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Montelukast Tablets

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

Montelukast SODIUM – Uses, Side Effects, and More

This medication may rarely cause serious mental/mood changes. These effects may occur even after the medication has been stopped. Tell your doctor right away if you or a caregiver/family member notice symptoms such as agitation, anxiety, abnormal dreams, depression, memory/attention problems, hallucinations, trouble sleeping, or changes in behavior (such as aggression, hostility, restlessness, sleepwalking, suicidal thoughts/attempts). Talk to your doctor about the risks and benefits of this medication.

Warnings:

Uses

Montelukast is used to control and prevent symptoms caused by asthma (such as wheezing and shortness of breath). It is also used before exercise to prevent breathing problems during exercise (bronchospasm). This medication can help decrease the number of times you need to use your quick relief inhaler.Montelukast is also used to relieve symptoms of hay fever and allergic rhinitis (such as sneezing, stuffy/runny/itchy nose). Since there are other allergy medications that may be safer (see also Warning section), this medication should be used for this condition only when you cannot take other allergy medications or they do not work well.This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks or breathing problems. If an asthma attack or sudden shortness of breath occurs, use your quick-relief inhaler as prescribed.This drug works by blocking certain natural substances (leukotrienes) that may cause or worsen asthma and allergies. It helps make breathing easier by reducing swelling (inflammation) in the airways.

How to use montelukast oral

Read the Medication Guide provided by your pharmacist before you start taking montelukast and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

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Take this medication by mouth with or without food as directed by your doctor. The dosage is based on your age and medical condition.

If you are using the chewable tablets, chew them thoroughly before swallowing. If your child cannot safely chew and swallow them, consult the doctor or pharmacist for advice.

Take this medication at the same time each day. If you are taking this medication for asthma or for both asthma and allergies, take your dose in the evening. If you are taking montelukast to prevent only allergies, take your dose either in the morning or the evening.

If you are taking this medication to prevent breathing problems during exercise, take your dose at least 2 hours before exercise. Do not take more than one dose in 24 hours. Do not take a dose before exercise if you are already taking this medication daily for asthma or allergies. Doing so may increase the risk of side effects.

Do not increase or decrease your dose or stop using this medication without consulting your doctor. Continue to use this medication regularly to keep your asthma under control, even during sudden asthma attacks or periods when you have no asthma symptoms. Continue to also take other medications for asthma as directed by your doctor. This medication works over time and is not meant to relieve sudden attacks of asthma. If an asthma attack or other breathing problem occurs, use your quick-relief inhaler as prescribed. You should always have a quick-relief inhaler with you. Consult your doctor or pharmacist for more details.

Get medical help right away if your asthma symptoms worsen and your quick-relief inhaler is not helping. Tell your doctor promptly if asthma symptoms, breathing problems, allergy symptoms, number of times you use your rescue inhaler last or get worse.

Montelukast Tablets

Medically reviewed by Drugs.com. Last updated on Jul 13, 2022.

Uses of Montelukast Tablets:

It is used to ease allergy signs.
It is used to prevent breathing problems that happen with exercise.
It is used to treat or prevent asthma.
It may be given to you for other reasons. Talk with the doctor.

For breathing problems:

This medicine is not to be used to treat intense flare-ups of shortness of breath. Use a rescue inhaler. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Montelukast Tablets?

If you are allergic to this medicine (montelukast tablets); any part of this medicine (montelukast tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (montelukast tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Montelukast Tablets?

For all uses of this medicine (montelukast tablets):

Tell all of your health care providers that you take this medicine (montelukast tablets). This includes your doctors, nurses, pharmacists, and dentists.
Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

For breathing problems:

Call your doctor right away if your breathing problems get worse, if your rescue inhaler does not work as well, or if you need to use your rescue inhaler more often.
If you take this medicine (montelukast tablets) for asthma or allergy, do not take another dose to prevent breathing problems that happen with exercise.
If you have asthma and taking aspirin makes it worse, keep avoiding aspirin and NSAIDs while you take this medicine (montelukast tablets).
If you are switching to this medicine (montelukast tablets) from a steroid, do not stop taking the steroid all of a sudden. The dose of the steroid may need to be slowly lowered to avoid side effects. Talk with the doctor.

