Abstract: Objective To analyze the data on adverse drug reactions caused by of drospirenone and ethinylestradiol tablets (II) in order to contribute to clinical rational application of this drug and to make recommendations for clinical application. Methods Case reports on adverse reactions associated with drospirenone and ethinylestradiol tablets (II) in Beijing between 2015 and 2018 were analyzed retrospectively. Results The adverse reactions caused by drospironone and ethinylestradiol tablets (II) were mainly manifested as reproductive system diseases, gastrointestinal diseases and nervous system diseases. Conclusion The adverse reactions induced by drospirenone and ethinylestradiol tablets are generally tolerable. Although low-dose drospironone and ethinylestradiol tablets cause fewer adverse reactions, the risk of venous thromboembolism remains. It is recommended that the risk of medication be assessed before use, a long-term, systematic follow-up be maintained with the patients, and high-quality reporting of adverse reactions be encouraged. In order to reduce the risk of drug use and promote the long-term rational use of drospirenone and ethinylestradiol (II), evidence should be updated and new adverse reactions should be added to the drug instructions.

Key words: drospirenone and ethinylestradiol tablets (II), adverse drug reactions(ADR), ADR reporting, rational clinical use