🇺🇸 Simvastatin/Ezetimibe in United States

FDA authorised Simvastatin/Ezetimibe on 23 July 2004 · 84 US adverse-event reports

Marketing authorisation

FDA — authorised 23 July 2004

  • Application: NDA021687
  • Marketing authorisation holder: ORGANON
  • Local brand name: VYTORIN
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

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. Blood Glucose Increased — 12 reports (14.29%)
  2. Hypoglycaemia — 11 reports (13.1%)
  3. Dyspnoea — 10 reports (11.9%)
  4. Dizziness — 9 reports (10.71%)
  5. Nausea — 8 reports (9.52%)
  6. Chest Pain — 7 reports (8.33%)
  7. Drug Interaction — 7 reports (8.33%)
  8. Fatigue — 7 reports (8.33%)
  9. Hypotension — 7 reports (8.33%)
  10. Atrial Fibrillation — 6 reports (7.14%)

Source database →

Other Cardiovascular approved in United States

Frequently asked questions

Is Simvastatin/Ezetimibe approved in United States?

Yes. FDA authorised it on 23 July 2004.

Who is the marketing authorisation holder for Simvastatin/Ezetimibe in United States?

ORGANON holds the US marketing authorisation.