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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.

DRONEDARONE: Side Effect Reports by Year

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Year-by-year breakdown of FAERS adverse event reports for DRONEDARONE. Total: 2,735 reports.

Year Reports Deaths Hospitalizations Death Rate
2002 1 0 0 N/A
2003 1 0 0 N/A
2004 1 0 1 N/A
2007 1 0 0 N/A
2008 4 0 1 N/A
2009 2 0 0 N/A
2010 26 2 13 7.7%
2011 36 5 11 13.9%
2012 18 1 7 5.6%
2013 73 8 36 11.0%
2014 139 10 56 7.2%
2015 125 5 44 4.0%
2016 112 6 29 5.4%
2017 83 3 36 3.6%
2018 75 4 35 5.3%
2019 47 5 13 10.6%
2020 31 0 6 N/A
2021 38 5 9 13.2%
2022 81 3 25 3.7%
2023 52 3 12 5.8%
2024 48 2 14 4.2%
2025 26 3 6 11.5%
Total 2,735 115 611 4.2%

FDA approval date: Jan 31, 2024.

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