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Hydralazine
Apresazide, Apresoline, Apresoline-esidrix, Bidil, Cam-ap-es, Dralserp, Dralzine, Hydra-zide, Hydrap-es, Hydroserpine (r), Ser-a-gen, Ser-ap-es, Serpasil-apresoline, Unipres (hydralazine) is a small molecule pharmaceutical. Hydralazine was first approved as Apresoline on 1982-01-01. It is used to treat heart failure, malignant hypertension, and pulmonary hypertension in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
cardiovascular diseasesD002318
Trade Name
FDA
EMA
Combinations
Bidil (generic drugs available since 1982-01-01, discontinued: Apresazide, Apresoline-esidrix, Cam-ap-es, Dralserp, Hydra-zide, Hydrap-es, Hydroserpine (r), Ser-a-gen, Ser-ap-es, Serpasil-apresoline, Unipres)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Hydralazine hydrochloride
Tradename
Company
Number
Date
Products
APRESOLINENovartisN-008303 DISCN1982-01-01
5 products, RLD
Hide discontinued
Hydralazine hydrochloride
+
Hydrochlorothiazide
Tradename
Company
Number
Date
Products
APRESOLINE-ESIDRIXNovartisN-012026 DISCN1982-01-01
1 products
Hide discontinued
Hydralazine hydrochloride
+
Hydrochlorothiazide
+
Reserpine
Tradename
Company
Number
Date
Products
SER-AP-ESNovartisN-012193 DISCN1982-01-01
1 products
Hide discontinued
Hydralazine hydrochloride
+
Isosorbide dinitrate
Tradename
Company
Number
Date
Products
BIDILAzurityN-020727 RX2005-06-23
1 products, RLD, RS
Hydralazine hydrochloride
+
Reserpine
Tradename
Company
Number
Date
Products
SERPASIL-APRESOLINENovartisN-009296 DISCN1982-01-01
2 products
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
bidilNew Drug Application2021-01-26
hydralazine hydrochlorideANDA2023-05-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
heart failureEFO_0003144D006333I50
malignant hypertensionEFO_1001031D006974—
pulmonary hypertensionEFO_0001361D006976I27.20
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
C: Cardiovascular system drugs
— C02: Antihypertensives
— C02D: Arteriolar smooth muscle, agents acting on
— C02DB: Hydrazinophthalazine derivatives acting on arteriolar smooth muscle
— C02DB02: Hydralazine
— C02L: Antihypertensives and diuretics in combination
— C02LG: Hydrazinophthalazine derivatives and diuretics
— C02LG02: Hydralazine and diuretics
HCPCS
Code
Description
J0360
Injection, hydralazine hcl, up to 20 mg
Clinical
Clinical Trials
38 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I1011—3510
Heart failureD006333EFO_0003144I501222—6
Type 2 diabetes mellitusD003924EFO_0001360E11———1—1
Systolic heart failureD054143EFO_1001207I50.20———1—1
Mitral valve insufficiencyD008944HP_0001653———1—1
Chronic kidney failureD007676EFO_0003884N18.6———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Uterine cervical neoplasmsD002583—12——3
Pregnancy-induced hypertensionD046110O13—11——2
Ovarian neoplasmsD010051EFO_0003893C56——1——1
Alzheimer diseaseD000544EFO_0000249F03——1——1
Cardio-renal syndromeD059347——1——1
Left ventricular dysfunctionD018487——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
StrokeD020521EFO_0000712I63.9—2——13
Cerebral hemorrhageD002543—2——13
Blood pressureD001794EFO_0004325—1———1
Cardiovascular diseasesD002318EFO_0000319I98—1———1
Vascular diseasesD014652EFO_0004264I77—1———1
Heart diseasesD006331EFO_0003777I51.9—1———1
Pre-eclampsiaD011225EFO_0000668O14—1———1
Drug-related side effects and adverse reactionsD064420T88.7—1———1
NeoplasmsD009369C80—1———1
Breast neoplasmsD001943EFO_0003869C5011———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—1————1
Lung neoplasmsD008175C34.901————1
Polycystic kidney diseasesD007690Q61.31————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Intracranial hemorrhagesD020300EFO_0000551I62————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameHYDRALAZINE
INNhydralazine
Description
Hydralazine is the 1-hydrazino derivative of phthalazine; a direct-acting vasodilator that is used as an antihypertensive agent. It has a role as an antihypertensive agent and a vasodilator agent. It is a member of phthalazines, an azaarene, an ortho-fused heteroarene and a member of hydrazines.
Classification
Small molecule
Drug classantihypertensives (hydrazine-phthalazines); antiarrhythmic/antianginal/antihypertensive agents, phthalazine like structure
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
NNc1nncc2ccccc12
Identifiers
PDB—
CAS-ID86-54-4
RxCUI5470
ChEMBL IDCHEMBL276832
ChEBI ID5775
PubChem CID3637
DrugBankDB01275
UNII ID26NAK24LS8 (ChemIDplus, GSRS)
Target
Agency Approved
No data
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 23,139 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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151 adverse events reported
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