FDA Adverse Events Reporting System (FAERS) Public Dashboard
The U.S. Food and Drug Administration launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System (FAERS). The new FAERS public dashboard enables users to search for and organize data by criteria such as drug/biological product, age of the patient, type of adverse event, year the adverse event occurred, or within a specific timeframe. The FDA is committed to improving transparency of adverse events reported with medical products and this enhanced portal now provides patients, doctors and others with easier access to the data they are interested in.
While the FAERS public dashboard now offers stakeholders many more 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. 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 still talk to their health care professional if they have any concerns regarding their medications.