🇺🇸 Jardiance in United States

FDA authorised Jardiance on 1 August 2014 · 24,562 US adverse-event reports

Marketing authorisations

FDA — authorised 1 August 2014

  • Application: NDA204629
  • Marketing authorisation holder: BOEHRINGER INGELHEIM
  • 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. Diabetic Ketoacidosis — 3,399 reports (13.84%)
  2. Blood Glucose Increased — 2,895 reports (11.79%)
  3. Nausea — 2,862 reports (11.65%)
  4. Diarrhoea — 2,488 reports (10.13%)
  5. Weight Decreased — 2,456 reports (10%)
  6. Fatigue — 2,287 reports (9.31%)
  7. Dizziness — 2,135 reports (8.69%)
  8. Vomiting — 2,059 reports (8.38%)
  9. Fungal Infection — 2,031 reports (8.27%)
  10. Off Label Use — 1,950 reports (7.94%)

Source database →

Other Metabolic approved in United States

Frequently asked questions

Is Jardiance approved in United States?

Yes. FDA authorised it on 1 August 2014; FDA has authorised it.

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

BOEHRINGER INGELHEIM holds the US marketing authorisation.