Irbesartan — uses, dosing, side effects & the brands that sell it · pharmaranks
Irbesartan: uses, dosing, side effects & brands
Irbesartan is an angiotensin 2 receptor blocker sold in the U.S. under 2 brand and generic names, for diabetic nephropathies, hypertension and left ventricular dysfunction. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
By the pharmaranks editorial team·Reviewed against the FDA (openFDA label, NDC Directory & Enforcement) sources·How we research
Key facts
Drug class
Angiotensin 2 Receptor Blocker
Treats
Diabetic Nephropathies, Hypertension and Left Ventricular Dysfunction
From the FDA label for Irbesartan (application ANDA079213). Other irbesartan products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Indication Dose Hypertension ( 2.2 ) 150 to 300 mg once daily Diabetic Nephropathy ( 2.3 ) 300 mg once daily 2.1 General Considerations Irbesartan tablets may be administered with other antihypertensive agents and with or without food. 2.2 Hypertension The recommended initial dose of irbesartan tablets is 150 mg once daily. The dosage can be increased to a maximum dose of 300 mg once daily as needed to control blood pressure [see Clinical Studies (14.1) ]. 2.3 Nephropathy in Type 2 Diabetic Patients The recommended dose is 300 mg once daily [see Clinical Studies (14.2) ]. 2.4 Dose Adjustment in Volume and Salt-Depleted Patients The recommended initial dose is 75 mg once daily in patients with depletion of intravascular volume or salt (e.g., patients treated vigorously with diuretics or on hemodialysis) [see Warnings and Precautions (5.2) ].
Irbesartan side effects
The following important adverse reactions are described elsewhere in the labeling: • Hypotension in Volume or Salt-Depleted Patients [see Warnings and Precautions (5.2) ] • Impaired Renal Function [see Warnings and Precautions (5.3) ] • 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthecare US LLC. at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Hypertension Irbesartan tablets have been evaluated for safety in more than 4300 patients with hypertension and about 5000 subjects overall. This experience includes 1303 patients treated for over 6 months and 407 patients for 1 year or more. In placebo-controlled clinical trials, the following adverse reactions were reported in at…
Irbesartan and food
Potassium-rich foods & salt substitutes
Don't use potassium-based salt substitutes unless your clinician approves, and ask before taking potassium supplements. Your clinician may check your potassium level with blood tests.
Irbesartan is an angiotensin II receptor (AT 1 subtype) antagonist. Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3-[ p -( o -1 H -tetrazol-5‑ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its empirical formula is C 25 H 28 N 6 O, and the structural formula: Irbesartan is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Irbesartan tablets are available for oral administration in unscored tablets containing 75 mg, 150 mg, or 300 mg of irbesartan. Inactive ingredients include: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, and magnesium stearate.
What kind of drug is irbesartan?
The FDA classifies irbesartan as an angiotensin 2 receptor blocker. Angiotensin II receptor blockers (ARBs) block the AT1 receptor that the hormone angiotensin II uses to tighten blood vessels and make the body hold onto salt and water. With that receptor blocked, vessels relax and widen, so blood pressure falls. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take irbesartan with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run irbesartan against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is irbesartan sold under?
We track 2 irbesartan-containing products in the U.S.: Irbesartan and Avapro. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does irbesartan come in?
Across the brands we track, irbesartan is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Who shouldn’t take irbesartan
Irbesartan tablets are contraindicated in patients who are hypersensitive to any component of this product. Do not coadministrate aliskiren with irbesartan tablets in patients with diabetes. • Hypersensitivity to any component of this product. ( 4 ) • Coadministration with aliskiren in patients with diabetes. ( 4 )
Irbesartan drug interactions
Lithium: Risk of lithium toxicity. ( 7 ) • Nonsteroidal Anti-inflammatory Drugs (NSAIDs) and COX-2 inhibitors: Increased risk of renal impairment. Reduced antihypertensive effects. ( 7 ) • Dual blockade of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia. ( 7 ) 7.1 Agents Increasing Serum Potassium Coadministration of irbesartan tablets with other drugs that raise serum potassium levels may result in hyperkalemia, sometimes severe. Monitor serum potassium in such patients. 7.2 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of irbesartan and lithium. Monitor lithium levels in patients receiving irbesartan and lithium. 7.3 Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists (including irbesartan) may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving irbesartan and NSAID therapy. The antihypertensive effect of angiotensin II receptor…
Yes. Our catalog lists 1 generic irbesartan product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has irbesartan been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions irbesartan. The most recent: Irbesartan Tablets USP (Jan 21, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.