Pharmacoepidemiol Risk Manage.  2025 Sep;17(2):198-210. 10.56142/perm.25.0023.

Signal Detection of Aripiprazole Using the Korea Adverse Event Reporting System Database

• Jo E
• Kim J
• Kaminska J
• Yang BR

• KMID: 2576742
• DOI: http://doi.org/10.56142/perm.25.0023

Abstract

Objective
Aripiprazole is an atypical antipsychotic for various psychiatric disorders, but its long-term safety data remain limited and prior studies are indication-specific. This study aimed to detect safety signals of aripiprazole compared with other atypical antipsychotics using the Korea Adverse Event Reporting System (KAERS) database.
Methods
Characteristics of adverse event (AE) reports for aripiprazole and other atypical antipsychotics in KIDS KAERS DB (2104A0022) (2010–2019) were analyzed, excluding follow-up reports. Disproportionality analyses used proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). A signal was defined as ≥2 reports and meeting one of: (1) PRR ≥ 2 and χ² ≥ 4 with ≥3 cases, (2) ROR ≥ 2 and χ² ≥ 4 with ≥3 cases, or (3) IC lower limit of 95% confidence interval (IC₀₂₅ ) > 0. Detected signals were compared with the Korean and US Food and Drug Administration (FDA) product labels to assess novelty.
Results
Among 21,983 AE reports for atypical antipsychotics, 2,221 included with aripiprazole. Fiftyone safety signals were identified for aripiprazole, of which 18 were not listed in Korean or US FDA labels. These unlisted events included epidermal necrolysis (PRR = 5.4, ROR = 5.4, IC₀₂₅ = 0.5), hepatic failure (PRR = 16.3, ROR = 16.3, IC₀₂₅ = 0.6), and pulmonary infiltration (PRR = 16.3, ROR = 16.3, IC₀₂₅ = 0.6).
Conclusion
This study highlights previously unreported AE signals of aripiprazole and provides updated pharmacovigilance data. However, inherent limitations of disproportionality analyses including potential reporting bias, should be acknowledged and further monitoring and pharmacoepidemiologic studies are warranted to support safer clinical use of aripiprazole in psychiatric care.

Keyword

Aripiprazole; KAERS database; Data mining; Signal; Pharmacovigilance