🇺🇸 factor VIII in United States

2,008 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. Pharmaceutical Product Complaint — 587 reports (29.23%)
  2. Adverse Event — 555 reports (27.64%)
  3. Haemorrhage — 219 reports (10.91%)
  4. Drug Ineffective — 158 reports (7.87%)
  5. Hiv Infection — 94 reports (4.68%)
  6. Haemarthrosis — 88 reports (4.38%)
  7. Hepatitis C Virus — 88 reports (4.38%)
  8. Factor Viii Inhibition — 87 reports (4.33%)
  9. Hepatitis C — 75 reports (3.74%)
  10. Acquired Haemophilia — 57 reports (2.84%)

Source database →

factor VIII 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 factor VIII approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for factor VIII in United States?

Novo Nordisk A/S is the originator. The local marketing authorisation holder may differ — check the official source linked above.