Montelukast Sodium

Applies to montelukast: oral packet, oral tablet, oral tablet chewable

Along with its needed effects, montelukast 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 while taking montelukast:

Less common

• Abdominal or stomach pain
• bloody nose
• flu-like symptoms
• general feeling of discomfort or illness
• headache
• joint pain
• pain or tenderness around the eyes and cheekbones
• shortness of breath or troubled breathing
• sweating
• tightness of the chest
• trouble with swallowing
• unusual tiredness or weakness

Rare

• Pus in the urine

Incidence not known

• Agitation
• anxiety
• attempts at killing oneself
• breathing problems
• confusion about identity, place, and time
• constipation
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling sad or empty
• hives or welts
• indigestion
• itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
• lack of appetite
• pains in the stomach, side, or abdomen, possibly moving to the back
• redness of the skin
• shaking or trembling of the hands or feet
• trouble with concentrating
• unable to sleep
• unpleasant breath odor
• upper right abdominal or stomach pain
• vomiting of blood
• yellow eyes or skin

Some side effects of montelukast 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:

Less common

• Acid or sour stomach
• belching
• blurred vision
• change in near or distance vision
• dental pain
• earache
• heartburn
• lack or loss of strength
• pain
• skin rash, encrusted, scaly and oozing
• stomach discomfort, upset, or pain

Incidence not known

• Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
• dreams that are unusual
• increased tendency to bleed
• large, flat, blue or purplish patches on the skin
• muscle aching or cramping
• sleepiness
• swollen joints

Applies to montelukast: oral granule, oral tablet, oral tablet chewable

The most common adverse reactions (incidence more than 5% and greater than placebo) were: Upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis, otitis.

Very rare (less than 0.01%): Churg-Strauss Syndrome

Churg-Strauss syndrome is a rare granulomatous eosinophilic condition that involves the upper and lower airways and manifests as rhinitis, sinusitis and asthma. If untreated the syndrome may progress to systemic vasculitis, peripheral neuropathy and potentially fatal cardiac complications. In most cases, the condition emerged during withdrawal of oral corticosteroid therapy. A causative role for leukotriene receptor antagonists has not been ruled out.

Very common (10% or more): Headache (18.4%)

Common (1% to 10%): Dizziness (1.9%)

Postmarketing reports: Disturbance in attention, irritability, memory impairment, tremor, drowsiness, paraesthesia/hypoesthesia, seizures

Common (1% to 10%): Rash (1.6%), atopic dermatitis, skin infection, eczema, urticaria

Postmarketing reports: Angioedema, bruising, erythema multiforme, erythema nodosum, pruritus, Stevens-Johnson syndrome/toxic epidermal necrolysis

Common (1% to 10%): Abdominal pain (2.9%), dyspepsia (2.1%), dental pain (1.7%), gastroenteritis (1.5%), nausea, diarrhea, dyspepsia, gastroenteritis, tooth infection

Common (1% to 10%): ALT increase (2.1%), AST increased (1.6%)

Postmarketing reports: Hepatic eosinophilic infiltration; cases of cholestatic hepatitis, hepatocellular liver-injury, and mixed-pattern liver injury. Most of these occurred in combination with other confounding factors, such as use of other medications, or when administered to patients who had underlying potential for liver disease such as alcohol use or other forms of hepatitis.

Common (1% to 10%): Myopia, conjunctivitis

Common (1% to 10%): Asthenia, fatigue (1.8%), fever (1.5%), trauma (1%), influenza, fever, otitis, viral infection, varicella, ear pain, otitis media

Uncommon (0.1% to 1%): Malaise

Postmarketing reports: Edema

Common (1% to 10%): Influenza (4.2%), cough (2.7%), nasal congestion (1.6%), pharyngitis, sinusitis, laryngitis, infective rhinitis, acute bronchitis, rhinorrhea, pneumonia, upper respiratory infection, wheezing, tonsillitis

Postmarketing reports: Epistaxis, pulmonary eosinophilia

Postmarketing reports: Palpitations

Postmarketing reports: Enuresis in children

Postmarketing reports: Increased bleeding tendency, thrombocytopenia

Postmarketing reports: Anaphylaxis

Postmarketing reports: Arthralgia, myalgia including muscle cramps

Postmarketing reports: Agitation including aggressive behavior or hostility, anxiousness, depression, disorientation, dream abnormalities, hallucinations, insomnia, restlessness, somnambulism, suicidal thinking and behavior (including suicide)