Irbesartan

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.<ref name=AHFS2019/> It is a reasonable initial treatment for high blood pressure.<ref name=AHFS2019/> It is taken by mouth.<ref name=AHFS2019/> Versions are available as the combination irbesartan/hydrochlorothiazide.<ref name=AHFS2019/><ref name="Avalide FDA label">Template:Cite web</ref><ref name="CoAprovel EPAR" /><ref>Template:Cite web</ref>

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,<ref name="Lewis-2001">Template:Cite journal</ref> hypertension and microalbuminuria (>30 mg/24 h) or proteinuria (>900 mg/24 h).<ref name="Rossi2006">Template:Cite book</ref>

Combination with diuretic

Irbesartan is also available in a fixed-dose combination formulation with hydrochlorothiazide, a thiazide diuretic, to achieve an additive antihypertensive effect.<ref>Template:Cite web</ref><ref>Template:Cite web</ref><ref name="CoAprovel EPAR">Template:Cite web</ref><ref>Template:Cite web</ref>

Side effects

Common side effects include dizziness, diarrhea, feeling tired, muscle pain, and heartburn.<ref name=AHFS2019/><ref name=BNF76/> Serious side effects may include kidney problems, low blood pressure, and angioedema.<ref name=AHFS2019/> Use in pregnancy may harm the baby and use when breastfeeding is not recommended.<ref name="Drugs.com pregnancy" />

Mechanism of action

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Irbesartan is an angiotensin II receptor antagonist and works by blocking the effects of angiotensin II.<ref name=AHFS2019>Template:Cite web</ref>

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.<ref name="Avapro FDA label" /><ref name="Drugs.com pregnancy"/>

It was patented in 1990, and approved for medical use in 1997.<ref name=Fis2006>Template:Cite book</ref> It is available as a generic medication.<ref name=BNF76>Template:Cite book</ref> In 2023, it was the 134th most commonly prescribed medication in the United States, with more than 4Template:Nbspmillion prescriptions.<ref name="Top 300">Template:Cite web</ref><ref>Template:Cite web</ref>

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.<ref>Template:Cite web</ref> Health Canada also reported nitrosamine impurities.<ref>Template:Cite web</ref>

The FDA issued revised guidelines about nitrosamine impurities in September 2024.<ref>Template:Cite web</ref>