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.
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.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
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.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
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.
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.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopXolegel 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 - for Healthcare Professionals
Dermatologic
Dermatologic side effects associated with ketoconazole shampoo have included hair discoloration, abnormal hair texture, oily hair texture, alopecia, scalp pustules, itching, skin burning sensation, contact dermatitis, rash, urticaria, skin irritation, dry skin, and mild dryness of the scalp. Ketoconazole topical cream has been associated with severe irritation, pruritus, and stinging. Impetigo, pyogenic granuloma, acne, nail discoloration, and the potential to cause irritation have been reported with ketoconazole gel. Reactions to a photoallergenicity study have been reported with ketoconazole foam. Ketoconazole foam may cause contact sensitization. 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
Hypersensitivity side effects associated with ketoconazole cream have included a painful allergic reaction (unspecified). Hypersensitivity reactions (including anaphylaxis) have been reported with ketoconazole shampoo during postmarketing experience.
Local
Local side effects associated with ketoconazole shampoo have included application site reactions. Application site burning (4.2%) and treatment-related application site reactions (dermatitis, discharge, dryness, erythema, irritation, pain, pruritus, and pustules; less than 1%) have been reported with ketoconazole gel. Application site burning (10%) and application site reaction (6%) have been reported with ketoconazole foam. Application site reactions that were reported in less than or equal to 1% of subjects using ketoconazole foam were dryness, erythema, irritation, paresthesia, pruritus, rash, and warmth. Burning sensation, pain, skin irritation, and erythema have been reported during postmarketing experience.
Nervous system
Nervous system side effects associated with ketoconazole gel have included headache (1.1%), dizziness (less than 1%), and paresthesia (less than 1%).
Ocular
Ocular side effects associated with ketoconazole gel have included eye irritation, eye swelling, and keratoconjunctivitis sicca in less than 1% of patients.
Other
Other side effects associated with ketoconazole shampoo have included the removal of the curl from permanently waved hair. Facial swelling has been reported with ketoconazole gel.
TopMore Xolegel resources
- Xolegel Topical Advanced Consumer (Micromedex) - Includes Dosage Information
- Xolegel Gel MedFacts Consumer Leaflet (Wolters Kluwer)
- Xolegel Prescribing Information (FDA)
- Xolegel Consumer Overview
- Extina Foam MedFacts Consumer Leaflet (Wolters Kluwer)
- Extina Consumer Overview
- Extina Prescribing Information (FDA)
- Kuric Cream MedFacts Consumer Leaflet (Wolters Kluwer)
- Nizoral A-D Shampoo MedFacts Consumer Leaflet (Wolters Kluwer)
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