🇺🇸 Exjade in United States

FDA authorised Exjade on 2 November 2005 · 14,805 US adverse-event reports

Marketing authorisations

FDA — authorised 2 November 2005

  • Application: NDA021882
  • Marketing authorisation holder: NOVARTIS
  • Local brand name: EXJADE
  • Indication: TABLET, FOR SUSPENSION — ORAL
  • 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. Death — 4,076 reports (27.53%)
  2. Diarrhoea — 1,959 reports (13.23%)
  3. Sickle Cell Anaemia With Crisis — 1,298 reports (8.77%)
  4. Pyrexia — 1,204 reports (8.13%)
  5. Haemoglobin Decreased — 1,166 reports (7.88%)
  6. Nausea — 1,152 reports (7.78%)
  7. Pneumonia — 1,066 reports (7.2%)
  8. Serum Ferritin Increased — 1,019 reports (6.88%)
  9. Malaise — 979 reports (6.61%)
  10. Fatigue — 886 reports (5.98%)

Source database →

Exjade in other countries

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

Other Other approved in United States

Frequently asked questions

Is Exjade approved in United States?

Yes. FDA authorised it on 2 November 2005; FDA has authorised it.

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

NOVARTIS holds the US marketing authorisation.