Prescription medicine
Montelukast Brand names: Singulair
Montelukast (Singulair) is a prescription medicine with an FDA approval on record since 1998. FDA's NDC Directory lists it from 36 generic labelers, and pharmacies paid $0.0419 per montelukast sod 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the montelukast FDA label on DailyMed (effective April 30, 2025, Organon LLC); the NDA 20829 record on Drugs@FDA; every montelukast label on DailyMed.
Highlights of the record
FDA label of April 30, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SERIOUS NEUROPSYCHIATRIC EVENTS.
Serious neuropsychiatric (NP) events have been reported with the use of SINGULAIR. 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). The mechanisms underlying NP events associated with SINGULAIR use are currently not well understood [see Warnings and Precautions (5.1) ]. Because of the risk of NP events, the benefits of SINGULAIR may not outweigh the risks in some patients, particularly when the symptoms of disease may be mild and adequately treated with alternative therapies. Reserve use of SINGULAIR 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 risks before prescribing SINGULAIR. Discuss the benefits and risks of SINGULAIR with patients and caregivers when prescribing SINGULAIR. Advise patients and/or caregivers to be alert for changes in behavior or new NP symptoms when taking SINGULAIR. If changes in behavior are observed, or if new NP symptoms or suicidal thoughts and/or behavior occur, advise patients to discontinue SINGULAIR and contact a healthcare provider immediately [see Warnings and Precautions (5.1) ]. […]
Used for
From the label: indications and usageSINGULAIR is a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 12 months of age and older ( 1.1 ).
Forms and strengths
- 4 mg
- 5 mg
- 10 mg
Chewable tablet; film-coated tablet; tablet; coated tablet; granule.
On the market
- Earliest approval on file
- February 20, 1998 Singulair, Organon; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 49 first August 3, 2012; 32 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 37 of which 36 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0419 per tablet Montelukast sod 10 mg tablet
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- 11 since 2013 1 Class I among all firms' recalls; latest October 13, 2023
- FAERS reports
- 174,997 through July 30, 2026
What is montelukast used for?
From the label: indications and usageSINGULAIR is a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 12 months of age and older ( 1.1 ). Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older ( 1.2 ). Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 6 months of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies ( 1.3 ). […]
Conditions named in the indications of montelukast's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Leukotriene Receptor Antagonist.
Source: FDA drug label (SINGULAIR), Organon LLC, effective April 30, 2025 (SPL set 482dcc92-b47f-4ea6-854a-f5ac2aea7842), via openFDA; the full label on DailyMed
What does the patient leaflet for montelukast say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about SINGULAIR?Serious mental health problems have happened in people taking SINGULAIR or even after treatment has stopped. This can happen in people with or without a history of mental health problems. Stop taking SINGULAIR and tell your healthcare provider right away if you or your child have any unusual changes in behavior or thinking, including any of these symptoms: agitation, including aggressive behavior or hostility attention problems bad or vivid dreams depression disorientation (confusion) feeling anxious irritability hallucinations (seeing or hearing things that are not really there) memory problems obsessive-compulsive symptoms restlessness sleep walking stuttering suicidal thoughts and actions (including suicide) tremor trouble sleeping uncontrolled muscle movements
From the patient leaflet: What should I avoid while taking SINGULAIR?If you have asthma and aspirin makes your asthma symptoms worse, continue to avoid taking aspirin or other medicines called non-steroidal anti-inflammatory drugs (NSAIDs) while taking SINGULAIR.
From the patient leaflet: How should I store SINGULAIR?Store SINGULAIR at room temperature between 68°F to 77°F (20°C to 25°C). Keep SINGULAIR in the package it comes in. Keep SINGULAIR in a dry place and keep it away from light. Keep SINGULAIR and all medicines out of reach of children.
Source: FDA drug label (SINGULAIR), Organon LLC, effective April 30, 2025 (SPL set 482dcc92-b47f-4ea6-854a-f5ac2aea7842), via openFDA; the full label on DailyMed
Is there a generic for montelukast (Singulair)?
The FDA approved the first generic montelukast on August 3, 2012. 49 generic applications are approved; 32 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists montelukast from 36 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1998 earliest approval on file
- 2012 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for montelukast (Singulair)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0419 per Montelukast sod 10 mg tablet, down 20% from $0.0521 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Montelukast sod 10 mg tablet (generic)
- Singulair 10 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Montelukast sod 10 mg tablet | Generic | $0.0419 per tablet | $1.26 | -20% |
| Montelukast sod 4 mg granules | Generic | $0.813 per unit | n/a | -25% |
| Montelukast sod 4 mg tablet chewable | Generic | $0.0753 per tablet | $2.26 | -12% |
| Montelukast sod 5 mg tablet chewable | Generic | $0.0704 per tablet | $2.11 | -5% |
| Singulair 10 mg tablet | Brand | $9.21 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $276.39 | +4% |
| Singulair 5 mg tablet chewable | Brand | $9.27 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $278.22 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is montelukast in shortage?
