Abstract：Objective To investigate the characteristics and regularity of adverse drug reactions (ADR) induced by Montelukast Sodium and provide reference for safe drug use in clinic.Methods The papers of CNKI,VIP and Wangfang were retrieved and analyzed for collecting ADR reports induced by Montelukast Sodium from January 2000 to December 2019.Results This study screened 29 articles with 32 cases of ADR.In the 32 cases of ADR,22 cases （68.75%）were male and 10 cases（31.25%） were female,the youngest patient was 12 months,the oldest patient was 86 years old,and mainly occurred 1 to 3 d after medication (34.38%).Patients mainly suffered from bronchial asthma,bronchitis.Systems/organs involved in ADR were the nervous and mental system,skin and its accessories,and urinary system.Conclusion The ADR monitoring should be strengthened for ensuring safe and rational use of Montelukast Sodium.
FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast （Singulair）；advises restricting use for allergic rhinitis[EB／OL].[2020-03-13／2020-07-22].https：//www.fda.gov/drugs/drugsafety-and-availability/fda-requires-boxed-warning-aboutserious-mental-health-side-effects-asthma-and-allergydrug.
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The United Kingdom：Montelukast （Singulair）：reminder of the risk of neuropsychiatric reactions.[EB/OL].[2019-09-20／2020-07-22].https：//www.drugoffice.gov.hk/eps/news/showNews/The+United+Kingdom% 3A+Montelukast+%28Singulair%29%3A+reminder+of+the+risk+of+neuropsychiatric+reactions/consumer/2019-09-20/en/37586.html.
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