🇺🇸 Avitene in United States

53 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. Aspartate Aminotransferase Increased — 15 reports (28.3%)
  2. Alanine Aminotransferase Increased — 13 reports (24.53%)
  3. Fatigue — 5 reports (9.43%)
  4. Blood Bilirubin Increased — 4 reports (7.55%)
  5. Platelet Count Decreased — 4 reports (7.55%)
  6. Dyspnoea — 3 reports (5.66%)
  7. White Blood Cell Count Decreased — 3 reports (5.66%)
  8. Abdominal Pain — 2 reports (3.77%)
  9. Drug Ineffective — 2 reports (3.77%)
  10. Headache — 2 reports (3.77%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Avitene approved in United States?

Yes. FDA has authorised it.

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

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the originator. The local marketing authorisation holder may differ — check the official source linked above.