Prescription medicine
Candesartan Brand names: Atacand
Candesartan (Atacand) is a prescription medicine with an FDA approval on record since 1998. FDA's NDC Directory lists it from 8 generic labelers, and pharmacies paid $0.478 per candesartan cilexetil 16 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the candesartan FDA label on DailyMed (effective January 15, 2026, Golden State Medical Supply, Inc.); the NDA 20838 record on Drugs@FDA; every candesartan label on DailyMed.
Highlights of the record
FDA label of January 15, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
FETAL TOXICITY.
When pregnancy is detected, discontinue candesartan cilexetil 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 candesartan cilexetil 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 usageCandesartan cilexetil is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension in adults and children 1 to < 17 years of age, to lower blood pressure.
Forms and strengths
- 4 mg
- 8 mg
- 16 mg
- 32 mg
Tablet.
On the market
- Earliest approval on file
- June 4, 1998 Atacand, Ani Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 7 first May 3, 2013; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 8 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.478 per tablet Candesartan cilexetil 16 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 9 since 2013 0 Class I among all firms' recalls; latest March 22, 2021; 1 more by firms not listed as its makers
- FAERS reports
- 60,889 through July 30, 2026
What is candesartan used for?
From the label: indications and usageCandesartan cilexetil is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension in adults and children 1 to < 17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions (1.1). Treatment of heart failure (NYHA class II-IV); candesartan cilexetil reduces cardiovascular death and heart failure hospitalization (1.2). 1.1 Hypertension Candesartan cilexetil is indicated for the treatment of hypertension in adults and in children 1 to <17 years of age, to lower blood pressure. […]
Conditions named in the indications of candesartan's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Angiotensin 2 Receptor Blocker.
Source: FDA drug label (Candesartan cilexetil), NDA020838 (Ani Pharms), as published by Golden State Medical Supply, Inc., effective January 15, 2026 (SPL set 15601654-76da-04cf-e063-6394a90a2cb5), via openFDA; the full label on DailyMed
What does the patient leaflet for candesartan 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 candesartan cilexetil?Candesartan cilexetil 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 candesartan cilexetil, tell your doctor right away.
From the patient leaflet: What should I avoid while taking candesartan cilexetil?Candesartan cilexetil can cause you to feel dizzy or tired. Do not drive, operate machinery, or do other dangerous activities until you know how candesartan cilexetil affects you.
From the patient leaflet: How should I store candesartan cilexetil?Do not keep medicine that is out of date or that you no longer need. Store candesartan cilexetil tablets at room temperature below 86°F (30°C). Store candesartan cilexetil oral suspension at room temperature below 86°F (30°C). Use the oral suspension within 30 days after first opening the bottle. Do not use after the expiration date stated on the bottle. Do not freeze. Keep the container of candesartan cilexetil closed tightly. Keep candesartan cilexetil and all medicine out of the reach of children.
Source: FDA drug label (Candesartan cilexetil), NDA020838 (Ani Pharms), as published by Golden State Medical Supply, Inc., effective January 15, 2026 (SPL set 15601654-76da-04cf-e063-6394a90a2cb5), via openFDA; the full label on DailyMed
Is there a generic for candesartan (Atacand)?
The FDA approved the first generic candesartan on May 3, 2013. 7 generic applications are approved; 6 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 candesartan from 8 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.
- 1998 earliest approval on file
- 2013 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 (Atacand)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.478 per Candesartan cilexetil 16 mg tablet, down 15% from $0.565 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.
- Candesartan cilexetil 16 mg tablet (generic)
- Atacand 16 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Candesartan cilexetil 16 mg tablet | Generic | $0.478 per tablet | $14.35 | -15% |
| Candesartan cilexetil 32 mg tablet | Generic | $0.519 per tablet | $15.57 | -9% |
| Candesartan cilexetil 4 mg tablet | Generic | $0.569 per tablet | $17.06 | +4% |
| Candesartan cilexetil 8 mg tablet | Generic | $0.536 per tablet | $16.09 | -17% |
| Atacand 16 mg tablet | Brand | $7.85 per tablet | $235.51 | -0.4% |
| Atacand 32 mg tablet | Brand | $9.90 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $297.11 | -0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has candesartan been recalled?
The FDA's Enforcement Report lists 10 recalls naming candesartan since 2013: 0 Class I (the most serious), 1 Class II, 9 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of candesartan and that holds 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 |
|---|---|---|---|
| September 13, 2021 | Class III | Viatris not a listed maker | Failed Impurities/Degradation Specifications; out of specification for Related Compound |
| March 22, 2021 | Class III | Macleods Pharma Usa Inc | Failed Impurities/Degradation Specifications |
| January 26, 2016 | Class III | Amerisource Health Services | Failed Impurities/Degradation Specifications; 9 month stability (manufacturer) |
| December 31, 2015 | Class III | Sandoz Inc | Failed Impurities/Degradation Specifications; 9 month stability timepoint |
| October 16, 2014 | Class III | Apotex Inc. | Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities. |
| October 2, 2014 | Class III | Sandoz, Inc | Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup: CANDESARTAN CILEXETIL, Tablet, 16 mg may have potentially been mislabeled as the following drug: IRBESARTAN, Tablet, 150 mg, NDC … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the candesartan label say about other medicines?
The candesartan label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name candesartan. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Source: FDA drug label (Candesartan cilexetil), NDA020838 (Ani Pharms), as published by Golden State Medical Supply, Inc., effective January 15, 2026 (SPL set 15601654-76da-04cf-e063-6394a90a2cb5), via openFDA; the full label on DailyMed
What do FAERS reports show for candesartan?
The FDA Adverse Event Reporting System holds 60,889 reports that list candesartan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 7,200 are coded as a death and 30,964 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?
79 other medicines are given the same way (oral) and in the same FDA class as candesartan 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, Heart failure | 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 |
| Sacubitril and valsartan | Heart failure | 27 labelers | $0.533 per unit 49-51 mg | 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 |
Every medicine labeled for the same conditions as candesartan
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does candesartan compare with medicines for the same use?
13 side-by-side pages set candesartan beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to candesartan
- 79 medicines for the same use
- Other ARBs
- the pharmacologic class, with prices and generics
- Candesartan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other