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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.

DIROXIMEL: Side Effect Reports by Year

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Year-by-year breakdown of FAERS adverse event reports for DIROXIMEL. Total: 10,626 reports.

Year Reports Deaths Hospitalizations Death Rate
2004 2 0 0 N/A
2009 1 0 1 N/A
2013 2 0 1 N/A
2014 3 0 1 N/A
2015 5 0 1 N/A
2016 4 0 3 N/A
2017 6 1 3 16.7%
2018 13 0 6 N/A
2019 43 2 10 4.7%
2020 297 3 55 1.0%
2021 1,257 27 225 2.1%
2022 1,299 59 310 4.5%
2023 1,064 47 243 4.4%
2024 796 36 213 4.5%
2025 307 20 82 6.5%
Total 10,626 305 2,113 2.9%

FDA approval date: Nov 12, 2025.

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