🇺🇸 Follistim in United States

FDA authorised Follistim on 23 March 2004 · 1,055 US adverse-event reports

Marketing authorisations

FDA — authorised 23 March 2004

  • Application: BLA021211
  • Marketing authorisation holder: ORGANON USA LLC
  • 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. No Adverse Event — 239 reports (22.65%)
  2. Headache — 157 reports (14.88%)
  3. Product Quality Issue — 141 reports (13.36%)
  4. Nausea — 79 reports (7.49%)
  5. Drug Ineffective — 76 reports (7.2%)
  6. Product Packaging Quantity Issue — 76 reports (7.2%)
  7. Abdominal Distension — 74 reports (7.01%)
  8. Incorrect Dose Administered — 74 reports (7.01%)
  9. Drug Dose Omission — 72 reports (6.82%)
  10. Fatigue — 67 reports (6.35%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Follistim approved in United States?

Yes. FDA authorised it on 23 March 2004; FDA has authorised it.

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

ORGANON USA LLC holds the US marketing authorisation.