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U.S. Department of Health and Human Services

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FAERS Reporting by Patient Outcomes by Year

(As of December 31, 2013)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 2004 until the end of 2013. 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 2004. Corresponding data appear in the accompanying table.


This table represents the patient outcome(s) for reports in FAERS since the year 2004 until the end of 2013. Serious outcomes include death, hospitalization, life-threatening, disability, congenital anomaly and/or other serious outcome.

YearDeathsSerious
200434,739198,828
200540,031256,208
200637,313264,240
200736,689272,345
200849,711318,565
200963,842373,512
201082,729471,327
201198,590573,402
2012118,444661,480
2013117,752711,232