Systemic Ketoconazole Contraindications in Pediatric Patients

Regulatory Warnings and Guidelines

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued explicit warnings against systemic ketoconazole use due to risks of hepatic toxicities, adrenal suppression, and drug interactions 1, 2
The American College of Clinical Oncology guidelines specifically excluded ketoconazole from their systematic review of antifungal prophylaxis in pediatric cancer patients based on these regulatory safety warnings 1, 2

For invasive candidiasis or systemic fungal infections in a 5-year-old, fluconazole is the first-line agent at 8-12 mg/kg once daily, as recommended by the Infectious Diseases Society of America 3
For children younger than 13 years requiring mold-active coverage, an echinocandin, voriconazole, or itraconazole should be used based on efficacy and adverse effect profiles, according to the American Academy of Pediatrics 2
Voriconazole can be dosed at 9 mg/kg twice daily orally with therapeutic drug monitoring to maintain trough levels ≥1 mg/L, as suggested by the American College of Clinical Pharmacology 3

For suspected fungal infection in a 5-year-old, identify infection type and location, and use the following treatments:
Never consider systemic ketoconazole regardless of infection severity or location, as recommended by the American College of Clinical Oncology 1, 2