Is Ketoconazole safe while breastfeeding?
Here is what LactMed, the Drugs and Lactation Database published by the U.S. National Institute of Child Health and Human Development (NICHD), reports about Ketoconazole. The text below is quoted from that source — it is not our own verdict.
Summary of use during breastfeeding
Because there is little published experience with ketoconazole or levoketoconazole during breastfeeding and its potential liver enzyme inhibition and liver toxicity, other agents are preferred. The manufacturers recommend that mothers taking ketoconazole or levoketoconazole avoid breastfeeding during treatment and for 1 day after the last dose.
Use of ketoconazole shampoo or topical use on the skin by the mother poses little to no risk to the breastfed infant.[1,2] However, topical use on the breast or nipples should be avoided in nursing mothers because of possible oral ingestion by the infant and the availability of safer alternatives. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.[3]
Effects on the breastfed infant
A mother taking ketoconazole 200 mg orally for 10 days noticed no adverse effects in her breastfed 1-month-old infant.[4]
Effects on milk supply
Relevant published information was not found as of the revision date.
Levels in milk
Maternal Levels. A mother who was 1 month postpartum took ketoconazole 200 mg orally for 10 days. A peak ketoconazole milk level of 220 mcg/L occurred 3.25 hours after the dose and the average milk level was 68 mcg/L. The authors calculated that an exclusively breastfed infant would ingest an average of 0.01 mg/kg daily or about 0.4% of the maternal weight-adjusted dosage and a maximum of 0.033 mg/kg daily or about 1.4% of the maternal weight-adjusted dosage.[4]
Infant Levels. Relevant published information was not found as of the revision date.
Alternatives LactMed lists
Ketoconazole in pregnancy
LactMed covers breastfeeding only. For what the NHS and the US prescribing label say about pregnancy, see:
Source: Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Ketoconazole” (LM361). LactMed on NCBI Bookshelf. LactMed is a registered trademark of the U.S. Department of Health and Human Services.
Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.