{"id":"tinidazole","rwe":[{"pmid":"41903970","year":"2026","title":"Portable smartphone-assisted fluorescence platform based on dual-excitation nitrogen-doped carbon dots for simultaneous detection of chlorogenic acid and tinidazole.","finding":"","journal":"Analytica chimica acta","studyType":"Clinical Study"},{"pmid":"41762605","year":"2026","title":"Microwave plasma torch mass spectrometry for rapid prediction of photo-thermal stability and degradation pathways of pharmaceuticals.","finding":"","journal":"Talanta","studyType":"Clinical Study"},{"pmid":"41758422","year":"2026","title":"Sustainable development of ZnO nanoparticles and nanocellulose-modified CPE for electrochemical sensing of tinidazole.","finding":"","journal":"Journal of materials science. Materials in medicine","studyType":"Clinical Study"},{"pmid":"41748875","year":"2026","title":"Novel magnetically retrievable SnO(2)/Fe(3)O(4)/WSe(2) heterojunction for the photocatalytic degradation of tinidazole through a synergistic strategy for environmental remediation.","finding":"","journal":"Scientific reports","studyType":"Clinical Study"},{"pmid":"41729428","year":"2026","title":"Treatment outcomes in symptomatic Dientamoeba fragilis infection: a prospective clinical and molecular study.","finding":"","journal":"Infection","studyType":"Clinical Study"}],"_fda":{"id":"8dbd79dd-9243-4413-aa01-ba1301573a48","set_id":"32167dd7-5d37-457b-9b00-cd735de6b060","openfda":{"nui":["N0000175435","M0014907"],"upc":["0364980426022"],"unii":["033KF7V46H"],"route":["ORAL"],"rxcui":["199519","477234"],"spl_id":["8dbd79dd-9243-4413-aa01-ba1301573a48"],"brand_name":["Tindazole"],"spl_set_id":["32167dd7-5d37-457b-9b00-cd735de6b060"],"package_ndc":["64980-426-02","64980-427-12"],"product_ndc":["64980-426","64980-427"],"generic_name":["TINIDAZOLE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"pharm_class_cs":["Nitroimidazoles [CS]"],"substance_name":["TINIDAZOLE"],"pharm_class_epc":["Nitroimidazole Antimicrobial [EPC]"],"manufacturer_name":["Rising Pharma Holdings, Inc."],"application_number":["ANDA202489"],"is_original_packager":[true]},"version":"6","pregnancy":["8.1 Pregnancy Risk Summary Available published data from a case-control study and case report with Tinidazole Tablets use in pregnant women are insufficient to identify a risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks associated with untreated lower genital tract infections during pregnancy (see Clinical Considerations) . In animal reproduction studies, oral administration of tinidazole to pregnant mice and rats during organogenesis at 6 and 3 times, respectively, the maximum recommended human dose (based on body surface area comparison) showed a slight increase in fetal mortality in rats at the highest dose, with no other adverse fetal effects noted in either species (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Embryo-fetal developmental toxicity studies in pregnant mice administered oral tinidazole on gestation days (GD) 7 to 12 indicated no embryo-fetal toxicity or malformations at the highest dose level of 2,500 mg/kg (approximately 6.3-fold the highest human therapeutic dose based upon body surface area conversions). In a study with pregnant rats administered oral tinidazole on GD 9 to 14, a slightly higher incidence of fetal mortality was observed at a maternal dose of 500 mg/kg (2.5-fold the highest human therapeutic dose based upon body surface area conversions). No biologically relevant neonatal developmental effects were observed in surviving rat neonates following maternal doses as high as 600 mg/kg (3-fold the highest human therapeutic dose based upon body surface area conversions)."],"overdosage":["10 OVERDOSAGE There are no reported overdoses with tinidazole in humans. Treatment of Overdosage: There is no specific antidote for the treatment of overdosage with tinidazole; therefore, treatment should be symptomatic and supportive. Gastric lavage may be helpful. Hemodialysis can be considered because approximately 43% of the amount present in the body is eliminated during a 6-hour hemodialysis session."],"description":["11 DESCRIPTION Tinidazole USP is a synthetic antiprotozoal and antibacterial agent. It is 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitroimidazole, a second-generation 2-methyl-5-nitroimidazole, which has a molecular weight of 247.27 and the following chemical structure: Tinidazole pink oral tablets contain 250 mg or 500 mg of tinidazole USP. Inactive ingredients include microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, triacetin, FD&C Red 40, FD&C Yellow 6 3a66b537-63a4-41f9-8415-5ed05bd8cbcf-01"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING Tinidazole Tablets USP 250 mg are pink color, circular shaped film coated scored tablets with \"250\" debossed on one side and \" T│P\" on the other side, supplied in bottles with child-resistant caps as: NDC 64980-426-02 Bottle of 20 Tinidazole Tablets USP 500 mg are pink color, capsule shaped film coated scored tablets with \"500\" debossed on one side and \" T│P\" on the other side, supplied in bottles with child-resistant caps as: NDC 64980-427-12 Bottle of 12 Storage: Store at controlled room temperature 20-25° C (68-77° F); excursions permitted to 15-30° C (59-86° F) [see USP]. Protect contents from light."],"boxed_warning":["WARNING: POTENTIAL RISK FOR CARCINOGENICITY Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent [see Nonclinical Toxicology ( 13.1 )]. Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Limit use of Tinidazole Tablets to approved indications only [see Indications and Usage ( 1.1 , 1.2 , 1.3 )]. Avoid chronic use [see Warnings and Precautions ( 5.1 )]. WARNING: POTENTIAL RISK FOR CARCINOGENICITY See full prescribing information for complete boxed warning. Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent ( 13.1 ). Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Limit use of Tinidazole Tablets to approved indications only ( 1.1 , 1.2 , 1.3 ). Avoid chronic use ( 5.1 )."],"geriatric_use":["8.5 Geriatric Use Clinical studies of tinidazole did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy."],"pediatric_use":["8.4 Pediatric Use Other than for use in the treatment of giardiasis and amebiasis in pediatric patients older than three years of age, safety and effectiveness of tinidazole in pediatric patients have not been established. Pediatric Administration: For those unable to swallow tablets, tinidazole tablets may be crushed in artificial cherry syrup, to be taken with food [see Dosage and Administration ( 2.2 )]."],"effective_time":"20250331","nursing_mothers":["8.3 Females and Males of Reproductive Potential Infertility Infertility Males Based on findings in rodents, Tinidazole may impair fertility in males of reproductive potential. It is not known whether effects on fertility are reversible [see Nonclinical Toxicology (13.1) ]."],"clinical_studies":["14 CLINICAL STUDIES 14.1 Trichomoniasis Tinidazole (2 g single oral dose) use in trichomoniasis has been well documented in 34 published reports from the world literature involving over 2,800 patients treated with tinidazole. In four published, blinded, randomized, comparative studies of the 2 g tinidazole single oral dose where efficacy was assessed by culture at time points post-treatment ranging from one week to one month, reported cure rates ranged from 92% (37/40) to 100% (65/65) (n=172 total subjects). In four published, blinded, randomized, comparative studies where efficacy was assessed by wet mount between 7-14 days post-treatment, reported cure rates ranged from 80% (8/10) to 100% (16/16) (n=116 total subjects). In these studies, tinidazole was superior to placebo and comparable to other anti-trichomonal drugs. The single oral 2 g tinidazole dose was also assessed in four open-label trials in men (one comparative to metronidazole and 3 single-arm studies). Parasitological evaluation of the urine was performed both pre- and post-treatment and reported cure rates ranged from 83% (25/30) to 100% (80/80) (n=142 total subjects). 