Last reviewed 2026-04-20 · How we verify

Fentanyl Transdermal

Fentanyl acts as an opioid agonist, primarily interacting with mu-opioid receptors in the brain, spinal cord, and other tissues.

At a glance

Mechanism of action

Fentanyl works by binding to mu-opioid receptors, which are found in the brain, spinal cord, and other tissues. This interaction leads to pain relief and other effects associated with opioid use.

Approved indications

No approved indications tracked.

Boxed warnings

• WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF FENTANYL TRANSDERMAL SYSTEM Addiction, Abuse, and Misuse Because the use of fentanyl transdermal system exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1) ] . Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of fentanyl transdermal system, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of fentanyl transdermal system are essential [see Warnings and Precautions (5.2) ]. Accidental Exposure Accidental exposure of even one dose of fentanyl transdermal system, especially in children, can result in a fatal overdose of fentanyl [see Warnings and Precautions (5.3)] . Deaths due to an overdose of fentanyl have occurred when children and adults were accidentally exposed to fentanyl transdermal system. Strict adherence to the recommended handling and disposal instructions is of the utmost importance to prevent accidental exposure [see Warnings and Precautions (5.3) ] . Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of fentanyl transdermal system and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [ see Warnings and Precautions (5.4) , Drug Interactions (7) ] . Neonatal Opioid Withdrawal Syndrome (NOWS) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see Warnings and Precautions (5.5) ] . Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription [see Warnings and Precautions (5.6) ]. Cytochrome P450 3A4 Interaction The concomitant use of fentanyl transdermal system with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving fentanyl transdermal system and any CYP 3A4 inhibitor or inducer [see Warnings and Precautions (5.7) and Clinical Pharmacology (12.3) ]. Risk of Increased Fentanyl Absorption with Application of External Heat Exposure of the fentanyl transdermal system application site and surrounding area to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, sunbathing, hot baths, saunas, hot tubs, and heated water beds may increase fentanyl absorption and has resulted in fatal overdose of fentanyl. Warn patients to avoid exposing the application site and surrounding area to direct external heat sources [see Warnings and Precautions (5.8) ]. WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF FENTANYL TRANSDERMAL SYSTEM See full prescribing information for complete boxed warning. Fentanyl transdermal system exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and reassess regularly for these behaviors or conditions. ( 5.1 ) Serious, life-threatening, or fatal respiratory depression may occur, especially upon initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of fentanyl transdermal system are essential. ( 5.2 ) Accidental exposure to fentanyl transdermal system, especially in children, can result in fatal overdose of fentanyl. ( 5.3 ) Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate. ( 5.4 , 7 ) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery. ( 5.5 ) Healthcare providers are strongly encouraged to complete a REMS compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription. ( 5.6 ) Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of fentanyl. ( 5.7 ) Exposure of the fentanyl transdermal system application site and surrounding area to direct external heat sources has resulted in fatal overdose of fentanyl. Warn patients to avoid exposing the fentanyl transdermal system application site and surrounding area to direct external heat sources. ( 5.8 )

Common side effects

• Palpitations
• Vertigo
• Nausea
• Vomiting
• Constipation
• Abdominal pain upper
• Dry mouth
• Fatigue
• Feeling cold
• Malaise
• Asthenia
• Edema peripheral

Key clinical trials

• Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery (NA)
• Evaluation of Fentanyl Transdermal Patch Absorption in Hemodynamically Unstable ICU Patients.
• Multimodal Analgesia vs. Routine Care Pain Management for Lumbar Spine Fusion Surgery: A Prospective Randomized Study (PHASE4)
• A Study to Evaluate the Adherence of 2 Strengths of Newly Manufactured Samples and Aged Samples of a New Formulation (JNJ-35685-AAA-G016 and JNJ-35685-AAA-G021) of Fentanyl Transdermal System Compared With Duragesic Fentanyl Transdermal Patch in Healthy Participants (PHASE1)
• Bioequivalence Study of Fentanyl Transdermal System (JNJ-35685-AAA-G021) Compared With DURAGESIC Fentanyl Transdermal Patch in Healthy Participants (PHASE1)
• Transdermal Fentanyl as a Form of Rebound Pain Reduction in Fast Track Programme in Primary Knee Arthroplasty.
• Totally Transdermal Sedation in the Weaning From Remifentanil Infusion (PHASE2)
• Study of the Effect of Clinical Procedures on Drug Delivery of Mylan Fentanyl Transdermal System 25 µg/hr and Duragesic® 25 µg/hr (PHASE1)

Primary sources

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