🇺🇸 Vitamin K Antagonist in United States

32 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. Cytolytic Hepatitis — 4 reports (12.5%)
  2. International Normalised Ratio Increased — 4 reports (12.5%)
  3. Antidepressant Drug Level Above Therapeutic — 3 reports (9.38%)
  4. Asterixis — 3 reports (9.38%)
  5. Confusional State — 3 reports (9.38%)
  6. Drug Interaction — 3 reports (9.38%)
  7. Encephalopathy — 3 reports (9.38%)
  8. Hepatitis Cholestatic — 3 reports (9.38%)
  9. Hypokalaemia — 3 reports (9.38%)
  10. Metabolic Acidosis — 3 reports (9.38%)

Source database →

Vitamin K Antagonist 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 Vitamin K Antagonist approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Vitamin K Antagonist in United States?

RenJi Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.