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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.

PROMETHAZINE: Side Effect Reports by Year

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Year-by-year breakdown of FAERS adverse event reports for PROMETHAZINE. Total: 7,796 reports.

Year Reports Deaths Hospitalizations Death Rate
2000 3 0 2 N/A
2001 8 0 4 N/A
2002 1 0 0 N/A
2003 5 2 1 40.0%
2004 5 0 1 N/A
2005 9 3 3 33.3%
2006 10 6 3 60.0%
2007 12 1 3 8.3%
2008 16 6 5 37.5%
2009 23 0 18 N/A
2010 19 3 15 15.8%
2011 38 9 15 23.7%
2012 141 125 5 88.7%
2013 50 20 12 40.0%
2014 88 9 24 10.2%
2015 80 9 31 11.3%
2016 112 20 45 17.9%
2017 90 20 34 22.2%
2018 2,031 35 1,905 1.7%
2019 1,421 43 1,297 3.0%
2020 162 62 65 38.3%
2021 159 67 65 42.1%
2022 106 24 16 22.6%
2023 136 29 70 21.3%
2024 127 12 66 9.4%
2025 37 1 13 2.7%
Total 7,796 1,206 4,470 15.5%

FDA approval date: Approved Prior to Jan 1, 1982.

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