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

463 healthcare professional-reported adverse event records for mirogabalin from the Japanese Adverse Drug Event Report database between January 2019 and June 2025. The dataset was created by Xinjuan Sun for a pharmacovigilance study identifying safety signals, including novel ones like pleural effusion and toxic encephalopathy. It was last updated on June 4, 2026.

Use Cases

• Identify novel adverse event signals for mirogabalin based on reported events like pleural effusion and toxic encephalopathy.
• Compare drug safety profiles between mirogabalin, pregabalin, and gabapentin based on reporting odds ratios.
• Analyze demographic differences in adverse event reporting based on sex and age subgroups mentioned in the description.
• Model time-to-onset patterns for adverse events using the reported median and Weibull parameters.

Strengths

• Contains 463 adverse event reports from healthcare professionals.
• Identifies 33 positive safety signals, including 6 novel ones.
• Includes comparative analysis with established drugs pregabalin and gabapentin.
• Provides demographic subgroup analysis by sex and age.

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 methods (ROR, IC).

Time Range

January 2019 to June 2025.

Freshness

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

Geography

Japan.