🇺🇸 Andexanet in United States

168 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. Death — 26 reports (15.48%)
  2. Heparin Resistance — 21 reports (12.5%)
  3. Cerebral Haemorrhage — 18 reports (10.71%)
  4. Cerebral Infarction — 18 reports (10.71%)
  5. Acute Myocardial Infarction — 16 reports (9.52%)
  6. Pulmonary Embolism — 16 reports (9.52%)
  7. Ischaemic Stroke — 15 reports (8.93%)
  8. Drug Interaction — 14 reports (8.33%)
  9. Off Label Use — 14 reports (8.33%)
  10. Drug Ineffective — 10 reports (5.95%)

Source database →

Andexanet in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Cardiovascular approved in United States

Frequently asked questions

Is Andexanet approved in United States?

Yes. FDA has authorised it.

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

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