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Drug ReportsHydroxyzine
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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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
skin and connective tissue diseasesD017437
signs and symptoms pathological conditionsD013568
chemically-induced disordersD064419
mental disordersD001523
Trade Name
FDA
EMA
Hydroxyzine, Hydroxyzine pamoate, Vistaril (discontinued: Atarax, Hy-pam, Hydroxyzine, Hydroxyzine pamoate, 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
Tradename
Company
Number
Date
Products
ATARAXPfizerN-010392 DISCN1982-01-01
4 products, RLD
VISTARILPfizerN-011111 DISCN1982-01-01
2 products, RLD
ATARAXRoerigN-010485 DISCN1982-01-01
1 products
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Hydroxyzine pamoate
Tradename
Company
Number
Date
Products
VISTARILPfizerN-011459 RX1982-01-01
2 products, RLD
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
atarax2006-06-20
hydoxyzine pamoateANDA2010-12-30
hydroxyzineANDA2024-08-05
hydroxyzine dihydrochlorideANDA2024-07-16
hydroxyzine hclANDA2024-09-13
hydroxyzine hcl hydroxyzine hydrochlorideANDA2023-04-13
hydroxyzine hydrochlorideANDA2025-09-25
hydroxyzine hydrochloride hydroxyzine hydrochlorideANDA2021-01-25
hydroxyzine pamoateANDA2025-09-11
mkh dose packunapproved drug other2019-03-05
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Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
substance withdrawal syndromeEFO_0005800D013375—
pruritus—D011537L29
vomiting—D014839R11.1
nausea—D009325R11.0
anxiety disordersEFO_0006788D001008F41.1
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
N: Nervous system drugs
— N05: Psycholeptics
— N05B: Anxiolytics
— N05BB: Diphenylmethane derivatives, anxiolytics
— N05BB01: Hydroxyzine
— N05BB51: Hydroxyzine, combinations
HCPCS
Code
Description
J3410
Injection, hydroxyzine hcl, up to 25 mg
Q0177
Hydroxyzine pamoate, 25 mg, oral, fda approved prescription anti-emetic, for use as a complete therapeutic substitute for an iv anti-emetic at the time of chemotherapy treatment, not to exceed a 48 hour dosage regimen
Clinical
Clinical Trials
123 clinical trials
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Indications Phases 4
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Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———2————2
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameHydroxyzine
INNhydroxyzine
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 classFirst generation antihistamine
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
OCCOCCN1CCN(C(c2ccccc2)c2ccc(Cl)cc2)CC1
Identifiers
PDB—
CAS-ID68-88-2
RxCUI—
ChEMBL IDCHEMBL896
ChEBI ID5818
PubChem CID3658
DrugBankDB00557
UNII ID30S50YM8OG (ChemIDplus, GSRS)
Target
Agency Approved
HRH1
HRH1
Organism
Homo sapiens
Gene name
HRH1
Gene synonyms
NCBI Gene ID
3269
Protein name
histamine H1 receptor
Protein synonyms
histamine receptor, subclass H1
Uniprot ID
Q6P9E5
Mouse ortholog
Hrh1 (15465)
histamine H1 receptor (Q91XN3)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Hydroxyzine
+
Ephedrine
+
Theophylline
Total medical expenditures per year (USD, in millions)
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Hydroxyzine
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,154 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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17,857 adverse events reported
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