Research Article
A Real-World Safety Analysis of Upadacitinib Based on FDA Adverse Event Reporting System (FAERS)
Table 2
Signal strength of AEs of upadacitinib at the system organ class (SOC) level in FAERS database.
| | SOC | N | ROR (95% one-sided CI) | PRR (χ2) | IC (IC025) | EBGM (EBGM05) |
| | General disorders and administration site conditions | 11072 | 1.23 (1.21) | 1.19 (17884.46) | 0.25 (0.22) | 1.19 (1.17) | | Musculoskeletal and connective tissue disordersa | 10720 | 4.54 (4.45) | 3.97 (313384.06) | 1.97 (1.94) | 3.94 (3.87) | | Infections and infestationsa | 8426 | 3.22 (3.15) | 2.94 (151011.89) | 1.54 (1.51) | 2.92 (2.87) | | Surgical and medical proceduresa | 4704 | 7.06 (6.85) | 6.63 (75323.39) | 2.7 (2.66) | 6.52 (6.35) | | Injury, poisoning, and procedural complications | 4416 | 0.69 (0.67) | 0.71 (16018.45) | −0.49 (−0.53) | 0.71 (0.69) | | Gastrointestinal disorders | 4060 | 0.98 (0.95) | 0.98 (24.55) | −0.03 (−0.08) | 0.98 (0.95) | | Nervous system disorders | 4026 | 1.04 (1.01) | 1.04 (149.02) | 0.06 (0.01) | 1.04 (1.01) | | Investigations | 3443 | 1.1 (1.07) | 1.1 (511.71) | 0.14 (0.09) | 1.1 (1.07) | | Skin and subcutaneous tissue disorders | 3108 | 1.01 (0.97) | 1.01 (4.8) | 0.01 (−0.04) | 1.01 (0.98) | | Respiratory, thoracic, and mediastinal disorders | 2907 | 1.22 (1.18) | 1.21 (1329.35) | 0.28 (0.23) | 1.21 (1.18) | | Neoplasms benign, malignant, and unspecified (including cysts and polyps) | 1333 | 0.54 (0.51) | 0.55 (5667.02) | −0.86 (−0.94) | 0.55 (0.52) | | Eye disorders | 1176 | 1.2 (1.13) | 1.19 (177.88) | 0.25 (0.17) | 1.19 (1.14) | | Psychiatric disorders | 1132 | 0.37 (0.35) | 0.38 (15636.93) | −1.37 (−1.46) | 0.38 (0.36) | | Cardiac disorders | 1117 | 1.07 (1.01) | 1.07 (27.14) | 0.1 (0.01) | 1.07 (1.02) | | Vascular disorders | 1092 | 1.1 (1.04) | 1.1 (51.1) | 0.14 (0.05) | 1.1 (1.05) | | Metabolism and nutrition disorders | 719 | 0.7 (0.65) | 0.71 (400.51) | −0.49 (−0.6) | 0.71 (0.67) | | Renal and urinary disorders | 693 | 0.62 (0.57) | 0.62 (815.32) | −0.68 (−0.79) | 0.62 (0.58) | | Social circumstancesa | 562 | 2.28 (2.09) | 2.26 (462.9) | 1.17 (1.05) | 2.26 (2.1) | | Immune system disorders | 435 | 0.7 (0.63) | 0.7 (160.58) | −0.51 (−0.65) | 0.7 (0.64) | | Blood and lymphatic system disorders | 427 | 0.47 (0.43) | 0.48 (997.85) | −1.06 (−1.19) | 0.48 (0.44) | | Hepatobiliary disorders | 305 | 0.72 (0.64) | 0.72 (64.17) | −0.47 (−0.63) | 0.72 (0.65) | | Ear and labyrinth disorders | 302 | 1.41 (1.26) | 1.41 (36.32) | 0.49 (0.33) | 1.4 (1.28) | | Reproductive system and breast disorders | 236 | 0.69 (0.61) | 0.69 (49.02) | −0.52 (−0.71) | 0.69 (0.62) | | Product issues | 89 | 0.09 (0.07) | 0.09 (3332.65) | −3.38 (−3.67) | 0.09 (0.08) | | Endocrine disorders | 86 | 0.63 (0.51) | 0.63 (11.13) | −0.65 (−0.95) | 0.63 (0.53) | | Pregnancy, puerperium, and perinatal conditions | 35 | 0.18 (0.13) | 0.18 (114.07) | −2.45 (−2.89) | 0.18 (0.13) | | Congenital, familial, and genetic disorders | 33 | 0.22 (0.15) | 0.22 (62.32) | −2.17 (−2.62) | 0.22 (0.16) |
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Notes: aindicates statistically significant signals with four algorithms.
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