Visualization of FDA Adverse Drug Reaction Reports: Development and Usability Study of the VisDrugs Web Server.

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 health care 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 the American Standard Code for Information Interchange (ASCII) format, covering the period from Q3 (third quarter) 2014 to Q3 2024. About 2,700,000 reports from health care 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 web-based analysis. The platform generates pie charts to visualize the most frequently reported ADRs, which are represented and analyzed using preferred terms based on the Medical Dictionary for Regulatory Activities (MedDRA) and forest plots illustrating reporting odds ratios (RORs) for these ADRs.

RESULTS

Using Paxlovid (COVID-19 treatment) and hydroxychloroquine (anti-malaria drug) as case studies, we benchmarked VisDrugs using reports for Paxlovid (n=16,708) and hydroxychloroquine (n=6150). Paxlovid was most frequently associated with "COVID-19" (ROR=47.26, 95% CI 45.22-49.40) and "dysgeusia" (ROR=59.65, 95% CI 55.56-64.03). Hydroxychloroquine showed strong associations with "retinal toxicity" (ROR=738.48, 95% CI 583.45-934.71), "retinopathy" (ROR=412.27, 95% CI 344.73-493.03), and "cardiotoxicity" (ROR=48.36, 95% CI 38.86-60.19). In subgroup analyses, female patients had significantly higher risks of retinopathy (3.24-fold) and cardiomyopathy (13.82-fold) compared to male patients, while patients aged >50 years had higher risks of retinopathy (4.20-fold) and cardiomyopathy (7.84-fold) compared to those ≤50 years. All differences were statistically significant (z test, P<.01). 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 health care 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.