🇺🇸 Duphaston in United States

439 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. Maternal Exposure During Pregnancy — 137 reports (31.21%)
  2. Abortion Spontaneous — 108 reports (24.6%)
  3. Ovarian Hyperstimulation Syndrome — 39 reports (8.88%)
  4. Foetal Exposure During Pregnancy — 28 reports (6.38%)
  5. Off Label Use — 27 reports (6.15%)
  6. Meningioma — 23 reports (5.24%)
  7. Headache — 21 reports (4.78%)
  8. Exposure During Pregnancy — 20 reports (4.56%)
  9. Fatigue — 18 reports (4.1%)
  10. Nausea — 18 reports (4.1%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Duphaston approved in United States?

Yes. FDA has authorised it.

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

El Shatby University Hospital for Obstetrics and Gynecology is the originator. The local marketing authorisation holder may differ — check the official source linked above.