Hydroxyzine
Atarax, Orgatrax, Vistaril (hydroxyzine) is a small molecule pharmaceutical. Hydroxyzine was first approved as Atarax on 1982-01-01. It is used to treat anxiety disorders, nausea, pruritus, substance withdrawal syndrome, and vomiting in the USA. The pharmaceutical is active against histamine H1 receptor.
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Trade Name
FDA
EMA
Vistaril (generic drugs available since 1982-01-01, discontinued: Atarax, Hy-pam, Orgatrax, Vistaril)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Hydroxyzine hydrochloride
Hydroxyzine pamoate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VISTARIL | Mylan | N-011459 RX | 1982-01-01 | 2 products, RLD |
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| hydroxyzine hydrochloride | ANDA | 2023-06-20 |
| vistaril | New Drug Application | 2023-05-31 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| anxiety disorders | EFO_0006788 | D001008 | F41.1 |
| nausea | HP_0002018 | D009325 | R11.0 |
| pruritus | HP_0000989 | D011537 | L29 |
| substance withdrawal syndrome | EFO_0005800 | D013375 | — |
| vomiting | HP_0002013 | D014839 | R11.1 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
Clinical
Clinical Trials
21 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Nausea | D009325 | HP_0002018 | R11.0 | — | — | — | 2 | — | 2 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | 1 | — | — | 1 | — | 2 |
| Healthy volunteers/patients | — | — | — | — | 2 | — | 2 | ||
| Smoking cessation | D016540 | EFO_0004319 | — | — | — | 1 | — | 1 | |
| Dental caries | D003731 | EFO_0003819 | K02 | — | — | — | 1 | — | 1 |
| Chronic urticaria | D000080223 | L50.8 | — | — | — | 1 | — | 1 | |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | 1 | — | 1 |
| Pruritus | D011537 | HP_0000989 | L29 | — | — | — | 1 | — | 1 |
| Vomiting | D014839 | HP_0002013 | R11.1 | — | — | — | 1 | — | 1 |
| Panic disorder | D016584 | EFO_0004262 | F41.0 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloproliferative disorders | D009196 | D47.1 | — | — | 1 | — | — | 1 | |
| Dementia | D003704 | F03 | — | — | 1 | — | — | 1 | |
| Psychophysiologic disorders | D011602 | F45.9 | — | — | 1 | — | — | 1 | |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | 1 | — | — | 1 |
| Depression | D003863 | F33.9 | — | — | 1 | — | — | 1 | |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | — | 1 | — | — | 1 |
| Child behavior | D002652 | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Substance-related disorders | D019966 | EFO_0003890 | F13 | — | — | — | — | 1 | 1 |
| Bradycardia | D001919 | HP_0001662 | R00.1 | — | — | — | — | 1 | 1 |
| Strabismus | D013285 | HP_0000486 | H50.2 | — | — | — | — | 1 | 1 |
| Oculocardiac reflex | D012024 | — | — | — | — | 1 | 1 | ||
| Sleep deprivation | D012892 | F51.12 | — | — | — | — | 1 | 1 | |
| Electroencephalography | D004569 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | HYDROXYZINE |
| INN | hydroxyzine |
| Description | Hydroxyzine is a N-alkylpiperazine that is piperzine in which the nitrogens atoms are substituted by 2-(2-hydroxyethoxy)ethyl and (4-chlorophenyl)(phenyl)methyl groups respectively. It has a role as a H1-receptor antagonist, an anxiolytic drug, a dermatologic drug, an antipruritic drug and an anticoronaviral agent. It is a N-alkylpiperazine, a hydroxyether and a member of monochlorobenzenes. |
| Classification | Small molecule |
| Drug class | First generation antihistamine |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | OCCOCCN1CCN(C(c2ccccc2)c2ccc(Cl)cc2)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 68-88-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL896 |
| ChEBI ID | 5818 |
| PubChem CID | 3658 |
| DrugBank | DB00557 |
| UNII ID | 30S50YM8OG (ChemIDplus, GSRS) |
Target
Variants
Clinical Variant
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Financial
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Trends
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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6,264 adverse events reported
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