IVACAFTOR: Side Effect Reports by Year
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Year-by-year breakdown of FAERS adverse event reports for IVACAFTOR. Total: 6,735 reports.
| Year | Reports | Deaths | Hospitalizations | Death Rate |
|---|---|---|---|---|
| 2005 | 1 | 0 | 1 | N/A |
| 2012 | 29 | 0 | 7 | N/A |
| 2013 | 45 | 1 | 20 | 2.2% |
| 2014 | 260 | 13 | 108 | 5.0% |
| 2015 | 297 | 12 | 142 | 4.0% |
| 2016 | 172 | 3 | 87 | 1.7% |
| 2017 | 334 | 10 | 149 | 3.0% |
| 2018 | 434 | 15 | 217 | 3.5% |
| 2019 | 759 | 15 | 383 | 2.0% |
| 2020 | 570 | 29 | 397 | 5.1% |
| 2021 | 384 | 18 | 273 | 4.7% |
| 2022 | 362 | 21 | 252 | 5.8% |
| 2023 | 342 | 21 | 222 | 6.1% |
| 2024 | 377 | 20 | 205 | 5.3% |
| 2025 | 121 | 4 | 93 | 3.3% |
| Total | 6,735 | 291 | 3,756 | 4.3% |
FDA approval date: Apr 29, 2019.