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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

BICALUTAMIDE: Side Effect Reports by Year

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Year-by-year breakdown of FAERS adverse event reports for BICALUTAMIDE. Total: 4,061 reports.

Year Reports Deaths Hospitalizations Death Rate
2000 1 0 0 N/A
2002 2 0 1 N/A
2003 1 0 0 N/A
2004 1 0 0 N/A
2005 5 0 5 N/A
2006 1 0 1 N/A
2007 4 1 1 25.0%
2008 4 1 1 25.0%
2009 4 1 2 25.0%
2010 21 3 5 14.3%
2011 22 1 9 4.5%
2012 26 1 15 3.8%
2013 78 9 30 11.5%
2014 170 23 79 13.5%
2015 205 29 97 14.1%
2016 240 50 112 20.8%
2017 261 15 135 5.7%
2018 298 35 154 11.7%
2019 273 16 144 5.9%
2020 201 24 92 11.9%
2021 141 11 43 7.8%
2022 110 9 59 8.2%
2023 52 3 16 5.8%
2024 67 1 28 1.5%
2025 15 1 4 6.7%
Total 4,061 462 1,486 11.4%

FDA approval date: Aug 28, 2009.

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