Two medicines, side by side
Zafirlukast vs montelukast
Zafirlukast and montelukast are both labeled for asthma. Drugs@FDA records approvals of zafirlukast since 1996 and of montelukast since 1998. Pharmacies paid $0.623 per zafirlukast 20 mg tablet and $0.0419 per montelukast sod 10 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. Only the montelukast label carries a boxed warning.
Check it at the source: the zafirlukast FDA label on DailyMed (effective December 1, 2023); the montelukast FDA label on DailyMed (effective April 30, 2025).
Highlights of the zafirlukast record
Zafirlukast (Accolate) · label of December 1, 2023
Used for
From the label: indicationsZafirlukast tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.
On the market
- Earliest approval on file
- September 26, 1996
- Generic labelers
- 5 labelers
- Pharmacy cost
- $0.623 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
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
Source: FDA drug labels via openFDA (Zafirlukast label of December 1, 2023, Montelukast label of April 30, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do zafirlukast and montelukast differ on the record?
Only the montelukast label carries a boxed warning.
Both are in FDA's class leukotriene receptor antagonists.
Half-life, in each label's words: Zafirlukast, “In the pivotal bioequivalence study, the mean terminal half-life of zafirlukast is approximately 10 hours in both …”; Montelukast, “In several studies, the mean plasma half-life of montelukast ranged from 2.7 to 5.5 hours in healthy young adults.”
Generics: zafirlukast since 2010; montelukast since 2012 (Drugs@FDA).
| Zafirlukast | Montelukast | |
|---|---|---|
| Labeled for | Asthma | Asthma, Allergies |
| Pharmacologic class | Leukotriene Receptor Antagonist | Leukotriene Receptor Antagonist |
| How it works (label) | n/a | 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. |
| Half-life (label) | In the pivotal bioequivalence study, the mean terminal half-life of zafirlukast is approximately 10 hours in both normal adult subjects and patients with asthma. | In several studies, the mean plasma half-life of montelukast ranged from 2.7 to 5.5 hours in healthy young adults. |
| Earliest approval on file (Drugs@FDA) | September 26, 1996 | February 20, 1998 |
| First generic approved | November 18, 2010 | August 3, 2012 |
| Generic labelers (NDC) | 5 labelers | 36 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.623 per tablet (Zafirlukast 20 mg tablet) | $0.0419 per tablet (Montelukast sod 10 mg tablet) |
| 12-month price change | -8% | -20% |
| Boxed warning | No | Yes |
| Shortage now | No current entry | A presentation being discontinued |
| Recalls recorded | 0 | 11 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 881 | 174,997 |
| 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 zafirlukast
- every medicine labeled for the same conditions