Two medicines, side by side
Montelukast vs albuterol
Montelukast and albuterol are both labeled for asthma. Drugs@FDA records approvals of montelukast since 1998 and of albuterol since 1981. Pharmacies paid $0.0419 per montelukast sod 10 mg tablet and $0.288 per albuterol sulfate 2 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, montelukast is a leukotriene receptor antagonist and albuterol a beta2-adrenergic agonist.
Check it at the source: the montelukast FDA label on DailyMed (effective April 30, 2025); the albuterol FDA label on DailyMed (effective April 30, 2026).
Highlights of the montelukast record
Montelukast (Singulair) · label of April 30, 2025
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) ].
Used for
From the label: indicationsSINGULAIR 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 ). […]
On the market
- Earliest approval on file
- February 20, 1998
- Generic labelers
- 36 labelers
- Pharmacy cost
- $0.0419 per tablet
Supply and safety
- Shortage
- A presentation being discontinued
- Recalls
- 11
Highlights of the albuterol record
Albuterol (Ventolin) · label of April 30, 2026
Used for
From the label: indicationsAlbuterol Inhalation Solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).
On the market
- Earliest approval on file
- May 1, 1981
- Generic labelers
- 40 labelers
- Pharmacy cost
- $0.288 per tablet
Supply and safety
- Shortage
- Resolved
- Recalls
- 20
Source: FDA drug labels via openFDA (Montelukast label of April 30, 2025, Albuterol label of April 30, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do montelukast and albuterol differ on the record?
In FDA's classes, montelukast is a leukotriene receptor antagonist and albuterol a beta2-adrenergic agonist.
Only the montelukast label carries a boxed warning.
Generics: montelukast since 2012; albuterol since 1989 (Drugs@FDA).
| Montelukast | Albuterol | |
|---|---|---|
| Labeled for | Asthma, Allergies | Asthma |
| Pharmacologic class | Leukotriene Receptor Antagonist | beta2-Adrenergic Agonist |
| How it works (label) | The cysteinyl leukotrienes (LTC 4 , LTD 4 , LTE 4 ) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. These eicosanoids bind to cysteinyl leukotriene (CysLT) receptors. | n/a |
| Half-life (label) | In several studies, the mean plasma half-life of montelukast ranged from 2.7 to 5.5 hours in healthy young adults. | n/a |
| Earliest approval on file (Drugs@FDA) | February 20, 1998 | May 1, 1981 |
| First generic approved | August 3, 2012 | January 30, 1989 |
| Generic labelers (NDC) | 36 labelers | 40 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.0419 per tablet (Montelukast sod 10 mg tablet) | $0.288 per tablet (Albuterol sulfate 2 mg tablet) |
| 12-month price change | -20% | -38% |
| Boxed warning | Yes | No |
| Shortage now | A presentation being discontinued | Resolved |
| Recalls recorded | 11 | 20 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 174,997 | 292,136 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What next?
- Alternatives to montelukast
- every medicine labeled for the same conditions