14.2 Giardiasis Tinidazole (2 g single dose) use in giardiasis has been documented in 19 published reports from the world literature involving over 1,600 patients (adults and pediatric patients). In eight controlled studies involving a total of 619 subjects of whom 299 were given the 2 g × 1 day (50 mg/kg × 1 day in pediatric patients) oral dose of tinidazole, reported cure rates ranged from 80% (40/50) to 100% (15/15). In three of these trials where the comparator was 2 to 3 days of various doses of metronidazole, reported cure rates for metronidazole were 76% (19/25) to 93% (14/15). Data comparing a single 2 g dose of tinidazole to usually recommended 5-7 days of metronidazole are limited. 14.3 Intestinal Amebiasis Tinidazole use in intestinal amebiasis has been documented in 26 published reports from the world literature involving over 1,400 patients. Most reports utilized tinidazole 2 g/day × 3 days. In four published, randomized, controlled studies (1 investigator single-blind, 3 open-label) of the 2 g/day × 3 days oral dose of tinidazole, reported cure rates after 3 days of therapy among a total of 220 subjects ranged from 86% (25/29) to 93% (25/27). 14.4 Amebic Liver Abscess Tinidazole use in amebic liver abscess has been documented in 18 published reports from the world literature involving over 470 patients. Most reports utilized tinidazole 2 g/day × 2-5 days. In seven published, randomized, controlled studies (1 double-blind, 1 single-blind, 5 open-label) of the 2 g/day × 2-5 days oral dose of tinidazole accompanied by aspiration of the liver abscess when clinically necessary, reported cure rates among 133 subjects ranged from 81% (17/21) to 100% (16/16). Four of these studies utilized at least 3 days of tinidazole. 14.5 Bacterial Vaginosis A randomized, double-blind, placebo-controlled clinical trial in 235 non-pregnant women was conducted to evaluate the efficacy of tinidazole for the treatment of bacterial vaginosis. A clinical diagnosis of bacterial vaginosis was based on Amsel's criteria and defined by the presence of an abnormal homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a \"fishy\" amine odor when mixed with a 10% KOH solution, and (c) contains ≥20% clue cells on microscopic examination. Clinical cure required a return to normal vaginal discharge and resolution of all Amsel's criteria. A microbiologic diagnosis of bacterial vaginosis was based on Gram stain of the vaginal smear demonstrating (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells, with quantification of these bacterial morphotypes to determine the Nugent score, where a score ≥4 was required for study inclusion and a score of 0-3 considered a microbiologic cure. Therapeutic cure was a composite endpoint, consisting of both a clinical cure and microbiologic cure. In patients with all four Amsel's criteria and with a baseline Nugent score ≥4, tinidazole oral tablets given as either 2 g once daily for 2 days or 1 g once daily for 5 days demonstrated superior efficacy over placebo tablets as measured by therapeutic cure, clinical cure, and a microbiologic cure. Table 2 Efficacy of Tinidazole Tablets in the Treatment of Bacterial Vaginosis in a Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial: Modified Intent-to-Treat Population 1 (n=227) Outcome Tinidazole Tablets 1 g × 5 days (n=76) Tinidazole Tablets 2 g × 2 days (n=73) Placebo (n=78) % Cure % Cure % Cure Therapeutic Cure Difference 2 97.5% CI 3 36.8 31.7 (16.8, 46.6) 27.4 22.3 (8.0, 36.6) 5.1 Clinical Cure Difference 2 97.5% CI 3 51.3 39.8 (23.3, 56.3) 35.6 24.1 (7.8, 40.3) 11.5 Nugent Score Cure Difference 2 97.5% CI 3 38.2 33.1 (18.1, 48.0) 27.4 22.3 (8.0, 36.6) 5.1 1 Modified Intent-to-Treat defined as all patients randomized with a baseline Nugent score of at least 4 2 Difference in cure rates (Tinidazole Tablets -placebo) 3 CI: confidence interval p-values for both Tinidazole Tablets regimens vs. placebo for therapeutic, clinical and Nugent score cure rates for both 2 and 5 days <0.001 The therapeutic cure rates reported in this clinical study conducted with Tinidazole Tablets were based on resolution of 4 out of 4 Amsel's criteria and a Nugent score of <4. The cure rates for previous clinical studies with other products approved for bacterial vaginosis were based on resolution of either 2 or 3 out of 4 Amsel's criteria. At the time of approval for other products for bacterial vaginosis, there was no requirement for a Nugent score on Gram stain, resulting in higher reported rates of cure for bacterial vaginosis for those products than for those reported here for tinidazole."],"pharmacodynamics":["12.2 Pharmacodynamics Tinidazole exposure-response relationships and the time course of pharmacodynamics response are unknown."],"pharmacokinetics":["12.3 Pharmacokinetics Absorption After oral administration, tinidazole is rapidly and completely absorbed. A bioavailability study of Tinidazole tablets was conducted in adult healthy volunteers. All subjects received a single oral dose of 2 g (four 500 mg tablets) of Tinidazole following an overnight fast. Oral administration of four 500 mg tablets of Tinidazole under fasted conditions produced a mean peak plasma concentration (C max ) of 47.7 (±7.5) µg/mL with a mean time to peak concentration (T max ) of 1.6 (±0.7) hours, and a mean area under the plasma concentration-time curve (AUC, 0-∞) of 901.6 (± 126.5) µg.hr/mL at 72 hours. The elimination half-life (T 1/2 ) was 13.2 (±1.4) hours. Mean plasma levels decreased to 14.3 µg/mL at 24 hours, 3.8 µg/mL at 48 hours and 0.8 µg/mL at 72 hours following administration. Steady-state conditions are reached in 2½ - 3 days of multi-day dosing. Administration of Tinidazole tablets with food resulted in a delay in T max of approximately 2 hours and a decline in C max of approximately 10% , compared to fasted conditions. However, administration of Tinidazole Tablets with food did not affect AUC or T 1/2 in this study. In healthy volunteers, administration of crushed Tinidazole tablets in artificial cherry syrup, [prepared as described in Dosage and Administration (2.2)] after an overnight fast had no effect on any pharmacokinetic parameter as compared to tablets swallowed whole under fasted conditions. Distribution: Tinidazole is distributed into virtually all tissues and body fluids and also crosses the blood-brain barrier. The apparent volume of distribution is about 50 liters. Plasma protein binding of tinidazole is 12%. Elimination The plasma half-life of tinidazole is approximately 12-14 hours. Metabolism: Tinidazole is significantly metabolized in humans prior to excretion. Tinidazole is partly metabolized by oxidation, hydroxylation, and conjugation. Tinidazole is the major