Ketoconazole  Breastfeeding
It is a well known fact that breastfeeding is best source of nutrition for infants. Breast milk provides minerals, vitamins and antibodies in most acceptable format when they need it. Nutrition taken by mother passes to breast-milk and same thing applies to medicines taken by mothers. Not all drugs cause problem for baby but some do. Lets analyze if Ketoconazole is safe for baby while breastfed.

What is Ketoconazole used for?

Ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections. Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. Ketoconazole tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid.

Is Ketoconazole usage safe while breastfeeding? If a lactating mother is using it can there be any effect on growth or development of infant?

Ketoconazole  safe for breastfeeding
Active ingredient in Ketoconazole is Ketoconazole and based on our analysis of Ketoconazole it appears that using Ketoconazole is safe in breastfeeding. Below is analysis of Ketoconazole while breastfeeding.

Statement of Manufacturer/Labeler about breastfeeding usage
Nursing Mothers Ketoconazole has been shown to be excreted in the milk. Mothers who are under treatment with ketoconazole tablets should not breast feed.

Ketoconazole Breastfeeding Analsys

Ketoconazole while Breastfeeding


CAS Number: 65277-42-1

A high protein-binding capacity may explain its low excretion into breastmilk observed after oral administration. 

Low levels that would reach the infant’s gut through breastmilk would barely be absorbed due to the alkaline environment that hinders the absorption.

 Because it is topically used on creams or vaginal ovules, it would have a low or nil absorption in mother’s plasma (Ene 1984, AEMPS 2015), hence, the amount excreted in milk is expected to be even lower than that following a systemic administration. 

It would be wise to avoid applying creams, gels and other topical products containing paraffin (mineral oil) on the nipple so that the infant could not ingest it (Noti 2003, Concin 2008). 

American Academy of Pediatrics: medication usually compatible with breastfeeding.

Ketoconazole Breastfeeding Analsys - 2

Ketoconazole while Breastfeeding

CAS Number: 65277-42-1

Ketoconazole  and breastfeeding

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]

Ketoconazole  safe for breastfeeding

What should I do if already breastfed my kid after using Ketoconazole ?

It is always a good idea to keep your healthcare provider or doctor informed about your drug usage during pregnancy and breastfeeding but if you have not informed your doctor about Ketoconazole and have used it then do not panic as Ketoconazole is mostly safe in breastfeeding and should not cause any harm to your baby.

I am nursing mother and my doctor has suggested me to use Ketoconazole , is it safe?

Definitely, Ketoconazole is safe in lactation for baby. No wonder your doctor has recommended it.

If I am using Ketoconazole , will my baby need extra monitoring?

No extra baby monitoring required while mother is using Ketoconazole

Who can I talk to if I have questions about usage of Ketoconazole in breastfeeding?

National Womens Health and Breastfeeding Helpline: 800-994-9662 (TDD 888-220-5446) 9 a.m. and 6 p.m. ET, Monday through Friday

National Breastfeeding Helpline: 0300-100-0212 9.30am to 9.30pm, daily
Association of Breastfeeding Mothers: 0300-330-5453
La Leche League: 0345-120-2918
The Breastfeeding Network supporter line in Bengali and Sylheti: 0300-456-2421
National Childbirth Trust (NCT): 0300-330-0700

National Breastfeeding Helpline: 1800-686-268 24 hours a day, 7 days a week

Telehealth Ontario for breastfeeding: 1-866-797-0000 24 hours a day, 7 days a week