Montelukast Drug Facts

Important Safety Information (Montelukast)

What is the FDA-approved use of montelukast? 1.1 Asthma Montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 15 years of age and older.

1.2 Exercise-Induced Bronchoconstriction (EIB) Montelukast sodium tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older.

1.3 Allergic Rhinitis Montelukast sodium tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients 15 years of age and older. Because the benefits of montelukast sodium tablets may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis, reserve use for patients who have an inadequate response or intolerance to alternative therapies.

Please see Full Prescribing Information, including BOXED WARNING, Medication Guide, and Instructions for use.


Serious neuropsychiatric (NP) events have been reported with the use of montelukast sodium. The types of events reported were highly variable, and included, but were not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior (including suicide). The mechanisms underlying NP events associated with montelukast sodium use are currently not well understood.

Because of the risk of NP events, the benefits of montelukast sodium may not outweigh the risks in some patients, particularly when the symptoms of disease may be mild and adequately treated with alternative therapies. Reserve use of montelukast sodium for patients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies. In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and risks before prescribing montelukast sodium.

Discuss the benefits and risks of montelukast sodium with patients and caregivers when prescribing montelukast sodium. Advise patients and/or caregivers to be alert for changes in behavior or new NP symptoms when taking montelukast sodium. If changes in behavior are observed, or if new NP symptoms or suicidal thoughts and/or behavior occur, advise patients to discontinue montelukast sodium and contact a healthcare provider immediately.

Do not take montelukast if you need relief right away for a sudden asthma attack or if you have hypersensitivity to any component of montelukast.

What are the most important things to know about montelukast?

Stop taking montelukast sodium tablets and tell your healthcare provider right away if you have any unusual changes in behavior or thinking, including any of these symptoms:

  • agitation, including aggressive behavior or hostility
  • attention problems
  • bad or vivid dreams
  • depression
  • disorientation (confusion)
  • feeling anxious
  • irritability
  • hallucinations (seeing or hearing things that are not really there)
  • memory problems
  • obsessive-compulsive symptoms
  • restlessness
  • sleep walking
  • stuttering
  • suicidal thoughts and actions (including suicide)
  • tremor
  • trouble sleeping
  • uncontrolled muscle movements

Increase in certain white blood cells (eosinophils) and possible inflamed blood vessels throughout the body (systemic vasculitis). Rarely, this can happen in people with asthma who take montelukast sodium tablets. This sometimes happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered.

What are the possible side effects of montelukast sodium tablets? The most common side effects of montelukast sodium tablets include:

  • upper respiratory infection
  • fever
  • headache
  • sore throat
  • cough
  • stomach pain
  • diarrhea
  • earache or ear infection
  • flu
  • runny nose
  • sinus infection

Talk to your healthcare provider right away if you get one or more of these symptoms:

  • a feeling of pins and needles or numbness of arms or legs
  • a flu-like illness
  • rash
  • severe inflammation (pain and swelling) of the sinuses (sinusitis)

You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

What should I tell my Picnic doctor before taking montelukast? Before taking montelukast, tell your healthcare provider about all your medical conditions, including if you:

  • Are allergic to aspirin
  • Have or have had mental health problems
  • Are pregnant or plan to become pregnant. Talk to your doctor if you are pregnant or plan to become pregnant, as montelukast may not be right for you.
  • Are breastfeeding or plan to breastfeed. It is not known if montelukast passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking montelukast.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how montelukast works, or montelukast may affect how your other medicines work.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm.

How should I take montelukast tablets?

  • Take montelukast sodium tablets exactly as prescribed by your Picnic doctor. Your Picnic doctor will tell you how much montelukast sodium tablets to take, and when to take it.
  • Stop taking montelukast sodium tablets and tell your healthcare provider right away if you or your child have any unusual changes in behavior or thinking.
  • You can take montelukast sodium tablets with food or without food.
  • If you miss a dose of montelukast sodium tablets, just take the next dose at your regular time. Do not take 2 doses at the same time.
  • If you take too much montelukast sodium, call your healthcare provider right away.

Trade Names


The list of names may not include all products that are available on the market.

What is this medicine?

MONTELUKAST (mon te LOO kast) is used to prevent and treat the symptoms of asthma. It is also used to treat allergies. Do not use for an acute asthma attack.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

This medicine can cause serious mental health problems. Patients of all ages and their families should watch for changes, especially sudden changes in mood, behaviors, thoughts, or feelings.

Some symptoms to watch for are depression, thoughts of suicide, aggressive behavior, wanting to hurt others, hostility, anger, anxiety, irritability, being suspicious or distrustful, or any unusual or extreme changes in behavior or mood. Call your healthcare provider right away for new or worsening mental problems. Call your healthcare provider as needed, especially if you are worried about symptoms.

Active ingredient: montelukast sodium 10mg

Inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mannitol and microcrystalline cellulose. The tablets are coated with opadry yellow which contains carnauba wax, hydroxypropyl cellulose, hypromellose, red iron oxide, titanium dioxide and yellow iron oxide

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • liver disease
  • an unusual or allergic reaction to montelukast, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

This medicine should be given by mouth. Follow the directions on the prescription label. Take this medicine at the same time every day. You may take this medicine with or without meals. Do not chew the tablets. Do not stop taking your medicine unless your doctor tells you to.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. While this drug may be prescribed for children as young as 15 years of age for selected conditions, precautions do apply.


If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medicine?

  • anti-infectives like rifampin and rifabutin
  • medicines for seizures like phenytoin, phenobarbital, and carbamazepine

This list may not describe all possible interactions. Give your health care provider a list of all themedicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash or hives, or swelling of the face, lips, or tongue
  • breathing problems
  • changes in emotions or moods
  • confusion
  • depressed mood
  • fever or infection
  • hallucinations
  • joint pain
  • painful lumps under the skin
  • pain, tingling, numbness in the hands or feet
  • redness, blistering, peeling, or loosening of the skin, including inside the mouth
  • restlessness
  • seizures
  • sleep walking
  • signs and symptoms of infection like fever; chills; cough; sore throat; flu-like illness
  • signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
  • sinus pain or swelling
  • stuttering
  • suicidal thoughts or other mood changes
  • tremors
  • trouble sleeping
  • uncontrolled muscle movements
  • unusual bleeding or bruising
  • vivid or bad dreams

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • dizziness
  • drowsiness
  • headache
  • runny nose
  • stomach upset
  • tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Tell your doctor or health care professional if your allergy or asthma symptoms do not improve. Take your medicine even when you do not have symptoms. Do not stop taking any of your medicine(s) unless your doctor tells you to.

If you have asthma, talk to your doctor about what to do in an acute asthma attack. Always have your inhaled rescue medicine for asthma attacks with you. Patients and their families should watch for new or worsening thoughts of suicide or depression. Also watch for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. Any worsening of mood or thoughts of suicide or dying should be reported to your health care professional right away.

Where should I keep my medicine?

Keep out of the reach of children. Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light and moisture. Keep this medicine in the original bottle. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.


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