Spironolactone

DRUG INFORMATION

  ADULT
    - • Heart Failure: Initiate treatment at 25 mg once daily
      Source: US FDA label for spironolactone (Spironolactone), section 'dosage and
      administration', retrieved 2026-08-29
    - • Hypertension: Initiate treatment at 25 to 100 mg daily in either single or
      divided doses
      Source: US FDA label for spironolactone (Spironolactone), section 'dosage and
      administration', retrieved 2026-08-29
    - The recommended initial daily dose is 100 mg in single or divided doses
      Source: US FDA label for spironolactone (Spironolactone), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Safety and effectiveness in pediatric patients have not been established.
      Source: US FDA label for spironolactone (Spironolactone), section 'pediatric use',
      retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Treatment of Heart Failure In patients with serum potassium ≤5.0 mEq/L and eGFR
      >50 mL/min/1.73 m², initiate treatment at 25 mg once daily.
      Source: US FDA label for spironolactone (Spironolactone), section 'dosage and
      administration', retrieved 2026-08-29
    - In patients with an eGFR between 30 and 50 mL/min/1.73 m 2 , consider initiating
      therapy at 25 mg every other day because of the risk of hyperkalemia [see
      Source: US FDA label for spironolactone (Spironolactone), section 'dosage and
      administration', retrieved 2026-08-29
    - Because elderly patients are more likely to have decreased renal function, monitor
      renal function. 8.6 Use in Renal Impairment Spironolactone is substantially
      excreted by the kidney, and the risk of adverse reactions to this drug may be
      greater in patients with impaired renal function.
      Source: US FDA label for spironolactone (Spironolactone), section 'use in specific
      populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Monitor potassium closely. 8.7 Use in Hepatic Impairment Spironolactone can cause
      sudden alterations of fluid and electrolyte balance which may precipitate impaired
      neurological function, worsening hepatic encephalopathy and coma in patients with
      hepatic disease with cirrhosis and ascites.
      Source: US FDA label for spironolactone (Spironolactone), section 'use in specific
      populations', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Based on mechanism of action and findings in animal studies,
      spironolactone may affect sex differentiation of the male during embryogenesis
      [see
      Source: US FDA label for spironolactone (Spironolactone), section 'pregnancy',
      retrieved 2026-08-29
    - Rat embryofetal studies report feminization of male fetuses and endocrine
      dysfunction in females exposed to spironolactone in utero.
      Source: US FDA label for spironolactone (Spironolactone), section 'pregnancy',
      retrieved 2026-08-29
    - Limited available data from published case reports and case series did not
      demonstrate an association of major malformations or other adverse pregnancy
      outcomes with spironolactone .
      Source: US FDA label for spironolactone (Spironolactone), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - Spironolactone has known endocrine effects in animals including progestational and
      antiandrogenic effects. 8.2 Lactation Risk Summary Spironolactone is not present
      in breastmilk; however, limited data from a lactating woman at 17 days postpartum
      reports the presence of the active metabolite, canrenone, in human breast milk in
      low amounts that are expected to be clinically inconsequential.
      Source: US FDA label for spironolactone (Spironolactone), section 'use in specific
      populations', retrieved 2026-08-29
    - In this case, there were no adverse effects reported for the breastfed infant
      after short term exposure to spironolactone; however, long term effects on a
      breastfed infant are unknown.
      Source: US FDA label for spironolactone (Spironolactone), section 'use in specific
      populations', retrieved 2026-08-29
    - Consider the developmental and health benefits of breastfeeding along with the
      mother’s clinical need for spironolactone and any potential adverse effects on the
      breastfed child from spironolactone or from the underlying maternal condition. 8.4
      Pediatric Use Safety and effectiveness in pediatric patients have not been
      established.
      Source: US FDA label for spironolactone (Spironolactone), section 'use in specific
      populations', retrieved 2026-08-29