🇺🇸 Feraheme in United States

FDA authorised Feraheme on 30 June 2009 · 2,048 US adverse-event reports

Marketing authorisations

FDA — authorised 30 June 2009

  • Application: NDA022180
  • Marketing authorisation holder: COVIS
  • Status: supplemented

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 — 419 reports (20.46%)
  2. Nausea — 224 reports (10.94%)
  3. Flushing — 222 reports (10.84%)
  4. Hypotension — 201 reports (9.81%)
  5. Back Pain — 192 reports (9.38%)
  6. Dizziness — 168 reports (8.2%)
  7. Anaphylactic Reaction — 164 reports (8.01%)
  8. Chest Discomfort — 158 reports (7.71%)
  9. Hypersensitivity — 156 reports (7.62%)
  10. Infusion Related Reaction — 144 reports (7.03%)

Source database →

Other Hematology approved in United States

Frequently asked questions

Is Feraheme approved in United States?

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

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

COVIS holds the US marketing authorisation.