Abstract: Objective To analyze the adverse drug reactions (ADR) caused by calcium dobesilate capsules in order to provide data for monitoring adverse reactions and rational drug use. Methods Four hundred and thirty-three reports of ADR involving calcium dobesilate capsules collected by Ningxia Adverse Drug Reaction database from June 1, 2009 to June 30, 2024 were retrospectively analyzed according to the patients’ conditions, correlation evaluation and outcomes of ADR, systems-organs involved and clinical manifestations. Results There were slightly more women than men involved in 433 ADR reports, and the vast majority were aged 41 to 80 (88.69%). Among these cases, 419 (96.77%) recovered or improved. The main systems-organs involved were the gastrointestinal system (46.54%), skin and subcutaneous tissues (16.19%), systemic diseases and various reactions at the sites of administration (12.65%) and the nervous system (10.29%). The dominating clinical manifestations were nausea, diarrhea, fever and rash. The main systems-organs involved in severe adverse reactions were the skin and subcutaneous tissues (33.85%), systemic diseases and various reactions at the sites of administration (29.23%) and the gastrointestinal system (10.77%). The main clinical manifestations of these severe adverse reactions were fever, rash, itching and abnormal liver function. Conclusion In addition to common gastrointestinal symptoms, fever caused by calcium dobesilate capsules may be a severe adverse reaction that is likely overlooked, accounting for approximately 35.14% of severe ADR reported. Additionally, severe cutaneous reactions, including severe drug eruptions, wheal skin lesions, and urticaria have been occasionally reported. It is recommended that special attention be paid to patients who experience fever and severe drug eruptions caused by calcium dobesilate capsules.

Key words: Calcium Dobesilate Capsules, Adverse Drug Reactions, Rational Drug Use, Fever, Drug Eruption