🇺🇸 Ferumoxytol injection in United States

FDA authorised Ferumoxytol injection on 30 June 2009 · 115 US adverse-event reports

Marketing authorisations

FDA — authorised 30 June 2009

  • Application: NDA022180
  • Marketing authorisation holder: AZURITY
  • Local brand name: FERAHEME
  • Indication: SOLUTION — INTRAVENOUS
  • Status: approved

Read official source →

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. Dyspnoea — 17 reports (14.78%)
  2. Nausea — 15 reports (13.04%)
  3. Unresponsive To Stimuli — 14 reports (12.17%)
  4. Hypotension — 13 reports (11.3%)
  5. Hypersensitivity — 11 reports (9.57%)
  6. Cardiac Arrest — 10 reports (8.7%)
  7. Flushing — 10 reports (8.7%)
  8. Chest Pain — 9 reports (7.83%)
  9. Hyperhidrosis — 8 reports (6.96%)
  10. Oxygen Saturation Decreased — 8 reports (6.96%)

Source database →

Ferumoxytol injection 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 Ferumoxytol injection approved in United States?

Yes. FDA authorised it on 30 June 2009; FDA has authorised it.

Who is the marketing authorisation holder for Ferumoxytol injection in United States?

AZURITY holds the US marketing authorisation.