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.