🇺🇸 Prostin in United States

FDA authorised Prostin on 16 October 1981 · 186 US adverse-event reports

Marketing authorisations

FDA — authorised 16 October 1981

  • Application: NDA018484
  • Marketing authorisation holder: PFIZER
  • 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. Drug Exposure During Pregnancy — 31 reports (16.67%)
  2. Caesarean Section — 30 reports (16.13%)
  3. Drug Ineffective — 26 reports (13.98%)
  4. Uterine Hyperstimulation — 17 reports (9.14%)
  5. Foetal Exposure During Delivery — 15 reports (8.06%)
  6. Off Label Use — 14 reports (7.53%)
  7. Pyrexia — 14 reports (7.53%)
  8. Bradycardia Foetal — 13 reports (6.99%)
  9. Maternal Exposure During Pregnancy — 13 reports (6.99%)
  10. Uterine Hypertonus — 13 reports (6.99%)

Source database →

Prostin in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is Prostin approved in United States?

Yes. FDA authorised it on 16 October 1981; FDA has authorised it.

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

PFIZER holds the US marketing authorisation.