🇺🇸 Prophylactic in United States

120 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. Postoperative Wound Infection — 35 reports (29.17%)
  2. Haemorrhage — 18 reports (15%)
  3. Anaemia — 14 reports (11.67%)
  4. Abortion Incomplete — 13 reports (10.83%)
  5. Menorrhagia — 8 reports (6.67%)
  6. Nausea — 8 reports (6.67%)
  7. Pyrexia — 8 reports (6.67%)
  8. Vaginal Haemorrhage — 6 reports (5%)
  9. Dizziness — 5 reports (4.17%)
  10. Dyspnoea — 5 reports (4.17%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Prophylactic approved in United States?

Yes. FDA has authorised it.

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

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta is the originator. The local marketing authorisation holder may differ — check the official source linked above.