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

A pharmacovigilance dataset by Hao Wen analyzes 41,775 reports from the FDA Adverse Event Reporting System (FAERS) from 2004 to 2024. It identifies significant statistical signals for 50 medications associated with cognitive disorders using four disproportionality analysis algorithms. The study includes cross-validation with Japanese and WHO adverse event databases.

Use Cases

• Identify drugs with disproportionate reporting of cognitive disorders based on four statistical algorithms.
• Validate pharmacovigilance signals through cross-database consistency checks with JADER and VigiAccess.
• Analyze reporting patterns and failure types for drug-related adverse events.
• Conduct subgroup analyses to identify vulnerable populations, such as children and seniors.
• Perform multivariate analysis on factors linked to higher reporting odds, including specific drugs and conditions.

Strengths

• Analyzes 41,775 adverse event reports spanning 20 years (2004–2024).
• Identifies significant signals for 50 medications using four distinct algorithms (ROR, PRR, BCPNN, MGPS).
• Cross-database validation confirms consistent signals for 92% of primary drug-event pairs.

Limitations

• Dataset size is 27.7 KB, indicating limited scope and likely summary-level data.
• Row count and column-level documentation are unknown, requiring manual inspection after download.
• Data reflects statistical associations from adverse event reports, not causal links.

Provenance

Source

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

Collection Method

Retrospective disproportionality analysis using four algorithms.

Time Range

2004–2024

Freshness

Last updated 2026-04-10 06:02:51

Geography

Primarily U.S. reports, with validation from Japanese and global WHO data.