Clobetasolside effects

The most common adverse reactions (incidence > 1%) are skin atrophy, telangiectasia, discomfort skin and skin dry. To report SUSPECTED ADVERSE REACTIONS, contact Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical

Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In controlled, clinical trials with clobetasol propionate lotion, 0.05%, the following adverse reactions have been reported: burning/stinging, skin dryness, irritation, erythema, folliculitis, pruritus, skin atrophy, and telangiectasia. The pooled incidence of local adverse reactions in trials for psoriasis and atopic dermatitis with clobetasol propionate lotion, 0.05% at 1% or greater was: Table 1: Adverse Reactions with Incidence ≥ 1% in Clinical Trials Adverse Reaction Incidence Skin Atrophy 4.2% Telangiectasia 3.2% Discomfort Skin 1.3% Skin Dry 1% Most local adverse events were rated as mild to moderate and they are not affected by age, race or gender. Systemic absorption of topical corticosteroids has produced hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

6.2 Postmarketing

Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during post-approval use of clobetasol propionate lotion, 0.05%.

Endocrine disorders: Cushing's syndrome, Adrenal suppression Skin: Rash, Pain of skin, Skin exfoliation, Skin chapped, Scaling, Induration/papulation, Lichenification.

Other: Psoriasis (aggravation), Plaque elevation, Excoriation.