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Xolegel

Last reviewed on RxList: 6/16/2017
Xolegel Side Effects Center

Last reviewed on RxList 6/16/2017

Xolegel (ketoconazole) is an antifungal medication used to treat fungal infections of the skin such as athlete's foot, jock itch, ringworm, and seborrhea (dry, flaking skin). Common side effects of Xolegel include burning, redness, itching, or dryness of the treated skin, or headache. Tell your doctor if you have serious side effects of Xolegel including severe application site reactions, oily or dry scalp, mild hair loss, pain or oozing of treated skin areas, or eye irritation.

The recommended dose of Xolegel is to apply once daily to the affected area for 2 weeks. Xolegel is for topical use only, and not for oral, ophthalmic, or intravaginal use. Other drugs may affect Xolegel topical. Tell your doctor all medications and supplements you use. During pregnancy, Xolegel should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Xolegel (ketoconazole) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Xolegel Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Xolegel (Ketoconazole)

Xolegel Professional Information

SIDE EFFECTS

Clinical Trial Experiences

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In the 3 safety and efficacy trials, 65 of 933 subjects (7%) experienced at least one treatment-related adverse event. The most common treatment-related adverse reaction was application site burning (4%). Treatment-related application site reactions that were reported in < 1% of subjects were: dermatitis, discharge, dryness, erythema, irritation, pain, pruritus, and pustules. Other treatment-related adverse reactions that were reported in < 1% of subjects were: eye irritation, eye swelling, keratoconjunctivitis sicca, impetigo, pyogenic granuloma, dizziness, headache, paresthesia, acne, nail discoloration, facial swelling.

Post-marketing Experience

Adverse events identified during post approval use with XOLEGEL include burning sensation, pain, skin irritation, and erythema. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Read the entire FDA prescribing information for Xolegel (Ketoconazole)

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© Xolegel Patient Information is supplied by Cerner Multum, Inc. and Xolegel Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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