Xolegel Side Effects
Please note - some side effects for Xolegel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Side Effects of Xolegel - for the Consumer
Xolegel Gel
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Xolegel Gel:
Seek medical attention right away if any of these SEVERE side effects occur when using Xolegel Gel:Mild burning at the application site.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blisters, irritation, pain, redness, or severe burning at the application site.
Xolegel CorePak Gel
All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Xolegel CorePak Gel:
Seek medical attention right away if any of these SEVERE side effects occur when using Xolegel CorePak Gel:Mild skin irritation or dryness; mild, temporary burning or stinging at the application site.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); infection; new or worsening irritation, pain, redness, blistering, or severe burning at the application site; skin thinning or discoloration.
Xolegel Duo Gel
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Xolegel Duo Gel:
Seek medical attention right away if any of these SEVERE side effects occur when using Xolegel Duo Gel:Mild burning at the application site.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blisters, irritation, pain, redness, or severe burning at the application site.
Xolegel Side Effects - for the Professional
Xolegel
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 practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
Overall Summary of Adverse Events Reported by >1% of Subjects
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NOTE: The same adverse event recorded by a subject at different visits count as one event for that subject, and the strongest intensity and relationship to treatment is used. At each level of summarization (System Organ Class and Preferred Term) subjects are only counted once. |
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| Adverse Event |
Xolegel Gel N (%) |
Gel Vehicle N=388 N (%) |
| Any Adverse Event | 89 (16.3) | 67 (17.3) |
| Application site burning | 23 (4.2) | 12 (3.1) |
| Headache | 6 (1.1) | 3 (0.8) |
In the three safety and efficacy studies, 65 of 933 subjects (7%) experienced at least one treatment-related adverse event. The most common treatment-related adverse event was application site burning. 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.
Contact sensitization, cumulative irritation, phototoxicity and photoallergy studies were conducted with Xolegel Gel. Under the conditions of study, Xolegel Gel did not demonstrate contact sensitization, phototoxicity or photoallergenicity, but did demonstrate potential to cause irritation.
TopSide Effects by Body System
Dermatologic
Dermatologic side effects associated with ketoconazole shampoo have included abnormal hair texture, oily hair texture, increased hair loss, scalp pustules, itching, and mild dryness of the scalp. Ketoconazole topical cream has been associated with severe irritation, pruritus, and stinging.
Hypersensitivity
Hypersensitivity reactions associated with excipients in the cream have included contact dermatitis. A painful allergic reaction (unspecified) to ketoconazole cream has also been reported.
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