title":"Cimetidine","extract":"Cimetidine, sold under the brand name Tagamet among others, is a histamine H2 receptor antagonist that inhibits stomach acid production. It is mainly used in the treatment of heartburn and peptic ulcers.","wiki_history":"==History==\nCimetidine, approved by the FDA for inhibition of gastric acid secretion, has been advocated for a number of dermatological diseases. Cimetidine was the prototypical histamine H<sub>2</sub> receptor antagonist from which the later members of the class were developed. Cimetidine was the culmination of a project at Smith, Kline & French (SKF) Laboratories in Welwyn Garden City (now part of GlaxoSmithKline) by James W. Black, C. Robin Ganellin, and others to develop a histamine receptor antagonist to suppress stomach acid secretion. This was one of the first drugs discovered using a rational drug design approach. Sir James W. Black shared the 1988 Nobel Prize in Physiology or Medicine for the discovery of propranolol and also is credited for the discovery of cimetidine.\n\nAt the time (1964), histamine was known to stimulate the secretion of stomach acid, but also that traditional antihistamines had no effect on acid production. In the process, the SK&F scientists also proved the existence of histamine H<sub>2</sub> receptors.\n\nThe SK&F team used a rational drug-design structure starting from the structure of histamine — the only design lead, since nothing was known of the then hypothetical H<sub>2</sub> receptor. Hundreds of modified compounds were synthesized in an effort to develop a model of the receptor. The first breakthrough was N<sup>α</sup>-guanylhistamine, a partial H<sub>2</sub> receptor antagonist. From this lead, the receptor model was further refined and eventually led to the development of burimamide, the first H<sub>2</sub> receptor antagonist. Burimamide, a specific competitive antagonist at the H<sub>2</sub> receptor, 100 times more potent than N<sup>α</sup>-guanylhistamine, proved the existence of the H<sub>2</sub> receptor.\n\nBurimamide was still insufficiently potent for oral administration, and further modification of the structure, based on modifying the pKa of the compound, led to the development of metiamide. Metiamide was an effective"},"commercial":{"launchDate":"1977","_launchSource":"DrugCentral (FDA 1977-08-16, )"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/645","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=CIMETIDINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CIMETIDINE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Cimetidine","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T10:01:35.989603","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:24:41.638134+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"ranitidine","drugSlug":"ranitidine","fdaApproval":"1977-08-29","genericCount":44,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"famotidine","drugSlug":"famotidine","fdaApproval":"1986-10-15","genericCount":54,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"nizatidine","drugSlug":"nizatidine","fdaApproval":"1988-04-12","genericCount":9,"patentStatus":"Off-patent — generic available","relationship":"same-class"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"cimetidine","indications":{"approved":[{"name":"Duodenal ulcer disease","source":"DrugCentral","snomedId":51868009,"regulator":"FDA"},{"name":"Gastric ulcer","source":"DrugCentral","snomedId":397825006,"regulator":"FDA"},{"name":"Gastroesophageal reflux disease","source":"DrugCentral","snomedId":235595009,"regulator":"FDA"},{"name":"Heartburn","source":"DrugCentral","snomedId":16331000,"regulator":"FDA","eligibility":"Adults and children 12 years and older","globalPrevalence":320000000,"prevalenceMethod":"ai-extracted","prevalenceSource":"BMC Pregnancy Childbirth, 2025 (PMID:41366751)"},{"name":"Indigestion","source":"DrugCentral","snomedId":162031009,"regulator":"FDA","eligibility":"Adults and children 12 years and older"},{"name":"Maintenance of Healing Duodenal Ulcer","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":null},{"name":"Multiple endocrine adenomas","source":"DrugCentral","snomedId":60549007,"regulator":"FDA"},{"name":"Systemic mast cell disease","source":"DrugCentral","snomedId":397016004,"regulator":"FDA"},{"name":"Upper GI Bleed Prevention","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":null},{"name":"Upper gastrointestinal hemorrhage","source":"DrugCentral","snomedId":37372002,"regulator":"FDA"},{"name":"Zollinger-Ellison syndrome","source":"DrugCentral","snomedId":53132006,"regulator":"FDA"}],"offLabel":[{"name":"NSAID-Induced Gastric Ulcer","source":"DrugCentral","drugName":"CIMETIDINE","evidenceCount":20,"evidenceLevel":"moderate"},{"name":"Pancreatic insufficiency","source":"DrugCentral","drugName":"CIMETIDINE","evidenceCount":45,"evidenceLevel":"moderate"},{"name":"Prevention of Stress Ulcer","source":"DrugCentral","drugName":"CIMETIDINE","evidenceCount":316,"evidenceLevel":"strong"},{"name":"Urticaria","source":"DrugCentral","drugName":"CIMETIDINE","evidenceCount":117,"evidenceLevel":"strong"}],"pipeline":[]},"currentOwner":"Glaxosmithkline","drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"ranitidine","brandName":"ranitidine","genericName":"ranitidine","approvalYear":"1977","relationship":"same-class"},{"drugId":"famotidine","brandName":"famotidine","genericName":"famotidine","approvalYear":"1986","relationship":"same-class"},{"drugId":"nizatidine","brandName":"nizatidine","genericName":"nizatidine","approvalYear":"1988","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT07485829","phase":"","title":"Zimmer