OBJECTIVE: To probe into the characteristics of adverse drug reactions induced by montelukast sodium in children

so as to provide guidance for clinical rational drug use. METHODS: CNKI

Wanfang Data and PubMed were searched from the establishment of the database to Oct. 2021 to collect the reports on adverse drug reactions induced by montelukast in children. The incidence and characteristics of adverse drug reactions induced by montelukast were studied by bibliometric analysis. RESULTS: A total of 12 748 literature were initially screened in the database. After reading literature abstracts

extracting case reports

deleting adult data

and excluding uncertain disease factors

23 literature（30 children） were included in the adverse drug reactions case reports of children. Among them

there were 13 literature（20 children） on neuropsychiatric adverse drug reactions

including nightmares

sleepwalking

excitement

emotional behavior disorders

aggression and convulsions. Digestive system adverse drug reactions were reported in 3 literature（3 children）

mainly manifested as liver function injury. Urinary system adverse drug reactions were reported in 3 literature（3 children）

mainly manifested as enuresis. Skin system adverse reactions were reported in 1 literature（1 child）

mainly manifested as pemphigus. Auditory system adverse drug reactions were reported in 1 literature（1 child）

mainly manifested as earache. Visual system adverse drug reactions were reported in 1 literature（1 child）

mainly manifested as headache. Musculoskeletal system adverse drug reactions were reported in 1 literature（1 child）

mainly manifested as arthralgia and muscle rigidity. CONCLUSIONS: Adverse drug reactions of montelukast in children mainly focuses on neuropsychiatric adverse drug reactions（>66%）

including nightmares

anxiety

aggression and emotional behavior disorders. The symptoms disappear within a short time after the drug withdrawal. The most important thing to be alerted to is suicide. In view of the above literature analysis

if neuropsychiatric adverse drug reactions occur during clinical use of montelukast

drug-related effects should be considered and treated accordingly.