🇺🇸 Fibrin Sealant in United States

30 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. Activated Partial Thromboplastin Time Prolonged — 4 reports (13.33%)
  2. Coagulation Factor V Level Decreased — 4 reports (13.33%)
  3. Prothrombin Time Prolonged — 4 reports (13.33%)
  4. Drug Ineffective — 3 reports (10%)
  5. Haemorrhage — 3 reports (10%)
  6. Thrombin Time Prolonged — 3 reports (10%)
  7. Wound Infection — 3 reports (10%)
  8. Abscess — 2 reports (6.67%)
  9. Air Embolism — 2 reports (6.67%)
  10. Anti Factor V Antibody Positive — 2 reports (6.67%)

Source database →

Fibrin Sealant 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 Fibrin Sealant approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Fibrin Sealant in United States?

Baxter Healthcare Corporation is the originator. The local marketing authorisation holder may differ — check the official source linked above.