Is itraconazole (antifungal medication) safe to use during lactation (breastfeeding)?

Itraconazole During Lactation

Itraconazole should be avoided during breastfeeding, and alternative antifungal agents that are compatible with lactation—particularly fluconazole for systemic infections or topical azoles (miconazole, clotrimazole) for localized infections—should be used instead. 1, 2

Primary Guideline Recommendations

• The American Academy of Pediatrics does not recommend itraconazole for breastfeeding mothers, explicitly distinguishing it from fluconazole, which is considered compatible with breastfeeding. 1

• The European Respiratory Society/Thoracic Society of Australia and New Zealand classifies itraconazole as only "possibly safe" during breastfeeding, noting that limited information is available in nursing mothers. 1

• The FDA drug label confirms that itraconazole is excreted in human milk, and states that the expected benefits of therapy for the mother should be weighed against the potential risk from exposure to the infant. 3

Key Safety Concerns

• While itraconazole is present in breast milk at amounts less than typical neonatal dosages and is poorly absorbed orally (which theoretically reduces infant exposure), the lack of robust safety data in breastfed infants is the primary reason for avoidance. 1

• Itraconazole may accumulate in breast milk over time with prolonged use, raising concerns about chronic low-level exposure to the nursing infant. 1

• The FDA label emphasizes that itraconazole crosses the placenta in animal models and causes teratogenicity at therapeutic doses, though this pregnancy concern is distinct from lactation safety. 3

Preferred Alternative Antifungal Agents

For Systemic Fungal Infections:

• Fluconazole is the preferred azole antifungal for nursing mothers and can be used at all doses without interrupting breastfeeding, as recommended by the Infectious Diseases Society of America (IDSA) and endorsed by the American Academy of Pediatrics. 2

• Fluconazole is present in breast milk at levels below neonatal therapeutic doses, and no problems have been observed in breastfed infants even with maternal high-dose regimens. 2

For Localized/Topical Fungal Infections:

• Topical azoles (miconazole, clotrimazole) and nystatin are classified as "compatible" with breastfeeding for treating conditions like nipple candidiasis or superficial skin infections. 4

• When using topical antifungals on nipples, excess cream should be removed before nursing to minimize infant exposure. 1, 4

Clinical Decision-Making Algorithm

1. Assess the severity and type of maternal fungal infection:

   • For systemic infections (e.g., invasive candidiasis, aspergillosis): Switch to fluconazole if clinically appropriate 2
   • For superficial infections (e.g., vaginal candidiasis, skin infections): Use topical azoles or single-dose fluconazole 150 mg 2, 4

2. If itraconazole is being considered due to specific fungal resistance or intolerance to alternatives:

   • The risk-benefit discussion must acknowledge the lack of safety data 1
   • Consider temporary interruption of breastfeeding during treatment, though this is generally discouraged given the benefits of continued nursing 5, 6

3. Avoid other azoles with even less safety data:

   • Posaconazole and voriconazole should be avoided during breastfeeding due to potential toxicity concerns and complete absence of safety data 1, 2, 4

Common Pitfalls to Avoid

• Do not assume all azole antifungals have equivalent lactation safety profiles—fluconazole has substantially more evidence supporting its use compared to itraconazole. 1, 2

• Do not rely solely on the theoretical calculation that itraconazole levels in milk are below neonatal doses—the lack of clinical outcome data in breastfed infants is the critical limitation. 1

• Do not unnecessarily discontinue breastfeeding when safer alternatives exist that allow continuation of nursing while treating the maternal infection effectively. 5, 6, 7