Aldactone (Spironolactone) Drug Information: Side Effects and Drug Interactions

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May 23, 2012

Aldactone

Diuretics »

What are diuretics and how do they work?

The amount of fluid (water) retained by the body is controlled primarily by the kidneys. This occurs due to the kidney's ability to control the retention and elimination of sodium and chloride, because the amounts of sodium, chloride, and water in the body are carefully balanced. Thus, if sodium and chloride are eliminated from the body, water also is eliminated. Conversely, if sodium and chloride are retained by the body, so is water.

The elimination of sodium, chloride, and water from the body is somewhat complex. In the kidneys, sodium, chloride, and other small molecules are filtered out of the blood and into the tubules of the kidney where urine is formed. Most of the sodium, chloride, and water are reabsorbed into the blood before the filtered fluid leaves the kidney in the form of urine. To make matters even more complex, there are different mechanisms that are active in different parts of the tu...

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SIDE EFFECTS

The following adverse reactions have been reported and, within each category (body system), are listed in order of decreasing severity.

Digestive: Gastric bleeding, ulceration, gastritis, diarrhea and cramping, nausea, vomiting.

Endocrine: Gynecomastia (see PRECAUTIONS), inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding. Carcinoma of the breast has been reported in patients taking Aldactone (spironolactone) but a cause and effect relationship has not been established.

Hematologic: Agranulocytosis.

Hypersensitivity: Fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis.

Metabolism: Hyperkalemia (see WARNINGS and PRECAUTIONS).

Nervous system/psychiatric: Mental confusion, ataxia, headache, drowsiness, lethargy.

Liver/biliary: A very few cases of mixed cholestatic/hepatocellular toxicity, with one reported fatality, have been reported with Aldactone (spironolactone) administration.

Renal: Renal dysfunction (including renal failure).

DRUG INTERACTIONS

ACE inhibitors: Concomitant administration of ACE inhibitors with potassium-sparing diuretics has been associated with severe hyperkalemia.

Alcohol, barbiturates, or narcotics: Potentiation of orthostatic hypotension may occur.

Corticosteroids, ACTH: Intensified electrolyte depletion, particularly hypokalemia, may occur.

Pressor amines (e.g., norepinephrine): Aldactone (spironolactone) reduces the vascular responsiveness to norepinephrine. Therefore, caution should be exercised in the management of patients subjected to regional or general anesthesia while they are being treated with Aldactone (spironolactone) .

Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine): Possible increased responsiveness to the muscle relaxant may result.

Lithium: Lithium generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity.

Nonsteroidal anti-inflammatory drugs (NSAIDs): In some patients, the administration of an NSAID can reduce the diuretic, natriuretic, and antihypertensive effect of loop, potassium-sparing and thiazide diuretics. Combination of NSAIDs, e.g., indomethacin, with potassium-sparing diuretics has been associated with severe hyperkalemia. Therefore, when Aldactone (spironolactone) and NSAIDs are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.

Digoxin: Aldactone (spironolactone) has been shown to increase the half-life of digoxin. This may result in increased serum digoxin levels and subsequent digitalis toxicity. It may be necessary to reduce the maintenance and digitalization doses when Aldactone (spironolactone) is administered, and the patient should be carefully monitored to avoid over or underdigitalization.

Drug/Laboratory test interactions

Several reports of possible interference with digoxin radioimmunoassay by Aldactone (spironolactone) , or its metabolites, have appeared in the literature. Neither the extent nor the potential clinical significance of its interference (which may be assay-specific) has been fully established.

Last reviewed on RxList: 12/15/2010
This monograph has been modified to include the generic and brand name in many instances.