Drug-induced cough risk: A pharmacovigilance study of FDA adverse event reporting system database

Abstract

Background

Drug-induced cough is a prevalent adverse drug reaction; however, the risk of cough associated with various drug classes in real-world settings has not been thoroughly elucidated.

Objectives

This study aims to systematically identify drug risk signals that are significantly associated with cough through the FAERS database, covering data from the first quarter of 2004 to the fourth quarter of 2024. The findings will provide evidence-based support for clinical medication safety and individualized monitoring.

Methods

We extracted reports in which cough was identified as the primary adverse event (AE) from the FAERS database. After data cleaning to exclude duplicate and non-drug-related records, use the Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) for disproportionality analysis. Standardize the Preferred Term (PT) for cough using MedDRA 27.1. Additionally, classify each drug using the World Health Organization's Anatomical Therapeutic Chemical (ATC) classification system.

Results

This study identified 1951 drugs associated with the AE of "cough," affecting a total of 247,158 patients. The drug categories most commonly linked to cough included antineoplastic and immunomodulating agents, respiratory system medications, and cardiovascular system medications. The drugs (primary suspect) with the highest number of reported cough cases were adalimumab, etanercept, and sacubitril/valsartan.

Conclusion

This study is the first to systematically reveal the strength of association and baseline characteristics between multiple categories of drugs and the risk of cough, confirming the high efficiency and sensitivity of the FAERS database in pharmacovigilance. The findings of this study provide an important basis for drug risk assessment and clinical intervention.