Long-Term Safety of Risperidone

In 2 pivotal trials comparing risperidone with placebo, the risk of adverse events was similarin both treatment groups when risperidone was given at the optimal clinical dose (1 mg/day). During12-month, open-label extensions to these studies, the incidence of de novo tardive dyskinesia wasvery low. No clinically significant adverse events, changes in vital signs, or laboratory signs were observed.In summary, the safety and tolerability of risperidone in treating elderly dementia sufferers hasbeen favorable in several clinical trials.