April 2024, UK MHRA -- Montelukast: reminder of the risk of neuropsychiatric reactions.
Healthcare professionals prescribing montelukast should be alert to the risk of neuropsychiatric reactions in all patients including children and adolescents. Reported neuropsychiatric reactions include sleep disorders, hallucinations, anxiety and depression, as well as changes in behaviour and mood. Healthcare professionals should advise patients and their caregivers to be alert to these risks and seek medical advice as soon as possible if neuropsychiatric reactions occur.
New boxed warnings are being added to the patient information leaflet supplied for montelukast in the UK.
- TRADE NAME: Singulair (Merck)
- INDICATIONS: Asthma
- CLASS: Leukotriene receptor antagonist
- HALF-LIFE: 2.7–5.5 hours
- CLINICALLY IMPORTANT, POTENTIALLY HAZARDOUS INTERACTIONS WITH:
Prednisone
FDA BLACK BOX WARNING (added April 2020)
WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS
SERIOUS NEUROPSYCHIATRIC EVENTS HAVE BEEN REPORTED IN PATIENTS TAKING MONTELUKAST
DISCUSS BENEFITS AND RISKS OF MONTELUKAST WITH PATIENTS AND CAREGIVERS
MONITOR FOR NEUROPSYCHIATRIC SYMPTOMS IN PATIENTS TAKING MONTELUKAST
DISCONTINUE MONTELUKAST IMMEDIATELY IF NEUROPSYCHIATRIC SYMPTOMS OCCUR
BECAUSE THE BENEFITS OF MONTELUKAST MAY NOT OUTWEIGH THE POTENTIAL RISK OF NEUROPSYCHIATRIC SYMPTOMS IN PATIENTS WITH ALLERGIC RHINITIS, RESERVE USE FOR PATIENTS WHO HAVE AN INADEQUATE RESPONSE OR INTOLERANCE TO ALTERNATIVE THERAPIES
See full prescribing information for complete boxed warning
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Page last updated 08/20/2025
