ReviewInternational journal of medical sciences2013
Data mining of the public version of the FDA Adverse Event Reporting System.
Review in International journal of medical sciences, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 615 papers, 2 of them syntheses that pooled it.
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
615 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Non-Relapse Mortality With Bispecific Antibodies in Hematologic Malignancies: A Dual Systematic Review and Pharmacovigilance Analysis.Hematological oncology · 2026Pooled it
- Characterization of the Safety Profile of the Triple Monoamine Reuptake Inhibitor Dasotraline Based on Clinical Trial Data and Disproportionality Analyses of Four Related Pharmacological Classes Using Real-World Data from the FDA Adverse Event Reporting System.Clinical drug investigation · 2026Pooled it
- Article
- Bone and growth safety profiles of biologic and conventional DMARDs in juvenile idiopathic arthritis: a 21-year FAERS disproportionality analysis.Inflammopharmacology · 2026Article
- Real-world evidence on gadoteridol safety: A 20-year FAERS database study revealing critical adverse reaction patterns.Medicine · 2026Article
- Article
- Antidepressant use and Parkinson's disease risk: Overall protective effect with drug-specific variation.General psychiatry · 2026Article
- Article
- Gastrointestinal and skin safety evaluation of pirfenidone versus nintedanib: an analysis of real-world pharmacovigilance and randomized controlled trials.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Thrombotic and ischemic event reporting with anticoagulant reversal agents: a multi-agent FAERS pharmacovigilance study.Journal of thrombosis and thrombolysis · 2026Article
- Multinational pharmacovigilance assessment of drug-associated esophageal ulceration and perforation: evidence from FAERS, JADER, and Canada Vigilance.BMC pharmacology & toxicology · 2026Article
- Assessing the real-world safety of sparsentan for immunoglobulin A nephropathy: insights from a comprehensive analysis of FAERS database.International urology and nephrology · 2026Article
- Sexual Safety Signals of Common Antidiabetic Drugs: Insights From FAERS Disproportionality Analysis.Andrology · 2026Article
- Disproportionality analysis of drug-associated tinnitus safety signals: a 43-year pharmacovigilance study.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Mining safety signals of PD-1/PD-L1 inhibitor-related adrenal insufficiency: a study based on the FAERS database.Journal of endocrinological investigation · 2026Article
- Integration of FAERS database and network toxicology to investigate adverse drug events and potential toxicological mechanisms of triazole antifungal agents.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Orlistat-Associated Gastrointestinal, Hepatobiliary, Pancreatic, and Anorectal Safety Signals: A FAERS Disproportionality and Regulatory Label Concordance Study.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Review
- Real-world analysis of depression-related adverse events associated with the adsorbed anthrax vaccine: integrating pharmacovigilance signals, machine learning risk prediction, and transcriptomic mechanisms.Infectious diseases of poverty · 2026Article
- A retrospective study comparing the severe cutaneous adverse reactions in patients receiving triazole antifungal therapy and literature analysis.Medical mycology · 2026Article
555 more citing papers are in PubMed but not listed here.
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
The US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS, formerly AERS) is a database that contains information on adverse event and medication error reports submitted to the FDA. Besides those from manufacturers, reports can be submitted from health care professionals and the public. The original system was started in 1969, but since the last major revision in 1997, reporting has markedly increased. Data mining algorithms have been developed for the quantitative detection of signals from such a large database, where a signal means a statistical association between a drug and an adverse event or a drug-associated adverse event, including the proportional reporting ratio (PRR), the reporting odds ratio (ROR), the information component (IC), and the empirical Bayes geometric mean (EBGM). A survey of our previous reports suggested that the ROR provided the highest number of signals, and the EBGM the lowest. Additionally, an analysis of warfarin-, aspirin- and clopidogrel-associated adverse events suggested that all EBGM-based signals were included in the PRR-based signals, and also in the IC- or ROR-based ones, and that the PRR- and IC-based signals were in the ROR-based ones. In this article, the latest information on this area is summarized for future pharmacoepidemiological studies and/or pharmacovigilance analyses.
Indexed as
Identifiers
What OpenQuestion holds
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.