Pharmacoepidemiologic study of antipsychotics safety

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To analyse spontaneous reports (SRs) of adverse drug reactions (ADRs) related to antipsychotics in Russia.

Material and methods

We used electronic database to extract SRs of ADRs related to typical and atypical antipsychotics in Russia from 01.04.2019 to 30.11.2022.


A total of 1,683 SRs of ADRs related to antipsychotic medicines were registered over the study period: 872 SRs for typical antipsychotics and 811 SRs for atypical antipsychotics. For typical antipsychotics, the most frequently reported SRs were “Neurological ADRs” (388 SRs, 43.31%) and “Somatic ADRs” (287 SRs, 32.04%).


Extrapyramidal disorders predominated among the ADRs reported for typical antipsychotics, while endocrine and metabolic disorders were the most common for atypical antipsychotics.

Key words

Antipsychotics, spontaneous reports, adverse drug reactions.