Montelukast side effects

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Phone:617-525-6884

List of side effects

Patients ≥ 15 years old (asthma)

Patients 6-14 years old (asthma)

Patients 2-5 years old (asthma)

Patients 6-23 Months old (asthma)

Patients ≥ 15 years old (seasonal allergic rhinitis)

Patients 2-14 years old (seasonal allergic rhinitis)

Patients ≥ 15 years old (perennial allergic rhinitis)

Patients 6 months to 14 years old (perennial allergic rhinitis)

Post-marketing experience

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Patients ≥ 15 years old (asthma)

Montelukast has been evaluated for safety in approximately 2950 adult and adolescent patients 15 years of age and older in clinical trials. In placebo-controlled clinical trials, the following adverse experiences reported with Montelukast occurred in greater than or equal to 1% of patients and at an incidence greater than that in patients treated with placebo, regardless of causality assessment: asthenia/fatigue, fever, abdominal pain, trauma, dyspepsia, infectious gastroenteritis, dental pain, dizziness, headache, nasal congestion, cough, influenza, rash, ALT increased, AST increased, pyuria.
The frequency of less common adverse events was comparable between Montelukast and placebo.
The safety profile of Montelukast when administered as a single dose for prevention of EIB in adult and adolescent patients 15 years of age and older was consistent with the safety profile previously described for Montelukast.
Cumulatively, 569 patients were treated with Montelukast for at least 6 months, 480 for one year, and 49 for two years in clinical trials. With prolonged treatment, the adverse experience profile did not significantly change. Return to top

Patients 6-14 years old (asthma)

Montelukast has been evaluated for safety in 476 pediatric patients 6 to 14 years of age. Cumulatively, 289 pediatric patients were treated with Montelukast for at least 6 months, and 241 for one year or longer in clinical trials. The safety profile of Montelukast in the 8-week, double-blind, pediatric efficacy trial was generally similar to the adult safety profile. In pediatric patients 6 to 14 years of age receiving Montelukast, the following events occurred with a frequency ≥2% and more frequently than in pediatric patients who received placebo, regardless of causality assessment: pharyngitis, influenza, fever, sinusitis, nausea, diarrhea, dyspepsia, otitis, viral infection, and laryngitis. The frequency of less common adverse events was comparable between Montelukast and placebo. With prolonged treatment, the adverse experience profile did not significantly change.
In studies evaluating growth rate, the safety profile in these pediatric patients was consistent with the safety profile previously described for Montelukast. In a 56-week, double-blind study evaluating growth rate in pediatric patients 6 to 8 years of age receiving Montelukast, the following events not previously observed with the use of Montelukast in this age group occurred with a frequency ≥2% and more frequently than in pediatric patients who received placebo, regardless of causality assessment: headache, rhinitis (infective), varicella, gastroenteritis, atopic dermatitis, acute bronchitis, tooth infection, skin infection, and myopia. Return to top

Patients 2-5 years old (asthma)

Montelukast has been evaluated for safety in 573 pediatric patients 2 to 5 years of age in single- and multiple-dose studies. Cumulatively, 426 pediatric patients 2 to 5 years of age were treated with Montelukast for at least 3 months, 230 for 6 months or longer, and 63 patients for one year or longer in clinical trials. Montelukast 4 mg administered once daily at bedtime was generally well tolerated in clinical trials. In pediatric patients 2 to 5 years of age receiving Montelukast, the following events occurred with a frequency ≥2% and more frequently than in pediatric patients who received placebo, regardless of causality assessment: fever, cough, abdominal pain, diarrhea, headache, rhinorrhea, sinusitis, otitis, influenza, rash, ear pain, gastroenteritis, eczema, urticaria, varicella, pneumonia, dermatitis, and conjunctivitis. Return to top

Patients 6-23 Months old (asthma)

