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Atacand: Uses, Dosage & Safety Information

Atacand

Atacand

Atacand

Candesartan cilexetil
Atacand is candesartan, an angiotensin receptor blocker for high blood pressure and for heart failure with reduced ejection fraction. Infants under one year must not receive it for high blood pressure, because such drugs can affect developing kidneys; children aged 1 to under 17 are dosed by weight or size. It is prescription-only.
  • ActiveIngredient: Candesartan cilexetil
  • DosageForm: Tablet
  • Dosage: 4 mg, 8 mg, 16 mg, 32 mg
  • Indications: Hypertension (adults and children 1 to <17); heart failure NYHA II–IV
  • Manufacturer: ANI Pharmaceuticals
  • Storage: Store at 20–25°C
  • Drug Status: Prescription Only
Drug Status: Prescription Only
Description

What is Atacand?

An age floor set by kidney development
Children under 1 year of age must not receive Atacand for high blood pressure: drugs acting directly on the renin-angiotensin system can affect the development of immature kidneys. From age 1 to under 17 it is indicated for high blood pressure, dosed by weight under 6 years, usually as an oral suspension, and by body weight band from 6 years.1

Candesartan blocks the angiotensin II type 1 receptor, so blood vessels relax and aldosterone falls. The tablet contains candesartan cilexetil, which is fully converted to candesartan during absorption; only a modest fraction reaches the circulation, and a high-fat meal does not change it.1

Candesartan is highly protein-bound and does not accumulate with once-daily dosing. It is not significantly metabolised by the cytochrome P450 system, so interactions through those enzymes are not expected; it is cleared partly unchanged in urine and mainly via bile.1

In heart failure, in CHARM-Added, it reduced cardiovascular death and heart failure hospitalisation when given on top of an ACE inhibitor, and the labelling states this added effect in the indication itself.1

Atacand was approved in June 1998 and remains on prescription in four tablet strengths; a combination with hydrochlorothiazide is marketed separately as Atacand HCT, and generic candesartan tablets are available.52

▶Clinical detailspharmacokinetics
Pharmacokinetic Figures From the
MeasureValue
BioavailabilityAbout 15%; not affected by a high-fat meal
Peak3 to 4 hours
Protein bindingOver 99%
Half-lifeAbout 9 hours; no accumulation
MetabolismMinor, to an inactive metabolite; not significant via cytochrome P450
ExcretionAbout 26% unchanged in urine; rest mainly via bile
Brain and placenta (rats)Crosses the blood-brain barrier poorly, if at all; crosses the placenta

Source: 1

General Instructions

How to Take Atacand

Once or twice a day, with or without food

Take Atacand as prescribed, with or without food. In high blood pressure most of the effect appears within 2 weeks and the full effect within 4 to 6 weeks.1

How much

Adults with high blood pressure usually start at 16 mg once daily if not volume-depleted, within a range of 8 mg to 32 mg a day as one or two doses. Heart failure starts at 4 mg once daily, doubled about every 2 weeks as tolerated toward 32 mg once daily. Children 1 to under 6 are dosed by weight with an oral suspension; from 6 years, by body-weight band.1

For children who cannot swallow tablets

A pharmacist can prepare an oral suspension from the tablets; shake it before each dose.1

What not to do

Do not take potassium supplements or salt substitutes without checking first, and do not give it to children under 1 year.1

Side Effects

What Are the Side Effects of Atacand?

In adult hypertension trials

Effects Reported in at Least 1% and
EffectCandesartanPlacebo
Upper respiratory tract infection6%4%
Dizziness4%3%
Back pain3%2%
Pharyngitis2%1%
Rhinitis2%1%

Source: 1

In heart failure

Most Common Adverse Reactions in
EffectRate
Abnormal renal function6.3%
Hypotension4.1%
Hyperkalaemia2.4%

Source: 1

Where candesartan was added to an ACE inhibitor in heart failure, abnormal renal function occurred in 15% of patients against 9% on placebo.1 Angioedema appears in the labelling among postmarketing reports, without a rate.

