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 for signals of drug-related cognitive disorders. The dataset, created by Hao Wen and updated in April 2026, identifies 50 medications with significant statistical associations. Cross-validation was performed using Japanese and WHO pharmacovigilance databases.

Use Cases

• Identifying medications with disproportionate reporting of cognitive disorders based on four signal detection algorithms (ROR, PRR, BCPNN, MGPS)
• Evaluating label warning gaps for drugs flagged as having significant signals
• Analyzing reporting patterns (early or random failure types) across different medications
• Conducting subgroup analyses to identify vulnerable populations (e.g., children, seniors) for specific drug classes
• Performing multivariate analysis on factors linked to higher reporting odds, such as concurrent conditions or drug combinations

Strengths

• Analysis covers 41,775 adverse event reports, providing a substantial sample
• Signal detection employed four distinct statistical algorithms for robustness
• Cross-database validation with JADER and WHO VigiAccess confirmed signals for 92% of primary drug-event pairs

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 15.3 KB DOCX file, indicating limited scope and likely summary-level data rather than raw reports

Provenance

Source

FDA Adverse Event Reporting System (FAERS), with validation from JADER and WHO VigiAccess

Collection Method

Retrospective disproportionality analysis using FAERS data

Time Range

2004–2024

Freshness

Last updated 2026-04-10 06:02:54

Geography

Primary source is U.S. (FAERS), with validation from Japanese and global (WHO) databases