🇺🇸 Jadenu in United States

FDA authorised Jadenu on 30 March 2015 · 2,235 US adverse-event reports

Marketing authorisations

FDA — authorised 30 March 2015

  • Application: NDA206910
  • Marketing authorisation holder: NOVARTIS PHARMS CORP
  • Local brand name: JADENU
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 18 May 2017

  • Application: NDA207968
  • Marketing authorisation holder: NOVARTIS
  • 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. Death — 511 reports (22.86%)
  2. Diarrhoea — 301 reports (13.47%)
  3. Off Label Use — 232 reports (10.38%)
  4. Sickle Cell Anaemia With Crisis — 223 reports (9.98%)
  5. Haemoglobin Decreased — 200 reports (8.95%)
  6. Nausea — 199 reports (8.9%)
  7. Fatigue — 169 reports (7.56%)
  8. Serum Ferritin Increased — 143 reports (6.4%)
  9. Malaise — 131 reports (5.86%)
  10. Pyrexia — 126 reports (5.64%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Jadenu approved in United States?

Yes. FDA authorised it on 30 March 2015; FDA authorised it on 18 May 2017; FDA has authorised it.

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

NOVARTIS PHARMS CORP holds the US marketing authorisation.