{"id":"ibuprofen-famotidine","safety":{"commonSideEffects":[{"rate":null,"effect":"Dyspepsia"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Abdominal pain"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ibuprofen is a nonsteroidal anti-inflammatory drug that inhibits cyclooxygenase (COX) enzymes to reduce inflammation and pain. Famotidine is an H2-receptor antagonist that decreases gastric acid secretion. The combination aims to provide NSAID efficacy while reducing the risk of NSAID-induced gastrointestinal ulcers and bleeding, a known adverse effect of ibuprofen monotherapy.","oneSentence":"This combination drug reduces stomach acid (via famotidine, an H2-receptor antagonist) while providing anti-inflammatory and analgesic effects (via ibuprofen, an NSAID), designed to minimize gastrointestinal injury from NSAID use.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:15:26.133Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic pain conditions where NSAID use is indicated, with reduced gastrointestinal risk"}]},"trialDetails":[{"nctId":"NCT00984815","phase":"PHASE3","title":"Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment","status":"COMPLETED","sponsor":"Amgen","startDate":"2009-09","conditions":"Osteoarthritis, Rheumatoid Arthritis, Chronic Low Back Pain","enrollment":86},{"nctId":"NCT00613106","phase":"PHASE3","title":"Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216)","status":"COMPLETED","sponsor":"Amgen","startDate":"2007-09","conditions":"Osteoarthritis, Rheumatoid Arthritis, Chronic Low Back Pain","enrollment":179},{"nctId":"NCT00450658","phase":"PHASE3","title":"Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers","status":"COMPLETED","sponsor":"Amgen","startDate":"2007-03","conditions":"Peptic Ulcer","enrollment":627},{"nctId":"NCT01563185","phase":"PHASE4","title":"Open-label Safety and Pharmacokinetic Study of DUEXIS® (Ibuprofen and Famotidine) Tablets in Juvenile Idiopathic Arthritis","status":"COMPLETED","sponsor":"Amgen","startDate":"2012-04","conditions":"Juvenile Idiopathic Arthritis","enrollment":12},{"nctId":"NCT00450216","phase":"PHASE3","title":"Efficacy and Safety Study of HZT-501 in Subjects Requiring Nonsteroidal Anti-Inflammatory Drug (NSAID) Treatment","status":"COMPLETED","sponsor":"Amgen","startDate":"2007-03","conditions":"Ulcer","enrollment":906},{"nctId":"NCT04990388","phase":"PHASE1, PHASE2","title":"Safety, Tolerability, and Pharmacokinetics of UX053 in Patients With Glycogen Storage Disease Type III (GSD III)","status":"TERMINATED","sponsor":"Ultragenyx Pharmaceutical Inc","startDate":"2021-10-18","conditions":"Glycogen Storage Disease Type III","enrollment":9},{"nctId":"NCT04990804","phase":"PHASE4","title":"Opioid Free vs. Standard Perioperative Pain Regimen for Anterior Cervical Discectomy and Fusion (ACDF) Surgery","status":"TERMINATED","sponsor":"Vanderbilt University Medical Center","startDate":"2021-08-01","conditions":"Opioid Use, Spinal Diseases, Surgery--Complications","enrollment":8},{"nctId":"NCT01734759","phase":"PHASE1","title":"Influence of Medication Taste on Pediatric Prescribers' Prescribing Habits","status":"COMPLETED","sponsor":"Mayo Clinic","startDate":"2012-11","conditions":"Healthy","enrollment":50}],"_emaApprovals":[],"_faersSignals":[{"count":1,"reaction":"ABDOMINAL PAIN UPPER"},{"count":1,"reaction":"ANKLE FRACTURE"},{"count":1,"reaction":"ARTHRALGIA"},{"count":1,"reaction":"BONE DISORDER"},{"count":1,"reaction":"COVID-19"},{"count":1,"reaction":"FALL"},{"count":1,"reaction":"FEELING HOT"},{"count":1,"reaction":"FIBULA FRACTURE"},{"count":1,"reaction":"FUNGAL INFECTION"},{"count":1,"reaction":"INFLUENZA"}],"_approvalHistory":[],"publicationCount":10,"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":"Ibuprofen/famotidine","genericName":"Ibuprofen/famotidine","companyName":"Amgen","companyId":"amgen","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This combination drug reduces stomach acid (via famotidine, an H2-receptor antagonist) while providing anti-inflammatory and analgesic effects (via ibuprofen, an NSAID), designed to minimize gastrointestinal injury from NSAID use. Used for Chronic pain conditions where NSAID use is indicated, with reduced gastrointestinal risk.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}