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. 2023 Jan 10;29(11):1730–1740. doi: 10.1093/ibd/izac269

Table 4.

Adverse events, infectious diseases, and other disorders reported during VDZ therapy.

Adverse Event UC (n = 147) CD (n = 127) Total
Infusion reaction and hypersensitivity 2 (1.4) 0 (0) 2 (0.7)
HBV reactivation 0 (0) 1 (0.8) 1 (0.4)
HCV reactivation 0 (0) 0 (0) 0 (0)
TB reactivation 0 (0) 0 (0) 0 (0)
Upper respiratory tract infection 0 (0) 1 (0.8) 1 (0.4)
Gastrointestinal tract infection 0 (0) 2 (1.6) 2 (0.7)
Others
 Hair loss 0 (0) 1 (0.8) 1 (0.4)
 Headache 1 (0.7) 0 (0) 1 (0.4)
SAE
 Pneumonia 0 (0) 0 (0) 0 (0)
 Opportunistic infection 0 (0) 1 (0.8) 1 (0.4)
 Intractable infection 0 (0) 1 (0.8) 1 (0.4)
 Intra-abdominal abscess 0 (0) 1 (0.8) 1 (0.4)
 Intestinal perforation 1 (0.7) 0 (0) 1 (0.4)
 Malignancy 0 (0) 0 (0) 0 (0)
 Mortality 0 (0) 0 (0) 0 (0)

Values are n (%).

Abbreviations: CD, Crohn’s disease; HBV, hepatitis B virus; HCV, hepatitis C virus; SAE, serious adverse event; TB, tuberculosis; UC, ulcerative colitis; VDZ, vedolizumab.