Prescription medicine
Irbesartan Brand names: Avapro
Irbesartan (Avapro) is a prescription medicine with an FDA approval on record since 1997. FDA's NDC Directory lists it from 23 generic labelers, and pharmacies paid $0.107 per irbesartan 150 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the irbesartan FDA label on DailyMed (effective August 6, 2026, Macleods Pharmaceuticals Limited); the NDA 20757 record on Drugs@FDA; every irbesartan label on DailyMed.
Highlights of the record
FDA label of August 6, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
FETAL TOXICITY •.
When pregnancy is detected, discontinue irbesartan tablets as soon as possible [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )].
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )]. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning.
When pregnancy is detected, discontinue irbesartan tablets as soon as possible. ( 5.1 , 8.1 )
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Used for
From the label: indications and usageIrbesartan is an angiotensin II receptor blocker (ARB) indicated for:
Treatment of hypertension, to lower blood pressure.
Forms and strengths
- 75 mg
- 150 mg
- 300 mg
Tablet; film-coated tablet.
On the market
- Earliest approval on file
- September 30, 1997 Avapro, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 23 first March 30, 2012; 15 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 24 of which 23 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.107 per tablet Irbesartan 150 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 10 since 2013 0 Class I among all firms' recalls; latest January 21, 2025; 2 more by firms not listed as its makers
- FAERS reports
- 44,400 through July 30, 2026
What is irbesartan used for?
From the label: indications and usageIrbesartan 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. ( 1.1 ) Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. ( 1.2 ) 1.1 Hypertension Irbesartan tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. […]
Conditions named in the indications of irbesartan's FDA labels, with every medicine labeled for each:
From other irbesartan labelsChronic kidney disease: Nephropathy in Type 2 Diabetic Patients Irbesartan tablets are indicated for the treatment of diabetic nephropathy in patients with type 2 diabetes and hypertension, an elevated serum creatinine, and proteinuria (>300 mg/day).
FDA pharmacologic class: Angiotensin 2 Receptor Blocker.
Source: FDA drug label (Irbesartan), Macleods Pharmaceuticals Limited, effective August 6, 2026 (SPL set e8635a1c-ae06-4e23-99f7-e704f91d6f43), via openFDA; the full label on DailyMed
Is there a generic for irbesartan (Avapro)?
The FDA approved the first generic irbesartan on March 30, 2012. 23 generic applications are approved; 15 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists irbesartan from 23 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1997 earliest approval on file
- 2012 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for irbesartan (Avapro)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.107 per Irbesartan 150 mg tablet, down 8% from $0.116 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Irbesartan 150 mg tablet (generic)
- Avapro 150 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Irbesartan 150 mg tablet | Generic | $0.107 per tablet | $3.21 | -8% |
| Irbesartan 300 mg tablet | Generic | $0.162 per tablet | $4.87 | +5% |
| Irbesartan 75 mg tablet | Generic | $0.0823 per tablet | $2.47 | -21% |
| Avapro 150 mg tablet | Brand | $7.34 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $220.35 | no change |
| Avapro 300 mg tablet | Brand | $8.79 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $263.76 | -0.3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has irbesartan been recalled?
The FDA's Enforcement Report lists 12 recalls naming irbesartan since 2013: 0 Class I (the most serious), 12 Class II, 0 Class III; 1 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of irbesartan and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 21, 2025 | Class II | AvKARE | Out of Specification for Dissolution |
| July 18, 2022 | Class II | Jubilant Cadista Pharmaceuticals, Inc. | Failed dissolution specifications. |
| July 18, 2022 | Class II | Jubilant Cadista Pharmaceuticals, Inc. | Failed Dissolution Specifications |
| October 12, 2021 | Class II | Lupin Pharmaceuticals Inc. | CGMP Deviations: impurity N-nitrosoirbesartan detected in API |
| January 18, 2019 | Class II | Prinston Pharmaceutical Inc | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim … |
| November 2, 2018 | Class II | Golden State Medical Supply Inc. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; IRBESARTAN, Tablet, 150 mg may be potentially mislabeled as ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg, NDC 00378041501 … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: IRBESARTAN, Tablet, 150 mg may have potentially been mislabeled as the following drug: BENAZEPRIL HCL, Tablet, 40 mg, NDC 65162075410 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the irbesartan label say about other medicines?
The irbesartan label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name irbesartan. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aliskiren | contraindications | Do not coadminister aliskiren with irbesartan tablets in patients with diabetes. |
| Lithium | drug interactions | Risk of lithium toxicity. |
Other labels that name irbesartan
Source: FDA drug label (Irbesartan), Macleods Pharmaceuticals Limited, effective August 6, 2026 (SPL set e8635a1c-ae06-4e23-99f7-e704f91d6f43), via openFDA; the full label on DailyMed
What do FAERS reports show for irbesartan?
The FDA Adverse Event Reporting System holds 44,400 reports that list irbesartan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,301 are coded as a death and 18,987 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as irbesartan?
71 other medicines are given the same way (oral) and in the same FDA class as irbesartan or labeled mainly for the same use (high blood pressure), the same class first. High blood pressure lists all 88 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Losartan | High blood pressure, Chronic kidney disease | 44 labelers | $0.0327 per tablet 50 mg tablet | No current entry |
| Valsartan | High blood pressure | 34 labelers | $0.0963 per tablet 40 mg tablet | A presentation being discontinued |
| Olmesartan | High blood pressure | 31 labelers | $0.0805 per tablet 20 mg tablet | No current entry |
| Hydrochlorothiazide and losartan | High blood pressure | 29 labelers | $0.0762 per tablet 100-12.5 mg tablet | No current entry |
| Hydrochlorothiazide and valsartan | High blood pressure | 18 labelers | $0.101 per tablet 160-12.5 mg tablet | No current entry |
| Telmisartan | High blood pressure | 28 labelers | $0.106 per tablet 20 mg tablet | No current entry |
| Hydrochlorothiazide and olmesartan | High blood pressure | 17 labelers | $0.165 per tablet 20-12.5 mg tablet | No current entry |
| Amlodipine and olmesartan | High blood pressure | 14 labelers | $0.248 per unit 10-20 mg | No current entry |
Every medicine labeled for the same conditions as irbesartan
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does irbesartan compare with medicines for the same use?
10 side-by-side pages set irbesartan beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to irbesartan
- 71 medicines for the same use
- Other ARBs
- the pharmacologic class, with prices and generics
- Irbesartan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other