FDA — authorised 15 October 2012
- Application: ANDA201505
- Marketing authorisation holder: APOTEX INC
- Local brand name: IRBESARTAN HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Irbesartan - Hydrochlorothiazide in United States
FDA authorised Irbesartan - Hydrochlorothiazide on 15 October 2012 · 356 US adverse-event reports
Marketing authorisations
FDA — authorised 27 February 2013
- Application: ANDA201524
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: IRBESARTAN; HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA090815
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: IRBESARTAN; HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
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.
- Window: 22 April 2025 – 22 April 2026
- Total reports: 356
Most-reported reactions
- Fatigue — 44 reports (12.36%)
- Drug Interaction — 39 reports (10.96%)
- Dyspnoea — 39 reports (10.96%)
- Diarrhoea — 38 reports (10.67%)
- Hypotension — 37 reports (10.39%)
- Hyponatraemia — 36 reports (10.11%)
- Nausea — 33 reports (9.27%)
- Vomiting — 33 reports (9.27%)
- Fall — 29 reports (8.15%)
- Acute Kidney Injury — 28 reports (7.87%)
Other Cardiovascular approved in United States
Frequently asked questions
Is Irbesartan - Hydrochlorothiazide approved in United States?
Yes. FDA authorised it on 15 October 2012; FDA authorised it on 27 February 2013; FDA has authorised it.
Who is the marketing authorisation holder for Irbesartan - Hydrochlorothiazide in United States?
APOTEX INC holds the US marketing authorisation.