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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.

BEDAQUILINE: Side Effect Reports by Year

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Year-by-year breakdown of FAERS adverse event reports for BEDAQUILINE. Total: 3,655 reports.

Year Reports Deaths Hospitalizations Death Rate
2001 1 0 0 N/A
2009 1 1 1 100.0%
2011 1 0 0 N/A
2012 5 0 4 N/A
2013 7 0 4 N/A
2014 12 3 3 25.0%
2015 59 14 21 23.7%
2016 157 59 70 37.6%
2017 274 104 153 38.0%
2018 634 209 259 33.0%
2019 515 105 196 20.4%
2020 180 47 69 26.1%
2021 110 25 44 22.7%
2022 200 41 85 20.5%
2023 223 76 91 34.1%
2024 204 82 54 40.2%
2025 73 33 15 45.2%
Total 3,655 1,137 1,250 31.1%

FDA approval date: Dec 28, 2012.

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