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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.

OMEGA-3-ACID ETHYL ESTERS: Side Effect Reports by Year

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Year-by-year breakdown of FAERS adverse event reports for OMEGA-3-ACID ETHYL ESTERS. Total: 2,207 reports.

Year Reports Deaths Hospitalizations Death Rate
2003 10 0 1 N/A
2004 1 0 0 N/A
2005 4 0 1 N/A
2006 10 1 8 10.0%
2007 26 1 25 3.8%
2008 57 0 56 N/A
2009 109 0 102 N/A
2010 79 0 71 N/A
2011 79 0 64 N/A
2012 75 0 67 N/A
2013 97 4 53 4.1%
2014 151 4 54 2.6%
2015 128 5 41 3.9%
2016 93 7 32 7.5%
2017 83 13 22 15.7%
2018 67 11 23 16.4%
2019 53 7 7 13.2%
2020 44 1 12 2.3%
2021 16 0 1 N/A
2022 8 0 1 N/A
2023 17 0 1 N/A
2024 6 0 0 N/A
2025 4 0 0 N/A
Total 2,207 79 789 3.6%

FDA approval date: Apr 7, 2014.

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