Aldactone Side Effects
Generic Name: spironolactone
Note: This document contains side effect information about spironolactone. Some of the dosage forms listed on this page may not apply to the brand name Aldactone.
Some side effects of Aldactone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to spironolactone: oral tablet
Along with its needed effects, spironolactone (the active ingredient contained in Aldactone) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking spironolactone:Incidence not known
- Abdominal or stomach cramping, burning, or tenderness
- bleeding gums
- bloody or black, tarry stools
- bloody urine
- breast pain
- chest pain
- clay-colored stools
- clear or bloody discharge from the nipple
- cloudy urine
- cough or hoarseness
- dark urine
- decrease in urine output or decrease in urine-concentrating ability
- difficulty with swallowing
- dimpling of the breast skin
- fast or irregular heartbeat
- fever with or without chills
- general feeling of tiredness or weakness
- increased thirst
- inverted nipple
- loss of appetite
- lower back or side pain
- lump in the breast or under the arm
- muscle pain or cramps
- muscle spasms or twitching
- nausea and vomiting
- painful or difficult urination
- persistent crusting or scaling of the nipple
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness or swelling of the breast
- severe stomach pain
- shakiness and unsteady walk
- skin rash
- sore on the skin of the breast that does not heal
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swelling of the face, fingers, feet, ankles, or lower legs
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- tightness in the chest
- troubled breathing
- unpleasant breath odor
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting of blood or material that looks like coffee grounds
- weight gain
- yellow eyes or skin
Get emergency help immediately if any of the following symptoms of overdose occur while taking spironolactone:Symptoms of overdose
- Irregular heartbeat
- numbness or tingling in the hands, feet, or lips
- rash with flat lesions or small raised lesions on the skin
- reddened skin
- weakness or heaviness of the legs
Some side effects of spironolactone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:Incidence not known
- Burning feeling in the chest or stomach
- hair loss or thinning of the hair
- itching skin
- leg cramps
- sores, welting, or blisters
- stomach upset
- swelling of the breasts or breast soreness in both females and males
- unusual dullness or feeling of sluggishness
For Healthcare Professionals
Applies to spironolactone: compounding powder, oral tablet
Metabolic side effects have been the most common side effects of spironolactone (the active ingredient contained in Aldactone) 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). Electrolyte disturbances have been reported postmarketing.
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.
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 (the active ingredient contained in Aldactone) 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 side effects have included renal insufficiency, manifested by increased BUN and serum creatinine.
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.
Cases of hyperkalemia associated with fatal and refractory ventricular fibrillation are reported during spironolactone (the active ingredient contained in Aldactone) 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.
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 (the active ingredient contained in Aldactone) was discontinued.
Dermatologic side effects have occurred in less than 5% of patients, and included rare cases of lichen planus and a lupus-like syndrome. Postmarketing dermatologic side effects have included Stevens-Johnson Syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), alopecia, and pruritus.
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.
Hypersensitivity side effects have included rashes which occurred in about 1% of patients. Rare cases of eosinophilia, contact dermatitis and anaphylaxis have been reported.
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 (the active ingredient contained in Aldactone) are at an increased risk (dose-related) of developing upper gastrointestinal adverse events such as gastric bleeding and gastric or duodenal ulcers.
Hematologic side effects have been rare, and included case reports of reversible leukopenia and agranulocytosis.
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.
A 53-year-old woman with aldosteronism secondary to an adrenal adenoma developed reversible hepatitis during spironolactone (the active ingredient contained in Aldactone) 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.
Animal studies have suggested an association between spironolactone (the active ingredient contained in Aldactone) 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).
Oncologic side effects have included isolated case reports of tumorigenesis but this has not been substantiated in large studies.
Postmarketing reports: Leg cramps
Postmarketing reports: Lethargy, dizziness
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