Ketoconazole Shampoo

To make sure this is the right treatment for you, before you start using ketoconazole shampoo it is important that you speak with a doctor or pharmacist if:

• You have ever had an allergic reaction to a medicine.
• You are pregnant or breast-feeding. This is because, while you are expecting or feeding a baby, you should only use medicines on the recommendation of a doctor.
• You are taking any other medicines or using any other medicated skin products. This includes any medicines you are taking which are available to buy without a prescription, such as herbal and complementary medicines.

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the ones associated with ketoconazole shampoo. You will find a full list in the manufacturer's information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.

If you experience any other symptoms which you think may be due to the shampoo, speak with your doctor or pharmacist for further advice.

Ketoconazole 2% shampoo is contraindicated in persons who have known hypersensitivity to the active ingredient or excipients of this formulation.

Severe hypersensitivity reactions, including anaphylaxis, have been reported during post-marketing use of Ketoconazole Shampoo. If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued.

Information for Patients:

Patients should be advised of the following:

• Ketoconazole 2% shampoo may be irritating to mucous membranes of the eyes and contact with this area should be avoided.
• The following have been reported with the use of ketoconazole 2% shampoo: hair discoloration and abnormal hair texture, removal of the curl from permanently waved hair, itching, skin burning sensation and contact dermatitis, hypersensitivity, angioedema, alopecia, rash, urticaria, skin irritation, dry skin, and application site reactions.
• Patients who develop allergic reactions, such as generalized rash, skin reactions, severe swelling, angioedema, or shortness of breath should discontinue ketoconazole and contact their physician immediately.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Long-term studies to assess the carcinogenic potential of ketoconazole 2% shampoo have not been conducted. A long-term feeding study of ketoconazole in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic activity. The dominant lethal mutation test in male and female mice revealed that single oral doses of ketoconazole as high as 80 mg/kg were not genotoxic. The Ames Salmonella microsomal activator assay was also negative.

Pregnancy: Teratogenic effects: Pregnancy Category C:

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. In humans, ketoconazole is not detected in plasma after chronic shampooing on the scalp.

Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day (a dose 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.

Nursing mothers: There are no adequate and well-controlled studies in nursing women. Ketoconazole is not detected in plasma after chronic shampooing on the scalp. Caution should be exercised when ketoconazole 2% shampoo is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in children have not been established.

Ketoconazole is used to treat a yeast infection of your skin called tinea versicolor.

This drug is available as an oral tablet, topical cream, topical foam, shampoo, and topical gel.

Ketoconazole shampoo is available as the brand-name drug called Nizoral. It’s also available as a generic drug.

The more common side effects of this drug include hair discoloration, abnormal hair texture, loss of curl from your hair, hair loss, burning or itching, rash, and dry skin.

What is ketoconazole?

Ketoconazole is a prescription drug. It’s available as an oral tablet, topical cream, topical foam, shampoo, and topical gel.

The shampoo is available as the brand-name drug called Nizoral. It’s also available as a generic drug. Generic drugs usually cost less. In some cases, they may not be available in every strength or form as the brand-name version. 

Why it's used

Ketoconazole is used to treat a yeast infection of the skin called tinea versicolor. You apply this drug to your hair and skin.

How it works

Ketoconazole belongs to a class of drugs called antifungals.

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