Do not take montelukast tablets if you are allergic to one of their ingredients.
Montelukast may cause serious side effects:
Behavior and mood related changes. Tell your healthcare provider right away if you experience:
- Agitation including aggressive behavior or hostility
- Memory problems
- Obsessive-compulsive symptoms
- Attention problems
- Restlessness
- Bad or vivid dreams
- Sleep walking
- Depression
- Stuttering
- Disorientation (confusion)
- Suicidal thoughts and actions
- Feeling anxious (including suicide)
- Hallucinations (seeing or hearing things that are not really there)
- Tremor
- Trouble sleeping
- Irritability
- 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. This sometimes happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. Tell your provider right away if you have any of the following 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)
The most common side effects of montelukast include:
- Upper respiratory infection
- Fever
- Headache
- Sore throat
- Cough
- Stomach pain
- Diarrhea
- Earache or ear infection
- Flu
- Runny nose
- Sinus infection
Other side effects with montelukast include:
- Increased bleeding tendency, low blood platelet count
- Allergic reactions [including swelling of the face, lips, tongue, and/or throat (which may cause trouble breathing or swallowing), hives and itching]
- Dizziness, drowsiness, pins and needles/numbness, seizures (convulsions or fits)
- Palpitations
- Nose bleed, stuffy nose, swelling (inflammation) of the lungs
- Heartburn, indigestion, inflammation of the pancreas, nausea, stomach or intestinal upset, vomiting
- Hepatitis
- Bruising
- Rash
- Severe skin reactions (erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis) that may occur without warning
- Joint pain, muscle aches and muscle cramps
- Bedwetting in children
- Tiredness, swelling
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of montelukast. For more information, ask your healthcare provider or pharmacist.
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.
- Your symptoms of allergic rhinitis are getting worse
- You have a reaction to the medication, including hives or difficulty breathing. In this case, seek immediate medical attention
Before using montelukast, tell your healthcare provider if you:
- Are allergic to aspirin
- Have any other medical conditions
- 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 breast-feeding or plan to breast-feed. 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, including, in some cases, death.
Montelukast is a prescription medicine that blocks substances in the body called leukotrienes. This may help to improve symptoms of asthma and allergic rhinitis. montelukast does not contain a steroid.
Montelukast is used to:
- Prevent asthma attacks and for the long-term treatment of asthma in adults and children ages 12 months and older. Do not take montelukast if you need relief right away for a sudden asthma attack. If you get an asthma attack, you should follow the instructions your healthcare provider gave you for treating asthma attacks.
- Prevent exercise-induced asthma in people 6 years of age and older.
- Help control the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose). Montelukast is used to treat:
outdoor allergies that happen part of the year (seasonal allergic rhinitis) in adults and children ages 2 years and older, and
indoor allergies that happen all year (perennial allergic rhinitis) in adults and children ages 6 months and older.
On the Ro platform, montelukast is only prescribed to help control the symptoms of allergic rhinitis in adults.
Montelukast is only prescribed for allergic rhinitis in adults over the Ro platform. Adults using montelukast for allergic rhinitis should:
- Take one montelukast tablet at about the same time each day.
- Take montelukast exactly as prescribed by your healthcare provider. Your healthcare provider will tell you how much montelukast to take, and when to take it.
- Do not stop taking montelukast or change when you take it without talking with your healthcare provider.
- You can take montelukast with food or without food.
- If you miss a dose of montelukast, just take the next dose at your regular time. Do not take 2 doses at the same time.
- If you take too much montelukast, call your healthcare provider or a Poison Control Center right away.
Please see the full Prescribing Information including the Patient Information sheet for complete safety information.