TABLE 3.
Basic information on ADEs related to upadacitinib used in IBD from the FAERS database (2019 Q3-2024 Q1).
| Factors | Case number | Case proportion |
|---|---|---|
| Year | ||
| 2019 | 2 | 0.1% |
| 2020 | 6 | 0.31% |
| 2021 | 11 | 0.57% |
| 2022 | 399 | 20.81% |
| 2023 | 1,135 | 59.21% |
| 2024 | 364 | 18.99% |
| Gender | ||
| female | 872 | 45.49% |
| male | 806 | 42.04% |
| unkown | 239 | 12.47% |
| Age (years) | ||
| <18 | 17 | 0.89% |
| 18–65 | 592 | 30.88% |
| ≥65 | 155 | 8.09% |
| Unknow | 1,153 | 60.15% |
| Reported countries | ||
| United States | 1,599 | 83.41% |
| Japan | 71 | 3.70% |
| Germany | 51 | 2.66% |
| Other | 196 | 10.22% |
| Reporter | ||
| Consumer | 1,127 | 58.79% |
| Physician | 466 | 24.31% |
| Pharmacist | 316 | 16.48% |
| Unknown | 8 | 0.42% |
| Serious outcomes | ||
| Hospitalization | 437 | 37.16% |
| Death | 48 | 4.08% |
| Life threatening | 16 | 1.36% |
| disability | 5 | 0.43% |
| Other serious | 667 | 56.72% |