drug-related constituent in plasma after human treatment, along with a small amount of the 2-hydroxymethyl metabolite. Tinidazole is biotransformed mainly by CYP3A4. In an in vitro metabolic drug interaction study, tinidazole concentrations of up to 75 µg/mL did not inhibit the enzyme activities of CYP1A2, CYP2B6, CYP2C9, CYP2D6, CYP2E1, and CYP3A4. The potential of tinidazole to induce the metabolism of other drugs has not been evaluated. Excretion Tinidazole is excreted by the liver and the kidneys. Tinidazole is excreted in the urine mainly as unchanged drug (approximately 20-25% of the administered dose). Approximately 12 % of the drug is excreted in the feces. Specific Populations Patients with impaired renal function: The pharmacokinetics of tinidazole in patients with severe renal impairment (CrCL < 22 mL/min) are not significantly different from the pharmacokinetics seen in healthy subjects. However, during hemodialysis, clearance of tinidazole is significantly increased; the half-life is reduced from 12.0 hours to 4.9 hours. Approximately 43% of the amount present in the body is eliminated during a 6-hour hemodialysis session [see Use in Specific Populations (8.6)] . The pharmacokinetics of tinidazole in patients undergoing routine continuous peritoneal dialysis have not been investigated. Patients with impaired hepatic function: There are no data on tinidazole pharmacokinetics in patients with impaired hepatic function. Reduction of metabolic elimination of metronidazole, a chemically-related nitroimidazole, in patients with hepatic dysfunction has been reported in several studies [see Use in Specific Populations (8.7)]."],"adverse_reactions":["6 ADVERSE REACTIONS Most common adverse reactions for a single 2 g dose of tinidazole (incidence >1%) are metallic/bitter taste, nausea, weakness/fatigue/malaise, dyspepsia/cramps/epigastric discomfort, vomiting, anorexia, headache, dizziness and constipation ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Among 3669 patients treated with a single 2 g dose of tinidazole, in both controlled and uncontrolled trichomoniasis and giardiasis clinical studies, adverse reactions were reported by 11.0% of patients. For multi-day dosing in controlled and uncontrolled amebiasis studies, adverse reactions were reported by 13.8% of 1765 patients. Common (≥1% incidence) adverse reactions reported by body system are as follows. (Note: Data described in Table 1 below are pooled from studies with variable designs and safety evaluations.) Other adverse reactions reported with tinidazole include: Central Nervous System: Two serious adverse reactions reported include convulsions and transient peripheral neuropathy including numbness and paresthesia [see Warnings and Precautions ( 5.1 )]. Other CNS reports include vertigo, ataxia, giddiness, insomnia, drowsiness. Gastrointestinal: tongue discoloration, stomatitis, diarrhea Hypersensitivity: urticaria, pruritis, rash, flushing, sweating, dryness of mouth, fever, burning sensation, thirst, salivation, angioedema Renal: darkened urine Cardiovascular: palpitations Hematopoietic: transient neutropenia, transient leukopenia Other: Candida overgrowth, increased vaginal discharge, oral candidiasis, hepatic abnormalities including raised transaminase level, arthralgias, myalgias, and arthritis. Table 1. Adverse Reactions Summary of Published Reports 2 g single dose Multi-day dose GI: Metallic/bitter taste 3.7% 6.3% Nausea 3.2% 4.5% Anorexia 1.5% 2.5% Dyspepsia/cramps/epigastric discomfort 1.8% 1.4% Vomiting 1.5% 0.9% Constipation 0.4% 1.4% CNS: Weakness/fatigue/malaise 2.1% 1.1% Dizziness 1.1% 0.5% Other: Headache 1.3% 0.7% Total patients with adverse reactions 11.0% (403/3669) 13.8% (244/1765) Rare reported adverse reactions include bronchospasm, dyspnea, coma, confusion, depression, furry tongue, pharyngitis and reversible thrombocytopenia. Adverse Reactions in Pediatric Patients: In pooled pediatric studies, adverse reactions reported in pediatric patients taking tinidazole were similar in nature and frequency to adult findings including nausea, vomiting, diarrhea, taste change, anorexia, and abdominal pain. Bacterial vaginosis: The most common adverse reactions in treated patients (incidence >2%), which were not identified in the trichomoniasis, giardiasis and amebiasis studies, are gastrointestinal: decreased appetite, and flatulence; renal: urinary tract infection, painful urination, and urine abnormality; and other reactions including pelvic pain, vulvo-vaginal discomfort, vaginal odor, menorrhagia, and upper respiratory tract infection [See Clinical Studies ( 14.5 )]. 6.2 Postmarketing Experience The following adverse reactions have been identified and reported during post-approval use of Tinidazole Tablets. Because the reports of these reactions are voluntary and the population is of uncertain size, it is not always possible to reliably estimate the frequency of the reaction or establish a causal relationship to drug exposure. Tinidazole: Severe acute hypersensitivity reactions have been reported on initial or subsequent exposure to tinidazole. Hypersensitivity reactions may include urticaria, pruritis, angioedema, Stevens-Johnson syndrome and erythema multiforme. Metronidazole, Another Nitroimidazole Product, Structurally Related to Tinidazole: Cases of severe irreversible hepatotoxicity/acute liver failure, including cases with fatal outcomes with very rapid onset after intiation of systemic use of metronidazole, another nitroimidazole agent structurally related to tinidazole, have been reported in patients with Cockayne syndrome (latency from drug start to signs of liver failure as short as 2 days) [see Contraindications ( 4 )]."],"contraindications":["4 CONTRAINDICATIONS The use of tinidazole is contraindicated: In patients with a previous history of hypersensitivity to tinidazole or other nitroimidazole derivatives. Reported reactions have ranged in severity from urticaria to Stevens-Johnson syndrome [see Adverse Reactions ( 6.1 , 6.2 )]. In patients with Cockayne syndrome. Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after intiation of metronidazole, another nitroimidazole drug, structurally related to tinidazole, in patients with Cockayne syndrome [see Adverse Reactions ( 6.2 )] Prior history of hypersensitivity to tinidazole or other nitroimidazole derivatives ( 4, 6.1, 6.2 ) Patients with Cockayne Syndrome ( 4 , 6.2 )"],"drug_interactions":["7 DRUG INTERACTIONS Although not specifically identified in studies with tinidazole, the following drug interactions were reported for metronidazole, a chemically-related nitroimidazole. Therefore, these drug interactions may occur with tinidazole. The following drug interactions were reported for metronidazole, a chemically-related nitroimidazole and may therefore occur with tinidazole: Warfarin and other oral coumarin anticoagulants: Anticoagulant dosage may need adjustment during and up to 8 days after tinidazole therapy ( 7.1 ) Alcohol-containing beverages/preparations: Avoid during and up to 3 days after tinidazole therapy ( 7.1 ) Lithium: Monitor serum lithium concentrations ( 7.1 ) Cyclosporine, tacrolimus: Monitor for toxicities of these immunosuppressive drugs ( 7.1 ) Fluorouracil: Monitor for fluorouracil-associated toxicities ( 7.1 ) Phenytoin, fosphenytoin: Adjustment of anticonvulsant and/or tinidazole dose(s) may be needed ( 7.1, 