Seek immediate medical attention if:
  • Puffiness of the lips, tongue, face or throat, even hours after a dose
  • Fainting, particularly after vomiting or diarrhoea
  • Weakness with an irregular heartbeat
  • A child passes much less urine than usual
  • You discover you are pregnant
Uses

What is Atacand Used For?

Labelled Indications and the
IndicationWho it coversEvidence
High blood pressureAdults and children aged 1 to under 1714 placebo-controlled adult trials (2,350 on candesartan, 1,027 on placebo): labelled doses lowered trough pressure by about 8–12/4–8 mmHg; two paediatric dose-ranging studies
Heart failureAdults with NYHA class II–IV and ejection fraction of 40% or lessCHARM-Alternative (2,028 patients intolerant of ACE inhibitors) and CHARM-Added (2,548 on ACE inhibitors), followed up to 4 years

Source: 1

CHARM Results
TrialAtacandPlaceboHazard ratio
CHARM-Alternative334 of 1,013406 of 1,0150.77 (p<0.001)
CHARM-Added483 of 1,276538 of 1,2720.85 (p=0.011)

Source: 1

In CHARM-Alternative, cardiovascular death alone was not significantly reduced (hazard ratio 0.85, p=0.072), whereas in CHARM-Added it was (0.84, p=0.029). In adult high blood pressure, most of the effect appeared within 2 weeks and the full effect within 4; there were no exaggerated first-dose effects, no rebound on abrupt withdrawal, and its highest labelled dose lowered pressure by 2 to 3 mmHg more than the highest dose of losartan in 1,268 patients. The effect was somewhat smaller in Black patients.1

In children aged 1 to under 6, 93 patients, 74% with kidney disease, had pressure falls of 6.0/5.2 to 12.0/11.1 mmHg from baseline, without a placebo group; in 240 children aged 6 to under 17, placebo-subtracted falls were 4.9/3.0 to 7.5/6.2 mmHg.1

Safety Advice

Interactions Alcohol:

Use with caution
Alcohol adds to dizziness, which occurred in 4% of adult hypertension trial patients against 3% on placebo.

Interactions Other Medications:

Unsafe
The most serious combination listed is with aliskiren in patients with diabetes (contraindicated): two drugs blocking one hormonal pathway. Every other combination, with its effect, is in the Interactions table.

Special Groups Pregnancy:

Unsafe
When pregnancy is detected, discontinue as soon as possible — the boxed warning.

Special Groups Breastfeeding:

Consult your doctor
Breastfeeding is advised against during treatment; candesartan appears in rat milk.

Special Groups Elderly:

Use with caution
Volume depletion from diuretics or illness makes symptomatic hypotension more likely.

Special Groups Children:

Use with caution
Indicated from age 1 to under 17 for high blood pressure; children under 1 must not receive it for high blood pressure.

Effects on Activities Driving:

Use with caution
Dizziness is most likely after a start or an increase. Do not drive until you know how it affects you.

Effects on Activities Operating Machinery:

Use with caution
The same applies. Kidney and liver guidance is in the Dosage table.
Warnings

Critical Warnings for Atacand Use

Boxed warning: fetal toxicity

Atacand can cause fetal harm; it is stopped as soon as pregnancy is detected.

Candesartan hypersensitivity

Contraindicated in people hypersensitive to candesartan or any component.1

Aliskiren in diabetes

Aliskiren is not coadministered with Atacand in patients with diabetes.

Low blood pressure

Symptomatic low blood pressure is most likely with volume or salt depletion, which is corrected before starting. In the CHARM heart failure programme it occurred in 18.8% on Atacand against 9.8% on placebo, and in 22.6% against 13.8% when added to an ACE inhibitor; 4.1% stopped for it.1

Kidneys and potassium

Kidney function is monitored; it can worsen, including acute kidney failure, particularly with renal artery stenosis, chronic kidney disease, severe heart failure or volume depletion. In CHARM, high potassium occurred in 6.3% against 2.1% on placebo, and 6.3% stopped for abnormal kidney function against 2.9%.1

See Interactions for the full list.

