Prescription medicine
Candesartan and hydrochlorothiazide Brand names: Atacand; first approved as Atacand Hct
Candesartan and hydrochlorothiazide (Atacand) is a prescription medicine with an FDA approval on record since 2000. FDA's NDC Directory lists it from 4 generic labelers, and pharmacies paid $0.954 per candesartan-hydrochlorothiazide 16-12.5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the candesartan and hydrochlorothiazide FDA label on DailyMed (effective December 22, 2025, ANI Pharmaceuticals, Inc.); the NDA 21093 record on Drugs@FDA; every candesartan and hydrochlorothiazide label on DailyMed.
Highlights of the record
FDA label of December 22, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
FETAL TOXICITY •.
When pregnancy is detected, discontinue candesartan cilexetil and hydrochlorothiazide tablets as soon as possible.
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See Warnings: Fetal Toxicity
Used for
From the label: indications and usageCandesartan cilexetil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure.
Forms and strengths
- 16 mg / 12.5 mg
- 32 mg / 25 mg
- 32 mg / 12.5 mg
Tablet.
On the market
- Earliest approval on file
- September 5, 2000 Atacand Hct, Ani Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first December 4, 2012; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 4 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.954 per tablet Candesartan-hydrochlorothiazide 16-12.5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2014 0 Class I among all firms' recalls; latest October 2, 2020
- FAERS reports
- 2,599 through July 30, 2026
What is candesartan and hydrochlorothiazide used for?
From the label: indications and usageCandesartan cilexetil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with candesartan cilexetil and hydrochlorothiazide tablets. […]
Conditions named in the indications of candesartan and hydrochlorothiazide's FDA labels, with every medicine labeled for each:
From other candesartan and hydrochlorothiazide labelsHigh blood pressure: INDICATIONS AND USAGE Candesartan cilexetil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure.
FDA pharmacologic class: Angiotensin 2 Receptor Blocker and Thiazide Diuretic.
Source: FDA drug label (Candesartan Cilexetil and Hydrochlorothiazide), NDA021093 (Ani Pharms), as published by ANI Pharmaceuticals, Inc., effective December 22, 2025 (SPL set bd8d318d-167a-4b26-935d-265dde3193de), via openFDA; the full label on DailyMed
Is there a generic for candesartan and hydrochlorothiazide (Atacand)?
The FDA approved the first generic candesartan and hydrochlorothiazide on December 4, 2012. 6 generic applications are approved; 5 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 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists candesartan and hydrochlorothiazide from 4 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.
- 2000 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 candesartan and hydrochlorothiazide (Atacand)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.954 per Candesartan-hydrochlorothiazide 16-12.5 mg tablet, up 13% from $0.842 on October 8, 2025. 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.
- Candesartan-hydrochlorothiazide 16-12.5 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Candesartan-hydrochlorothiazide 16-12.5 mg tablet | Generic | $0.954 per tablet | $28.63 | +13% |
| Candesartan-hydrochlorothiazide 32-12.5 mg tablet | Generic | $0.820 per tablet | $24.60 | -32% |
| Candesartan-hydrochlorothiazide 32-25 mg tablet | Generic | $1.08 per tablet | $32.33 | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has candesartan and hydrochlorothiazide been recalled?
The FDA's Enforcement Report lists 2 recalls naming candesartan and hydrochlorothiazide since 2014: 0 Class I (the most serious), 0 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 2, 2020 | Class III | Mylan Pharmaceuticals Inc. | Out-of-specification organic impurity results obtained during routine stability testing. |
| August 21, 2014 | Class III | Apotex Corp. | Failed Impurity/Degradation Specification; high out of specification for CAD II degradant |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the candesartan and hydrochlorothiazide label say about other medicines?
The candesartan and hydrochlorothiazide label names 9 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 co-administer aliskiren with candesartan cilexetil and hydrochlorothiazide tablets in patients with diabetes (see PRECAUTIONS, Drug Interactions ). |
| Cholestyramine | drug interactions | Ion Exchange resins − Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85% and 43%, respectively. |
| Colestipol | drug interactions | Ion Exchange resins − Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85% and 43%, respectively. |
| Cyclophosphamide | drug interactions | Cytotoxic products – Thiazides may reduce the renal excretion of cytotoxic medicinal products (e.g. cyclophosphamide, methotrexate) and potentiate their myelosuppressive effects. |
| Cyclosporine | drug interactions | Cyclosporine − Concomitant treatment with cyclosporine may increase the risk of hyperuricemia and gout-type complications. |
| Diazoxide | drug interactions | Diazoxide − the hyperglycemic effect of diazoxide may be enhanced by thiazides. |
| Digoxin | drug interactions | Digitalis − Thiazide-induced hypokalemia or hypomagnesemia may predispose to digoxin toxicity. |
| Lithium | drug interactions | Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists or hydrochlorothiazide. |
| Methotrexate | drug interactions | Cytotoxic products – Thiazides may reduce the renal excretion of cytotoxic medicinal products (e.g. cyclophosphamide, methotrexate) and potentiate their myelosuppressive effects. |
Check candesartan and hydrochlorothiazide against other medicines
Source: FDA drug label (Candesartan Cilexetil and Hydrochlorothiazide), NDA021093 (Ani Pharms), as published by ANI Pharmaceuticals, Inc., effective December 22, 2025 (SPL set bd8d318d-167a-4b26-935d-265dde3193de), via openFDA; the full label on DailyMed
What do FAERS reports show for candesartan and hydrochlorothiazide?
The FDA Adverse Event Reporting System holds 2,599 reports that list candesartan and hydrochlorothiazide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 165 are coded as a death and 1,240 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 candesartan and hydrochlorothiazide?
56 other medicines are given the same way (oral) and in the same FDA class as candesartan and hydrochlorothiazide 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 |
| 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 |
| 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 candesartan and hydrochlorothiazide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to candesartan and hydrochlorothiazide
- 56 medicines for the same use
- Other ARBs
- the pharmacologic class, with prices and generics
- Candesartan and hydrochlorothiazide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other