Prescription medication · Leukotriene Receptor Antagonist
montelukast
Also sold as Singulair. Montelukast is used to prevent asthma symptoms and treat long-term asthma.
Data updated 2026-05-15
- 78,359
- FDA reportsOften reported
- 8
- InteractionsFew interactions
- 99% less
- Generic vs brandHuge savings
- In shortage
- FDA status
What the data shows
montelukast (Singulair) is a prescription Leukotriene Receptor Antagonist, more reported than most tracked drugs (78,359 FDA reports), whose generic costs a fraction of the brand (about 99% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
montelukast (Singulair) is a prescription Leukotriene Receptor Antagonist. Montelukast is used to prevent asthma symptoms and treat long-term asthma.
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.
Verify with FDA → · CMS NADAC pricing →
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 →
NADAC price trail: MONTELUKAST SOD 10 MG TABLET
Same CMS presentation as the headline generic unit price above (3 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -18.3% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| July 17, 2024 | $0.0463/EA | - | 1 |
| October 23, 2024 | $0.0610/EA | +31.9% | 4 |
| December 18, 2024 | $0.0498/EA | -18.3% | 33 |
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.
The sections below are summarized in plain English from montelukast's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
Side Effects (from patient reports)
Based on 78,359 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for montelukast, by number of reports
- Dyspnoea
Dyspnoea
7,723 reports
- Asthma
Asthma
7,439 reports
- Fatigue
Fatigue
5,505 reports
- Headache
Headache
4,786 reports
- Cough
Cough
4,617 reports
- Nausea
Nausea
4,214 reports
- Pneumonia
Pneumonia
3,835 reports
- Pain
Pain
3,602 reports
- Anxiety
Anxiety
3,466 reports
- Diarrhoea
Diarrhoea
3,414 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for montelukast each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where montelukast sits
montelukast has more FDA adverse-event reports than 82% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is montelukast; the line is the median (50th percentile).
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
Reports Mentioning Death
3,777
4.8% of reports — not proof of cause
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 |
| 4 | FATIGUE | 5,505 |
| 5 | HEADACHE | 4,786 |
| 6 | COUGH | 4,617 |
| 7 | NAUSEA | 4,214 |
| 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 |
| 16 | PRURITUS | 2,900 |
| 17 | RASH | 2,866 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: 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.
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.
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for montelukast?
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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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for montelukast: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 78,359.
- omalizumab Δ 1,389 reports · Anti-IgE Monoclonal Antibody 79,748reports
- sulfasalazine Δ 2,089 reports · Disease-Modifying Antirheumatic Drug (DMARD) 76,270reports
- naproxen Δ 2,447 reports · Nonsteroidal Anti-Inflammatory Drug (NSAID) 75,912reports
- diclofenac Δ 3,806 reports · Nonsteroidal Anti-Inflammatory Drug (NSAID) 82,165reports
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 4.82%.
- capsaicin Δ 0.03 pts · 3,030 reports · Topical Analgesic 4.85%death share
- tofacitinib Δ 0.06 pts · 181,998 reports · JAK Inhibitor 4.76%death share
- mometasone Δ 0.08 pts · 17,186 reports · Inhaled Corticosteroid 4.74%death share
- teriparatide Δ 0.09 pts · 111,257 reports · Parathyroid Hormone Analog 4.73%death share
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
FDA bioequivalence and label-record context for narrow therapeutic index medicines
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 78,359 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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: October 1, 2023
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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