🇺🇸 Buprenorphine Transdermal System in United States

1,169 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. Product Adhesion Issue — 466 reports (39.86%)
  2. No Adverse Event — 360 reports (30.8%)
  3. Drug Ineffective — 90 reports (7.7%)
  4. Application Site Pruritus — 57 reports (4.88%)
  5. Product Substitution Issue — 45 reports (3.85%)
  6. Application Site Rash — 36 reports (3.08%)
  7. Application Site Erythema — 31 reports (2.65%)
  8. Pain — 31 reports (2.65%)
  9. Application Site Pain — 27 reports (2.31%)
  10. Pruritus — 26 reports (2.22%)

Source database →

Buprenorphine 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 Buprenorphine Transdermal System approved in United States?

Yes. FDA has authorised it.

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

Mundipharma K.K. is the originator. The local marketing authorisation holder may differ — check the official source linked above.