Pediatric Medication

This information from Lexicomp® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.

Brand Names: US


Brand Names: Canada

ACH-Montelukast [DSC]; AG-Montelukast; APO-Montelukast; Auro-Montelukast; BIO-Montelukast; DOM-Montelukast; DOM-Montelukast FC; JAMP-Montelukast; M-Montelukast; Mar-Montelukast; MINT-Montelukast; MYLAN-Montelukast [DSC]; NRA-Montelukast; PMS-Montelukast; PRIVA-Montelukast; RAN-Montelukast; RIVA-Montelukast FC; SANDOZ Montelukast; Singulair; TEVA-Montelukast


For all uses of this drug:

  • Severe mental health problems have happened with this drug or after it has been stopped. These problems include depression or suicidal thoughts or actions. These problems can happen in people with and without a history of mental or mood problems. Watch people who take this drug closely. Call the doctor right away if any changes in mood or behavior that are new or worse occur. This includes signs like depression; thoughts or actions of suicide; not able to focus; bad or strange dreams; anxiety; hallucinations (seeing or hearing things that are not there); memory problems; sleep walking; stuttering; shakiness; trouble sleeping; trouble controlling body movements; or feeling agitated, confused, irritable, or restless. Talk with the doctor to be sure that the benefits of this drug are more than the risks.

For allergic reasons:

  • This drug must only be used when other drugs cannot be used or have not worked. If you have questions, talk with the doctor.

What is this drug used for?

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

For breathing problems:

  • This drug 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 the doctor BEFORE my child takes this drug?

  • If your child is allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had.

This drug may interact with other drugs or health problems.

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

What are some things I need to know or do while my child takes this drug?

For all uses of this drug:

  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • If your child has phenylketonuria (PKU), talk with your child’s doctor. Some products have phenylalanine.

If your child is pregnant or breast-feeding a baby:

  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.

For breathing problems:

  • Call the doctor right away if your child has breathing problems that get worse, if the rescue inhaler does not work as well, or if your child needs to use the rescue inhaler more often.
  • If your child takes this drug for asthma or allergy, do not give another dose to prevent breathing problems that happen with exercise.
  • If your child has asthma and taking aspirin makes it worse, make sure your child avoids aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen while your child takes this drug.
  • If your child is switching to this drug from a steroid, do not stop giving the steroid to your child all of a sudden. The dose of the steroid may need to be slowly lowered to avoid side effects. Talk with the doctor.

What are some side effects that I need to call my child’s 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 child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:

  • 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 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.
  • Trouble breathing that is new or worse.
  • Fever.
  • Flu-like signs.
  • Sinus pain.
  • A burning, numbness, or tingling feeling that is not normal.
  • Ear pain.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child 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 child’s doctor. Call your child’s doctor for medical advice about side effects.

You may report side effects to your national health agency.

How is this drug best given?

Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.

All products:

  • Give this drug with or without food.
  • Keep giving this drug even when your child is not having symptoms.
  • If working out or playing sports causes your child signs, give at least 2 hours before your child does it.
  • If this drug is for asthma, give in the evening.

Chewable tablet:

  • Have your child chew well before swallowing.


  • Granules may be placed right in the mouth or mixed with cold or room temperature applesauce, baby formula, breast milk, mashed carrots, rice, or ice cream. Do not mix granules in other liquids.
  • Do not open the packet until you are ready to give a dose. Give the dose within 15 minutes after opening the packet. Do not store for future use.

What do I do if my child misses a dose?

  • Skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.

How do I store and/or throw out this drug?

  • 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.

General drug facts

  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s 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.

Consumer Information Use and Disclaimer

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

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