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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.

NITISINONE: Side Effect Reports by Year

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Year-by-year breakdown of FAERS adverse event reports for NITISINONE. Total: 752 reports.

Year Reports Deaths Hospitalizations Death Rate
2008 3 0 2 N/A
2009 1 0 1 N/A
2010 2 0 1 N/A
2012 10 1 2 10.0%
2013 14 1 1 7.1%
2014 23 2 10 8.7%
2015 37 3 12 8.1%
2016 35 7 13 20.0%
2017 42 3 15 7.1%
2018 60 5 18 8.3%
2019 29 7 12 24.1%
2020 15 4 3 26.7%
2021 8 4 0 50.0%
2022 10 0 2 N/A
2023 15 1 4 6.7%
2024 12 0 8 N/A
2025 8 0 2 N/A
Total 752 96 198 12.8%

FDA approval date: Apr 22, 2016.

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