Dosage

Dosage

Atacand Tablets
FormulationActive IngredientsClinical Note
Tablets 4 mg, 8 mg, 16 mg, 32 mgCandesartan cilexetilScored; can be made into an oral suspension
Moderate hepatic impairmentCandesartan cilexetilStart at 8 mg for high blood pressure
Renal impairment or volume depletion, including dialysisCandesartan cilexetilLower blood pressure more likely; a lower starting dose and monitoring may be needed
Children under 1 yearCandesartan cilexetilMust not be used for high blood pressure

Source: 12

Exceeding the dose
Overdose would most likely cause low blood pressure, dizziness and a fast heartbeat, or a slow one through vagal stimulation. Candesartan cannot be removed by haemodialysis. Seek urgent help after an overdose.
Interactions

What Does Atacand Interact With?

Interactions by Severity
Interacting SubstanceEffect and RiskSeverityDocumentation
Aliskiren, in diabetesContraindicated; also avoided with filtration below 60ContraindicatedExcellent — labelled contraindication
ACE inhibitor plus a mineralocorticoid receptor antagonistTriple combination generally advised againstMajorGood — labelled interaction
Other RAS blockersMore low blood pressure, high potassium and kidney changes; in heart failure, adding Atacand to an ACE inhibitor is a labelled use with close monitoringMajorGood — labelled interaction
LithiumHigher lithium levels and toxicity; monitorMajorGood — labelled interaction
Potassium-sparing diuretics, potassium supplements or salt substitutesHigh potassium; monitorMajorGood — labelled interaction
NSAIDs, including COX-2 inhibitorsWorsening kidney function in at-risk patients; weaker blood-pressure effectMajorGood — labelled interaction

Source: 1

Because candesartan is not significantly metabolised by cytochrome P450 enzymes and does not affect them, interactions with drugs that inhibit or use those enzymes are not expected.1

FAQs
Yes, in CHARM-Added. In 2,548 patients already taking an ACE inhibitor, it reduced cardiovascular death or heart failure hospitalisation (hazard ratio 0.85), although low blood pressure was more common (22.6% against 13.8%).
In 1,268 people with mild to moderate high blood pressure, candesartan 32 mg lowered blood pressure by 2 to 3 mmHg more on average than losartan 100 mg, at both peak and trough. Twice-daily dosing of either was not studied.
In long-term high blood pressure studies of up to a year, there was no rebound in blood pressure after abrupt withdrawal. Stopping still needs your prescriber, especially in heart failure.
Breastfeeding is advised against during treatment. It is not known whether candesartan passes into human milk, but it does in rats, and the drug can cause serious reactions in infants.
Drugs acting directly on the renin-angiotensin system can affect the development of immature kidneys, so Atacand must not be given for high blood pressure to children under 1 year.
Evidence and Reported Data

Evidence Scope

What we know
  • In CHARM-Alternative and CHARM-Added, Atacand reduced cardiovascular death or heart failure hospitalisation (hazard ratios 0.77 and 0.85).1
  • In 14 adult trials, 8 to 32 mg lowered trough blood pressure by about 8–12/4–8 mmHg, without rebound on withdrawal.1
  • Children under 1 year must not receive it for high blood pressure.1
What remains uncertain
  • The true size of the effect in young children. The study in ages 1 to under 6 had no placebo group, so the change from baseline likely overestimates it.
  • Its effect in children with poor kidney function. Children with filtration below 30 were not studied.
  • Dosing in severe liver impairment. The labelling cannot give advice.
  • Whether candesartan passes into human milk. This is not known.
  • How often angioedema occurs. Listed among postmarketing reports without a rate.
  • What several report terms below reflect. Lack of effect and use outside the labelled indications appear among the commonest, describing use rather than reactions.

Reports in the FDA Adverse Event Reporting System

As of the data cut of 30 July 2026, the FDA Adverse Event Reporting System held 28,386 reports listing candesartan cilexetil among the medicines taken. The ten reactions named most often in those reports are below.

