Note: This document contains side effect information about ketoconazole topical. Some dosage forms listed on this page may not apply to the brand name Xolegel.

Applies to ketoconazole topical: topical cream, topical foam, topical gel/jelly, topical shampoo.

Serious side effects of Xolegel

Along with its needed effects, ketoconazole topical (the active ingredient contained in Xolegel) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ketoconazole topical:

Less common—For cream, shampoo, foam, or gel

• Itching, stinging, burning, or irritation not present before use of this medicine

Rare—For cream, foam, or gel

• Acne
• bleeding from sore in the mouth
• blistering, crusting, irritation, itching, or reddening of the skin
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• cracked, dry, or scaly skin
• discoloration of the fingernails or toenails
• dizziness
• eye dryness, irritation, or swelling
• red rash with watery, yellow-colored, or pus filled blisters with or without thick yellow to honey-colored crusts
• skin dryness, pain, rash, redness, or swelling
• sore in the mouth or on the gums
• swelling of the face

Rare—For shampoo

• Hair loss and irritation

Incidence not known—For gel

• Pain

Incidence not known—For shampoo

• Blistering, burning, crusting, dryness, or flaking of the skin
• burning sensation of the skin
• burning, itching, redness, skin rash, swelling, or soreness at the application site
• discoloration of the hair
• dry skin
• fast heartbeat
• fever
• hives
• hoarseness
• irritation
• itching, scaling, severe redness, or soreness of the skin
• joint pain, stiffness, or swelling
• rash
• shortness of breath
• swelling of the eyelids, face, lips, hands, or feet
• thinning of the hair
• tightness in the chest
• troubled breathing or swallowing
• wheezing

Other side effects of Xolegel

Some side effects of ketoconazole topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common—For shampoo or gel

• Dryness or oiliness of the hair and scalp
• headache

Rare—For shampoo

• Abnormal hair texture
• mild dryness of the skin
• scalp pustules

For Healthcare Professionals

Applies to ketoconazole topical: topical cream, topical foam, topical gel, topical kit, topical shampoo.

Dermatologic

Cream:

-Common (1% to 10%): Skin burning sensation

-Uncommon (0.1% to 1%): Bullous eruption, contact dermatitis, rash, skin exfoliation, sticky skin

-Frequency not reported: Severe irritation, pruritus, stinging, urticaria

Foam:

-Frequency not reported: Reactions to a photoallergenicity study, contact sensitization

-Postmarketing reports: Skin burning sensation, erythema

Gel:

-Frequency not reported: Impetigo, pyogenic granuloma, acne, nail discoloration

Shampoo:

-Uncommon (0.1% to 1%): Alopecia, dry skin, abnormal hair texture, rash, skin burning sensation, folliculitis

-Rare (0.01% to 0.1%): Acne, contact dermatitis, skin disorder, skin exfoliation

-Frequency not reported: Normal hair loss increased, irritation, scalp pustules, mild skin dryness, oiliness/dryness of hair and scalp, pruritus

-Postmarketing reports: Hair discoloration/hair color changes, itching, angioedema, urticaria, skin irritation^[Ref]

Rare reports of contact dermatitis have been associated with the cream or 1 of its excipients (i.e., sodium sulfite or propylene glycol) during postmarketing experience.

Alopecia, dry skin, abnormal hair texture, rash, skin burning sensation, and contact dermatitis have also been reported during postmarketing experience with the shampoo.^[Ref]

Local

Cream:

-Common (1% to 10%): Application site pruritus, application site erythema

-Uncommon (0.1% to 1%): Application site bleeding, application site discomfort, application site dryness, application site inflammation, application site irritation, application site paresthesia, application site reaction

Foam:

-Common (1% to 10%): Application site burning, application site reaction

-Frequency not reported: Application site reactions (dryness, erythema, irritation, paresthesia, pruritus, rash, warmth)

-Postmarketing reports: Application site pain, application site burn

Gel:

-Common (1% to 10%): Application site burning

-Frequency not reported: Treatment-related application site reactions (dermatitis, discharge, dryness, erythema, irritation, pain, pruritus, pustules)

-Postmarketing reports: Burning sensation, pain, skin irritation, erythema

Shampoo:

-Uncommon (0.1% to 1%): Application site erythema, application site irritation, application site pruritus, application site reaction

-Rare (0.01% to 0.1%): Application site hypersensitivity, application site pustules

Application site reactions have also been reported during postmarketing experience with the shampoo.

Hypersensitivity

Cream:

-Uncommon (0.1% to 1%): Hypersensitivity

-Frequency not reported: Painful allergic reaction

Shampoo:

-Rare (0.01% to 0.1%): Hypersensitivity

-Postmarketing reports: Hypersensitivity reactions (including anaphylaxis)^[Ref]

Nervous system

Gel:

-Frequency not reported: Headache, dizziness, paresthesia

Shampoo:

-Rare (0.01% to 0.1%): Dysgeusia

Ocular

Gel:

-Frequency not reported: Eye irritation, eye swelling, keratoconjunctivitis sicca

Shampoo:

-Uncommon (0.1% to 1%): Increased lacrimation

-Rare (0.01% to 0.1%): Eye irritation

Other

Gel:

-Frequency not reported: Facial swelling

Shampoo:

-Frequency not reported: Removal of curl from permanently waved hair

Gastrointestinal

Foam:

-Postmarketing reports: Cheilitis