7.2 ) CYP3A4 inducers/inhibitors: Monitor for decreased tinidazole effect or increased adverse reactions ( 7.2 ) 7.1 Potential Effects of Tinidazole on Other Drugs Warfarin and Other Oral Coumarin Anticoagulants: As with metronidazole, tinidazole may enhance the effect of warfarin and other coumarin anticoagulants, resulting in a prolongation of prothrombin time. The dosage of oral anticoagulants may need to be adjusted during tinidazole co-administration and up to 8 days after discontinuation. Alcohols, Disulfiram: Alcoholic beverages and preparations containing ethanol or propylene glycol should be avoided during tinidazole therapy and for 3 days afterward because abdominal cramps, nausea, vomiting, headaches, and flushing may occur. Psychotic reactions have been reported in alcoholic patients using metronidazole and disulfiram concurrently. Though no similar reactions have been reported with tinidazole, tinidazole should not be given to patients who have taken disulfiram within the last two weeks. Lithium: Metronidazole has been reported to elevate serum lithium levels. It is not known if tinidazole shares this property with metronidazole, but consideration should be given to measuring serum lithium and creatinine levels after several days of simultaneous lithium and tinidazole treatment to detect potential lithium intoxication. Phenytoin, Fosphenytoin: Concomitant administration of oral metronidazole and intravenous phenytoin was reported to result in prolongation of the half-life and reduction in the clearance of phenytoin. Metronidazole did not significantly affect the pharmacokinetics of orally-administered phenytoin. Cyclosporine, Tacrolimus: There are several case reports suggesting that metronidazole has the potential to increase the levels of cyclosporine and tacrolimus. During tinidazole co-administration with either of these drugs, the patient should be monitored for signs of calcineurin-inhibitor associated toxicities Fluorouracil: Metronidazole was shown to decrease the clearance of fluorouracil, resulting in an increase in side-effects without an increase in therapeutic benefits. If the concomitant use of tinidazole and fluorouracil cannot be avoided, the patient should be monitored for fluorouracil-associated toxicities. 7.2 Potential Effects of Other Drugs on Tinidazole CYP3A4 Inducers and Inhibitors: Simultaneous administration of tinidazole with drugs that induce liver microsomal enzymes, i.e., CYP3A4 inducers such as phenobarbital, rifampin, phenytoin, and fosphenytoin (a pro-drug of phenytoin), may accelerate the elimination of tinidazole, decreasing the plasma level of tinidazole. Simultaneous administration of drugs that inhibit the activity of liver microsomal enzymes, i.e., CYP3A4 inhibitors such as cimetidine and ketoconazole, may prolong the half-life and decrease the plasma clearance of tinidazole, increasing the plasma concentrations of tinidazole. Cholestyramine: Cholestyramine was shown to decrease the oral bioavailability of metronidazole by 21%. Thus, it is advisable to separate dosing of cholestyramine and tinidazole to minimize any potential effect on the oral bioavailability of tinidazole. Oxytetracycline: Oxytetracycline was reported to antagonize the therapeutic effect of metronidazole. 7.3 Laboratory Test Interactions Tinidazole, like metronidazole, may interfere with certain types of determinations of serum chemistry values, such as aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT), lactate dehydrogenase (LDH), triglycerides, and hexokinase glucose. Values of zero may be observed. All of the assays in which interference has been reported involve enzymatic coupling of the assay to oxidation-reduction of nicotinamide adenine dinucleotide (NAD + ↔ NADH). Potential interference is due to the similarity of absorbance peaks of NADH and tinidazole. Tinidazole, like metronidazole, may produce transient leukopenia and neutropenia; however, no persistent hematological abnormalities attributable to tinidazole have been observed in clinical studies. Total and differential leukocyte counts are recommended if re-treatment is necessary."],"mechanism_of_action":["12.1 Mechanism of Action Tinidazole is an antiprotozoal, antibacterial agent. [See Clinical Pharmacology (12.4) ]."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Tinidazole is an antiprotozoal, antibacterial agent. [See Clinical Pharmacology (12.4) ]. 12.2 Pharmacodynamics Tinidazole exposure-response relationships and the time course of pharmacodynamics response are unknown. 12.3 Pharmacokinetics Absorption After oral administration, tinidazole is rapidly and completely absorbed. A bioavailability study of Tinidazole tablets was conducted in adult healthy volunteers. All subjects received a single oral dose of 2 g (four 500 mg tablets) of Tinidazole following an overnight fast. Oral administration of four 500 mg tablets of Tinidazole under fasted conditions produced a mean peak plasma concentration (C max ) of 47.7 (±7.5) µg/mL with a mean time to peak concentration (T max ) of 1.6 (±0.7) hours, and a mean area under the plasma concentration-time curve (AUC, 0-∞) of 901.6 (± 126.5) µg.hr/mL at 72 hours. The elimination half-life (T 1/2 ) was 13.2 (±1.4) hours. Mean plasma levels decreased to 14.3 µg/mL at 24 hours, 3.8 µg/mL at 48 hours and 0.8 µg/mL at 72 hours following administration. Steady-state conditions are reached in 2½ - 3 days of multi-day dosing. Administration of Tinidazole tablets with food resulted in a delay in T max of approximately 2 hours and a decline in C max of approximately 10% , compared to fasted conditions. However, administration of Tinidazole Tablets with food did not affect AUC or T 1/2 in this study. In healthy volunteers, administration of crushed Tinidazole tablets in artificial cherry syrup, [prepared as described in Dosage and Administration (2.2)] after an overnight fast had no effect on any pharmacokinetic parameter as compared to tablets swallowed whole under fasted conditions. Distribution: Tinidazole is distributed into virtually all tissues and body fluids and also crosses the blood-brain barrier. The apparent volume of distribution is about 50 liters. Plasma protein binding of tinidazole is 12%. Elimination The plasma half-life of tinidazole is approximately 12-14 hours. Metabolism: Tinidazole is significantly metabolized in humans prior to excretion. Tinidazole is partly metabolized by oxidation, hydroxylation, and conjugation. Tinidazole is the major drug-related constituent in plasma after human treatment, along with a small amount of the 2-hydroxymethyl metabolite. Tinidazole is biotransformed mainly by CYP3A4. In an in vitro metabolic drug interaction study, tinidazole concentrations of up to 75 µg/mL did not inhibit the enzyme activities of CYP1A2, CYP2B6, CYP2C9, CYP2D6, CYP2E1, and CYP3A4. The potential of tinidazole to induce the metabolism of other drugs has not been evaluated. Excretion Tinidazole is excreted by the liver and the kidneys. Tinidazole is excreted in the urine mainly as unchanged drug (approximately 20-25% of the administered dose). Approximately 12 % of the drug is excreted in the feces. Specific Populations Patients with impaired renal function: The pharmacokinetics of tinidazole in patients with severe renal impairment (CrCL < 22 mL/min) are not significantly different from the pharmacokinetics seen in healthy subjects. However, during hemodialysis, clearance of tinidazole is significantly increased; the half-life is reduced from 12.0 hours to 4.9 hours. Approximately 43% of the amount present in the body is eliminated during a 6-hour hemodialysis session [see Use in Specific Populations (8.6)] . The pharmacokinetics of tinidazole in patients undergoing routine continuous peritoneal dialysis have not been investigated. Patients with impaired hepatic function: There are no data on tinidazole pharmacokinetics in patients with impaired hepatic function. Reduction of metabolic elimination of metronidazole, a chemically-related nitroimidazole, in patients with hepatic dysfunction has been reported in several studies [see Use in Specific Populations (8.7)]. 