montelukast
Brand names: Singulair
Montelukast is a medicine that helps control asthma and allergies. It works by blocking certain natural substances in your body that cause asthma and allergy symptoms.
Drug Shortage Alert
montelukast is currently listed as to be discontinued by the FDA. Affected manufacturer: Organon.
View all drug shortages →Drug Pricing (NADAC)
Brand Price
$8.40/unit
Generic Price
$0.05/unit
Generic Savings
99%
Generic Available
Yes (24 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Montelukast is used to prevent asthma symptoms and treat long-term asthma.
Common side effects
Upper respiratory infection, Fever, Headache
Key warnings
Do not use montelukast to treat a sudden asthma attack.
How It Works
This medicine blocks leukotrienes, which are substances your body releases that cause swelling in the lungs and tightening of the muscles around your airways. By blocking these substances, montelukast helps you breathe easier. It also reduces allergy symptoms.
How to Take It
Take montelukast once a day, in the evening for asthma or once daily for allergies. For exercise, take one dose at least 2 hours before you exercise. Do not take an extra dose within 24 hours. You can take it with or without food.
Pregnancy & Breastfeeding
If you are pregnant, talk to your doctor before taking montelukast. It is not known if montelukast passes into breast milk, so talk to your doctor if you are breastfeeding.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
Storage
Store montelukast tablets at room temperature, away from moisture and light, and in the original container.
Side Effects (from patient reports)
Based on 51,550 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 78,359 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2002–2025.
Total Reports
78,359
Death-Related Reports
3,777
Hospitalization Reports
21,518
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DYSPNOEA | 7,723 |
| 2 | ASTHMA | 7,439 |
| 3 | DRUG INEFFECTIVE | 5,931 |
| 4 | FATIGUE | 5,505 |
| 5 | HEADACHE | 4,786 |
| 6 | COUGH | 4,617 |
| 7 | NAUSEA | 4,214 |
| 8 | OFF LABEL USE | 3,899 |
| 9 | PNEUMONIA | 3,835 |
| 10 | PAIN | 3,602 |
| 11 | ANXIETY | 3,466 |
| 12 | DIARRHOEA | 3,414 |
| 13 | WHEEZING | 3,264 |
| 14 | MALAISE | 2,946 |
| 15 | DIZZINESS | 2,922 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Do not use montelukast to treat a sudden asthma attack. Always have your rescue medicine with you. Do not suddenly stop taking steroid medicines if you are also taking montelukast. Some patients have experienced changes in behavior or mood, including suicidal thoughts. Tell your doctor right away if you notice these changes.
Known Drug Interactions
DRUG INTERACTIONS No dose adjustment is needed when montelukast sodium is co-administered with theophylline, prednisone, prednisolone, oral contraceptives, terfenadine, 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)] .
Mechanism: These two medicines do not have a known interaction that changes how they work in your body.
What to do: You can take these medications together at your normal doses without needing any adjustments.
DRUG INTERACTIONS No dose adjustment is needed when montelukast sodium is co-administered with theophylline, prednisone, prednisolone, oral contraceptives, terfenadine, 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)] .
Mechanism: These two medicines do not interfere with each other, so they do not change how the other drug is processed.
What to do: No dose changes are needed when you take these two medicines at the same time.
DRUG INTERACTIONS No dose adjustment is needed when montelukast sodium is co-administered with theophylline, prednisone, prednisolone, oral contraceptives, terfenadine, 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)] .
Mechanism: There is no evidence that these medicines affect each other's levels or performance in the body.
What to do: You can safely take these medicines together without adjusting your current dosages.
DRUG INTERACTIONS No dose adjustment is needed when montelukast sodium is co-administered with theophylline, prednisone, prednisolone, oral contraceptives, terfenadine, 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)] .
Mechanism: These drugs do not significantly change how the body processes each other.
What to do: You can take these medicines together without needing to change your dose.
DRUG INTERACTIONS No dose adjustment is needed when montelukast sodium is co-administered with theophylline, prednisone, prednisolone, oral contraceptives, terfenadine, 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)] .
Mechanism: These medications do not interfere with each other's levels in the blood.
What to do: No dose changes are necessary when taking these two drugs together.
Common Questions
Can I use montelukast for a sudden asthma attack?
Can I stop taking my steroid medicine if I take montelukast?
What should I do if I experience mood changes while taking montelukast?
Can I take montelukast if I am allergic to aspirin?
How old do you have to be to take montelukast?
Can I take montelukast if I have phenylketonuria (PKU)?
Does montelukast interact with other medicines?
How long does it take for montelukast to start working?
Can I take an extra dose of montelukast if I forget to take it before exercise?
What does 'leukotriene receptor antagonist' mean?
What are the common side effects of montelukast?
Does montelukast interact with other medications?
What drug class is montelukast?
Is there a generic version of montelukast?
Is montelukast safe during pregnancy?
Has montelukast been recalled?
Is montelukast currently in shortage?
Active Recalls
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Preferred Pharmaceuticals, Inc.
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for montelukast
The FDA label for montelukast (sold under brand names such as Singulair) classifies it as a prescription-only medication in the Leukotriene Receptor Antagonist class. Montelukast is used to prevent asthma symptoms and treat long-term asthma. Official labeling lists 12 commonly reported side effects, including Upper respiratory infection, Fever, Headache.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 51,550 voluntary reports. The database also lists 8 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $0.05 versus $8.40 for the brand — a 99% generic savings.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC). Shortage status: FDA Drug Shortages Database.
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: October 1, 2023
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages