Two medicines, side by side
Levocetirizine vs montelukast
Levocetirizine and montelukast are both labeled for allergies. Drugs@FDA records approvals of levocetirizine since 2007 and of montelukast since 1998. Pharmacies paid $0.0511 per levocetirizine 5 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. In FDA's classes, levocetirizine is a histamine-1 receptor antagonist and montelukast a leukotriene receptor antagonist.
Check it at the source: the levocetirizine FDA label on DailyMed (effective March 11, 2026); the montelukast FDA label on DailyMed (effective April 30, 2025).
Highlights of the levocetirizine record
Levocetirizine (Xyzal) · label of March 11, 2026
Used for
From the label: indicationstemporarily relieves these symptoms due to hay fever or other respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
On the market
- Earliest approval on file
- May 25, 2007
- Generic labelers
- 53 labelers
- Pharmacy cost
- $0.0511 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 1
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 (Levocetirizine label of March 11, 2026, Montelukast label of April 30, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do levocetirizine and montelukast differ on the record?
In FDA's classes, levocetirizine is a histamine-1 receptor antagonist and montelukast a leukotriene receptor antagonist.
Only the montelukast label carries a boxed warning.
Generics: levocetirizine since 2010; montelukast since 2012 (Drugs@FDA).
| Levocetirizine | Montelukast | |
|---|---|---|
| Labeled for | Allergies | Asthma, Allergies |
| Pharmacologic class | Histamine-1 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) | n/a | 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) | May 25, 2007 | February 20, 1998 |
| First generic approved | November 26, 2010 | August 3, 2012 |
| Generic labelers (NDC) | 53 labelers | 36 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.0511 per tablet (Levocetirizine 5 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 | 1 | 11 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 23,887 | 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 levocetirizine
- every medicine labeled for the same conditions