🇺🇸 Vagifem in United States

FDA authorised Vagifem on 26 March 1999 · 3,114 US adverse-event reports

Marketing authorisations

FDA — authorised 26 March 1999

  • Application: NDA020908
  • Marketing authorisation holder: NOVO NORDISK INC
  • 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 — 445 reports (14.29%)
  2. Fatigue — 335 reports (10.76%)
  3. Arthralgia — 328 reports (10.53%)
  4. Nausea — 323 reports (10.37%)
  5. Headache — 318 reports (10.21%)
  6. Off Label Use — 288 reports (9.25%)
  7. Pain — 280 reports (8.99%)
  8. Malaise — 273 reports (8.77%)
  9. Diarrhoea — 271 reports (8.7%)
  10. Dizziness — 253 reports (8.12%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Vagifem approved in United States?

Yes. FDA authorised it on 26 March 1999; FDA has authorised it.

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

NOVO NORDISK INC holds the US marketing authorisation.