Incidence, clinical features and risk factors of tacrolimus induced idiosyncratic liver injury in renal transplant recipients: A nested case-control study.

Rare data reported tacrolimus-induced liver injury (tac-DILI) in real world. We performed a nested case-control analysis of 1,010 renal transplant recipients. Recipients with tac-DILI were randomly matched at a ratio of 1:4 by the year of admission to the remaining recipients without tac-DILI to explore risk factors. The incidence of tac-DILI was 8.9% (95% CI = 7.2-10.7%). The most common type was cholestatic pattern (6.7%, 95% CI = 5.2-8.3%), followed by hepatocellular (1.6%, 95% CI = 0.8-2.4%) and mixed patterns (0.6%, 95% CI = 0.1-1.1%). 98.9% of recipients with tac-DILI have mild severity. The latency period were 42.0 (range, 21.5-99.8 days), 14.0 (range, 9.0-80.3 days), 16.0 (range, 11.5-24.5 days), and 49.0 days (range, 28.0-105.6 days) for total, hepatocellular, mixed, and cholestatic patterns, respectively. Baseline ALP level (OR = 1.015, 95% CI = 1.006-1.025, = 0.002), age (OR = 0.971, 95% CI = 0.949-0.994 = 0.006), and body weight (OR = 0.960, 95% CI = 0.940-0.982, < 0.001) were independent risk factors. In conclusion, cholestatic pattern represents the most frequent type of tac-DILI. Young age, low body weight and abnormal baseline ALP level were risk factors.