MedPath

Cetirizine

Generic Name
Cetirizine
Brand Names
Aller-tec, Aller-tec D, Quzyttir, Reactine, Wal Zyr 24 Hour Allergy, Wal Zyr D, Wal-zyr, Zerviate, Zyrtec, Zyrtec-D
Drug Type
Small Molecule
Chemical Formula
C21H25ClN2O3
CAS Number
83881-51-0
Unique Ingredient Identifier
YO7261ME24

Overview

Cetirizine, also commonly known as Zyrtec, is an orally active second-generation histamine H1 antagonist proven effective in the treatment of various allergic symptoms, such as sneezing, coughing, nasal congestion, hives, and other symptoms , . One of the most common uses for this drug is for a condition called allergic rhinitis. The prevalence of allergic rhinitis in the United States is about 15% according to physician diagnoses, and up to 30%, according to self-reported nasal symptoms. Allergic rhinitis is associated with multiple missed or unproductive days at work and school, problems with sleep, and other difficulties with day to day activities for many individuals . Furthermore, some antihistamine agents that are used to treat this condition cause undesirable, sedating effects . Cetirizine is one of the first second-generation H1 antihistamines (SGAHs) formulated to selectively inhibit the H1 receptor without sedating effects .

Indication

Seasonal Allergic Rhinitis: Indicated for the relief of symptoms associated with seasonal allergic rhinitis caused by allergens such as ragweed, grass and tree pollens in adults and children 2 years of age and above. Symptoms treated effectively include sneezing, rhinorrhea, nasal pruritus, ocular pruritus, tearing, and redness of the eyes . Perennial allergic rhinitis: This drug is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens including dust mites, animal dander, and molds in adults and children 6 months of age and older. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing . Chronic urticaria: Cetirizine is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older. It markedly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus .

Associated Conditions

  • Allergy to Tree Pollen
  • Chronic Idiopathic Urticaria
  • Flu caused by Influenza
  • Perennial Allergic Rhinitis (PAR)
  • Respiratory Allergy
  • Seasonal Allergic Rhinitis

Clinical Trials

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
WALGREEN CO.
0363-0068
ORAL
10 mg in 1 1
4/5/2025
Costco Wholesale Company
63981-458
ORAL
10 mg in 1 1
6/10/2025
PAI Holdings, LLC dba PAI Pharma
0121-0874
ORAL
1 mg in 1 mL
3/20/2024
Eyevance Pharmaceuticals
71776-024
OPHTHALMIC
2.4 mg in 1 mL
10/9/2023
Taro Pharmaceuticals U.S.A., Inc.
51672-4070
ORAL
1 mg in 1 mL
1/24/2024
Proficient Rx LP
71205-435
ORAL
1 mg in 1 mL
3/1/2020
Aidarex Pharmaceuticals LLC
33261-924
ORAL
1 mg in 1 mL
8/24/2018
A-S Medication Solutions
50090-4288
ORAL
1 mg in 1 mL
6/14/2017
INNOVUS PHARMACEUTICALS, INC.
57483-190
ORAL
10 mg in 1 1
4/28/2025
Bryant Ranch Prepack
72162-2173
ORAL
10 mg in 1 1
5/21/2025

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
SIMTEC TABLET 10 mg
SIN13088P
TABLET, FILM COATED
10 mg
4/14/2005
ZYRTEC-R ORAL SOLUTION 1 MG/ML
SIN15437P
SOLUTION
5 MG/5 ML
2/27/2018
AXCEL CETIRIZINE SYRUP 5MG/5ML
SIN14690P
LIQUID
5MG/5ML
12/4/2014
Sunizine Syrup 5mg / 5ml
SIN13700P
SYRUP
5mg/5ml
9/17/2009
ZYRTEC TABLET 10 mg
SIN03022P
TABLET, FILM COATED
10 mg
6/3/1989
CERITEC FILM COATED TABLET 10MG
SIN14020P
TABLET, FILM COATED
10 mg
9/22/2011
ATRIZIN TABLET 10 MG
SIN13069P
TABLET
10 MG
3/22/2005
ALLERCET TABLET 10 mg
SIN08756P
TABLET, FILM COATED
10 mg
6/20/1996
TERIZIN TABLETS 10 mg
SIN11214P
TABLET, FILM COATED
10 mg
11/4/1999
SIMTEC TABLET 10MG (OTC)
SIN15142P
TABLET, FILM COATED
10MG
12/21/2016

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
CETIRIZINE
02375087
Tablet - Oral
5 MG
N/A
EXTRA STRENGTH ALLERGY RELIEF
juno otc inc
02545071
Tablet - Oral
10 MG
N/A
CETIRIZINE HYDROCHLORIDE TABLETS
vita health products inc
02533154
Tablet - Oral
20 MG
N/A
ALLERGY RELIEF 10 MG
vita health products inc
02355868
Tablet - Oral
10 MG
N/A
REACTINE CHEWABLE TABLETS 5 MG
mcneil consumer healthcare division of johnson & johnson inc
02295059
Tablet (Chewable) - Oral
5 MG
N/A
RHINARIS RELIEF
pendopharm division of pharmascience inc
02318873
Tablet - Oral
5 MG
N/A
JAMP-CETIRIZINE
02451751
Tablet - Oral
5 MG
8/31/2016
JAMP-CETIRIZINE
02451778
Tablet - Oral
10 MG
4/5/2016
ALLERGY RELIEF
02315947
Tablet - Oral
5 MG
N/A
MAR-CETIRIZINE
marcan pharmaceuticals inc
02427125
Tablet - Oral
5 MG
N/A

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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