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Two medicines, side by side

Acebutolol vs amlodipine/valsartan

Acebutolol and amlodipine/valsartan are both labeled for high blood pressure. Drugs@FDA records approvals of acebutolol since 1984 and of amlodipine/valsartan since 2007. Pharmacies paid $0.615 per acebutolol 200 mg capsule and $0.330 per unit (Amlodipine-valsartan 10-160 mg) (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, acebutolol is a beta-adrenergic blocker and amlodipine/valsartan a calcium channel blocker.

Check it at the source: the acebutolol FDA label on DailyMed (effective December 11, 2024); the amlodipine/valsartan FDA label on DailyMed (effective February 17, 2026).

Highlights of the acebutolol record

Acebutolol (Sectral) · label of December 11, 2024

Used for

From the label: indications

Hypertension Acebutolol hydrochloride capsules are indicated for the management of hypertension in adults. It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. […]

On the market

Earliest approval on file
December 28, 1984
Generic labelers
6 labelers
Pharmacy cost
$0.615 per capsule

Supply and safety

Shortage
No current entry
Recalls
0

Highlights of the amlodipine and valsartan record

Amlodipine and valsartan (Exforge) · label of February 17, 2026

Boxed warning

FETAL TOXICITY When pregnancy is detected, discontinue Exforge as soon as possible. (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue Exforge as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Used for

From the label: indications

Exforge is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). […]

On the market

Earliest approval on file
June 20, 2007
Generic labelers
9 labelers
Pharmacy cost
$0.330 per unit

Supply and safety

Shortage
No current entry
Recalls
20

Source: FDA drug labels via openFDA (Acebutolol label of December 11, 2024, Amlodipine/valsartan label of February 17, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do acebutolol and amlodipine/valsartan differ on the record?

In FDA's classes, acebutolol is a beta-adrenergic blocker and amlodipine/valsartan a calcium channel blocker.

Half-life, in each label's words: Acebutolol, “The plasma elimination half-life of acebutolol is approximately 3 to 4 hours, while that of its metabolite, diacetolol …”; Amlodipine/valsartan, “Elimination of amlodipine from the plasma is biphasic with a terminal elimination half-life of about 30 to 50 hours.”

Only the amlodipine/valsartan label carries a boxed warning.

Generics: acebutolol since 1995; amlodipine/valsartan since 2013 (Drugs@FDA).

AcebutololAmlodipine/valsartan
Labeled forHigh blood pressureHigh blood pressure
Pharmacologic classbeta-Adrenergic BlockerAngiotensin 2 Receptor Blocker, Calcium Channel Blocker, Dihydropyridine Calcium Channel Blocker
How it works (label)n/aAmlodipine Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle.
Half-life (label)The plasma elimination half-life of acebutolol is approximately 3 to 4 hours, while that of its metabolite, diacetolol, is 8 to 13 hours.Elimination of amlodipine from the plasma is biphasic with a terminal elimination half-life of about 30 to 50 hours.
Earliest approval on file (Drugs@FDA)December 28, 1984June 20, 2007
First generic approvedApril 24, 1995March 28, 2013
Generic labelers (NDC)6 labelers9 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$0.615 per capsule (Acebutolol 200 mg capsule)$0.330 per unit (Amlodipine-valsartan 10-160 mg)
12-month price change-0.3%-35%
Boxed warningNoYes
Shortage nowNo current entryNo current entry
Recalls recorded020
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)1,25811,192
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)

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