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 study employed four disproportionality analysis algorithms and validated results across Japanese and WHO databases. Hao Wen published the findings in 2026, highlighting that 74% of flagged drugs lacked FDA label warnings.

Use Cases

• Signal detection for drug-related cognitive disorders based on disproportionality analysis algorithms (ROR, PRR, BCPNN, MGPS)
• Cross-database validation of pharmacovigilance signals using FAERS, JADER, and WHO VigiAccess data
• Subgroup analysis of adverse event reporting patterns in vulnerable populations like children and seniors
• Multivariate analysis to identify factors associated with higher reporting odds for cognitive disorders

Strengths

• Analysis covers 41,775 adverse event reports
• Cross-validation performed using three international databases (FAERS, JADER, WHO VigiAccess)
• Results validated for 92% of primary drug-event pairs across databases

Limitations

• Row count for the underlying data is unknown
• Column-level documentation is absent; field semantics must be inferred after download
• Data reflects reporting bias inherent to voluntary adverse event systems

Provenance

Source

FDA Adverse Event Reporting System (FAERS)

Collection Method

Retrospective disproportionality analysis

Time Range

2004–2024

Freshness

Last updated 2026-04-10 06:02:52

Geography

Primary coverage is U.S. reports, with validation using Japanese and global databases