Ketoconazole

DRUG INFORMATION

  ADULT
    - 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

  CHILD
    - 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

  RENAL IMPAIRMENT
    - 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

  HEPATIC IMPAIRMENT
    - 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

  PREGNANCY
    - 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
    - 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
    - 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

  BREASTFEEDING
    - 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
    - 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
    - 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