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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.

OSIMERTINIB: Side Effect Reports by Year

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Year-by-year breakdown of FAERS adverse event reports for OSIMERTINIB. Total: 27,750 reports.

Year Reports Deaths Hospitalizations Death Rate
2000 1 0 0 N/A
2001 1 1 0 100.0%
2004 2 0 0 N/A
2005 2 0 0 N/A
2008 1 1 1 100.0%
2009 1 0 0 N/A
2010 3 2 0 66.7%
2011 1 0 0 N/A
2013 7 1 1 14.3%
2014 16 2 6 12.5%
2015 89 25 57 28.1%
2016 624 232 312 37.2%
2017 672 268 312 39.9%
2018 811 284 331 35.0%
2019 1,094 424 340 38.8%
2020 1,631 1,000 345 61.3%
2021 1,783 1,150 328 64.5%
2022 1,922 1,296 300 67.4%
2023 1,912 1,255 365 65.6%
2024 1,358 673 355 49.6%
2025 750 279 236 37.2%
Total 27,750 12,456 5,277 44.9%

FDA approval date: Nov 13, 2015.

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