irbesartan
Brand names: Avapro
Irbesartan is a medicine that lowers blood pressure. It belongs to a class of drugs called angiotensin II receptor blockers (ARBs).
Drug Pricing (NADAC)
Brand Price
$7.35/unit
Generic Price
$0.11/unit
Generic Savings
99%
Generic Available
Yes (21 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Irbesartan is used to treat high blood pressure (hypertension).
Common side effects
Diarrhea, Heartburn, Tiredness
Key warnings
Irbesartan can harm your unborn baby.
How It Works
Irbesartan blocks a substance in your body that tightens blood vessels. This helps blood vessels relax and widens them, which lowers blood pressure. It also helps protect the kidneys in people with diabetes.
How to Take It
Take irbesartan once a day, as prescribed by your doctor. You can take it with or without food. The usual starting dose for high blood pressure is 150 mg daily, which may be increased to 300 mg. For diabetic kidney disease, the usual dose is 300 mg daily.
Pregnancy & Breastfeeding
Irbesartan can cause serious harm or death to an unborn baby. Do not take this medicine if you are pregnant. Talk to your doctor if you are breastfeeding, as this medication may not be safe for your baby.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose and continue with your regular schedule.
Storage
Store irbesartan tablets at room temperature (68°F to 77°F).
Side Effects (from patient reports)
Based on 20,779 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 43,004 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2001–2025.
Total Reports
43,004
Death-Related Reports
3,218
Hospitalization Reports
18,387
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | FATIGUE | 2,460 |
| 2 | NAUSEA | 2,420 |
| 3 | DIARRHOEA | 2,261 |
| 4 | DRUG INEFFECTIVE | 2,136 |
| 5 | ACUTE KIDNEY INJURY | 2,054 |
| 6 | DIZZINESS | 1,985 |
| 7 | DYSPNOEA | 1,981 |
| 8 | FALL | 1,927 |
| 9 | HEADACHE | 1,871 |
| 10 | ASTHENIA | 1,683 |
| 11 | OFF LABEL USE | 1,648 |
| 12 | MALAISE | 1,592 |
| 13 | PAIN | 1,513 |
| 14 | VOMITING | 1,496 |
| 15 | BLOOD PRESSURE INCREASED | 1,479 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Irbesartan can harm your unborn baby. If you are pregnant or plan to become pregnant, tell your doctor right away. Stop taking irbesartan as soon as you know you are pregnant.
Known Drug Interactions
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. Do not coadminister aliskiren with irbesartan tablets in patients with diabetes. Avoid use of aliskiren with irbesartan tablets in patients with renal impairment (GFR <60 mL/min).
Mechanism: These drugs both work on the same system in the body, which can lead to dangerously low blood pressure or kidney failure.
What to do: Avoid this combination if you have diabetes or kidney problems, and have your doctor check your kidney function regularly.
7 DRUG INTERACTIONS Lithium: Risk of lithium toxicity. 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.
Mechanism: Irbesartan can make it harder for your kidneys to remove lithium from your body, which causes lithium levels to rise. This increase can lead to dangerous side effects or toxicity.
What to do: Your doctor should monitor your lithium blood levels closely while you are taking both medications.
Common Questions
Can I take irbesartan with other blood pressure medicines?
Can I drink alcohol while taking irbesartan?
What should I do if I feel dizzy after taking irbesartan?
Does irbesartan have any effect on my kidneys?
Can I take irbesartan if I have diabetes?
Will irbesartan cure my high blood pressure?
Are there any foods I should avoid while taking irbesartan?
Can I stop taking irbesartan if my blood pressure is normal?
Does irbesartan interact with any other medications?
How long does it take for irbesartan to lower my blood pressure?
What are the common side effects of irbesartan?
Does irbesartan interact with other medications?
What drug class is irbesartan?
Is there a generic version of irbesartan?
Is irbesartan safe during pregnancy?
Related Medications in Angiotensin II Receptor Blocker (ARB)
Other drugs grouped near irbesartan — same-class peers and common alternatives.
acebutolol
Sectral
Acebutolol is a medicine that helps lower blood pressure and control irregular heartbeats.
Compare with irbesartan →
aliskiren
Tekturna
Tekturna is a medicine used to treat high blood pressure.
Compare with irbesartan →
amiloride
Midamor
Amiloride is a water pill that helps your body hold onto potassium.
Compare with irbesartan →
amlodipine
Norvasc
Amlodipine (Norvasc) is a drug that lowers blood pressure and treats chest pain.
Compare with irbesartan →
amlodipine/benazepril
Lotrel
Lotrel is a combination medicine that contains amlodipine and benazepril.
Compare with irbesartan →
Medication Guides
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Common Drug Interactions
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What the FDA Data Shows for irbesartan
The FDA label for irbesartan (sold under brand names such as Avapro) classifies it as a prescription-only medication in the Angiotensin II Receptor Blocker (ARB) class. Irbesartan is used to treat high blood pressure (hypertension). Official labeling lists 7 commonly reported side effects, including Diarrhea, Heartburn, Tiredness.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 20,779 voluntary reports. The database also lists 2 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.11 versus $7.35 for the brand — a 99% generic savings.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: January 27, 2026
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages