Abstract: Objective To investigate the clinical characteristics and regularity of adverse reactions in children with drug-induced liver injury (DILI), and to provide a theoretical reference for the safe and rational use of drugs by clinical pediatricians. Methods The clinical data of 114 children with DILI admitted to our hospital from January 2020~December 2022 were collected, including gender, age, history of underlying diseases, medication time, drug type, mode of administration, clinical manifestations, treatment outcomes, etc., and the clinical characteristics and regularities of DILI occurrence were summarized. Methods Among the 114 patients, 69 (60.5%) were 13~18 years old, with 33 males and 36 females, accounting for the largest proportion. 10 cases (8.8%) that were ≤ 1 year of age accounted for the lowest proportion. Respiratory tract infection affected 31 cases (27.2%) was the most common underlying disease. Ninety-nine cases (86.8%) had clinical symptoms and 15 cases (13.2%) had no obvious symptoms. The clinical symptoms included decreased appetite, fatigue, fever, vomiting, jaundice, rash, nausea and abdominal distention; Among the 114 patients, there were 97 cases (85.1%) of hepatocellular injury type, 6 cases (5.3%) of cholestatic type, and 11 cases (9.6%) of mixed type. The serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) levels of patients with hepatocellular injury was (531.7±149.6) U/L, (765.6±217.5) U/L, and (330.4±187.5) U/L, respectively, which was significantly higher than those of cholestatic type [(296.1±105.5) U/L, (123.4±79.1) and (301.2±101.3) U/L, respectively] and those of mixed type [(167.9±72.8) U/L, (358.2±104.7) U/L, and (198.3±171.6)U/L, respectively]( All P<0.05). Among the 114 patients, 65 (74.1%) patients improved, 32 (28.1%) patients were cured, 4 (3.5%) patients were uncured, and 13 (11.5%) patients had unknown clinical outcomes. The drug categories that caused DILI in children were antibacterial drugs (26.7%), traditional Chinese medicines (21.6%), antipyretic analgesics (18.8%), tumor chemotherapy drugs (11.9%), anti-tuberculosis drugs (10.2%), psychiatric drugs (5.7%), antivirals (2.8%) and hormones (2.27%). The causal drugs were administered orally in ninety-three cases (52.8%), accounting for the largest proportion, and the number of onset days was (30.2±8.9) days; The minimum proportion was 1 case (0.5%) who was administered by subcutaneous injection, and the number of onset days was (20.0±0.0) days. Conclusion Clinicians should be cautious about the use of drugs in children. Children's own factors, drug factors and clinical characteristics should all be considered. Active drug publicity and regular testing are necessary for the prevention, early diagnosis and treatment of DILI in children, and to ensure the safety of children's medication.

Key words: Drug-induced liver injury, Clinical features, Child, Rational use of medicines