Comparative analysis of the characteristics and trends of adverse drug reaction reports from patients in Japan and the Japanese Adverse Drug Event Report database.

ABSTRACT:

Aims

Spontaneous reporting of adverse drug reactions (ADR) after a product has reached the market is essential for drug safety. This study analysed patient ADR reports and compared them with reports from the Japanese Adverse Drug Event Report (JADER) database to identify differences and trends.

Methods

ADR reports from the Pharmaceuticals and Medical Devices Agency website, including patient reports from March 2019 to March 2024, and JADER reports from January 2019 to March 2024, were utilized. Information on demographics, drugs, ADR types and outcomes was analysed. Frequencies and comparisons between the two reporting groups were performed.

Results

A total of 2913 patient reports and 343 894 JADER reports were analysed. Patients were often younger (30-50 years) and m

SUBMITTER: Tsuchiya M 

PROVIDER: S-EPMC12850622 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature