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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 - 2015

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Oct 2014N/A63,010
Nov 2014N/A56,308
Dec 2014N/A64,890
Jan 2015N/A64,450
Feb 2015N/A90,087
Mar 2015N/A73,842
Apr 2015N/ATBD
May 2015N/ATBD
Jun 2015N/ATBD
Jul 2015N/ATBD
Aug 2015N/ATBD
Sep 2015N/ATBD

FY 2015 YTD: 411,587


  • 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.