Is Ketoconazole Shampoo Safe? Understanding Side Effects and Proper Use

Ketoconazole shampoo is a medicated treatment used to manage fungal infections of the scalp and skin. It is available in both over-the-counter (OTC) and prescription strengths, and is commonly used to treat conditions like dandruff, seborrheic dermatitis, and tinea versicolor. While generally safe, it's important to understand the potential side effects and how to use the shampoo correctly.

What is Ketoconazole Shampoo?

Ketoconazole is a synthetic azole compound with topical and systemic antifungal properties. Ketoconazole shampoo is a red/orange liquid intended for topical application. It works by stopping the growth of fungi. It is approved by the Food and Drug Administration (FDA) for the treatment of tinea versicolor and is commonly used off-label for other conditions. Shampoos containing ketoconazole are available both over the counter (OTC) and by prescription from your doctor.

Uses of Ketoconazole Shampoo

Ketoconazole shampoo can help treat a range of conditions, including:

Dandruff: The shampoo is commonly advertised as a dandruff treatment, particularly for dandruff caused by seborrheic dermatitis. Dry scalp causes some dandruff, but other dandruff can be due to seborrheic dermatitis.
Seborrheic Dermatitis: This condition may be associated with an overgrowth of Malassezia, a yeast fungus that’s naturally present on your skin. Ketoconazole can help treat dandruff by reducing the fungus and decreasing inflammation.
Psoriasis: Ketoconazole is a common treatment for psoriasis, another inflammatory skin disease that causes skin flaking, skin plaques, and redness or other skin discoloration. Yeast-like fungus often infects these skin plaques. Prescription ketoconazole may be necessary to treat psoriasis flares.
Tinea Infections: Ketoconazole shampoo can also treat tinea capitis and tinea versicolor. Tinea capitis is a superficial, ringworm-like fungus infection that can affect your scalp. Tinea versicolor is a skin infection caused by overgrowth of a type of yeast that naturally lives on your skin.
Hair Loss: Some evidence suggests that it may also help promote hair growth or reduce hair loss. One 1998 study indicated that 2% ketoconazole shampoo increased hair density, as well as the proportion and size of anagen hair follicles, at nearly the same rate as minoxidil regimens. Despite the strong record of evidence, the FDA hasn’t yet approved the use of ketoconazole shampoo to treat hair loss. But many hair loss specialists have been prescribing it that way for years and consider it a standard part of the treatment regimen.

How to Use Ketoconazole Shampoo

To use it on your scalp, apply the shampoo to wet hair. Lather it well and give it time to soak into your scalp before rinsing. You can then condition the ends of your hair, rinse, and dry as you usually would.

If you’re using ketoconazole shampoo on an area other than your scalp, apply it to the affected area and let it sit for 5 minutes. Wash it off thoroughly with water, and then dry your skin.

Read also: Uses of Nizoral Shampoo

The dosage, number of applications, and the length of treatment depends on the strength of the shampoo (2% or 1%) and the condition being treated.

Wet hair and scalp completely with water.
Apply enough shampoo to produce enough lather to clean hair and scalp.
Massage gently over entire scalp.
Rinse hair with warm water.
Repeat this process if directed to do so by your doctor.
If using the over-the-counter strength of the shampoo (1%), apply the shampoo, lather, and rinse thoroughly. Repeat this process.
If treating skin other than the scalp, wet the skin and apply the shampoo to affected area and the surrounding healthy skin.
Avoid contact with the eyes. If this occurs, rinse thoroughly with water.

How often and how long you’ll use the shampoo will depend on several factors, such as:

The strength of the shampoo (1% for the OTC version or 2% for the prescription version)
The condition you’re using it to treat
The severity of your current symptoms

Based on these factors, your doctor might ask you to use the shampoo anywhere from every other day to once per week.

Use ketoconazole shampoo exactly as your doctor recommends. Do not use it more or less frequently than your doctor tells you to.

You should start to see results within 2 to 4 weeks after you begin using the shampoo, unless your doctor tells you otherwise for your particular condition. If you don’t see any improvement after a month, ask your doctor whether a different treatment option is necessary.

Potential Side Effects of Ketoconazole Shampoo

Ketoconazole shampoo has an excellent safety profile, with mild adverse events occurring in only 1% to 7% of patients.

