🇺🇸 follitropin alpha in United States

FDA authorised follitropin alpha on 18 September 1986 · 38 US adverse-event reports

Marketing authorisation

FDA — authorised 18 September 1986

  • Application: NDA019415
  • Marketing authorisation holder: SERONO
  • Local brand name: METRODIN
  • Indication: INJECTABLE — INTRAMUSCULAR
  • Status: approved

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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. Ovarian Hyperstimulation Syndrome — 9 reports (23.68%)
  2. Ascites — 6 reports (15.79%)
  3. Drug Exposure During Pregnancy — 4 reports (10.53%)
  4. Ovarian Enlargement — 4 reports (10.53%)
  5. Drug Exposure Before Pregnancy — 3 reports (7.89%)
  6. Myocardial Infarction — 3 reports (7.89%)
  7. Pleural Effusion — 3 reports (7.89%)
  8. Abortion Spontaneous — 2 reports (5.26%)
  9. Caesarean Section — 2 reports (5.26%)
  10. Multiple Pregnancy — 2 reports (5.26%)

Source database →

Frequently asked questions

Is follitropin alpha approved in United States?

Yes. FDA authorised it on 18 September 1986.

Who is the marketing authorisation holder for follitropin alpha in United States?

SERONO holds the US marketing authorisation.