Abstract: Objective To analyze the safety information of oral preparations of Calcium Dobesilate and provide reference for rational clinical drug use. Methods Individual cases of adverse drug reactions reported in China adverse drug reaction (ADR) database between January 1, 2004 and March 31, 2023, domestic and international literature published from January 1, 2000 to March 31, 2023, domestic and international drug specifications were analyzed. Results From January 1, 2004 to March 31, 2023, there were a total of 3 815 ADR reports of Calcium Dobesilate preparations in the database, involving 182 serious cases.in the reports of severe cases, skin damage was reported more frequently; Toxic epidermal necrolysis is more prominent in the literature, and the patients were accompanied by renal impairment. Conclusion Calcium Dobesilate oral preparation may cause serious skin damage, especially in patients with renal impairment requiring dialysis, and Medical institutions should pay attention to this risk. Marketing authorization holders should strengthen the monitoring of adverse reactions and update the information on safety in drug labels in time.

Key words: Calcium Dobesilate, Adverse Drug Reaction, Risk, Fever, Toxic Epidermal Necrolysis(TEN), Regulatory Measures, Instruction