Patient Medication Guide

This medication carries a boxed warning, the FDA's most serious type of warning, about serious neuropsychiatric events, meaning changes in mood, thinking, or behavior.

The label lists reported events including agitation, aggression, depression, sleep disturbances, and suicidal thoughts and behavior, including suicide.

The FDA label states that because of this risk, the benefits may not outweigh the risks for some people, particularly when symptoms are mild and could be treated with other options.

If you or someone taking this medication notices changes in behavior, new mental-health symptoms, or suicidal thoughts, the label directs patients to stop the medication and contact a healthcare provider immediately.

4 citations from the FDA label.

Montelukast, sold under the brand name Singulair, is a leukotriene receptor antagonist. It is taken by mouth as a tablet.

Leukotrienes are substances released by cells in your body that contribute to airway swelling, tightening of airway muscles, and allergy symptoms. This medication blocks a receptor those substances act on.

It is a long-term control medication. It is not a rescue inhaler and does not work quickly to open the airways during an attack.

3 citations from the FDA label.

Asthma: to help prevent and manage asthma over time, in people 12 months of age and older.

Exercise-induced bronchoconstriction (EIB): to help prevent breathing problems brought on by exercise, in people 6 years of age and older.

Allergic rhinitis: to relieve symptoms of seasonal allergies (age 2 and older) and year-round allergies (age 6 months and older).

For allergy symptoms, the label says to reserve this medication for people who have an inadequate response to, or cannot tolerate, other treatments.

5 citations from the FDA label.

This medication is not indicated to treat an acute asthma attack. It is not a substitute for a rescue inhaler.

The label instructs that people taking it should have appropriate rescue medication available.

It should not be abruptly substituted for inhaled or oral corticosteroids.

People with known aspirin sensitivity should continue to avoid aspirin and NSAIDs while taking it.

4 citations from the FDA label.

The label lists these as the most common adverse reactions reported at 5% or more, and more often than with placebo: upper respiratory infection, fever, headache, sore throat, cough, abdominal pain, diarrhea, ear infection, influenza, runny nose, sinusitis, and ear inflammation.

An important caveat from the label itself: rates seen in clinical trials cannot be directly compared with rates from other drugs' trials, and may not reflect what happens in everyday practice.

3 citations from the FDA label.

Mental-health and behavior changes. See the boxed warning above. This is the most serious identified risk. The label reports these events in adults, adolescents, and children, both in people who had a previous psychiatric history and people who did not.

The label states it is difficult to identify who is at risk, or to quantify how large the risk is.

Systemic eosinophilia, sometimes with features of vasculitis consistent with Churg-Strauss syndrome, has been reported. The label notes these events have sometimes been associated with reducing oral corticosteroid therapy.

4 citations from the FDA label.

The label lists one contraindication: hypersensitivity to any component of the medication.

For drug interactions, the label states that no dose adjustment is needed when it is taken with a list of common medications including theophylline, prednisone, oral contraceptives, digoxin, warfarin, and others.

This does not mean no interaction is possible with any medication. Your pharmacist can check your specific medication list.

2 citations from the FDA label.

Pregnancy: the label states that available data from published studies over decades have not established a drug-associated risk of major birth defects. It also notes that all pregnancies carry a background risk, and that poorly controlled asthma carries its own risks.

Children: safety and effectiveness for asthma have been established in children 6 to 14 years of age, with safety and efficacy data similar to adults. Children in that age range use a different strength than the 10 mg tablet.

Older adults: the label states no dosage adjustment in the elderly is required, while noting that greater sensitivity in some older individuals cannot be ruled out.

5 citations from the FDA label.

For asthma, the label describes once-daily dosing in the evening, with or without food.

For preventing exercise-induced breathing problems, the label describes one tablet at least 2 hours before exercise.

People who have both asthma and allergic rhinitis are directed to take only one dose daily, in the evening.

This is what the label says in general. It is not a dosing instruction for you. Follow the directions on your own prescription and ask your prescriber or pharmacist about your situation.

7 citations from the FDA label.

The label directs suspected adverse reactions to be reported to the manufacturer at 1-844-674-3200, or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Reporting side effects is how safety signals like the boxed warning on this medication get identified in the first place.

1 citation from the FDA label.