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Two medicines, side by side

Aliskiren vs hydrochlorothiazide

Aliskiren and hydrochlorothiazide are both labeled for high blood pressure. Drugs@FDA records approvals of aliskiren since 2007 and of hydrochlorothiazide since 1959. Pharmacies paid $3.94 per aliskiren 150 mg tablet and $0.0115 per hydrochlorothiazide 25 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. Hydrochlorothiazide's other strengths are brand-only: $4.46 per mL (Inzirqo 10 mg/mL oral suspension). In FDA's classes, aliskiren is a renin inhibitor and hydrochlorothiazide a thiazide diuretic.

Check it at the source: the aliskiren FDA label on DailyMed (effective March 7, 2024); the hydrochlorothiazide FDA label on DailyMed (effective June 12, 2026).

Highlights of the aliskiren record

Aliskiren (Tekturna) · label of March 7, 2024

Boxed warning

FETAL TOXICITY When pregnancy is detected, discontinue Tekturna as soon as possible. ( 5.1 , 8.1 ) Drugs that act directly on the renin-angiotensin system 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 Tekturna as soon as possible. ( 5.1 , 8.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Used for

From the label: indications

Tekturna is a renin inhibitor (RI) indicated for the treatment of hypertension in adults and in pediatric patients weighing 50 kg or greater who are at least 6 years of age, 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
March 5, 2007
Generic labelers
1 labeler
Pharmacy cost
$3.94 per tablet

Supply and safety

Shortage
No current entry
Recalls
0

Highlights of the hydrochlorothiazide record

Hydrochlorothiazide (Inzirqo) · label of June 12, 2026

Used for

From the label: indications

Hydrochlorothiazide tablets USP are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets USP have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. […]

On the market

Earliest approval on file
February 12, 1959
Generic labelers
43 labelers
Pharmacy cost
$0.0115 per tablet

Supply and safety

Shortage
A presentation being discontinued
Recalls
7

Source: FDA drug labels via openFDA (Aliskiren label of March 7, 2024, Hydrochlorothiazide label of June 12, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do aliskiren and hydrochlorothiazide differ on the record?

In FDA's classes, aliskiren is a renin inhibitor and hydrochlorothiazide a thiazide diuretic.

Half-life, in each label's words: Aliskiren, “12.3 Pharmacokinetics Aliskiren is poorly absorbed (bioavailability about 2.5%) with an approximate accumulation …”; Hydrochlorothiazide, “When plasma levels have been followed for at least 24 hours, the plasma half-life has been observed to vary between 5.6 …”

Only the aliskiren label carries a boxed warning.

Generics: aliskiren since 2019; hydrochlorothiazide since 1973 (Drugs@FDA).

AliskirenHydrochlorothiazide
Labeled forHigh blood pressureHeart failure, High blood pressure, Edema (fluid retention)
Pharmacologic classRenin InhibitorThiazide Diuretic
How it works (label)Renin is secreted by the kidney in response to decreases in blood volume and renal perfusion. Renin cleaves angiotensinogen to form the inactive decapeptide angiotensin I (Ang I).n/a
Half-life (label)12.3 Pharmacokinetics Aliskiren is poorly absorbed (bioavailability about 2.5%) with an approximate accumulation half-life of 24 hours.When 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)March 5, 2007February 12, 1959
First generic approvedMarch 22, 2019January 12, 1973
Generic labelers (NDC)1 labeler43 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$3.94 per tablet (Aliskiren 150 mg tablet)$0.0115 per tablet (Hydrochlorothiazide 25 mg tablet)
12-month price change-2%-7%
Boxed warningYesNo
Shortage nowNo current entryA presentation being discontinued
Recalls recorded07
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)5,999144,413
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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