Fentanyl Transdermal System (marketed as Duragesic) Information
The fentanyl transdermal system (patch) is used for the management of persistent, moderate to severe chronic pain in opioid-tolerant patients when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA MedWatch program, using the contact information at the bottom of this page.
Safety Information
- FDA Drug Safety Communication: FDA requiring color changes to Duragesic (fentanyl) pain patches to aid safetyâemphasizing that accidental exposure to used patches can cause death
- FDA Reminds the Public about the Potential for Life-Threatening Harm from Accidental Exposure to Fentanyl Transdermal Systems (âPatchesâ)
- Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids
- Fentanyl Patch Can Be Deadly to Children
- Avoiding Fatal Overdoses with Fentanyl Patches
- Preventing Patient Deaths from Fentanyl Patches
- Errors Using Transdermal Patches
- Safe Use Initiative: Fentanyl Transdermal System âPatchesâ: Safe Disposal
Regulatory History and Labeling from Drugs@FDA
Historical Information
- Information for Healthcare Professionals: Fentanyl Transdermal System (marketed as Duragesic and generics) (12/21/2007 update)
- FDA Public Health Advisory: Important Information for the Safe Use of Fentanyl Transdermal System (Patch)
- FDA Issues Second Safety Warning on Fentanyl Skin Patch
- Drug Safety Podcast: Fentanyl Transdermal System (Patch) (marketed as Duragesic and generics)
- Safety Warnings Regarding Use of Fentanyl Transdermal (Skin) Patches
- Information for Healthcare Professionals: Fentanyl Transdermal System (marketed as Duragesic and generics) (07/15/05)
- FDA Issues Public Health Advisory on the Fentanyl Patch
- Duragesic (fentanyl transdermal system)
More Information
- Disposal of Unused Medicines: What You Should Know
- Medication Disposal: Questions and Answers
- How to Dispose of Unused Medicines
- DEA Nationwide Prescription Drug Take-Back Initiative
- Proper disposal of fentanyl patches is critical to prevent accidental exposure
- CDER Takes Steps to End Prescription Pain Medicine Misuse, Abuse, and Addiction
- FDA Works to Reduce Risk of Opioid Pain Relievers