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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.

REGORAFENIB: Side Effect Reports by Year

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Year-by-year breakdown of FAERS adverse event reports for REGORAFENIB. Total: 9,441 reports.

Year Reports Deaths Hospitalizations Death Rate
2002 2 0 0 N/A
2004 1 0 0 N/A
2006 4 1 0 25.0%
2007 1 0 0 N/A
2008 3 0 1 N/A
2010 2 1 1 50.0%
2011 7 1 0 14.3%
2012 44 8 28 18.2%
2013 278 83 151 29.9%
2014 532 150 269 28.2%
2015 707 170 302 24.0%
2016 539 121 238 22.4%
2017 765 144 331 18.8%
2018 687 117 284 17.0%
2019 608 115 255 18.9%
2020 522 103 203 19.7%
2021 496 61 229 12.3%
2022 431 79 198 18.3%
2023 334 50 137 15.0%
2024 282 72 106 25.5%
2025 161 50 64 31.1%
Total 9,441 1,869 3,363 19.8%

FDA approval date: Jan 13, 2025.

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