MHRA Alert – Montelukast and Neuropsychiatric Reactions in All Ages

Important Safety Reminder

The MHRA has issued a reminder about the risk of neuropsychiatric reactions associated with montelukast use. This alert applies to all patient groups, including children and adolescents, and reinforces previous safety communications on this issue.

Key Safety Points

• Neuropsychiatric reactions have been reported in patients taking montelukast
• Reported effects include sleep disorders, hallucinations, mood changes, suicidal thoughts and behaviour, and other psychiatric symptoms
• These reactions can occur in any patient, regardless of age
• Risk should be considered when prescribing and during ongoing treatment

Affected Medication

• Montelukast (all formulations and indications)

Recommended Actions

• Be alert to neuropsychiatric symptoms in all patients prescribed montelukast
• Counsel patients and carers about potential neuropsychiatric effects before and during treatment
• Monitor patients regularly for emerging psychiatric or behavioural changes
• Document any neuropsychiatric events and report via the Yellow Card scheme if appropriate
• Review the benefit–risk profile if neuropsychiatric reactions occur

Further Information

For the full MHRA alert and detailed guidance, visit the MHRA Drug Safety Update.