Generic name: montelukast sodium
Dosage form: tablet, chewable
Drug class:Leukotriene modifiers
Medically reviewed by Drugs.com. Last updated on Mar 1, 2022.
On This Page
- Boxed Warning
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Contraindications
- Warnings and Precautions
- Adverse Reactions/Side Effects
- Drug Interactions
- Use In Specific Populations
- Overdosage
- Description
- Clinical Pharmacology
- Nonclinical Toxicology
- Clinical Studies
- How Supplied/Storage and Handling
- Patient Counseling Information
- Medication Guide
WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS
Serious neuropsychiatric (NP) events have been reported with the use of montelukast sodium chewable tablets. The types of events reported were highly variable, and included, but were not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior (including suicide). The mechanisms underlying NP events associated with montelukast sodium use are currently not well understood [see Warnings and Precautions (5.1)].
Because of the risk of NP events, the benefits of montelukast sodium may not outweigh the risks in...
