Expert Pharmacy Insights

Montelukast Side Effects: What the Trial Data and the Boxed Warning Actually Say

Montelukast trial data and boxed warning read very differently. In placebo-controlled trials the adverse reaction rates were nearly identical to placebo, with headache at 18.4 percent versus 18.1 percent on placebo. The 2020 FDA boxed warning came from post-marketing reports instead. This guide separates the two, with the full Table 1 rates, the psychiatric reports list, paediatric data and dosing by age.