🇺🇸 Fibrogammin in United States

72 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. Drug Ineffective — 11 reports (15.28%)
  2. No Adverse Event — 11 reports (15.28%)
  3. Exposure During Pregnancy — 8 reports (11.11%)
  4. Product Use In Unapproved Indication — 7 reports (9.72%)
  5. Abortion Spontaneous — 6 reports (8.33%)
  6. Device Issue — 6 reports (8.33%)
  7. Factor Xiii Inhibition — 6 reports (8.33%)
  8. Haemorrhage — 6 reports (8.33%)
  9. Off Label Use — 6 reports (8.33%)
  10. Drug Ineffective For Unapproved Indication — 5 reports (6.94%)

Source database →

Fibrogammin 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 Fibrogammin approved in United States?

Yes. FDA has authorised it.

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

Christian Haslinger is the originator. The local marketing authorisation holder may differ — check the official source linked above.