FDA label
What is minoxidil used for?
The FDA-approved uses of minoxidil, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Because of the potential for serious adverse effects, minoxidil tablets are indicated only in the treatment of hypertension that is symptomatic or associated with target organ damage and is not manageable with maximum therapeutic doses of a diuretic plus two other antihypertensive drugs. At the present time use in milder degrees of hypertension is not recommended because the benefit-risk relati...”
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Minoxidil, tablet
Indications and Usage, quoted from the label by Par Health USA, LLC (ANDA071826). Cross-references to other label sections are left out.
Because of the potential for serious adverse effects, minoxidil tablets are indicated only in the treatment of hypertension that is symptomatic or associated with target organ damage and is not manageable with maximum therapeutic doses of a diuretic plus two other antihypertensive drugs. At the present time use in milder degrees of hypertension is not recommended because the benefit-risk relationship in such patients has not been defined.
Minoxidil reduced supine diastolic blood pressure by 20 mmHg or to 90 mmHg or less in approximately 75% of patients, most of who had hypertension that could not be controlled by other drugs.
Source: DailyMed label, set id 8f3800f0-b6da-4dfe-8c32-39bb5eb0262a, version 11, effective June 11, 2026. NDC 49884-256, one of 32 listings for this product.
Questions
What is minoxidil used for?
The FDA label says: “Because of the potential for serious adverse effects, minoxidil tablets are indicated only in the treatment of hypertension that is symptomatic or associated with target organ damage and is not manageable with maximum therapeutic doses of a diuretic plus two other antihypertensive drugs. At the present time use in milder degrees of hypertension is not recommended because the benefit-risk relati...”
What drug class is minoxidil?
FDA lists minoxidil in the Arteriolar Vasodilator established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.