🇺🇸 Fentanyl Transdermal in United States

FDA authorised Fentanyl Transdermal on 9 February 2011 · 15,638 US adverse-event reports

Marketing authorisations

FDA — authorised 9 February 2011

  • Application: ANDA077154
  • Marketing authorisation holder: SPECGX LLC
  • Status: supplemented

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 — 3,107 reports (19.87%)
  2. Product Adhesion Issue — 2,749 reports (17.58%)
  3. Product Quality Issue — 1,615 reports (10.33%)
  4. Wrong Technique In Drug Usage Process — 1,584 reports (10.13%)
  5. Pain — 1,445 reports (9.24%)
  6. Wrong Technique In Product Usage Process — 1,439 reports (9.2%)
  7. Drug Effect Decreased — 1,153 reports (7.37%)
  8. Nausea — 894 reports (5.72%)
  9. Withdrawal Syndrome — 876 reports (5.6%)
  10. Hyperhidrosis — 776 reports (4.96%)

Source database →

Fentanyl Transdermal 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 approved in United States?

Yes. FDA authorised it on 9 February 2011; FDA has authorised it.

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

SPECGX LLC holds the US marketing authorisation.