12.4 Microbiology Mechanism of Action Tinidazole is an antiprotozoal, antibacterial agent. The nitro- group of tinidazole is reduced by cell extracts of Trichomonas. The free nitro radical generated as a result of this reduction may be responsible for the antiprotozoal activity. Chemically reduced tinidazole was shown to release nitrites and cause damage to purified bacterial DNA in vitro. Additionally, the drug caused DNA base changes in bacterial cells and DNA strand breakage in mammalian cells. The mechanism by which tinidazole exhibits activity against Giardia and Entamoeba species is not known. Antibacterial Culture and sensitivity testing of bacteria are not routinely performed to establish the diagnosis of bacterial vaginosis [see Indications and Usage (1.4)]; standard methodology for the susceptibility testing of potential bacterial pathogens, Gardnerella vaginalis, Mobiluncus spp. or Mycoplasma hominis, has not been defined. The following in vitro data are available, but their clinical significance is unknown. Tinidazole is active in vitro against most strains of the following organisms that have been reported to be associated with bacterial vaginosis: Bacteroides spp. Gardnerella vaginalis Prevotella spp. Tinidazole does not appear to have activity against most strains of vaginal lactobacilli. Antiprotozoal Tinidazole demonstrates activity both in vitro and in clinical infections against the following protozoa: Trichomonas vaginalis; Giardia duodenalis (also termed G. lamblia ); and Entamoeba histolytica. For protozoal parasites, standardized susceptibility tests do not exist for use in clinical microbiology laboratories. Drug Resistance The development of resistance to tinidazole by G. duodenalis, E. histolytica, or bacteria associated with bacterial vaginosis has not been examined. Cross-resistance Approximately 38% of T. vaginalis isolates exhibiting reduced susceptibility to metronidazole also show reduced susceptibility to tinidazole in vitro. The clinical significance of such an effect is not known."],"indications_and_usage":["1 INDICATIONS AND USAGE Tinidazole Tablet is a nitroimidazole antimicrobial indicated for: Trichomoniasis ( 1.1 ) Giardiasis: in patients age 3 and older ( 1.2 ) Amebiasis: in patients age 3 and older ( 1.3 ) Bacterial Vaginosis: in adult women ( 1.4, 8.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tinidazole Tablets and other antibacterial drugs, Tinidazole Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria (1.5) . 1.1 Trichomoniasis Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis. The organism should be identified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, partners of infected patients should be treated simultaneously in order to prevent re-infection [see Clinical Studies ( 14.1 )]. 1.2 Giardiasis Tinidazole is indicated for the treatment of giardiasis caused by Giardia duodenalis (also termed G. lamblia ) in both adults and pediatric patients older than three years of age [see Clinical Studies ( 14.2 )]. 1.3 Amebiasis Tinidazole is indicated for the treatment of intestinal amebiasis and amebic liver abscess caused by Entamoeba histolytica in both adults and pediatric patients older than three years of age. It is not indicated in the treatment of asymptomatic cyst passage [see Clinical Studies ( 14.3 , 14.4 )]. 1.4 Bacterial Vaginosis Tinidazole is indicated for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, or anaerobic vaginosis) in adult women [see Use in Specific Populations ( 8.1 ) and Clinical Studies ( 14.5 )] . Other pathogens commonly associated with vulvovaginitis such as Trichomonas vaginalis , Chlamydia trachomatis , Neisseria gonorrhoeae , Candida albicans and Herpes simplex virus should be ruled out. 1.5 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tinidazole Tablets and other antibacterial drugs, Tinidazole Tablets should be used only to treat or prevent infections, that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemology and susceptibility patterns may contribute to the empiric selection of therapy."],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Seizures and neuropathy have been reported. Discontinue Tinidazole Tablets if abnormal neurologic signs develop ( 5.1 ) Vaginal candidiasis may develop with Tinidazole Tablets and require treatment with an antifungal agent ( 5.2 ) Use Tinidazole Tablets with caution in patients with blood dyscrasias. Tinidazole Tablets may produce transient leukopenia and neutropenia ( 5.3, 7.3 ) 5.1 Potential for Genotoxicity and Carcinogenicity Carcinogenicity has been seen in mice and rats treated chronically with nitroimidazole derivatives, which are structurally related to tinidazole [see Nonclinical Toxicology ( 13.1 )] . Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. However, it is unclear if the positive tumor findings in lifetime rodent studies indicate a risk to patients taking a short course or single dose of Tinidazole Tablet. Use should be limited to approved indications only. Avoid chronic use. 5.2 Neurological Adverse Reactions Convulsive seizures and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, have been reported in patients treated with tinidazole. The appearance of abnormal neurologic signs demands the prompt discontinuation of tinidazole therapy. 5.3 Vaginal Candidiasis The use of tinidazole may result in Candida vaginitis. In a clinical study of 235 women who received tinidazole for bacterial vaginosis, a vaginal fungal infection developed in 11 (4.7%) of all study subjects [see Clinical Studies ( 14.5 )]. 5.4 Blood Dyscrasia Tinidazole should be used with caution in patients with evidence of or history of blood dyscrasia [see Drug Interactions ( 7.3 )]. 5.5 Development of Drug-Resistant Bacteria Prescribing Tinidazole Tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria."],"clinical_studies_table":["
OutcomeTinidazole Tablets 1 g × 5 days (n=76)Tinidazole Tablets 2 g × 2 days (n=73)Placebo (n=78)
% Cure% Cure% Cure
Therapeutic Cure Difference2 97.5% CI336.8 31.7 (16.8, 46.6)27.4 22.3 (8.0, 36.6)5.1
Clinical Cure Difference2 97.5% CI351.3 39.8 (23.3, 56.3)35.6 24.1 (7.8, 40.3)11.5
Nugent Score Cure Difference2 97.5% CI338.2 33.1 (18.1, 48.0)27.4 22.3 (8.0, 36.6)5.1
