{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,16]],"date-time":"2026-03-16T19:24:07Z","timestamp":1773689047668,"version":"3.50.1"},"reference-count":67,"publisher":"MDPI AG","issue":"11","license":[{"start":{"date-parts":[[2022,11,21]],"date-time":"2022-11-21T00:00:00Z","timestamp":1668988800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Children"],"abstract":"<jats:p>Montelukast is a leukotriene receptor antagonist (LTRA) commonly prescribed for asthma, allergic rhinitis and sleep-related breathing disorders. Recently, some studies have reported several adverse events, such as neuropsychiatric disorders and sleep disturbances, among children. Objective: To obtain more insight into the safety profile of montelukast for children with asthma, allergic rhinitis and sleep-related breathing disorders. Method and results: We retrospectively studied all adverse drug reactions to montelukast among 385 children 6 months or older in six tertiary centers over a two-year period. A total of 89.6% were asthmatic, 50% had allergic rhinitis and 13.6% had sleep-related breathing disorders; Singulair was the most common type of montelukast used (67.9%). This study reported a high prevalence of adverse drug reactions among 123 patients (31.9%), predominantly in those aged 4\u20139 years (52.8%), followed by adolescents (24.4%) and toddlers (22.8%). Two (ADRs) were reported in 9.8% of the children, while three or more were reported in 5.5%. Sleep disturbance was the most common (ADRs), affecting 15.1% of participants (overlap was common; 5.5% of children experienced sleep difficulties, 4.4% experienced sleep interruption and decreased sleep, and 1.82% experienced nightmares), followed by agitation (10.4%), pain (9.4%) and hyperactivity (6.8%). No serious (ADRs) were reported. Eleven percent of families faced difficulties in purchasing montelukast, and only 57% of families had insurance. Misconceptions were common (9.8% reported it to be a steroid, while 30.6% believed it to be a bronchodilator). Although 81% of the families believed it was an effective and preventive medication, 5.3% stopped the drug due to concern about side effects, especially agitation (3%) and nightmares (0.6%). Conclusion: These data demonstrate that montelukast is effective, but the associated adverse neuropsychiatric drug reactions are more prevalent than those reported in the literature. In particular, sleep disturbance, agitation, pain and hyperactivity were observed. Pediatricians should be aware of such (ADRs). Misconceptions about montelukast are still common, and parental counseling and urgent epidemiological studies are needed to quantify the risk for management plans.<\/jats:p>","DOI":"10.3390\/children9111783","type":"journal-article","created":{"date-parts":[[2022,11,22]],"date-time":"2022-11-22T03:02:16Z","timestamp":1669086136000},"page":"1783","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Adverse Drug Reactions (ADRs) of Montelukast in Children"],"prefix":"10.3390","volume":"9","author":[{"given":"Abdullah","family":"Al-Shamrani","sequence":"first","affiliation":[{"name":"Department of Pediatrics, Prince Sultan Military Medical City, AL Faisal University, P.O. Box 7897, Riyadh 11159, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2913-8340","authenticated-orcid":false,"given":"Saleh","family":"Alharbi","sequence":"additional","affiliation":[{"name":"Dr. Soliman Fakeeh Hospital, P.O. Box 2537, Jeddah 21461, Saudi Arabia"},{"name":"Department of Paediatrics, Umm Al-Qura University, Mecca 24382, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sumayyah","family":"Kobeisy","sequence":"additional","affiliation":[{"name":"Dr. Soliman Fakeeh Hospital, P.O. Box 2537, Jeddah 21461, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Suzan A.","family":"AlKhater","sequence":"additional","affiliation":[{"name":"College of Medicine, Imam Abdulrahman Bin Faisal University, Dammam 34212, Saudi Arabia"},{"name":"Department of Pediatrics, King Fahd Hospital of the University, Al-Khobar 31952, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Haleimah","family":"Alalkami","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Abha Maternity & Children Hospital, P.O. Box 62521, Abha 1650, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Turki","family":"Alahmadi","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Faculty of Medicine, King Abdulaziz University, Jeddah 21589, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aisha","family":"Almutairi","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, College of Medicine, Qassim University, P.O. Box 7897, Buraidah 51452, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adel S.","family":"Alharbi","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Prince Sultan Military Medical City, AL Faisal University, P.O. Box 7897, Riyadh 11159, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3957-9964","authenticated-orcid":false,"given":"Abdullah A.","family":"Yousef","sequence":"additional","affiliation":[{"name":"College of Medicine, Imam Abdulrahman Bin Faisal University, Dammam 34212, Saudi Arabia"},{"name":"Department of Pediatrics, King Fahd Hospital of the University, Al-Khobar 31952, Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2022,11,21]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"16","DOI":"10.1034\/j.1398-9995.57.s72.2.x","article-title":"Leukotriene receptor antagonists in the treatment of asthma: An update","volume":"57","author":"Balzano","year":"2002","journal-title":"Allergy"},{"key":"ref_2","unstructured":"US Food and Drug Administration (2019, March 06). 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