🇺🇸 Dinoprostone vaginal insert in United States

76 US adverse-event reports

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 — 15 reports (19.74%)
  2. Caesarean Section — 14 reports (18.42%)
  3. Maternal Drugs Affecting Foetus — 12 reports (15.79%)
  4. Uterine Hypertonus — 7 reports (9.21%)
  5. Intra-Uterine Death — 6 reports (7.89%)
  6. Premature Separation Of Placenta — 6 reports (7.89%)
  7. Apgar Score Low — 5 reports (6.58%)
  8. Anaphylactoid Syndrome Of Pregnancy — 4 reports (5.26%)
  9. Precipitate Labour — 4 reports (5.26%)
  10. Bradycardia Foetal — 3 reports (3.95%)

Source database →

Other Obstetrics approved in United States

Frequently asked questions

Is Dinoprostone vaginal insert approved in United States?

Dinoprostone vaginal insert does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Dinoprostone vaginal insert in United States?

HaEmek Medical Center, Israel is the originator. The local marketing authorisation holder may differ — check the official source linked above.