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Food and Drug Administration

The Food and Drug Administration (FDA or USFDA) is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods and feed, and veterinary products.

Other Access

The information on this page (the dataset metadata) is also available in these formats.

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Adverse Event Reporting System (AERS)

The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's post-marketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses AERS to monitor for new adverse events and medication errors that might occur with these marketed products. Reporting of adverse events from the point of care is voluntary in the United States. FDA receives some adverse event and medication error reports directly from health care professionals (such as physicians, pharmacists, nurses and others) and consumers (such as patients, family members, lawyers and others). Healthcare professionals and consumers may also report these events to the products' manufacturers. If a manufacturer receives an adverse event report, it is required to send the report to FDA as specified by regulations. The files listed on this page contain raw data extracted from the AERS database for the indicated time ranges and are not cumulative. Users of these files need to be familiar with creation of relational databases using applications such as ORACLE, Microsoft Office Access, MySQL and IBM DB2 or the use of ASCII files with SAS analytic tools. A simple search of AERS data cannot be performed with these files by persons who are not familiar with creation of relational databases.

Source: open.fda.gov

Data and Resources

FieldValue
Publisher
Bureau Code
009:10 - Food and Drug Administration
Modified
2004-01-01
Release Date
2004-01-01
Homepage URL
Identifier
b454bed2-730a-4e06-becb-0f599f2ad62a
Temporal Coverage
Thursday, January 1, 2004 - 05:00 to Monday, December 31, 2012 - 05:00
License
Contact Name
FDA Enterprise Data Inventory
Contact Email
Public Access Level
Public
Program Code
009:000 - Department of Health and Human Services - (Primary Program Not Available)
Harvested from open.fda.gov
Harvest Source Titleopen.fda.gov
Harvest Source URIhttps://open.fda.gov/data.json
Last Harvest PerformedMon, 12/17/2018 - 02:49