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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.

LORATADINE: Side Effect Reports by Year

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Year-by-year breakdown of FAERS adverse event reports for LORATADINE. Total: 25,422 reports.

Year Reports Deaths Hospitalizations Death Rate
2000 6 0 3 N/A
2001 5 0 1 N/A
2002 4 1 1 25.0%
2003 2 0 2 N/A
2004 4 1 0 25.0%
2005 5 0 1 N/A
2006 12 1 2 8.3%
2007 7 1 0 14.3%
2008 23 1 16 4.3%
2009 11 0 3 N/A
2010 17 0 0 N/A
2011 28 1 5 3.6%
2012 41 3 3 7.3%
2013 78 3 12 3.8%
2014 751 3 66 0.4%
2015 1,607 11 35 0.7%
2016 1,703 14 61 0.8%
2017 1,575 21 51 1.3%
2018 1,311 11 79 0.8%
2019 1,269 7 60 0.6%
2020 760 3 47 0.4%
2021 854 17 75 2.0%
2022 550 17 31 3.1%
2023 433 9 22 2.1%
2024 344 1 28 0.3%
2025 205 1 14 0.5%
Total 25,422 372 1,472 1.5%

FDA approval date: Apr 11, 2007.

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