Association between antipsychotics and pulmonary embolism: a pharmacovigilance analysis.

Background: Previous studies have documented an increased risk of pulmonary embolism (PE) in patients with schizophrenia taking antipsychotics (APs). However, specific data from real-world studies remain limited. This study aims to investigate the potential relationship between APs and PE.

Research Design And Methods: In the Food and Drug Administration Adverse Event Reporting System (FAERS), from the first quarter of 2018 to the first quarter of 2023, all PE cases suspected of being induced by APs were collected for disproportionality analysis, and the reporting odds ratio (ROR) was used to evaluate associations. Mortality, life-threatening events, and hospitalizations were also analyzed for each APs.

Results: A total of 1,676 cases of PE related to APs were included. APs were significantly associated with PE (ROR 2.00, 1.91-2.10), including chlorpromazine ( = 41), haloperidol ( = 164), loxapine ( = 37), olanzapine ( = 461), paliperidone ( = 161), quetiapine ( = 526), risperidone ( = 274), aripiprazole ( = 254), and clozapine ( = 234). The median onset time of PE was 29 days. Among all cases, 347 (20.7%) resulted in death, with haloperidol (53.2%) having a higher mortality rate than other APs.

Conclusions: APs may increase the risk of PE in patients with schizophrenia.