🇺🇸 Farxiga in United States

FDA authorised Farxiga on 8 January 2014 · 12,826 US adverse-event reports

Marketing authorisations

FDA — authorised 8 January 2014

  • Application: NDA202293
  • Marketing authorisation holder: ASTRAZENECA AB
  • 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 — 3,637 reports (28.36%)
  2. Fungal Infection — 1,244 reports (9.7%)
  3. Blood Glucose Increased — 1,168 reports (9.11%)
  4. Fatigue — 1,142 reports (8.9%)
  5. Weight Decreased — 1,097 reports (8.55%)
  6. Nausea — 1,084 reports (8.45%)
  7. Dizziness — 1,052 reports (8.2%)
  8. Diarrhoea — 933 reports (7.27%)
  9. Dyspnoea — 760 reports (5.93%)
  10. Urinary Tract Infection — 709 reports (5.53%)

Source database →

Other Metabolic approved in United States

Frequently asked questions

Is Farxiga approved in United States?

Yes. FDA authorised it on 8 January 2014; FDA has authorised it.

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

ASTRAZENECA AB holds the US marketing authorisation.