Extina Side Effects
Please note - some side effects for Extina 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 Extina - for the Consumer
Extina Foam
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 Extina Foam:
Seek medical attention right away if any of these SEVERE side effects occur when using Extina Foam:Mild, temporary burning or stinging.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); redness, irritation, or severe burning of the skin.
Extina Side Effects - for the Professional
Extina
The most common adverse reactions observed in clinical studies (incidence >1%) were application site burning and application site reaction (6.1 Adverse Reactions in Clinical Trials).
To report SUSPECTED ADVERSE REACTIONS, contact Stiefel Laboratories, Inc. at 1-888-500-DERM and adverse.event@stiefel.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
See 17 for PATIENT COUNSELING INFORMATION
Revised: 08/2008
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6.1 Adverse Reactions in Clinical Trials 8. USE IN SPECIFIC POPULATIONS 13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility 16. HOW SUPPLIED/STORAGE AND HANDLING |
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FULL PRESCRIBING INFORMATION Top
Side 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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