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Two medicines, side by side

Candesartan vs irbesartan

Candesartan and irbesartan are both labeled for high blood pressure. Drugs@FDA records approvals of candesartan since 1998 and of irbesartan since 1997. Pharmacies paid $0.478 per candesartan cilexetil 16 mg tablet and $0.107 per irbesartan 150 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. How each works, in its label's words: Candesartan, “Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II).”; Irbesartan, “Angiotensin II is a potent vasoconstrictor formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II).”

Check it at the source: the candesartan FDA label on DailyMed (effective January 15, 2026); the irbesartan FDA label on DailyMed (effective August 6, 2026).

Highlights of the candesartan record

Candesartan (Atacand) · label of January 15, 2026

Boxed warning

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.

Used for

From the label: indications

Candesartan 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). […]

On the market

Earliest approval on file
June 4, 1998
Generic labelers
8 labelers
Pharmacy cost
$0.478 per tablet

Supply and safety

Shortage
No current entry
Recalls
9

Highlights of the irbesartan record

Irbesartan (Avapro) · label of August 6, 2026

Boxed warning

FETAL TOXICITY

When pregnancy is detected, discontinue irbesartan tablets 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.

Used for

From the label: indications

Irbesartan is an angiotensin II receptor blocker (ARB) 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 ) Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. […]

On the market

Earliest approval on file
September 30, 1997
Generic labelers
23 labelers
Pharmacy cost
$0.107 per tablet

Supply and safety

Shortage
No current entry
Recalls
10

Source: FDA drug labels via openFDA (Candesartan label of January 15, 2026, Irbesartan label of August 6, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do candesartan and irbesartan differ on the record?

How each works, in its label's words: Candesartan, “Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II).”; Irbesartan, “Angiotensin II is a potent vasoconstrictor formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II).”

Both are in FDA's class angiotensin 2 receptor blockers.

Half-life, in each label's words: Candesartan, “The elimination half-life of candesartan is approximately 9 hours.”; Irbesartan, “The terminal elimination half-life of irbesartan averages 11 to 15 hours.”

Both labels carry a boxed warning; the records quote them.

Generics: candesartan since 2013; irbesartan since 2012 (Drugs@FDA).

CandesartanIrbesartan
Labeled forHigh blood pressure, Heart failureHigh blood pressure, Chronic kidney disease
Pharmacologic classAngiotensin 2 Receptor BlockerAngiotensin 2 Receptor Blocker
How it works (label)Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II).Angiotensin II is a potent vasoconstrictor formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II).
Half-life (label)The elimination half-life of candesartan is approximately 9 hours.The terminal elimination half-life of irbesartan averages 11 to 15 hours.
Earliest approval on file (Drugs@FDA)June 4, 1998September 30, 1997
First generic approvedMay 3, 2013March 30, 2012
Generic labelers (NDC)8 labelers23 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$0.478 per tablet (Candesartan cilexetil 16 mg tablet)$0.107 per tablet (Irbesartan 150 mg tablet)
12-month price change-15%-8%
Boxed warningYesYes
Shortage nowNo current entryNo current entry
Recalls recorded910
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)60,88944,400
DEA schedulenonenone

Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)

What next?

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