How is this medicine (Montelukast Tablets) best taken?

Use this medicine (montelukast tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

Take with or without food.
Keep taking this medicine (montelukast tablets) even when you are not having symptoms.
If working out or playing sports causes signs, use at least 2 hours before doing it.
If this medicine (montelukast tablets) is for asthma, take in the evening.

What do I do if I miss a dose?

Skip the missed dose and go back to your normal time.
Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

For all patients taking this medicine (montelukast tablets):

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
Signs or symptoms of depression, suicidal thoughts, emotional ups and downs, abnormal thinking, anxiety, or lack of interest in life.
Signs of a very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
Hallucinations (seeing or hearing things that are not there).
Memory problems or loss.
Feeling confused, not able to focus, or change in behavior.
Strange or odd dreams.
Trouble sleeping.
Trouble speaking.
Restlessness.
Sleepwalking.
Shakiness.
Trouble controlling body movements.
Seizures.
Trouble breathing that is new or worse.
Fever.
Flu-like signs.
Sinus pain.
Chest pain.
A heartbeat that does not feel normal.
Any unexplained bruising or bleeding.
A burning, numbness, or tingling feeling that is not normal.
Ear pain.
Muscle or joint pain.
Swelling.

What are some other side effects of Montelukast Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

Headache.
Stomach pain or diarrhea.
Signs of a common cold.
Cough.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Montelukast Tablets?

Store at room temperature protected from light. Store in a dry place. Do not store in a bathroom.
Store in original container.
Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

If your symptoms or health problems do not get better or if they become worse, call your doctor.
Do not share your drugs with others and do not take anyone else’s drugs.
Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine (montelukast tablets), please talk with your doctor, nurse, pharmacist, or other health care provider.
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

More about montelukast

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Drug Information
Montelukast (Advanced Reading)
Montelukast Chewable Tablets
Montelukast Oral Granules
During pregnancy
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Breastfeeding
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Professional resources

Prescribing Information
Drug class: leukotriene modifiers

Related treatment guides

COPD
Allergic Rhinitis
Asthma, Maintenance
Bronchospasm Prophylaxis
Asthma

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Montelukast Sodium Tablets

How does this medication work? What will it do for me?

Montelukast belongs to a group of medications known as leukotriene receptor antagonists. It is used to prevent and manage asthma symptoms and to relieve the symptoms of seasonal allergies, also known as seasonal allergic rhinitis or hay fever. It may also be used to treat asthma symptoms caused by exercise (exercise-induced bronchoconstriction). It works by blocking the effects of leukotrienes, a substance produced by the body in response to certain “triggers” that cause narrowing and swelling of airways in the lungs. It may be taken alone or in addition to other asthma medications. Montelukast usually starts to work within one day.

When used to prevent and manage asthma, it is important to understand that montelukast should not be used to relieve an asthma attack once it has started. People with asthma should always have their fast-acting asthma relief medication on hand to treat an asthma attack.

Your doctor may have suggested this medication for conditions other than the ones listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each beige, rounded square, biconvex, film-coated tablet, engraved with “M10” on one side and plain on other side, contains 10 mg of montelukast as montelukast sodium. Nonmedicinal ingredients: croscarmellose sodium, low substituted hydroxypropyl cellulose, magnesium stearate, microcelac100 (co-precipitated product of lactose monohydrate 75% w/w and microcrystalline cellulose 25% w/w), hydroxypropyl cellulose, hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide.

How should I use this medication?

For seasonal allergic rhinitis, the recommended dose of montelukast for adults and adolescents 15 years and older is one 10 mg tablet taken once a day in the evening.

