🇺🇸 dinoprostone vaginal delivery system in United States

23 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. Caesarean Section — 4 reports (17.39%)
  2. Maternal Drugs Affecting Foetus — 4 reports (17.39%)
  3. Foetal Death — 3 reports (13.04%)
  4. Disseminated Intravascular Coagulation — 2 reports (8.7%)
  5. Foetal Distress Syndrome — 2 reports (8.7%)
  6. Foetal Exposure During Delivery — 2 reports (8.7%)
  7. Postpartum Haemorrhage — 2 reports (8.7%)
  8. Uterine Hyperstimulation — 2 reports (8.7%)
  9. Anaphylactoid Syndrome Of Pregnancy — 1 report (4.35%)
  10. Apgar Score Low — 1 report (4.35%)

Source database →

dinoprostone vaginal delivery system in other countries

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

Frequently asked questions

Is dinoprostone vaginal delivery system approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for dinoprostone vaginal delivery system in United States?

University Medical Centre Ljubljana is the originator. The local marketing authorisation holder may differ — check the official source linked above.