{"id":"fdc-ketoprofen-omeprazole","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Dyspepsia"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Abdominal pain"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ketoprofen inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing pain and inflammation. Omeprazole suppresses gastric acid secretion by inhibiting the H+/K+-ATPase pump, protecting against NSAID-induced gastrointestinal ulceration and damage. The combination allows NSAID efficacy while mitigating GI toxicity.","oneSentence":"This fixed-dose combination reduces pain and inflammation via ketoprofen (NSAID) while protecting the stomach lining via omeprazole (proton pump inhibitor).","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:12:20.143Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic pain conditions requiring NSAID therapy with gastric protection"},{"name":"Osteoarthritis or rheumatoid arthritis with high GI ulcer risk"}]},"trialDetails":[{"nctId":"NCT00971581","phase":"PHASE3","title":"Safety, Tolerability and Efficacy Study With a Fixed-Dose Combination (FDC) Ketoprofen Plus Omeprazole","status":"COMPLETED","sponsor":"Sanofi","startDate":"2009-08","conditions":"Pain","enrollment":52}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"FDC KETOPROFEN+OMEPRAZOLE","genericName":"FDC KETOPROFEN+OMEPRAZOLE","companyName":"Sanofi","companyId":"sanofi","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This fixed-dose combination reduces pain and inflammation via ketoprofen (NSAID) while protecting the stomach lining via omeprazole (proton pump inhibitor). Used for Chronic pain conditions requiring NSAID therapy with gastric protection, Osteoarthritis or rheumatoid arthritis with high GI ulcer risk.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}