Desonate Side Effects

Please note - some side effects for Desonate 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 Desonate - for the Consumer

Desonate 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 Desonate Gel:

Mild, temporary itching or burning when first applied.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; inflamed hair follicles; inflammation around the mouth; severe or persistent burning, irritation, redness, or swelling of the skin; thinning, softening, or discoloration of the skin.

Desonate Side Effects - for the Professional

Desonate

In controlled clinical studies of 425 Desonate Gel treated subjects and 157 Vehicle-treated subjects, adverse events occurred at the application site in 3% of subjects treated with Desonate Gel and the incidence rate was not higher compared with vehicle-treated subjects. The most common local adverse events in Desonate Gel- treated subjects were application site burning in 1% (4/425) and rash in 1% (3/425) followed by application site pruritus in <1% (2/425) .

Adverse events that resulted in premature discontinuation of study drug in Desonate Gel treated subjects were telangiectasia and worsening of atopic dermatitis in one subject each.  Additional adverse events observed during clinical trials for patients treated with Desonate Gel included headache in 2% (8/425) compared with 1% (2/157) in those treated with vehicle.

The following additional local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, secondary infection, skin atrophy, striae, and miliaria.

Side Effects by Body System

Endocrine

Endocrinologic side effects of topical corticosteroids have been rare. Rarely, the hypothalamic-pituitary-adrenal axis has been suppressed. This suppression was more likely when higher potency topical steroids were used over extensive areas and when occlusive dressings were used.

Local

Skin on the face, axillae, and groin appear to be most susceptible to the adverse, long-term effects of topical steroids.

Topical corticosteroid use may inhibit local immune response rendering the skin more susceptible to infections. Folliculitis has occasionally been reported.

Perioral dermatitis or rosacea-like dermatitis has occurred in patients treated with potent topical corticosteroids who are of seborrheic skin type. This condition may flare temporarily upon discontinuation of topical steroids, prompting patients to continue their use. If topical corticosteroids are discontinued, this flare and the initial dermatitis generally resolves over a few weeks.

Local side effects have commonly included burning, itching, or irritation, especially when applied to denuded skin or with occlusive dressings. Long-term use of topical corticosteroids has resulted in skin atrophy and thinning, and the development of striae, telangiectasia, subcutaneous hemorrhage, and easy bruising and bleeding. Allergic contact dermatitis has been occasionally reported.

General

The use of low potency topically applied corticosteroids has been generally well tolerated.

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