{"id":"omeprazole","rwe":[],"_fda":{"id":"bbbf9415-a533-1629-8f52-3f286fdc2d46","set_id":"0057cb91-fc5e-8e9d-a926-299405c5c3a8","openfda":{"nui":["N0000175525","N0000000147","N0000182140"],"unii":["KG60484QX9"],"route":["ORAL"],"rxcui":["402014"],"spl_id":["bbbf9415-a533-1629-8f52-3f286fdc2d46"],"brand_name":["Omeprazole"],"spl_set_id":["0057cb91-fc5e-8e9d-a926-299405c5c3a8"],"package_ndc":["63868-471-42","63868-471-14"],"product_ndc":["63868-471"],"generic_name":["OMEPRAZOLE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["OMEPRAZOLE"],"pharm_class_epc":["Proton Pump Inhibitor [EPC]"],"pharm_class_moa":["Proton Pump Inhibitors [MoA]","Cytochrome P450 2C19 Inhibitors [MoA]"],"manufacturer_name":["Chain Drug Marketing Association INC"],"application_number":["ANDA207740"],"is_original_packager":[true]},"purpose":["Purpose Acid reducer"],"version":"4","stop_use":["Stop use and ask doctor if: your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months you get diarrhea you develop a rash or joint pain"],"warnings":["Warnings Allergy alert: do not use if you are allergic to omeprazole omeprazole may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If an allergic reaction occurs, stop use and seek medical help right away. Do not use if you have: trouble or pain swallowing food, vomiting with blood, or bloody or black stools heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadednes frequent chest pain These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have : had heartburn over 3 months. This may be a sign of a more serious condition. frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs. Stop use and ask doctor if: your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months you get diarrhea you develop a rash or joint pain If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)"],"questions":["Questions or comments? call 1-888-375-3784 Distributed by: Dr. Reddy’s Laboratories Inc., Princeton, NJ 08540 Made in India"],"ask_doctor":["Ask a doctor before use if you have : had heartburn over 3 months. This may be a sign of a more serious condition. frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain"],"do_not_use":["Do not use if you have: trouble or pain swallowing food, vomiting with blood, or bloody or black stools heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadednes frequent chest pain These may be signs of a serious condition. See your doctor."],"effective_time":"20241110","active_ingredient":["Active ingredient(s) Omeprazole USP, 20 mg"],"inactive_ingredient":["Inactive ingredients ammonia solution, ammonium hydroxide, carnauba wax, hypromellose acetate succinate, hypromellose, iron oxide black, lactose monohydrate, monoethanolamine, n-butyl alcohol, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, red iron oxide, sodium stearate, sodium starch glycolate, shellac glaze, sodium lauryl sulphate, sodium stearyl fumarate, talc, titanium dioxide, triethyl citrate, yellow iron oxide"],"indications_and_usage":["Use(s) treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs."],"spl_unclassified_section":["Other information read the directions and warnings before use keep the carton. It contains important information. store at 20 to 25°C (68 to 77° F) and protect from moisture"],"dosage_and_administration":["Directions for adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment swallow 1 tablet with a glass of water before eating in the morning take every day for 14 days do not take more than 1 tablet a day do not use for more than 14 days unless directed by your doctor swallow whole. Do not chew or crush tablets Repeated 14-Day Courses (if needed) you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition."],"spl_product_data_elements":["Omeprazole Omeprazole OMEPRAZOLE OMEPRAZOLE AMMONIA CARNAUBA WAX HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S) HYPROMELLOSES FERROSOFERRIC OXIDE LACTOSE MONOHYDRATE MONOETHANOLAMINE BUTYL ALCOHOL Polyethylene Glycol 3350 POLYVINYL ALCOHOL POVIDONE PROPYLENE GLYCOL FERRIC OXIDE RED SODIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO SHELLAC SODIUM LAURYL SULFATE SODIUM STEARYL FUMARATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE FERRIC OXIDE YELLOW brownish pink O20 Carton Container"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)"],"package_label_principal_display_panel":["Principal Display Panel"]},"tags":[],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":["Acute nephropathy","Atrophic gastritis","Chronic heart failure","Disease of liver","Edema","Fracture of bone","Hepatic failure","Hypomagnesemia","Oliguria","Osteoporosis"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"approved","trials":["NCT00243724","NCT04034641","NCT00303264","NCT01911728","NCT00164931","NCT00164866","NCT03866434","NCT02685436","NCT03647852","NCT03779087","NCT04178187","NCT01822600","NCT01517399","NCT01874535","NCT01119768","NCT05635110","NCT00981929","NCT01980095","NCT03943992","NCT06719622","NCT05038969","NCT02433457","NCT04696783","NCT01777854","NCT05624229","NCT03086070","NCT06215430","NCT03198507","NCT05264142","NCT04914936","NCT01599858","NCT00930306","NCT00442208","NCT07104318","NCT00559182","NCT06811207","NCT03908619","NCT01415128","NCT03127046","NCT05467475","NCT02772601","NCT01129375","NCT05852769","NCT03505853","NCT05849883","NCT06949124","NCT01470690","NCT04254783","NCT00849329","NCT03736369"],"aliases":["Prilosec","Losec","Omez"],"patents":[{"type":"Formulation","number":"10835488","applicant":"DEXCEL PHARMA TECHNOLOGIES LTD","territory":"US","tradeName":"OMEPRAZOLE","expiryDate":"2036-12-08"},{"type":"Formulation","number":"10076494","applicant":"DEXCEL PHARMA TECHNOLOGIES