Cetirizine
Cetirizine, Quzyttir, Zerviate, Zyrtec (cetirizine) is a small molecule pharmaceutical. Cetirizine was first approved as Zyrtec on 1996-09-27. It is used to treat allergic rhinitis perennial and urticaria in the USA. The pharmaceutical is active against histamine H1 receptor.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Cetirizine, Quzyttir, Zerviate, Zyrtec (discontinued: Cetirizine, Zyrtec)
CombinationsCetirizine pseudoephedrine, Zyrtec (discontinued: Cetirizine pseudoephedrine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cetirizine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE ALLERGY | BionPharma | N-022429 OTC | 2009-07-23 | 1 products, RLD |
| CETIRIZINE HYDROCHLORIDE HIVES RELIEF | BionPharma | N-022429 OTC | 2009-07-23 | 2 products, RLD |
| CETIRIZINE HYDROCHLORIDE ALLERGY | BionPharma | N-022429 OTC | 2009-07-23 | 1 products, RLD, RS |
| ZERVIATE | Harrow | N-208694 RX | 2017-05-30 | 1 products, RLD, RS |
| CHILDREN'S ZYRTEC HIVES RELIEF | Johnson & Johnson | N-022155 OTC | 2007-11-16 | 1 products, RLD, RS |
| CHILDREN'S ZYRTEC ALLERGY | Johnson & Johnson | N-022155 OTC | 2007-11-16 | 1 products, RLD, RS |
| CHILDREN'S ZYRTEC ALLERGY | Johnson & Johnson | N-021621 OTC | 2007-11-16 | 2 products, RLD |
| ZYRTEC ALLERGY | Johnson & Johnson | N-022578 OTC | 2010-09-03 | 1 products, RLD, RS |
| ZYRTEC ALLERGY | Johnson & Johnson | N-019835 OTC | 2007-11-16 | 1 products, RLD, RS |
| QUZYTTIR | JDP Therapeutics | N-211415 RX | 2019-10-04 | 1 products, RLD, RS |
Show 5 discontinued
Cetirizine hydrochloride
+
Pseudoephedrine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZYRTEC-D 12 HOUR | Johnson & Johnson | N-021150 OTC | 2007-11-09 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 12 hour allergy d | ANDA | 2020-09-03 |
| 24 hour allergy | New Drug Application | 2024-04-01 |
| all day | ANDA | 2020-06-18 |
| all day allergy | ANDA | 2024-12-11 |
| all day allergy d | ANDA | 2025-02-12 |
| all day allergy relief | ANDA | 2024-12-20 |
| all day allergy relief d | ANDA | 2018-12-06 |
| allergy | ANDA | 2024-06-03 |
| allergy and congestion relief d | ANDA | 2023-05-30 |
| allergy relief | ANDA | 2025-03-13 |
Show 122 more
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Cetirizine Hydrochloride, Zerviate, Eyevance | |||
| 9254286 | 2032-07-09 | DP | |
| 8829005 | 2030-03-15 | U-1680 | |
| 9750684 | 2030-03-15 | DP | |
| 9993471 | 2030-03-15 | U-1680 | |
| Cetirizine Hydrochloride, Quzyttir, Jdp | |||
| 8263581 | 2030-02-28 | U-2635 | |
| 8314083 | 2030-02-28 | U-2634 | |
| 8513259 | 2030-02-11 | U-2636 | |
| 9119771 | 2030-02-11 | U-2635 | |
| 9180090 | 2030-02-11 | U-2635 | |
ATC Codes
R: Respiratory system drugs
— R06: Antihistamines for systemic use
— R06A: Antihistamines for systemic use
— R06AE: Piperazine derivatives, systemic antihistamines
— R06AE07: Cetirizine
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01G: Decongestants and antiallergics
— S01GX: Other antiallergics in atc
— S01GX12: Cetirizine
HCPCS
Code | Description |
|---|---|
| J1201 | Injection, cetirizine hydrochloride, 0.5 mg |
Clinical
Clinical Trials
146 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rhinitis | D012220 | EFO_0008521 | J31 | 3 | 9 | 14 | 15 | 8 | 49 |
| Allergic rhinitis | D065631 | — | J30.9 | 2 | 9 | 13 | 15 | 8 | 47 |
| Allergic rhinitis seasonal | D006255 | EFO_0003956 | J30 | — | 7 | 3 | 8 | 4 | 22 |
| Healthy volunteers/patients | — | — | — | 9 | — | 1 | 1 | 2 | 13 |
| Urticaria | D014581 | EFO_0005531 | L50 | 1 | 1 | 5 | 5 | 1 | 13 |
| Allergic rhinitis perennial | D012221 | EFO_1001417 | J30.89 | 1 | — | 7 | 5 | — | 13 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | 5 | 1 | — | 3 | 1 | 10 |
