🇺🇸 Avandia in United States

107,032 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. Myocardial Infarction — 33,732 reports (31.52%)
  2. Cardiac Failure Congestive — 26,014 reports (24.3%)
  3. Cerebrovascular Accident — 14,854 reports (13.88%)
  4. Coronary Artery Disease — 9,447 reports (8.83%)
  5. Cardiac Disorder — 6,740 reports (6.3%)
  6. Death — 5,062 reports (4.73%)
  7. Acute Myocardial Infarction — 3,382 reports (3.16%)
  8. Injury — 2,822 reports (2.64%)
  9. Chest Pain — 2,566 reports (2.4%)
  10. Cardiovascular Disorder — 2,413 reports (2.25%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Avandia approved in United States?

Yes. FDA has authorised it.

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

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