Fentanyl transdermal system: US FDA label indications

US FDA labelNot medical advice

The product name above is taken from the label's own indications text; the source record has no brand or generic name field.

Indications and usage (label excerpt)

1 INDICATIONS & USAGE Fentanyl transdermal system is a transdermal formulation of fentanyl indicated for the management of persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age and older when a continuous, around-the-clock opioid analgesic is required for an extended period of time, and the patient cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids. Patients considered opioid-tolerant are those who are taking at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid for a week or longer. Fentanyl transdermal system contains fentanyl, a full opioid agonist. Fentanyl transdermal system is indicated for the management of persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age and older when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. ( 1 ) Fentanyl transdermal system is NOT intended for use as an as-needed analgesic. ( 1 )

Warnings (label excerpt)

5 WARNINGS AND PRECAUTIONS Fentanyl transdermal system can be abused. Use caution when prescribing if there is an increased risk of misuse, abuse, or diversion. ( 5.1 ) Fatal respiratory depression can occur with fentanyl transdermal system. Monitor patients accordingly Use with extreme caution in patients at risk of respiratory depression. ( 5.2 ) Accidental exposure of fentanyl transdermal system, especially in children, can result in a fatal overdose of fentanyl. ( 5.3 ) Use fentanyl transdermal system with extreme caution in patients susceptible to intracranial effects of CO 2 retention. ( 5.6 ) Fentanyl transdermal system may have additive effects when used in conjunction with other CNS depressants, alcohol, and drugs of abuse. ( 5.7 ) Use of fentanyl transdermal system with a CYP3A4 inhibitor may result in an increase in fentanyl plasma concentrations. Monitor patients accordingly and adjust dosage if necessary. ( 5.8 ) Fentanyl transdermal system may produce bradycardia. Adminis…

Excerpts are shortened. Read the full label, and ask a pharmacist or prescriber about any medicine. Full label on DailyMed(opens in a new tab) For products sold in Canada, see the Health Canada Drug Product Database(opens in a new tab).

Trials whose interventions mention this drug

Canadian trials first. Showing 50 of 57. A match on the drug name does not mean the trial studied this specific product.

