Hydroxyzine
Hydroxyzine, 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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Commercial
Trade Name
FDA
EMA
Hydroxyzine, Hydroxyzine pamoate, Vistaril (discontinued: Atarax, Hy-pam, Hydroxyzine, Hydroxyzine pamoate, Orgatrax, Vistaril)
Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Hydroxyzine hydrochloride
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| atarax | 2006-06-20 | |
| hydoxyzine pamoate | ANDA | 2010-12-30 |
| hydroxyzine | ANDA | 2024-08-05 |
| hydroxyzine dihydrochloride | ANDA | 2024-07-16 |
| hydroxyzine hcl | ANDA | 2024-09-13 |
| hydroxyzine hcl hydroxyzine hydrochloride | ANDA | 2023-04-13 |
| hydroxyzine hydrochloride | ANDA | 2024-10-28 |
| hydroxyzine hydrochloride hydroxyzine hydrochloride | ANDA | 2021-01-25 |
| hydroxyzine pamoate | ANDA | 2024-10-10 |
| mkh dose pack | unapproved drug other | 2019-03-05 |
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Indications
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Clinical
Clinical Trials
43 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | 1 | — | 1 | 1 | 2 | 5 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | 2 | — | — | 1 | — | 3 |
| Pruritus | D011537 | HP_0000989 | L29 | — | — | 1 | 1 | — | 2 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | 1 | 1 | — | 2 |
| Nausea | D009325 | HP_0002018 | R11.0 | — | — | — | 2 | — | 2 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | 1 | 1 | 2 |
| Dental caries | D003731 | EFO_0003819 | K02 | — | — | 1 | 1 | — | 2 |
| Healthy volunteers/patients | — | — | — | — | — | — | 2 | — | 2 |
| Psychomotor agitation | D011595 | — | — | — | — | — | 1 | — | 1 |
| Psychotic disorders | D011618 | — | F20.81 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Depression | D003863 | — | F33.9 | — | — | 2 | — | — | 2 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | — | 1 | 1 | — | 1 | 2 |
| Dental anxiety | D016854 | — | — | — | — | 1 | — | 1 | 2 |
| Myeloproliferative disorders | D009196 | — | D47.1 | — | — | 1 | — | — | 1 |
| Epidermolysis bullosa simplex | D016110 | — | Q81.0 | — | 1 | 1 | — | — | 1 |
| Epidermolysis bullosa | D004820 | — | Q81 | — | 1 | 1 | — | — | 1 |
| Dementia | D003704 | EFO_0003862 | F03 | — | — | 1 | — | — | 1 |
| Psychophysiologic disorders | D011602 | — | F45.9 | — | — | 1 | — | — | 1 |
| Somatoform disorders | D013001 | — | F45 | — | — | 1 | — | — | 1 |
| Critical illness | D016638 | — | — | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis b | D006509 | — | — | 1 | 4 | — | — | — | 5 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | 1 | 4 | — | — | — | 5 |
| Hepatitis | D006505 | HP_0012115 | K75.9 | 1 | 4 | — | — | — | 5 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 1 | 4 | — | — | — | 5 |
| Colorectal neoplasms | D015179 | — | — | — | 1 | — | — | — | 1 |
| Colonic neoplasms | D003110 | — | C18 | — | 1 | — | — | — | 1 |
| Exanthema | D005076 | HP_0000988 | — | — | 1 | — | — | — | 1 |
| Hepatitis d | D003699 | EFO_0007304 | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Traumatic brain injuries | D000070642 | — | S06 | 1 | — | — | — | — | 1 |
| Brain concussion | D001924 | — | S06.0 | 1 | — | — | — | — | 1 |
| Brain injuries | D001930 | — | S06.9 | 1 | — | — | — | — | 1 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | 1 | — | — | — | — | 1 |
| Traumatic stress disorders | D040921 | — | — | 1 | — | — | — | — | 1 |
| Anesthesia | D000758 | — | — | 1 | — | — | — | — | 1 |
| Psychological stress | D013315 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Aortic valve stenosis | D001024 | HP_0001650 | — | — | — | — | — | 1 | 1 |
| Bradycardia | D001919 | HP_0001662 | R00.1 | — | — | — | — | 1 | 1 |
| Strabismus | D013285 | HP_0000486 | H50.2 | — | — | — | — | 1 | 1 |
| Oculocardiac reflex | D012024 | — | — | — | — | — | — | 1 | 1 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | — | — | — | 1 | 1 |
| Long qt syndrome | D008133 | HP_0001657 | I45.81 | — | — | — | — | 1 | 1 |
| Hip fractures | D006620 | EFO_0003964 | S72.00 | — | — | — | — | 1 | 1 |
| Sleep deprivation | D012892 | — | F51.12 | — | — | — | — | 1 | 1 |
| Electroencephalography | D004569 | — | — | — | — | — | — | 1 | 1 |
| Hematologic neoplasms | D019337 | — | — | — | — | — | — | 1 | 1 |
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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) |
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Hydroxyzine
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Ephedrine
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Theophylline
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Hydroxyzine
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16,729 adverse events reported
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