Xolegel (Ketoconazole) Drug Information: Side Effects and Drug Interactions

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May 27, 2012

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Dandruff (Seborrhea) »

What is dandruff (seborrhea)?

It is a common form of skin eczema that occurs in parts of the body with high oil (sebum) production. Body areas that are commonly affected include the scalp, ears, face, chest, and folds of skin, such as the underarms or the skin below breasts or overhanging abdominal folds. The cause of seborrhea is unknown, although a yeast that often lives on the skin, Malassezia furfur, may play a role.

One common manifestation of seborrhea that affects the scalp is dandruff. Scalp seborrhea can also present as thick, flaky, localized patches of scale. On the face, seborrhea produces reddish-brown, dry-looking, or thick, greasy scales on the eyebrows, sides of the nose, and behind the ears. Reddish, scaly patches may also appear in the folds of skin mentioned above. Although skin affected by seborrhea may feel "dry," moisturizing only makes them redder.

Scalp seborrhea and dandruff do not cause perm...

Read the Dandruff (Seborrhea) article »

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SIDE EFFECTS

Clinical Trial Experience

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 of XOLEGEL (ketoconazole) 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.

DRUG INTERACTIONS

Formal drug interaction studies with XOLEGEL (ketoconazole) 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.

Last reviewed on RxList: 1/31/2011
This monograph has been modified to include the generic and brand name in many instances.