🇺🇸 vectibix in United States

FDA authorised vectibix on 27 September 2006 · 5,652 US adverse-event reports

Marketing authorisations

FDA — authorised 27 September 2006

  • Application: BLA125147
  • Marketing authorisation holder: AMGEN
  • Status: approved

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 — 1,302 reports (23.04%)
  2. Diarrhoea — 697 reports (12.33%)
  3. Skin Toxicity — 557 reports (9.85%)
  4. Dermatitis Acneiform — 522 reports (9.24%)
  5. Death — 506 reports (8.95%)
  6. Hypomagnesaemia — 456 reports (8.07%)
  7. Disease Progression — 444 reports (7.86%)
  8. Neuropathy Peripheral — 402 reports (7.11%)
  9. Neutropenia — 391 reports (6.92%)
  10. Nausea — 375 reports (6.63%)

Source database →

Other Oncology approved in United States

Frequently asked questions

Is vectibix approved in United States?

Yes. FDA authorised it on 27 September 2006; FDA has authorised it.

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

AMGEN holds the US marketing authorisation.