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Ann Allergy Asthma Immunol. 2001 Jun;86(6 Suppl 1):18-23.

Safety of antileukotriene agents in asthma management.

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UCLA School of Medicine, University of California at Los Angeles, 90025, USA.



This article presents information on the safety of zafirlukast, montelukast, and zileuton, three antileukotrienes (anti-LTs) approved in the United States for the prophylaxis and treatment of asthma. After reading this article, readers should have an understanding both of the general safety of anti-LTs and their specific adverse effects.


Relevant and appropriate controlled clinical studies on the safety of anti-LTs in asthma were used. Only literature in the English language was reviewed.


Material was taken from academic/scholarly journals and appropriate reviews.


Antiasthma agents, including corticosteroids, beta2-agonists, and methylxanthines, may be categorized into two classes: those used for the long-term control and prevention of persistent asthma and those used for the prompt relief of acute symptoms and exacerbations of the disease. Although most agents are safe and well tolerated when used properly, adverse effects may occur with use at higher dose levels. The anti-LTs, including zafirlukast, montelukast, and zileuton, are the first new pharmacologic class in the therapeutic armamentarium for asthma management to be approved in the United States in the past 20 years. Both zafirlukast and montelukast carry pregnancy category B classification whereas zileuton carries pregnancy category C classification. The most common adverse effects observed in clinical trials were headache, pharyngitis, abdominal pain, dyspepsia, and cough.


The results of clinical trials and real-world experience indicate that these agents are generally safe and well tolerated, with an incidence of adverse effects comparable with placebo.

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