Ketoconazole

The Basics

What is Ketoconazole?

Used to treat skin infections such as athlete’s foot, jock itch, ringworm, and certain kinds of dandruff; also used to treat pityriasis, a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs.

Brand names for Ketoconazole

Kuric

How Ketoconazole is classified

Antifungal Agents, Dermatologic Agents

Ketoconazole During Pregnancy

Ketoconazole pregnancy category

Category CNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Ketoconazole while pregnant

Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day, (10 times the maximum recommended human oral dose). However, these effects may be related to maternal toxicity, which was seen at this and higher dose levels. There are no adequate and well-controlled studies in pregnant women. Ketoconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Taking Ketoconazole While Breastfeeding

What are recommendations for lactation if you're taking Ketoconazole?

Because there is little published experience with ketoconazole during breastfeeding and its potential liver enzyme inhibition and liver toxicity, other agents may be preferred. However, if oral ketoconazole is required by the mother, it may not be a reason to discontinue breastfeeding.[1] Taking the dose just before the infant’s longest sleep period or avoiding breastfeeding from 2 to 5 hours after the dose might decrease the infant’s exposure to ketoconazole. Use of ketoconazole shampoo or topical use on the skin by the mother poses little or no risk to the breastfed infant.[2][3] 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.[4]

Maternal / infant drug levels

Because there is little published experience with ketoconazole during breastfeeding and its potential liver enzyme inhibition and liver toxicity, other agents may be preferred. However, if oral ketoconazole is required by the mother, it may not be a reason to discontinue breastfeeding.[1] Taking the dose just before the infant’s longest sleep period or avoiding breastfeeding from 2 to 5 hours after the dose might decrease the infant’s exposure to ketoconazole. Use of ketoconazole shampoo or topical use on the skin by the mother poses little or no risk to the breastfed infant.[2][3] 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.[4]

Possible effects of Ketoconazole on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Ketoconazole

Clotrimazole, Fluconazole, Miconazole, Nystatin.