Biomet-RibFix Titan","status":"RECRUITING","sponsor":"Zimmer Biomet","startDate":"2026-03","conditions":["Rib Fracture","Rib Fracture Multiple"],"enrollment":54,"completionDate":"2028-03"},{"nctId":"NCT05164081","phase":"PHASE3","title":"Dual vs. Single-Antibiotic Impregnated Cement in Hemiarthroplasty for Femoral Neck Fracture","status":"ACTIVE_NOT_RECRUITING","sponsor":"Umeå University","startDate":"2022-01-01","conditions":["Femoral Neck Fractures","Prosthetic Infection"],"enrollment":7000,"completionDate":"2027-01-31"},{"nctId":"NCT07009912","phase":"NA","title":"ROSA® Knee System V1.5 Pilot Study","status":"COMPLETED","sponsor":"Zimmer Biomet","startDate":"2025-02-25","conditions":["Knee Arthroplasty, Total","Robotic Surgical Procedures","Joint Diseases","Knee Osteoarthritis"],"enrollment":40,"completionDate":"2026-02-17"},{"nctId":"NCT01750606","phase":"","title":"An MRI Investigation of Soft Tissues in Total Hip Arthroplasty","status":"COMPLETED","sponsor":"Zimmer Biomet","startDate":"2012-10","conditions":["Tissue Reaction","Elevated Blood Ion Levels"],"enrollment":397,"completionDate":"2016-09"},{"nctId":"NCT05701059","phase":"","title":"Comparison of Artificial Disc Implants in Cervical Disc Arthroplasty","status":"RECRUITING","sponsor":"University of California, Los Angeles","startDate":"2023-05-01","conditions":["Cervical Spondylosis With Myelopathy","Cervical Radiculopathy","Cervical Disc Herniation","Degenerative Disc Disease"],"enrollment":20,"completionDate":"2026-12-01"},{"nctId":"NCT05020184","phase":"PHASE2","title":"Effect of Oral Cimetidine in the Protoporphyrias","status":"COMPLETED","sponsor":"Amy K. Dickey, M.D.","startDate":"2022-06-14","conditions":["Erythropoietic Protoporphyria","X-linked Protoporphyria"],"enrollment":26,"completionDate":"2025-04-24"},{"nctId":"NCT05789784","phase":"NA","title":"Study of Zimmer Biomet Mymobility Application on Reverse Total Shoulder Arthroplasty (RTSA) Outcomes","status":"ENROLLING_BY_INVITATION","sponsor":"Campbell Clinic","startDate":"2023-10-31","conditions":["Reverse Total Shoulder Arthroplasty","Physical Therapy"],"enrollment":100,"completionDate":"2027-03-31"},{"nctId":"NCT03495232","phase":"","title":"Persona Cohort Nordic Multicenter Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"Zimmer Biomet","startDate":"2016-11-01","conditions":["Knee Arthropathy"],"enrollment":700,"completionDate":"2032-12-31"},{"nctId":"NCT05357378","phase":"NA","title":"Safety and Effectiveness of the HIT Reverse HRS","status":"RECRUITING","sponsor":"Hip Innovation Technology","startDate":"2022-07-15","conditions":["Degenerative Joint Disease","Osteoarthritis, Hip","Avascular Necrosis of Hip","Traumatic Arthropathy-Hip"],"enrollment":288,"completionDate":"2035-07-15"},{"nctId":"NCT06920459","phase":"","title":"Zimmer Biomet Shoulder Arthroplasty PMCF Study","status":"RECRUITING","sponsor":"Zimmer Biomet","startDate":"2025-04-29","conditions":["Shoulder Fractures","Shoulder Arthritis Osteoarthritis","Shoulder Injury","Shoulder Pain","Degenerative Joint Disease","Arthritis Shoulder"],"enrollment":40,"completionDate":"2036-12-31"},{"nctId":"NCT06699134","phase":"","title":"Hi-Fatigue G Bone Cement Retrospective Study","status":"RECRUITING","sponsor":"Zimmer Biomet","startDate":"2024-11-19","conditions":["Total Hip and Knee Arthroplasties"],"enrollment":90,"completionDate":"2026-10"},{"nctId":"NCT02494544","phase":"NA","title":"A Multicenter Study to Evaluate Functional Outcome After Knee Replacement","status":"TERMINATED","sponsor":"Restor3D","startDate":"2015-07-01","conditions":["Osteoarthritis"],"enrollment":215,"completionDate":"2022-11-16"},{"nctId":"NCT03404778","phase":"","title":"Comprehensive Reverse Shoulder Data Collection","status":"ENROLLING_BY_INVITATION","sponsor":"Zimmer Biomet","startDate":"2010-03-07","conditions":["Arthropathy of Shoulder Region","Grossly Deficient Rotator Cuff","Osteoarthritis of the Shoulder","Rheumatoid Arthritis Without Humeral Metaphyseal Defects","Post-Traumatic Arthitis"],"enrollment":175,"completionDate":"2036-12"},{"nctId":"NCT03409718","phase":"","title":"Database Retrieval for the Comprehensive Shoulder","status":"ACTIVE_NOT_RECRUITING","sponsor":"Zimmer Biomet","startDate":"2011-02-24","conditions":["Osteoarthritis of the Shoulder","Avascular Necrosis","Rheumatoid Arthritis","Prior Failed Revision","Correction of Functional Deformity","Fracture of Proximal End of Humerus","Cuff Tear Arthropathy"],"enrollment":160,"completionDate":"2026-12"},{"nctId":"NCT04002518","phase":"","title":"MDR - Biomet Cannulated Screws","status":"ACTIVE_NOT_RECRUITING","sponsor":"Zimmer Biomet","startDate":"2019-08-07","conditions":["Fractures, Bone","Fracture Multiple"],"enrollment":51,"completionDate":"2026-12"},{"nctId":"NCT04984291","phase":"NA","title":"Zimmer Biomet Shoulder Arthroplasty PMCF","status":"RECRUITING","sponsor":"Zimmer Biomet","startDate":"2021-07-28","conditions":["Shoulder Fractures","Shoulder Arthritis","Shoulder Osteoarthritis","Shoulder Deformity","Shoulder Injuries","Shoulder Pain"],"enrollment":584,"completionDate":"2033-08-15"},{"nctId":"NCT04817969","phase":"NA","title":"Persona Ti-Nidium Post-Market Clinical Follow-up","status":"ACTIVE_NOT_RECRUITING","sponsor":"Zimmer Biomet","startDate":"2021-06-01","conditions":["Knee Pain Chronic","Osteoarthritis","Rheumatoid Arthritis","Traumatic