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. Hao Wen conducted a disproportionality analysis using four algorithms and cross-database validation with JADER and WHO VigiAccess. The study identified 50 medications with significant signals, with 74% lacking 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 based on FAERS, JADER, and WHO VigiAccess data
• Subgroup analysis of adverse event reporting patterns in vulnerable populations (e.g., children, seniors)
• Multivariate analysis of factors associated with higher reporting odds for cognitive disorders

Strengths

• 41,775 adverse event reports provide a substantial sample for analysis
• Cross-database validation with JADER and WHO VigiAccess confirmed signals for 92% of primary drug-event pairs
• Analysis spans a 20-year time range (2004-2024) from FAERS

Limitations

• Column-level documentation is absent; field semantics must be inferred after download
• Row count for the underlying data tables is unknown, which may limit suitability assessment
• The dataset is a 27.7 KB DOCX file, suggesting it contains summary analysis results rather than raw data

Provenance

Source

FDA Adverse Event Reporting System (FAERS), with validation using Japanese Adverse Drug Event Report (JADER) and WHO VigiAccess databases

Collection Method

Retrospective disproportionality analysis using Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN) and Multi-Item Gamma Poisson Shrinker (MGPS)

Time Range

2004–2024

Freshness

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

Geography

Primary source is U.S. (FAERS), with validation from Japan (JADER) and global (WHO VigiAccess)