🇺🇸 Human thrombin in United States

291 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. Off Label Use — 99 reports (34.02%)
  2. Product Use In Unapproved Indication — 38 reports (13.06%)
  3. Drug Ineffective For Unapproved Indication — 24 reports (8.25%)
  4. Haemorrhage — 22 reports (7.56%)
  5. Anaphylactic Reaction — 21 reports (7.22%)
  6. Haemothorax — 19 reports (6.53%)
  7. Shock Haemorrhagic — 19 reports (6.53%)
  8. Blood Pressure Increased — 17 reports (5.84%)
  9. Angiopathy — 16 reports (5.5%)
  10. Drug Ineffective — 16 reports (5.5%)

Source database →

Human thrombin 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 Human thrombin approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Human thrombin in United States?

Instituto Grifols, S.A. is the originator. The local marketing authorisation holder may differ — check the official source linked above.