| Chronic urticaria | D000080223 | — | L50.8 | — | 1 | 2 | 4 | — | 7 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 1 | — | 3 | — | 4 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 1 | — | 1 | 2 | — | 4 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Conjunctivitis | D003231 | — | H10 | — | 2 | 5 | — | — | 6 |
| Allergic conjunctivitis | D003233 | EFO_0007141 | H10.44 | — | 2 | 5 | — | — | 6 |
| Dermatitis | D003872 | — | L30.9 | 1 | 1 | 2 | — | 1 | 5 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | 1 | — | — | 3 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | 1 | 1 | — | 1 | 3 |
| Eczema | D004485 | — | L30.9 | — | 1 | 1 | — | 1 | 3 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | — | 1 | — | — | 1 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | — | — | 1 | — | — | 1 |
| Head and neck neoplasms | D006258 | — | — | — | — | 1 | — | — | 1 |
| Esophageal neoplasms | D004938 | — | C15 | — | — | 1 | — | — | 1 |
Show 7 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis b | D006509 | — | — | — | 4 | — | — | — | 4 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | — | 4 | — | — | — | 4 |
| Hepatitis | D006505 | — | K75.9 | — | 4 | — | — | — | 4 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | — | 4 | — | — | — | 4 |
| Disease | D004194 | EFO_0000408 | R69 | 1 | 1 | — | — | 2 | 3 |
| Syndrome | D013577 | — | — | — | 2 | — | — | 1 | 3 |
| Nephrotic syndrome | D009404 | EFO_0004255 | N04 | — | 2 | — | — | — | 2 |
| Nephrosis | D009401 | — | — | — | 2 | — | — | — | 2 |
| Hepatitis d | D003699 | EFO_0007304 | — | — | 1 | — | — | — | 1 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | 1 | — | — | — | 1 |
Show 17 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 3 | — | — | — | — | 3 |
| Chronic progressive multiple sclerosis | D020528 | EFO_0003840 | — | 1 | — | — | — | — | 1 |
| Prostatitis | D011472 | EFO_0003830 | N41 | 1 | — | — | — | — | 1 |
| Pelvic pain | D017699 | — | — | 1 | — | — | — | — | 1 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | 1 | — | — | — | — | 1 |
| Larva migrans | D007815 | EFO_0007391 | B76.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | — | — | — | — | 1 | 1 |
| Diarrhea | D003967 | — | R19.7 | — | — | — | — | 1 | 1 |
| Cognition | D003071 | EFO_0003925 | — | — | — | — | — | 1 | 1 |
| Actinic keratosis | D055623 | — | L57.0 | — | — | — | — | 1 | 1 |
| Keratosis | D007642 | — | — | — | — | — | — | 1 | 1 |
| Sinusitis | D012852 | EFO_0007486 | J32 | — | — | — | — | 1 | 1 |
| Vasomotor rhinitis | D012223 | EFO_0007533 | J30.0 | — | — | — | — | 1 | 1 |
| Peripheral nervous system diseases | D010523 | — | G64 | — | — | — | — | 1 | 1 |
| Electroacupuncture | D015671 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Cetirizine |
| INN | cetirizine |
| Description | Cetirizine is a member of the class of piperazines that is piperazine in which the hydrogens attached to nitrogen are replaced by a (4-chlorophenyl)(phenyl)methyl and a 2-(carboxymethoxy)ethyl group respectively. It has a role as an anti-allergic agent, a H1-receptor antagonist, an environmental contaminant and a xenobiotic. It is a monocarboxylic acid, a member of piperazines, a member of monochlorobenzenes and an ether. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C(O)COCCN1CCN(C(c2ccccc2)c2ccc(Cl)cc2)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 83881-51-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1000 |
| ChEBI ID | 3561 |
| PubChem CID | 2678 |
| DrugBank | DB00341 |
| UNII ID | YO7261ME24 (ChemIDplus, GSRS) |
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Cetirizine
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Cetirizine
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Pseudoephedrine
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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58,546 adverse events reported
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