Fluconazole Safety During Breastfeeding
Fluconazole is compatible with breastfeeding and can be safely used by lactating mothers, as the amount present in breast milk is less than the neonatal therapeutic dosage and no problems have been observed in breastfed infants from mothers treated with oral fluconazole. 1
Evidence for Safety
The European Respiratory Society/Thoracic Society of Australia and New Zealand (ERS/TSANZ) task force statement clearly indicates that fluconazole is compatible with breastfeeding, noting that:
- Fluconazole is present in breast milk but at levels less than the neonatal therapeutic dosage
- No adverse effects have been observed in breastfed infants whose mothers were taking fluconazole 1
This is further supported by the Infectious Diseases Society of America (IDSA) guidelines, which specifically state that breastfeeding is acceptable for mothers taking fluconazole, while other azole antifungals are not recommended during breastfeeding 1.
Pharmacokinetic Considerations
According to the FDA drug label information:
- After a single 150 mg dose, fluconazole appears in breast milk at low levels
- The estimated daily infant dose from breast milk is approximately 0.39 mg/kg/day
- This represents about 13% of the recommended pediatric dose for oropharyngeal candidiasis
- A published survey of 96 breastfeeding women treated with fluconazole 150 mg every other day reported no serious adverse reactions in infants 2
Clinical Application
Dosing Considerations
- Standard treatment doses (such as 150 mg for vaginal candidiasis) are considered safe during breastfeeding
- For more prolonged treatment (such as for nipple/breast candidiasis), doses of 100-200 mg daily have been used successfully without reported adverse effects in infants 3
Monitoring
- No special monitoring of the infant is required when the mother is taking fluconazole
- Unlike other azole antifungals, interruption of breastfeeding is not necessary with fluconazole 1
Common Clinical Scenarios
Vaginal Candidiasis
- Single-dose fluconazole (150 mg) is an effective and safe treatment option for breastfeeding mothers with vaginal candidiasis 4
Nipple/Breast Candidiasis
- Fluconazole may be used for treating persistent nipple/breast candidiasis in breastfeeding mothers
- Treatment regimens that have been used include 200 mg loading dose followed by 100-200 mg daily for 2-6 weeks 3, 5
Important Distinctions from Other Azoles
While fluconazole is compatible with breastfeeding, it's important to note that:
- Other azole antifungals (such as itraconazole, posaconazole, voriconazole) are not recommended during breastfeeding 1
- The American Academy of Pediatrics specifically identifies fluconazole as the only azole antifungal that is likely safe for use during breastfeeding 1
Conclusion
Based on the available evidence, fluconazole can be safely used by breastfeeding mothers without interruption of breastfeeding. The amount transferred to the infant through breast milk is minimal and well below therapeutic doses used for infants, with no reported adverse effects in breastfed infants.