The safety of risperidone: a post-marketing study on 7684 patients

Risperidone is a relatively new antipsychotic agent licensed for the treatment of schizophrenia and other psychotic conditions in patients aged 15 years or older. This study examines the safety of risperidone used in general practice. Information was collected for 7684 patients included in a non-interventional observational cohort study conducted by means of Prescription-Event Monitoring. Incidence rates were calculated to rank the frequency of reported events. Drowsiness/sedation was the most frequent reason for stopping risperidone and the most frequently reported event. Extrapyramidal symptoms were reported rarely, but were more frequent in the elderly. 98 (1.3 per cent) patients were aged less than 15 years. Eight overdoses of risperidone alone were reported with no serious clinical sequelae. Risperidone appears to be well tolerated. (C) 1998 John Wiley & Sons, Ltd.