From the Guidelines
Montelukast is generally well-tolerated, but it can cause rare cases of Churg-Strauss syndrome, although the association is unclear.
Side Effects of Montelukast
- No specific adverse effects have been identified in patients taking 4-mg or 5-mg chewable tablets or 10-mg tablets 1.
- Rare cases of Churg-Strauss syndrome have occurred, but the association with montelukast is unclear 1.
Important Considerations
- The evidence suggests that montelukast is safe for use in patients of all ages, with no specific adverse effects identified in children or adults 1.
- However, as with any medication, it is essential to monitor patients for potential side effects and report any unusual symptoms to their healthcare provider.
Comparison to Other Medications
- Other leukotriene modifiers, such as zafirlukast, have been associated with more severe side effects, including reversible hepatitis and irreversible hepatic failure 1.
- In contrast, montelukast has a more favorable safety profile, making it a popular choice for the treatment of asthma and other conditions 1.
From the FDA Drug Label
The most frequently occurring adverse experiences were consistent with the safety profile of SINGULAIR and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. The side effects of Montelukast include:
- Abdominal pain
- Somnolence
- Thirst
- Headache
- Vomiting
- Psychomotor hyperactivity 2
From the Research
Side Effects of Montelukast
The side effects of montelukast have been studied in various research papers, with some indicating a potential association with neuropsychiatric adverse events. Some of the reported side effects include:
- Anxiety disorders 3
- Depression 3, 4
- Sleep-related disorders, including insomnia and sleep disturbances 3, 5
- Suicidal ideation and suicidal actions 4, 6
- Disrupted control of activity, attention, and behavior 7
- Confusion and psychotic-like symptoms 7
- Agitation 5
- Pain 5
- Hyperactivity 5
- Nightmares 5
Neuropsychiatric Adverse Events
Several studies have investigated the risk of neuropsychiatric adverse events associated with montelukast use. These studies have reported:
- An increased risk of neuropsychiatric adverse events in patients with asthma or allergic rhinitis 3, 6
- A significant association between montelukast and neuropsychiatric adverse events, including suicidal ideation and depression 4
- No substantial differences in the risk of specific neuropsychiatric adverse events between montelukast and long-acting β-agonists (LABA) users 7
Population-Based Studies
Population-based studies have also been conducted to assess the risk of neuropsychiatric adverse events associated with montelukast use. These studies have reported: