Abstract: Objective To analyze the regularity and characteristics of adverse drug reactions (ADRs) caused by escitalopram oxalate tablets in order to provide a reference for clinical medication. Methods Reports of ADRs caused by escitalopram oxalate tablets collected by an ADR database in 2010-2025 were retrieved before the basic data of patients, system and organs involved, clinical manifestations and risk factors for severe ADRs were analyzed. Results A total of 1 115 ADR reports were collected, 83 of which involved (7.44%) new and mild ADRs, and 232 (20.81%) involved severe ones. The ratio of males to females was 1∶1.75. Patients aged 45 to 64 accounted for 39.46%, compared with 5.11% among those under 18. The dosage was usually 10 mg per day (45.29%), and dosages exceeding 20 mg per day accounted for 3.14%. Most of these ADRs occurred within one week of treatment, accounting for 53.19%. The symptoms were mostly gastrointestinal damage, damage to central and peripheral nervous systems, damage to the hepatobiliary system, and mental disorders, manifested as nausea, constipation, dizziness, abnormal liver function, drowsiness, palpitations, rash, fatigue, and leukopenia. Most of the patients improved (55.25%) or recovered (36.95%) after treatment. The combined drugs included lorazepam tablets, buspirone hydrochloride tablets, olanzapine tablets, tandospirone citrate capsules, and other psychotropic drugs. Conclusion ADRs caused by escitalopram oxalate tablets involve multiple systems and organs. Leukopenia and neutropenia are new ADR signals with more reported cases. Patients' gender, age, and concomitant medication are risk factors for severe ADRs. Clinicians should devote more effort to monitoring and effective management of new ADR signals.

Key words: Escitalopram Oxalate Tablets, Leukopenia, Gastrointestinal Damage, Damage to Central and Peripheral Nervous Systems, Damage to the Hepatobiliary System, Mental Disorders, Adverse Drug Reaction