🇺🇸 Contrave in United States

FDA authorised Contrave on 10 September 2014 · 7,712 US adverse-event reports

Marketing authorisations

FDA — authorised 10 September 2014

  • Application: NDA200063
  • Marketing authorisation holder: NALPROPION
  • 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. Nausea — 1,977 reports (25.64%)
  2. Headache — 1,109 reports (14.38%)
  3. Dizziness — 1,042 reports (13.51%)
  4. Vomiting — 671 reports (8.7%)
  5. Constipation — 643 reports (8.34%)
  6. Feeling Abnormal — 582 reports (7.55%)
  7. Fatigue — 517 reports (6.7%)
  8. Anxiety — 404 reports (5.24%)
  9. Insomnia — 392 reports (5.08%)
  10. Diarrhoea — 375 reports (4.86%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Contrave approved in United States?

Yes. FDA authorised it on 10 September 2014; FDA has authorised it.

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

NALPROPION holds the US marketing authorisation.