{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "spironolactone",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "• Heart Failure: Initiate treatment at 25 mg once daily",
        "source": "US FDA label for spironolactone (Spironolactone), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/spironolactone.json",
        "verbatim": true
      },
      {
        "text": "• 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",
        "cached_file": "labels/spironolactone.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/spironolactone.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Safety and effectiveness in pediatric patients have not been established.",
        "source": "US FDA label for spironolactone (Spironolactone), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/spironolactone.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "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",
        "cached_file": "labels/spironolactone.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/spironolactone.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/spironolactone.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "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",
        "cached_file": "labels/spironolactone.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "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",
        "cached_file": "labels/spironolactone.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/spironolactone.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/spironolactone.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "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",
        "cached_file": "labels/spironolactone.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/spironolactone.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/spironolactone.json",
        "verbatim": true
      }
    ]
  }
}