🇺🇸 Faslodex in United States

FDA authorised Faslodex on 25 April 2002 · 13,337 US adverse-event reports

Marketing authorisations

FDA — authorised 25 April 2002

  • Application: NDA021344
  • Marketing authorisation holder: ASTRAZENECA
  • 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. Fatigue — 2,467 reports (18.5%)
  2. Nausea — 1,550 reports (11.62%)
  3. White Blood Cell Count Decreased — 1,450 reports (10.87%)
  4. Malignant Neoplasm Progression — 1,432 reports (10.74%)
  5. Death — 1,368 reports (10.26%)
  6. Diarrhoea — 1,254 reports (9.4%)
  7. Neoplasm Progression — 1,196 reports (8.97%)
  8. Pain — 926 reports (6.94%)
  9. Neutropenia — 855 reports (6.41%)
  10. Asthenia — 839 reports (6.29%)

Source database →

Faslodex in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in United States

Frequently asked questions

Is Faslodex approved in United States?

Yes. FDA authorised it on 25 April 2002; FDA has authorised it.

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

ASTRAZENECA holds the US marketing authorisation.