Search and Analysis of the Food and Drug Administration's FDA Adverse Event Reporting System (FAERS)

The Food and Drug Administration (FDA) is a regulatory body in the United States that provides oversight for the safety of marketed prescription and non-prescription medications. The FDA established a post-marketing surveillance system called the FDA Adverse Event Reporting System (FAERS), which is an electronic database that receives reports of adverse effects suspected as being related to an FDA-approved drug. The FDA routinely mines FAERS to search for unexpected drug safety issues and allows extramural researchers to mine the database as well. FAERS search strategies for extramural researchers include downloading of raw data, use of the publicly accessible search engine called the FAERS Public Dashboard, filing a Freedom of Information Act (FOIA) request, and utilizing a commercial vendor to search and analyze data. Use of the FAERS allows for identification of unexpected drug safety issues and can lead to regulatory changes based on its findings. However, FAERS does have limitations such as extensive under-reporting of adverse drug reactions, lack of demonstration of causality for individual reports, reporting biases, and the lack of comparator populations. Other FDA post-marketing surveillance systems include the Vaccine Adverse Event Reporting System (VAERS), the Medical Device and User Facility Device Experience (MAUDE), and the Sentinel Initiative.