{"id":"tramadol-hydrochloride-acetaminophen-tab","safety":{"commonSideEffects":[{"rate":"15-25","effect":"Nausea"},{"rate":"10-20","effect":"Dizziness"},{"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":"anthropic-haiku","explanation":"Tramadol is a synthetic opioid that works through dual mechanisms: it binds to mu-opioid receptors and 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, providing additional analgesic and antipyretic activity. The combination provides enhanced pain relief for moderate to moderately severe pain.","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":"2026-03-28T01:39:44.233Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Moderate to moderately severe acute pain"}]},"trialDetails":[{"nctId":"NCT06345716","phase":"PHASE2","title":"Paracetamol-Tramadol and Paracetamol-caffeine Versus Placebo in the Emergency Discharge Treatment of Renal Colic","status":"RECRUITING","sponsor":"University of Monastir","startDate":"2024-04-10","conditions":"Renal Colic","enrollment":1500},{"nctId":"NCT06590714","phase":"NA","title":"Perioperative Polmacoxib Reduce Opioid Consumption for Post Operative Pain After Rotator Cuff Tear.","status":"RECRUITING","sponsor":"Eulji University Hospital","startDate":"2024-08-23","conditions":"Rotator Cuff Tear","enrollment":150},{"nctId":"NCT04533009","phase":"PHASE4","title":"Tramadol-paracetamol Combination in Treatment of Patients Undergoing Spinal Surgery","status":"UNKNOWN","sponsor":"Kuopio University Hospital","startDate":"2020-02-01","conditions":"Pain, Postoperative","enrollment":120},{"nctId":"NCT02845271","phase":"PHASE2","title":"Proof-of-concept Study to Assess the Efficacy, Tolerability and Safety of a Single Intraarticular Dose of GZ389988 Versus Placebo in Patients With Painful Osteoarthritis of the Knee","status":"COMPLETED","sponsor":"Genzyme, a Sanofi Company","startDate":"2016-07-21","conditions":"Osteoarthritis","enrollment":104},{"nctId":"NCT04968158","phase":"PHASE3","title":"Efficacy and Safety of Fixed-dose Combination of Etoricoxib/Tramadol vs Acetaminophen/Tramadol for Acute Low Back Pain","status":"COMPLETED","sponsor":"Laboratorios Silanes S.A. de C.V.","startDate":"2021-11-29","conditions":"Acute Low Back Pain","enrollment":124},{"nctId":"NCT03586934","phase":"PHASE3","title":"Multimodal Analgesia in Shoulder Arthroplasty","status":"WITHDRAWN","sponsor":"Rush University Medical Center","startDate":"2018-06-01","conditions":"Shoulder Pain, Opioid Use","enrollment":""},{"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":"NCT02777970","phase":"PHASE4","title":"Tramadol Hydrochloride and Dexketoprofen Trometamol for the Oral Treatment of Moderate to Severe Acute Pain Following Removal of Impacted Lower Third Molar","status":"COMPLETED","sponsor":"Menarini Group","startDate":"2016-04","conditions":"Acute Pain","enrollment":654},{"nctId":"NCT03803371","phase":"PHASE4","title":"Bioequivalence Study of Tramadol Hydrochloride /Paracetamol Tablets Versus Ultracet Tablets","status":"COMPLETED","sponsor":"Pfizer","startDate":"2019-03-26","conditions":"Healthy","enrollment":60},{"nctId":"NCT00652821","phase":"PHASE1","title":"Bioavailability Study of Tramadol/APAP Tablets Under Fed Conditions","status":"COMPLETED","sponsor":"Par Pharmaceutical, Inc.","startDate":"2002-05","conditions":"To Determine Bioequivalence Under Fed Conditions","enrollment":22},{"nctId":"NCT00679614","phase":"PHASE3","title":"Effect of Combined Use of Naloxone and Tramacet on Postop Analgesia in Elderly Patients Having Joint Replacement Surgery","status":"COMPLETED","sponsor":"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","startDate":"2007-12-17","conditions":"Hip Arthroplasty, Knee Arthroplasty, Spinal Anesthesia","enrollment":45},{"nctId":"NCT02440399","phase":"NA","title":"To Compare the Efficacy and Patients' Satisfaction for the Treatment of Post Cesarean Pain of Two Protocols: Oral Medications in Fixed Time Interval Administration Versus Spinal Morphine","status":"COMPLETED","sponsor":"HaEmek Medical Center, Israel","startDate":"2015-07","conditions":"Post Cesarean Pain Management","enrollment":200},{"nctId":"NCT02465866","phase":"PHASE1","title":"A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions","status":"COMPLETED","sponsor":"Charleston Laboratories, Inc","startDate":"2014-11","conditions":"Healthy","enrollment":20},{"nctId":"NCT01920386","phase":"PHASE3","title":"Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Acute Toothache Patients After Teeth Extraction Surgery","status":"COMPLETED","sponsor":"Daewon Pharmaceutical Co., Ltd.","startDate":"2013-06","conditions":"Acute Toothache Patients Above Moderate Pain After Teeth Extraction Surgery","enrollment":240},{"nctId":"NCT01983111","phase":"PHASE4","title":"Compare the Efficacy and Safety of Norspan to Tramadol/Acetaminophen With Prolonged Postoperative Pain (PASSION)","status":"COMPLETED","sponsor":"Mundipharma Korea Ltd","startDate":"2013-10","conditions":"Pain","enrollment":136},{"nctId":"NCT02750696","phase":"NA","title":"Comparison