Adverse events are rare after single-dose montelukast exposures in children

Montelukast sodium is a leukotriene-receptor antagonist approved as a controller medication for chronic asthma and allergic rhinitis in children and adults. We sought to characterize adverse events associated with single montelukast exposures in children ages 5-17 years and to determine whether adverse events were dose related for all-dose and for ultra-high-dose (≥50 mg) exposures.

This is a retrospective analysis of data from the National Poison Data System for exposures that included montelukast in individuals aged 5-17 years for calendar years 2000-2016. Filters were applied to identify exposure events in which montelukast was the primary exposure and for which the exact or lowest-possible ingested dose was recorded. Characteristics of adverse events were examined using descriptive statistics and multivariable logistic models were used to examine whether associations of montelukast and adverse events were dose related.

During the 17-year study period, there were 17,069 montelukast exposures available for analyses. Patients were median [interquartile range] age 7 (5, 9) years, and 10,907 (64%) male gender. Abdominal pain was the most common adverse event (0.23%). There were 618 ultra-high-dose exposures (≥50 mg). These patients had median age 6 (5, 8) years, and 347 (56%) male gender. Abdominal pain was the most common adverse event (1.46%). Increasing ingested dose was associated with abdominal pain (adjusted odds ratio, 1.01, 95% confidence interval 1.01, 1.02) after adjustment for age and gender. No serious or life-threatening events were reported.

Single-dose exposures of montelukast up to 445 mg are rarely associated with any adverse events and are not associated with serious or life-threatening adverse events in children aged 5-17 years.