Main Article Content

Abstract

Depression and nightmares are caused by Montelukast. Montelukast is a selective leukotriene receptor antagonist (LRTA) and US-FDA issued a black box warning in 2020. In this case report, a 14 year old female was prescribed a combination of Tab. Montelukast and Tab. Fexofenadine for the treatment of bronchial asthma exacerbations. After this, she started experiencing multiple episodes of depression and nightmares. The patient was asked to avoid Montelukast after which the patient's condition improved and she was started on MDI Formoterol fumarate and Budesonide powder for inhalation and Tab. Desloratadine for further management. After stopping the drug, her condition improved. This case underlines the importance of monitoring for rare but serious side effects of leukotriene receptor antagonist and highlights the need for further research into their mechanisms and risk factors.

Keywords

Montelukast depression nightmare bronchial asthma Fexofenadine

Article Details

How to Cite
Christeena Mary Viji, & Karun Kumar. (2025). A Case Report On Montelukast And Fexofenadine Induced Depression And Nightmares. International Journal of Research in Pharmacology & Pharmacotherapeutics, 14(1), 155-157. Retrieved from https://ijrpp.com/ijrpp/article/view/630

References

  1. 1. Watson S, Kaminsky E, Taavola H, Attalla M, Yue QY. Montelukast and Nightmares: Further Characterisation Using Data from VigiBase. Drug Safety. 2022 Jun;45(6):675–84.
  2. 2. Kelsay K. Assessing risk: Data from montelukast clinical trials. Journal of Allergy and Clinical Immunology. 2009 Oct;124(4):697–8.
  3. 3. Holbrook JT, Harik-Khan R. Montelukast and emotional well-being as a marker for depression: Results from 3 randomized, double-masked clinical trials. Journal of Allergy and Clinical Immunology. 2008 Oct;122(4):828–9.
  4. 4. Philip G, Hustad C, Noonan G, Malice MP, Ezekowitz A, Reiss TF, et al. Reports of suicidality in clinical trials of montelukast. The Journal of Allergy and Clinical Immunology [Internet]. 2009 Oct 1 [cited 2020 Mar 26];124(4):691-696.e6. Available from: https://www.ncbi.nlm.nih.gov/pubmed/19815114
  5. 5. Philip G, Hustad CM, Marie-Pierre Malice, Noonan G, Ezekowitz A, Reiss TF, et al. Analysis of behavior-related adverse experiences in clinical trials of montelukast. 2009 Oct 1;124(4):699-706.e8.
  6. 6. Calapai G, Casciaro M, Miroddi M, Calapai F, Navarra M, Gangemi S. Montelukast-Induced Adverse Drug Reactions: A Review of Case Reports in the Literature. Pharmacology. 2014;94(1-2):60–70.
  7. 7. Haarman MG, van Hunsel F, de Vries TW. Adverse drug reactions of montelukast in children and adults. Pharmacology Research & Perspectives [Internet]. 2017 Sep 20;5(5). Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5625152/
  8. 8. Donmez Y, Karaer I. Does short-term montelukast treatment cause sleep problems or psychiatric problems in children? A preliminary study. Annals of Medical Research. 2020;27(10):2654.
  9. 9. Lo CWH, Pathadka S, Qin SX, Fung LWY, Yan VKC, Yiu HHE, et al. Neuropsychiatric events associated with montelukast in patients with asthma: a systematic review. European Respiratory Review: An Official Journal of the European Respiratory Society [Internet]. 2023 Sep 30 [cited 2023 Sep 30];32(169):230079. Available from: https://pubmed.ncbi.nlm.nih.gov/37758273/
  10. 10. Marques CF, Marques MM, Justino GC. The mechanisms underlying montelukast’s neuropsychiatric effects - new insights from a combined metabolic and multiomics approach. Life Sciences [Internet]. 2022 Dec 1;310:121056. Available from: https://www.sciencedirect.com/science/article/pii/S0024320522007561
  11. 11. Aldea Perona A, García-Sáiz M, Sanz Álvarez E. Psychiatric Disorders and Montelukast in Children: A Disproportionality Analysis of the VigiBase®. Drug Safety. 2015 Nov 30;39(1):69–78.
  12. 12. The use of the WHO-UMC system for standardized case causality assessment The use of the WHO-UMC system for standardized case causality assessment Why causality assessment? [Internet]. Available from: https://www.who.int/docs/default-source/medicines/pharmacovigilance/whocausality-assessment.pdf
  13. 13. Adverse drug reactions [Internet]. Clinical Gate. 2015. Available from: https://clinicalgate.com/adverse-drug-reactions/
  14. 14. Paljarvi T, Forton JT, Thompson C, Luciano S, Herttua K, Fazel S. Neuropsychiatric diagnoses after montelukast initiation in paediatric patients with asthma. Thorax. 2024 Nov 22;thorax-2024-221590.
  15. 15. Uğur Altaş, Zeynep Meva Altaş, Fırat Öz, Mehmet Yaşar Özkars. Evaluation of Neuropsychiatric Effects of Montelukast–Levocetirizine Combination Therapy in Children with Asthma and Allergic Rhinitis. Children (Basel). 2023 Jul 28;10(8):1301–1.
  16. 16. Al-Shamrani A, Alharbi S, Kobeisy S, AlKhater SA, Alalkami H, Alahmadi T, et al. Adverse Drug Reactions (ADRs) of Montelukast in Children. Children. 2022 Nov 21;9(11):1783.
  17. 17. VigiAccess [Internet]. www.vigiaccess.org. Available from: https://www.vigiaccess.org/
  18. 18. World. Depression [Internet]. Who.int. World Health Organization: WHO; 2019. Available from: https://www.who.int/health-topics/depression
  19. 19. Mahatme M, Dakhale G, Tadke K, Hiware S, Dudhgaonkar S, Wankhede S. Comparison of efficacy, safety, and cost-effectiveness of montelukast-levocetirizine and montelukast-fexofenadine in patients of allergic rhinitis: A randomized, double-blind clinical trial. Indian Journal of Pharmacology. 2016;48(6):649.