ArticleScientific data2016
A curated and standardized adverse drug event resource to accelerate drug safety research.
Article in Scientific data, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 131 papers, 1 of them a synthesis 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
131 citing papers in PubMed, 1 synthesis or guideline pooled it.
- An OMOP-CDM based pharmacovigilance data-processing pipeline (PDP) providing active surveillance for ADR signal detection from real-world data sources.BMC medical informatics and decision making · 2021Pooled it
- Safety profiles of calcineurin inhibitor-related infections in the pediatric population: a real-world pharmacovigilance analysis.European journal of pediatrics · 2026Article
- Real-world safety profile of fezolinetant: a disproportionality analysis based on the FAERS database.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- The Real-World Safety Profile of Immune Checkpoint Inhibitors in Melanoma: FAERS Pharmacovigilance Analysis Complemented by Randomized Trial Evidence.Health science reports · 2026Article
- HIV as a Host Susceptibility State for Severe Drug Hypersensitivity: Disentangling Biological Susceptibility from Drug Exposure in the FAERS Database.medRxiv : the preprint server for health sciences · 2026Article
- Psychiatric Safety Signals of GLP-1 Receptor Agonists: A FAERS-Based Pharmacovigilance Study with Explainable Machine Learning.Pharmaceuticals (Basel, Switzerland) · 2026Article
- KAN-PROSPECT: a Kolmogorov-Arnold Networks-integrated framework for predicting the effects and adverse reactions of natural products via transfer learning.Scientific reports · 2026Article
- Article
- Integration of Clinical Pharmacokinetic Database With Compartmental Modeling and Regulatory Data Analysis.Current therapeutic research, clinical and experimental · 2026Article
- Motif-Level Graph Learning Enables Interpretable Prediction of Drug-Induced QT Prolongation via Cooperative Substructural Determinants.International journal of molecular sciences · 2026Article
- Post-marketing safety surveillance of tarlatamab: a real-world pharmacovigilance study based on the FAERS database.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Seizures Risk Related to Atypical Antipsychotics: A Disproportionality Analysis Based on the FDA Adverse Event Reporting System (FAERS).Alpha psychiatry · 2026Article
- Cross-national pharmacovigilance of drug-induced intestinal obstruction: disproportionality signals in FAERS and external validation in JADER.Frontiers in pharmacology · 2026Article
- Respiratory adverse events associated with PD-1/PD-L1 inhibitors: an analysis based on the FDA adverse event reporting system.Frontiers in oncology · 2026Article
- Cardiac disorders associated with compound long-acting bronchodilators for inhalation: a pharmacovigilance analysis of the FDA adverse event reporting system database.Frontiers in cardiovascular medicine · 2026Article
- Neuropsychiatric adverse events of SGLT2 inhibitors: a pharmacovigilance analysis of the FDA adverse event reporting system database.Frontiers in medicine · 2026Article
- Ocular safety signals of sphingosine-1-phosphate receptor modulators in postmarketing surveillance.Frontiers in pharmacology · 2026Article
- Disproportionality analysis of off-label intravitreal bevacizumab in the FDA Adverse Event Reporting System database.Therapeutic advances in drug safety · 2026Article
- A Vanished Association Between Proton Pump Inhibitors and Clostridioides Difficile Infection After Minimizing Bias.Journal of clinical medicine · 2025Article
- Completeness of spontaneously reported adverse drug reactions in 4 databases.British journal of clinical pharmacology · 2025Article
71 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
6 authors.
Funding
Abstract
Identification of adverse drug reactions (ADRs) during the post-marketing phase is one of the most important goals of drug safety surveillance. Spontaneous reporting systems (SRS) data, which are the mainstay of traditional drug safety surveillance, are used for hypothesis generation and to validate the newer approaches. The publicly available US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) data requires substantial curation before they can be used appropriately, and applying different strategies for data cleaning and normalization can have material impact on analysis results. We provide a curated and standardized version of FAERS removing duplicate case records, applying standardized vocabularies with drug names mapped to RxNorm concepts and outcomes mapped to SNOMED-CT concepts, and pre-computed summary statistics about drug-outcome relationships for general consumption. This publicly available resource, along with the source code, will accelerate drug safety research by reducing the amount of time spent performing data management on the source FAERS reports, improving the quality of the underlying data, and enabling standardized analyses using common vocabularies.
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.