FDA Adverse Event Reporting System
The FDA Adverse Event Reporting System (FAERS) is a database that contains adverse event reports, medication error reports, and product quality complaints resulting in adverse events submitted to the FDA. FAERS supports the FDA's post-marketing safety surveillance program for drug and therapeutic biologic products. The database adheres to ICH E2B international safety reporting guidance, and adverse events are coded using MedDRA (Medical Dictionary for Regulatory Activities) terminology. FAERS provides quarterly data files in ASCII and XML formats dating back to 2012, with archives available for earlier data.
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