Drug-Induced Interstitial Lung Disease: A Real-World Pharmacovigilance Study Based on an Adverse Event Reporting System.

[INTRODUCTION] Drug-induced interstitial lung disease (DILD) involves different pathogenic mechanisms, and it is difficult for clinicians to identify the culprit drug. There is currently no systematic research that allows us to understand the comprehensive situation of potential risk drugs and culprit drugs for DILD.

[METHODS] This study retrospectively analyzed all adverse events related to DILD in FAERS, compiled a list of potential risk drugs leading to DILD and calculated the reporting ratio. In addition, all drugs within the list were detected using disproportionality analysis, a list of culprit drugs was developed based on the signal detection results, and the signal distribution characteristics were summarized.

[RESULTS] We obtained 108,891 DILD-related reports and identified 1,445 potential risk drugs from them. Overall, the drug with the highest number of reports was methotrexate, followed by amiodarone, nivolumab, pembrolizumab, and rituximab. Classifying all potential risk drugs (second-level ATC subgroup), the subgroup with the highest number of reports is antineoplastic agents. Finally, we determined the list of culprit drugs, and 171 drugs showed positive signals by signal detection, while the other 1,274 drugs were determined to be negative, with amiodarone obtaining the highest number of positive signals. All the culprit drugs were classified and distributed them positively and negatively. The number of drugs with positive signals is less than that with negative signals, and antineoplastic agents (L01) have the highest proportion among all positive drugs.

[CONCLUSION] This study comprehensively displays all drugs related to DILD from a landscape perspective, promoting the rational use of drugs in clinical practice.