Abstract: Objective To analyze the characteristics of adverse drug reactions (ADR) from a Grade III Level A maternal and child health hospital in Shanghai, so as to provide reference for the safe and rational drug use in female patients. Methods A total of 133 cases of ADR reported to the National Adverse Drug Reaction Monitoring System from January 1, 2022 to June 30, 2024 by the hospital were collected. Retrospective analysis was conducted on patients’ gender, age,reasons for medication, classifications of suspected drugs, routes of administration, time of ADR, involved system-organs and clinical manifestations, and ADR prognosis. Results Among the 133 cases of ADR, most patients were woman over 18 years old. The most used drugs were for anti-gynecological tumors therapy and anti-infection therapy, with the ages of major patients being over 45 years old (66.67%) and 18 to 44 years old (74.57%), respectively. A total of 73 drugs and 183 times of administration were involved. The most used suspected drugs were anti-tumor drugs docetaxel injection and paclitaxel injection. The main administration route was intravenous infusion (81.97%). 70.68% of the ADR occurred within one day after medication.The skin and its appendages were most affected (32.35%). There were 16 serious ADR cases (12.03%), 13 of which involved tumor chemotherapy drugs. Most of the symptoms were relieved after drug withdrawal or treatment. Conclusion Women suffering from gynecological tumor diseases are prone to ADR when using chemotherapy drugs, therefore, ADR monitoring and prediction should be strengthened. As to medication for pregnant and parturient women, much attention should be paid to drugs with high incidence of ADR to promote safe and rational drug use in clinic.

Key words: Female Patients, Gynecological Tumor Diseases, Pregnant and Parturient Women, Paclitaxel Injection, Docetaxel Injection, Anti-Infection, Adverse Drug Reaction, Rational Drug Use