"],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Metronidazole, a chemically-related nitroimidazole, has been reported to be carcinogenic in mice and rats but not hamsters. In several studies metronidazole showed evidence of pulmonary, hepatic, and lymphatic tumorigenesis in mice and mammary and hepatic tumors in female rats. Tinidazole carcinogenicity studies in rats, mice or hamsters have not been reported. Tinidazole was mutagenic in the TA 100, S. typhimurium tester strain both with and without the metabolic activation system and was negative for mutagenicity in the TA 98 strain. Mutagenicity results were mixed (positive and negative) in the TA 1535, 1537, and 1538 strains. Tinidazole was also mutagenic in a tester strain of Klebsiella pneumonia . Tinidazole was negative for mutagenicity in a mammalian cell culture system utilizing Chinese hamster lung V79 cells (HGPRT test system) and negative for genotoxicity in the Chinese hamster ovary (CHO) sister chromatid exchange assay. Tinidazole was positive for in vivo genotoxicity in the mouse micronucleus assay. In a 60-day male rat fertility study, oral doses of 600 mg/kg (approximately 3-fold the highest human therapeutic dose based on body surface area conversions) reduced fertility and produced testicular histopathology, including tubular degeneration, vacuolation of the seminiferous epithelium in the testis, and hypospermia in the epididymis. At 300 and 600 mg/kg dose levels, significant effects on sperm parameters were observed, including dose-related reduction in sperm motility, epididymal sperm numbers, percentage of normal sperm, retention of spermatids, and decreased epididymal weights. No effects on sperm parameters were observed at 100 mg/kg (approximately 0.5-fold the highest human therapeutic dose based upon body surface area conversions). This effect is characteristic of agents in the 5-nitroimidazole class."],"adverse_reactions_table":["
2 g single doseMulti-day dose
GI: Metallic/bitter taste3.7%6.3%
Nausea3.2%4.5%
Anorexia1.5%2.5%
Dyspepsia/cramps/epigastric discomfort1.8%1.4%
Vomiting1.5%0.9%
Constipation0.4%1.4%
CNS: Weakness/fatigue/malaise2.1%1.1%
Dizziness1.1%0.5%
Other: Headache1.3%0.7%
Total patients with adverse reactions11.0% (403/3669)13.8% (244/1765)
"],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Administration of Drug Patients should be told to take Tinidazole Tablets with food to minimize the incidence of epigastric discomfort and other gastrointestinal side-effects. Food does not affect the oral bioavailability of tinidazole. Alcohol Avoidance Patients should be told to avoid alcoholic beverages and preparations containing ethanol or propylene glycol during Tinidazole Tablets therapy and for 3 days afterward because abdominal cramps, nausea, vomiting, headaches, and flushing may occur. Lactation Advise women not to breastfeed during treatment with Tinidazole Tablets and to discontinue breastfeeding for 72 hours following the administration of Tinidazole Tablets. Also, advise a nursing mother that she may choose to pump and discard her milk for 72 hours after administration of Tinidazole Tablets [see Use in Specific Populations ( 8.2 )]. Infertility Advise males of reproductive potential that Tinidazole Tablets may impair fertility [see Use in Specific Populations ( 8.3 ) and Nonclinical Toxicology ( 13.1 )]. Drug Resistance Patients should be counseled that antibacterial drugs including Tinidazole Tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Tinidazole Tablet is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Tinidazole Tablets or other antibacterial drugs in the future. Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.) Mumbai 400 030, India Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Revised: 03/2025 141037 rising-logo"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION Trichomoniasis: a single 2 g oral dose taken with food. Treat sexual partners with the same dose and at the same time ( 2.3 ) Giardiasis: Adults: a single 2 g dose taken with food. Pediatric patients older than three years of age: a single dose of 50 mg/kg (up to 2 g) with food ( 2.4 ) Amebiasis, Intestinal: Adults: 2 g per day for 3 days with food. Pediatric patients older than three years of age: 50 mg/kg/day (up to 2 g per day) for 3 days with food ( 2.5 ). Amebic liver abscess: Adults: 2 g per day for 3-5 days with food. Pediatric patients older than three years of age: 50 mg/kg/day (up to 2 g per day) for 3-5 days with food ( 2.5 ) Bacterial vaginosis: Adult women: 2 g once daily for 2 days taken with food, or 1 g once daily for 5 days taken with food ( 2.6 ) 2.1 Dosing Instructions It is advisable to take tinidazole with food to minimize the incidence of epigastric discomfort and other gastrointestinal side-effects. Food does not affect the oral bioavailability of tinidazole [see Clinical Pharmacology ( 12.3 )]. Alcoholic beverages should be avoided when taking tinidazole and for 3 days afterwards [see Drug Interactions ( 7.1 )]. 2.2 Compounding of the Oral Suspension For those unable to swallow tablets, tinidazole tablets may be crushed in artificial cherry syrup to be taken with food. Procedure for Extemporaneous Pharmacy Compounding of the Oral Suspension: Pulverize four 500 mg oral tablets with a mortar and pestle. Add approximately 10 mL of cherry syrup to the powder and mix until smooth. Transfer the suspension to a graduated amber container. Use several small rinses of cherry syrup to transfer any remaining drug in the mortar to the final suspension for a final volume of 30 mL. The suspension of crushed tablets in artificial cherry syrup is stable for 7 days at room temperature. When this suspension is used, it should be shaken well before each administration. 2.3 Trichomoniasis The recommended dose in both females and males is a single 2 g oral dose taken with food. Since trichomoniasis is a sexually transmitted disease, sexual partners should be treated with the same dose and at the same time. 2.4 Giardiasis The recommended dose in adults is a single 2 g dose taken with food. In pediatric patients older than three years of age, the recommended dose is a single dose of 50 mg/kg (up to 2 g) with food. 2.5 Amebiasis Intestinal: The recommended dose in adults is a 2 g dose per day for 3 days taken with food. In pediatric patients older than three years of age, the recommended dose is 50 mg/kg/day (up to 2 g per day) for 3 days with food. Amebic Liver Abscess: The recommended dose in adults is a 2 g dose per day for 3-5 days taken with food. In pediatric patients older than three years of age, the recommended dose is 50 mg/kg/day (up to 2 g per day) for 3-5 days with food. There are limited pediatric data on durations of therapy exceeding 3 days, although a small number of children were treated for 5 days without additional reported adverse reactions. Children should be closely monitored when treatment durations exceed 3 days. 2.6 Bacterial Vaginosis The recommended dose is a 2 g oral dose once daily for 2 days taken with food or a 1 g oral dose once daily for 5 days taken with food. The use of tinidazole in pregnant patients has not been studied for bacterial vaginosis."],"spl_product_data_elements":["Tindazole Tinidazole TINIDAZOLE TINIDAZOLE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM STARCH, CORN MAGNESIUM STEARATE HYPROMELLOSES TITANIUM DIOXIDE POLYETHYLENE GLYCOL TRIACETIN FD&C RED NO. 40 FD&C YELLOW NO. 6 Circular TP;250 Tindazole Tinidazole TINIDAZOLE TINIDAZOLE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM STARCH, CORN MAGNESIUM STEARATE HYPROMELLOSES TITANIUM DIOXIDE POLYETHYLENE GLYCOL TRIACETIN FD&C RED NO. 40 FD&C YELLOW NO. 6 Capsule Shaped TP;500"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS 250 mg tablets are pink color, circular shaped film coated