{"id":"ultracet","safety":{"commonSideEffects":[{"rate":"25-30","effect":"Dizziness"},{"rate":"15-20","effect":"Nausea"},{"rate":"10-15","effect":"Constipation"},{"rate":"10-15","effect":"Headache"},{"rate":"10-15","effect":"Somnolence"},{"rate":"5-10","effect":"Vomiting"},{"rate":"5-10","effect":"Pruritus"}]},"_chembl":null,"_dailymed":{"setId":"5d64d06a-1c95-4ec2-97ab-d0b2c57f261f","title":"ULTRACET (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Tramadol acts as a weak mu-opioid receptor agonist and inhibits the reuptake of norepinephrine and serotonin, enhancing descending pain inhibitory pathways. Acetaminophen works through unclear mechanisms involving central COX inhibition and endocannabinoid pathways. Together, these agents provide synergistic analgesia for moderate pain.","oneSentence":"Ultracet combines tramadol (an opioid agonist and monoamine reuptake inhibitor) with acetaminophen to provide enhanced pain relief through dual analgesic pathways.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:42:10.036Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Moderate acute pain in adults"}]},"trialDetails":[{"nctId":"NCT01880125","phase":"PHASE1","title":"Assessment of the Pharmacokinetics of a Sustained Release Formulation of a Tramadol/Acetaminophen Combination","status":"COMPLETED","sponsor":"Yungjin Pharm. Co., Ltd.","startDate":"2012-01","conditions":"Pain","enrollment":24},{"nctId":"NCT00766402","phase":"PHASE4","title":"An Efficacy and Safety Study of Tramadol/Acetaminophen Versus Diclofenac in the Treatment of Pain in Participants With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-rheumatic Drugs (DMARDs)","status":"TERMINATED","sponsor":"Johnson & Johnson Taiwan Ltd","startDate":"2008-10","conditions":"Spondylitis, Ankylosing, Pain","enrollment":8},{"nctId":"NCT00973232","phase":"PHASE1","title":"A Comparative Bioavailability/Food Effect Study of Immediate-Release and Extended-Release Tramadol HCl/Acetaminophen Combination Products Following Single-Dose and Multiple-Dose Administration in Healthy Adult Volunteers","status":"COMPLETED","sponsor":"Labopharm Inc.","startDate":"2008-05","conditions":"Healthy","enrollment":58},{"nctId":"NCT00236483","phase":"PHASE4","title":"A Comparison of the Effectiveness and Safety of ULTRACET® (Tramadol Hydrochloride/Acetaminophen) Versus ULTRAM® (Tramadol Hydrochloride) Versus Placebo in Patients With Pain After Oral Surgery","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2002-11","conditions":"Surgery, Oral, Pain, Postoperative","enrollment":456},{"nctId":"NCT00210561","phase":"PHASE4","title":"A Study of the Effectiveness and Safety of Tramadol HCl/Acetaminophen Compared to Placebo in Treating Acute Low Back Pain","status":"TERMINATED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2005-03","conditions":"Back Pain, Low Back Pain","enrollment":22},{"nctId":"NCT00297375","phase":"PHASE4","title":"A Study Comparing the Effectiveness and Safety of ULTRACET® (Tramadol HCl/Acetaminophen) Versus Placebo for the Treatment of Acute Pain From a Migraine Headache","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2003-04","conditions":"Migraine, Head Pain, Headache","enrollment":375},{"nctId":"NCT00576173","phase":"PHASE4","title":"An Open Label Study to Evaluate Safety, Tolerability and Clinical Utility of ULTRACET® (37.5mg Tramadol Hydrochloride/325mg Acetaminophen) for the Treatment of Breakthrough Pain in Cancer Patients","status":"COMPLETED","sponsor":"Johnson & Johnson Taiwan Ltd","startDate":"2005-12","conditions":"Pain","enrollment":60},{"nctId":"NCT00647517","phase":"PHASE4","title":"Tramadol/Acetaminophen(Ultracet) AS add-on Therapy in the Treatment of Patients With Ankylosing Spondylitis","status":"COMPLETED","sponsor":"Chung Shan Medical University","startDate":"2008-03","conditions":"Ankylosing Spondylitis","enrollment":60}],"_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":["Tramadol/APAP","Tramadol APAP"],"phase":"marketed","status":"active","brandName":"Ultracet®","genericName":"Ultracet®","companyName":"Labopharm Inc.","companyId":"labopharm-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ultracet combines tramadol (an opioid agonist and monoamine reuptake inhibitor) with acetaminophen to provide enhanced pain relief through dual analgesic pathways. Used for Moderate acute pain in adults.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}