🇺🇸 Minprostin in United States

130 US adverse-event reports

Marketing authorisation

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. Foetal Exposure During Pregnancy — 30 reports (23.08%)
  2. Small For Dates Baby — 22 reports (16.92%)
  3. Meconium In Amniotic Fluid — 15 reports (11.54%)
  4. Exposure During Pregnancy — 13 reports (10%)
  5. Hypoglycaemia Neonatal — 13 reports (10%)
  6. Maternal Exposure During Pregnancy — 9 reports (6.92%)
  7. Anomaly Of External Ear Congenital — 8 reports (6.15%)
  8. Atrial Septal Defect — 8 reports (6.15%)
  9. Foetal Heart Rate Deceleration Abnormality — 6 reports (4.62%)
  10. Respiratory Disorder Neonatal — 6 reports (4.62%)

Source database →

Minprostin 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 Minprostin approved in United States?

Yes. FDA has authorised it.

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

Glostrup University Hospital, Copenhagen is the originator. The local marketing authorisation holder may differ — check the official source linked above.