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Montelukast is an effective leukotriene receptor antagonist used to manage asthma and alleviate symptoms of allergic rhinitis. As an FDA-approved medication, it targets the inflammatory processes triggered by leukotrienes, substances your immune system releases in response to allergens or stress, contributing to constricted airways and mucus buildup. Suitable for both adults and children, Montelukast is available in various forms, including 10 mg tablets for adults, 5 mg and 4 mg chewable tablets for children, and 4 mg oral granules for toddlers. Common side effects are mild but can include headache and abdominal pain, with more serious effects like mood changes warranting immediate consultation with a healthcare provider. Montelukast should be stored at room temperature, away from moisture and heat.

Montelukast Overview

Montelukast, a leukotriene receptor antagonist known as a leukotriene modifier, is the active ingredient in medications designed to manage and prevent asthma and allergic rhinitis symptoms. This FDA-approved drug works by blocking the action of leukotrienes, substances released by the immune system that cause inflammation, bronchoconstriction, and mucus production. Montelukast is particularly effective in reducing these symptoms relieving those suffering from chronic respiratory conditions triggered by allergies or physical activity.

Available in various forms, Montelukast is dosed as 10 mg tablets for adults and children over 15, 5 mg or 4 mg chewable tablets for children aged 6 to 14 and 2 to 5, respectively, and 4 mg oral granules for younger children. It’s taken once daily, ideally in the evening for asthma and at any convenient time for allergies. The medication can be taken with or without food and is not intended for immediate relief of acute symptoms, making it important also to have a rescue inhaler for asthma attacks.

Common side effects include headache, stomach pain & dizziness, while serious reactions may involve mood changes and allergic responses. Safety measures include avoiding Montelukast if allergic to any of its components and monitoring for mood alterations or signs of an allergic reaction. Missed doses should be taken when remembered unless close to the next dose. In cases of overdose, immediate medical attention is required. Store Montelukast at room temperature, protected from moisture and direct sunlight, and ensure it is out of reach of children. Users should regularly consult their healthcare provider to ensure the medication continues to meet their needs without undue risk.

Uses of Montelukast 

  • Manage asthma
  • Prevent short-term exercise-induced bronchoconstriction
  • Alleviate allergic rhinitis symptoms in individuals who cannot use or have not responded adequately to other treatments.

Montelukast  Dosage

Montelukast comes in the following dosage forms and strengths:


  • 10 mg

Tablet, chewable

  • 4 mg
  • 5 mg

Oral granules

  • 4 mg//packet

Recommended Dosage for Different Patients/Montelukast


  • Asthma, Exercise-Induced Asthma, or Allergies:
    • Adults and Children Aged 15 and Above: The standard dosage is 10 mg taken orally once a day.

Chewable Tablets:

  • Asthma or Allergies:
    • Children 6 to 14 Years: 5 mg chewed and swallowed once daily.
    • Children 2 to 5 Years: 4 mg chewed and swallowed once daily.
  • Exercise-Induced Asthma:
    • Children 6 to 14 Years: The routine dosage is 5 mg, chewed and swallowed once daily.

Oral Granules:

  • Asthma:
    • Children 1 to 5 Years: Typically, one 4 mg packet is taken orally once a day.
  • Allergies:
    • Children 2 to 5 Years (Seasonal or Year-Round): Standard dosage is one 4 mg packet orally once daily.
    • Children 6 to 23 Months (Year-Round Allergies Only): Administer one 4 mg packet orally once daily.

[Note: These recommendations may vary for the individual. Consult with your doctor to customize your Montelukast dosage based on your specific needs.]

How to Take Montelukast?

  • The typical dose for adults and adolescents 15 years and older is one 10mg tablet daily. Children may have different dosages based on age.
  • For asthma, it’s usually taken once daily in the evening. For allergies, it can be taken at any time of day.
  • Take Montelukast at the same time each day to maintain consistent blood levels.
  • It can be taken with or without food.
  • For tablets, swallow them whole with water. Chewable tablets should be chewed thoroughly before eating.
  • Montelukast is not for treating acute asthma attacks. Use your rescue inhaler for sudden symptoms.
  • Continue taking Montelukast even when you feel well unless directed otherwise by your doctor.

[Note: Your doctor will determine the appropriate dosage for you based on your condition, adhering to established guidelines and clinical studies of the medication. Dosage adjustments may be made as necessary.]

