🇺🇸 "Standard" rFSH dose in United States

FDA authorised "Standard" rFSH dose on 22 January 1985 · 3,198 US adverse-event reports

Marketing authorisation

FDA — authorised 22 January 1985

  • Application: ANDA088390
  • Marketing authorisation holder: DEPROCO
  • Status: supplemented

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. Off Label Use — 448 reports (14.01%)
  2. Drug Ineffective — 436 reports (13.63%)
  3. Product Quality Issue — 390 reports (12.2%)
  4. No Adverse Event — 378 reports (11.82%)
  5. Death — 288 reports (9.01%)
  6. Nausea — 281 reports (8.79%)
  7. Diarrhoea — 266 reports (8.32%)
  8. Fatigue — 253 reports (7.91%)
  9. Drug Dose Omission — 244 reports (7.63%)
  10. Haemorrhage — 214 reports (6.69%)

Source database →

Other Reproductive Medicine / Fertility approved in United States

Frequently asked questions

Is "Standard" rFSH dose approved in United States?

Yes. FDA authorised it on 22 January 1985.

Who is the marketing authorisation holder for "Standard" rFSH dose in United States?

DEPROCO holds the US marketing authorisation.