Ketoconazole topical Side Effects

Some side effects of ketoconazole topical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

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

Get emergency medical help if you have any of these signs of an allergic reaction while taking ketoconazole topical: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using ketoconazole topical and call your doctor at once if you have a serious side effect such as:

• severe itching, burning, or irritation where the medicine is applied;

• oily or dry scalp, mild hair loss;

• redness, pain, or oozing of treated skin areas; or

• eye redness, swelling, or irritation.

Less serious side effects include:

• mild skin itching or irritation;

• dry skin; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

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

Dermatologic

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: Hair discoloration, abnormal hair texture, oily hair texture, alopecia, scalp pustules, itching, skin burning sensation, contact dermatitis, rash, urticaria, skin irritation, dry skin, mild dryness of the scalp
Postmarketing reports: Cream: Contact dermatitis

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.

Hypersensitivity

Frequency not reported: Cream: Painful allergic reaction (unspecified)
Postmarketing reports: Shampoo: Hypersensitivity reactions (including anaphylaxis), angioedema

Local

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%)
Frequency not reported: Shampoo: Application site reactions
Postmarketing reports: Burning sensation, pain, skin irritation, erythema

Nervous system

Common (1% to 10%): Gel: Headache (1.1%)
Uncommon (0.1% to 1%): Gel: Dizziness (less than 1%), paresthesia (less than 1%)

Ocular

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

Other

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

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