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Drug ReportsHydralazine
Hydralazine
Bidil, Cam-ap-es, Dralserp, Hydra-zide, Hydralazine, 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
Clinical
Drug
Target
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Financial
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Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
cardiovascular diseasesD002318
Trade Name
FDA
EMA
Hydralazine (discontinued: Apresoline, Dralzine, Hydralazine)
Combinations
Bidil, Hydra-zide, Isosorbide hydralazine (discontinued: Apresazide, Apresoline-esidrix, Cam-ap-es, Dralserp, Hydra-zide, Hydralazine hydrochloride, hydrochlorothiazide reserpine, Hydralazine hydrochloride-hydrochlorothiazide-reserpine, Hydralazine hydrochlorothiazide, Hydralazine w/ hydrochlorothiazide, Hydralazine, hydrochlorothiazide w/ reserpine, Hydrap-es, Hydrochlorothiazide w/ hydralazine, Hydrochlorothiazide w/ reserpine hydralazine, Hydroserpine (r), Reserpine, hydralazine hydrochlorothiazide, Reserpine, hydrochlorothiazide, hydralazine, 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
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Hydralazine hydrochloride
+
Hydrochlorothiazide
+
Reserpine
Tradename
Company
Number
Date
Products
SER-AP-ESNovartisN-012193 DISCN1982-01-01
1 products
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Hydralazine hydrochloride
+
Reserpine
Tradename
Company
Number
Date
Products
SERPASIL-APRESOLINENovartisN-009296 DISCN1982-01-01
2 products
Hide discontinued
Hydralazine hydrochloride
+
Isosorbide dinitrate
Tradename
Company
Number
Date
Products
BIDILAzurityN-020727 RX2005-06-23
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
bidilNew Drug Application2022-07-19
hydralazineANDA2022-02-15
hydralazine hclANDA2019-04-30
hydralazine hydrochlorideANDA2025-09-26
hydralazine hydrocloride2006-09-19
isosorbide dinitrate and hydralazine hydrochlorideANDA2025-06-03
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
heart failureEFO_0003144D006333I50
pulmonary hypertensionEFO_0001361D006976I27.20
malignant hypertensionEFO_1001031D006974—
hypertensionEFO_0000537D006973I10
nephrotic syndromeEFO_0004255D009404N04
edema—D004487R60.9
dyskinesias—D020820G24
schizophreniaEFO_0000692D012559F20
coronary disease—D003327—
angina pectorisEFO_0003913D000787I20
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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
72 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_0000537I1023441123
Heart failureD006333EFO_0003144I501337417
Diabetes mellitusD003920EFO_0000400E08-E13——12—3
Type 2 diabetes mellitusD003924EFO_0001360E11——11—2
Healthy volunteers/patients———1——1—2
Cardiogenic shockD012770—R57.0———1—1
Low cardiac outputD002303—————1—1
Continuous ambulatory peritoneal dialysisD010531—————1—1
Insulin resistanceD007333EFO_0002614E88.819———1—1
Systolic heart failureD054143EFO_1001207I50.20———1—1
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pregnancy-induced hypertensionD046110—O13—11—24
Kidney diseasesD007674EFO_0003086N08112——3
Uterine cervical neoplasmsD002583———12——3
Polycystic kidney diseasesD007690—Q61.31—1——2
Cardiovascular diseasesD002318EFO_0000319I98—11——2
SyndromeD013577———11——2
HypercholesterolemiaD006937————1——1
Coronary diseaseD003327————1——1
AtherosclerosisD050197EFO_0003914I25.1——1——1
Ovarian neoplasmsD010051EFO_0003893C56——1——1
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
StrokeD020521EFO_0000712I63.9—2——24
HemorrhageD006470MP_0001914R58—2——24
Cerebral hemorrhageD002543———2——24
Pre-eclampsiaD011225EFO_0000668O1412——13
Blood pressureD001794EFO_0004325—11———2
Breast neoplasmsD001943EFO_0003869C5012———2
ThrombectomyD017131———2———2
Heart diseasesD006331EFO_0003777I51.9—1——12
EclampsiaD004461—O15—1——12
Myelodysplastic syndromesD009190—D46—1———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pure autonomic failureD054970——1————1
Lung neoplasmsD008175—C34.901————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Intracranial hemorrhagesD020300EFO_0000551I62————22
Pulmonary arterial hypertensionD000081029——————22
Covid-19D000086382—U07.1————11
DeliriumD003693—R41.0————11
Emergence deliriumD000071257——————11
Hypertensive crisisD000096003—I16————11
ProteinuriaD011507—R80————11
AlbuminuriaD000419EFO_0004285R80.9————11
Congenital heart defectsD006330—Q24.9————11
Cerebrovascular disordersD002561EFO_0003763I60-I69————11
Show 3 more
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)Loading
Structure (InChI/SMILES or Protein Sequence)
NNc1nncc2ccccc12
Identifiers
PDB—
CAS-ID86-54-4
RxCUI—
ChEMBL IDCHEMBL276832
ChEBI ID5775
PubChem CID3637
DrugBankDB01275
UNII ID26NAK24LS8 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
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Estimated US medical usage
Hydralazine
Total medical expenditures per year (USD, in millions)
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Hydralazine
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Hydrochlorothiazide
Total medical expenditures per year (USD, in millions)
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Hydralazine
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Hydrochlorothiazide
+
Reserpine
Total medical expenditures per year (USD, in millions)
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Hydralazine
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Isosorbide dinitrate
Total medical expenditures per year (USD, in millions)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 11,596 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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6,988 adverse events reported
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