Two medicines, side by side
Montelukast vs cetirizine
Montelukast and cetirizine are both labeled for allergies. Drugs@FDA records approvals of montelukast since 1998 and of cetirizine since 1995. Pharmacies paid $0.0419 per montelukast sod 10 mg tablet and $0.0613 per cetirizine HCl 10 mg tablet (NADAC, October 7, 2026). Cetirizine's other strengths are brand-only: $7.35 per unit (Zerviate 0.24% eye drop). In FDA's classes, montelukast is a leukotriene receptor antagonist and cetirizine a histamine-1 receptor antagonist.
Check it at the source: the montelukast FDA label on DailyMed (effective April 30, 2025); the cetirizine FDA label on DailyMed (effective August 7, 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 cetirizine record
Cetirizine (All) · label of August 7, 2026
Used for
From the label: indicationstemporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose, • sneezing, • itchy, watery eyes, • itching of the nose or throat
On the market
- Earliest approval on file
- December 8, 1995
- Generic labelers
- 149 labelers
- Pharmacy cost
- $0.0613 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 19
Source: FDA drug labels via openFDA (Montelukast label of April 30, 2025, Cetirizine label of August 7, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do montelukast and cetirizine differ on the record?
In FDA's classes, montelukast is a leukotriene receptor antagonist and cetirizine a histamine-1 receptor antagonist.
Only the montelukast label carries a boxed warning.
Generics: montelukast since 2012; cetirizine since 2007 (Drugs@FDA).
| Montelukast | Cetirizine | |
|---|---|---|
| Labeled for | Asthma, Allergies | Allergies |
| Pharmacologic class | Leukotriene Receptor Antagonist | Histamine-1 Receptor Antagonist |
| 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 | December 8, 1995 |
| First generic approved | August 3, 2012 | December 27, 2007 |
| Generic labelers (NDC) | 36 labelers | 149 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.0419 per tablet (Montelukast sod 10 mg tablet) | $0.0613 per tablet (Cetirizine HCl 10 mg tablet) |
| 12-month price change | -20% | -11% |
| Boxed warning | Yes | No |
| Shortage now | A presentation being discontinued | No current entry |
| Recalls recorded | 11 | 19 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 174,997 | 171,713 |
| 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