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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.

SOFOSBUVIR: Side Effect Reports by Year

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Year-by-year breakdown of FAERS adverse event reports for SOFOSBUVIR. Total: 17,291 reports.

Year Reports Deaths Hospitalizations Death Rate
2000 1 0 0 N/A
2003 3 0 1 N/A
2005 1 0 1 N/A
2006 1 0 0 N/A
2008 7 0 5 N/A
2009 3 2 1 66.7%
2010 4 0 0 N/A
2011 3 1 2 33.3%
2012 27 0 13 N/A
2013 45 5 22 11.1%
2014 2,514 192 914 7.6%
2015 2,517 330 1,064 13.1%
2016 2,322 190 628 8.2%
2017 528 48 202 9.1%
2018 140 15 46 10.7%
2019 49 6 18 12.2%
2020 16 0 4 N/A
2021 12 0 3 N/A
2022 9 1 4 11.1%
2023 4 0 0 N/A
2024 3 2 0 66.7%
Total 17,291 1,642 4,103 9.5%

FDA approval date: Aug 28, 2019.

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