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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.

SIROLIMUS: Side Effect Reports by Year

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Year-by-year breakdown of FAERS adverse event reports for SIROLIMUS. Total: 11,371 reports.

Year Reports Deaths Hospitalizations Death Rate
2000 11 1 6 9.1%
2001 15 1 11 6.7%
2002 8 0 4 N/A
2003 20 7 11 35.0%
2004 23 3 16 13.0%
2005 32 5 15 15.6%
2006 27 9 17 33.3%
2007 10 1 3 10.0%
2008 44 9 28 20.5%
2009 42 8 21 19.0%
2010 43 5 21 11.6%
2011 53 4 29 7.5%
2012 74 10 40 13.5%
2013 106 15 51 14.2%
2014 162 20 83 12.3%
2015 311 40 182 12.9%
2016 294 33 143 11.2%
2017 279 47 115 16.8%
2018 385 50 156 13.0%
2019 352 33 106 9.4%
2020 231 45 86 19.5%
2021 160 40 76 25.0%
2022 220 61 101 27.7%
2023 141 14 59 9.9%
2024 135 25 50 18.5%
2025 46 11 13 23.9%
Total 11,371 1,737 3,535 15.3%

FDA approval date: Aug 22, 2002.

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