🇺🇸 losartan and HCTZ in United States

FDA authorised losartan and HCTZ on 26 September 2007 · 11 US adverse-event reports

Marketing authorisation

FDA — authorised 26 September 2007

  • Application: NDA022100
  • Marketing authorisation holder: COSETTE
  • Local brand name: AZOR
  • 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. Nausea — 2 reports (18.18%)
  2. Blood Glucose Increased — 1 report (9.09%)
  3. Blood Triglycerides Increased — 1 report (9.09%)
  4. Bronchitis — 1 report (9.09%)
  5. Chest Pain — 1 report (9.09%)
  6. Dizziness — 1 report (9.09%)
  7. Drug Dose Omission — 1 report (9.09%)
  8. Drug Ineffective — 1 report (9.09%)
  9. Dyspnoea — 1 report (9.09%)
  10. Feeling Abnormal — 1 report (9.09%)

Source database →

Other Cardiovascular approved in United States

Frequently asked questions

Is losartan and HCTZ approved in United States?

Yes. FDA authorised it on 26 September 2007.

Who is the marketing authorisation holder for losartan and HCTZ in United States?

COSETTE holds the US marketing authorisation.