Media Releases

Parents need advice, not alarm, on reported side-effects of montelukast in children

5 Sep 2016

On 5 September 2016, the 7.30 program aired a story about behavioural changes in children taking the asthma drug montelukast (available as generic tablets and as brand name Singulair).

The National Asthma Council Australia advises that if parents are concerned about their child, they should speak to their child’s doctor; however, they should not stop their child’s medication without first seeking medical advice as untreated asthma can be life-threatening.

Professor Adam Jaffé, respiratory paediatrician and head of paediatrics at the University of NSW, said that the potential link between montelukast and behavioural changes was first raised some years ago.

"It is a highly effective medication for many children with asthma and has an excellent safety record; thousands of children have taken the medication without any problems. The behavioural changes seen are extremely rare, but when they occur, are a serious issue and worrisome for parents.

“Researchers have been investigating this issue for many years and have not come up with a conclusive answer. The latest studies have not confirmed causality between this drug and behaviour-related side-effects.

“Nonetheless, there is a potential association. Doctors should talk to parents about the possible side-effects, carefully monitor children taking montelukast and be ready to stop the treatment if there are any concerns,” Professor Jaffé said. 

Professor Amanda Barnard, Chair of the National Asthma Council Australia’s Guidelines Committee on which Professor Jaffé also sits, said that the issue was considered carefully in the development of the asthma guidelines for health professionals.

“The Australian Asthma Handbook, which contains Australia's national guidelines for asthma management, advises doctors that when prescribing montelukast to children they should let parents know of the potential association of the drug with possible behavioural side-effects and that treatment should be ceased if effects are suspected.

“Other preventer medications for children are available. Our Handbook advises doctors to discuss treatment options with parents, aiming for an effective asthma management approach that meets the needs and preferences of the child and their parents,” Professor Barnard said.

Montelukast is a daily preventer tablet for asthma. It is not an inhaler or puffer, nor should it be confused with the prednisone or prednisolone tablets that a child with asthma might take for a few days during a serious flare-up.

For more information, parents are advised to visit the National Asthma Council Australia website: