Montelukast
Montelukast sodium · Say it: mon-te-LOO-kast SOE-dee-um
A prescription tablet taken by people aged 15 and older to help control asthma, prevent exercise-induced asthma, and relieve allergy symptoms of the nose, but it carries a boxed warning about serious mental health side effects.
Brand names: Singulair
⬛ Boxed warning (the FDA's strongest warning)
The boxed warning says serious neuropsychiatric (mental health and behavior) events have been reported with montelukast. These included agitation, aggression, depression, sleep disturbances, and suicidal thoughts and behavior, including suicide. The label says the cause is not well understood. Because of this risk, the benefits may not outweigh the risks in some patients, especially when symptoms are mild and can be treated with other therapies. The label says to reserve use for allergic rhinitis in people with an inadequate response or intolerance to other therapies. For asthma or exercise-induced bronchoconstriction, the prescriber should consider the benefits and risks. Patients and caregivers should be alert for changes in behavior or new symptoms. If these occur, the label advises stopping the medicine and contacting a healthcare provider immediately.
Used for
Preventing asthma attacks and long-term treatment of asthma in people 15 years of age and older. The label says it is not for relief of a sudden asthma attack.
Comes as
10 mg film-coated tablets (beige, rounded square shape)
Common side effects
Stomach (abdominal) pain, Tiredness or weakness, Fever
| Generic name | Montelukast sodium |
|---|---|
| Brand names | Singulair |
| Type of medicine | A leukotriene receptor antagonist, a medicine that blocks substances in the body called leukotrienes. |
| How it is sold | Prescription tablet |
| Comes as | 10 mg film-coated tablets (beige, rounded square shape) |
| Route | oral |
| Boxed warning | Yes, see below |
| Label date | 2026-08-04 |
💊 What is Montelukast used for?
- Preventing asthma attacks and long-term treatment of asthma in people 15 years of age and older. The label says it is not for relief of a sudden asthma attack.
- Preventing exercise-induced bronchoconstriction (exercise-induced asthma) in people 15 years of age and older.
- Relieving symptoms of seasonal allergic rhinitis (outdoor allergies) in people 15 years of age and older.
- Relieving symptoms of perennial allergic rhinitis (indoor allergies that happen all year) in people 15 years of age and older.
- For allergy symptoms, the label says it is reserved for people who did not respond well enough to, or could not tolerate, other medicines.
How it works
The label says the medicine blocks substances in the body called leukotrienes. Leukotrienes are involved in asthma and inflammation of the lining of the nose, so blocking them may help improve these symptoms.
How it is usually taken
- For asthma, the label says the tablet is taken once a day in the evening, with or without food, and continued every day as prescribed even when there are no symptoms. For exercise-induced asthma, it is taken at least 2 hours before exercise. For allergic rhinitis, it is taken once a day at about the same time each day. The label says it can be taken with or without food. People are usually told to follow the instructions from their prescriber or pharmacist.
Comes as
- 10 mg film-coated tablets (beige, rounded square shape)
⚠️ Montelukast side effects
Common side effects
- Stomach (abdominal) pain
- Tiredness or weakness
- Fever
- Dental pain
- Indigestion (dyspepsia)
- Infectious gastroenteritis (stomach infection)
- Headache
- Dizziness
- Influenza (flu)
- Cough
- Nasal congestion
- Rash
- Upper respiratory infection, sinusitis, ear infection (otitis media), and pharyngitis (sore throat) were also among the most common reactions in the label's trials
Get medical help right away if
- Get medical help right away if you or your child have any unusual changes in behavior or thinking, such as agitation, aggressive behavior, hostility, depression, confusion, hallucinations, memory problems, trouble sleeping, sleepwalking, or uncontrolled muscle movements.
- Get medical help right away if you have thoughts of suicide or harming yourself.
- Stop taking the medicine and tell your healthcare provider right away if these symptoms occur. The label says mental health events can happen with or without a history of mental health problems, and some have occurred after treatment stopped.
- Get medical help right away if you notice signs of an increase in certain white blood cells (eosinophils) or symptoms of inflamed blood vessels (vasculitis). The label says these have sometimes been reported when oral corticosteroid doses were reduced.
🛑 Who should not take Montelukast, and who should be careful
The label says not to take it if
- You are allergic to any of the ingredients in montelukast sodium tablets. The label says to check the Medication Guide for a complete list of ingredients.
Tell your doctor before taking it if
- Tell your healthcare provider about all your medical conditions, especially if you have or have had mental health problems.
- Tell your provider if you are allergic to aspirin. If aspirin makes your asthma worse, the label says to keep avoiding aspirin and other NSAID medicines while taking montelukast.
- Tell your provider if you are pregnant or plan to become pregnant, or if you are breastfeeding or plan to breastfeed.
- Tell your provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
- The label says montelukast is not for relief of a sudden asthma attack, so you should always have your rescue inhaler with you and follow your provider's instructions for asthma attacks.
- Do not reduce or replace inhaled or oral corticosteroids on your own. The label says these may be reduced gradually under medical supervision only.
🔀 Montelukast with other medicines, food and alcohol
The label says to discuss these with your doctor or pharmacist
- The label says no dose adjustment is needed when montelukast is taken with theophylline, prednisone, prednisolone, oral contraceptives, fexofenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative hypnotics, non-steroidal anti-inflammatory agents (NSAIDs), benzodiazepines, decongestants, or cytochrome P450 enzyme inducers.
- The label says some medicines may affect how montelukast works, or montelukast may affect how other medicines work, so tell your provider about everything you take.
