Research Article

A Real-World Safety Analysis of Upadacitinib Based on FDA Adverse Event Reporting System (FAERS)

Table 3

Signal strength of reports of upadacitinib at the preferred terms level in FAERS database.

SOCPreferred terms (PTs)NROR (95% one-sided CI)PRR (χ2)IC (IC025)EBGM (EBGM05)

Infections and infestationsCOVID-1917195.39 (5.14)5.28 (9105.87)2.38 (2.31)5.21 (5)
Urinary tract infection6304.43 (4.09)4.4 (1108.22)2.12 (2.01)4.35 (4.07)
Pneumonia5742.22 (2.05)2.21 (463.05)1.14 (1.02)2.2 (2.06)
Nasopharyngitis4613.11 (2.84)3.1 (456.05)1.62 (1.49)3.08 (2.85)
Herpes zoster3987.73 (7)7.69 (560.05)2.91 (2.77)7.53 (6.93)
Infection3502.77 (2.49)2.76 (233.1)1.46 (1.31)2.75 (2.51)
Sinusitis3434.01 (3.6)3.99 (308.91)1.98 (1.83)3.95 (3.62)
Influenza2693.25 (2.89)3.25 (161.88)1.69 (1.52)3.22 (2.91)
Bronchitis1743.29 (2.83)3.28 (68.35)1.7 (1.49)3.26 (2.87)
Upper respiratory tract infection1444.33 (3.67)4.32 (57.17)2.1 (1.86)4.27 (3.72)
Localised infection1315.93 (4.99)5.92 (55.35)2.54 (2.3)5.83 (5.05)
Diverticulitis1215.2 (4.34)5.19 (44.56)2.36 (2.1)5.12 (4.41)
Ear infection1004.51 (3.71)4.51 (28.28)2.16 (1.88)4.46 (3.78)
COVID-19 pneumonia983.95 (3.24)3.95 (25)1.97 (1.69)3.91 (3.31)
Cystitis983.69 (3.02)3.69 (23.82)1.87 (1.59)3.66 (3.09)
Kidney infection945.2 (4.24)5.19 (26.89)2.36 (2.07)5.12 (4.32)
Oral herpes714.05 (3.21)4.05 (13.34)2 (1.67)4.01 (3.3)
Staphylococcal infection713.21 (2.54)3.21 (11.14)1.67 (1.34)3.18 (2.62)
Viral infection632.72 (2.12)2.72 (7.41)1.44 (1.09)2.71 (2.2)
Postprocedural infection628.47 (6.58)8.47 (13.96)3.05 (2.68)8.27 (6.69)
Tooth infection604.94 (3.83)4.94 (10.69)2.29 (1.93)4.88 (3.94)
Respiratory tract infection552.65 (2.03)2.65 (5.48)1.4 (1.03)2.64 (2.11)
Bacterial infection543.66 (2.8)3.66 (7.18)1.86 (1.48)3.63 (2.9)
Postoperative wound infection457.33 (5.46)7.33 (7.05)2.84 (2.42)7.18 (5.61)
Eye infection444.47 (3.32)4.47 (5.45)2.14 (1.72)4.42 (3.45)
Gastroenteritis viral443.52 (2.62)3.52 (4.63)1.8 (1.39)3.49 (2.72)

Neoplasms benign, malignant, and unspecified (including cysts and polyps)Skin cancer1534.88 (4.16)4.87 (69.02)2.27 (2.04)4.81 (4.21)
Basal cell carcinoma715.01 (3.96)5 (15.07)2.3 (1.97)4.94 (4.06)
Squamous cell carcinoma of skin509.54 (7.2)9.54 (9.35)3.21 (2.8)9.28 (7.33)
Malignant melanoma463.37 (2.52)3.37 (4.88)1.74 (1.34)3.34 (2.62)

Cardiac disordersMyocardial infarction2252.94 (2.58)2.94 (102.88)1.55 (1.36)2.92 (2.61)

Vascular disordersThrombosis2293.35 (2.94)3.34 (120.29)1.73 (1.54)3.32 (2.97)

