FDA Adverse Event Reports for Drug-Related Cognitive Disorders, 2004-2024

41,775 adverse event reports from the FDA Adverse Event Reporting System (FAERS) analyzed for signals of drug-related cognitive disorders. The analysis employed four disproportionality algorithms and was validated against Japanese and WHO databases. Hao Wen authored this pharmacovigilance study, which was last updated in April 2026.

Use Cases

• Identifying drug safety signals based on disproportionality analysis results mentioned in the description
• Validating pharmacovigilance models based on cross-database consistency checks with JADER and VigiAccess
• Analyzing reporting patterns for vulnerable subgroups based on mentions of children and seniors
• Investigating factors associated with higher reporting odds based on multivariate analysis results

Strengths

• Analysis spans 20 years of FDA adverse event data (2004-2024)
• Cross-validation performed with two additional international databases (JADER and WHO VigiAccess)
• Results include signals for 50 medications identified by four distinct algorithms

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 FAERS, with the U.S. having the most reports

Provenance

Source

FDA Adverse Event Reporting System (FAERS)

Collection Method

Retrospective disproportionality analysis using ROR, PRR, BCPNN, and MGPS algorithms

Time Range

2004–2024

Freshness

Last updated 2026-04-10 06:02:53; freshness should be verified

Geography

Primarily United States, with validation using Japanese and global WHO data