Not approved for the treatment of dementia-related psychosis and not recommended for use in this particular group of patients (increased risk of death and cerebrovascular adverse events). Neuroleptic malignant syndrome has been reported. May cause tardive dyskinesia. Hyperglycemia or exacerbation of pre-existing diabetes has occasionally been reported during treatment. Patients should receive regular monitoring of weight. May induce orthostatic hypotension and syncope, especially early in treatment. Should be used with caution in the elderly and in known cardiovascular disease (e.g. heart failure, myocardial infarction or ischemia, conduction abnormalities), cerebrovascular disease, or conditions that predispose to hypotension (e.g. dehydration and hypovolemia). Leukopenia, neutropenia, and agranulocytosis have been reported with antipsychotics. Caution should be exercised when drug is prescribed in known cardiovascular disease or family history of QT prolongation, and in concomitant use with other medicinal products thought to prolong the QT interval. Use cautiously in patients with history of seizures or with conditions that lower the seizure threshold. The possibility of a suicide attempt is inherent in schizophrenia and bipolar disorder. Use with caution in Parkinson’s disease or dementia with Lewy bodies (increased risk of neuroleptic malignant syndrome, and increased sensitivity to antipsychotics). Not recommended in severe hepatic impairment. Cases of dysphagia were occasionally reported. May cause somnolence and sedation.