{"id":"ibuprofen-plus-caffeine","safety":{"commonSideEffects":[{"rate":null,"effect":"Gastrointestinal upset"},{"rate":null,"effect":"Dyspepsia"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Jitteriness or nervousness (caffeine-related)"},{"rate":null,"effect":"Insomnia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that blocks COX-1 and COX-2 enzymes, thereby decreasing prostaglandin production and providing anti-inflammatory, analgesic, and antipyretic effects. Caffeine acts as an adenosine receptor antagonist and enhances the analgesic potency of ibuprofen, allowing for lower doses and faster pain relief while also counteracting potential sedation.","oneSentence":"Ibuprofen inhibits cyclooxygenase enzymes to reduce prostaglandin synthesis and inflammation, while caffeine enhances analgesic efficacy and reduces drowsiness.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:15:26.123Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute pain relief (headache, migraine, dental pain, musculoskeletal pain)"}]},"trialDetails":[{"nctId":"NCT01462370","phase":"PHASE3","title":"Study to Assess the Safety and Efficacy of Etoricoxib Versus Ibuprofen in the Treatment of Dysmenorrhea (MK-0663-145 AM1)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2011-11","conditions":"Dysmenorrhea","enrollment":139},{"nctId":"NCT02344225","phase":"PHASE2","title":"Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP Study)","status":"COMPLETED","sponsor":"State University of New York - Downstate Medical Center","startDate":"2015-01-01","conditions":"Retinopathy of Prematurity","enrollment":14},{"nctId":"NCT03003000","phase":"PHASE3","title":"Ibuprofen/Caffeine Lower Back or Neck Pain Study","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2016-12-20","conditions":"Back Pain, Neck Pain","enrollment":635},{"nctId":"NCT02863575","phase":"PHASE3","title":"A Dental Pain Study Comparing The Analgesic Efficacy Of Ibuprofen/Caffeine","status":"COMPLETED","sponsor":"Pfizer","startDate":"2017-10-24","conditions":"Pain","enrollment":374},{"nctId":"NCT01842633","phase":"PHASE3","title":"Clinical Study to Evaluate Efficacy of New Paracetamol Formulation Compared to Ibuprofen in Headache","status":"TERMINATED","sponsor":"GlaxoSmithKline","startDate":"2013-04-01","conditions":"Pain","enrollment":365},{"nctId":"NCT00223691","phase":"PHASE1","title":"Treatment of Orthostatic Hypotension in Autonomic Failure","status":"COMPLETED","sponsor":"Vanderbilt University","startDate":"2002-03","conditions":"Autonomic Failure, Orthostatic Hypotension","enrollment":389},{"nctId":"NCT01929031","phase":"PHASE3","title":"Efficacy and Safety of Ibuprofen and Caffeine in Dental Pain","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2013-08","conditions":"Pain, Postoperative, Tooth Diseases","enrollment":562},{"nctId":"NCT01755702","phase":"PHASE2, PHASE3","title":"Paracetamol With Caffeine to Treat Episodic Tension Type Headache","status":"TERMINATED","sponsor":"GlaxoSmithKline","startDate":"2009-07","conditions":"Headache, Tension-Type","enrollment":66},{"nctId":"NCT01426971","phase":"PHASE3","title":"Ibuprofen Versus Ibuprofen Plus Caffeine in the Treatment of Migraine.","status":"WITHDRAWN","sponsor":"Sanofi","startDate":"2012-12","conditions":"Pain","enrollment":""},{"nctId":"NCT01172405","phase":"PHASE3","title":"Efficacy and Safety Study to Compare Ibuprofen + Caffeine With Ibuprofen Alone in the Treatment of Headache","status":"UNKNOWN","sponsor":"Mantecorp Industria Quimica e Farmaceutica Ltd.","startDate":"2010-10","conditions":"Headache","enrollment":144}],"_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":"Ibuprofen plus caffeine","genericName":"Ibuprofen plus caffeine","companyName":"Mantecorp Industria Quimica e Farmaceutica Ltd.","companyId":"mantecorp-industria-quimica-e-farmaceutica-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ibuprofen inhibits cyclooxygenase enzymes to reduce prostaglandin synthesis and inflammation, while caffeine enhances analgesic efficacy and reduces drowsiness. Used for Acute pain relief (headache, migraine, dental pain, musculoskeletal pain).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}