ADVERSE REACTIONS
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 clinical practice.
In controlled trials with clobetasol propionate formulations, the following adverse reactions have been reported:
burning/stinging, pruritis, irritation, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers,
tenderness in the elbow, skin atrophy, and telangiectasia. The incidence of local adverse reactions reported in the trials with
Temovate® E was less than 2% of patients treated with the exception of burning/stinging which occurred in 5% of treated patients.
|
