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
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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 | 2025-10-31 |
| hydroxyzine dihydrochloride | ANDA | 2024-07-16 |
| hydroxyzine hcl | ANDA | 2024-09-13 |
| hydroxyzine hcl hydroxyzine hydrochloride | ANDA | 2023-04-13 |
| hydroxyzine hydrochloride | ANDA | 2025-11-20 |
| hydroxyzine hydrochloride hydroxyzine hydrochloride | ANDA | 2021-01-25 |
| hydroxyzine pamoate | ANDA | 2025-11-05 |
| mkh dose pack | unapproved drug other | 2019-03-05 |
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Indications
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Clinical
Clinical Trials
124 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 | D065631 | — | J30.9 | — | 5 | 4 | 9 | 2 | 20 |
| Allergic rhinitis seasonal | D006255 | EFO_0003956 | J30 | — | 5 | 3 | 7 | 4 | 19 |
| Healthy volunteers/patients | — | — | — | 7 | — | 1 | 2 | 2 | 12 |
| Urticaria | D014581 | EFO_0005531 | L50 | 1 | — | 2 | 4 | 1 | 8 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | 3 | 1 | 1 | 2 | 1 | 8 |
| Rhinitis | D012220 | EFO_0008521 | J31 | 1 | 2 | 1 | 3 | — | 7 |
| Allergic rhinitis perennial | D012221 | EFO_1001417 | J30.89 | — | — | 3 | 3 | — | 6 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | 1 | — | 1 | 1 | 2 | 5 |
| Pruritus | D011537 | — | L29 | — | — | 2 | 2 | — | 4 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 1 | — | 3 | — | 4 |
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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 |
| Chronic pain | D059350 | — | — | 1 | — | 1 | — | — | 2 |
| Dermatitis | D003872 | — | L30.9 | 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 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 1 | — | — | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | — | 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 | — | 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 |
| Rectal neoplasms | D012004 | — | — | — | 1 | — | — | — | 1 |
| Exanthema | D005076 | — | — | — | 1 | — | — | — | 1 |
| Hepatitis d | D003699 | EFO_0007304 | — | — | 1 | — | — | — | 1 |
| Neuromyelitis optica | D009471 | EFO_0004256 | G36.0 | 1 | 1 | — | — | — | 1 |
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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 |
| Pelvic pain | D017699 | — | — | 1 | — | — | — | — | 1 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | 1 | — | — | — | — | 1 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | — | — | — | — | 2 | 2 |
| Aortic valve stenosis | D001024 | EFO_0000266 | — | — | — | — | — | 1 | 1 |
| Cognition | D003071 | EFO_0003925 | — | — | — | — | — | 1 | 1 |
| Bradycardia | D001919 | — | R00.1 | — | — | — | — | 1 | 1 |
| Strabismus | D013285 | — | H50.2 | — | — | — | — | 1 | 1 |
| Oculocardiac reflex | D012024 | — | — | — | — | — | — | 1 | 1 |
| Sinusitis | D012852 | EFO_0007486 | J32 | — | — | — | — | 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 |
Show 6 more
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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17,857 adverse events reported
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