🇺🇸 pregnyl in United States

FDA authorised pregnyl on 20 October 1976 · 983 US adverse-event reports

Marketing authorisations

FDA — authorised 20 October 1976

  • Application: BLA017692
  • 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 — 207 reports (21.06%)
  2. Ovarian Hyperstimulation Syndrome — 196 reports (19.94%)
  3. Product Dose Omission Issue — 104 reports (10.58%)
  4. Inappropriate Schedule Of Drug Administration — 83 reports (8.44%)
  5. Product Packaging Quantity Issue — 81 reports (8.24%)
  6. Product Quality Issue — 77 reports (7.83%)
  7. Product Dose Omission — 73 reports (7.43%)
  8. Drug Ineffective — 66 reports (6.71%)
  9. Injection Site Pain — 52 reports (5.29%)
  10. Product Use In Unapproved Indication — 44 reports (4.48%)

Source database →

Other Other approved in United States

Frequently asked questions

Is pregnyl approved in United States?

Yes. FDA authorised it on 20 October 1976; FDA has authorised it.

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

ORGANON USA LLC holds the US marketing authorisation.