FDA Adverse Event Reporting System (FAERS) Database
Frequently Asked Questions (FAQs) about FAERS Additional Information Quarterly Data Files from the FDA Adverse Event Reporting System (FAERS) Reporting an Adverse Event or …
FDA Adverse Event Reporting System - Wikipedia
The FDA Adverse Event Reporting System (FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration 's (FDA) postmarketing …
FDA Adverse Event Reporting System (FAERS) Essentials: A Guide …
May 19, 2025 · Adverse event reports, also called individual case safety reports (ICSRs), submitted to FDA, are collected and stored in the FDA Adverse Event Reporting System …
FDA Adverse Event Reporting System (FAERS) Public Dashboard
Dec 7, 2023 · The intention of this tool is to expand access of FAERS data to the general public to search for information related to human adverse events reported to the FDA by the …
FDA Adverse Event Reporting System – Knowledge and …
The FDA Adverse Event Reporting System (FAERS) is a database utilized by the US Food and Drug Administration (FDA) to collect, store, and analyze post-marketing safety surveillance …
The FAERS Database: Its Role in Drug Safety and Limitations
Jul 21, 2025 · The U.S. Food and Drug Administration (FDA) Adverse Event Reporting System, or FAERS, is a database containing reports of adverse events, medication errors, and product …
FDA Adverse Event Reporting System (FAERS) | ComplianceQuest
FAERS plays a vital role in post-market surveillance, helping the FDA identify safety concerns, unusual side effects, and emerging drug and product safety trends. This data-driven system is …
openFDA - Food and Drug Administration
The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database is designed to …
FDA Adverse Event Reporting System (FAERS) Electronic …
Sep 12, 2025 · This page provides drug and nonvaccine biological product manufacturers, distributors, packers, outsourcing facilities, and other interested parties with information about …
Questions and Answers on FDA's Adverse Event Reporting System (FAERS)
FAERS is a useful tool for FDA for activities such as looking for new safety concerns that might be related to a marketed product, evaluating a manufacturer's compliance to reporting regulations...