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Montelukast

Also sold as Montelukast

Medicine summary · from official FDA labels · Oct 19, 2026

Serious warning: WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS Serious neuropsychiatric (NP) events have been reported with the use of montelukast sodium tablets. The types of events reported were highly variable, and included, but were not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior (including suicide).
6 recalls on record — a recall affects specific batches; check with your pharmacist.

What it’s used for

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 ).

How to take it

Administration (by indications): Asthma: Once daily in the evening for patients 15 years of age and older ( 2. 1 ).

Important warnings

Do not prescribe montelukast sodium to treat an acute asthma attack ( 5. 2 ).

Common side effects

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.

Interactions

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.

If pregnant or breastfeeding

8.

Forms & strengths

10 MG Oral Tablet · 5 MG Chewable Tablet · 4 MG Chewable Tablet · 4 MG Oral Tablet · 5 MG Oral Tablet

Questions to ask your doctor or pharmacist

  • Is this the right medicine for my condition, and how long should I take it?
  • What side effects should I watch for, and which need urgent attention?
  • Does this interact with my other medicines, supplements, or alcohol?
  • What should I do if I miss a dose or take too much?