Abstract: Objective To evaluate the post marketing safety signals of hydroxychloroquine sulfate recommended by the expert consensus on comprehensive treatment of coronavirus diseases in Shanghai in 2019 in order to provide evidence for safe clinical use of this drug. Methods ADR related to the suspected drug commonly known as "hydroxychloroquine sulfate" that were collected by Anhui ADR monitoring system between Jan 1, 2004 and Dec 31, 2020 were selected. The report odds ratio (ROR) method was used for signal detection, focusing on the extraction, analysis, evaluation and data mining of cases of such adverse reactions as visual impairment. Results Among the 292 case reports, ADR mostly involved the skin and its appendages, central and peripheral nervous systems and the gastrointestinal system, and were manifested as visual impairment, hearing and vestibular dysfunction. According to signal detection, 30 cases involved visual impairment, accounting for 10.3% of the total cases of ADR. The top ten signal values were related to photophobia, blurred vision, visual abnormalities, adverse reactions of eyes and other visual impairment. The incidence of visual impairment was the highest among patients whose primary disease was systemic lupus erythematosus. The time interval of ADR was wide among patients with visual impairment. Conclusion Signal detection of ADR based on the real world can help assess the safety of hydroxychloroquine sulfate, which is expected to provide reference for the rational use of drugs for COVID-19 and for clinical utilization of conventional drugs.

Key words: hydroxychloroquine sulfate, COVID-19, visual impairment, signal detection, adverse drug reaction