🇺🇸 Buprenorphine (Subutex) in United States

11 US adverse-event reports

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. Vomiting — 2 reports (18.18%)
  2. Amnesia — 1 report (9.09%)
  3. Apnoea — 1 report (9.09%)
  4. Aspiration — 1 report (9.09%)
  5. Blood Culture Positive — 1 report (9.09%)
  6. Citrobacter Test Positive — 1 report (9.09%)
  7. Confusional State — 1 report (9.09%)
  8. Diarrhoea — 1 report (9.09%)
  9. Dizziness — 1 report (9.09%)
  10. Drug Hypersensitivity — 1 report (9.09%)

Source database →

Other Psychiatry / Addiction Medicine approved in United States

Frequently asked questions

Is Buprenorphine (Subutex) approved in United States?

Buprenorphine (Subutex) does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Buprenorphine (Subutex) in United States?

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