ADVERSE REACTIONS
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.
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