{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "ketoconazole",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Ketoconazole foam, 2% should be applied to the affected area(s) twice daily for four weeks. Hold the container upright, and dispense ketoconazole foam, 2% into the cap of the can or other cool surface in an amount sufficient to cover the affected area(s). Dispensing directly onto hands is not recommended, as the foam will begin to melt immediately upon contact with warm skin.",
        "source": "US FDA label for ketoconazole (ketoconazole), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/ketoconazole.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and effectiveness of ketoconazole foam, 2% in pediatric patients less than 12 years of age have not been established. Of the 672 subjects treated with ketoconazole foam, 2% in the clinical trials, 44 (7%) were from 12 to 17 years of age. [See Clinical Studies (14) ].",
        "source": "US FDA label for ketoconazole (ketoconazole), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/ketoconazole.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "No kidney-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for ketoconazole (ketoconazole), retrieved 2026-08-29",
        "cached_file": "labels/ketoconazole.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "No liver-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for ketoconazole (ketoconazole), retrieved 2026-08-29",
        "cached_file": "labels/ketoconazole.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary There are no available data on ketoconazole foam, 2% use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.",
        "source": "US FDA label for ketoconazole (ketoconazole), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/ketoconazole.json",
        "verbatim": true
      },
      {
        "text": "No reproductive studies in animals have been performed with ketoconazole foam, 2%.",
        "source": "US FDA label for ketoconazole (ketoconazole), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/ketoconazole.json",
        "verbatim": true
      },
      {
        "text": "In animal reproduction studies with pregnant mice, rats and rabbits both embryotoxic and developmental effects (structural abnormalities) were observed following oral dosing of ketoconazole during organogenesis.",
        "source": "US FDA label for ketoconazole (ketoconazole), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/ketoconazole.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Infertility In animal fertility studies in rats and dogs, administration of oral doses of ketoconazole between 3-day and 3-month periods resulted in infertility that was reversible [see Nonclinical Toxicology (13.1)] .",
        "source": "US FDA label for ketoconazole (ketoconazole), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/ketoconazole.json",
        "verbatim": true
      },
      {
        "text": "In pregnant rabbits orally administered ketoconazole, evidence of embryotoxicity (increased resorptions) was observed at 10 mg/kg (1.2 times the MRHD based on BSA comparisons) and higher and an increased incidence of skeletal abnormalities was observed at 40 mg/kg (4.8 times the MRHD based on BSA comparisons).",
        "source": "US FDA label for ketoconazole (ketoconazole), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/ketoconazole.json",
        "verbatim": true
      },
      {
        "text": "The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ketoconazole foam, 2% and any potential adverse effects on the breastfed infant from ketoconazole foam, 2% or from the underlying maternal condition.",
        "source": "US FDA label for ketoconazole (ketoconazole), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/ketoconazole.json",
        "verbatim": true
      }
    ]
  }
}