Prescription medicine
Hydrochlorothiazide and irbesartan Brand names: Avalide
Hydrochlorothiazide and irbesartan (Avalide) is a prescription medicine with an FDA approval on record since 1997. FDA's NDC Directory lists it from 11 generic labelers, and pharmacies paid $0.149 per irbesartan-hydrochlorothiazide 150-12.5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the hydrochlorothiazide and irbesartan FDA label on DailyMed (effective October 7, 2025, Sanofi-Aventis U.S. LLC); the NDA 20758 record on Drugs@FDA; every hydrochlorothiazide and irbesartan label on DailyMed.
Highlights of the record
FDA label of October 7, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
FETAL TOXICITY.
When pregnancy is detected, discontinue AVALIDE 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 AVALIDE 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 usageAVALIDE ® (irbesartan and hydrochlorothiazide) tablets are indicated for the treatment of hypertension.
Forms and strengths
- 150 mg / 12.5 mg
- 300 mg / 12.5 mg
- 300 mg / 25 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- September 30, 1997 Avalide, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 15 first March 30, 2012; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 12 of which 11 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.149 per tablet Irbesartan-hydrochlorothiazide 150-12.5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 8 since 2015 0 Class I among all firms' recalls; latest October 12, 2021
- FAERS reports
- 5,302 through July 30, 2026
What is hydrochlorothiazide and irbesartan used for?
From the label: indications and usageAVALIDE ® (irbesartan and hydrochlorothiazide) tablets are indicated for the treatment of hypertension. AVALIDE may be used in patients whose blood pressure is not adequately controlled on monotherapy. AVALIDE may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of AVALIDE as initial therapy for hypertension should be based on an assessment of potential benefits and risks. […]
Conditions named in the indications of hydrochlorothiazide and irbesartan's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Angiotensin 2 Receptor Blocker and Thiazide Diuretic.
Source: FDA drug label (Avalide), Sanofi-Aventis U.S. LLC, effective October 7, 2025 (SPL set 0d91895e-c869-4b33-9b83-d55c1ad6317e), via openFDA; the full label on DailyMed
Is there a generic for hydrochlorothiazide and irbesartan (Avalide)?
The FDA approved the first generic hydrochlorothiazide and irbesartan on March 30, 2012. 15 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 6 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists hydrochlorothiazide and irbesartan from 11 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 hydrochlorothiazide and irbesartan (Avalide)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.149 per Irbesartan-hydrochlorothiazide 150-12.5 mg tablet, down 9% from $0.164 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-hydrochlorothiazide 150-12.5 mg tablet (generic)
- Avalide 150-12.5 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Irbesartan-hydrochlorothiazide 150-12.5 mg tablet | Generic | $0.149 per tablet | $4.46 | -9% |
| Irbesartan-hydrochlorothiazide 300-12.5 mg tablet | Generic | $0.188 per tablet | $5.64 | -5% |
| Avalide 150-12.5 mg tablet | Brand | $8.91 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $267.33 | no change |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has hydrochlorothiazide and irbesartan been recalled?
The FDA's Enforcement Report lists 8 recalls naming hydrochlorothiazide and irbesartan since 2015: 0 Class I (the most serious), 6 Class II, 2 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| 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 … |
| May 30, 2016 | Class III | Prinston Pharmaceutical Inc | Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on … |
| October 20, 2015 | Class III | Teva Pharmaceutical Industries | Labeling: Incorrect or Missing Lot AND/OR Exp Date. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the hydrochlorothiazide and irbesartan label say about other medicines?
The hydrochlorothiazide and irbesartan label names 5 other medicines in its interaction, contraindication or warning sections. 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 AVALIDE in patients with diabetes [see Drug Interactions (7) ]. |
| Carbamazepine | drug interactions | Increases in serum lithium concentrations and lithium toxicity. ( 7 ) Carbamazepine: Increased risk of hyponatremia. |
| Cholestyramine | drug interactions | Dosage adjustment of antidiabetic may be required. ( 7 ) Cholestyramine and colestipol: Reduced absorption of thiazides. |
| Colestipol | drug interactions | Dosage adjustment of antidiabetic may be required. ( 7 ) Cholestyramine and colestipol: Reduced absorption of thiazides. |
| Lithium | drug interactions | Increases in serum lithium concentrations and lithium toxicity. ( 7 ) Carbamazepine: Increased risk of hyponatremia. |
Check hydrochlorothiazide and irbesartan against other medicines
Source: FDA drug label (Avalide), Sanofi-Aventis U.S. LLC, effective October 7, 2025 (SPL set 0d91895e-c869-4b33-9b83-d55c1ad6317e), via openFDA; the full label on DailyMed
What do FAERS reports show for hydrochlorothiazide and irbesartan?
The FDA Adverse Event Reporting System holds 5,302 reports that list hydrochlorothiazide and irbesartan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 277 are coded as a death and 1,518 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 hydrochlorothiazide and irbesartan?
56 other medicines are given the same way (oral) and in the same FDA class as hydrochlorothiazide and 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 | 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 |
| Telmisartan | High blood pressure | 28 labelers | $0.106 per tablet 20 mg tablet | No current entry |
| Amlodipine and olmesartan | High blood pressure | 14 labelers | $0.248 per unit 10-20 mg | No current entry |
| Amlodipine and valsartan | High blood pressure | 9 labelers | $0.330 per unit 10-160 mg | No current entry |
| Candesartan | High blood pressure | 8 labelers | $0.478 per tablet 16 mg tablet | No current entry |
| Amlodipine and telmisartan | High blood pressure | 3 labelers | $2.88 per unit 40-10 | No current entry |
Every medicine labeled for the same conditions as hydrochlorothiazide and irbesartan
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to hydrochlorothiazide and irbesartan
- 56 medicines for the same use
- Other ARBs
- the pharmacologic class, with prices and generics
- Hydrochlorothiazide and irbesartan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other