🇺🇸 Hydrochlorothiazide (HCTZ) in United States

FDA authorised Hydrochlorothiazide (HCTZ) on 27 December 1996 · 39 US adverse-event reports

Marketing authorisation

FDA — authorised 27 December 1996

  • Application: NDA020504
  • Marketing authorisation holder: TEVA BRANDED PHARM
  • Local brand name: MICROZIDE
  • Indication: CAPSULE — 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. Drug Ineffective — 7 reports (17.95%)
  2. Acute Kidney Injury — 5 reports (12.82%)
  3. Chronic Kidney Disease — 4 reports (10.26%)
  4. Malaise — 4 reports (10.26%)
  5. Pain — 4 reports (10.26%)
  6. Balance Disorder — 3 reports (7.69%)
  7. Condition Aggravated — 3 reports (7.69%)
  8. Dizziness — 3 reports (7.69%)
  9. Fall — 3 reports (7.69%)
  10. Nausea — 3 reports (7.69%)

Source database →

Other Cardiovascular approved in United States

Frequently asked questions

Is Hydrochlorothiazide (HCTZ) approved in United States?

Yes. FDA authorised it on 27 December 1996.

Who is the marketing authorisation holder for Hydrochlorothiazide (HCTZ) in United States?

TEVA BRANDED PHARM holds the US marketing authorisation.