Montelukast — Membership Pricing

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Other medications associated with the same conditions in this catalog.

Also listed for Allergic Rhinitis

• Cetirizine
• Fexofenadine
• Fluticasone
• Fluticasone Propionate 16g m 50mcg/spray Nasal Spray
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Also listed for Asthma

• Albuterol HFA
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Other medications in Respiratory

• Salmeterol
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• Treprostinil Oral
• Zafirlukast
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• Albuterol
• Budesonide

About Montelukast

Montelukast is a widely prescribed medication offering significant relief for millions suffering from chronic asthma and seasonal or perennial allergy symptoms. By targeting key inflammatory pathways, it helps improve breathing and reduce allergic reactions.

The information above is for educational purposes only and does not constitute medical advice. Consult your healthcare provider before making medication decisions.

What Montelukast is approved for (FDA label)

Montelukast sodium tablets are a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 15 years of age and older ( 1.1 ). Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older ( 1.2 ). Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies ( 1.3 ).

Source: Read the full FDA label on DailyMed. Label effective date: August 4, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Montelukast (FDA label)

WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS Serious neuropsychiatric (NP) events have been reported with the use of montelukast sodium tablets. The typesof events reported were highly variable, and included, but were not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior (including suicide). The mechanisms underlying NP events associated with montelukast sodium tablets use are currently not well understood [ see Warnings and Precautions ( 5.1 ) ]. Because of the risk of NP events, the benefits of montelukast sodium tablets may not outweigh the risks in somepatients, particularly when the symptoms of disease may be mild and adequately treated with alternative therapies. Reserve use of montelukast sodium tablets for patients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies [ see Indications and Usage ( 1.3 )]. In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and risksbefore prescribing montelukast sodium tablets. Discuss the benefits and risks of montelukast sodium tablets with patients and caregivers when prescribing montelukast sodium tablets. Advise patients and/or caregivers to be alert for changes in behavior or new NP symptoms when taking montelukast sodium tablets. If changes in behavior are observed, or if new NP symptomsor suicidal thoughts and/or behavior occur, advise patients to discontinue montelukast sodium tablets and contact a healthcare provider immediately [ see Warnings and Precautions ( 5.1 ) ].

Source: FDA prescribing information (DailyMed). Set ID: 583a9499-97f0-2ebf-e063-6394a90a35af. SPL document ID: 583a9499-97c0-2ebf-e063-6394a90a35af. Label effective date: August 4, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Montelukast (FDA label)

Montelukast sodium Film-Coated Tablets, 10 mg are beige, rounded square-shaped biconvex tablets, debossed 'CL 26' on one side of the tablet and having plain surface on other side. • Tablets: 10 mg ( 3 )

Source: FDA prescribing information (DailyMed). Set ID: 583a9499-97f0-2ebf-e063-6394a90a35af. SPL document ID: 583a9499-97c0-2ebf-e063-6394a90a35af. Label effective date: August 4, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Montelukast (FDA label)

The following clinically significant adverse reactions are described elsewhere in the labeling: Neuropsychiatric Events [see Warnings and Precautions ( 5.1 )] Most common adverse reactions (incidence ≥ 5% and greater than placebo listed in descending order of frequency): upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis, otitis ( 6.1 ).To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc., at 1-888-943-3210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Source: FDA prescribing information (DailyMed). Set ID: 583a9499-97f0-2ebf-e063-6394a90a35af. SPL document ID: 583a9499-97c0-2ebf-e063-6394a90a35af. Label effective date: August 4, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Montelukast (FDA label)

Montelukast sodium is contraindicated in patients with hypersensitivity to any of its components. Hypersensitivity to any component of montelukast sodium ( 4 ).

Source: FDA prescribing information (DailyMed). Set ID: 583a9499-97f0-2ebf-e063-6394a90a35af. SPL document ID: 583a9499-97c0-2ebf-e063-6394a90a35af. Label effective date: August 4, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Montelukast (FDA label)

Do not prescribe montelukast sodium to treat an acute asthma attack ( 5.2 ). Advise patients to have appropriate rescue medication available ( 5.2 ). Inhaled corticosteroid may be reduced gradually. Do not abruptly substitute montelukast sodium for inhaled or oral corticosteroids ( 5.3 ). Patients with known aspirin sensitivity should continue to avoid aspirin or non-steroidal anti-inflammatory agents while taking montelukast sodium ( 5.4 ). Systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, has been reported. These events have been sometimes associated with the reduction of oral corticosteroid therapy ( 5.5 and 6.2 ). 5.1 Neuropsychiatric Events Serious neuropsychiatric (NP) events have been reported with use of montelukast sodium.

Source: FDA prescribing information (DailyMed). Set ID: 583a9499-97f0-2ebf-e063-6394a90a35af. SPL document ID: 583a9499-97c0-2ebf-e063-6394a90a35af. Label effective date: August 4, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Montelukast (FDA label)

No dose adjustment is needed when montelukast sodium is co-administered with theophylline, prednisone, prednisolone, oral contraceptives, fexofenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, and Cytochrome P450 (CYP) enzyme inducers [see Clinical Pharmacology ( 12.3 )].

Source: FDA prescribing information (DailyMed). Set ID: 583a9499-97f0-2ebf-e063-6394a90a35af. SPL document ID: 583a9499-97c0-2ebf-e063-6394a90a35af. Label effective date: August 4, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.