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Two medicines, side by side

Spironolactone vs minoxidil

Spironolactone and minoxidil are both labeled for high blood pressure. Drugs@FDA records approvals of spironolactone since 1960 and of minoxidil since 1979. Pharmacies paid $0.0426 per spironolactone 25 mg tablet and $0.156 per minoxidil 10 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, spironolactone is an aldosterone antagonist and minoxidil an arteriolar vasodilator.

Check it at the source: the spironolactone FDA label on DailyMed (effective November 28, 2025); the minoxidil FDA label on DailyMed (effective September 6, 2024).

Highlights of the spironolactone record

Spironolactone (Aldactone) · label of November 28, 2025

Used for

From the label: indications

ALDACTONE is an aldosterone antagonist indicated for: • The treatment of NYHA Class III–IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure ( 1.1 ). • Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. […]

On the market

Earliest approval on file
January 21, 1960
Generic labelers
38 labelers
Pharmacy cost
$0.0426 per tablet

Supply and safety

Shortage
A presentation being discontinued
Recalls
6

Highlights of the minoxidil record

Minoxidil (Rogaine) · label of September 6, 2024

Used for

From the label: indications

to regrow hair on the scalp

On the market

Earliest approval on file
October 18, 1979
Generic labelers
86 labelers
Pharmacy cost
$0.156 per tablet

Supply and safety

Shortage
No current entry
Recalls
1

Source: FDA drug labels via openFDA (Spironolactone label of November 28, 2025, Minoxidil label of September 6, 2024); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do spironolactone and minoxidil differ on the record?

In FDA's classes, spironolactone is an aldosterone antagonist and minoxidil an arteriolar vasodilator.

Only the minoxidil label carries a boxed warning.

Generics: spironolactone since 1980; minoxidil since 1987 (Drugs@FDA).

SpironolactoneMinoxidil
Labeled forHeart failure, Edema (fluid retention), High blood pressureHigh blood pressure
Pharmacologic classAldosterone AntagonistArteriolar Vasodilator
How it works (label)Spironolactone and its active metabolites are specific pharmacologic antagonists of aldosterone, acting primarily through competitive binding of receptors at the aldosterone-dependent sodium-potassium exchange site in the distal convoluted …n/a
Half-life (label)The mean half-life values of its metabolites including canrenone, 7-α-(thiomethyl) spirolactone (TMS), and 6-β-hydroxy-7-α-(thiomethyl) spirolactone (HTMS) are 16.5, 13.8, and 15 hours, respectively.n/a
Earliest approval on file (Drugs@FDA)January 21, 1960October 18, 1979
First generic approvedMay 7, 1980March 3, 1987
Generic labelers (NDC)38 labelers86 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$0.0426 per tablet (Spironolactone 25 mg tablet)$0.156 per tablet (Minoxidil 10 mg tablet)
12-month price change-14%-17%
Boxed warningNoYes
Shortage nowA presentation being discontinuedNo current entry
Recalls recorded61
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)139,75744,687
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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