Common Side Effects:

Abnormal hair texture
Oiliness or dryness of the hair and scalp
Discoloration
Irritation
Pimple-like bumps on the scalp
Burning, irritation, itching, or stinging where it is applied
Dryness
Redness

Rare and Serious Side Effects:

Allergic Reactions: A very serious allergic reaction to this drug is rare, but possible. Anaphylactic reactions and other severe hypersensitivities have also been reported with ketoconazole use.
Hair Discoloration: Ketoconazole shampoo-induced hair discoloration has been reported in postmarketing pharmaceutical studies but, to our knowledge, has not been described in the literature. One case report described a 61-year-old African American woman, who presented with nonscarring hair loss secondary to androgenic alopecia versus telogen effluvium, developed pink hair discoloration 3 weeks after initiating therapy with ketoconazole 2% shampoo.
Hair Loss: In rare cases, ketoconazole shampoo can result in hair loss.

Seek medical attention right away if you have symptoms of an allergic reaction, such as:

Severe itching
Swelling of your face, tongue, or throat
Difficulty breathing
Rash
Dizziness
Anaphylactic reactions and other severe hypersensitivities have also been reported with ketoconazole use.
Breathing problems or wheezing
Racing heart
Fever or general ill feeling
Swollen lymph nodes
Swelling of the face, lips, mouth, tongue, or throat
Trouble swallowing or throat tightness
Itching, skin rash, or pale red bumps on the skin called hives
Nausea or vomiting
Dizziness, feeling lightheaded, or fainting
Stomach cramps
Joint pain

Important Considerations:

If your hair is permed, ketoconazole may cause your hair to lose its curl.
The foam form of this medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Who Should Not Use Ketoconazole Shampoo?

Allergies: People who are allergic to ketoconazole or any of the inactive ingredients in the shampoo should not use it.
Pregnancy and Breastfeeding: This medication should be used only if clearly needed during pregnancy. It is unknown if this drug passes into breast milk. If you’re pregnant and have concerns about using an antifungal treatment, talk with your doctor before using even the OTC version of this antifungal shampoo.
Children: The safety of ketoconazole in children has not been well studied, either. It’s best not to use ketoconazole shampoo on children under 12 years of age unless instructed to do so by their pediatrician.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not use any other skin products without telling your care team.

Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time.

Read also: Benefits of Ketoconazole Shampoo

Storage

Different brands/strengths of this medication may have different storage requirements. Read the package labeling or ask your pharmacist for the storage requirements for the product you are using. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Topical ketoconazole should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C), for shorter periods of time, such as when transporting it. Topical ketoconazole foam is flammable. Keep it away from open flames.

Important Note

This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and check you for any problems or unwanted effects that may be caused by this medicine. Do not use this medicine for a skin problem that has not been checked by your doctor. If your skin problem does not improve within 2 weeks for cutaneous candidiasis, pityriasis versicolor, tinea corporis, or tinea cruris; or 4 weeks for seborrheic dermatitis; or 4 to 6 weeks for tinea pedis, or if it becomes worse, check with your doctor.

Additional Tips for Specific Conditions

Athlete's Foot (Tinea Pedis): Avoid wearing socks made from wool or synthetic materials (e.g., rayon or nylon). Instead, wear clean, cotton socks and change them daily or more often if your feet sweat a lot. Wear sandals or well-ventilated shoes (e.g., shoes with holes). Use a bland, absorbent powder (e.g., talcum powder) or an antifungal powder between the toes, on the feet, and in socks and shoes one or two times a day. It is best to use the powder between the times you use the cream.
Ringworm of the Groin (Tinea Cruris): Avoid wearing underwear that is tight-fitting or made from synthetic materials (e.g., rayon or nylon). Instead, wear loose-fitting, cotton underwear. Use a bland, absorbent powder (e.g., talcum powder) or an antifungal powder on the skin. It is best to use the powder between the times you use ketoconazole cream.

Alternatives to Ketoconazole Shampoo

If ketoconazole shampoo doesn’t work to treat your skin condition, you might need to try an alternative. Options might include other medications, such as oral antifungals, to help treat your overall condition or more widespread infections. There are also other medicated shampoos that you can try.

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