ArticleHealthcare (Basel, Switzerland)2022
A Standardized Dataset of a Spontaneous Adverse Event Reporting System.
Article in Healthcare (Basel, Switzerland), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 97 papers.
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
97 citing papers in PubMed, 124 citations in OpenAlex.
- Safety Profile of Chimeric Antigen Receptor T-cell Therapies in Diffuse Large B-cell Lymphoma: An Analysis of Real-World Adverse Event Reporting From the FDA Adverse Event Reporting System.Mayo Clinic proceedings. Innovations, quality & outcomes · 2026Article
- Comparative Adverse Event Reporting Patterns of Amoxicillin and Amoxicillin/Clavulanic Acid in FAERS: A 2022-2025 Disproportionality Analysis.Health science reports · 2026Article
- Cardiotoxicity of macrolide antibiotics: a pharmacovigilance study integrating FAERS and JADER databases.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Safety profiles of calcineurin inhibitor-related infections in the pediatric population: a real-world pharmacovigilance analysis.European journal of pediatrics · 2026Article
- Reporting patterns of adverse drug withdrawal events using individual case safety reports in the FAERS and Eudravigilance databases.Exploratory research in clinical and social pharmacy · 2026Article
- Target-Specific Dermatological Adverse Event Reporting With T-Cell-Engaging Bispecific Antibodies: A Pharmacovigilance Analysis of FAERS and Canada Vigilance, 2016-2026.Cancer medicine · 2026Article
- Biomedical Large Language Models and Prompt Engineering for Causality Assessment of Individual Case Safety Reports in Pharmacovigilance.Pharmaceutical research · 2026Article
- Disproportionality analysis of adverse events associated with degarelix: a real-world study from the FDA Adverse Event Reporting System (FAERS) database.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Article
- Signal detection and analysis of adverse events associated with sevelamer post-marketing based on the FAERS database.Medicine · 2026Article
- Article
- Safety Profile of Zavegepant in the Treatment of Acute Migraine: Insights from the FDA Adverse Event Monitoring System Database.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Pharmacovigilance evaluation of somatrogon-associated adverse events in real-world databases.Endocrine connections · 2026Article
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- Article
- Musculoskeletal adverse events with incretin-based diabetes drugs: a FAERS pharmacovigilance study.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Real-world disproportionality analysis of trabectedin using the United States food and drug administration adverse event reporting system.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Article
- Seizures Risk Related to Atypical Antipsychotics: A Disproportionality Analysis Based on the FDA Adverse Event Reporting System (FAERS).Alpha psychiatry · 2026Article
- Disproportionality analysis of adverse events associated with bimekizumab: a real-world study based on FDA Adverse Event Reporting System (FAERS) Database.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Mechanistic insights into taxane-induced psychiatric adverse events: a global pharmacovigilance and experimental investigation.Molecular psychiatry · 2026Article
37 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
5 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
One of the largest spontaneous adverse events reporting databases in the world is the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). Unfortunately, researchers face many obstacles in analyzing data from the FAERS database. One of the major obstacles is the unstructured entry of drug names into the FAERS, as reporters might use generic names or trade names with different naming structures from all over the world and, in some cases, with typographical errors. Moreover, report duplication is a known problem in spontaneous adverse event-reporting systems, including the FAERS database. Hence, thorough text processing for database entries, especially drug name entries, coupled with a practical case-deduplication logic, is a prerequisite to analyze the database, which is a time- and resource-consuming procedure. In this study, we provide a clean, deduplicated, and ready-to-import dataset into any relational database management software of the FAERS database up to September 2021. Drug names are standardized to the RxNorm vocabulary and normalized to the single active ingredient level. Moreover, a pre-calculated disproportionate analysis is provided, which includes the reporting odds ratio (ROR), proportional reporting ratio (PRR), Chi-squared analysis with Yates correction (x2), and information component (IC) for each drug-adverse event pair in the database.
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.