For asthma, the recommended dose of montelukast for adults and adolescents 15 years and older is one 10 mg tablet taken once a day in the evening. For children 6 to 14 years old, the recommended dose is one chewable 5 mg tablet taken once a day in the evening. For children 2 to 5 years old, the recommended dose is one chewable 4 mg tablet or one packet of 4 mg granules taken in the evening.

Montelukast can be taken with or without food.

The oral granules can be given either directly in the mouth, or mixed with a spoonful of cold or room temperature soft food (e.g., apple sauce). The packet should not be opened until ready to use. After opening the packet, the full dose of oral granules must be given within 15 minutes. Do not store any oral granule and food mixture for later use. Do not mix the oral granules in liquid. Children may drink liquids after swallowing the oral granules.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you are allergic to montelukast or any ingredients of the medication.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

abdominal or stomach pain
abnormal dreams
bedwetting (for children)
diarrhea
dizziness
drowsiness
fatigue
fever
headache
muscle aches or cramps
scaly and itchy skin
skin rash
symptoms of a cold (i.e., sore throat, runny nose, nasal congestion)
thirst
trouble sleeping
weakness or unusual tiredness

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

aggressive behaviour (such as temper tantrums in children)
asthma symptoms
behaviour changes (e.g., anxiety, irritability, aggressiveness, hostility)
disorientation (not knowing time of day, location)
hyperactivity
memory problems
pounding, fast, or irregular heartbeat
red lumps under the skin, most commonly on the shins
respiratory tract infection
restlessness
seeing or hearing things that are not there (hallucinations)
signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)
signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
sleepwalking
swelling
tremor
trouble paying attention
uncontrolled muscle movement

Are there any other precautions or warnings for this medication?

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

Asthma attacks and asthma control: The effectiveness of montelukast in treating acute asthma attacks has not been established. You should not use it to treat an acute asthma attack – have your rescue medication ready in case of an acute attack. Do not stop taking montelukast without consulting your doctor. For this medication to be effective, it is important to take it regularly on a daily basis, even if you feel your asthma is under control, unless otherwise directed by your doctor.

If you feel your asthma symptoms are not improving or are getting worse while taking this medication, contact your doctor. If your asthma is made worse by acetylsalicylic acid (ASA), do not take ASA or other nonsteroidal anti-inflammatory medications (NSAIDS; e.g., ibuprofen, ketoprofen, naproxen). If your asthma is made worse by exercise, continue to use the medications your doctor has prescribed before exercise.

Behaviour changes: Some people have reported changes in behaviour associated with taking montelukast. There have been occasional reports of aggressive behaviour or hostility, anxiousness, disorientation, decreased memory, sleep disturbances, or suicidal thoughts and behaviour. If you experience any of these effects or notice them in a family member who is taking this medication, contact your doctor as soon as possible.

Depression: Montelukast has been associated with mood swings and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking this medication, contact your doctor as soon as possible.

Phenylketonuria: The chewable tablet form of this medication contains aspartame, an artificial sweetener which contains phenylalanine. The 4 mg chewable tablet contains 0.674 mg of phenylalanine, and the 5 mg chewable tablet contains 0.842 mg. People with phenylketonuria are unable to break phenylalanine down to get rid of it. If you have phenylketonuria, talk to your doctor about other alternatives.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. The safety of using montelukast for people with severely reduced liver function has not been established. If you have reduced liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if montelukast passes into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of montelukast have not been established for children under 2 years old. Montelukast can be used to treat asthma for children aged 2 years and older and to treat seasonal allergies for adolescents 15 years and older.

What other drugs could interact with this medication?

There may be an interaction between montelukast and any of the following:

gemfibrozil
lumacaftor and ivacaftor

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

stop taking one of the medications,
change one of the medications to another,
change how you are taking one or both of the medications, or
leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking.
Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Montelukast Tablets

Montelukast SODIUM – Uses, Side Effects, and More