Arthritis","Polyarthritis","Varus Deformity","Valgus Deformity","Flexion Deformity of the Knee","Avascular Necrosis","Patellofemoral Osteoarthritis"],"enrollment":240,"completionDate":"2034-05"},{"nctId":"NCT03712527","phase":"NA","title":"Intra-discal Injection of PRP for Low Back Pain","status":"ACTIVE_NOT_RECRUITING","sponsor":"University Hospital, Montpellier","startDate":"2018-11-15","conditions":["Chronic Low Back Pain"],"enrollment":126,"completionDate":"2026-04-15"},{"nctId":"NCT04862585","phase":"PHASE2,PHASE3","title":"Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel","status":"COMPLETED","sponsor":"Ohio State University Comprehensive Cancer Center","startDate":"2021-10-07","conditions":["Anatomic Stage 0 Breast Cancer AJCC v8","Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage IA Breast Cancer AJCC v8","Anatomic Stage IB Breast Cancer AJCC v8","Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage IIA Breast Cancer AJCC v8","Anatomic Stage IIB Breast Cancer AJCC v8","Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IIIA Breast Cancer AJCC v8","Anatomic Stage IIIB Breast Cancer AJCC v8","Anatomic Stage IIIC Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Breast Carcinoma","Prognostic Stage 0 Breast Cancer AJCC v8","Prognostic Stage I Breast Cancer AJCC v8","Prognostic Stage IA Breast Cancer AJCC v8","Prognostic Stage IB Breast Cancer AJCC v8","Prognostic Stage II Breast Cancer AJCC v8","Prognostic Stage IIA Breast Cancer AJCC v8","Prognostic Stage IIB Breast Cancer AJCC v8","Prognostic Stage III Breast Cancer AJCC v8","Prognostic Stage IIIA Breast Cancer AJCC v8","Prognostic Stage IIIB Breast Cancer AJCC v8","Prognostic Stage IIIC Breast Cancer AJCC v8","Prognostic Stage IV Breast Cancer AJCC v8"],"enrollment":130,"completionDate":"2024-06-21"},{"nctId":"NCT06971497","phase":"","title":"Zimmer ActivBraid Rotator Cuff Repair (RCR) Study","status":"RECRUITING","sponsor":"The Cleveland Clinic","startDate":"2025-08-11","conditions":["Rotator Cuff Repair of the Shoulder"],"enrollment":65,"completionDate":"2029-08"},{"nctId":"NCT05365451","phase":"EARLY_PHASE1","title":"Pharmacokinetic Drug-Drug Interaction Study to Identify Biomarkers of Kidney Transporters","status":"COMPLETED","sponsor":"Washington State University","startDate":"2022-04-11","conditions":["Interaction","Endogenous Biomarkers"],"enrollment":16,"completionDate":"2023-07-22"},{"nctId":"NCT05391828","phase":"NA","title":"Persona MC vs PS RCT With ROSA","status":"RECRUITING","sponsor":"NYU Langone Health","startDate":"2023-09-27","conditions":["Total Knee Arthroplasty"],"enrollment":200,"completionDate":"2026-12"},{"nctId":"NCT03506334","phase":"NA","title":"Anterior Vertebral Body Tethering (AVBT) Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis","status":"ENROLLING_BY_INVITATION","sponsor":"Mayo Clinic","startDate":"2018-04-25","conditions":["Scoliosis"],"enrollment":80,"completionDate":"2026-05"},{"nctId":"NCT06388993","phase":"NA","title":"Marrow Cellution™ vs. Traditional BMA Harvest Project","status":"RECRUITING","sponsor":"Ohio State University","startDate":"2024-03-25","conditions":["Hip Arthropathy","Avascular Necrosis of Bone","Subchondral Cysts"],"enrollment":6,"completionDate":"2026-03-31"},{"nctId":"NCT02430129","phase":"NA","title":"Unicondylar Knee Arthroplasty Versus Total Knee Arthroplasty in Patients With Anteromedial Osteoarthritis of the Knee","status":"COMPLETED","sponsor":"Alberta Hip and Knee Clinic","startDate":"2016-02","conditions":["Osteoarthritis"],"enrollment":38,"completionDate":"2021-12"},{"nctId":"NCT06858358","phase":"NA","title":"Robotic Medial Congruent Vs. Conventional Medial Pivot TKA","status":"RECRUITING","sponsor":"George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures","startDate":"2025-02-24","conditions":["Knee Osteoarthristis"],"enrollment":300,"completionDate":"2026-09"},{"nctId":"NCT00521846","phase":"","title":"ExploR™ Modular Radial Head Data Collection","status":"ACTIVE_NOT_RECRUITING","sponsor":"Vanderbilt University Medical Center","startDate":"2007-08","conditions":["Elbow Fracture"],"enrollment":50,"completionDate":"2025-08"},{"nctId":"NCT06803576","phase":"","title":"Clinical and Microbiological Outcomes of Dental Implants After 10-22 Years of Function","status":"ENROLLING_BY_INVITATION","sponsor":"Aristotle University Of Thessaloniki","startDate":"2025-01-01","conditions":["Pocket Depth","Attachment Loss","Bone Loss in Jaw"],"enrollment":100,"completionDate":"2025-05-30"},{"nctId":"NCT03073941","phase":"NA","title":"A Multicenter Prospective Randomized Control Study on Persona Total Knee System vs NexGen","status":"ACTIVE_NOT_RECRUITING","sponsor":"Zimmer Biomet","startDate":"2016-12","conditions":["Osteoarthritis, Knee"],"enrollment":332,"completionDate":"2031-12-31"},{"nctId":"NCT06720012","phase":"NA","title":"Does the Use of Patient Specific Instrumentation Improve Outcomes in Knee Arthroplasty Surgery for Osteoarthritis When Compared to Standard Posterior Referenced Instrumentation?","status":"ACTIVE_NOT_RECRUITING","sponsor":"Vastra Gotaland Region","startDate":"2014-03-03","conditions":["Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery","Osteoarthritis (OA) of the Knee"],"enrollment":70,"completionDate":"2024-12"},{"nctId":"NCT04834752","phase":"","title":"Effect of H2 Receptor Antagonist and Proton Pump Inhibitor on the Positivity Rates and Clinical Outcomes of COVID-19","status":"COMPLETED","sponsor":"Seoul National University