Irbesartan, sold under the brand name Aprovel among others, is a medication used to treat hypertension (high blood pressure), heart failure, and diabetic kidney disease. It is a reasonable initial treatment for high blood pressure. It is taken by mouth. Versions are available as the combination irbesartan/hydrochlorothiazide.[5][6]
Medical uses
Irbesartan is used for the treatment of hypertension. It may also delay progression of diabetic nephropathy and is also indicated for the reduction of renal disease progression in patients with type 2 diabetes,[7] hypertension and microalbuminuria (>30 mg/24 h) or proteinuria (>900 mg/24 h).[8]
Side effects
Common side effects include dizziness, diarrhea, feeling tired, muscle pain, and heartburn. Serious side effects may include kidney problems, low blood pressure, and angioedema. Use in pregnancy may harm the baby and use when breastfeeding is not recommended.[1]
Mechanism of action
Irbesartan is an angiotensin II receptor antagonist and works by blocking the effects of angiotensin II.[13]
History
Irbesartan was developed by Sanofi Research (part of Sanofi-Aventis). It is jointly marketed by Sanofi-Aventis and Bristol-Myers Squibb under the brand names Aprovel, Karvea, and Avapro.[3][1]
It was patented in 1990, and approved for medical use in 1997.[14] It is available as a generic medication.[15] In 2023, it was the 134th most commonly prescribed medication in the United States, with more than 4million prescriptions.[16][17]
Society and culture
Recalls
In 2018, the US Food and Drug Administration (FDA) reported that some versions of the angiotensin II receptor blocker medicines (including valsartan, losartan, irbesartan and other "-sartan" drugs) contain nitrosamine impurities.[18] Health Canada also reported nitrosamine impurities.[19]
The FDA issued revised guidelines about nitrosamine impurities in September 2024.[20]
References
- Irbesartan Pregnancy and Breastfeeding Warnings Drugs.com, 16 August 2018, retrieved 19 March 2020^
- Prescription medicines: registration of new generic medicines and biosimilar medicines, 2017 Therapeutic Goods Administration (TGA), 21 June 2022, retrieved 30 March 2024^
- Avapro- irbesartan tablet, film coated DailyMed, 9 May 2025, retrieved 5 August 2025^
- Aprovel EPAR European Medicines Agency (EMA), 27 August 1997, retrieved 13 June 2024^
- Avalide- irbesartan and hydrochlorothiazide tablet, film coated DailyMed, 31 July 2018, retrieved 19 March 2020^
- Karvezide EPAR European Medicines Agency (EMA), 16 October 1998, retrieved 30 August 2024^
- Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes The New England Journal of Medicine, September 2001^
- Australian Medicines Handbook Australian Medicines Handbook, 2006^
- Prescription medicines: registration of new generic medicines and biosimilar medicines, 2017 Therapeutic Goods Administration (TGA), 21 June 2022, retrieved 30 March 2024^
- Irbesartan and Hydrochlorothiazide (Professional Patient Advice) Drugs.com, 5 June 2019, retrieved 19 March 2020^
- CoAprovel EPAR European Medicines Agency (EMA), 15 October 1998, retrieved 13 June 2024^
- Irbesartan and hydrochlorothiazide Advanced Patient Information Drugs.com, 24 December 2019, retrieved 19 March 2020^
- Irbesartan Monograph for Professionals Drugs.com, American Society of Health-System Pharmacists, retrieved 3 March 2019^
- Analogue-based Drug Discovery John Wiley & Sons, 2006^
- British national formulary : BNF 76 Pharmaceutical Press, 2018^
- Top 300 of 2023 ClinCalc, retrieved 12 August 2025^
- Irbesartan Drug Usage Statistics, United States, 2013 - 2023 ClinCalc, retrieved 18 August 2025^
- Recalls of Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan U.S. Food and Drug Administration (FDA), 10 May 2021, retrieved 30 January 2023^
- Nitrosamine impurities in medications: Guidance Health Canada, 4 April 2022, retrieved 24 April 2023^
- Control of Nitrosamine Impurities in Human Drugs U.S. Food and Drug Administration, 24 February 2021, retrieved 6 September 2024^