ADVERSE REACTIONS
In a controlled clinical study of 581 patients 3 months to 17 years of age, adverse events occurred at the application site in 6% of subjects treated with Verdeso Foam and 14% of subjects treated with vehicle foam. Other commonly reported adverse events for Verdeso Foam and vehicle foam are noted in Table 1 - Commonly Occurring Adverse Events.
Table 1 - Commonly Occurring Adverse Events | Verdeso Foam | Vehicle Foam |
| Adverse Event | (N=387) | (N=194) |
| System Organ Class | | |
| General disorders and administration site conditions | 32 (8%) | 31 (16%) |
| Application site burning | 11 (3%) | 15 (8%) |
| Application site atrophy | 5 (1%) | 0 (0%) |
| Application site dermatitis | 2 (1%) | 1 (1%) |
| Application site reaction | 3 (1%) | 6 (3%) |
| Infections and infestations | 79 (20%) | 38 (20%) |
| Upper respiratory tract infection | 37 (10%) | 12 (6%) |
| Pharyngitis | 2 (1%) | 0 (0%) |
| Pharyngitis streptococcal | 2 (1%) | 1 (1%) |
| Viral Infection | 6 (2%) | 0 (0%) |
| Nervous System Disorder | 7 (2%) | 1 (1%) |
| Headache | 7 (2%) | 1 (1%) |
| Psychiatric Disorder | 3 (1%) | 0 (0%) |
| Irritability | 2 (1%) | 0 (0%) |
| Respiratory, Thoracic and Mediastinal Disorders | 27 (7%) | 7 (4%) |
| Asthma | 3 (1%) | 0 (0%) |
| Cough | 14 (4%) | 3 (2%) |
| Skin and Subcutaneous Tissue Disorders | 10 (3%) | 6 (3%) |
| Dermatitis contact | 3 (1%) | 2 (1%) |
| Telangiectasia | 3 (1%) | 0 (0%) |
Elevated blood pressure was observed in 6 (2%) subjects receiving Verdeso Foam and 1 (1%) subject receiving vehicle foam. Other local adverse events occurred at rates less than 1.0%. The majority of adverse reactions were transient and mild to moderate in severity, and they were not affected by age, race or gender. The following additional local adverse reactions have been reported with topical corticosteroids. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria.
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