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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.

VARENICLINE: Side Effect Reports by Year

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Year-by-year breakdown of FAERS adverse event reports for VARENICLINE. Total: 20,408 reports.

Year Reports Deaths Hospitalizations Death Rate
2000 10 0 1 N/A
2001 5 0 1 N/A
2002 3 0 0 N/A
2003 5 0 0 N/A
2004 7 0 3 N/A
2005 12 0 5 N/A
2006 33 2 6 6.1%
2007 90 4 18 4.4%
2008 193 10 31 5.2%
2009 143 9 37 6.3%
2010 132 6 24 4.5%
2011 166 11 39 6.6%
2012 126 5 18 4.0%
2013 169 5 47 3.0%
2014 755 30 167 4.0%
2015 857 26 153 3.0%
2016 688 23 116 3.3%
2017 697 15 94 2.2%
2018 584 12 98 2.1%
2019 528 16 102 3.0%
2020 349 4 68 1.1%
2021 449 4 73 0.9%
2022 393 2 11 0.5%
2023 354 0 10 N/A
2024 298 2 11 0.7%
2025 109 0 6 N/A
Total 20,408 458 1,754 2.2%

FDA approval date: Apr 8, 2025.

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