The only local adverse reaction reported to be possibly or probably related to treatment with DIPROLENE AF (betamethasone) Cream 0.05% during adult controlled clinical studies was stinging. It occurred in 1 patient, 0.4%, of the 242 patients or subjects involved in the studies.
Adverse reactions reported to be possibly or probably related to treatment with DIPROLENE AF (betamethasone) Cream 0.05% during a pediatric clinical study include signs of skin atrophy (telangiectasia, bruising, shininess). Skin atrophy occurred in 7 of 67 (10%) patients, involving all age groups from 3 months – 12 years of age.
The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended. These reactions dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria.
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.