scored tablets with \"250\" debossed on one side and \" T│P\" on the other side 500 mg tablets are pink color, capsule shaped film coated scored tablets with \"500\" debossed on one side and \" T│P\" on the other side Tablets: 250 mg and 500 mg, scored ( 3 )"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS Pediatric Use: Data on tinidazole use in children is limited to treatment of giardiasis and amebiasis in patients age 3 and older ( 8.4 ) Hemodialysis patients: If tinidazole is administered the same day and prior to hemodialysis, administer an additional ½ dose after end of hemodialysis ( 8.6, 12.3 ) Lactation: Breastfeeding is not recommended. Discontinue breastfeeding during and for 72 hours after the last dose of Tinidazole Tablet (8.2) 8.1 Pregnancy Risk Summary Available published data from a case-control study and case report with Tinidazole Tablets use in pregnant women are insufficient to identify a risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks associated with untreated lower genital tract infections during pregnancy (see Clinical Considerations) . In animal reproduction studies, oral administration of tinidazole to pregnant mice and rats during organogenesis at 6 and 3 times, respectively, the maximum recommended human dose (based on body surface area comparison) showed a slight increase in fetal mortality in rats at the highest dose, with no other adverse fetal effects noted in either species (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Embryo-fetal developmental toxicity studies in pregnant mice administered oral tinidazole on gestation days (GD) 7 to 12 indicated no embryo-fetal toxicity or malformations at the highest dose level of 2,500 mg/kg (approximately 6.3-fold the highest human therapeutic dose based upon body surface area conversions). In a study with pregnant rats administered oral tinidazole on GD 9 to 14, a slightly higher incidence of fetal mortality was observed at a maternal dose of 500 mg/kg (2.5-fold the highest human therapeutic dose based upon body surface area conversions). No biologically relevant neonatal developmental effects were observed in surviving rat neonates following maternal doses as high as 600 mg/kg (3-fold the highest human therapeutic dose based upon body surface area conversions). 8.2 Lactation Risk Summary Limited published literature, based on breast milk sampling, reports that tinidazole is present in human milk. There are no reports of adverse effects on the breastfed infant and no information on the effects of tinidazole on milk production. Because of the potential for serious adverse reactions, including tumorigenicity, advise patients that breastfeeding is not recommended during treatment with Tinidazole Tablets and for 72 hours (based on half-life) after administration of Tinidazole Tablets. Clinical Considerations A nursing mother may choose to pump and discard her milk during treatment and for 72 hours after administration of Tinidazole Tablets to minimize exposure to the breastfeeding infant. 8.3 Females and Males of Reproductive Potential Infertility Infertility Males Based on findings in rodents, Tinidazole may impair fertility in males of reproductive potential. It is not known whether effects on fertility are reversible [see Nonclinical Toxicology (13.1) ]. 8.4 Pediatric Use Other than for use in the treatment of giardiasis and amebiasis in pediatric patients older than three years of age, safety and effectiveness of tinidazole in pediatric patients have not been established. Pediatric Administration: For those unable to swallow tablets, tinidazole tablets may be crushed in artificial cherry syrup, to be taken with food [see Dosage and Administration ( 2.2 )]. 8.5 Geriatric Use Clinical studies of tinidazole did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 8.6 Renal Impairment Because the pharmacokinetics of tinidazole in patients with severe renal impairment (CrCL < 22 mL/min) are not significantly different from those in healthy subjects, no dose adjustments are necessary in these patients. Patients undergoing hemodialysis: If tinidazole is administered on the same day as and prior to hemodialysis, it is recommended that an additional dose of tinidazole equivalent to one-half of the recommended dose be administered after the end of the hemodialysis [see Clinical Pharmacology ( 12.3 )]. 8.7 Hepatic Impairment There are no data on tinidazole pharmacokinetics in patients with impaired hepatic function. Reduced elimination of metronidazole, a chemically-related nitroimidazole, has been reported in this population. Usual recommended doses of tinidazole should be administered cautiously in patients with hepatic dysfunction [see Clinical Pharmacology ( 12.3 )]."],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 64980-426-02 Tinidazole Tablets, USP 250 mg R x only 20 Tablets tinidazole-250mg","PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 64980-427-12 Tinidazole Tablets, USP 500 mg R x only 12 Tablets tinidazole-500mg"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Metronidazole, a chemically-related nitroimidazole, has been reported to be carcinogenic in mice and rats but not hamsters. In several studies metronidazole showed evidence of pulmonary, hepatic, and lymphatic tumorigenesis in mice and mammary and hepatic tumors in female rats. Tinidazole carcinogenicity studies in rats, mice or hamsters have not been reported. Tinidazole was mutagenic in the TA 100, S. typhimurium tester strain both with and without the metabolic activation system and was negative for mutagenicity in the TA 98 strain. Mutagenicity results were mixed (positive and negative) in the TA 1535, 1537, and 1538 strains. Tinidazole was also mutagenic in a tester strain of Klebsiella pneumonia . Tinidazole was negative for mutagenicity in a mammalian cell culture system utilizing Chinese hamster lung V79 cells (HGPRT test system) and negative for genotoxicity in the Chinese hamster ovary (CHO) sister chromatid exchange assay. Tinidazole was positive for in vivo genotoxicity in the mouse micronucleus assay. In a 60-day male rat fertility study, oral doses of 600 mg/kg (approximately 3-fold the highest human therapeutic dose based on body surface area conversions) reduced fertility and produced testicular histopathology, including tubular degeneration, vacuolation of the seminiferous epithelium in the testis, and hypospermia in the epididymis. At 300 and 600 mg/kg dose levels, significant effects on sperm parameters were observed, including dose-related reduction in sperm motility, epididymal sperm numbers, percentage of normal sperm, retention of spermatids, and decreased epididymal weights. No effects on sperm parameters were observed at 100 mg/kg (approximately 0.5-fold the highest human therapeutic dose based upon body surface area conversions). This effect is characteristic of agents in the 5-nitroimidazole class."]