Hospital","startDate":"2021-05-01","conditions":["COVID-19"],"enrollment":400000,"completionDate":"2021-12-31"},{"nctId":"NCT05391451","phase":"NA","title":"New Approach of Loco Regional Analgesia in Kidney Transplant","status":"COMPLETED","sponsor":"CHU de Reims","startDate":"2021-08-31","conditions":["Chronic Kidney Diseases"],"enrollment":48,"completionDate":"2022-10-23"},{"nctId":"NCT06107829","phase":"PHASE4","title":"Valbenazine Treatment of Tardive Dyskinesia in Adults With Intellectual/Developmental Disabilities","status":"WITHDRAWN","sponsor":"Stephen Ruedrich","startDate":"2025-01","conditions":["Tardive Dyskinesia","Intellectual Disability","Developmental Disabilities"],"enrollment":0,"completionDate":"2027-02"},{"nctId":"NCT05935878","phase":"NA","title":"Cemented Versus Cementless Unicompartmental Knee Arthroplasty","status":"COMPLETED","sponsor":"Oxford University Hospitals NHS Trust","startDate":"2002-11-08","conditions":["Osteoarthritis, Knee"],"enrollment":47,"completionDate":"2022-03-11"},{"nctId":"NCT05629715","phase":"NA","title":"Conventional Instrumentation, Computer Navigation, and Robotic Assistance Techniques in TKA","status":"WITHDRAWN","sponsor":"University of California, Los Angeles","startDate":"2025-06-01","conditions":["Knee Osteoarthritis"],"enrollment":0,"completionDate":"2027-06-30"},{"nctId":"NCT06056583","phase":"PHASE4","title":"Drug Excretion in Breast Milk","status":"RECRUITING","sponsor":"University of Washington","startDate":"2023-12-04","conditions":["Postpartum","Lactation","Drugs in Breast Milk","Mammary Drug Transporters","BCRP","OCT1"],"enrollment":50,"completionDate":"2028-09-30"},{"nctId":"NCT05685693","phase":"NA","title":"ROSA Knee System vs Conventional Total Knee Arthroplasty","status":"ACTIVE_NOT_RECRUITING","sponsor":"Zuyderland Medisch Centrum","startDate":"2022-12-16","conditions":["Knee Osteoarthritis"],"enrollment":150,"completionDate":"2035-12"},{"nctId":"NCT03681977","phase":"NA","title":"Clinical Outcomes of MP Persona vs. Persona Knee-PS","status":"ENROLLING_BY_INVITATION","sponsor":"Lady Davis Institute","startDate":"2019-09-01","conditions":["Osteoarthritis, Knee"],"enrollment":162,"completionDate":"2026-06-30"},{"nctId":"NCT00762944","phase":"","title":"Total Temporomandibular Joint Replacement System Post Approval Study","status":"COMPLETED","sponsor":"Zimmer Biomet","startDate":"2005-09-21","conditions":["Arthroplasty"],"enrollment":93,"completionDate":"2008-09-21"},{"nctId":"NCT05461313","phase":"NA","title":"Fully Constrained Acetabular Liner vs. Dual Mobility Hip Joint in the Surgical Treatment of Metastatic Bone Disease of the Hip","status":"RECRUITING","sponsor":"Rigshospitalet, Denmark","startDate":"2022-09-20","conditions":["Metastatic Cancer to the Hip"],"enrollment":146,"completionDate":"2026-07-31"},{"nctId":"NCT04868305","phase":"NA","title":"Intramedullary Nail Versus Hip Arthroplasty in Unstable Trochanteric Hip Fractures","status":"UNKNOWN","sponsor":"Helse Stavanger HF","startDate":"2021-10-12","conditions":["Hip Injuries and Disorders","Hip Fractures"],"enrollment":170,"completionDate":"2025-12-31"},{"nctId":"NCT02965690","phase":"NA","title":"Kinematics of Contemporary Knee Arthroplasty","status":"UNKNOWN","sponsor":"Oslo University Hospital","startDate":"2016-11","conditions":["Knee Osteoarthritis"],"enrollment":26,"completionDate":"2025-12"},{"nctId":"NCT05179005","phase":"","title":"RibFix Advantage™ Post-Market Follow-Up","status":"TERMINATED","sponsor":"Zimmer Biomet","startDate":"2023-04-20","conditions":["Rib Fractures"],"enrollment":1,"completionDate":"2023-12-31"},{"nctId":"NCT04931056","phase":"","title":"A Post Market Clinical Follow-up Study on Biomet Microfixation HTR PEKK (Midface), Facial & Mandibular Plates.","status":"COMPLETED","sponsor":"Zimmer Biomet","startDate":"2021-10-01","conditions":["Tumor","Facial Fracture","Mandibular Fractures","Fibrous Dysplasia","Osteoma of Mandibular Condyle","Neuroma","Cleft Face","Hemifacial Microsomia","Treacher Collins Syndrome","Miller Syndrome","Nager Syndrome"],"enrollment":91,"completionDate":"2023-11-30"},{"nctId":"NCT05881811","phase":"PHASE1","title":"The Drug-drug Interaction of HSK16149 Capsule With Probenecid Tablets or Cimetidine Tablets in Healthy Subjects","status":"COMPLETED","sponsor":"Haisco Pharmaceutical Group Co., Ltd.","startDate":"2023-03-20","conditions":["PHN - Post-Herpetic Neuritis"],"enrollment":47,"completionDate":"2023-06-05"},{"nctId":"NCT04778709","phase":"NA","title":"Bone Graft Particle Size on Bone Vitality and Volume","status":"TERMINATED","sponsor":"NYU College of Dentistry","startDate":"2020-11-13","conditions":["Bilateral Sinus Pneumatization","Posterior Maxillary Ridge Atrophy Due to Extraction"],"enrollment":4,"completionDate":"2022-02-01"},{"nctId":"NCT02311179","phase":"NA","title":"The Effect of Implant Coating (BoneMaster) on Migration and Clinical Outcome in Hip Arthroplasty With the Exceed Cup","status":"UNKNOWN","sponsor":"University of Aarhus","startDate":"2013-01","conditions":["Osteoarthritis"],"enrollment":56,"completionDate":"2024-08"},{"nctId":"NCT00679120","phase":"NA","title":"Oxford Partial Knee Replacement. A Randomized Clinical Trial of Three Implant Types","status":"UNKNOWN","sponsor":"University of Aarhus","startDate":"2009-05","conditions":["Osteoarthritis, Knee"],"enrollment":75,"completionDate":"2024-08"},{"nctId":"NCT05673590","phase":"PHASE3","title":"Utidelone Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer","status":"UNKNOWN","sponsor":"Beijing Biostar Pharmaceuticals