🇺🇸 Fondaparinux Sodium (Arixtra) in United States

FDA authorised Fondaparinux Sodium (Arixtra) on 7 December 2001 · 10 US adverse-event reports

Marketing authorisation

FDA — authorised 7 December 2001

  • Application: NDA021345
  • Marketing authorisation holder: MYLAN IRELAND LTD
  • Local brand name: ARIXTRA
  • Indication: SOLUTION — SUBCUTANEOUS
  • Status: approved

Read official source →

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. Abdominal Wall Haematoma — 1 report (10%)
  2. Cough — 1 report (10%)
  3. Deep Vein Thrombosis — 1 report (10%)
  4. Drug Administration Error — 1 report (10%)
  5. False Positive Investigation Result — 1 report (10%)
  6. Gastritis — 1 report (10%)
  7. Haemorrhage — 1 report (10%)
  8. Intra-Abdominal Haemorrhage — 1 report (10%)
  9. Leukocytosis — 1 report (10%)
  10. Nausea — 1 report (10%)

Source database →

Fondaparinux Sodium (Arixtra) 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 Fondaparinux Sodium (Arixtra) approved in United States?

Yes. FDA authorised it on 7 December 2001.

Who is the marketing authorisation holder for Fondaparinux Sodium (Arixtra) in United States?

MYLAN IRELAND LTD holds the US marketing authorisation.