{"id":"comparator-acetaminophen-codeine","safety":{"commonSideEffects":[{"rate":null,"effect":"Drowsiness"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Constipation"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Respiratory depression"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Acetaminophen's exact mechanism is not fully understood but is believed to involve inhibition of prostaglandin synthesis in the central nervous system and modulation of serotonergic and cannabinoid pathways. Codeine is a prodrug that is metabolized to morphine and acts as a mu-opioid receptor agonist, providing additional analgesic and antitussive effects. The combination provides synergistic pain relief for moderate pain conditions.","oneSentence":"Acetaminophen reduces fever and pain through central nervous system effects, while codeine is an opioid agonist that enhances analgesia and suppresses cough.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:06:53.126Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Moderate pain"},{"name":"Pain with fever"}]},"trialDetails":[{"nctId":"NCT05488847","phase":"PHASE4","title":"Opioid-Free Pain Protocol After Shoulder Arthroplasty","status":"ACTIVE_NOT_RECRUITING","sponsor":"Henry Ford Health System","startDate":"2022-06-25","conditions":"Shoulder Arthropathy, Shoulder Pain","enrollment":83},{"nctId":"NCT03789318","phase":"PHASE2","title":"Study in Subjects Undergoing Complete Abdominoplasty","status":"COMPLETED","sponsor":"Concentric Analgesics","startDate":"2018-12-03","conditions":"Postsurgical Pain","enrollment":54},{"nctId":"NCT02197156","phase":"PHASE2","title":"A Multicenter Active Comparator Study of HC-ER in Adults Following Bunionectomy Surgery","status":"COMPLETED","sponsor":"Zogenix, Inc.","startDate":"2002-08","conditions":"Postoperative Pain","enrollment":241},{"nctId":"NCT00694369","phase":"PHASE3","title":"A Study to Asses the Effect of MK0663 in the Treatment of Patients With Postoperative Dental Pain (0663-092)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2008-06","conditions":"Postoperative Dental Pain","enrollment":588},{"nctId":"NCT00685295","phase":"PHASE1, PHASE2","title":"Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2008-08","conditions":"Pain, Fracture, Sprain","enrollment":60},{"nctId":"NCT00390260","phase":"PHASE3","title":"Effect of Rofecoxib and a Narcotic Analgesic to Treat Pain Following Arthroscopic Surgery (0966-179)(COMPLETED)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2002-02","conditions":"Pain, Postoperative Arthroscopy","enrollment":420},{"nctId":"NCT02462811","phase":"PHASE3","title":"A Double-Blind, Randomized, Active- and Placebo-Controlled, Multiple-Dose Multi-Center Phase 3 Study of the Safety and Efficacy of CL-108 in the Treatment of Moderate to Severe Acute Pain and Opioid-Induced Nausea and Vomiting (OINV)","status":"COMPLETED","sponsor":"Joseph Hazelton","startDate":"2014-09","conditions":"Pain, Nausea, Vomiting","enrollment":552},{"nctId":"NCT02902666","phase":"PHASE1","title":"Bioequivalence Study of One Tablet of Paracetamol 1000 mg + Codeine 30 mg vs. Two Tablets of Paracetamol 500 mg + Codeine 30 mg","status":"COMPLETED","sponsor":"Aziende Chimiche Riunite Angelini Francesco S.p.A","startDate":"2016-04","conditions":"Healthy","enrollment":46},{"nctId":"NCT00802087","phase":"PHASE1","title":"Single Dose Pharmacokinetics of Egalet® Hydrocodone","status":"COMPLETED","sponsor":"Egalet Ltd","startDate":"2008-11","conditions":"Pain","enrollment":28},{"nctId":"NCT02625753","phase":"PHASE3","title":"Codeine Plus Paracetamol Versus Placebo for PRK Post-operative Pain","status":"COMPLETED","sponsor":"University of Sao Paulo General Hospital","startDate":"2014-11","conditions":"Myopia","enrollment":40}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":68,"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":"Comparator: acetaminophen + codeine","genericName":"Comparator: acetaminophen + codeine","companyName":"Organon and Co","companyId":"organon-and-co","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Acetaminophen reduces fever and pain through central nervous system effects, while codeine is an opioid agonist that enhances analgesia and suppresses cough. Used for Moderate pain, Pain with fever.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}