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Abstract
Background. Akathisia is a distressing antipsychotic-associated syndrome that can be mistaken for psychiatric agitation. Comparative spontaneous-report analyses may identify reporting patterns, but they cannot estimate clinical incidence.
Objective. To estimate crude and year-adjusted reporting disproportionality of akathisia for cariprazine and brexpiprazole versus aripiprazole, to assess variation across report-receipt years, and to evaluate robustness to alternative cohort definitions.
Methods. This retrospective case-non-case study used the openFDA endpoint of the FDA Adverse Event Reporting System (FAERS). The primary cohort held mutually exclusive reports naming cariprazine, brexpiprazole, or aripiprazole, received from 1 January 2015 through 30 March 2026. Cases contained the exact Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term (PT) Akathisia. We calculated reporting proportions, reporting odds ratios (RORs), proportional reporting ratios (PRRs), year-stratified Mantel–Haenszel RORs (MH-RORs), Tarone-adjusted Breslow–Day tests, and pairwise binomial models adjusted for year. Two cohort-definition sensitivity analyses were performed.
Results. Among 113,653 reports, 3,079 contained exact-PT akathisia: 374/8,901 cariprazine, 691/14,411 brexpiprazole, and 2,014/90,341 aripiprazole reports. Crude RORs versus aripiprazole were 1.92 (95% CI 1.72–2.15) for cariprazine and 2.21 (2.02–2.41) for brexpiprazole. Corresponding MH-RORs were 1.77 (1.58–1.99) and 2.21 (2.02–2.42). The cariprazine-brexpiprazole contrast moved from a crude ROR of 0.87 (0.77–0.99) to an MH-ROR of 1.06 (0.92–1.21). Heterogeneity across years was present in all comparisons.
Conclusion. Cariprazine and brexpiprazole showed higher akathisia reporting disproportionality than aripiprazole in this FAERS snapshot. The data did not support a stable ranking between the two. These are pharmacovigilance signals. They are not estimates of patient-level risk.
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