LTD","territory":"US","tradeName":"OMEPRAZOLE","expiryDate":"2036-12-08"}],"pricing":[],"_sources":{"_fda":{"url":"","method":"api_direct","source":"FDA OpenFDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:55:07.265179+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"Haiku strategic summary","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T07:55:09.092873+00:00"}},"allNames":"prilosec","offLabel":[],"timeline":[],"aiSummary":"Prilosec, also known as omeprazole, is a small molecule inhibitor of the potassium-transporting ATPase. It is used to treat conditions such as gastroesophageal reflux disease (GERD), peptic ulcer disease, and Zollinger–Ellison syndrome.","brandName":"Prilosec","companyId":"astrazeneca","ecosystem":[],"mechanism":{"target":"ATP-binding cassette sub-family G member 2, Cytochrome P450 1A2, Cytochrome P450 2C19","novelty":"","modality":"Small molecule","drugClass":"Proton pump inhibitor (PPI)","explanation":"Omeprazole was the first proton pump inhibitor, revolutionizing the treatment of acid-related disorders. It works by irreversibly binding to the hydrogen-potassium ATPase enzyme system on the surface of gastric parietal cells, blocking the final step of acid production. A single dose suppresses about 90% of daily gastric acid output. Developed by Astra AB, it became one of the best-selling drugs in pharmaceutical history and is now available OTC.","oneSentence":"Irreversibly inhibits the hydrogen-potassium ATPase (proton pump) in gastric parietal cells, potently suppressing stomach acid secretion.","technicalDetail":""},"commercial":{"revenueYear":2023,"annualRevenue":1041,"revenueSource":"Groq: Pfizer 10-K FY2023","revenueCurrency":"USD","revenueConfidence":"groq-knowledge"},"references":[],"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T08:28:03.190683+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"companyName":"AstraZeneca (originally Astra AB)","competitors":[],"genericName":"omeprazole","indications":{"approved":[{"name":"Duodenal Ulcer due to H. Pylori","diseaseId":"duodenal-ulcer-due-to-h.-pylori","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Duodenal ulcer disease","diseaseId":"duodenal-ulcer-disease","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Erosive esophagitis","diseaseId":"erosive-esophagitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Gastric Hypersecretory Conditions","diseaseId":"gastric-hypersecretory-conditions","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Gastric ulcer","diseaseId":"gastric-ulcer","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Gastroesophageal reflux disease","diseaseId":"gastroesophageal-reflux-disease","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Maintenance of Healing Erosive Esophagitis","diseaseId":"maintenance-of-healing-erosive-esophagitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Pathological Gastric Hypersecretory Condition","diseaseId":"pathological-gastric-hypersecretory-condition","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Peptic reflux disease","diseaseId":"peptic-reflux-disease","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Peptic ulcer","diseaseId":"peptic-ulcer","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Reduction of risk of upper gastrointestinal bleeding","diseaseId":"reduction-of-risk-of-upper-gastrointestinal-bleeding","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Zollinger-Ellison syndrome","diseaseId":"zollinger-ellison-syndrome","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT00243724","phase":"Phase 3","title":"An Open-Label, Parallel-Group, Multi-Centre Study to Determine the Effect of Treatment With Esomeprazole for Six Months on Histological Markers of Esophageal Epithelial Acid-Related Disease in Patient","status":"COMPLETED","sponsor":"AstraZeneca","isPivotal":true,"enrollment":350,"indication":"Gastroesophageal Reflux, Heartburn","completionDate":"2007-06"},{"nctId":"NCT04034641","phase":"Phase 4","title":"Clinical Study on Bifidobacterium Quadruple Live Bacteria Tablets (Si Lian Kang) Reducing the Incidence Rate of Adverse Reactions in Helicobacter Pylori Quadruple Eradication Therapy and on the Effect","status":"UNKNOWN","sponsor":"Hangzhou Grand Biologic Pharmaceutical, Inc.","isPivotal":false,"enrollment":238,"indication":"Helicobacter Pylori Eradication","completionDate":"2021-12-31"},{"nctId":"NCT00303264","phase":"Phase 2","title":"A Phase II Study to Investigate the Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia.","status":"COMPLETED","sponsor":"Forest Laboratories","isPivotal":false,"enrollment":48,"indication":"Dyspepsia","completionDate":"2007-08"},{"nctId":"NCT01911728","phase":"Phase 1","title":"A Phase I Open-label Study to Evaluate the Effect of Multiple Doses of MDV3100 (ASP9785) on the Pharmacokinetics of Substrates for CYP2C8, CYP2C9, CYP2C19, and CYP3A4 in Patients With Castration-resis","status":"COMPLETED","sponsor":"Astellas Pharma Europe B.V.","isPivotal":false,"enrollment":14,"indication":"Pharmacokinetics of MDV3100, Castration Resistant Prostate Cancer (CRPC)","completionDate":"2012-02-21"},{"nctId":"NCT00164931","phase":"Phase 3","title":"Phase 3 Study of Prospective Randomized Trial Comparing Adjunctive High Dose Omeprazole Infusion Against Scheduled Second Endoscopy in the Prevention of Peptic Ulcer Rebleeding After Therapeutic Endos","status":"COMPLETED","sponsor":"Chinese University of Hong Kong","isPivotal":true,"enrollment":240,"indication":"Peptic Ulcer Hemorrhage","completionDate":""},{"nctId":"NCT00164866","phase":"Phase 4","title":"Administration of Intravenous Proton Pump Inhibitor Prior to Endoscopy [APPE] in Patients With Upper Gastrointestinal Bleeding; 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