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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2012/07/27 | Phase 2 | Completed | |||
2012/06/19 | Phase 1 | Completed | |||
2011/12/02 | Phase 3 | Completed | |||
2011/03/24 | Phase 1 | Completed | |||
2011/03/18 | Not Applicable | Completed | |||
2010/11/16 | Phase 2 | Completed | |||
2010/05/21 | Phase 3 | Completed | |||
2010/04/13 | Phase 2 | Completed | |||
2010/02/08 | Phase 1 | Completed | |||
2010/02/08 | Phase 1 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| BETTER LIVING BRANDS, LLC | 21130-712 | ORAL | 10 mg in 1 1 | 6/28/2025 | |
| Kenvue Brands LLC | 50580-791 | ORAL | 10 mg in 1 1 | 4/7/2025 | |
| Bryant Ranch Prepack | 63629-4914 | ORAL | 5 mg in 1 1 | 12/12/2017 | |
| Rite Aid Corporation | 11822-1189 | ORAL | 5 mg in 5 mL | 5/7/2025 | |
| WOCKHARDT LLC. | 64679-693 | ORAL | 1 mg in 1 mL | 4/27/2010 | |
| A-S Medication Solutions | 50090-3885 | ORAL | 1 mg in 1 mL | 1/21/2019 | |
| CVS Pharmacy | 69842-741 | ORAL | 10 mg in 1 1 | 7/30/2025 | |
| Meijer Distribution Inc | 41250-475 | ORAL | 5 mg in 5 mL | 4/29/2025 | |
| Breckenridge Pharmaceutical, Inc. | 51991-837 | ORAL | 1 mg in 1 mL | 7/12/2022 | |
| Kroger Company | 30142-475 | ORAL | 5 mg in 5 mL | 4/29/2025 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| PHARMACY ACTION CETRELIEF cetirizine hydrochloride 10mg tablet blister pack (unscheduled) | 337511 | Medicine | A | 6/5/2020 | |
| NOUMED CETIRIZINE cetirizine hydrochloride 10 mg film-coated tablet blister pack | 347011 | Medicine | A | 11/2/2020 | |
| PHARMACY ACTION Cetrelief cetirizine hydrochloride 10mg tablet blister pack | 190243 | Medicine | A | 10/5/2011 | |
| ZERTINE cetirizine hydrochloride 10 mg tablet blister pack | 287404 | Medicine | A | 4/3/2017 | |
| TRUST CETIRIZINE cetirizine hydrocholoride 10 mg tablet blister pack | 160460 | Medicine | A | 3/26/2009 | |
| ZYRTEC Cetirizine hydrochloride 5mg/5mL oral liquid bottle | 60948 | Medicine | A | 8/28/1997 | |
| ZERTINE cetirizine hydrochloride 10 mg tablet blister pack (General sale) | 287545 | Medicine | A | 4/5/2017 | |
| Histaclear | 389829 | Medicine | A | 6/8/2022 | |
| MEDREICH CETIRIZINE HYDROCHLORIDE 10 mg tablet blister pack | 155407 | Medicine | A | 9/26/2008 | |
| CETIRIZINE NHPL ORAL LIQUID cetirizine hydrochloride 1 mg/mL oral liquid bottle | 312193 | Medicine | A | 12/4/2018 |
Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| REACTINE ALLERGY LIQUID GELS | mcneil consumer healthcare division of johnson & johnson inc | 02368064 | Capsule (Immediate Release) - Oral | 10 MG | 4/1/2012 |
| REACTINE ALLERGY | mcneil consumer healthcare division of johnson & johnson inc | 02486954 | Syrup - Oral | 5 MG / 5 ML | 2/6/2020 |
| REACTINE TAB 10MG | 01900986 | Tablet - Oral | 10 MG | 12/31/1991 | |
| REACTINE CHEWABLE TABLETS 10 MG | mcneil consumer healthcare division of johnson & johnson inc | 02295067 | Tablet (Chewable) - Oral | 10 MG | N/A |
| APO-CETIRIZINE | 02240910 | Tablet - Oral | 5 MG | 3/22/2000 | |
| APO-CETIRIZINE | 02231603 | Tablet - Oral | 10 MG | 10/21/1998 | |
| JAMP-CETIRIZINE | 02466171 | Tablet - Oral | 20 MG | 10/5/2017 | |
| CETIRIZINE | sanis health inc | 02515695 | Tablet - Oral | 20 MG | 11/30/2021 |
| DOM-CETIRIZINE | dominion pharmacal | 02344572 | Tablet - Oral | 20 MG | N/A |
| ALLERGY RELIEF CETIRIZINE HYDROCHLORIDE LIQUID GELS | Strides Pharma Canada Inc | 02516497 | Capsule (Immediate Release) - Oral | 10 MG | N/A |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
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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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