Objective To mine adverse drug event (ADE) signals of movement disorders in the pediatric population (0-17 years) using disproportionality analysis based on the US FDA Adverse Event Monitoring System (AEMS), analyze the age and sex distribution characteristics, and to identify high-risk drugs for safer pediatric prescribing.

Methods Movement disorder was adopted as the preferred term (PT). ADE reports involving movement disorders in the pediatric population from January 1, 2004, to March 31, 2026, were retrieved from the AEMS database. Four disproportionality analysis methods were used for data mining of ADE risk signals.

Results A total of 1,113 ADE reports associated with movement disorders were enrolled, covering 524 drugs. After screening, 67 drugs with positive risk signals were identified. Male children accounted for the majority (54.81%), and patients aged 3-11 years constituted the largest age group (45.01%). Severe ADEs made up 86.16%, with hospitalization being the predominant clinical outcome (32.85%). Most reports originated from the United States (24.17%), and health professionals were the primary reporters (55.08%). Risk signal analysis indicated that drugs associated with movement disorders were mainly nervous system agents (35 drugs, 52.24%), followed by endocrine drugs (7 drugs, 10.45%) and anti-infective agents (7 drugs, 10.45%), alongside a small number of digestive system drugs, cardiovascular drugs, antineoplastic agents, etc. Several drugs without documented risk of movement disorders in their prescribing information, including abacavir, lamivudine, nevirapine, montelukast and so on.

Conclusion Clinicians should exercise heightened vigilance for movement disorder ADEs when prescribing nervous system and endocrine system drugs to pediatric patients, with particular attention to males and children aged 3-11 years, thereby ensuring safe medication use in children..

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