Identification

Name

FDA Adverse Event Reporting System

Short name

FAERS

Status

Active

Category

Data Source

Organizations
(1) Food and Drug Administration (FDA)
Update frequency

Quarterly

Created

2014-07-08 21:11:27+00:00

Modified

2016-07-07 18:32:28.513017+00:00

Basic Information

Overview

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.

Goals
(1) Baseline awareness
URL http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm
URL (alternate) http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm082193.htm
Related system
(1) MedWatch ()

Disease and Geography

Locations
(1) All States and Territories

Datastreams

Data sources
(1) Official Reports