50 trials, recruiting first

		Phase	Countries
Fentanyl Sublingual Spray for the Treatment of Acute Procedure-related Pain in a Monitored Setting NCT02138409	Withdrawn	Phase 3		INSYS Therapeutics Inc	2017-12-30
Nasal Fentanyl for Chronic Cancer Pain NCT01906073	Withdrawn	Phase 3		Norwegian University of Science and Technology	2017-01
Ischemic Pain Control With Analgesic Methods Clinical Trial NCT02841488	Unknown status	Phase 3		University of Sao Paulo General Hospital	2016-09
Does Intraoperative Methadone Prevent Postoperative Pain in Bariatric Surgery? NCT02775474	Completed	Phase 4	Brazil	University of Sao Paulo General Hospital	2016-06
Remifentanil vs Fentanyl During Cardiac Surgery and Chronic Thoracic Pain NCT02031016	Completed	Phase 4	Netherlands	St. Antonius Hospital	2014-02
Prospective Randomized Trial Comparing the Effectiveness of Continuous Paravertebral Infusion of Local Anesthetics Versus Intravenous Patient-controlled Analgesia on Acute and Chronic Neuropathic Pain After VATS Lobectomy NCT01703351	Completed	Phase 2	South Korea	Yonsei University	2012-10-04
Use of Fentanyl Patch in Partial Doses Than the Original NCT01403363	Unknown status	Not applicable	Israel	Meir Medical Center	2012-03
The Effectiveness and Tolerability of Fentanyl Matrix in Chronic Non-cancer Pain; Assessment of Patient's Pain Treatment Goal Achievement NCT01688583	Completed		South Korea	Janssen Korea, Ltd., Korea	2011-12
Sedation in Endoscopic Retrograde Cholangiopancreatography (ERCP) With or Without Opioids NCT01304342	Completed	Not applicable	Greece	University of Athens	2011-02
Dexmedetomidine Versus Fentanyl Following Pressure Equalization Tube Placement NCT01188551	Completed	Phase 2, Phase 3	United States	Nationwide Children's Hospital	2011-01
Nasal Fentanyl for Patient Controlled Treatment of Pain in Cancer NCT01248611	Completed	Phase 1, Phase 2	Norway	St. Olavs Hospital	2011-01
The Effect of Choice of Intraoperative Opioid on Postoperative Pain NCT01542645	Completed	Phase 4	United States	Endeavor Health	2010-09
Gabapentin Versus Transdermal Fentanyl Matrix for Chronic Neuropathic Pain NCT01127100	Completed	Phase 4	South Korea	Seoul National University Hospital	2010-05
Postoperative Analgesia Impact of Narcotic Free Anesthesia NCT01544959	Completed	Not applicable	Canada	Université de Sherbrooke	2010-01
Prospective Study About Clinical and Pharmacogenetic Safety of Opioid Use for Chronic Pain NCT00916890	Suspended	Phase 4	Italy	Fondazione IRCCS Policlinico San Matteo di Pavia	2009-02
A Confirmatory Study of Fentanyl in Participants With Osteoarthritis or Low Back Pain NCT01008618	Completed	Phase 3	Japan	Janssen Pharmaceutical K.K.	2009-01
An Efficacy and Safety Study of Fentanyl Transdermal Patch in Filipino Participants With Osteoarthritis and Chronic Low Back Pain NCT01795898	Completed	Phase 4	Philippines	Janssen Pharmaceutica	2009-01
Fentanyl Buccal Tablets Versus Immediate Release Oxycodone for Breakthrough Pain in Patients With Chronic Pain NCT00813488	Completed	Phase 3	United States	Cephalon	2008-12
An Efficacy and Safety Study of Fentanyl in Participants With Chronic Pain NCT00788372	Completed	Phase 3	Japan	Janssen Pharmaceutical K.K.	2008-11
Observational Study Investigating the Effectiveness of Fentanyl Matrix in Relieving Pain and Improving Function in Patients With Osteoarthritis of the Knee or Hip NCT01119885	Completed			Janssen Korea, Ltd., Korea	2008-08
An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Severe Chronic Low Back Pain NCT01774903	Completed	Phase 4	Thailand	Janssen-Cilag Ltd.,Thailand	2008-08
Long-term Extension Study of BEMA™ Fentanyl NCT00696137	Completed	Phase 3		BioDelivery Sciences International	2008-06
Matrifen® for Therapy of Severe Chronic Pain® NCT00699335	Completed		Germany	Nycomed	2008-06
Study on Impact of Fentanyl Matrix on Improvement of Pain and Functioning in Spinal Disorder-related Pain NCT00797017	Completed			Janssen Korea, Ltd., Korea	2008-05
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain NCT00538850	Completed	Phase 3	United States	INSYS Therapeutics Inc	2007-10
Studying Fentanyl in Patients With Cancer NCT00899951	Terminated		United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	2007-10
Efficacy and Safety of Fentanyl Buccal Tablets Compared With Oxycodone for the Management of Break Through Pain NCT00463047	Completed	Phase 3	United States	Cephalon	2007-07
Open-Label Study to Evaluate the Effect of Treatment With Fentanyl Buccal Tablets on Pain Anxiety Symptoms When Used for the Management of Breakthrough Pain NCT00387010	Terminated	Phase 3	United States	Cephalon	2006-12
Study to Evaluate the Efficacy and Safety of OraVescent Fentanyl Citrate Treatment for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Noncancer-Related Chronic Pain NCT00343733	Completed	Phase 3	United States	Cephalon	2006-08
Study of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy NCT00293020	Completed	Phase 3	United States	BioDelivery Sciences International	2006-02
Opioid Rotation Versus Combination for Chronic Uncontrolled Cancer Pain NCT00478101	Completed	Phase 2		Gachon University Gil Medical Center	2006-02
Fentanyl Transdermal Patch With CHADD™ for Breakthrough Pain in Patients With Moderate to Severe Non-Malignant Pain NCT00278824	Terminated	Phase 2	United States	ZARS Pharma Inc.	2006-01
Efficacy and Safety Study of Fentanyl Transdermal Patch for Treatment of Chronic Pain NCT01902524	Completed	Phase 4	South Korea	Janssen Korea, Ltd., Korea	2005-10
Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for Management of Breakthrough Pain NCT00214942	Completed	Phase 3	United States	Cephalon	2005-09
Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for the Management of Breakthrough Pain NCT00214955	Completed	Phase 3	United States	Cephalon	2005-09
Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Moderate to Severe Cancer Pain NCT00126789	Terminated	Phase 3	United States	ZARS Pharma Inc.	2005-08
Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Chronic, Moderate to Severe Non-Malignant Pain NCT00126763	Terminated	Phase 3	United States	ZARS Pharma Inc.	2005-07
Phase III Clinical Trial of Fentanyl Transdermal Matrix Patch, in the Management of Chronic Intractable Pain- Assessment of Effectiveness, Safety and Pharmacokinetics NCT00216684	Completed	Phase 3		Janssen Pharmaceutical K.K.	2005-05
Evaluating the Safety and Tolerability of OraVescent Fentanyl for Opioid Tolerant Patients With Noncancer Related Breakthrough Pain NCT00228605	Completed	Phase 3	United States	Cephalon	2005-03
Efficacy and Safety of FITpatch Compared to Standard Opioid Treatment in Cancer Pain (FT-015-IN) NCT00279344	Completed	Phase 3		Nycomed	2004-09
Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Chronic, Moderate to Severe Osteoarthritis (OA) Pain NCT00108771	Completed	Phase 2	United States	ZARS Pharma Inc.	2004-04
An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Thai Participants With Chronic Non-Malignant Pain NCT01816243	Completed	Phase 4	Thailand	Janssen-Cilag Ltd.,Thailand	2004-04
Efficacy of Transdermal Fentanyl for Chronic Neuropathic Pain NCT00181246	Completed	Not applicable		Johns Hopkins University	2003-10
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). NCT00576017	Completed	Phase 4		Janssen-Cilag, S.A.	2003-10
Evaluation of the Efficacy and Safety of Fentanyl Delivered by Adhesive Skin Patch in Out-Patients With Chronic Cancer Pain NCT00236327	Terminated	Phase 4		Janssen Cilag S.A.S.	2003-06
A Study to Evaluate the Safety of D-TRANS Fentanyl With Naltrexone in Adult Patients With Chronic Pain and Who Are Opioid Tolerant NCT00650182	Completed	Phase 2		Alza Corporation, DE, USA	2003-01
Duragesic® (Fentanyl Transdermal System) Functionality Trial in Chronic Low Back Pain NCT00237341	Completed	Phase 4		PriCara, Unit of Ortho-McNeil, Inc.	2002-06
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 NCT00271466	Completed	Phase 3		Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	2000-02
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 NCT00271414	Completed	Phase 3		Janssen Pharmaceutica N.V., Belgium	1999-03
A Study to Assess the Safety and Effectiveness of Durogesic (Fentanyl Transdermal Patch) in the Treatment of Children With Chronic Pain Requiring Long-term Narcotic Pain Relief Therapy NCT00271453	Completed	Phase 3		Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	1996-02

Source: openFDA drug label (US FDA), snapshot October 2026. Not a Health Canada Product Monograph.