},"tags":[{"label":"Nitroimidazole Antimicrobial","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"A02BD09","category":"atc"},{"label":"Oral","category":"route"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Acute amebiasis","category":"indication"},{"label":"Amebic liver abscess","category":"indication"},{"label":"Bacterial vaginosis","category":"indication"},{"label":"Giardiasis","category":"indication"},{"label":"Infection by Trichomonas","category":"indication"},{"label":"Mission Pharma","category":"company"},{"label":"Approved 2000s","category":"decade"},{"label":"Alkylating Agents","category":"pharmacology"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Antiparasitic Agents","category":"pharmacology"},{"label":"Antiprotozoal Agents","category":"pharmacology"},{"label":"Antitrichomonal Agents","category":"pharmacology"},{"label":"Noxae","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":["WARNING: POTENTIAL RISK FOR CARCINOGENICITY Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent [see Nonclinical Toxicology ( 13.1 )]. Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Limit use of Tinidazole Tablets to approved indications only [see Indications and Usage ( 1.1 , 1.2 , 1.3 )]. Avoid chronic use [see Warnings and Precautions ( 5.1 )]. WARNING: POTENTIAL RISK FOR CARCINOGENICITY See full prescribing information for complete boxed warning. Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent ( 13.1 ). Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Limit use of Tinidazole Tablets to approved indications only ( 1.1 , 1.2 , 1.3 ). Avoid chronic use ( 5.1 )."],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"32 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"28 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"26 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"25 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"23 reports"},{"date":"","signal":"PRURITUS","source":"FDA FAERS","actionTaken":"23 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"23 reports"},{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"21 reports"},{"date":"","signal":"ANXIETY","source":"FDA FAERS","actionTaken":"20 reports"},{"date":"","signal":"NEUROPATHY PERIPHERAL","source":"FDA FAERS","actionTaken":"19 reports"}],"drugInteractions":[{"drug":"Warfarin and other oral coumarin anticoagulants","severity":"major","mechanism":"Tinidazole may enhance the effect of warfarin and other coumarin anticoagulants","management":"Adjustment of oral anticoagulant dosage may be needed during and up to 8 days after tinidazole therapy","clinicalEffect":"Prolongation of prothrombin time"},{"drug":"Alcohol-containing beverages/preparations","severity":"moderate","mechanism":"Unknown, but similar effects as with metronidazole","management":"Avoid during and up to 3 days after tinidazole therapy","clinicalEffect":"Abdominal cramps, nausea, vomiting, headaches, and flushing"},{"drug":"Disulfiram","severity":"moderate","mechanism":"Unknown, but similar effects as with metronidazole","management":"Do not give tinidazole to patients who have taken disulfiram within the last two weeks","clinicalEffect":"Potential psychotic reactions"},{"drug":"Lithium","severity":"moderate","mechanism":"May elevate serum lithium levels","management":"Monitor serum lithium and creatinine levels after several days of simultaneous lithium and tinidazole treatment","clinicalEffect":"Potential lithium intoxication"},{"drug":"Phenytoin, Fosphenytoin","severity":"major","mechanism":"May prolong the half-life and reduce the clearance of phenytoin","management":"Adjustment of anticonvulsant and/or tinidazole dose(s) may be needed","clinicalEffect":"Altered phenytoin pharmacokinetics"},{"drug":"Cyclosporine, Tacrolimus","severity":"major","mechanism":"May increase the levels of cyclosporine and tacrolimus","management":"Monitor for signs of calcineurin-inhibitor associated toxicities during co-administration","clinicalEffect":"Increased risk of calcineurin-inhibitor associated toxicities"},{"drug":"Fluorouracil","severity":"major","mechanism":"May decrease the clearance of fluorouracil","management":"Monitor for fluorouracil-associated toxicities","clinicalEffect":"Increased risk of fluorouracil-associated toxicities"},{"drug":"CYP3A4 inducers/inhibitors","severity":"moderate","mechanism":"May alter the metabolism of tinidazole","management":"Monitor for decreased tinidazole effect or increased adverse reactions","clinicalEffect":"Decreased tinidazole effect or increased adverse reactions"}],"commonSideEffects":[{"effect":"urinary tract infection","drugRate":"≥2%","severity":"common","_validated":true},{"effect":"painful urination","drugRate":"≥2%","severity":"common","_validated":true},{"effect":"urine abnormality","drugRate":"≥2%","severity":"common","_validated":true},{"effect":"flatulence","drugRate":"≥2%","severity":"common","_validated":true},{"effect":"decreased appetite","drugRate":"≥2%","severity":"common","_validated":true},{"effect":"upper respiratory tract infection","drugRate":"reported","severity":"unknown"},{"effect":"menorrhagia","drugRate":"reported","severity":"unknown"},{"effect":"vulvo-vaginal discomfort","drugRate":"reported","severity":"unknown"},{"effect":"vaginal odor","drugRate":"reported","severity":"unknown"},{"effect":"pelvic pain","drugRate":"reported","severity":"unknown"},{"effect":"hypersensitivity reactions","drugRate":"reported","severity":"unknown"},{"effect":"urticaria","drugRate":"reported","severity":"unknown"},{"effect":"pruritis","drugRate":"reported","severity":"unknown"},{"effect":"angioedema","drugRate":"reported","severity":"unknown"},{"effect":"Stevens-Johnson syndrome","drugRate":"reported","severity":"unknown"},{"effect":"erythema multiforme","drugRate":"reported","severity":"unknown"}],"contraindications":["Breastfeeding (mother)","Epilepsy","Neutropenic disorder","Peripheral nerve disease"],"specialPopulations":{"Pregnancy":"The use of tinidazole in pregnant patients has not been studied. Since tinidazole crosses the placental barrier and enters fetal circulation it should not be administered to pregnant patients in the first trimester.","Geriatric use":"Clinical studies of tinidazole did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.","Paediatric use":"Other than for use in the treatment of giardiasis and amebiasis in pediatric patients older than three years of age, safety and effectiveness of tinidazole in pediatric patients have not been established."}},"trials":[],"aliases":[],"company":"Mission Pharma","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$2.7057/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$988","description":"TINIDAZOLE 500 MG TABLET","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=TINIDAZOLE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:27:15.840156+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T01:28:43.246154+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:27:22.158909+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T01:27:14.478086+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=TINIDAZOLE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:27:22.833759+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":"2026-04-20T01:27:13.203160+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:27:13.203208+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:28:33.678360+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (boxed_warning)","rawText":"WARNING: POTENTIAL RISK FOR CARCINOGENICITY Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent [see Nonclinical Toxicology ( 13.1 )]. Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Limit use of Tinidazole Tablets to approved indications only [see Indications and Usage ( 1.1 , 1.2 , 1.3 )]. Avoid chronic use [see Warnings and Precautions ( 5.1 )]. 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