JMIR Publications

ABSTRACT

Background:

Adverse drug reactions (ADRs) are a major concern in drug safety and the FDA Adverse Event Reporting System (FAERS) provides valuable ADR data. However, analyzing FAERS data is complex and requires bioinformatics expertise. Despite the vast amount of ADR data available, there is a lack of user-friendly tools that enable efficient visualization and comparison of ADRs for researchers and healthcare professionals.

Objective:

This study aimed to develop VisDrugs, a web-based platform that simplifies ADR visualization and comparison using FAERS data. The platform was designed to assist researchers and clinicians in assessing drug safety through interactive and interpretable graphical representations of ADR patterns.

Methods:

FAERS data were extracted in ASCII format, covering the period from Q3 2014 to Q3 2024. Reports from healthcare professionals, where only a single drug was implicated, were aggregated and processed using R for statistical analysis and visualization. The results are presented on a web-based platform for interactive online analysis. The platform generates pie charts displaying the most frequently reported Preferred Terms (PTs) based on Medical Dictionary for Regulatory Activities (MedDRA) terminology and forest plots illustrating Reporting Odds Ratios (RORs) for these PTs.

Results:

Using Paxlovid (COVID-19 treatment) and Hydroxychloroquine (anti-malaria drug) as case studies, we found that Paxlovid was predominantly associated with PTs related to COVID-19, while Hydroxychloroquine demonstrated association with retinopathy and cardiomyopathy. The platform's subgroup analysis function elucidated that advanced age and female gender were correlated with an increased risk of Hydroxychloroquine-related retinopathy and cardiomyopathy. The majority of findings align with existing research, thereby validating the platform's utility. Clinical personnel have evaluated and refined the platform based on user feedback, confirming its efficacy in visualizing complex ADR data and identifying adverse effects across various drug subgroups.

Conclusions:

VisDrugs is a valuable tool for ADR analysis, offering an intuitive interface for exploring FAERS data. By visualizing and comparing ADRs, it helps researchers and healthcare providers assess drug safety efficiently. The platform’s demographic analysis features add insights into ADR variations by age and gender, supporting drug safety research. In the future, the website will include more subgroup or condition filtering options, offering personalized ADR analysis and comparison features to meet the diverse research needs of users.