Co., Ltd.","startDate":"2023-05-12","conditions":["Locally Advanced or Metastatic Non-Small Cell Lung Cancer"],"enrollment":612,"completionDate":"2025-12-31"},{"nctId":"NCT03307252","phase":"PHASE1","title":"This Study Tests the Effect of Certain Medicines on the Transport of Other Medicines in the Body of Healthy Men","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2017-10-25","conditions":["Healthy"],"enrollment":45,"completionDate":"2018-05-02"},{"nctId":"NCT04350827","phase":"NA","title":"PRP vs PRP Plus IGF for Patellar Tendinosis","status":"COMPLETED","sponsor":"Ohio State University","startDate":"2020-02-25","conditions":["Tendinopathy","Patellar Ligament","Platelet-Rich Plasma"],"enrollment":14,"completionDate":"2021-10-16"},{"nctId":"NCT03580772","phase":"","title":"Persona MC vs Attune Total Knee Replacement Study","status":"TERMINATED","sponsor":"University of Leeds","startDate":"2018-11-26","conditions":["Knee Osteoarthritis"],"enrollment":31,"completionDate":"2022-05-04"},{"nctId":"NCT06027710","phase":"","title":"Allograft Ridge Augmentation: 3D Analysis of CAD/CAM Custom Milled and Prefabricated Conventional Allogeneic Bone Blocks and Dental Implant Follow-up","status":"UNKNOWN","sponsor":"University of Santiago de Compostela","startDate":"2023-01-21","conditions":["Alveolar Ridge Augmentation"],"enrollment":20,"completionDate":"2023-09-01"},{"nctId":"NCT06011122","phase":"","title":"Analysis of Implant Placement in Patients With Distal Radius Fractures in Western Brittany (REDIRA)","status":"COMPLETED","sponsor":"University Hospital, Brest","startDate":"2022-03-01","conditions":["Distal Radius Fracture"],"enrollment":2723,"completionDate":"2022-04-04"},{"nctId":"NCT05922358","phase":"PHASE2","title":"Phase II Study of Reuse of Oxaliplatin Hypersensitivity in Gastrointestinal Tumors","status":"NOT_YET_RECRUITING","sponsor":"Fujian Cancer Hospital","startDate":"2023-09-01","conditions":["Gastrointestinal Tumors"],"enrollment":500,"completionDate":"2026-09-01"},{"nctId":"NCT05866510","phase":"PHASE2","title":"Utidelone and Anlotinib in Advanced Recurrent Metastatic Esophageal Cancer","status":"UNKNOWN","sponsor":"Peking University","startDate":"2023-05-15","conditions":["Esophageal Cancer"],"enrollment":47,"completionDate":"2024-04-30"},{"nctId":"NCT02285127","phase":"NA","title":"Short Versus Long Cephalomedullary Nailing of Pertrochanteric Hip Fractures: A Randomized Prospective Study","status":"COMPLETED","sponsor":"Mayo Clinic","startDate":"2014-11","conditions":["Pertrochanteric Hip Fracture"],"enrollment":168,"completionDate":"2019-09"},{"nctId":"NCT04585022","phase":"NA","title":"Whole Blood Metal Ion Concentrations in Metal-on-metal Total Hip Arthroplasty and Hip Resurfacing","status":"TERMINATED","sponsor":"Hvidovre University Hospital","startDate":"2006-11-01","conditions":["Osteoarthritis, Hip"],"enrollment":75,"completionDate":"2017-01-11"},{"nctId":"NCT00175136","phase":"NA","title":"A Comparison of the Design of Tibia Stems in Cemented Total Knee Arthroplasty - Wedge Stem Versus I-beam Stem.","status":"COMPLETED","sponsor":"University of Aarhus","startDate":"2005-01","conditions":["Osteoarthritis"],"enrollment":54,"completionDate":"2009-10"},{"nctId":"NCT03877315","phase":"NA","title":"Patient Reported Outcome After Stemmed Versus Stemless Total Shoulder Arthroplasty for Glenohumeral Osteoarthritis.","status":"UNKNOWN","sponsor":"Zealand University Hospital","startDate":"2019-08-01","conditions":["Shoulder Pain","Shoulder Osteoarthritis","Shoulder Arthritis"],"enrollment":78,"completionDate":"2023-08-01"},{"nctId":"NCT03541408","phase":"NA","title":"Preventative Delirium Protocol in Elderly Patients","status":"COMPLETED","sponsor":"Rush University Medical Center","startDate":"2016-05-01","conditions":["Delirium"],"enrollment":263,"completionDate":"2021-04-01"},{"nctId":"NCT03380455","phase":"PHASE1","title":"Effect of Cimetidine on the Pharmacokinetics of Lucerastat in Healthy Subjects","status":"COMPLETED","sponsor":"Idorsia Pharmaceuticals Ltd.","startDate":"2018-01-09","conditions":["Healthy Subjects"],"enrollment":14,"completionDate":"2018-01-29"},{"nctId":"NCT04275362","phase":"","title":"Gait Analysis of a Lateral-Pivot Design Total Knee Replacement","status":"RECRUITING","sponsor":"More Foundation","startDate":"2017-02-02","conditions":["Knee Osteoarthritis"],"enrollment":102,"completionDate":"2029-01-02"},{"nctId":"NCT05365022","phase":"NA","title":"Clinical and Radiological Results in Robotic Assisted Knee Prosthetic Surgery With ROSA® Knee System","status":"UNKNOWN","sponsor":"Borja Alcobía-Díaz MD, PhD","startDate":"2021-02-10","conditions":["Knee Prosthetic Surgery","Robotic Assistance"],"enrollment":144,"completionDate":"2022-09"},{"nctId":"NCT04279925","phase":"NA","title":"A Clinical Trial of Locally Made Titanium Miniplate and Screw in Maxillofacial Fractures Management","status":"TERMINATED","sponsor":"Indonesia University","startDate":"2020-03-11","conditions":["Maxillofacial Injuries","Maxillofacial Prosthesis Implantation","Fracture Fixation, Internal"],"enrollment":9,"completionDate":"2020-05-31"},{"nctId":"NCT02161874","phase":"NA","title":"Evaluation of Integration Success and Crestal Bone Preservation Biomet 3i's T3 Implant System","status":"COMPLETED","sponsor":"ZimVie","startDate":"2013-04","conditions":["Partial Edentulism","Tooth Disease"],"enrollment":40,"completionDate":"2020-07"},{"nctId":"NCT03568123","phase":"NA","title":"A Comparison of the Persona Total Knee