Post-marketing Safety Signals for Mirogabalin from JADER Database (2019-2025)

A pharmacovigilance analysis of 463 adverse event reports for mirogabalin from the Japanese Adverse Drug Event Report (JADER) database between January 2019 and June 2025. The study, authored by Xinjuan Sun, identifies 33 positive safety signals, including six novel potential adverse events. It compares signal strength with pregabalin and gabapentin and analyzes demographic differences.

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.
• Investigating demographic risk factors for adverse events based on subgroup analyses by sex and age.
• Analyzing time-to-onset patterns for adverse reactions using Weibull modeling results.

Strengths

• Analysis covers a specific 6.5-year time range (January 2019–June 2025).
• Identifies 33 positive safety signals and six novel potential adverse events with specific case counts.
• Includes comparative analysis with pregabalin and gabapentin, reporting specific Reporting Odds Ratios.
• Performs subgroup analyses by sex and age, revealing distinct reporting patterns.

Limitations

• Row count is unknown, which may limit suitability assessment.
• Column-level documentation is absent; field semantics must be inferred after download.
• Data may reflect geographic bias inherent to the Japanese 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–June 2025

Freshness

Last updated 2026-06-04 05:42:39; freshness should be verified.

Geography

Japan