🇺🇸 Myfortic in United States

FDA authorised Myfortic on 27 February 2004 · 5,474 US adverse-event reports

Marketing authorisations

FDA — authorised 27 February 2004

  • Application: NDA050791
  • 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. Diarrhoea — 928 reports (16.95%)
  2. Death — 724 reports (13.23%)
  3. Off Label Use — 603 reports (11.02%)
  4. Pyrexia — 599 reports (10.94%)
  5. Blood Creatinine Increased — 562 reports (10.27%)
  6. Nausea — 430 reports (7.86%)
  7. Vomiting — 420 reports (7.67%)
  8. Malaise — 408 reports (7.45%)
  9. Acute Kidney Injury — 404 reports (7.38%)
  10. Hypertension — 396 reports (7.23%)

Source database →

Myfortic 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 Myfortic approved in United States?

Yes. FDA authorised it on 27 February 2004; FDA has authorised it.

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

NOVARTIS holds the US marketing authorisation.