Note: This document contains side effect information about spironolactone. Some dosage forms listed on this page may not apply to the brand name Aldactone.

Applies to spironolactone: oral suspension, oral tablets.

Side effects include:

Most common adverse effect (incidence >5%): Gynecomastia.

Other adverse effects: Hyperkalemia; hypotension; worsening renal function; hyponatremia; hypomagnesemia; hypocalcemia; hypochloremic alkalosis; hyperglycemia; impaired neurologic function/coma in patients with hepatic impairment, cirrhosis and ascites.

For Healthcare Professionals

Applies to spironolactone: compounding powder, oral suspension, oral tablet.

General

The most common adverse effect was gynecomastia.^[Ref]

Endocrine

Very common (10% or more): Gynecomastia (13%)

Frequency not reported: Breast disorders in women, slight androgenic effects, breast tenderness in women, voice deepening in women, breast pain^[Ref]

Metabolic

Common (1% to 10%): Hyperkalemia, hyponatremia

Uncommon (0.1% to 1%): Acidosis in patients with liver problems

Rare (less than 0.1%): Dehydration, porphyria, hyperuricemia

Frequency not reported: Reversible hyperchloremic metabolic acidosis in patients with decompensated hepatic cirrhosis, electrolyte disturbances^[Ref]

Genitourinary

Common (1% to 10%): Changes in vaginal secretions, amenorrhea, postmenopausal bleeding

Frequency not reported: Reproductive system disorders, erectile dysfunction, impotence, menstrual disorders^[Ref]

Nervous system

Common (1% to 10%): Lethargy in patients with cirrhosis, paresthesia

Rare (less than 0.1%): Paralysis, paraplegia of the limbs due to hyperkalemia

Frequency not reported: Headache, drowsiness, dizziness, ataxia^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting

Very rare (less than 0.01%): Gastric inflammation, gastric ulcers, intestinal hemorrhage, cramps

Frequency not reported: Digestive system disorders, diarrhea, indigestion, gastric bleeding^[Ref]

Psychiatric

Common (1% to 10%): Libido reduced in women

Uncommon (0.1% to 1%): Confusion

Frequency not reported: Libido reduced in men^[Ref]

Oncologic

Common (1% to 10%): Malaise

Very rare (less than 0.01%): Breast cancer^[Ref]

Other

Common (1% to 10%): Weakness

Frequency not reported: Fatigue, fever^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash, urticaria, erythema, chloasma, pruritus, exanthema

Rare (less than 0.1%): Eczema

Very rare (less than 0.01%): Alopecia, erythema annulare centrifugum, hypertrichosis

Frequency not reported: Hirsutism, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), maculopapular or erythematous cutaneous eruptions^[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Muscle spasms, leg cramps

Very rare (less than 0.01%): Systemic lupus erythematosus, osteomalacia^[Ref]

Renal

Uncommon (0.1% to 1%): Serum creatinine elevated

Rare (less than 0.1%): BUN increased

Very rare (less than 0.01%): Acute renal failure

Frequency not reported: Renal dysfunction^[Ref]

Hematologic

Rare (less than 0.1%): Thrombocytopenia, eosinophilia, leukopenia

Frequency not reported: Agranulocytosis^[Ref]

Immunologic

Rare (less than 0.1%): Hypersensitivity

Frequency not reported: Anaphylactic reactions^[Ref]

Cardiovascular

Very rare (less than 0.01%): Vasculitis

Frequency not reported: Mild hypotension^[Ref]

Hepatic

Very rare (less than 0.01%): Hepatitis

Frequency not reported: Mixed cholestatic/hepatocellular toxicity^[Ref]