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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.

URSODIOL: Side Effect Reports by Year

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Year-by-year breakdown of FAERS adverse event reports for URSODIOL. Total: 3,624 reports.

Year Reports Deaths Hospitalizations Death Rate
2000 1 0 0 N/A
2001 17 1 17 5.9%
2004 2 0 1 N/A
2006 2 0 1 N/A
2007 5 3 0 60.0%
2008 1 0 0 N/A
2009 13 0 12 N/A
2010 5 0 1 N/A
2011 17 6 12 35.3%
2012 10 1 5 10.0%
2013 39 5 16 12.8%
2014 72 10 46 13.9%
2015 119 14 71 11.8%
2016 147 9 55 6.1%
2017 145 15 77 10.3%
2018 147 20 56 13.6%
2019 141 24 73 17.0%
2020 83 5 38 6.0%
2021 80 11 41 13.8%
2022 134 38 68 28.4%
2023 71 4 41 5.6%
2024 110 2 51 1.8%
2025 36 13 6 36.1%
Total 3,624 539 1,257 14.9%

FDA approval date: Aug 14, 2024.

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