{"id":"fentanyl-tts","safety":{"commonSideEffects":[{"rate":"10-20","effect":"Nausea"},{"rate":"15-25","effect":"Constipation"},{"rate":"5-15","effect":"Dizziness"},{"rate":"10-20","effect":"Somnolence"},{"rate":"5-10","effect":"Headache"},{"rate":"5-10","effect":"Vomiting"},{"rate":"5-15","effect":"Application site reactions"}]},"_chembl":{"chemblId":"CHEMBL1201159","moleculeType":"Small molecule","molecularWeight":"372.94"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Fentanyl is a potent synthetic opioid agonist that binds to mu (μ) opioid receptors in the central and peripheral nervous system, inhibiting pain signal transmission and producing analgesia. The transdermal therapeutic system (TTS) formulation allows continuous delivery of fentanyl over 72 hours, maintaining steady-state plasma concentrations and providing sustained pain control without frequent dosing.","oneSentence":"Fentanyl-TTS is a transdermal patch that delivers the opioid fentanyl through the skin at a controlled rate to provide long-acting pain relief.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:30:22.787Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic pain in opioid-tolerant patients"},{"name":"Cancer pain"},{"name":"Severe chronic pain requiring opioid therapy"}]},"trialDetails":[{"nctId":"NCT04026022","phase":"PHASE3","title":"Traumatologic Acute Pain Management With Fentanyl Transdermal Therapeutic System (TTS)","status":"COMPLETED","sponsor":"Medical University of Graz","startDate":"2019-06-30","conditions":"Hip Fractures (ICD-10 72.01-72.2)","enrollment":145},{"nctId":"NCT03051503","phase":"PHASE4","title":"Efficacy of Transdermal Fentanyl Patches in Relief of Acute Postoperative Pain After Mastectomy","status":"UNKNOWN","sponsor":"South Egypt Cancer Institute","startDate":"2017-02-02","conditions":"Breast Cancer Female","enrollment":60},{"nctId":"NCT00771199","phase":"PHASE4","title":"An Efficacy and Safety Study of Low-dose Transdermal Therapeutic System (TTS)-Fentanyl D-Trans in Taiwan Participants With Cancer Pain","status":"COMPLETED","sponsor":"Janssen-Cilag Ltd.","startDate":"2008-10","conditions":"Cancer, Pain","enrollment":14},{"nctId":"NCT01902524","phase":"PHASE4","title":"Efficacy and Safety Study of Fentanyl Transdermal Patch for Treatment of Chronic Pain","status":"COMPLETED","sponsor":"Janssen Korea, Ltd., Korea","startDate":"2005-10","conditions":"Chronic Pain","enrollment":65},{"nctId":"NCT01060124","phase":"PHASE4","title":"An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Cancer Participants With Inadequately Controlled Pain by Non-Narcotic Analgesics","status":"COMPLETED","sponsor":"Janssen Korea, Ltd., Korea","startDate":"2007-04","conditions":"Pain; Cancer","enrollment":103},{"nctId":"NCT01816243","phase":"PHASE4","title":"An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Thai Participants With Chronic Non-Malignant Pain","status":"COMPLETED","sponsor":"Janssen-Cilag Ltd.,Thailand","startDate":"2004-04","conditions":"Chronic Pain","enrollment":39},{"nctId":"NCT01742897","phase":"PHASE4","title":"Efficacy and Safety Study of Transdermal Therapeutic System (TTS) Fentanyl in Participants With Osteoarthritis Knee Pain","status":"COMPLETED","sponsor":"Janssen-Cilag Ltd.,Thailand","startDate":"2008-08","conditions":"Osteoarthritis, Knee","enrollment":35},{"nctId":"NCT01774929","phase":"PHASE4","title":"An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Participants With Osteoarthritis","status":"COMPLETED","sponsor":"Janssen-Cilag Ltd.,Thailand","startDate":"2008-10","conditions":"Osteoarthritis","enrollment":35},{"nctId":"NCT01774903","phase":"PHASE4","title":"An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Severe Chronic Low Back Pain","status":"COMPLETED","sponsor":"Janssen-Cilag Ltd.,Thailand","startDate":"2008-08","conditions":"Low Back Pain","enrollment":45},{"nctId":"NCT00269737","phase":"PHASE3","title":"Efficacy of the Fentanyl Transdermal Therapeutic System (TTS) in the Management of Pain in Patients With Cancer","status":"COMPLETED","sponsor":"Alza Corporation, DE, USA","startDate":"1986-05","conditions":"Pain, Cancer","enrollment":7},{"nctId":"NCT00576017","phase":"PHASE4","title":"A Study to Evaluate the Safety and Effectiveness of Fentanyl-TTS Compared to Weak Opioids in Patients With Moderate to Severe Chronic Cancer Pain Previously Treated With NSAIDS (Non-steroidal Anti-inflammatory Drugs).","status":"COMPLETED","sponsor":"Janssen-Cilag, S.A.","startDate":"2003-10","conditions":"Pain","enrollment":19},{"nctId":"NCT00269763","phase":"PHASE3","title":"Clinical Use and Safety of the Fentanyl Transdermal Therapeutic System (TTS) in the Management of Pain in Patients With Cancer","status":"COMPLETED","sponsor":"Alza Corporation, DE, USA","startDate":"1987-10","conditions":"Pain, Cancer","enrollment":32},{"nctId":"NCT00271466","phase":"PHASE3","title":"A Study to Assess the Safety, Dose Conversion, and Dose Individualization of Duragesic® (Fentanyl Transdermal Patch) in the Treatment of Children With Chronic Pain Requiring Narcotic Pain Relief Therapy","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2000-02","conditions":"Chronic Pain","enrollment":199},{"nctId":"NCT00271414","phase":"PHASE3","title":"A 15-day Study to Assess the Safety and Clinical Utility of Duragesic (Fentanyl Transdermal Patch) in the Treatment of Children With Continuous Pain Requiring Narcotic Pain Relief Therapy","status":"COMPLETED","sponsor":"Janssen Pharmaceutica N.V., Belgium","startDate":"1999-03","conditions":"Chronic Pain","enrollment":53}],"_emaApprovals":[],"_faersSignals":[{"count":5,"reaction":"NAUSEA"},{"count":4,"reaction":"DIZZINESS"},{"count":4,"reaction":"GENERAL PHYSICAL HEALTH DETERIORATION"},{"count":3,"reaction":"ALTERED STATE OF CONSCIOUSNESS"},{"count":3,"reaction":"ANAEMIA"},{"count":3,"reaction":"DRUG DEPENDENCE"},{"count":3,"reaction":"DRUG INTERACTION"},{"count":3,"reaction":"PNEUMONIA"},{"count":3,"reaction":"VOMITING"},{"count":2,"reaction":"BLOOD URINE PRESENT"}],"_approvalHistory":[],"publicationCount":46,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["fentanyl"],"phase":"marketed","status":"active","brandName":"Fentanyl-TTS","genericName":"Fentanyl-TTS","companyName":"Janssen-Cilag, S.A.","companyId":"janssen-cilag-s-a","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Fentanyl-TTS is a transdermal patch that delivers the opioid fentanyl through the skin at a controlled rate to provide long-acting pain relief. Used for Chronic pain in opioid-tolerant patients, Cancer pain, Severe chronic pain requiring opioid therapy.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}