FAERS (now AEMS)
The vocabulary of getting a claim paid, of FDA enforcement, and of what on-label and off-label really mean.
What is FAERS (now AEMS)?
FDA's database of voluntary reports of suspected drug side effects.
FDA now lists it as the Adverse Event Monitoring System (AEMS), formerly the FDA Adverse Event Reporting System, and most published papers still say FAERS. A report does not show the drug caused the problem, and because nobody counts how many people took the drug, the numbers cannot give a rate.
Related reading: Compounded GLP-1s and the Adverse Event Reports
GLP Watchdog writes these definitions from FDA labels and peer-reviewed PubMed literature.
Where FAERS (now AEMS) comes up on this site
On GLP Watchdog, FAERS comes up in 3 research articles.
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