{"id":"tapentadol-ir","safety":{"boxedWarning":"Addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; and risks from concomitant use with benzodiazepines or other CNS depressants.","commonSideEffects":["nausea","dizziness","vomiting","constipation","somnolence"],"contraindications":["significant respiratory depression","acute or severe bronchial asthma","concurrent MAO inhibitor use or within 14 days"]},"_chembl":null,"modality":"Small molecule","_dailymed":null,"mechanism":{"target":"mu-opioid receptor and norepinephrine transporter","explanation":"Tapentadol binds to mu-opioid receptors in the central nervous system to produce analgesic effects while simultaneously inhibiting norepinephrine reuptake. This dual mechanism provides pain relief through complementary pathways, potentially offering improved tolerability compared to pure opioid agonists.","oneSentence":"Tapentadol works through dual mechanisms: mu-opioid receptor agonism and norepinephrine reuptake inhibition to provide centrally-mediated analgesia."},"_scrapedAt":"2026-03-28T01:37:32.276Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_claudeStub":{"ts":1779122767,"model":"claude-sonnet-4-5-20250929"},"competitors":[{"name":"tramadol","brand":"Ultram","company":"Janssen","rationale":"Dual-mechanism opioid analgesic for moderate to moderately severe pain"},{"name":"oxycodone IR","brand":"Roxicodone","company":null,"rationale":"Immediate-release opioid for moderate to severe acute pain"},{"name":"hydrocodone/acetaminophen","brand":"Vicodin","company":null,"rationale":"Combination opioid analgesic for moderate to severe pain"}],"description":"Tapentadol IR is an immediate-release centrally acting analgesic used for moderate to severe acute pain. It combines mu-opioid receptor agonism with norepinephrine reuptake inhibition, offering dual-mechanism pain relief. Developed by Ortho-McNeil Janssen, it provides an alternative to traditional opioids.","indications":{"approved":[{"status":"approved","condition":"moderate to severe acute pain","patientPopulation":"adults"}]},"trialDetails":[{"nctId":"NCT01615510","phase":"PHASE1","title":"Evaluation of the Antihyperalgesic Effect of Tapentadol in Two Human Experimental Models","status":"TERMINATED","sponsor":"University Hospital Schleswig-Holstein","startDate":"2012-10","conditions":"Pain, Hyperalgesia, Allodynia","enrollment":24},{"nctId":"NCT02081391","phase":"PHASE3","title":"A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain","status":"COMPLETED","sponsor":"Grünenthal GmbH","startDate":"2015-02-19","conditions":"Acute Pain","enrollment":216},{"nctId":"NCT00478023","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain After Abdominal Hysterectomy","status":"COMPLETED","sponsor":"Grünenthal GmbH","startDate":"2007-05","conditions":"Hysterectomy, Postoperative","enrollment":854},{"nctId":"NCT00983073","phase":"PHASE3","title":"Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Pain Due to Osteoarthritis Taking Either WHO Step I or Step II Analgesics or no Regular Analgesic","status":"COMPLETED","sponsor":"Grünenthal GmbH","startDate":"2009-09","conditions":"Chronic Pain, Osteoarthritis","enrollment":224},{"nctId":"NCT00982280","phase":"PHASE3","title":"Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Pain Due to Osteoarthritis Taking WHO Step III Analgesics But Showing a Lack of Tolerability.","status":"TERMINATED","sponsor":"Grünenthal GmbH","startDate":"2009-09","conditions":"Chronic Pain, Osteoarthritis","enrollment":82},{"nctId":"NCT03979989","phase":"PHASE1","title":"Drug-drug Interaction Study to Evaluate the Effect of Omeprazole on CG5503 (Tapentadol)","status":"COMPLETED","sponsor":"Grünenthal GmbH","startDate":"2005-09-28","conditions":"Pharmacokinetic","enrollment":32},{"nctId":"NCT00983385","phase":"PHASE3","title":"Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics","status":"COMPLETED","sponsor":"Grünenthal GmbH","startDate":"2009-09-30","conditions":"Chronic Pain, Low Back Pain","enrollment":208},{"nctId":"NCT01719601","phase":"","title":"A Safety and Effectiveness Study of Immediate Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Acute Non-Cancer Pain","status":"WITHDRAWN","sponsor":"Janssen Pharmaceutica","startDate":"2014-10","conditions":"Moderate to Severe Acute Non-Cancer Pain","enrollment":""},{"nctId":"NCT00594516","phase":"PHASE3","title":"Study on the Safety and Effectiveness of Switching Between Two Forms of Tapentadol in Patients With Chronic Low Back Pain","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2007-12","conditions":"Low Back Pain","enrollment":117},{"nctId":"NCT01813890","phase":"PHASE3","title":"A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy Compared With Placebo","status":"COMPLETED","sponsor":"Janssen-Cilag International NV","startDate":"2013-01","conditions":"Hallux