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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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Drug
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Safety
Events Timeline
5D
1M
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2Y
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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
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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
+
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
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Labels
FDA
EMA
Brand Name
Status
Last Update
bidilNew Drug Application2020-07-29
hydralazineANDA2022-02-15
hydralazine hclANDA2019-04-30
hydralazine hydrochlorideANDA2024-01-30
hydralazine hydrocloride2006-09-19
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
212 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_0000537I1031241121
Heart failureD006333HP_0001635I501334616
Type 2 diabetes mellitusD003924EFO_0001360E111236
Postoperative painD010149G89.183225
Chronic renal insufficiencyD051436N18123
Chronic kidney failureD007676EFO_0003884N18.622
EpilepsyD004827EFO_0000474G40.9112
Neuromuscular blockadeD019148112
Coronary artery diseaseD003324I25.1112
Cardiogenic shockD012770R57.011
Show 13 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
StrokeD020521EFO_0000712I63.9235
Cerebral hemorrhageD002543224
Myelodysplastic syndromesD009190D4633
Breast neoplasmsD001943EFO_0003869C501123
NeoplasmsD009369C80123
Blood pressureD001794EFO_0004325112
Rectal neoplasmsD012004122
Myeloid leukemia acuteD015470C92.022
Non-hodgkin lymphomaD008228C85.922
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.022
Show 23 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471C61123
Renal insufficiencyD051437HP_0000083N19123
Healthy volunteers/patients33
Colorectal neoplasmsD015179123
HemorrhageD006470MP_0001914R5811
Lung neoplasmsD008175HP_0100526C34.9011
Respiratory distress syndromeD012128EFO_1000637J8011
HypoxiaD000860HP_0012418R09.0211
Drug interactionsD00434711
Nasal polypsD009298HP_0100582J3311
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Covid-19D000086382U07.166
AnesthesiaD00075833
ObesityD009765EFO_0001073E66.933
Type 1 diabetes mellitusD003922EFO_0001359E1022
DeliriumD003693R41.022
Down syndromeD004314EFO_0001064Q9022
Trisomy 18 syndromeD000073842Q91.322
Trisomy 13 syndromeD000073839Q91.722
SepsisD018805HP_0100806A41.922
InfectionsD007239EFO_000054422
Show 111 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
$
£
No data
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
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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 25,032 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,738 adverse events reported
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