Retrieval and analysis of cyclopentolate hydrochloride eye drops related adverse drug reaction signals based on OpenFDA

[Objective] To retrieve and analyze adverse drug reactions (ADRs) of cyclopentolate hydrochloride eye drops on the US Food and drug Administration Public Data Open Project (OpenFDA), so as to provide reference for clinical rational drug use. [Methods] Using "Cyclopentolate hydrochloride eye drops" as the search term, retrieve all information related to ADRs of cyclopentolate hydrochloride eye drops from the OpenFDA database from January 1, 2004 to August 1, 2024, and analyze the retrieved data [Results] A total of 1 185 cases of ADRs associated with cyclopentolate hydrochloride eye drops were found. Among the 1185 patients, 516 were female and 483 were male (43.54 % vs 40.76 %) after excluding the unknown gender. After excluding patients with unknown age, the incidence of ADRs was higher in patients aged 65~ < 80 years old (221 cases, 18.65 %), 50~< 65 years old (176 cases, 14.85 %), and 3~ < 13 years old (140 cases, 11.81 %). The ADRs with high incidence of cyclopentolate hydrochloride eye drops were ocular organ diseases (767 cases, 64.73 %), nervous system diseases (254 cases, 21.43 %) and gastrointestinal system diseases (228 cases, 19.24 %). [Conclusions] Cyclopentolate hydrochloride eye drops can cause local and systemic adverse reactions.In clinical use, the patient 's disease history and medication history should be asked in detail, and medication monitoring should be strengthened to improve the safety of patient medication.