Alcohol and food
The label says the tablet can be taken with or without food. The label does not mention alcohol.
🤰 Montelukast in pregnancy and breastfeeding
Pregnancy
The label says published studies have not established a drug-associated risk of major birth defects, but the studies have limitations. It also says poorly or moderately controlled asthma during pregnancy increases risks to the mother and baby. Animal studies did not show adverse developmental effects. Talk to your healthcare provider if you are pregnant or plan to become pregnant, since the label says montelukast may not be right for you.
Breastfeeding
The label says it is not known whether montelukast passes into breast milk. Talk to your healthcare provider about the best way to feed your baby while taking this medicine.
🗓️ Storage, missed doses and taking too much
Storage
Store at 20 to 25 degrees C (68 to 77 degrees F), with brief excursions permitted to 15 to 30 degrees C (59 to 86 degrees F). Protect from moisture and light. Keep in the original package.
If a dose is missed
The label says that if you miss a dose, take the next dose at your regular time. Do not take 2 doses at the same time.
If too much is taken
The label says there is no specific information on treating an overdose. Supportive measures are used, such as removing unabsorbed material from the stomach and intestines, clinical monitoring, and supportive therapy if needed. The Medication Guide says that if you take too much, call your healthcare provider right away.
🗒️ Questions to ask about Montelukast
🎯 Check what you understood
1. According to the boxed warning, what should you do if you notice new mood or behavior changes while taking montelukast?
2. When is the tablet taken for exercise-induced asthma?
3. What does the label say about using montelukast for a sudden asthma attack?
❓ Montelukast: frequently asked questions
What is montelukast used for?
The label says it is used to prevent and treat asthma, prevent exercise-induced asthma, and relieve symptoms of seasonal and perennial allergic rhinitis in people 15 years of age and older. It is not for treating a sudden asthma attack.
What is the most important warning about montelukast?
The boxed warning covers serious neuropsychiatric events, including agitation, depression, sleep problems, and suicidal thoughts or behavior. The label says to watch for these changes and contact a healthcare provider right away if they occur.
Should montelukast be taken with food?
The label says it can be taken with or without food. For asthma, it is taken once daily in the evening.
What should I do if I miss a dose?
The label says to take the next dose at your regular time and not to take 2 doses at the same time.
Can montelukast be used during pregnancy?
The label says studies have not established a drug-associated risk of major birth defects, but the studies have limitations. It advises talking to your healthcare provider if you are pregnant or planning to become pregnant.
🧪 Tests and reports linked to Montelukast
The label text mentions these. If you have one of these reports, get every line of it explained.
- Thyroid tests
a test or report linked to this medicine
- Culture and sensitivity
a test or report linked to this medicine
- Urinalysis
a test or report linked to this medicine
- Complete blood count (CBC)
a test or report linked to this medicine
- Pregnancy hCG test
a test or report linked to this medicine
📖 Medical words used on this page
- Acute Otitis Media
Acute otitis media is a sudden infection of the middle ear, behind the eardrum, common in young children.
- Acute vs chronic
Acute means something started recently or suddenly. Chronic means it has lasted a long time or keeps coming back.
- Allergic reaction
An allergic reaction is when the immune system overreacts to something harmless, such as a medicine or food, causing symptoms from a rash to swelling.
- Benzodiazepine
A benzodiazepine is a type of calming medicine used for anxiety, sleep problems, seizures or muscle spasm. It can cause drowsiness and dependence.
- Boxed warning
A boxed warning is the strongest safety warning on a US medicine label, printed in a box, about a serious or life-threatening risk.
- Bronchodilator
A bronchodilator is a medicine that relaxes the muscles around the airways so they open wider and breathing becomes easier.
- Bronchospasm
Bronchospasm is a sudden tightening of the muscles around the airways, making it hard to breathe. Severe bronchospasm needs urgent help.
- Bronchospastic Disease
Bronchospastic disease means a lung condition, such as asthma, in which the airways tend to tighten suddenly (bronchospasm).
- CNS depressant
A CNS depressant is any medicine or substance that slows down brain and nerve activity, causing drowsiness, relaxation or slower breathing.
- Congenital malformations
Congenital malformations are differences in the structure of the body that are present at birth, such as heart, spine or lip and palate defects.
- Contraindication
A contraindication is a reason not to use a particular medicine, test or procedure for a person because it could cause harm.
- Corticosteroid
A corticosteroid is a medicine similar to the body's own hormone cortisol, used to reduce inflammation and calm the immune system.
- Excessive moisture
On a medicine label, 'protect from excessive moisture' is a storage instruction: keep the product dry so it does not break down or lose strength.
- Film-coated
Film-coated means a tablet has a thin outer layer that makes it easier to swallow, masks taste, or protects the medicine inside.
📖 Medical words on this page
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Have the leaflet or prescription in front of you?
Explain my leafletDecode my prescription🔗 Trusted sources about Montelukast
- Full official label on DailyMed ↗
US National Library of Medicine: the complete FDA label this page is based on
- Montelukast on MedlinePlus ↗
US National Library of Medicine's patient drug information
- Montelukast on the NHS website ↗
UK National Health Service medicine guide
Report a side effect or check safety alerts
- Report a side effect in the US (FDA MedWatch) ↗
- Report a side effect in the UK (Yellow Card) ↗
- FDA recalls and safety alerts ↗
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Source: official FDA drug label (label updated 2026-08-04). Read the full label on DailyMed
MedicDecode explains the official label in plain words. It is not medical advice and does not replace your doctor or pharmacist. Never start, stop or change a medicine because of what you read here.