🇺🇸 Valsartan+/- Hydrochlorothiazide in United States

FDA authorised Valsartan+/- Hydrochlorothiazide on 1 June 2015 · 585 US adverse-event reports

Marketing authorisations

FDA — authorised 1 June 2015

  • Application: ANDA201087
  • Marketing authorisation holder: STRIDES PHARMA INTL
  • Status: supplemented

FDA

  • Application: ANDA091654
  • Marketing authorisation holder: TORRENT PHARMS LTD
  • Local brand name: VALSARTAN; HYDROCHLOROTHIAZIDE
  • 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. Fatigue — 73 reports (12.48%)
  2. Nausea — 70 reports (11.97%)
  3. Diarrhoea — 67 reports (11.45%)
  4. Dizziness — 67 reports (11.45%)
  5. Drug Ineffective — 62 reports (10.6%)
  6. Dyspnoea — 62 reports (10.6%)
  7. Vomiting — 51 reports (8.72%)
  8. Hypertension — 47 reports (8.03%)
  9. Acute Kidney Injury — 43 reports (7.35%)
  10. Blood Pressure Increased — 43 reports (7.35%)

Source database →

Other Cardiovascular approved in United States

Frequently asked questions

Is Valsartan+/- Hydrochlorothiazide approved in United States?

Yes. FDA authorised it on 1 June 2015; FDA has authorised it.

Who is the marketing authorisation holder for Valsartan+/- Hydrochlorothiazide in United States?

STRIDES PHARMA INTL holds the US marketing authorisation.