adverse reactions
ADVERSE REACTIONS In controlled clinical studies involving 319 patients, the incidence of adverse reactions associated with the use of Mometasone Furoate Cream USP, 0.1% was 1.6%. Reported reactions included burning, pruritus, and skin atrophy. Reports of rosacea associated with the use of Mometasone Furoate Cream USP, 0.1% have also 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 Mometasone Furoate Cream USP, 0.1% was approximately 7%. Reported reaction included stinging, pruritus, and furunculosis. The following adverse reactions were reported to be possibly or probably related to treatment with Mometasone Furoate Cream USP, 0.1% during clinical studies in 4% of 182 pediatric patients 6 months to 2 years of age: decreased glucocorticoid levels, 2; paresthesia, 2; folliculitis, 1; moniliasis, 1; bacterial infection, 1; skin depigmentation, 1. The following signs of skin atrophy were also observed among 97 patients treated with Mometasone Furoate Cream USP, 0.1% in a clinical study: shininess 4, telangiectasia 1, loss of elasticity 4, loss of normal skin markings 4, thinness 1, and bruising 1. Striae 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, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, and miliaria.