Valgus","enrollment":60},{"nctId":"NCT00771758","phase":"PHASE3","title":"Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis","status":"COMPLETED","sponsor":"Ortho-McNeil Janssen Scientific Affairs, LLC","startDate":"2008-09","conditions":"Back Pain","enrollment":108},{"nctId":"NCT01516008","phase":"PHASE3","title":"A Study of Tapentadol Immediate-Release in the Treatment of Patients With Acute Pain From Bunionectomy","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2012-01","conditions":"Hallux Valgus","enrollment":353},{"nctId":"NCT00364533","phase":"PHASE3","title":"A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain After Hip Replacement Surgery Compared With Oxycodone and Placebo Followed by a Voluntary Open-Label Extension For Safety","status":"TERMINATED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2006-10","conditions":"Arthroplasty","enrollment":367},{"nctId":"NCT00986180","phase":"PHASE3","title":"NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain","status":"COMPLETED","sponsor":"Ortho-McNeil Janssen Scientific Affairs, LLC","startDate":"2009-09","conditions":"Pain, Back Pain, Low Back Pain","enrollment":667},{"nctId":"NCT01500317","phase":"PHASE4","title":"Comparison of the Effects of Tapentadol and Oxycodone on Gastrointestinal and Colonic Transit in Humans","status":"COMPLETED","sponsor":"Mayo Clinic","startDate":"2011-05","conditions":"Effects of 2 Mu-opiates on Gastrointestinal Transit","enrollment":38},{"nctId":"NCT00814580","phase":"PHASE3","title":"Safety and Efficacy of Tapentadol Immediate Release (IR) and Oxycodone IR for Treatment of Acute Post-op Pain Following Elective Arthroscopic (Surgery Using a Thin Flexible Scope) Shoulder Surgery","status":"COMPLETED","sponsor":"Ortho-McNeil Janssen Scientific Affairs, LLC","startDate":"2008-12","conditions":"Postoperative Pain","enrollment":382},{"nctId":"NCT01545778","phase":"","title":"Risk of Shopping Behavior of Tapentadol Immediate-Release (IR) Compared to Oxycodone Immediate-Release (IR)","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2010-02","conditions":"Substance Abuse Detection","enrollment":646620},{"nctId":"NCT00784277","phase":"PHASE3","title":"A Study to Compare the Frequency of Constipation Symptoms With Tapentadol Immediate Release (IR) Treatment Versus Oxycodone IR Treatment in Patients With End-stage Joint Disease","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2008-10","conditions":"Joint Diseases, Arthritis, Osteoarthritis","enrollment":597},{"nctId":"NCT00609466","phase":"PHASE3","title":"A Trial to Evaluate CG5503 Efficacy and Safety in Acute Pain After Bunionectomy","status":"COMPLETED","sponsor":"Grünenthal GmbH","startDate":"2007-09","conditions":"Bunionectomy, Pain, Postoperative Pain","enrollment":291},{"nctId":"NCT00361582","phase":"PHASE3","title":"A Study to Evaluate the Effectiveness and Safety of Multiple Doses of Tapentadol(CG5503) in Patients Awaiting Joint Replacement Surgery","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2006-10","conditions":"Osteoarthritis, Pain Assessment, Arthralgia","enrollment":669},{"nctId":"NCT00364546","phase":"PHASE3","title":"A Study to Evaluate 90-Day Safety of Tapentadol(CG5503) Immediate Release (IR) or Oxycodone Immediate Release in Patients With Chronic Pain","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2006-07","conditions":"Osteoarthritis, Pain Intensity Assessment, Arthralgia","enrollment":877},{"nctId":"NCT00364247","phase":"PHASE3","title":"A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain From Bunionectomy Compared With Placebo Followed by a Voluntary Open Label Extension for Safety.","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"","conditions":"Arthralgia, Bunion, Hallux Valgus","enrollment":602},{"nctId":"NCT00806247","phase":"PHASE2","title":"A Randomized, Double-Blind, Parallel-Arm, Placebo and Active Controlled Dose-Ranging Study of the Efficacy and Safety of Multiple Doses of Tapentadol IR for Postoperative Pain Following Bunionectomy Surgery","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2005-01","conditions":"Pain, Postoperative Pain","enrollment":480}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":45,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"tapentadol IR","genericName":"tapentadol IR","companyName":"Ortho-McNeil Janssen Scientific Affairs, LLC","companyId":"ortho-mcneil-janssen-scientific-affairs-llc","firstApprovalDate":"","aiSummary":"Tapentadol IR is a small molecule used to treat various conditions, including chronic pain, low back pain, and osteoarthritis. It is available in capsule form and has been studied in clinical trials for its pharmacokinetic properties and interactions with other medications, such as omeprazole.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}