ISOTRETINOIN: Side Effect Reports by Year
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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.