Last reviewed 2026-04-20 · How we verify

Singulair

At a glance

Approved indications

• Allergic asthma
• Allergic rhinitis
• Asthma management
• Exercise-Induced Bronchospasm Prevention
• Non-allergic asthma

Common side effects

• Upper respiratory infection
• Fever
• Headache
• Pharyngitis
• Cough
• Abdominal pain
• Diarrhea
• Otitis media
• Influenza
• Rhinorrhea
• Sinusitis
• Otitis

Key clinical trials

• PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia (PHASE1, PHASE2)
• BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP) (PHASE2)
• Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease (PHASE2)
• Efficacy of Montelukast in Reducing the Incidence and Severity of Monoclonal Antibodies Associated Infusion Reactions (PHASE2)
• ACTIV-6: COVID-19 Study of Repurposed Medications (PHASE3)
• Clinical Evaluation of Montelukast in Veterans With Gulf War Illness (PHASE1)
• Treating Exacerbations of Asthma With Oral Montelukast in Children (PHASE2)
• MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial) (EARLY_PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Singulair CI brief — competitive landscape report
• Singulair updates RSS · CI watch RSS
• Genuine Research Center, Egypt portfolio CI