How Does Montelukast Work?

Montelukast is categorized as a leukotriene receptor antagonist, commonly called a leukotriene modifier. This classification refers to a group of medications that share a similar mechanism of action, which describes the specific way a drug functions within the body.

Leukotrienes, substances released by the immune system in response to various triggers, contribute to inflammation in the body. This inflammation can cause symptoms such as increased mucus production and difficulty breathing, which are common in individuals with asthma or allergies.

By functioning as a leukotriene receptor antagonist, Montelukast helps decrease inflammation in the airways, including the lungs and nasal passages. It effectively keeps the airways open and reduces the immune system’s excessive responses to triggers like cold weather or exercise for asthma and pollen, mold, or pet dander for allergic rhinitis.

Important Safety Information

Montelukast Side Effects

Common side effects of Montelukast may include:

  • Headache
  • Abdominal pain
  • Nausea
  • Diarrhea
  • Fatigue
  • Dizziness
  • Upper respiratory infection symptoms (e.g., stuffy or runny nose, sore throat)
  • Cough
  • Rash


Serious side effects of Montelukast may include:

  • Suicidal thoughts or behavior (particularly in children & teenagers)
  • Mood changes, including agitation, aggression, anxiety, and depression
  • Allergic reactions, such as swelling of the face, throat, or tongue; difficulty breathing; and severe rash
  • Persistent or severe headache
  • Persistent stomach pain
  • Liver issues, such as jaundice (yellowing of the skin or eyes)
  • Unusual bleeding or bruising
  • Changes in vision
  • Persistent fatigue or weakness

[Note: This list may not cover all side effects. For medical advice regarding side effects, always consult your healthcare provider.]

Montelukast Warnings

  • Mental Health Concerns Montelukast: may cause rare but significant changes in behavior, with symptoms varying from irritability and memory issues to hallucinations and thoughts of suicide. These effects can occur in individuals with or without previous mental health issues. It’s crucial to monitor any behavioral changes closely. If such symptoms are observed, either by you or someone close to you, contact your healthcare provider immediately.
  • Asthma Management Warning Montelukast: This is not designed to manage acute asthma attacks. Always carry a quick-acting rescue inhaler, particularly during activities that may trigger shortness of breath. If your asthma symptoms persist or worsen while on Montelukast, discuss it with your healthcare provider.
  • Elevated Eosinophil Counts: In rare cases, individuals with asthma on Montelukast have experienced increased eosinophil levels, a type of white blood cell associated with allergic reactions.
  • Symptoms may include red patches or rashes on the lower legs, numbness, tingling, or worsening asthma. If you experience any of these symptoms, inform your healthcare provider for assessment.
  • Warning for Individuals with Phenylketonuria (PKU) Montelukast: Cheese tablets contain phenylalanine, a part of the sweetener aspartame. Individuals with PKU, a genetic disorder that results in excessive phenylalanine buildup, should avoid these chewable tablets to prevent serious health issues.

Montelukast Boxed Warning 

Montelukast is subject to a boxed warning, the highest level of caution mandated by the Food and Drug Administration (FDA). This warning highlights potential serious risks associated with the medication, specifically severe changes in behavior and mood. Since its approval, there have been reports of individuals experiencing depression, aggression, hallucinations, memory issues, and suicidal thoughts or behaviors while on Montelukast. The oral tablets should be prescribed only when the treatment benefits outweigh these serious risks. If you observe any alterations in mood or behavior while taking Montelukast, it is crucial to contact your doctor immediately.

Montelukast Precautions

  • Inform your healthcare provider if you have had any previous allergic reactions to Montelukast or any of its components.
  • Monitor regularly for any changes in behavior or mood, such as agitation, aggression, depression, or suicidal thoughts, especially in children and adolescents.
  • Patients with PKU should avoid chewable tablets, which contain phenylalanine.
  • Discuss with your doctor if you are pregnant or plan to become pregnant or if you are breastfeeding. The effects of Montelukast on the fetus and newborns are not fully known.
  • Share your complete medical history with your doctor, especially if you have liver disease, epilepsy, or a history of mental health problems.
  • Montelukast is not intended to relieve acute asthma attacks. Always have a rescue inhaler on hand for sudden asthma symptoms.
  • Check with your healthcare provider about all other medications you are taking, as Montelukast can interact with other drugs, potentially altering its effectiveness or increasing side effects.
  • Inform your surgeon or dentist that you are taking Montelukast. Your treatment may need to be adjusted before certain procedures.
  • Adhere strictly to the prescribed dosage & administration instructions. Do not alter the dose or frequency of the medication without consulting your medical professional.
  • Regular visits to your healthcare provider are recommended to monitor your progress & adjust the treatment as necessary.

