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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 - 2014

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Oct 2013N/A56,875
Nov 2013N/A52,287
Dec 2013N/A46,404
Jan 2014N/A62,557
Feb 2014N/A60,517
Mar 2014N/A62,594
Apr 2014N/A90,087
May 2014N/A54,834
Jun 2014N/A58,310
Jul 2014N/A64,963
Aug 2014N/A57,028
Sep 2014N/A58,681

FY 2014 Total: 735,137


  • 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.