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Montelukast For Kids: 17 Behavior Or Mood-Related Changes To Tell The Doctor
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  • People with asthma or allergic rhinitis can benefit from a dose of montelukast in relieving symptoms and even preventing attacks. It is prescribed widely, but there are serious mental health side effects, according to medical experts.

    In fact, the U.S. Food and Drug Administration (FDA) requires a boxed warning on the drug.

    Uses of montelukast

    Montelukast is medication that belongs to the classification called leukotriene receptor antagonists (LTRA). It works by blocking the action of substances in the body that cause the symptoms of asthma and allergic rhinitis. It is sold under several brand names and comes as a tablet, chewable tablet, and granules to take by mouth.

    Doctors usually prescribe montelukast to:

    • Prevent wheezing, difficulty breathing, chest tightness, and coughing caused by asthmas in adults and children 12 months of age and older.
    • Prevent bronchospasm or breathing difficulties during exercise in adults and children 6 years of age and older.
    • Treat symptoms of allergic rhinitis, such as sneezing and stuffy or itchy nose, but only if the condition can’t be treated with other medications. Allergic rhinitis has two types, seasonal (it occurs only at certain times of the year in adults and children 2 years of age and older) and perennial (occurs all year round in adults and children 6 months of age and older).

    How to give montelukast for kids

    The use of montelukast may affect people with acute asthma, mental health problems, and phenylketonuria (PKU).

    Mayo Clinic stresses that montelukast does not provide relief during an asthma attack. The drug is taken to prevent attacks.


    Your doctor determines the use and dose for your child — give the medicine only as directed. Never give your child more or less of it or take more often than prescribed.

    Carefully follow the directions on your prescription label and if there’s any part that you don’t understand, don’t hesitate to ask your doctor or pharmacist.

    Here are a few more things to remember: 

    • You can dissolve the oral granules in 1 teaspoonful (5 mL) of baby formula or breast milk. Do not mix this medicine with any other liquid. You can mix it in with a spoonful of soft food, such as applesauce, carrots, rice, or ice cream. 
    • If you add it to milk, it must be given within 15 minutes and must NOT be stored for future use.
    • Montelukast can be taken once a day with or without food.
    • When it is prescribed for allergic rhinitis, it is advisable to take it at the same time every day.

    Montelukast side effects

    In no uncertain terms is montelukast to be taken without guidance and prescription from a doctor. The drug has been found to cause mental health side effects. These include agitation, aggression, depression, sleep disturbances, and suicidal thoughts and behavior, according to Mayo Clinic (more below). The reason is still unclear, though. 

    In early 2020, the U.S. FDA had announced it was taking measures in strengthening existing warnings about serious behavior and mood-related changes. Thus all brands of montelukast are now required to contain a boxed warning. 

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    “We are taking this action after a review of available information led us to reevaluate the benefits and risks of montelukast use,” the agency says on its website. 

    “Montelukast prescribing information already includes warnings about mental health side effects, including suicidal thoughts or actions; however many health care professionals and patients/caregivers are not aware of the risk.”

    FDA recommends telling your doctor immediately if you observe behavior or mood-related changes in your child like the following:

    1. agitation, including aggressive behavior or hostility
    2. attention problems
    3. bad or vivid dreams
    4. depression
    5. disorientation or confusion
    6. feeling anxious
    7. hallucinations (seeing or hearing things that are not really there)
    8. irritability
    9. memory problems
    10. obsessive-compulsive symptoms
    11. restlessness
    12. sleepwalking
    13. stuttering
    14. suicidal thoughts and actions
    15. tremor or shakiness
    16. trouble sleeping
    17. uncontrolled muscle movements

    Let your doctor know if you’re taking other drugs to avoid increasing the risk of side effects. You may also be given instructions concerning food, alcohol, and tobacco.

    Risks vs benefits of montelukast

    Before deciding to take any drug, doctors typically advice weighing the risks against the benefits it brings. Montelukast continues to be prescribed because it is an effective long-term treatment for asthma. 

    If you still have reservations, do not hesitate to discuss them with your doctor when it is prescribed. There are also other factors to consider such as: 


    Make sure to tell your doctor if you ever had any unusual or allergic reaction to any other medicine, certain foods, dyes, preservatives, or animals.


    Safety and efficacy of montelukast have not been established in children below the age of 1. But appropriate studies performed so far have not shown pediatric-specific problems that would limit the usefulness of montelukast in children:

    • 1 year of age and older with asthma
    • 2 years of age and older with exercise-induced bronchoconstriction
    • 2 years old age and older with seasonal allergic rhinitis
    • 6 months of age and older with perennial allergic rhinitis

    Studies reveal that elderly patients have been found to be more sensitive to the effects of the medicine than younger adults. However, there have been no geriatric-specific problems cited that would limit the usefulness of the medicine.


    There aren’t enough studies in women for determining infant risk when using montelukast during breastfeeding. Again, weigh the potential benefits against the possible risks with your doctor.

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