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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.

ENTECAVIR: Side Effect Reports by Year

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Year-by-year breakdown of FAERS adverse event reports for ENTECAVIR. Total: 4,487 reports.

Year Reports Deaths Hospitalizations Death Rate
2001 1 0 0 N/A
2002 10 0 10 N/A
2003 1 0 0 N/A
2004 7 0 2 N/A
2005 4 0 2 N/A
2006 11 0 9 N/A
2007 17 2 9 11.8%
2008 20 2 8 10.0%
2009 34 0 4 N/A
2010 27 2 5 7.4%
2011 25 4 8 16.0%
2012 24 1 8 4.2%
2013 57 7 23 12.3%
2014 166 55 57 33.1%
2015 188 35 86 18.6%
2016 163 38 61 23.3%
2017 156 14 46 9.0%
2018 239 21 57 8.8%
2019 274 27 67 9.9%
2020 136 19 53 14.0%
2021 128 30 62 23.4%
2022 80 20 17 25.0%
2023 84 29 19 34.5%
2024 56 14 28 25.0%
2025 33 3 16 9.1%
Total 4,487 726 1,133 16.2%

FDA approval date: Aug 10, 2020.

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ENTECAVIR Full Profile Patient Demographics Drug Interactions