No black box warning on record for Montelukast

As of the latest FDA labeling reviewed, Montelukast (montelukast sodium) does not carry a black box warning. Standard warnings and precautions still apply — see the full Montelukast medicine page for the complete safety profile.

Other warnings & precautions

Neuropsychiatric Events (Boxed Warning, 2020): Montelukast can cause serious neuropsychiatric adverse events including agitation, anxiousness, dream abnormalities, hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior, tremor. Discontinue immediately if these events occur. Given this risk, do not use montelukast when alternative therapies are adequate (ICS for asthma; intranasal antihistamines or steroids for allergic rhinitis are alternatives).
Appropriate Patient Selection: Before prescribing montelukast, discuss the benefits and risks with patients. For asthma, inhaled corticosteroids remain preferred controller therapy. For allergic rhinitis, antihistamines and nasal steroids are first-line. Montelukast should generally not be the first-choice treatment.
Eosinophilic Conditions: Montelukast has been associated with eosinophilic conditions including Churg-Strauss syndrome. This is most often seen when oral corticosteroids are reduced, suggesting these conditions may have been masked by corticosteroids. Evaluate for eosinophilia and vasculitis in patients developing these features.

No black box warning on record for Montelukast

Other warnings & precautions

Neuropsychiatric Events (Boxed Warning, 2020): Montelukast can cause serious neuropsychiatric adverse events including agitation, anxiousness, dream abnormalities, hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior, tremor. Discontinue immediately if these events occur. Given this risk, do not use montelukast when alternative therapies are adequate (ICS for asthma; intranasal antihistamines or steroids for allergic rhinitis are alternatives).
Appropriate Patient Selection: Before prescribing montelukast, discuss the benefits and risks with patients. For asthma, inhaled corticosteroids remain preferred controller therapy. For allergic rhinitis, antihistamines and nasal steroids are first-line. Montelukast should generally not be the first-choice treatment.
Eosinophilic Conditions: Montelukast has been associated with eosinophilic conditions including Churg-Strauss syndrome. This is most often seen when oral corticosteroids are reduced, suggesting these conditions may have been masked by corticosteroids. Evaluate for eosinophilia and vasculitis in patients developing these features.

Montelukast Black Box Warning

No black box warning on record for Montelukast

Other warnings & precautions

Montelukast Black Box Warning

No black box warning on record for Montelukast

Other warnings & precautions