Respiratory, thoracic, and mediastinal disordersLung disorder1042.59 (2.13)2.58 (18.98)1.36 (1.09)2.57 (2.19)
Chronic obstructive pulmonary disease992.63 (2.16)2.63 (17.56)1.39 (1.11)2.61 (2.21)
Pulmonary thrombosis777.09 (5.66)7.09 (20.42)2.8 (2.47)6.95 (5.75)
Pulmonary fibrosis634.47 (3.49)4.47 (11.17)2.14 (1.79)4.42 (3.59)
Respiratory disorder622.62 (2.04)2.62 (6.87)1.38 (1.04)2.61 (2.12)
Sinus disorder603.61 (2.79)3.6 (8.77)1.84 (1.48)3.57 (2.89)

Metabolism and nutrition disordersHypophagia552.83 (2.17)2.82 (5.89)1.49 (1.12)2.81 (2.25)

Nervous system disordersCerebrovascular accident2512.46 (2.17)2.46 (103.55)1.29 (1.11)2.45 (2.2)
Carpal tunnel syndrome1079.48 (7.82)9.47 (42.75)3.2 (2.93)9.22 (7.85)
Sciatica836.58 (5.29)6.57 (23.12)2.69 (2.38)6.46 (5.38)
Dysstasia763.2 (2.55)3.2 (12.73)1.67 (1.35)3.17 (2.63)
Nerve compression709.17 (7.23)9.16 (18.15)3.16 (2.81)8.93 (7.32)
Transient ischaemic attack563.1 (2.38)3.09 (6.71)1.62 (1.25)3.07 (2.47)

Skin and subcutaneous tissue disordersAcne3933.45 (3.12)3.44 (362.94)1.77 (1.63)3.41 (3.14)
Dermatitis atopic1253.41 (2.86)3.41 (36.41)1.76 (1.51)3.38 (2.92)
Skin disorder1204.18 (3.49)4.18 (38.89)2.05 (1.79)4.13 (3.55)
Eczema942.67 (2.18)2.66 (16.09)1.41 (1.12)2.65 (2.23)
Skin ulcer552.55 (1.96)2.55 (5.22)1.34 (0.98)2.54 (2.03)

Hepatobiliary disordersCholelithiasis482.63 (1.98)2.63 (4.13)1.39 (0.99)2.62 (2.06)

Renal and urinary disordersNephrolithiasis1363.37 (2.85)3.37 (42.68)1.74 (1.5)3.34 (2.9)

Eye disordersCataract3256.62 (5.93)6.59 (355.04)2.7 (2.54)6.48 (5.91)

Gastrointestinal disordersGastric disorder1103.15 (2.61)3.15 (26.33)1.65 (1.38)3.13 (2.67)

General disorders and administration site conditionsPain20483.09 (2.96)3.03 (8864.88)1.59 (1.52)3.01 (2.9)
Peripheral swelling6303.79 (3.5)3.76 (1001.38)1.9 (1.79)3.73 (3.49)
Illness4673.7 (3.38)3.68 (541.4)1.87 (1.74)3.65 (3.38)
Gait disturbance3682.46 (2.22)2.45 (221.91)1.29 (1.14)2.44 (2.24)
Unevaluable event2834.56 (4.06)4.55 (227.7)2.17 (2)4.5 (4.08)
Inflammation2635.33 (4.72)5.32 (212.95)2.39 (2.22)5.24 (4.73)
Swelling2332.62 (2.3)2.61 (96.57)1.38 (1.19)2.6 (2.33)
Gait inability1864.39 (3.79)4.38 (96.18)2.11 (1.91)4.33 (3.84)
Impaired healing953.99 (3.26)3.99 (23.65)1.98 (1.7)3.95 (3.33)
Hernia724.37 (3.46)4.36 (14.38)2.11 (1.78)4.32 (3.55)
Nodule615.44 (4.22)5.44 (11.57)2.42 (2.06)5.36 (4.34)
Cyst545.18 (3.96)5.18 (8.86)2.35 (1.97)5.11 (4.08)

Immune system disordersImmunodeficiency624.05 (3.15)4.05 (10.18)2 (1.65)4.01 (3.25)

