Can I Use Ketoconazole Shampoo if I Am Pregnant or Breastfeeding?

Ketoconazole shampoo is a common treatment for severe dandruff, seborrheic dermatitis, and even fungal-related hair loss on the scalp. However, when you're pregnant or breastfeeding, any product you use on your body deserves a second look.

Is it safe to continue using this shampoo? Let's break it down in detail.

What is ketoconazole and how does it work?

Ketoconazole is a powerful antifungal that fights fungal and yeast infections. Found in medicated shampoos like the popular Nizoral, it works by attacking the cell membrane of fungi, preventing them from growing and multiplying. This helps relieve itching, scaling, and scalp inflammation.

In shampoos, it's usually found in 1% (over-the-counter) and 2% (prescription) strengths. The lower-strength version is more affordable, but both have the same active ingredient.

Ketoconazole During Pregnancy: Is It Safe?

Pregnancy is a time when the safety of any medication or topical product is a primary concern, because some of what is applied to the skin can be absorbed.

The US prescription label for ketoconazole 2% shampoo places it in pregnancy category C. It says there are no adequate and well-controlled studies in pregnant women, and that high oral doses caused limb defects in rats (possibly linked to toxicity in the mothers). The label says it should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus (DailyMed, ketoconazole shampoo 2%).

The same label reports that ketoconazole was not detected in the blood of patients who shampooed with it regularly for months. That is reassuring, but it is not the same as a study in pregnancy.

Ask your doctor, midwife or pharmacist before using it while pregnant. The US over-the-counter 1% label says: if pregnant or breast-feeding, ask a doctor before use (DailyMed, Nizoral 1%).

What about breastfeeding?

During breastfeeding, the main concern is whether ketoconazole can pass into breast milk and affect the baby.

The label reports that ketoconazole was not detected in the blood of people who shampooed with it regularly, which suggests little is absorbed, but levels in breast milk after shampoo use have not been measured.

The US 2% label says there are no adequate studies in nursing women and advises caution when the shampoo is used while breastfeeding. Oral ketoconazole tablets are a different product: they carry a boxed warning for liver injury, and their label says mothers taking them should not breastfeed (DailyMed, ketoconazole tablets).

Are there alternatives?

Other anti-dandruff shampoos, such as those containing zinc pyrithione or selenium sulfide, are also available. Ask a pharmacist which product suits you during pregnancy or breastfeeding.

Conclusion: Should you use ketoconazole during pregnancy or breastfeeding?

There are no adequate studies of ketoconazole shampoo in pregnant or breastfeeding women. The label reports that it was not found in the blood after long-term scalp use, and says it should be used in pregnancy only if the benefit justifies the risk. Ask your doctor, midwife or pharmacist before using it while pregnant or breastfeeding.

If dermatitis or dandruff is affecting your quality of life, your doctor or pharmacist can help you weigh the options.

References

DailyMed. Ketoconazole shampoo 2%, prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=99da5233-2760-46f6-8fb3-d9df5da70bfb

DailyMed. Nizoral Anti-Dandruff (ketoconazole 1%) Drug Facts. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a17b7424-ee7e-4fcc-b6b3-0904932ae319

DailyMed. Ketoconazole tablets, prescribing information (boxed warning). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6d4be760-c723-4f54-a854-12c61cf91703