Pemetrexed Adverse Events from FDA FAERS Database, 2004-2024

27,098 adverse event reports for the chemotherapy drug pemetrexed were extracted from the US FDA Adverse Event Reporting System (FAERS) from 2004 to 2024. The dataset, authored by Lei Wang and published on figshare in 2026, includes disproportionality analysis results identifying 653 significant safety signals across 27 System Organ Classes. It captures sex-stratified findings and bimodal time-to-onset patterns for reported events.

Use Cases

• Identify disproportionate reporting signals for pemetrexed based on statistical measures like ROR, PRR, EBGM, and BCPNN mentioned in the description.
• Analyze temporal patterns of adverse events based on the bimodal time-to-onset distribution described (0-30 days and 181-360 days).
• Investigate sex-specific risk profiles for toxicities based on the reported male predominance in respiratory toxicity and female predisposition to renal injury.
• Explore unlabeled safety signals in endocrine, renal, and dermatologic manifestations as highlighted in the study conclusions.

Strengths

• Contains 27,098 primary suspect reports, providing a substantial case count for analysis.
• Covers a 20-year time range (2004-2024) from the FAERS database, offering longitudinal perspective.
• Reports 653 significant signals of disproportionate reporting (SDRs) across 27 System Organ Classes, indicating detailed signal detection.

Limitations

• Row count and column-level documentation are unknown, which may limit suitability assessment.
• Data is presented in a DOCX file (97.5 KB), suggesting it may be a summary document rather than raw structured data.
• The dataset's freshness should be verified as the last update date (2026-04-15) is in the future relative to the current date.

Provenance

Source

US Food and Drug Administration Adverse Event Reporting System (FAERS)

Collection Method

Reports retrieved from the FAERS database and analyzed using disproportionality analyses (ROR, PRR, EBGM, BCPNN).

Time Range

First quarter of 2004 through the fourth quarter of 2024

Freshness

Last updated 2026-04-15 05:43:59

Geography

United States (based on FDA FAERS source)