🇺🇸 Erbitux in United States

FDA authorised Erbitux on 12 February 2004 · 8,920 US adverse-event reports

Marketing authorisations

FDA — authorised 12 February 2004

  • Application: BLA125084
  • Marketing authorisation holder: IMCLONE
  • 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. Rash — 1,770 reports (19.84%)
  2. Infusion Related Reaction — 974 reports (10.92%)
  3. Off Label Use — 969 reports (10.86%)
  4. Diarrhoea — 959 reports (10.75%)
  5. Dyspnoea — 925 reports (10.37%)
  6. Nausea — 834 reports (9.35%)
  7. Vomiting — 698 reports (7.83%)
  8. Death — 619 reports (6.94%)
  9. Hypotension — 593 reports (6.65%)
  10. Pyrexia — 579 reports (6.49%)

Source database →

Other Oncology approved in United States

Frequently asked questions

Is Erbitux approved in United States?

Yes. FDA authorised it on 12 February 2004; FDA has authorised it.

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

IMCLONE holds the US marketing authorisation.