Montelukast Missed Dose

If you miss a dose of Montelukast, take it as soon as you remember. However, if it’s almost time for your next dose, leave the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for the missed one. Consistency in timing can enhance the medication’s effectiveness, so try to take it simultaneously each day.

[Note: If you miss a dose of Montelukast and are uncertain when to take the next one, seek advice from your medical professional or pharmacist promptly.]

Montelukast Overdose

If you note an overdose of Montelukast, seek immediate medical attention. Symptoms of an overdose can indicate severe headache, drowsiness, thirst, hyperactivity, vomiting, or a feeling of restlessness. It’s crucial to adhere to the advised dosage and schedule to prevent overdosing. Emergency medical treatment is essential in managing the symptoms and avoiding potential complications from an overdose of Montelukast.

[Note: If you have taken more than the prescribed dose of Montelukast, seek immediate medical assistance or call the Poison Help line at 1-800-222-1222.]

Montelukast Storage

  • Store Montelukast at room temperature, typically between 20°C to 25°C (68°F to 77°F).
  • Protect the medication from moisture & excessive heat. Do not store in the bathroom or near a heat source.
  • Keep Montelukast in its original packaging until use to protect it from light and moisture.
  • Ensure that Montelukast is stored out of reach & sight of children to prevent accidental ingestion.
  • Avoid storing the medication in direct sunlight, as it can degrade the active ingredients.
  • Regularly check the expiration date of Montelukast on the packaging, and do not use the medication past this date.
  • Follow local guidelines to dispose of expired or unused Montelukast or take it to a pharmacy for proper disposal.

[Note: Consult your healthcare professional about the correct disposal of any unused Montelukast and for any queries regarding its storage.]

Montelukast Interactions

  • Strong CYP3A4 inducers: Medications like rifampin, phenobarbital, and phenytoin can decrease the effectiveness of Montelukast.
  • CYP2C8 inhibitors: Drugs like gemfibrozil can increase Montelukast levels in the body.
  • Warfarin: Montelukast may increase the effect of warfarin, potentially increasing bleeding risk.
  • Seizure medications: Phenobarbital and phenytoin may decrease Montelukast levels.
  • Corticosteroids: While not directly interacting, Montelukast may allow some patients to reduce their corticosteroid dose.
  • Other asthma medications: Generally safe to use with other asthma medications, but always consult your healthcare provider.
  • Theophylline: No significant interaction, but monitoring may be advised when used together.
  • Probenecid: May increase Montelukast levels in the body.
  • St. John’s Wort: May decrease Montelukast levels.
  • Grapefruit juice: May increase Montelukast levels, though the clinical significance is unclear.

[Note: This isn’t a complete list, and there could be other drugs that interact with Montelukast. Make sure to tell your doctor about any prescription, over-the-counter medicines, and herbal products you’re taking.]

Montelukast Alternatives

[Note: Your doctor will choose what’s best for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may cause serious side effects.] 

Frequently Asked Questions

Can Montelukast lead to weight gain?

Weight gain is not typically associated with Montelukast. If you experience unexpected weight gain while taking this medication, it’s important to discuss it with your healthcare provider.

Why is it recommended to take Montelukas at night for asthma?

In clinical trials, Montelukast was administered to asthma patients in the evening, and its effects were not studied during other times of the day. Although it might still be effective if taken at different times, the recommendation to use it at night stems from the fact that this was the regimen under which it was initially tested and studied. Therefore, to align with the studied protocol, taking it at night for asthma is advised.

Is Montelukast considered a steroid?

No, Montelukast is not a steroid. Although it shares a common function with steroids in blocking substances that trigger inflammation and swelling in the body, it operates through a different mechanism. This difference in action means that Montelukast and steroids can produce distinct side effects. Notably, Montelukast may result in fewer long-term side effects than inhaled steroids.

Is Montelukast effective during an asthma attack?

No, Montelukast is unsuitable for immediate relief during an asthma attack. It is crucial to have a rescue inhaler available for such emergencies to help you breathe. Montelukast is designed to manage asthma over an extended period, not for sudden symptoms.

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