Two medicines, side by side
Montelukast vs dexamethasone
Montelukast and dexamethasone are both labeled for asthma and allergies. Drugs@FDA records approvals of montelukast since 1998 and of dexamethasone since 1958. Pharmacies paid $0.0419 per montelukast sod 10 mg tablet and $0.193 per dexamethasone 4 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 dexamethasone a corticosteroid.
Check it at the source: the montelukast FDA label on DailyMed (effective April 30, 2025); the dexamethasone FDA label on DailyMed (effective June 6, 2025).
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 dexamethasone record
Dexamethasone (Decadron) · label of June 6, 2025
Used for
From the label: indicationsAllergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. […]
On the market
- Earliest approval on file
- October 30, 1958
- Generic labelers
- 60 labelers
- Pharmacy cost
- $0.193 per tablet
Supply and safety
- Shortage
- In shortage
- Recalls
- 8
Source: FDA drug labels via openFDA (Montelukast label of April 30, 2025, Dexamethasone label of June 6, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do montelukast and dexamethasone differ on the record?
In FDA's classes, montelukast is a leukotriene receptor antagonist and dexamethasone a corticosteroid.
Only the montelukast label carries a boxed warning.
Generics: montelukast since 2012; dexamethasone since 1971 (Drugs@FDA).
| Montelukast | Dexamethasone | |
|---|---|---|
| Labeled for | Asthma, Allergies | Asthma, Eczema (atopic dermatitis), Leukemia, lymphoma and myeloma, Herpes and shingles, Crohn's disease and ulcerative colitis, Multiple sclerosis, Osteoarthritis, Rheumatoid arthritis, Psoriasis, Allergies, Anemia, Pain |
| Pharmacologic class | Leukotriene Receptor Antagonist | Corticosteroid |
| 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 | October 30, 1958 |
| First generic approved | August 3, 2012 | October 20, 1971 |
| Generic labelers (NDC) | 36 labelers | 60 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.0419 per tablet (Montelukast sod 10 mg tablet) | $0.193 per tablet (Dexamethasone 4 mg tablet) |
| 12-month price change | -20% | -26% |
| Boxed warning | Yes | No |
| Shortage now | A presentation being discontinued | In shortage |
| Recalls recorded | 11 | 8 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 174,997 | 304,163 |
| 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