Applies to montelukast: oral granules, oral tablets chewable or film-coated.
Warning
- Serious neuropsychiatric effects, including suicidal thoughts or behavior, reported in patients receiving montelukast.128 129 (See Neuropsychiatric Effects under Cautions.)
- Discuss benefits and risks of treatment with patients and caregivers; monitor patients receiving montelukast for neuropsychiatric symptoms.128 129
- Discontinue montelukast if neuropsychiatric symptoms occur and contact a clinician immediately.128 129
- Benefits of montelukast treatment may not outweigh the risks of neuropsychiatric symptoms, especially for respiratory disease symptoms that may be mild and adequately treated with alternative therapies.128 129 Reserve use of the drug for patients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies.128 129 In patients with asthma or exercise-induced bronchospasm, consider the benefits and risks of treatment before prescribing montelukast.128 129
Side effects include:
Headache, influenza, abdominal pain, cough.
For Healthcare Professionals
Applies to montelukast: oral granule, oral tablet, oral tablet chewable.
General
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.[Ref]
Immunologic
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.[Ref]
Very rare (less than 0.01%): Churg-Strauss Syndrome[Ref]
Nervous system
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[Ref]
Dermatologic
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[Ref]
Gastrointestinal
Common (1% to 10%): Abdominal pain (2.9%), dyspepsia (2.1%), dental pain (1.7%), gastroenteritis (1.5%), nausea, diarrhea, dyspepsia, gastroenteritis, tooth infection[Ref]
Hepatic
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.[Ref]
Ocular
Common (1% to 10%): Myopia, conjunctivitis[Ref]
Other
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[Ref]
Respiratory
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[Ref]
Cardiovascular
Postmarketing reports: Palpitations[Ref]
Genitourinary
Postmarketing reports: Enuresis in children[Ref]
Hematologic
Postmarketing reports: Increased bleeding tendency, thrombocytopenia[Ref]
Hypersensitivity
Postmarketing reports: Anaphylaxis[Ref]
Musculoskeletal
Postmarketing reports: Arthralgia, myalgia including muscle cramps[Ref]
Psychiatric
Postmarketing reports: Agitation including aggressive behavior or hostility, anxiousness, depression, disorientation, dream abnormalities, hallucinations, insomnia, restlessness, somnambulism, suicidal thinking and behavior (including suicide), tic, obsessive-compulsive symptoms, dysphemia/stuttering[Ref]