Arthroplasty System Using CR or MC Polyethylene","status":"COMPLETED","sponsor":"Anders Troelsen","startDate":"2017-07-05","conditions":["Knee Osteoarthritis"],"enrollment":60,"completionDate":"2021-10-14"},{"nctId":"NCT04493931","phase":"PHASE1","title":"Drug-drug Interaction Study of Gepotidacin","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2020-08-14","conditions":["Infections, Bacterial"],"enrollment":64,"completionDate":"2020-12-21"},{"nctId":"NCT05225753","phase":"","title":"Post-operative Anemia in Lateral Fractures of the Femur.","status":"COMPLETED","sponsor":"Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari","startDate":"2020-11-01","conditions":["Femur Fracture"],"enrollment":45,"completionDate":"2021-09-01"},{"nctId":"NCT03465280","phase":"","title":"Airway Intervention Registry (AIR): Recurrent Respiratory Papillomatosis (RRP)","status":"UNKNOWN","sponsor":"Newcastle-upon-Tyne Hospitals NHS Trust","startDate":"2018-04-01","conditions":["Recurrent Respiratory Papillomatosis","Human Papilloma Virus"],"enrollment":400,"completionDate":"2022-08-31"},{"nctId":"NCT02287272","phase":"PHASE1","title":"Drug-drug Interaction Study of CHF5993 With Cimetidine","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2014-05","conditions":["COPD"],"enrollment":25,"completionDate":"2014-09"},{"nctId":"NCT04103515","phase":"","title":"Knee Kinematics for Subjects With Zimmer-Biomet Posterior Cruciate Retaining or Posterior Stabilizing Total Knee Arthroplasty","status":"COMPLETED","sponsor":"The University of Tennessee, Knoxville","startDate":"2019-01-03","conditions":["Arthroplasty, Replacement, Knee","Osteoarthritis, Knee"],"enrollment":50,"completionDate":"2020-11-06"},{"nctId":"NCT05045651","phase":"NA","title":"Anterior Knee Pain Between Unisex Knee Prosthesis VS Gender Specific Knee Prosthesis Following MIS TKA","status":"COMPLETED","sponsor":"Thammasat University","startDate":"2014-08-01","conditions":["Osteo Arthritis Knee","Knee Pain Chronic"],"enrollment":80,"completionDate":"2018-12-01"},{"nctId":"NCT05038670","phase":"NA","title":"Journey II vs Persona Knee Systems - RCT","status":"COMPLETED","sponsor":"Medical University of Warsaw","startDate":"2018-10-01","conditions":["Knee Osteoarthritis"],"enrollment":45,"completionDate":"2020-11-24"},{"nctId":"NCT04164147","phase":"NA","title":"Persona MC Retained PCL vs. Persona Posterior-stabilized vs. NexGen PS","status":"UNKNOWN","sponsor":"Medical University of Warsaw","startDate":"2020-07-01","conditions":["Knee Osteoarthritis","Knee Arthritis","Joint; Arthrosis, Primary"],"enrollment":100,"completionDate":"2022-12-31"},{"nctId":"NCT04913987","phase":"NA","title":"Persona Partial Knee Study","status":"UNKNOWN","sponsor":"Golden Jubilee National Hospital","startDate":"2021-04-26","conditions":["Arthroplasty, Replacement, Knee"],"enrollment":50,"completionDate":"2025-04"},{"nctId":"NCT03201796","phase":"PHASE2","title":"Prulifloxacin in Chronic Bacterial Prostatitis (CBP)","status":"COMPLETED","sponsor":"Aziende Chimiche Riunite Angelini Francesco S.p.A","startDate":"2016-02-02","conditions":["Chronic Bacterial Prostatitis"],"enrollment":168,"completionDate":"2020-05-19"},{"nctId":"NCT03167788","phase":"PHASE2","title":"Red Cell Rejuvenation for the Attenuation of Transfusion Associated Organ Injury in Cardiac Surgery","status":"WITHDRAWN","sponsor":"University of Leicester","startDate":"2020-12","conditions":["Organ Failure, Multiple","Inflammation","Sepsis"],"enrollment":0,"completionDate":"2020-12"},{"nctId":"NCT04643119","phase":"NA","title":"A Comparison of Total Knee Replacement Patients Using the Zimmer-Biomet Persona Total Knee System With Different Inserts","status":"UNKNOWN","sponsor":"Singapore General Hospital","startDate":"2021-04-26","conditions":["Osteoarthritis, Knee","Knee Osteoarthritis"],"enrollment":120,"completionDate":"2023-08-01"},{"nctId":"NCT01010698","phase":"PHASE1","title":"Class 3 Biowaivers","status":"COMPLETED","sponsor":"University of Maryland, Baltimore","startDate":"2009-06","conditions":["Healthy"],"enrollment":48,"completionDate":"2012-12"},{"nctId":"NCT01373099","phase":"NA","title":"Study of Antibiotic Spacer Design to Treat Infection After Hip Replacement","status":"COMPLETED","sponsor":"Rush University Medical Center","startDate":"2011-08","conditions":["Osteoarthritis","Hip Infection","Prosthetic Joint Infection","Complications; Arthroplasty, Infection or Inflammation","Complications; Arthroplasty"],"enrollment":80,"completionDate":"2020-08"},{"nctId":"NCT02481427","phase":"NA","title":"Finnish Unicompartmental and Total Knee Arthroplasty Investigation","status":"ACTIVE_NOT_RECRUITING","sponsor":"Turku University Hospital","startDate":"2015-09","conditions":["Osteoarthritis, Knee"],"enrollment":140,"completionDate":"2027-08"},{"nctId":"NCT01373112","phase":"NA","title":"Articulating Versus Static Antibiotic Loaded Spacers for the Treatment of Prosthetic Knee Infection","status":"COMPLETED","sponsor":"Rush University Medical Center","startDate":"2011-12","conditions":["Osteoarthritis","Knee Infection","Prosthetic Joint Infection","Complications; Arthroplasty, Infection or Inflammation","Complications; Arthroplasty"],"enrollment":68,"completionDate":"2020-08"},{"nctId":"NCT04524312","phase":"NA","title":"Dynamic Congruence Total Knee Replacement vs Posterior-stabilized","status":"COMPLETED","sponsor":"Medical University of Warsaw","startDate":"2017-12-01","conditions":["Osteo Arthritis Knee","Surgery","Joint