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

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

Use Cases

• Signal detection for drug safety based on disproportionality analysis algorithms mentioned in the description
• Cross-validation of pharmacovigilance findings based on multi-database comparison
• Subgroup analysis of adverse event reporting patterns based on vulnerable populations like children and seniors
• Identifying drugs lacking FDA label warnings based on the reported 74% of medications without cognitive disorder warnings

Strengths

• Analysis covers 41,775 adverse event reports
• Data spans a 20-year period from 2004 to 2024
• Cross-validation performed with Japanese (JADER) and WHO (VigiAccess) databases
• Identified 50 medications with significant signals using four algorithms

Limitations

• Column-level documentation is absent; field semantics must be inferred after download
• Row count is unknown, which may limit suitability assessment
• Data reflects statistical associations from adverse event reports, not causal links

Provenance

Source

FDA Adverse Event Reporting System (FAERS)

Collection Method

Retrospective disproportionality analysis

Time Range

2004–2024

Freshness

Last updated 2026-04-10 06:02:49

Geography

United States (primary source), with validation using Japanese and global WHO data