SINGULAIR offers an established safety
profile for patients with allergic rhinitis.
In adults and adolescents aged >15 years with seasonal or perennial allergic rhinitis, the following adverse events were reported with a frequency of >1% and at an incidence greater than placebo, regardless of causality assessment: sinusitis, upper respiratory infection, sinus headache, cough, epistaxis, and increased ALT.
In pediatric patients aged 2 to 14 years with seasonal allergic rhinitis, the following adverse events occurred with a frequency of >2% and at an incidence greater than placebo, regardless of causality assessment: headache, otitis media, pharyngitis, and upper respiratory infection. The safety profile in patients aged 2 to 14 years with perennial allergic rhinitis is supported by the established safety profile in patients aged 2 to 14 years with seasonal allergic rhinitis.
In pediatric patients aged 6 to 23 months with asthma, the following events occurred with a frequency of >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 safety profile in patients aged 6 to 23 months with perennial allergic rhinitis is supported by data from studies in asthma in this pediatric population and from adult studies.
SINGULAIR is indicated for relief of symptoms of allergic rhinitis (seasonal allergic rhinitis in adults and children aged 2 years and older and perennial allergic rhinitis in adults and children aged 6 months and older).
ADDITIONAL SAFETY INFORMATION
- Neuropsychiatric events have been reported in patients taking SINGULAIR. These events included agitation, aggressive behavior or hostility, anxiousness, depression, dream abnormalities, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thinking and behavior (including suicide), and tremor. The clinical details of some postmarketing reports appear consistent with a drug-induced effect. Patients should be advised to report any neuropsychiatric events.
- In clinical trials in patients with allergic rhinitis, adverse events varied by age. The most commonly reported adverse events, occurring at a frequency of >1% and at an incidence greater than placebo, regardless of causality assessment, were sinusitis, upper respiratory infection, sinus headache, cough, epistaxis, headache, otitis media, pharyngitis, and increased ALT.
- SINGULAIR is contraindicated in patients with hypersensitivity to any component of this product.
Before prescribing SINGULAIR, please read the Prescribing Information.
20951837(3)-02/10-SNG
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