FDA Adverse Event Reporting System

The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA.

About FAERS

The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database is designed to support the FDA's post-marketing safety surveillance program for drug and therapeutic biologic products. The informatic structure of the FAERS database adheres to the international safety reporting guidance issued by the International Conference on Harmonisation (ICH E2B). Adverse events and medication errors are coded to terms in the Medical Dictionary for Regulatory Activities (MedDRA) terminology.

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General information
Learn more about FDA Adverse Event Reporting System

Original dataset downloads
FAERS download information

Provider

FDA

Updates

Frequency Quarterly

Lag in data updates 3 months

Time period

Earliest data Q1 2014