Can I take fluconazole while pregnant or breastfeeding?

Pregnancy Teratogenic Effects. Potential for Fetal Harm: Use in pregnancy should be avoided except in patients with severe or potentially life-threatening fungal infections in whom fluconazole may be used if the anticipated benefit outweighs the possible risk to the fetus. A few published case reports describe a pattern of distinct congenital anomalies in infants exposed in utero to high dose maternal fluconazole (400 to 800 mg/day) during most or all of the first trimester. These reported anomalies are similar to those seen in animal studies. Effective contraceptive measures should be considered in women of child-bearing potential who are being treated with fluconazole 400 to 800 mg/day and should continue throughout the treatment period and for approximately 1 week (5 to 6 half-lives) after the final dose. If fluconazole is used during pregnancy, or if the patient becomes pregnant while taking the drug, the patient should be informed of the potential hazard to the fetus.

Prescribing label, section “Pregnancy” (opening excerpt): Fluconazole (oral), REMEDYREPACK INC. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

Fluconazole is acceptable in nursing mothers because amounts excreted into breastmilk are less than the neonatal fluconazole dosage.[1] Although no adequate clinical studies on fluconazole in Candida mastitis have been published, a survey of members of the Academy of Breastfeeding Medicine found that fluconazole is often prescribed for nursing mothers to treat breast candidiasis, especially with recurrent or persistent infections.[2] Treatment of the mother and infant simultaneously with fluconazole is often used when other treatments fail.[2-5] The most common maternal dosage regimen is 400 mg once, followed by 200 mg daily for at least 2 weeks or until pain is resolved,[6,7] although a study in Australia used a dose of 150 mg every other day until breast pain resolved.[8] The dosage of fluconazole in breastmilk with these maternal dosages is not sufficient to treat oral thrush in the infant.

“Summary of Use during Lactation”, LactMed record “Fluconazole” (LM357), quoted verbatim. Everything LactMed reports about Fluconazole while breastfeeding.

Nursing Mothers Fluconazole was present in low levels in breast milk following administration of a single 150 mg dose, based on data from a study in 10 breastfeeding women who temporarily or permanently discontinued breastfeeding 5 days to 19 months postpartum. The estimated daily infant dose of fluconazole from breast milk (assuming mean milk consumption of 150 mL/kg/day) based on the mean peak milk concentration (2.61 mcg/mL [range:1.57 to 3.65 mcg/mL] at 5.2 hours post-dose) was 0.39 mg/kg/day, which is approximately 13% of the recommended pediatric dose for oropharyngeal candidiasis. (Labeled pediatric dose is 6 mg/kg/day of the first day followed by 3 mg/kg/day; estimated infant dose is 13% of 3 mg/kg/day maintenance dose). There are no data on fluconazole levels in milk after repeated use or after high-dose fluconazole. A published survey of 96 breastfeeding women who were treated with fluconazole 150 mg every other day (average of 7.3 capsules [range 1 to 29 capsules]) for lactation-associated candida of the breasts reported no serious adverse reactions in infants. Caution should be exercised when fluconazole is administered to a nursing woman.

Prescribing label, section “Nursing Mothers”: Fluconazole (oral), REMEDYREPACK INC. Label on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.