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.

ISOTRETINOIN: 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 ISOTRETINOIN. Total: 34,934 reports.

Year Reports Deaths Hospitalizations Death Rate
2000 60 1 15 1.7%
2001 46 0 9 N/A
2002 66 1 22 1.5%
2003 43 2 15 4.7%
2004 36 2 4 5.6%
2005 35 2 6 5.7%
2006 36 1 10 2.8%
2007 33 0 11 N/A
2008 36 1 4 2.8%
2009 27 1 1 3.7%
2010 49 7 5 14.3%
2011 24 2 4 8.3%
2012 32 0 6 N/A
2013 144 2 12 1.4%
2014 1,075 10 47 0.9%
2015 1,275 10 71 0.8%
2016 1,276 12 52 0.9%
2017 1,409 8 70 0.6%
2018 1,744 10 67 0.6%
2019 1,629 22 71 1.4%
2020 864 7 47 0.8%
2021 1,131 11 35 1.0%
2022 1,311 7 49 0.5%
2023 1,337 10 44 0.7%
2024 1,448 8 38 0.6%
2025 847 7 14 0.8%
Total 34,934 301 1,450 0.9%

FDA approval date: Apr 11, 2003.

More About ISOTRETINOIN

ISOTRETINOIN Full Profile Patient Demographics Drug Interactions