Irbesartan is an angiotensin 2 receptor blocker indicated for treatment of hypertension, to lower blood pressure, among other approved uses. It is available as tablets for oral use. MedsAcross supplies Irbesartan for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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. Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria.
Source: US FDA prescribing information
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 homeostasis. Irbesartan is a specific competitive antagonist of AT 1 receptors with a much greater affinity (more than 8500-fold) for the AT 1 receptor than for the AT 2 receptor and no agonist activity.
Source: US FDA prescribing information
Indication Dose Hypertension 150 to 300 mg once daily Diabetic Nephropathy 300 mg once daily General Considerations AVAPRO may be administered with other antihypertensive agents and with or without food.
Source: US FDA prescribing information
AVAPRO is contraindicated in patients who are hypersensitive to any component of this product. Do not coadminister aliskiren with AVAPRO in patients with diabetes. Hypersensitivity to any component of this product. Coadministration with aliskiren in patients with diabetes.
Source: US FDA prescribing information
Boxed warning (fetal toxicity): When pregnancy is detected, discontinue AVAPRO as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. Hypotension: Correct volume or salt depletion prior to administration. Monitor renal function and serum potassium. Fetal Toxicity AVAPRO can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue AVAPRO as soon as possible.
Source: US FDA prescribing information
The following important adverse reactions are described elsewhere in the labeling: Hypotension in Volume or Salt-Depleted Patients Impaired Renal Function Nephropathy in type 2 diabetic patients: The most common adverse reactions which were more frequent than placebo were hyperkalemia dizziness, orthostatic dizziness, and orthostatic hypotension.
Source: US FDA prescribing information
Lithium: Risk of lithium toxicity. Nonsteroidal Anti-inflammatory Drugs (NSAIDs) and COX-2 inhibitors: Increased risk of renal impairment. Reduced antihypertensive effects. Dual blockade of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia.
Source: US FDA prescribing information
Store at 25°C (77°F), excursions permitted to 15°C–30°C (59°F–86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
5 presentations of Irbesartan, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Irbesartan 150 mg tabletOralGeneric name | — | US FDA | Available on request |
| Irbesartan 300 mg tabletOralGeneric name | — | US FDA | Available on request |
| Irbesartan 75 mg tabletOralGeneric name | — | US FDA | Available on request |
| Avapro 150 mg tabletOral | Sanofi-Aventis | US FDA | Available on request |
| Avapro 300 mg tabletOral | Sanofi-Aventis | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Irbesartan in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 5 presentations of Irbesartan and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Irbesartan, including Avapro.
Yes. The US FDA first approved Irbesartan on 30 September 1997, according to Drugs@FDA.
Yes. Irbesartan has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Irbesartan is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Irbesartan is classified under ATC code C09CA04 (Irbesartan).
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