FDA label
What is amiloride used for?
The FDA-approved uses of amiloride, 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: “Amiloride HCl is indicated as adjunctive treatment with thiazide diuretics or other kaliuretic-diuretic agents in congestive heart failure or hypertension to:”
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Amiloride Hydrochloride, tablet
Indications and Usage, quoted from the label by Par Health USA, LLC (ANDA070346). Cross-references to other label sections are left out.
Amiloride HCl is indicated as adjunctive treatment with thiazide diuretics or other kaliuretic-diuretic agents in congestive heart failure or hypertension to:
a. help restore normal serum potassium levels in patients who develop hypokalemia on the kaliuretic diuretic.
b. prevent development of hypokalemia in patients who would be exposed to particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.
The use of potassium-conserving agents is often unnecessary in patients receiving diuretics for uncomplicated essential hypertension when such patients have a normal diet. Amiloride HCl has little additive diuretic or antihypertensive effect when added to a thiazide diuretic.
Amiloride HCl should rarely be used alone. It has weak (compared with thiazides) diuretic and antihypertensive effects. Used as single agents, potassium sparing diuretics, including amiloride HCl, result in an increased risk of hyperkalemia (approximately 10% with amiloride). Amiloride HCl should be used alone only when persistent hypokalemia has been documented and only with careful titration of the dose and close monitoring of serum electrolytes.
Source: DailyMed label, set id e0cc2d44-436a-47e8-a890-589882fff4c4, version 13, effective July 28, 2026. NDC 49884-117, one of 2 listings for this product.
Questions
What is amiloride used for?
The FDA label says: “Amiloride HCl is indicated as adjunctive treatment with thiazide diuretics or other kaliuretic-diuretic agents in congestive heart failure or hypertension to:”
What drug class is amiloride?
FDA lists amiloride in the Potassium-sparing Diuretic 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.