Verdeso Side Effects

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

Verdeso 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 Verdeso Foam:

Mild, temporary stinging 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.

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.

Verdeso Side Effects - for the Professional

Verdeso

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rate 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 a controlled clinical study of 581 patients 3 months to 17 years of age, adverse reactions occurred at the application site in 6% of subjects treated with Verdeso Foam and 14% of subjects treated with Vehicle Foam. Other commonly reported adverse reactions for Verdeso Foam and Vehicle Foam are noted in Table 1.

Other local adverse events occurred at rates less than 1.0%. The majority of adverse reactions were transient and mild to moderate in severity, and they were not affected by age, race, or gender.

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

Post-marketing Experience

The following adverse reactions have been identified during post approval use of Verdeso Foam: application site irritation, application site erythema, application site reactions, skin reactions, and swelling face. Because these reactions 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.

Side Effects by Body System - for Healthcare Professionals

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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