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Aclovate Side Effects

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

Aclovate Cream

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 Aclovate Cream:

None.

Seek medical attention right away if any of these SEVERE side effects occur when using Aclovate Cream:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, itching, redness, skin thinning and discoloration, or swelling not present before using Aclovate Cream.

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.

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Aclovate Side Effects - for the Professional

Aclovate

The following local adverse reactions have been reported with Aclovate® Cream in approximately 2% of patients: itching and burning, erythema, dryness, irritation, and papular rashes.

The following local adverse reactions have been reported with Aclovate® Ointment in approximately 1% of patients: itching, burning, and erythema. The following additional local adverse reactions have been reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.

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Side Effects by Body System - for Healthcare Professionals

Endocrine

Endocrinologic side effects 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

Local side effects of 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.

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.

General

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

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