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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.

HYDROXYUREA: Side Effect Reports by Year

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Year-by-year breakdown of FAERS adverse event reports for HYDROXYUREA. Total: 5,966 reports.

Year Reports Deaths Hospitalizations Death Rate
2000 4 0 1 N/A
2002 4 1 1 25.0%
2003 7 2 3 28.6%
2004 6 0 3 N/A
2005 9 0 1 N/A
2006 8 1 2 12.5%
2007 5 0 3 N/A
2008 13 3 7 23.1%
2009 11 2 3 18.2%
2010 10 1 3 10.0%
2011 30 11 13 36.7%
2012 30 1 7 3.3%
2013 72 11 40 15.3%
2014 167 28 95 16.8%
2015 183 27 85 14.8%
2016 212 38 112 17.9%
2017 243 20 97 8.2%
2018 268 30 143 11.2%
2019 290 29 138 10.0%
2020 257 39 122 15.2%
2021 206 11 78 5.3%
2022 226 28 100 12.4%
2023 172 15 95 8.7%
2024 131 5 81 3.8%
2025 46 3 19 6.5%
Total 5,966 664 2,103 11.1%

FDA approval date: Approved Prior to Jan 1, 1982.

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