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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.

RALOXIFENE: Side Effect Reports by Year

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Year-by-year breakdown of FAERS adverse event reports for RALOXIFENE. Total: 4,185 reports.

Year Reports Deaths Hospitalizations Death Rate
2000 8 0 2 N/A
2001 5 0 1 N/A
2002 9 0 0 N/A
2003 11 0 2 N/A
2004 11 0 2 N/A
2005 25 0 2 N/A
2006 58 1 6 1.7%
2007 120 0 6 N/A
2008 311 1 15 0.3%
2009 177 0 13 N/A
2010 108 0 14 N/A
2011 77 0 10 N/A
2012 59 3 13 5.1%
2013 50 1 9 2.0%
2014 54 1 12 1.9%
2015 67 1 26 1.5%
2016 42 1 8 2.4%
2017 38 1 13 2.6%
2018 41 4 16 9.8%
2019 21 1 5 4.8%
2020 20 0 10 N/A
2021 21 1 5 4.8%
2022 14 0 4 N/A
2023 5 0 2 N/A
2024 11 1 7 9.1%
2025 4 0 1 N/A
Total 4,185 34 346 0.8%

FDA approval date: Apr 8, 2016.

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