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Ketoconazole can pass into breast milk and may harm a nursing babyYou should not breast-feed while using this medicine.

Ketoconazole is not for use in treating fungal infections of the fingernails or toenailsThis medicine is also not for use in treating prostate cancer or Cushing syndrome.

Serious hepatotoxicityincluding cases with a fatal outcome or requiring liver transplantationhas occurred with the use of oral ketoconazoleSome patients had no obvious risk factors for liver diseaseSerious hepatotoxicity was reported both by patients receiving high doses for short treatment durations and by patients receiving low doses for long durations.

Serious hepatotoxicityincluding cases with a fatal outcome or requiring liver transplantation has occurred with the use of oral ketoconazoleSome patients had no obvious risk factors for liver diseasePatients receiving this drug should be informed by the physician of the risk and should be closely monitoredSee WARNINGS section.

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