FDA Adverse Event Reporting System (FAERS) Database Drug Approvals and Databases Resources for Information | Approved Drugs
Search the FDA FAERS and MAUDE databases (drug and medical device adverse events).
Learn about the FDA Adverse Event Reporting System (FAERS), now updated in real time with over 31 million reports, for post-marketing drug safety surveillance, signal detection, and AI-enhanced pharmacovigilance.
The FDA Adverse Event Reporting System (FAERS) is a large public database used for post-marketing safety surveillance of medications and therapeutic biologic products (FDA, 2024a). The FAERS database comprises over 30 million AE reports submitted by pharmaceutical companies, healthcare professionals and consumers over the past 56 years (FDA ...
I have used FAERS variable names in the AERS files in cases where the variables are the same. The FDA Adverse Event Reporting System (FAERS) data is offered here in SAS, Stata, and CSV formats to make the database a bit easier to use.
The FAERS is a public, accessible, and free database in the United States that contains tens of millions of AE reports voluntarily submitted by health professionals, consumers, manufacturers, and others, which is designed to support the FDA’s safety monitoring for post-marketing drug and biological products (Cirmi et al., 2020; Hu et al., 2020).
FAERS is a useful tool for the FDA, which uses it 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 and responding to outside requests for information.
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 pharmaceutical industry ...