🇺🇸 tisseel in United States

325 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 — 68 reports (20.92%)
  2. Post Procedural Complication — 37 reports (11.38%)
  3. Haemorrhage — 34 reports (10.46%)
  4. Seroma — 32 reports (9.85%)
  5. Anaphylactic Reaction — 31 reports (9.54%)
  6. Cerebrospinal Fluid Leakage — 29 reports (8.92%)
  7. Graft Complication — 29 reports (8.92%)
  8. Off Label Use — 22 reports (6.77%)
  9. Pain — 22 reports (6.77%)
  10. Hypersensitivity — 21 reports (6.46%)

Source database →

tisseel 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 tisseel approved in United States?

Yes. FDA has authorised it.

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

Centre Hospitalier Universitaire, Amiens is the originator. The local marketing authorisation holder may differ — check the official source linked above.