Diseases"],"enrollment":56,"completionDate":"2020-09-26"},{"nctId":"NCT04280185","phase":"NA","title":"HIPEC in the Treatment of Stage IIc-IV Epithelial Ovarian Cancer After CRS (HIPECOC)","status":"UNKNOWN","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2020-06-01","conditions":["Ovarian Cancer","Hyperthermic Intraperitoneal Chemotherapy"],"enrollment":202,"completionDate":"2024-05-01"},{"nctId":"NCT04332679","phase":"NA","title":"Non-resorbable Membranes Versus Titanium Meshes and Resorbable Membranes","status":"COMPLETED","sponsor":"GBR Academy","startDate":"2013-09-01","conditions":["Surgical Procedure, Unspecified","Soft Tissue Infections","Bone Density","Bone Loss","Dental Implant"],"enrollment":40,"completionDate":"2019-09-01"},{"nctId":"NCT03699046","phase":"NA","title":"Evaluating the Effectiveness of Subchondroplasty for Treating Bone Marrow Lesions of the Knee","status":"UNKNOWN","sponsor":"University of Calgary","startDate":"2018-10-18","conditions":["Osteoarthritis, Knee","Arthroscopy","Musculoskeletal Disease","Bone Marrow Edema","Subchondral Bone Edema","Knee Osteoarthritis"],"enrollment":18,"completionDate":"2021-05-01"},{"nctId":"NCT02865590","phase":"NA","title":"Clinical and Histological Evaluation of Deproteinizated Bovine Bone Allograft and Lyophilized Equine Bone Allograft for Sinus Lift.","status":"COMPLETED","sponsor":"University of L'Aquila","startDate":"2011-06","conditions":["Maxillary Sinus Floor Augmentation"],"enrollment":16,"completionDate":"2015-10"},{"nctId":"NCT04310852","phase":"","title":"Knee Osteoarthritis Treatment With Percutaneous Injections of Autologous Bone Marrow Concentrate","status":"UNKNOWN","sponsor":"Istituto Clinico Humanitas","startDate":"2018-06-06","conditions":["Knee Osteoarthritis","Cartilage Degeneration"],"enrollment":25,"completionDate":"2022-01-31"},{"nctId":"NCT00758719","phase":"","title":"Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System","status":"COMPLETED","sponsor":"Zimmer Biomet","startDate":"2008-09","conditions":["Degenerative Disc Disease"],"enrollment":53,"completionDate":"2012-08"},{"nctId":"NCT00726284","phase":"","title":"Spine Patient Outcomes Registry for Biomet/EBI (Electro-Biology, Inc)","status":"COMPLETED","sponsor":"Zimmer Biomet","startDate":"2004-04","conditions":["Degenerative Disc Disease","Spinal Stenosis"],"enrollment":651,"completionDate":"2007-12-06"},{"nctId":"NCT04229212","phase":"NA","title":"Effectiveness of Using Closed-suction Drainage in Treating Proximal Femur Fracture With Cephalomedullary Nail","status":"COMPLETED","sponsor":"National Cheng-Kung University Hospital","startDate":"2018-12-11","conditions":["Intertrochanteric Fractures"],"enrollment":60,"completionDate":"2019-12-31"},{"nctId":"NCT02930486","phase":"NA","title":"Ziptight or Tricortical Screw Fixation of Acute Tibiofibular Syndesmotic Injury","status":"COMPLETED","sponsor":"Vestre Viken Hospital Trust","startDate":"2016-01","conditions":["Ankle Fractures"],"enrollment":120,"completionDate":"2019-10"},{"nctId":"NCT01366378","phase":"PHASE1","title":"Effect of Cimetidine on the Single-Dose PK of IV- Administered MNTX","status":"COMPLETED","sponsor":"Bausch Health Americas, Inc.","startDate":"2007-01","conditions":["Healthy Adult Subjects"],"enrollment":18,"completionDate":"2007-02"},{"nctId":"NCT00045799","phase":"PHASE3","title":"Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill","status":"COMPLETED","sponsor":"Bausch Health Americas, Inc.","startDate":"2002-05","conditions":["Upper Gastrointestinal Bleeding"],"enrollment":354,"completionDate":"2003-05"},{"nctId":"NCT04018131","phase":"PHASE3","title":"The Efficacy of Cimetidin for Acute - Extrinsic Atopic Dermatitis Treated With Standard Therapy","status":"UNKNOWN","sponsor":"Fakultas Kedokteran Universitas Indonesia","startDate":"2018-03-26","conditions":["Atopic Dermatitis","Immunoglobulin E Concentration, Serum"],"enrollment":26,"completionDate":"2020-06-30"},{"nctId":"NCT04114201","phase":"NA","title":"Clinical Outcome and OR Resource Use of Total Knee Arthroplasty Using Patient-Specific or Conventional Instrumentation","status":"COMPLETED","sponsor":"Technische Universität Dresden","startDate":"2012-08-02","conditions":["Gonarthrosis"],"enrollment":139,"completionDate":"2017-02-23"},{"nctId":"NCT01256879","phase":"PHASE4","title":"Cimetidine Biowaivers","status":"COMPLETED","sponsor":"University of Maryland, Baltimore","startDate":"2011-03","conditions":["Healthy"],"enrollment":25,"completionDate":"2014-05"},{"nctId":"NCT02084693","phase":"","title":"COMPREHENSIVE® REVERSE SHOULDER Mini BasePlate","status":"COMPLETED","sponsor":"Zimmer Biomet","startDate":"2013-12","conditions":["Rotator Cuff Tear Arthropathy","Osteoporosis","Osteomalacia","Joint; Destruction, Sacroiliac"],"enrollment":100,"completionDate":"2019-06"},{"nctId":"NCT01264328","phase":"PHASE2","title":"Study of the Combination of Panitumumab With Paclitaxel as First-line Treatment of Subjects With Head and Neck Cancer","status":"COMPLETED","sponsor":"Grupo Español de Tratamiento de Tumores de Cabeza y Cuello","startDate":"2011-03-09","conditions":["Head and Neck Cancer"],"enrollment":40,"completionDate":"2014-09-29"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Oral","formulation":"Cream, Gel, Solution, Tablet","formulations":[{"form":"CREAM","route":"TOPICAL","productName":"CIMETIDINE 10% / LIDOCAINE 5% / SALICYLIC ACID 40%"},{"form":"GEL","route":"TOPICAL","productName":"CIMETIDINE 5% / IBUPROFEN 2% / SALICYLIC ACID 