Long-term safety of risperidone.

In 2 pivotal trials comparing risperidone with placebo, the risk of adverse events was similar in both treatment groups when risperidone was given at the optimal clinical dose (1 mg/day). During 12-month, open-label extensions to these studies, the incidence of de novo tardive dyskinesia was very 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 has been favorable in several clinical trials.