Prescription medication · Angiotensin II Receptor Blocker (ARB)
irbesartan
Also sold as Avapro. Irbesartan is used to treat high blood pressure (hypertension).
Data updated 2026-05-15
- 43,004
- FDA reportsOften reported
- 2
- InteractionsFew interactions
- 99% less
- Generic vs brandHuge savings
- $7.35
- Brand price (NADAC)
What the data shows
irbesartan (Avapro) is a prescription Angiotensin II Receptor Blocker (ARB), reported at a middle-of-the-pack volume (43,004 FDA reports), whose generic costs a fraction of the brand (about 99% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
irbesartan (Avapro) is a prescription Angiotensin II Receptor Blocker (ARB). Irbesartan is used to treat high blood pressure (hypertension).
Irbesartan is a medicine that lowers blood pressure. It belongs to a class of drugs called angiotensin II receptor blockers (ARBs).
Verify with FDA → · CMS NADAC pricing →
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 →
NADAC price trail: IRBESARTAN 150 MG TABLET
Same CMS presentation as the headline generic unit price above (3 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -22.8% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| December 20, 2023 | $0.1425/EA | - | 2 |
| September 18, 2024 | $0.1425/EA | 0% | 1 |
| December 18, 2024 | $0.1101/EA | -22.8% | 20 |
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.
The sections below are summarized in plain English from irbesartan's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
Side Effects (from patient reports)
Based on 43,004 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for irbesartan, by number of reports
- Fatigue
Fatigue
2,460 reports
- Nausea
Nausea
2,420 reports
- Diarrhoea
Diarrhoea
2,261 reports
- Acute Kidney Injury
Acute Kidney Injury
2,054 reports
- Dizziness
Dizziness
1,985 reports
- Dyspnoea
Dyspnoea
1,981 reports
- Fall
Fall
1,927 reports
- Headache
Headache
1,871 reports
- Asthenia
Asthenia
1,683 reports
- Malaise
Malaise
1,592 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for irbesartan each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where irbesartan sits
irbesartan has more FDA adverse-event reports than 71% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is irbesartan; the line is the median (50th percentile).
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
Reports Mentioning Death
3,218
7.5% of reports — not proof of cause
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 |
| 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 |
| 12 | MALAISE | 1,592 |
| 13 | PAIN | 1,513 |
| 14 | VOMITING | 1,496 |
| 15 | BLOOD PRESSURE INCREASED | 1,479 |
| 16 | COUGH | 1,434 |
| 17 | HYPOTENSION | 1,426 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: 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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for irbesartan?
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 →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for irbesartan: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 43,004.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 7.48%.
- mepolizumab Δ 0.04 pts · 47,215 reports · Anti-IL-5 Monoclonal Antibody 7.52%death share
- baclofen Δ 0.04 pts · 83,476 reports · GABA-B Agonist (Muscle Relaxant) 7.44%death share
- amitriptyline Δ 0.05 pts · 16,403 reports · Tricyclic Antidepressant (TCA) 7.53%death share
- ivabradine Δ 0.07 pts · 6,539 reports · HCN Channel Blocker 7.55%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 43,004 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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: January 27, 2026
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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