Section 02 · Monograph

Candesartan

Reviewed Nov 2026FDA label

AtacandARB

Indications

Hypertension — treatment of high blood pressure in adults and pediatric patients 1 to less than 17 years of age, to lower blood pressure (candesartan cilexetil)FDA-labeled
Heart failure — treatment of heart failure (NYHA class II-IV) in adults with left ventricular systolic dysfunction (ejection fraction ≤40%), to reduce cardiovascular death and heart-failure hospitalizationsFDA-labeled

Migraine prophylaxis (off-label) — angiotensin II receptor blocker (ARB) supported by randomized controlled trial evidence (e.g., the CAMG/Tronvik trial) for episodic migraine preventionOff-label

Selective angiotensin II receptor (AT1 subtype) antagonist that blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II
Action is independent of the pathway for angiotensin II synthesis (unlike ACE inhibitors, does not depend on inhibiting ACE/kininase II, so does not affect bradykinin metabolism)
Blockade of the renin-angiotensin-aldosterone system (RAAS) removes the negative feedback of angiotensin II on renin secretion, leading to increased plasma renin activity and angiotensin II levels, which do not overcome the effect of candesartan on blood pressure

Adult hypertension: initiate 16 mg once daily in patients not volume-depleted; usual dosage range 8-32 mg/day given as a single dose or in two divided doses; doses above 32 mg do not appear to give a greater effect
Heart failure: initiate 4 mg once daily; double the dose at approximately 2-week intervals as tolerated, to a target maintenance dose of 32 mg once daily
Off-label migraine prophylaxis (not FDA-labeled dosing): trial-based regimens commonly used in clinical practice are around 16 mg/day, titrated from a lower starting dose — confirm against current guideline sources, as this is not an FDA-approved indication or labeled regimen
Volume- or salt-depleted patients: consider a lower starting dose with close monitoring

Pediatric hypertension (1 to <6 years): initiate approximately 0.20 mg/kg once daily as oral suspension; range 0.05-0.4 mg/kg/day
Pediatric hypertension (6 to <17 years): initiate 4-8 mg once daily (weight <50 kg) or 8-16 mg once daily (weight ≥50 kg); max 32 mg/day

Dual blockade of the RAAS (combination with ACE inhibitors or aliskiren): increased risk of hypotension, hyperkalemia, and changes in renal function; contraindicated with aliskiren in diabetics
Lithium: increased serum lithium concentrations and risk of lithium toxicity reported with concomitant ARB use
NSAIDs/COX-2 inhibitors: may reduce the antihypertensive effect and can worsen renal function, particularly in volume-depleted patients or those with compromised renal function
Potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium: increased risk of hyperkalemia

Headache
Dizziness
Upper respiratory infection symptoms
Back pain
Hypotension (notably in heart failure population)
Hyperkalemia
Increased serum creatinine / abnormal renal function (notably in heart failure population)
Angioedema (rare, class effect)

Blood pressure, especially during initiation and dose titration
Serum creatinine and renal function, particularly in heart failure patients, the volume-depleted, or those on concomitant RAAS-acting drugs or NSAIDs
Serum potassium, particularly in heart failure patients or those on potassium-sparing diuretics/supplements
Pregnancy status — discontinue promptly if pregnancy is detected

Boxed warning: drugs that act directly on the renin-angiotensin system, including candesartan, can cause injury and death to the developing fetus when used during the second and third trimesters of pregnancy
Discontinue candesartan as soon as possible once pregnancy is detected
Fetal toxicities include oligohydramnios (which can be associated with fetal lung hypoplasia and skeletal deformations), fetal renal failure, hypotension, and neonatal skull hypoplasia; oligohydramnios may not appear until after irreversible fetal injury has occurred
Data on first-trimester use have not shown a clear increased risk of major congenital malformations, but use during the entire pregnancy should be avoided given second/third trimester risk
Lactation: candesartan has been shown to be present in rat milk; it is not known whether it is excreted in human milk — because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug