FAERS Database Analysis: Antibiotic Use and Immune-Related Adverse Events

Jia Yu analyzed data from the FDA Adverse Event Reporting System (FAERS) database from 2014 to Q4 2024. The study includes 155,157 patients treated with immune checkpoint inhibitors (ICIs), of whom 9,518 received antibiotic therapy. It evaluates associations between antibiotic use and the reported frequency and timing of immune-related adverse events.

Use Cases

• Assessing the association between antibiotic use and immune-related adverse event risk based on odds ratios and confidence intervals.
• Analyzing differences in adverse event timing based on antibiotic co-reporting status using median time-to-event data.
• Comparing risk profiles across different antibiotic categories and ICI regimens based on stratified analysis results.

Strengths

• Includes 155,157 patient records from a major pharmacovigilance database.
• Provides specific statistical results, including an odds ratio of 1.17 for increased irAE frequency with antibiotic use.
• Reports detailed temporal analysis, showing a median time to first irAE of 31 days for the antibiotic group.

Limitations

• Description metadata is limited; actual data quality requires manual inspection after download.
• Column-level documentation is absent; field semantics must be inferred after download.
• Data may reflect reporting bias inherent to spontaneous reporting systems like FAERS.

Provenance

Source

FDA Adverse Event Reporting System (FAERS) database.

Collection Method

Analysis of spontaneous adverse event reports using multivariable logistic regression and descriptive statistics.

Time Range

2014 to Q4 2024

Freshness

Last updated 2026-05-05 05:28:46; freshness should be verified.