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Xolegel Side Effects

Generic Name: ketoconazole topical

Note: This page contains side effects data for the generic drug ketoconazole topical. It is possible that some of the dosage forms included below may not apply to the brand name Xolegel.

For the Consumer

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

As well as its needed effects, ketoconazole topical (the active ingredient contained in Xolegel) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking ketoconazole topical, check with your doctor immediately:

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

Minor Side Effects

Some ketoconazole topical side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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


Frequency not reported:
-Cream: Severe irritation, pruritus, stinging
-Foam: Reactions to a photoallergenicity study, contact sensitization
-Gel: Impetigo, pyogenic granuloma, acne, nail discoloration, potential to cause irritation
-Shampoo: Oily hair texture, scalp pustules, mild dryness of the scalp

Postmarketing reports:
-Cream: Contact dermatitis
-Shampoo: Hair discoloration, abnormal hair texture, itching, skin burning sensation, contact dermatitis, alopecia, rash, urticaria, skin irritation, dry skin[Ref]

Rare reports of contact dermatitis have been associated with ketoconazole cream or one of its excipients, namely sodium sulfite or propylene glycol, during postmarketing experience.[Ref]


Frequency not reported:
-Cream: Painful allergic reaction (unspecified)

Postmarketing reports:
-Shampoo: Hypersensitivity reactions (including anaphylaxis), angioedema[Ref]


Very common (10% or more):
-Foam: Application site burning (10%)

Common (1% to 10%):
-Foam: Application site reaction (6%)
-Gel: Application site burning (4.2%)

Uncommon (0.1% to 1%):
-Foam: Application site reactions (dryness, erythema, irritation, paresthesia, pruritus, rash, warmth; 1% or less)
-Gel: Treatment-related application site reactions (dermatitis, discharge, dryness, erythema, irritation, pain, pruritus, pustules; less than 1%)

Postmarketing reports:
-Burning sensation, pain, skin irritation, erythema
-Shampoo: Application site reactions

Nervous system

Common (1% to 10%):
-Gel: Headache (1.1%)

Uncommon (0.1% to 1%):
-Gel: Dizziness (less than 1%), paresthesia (less than 1%)


Uncommon (0.1% to 1%):
-Gel: Eye irritation (less than 1%), eye swelling (less than 1%), keratoconjunctivitis sicca (less than 1%)


Frequency not reported:
-Gel: Facial swelling
-Shampoo: Removal of the curl from permanently waved hair


1. "Product Information. Nizoral (ketoconazole)." Janssen Pharmaceutica, Titusville, NJ.

It is possible that some side effects of Xolegel may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.