Aldactone Side Effects

Generic Name: spironolactone

Please note - some side effects for Aldactone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Aldactone - for the Consumer

Aldactone

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Aldactone:

Diarrhea; drowsiness; headache; nausea; stomach cramping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; change in the amount of urine produced; confusion; dark urine; decreased sexual ability; enlarged breasts in men; irregular or missed menstrual periods; pale stools; severe or persistent stomach pain; symptoms of abnormal fluid or electrolyte levels (eg, fast, slow, or irregular heartbeat; increased thirst; muscle weakness; severe or persistent dry mouth, nausea, or vomiting; severe or persistent dizziness or drowsiness; unusual fatigue or sluggishness; tingling sensation); yellowing of the skin or eyes.

Aldactone Side Effects - for the Professional

Aldactone

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

Hematologic: Agranulocytosis.

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

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 spironolactone administration.

Renal: Renal dysfunction (including renal failure).

Side Effects by Body System

Metabolic

One of the most sensitive and quickest tests for hyperkalemia is the electrocardiogram (ECG), which usually demonstrates pronounced, "tented", or "peaked" T-waves, if not QRS widening. The first line of treatment for hyperkalemia with ECG changes is intravenous calcium. A second line therapy is prompt treatment with intravenous glucose 20% to 50% and regular insulin 0.25 to 0.50 units for every gram of glucose given. Moderate hyperkalemia can sometimes be successfully treated with sodium polystyrene sulfonate exchange resin.

Results of a case-controlled study revealed that heart failure patients who develop hyperkalemia while receiving spironolactone tend to be older, likely to have diabetes, have higher baseline potassium levels, and are receiving a beta-blocker. In this study, hyperkalemia requiring discontinuation of therapy occurred in 3.6% of patients and the rate of serious hyperkalemia (i.e., greater than 6.0 mEq/L) was 1.6%. In contrast, another study reported that 24% of their heart failure patients developed hyperkalemia and 12% developed serious hyperkalemia while receiving spironolactone. Also, 31% of patients developed hyponatremia.

Hyperchloremic metabolic acidosis is associated with spironolactone therapy in patients with liver disease and/or severe renal dysfunction.

Metabolic side effects have been the most common side effects of spironolactone. Hyperkalemia has been reported in approximately 10% of patients, which has caused intermittent muscle paralysis and death in rare cases. Hyperkalemia is particularly likely in patients with renal dysfunction. Hyponatremia has been reported in 12% of patients, and may be more likely in patients with liver disease due to the nonosmotic release of antidiuretic hormone (ADH).

Endocrine

Spironolactone interferes with 17-hydroxylase activity, which causes a decrease in testosterone synthesis. It also inhibits the intracellular binding of dihydrotestosterone to its receptor.

Rare cases of young women with liver disease who developed menarche only after spironolactone was discontinued are reported. Since estradiol synthesis is partially dependent on testosterone synthesis, spironolactone may cause primary or secondary amenorrhea in adolescents.

Endocrinologic side effects have been due to the antiandrogenic properties of spironolactone. Five percent to 30% of male patients complained of gynecomastia, impotence or diminished libido. Female patients reported hirsutism, oligomenorrhea, amenorrhea, menorrhagia, and breast tenderness. These side effects appeared to be dose-related, and were more likely during long-term therapy. Gynecomastia may be more likely in some male patients with liver disease due to the increased conversion of androgens to estrogens in severe liver disease.

Renal

Results of a case-controlled study indicate that heart failure patients who developed renal insufficiency while receiving spironolactone tended to have a lower baseline body weight, a higher baseline serum creatinine, required higher doses of loop diuretics, and were also likely to be receiving a thiazide diuretic. In this study, the incidence of renal insufficiency requiring discontinuation of therapy was 3.7%. In contrast, another study reported that 25% of their heart failure patients developed renal insufficiency while receiving spironolactone.

Renal side effects have included renal insufficiency, manifested by increased BUN and serum creatinine.

Cardiovascular

Cases of hyperkalemia associated with fatal and refractory ventricular fibrillation are reported during spironolactone therapy.

Cardiovascular side effects have included mainly hypovolemia, although the risk of hyperkalemia associated spironolactone has been important, especially in some patients with heart disease.

Dermatologic

Dermatologic side effects have occurred in less than 5% of patients, and included rare cases of lichen planus and a lupus-like syndrome.

In one case, histology of an associated lupoid eruption was consistent with lupus erythematosus, including immune deposits at the dermal-epidermal junction. There was a striking absence of serologic signs of lupus, however, and the rash resolved after spironolactone was discontinued.

Hypersensitivity

Hypersensitivity side effects have included rashes which occurred in about 1% of patients. Rare cases of eosinophilia, contact dermatitis and anaphylaxis have been reported.

A 44-year-old woman developed acute pulmonary edema, disseminated intravascular coagulation, and a generalized rash within 30 minutes of ingesting a single spironolactone-hydrochlorothiazide tablet. An inadvertent rechallenge resulted in the same sequelae.

Gastrointestinal

Gastrointestinal side effects have been minor. General abdominal discomfort, diarrhea, and vomiting were reported in less than 5% of patients. However, a case-controlled study has revealed that patients receiving spironolactone are at an increased risk (dose-related) of developing upper gastrointestinal adverse events such as gastric bleeding and gastric or duodenal ulcers.

Hematologic

Some cases of agranulocytosis are associated with a normal bone marrow, suggesting peripheral destruction of white blood cells, while some cases of agranulocytosis have been associated with bone marrow hypocellularity of the myelocytic cell lines.

Hematologic side effects have been rare, and included case reports of reversible leukopenia and agranulocytosis.

Hepatic

A 53-year-old woman with aldosteronism secondary to an adrenal adenoma developed reversible hepatitis during spironolactone therapy. The syndrome resolved upon drug discontinuation, and was reproducible on rechallenge. The authors did not find signs or symptoms of hypersensitivity to the drug.

A 74-year-old man with edema, minimal alcohol consumption (less than 30 g/day), and no history of liver or biliary disease became icteric 7 weeks after beginning spironolactone therapy. Liver biopsy revealed cholestatic lesions with many biliary thrombi and overloaded centrilobular cells, damaged hepatocytes, and focal necrosis. Infectious hepatitis was serologically excluded. All liver function abnormalities normalized 3 months after discontinuing spironolactone. The authors of this case report point out the structural similarity between spironolactone and steroids, drugs which are associated with cholestatic liver injury.

Hepatic side effects have been rare. Two cases of hepatitis have been strongly associated with spironolactone.

Oncologic

Oncologic side effects have included isolated case reports of tumorigenesis but this has not been substantiated in large studies.

Animal studies have suggested an association between spironolactone with benign adenomas of the thyroid and testes, malignant breast tumors, proliferative changes in the liver, including hepatocellular carcinoma, and leukemia. Dosages used in these studies were 25 to 250 times the maximum recommended human dosage (on a per kg basis).

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