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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/12/31 | Phase 3 | Completed | |||
2023/11/13 | Phase 1 | Recruiting | |||
2023/09/15 | N/A | Completed | |||
2023/08/31 | Phase 4 | Completed | |||
2023/07/14 | Phase 3 | Terminated | |||
2021/10/27 | Phase 4 | Terminated | |||
2021/04/08 | Phase 4 | Withdrawn | |||
2020/07/22 | Phase 2 | Completed | |||
2020/03/03 | Phase 4 | UNKNOWN | |||
2020/01/22 | Phase 3 | Completed | Ciusss de L'Est de l'Île de Montréal |
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. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| TERIZINE TAB 10MG | N/A | N/A | N/A | 3/6/2006 | |
| CETIRIZINE DIHYDROCHLORIDE TABLETS 10MG | N/A | N/A | N/A | 5/9/2024 | |
| CYTEC TAB 10MG | N/A | N/A | N/A | 11/1/2003 | |
| BF-CETIRIZINE ORAL DROPS 10MG/ML | N/A | N/A | N/A | 11/11/2024 | |
| AXCEL CETIRIZINE SYRUP 5MG/5ML | N/A | N/A | N/A | 8/30/2016 | |
| SETIN TAB 10MG | N/A | N/A | N/A | 10/28/2011 | |
| HOVID CETIRIZINE TABLETS 10MG | N/A | N/A | N/A | 8/16/2024 | |
| PHARMANIAGA CETIRIZINE ORAL SOLN 0.1% W/V | N/A | N/A | N/A | 10/28/2008 | |
| ALTIRIN TABLETS 10MG | N/A | N/A | N/A | 1/7/2014 | |
| SALLNO TABLETS 10MG | N/A | N/A | N/A | 10/8/2024 |
TGA Drug Approvals
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 |
|---|---|---|---|---|---|
| ZYRTEC COMPRIMIDOS RECUBIERTOS | Vedim Sp. Z O.O. | R1846 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| CETIRIZINA UXA 10 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Uxa Farma S.A. | 90402 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
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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