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The following adverse reactions have been reported and, within each category (body system), are listed in order of decreasing severity.
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 but a cause and effect relationship has not been established.
Liver / biliary: A very few cases of mixed cholestatic/hepatocellular toxicity, with one reported fatality, have been reported with ALDACTONE administration.
Renal: Renal dysfunction (including renal failure).
Skin: Stevens-Johnson Syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS).
Read the Aldactone (spironolactone) Side Effects Center for a complete guide to possible side effects
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.
Intensified electrolyte depletion, particularly hypokalemia, may occur.
Pressor amines (e.g., norepinephrine)
ALDACTONE 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.
Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine)
Possible increased responsiveness to the muscle relaxant may result.
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)
n 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 and NSAIDs are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.
ALDACTONE 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 is administered, and the patient should be carefully monitored to avoid over- or under-digitalization.
Drug/Laboratory test interactions
Several reports of possible interference with digoxin radioimmunoassay by ALDACTONE, 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.
Read the Aldactone Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 10/1/2012
This monograph has been modified to include the generic and brand name in many instances.
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