OBJECTIVE: To analyze the characteristics and laws of ADR induced by monoclonal antitumor drugs, and to provide reference for clinical medication safety. METHODS: 148 cases of ADR induced by monoclonal antitumor drugs were selected from our hospital during Jan. 2012-Feb. 2016, and analyzed statistically in respects of patients’ gender and age, primary disease, drug kind, the occurrence of ADR, clinical manifestations, treatment and outcome, etc. RESULTS: Among 148 ADR cases, there were 80 male and 68 female with ratio of 1.176 5 ∶ 1. High-risk aged 50 to 59 years old (32.43%); of primary disease, the proportion of non-Hodgkin lymphoma was the highest (37.84%); 5 kinds of drugs were involved, among which ADR induced by Rituximab injection took up the highest proportion (47.97%); most of ADR occurred within 1 d after medication (54.73%); ADR mainly involved digestive system (41.89%); main clinical manifestations were chronic hepatic fibrosis, loss of appetite, constipation, nausea and vomiting; there were 9 severe ADR cases (6.08%), 5 new general ADR cases (3.38%) and 2 new severe ADR cases (1.35%). After symptomatic treatment, the total effective rate was 98.65%. CONCLUSIONS: ADR induced by monoclonal antitumor drugs appear in all ages, the primary disease is wide; it causes multiple systems/orgars involved and complex clinical manifestations, great harm. Therefore, great importance should be attached to rational drug use monitoring and countermeasures in order to improve the safety of drug use.