🇺🇸 Olmesartan medoxomil tablets in United States

FDA authorised Olmesartan medoxomil tablets on 25 April 2002 · 94 US adverse-event reports

Marketing authorisation

FDA — authorised 25 April 2002

  • Application: NDA021286
  • Marketing authorisation holder: COSETTE
  • Local brand name: BENICAR
  • Indication: TABLET — ORAL
  • Status: approved

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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. Diarrhoea — 15 reports (15.96%)
  2. Drug Ineffective — 12 reports (12.77%)
  3. Product Substitution Issue — 12 reports (12.77%)
  4. Weight Decreased — 11 reports (11.7%)
  5. Product Quality Issue — 10 reports (10.64%)
  6. Dehydration — 8 reports (8.51%)
  7. Headache — 7 reports (7.45%)
  8. Wrong Technique In Product Usage Process — 7 reports (7.45%)
  9. Blood Pressure Increased — 6 reports (6.38%)
  10. Dizziness — 6 reports (6.38%)

Source database →

Other Cardiovascular approved in United States

Frequently asked questions

Is Olmesartan medoxomil tablets approved in United States?

Yes. FDA authorised it on 25 April 2002.

Who is the marketing authorisation holder for Olmesartan medoxomil tablets in United States?

COSETTE holds the US marketing authorisation.