Injury, poisoning, and procedural complicationsFall8393.23 (3.02)3.2 (1560.17)1.67 (1.57)3.18 (3)
Procedural pain1226.23 (5.2)6.22 (48.93)2.61 (2.36)6.11 (5.26)
Hip fracture1184.72 (3.94)4.72 (40.36)2.22 (1.96)4.66 (4)
Postprocedural complication1069.16 (7.55)9.15 (41.61)3.16 (2.88)8.91 (7.58)
Upper limb fracture915.27 (4.28)5.26 (25.36)2.38 (2.08)5.19 (4.36)
Road traffic accident862.92 (2.36)2.92 (14.92)1.54 (1.24)2.9 (2.43)
Spinal fracture845.03 (4.05)5.02 (21.13)2.31 (2)4.96 (4.14)
Limb injury823.1 (2.49)3.09 (14.38)1.62 (1.31)3.07 (2.56)
Joint injury814.44 (3.56)4.44 (18.38)2.13 (1.82)4.39 (3.65)
Ankle fracture806.29 (5.04)6.28 (21.12)2.63 (2.31)6.18 (5.13)
Femur fracture764.25 (3.39)4.24 (15.76)2.07 (1.75)4.2 (3.48)
Lower limb fracture745.02 (3.99)5.02 (16.39)2.31 (1.98)4.95 (4.09)
Tendon rupture709.82 (7.74)9.81 (18.45)3.25 (2.91)9.54 (7.82)
Head injury662.86 (2.24)2.85 (8.58)1.5 (1.17)2.84 (2.32)
Rib fracture633.63 (2.83)3.62 (9.71)1.85 (1.5)3.59 (2.92)
Foot fracture623.77 (2.94)3.77 (9.69)1.9 (1.55)3.74 (3.03)
Meniscus injury5910.38 (8.01)10.37 (13.27)3.33 (2.95)10.07 (8.1)
Joint dislocation587.23 (5.57)7.22 (11.66)2.82 (2.45)7.08 (5.7)
Wrist fracture454.57 (3.41)4.57 (5.77)2.18 (1.76)4.52 (3.53)
Muscle strain435.99 (4.43)5.98 (5.99)2.56 (2.13)5.89 (4.57)
Ligament sprain414.58 (3.36)4.57 (4.79)2.18 (1.74)4.52 (3.49)
Pelvic fracture406.94 (5.08)6.94 (5.47)2.77 (2.31)6.81 (5.24)
Back injury384.69 (3.41)4.69 (4.17)2.21 (1.76)4.64 (3.55)

InvestigationsBlood cholesterol increased2468.3 (7.31)8.27 (218.4)3.02 (2.83)8.09 (7.27)
SARS-CoV-2 test positive1856.14 (5.31)6.12 (111.88)2.59 (2.38)6.03 (5.33)
Hepatic enzyme increased1702.87 (2.47)2.86 (57.18)1.51 (1.29)2.85 (2.51)
Grip strength decreased12216.08 (13.4)16.05 (61.09)3.94 (3.67)15.32 (13.15)
Inflammatory marker increased5911.26 (8.68)11.25 (13.49)3.44 (3.06)10.89 (8.76)
Product residue present465.83 (4.36)5.83 (6.78)2.52 (2.1)5.74 (4.5)

Musculoskeletal and connective tissue disordersArthralgia17194.87 (4.64)4.77 (8660.33)2.24 (2.17)4.71 (4.52)
Rheumatoid arthritis131811.03 (10.44)10.83 (6692.69)3.39 (3.31)10.5 (10.03)
Pain in extremity12305.47 (5.16)5.38 (4697.75)2.41 (2.33)5.31 (5.06)
Musculoskeletal stiffness6508.04 (7.44)7.97 (1510.13)2.96 (2.85)7.8 (7.3)
Back pain5773.24 (2.98)3.22 (740.3)1.68 (1.56)3.2 (2.98)
Joint swelling4563.8 (3.46)3.78 (525.91)1.91 (1.77)3.75 (3.47)
Mobility decreased3906.38 (5.77)6.35 (504.31)2.64 (2.5)6.24 (5.74)
Arthritis3254.63 (4.15)4.61 (302.66)2.19 (2.03)4.56 (4.16)
Osteoarthritis2978.46 (7.54)8.43 (319.97)3.04 (2.88)8.23 (7.47)
Arthropathy2574.45 (3.93)4.43 (185.09)2.13 (1.96)4.39 (3.96)
Joint range of motion decreased23122.41 (19.61)22.34 (227.29)4.39 (4.19)20.91 (18.7)
Musculoskeletal disorder19712.51 (10.84)12.47 (153.29)3.59 (3.38)12.03 (10.68)
Joint stiffness1567.24 (6.18)7.23 (84.36)2.83 (2.6)7.09 (6.2)
Intervertebral disc protrusion1429.11 (7.7)9.09 (74.56)3.15 (2.91)8.86 (7.7)
Systemic lupus erythematosus1423.83 (3.25)3.83 (51.38)1.92 (1.69)3.79 (3.3)
Neck pain1393.2 (2.7)3.19 (42.55)1.66 (1.43)3.17 (2.76)
Psoriatic arthropathy1052.53 (2.09)2.53 (18.79)1.33 (1.06)2.51 (2.14)
Rotator cuff syndrome879.91 (8.01)9.9 (28.56)3.27 (2.96)9.63 (8.05)
Back disorder836.43 (5.17)6.42 (22.93)2.66 (2.35)6.31 (5.26)
Fibromyalgia814.03 (3.23)4.02 (17.3)1.99 (1.69)3.98 (3.32)
Foot deformity807.75 (6.21)7.75 (22.66)2.92 (2.6)7.58 (6.3)
Exostosis548.77 (6.69)8.77 (10.68)3.1 (2.7)8.55 (6.82)
Spinal stenosis527.38 (5.61)7.38 (9.43)2.85 (2.46)7.23 (5.74)
Finger deformity4711.59 (8.66)11.59 (8.61)3.49 (3.05)11.21 (8.78)
Intervertebral disc degeneration476.66 (4.99)6.65 (7.44)2.71 (2.29)6.53 (5.13)
Trigger finger4412.36 (9.14)12.35 (7.63)3.58 (3.12)11.92 (9.26)
Joint noise3412.09 (8.59)12.09 (4.54)3.55 (3.02)11.67 (8.76)
Joint lock3215.76 (11.05)15.75 (4.19)3.91 (3.34)15.04 (11.17)

