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 but a cause and effect relationship has not been established.
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 administration.
Renal: Renal dysfunction (including renal failure).
Skin: Stevens-Johnson Syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS).