Post-marketing Safety Evaluation of Mirogabalin Using the JADER Database

A pharmacovigilance analysis of 463 adverse event reports for mirogabalin from the Japanese Adverse Drug Event Report (JADER) database covering January 2019 to June 2025. The study identifies 33 positive safety signals, including six novel potential adverse events, and compares signal strength with pregabalin and gabapentin. The dataset was created by Xinjuan Sun and last updated on June 4, 2026.

Use Cases

• Identifying novel adverse drug event signals based on disproportionality analysis results.
• Comparing drug safety profiles between mirogabalin and established gabapentinoids based on reported signal strengths.
• Analyzing demographic differences in adverse event reporting based on sex and age subgroup analyses.
• Modeling time-to-onset patterns for adverse events based on Weibull modeling results.

Strengths

• Analysis is based on 463 healthcare professional-reported adverse event reports.
• Identifies 33 positive safety signals, including six novel ones such as pleural effusion and toxic encephalopathy.
• Includes comparative analysis with pregabalin and gabapentin using reporting odds ratios.
• Conducts subgroup analyses by sex and age, and sensitivity analyses restricted to monotherapy reports.

Limitations

• Dataset size is small at 18.1 KB, indicating limited scope.
• Row count and column-level documentation are absent; field semantics must be inferred after download.
• Data may reflect geographic bias inherent to the Japanese Adverse Drug Event Report (JADER) database.

Provenance

Source

Japanese Adverse Drug Event Report (JADER) database.

Collection Method

Pharmacovigilance analysis using disproportionality analysis (Reporting Odds Ratio and Information Component methods).

Time Range

January 2019 to June 2025.

Freshness

Last updated 2026-06-04 05:42:38; freshness should be verified.

Geography

Japan.