Objective  To analyze the characteristics of serious adverse drug reactions(ADR) associated with antineoplastic drugs in Haikou area, and provide scientific basis for the safety re-evaluation of antineoplastic drugs.

  Methods  Serious ADR reports induced by antineoplastic drugs occurred in ADR Monitoring Center in Haikou City from 2017 to 2019 were retrieved, characteristics of ADR induced by antineoplastic drugs were analyzed.

  Results  The number of serious ADR reports induced by antineoplastic drugs in Haikou area was increased from 2017 to 2019. Serious ADR reports of 44 cases showed that the sex ratio was balanced, ADR usually concentrated in patients aged ≥ 60 years by way of intravenous administration, and mainly occurred within 1 h after medication. There were 8 categories of antineoplastic drugs with a total of 26 types in the 44 ADR reports, in which the top one category was platinum antineoplastic drugs. The main adverse reactions caused by antineoplastic drugs were anaphylactic shock, severe anaphylactic reaction, myelosuppression, high fever and so on. There were 21 patients with new and serious ADR unrecorded in medicine specification.

  Conclusion  It is necessary to know the ADR of antineoplastic drugs and principles of combined medication in clinical practice for physicians, and take adequate measures to deal with ADS, so as to protect the safety and health of the patients.