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Two medicines, side by side

Chlorpheniramine vs montelukast

Chlorpheniramine and montelukast are both labeled for allergies. Drugs@FDA records approvals of chlorpheniramine since 1949 and of montelukast since 1998. Pharmacies paid $0.0177 per allergy 4 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, chlorpheniramine is a histamine-1 receptor antagonist and montelukast a leukotriene receptor antagonist.

Check it at the source: the chlorpheniramine FDA label on DailyMed (effective December 19, 2018); the montelukast FDA label on DailyMed (effective April 30, 2025).

Highlights of the chlorpheniramine record

Chlorpheniramine (Chlor-Trimeton) · label of December 19, 2018

Used for

From the label: indications

temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose itchy, watery eyes itching of the nose or throat

On the market

Earliest approval on file
July 13, 1949
Generic labelers
2 labelers
Pharmacy cost
$0.0177 per tablet

Supply and safety

Shortage
No current entry
Recalls
0

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 (Chlorpheniramine label of December 19, 2018, Montelukast label of April 30, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do chlorpheniramine and montelukast differ on the record?

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

Only the montelukast label carries a boxed warning.

Generics: chlorpheniramine since 1972; montelukast since 2012 (Drugs@FDA).

ChlorpheniramineMontelukast
Labeled forAllergiesAsthma, Allergies
Pharmacologic classHistamine-1 Receptor AntagonistLeukotriene Receptor Antagonist
How it works (label)n/aThe 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/aIn 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)July 13, 1949February 20, 1998
First generic approvedMay 9, 1972August 3, 2012
Generic labelers (NDC)2 labelers36 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$0.0177 per tablet (Allergy 4 mg tablet)$0.0419 per tablet (Montelukast sod 10 mg tablet)
12-month price change+8%-20%
Boxed warningNoYes
Shortage nowNo current entryA presentation being discontinued
Recalls recorded011
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)6,553174,997
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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