🇺🇸 Suboxone in United States

FDA authorised Suboxone on 30 August 2010 · 22,075 US adverse-event reports

Marketing authorisations

FDA — authorised 30 August 2010

  • Application: NDA022410
  • Marketing authorisation holder: INDIVIOR
  • 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 Dependence — 4,368 reports (19.79%)
  2. Drug Withdrawal Syndrome — 3,610 reports (16.35%)
  3. Pain — 2,647 reports (11.99%)
  4. Off Label Use — 2,186 reports (9.9%)
  5. Overdose — 1,887 reports (8.55%)
  6. Nausea — 1,753 reports (7.94%)
  7. Emotional Distress — 1,473 reports (6.67%)
  8. Vomiting — 1,467 reports (6.65%)
  9. Anxiety — 1,429 reports (6.47%)
  10. Foetal Exposure During Pregnancy — 1,255 reports (5.69%)

Source database →

Suboxone in other countries

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

Other Other approved in United States

Frequently asked questions

Is Suboxone approved in United States?

Yes. FDA authorised it on 30 August 2010; FDA has authorised it.

Who is the marketing authorisation holder for Suboxone in United States?

INDIVIOR holds the US marketing authorisation.