The Therapeutic Goods Administration (TGA) has issued a new safety alert for montelukast. A boxed warning highlighting possible neuropsychiatric adverse events is being added to all montelukast product information and consumer medicine information documents.

The TGA previously released an alert regarding this issue in 2018. A further investigation was undertaken in 2024 after international regulators strengthened their warnings. While this most recent review did not uncover any new risks, the Australian Advisory Committee on Medicines recommended enhanced warnings to address consumer concerns and better align with international practice.

Montelukast is a leukotriene antagonist that is indicated in the management of chronic asthma and seasonal allergic rhinitis. Neuropsychiatric events have been reported in all age groups taking montelukast. The most common of these reactions are aggression, anxiety, suicidal ideation, depression, and sleep disturbances. While reactions are typically mild, the TGA has received seven reports of completed suicide in association with montelukast over the past ten years.

It is important to note that causality has not been established for montelukast. However, the TGA advises healthcare professionals to inform patients and their carers of the possibility of neuropsychiatric reactions and to seek immediate medical advice if they occur.

The TGA encourages the reporting of all suspected adverse events.

References:

  1. Department of Health and Aged Care. Database of Adverse Event Notifications (DAEN) – medicines. Woden: Therapeutic Goods Administration; 2025. <accessed 24/1/2025>
  2. Department of Health and Aged Care. More prominent safety warnings about the neuropsychiatric effects of montelukast. Woden: Therapeutic Goods Administration; 2025.
  3. Paljarvi T, Forton JT, Thompson C, Luciano S, Herttua K, Fazel S. Neuropsychiatric diagnoses after montelukast initiation in paediatric patients with asthma. Thorax 2025; 80: 9-15.
  4. Rayner DG, Liu M, Chu AW, Saini SS, Bernstein JA, Chu DK, et al. Leukotriene receptor antagonists as add-on therapy to antihistamines for urticaria: Systematic review and meta-analysis of randomized clinical trials. J Allergy Clin Immunol. 2024; 154(4): 996-1007.

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