Elocon Side Effects

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

Elocon 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 Elocon Cream:

Burning; flushing; itching; redness; second infection; skin thinning and discoloration; swelling; tingling/stinging; wasting of the skin.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

Elocon Lotion

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 Elocon Lotion:

Acne-like condition; burning; mild, temporary stinging when the medicine is applied.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); redness; swelling.

Elocon Side Effects - for the Professional

Elocon

In controlled clinical studies involving 812 patients, the incidence of adverse reactions associated with the use of Elocon Ointment 0.1% was 4.8%. Reported reactions included burning, pruritus, skin atrophy, tingling/stinging, and furunculosis. Reports of rosacea associated with the use of Elocon Ointment 0.1% have been received. In controlled clinical studies (n=74) involving pediatric patients 2 to 12 years of age, the incidence of adverse experiences associated with the use of Elocon Cream is approximately 7%. Reported reactions included stinging, pruritus, and furunculosis.

The following adverse reactions were reported to be possibly or probably related to treatment with Elocon Ointment 0.1% during a clinical study, in 5% of 63 pediatric patients 6 months to 2 years of age: decreased glucocorticoid levels, 1; an unspecified skin disorder, 1; and a bacterial skin infection, 1. The following signs of skin atrophy were also observed among 63 patients treated with Elocon Ointment 0.1% in a clinical study: shininess 4, telangiectasia 1, loss of elasticity 4, loss of normal skin markings 4, thinness 1. Striae and bruising were not observed in this study.

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 an approximate decreasing order of occurrence: irritation, dryness, fol-liculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, and miliaria.

Side Effects by Body System

General

Mometasone topical is generally well tolerated and adverse effects have been limited to dermatologic symptoms.

Dermatologic

Dermatologic side effects have included burning, pruritus, and skin atrophy. Rosacea has been reported.

Endocrine

Mometasone preparations may cause reversible endocrine side effects in some individuals. Patients using mometasone topical on large areas, for extended periods of time, or with occlusive dressings should be monitored periodically for hypothalamic-pituitary-adrenal (HPA) axis suppression.

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