FAERS was the FDA's Adverse Event Reporting System, a public database of side-effect reports submitted after a drug reaches the market. On March 11, 2026, the FDA replaced it with the FDA Adverse Event Monitoring System (AEMS), which merges FAERS, the vaccine database VAERS, and other product databases into one public dashboard (FDA, March 11, 2026 (external link)). Studies built on the older data still say "FAERS," so you'll keep seeing the name. Anyone can file a report: patients, caregivers, pharmacists, doctors, and (by legal requirement) manufacturers. The FDA mines the reports for "signals," patterns that might indicate a problem the clinical trials were too small or too short to catch.
Many of the headlines about GLP-1 side effects (hair loss, mood changes, suicidal thoughts, gastroparesis) started as FAERS analyses. Those signals are worth taking seriously, but the database has hard limits: reports are unverified, one event can be filed several times, and there is no denominator, so FAERS cannot say how often a side effect happens per person taking the drug. The FDA's AEMS dashboard carries the same caveats (FDA AEMS Public Dashboard (external link)). Media attention also drives reporting up on its own. A FAERS signal means something needs study; it does not show cause. See mood changes and anhedonia on a GLP-1 for a worked example of how such a signal gets investigated.