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Xolegel

  • Generic Name: ketoconazole
  • Brand Name: Xolegel

Xolegel (Ketoconazole) side effects drug center

Xolegel Side Effects Center

What Is Xolegel?

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).

What Are Side Effects of Xolegel?

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

    Dosage for Xolegel

    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.

    What Drugs, Substances, or Supplements Interact with Xolegel?

    Other drugs may affect Xolegel topical. Tell your doctor all medications and supplements you use.

    Xolegel During Pregnancy and Breastfeeding

    During pregnancy, Xolegel should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

    Additional Information

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

Xolegel Consumer Information

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

Call your doctor at once if you have:

  • burning, stinging, or severe irritation after using this medicine;
  • redness, pain, or oozing of treated skin; or
  • shortness of breath.

Common side effects may include:

  • thinning hair;
  • changes in the color or texture of your hair;
  • dry skin; or
  • mild itching.

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 Trials 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.

DRUG INTERACTIONS

Formal drug interaction studies with XOLEGEL have not been performed. Coadministration of oral ketoconazole with CYP3A4 metabolized HMG-CoA reductase inhibitors such as simvastatin, lovastatin and atorvastatin, may increase the risk of skeletal muscle toxicity, including rhabdomyolysis. These effects have not been observed with topically administered ketoconazole.

Read the entire FDA prescribing information for Xolegel (Ketoconazole)

© 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.