ArticleClinical pharmacology and therapeutics2025
FDA Adverse Event Reporting System (FAERS) Essentials: A Guide to Understanding, Applying, and Interpreting Adverse Event Data Reported to FAERS.
Article in Clinical pharmacology and therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 72 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
72 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Post-marketing safety of CGRP monoclonal antibodies and gepants: A systematic review of spontaneous reporting system data.Headache · 2026Pooled it
- Regulatory, clinical, and post-marketing challenges of lecanemab for Alzheimer's disease: insights from real-world data.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026Pooled it
- Pharmacovigilance of Androgen Receptor Pathway Inhibitors in Prostate Cancer: The Impact of Docetaxel Co-Reporting.Cancers · 2026Article
- SafeSense: An open-access safety atlas for antisense oligonucleotides adverse events in human.Molecular therapy. Nucleic acids · 2026Article
- Analysis of Suffix Use for Biosimilar Product Identification in Postmarketing Adverse Event Reporting.Clinical pharmacology and therapeutics · 2026Article
- Cardiovascular Safety Signals of Osteoporosis Therapies: A FAERS Pharmacovigilance Study.Mediterranean journal of rheumatology · 2026Article
- Adverse events associated with immune checkpoint inhibitors in combination with chemotherapy in lung cancer: a real-world analysis.Journal of thoracic disease · 2026Article
- Drug Safety and Polypharmacy Signals in Ibrutinib-Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Age- and Sex-Specific FAERS Analysis of CYP3A Modifier and Antithrombotic Co-Exposure.Journal of clinical medicine · 2026Article
- Drug-induced fever: a pharmacovigilance analysis based on the FDA adverse event reporting system.International journal of clinical pharmacy · 2026Article
- Patient-Level Risk Characterization of Drug-Associated Hidradenitis Suppurativa Using Machine Learning.medRxiv : the preprint server for health sciences · 2026Article
- Drug-Associated Vanishing Bile Duct Syndrome: Screening for Potential Pharmaceutical Triggers Using the WHO Pharmacovigilance Database.Life (Basel, Switzerland) · 2026Article
- A real-world pharmacovigilance study of dacomitinib based on FDA adverse event reporting system (FAERS) database.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Comment on "Safety profile and potential clinical risks of xanomeline and trospium chloride" - Confirmatory findings from an independent FAERS analysis.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026Article
- Safety Profile of Zavegepant in the Treatment of Acute Migraine: Insights from the FDA Adverse Event Monitoring System Database.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Reviewing the Computational Landscape of Drug Repurposing: Evolution from Structure-Based Methods to LLM-Based Methods.Biomolecules · 2026Review
- Age-Dependent Differences in Canakinumab Safety: A Comprehensive Pharmacovigilance Analysis Using the FAERS Database.Pharmacology research & perspectives · 2026Article
- Integrating Pharmacovigilance Data Mining and Mendelian Randomization to Identify Risk Profiles and Causal Targets of Opioid-Induced Delirium.CNS neuroscience & therapeutics · 2026Article
- Persistent rise in device-related errors for CGRP monoclonal antibodies: impact of the COVID-19 pandemic and post-pandemic implications.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Regulatory challenges and current policy for cardiotoxicity detection in oncology drug development.Journal of thrombosis and thrombolysis · 2026Article
- Monogenic Syndromes as a Cause of Adverse Drug Reactions in the Russian Population.International journal of molecular sciences · 2026Article
12 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
Abstract
The US Food and Drug Administration (FDA) performs safety assessments throughout the life cycle of a drug. Postmarketing safety surveillance promotes the identification of adverse events not known at the time of approval. Adverse event reports, also called individual case safety reports (ICSRs), submitted to FDA, are collected and stored in the FDA Adverse Event Reporting System (FAERS). ICSRs stored in FAERS may be reviewed-along with multiple other data sources-to detect potential safety signals and to perform a thorough evaluation to determine if a causal association exists between a drug and an adverse event. Although FAERS is a powerful tool for drug safety surveillance and assessment, understanding the content, application, and proper interpretation of the data contained in FAERS is necessary to reach scientifically and medically accurate conclusions and contextualize findings. This article aims to highlight considerations and explain fundamental concepts of FAERS to promote accurate analyses and appropriate interpretation of the data available.
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.