{"id":"tramadol-hcl-acetaminophen-extended-release","safety":{"commonSideEffects":[{"rate":"15-25","effect":"Dizziness"},{"rate":"10-20","effect":"Nausea"},{"rate":"10-15","effect":"Constipation"},{"rate":"5-10","effect":"Headache"},{"rate":"5-10","effect":"Somnolence"},{"rate":"5-10","effect":"Vomiting"},{"rate":"5-8","effect":"Pruritus"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Tramadol is a synthetic opioid that works through dual mechanisms: it binds to mu-opioid receptors and also inhibits the reuptake of norepinephrine and serotonin in the central nervous system, enhancing pain modulation. Acetaminophen complements this by inhibiting prostaglandin synthesis in the CNS. The extended-release formulation provides sustained analgesia over an extended dosing interval.","oneSentence":"Tramadol inhibits norepinephrine and serotonin reuptake while acting as a weak opioid agonist, and acetaminophen reduces pain through central analgesic and antipyretic effects.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:39:04.418Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Moderate to moderately severe pain (chronic pain management)"}]},"trialDetails":[{"nctId":"NCT01819805","phase":"","title":"A Study to Assess the Improvement of Pain and Health-Related Quality of Life in Patients With Chronic Non-Malignant Pain Taking Tramadol Hydrochloride and Acetaminophen","status":"COMPLETED","sponsor":"Janssen Korea, Ltd., Korea","startDate":"2011-09","conditions":"Chronic Pain","enrollment":1065},{"nctId":"NCT01778075","phase":"PHASE1","title":"A Study to Assess the Bioequivalence of a New ULTRACET Extended Release (ER) Tablet With Respect to a Marketed ULTRACET ER Tablet Under Fasted Condition","status":"COMPLETED","sponsor":"Janssen Korea, Ltd., Korea","startDate":"2012-12","conditions":"Healthy","enrollment":56},{"nctId":"NCT01112267","phase":"PHASE3","title":"An Efficacy and Safety Study of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen in Participants With Chronic Low-Back Pain","status":"COMPLETED","sponsor":"Janssen Korea, Ltd., Korea","startDate":"2009-05","conditions":"Low Back Pain","enrollment":248},{"nctId":"NCT01814878","phase":"PHASE3","title":"A Study Comparing the Effectiveness and Safety of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen With Immediate Release (IR) Tramadol HCl/Acetaminophen in Participants With Moderate to Severe Postoperative Pain","status":"COMPLETED","sponsor":"Janssen Korea, Ltd., Korea","startDate":"2009-11","conditions":"Pain, Postoperative","enrollment":320},{"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}],"_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":["Ultracet Extended Relaese","Ultracet","Ultracet ER semi"],"phase":"marketed","status":"active","brandName":"Tramadol HCl/acetaminophen Extended Release","genericName":"Tramadol HCl/acetaminophen Extended Release","companyName":"Janssen Korea, Ltd., Korea","companyId":"janssen-korea-ltd-korea","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Tramadol inhibits norepinephrine and serotonin reuptake while acting as a weak opioid agonist, and acetaminophen reduces pain through central analgesic and antipyretic effects. Used for Moderate to moderately severe pain (chronic pain management).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}