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U.S. Department of Health and Human Services

Drugs

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FAERS Patient Outcomes by Year

(As of June 30, 2012)Back to FAERS Statistics Main Page

These data describe the outcome of the patient as defined in U.S. reporting regulations (21 CFR 310.305, 314.80, 314.98, 600.80) and Forms FDA 3500 and 3500A (the MedWatch forms). Serious means that one or more of the following outcomes were documented in the report: death, hospitalization, life-threatening, disability, congenital anomaly and/or other serious outcome. Documenting one or more of these outcomes in a report does not necessarily mean that the suspect product(s) named in the report was the cause of these outcomes.


This figure illustrates the patient outcome(s) for reports in FAERS since the year 2003 until the end of the second quarter of 2012. Serious outcomes include death, hospitalization, life-threatening, disability, congenital anomaly and/or other serious outcome.

Patient outcome(s) for reports in FAERS since the year 2003. Serious outcomes include death, hospitalization, life-threatening, disability, congenital anomaly and/or other serious outcome. Corresponding data appear in the accompanying table.


This figure illustrates the patient outcome(s) for reports in FAERS since the year 2003 until the end of the second quarter of 2012. Serious outcomes include death, hospitalization, life-threatening, disability, congenital anomaly and/or other serious outcome.

YearDeathsSerious
2003
34,948
176,256
2004
34,746
198,832
2005
40,035
256,211
2006
37,309
264,223
2007
36,689
272,345
2008
49,710
318,563
2009
63,839
373,486
2010
82,724
471,277
2011
98,518
573,111
2012 (Q2)
54,783
325,864