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Montelukast is associated with various side effects ranging from headaches, coughs, and stomach pains to flu-like symptoms. The boxed warnings highlight neuropsychiatric risks such as sleep disturbances, anxiousness, depression, agitation, attention or memory issues, insomnia, hallucinations, and suicidal behavior. “Healthcare professionals should inform patients of these potential side effects,” said Alison Cave, MHRA’s chief safety officer, in a press release.

“Patients and carers should immediately speak to their prescriber or seek urgent medical attention if the patient experiences any neuropsychiatric symptoms while using montelukast.” “The incidence of neuropsychiatric events associated with montelukast is unknown, but some reports are serious, and many patients and health care professionals are not fully aware of these risks,” said Sally Seymour, director of the Division of Pulmonary, Allergy, and Rheumatology Products at the FDA in a press release. She emphasized that numerous other medications, which are safe and have a proven track record for treating allergies, are available.



Montelukast, functioning as a leukotriene receptor antagonist, targets leukotrienes—key elements in the body’s inflammatory response to allergens. These chemicals tighten airway muscles and increase mucus production, leading to symptoms like coughing and throat tightness. By blocking these problematic chemicals, montelukast alleviates the chronic symptoms of asthma and allerg.

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