🇺🇸 FVIII in United States

20 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. Factor Viii Inhibition — 4 reports (20%)
  2. Pulmonary Embolism — 4 reports (20%)
  3. Haemorrhage — 3 reports (15%)
  4. Device Related Infection — 2 reports (10%)
  5. Drug Ineffective For Unapproved Indication — 2 reports (10%)
  6. Abdominal Pain — 1 report (5%)
  7. Acute Myocardial Infarction — 1 report (5%)
  8. Anaemia — 1 report (5%)
  9. Cardiomegaly — 1 report (5%)
  10. Central Nervous System Haemorrhage — 1 report (5%)

Source database →

FVIII 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 FVIII approved in United States?

Yes. FDA has authorised it.

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

Wayne State University is the originator. The local marketing authorisation holder may differ — check the official source linked above.