ArticleJMIR formative research2025
Visualization of FDA Adverse Drug Reaction Reports: Development and Usability Study of the VisDrugs Web Server.
Article in JMIR formative research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Monogenic Syndromes as a Cause of Adverse Drug Reactions in the Russian Population.International journal of molecular sciences · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
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 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.