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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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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
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
Tradename
Company
Number
Date
Products
ATARAXMylanN-010392 DISCN1982-01-01
4 products, RLD
VISTARILMylanN-011111 DISCN1982-01-01
2 products, RLD
ATARAXRoerigN-010485 DISCN1982-01-01
1 products
Hide discontinued
Hydroxyzine pamoate
Tradename
Company
Number
Date
Products
VISTARILMylanN-011459 RX1982-01-01
2 products, RLD
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
hydroxyzine hydrochlorideANDA2023-06-20
vistarilNew Drug Application2023-05-31
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
anxiety disordersEFO_0006788D001008F41.1
nauseaHP_0002018D009325R11.0
pruritusHP_0000989D011537L29
substance withdrawal syndromeEFO_0005800D013375
vomitingHP_0002013D014839R11.1
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
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
NauseaD009325HP_0002018R11.022
AnxietyD001007EFO_0005230F41.1112
Healthy volunteers/patients22
Smoking cessationD016540EFO_000431911
Dental cariesD003731EFO_0003819K0211
Chronic urticariaD000080223L50.811
PainD010146EFO_0003843R5211
PruritusD011537HP_0000989L2911
VomitingD014839HP_0002013R11.111
Panic disorderD016584EFO_0004262F41.011
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myeloproliferative disordersD009196D47.111
DementiaD003704F0311
Psychophysiologic disordersD011602F45.911
SchizophreniaD012559EFO_0000692F2011
DepressionD003863F33.911
Anxiety disordersD001008EFO_0006788F41.111
Child behaviorD00265211
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 disordersD019966EFO_0003890F1311
BradycardiaD001919HP_0001662R00.111
StrabismusD013285HP_0000486H50.211
Oculocardiac reflexD01202411
Sleep deprivationD012892F51.1211
ElectroencephalographyD00456911
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)
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
Protein name
histamine H1 receptor
Protein synonyms
histamine receptor, subclass H1
Uniprot ID
Mouse ortholog
Hrh1 (15465)
histamine H1 receptor (Q91XN3)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,034 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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6,264 adverse events reported
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