ALDACTONE (Spironolactone Tablets, USP) Adverse Reactions

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The following adverse reactions have been reported in association with ALDACTONE (spironolactone):

Blood and lymphatic system disorders: Leukopenia (including agranulocytosis), thrombocytopenia, anemia.

Gastrointestinal disorders: Diarrhea and cramping, gastric bleeding, gastritis, nausea, ulceration, vomiting.

General disorders and administration site conditions: Malaise. ATAXIA

Hepatobiliary disorders: Abnormal hepatic function. A few cases of mixed cholestatic/hepatocellular toxicity, with one reported fatality, have been reported with spironolactone administration.

Immune system disorders: Drug fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis, pruritus, rash.

Metabolism and nutrition disorders: Electrolyte disturbances, hyperkalemia.

Musculoskeletal and connective tissue disorders: Leg cramps, muscle spasms, rhabdomyolysis, myalgia, weakness

Nervous system/psychiatric disorders: Mental confusion, ataxia, headache, drowsiness, lethargy, dizziness, change in libido.

Renal and urinary disorders: Renal dysfunction (including acute renal failure).

Reproductive system and breast disorders: gynecomastia* (see WARNINGS and PRECAUTIONS-Carcinogenesis and Mutagenesis), erectile dysfunction (inability to achieve or maintain erection), abnormal semen (decreased motility and sperm count), irregular menses or amenorrhea, postmenopausal bleeding, benign breast neoplasm, breast pain, breast carcinoma (including male patients)

Respiratory, thoracic and mediastinal disorders: Dysphonia, dyspnea.

Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug rash with eosinophilia and systemic symptoms (DRESS), alopecia, hypertrichosis.

*Gynecomastia may develop with the use of spironolactone, and physicians should be advised of its possible occurrence. Development of gynecomastia is related to both dose and duration of therapy. If gynecomastia develops, discontinue the drug. Gynecomastia is usually reversible when spironolactone is discontinued, although in rare instances some breast enlargement may persist.

Adverse reactions are usually reversible upon discontinuation of the drug.