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Two medicines, side by side

Amlodipine vs amlodipine/hydrochlorothiazide/olmesartan

Amlodipine and amlodipine/hydrochlorothiazide/olmesartan are both labeled for high blood pressure. Drugs@FDA records approvals of amlodipine since 1992 and of amlodipine/hydrochlorothiazide/olmesartan since 2010. Pharmacies paid $0.0102 per amlodipine besylate 5 mg tablet and $0.776 per unit (Olmsrtn-amldpn-hydrochlorothiazide 20-5-12.5) (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. How each works, in its label's words: Amlodipine, “Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow‑channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac …”; Amlodipine/hydrochlorothiazide/olmesartan, “The active ingredients of Tribenzor target three separate mechanisms involved in blood pressure regulation.”

Check it at the source: the amlodipine FDA label on DailyMed (effective February 15, 2023); the amlodipine/hydrochlorothiazide/olmesartan FDA label on DailyMed (effective July 12, 2023).

Highlights of the amlodipine record

Amlodipine (Norvasc) · label of February 15, 2023

Used for

From the label: indications

NORVASC is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: • Hypertension ( 1.1 ) o NORVASC is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. […]

On the market

Earliest approval on file
July 31, 1992
Generic labelers
42 labelers
Pharmacy cost
$0.0102 per tablet

Supply and safety

Shortage
No current entry
Recalls
30

Highlights of the amlodipine and hydrochlorothiazide and olmesartan record

Amlodipine and hydrochlorothiazide and olmesartan (Tribenzor) · label of July 12, 2023

Boxed warning

FETAL TOXICITY When pregnancy is detected, discontinue Tribenzor as soon as possible. ( 5.1 , 8.1 ) Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus. ( 5.1 , 8.1 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue Tribenzor as soon as possible ( 5.1 , 8.1 ).

Used for

From the label: indications

Tribenzor is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. […]

On the market

Earliest approval on file
July 23, 2010
Generic labelers
8 labelers
Pharmacy cost
$0.776 per unit

Supply and safety

Shortage
No current entry
Recalls
0

Source: FDA drug labels via openFDA (Amlodipine label of February 15, 2023, Amlodipine/hydrochlorothiazide/olmesartan label of July 12, 2023); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do amlodipine and amlodipine/hydrochlorothiazide/olmesartan differ on the record?

How each works, in its label's words: Amlodipine, “Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow‑channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac …”; Amlodipine/hydrochlorothiazide/olmesartan, “The active ingredients of Tribenzor target three separate mechanisms involved in blood pressure regulation.”

Only the amlodipine/hydrochlorothiazide/olmesartan label carries a boxed warning.

Both are in FDA's class calcium channel blockers.

Generics: amlodipine since 2005; amlodipine/hydrochlorothiazide/olmesartan since 2016 (Drugs@FDA).

AmlodipineAmlodipine/hydrochlorothiazide/olmesartan
Labeled forHigh blood pressure, Angina, Heart attack and coronary artery diseaseHigh blood pressure
Pharmacologic classCalcium Channel Blocker, Dihydropyridine Calcium Channel BlockerAngiotensin 2 Receptor Blocker, Calcium Channel Blocker, Dihydropyridine Calcium Channel Blocker, Thiazide Diuretic
How it works (label)Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow‑channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle.The active ingredients of Tribenzor target three separate mechanisms involved in blood pressure regulation.
Half-life (label)n/aWhen plasma levels have been followed for at least 24 hours, the plasma half-life has been observed to vary between 5.6 and 14.8 hours.
Earliest approval on file (Drugs@FDA)July 31, 1992July 23, 2010
First generic approvedOctober 3, 2005October 26, 2016
Generic labelers (NDC)42 labelers8 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$0.0102 per tablet (Amlodipine besylate 5 mg tablet)$0.776 per unit (Olmsrtn-amldpn-hydrochlorothiazide 20-5-12.5)
12-month price change-10%-14%
Boxed warningNoYes
Shortage nowNo current entryNo current entry
Recalls recorded300
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)409,1861,260
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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