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
Trade Name
FDA
EMA
Quzyttir, Zerviate, Zyrtec (generic drugs available since 2007-12-27)
CombinationsZyrtec (generic drugs available since 2007-12-27)
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 | Eyevance | N-208694 RX | 2017-05-30 | 1 products, RLD, RS |
| ZYRTEC ALLERGY | Johnson & Johnson | N-019835 OTC | 2007-11-16 | 1 products, RLD, RS |
| CHILDREN'S ZYRTEC ALLERGY | Johnson & Johnson | N-021621 OTC | 2007-11-16 | 2 products, RLD |
| 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 |
| ZYRTEC ALLERGY | Johnson & Johnson | N-022578 OTC | 2010-09-03 | 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 |
|---|---|---|
| childrens zyrtec allergy | New Drug Application | 2023-06-06 |
| quzyttir | New Drug Application | 2020-04-02 |
| zerviate | New Drug Application | 2020-06-25 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| allergic rhinitis perennial | EFO_1001417 | D012221 | J30.89 |
| urticaria | EFO_0005531 | D014581 | L50 |
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
87 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Allergic rhinitis seasonal | D006255 | EFO_0003956 | J30 | — | 6 | 2 | 6 | 4 | 18 |
| Allergic rhinitis perennial | D012221 | EFO_1001417 | J30.89 | — | — | 6 | 3 | — | 9 |
| Allergic rhinitis | D065631 | J30.9 | — | 2 | 2 | 5 | — | 9 | |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | 5 | — | — | 2 | — | 7 |
| Asthma | D001249 | EFO_0000270 | J45 | — | — | — | 3 | — | 3 |
| Urticaria | D014581 | EFO_0005531 | L50 | — | — | — | 3 | — | 3 |
| Rhinitis | D012220 | EFO_0008521 | J31 | 1 | 1 | — | 1 | — | 3 |
| Alopecia | D000505 | HP_0002293 | L64 | — | 1 | 1 | 1 | — | 2 |
| Pruritus | D011537 | HP_0000989 | L29 | — | — | 1 | 1 | — | 2 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | — | 1 | — | 1 |
Show 6 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 8 | — | 1 | — | 2 | 11 | ||
| Allergic conjunctivitis | D003233 | EFO_0007141 | H10.44 | — | 1 | 5 | — | — | 5 |
| Dermatitis | D003872 | HP_0011123 | L30.9 | 1 | — | 1 | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 1 | — | — | 1 |
| 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 | |
| Lung neoplasms | D008175 | C34.90 | — | — | 1 | — | — | 1 | |
| Uterine cervical neoplasms | D002583 | — | — | 1 | — | — | 1 |
Show 3 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuromyelitis optica | D009471 | EFO_0004256 | G36.0 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatitis | D011472 | EFO_0003830 | N41 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Cognition | D003071 | EFO_0003925 | — | — | — | — | 1 | 1 | |
| Actinic keratosis | D055623 | L57.0 | — | — | — | — | 1 | 1 | |
| Sinusitis | D012852 | EFO_0007486 | J32 | — | — | — | — | 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 | 5DQF |
| CAS-ID | 83881-51-0 |
| RxCUI | 20610 |
| ChEMBL ID | CHEMBL1000 |
| ChEBI ID | 3561 |
| PubChem CID | 2678 |
| DrugBank | DB00341 |
| UNII ID | YO7261ME24 (ChemIDplus, GSRS) |
Target
Variants
Clinical Variant
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Financial
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Trends
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,999 adverse events reported
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