Montelukast safety alert

Montelukast is a prescription medicine used to prevent and treat chronic asthma in adults and children aged 2 years and older. It is also used to treat the symptoms of seasonal allergic rhinitis (hay fever). 

Extra safety information is being added to all montelukast products to highlight the existing warnings about serious behaviour and mood-related changes that have been reported in patients taking this medicine. The safety information includes:

• a new warning at the start of the Product Information and Consumer Medicine Information sheets
• additional information for doctors and patients on what to do if serious behaviour and mood-related changes happen.

Please note that this is not new information. It is a reminder to watch out for these possible side effects if taking montelukast.

What patients or their carers should do

You should immediately let your doctor know if you, your child or someone you care for who is taking montelukast starts to have:

• agitation, including aggressive behaviour and/or hostility (such as temper tantrums in children)
• suicidal thoughts and actions
• tremor (trembling or shaking)
• irritability, restlessness
• anxiousness, depression (sad mood)
• disorientation (can’t tell the correct time, where you/they are or who someone you/they know is)
• difficulty concentrating or remembering things
• hallucinations (seeing, feeling or hearing things that are not there)
• difficulty sleeping, episodes of sleep-walking.

What health professionals should do

Be alert to the updated warnings in the montelukast Product Information - external site.

Health professionals should:

• look out for neuropsychiatric reactions in patients taking montelukast and discontinue treatment if new or worsening symptoms occur
• advise patients and their carers to be alert for changes in behaviour or for new neuropsychiatric symptoms and to seek medical advice immediately if they occur
• provide the Consumer Medicine Information - external site to patients to remind them of these effects, if needed.

For more detailed information written for health professionals, including the full text of the additional warnings, see the Medicine Safety Update article.