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Table 4 Safety of intravenous tacrolimus

From: Intravenous tacrolimus is a superior induction therapy for acute severe ulcerative colitis compared to oral tacrolimus

  Oral (N = 22) Intravenous (N = 65) p value
Whole adverse events 8 (36%) 20 (31%) 0.79
Tremor 4 (18%) 8 (12%) 0.49
Nausea 1 (5%) 3 (5%) 1
Hot flush 1 (5%) 2 (3%) 1
Kidney disorder 2 (9%) 2 (3%) 0.26
Peripheral neuropathy 1 (5%) 2 (3%) 1
Headache   1 (2%)  
Tachycardia   1 (2%)  
Rash   1 (2%)  
Hematopenia   1 (2%)  
Pneumonia   1 (2%)  
  1. Less than one-third of patients experienced adverse events in both tacrolimus groups during the study. Most adverse events were non-serious, including tremors, nausea, hot flashes, and peripheral neuropathies, and did not require tacrolimus discontinuation or additional treatment. Kidney disorder was a common adverse event; four patients had slight kidney disorders that recovered with dose reduction of tacrolimus and did not require tacrolimus discontinuation. One patient had pneumonia which required discontinuation of tacrolimus and colectomy
  2. Categorical variables were compared using Fischer’s exact test