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CaroSpir Side Effects

Generic name: spironolactone

Medically reviewed by Drugs.com. Last updated on Oct 11, 2022.

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

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]

Frequently asked questions

References

1. "Product Information. Aldactone (spironolactone)." Searle (2001):

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.