🇺🇸 Protamin in United States

50 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. Aspiration — 7 reports (14%)
  2. Cardiovascular Disorder — 7 reports (14%)
  3. Retroperitoneal Haemorrhage — 7 reports (14%)
  4. Pyrexia — 5 reports (10%)
  5. Resuscitation — 5 reports (10%)
  6. Blister — 4 reports (8%)
  7. Erythema — 4 reports (8%)
  8. Lip Erosion — 4 reports (8%)
  9. Stevens-Johnson Syndrome — 4 reports (8%)
  10. Post Procedural Complication — 3 reports (6%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Protamin approved in United States?

Yes. FDA has authorised it.

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

University of Ioannina is the originator. The local marketing authorisation holder may differ — check the official source linked above.