Risperidone elevates stroke risk in people with dementia having prior history of CVD: Study

A new study published in The British Journal of Psychiatry showed that risperidone increases the risk of stroke in the individuals with dementia who have a history of cardiovascular disease (CVD).

An increased incidence of cerebrovascular adverse events, including stroke, has been associated with risperidone, an atypical antipsychotic often used to treat behavioral and psychiatric symptoms in dementia. The existence of underlying CVD, which is prevalent in older dementia patients, may have an impact on this risk. 

A dose-dependent and time-sensitive increase in stroke incidence has been reported by observational studies and post-marketing evaluations, especially during the first few weeks of therapy. The balance between possible vascular risks and therapeutic advantages is called into question by this. Examining this relationship can help develop more individualized treatment plans and safer antipsychotic usage in groups at risk for dementia. Thus, this study assessed the risk of stroke linked to risperidone in several patient subgroups based on history of stroke and CVD.

Between 2004 and 2023, people diagnosed with dementia beyond the age of 65 were identified using anonymized primary care data from the UK-based Clinical Practice Research Datalink. Propensity-score-matched controls and those starting risperidone were compared for stroke risk over a one-year period in subgroups with and without a history of stroke and any CVD.

Risperidone was linked to a higher risk of stroke in the entire population (28 403 risperidone users and 136 324 matched controls) (adjusted hazard ratio: 1.28; 95% CI: 1.20–1.37). The incidence rate of stroke in the risperidone user group was significantly greater among those with a history of CVD (incidence rate: 94.1 per 1000 person-years) and stroke (incidence rate: 222 per 1000 person-years) than in the cohort as a whole (incidence rate: 53.3 per 1000 person-years).

All CVD and stroke subgroup comparisons showed comparable relative risks associated with risperidone (hazard ratios between 1.23 and 1.44). Overall, regardless of the patient's CVD burden, these findings suggest that risperidone raises the risk of stroke in subgroups of patients with a history of stroke or CVD, as well as in those without any prior history of CVD.

Source:

Choma, J., Griffiths, A., Henley, W., Mueller, C., Williams, N., Ballard, C., Hopkins, R., Young, K. G., Dennis, J. M., & Creese, B. (2025). Risk of stroke associated with risperidone in dementia with and without comorbid cardiovascular disease: population-based matched cohort study. The British Journal of Psychiatry: The Journal of Mental Science, 1–7. https://doi.org/10.1192/bjp.2025.10419