🇺🇸 Utrogestan in United States

505 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. Exposure During Pregnancy — 83 reports (16.44%)
  2. Headache — 63 reports (12.48%)
  3. Fatigue — 58 reports (11.49%)
  4. Arthralgia — 50 reports (9.9%)
  5. Anxiety — 45 reports (8.91%)
  6. Insomnia — 45 reports (8.91%)
  7. Nausea — 43 reports (8.51%)
  8. Dizziness — 40 reports (7.92%)
  9. Foetal Exposure During Pregnancy — 40 reports (7.92%)
  10. Maternal Exposure During Pregnancy — 38 reports (7.52%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Utrogestan approved in United States?

Yes. FDA has authorised it.

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

Insel Gruppe AG, University Hospital Bern is the originator. The local marketing authorisation holder may differ — check the official source linked above.