ROFLUMILAST: Side Effect Reports by Year
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Year-by-year breakdown of FAERS adverse event reports for ROFLUMILAST. Total: 2,700 reports.
| Year | Reports | Deaths | Hospitalizations | Death Rate |
|---|---|---|---|---|
| 2000 | 1 | 0 | 0 | N/A |
| 2002 | 2 | 0 | 0 | N/A |
| 2003 | 1 | 0 | 1 | N/A |
| 2006 | 2 | 0 | 1 | N/A |
| 2007 | 2 | 0 | 1 | N/A |
| 2008 | 1 | 0 | 1 | N/A |
| 2009 | 2 | 1 | 1 | 50.0% |
| 2010 | 10 | 0 | 5 | N/A |
| 2011 | 11 | 4 | 6 | 36.4% |
| 2012 | 29 | 6 | 12 | 20.7% |
| 2013 | 96 | 11 | 68 | 11.5% |
| 2014 | 195 | 33 | 108 | 16.9% |
| 2015 | 110 | 12 | 55 | 10.9% |
| 2016 | 101 | 8 | 40 | 7.9% |
| 2017 | 78 | 6 | 17 | 7.7% |
| 2018 | 62 | 9 | 15 | 14.5% |
| 2019 | 73 | 8 | 16 | 11.0% |
| 2020 | 59 | 28 | 12 | 47.5% |
| 2021 | 97 | 62 | 6 | 63.9% |
| 2022 | 96 | 61 | 13 | 63.5% |
| 2023 | 118 | 69 | 9 | 58.5% |
| 2024 | 73 | 9 | 5 | 12.3% |
| 2025 | 51 | 1 | 8 | 2.0% |
| Total | 2,700 | 645 | 625 | 23.9% |
FDA approval date: Apr 17, 2023.