Prescription medicine
Hydrochlorothiazide and losartan Brand names: Hyzaar
Hydrochlorothiazide and losartan (Hyzaar) is a prescription medicine with an FDA approval on record since 1995. FDA's NDC Directory lists it from 29 generic labelers, and pharmacies paid $0.0762 per losartan-hydrochlorothiazide 100-12.5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the hydrochlorothiazide and losartan FDA label on DailyMed (effective November 26, 2025, Organon LLC); the NDA 20387 record on Drugs@FDA; every hydrochlorothiazide and losartan label on DailyMed.
Highlights of the record
FDA label of November 26, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
FETAL TOXICITY.
When pregnancy is detected, discontinue HYZAAR as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) ]. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue HYZAAR as soon as possible. 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 usageHYZAAR is a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: Treatment of hypertension, to lower blood pressure.
Forms and strengths
- 12.5 mg / 100 mg
- 12.5 mg / 50 mg
- 25 mg / 100 mg
- 50 mg / 12.5 mg
- 100 mg / 25 mg
- 100 mg / 12.5 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- April 28, 1995 Hyzaar, Organon; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 18 first April 6, 2010; 11 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 30 of which 29 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0762 per tablet Losartan-hydrochlorothiazide 100-12.5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 29 since 2014 0 Class I among all firms' recalls; latest May 7, 2024
- FAERS reports
- 11,546 through July 30, 2026
What is hydrochlorothiazide and losartan used for?
From the label: indications and usageHYZAAR is a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic 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 ) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2 ) 1.1 Hypertension HYZAAR ® is indicated for the treatment of hypertension, to lower blood pressure. […]
Conditions named in the indications of hydrochlorothiazide and losartan's FDA labels, with every medicine labeled for each:
From other hydrochlorothiazide and losartan labelsStroke prevention: Patients with Left Ventricular Hypertrophy HYZAAR is indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients. …
FDA pharmacologic class: Angiotensin 2 Receptor Blocker and Thiazide Diuretic.
Source: FDA drug label (HYZAAR), Organon LLC, effective November 26, 2025 (SPL set 4116ccde-2e23-45f4-b12f-6337df877744), via openFDA; the full label on DailyMed
What does the patient leaflet for hydrochlorothiazide and losartan say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about HYZAAR?HYZAAR can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking HYZAAR tell your doctor right away.
From the patient leaflet: How should I store HYZAAR?Store HYZAAR at room temperature at 59°F to 86°F (15°C to 30°C). Keep HYZAAR in a tightly closed container, and keep HYZAAR out of the light. Keep HYZAAR and all medicines out of the reach of children.
Source: FDA drug label (HYZAAR), Organon LLC, effective November 26, 2025 (SPL set 4116ccde-2e23-45f4-b12f-6337df877744), via openFDA; the full label on DailyMed
Is there a generic for hydrochlorothiazide and losartan (Hyzaar)?
The FDA approved the first generic hydrochlorothiazide and losartan on April 6, 2010. 18 generic applications are approved; 11 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 hydrochlorothiazide and losartan from 29 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.
- 1995 earliest approval on file
- 2010 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 losartan (Hyzaar)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0762 per Losartan-hydrochlorothiazide 100-12.5 mg tablet, down 20% from $0.0951 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.
- Losartan-hydrochlorothiazide 50-12.5 mg tablet (generic)
- Hyzaar 50-12.5 tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Losartan-hydrochlorothiazide 100-12.5 mg tablet | Generic | $0.0762 per tablet | $2.29 | -20% |
| Losartan-hydrochlorothiazide 100-25 mg tablet | Generic | $0.0793 per tablet | $2.38 | -9% |
| Losartan-hydrochlorothiazide 50-12.5 mg tablet | Generic | $0.0554 per tablet | $1.66 | -29% |
| Hyzaar 100-12.5 tablet | Brand | $6.82 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $204.60 | +5% |
| Hyzaar 100-25 tablet | Brand | $6.80 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $203.90 | +4% |
| Hyzaar 50-12.5 tablet | Brand | $5.01 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $150.25 | +5% |
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 losartan been recalled?
The FDA's Enforcement Report lists 29 recalls naming hydrochlorothiazide and losartan since 2014: 0 Class I (the most serious), 29 Class II, 0 Class III; 11 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 7, 2024 | Class II | MACLEODS PHARMA USA, INC | Presence of foreign substance: plastic-like substance. |
| June 10, 2022 | Class II | Macleods Pharma Usa Inc | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
| May 11, 2022 | Class II | Direct Rx | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . |
| May 5, 2022 | Class II | Direct Rx | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
| April 15, 2022 | Class II | Macleods Pharma Usa Inc | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
| March 31, 2022 | Class II | Lupin Pharmaceuticals Inc. | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
| September 19, 2019 | Class II | Torrent Pharma Inc. | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily … |
| June 20, 2019 | Class II | Macleods Pharma Usa Inc | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the hydrochlorothiazide and losartan label say about other medicines?
The hydrochlorothiazide and losartan 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 | In patients with anuria For coadministration with aliskiren in patients with diabetes Hypersensitivity to any component of HYZAAR. ( 4 ) Anuria. ( 4 ) Coadministration with aliskiren in patients with diabetes. |
| Cholestyramine | drug interactions | … syncope, and hyperkalemia. ( 7.4 ) Antidiabetic drugs: dosage adjustment of antidiabetic may be required. ( 7.5 ) Cholestyramine and colestipol: |
| Colestipol | drug interactions | … ( 7.4 ) Antidiabetic drugs: dosage adjustment of antidiabetic may be required. ( 7.5 ) Cholestyramine and colestipol: |
| Lisinopril | drug interactions | The Veterans Affairs Nephropathy in Diabetes (VA NEPHRON-D) trial enrolled 1448 patients with type 2 diabetes, elevated urinary-albumin-to-creatinine ratio, and decreased estimated glomerular filtration rate (GFR 30 to 89.9 mL/min), randomized them to lisinopril or placebo on a background of losartan therapy and … |
| Lithium | drug interactions | Risk of lithium toxicity. ( 7.2 ) Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): increased risk of renal impairment and reduced diuretic, natriuretic, and antihypertensive effects. ( 7.3 ) Dual inhibition of the renin-angiotensin system: increased risk of renal impairment, hypotension, syncope, and hyperkalemia. … |
Check hydrochlorothiazide and losartan against other medicines
Source: FDA drug label (HYZAAR), Organon LLC, effective November 26, 2025 (SPL set 4116ccde-2e23-45f4-b12f-6337df877744), via openFDA; the full label on DailyMed
What do FAERS reports show for hydrochlorothiazide and losartan?
The FDA Adverse Event Reporting System holds 11,546 reports that list hydrochlorothiazide and losartan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 697 are coded as a death and 4,027 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 losartan?
56 other medicines are given the same way (oral) and in the same FDA class as hydrochlorothiazide and losartan 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 |
|---|---|---|---|---|
| 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 |
| Irbesartan | High blood pressure | 23 labelers | $0.107 per tablet 150 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 losartan
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does hydrochlorothiazide and losartan compare with medicines for the same use?
1 side-by-side page set hydrochlorothiazide and losartan beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to hydrochlorothiazide and losartan
- 56 medicines for the same use
- Other ARBs
- the pharmacologic class, with prices and generics
- Hydrochlorothiazide and losartan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other