Social circumstancesLoss of personal independence in daily activities3184.53 (4.05)4.51 (286.19)2.16 (2)4.46 (4.06)
Bedridden474.86 (3.64)4.85 (6.5)2.26 (1.85)4.79 (3.77)
Walking aid user419.39 (6.88)9.39 (6.26)3.19 (2.73)9.14 (7.05)
Surgical and medical proceduresTherapy interrupted6447.92 (7.32)7.85 (1476.08)2.94 (2.83)7.69 (7.2)
Surgery62713.87 (12.8)13.75 (1578.74)3.72 (3.61)13.21 (12.35)
Knee arthroplasty40024.85 (22.44)24.71 (687.74)4.52 (4.38)22.97 (21.08)
Spinal operation30225.47 (22.64)25.36 (392.85)4.56 (4.39)23.52 (21.32)
Hip arthroplasty20716.29 (14.17)16.25 (176.16)3.95 (3.75)15.49 (13.78)
Knee operation20226.83 (23.23)26.75 (176.5)4.63 (4.42)24.71 (21.91)
Foot operation9927.22 (22.16)27.18 (42.44)4.65 (4.34)25.08 (21.12)
Limb operation9926.8 (21.82)26.76 (42.39)4.63 (4.32)24.72 (20.81)
Shoulder operation8626.16 (20.99)26.13 (31.93)4.6 (4.26)24.18 (20.11)
Hip surgery8218 (14.4)17.98 (27.99)4.09 (3.76)17.05 (14.15)
Shoulder arthroplasty7436.24 (28.48)36.2 (24.17)5.02 (4.64)32.53 (26.59)
Spinal fusion surgery5820.29 (15.56)20.27 (14.19)4.26 (3.84)19.09 (15.29)
Neck surgery5325.46 (19.24)25.44 (12.1)4.56 (4.11)23.6 (18.67)
Eye operation5013.62 (10.26)13.61 (10.02)3.71 (3.28)13.08 (10.32)
Hysterectomy448.18 (6.06)8.18 (6.96)3 (2.56)7.99 (6.22)
Oral surgery4325.74 (18.86)25.73 (7.97)4.58 (4.06)23.84 (18.37)
Joint arthroplasty4029.79 (21.53)29.77 (6.97)4.77 (4.22)27.26 (20.78)
Cholecystectomy395.93 (4.32)5.93 (4.91)2.55 (2.09)5.84 (4.48)
Tooth extraction394.75 (3.46)4.75 (4.42)2.23 (1.78)4.69 (3.6)
Medical device implantation3630.7 (21.8)30.68 (5.66)4.81 (4.21)28.02 (21.04)
Dental operation3620.79 (14.83)20.78 (5.48)4.29 (3.74)19.54 (14.73)
Ankle operation3126.88 (18.62)26.86 (4.16)4.63 (3.99)24.81 (18.25)

Note. New and significant signals of upadacitinib-associated AEs from FAERS database.