Updates to FDA’s Adverse Events Reporting System (FAERS) Dashboard

Today the U.S. Food and Drug Administration launched a number of improvements to the FDA’s Adverse Event Reporting System (FAERS) dashboard. The FDA is committed to improving the FAERS dashboard and is implementing these changes based on user feedback received since the dashboard was launched in September 2017. The changes encompass a wide-range of items, such as enabling the selection of multiple products for a search and the downloading of search results, as well as enhancing display formats so more information is shown in one screen.

 

While the FAERS dashboard offers stakeholders many ways of searching for and organizing data on adverse events reported to the FDA for many drug and biologic products, there remain limitations to the data that should be noted. For example, as discussed in the Center for Drug Evaluation and Research’s FAERS podcast, while FAERS contains reports on adverse events associated with a particular drug or biologic, this does not mean that the drug or biologic caused the adverse event. Importantly, the FAERS data by themselves are not an indicator of the safety profile of the drug or biologic. Patients should talk to their health care professional if they have any concerns regarding their medications. For more information on using the FAERS dashboard please see the FAERS webinar and the FAERS dashboard FAQ page.