Montelukast (Oral Route)

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Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Abdominal or stomach pain
• Bloody nose
• Body aches or pain
• Chills
• Colds
• Congestion
• Cough or hoarseness
• Cough producing mucus
• Diarrhea
• Difficulty with breathing
• Dryness or soreness of the throat
• Fever
• Flu-like symptoms
• General feeling of discomfort or illness
• Headache
• Joint pain
• Loss of appetite
• Muscle aches and pains
• Nausea
• Pain or tenderness around the eyes and cheekbones
• Shivering
• Shortness of breath or troubled breathing
• Sneezing
• Stuffy or runny nose
• Sweating
• Tender or swollen glands in the neck
• Tightness of the chest or wheezing
• Trauma
• Trouble with sleeping
• Trouble with swallowing
• Unusual tiredness or weakness
• Voice changes
• Vomiting
• Weakness

• Pus in the urine

• Aggression
• Agitation
• Anxiety
• Attempts at killing oneself
• Bloating
• Breathing problems
• Clay-colored stools
• Confusion about identity, place, and time
• Constipation
• Convulsions (seizures)
• Dark-colored urine
• Discouragement
• Dry mouth
• Fast, irregular, pounding, or racing heartbeat or pulse
• Feeling sad or empty
• General tiredness and weakness
• Hives or welts
• Indigestion
• Irritability
• Itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
• Lack of appetite
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Light-colored stools
• Loss of bladder control
• Loss of interest or pleasure
• Muscle spasm or jerking of all extremities
• Nervousness
• Pains in the stomach, side, or abdomen, possibly moving to the back
• Redness of the skin
• Restlessness
• Seeing, hearing, or feeling things that are not there
• Shakiness in the legs, arms, hands, or feet
• Shaking or trembling of the hands or feet
• Sleeplessness
• Sudden loss of consciousness
• Tiredness
• Trouble with breathing
• Trouble with concentrating
• Unable to sleep
• Unpleasant breath odor
• Upper right abdominal pain
• Vomiting of blood
• Yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• Belching
• Blurred vision
• Change in near or distance vision
• Dental pain
• Difficulty in focusing the eyes
• Earache
• Heartburn
• Lack or loss of strength
• Pain
• Redness
• Redness or swelling in the ear
• Skin rash, encrusted, scaly and oozing
• Stomach discomfort, upset, or pain
• Swelling
• Tenderness
• Warmth on the skin

• Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
• Difficulty with moving
• Dreams that are unusual
• Increased tendency to bleed
• Large, flat, blue or purplish patches on the skin
• Muscle aching or cramping
• Muscle pain or stiffness
• Sleepiness
• Swollen joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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