Adverse Event Reporting System (AERS) Statistics

Adverse Event Reporting System (AERS) Statistics
as of December 31, 2008

The Adverse Event Reporting System (AERS) contains over four million reports of adverse events and reflects data from 1969 to the present. Data from AERS are presented here as summary statistics. These summary statistics cover data received over the last ten years. These data are presented at the individual report level; some of the numbers may reflect duplicate reporting due to factors such as follow-up reports received on a case or different persons reporting on the same patient case. We will update these data files each quarter; therefore, the most recent year displayed may contain only partial year data.

Reports Received and Reports Entered into AERS by Year
Number of reports received by FDA and entered into AERS by type of report since the year 1999.


Domestic and Foreign Reports by Year
Number of domestic (U.S.) and foreign reports in AERS since the year 1999.


Reporting by Healthcare Providers and Consumers by Year
Number of reports in AERS by type of reporter (Healthcare Professional [HCP] or consumer) since the year 1999.


Patient Outcomes by Year
Patient outcome(s) for reports in AERS since the year 1999. Serious outcomes include death, hospitalization, life-threatening, disability, congenital anomaly and/or other serious outcome.
Date created: June 6, 2008; updated April 6, 2009

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Adverse Event Reporting System (AERS) Statistics