Drug Discov Ther. 2025;19(1):10-21. (DOI: 10.5582/ddt.2024.01090)

Characteristics and patterns of adverse event reports in the Japanese Adverse Drug Event Report database over two decades (2004–2023): Exploring findings on sexes and age groups

Tanaka H, Takigawa M, Ide N, Ishii T

Recently, increased attention has been paid to the consideration of individual characteristics, including sex and age, in the context of medication use and adverse events. However, the characteristics and patterns of adverse events reported in the Japanese Adverse Drug Event Report (JADER) database stratified by sex and age have not yet been clarified. This study aimed to clarify the characteristics and patterns of adverse event reports in the JADER database over a 20-year period (April 2004–March 2024). Data were stratified into 20 groups based on sex and age (aged 0–9 years, 10–19 years, 20–29 years, 30–39 years, 40–49 years, 50–59 years, 60–69 years, 70–79 years, 80–89 years, and ≥90 years). The female/male ratio of adverse event reports in JADER was 0.95. The largest group comprised males in their 70s. Adjusting for the proportion of adverse event reports in each group according to the demographic composition in 2015 highlighted that the reporting rates of adverse events were higher in people aged ≥70 years and that females aged 20–49 years reported more adverse events than males. Medical history, causative drugs, and adverse events reported to JADER were characterized by combinations of sex and age. Our results provide additional insights into the interpretation of previous studies using JADER. In addition, the results of this study will help understand the characteristics of adverse event reports contained in JADER and conduct appropriate subgroup and sensitivity analyses.

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