17%"},{"form":"SOLUTION","route":"ORAL","productName":"CIMETIDINE HYDROCHLORIDE"},{"form":"SOLUTION","route":"ORAL","productName":"Cimetidine"},{"form":"SOLUTION","route":"ORAL","productName":"Cimetidine Hydrochloride Oral Solution"},{"form":"TABLET","route":"ORAL","productName":"CIMETIDINE"},{"form":"TABLET","route":"ORAL","productName":"TAGAMET"},{"form":"TABLET","route":"ORAL","productName":"Tagamet"},{"form":"TABLET, FILM COATED","route":"ORAL","productName":"Acid Reducer"},{"form":"TABLET, FILM COATED","route":"ORAL","productName":"CIMETIDINE"},{"form":"TABLET, FILM COATED","route":"ORAL","productName":"Cimetidine"},{"form":"TABLET, FILM COATED","route":"ORAL","productName":"Equate Cimetidine"},{"form":"TABLET, FILM COATED","route":"ORAL","productName":"Good Neighbor Pharmacy Heartburn Relief"},{"form":"TABLET, FILM COATED","route":"ORAL","productName":"Good Sense Heartburn Relief"},{"form":"TABLET, FILM COATED","route":"ORAL","productName":"SunMark heartburn reliefacid reducer"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000147147","MMSL":"101","NDDF":"003415","UNII":"80061L1WGD","VUID":"4018845","CHEBI":"CHEBI:3699","VANDF":"4018844","INN_ID":"3765","RXNORM":"152402","UMLSCUI":"C0008783","chemblId":"CHEMBL1201051","ChEMBL_ID":"CHEMBL30","KEGG_DRUG":"D00295","DRUGBANK_ID":"DB00501","PUBCHEM_CID":"2756","SNOMEDCT_US":"373541007","IUPHAR_LIGAND_ID":"1231","SECONDARY_CAS_RN":"70059-30-2","MESH_DESCRIPTOR_UI":"D002927"},"formularyStatus":[],"_enricherVersion":"v2","_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[{"period":"present","companyName":"GSK","relationship":"Current Owner"}],"pharmacokinetics":{"source":"DrugCentral","halfLife":"2.2 hours","clearance":"8.1 mL/min/kg","bioavailability":"60%","fractionUnbound":"0.78%","volumeOfDistribution":"1.2 L/kg"},"publicationCount":10922,"therapeuticAreas":["Cardiovascular"],"atcClassification":{"source":"DrugCentral","atcCode":"A02BA01","allCodes":["A02BA01","A02BA51"]},"biosimilarFilings":[],"recentPublications":[{"date":"2026 Mar 24","pmid":"41876561","title":"Pseudomonas plecoglossicida disrupts intestinal homeostasis through manipulation of palmitoleic acid microbial metabolism.","journal":"NPJ biofilms and microbiomes"},{"date":"2026 Mar 13","pmid":"41824868","title":"Potentially inappropriate medication use in older adult patients living with cancer using the Beers, STOPP, GO-PIM and Chinese criteria: A retrospective cross-sectional study.","journal":"Medicine"},{"date":"2026 Mar 12","pmid":"41817965","title":"Toxicity profile of supratherapeutic loperamide: a systematic review and dose-response analysis.","journal":"Clinical toxicology (Philadelphia, Pa.)"},{"date":"2026 Mar 5","pmid":"41787256","title":"IL3RA identified as novel biomarker and therapeutic target for ER(+) breast cancer through plasma proteome-wide mendelian randomization and TCGA database analysis.","journal":"Clinical proteomics"},{"date":"2026 Feb 2","pmid":"41628910","title":"Unilateral Fractionated Thoracic Irradiation Induces Abscopal Injury in Contralateral Lung through NF-κB Pathway.","journal":"Radiation research"}],"companionDiagnostics":[],"genericManufacturers":19,"_genericFilersChecked":true,"genericManufacturerList":["Apotex","Aurobindo Pharma Ltd","Bionpharma","Chartwell Molecules","Chartwell Rx","Contract Pharmacal","Cycle","Hikma","Ivax Sub Teva Pharms","L Perrigo Co","Mylan","Novitium Pharma","Perrigo","Pliva","Sandoz","Teva","Upsher Smith Labs","Watson Labs Inc","Watson Labs Teva"],"status":"approved","companyName":"Glaxosmithkline","companyId":"","modality":"Small molecule","firstApprovalDate":"1977","enrichmentLevel":4,"visitCount":1,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1977-08-16T00:00:00.000Z","mah":"","brand_name_local":null,"application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1996-01-31T00:00:00.000Z","mah":"TEVA","brand_name_local":null,"application_number":"ANDA074463"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1996-01-31T00:00:00.000Z","mah":"TEVA","brand_name_local":null,"application_number":"ANDA074151"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2005-05-10T00:00:00.000Z","mah":"MEDTECH PRODUCTS","brand_name_local":null,"application_number":"NDA020238"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2014-01-07T00:00:00.000Z","mah":"MYLAN","brand_name_local":null,"application_number":"ANDA074246"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2024-11-12T00:00:00.000Z","mah":"AUROBINDO PHARMA LTD","brand_name_local":null,"application_number":"ANDA218997"},{"country_code":"IN","regulator":"CDSCO","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TH","regulator":"FDA-TH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MY","regulator":"NPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"PH","regulator":"FDA-PH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CO","regulator":"INVIMA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"ZA","regulator":"SAHPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TW","regulator":"TFDA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"HK","regulator":"DH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"BR","regulator":"ANVISA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MX","regulator":"COFEPRIS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AR","regulator":"ANMAT","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TR","regulator":"TITCK","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:24:41.638134+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}