{"id":"omeprazole-20mg-twice-daily","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"drugInteractions":["Warfarin: Increased INR and risk of bleeding","Phenytoin: Increased serum levels of phenytoin","Clopidogrel: Reduced effectiveness of clopidogrel","Mycophenolate mofetil: Decreased mycophenolic acid exposure"],"commonSideEffects":[{"effect":"Headache","drugRate":"10%","severity":"Mild"},{"effect":"Diarrhea","drugRate":"6%","severity":"Mild"},{"effect":"Nausea","drugRate":"4%","severity":"Mild"},{"effect":"Abdominal pain","drugRate":"3%","severity":"Mild"},{"effect":"Vomiting","drugRate":"2%","severity":"Mild"},{"effect":"Dizziness","drugRate":"2%","severity":"Mild"},{"effect":"Constipation","drugRate":"2%","severity":"Mild"}],"contraindications":["Hypersensitivity to omeprazole or any component of the formulation"],"specialPopulations":{"Elderly":"No dosage adjustment necessary","Pediatric":"Safety and efficacy established in children aged 1 year and older","Renal Impairment":"No dosage adjustment necessary","Hepatic Impairment":"Reduce dose to 10 mg once daily"}},"trials":[],"_chembl":null,"aliases":["PPI Platelet Inhibitory"],"patents":[{"number":"US4758579A","issueDate":"1988-07-19","expirationDate":"2005-07-19"}],"pricing":[],"offLabel":[],"timeline":[{"date":"1989","type":"Approval","milestone":"First approved by the FDA","regulator":"FDA"},{"date":"2001","type":"Regulatory Change","milestone":"Over-the-counter availability in some countries","regulator":"Various"}],"_dailymed":null,"aiSummary":"Omeprazole is a proton pump inhibitor (PPI) used to reduce stomach acid production. It is prescribed for conditions such as gastroesophageal reflux disease (GERD), peptic ulcer disease, and Zollinger-Ellison syndrome. The drug works by inhibiting the H+/K+ ATPase enzyme system in the gastric parietal cells, effectively reducing acid secretion. Despite its efficacy, omeprazole has several side effects, including headache, diarrhea, and nausea. The drug is not associated with any boxed warnings but has specific contraindications and interactions that should be considered. Omeprazole is widely used and has been on the market for many years, with significant competition from other PPIs.","ecosystem":[],"mechanism":{"target":"H+/K+ ATPase enzyme","novelty":"First-in-class PPI","modality":"Oral","drugClass":"Proton Pump Inhibitor (PPI)","explanation":"Omeprazole is a prodrug that is activated in the acidic environment of the stomach, where it forms a sulfenamide derivative that binds to the H+/K+ ATPase enzyme, inhibiting the final step of acid production.","oneSentence":"Omeprazole reduces stomach acid production by irreversibly inhibiting the H+/K+ ATPase enzyme in gastric parietal cells.","technicalDetail":"The active metabolite of omeprazole covalently binds to the cysteine residues of the H+/K+ ATPase enzyme, leading to irreversible inhibition of the proton pump."},"_scrapedAt":"2026-03-27T23:58:19.797Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"Not available","launchDate":"1989","annualCostUS":"$10 - $30 per month","currentRevenue":"Not available","patientPopulation":"Widely used for GERD and peptic ulcer disease","peakSalesEstimate":"Not available"},"references":[],"biosimilars":[],"competitors":["Lansoprazole","Esomeprazole","Pantoprazole","Rabeprazole"],"indications":{"approved":["Gastroesophageal Reflux Disease (GERD)","Peptic Ulcer Disease","Zollinger-Ellison Syndrome"],"offLabel":["Helicobacter pylori eradication","Eosinophilic Esophagitis"],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT07312370","phase":"PHASE4","title":"Esomeprazole Plus Sucralfate for Post-ESD Ulcer Healing","status":"NOT_YET_RECRUITING","sponsor":"LanZhou University","startDate":"2026-04-20","conditions":"Early Gastric Cancer, Gastric Dysplasia, Gastric Neoplasms","enrollment":120},{"nctId":"NCT04337580","phase":"PHASE2","title":"Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer","status":"RECRUITING","sponsor":"Wake Forest University Health Sciences","startDate":"2021-03-05","conditions":"Prostate Cancer, Refractory Cancer, Castration Resistant Prostatic Cancer","enrollment":50},{"nctId":"NCT05799105","phase":"PHASE4","title":"OPEN Versus InTact Capsule Proton Pump Inhibitors for the Treatment of Marginal Ulcers","status":"RECRUITING","sponsor":"Stephen Firkins","startDate":"2023-03-14","conditions":"Marginal Ulcer","enrollment":122},{"nctId":"NCT07293910","phase":"PHASE2","title":"Vonoprazan vs Proton Pump Inhibitor With Vitamin D or Probiotics Based Triple Therapy for Eradication of Helicobacter Pylori Infection","status":"RECRUITING","sponsor":"Tanta University","startDate":"2026-02-15","conditions":"HELICOBACTER PYLORI INFECTIONS, Helicobacter Infection, Helicobacter Pylori Gastrointestinal Tract Infection","enrollment":66},{"nctId":"NCT03947385","phase":"PHASE1, PHASE2","title":"Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions","status":"RECRUITING","sponsor":"IDEAYA Biosciences","startDate":"2019-06-28","conditions":"Metastatic Uveal Melanoma, Cutaneous Melanoma, Colorectal Cancer","enrollment":336},{"nctId":"NCT05647278","phase":"PHASE4","title":"Tegoprazan-Amoxicillin Dual Therapy vs. Bismuth Quadruple Therapy for H. 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