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Avapro

Irbesartan

An oral daily medication used to treat high blood pressure and kidney disease caused by diabetes.

Generic name
Irbesartan
Brand name
Avapro
Route
Oral
Marketed by
Sanofi
FDA pharmacologic class
Angiotensin 2 Receptor Blocker; Angiotensin 2 Receptor Antagonists
First FDA approval
30 Sep 1997

Where Irbesartan is approved

All regulators →

Of the three regulators tracked here, the first to approve Irbesartan was the EU, on 26 Aug 1997. It is approved in 3 of the 3 regulators tracked here.

USUnited States (FDA)
30 Sep 1997
Avapro
NDA020757 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
26 Aug 1997
Aprovel
EMA product page
First centralised authorisation
CACanada (Health Canada)
1 Jun 1998
Avapro
Notice of Compliance 2987
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

What health systems spend on Irbesartan

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ENNHS England
£3.9m
1,554,805 items dispensed, Aug 2025 to Jul 2026
+27% on the previous 12 months
Net ingredient cost, community prescriptions
USUS Medicaid
$3.0m
185,145 prescriptions in 2025 · Irbesartan, Irbesartan
-8% on 2024
Amount Medicaid reimbursed, before rebates

From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.

How Irbesartan works

All drug targets →
  • Type-1 angiotensin II receptor antagonist Antagonist
    Target: AGTR1 angiotensin II receptor type 1
    ✓ In ChEMBL and the Guide to Pharmacology
Diseases it has been tested for in clinical trials, by furthest phase
  • Arterial dissectionPhase 3
  • COVID-19Phase 3
  • Ehlers-Danlos syndrome, vascular typePhase 3
  • Hepatic fibrosisPhase 3
  • HypercholesterolemiaPhase 3
  • Moderate albuminuriaPhase 3
  • SepsisPhase 3
  • Arterial stiffness measurementPhase 3
  • Chronic hepatitis C virus infectionPhase 3
  • Cirrhosis of liverPhase 3
20 diseases in all

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1513, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 589, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Irbesartan

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Reference identifiers for Irbesartan

ATC code
C09CA04
ChEMBL
CHEMBL1513
DrugBank
DB01029
PubChem CID
3749
CAS number
138402-11-6
FDA UNII
J0E2756Z7N
Wikidata
Q947266
Wikipedia
Irbesartan

Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.

What Avapro is used for

AVAPRO is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. ( 1.2 ) 1.1 Hypertension AVAPRO ® is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid…

How it works

12.1 Mechanism of Action Angiotensin II is a potent vasoconstrictor formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the primary vasoactive hormone of the renin-angiotensin system, and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Irbesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively binding to the AT 1 angiotensin II receptor found in many tissues (e.g., vascular smooth muscle, adrenal gland). There is also an AT 2 receptor in many tissues, but it is not involved in cardiovascular homeosta…

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How this page is built

The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.

Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 7 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.