Most Frequently Named Reactions in
Reaction as codedReports naming it
Shortness of breath1,821
Fatigue1,818
Drug ineffective1,794
Nausea1,752
Headache1,682
Dizziness1,653
Malaise1,431
Diarrhoea1,428
Fall1,367
Off label use1,358

Source: 4

What these numbers are, and what they are not

Four distinctions matter, and collapsing any two of them produces a false statement:

  • These are reports mentioning the active ingredient, submitted voluntarily by clinicians, patients and manufacturers.
  • They are not events shown to have been caused by the drug. A report records that something happened to someone taking the medicine, nothing more; most reports list several medicines.
  • They are not product-specific or brand-specific. The query is by active ingredient and covers every product containing it.
  • They are not a frequency or a risk estimate. No denominator exists: how many people took the drug and reported nothing is unknown.

See Evidence Scope above for the limitations of postmarketing data.

Who was this medicine studied in?

No FDA Drug Trials Snapshot exists: Atacand was approved in 1998, and the programme began publishing in 2015.32 Safety data come from more than 3,600 adults, and the CHARM trials enrolled 4,576 heart failure patients. In children, 93 aged 1 to under 6 (74% with kidney disease) and 240 aged 6 to under 17 (47% Black) were studied. The blood-pressure effect was similar by sex and age, somewhat smaller in Black patients.1

Who this is and is not appropriate for

Typically considered for: adults and children aged 1 to under 17 with high blood pressure, and adults with heart failure and ejection fraction of 40% or less.

Not appropriate for: pregnancy; infants under 1 for high blood pressure; hypersensitivity to candesartan; aliskiren in diabetes; children with filtration below 30.1

Where to report and verify

Routing to Official Registries
What you needWhere to go
Report a side effectFDA MedWatch
Pregnancy-specific dataMotherToBaby
Full prescribing informationDailyMed
Verify a pharmacy websiteFDA BeSafeRx · LegitScript
References

References

  1. FDA Prescribing Information, ATACAND (candesartan cilexetil) — Boxed Warning, Indications and Usage, Dosage and Administration 2.1 to 2.3, Warnings and Precautions 5.2 to 5.5, Adverse Reactions, Use in Specific Populations 8.4
    Label revised 2025-12 · Accessed 2026-09-24
    Used for: both indications and the CHARM, adult and paediatric trials; pharmacokinetics; all doses, the suspension and organ adjustments; the boxed warning, contraindications and warnings with their rates; the interactions; the side-effect rates; lactation and paediatric use; overdose.
    dailymed.nlm.nih.gov — ATACAND SPL
  2. Drugs@FDA — application records NDA 020838 and NDA 021093
    Records accessed 2026-09-24
    Used for: the current prescription marketing status of the brand and its thiazide combination.
    accessdata.fda.gov — Drugs@FDA
  3. FDA — Drug Trials Snapshots programme scope
    Programme current · Accessed 2026-09-24
    Used for: the programme start, explaining why this medicine has no Snapshot.
    fda.gov — Drug Trials Snapshots
  4. openFDA — FDA Adverse Event Reporting System, drug event API query for candesartan cilexetil
    Data cut 2026-07-30 · Accessed 2026-09-24
    Used for: the 28,386 report total and the ten coded terms tabulated above, queried by ingredient.
    open.fda.gov — drug adverse event API
  5. FDA Orange Book — candesartan cilexetil
    Current edition · Accessed 2026-09-28
    Used for: reference-standard and generic availability.
    accessdata.fda.gov — Orange Book

How this page was sourced

Every rate on this page is a labelled figure with its comparator. A draft assigned frequency bands and a comparison with ACE inhibitors from general class knowledge; checking them against the labelling showed the bands were wrong and the comparison absent, and they were replaced with the labelled numbers before publication.

FAERS counts are included because the catalogue has no separate page for this active ingredient.

Review cycle. Clinical review completed 28 September 2026. Next review due by 28 September 2027, or earlier if the labelling is revised.

Disclaimer

Disclaimer: The information on this site is provided for informational purposes only and is not medical advice. It does not replace professional medical consultation, diagnosis, or treatment. Do not self-medicate based on the information presented on this site. Always consult with a doctor or other qualified healthcare professional before making any decisions about your health.