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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.

LACTULOSE: Side Effect Reports by Year

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Year-by-year breakdown of FAERS adverse event reports for LACTULOSE. Total: 3,983 reports.

Year Reports Deaths Hospitalizations Death Rate
2000 2 0 2 N/A
2001 25 1 16 4.0%
2006 45 0 3 N/A
2008 6 0 6 N/A
2009 8 1 1 12.5%
2010 4 0 3 N/A
2011 6 1 4 16.7%
2012 18 1 13 5.6%
2013 14 0 6 N/A
2014 53 14 23 26.4%
2015 109 16 63 14.7%
2016 196 25 103 12.8%
2017 125 8 69 6.4%
2018 188 26 103 13.8%
2019 154 26 83 16.9%
2020 321 110 197 34.3%
2021 105 14 44 13.3%
2022 90 6 47 6.7%
2023 106 2 38 1.9%
2024 56 2 24 3.6%
2025 24 1 12 4.2%
Total 3,983 517 2,064 13.0%

FDA approval date: Approved Prior to Jan 1, 1982.

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