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

Itraconazole Should Be Avoided During Breastfeeding

Itraconazole is not recommended for breastfeeding mothers and should be avoided due to lack of safety data and potential toxicity concerns, with fluconazole being the preferred alternative azole antifungal for nursing mothers. 1, 2

Primary Guideline Recommendations

• The Infectious Diseases Society of America (IDSA) explicitly states that itraconazole should be avoided during breastfeeding due to lack of safety data and potential toxicity concerns. 1, 2

• The American Academy of Pediatrics does not classify itraconazole as compatible with breastfeeding, in contrast to fluconazole which receives their explicit endorsement. 2

• The European Respiratory Society/Thoracic Society of Australia and New Zealand (ERS/TSANZ) classifies itraconazole as only "possibly safe" during breastfeeding, noting limited information available in nursing mothers. 2

Evidence on Breast Milk Excretion

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

• While itraconazole is present in breast milk at amounts less than neonatal dosage and is poorly absorbed orally (which theoretically reduces infant exposure), this does not override the guideline recommendations against its use. 2

• A concerning feature is that itraconazole may accumulate in breast milk over time with prolonged use. 2

Preferred Alternative: Fluconazole

• Fluconazole is the preferred azole antifungal for nursing mothers and can be used safely without interrupting breastfeeding. 1

• The IDSA recommends that breastfeeding mothers can continue nursing while taking fluconazole without interruption, as it is present in breast milk at levels less than neonatal dosage. 1

• The American Academy of Pediatrics considers fluconazole compatible with breastfeeding, providing the highest level of guideline support. 1

Topical Alternatives for Localized Infections

• For nipple or localized breast infections, topical azoles like miconazole or clotrimazole are classified as "compatible" with breastfeeding and represent safer first-line options. 1, 4

• Nystatin cream is also compatible with breastfeeding, though any excess cream should be removed from nipples before nursing. 2, 4

Clinical Decision-Making Algorithm

When a breastfeeding mother requires antifungal therapy:

1. For systemic fungal infections: Use fluconazole as the first-line azole antifungal 1

2. For localized nipple/breast infections: Use topical miconazole, clotrimazole, or nystatin 4

3. Avoid itraconazole, posaconazole, and voriconazole due to lack of safety data and potential toxicity 1, 2

4. If itraconazole is deemed absolutely necessary: Consider the severity of maternal infection and discuss temporary cessation of breastfeeding, though this should be a last resort given the benefits of breastfeeding 2

Important Caveats

• The general principle that most drugs transfer into breast milk in small amounts and are relatively safe 5 does not apply to itraconazole, which is specifically contraindicated by major guideline organizations. 1, 2

• Do not confuse pregnancy safety with breastfeeding safety—drugs that may be acceptable in pregnancy are not necessarily safe during lactation. 6