Spironolactone 25 mg Tablets — Generic For Aldactone — Ascend

These highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively.

See full prescribing information for SPIRONOLACTONE TABLETS.

SPIRONOLACTONE tablets, for oral use

Initial U.S. Approval: 1960

Indications And Usage

Spironolactone 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. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.2).

The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response (1.3).

Treatment of primary hyperaldosteronism for: (1.4)

Short-term preoperative treatment

Long-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia

Dosage And Administration

Heart Failure: Initiate treatment at 25 mg once daily (2.2).

Hypertension: Initiate treatment at 25 to 100 mg daily in either single or divided doses (2.3).

Edema: Initiate therapy in a hospital setting and titrate slowly. The recommended initial daily dose is 100 mg in single or divided doses (2.4).

Primary hyperaldosteronism: Initiate treatment at 100 to 400 mg in preparation for surgery. In patients unsuitable for surgery use the lowest effective dosage determined for the individual patient (2.5).

Dosage Forms And Strengths

Tablets: 25 mg, 50 mg, and 100 mg (3).

Contraindications

Spironolactone is contraindicated in patients with (4):

Hyperkalemia

Addison’s disease

Concomitant use of eplerenone

Warnings And Precautions

Hyperkalemia: Monitor serum potassium within one week of initiation and regularly thereafter (5.1).

Hypotension and Worsening Renal Function: Monitor volume status and renal function periodically (5.2).

Electrolyte and Metabolic Abnormalities: Monitor serum electrolytes, uric acid and blood glucose periodically (5.3).

Gynecomastia: Spironolactone can cause gynecomastia (5.4).

Adverse Reactions

The most common adverse reaction with spironolactone treatment is gynecomastia (5.4, 6).

To report SUSPECTED ADVERSE REACTIONS, contact Oxford, at 1-844-508-1455, 8:00 am – 4:30 ET, Monday – Friday or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Agents increasing serum potassium: Concomitant administration can lead to hyperkalemia (5.1, 7.1).

Lithium: Increased risk of lithium toxicity (7.2).

NSAIDs: May reduce the diuretic, natriuretic and antihypertensive effect of spironolactone (7.3).

Digoxin: spironolactone can interfere with radioimmunologic assays of digoxin exposure (7.4).

Cholestyramine: Hyperkalemic metabolic acidosis has been reported with concomitant use (7.5).

Acetylsalicylic Acid (ASA): ASA may reduce the efficacy of spironolactone (7.6)

Abiraterone: May increase prostate-specific antigen (PSA) levels (7.7).

Mitotane: Avoid concomitant use of spironolactone and mitotane (7.8).

Use In Specific Populations

Pregnancy: Based on animal data, spironolactone may affect sex differentiation of the male during embryogenesis (8.1).

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 2/2026