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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.

ROFLUMILAST: Side Effect Reports by Year

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Year-by-year breakdown of FAERS adverse event reports for ROFLUMILAST. Total: 2,700 reports.

Year Reports Deaths Hospitalizations Death Rate
2000 1 0 0 N/A
2002 2 0 0 N/A
2003 1 0 1 N/A
2006 2 0 1 N/A
2007 2 0 1 N/A
2008 1 0 1 N/A
2009 2 1 1 50.0%
2010 10 0 5 N/A
2011 11 4 6 36.4%
2012 29 6 12 20.7%
2013 96 11 68 11.5%
2014 195 33 108 16.9%
2015 110 12 55 10.9%
2016 101 8 40 7.9%
2017 78 6 17 7.7%
2018 62 9 15 14.5%
2019 73 8 16 11.0%
2020 59 28 12 47.5%
2021 97 62 6 63.9%
2022 96 61 13 63.5%
2023 118 69 9 58.5%
2024 73 9 5 12.3%
2025 51 1 8 2.0%
Total 2,700 645 625 23.9%

FDA approval date: Apr 17, 2023.

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