Research Article
A Real-World Safety Analysis of Upadacitinib Based on FDA Adverse Event Reporting System (FAERS)
Table 1
Clinical characteristics of reports with upadacitinib from the FAERS database.
| | Number of events | 23683 |
| | Gender | | | Female | 17202 (72.63%) | | Male | 5260 (22.21%) | | Unknown | 1221 (5.16%) | | Age (years) | | | <20 | 112 (0.47%) | | 20≤ and <40 | 733 (3.10%) | | ≥40 | 9478 (40.02) | | Unknown | 13360 (56.41%) | | Indications (top four) | | | Rheumatoid arthritis | 21085 (63.45%) | | COVID-19 immunisation | 7172 (21.58%) | | Psoriatic arthropathy | 1154 (3.47%) | | Dermatitis atopic | 1012 (3.05%) | | Serious outcome | | | Other serious medical events | 8707 (36.76%) | | Hospitalization | 4872 (20.57%) | | Death | 773 (3.26%) | | Disability | 226 (0.95%) | | Life-threatening | 140 (0.59%) | | Required intervention to prevent permanent impairment/damage | 13 (0.05%) | | Congenital anomaly | 4 (0.02%) | | Reported countries (top five) | | | US (America) | 17626 (74.42%) | | CA (Canada) | 1681 (7.10%) | | BR (Brazil) | 650 (2.74%) | | DE (Germany) | 626 (2.64%) | | JP (Japan) | 412 (1.74%) | | FR (France) | 144 (0.61%) | | Reported person | | | Consumer | 18097 (76.41%) | | Physician | 2398 (10.13%) | | Pharmacist | 2039 (8.61%) | | Other health-professional | 11 (0.05%) | | Lawyer | 1 (<0.01%) | | Reporting year | | | 2022 | 15864 (66.98%) | | 2021 | 5351 (22.59%) | | 2020 | 2302 (9.72%) | | 2019 | 164 (0.69%) |
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