No montelukast presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated November 17, 2025. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Singulair, Tablet, Chewable, 4 mg (NDC 78206-170-01) | Organon | To Be Discontinued | November 17, 2025 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has montelukast been recalled?
The FDA's Enforcement Report lists 11 recalls naming montelukast since 2013: 1 Class I (the most serious), 7 Class II, 3 Class III; 2 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 13, 2023 | Class II | Dr. Reddy's Laboratories, Inc. | Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg. |
| April 6, 2023 | Class II | PD-Rx Pharmaceuticals, Inc. | CGMP deviations. |
| March 23, 2023 | Class II | Preferred Pharmaceuticals, Inc. | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. |
| March 13, 2023 | Class II | Direct Rx | cGMP deviations |
| February 7, 2023 | Class II | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. |
| January 20, 2020 | Class III | Macleods Pharma Usa Inc | Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product |
| August 20, 2018 | Class II | Hetero Labs Limited Unit V | Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets. |
| August 15, 2018 | Class I | Hetero Labs Limited Unit V | Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the montelukast label say about other medicines?
The montelukast label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name montelukast. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | warnings and precautions | Patients with known aspirin sensitivity should continue to avoid aspirin or non-steroidal anti-inflammatory agents while taking SINGULAIR ( 5.4 ). |
| Digoxin | drug interactions | DRUG INTERACTIONS No dose adjustment is needed when SINGULAIR 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 … |
| Fexofenadine | drug interactions | DRUG INTERACTIONS No dose adjustment is needed when SINGULAIR 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 … |
| Gemfibrozil | drug interactions | DRUG INTERACTIONS No dose adjustment is needed when SINGULAIR 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 … |
| Itraconazole | drug interactions | DRUG INTERACTIONS No dose adjustment is needed when SINGULAIR 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 … |
| Prednisolone | drug interactions | DRUG INTERACTIONS No dose adjustment is needed when SINGULAIR 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 … |
| Prednisone | drug interactions | DRUG INTERACTIONS No dose adjustment is needed when SINGULAIR 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 … |
| Theophylline | drug interactions | DRUG INTERACTIONS No dose adjustment is needed when SINGULAIR 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 … |
| Warfarin | drug interactions | DRUG INTERACTIONS No dose adjustment is needed when SINGULAIR 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 … |
Other labels that name montelukast
Source: FDA drug label (SINGULAIR), Organon LLC, effective April 30, 2025 (SPL set 482dcc92-b47f-4ea6-854a-f5ac2aea7842), via openFDA; the full label on DailyMed
What do FAERS reports show for montelukast?
The FDA Adverse Event Reporting System holds 174,997 reports that list montelukast among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 7,487 are coded as a death and 47,569 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as montelukast?
9 other medicines are given the same way (oral) and in the same FDA class as montelukast or labeled mainly for the same use (asthma), the same class first. Asthma lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Zafirlukast | Asthma | 5 labelers | $0.623 per tablet 20 mg tablet | No current entry |
| Dexamethasone | Asthma, Allergies | 41 labelers | $0.193 per tablet 4 mg tablet | In shortage |
| Theophylline | Asthma | 26 labelers | $0.330 per tablet 300 mg tablet | No current entry |
| Albuterol | Asthma | 14 labelers | $0.288 per tablet 2 mg tablet | Resolved |
| Budesonide | Asthma | 14 labelers | $0.498 per capsule 3 mg capsule | No current entry |
| Zileuton | Asthma | 5 labelers | $2.05 per tablet 600 mg tablet | No current entry |
| Ephedrine | Asthma | none listed | n/a | No current entry |
| Cromolyn | Asthma | 3 labelers | $0.349 per mL 100 mg/5 mL oral conc | Listed; available |
Every medicine labeled for the same conditions as montelukast
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does montelukast compare with medicines for the same use?
11 side-by-side pages set montelukast beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to montelukast
- 9 medicines for the same use
- Other leukotriene receptor antagonists
- the pharmacologic class, with prices and generics
- Montelukast side effects
- the label's list beside FAERS reports
- Montelukast shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other