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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.

TROFINETIDE: Side Effect Reports by Year

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Year-by-year breakdown of FAERS adverse event reports for TROFINETIDE. Total: 4,764 reports.

Year Reports Deaths Hospitalizations Death Rate
2016 1 1 0 100.0%
2017 1 0 0 N/A
2018 1 0 1 N/A
2020 1 0 0 N/A
2021 2 0 0 N/A
2022 3 0 0 N/A
2023 723 7 165 1.0%
2024 555 5 105 0.9%
2025 207 3 36 1.4%
Total 4,764 27 581 0.6%

FDA approval date: Dec 11, 2025.

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