Headache Incidence with Singulair (Montelukast)
Based on FDA-approved labeling data, headache occurs in approximately 18.4% of adult patients taking Singulair (montelukast) 10 mg daily, compared to 18.1% with placebo—representing no clinically significant difference from placebo rates. 1
Adult and Adolescent Patients (≥15 Years)
The FDA prescribing information provides the most definitive data for headache incidence:
- Headache occurred in 18.4% of patients receiving montelukast 10 mg/day in placebo-controlled trials 1
- Placebo group experienced headache in 18.1% of cases 1
- This minimal difference (0.3%) indicates headache is not attributable to the medication itself but rather reflects the baseline rate in the asthma population 1
The FDA data represents 1,955 patients treated with montelukast in controlled clinical trials, providing robust statistical power for this assessment. 1
Pediatric Populations
Children 6-14 Years of Age
- Headache occurred at a rate ≥2% and more frequently than placebo in some pediatric studies, though specific percentages are not provided in the FDA labeling 1
- The American Academy of Allergy, Asthma, and Immunology confirms that headache is a common side effect in pediatric patients 2
Children 2-5 Years of Age
- Headache was reported with a frequency ≥2% and more frequently than placebo 1
- The overall safety profile remained similar to older age groups 1
Long-Term Safety Data
Comprehensive pooled analyses demonstrate consistent findings:
- In 2,031 adult patients treated for up to 4.1 years, headache incidence remained similar to placebo throughout the treatment duration 3
- Analysis of 3,386 adult patients showed no clinically relevant differences in headache rates between montelukast and placebo groups 3
- The most common adverse effect in pediatric studies was headache, but at rates not statistically significantly different from placebo 4
Clinical Context and Interpretation
The key clinical takeaway is that while headache is commonly reported (approximately 1 in 5 patients), it occurs at essentially the same rate whether patients take montelukast or placebo. 1 This suggests that headaches in these patients are more likely related to:
- The underlying asthma or allergic condition itself 1
- Concurrent respiratory infections 1
- Other comorbid factors 3
Rather than being caused by the medication.
Important Safety Considerations
While headache itself is not a medication-related concern, the FDA issued a black box warning in 2020 regarding serious neuropsychiatric events including depression, anxiety, sleep disturbances, and suicidal thoughts—risks that should be carefully weighed against benefits, particularly in mild disease. 2
Dose-Response Relationship
No dose-related increase in headache was observed even at doses up to 200 mg per day (20 times the recommended dose) administered for 5 months, further supporting that headache is not a medication-induced adverse effect. 3