Reporting Frequency of Antipsychotics-Induced Tardive Dyskinesia and Other Extrapyramidal Symptoms: Analysis Based on a Spontaneous Reporting System Database in Japan.

First- and second-generation antipsychotics (FGAs and SGAs, respectively) with dopamine-antagonizing properties may cause involuntary movement-related adverse drug reactions (ADRs). However, the risk in the Japanese population is not well characterized. In this study, we analyzed spontaneous ADR reports from the Japanese Adverse Drug Event Report (JADER) database and evaluated the reporting odds ratios (RORs) of tardive dyskinesia (TD) and other extrapyramidal symptoms (EPS) associated with antipsychotics. SGAs were evaluated both as a whole class and as subgroups based on their primary pharmacological mode of action. From 1 April 2011 to 31 March 2020, 1 197 065 ADRs, including 760 TD and 6059 EPS cases, were identified for this study. By calculating RORs, risk signals were detected with both FGAs and SGAs for TD and EPS compared with non-antipsychotics, with an ROR (95% confidence interval (CI)) of 153.9 (125.64-188.34) with FGAs for TD and 95.3 (80.61-112.65) with SGAs total for TD. No risk signals were detected for SGAs total data or any SGA subgroups versus FGAs. The ROR (95% CI) with SGAs total versus FGAs for TD was 0.62 (0.51-0.75), for dyskinesia: 0.55 (0.42-0.72), and for parkinsonism: 0.43 (0.35-0.52), showing that SGAs were associated with lower reporting frequency versus FGAs, but not for akathisia and dystonia. In conclusion, both FGAs and SGAs were associated with risks for TD and EPS compared with non-antipsychotics in the Japanese population, and SGAs total or all SGA subgroups showed no risk signals compared with FGAs.