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.
Key facts
- Drug class
- Angiotensin 2 Receptor Blocker
- Treats
- Diabetic Nephropathies, Hypertension and Left Ventricular Dysfunction
- Available as
- Tablet
- Sold as
- 2 products — Avapro and Irbesartan
- Prescription?
- Prescription only
- Generic available?
- Yes
- What the pharmacy pays
- about $3 for a 30-count supply — not your price
- Boxed warning
- Boxed warning
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How irbesartan is dosed
From the FDA label for Avapro (application NDA020757). 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 AVAPRO may be administered with other antihypertensive agents and with or without food. 2.2 Hypertension The recommended initial dose of AVAPRO 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 sanofi-aventis U.S. LLC at 1-800-633-1610 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 AVAPRO has 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 least 1% of patients…
Who shouldn’t take irbesartan
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. ( 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 AVAPRO 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 antagonists, including irbesartan, may be attenuated by NSAIDs including selective COX-2 inhibitors. 7.4 Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on AVAPRO and other agents that affect the RAS. Do not coadminister aliskiren with AVAPRO in patients with diabetes. Avoid use of aliskiren with AVAPRO in patients with renal impairment (GFR <60 mL/min).
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.
Lisinopril (an ACE inhibitor) — MedlinePlus (U.S. National Library of Medicine) ↗
Every irbesartan product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Tablet | Generic | $3 | View → | |
| 2 | 66/100 | Prescription | Tablet | Generic | $3 | View → |
What irbesartan pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Combination products containing irbesartan
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
Irbesartan recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Irbesartan and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for irbesartan: levels in milk, effects in breastfed infants, and the drugs it would consider insteadBecause no information is available on the use of irbesartan during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.
National Institute of Child Health and Human Development, record revised July 15, 2026. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about irbesartan
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 39,171 reports naming irbesartan, and the FDA flagged 86% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- acute kidney injury2,349 reports
- fatigue2,050 reports
- nausea2,002 reports
- diarrhoea1,971 reports
- fall1,794 reports
- dyspnoea1,705 reports
- dizziness1,562 reports
- headache1,562 reports
Read these as a signal, not a rate. A report does not mean irbesartan caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 25, 2026.
Related guides
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Frequently asked questions
What is irbesartan?
Avapro (Irbesartan) is an angiotensin 2 receptor blocker used to treat Diabetic Nephropathies, Hypertension, Left Ventricular Dysfunction.
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.: Avapro and Irbesartan. 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.
Is there a generic irbesartan?
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.
What should I avoid while taking irbesartan?
Food: salt substitutes containing potassium, and large amounts of potassium-rich foods or supplements — see the food section above for what each one does and whether it means avoiding it or just being consistent. This is what the FDA label and our cited sources say — it is not a complete list. Your pharmacist can check your own combination.
Cite this page
- APA
- pharmaranks. (2026, July 24). Irbesartan: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/irbesartan
- MLA
- “Irbesartan: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/irbesartan.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
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.
Read the full FDA label for irbesartan on DailyMed (NIH) ↗ — including its boxed warning in full.