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Two medicines, side by side

Desloratadine vs montelukast

Desloratadine and montelukast are both labeled for allergies. Drugs@FDA records approvals of desloratadine since 2001 and of montelukast since 1998. Pharmacies paid $0.258 per desloratadine 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, desloratadine is a histamine-1 receptor antagonist and montelukast a leukotriene receptor antagonist.

Check it at the source: the desloratadine FDA label on DailyMed (effective May 17, 2025); the montelukast FDA label on DailyMed (effective April 30, 2025).

Highlights of the desloratadine record

Desloratadine (Clarinex) · label of May 17, 2025

Used for

From the label: indications

CLARINEX is a histamine-1 (H1) receptor antagonist indicated for: Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 2 years of age and older. ( 1.1 ) Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 6 months of age and older. […]

On the market

Earliest approval on file
December 21, 2001
Generic labelers
9 labelers
Pharmacy cost
$0.258 per tablet

Supply and safety

Shortage
No current entry
Recalls
1

Highlights of the montelukast record

Montelukast (Singulair) · label of April 30, 2025

Boxed warning

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: indications

SINGULAIR 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 (Desloratadine label of May 17, 2025, Montelukast label of April 30, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do desloratadine and montelukast differ on the record?

In FDA's classes, desloratadine is a histamine-1 receptor antagonist and montelukast a leukotriene receptor antagonist.

How each works, in its label's words: Desloratadine, “Desloratadine is a long-acting tricyclic histamine antagonist with selective H 1 -receptor histamine antagonist activity.”; Montelukast, “These eicosanoids bind to cysteinyl leukotriene (CysLT) receptors.”

Half-life, in each label's words: Desloratadine, “pproximately 6% of subjects were poor metabolizers of desloratadine (defined as a subject with an AUC ratio of …”; Montelukast, “In several studies, the mean plasma half-life of montelukast ranged from 2.7 to 5.5 hours in healthy young adults.”

Only the montelukast label carries a boxed warning.

Generics: desloratadine since 2010; montelukast since 2012 (Drugs@FDA).

DesloratadineMontelukast
Labeled forAllergiesAsthma, Allergies
Pharmacologic classHistamine-1 Receptor AntagonistLeukotriene Receptor Antagonist
How it works (label)Desloratadine is a long-acting tricyclic histamine antagonist with selective H 1 -receptor histamine antagonist activity.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)pproximately 6% of subjects were poor metabolizers of desloratadine (defined as a subject with an AUC ratio of 3-hydroxydesloratadine to desloratadine less than 0.1, or a subject with a desloratadine half-life exceeding …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)December 21, 2001February 20, 1998
First generic approvedFebruary 19, 2010August 3, 2012
Generic labelers (NDC)9 labelers36 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$0.258 per tablet (Desloratadine 5 mg tablet)$0.0419 per tablet (Montelukast sod 10 mg tablet)
12-month price change-13%-20%
Boxed warningNoYes
Shortage nowNo current entryA presentation being discontinued
Recalls recorded111
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)10,661174,997
DEA schedulenonenone

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?

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