🇺🇸 dapagliflozine in United States

50 US adverse-event reports

Marketing authorisation

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 — 10 reports (20%)
  2. Ketoacidosis — 7 reports (14%)
  3. Acute Kidney Injury — 5 reports (10%)
  4. Diarrhoea — 5 reports (10%)
  5. Arthralgia — 4 reports (8%)
  6. Atrial Fibrillation — 4 reports (8%)
  7. Drug Interaction — 4 reports (8%)
  8. Myocardial Infarction — 4 reports (8%)
  9. Vomiting — 4 reports (8%)
  10. Chest Pain — 3 reports (6%)

Source database →

Other Other approved in United States

Frequently asked questions

Is dapagliflozine approved in United States?

Yes. FDA has authorised it.

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

Mansoura University is the originator. The local marketing authorisation holder may differ — check the official source linked above.