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U.S. Department of Health and Human Services

About FDA

Number of Adverse Events (AE) reported for drugs/biological products (15-day manufacture reports)

Dictionary: The FDA receives hundreds of thousands of AE reports each year. The AE reports are monitored very closely to determine whether or not a serious safety signal is observed and whether a regulatory action might be necessary.

Information is current as of March 31, 2015.

Fiscal Year - 2013

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Oct 2012N/A49,829
Nov 2012N/A51,883
Dec 2012N/A44,188
Jan 2013N/A47,937
Feb 2013N/A46,534
Mar 2013N/A49,968
Apr 2013N/A50,003
May 2013N/A49,177
Jun 2013N/A46,570
Jul 2013N/A53,597
Aug 2013N/A54,575
Sep 2013N/A47,049

FY 2013 Total: 591,310


  • CDER created new measures and began collecting data in July 2012. Therefore, FY12 will only include 3 months of data.


Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.