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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\u2014along with multiple other data sources\u2014to 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.<\/jats:p>","DOI":"10.1002\/cpt.3701","type":"journal-article","created":{"date-parts":[[2025,5,19]],"date-time":"2025-05-19T05:55:57Z","timestamp":1747634157000},"page":"567-582","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":145,"title":["<scp>FDA<\/scp>\n                    Adverse Event Reporting System (\n                    <scp>FAERS<\/scp>\n                    ) Essentials: A Guide to Understanding, Applying, and Interpreting Adverse Event Data Reported to\n                    <scp>FAERS<\/scp>"],"prefix":"10.1002","volume":"118","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-2237-060X","authenticated-orcid":false,"given":"Emeri","family":"Potter","sequence":"first","affiliation":[{"name":"Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research US Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7131-7166","authenticated-orcid":false,"given":"Melissa","family":"Reyes","sequence":"additional","affiliation":[{"name":"Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research US Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7797-0150","authenticated-orcid":false,"given":"Jennifer","family":"Naples","sequence":"additional","affiliation":[{"name":"Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research US Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4874-5864","authenticated-orcid":false,"given":"Gerald","family":"Dal Pan","sequence":"additional","affiliation":[{"name":"Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research US Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,5,19]]},"reference":[{"key":"e_1_2_13_1_1","unstructured":"U.S. Code.Federal Food Drug and Cosmetic Act Subchapter V\u2010Drugs and Devices Sec. 355\u2010New Drugs 21 USC \u00a7 355<https:\/\/www.govinfo.gov\/app\/details\/USCODE\u20102023\u2010title21\/USCODE\u20102023\u2010title21\u2010chap9\u2010subchapV\u2010partA\u2010sec355> (2023). 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