Safety and effectiveness in pediatric patients younger than 12 months of age with asthma have not been established.
Montelukast has been evaluated for safety in 175 pediatric patients 6 to 23 months of age. The safety profile of Montelukast in a 6-week, double-blind, placebo-controlled clinical study was generally similar to the safety profile in adults and pediatric patients 2 to 14 years of age. Montelukast administered once daily at bedtime was generally well tolerated. In pediatric patients 6 to 23 months of age receiving Montelukast, the following events occurred with a frequency ≥2% and more frequently than in pediatric patients who received placebo, regardless of causality assessment: upper respiratory infection, wheezing; otitis media; pharyngitis, tonsillitis, cough; and rhinitis. The frequency of less common adverse events was comparable between Montelukast and placebo. Return to top

Patients ≥ 15 years old (seasonal allergic rhinitis)

Montelukast has been evaluated for safety in 2199 adult and adolescent patients 15 years of age and older in clinical trials. Montelukast administered once daily in the morning or in the evening was generally well tolerated with a safety profile similar to that of placebo. In placebo-controlled clinical trials, the following event was reported with Montelukast with a frequency ≥1% and at an incidence greater than placebo, regardless of causality assessment: upper respiratory infection, 1.9% of patients receiving Montelukast vs. 1.5% of patients receiving placebo. In a 4-week, placebo-controlled clinical study, the safety profile was consistent with that observed in 2-week studies. The incidence of somnolence was similar to that of placebo in all studies. Return to top

Patients 2-14 years old (seasonal allergic rhinitis)

Montelukast has been evaluated in 280 pediatric patients 2 to 14 years of age in a 2-week, multicenter, double-blind, placebo-controlled, parallel-group safety study. Montelukast administered once daily in the evening was generally well tolerated with a safety profile similar to that of placebo. In this study, the following events occurred with a frequency ≥2% and at an incidence greater than placebo, regardless of causality assessment: headache, otitis media, pharyngitis, and upper respiratory infection. Return to top

Patients ≥ 15 years old (perennial allergic rhinitis)

Montelukast has been evaluated for safety in 3357 adult and adolescent patients 15 years of age and older with perennial allergic rhinitis of whom 1632 received Montelukast in two, 6-week, clinical studies. Montelukast administered once daily was generally well tolerated, with a safety profile consistent with that observed in patients with seasonal allergic rhinitis and similar to that of placebo. In these two studies, the following events were reported with Montelukast with a frequency ≥1% and at an incidence greater than placebo, regardless of causality assessment: sinusitis, upper respiratory infection, sinus headache, cough, epistaxis, and increased ALT. The incidence of somnolence was similar to that of placebo. Return to top

Patients 6 months to 14 years old (perennial allergic rhinitis)

The safety in patients 2 to 14 years of age with perennial allergic rhinitis is supported by the established safety in patients 2 to 14 years of age with seasonal allergic rhinitis. The safety in patients 6 to 23 months of age is supported by data from pharmacokinetic and safety and efficacy studies in asthma in this pediatric population and from adult pharmacokinetic studies. Return to top

Post-marketing experience

The following additional adverse reactions have been reported in post-marketing use:

• Blood and lymphatic system disorders: increased bleeding tendency
• Immune system disorders: hypersensitivity reactions including anaphylaxis, very rarely hepatic eosinophilic infiltration
• Psychiatric disorders: agitation including aggressive behavior, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (suicidality), tremor
• Nervous system disorders: drowsiness, paraesthesia/hypoesthesia, very rarely seizures
• Cardiac disorders: palpitations
• Gastrointestinal disorders: diarrhea, dyspepsia, nausea, very rarely pancreatitis, vomiting
• Hepatobiliary disorders: Rare cases of cholestatic hepatitis, hepatocellular liver-injury, and mixed-pattern liver injury have been reported in patients treated with Montelukast. Most of these occurred in combination with other confounding factors, such as use of other medications, or when Montelukast was administered to patients who had underlying potential for liver disease such as alcohol use or other forms of hepatitis.
• Skin and subcutaneous tissue disorders: angioedema, bruising, erythema nodosum, pruritus, urticaria
• Musculoskeletal and connective tissue disorders: arthralgia, myalgia including muscle cramps
• General disorders and administration site conditions: edema

In rare cases, patients with asthma on therapy with Montelukast may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy. These events usually, but not always, have been associated with the reduction of oral corticosteroid therapy. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal association between Montelukast and these underlying conditions has not been established. Return to top

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The content of this page is taken from the FDA package insert for this drug and should not be edited.