Skip to content
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.

MONTELUKAST: Side Effect Reports by Year

Boost Your Natural Energy & Metabolism

Mitolyn — 6 exotic plants to unlock your body's fat-burning power. 90-day guarantee.

Try Mitolyn Now

Year-by-year breakdown of FAERS adverse event reports for MONTELUKAST. Total: 26,982 reports.

Year Reports Deaths Hospitalizations Death Rate
2000 30 0 20 N/A
2001 14 0 6 N/A
2002 29 2 21 6.9%
2003 30 2 10 6.7%
2004 25 2 12 8.0%
2005 51 2 34 3.9%
2006 34 0 10 N/A
2007 28 1 16 3.6%
2008 40 3 12 7.5%
2009 67 5 29 7.5%
2010 82 2 25 2.4%
2011 69 2 11 2.9%
2012 148 5 44 3.4%
2013 244 7 45 2.9%
2014 440 15 89 3.4%
2015 710 15 169 2.1%
2016 741 32 171 4.3%
2017 1,027 37 270 3.6%
2018 1,164 38 321 3.3%
2019 940 22 193 2.3%
2020 980 37 202 3.8%
2021 798 24 169 3.0%
2022 738 33 139 4.5%
2023 664 28 116 4.2%
2024 613 20 73 3.3%
2025 242 0 60 N/A
Total 26,982 873 7,555 3.2%

FDA approval date: Apr 18, 2017.

More About MONTELUKAST

MONTELUKAST Full Profile Patient Demographics Drug Interactions