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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.

SAPROPTERIN: Side Effect Reports by Year

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Year-by-year breakdown of FAERS adverse event reports for SAPROPTERIN. Total: 5,539 reports.

Year Reports Deaths Hospitalizations Death Rate
2005 1 0 0 N/A
2009 3 0 1 N/A
2010 1 0 0 N/A
2011 3 0 0 N/A
2012 9 0 3 N/A
2013 31 0 3 N/A
2014 132 1 11 0.8%
2015 163 3 13 1.8%
2016 171 2 26 1.2%
2017 215 1 27 0.5%
2018 237 5 27 2.1%
2019 206 2 23 1.0%
2020 221 4 23 1.8%
2021 141 2 15 1.4%
2022 104 5 18 4.8%
2023 129 3 9 2.3%
2024 87 2 10 2.3%
2025 53 1 8 1.9%
Total 5,539 60 339 1.1%

FDA approval date: Apr 29, 2025.

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