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U.S. Department of Health and Human Services

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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 December 31, 2017.

Fiscal Year - 2017

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Oct 2016N/A67,805
Nov 2016N/A73,397
Dec 2016N/A75,414
Jan 2017N/A75,733
Feb 2017N/A72,852
Mar 2017N/A83,383
Apr 2017N/A72,402
May 2017N/A80,430
Jun 2017N/A79,900
Jul 2017N/A75,854
Aug 2017N/A80,126
Sep 2017N/A77,183

FY 2017 Total: 914,479

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.