🇺🇸 Fentanyl Transdermal System in United States

15,602 US adverse-event reports

Marketing authorisation

FDA

  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Drug Ineffective — 3,099 reports (19.86%)
  2. Product Adhesion Issue — 2,744 reports (17.59%)
  3. Product Quality Issue — 1,611 reports (10.33%)
  4. Wrong Technique In Drug Usage Process — 1,582 reports (10.14%)
  5. Wrong Technique In Product Usage Process — 1,439 reports (9.22%)
  6. Pain — 1,437 reports (9.21%)
  7. Drug Effect Decreased — 1,152 reports (7.38%)
  8. Nausea — 890 reports (5.7%)
  9. Withdrawal Syndrome — 873 reports (5.6%)
  10. Hyperhidrosis — 775 reports (4.97%)

Source database →

Fentanyl Transdermal System in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Fentanyl Transdermal System approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Fentanyl Transdermal System in United States?

Medical University of Graz is the originator. The local marketing authorisation holder may differ — check the official source linked above.