of Two Combinations of Opioid and Non-opioid Analgesics for Acute Periradicular Abscess","status":"COMPLETED","sponsor":"Federal University of Rio Grande do Sul","startDate":"2013-04","conditions":"Periapical Abscess","enrollment":27},{"nctId":"NCT00737048","phase":"PHASE3","title":"A Comparative Study of JNS013 in Participants With Post-Tooth-Extraction Pain","status":"COMPLETED","sponsor":"Janssen Pharmaceutical K.K.","startDate":"2008-03","conditions":"Pain, Postoperative Pain","enrollment":328},{"nctId":"NCT01764048","phase":"NA","title":"To Compare the Efficacy and Patient's Satisfaction From Pain Management of Women After Cesarean Section by Pain Relievers' Administration in Fix Protocol Compared to Protocol Following Demand","status":"COMPLETED","sponsor":"HaEmek Medical Center, Israel","startDate":"2012-11","conditions":"Pain Management, Cesarean Section","enrollment":214},{"nctId":"NCT00772967","phase":"PHASE1","title":"A Study to Evaluate the Effect of Analgesics on a Walking Model of Knee Pain (0000-105)(COMPLETED)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2008-06","conditions":"Osteoarthritis","enrollment":22},{"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":"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":"NCT00736957","phase":"PHASE3","title":"A Long-term Efficacy and Safety Study of Tramadol Hydrochloride Plus Acetaminophen (JNS013) in Japanese Participants With Chronic Pain","status":"COMPLETED","sponsor":"Janssen Pharmaceutical K.K.","startDate":"2008-05","conditions":"Chronic Pain","enrollment":219},{"nctId":"NCT00642837","phase":"","title":"A Study on Health - Related Quality of Life in Patients With Rheumatic Diseases Taking Tramadol 37.5mg/Acetaminophen 325mg Tablets","status":"COMPLETED","sponsor":"Janssen Korea, Ltd., Korea","startDate":"2007-09","conditions":"Rheumatic Diseases","enrollment":982},{"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":"NCT01968018","phase":"PHASE4","title":"A Study of Safety and Effectiveness of Ultracet in Patients With Chronic Cancer Pain","status":"COMPLETED","sponsor":"Janssen-Cilag Ltd.,Thailand","startDate":"2004-07","conditions":"Cancer","enrollment":35},{"nctId":"NCT00736853","phase":"PHASE3","title":"An Efficacy and Safety Study of Acetaminophen Plus Tramadol Hydrochloride (JNS013) in Participants With Chronic Pain","status":"COMPLETED","sponsor":"Janssen Pharmaceutical K.K.","startDate":"2008-06","conditions":"Pain","enrollment":321},{"nctId":"NCT00634543","phase":"PHASE4","title":"A Study to Compare Safety and Efficacy of Tramadol Hydrochloride/Acetaminophen With Gabapentin in Participants With Diabetic Neuropathy","status":"COMPLETED","sponsor":"Janssen Korea, Ltd., Korea","startDate":"2006-12","conditions":"Diabetic Neuropathy","enrollment":162},{"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":"NCT00635349","phase":"PHASE4","title":"A Comparative Study of Tramadol Hydrochloride Plus Acetaminophen Tablets Maintenance Versus Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Maintenance in Participants With Knee Osteoarthritis","status":"COMPLETED","sponsor":"Janssen Korea, Ltd., Korea","startDate":"2007-05","conditions":"Osteoarthritis","enrollment":143},{"nctId":"NCT00766675","phase":"PHASE4","title":"An Efficacy Study of Combination of Tramadol and Acetaminophen Tablets in the Treatment of Participants With Fibromyalgia Pain","status":"COMPLETED","sponsor":"Johnson & Johnson Taiwan Ltd","startDate":"2008-10","conditions":"Pain, Fibromyalgia","enrollment":80},{"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":"NCT01776515","phase":"PHASE1","title":"Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Low Back Pain Patients","status":"COMPLETED","sponsor":"Daewon Pharmaceutical Co., Ltd.","startDate":"2012-01","conditions":"Low Back Pain","enrollment":""},{"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":"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},{"nctId":"NCT01063842","phase":"PHASE4","title":"A Study of the Tolerability of Titrated Dose Tramadol/Acetaminophen Combination Tablet in Korean Patients With Osteoarthritis","status":"COMPLETED","sponsor":"Janssen Korea, Ltd., Korea","startDate":"2005-08","conditions":"Osteoarthritis","enrollment":250},{"nctId":"NCT00653315","phase":"PHASE1","title":"Bioavailability Study of Tramadol/APAP Tablets Under Fasting Conditions","status":"COMPLETED","sponsor":"Par Pharmaceutical, Inc.","startDate":"2002-05","conditions":"To Determine Bioequivalence Under Fasting Conditions","enrollment":28}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"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":"Tramadol hydrochloride/Acetaminophen Tab.","genericName":"Tramadol hydrochloride/Acetaminophen Tab.","companyName":"Daewon Pharmaceutical Co., Ltd.","companyId":"daewon-pharmaceutical-co-ltd","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 acute pain.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}