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
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| respiratory tract diseases | D012140 |
| cardiovascular diseases | D002318 |
Trade Name
FDA
EMA
Hydralazine (discontinued: Apresoline, Dralzine, Hydralazine)
CombinationsBidil, 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
Hydralazine hydrochloride
+
Hydrochlorothiazide
Hydralazine hydrochloride
+
Hydrochlorothiazide
+
Reserpine
Hydralazine hydrochloride
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Reserpine
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| bidil | New Drug Application | 2022-07-19 |
| hydralazine | ANDA | 2022-02-15 |
| hydralazine hcl | ANDA | 2019-04-30 |
| hydralazine hydrochloride | ANDA | 2025-03-25 |
| hydralazine hydrocloride | 2006-09-19 | |
| isosorbide dinitrate and hydralazine hydrochloride | NDA authorized generic | 2024-07-01 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
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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
64 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | 2 | 3 | 4 | 4 | 11 | 23 |
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | 3 | 3 | 6 | 3 | 15 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | 1 | 2 | — | 3 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | 1 | 1 | — | 2 |
| Cardiogenic shock | D012770 | — | R57.0 | — | — | — | 1 | — | 1 |
| Low cardiac output | D002303 | — | — | — | — | — | 1 | — | 1 |
| Continuous ambulatory peritoneal dialysis | D010531 | — | — | — | — | — | 1 | — | 1 |
| Systolic heart failure | D054143 | EFO_1001207 | I50.20 | — | — | — | 1 | — | 1 |
| Mitral valve insufficiency | D008944 | — | — | — | — | — | 1 | — | 1 |
| Systolic murmurs | D054160 | — | R01.1 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 2 | 1 | — | 2 | 5 |
| Pregnancy-induced hypertension | D046110 | — | O13 | — | 1 | 1 | — | 2 | 4 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | 1 | 2 | — | — | 3 |
| Uterine cervical neoplasms | D002583 | — | — | — | 1 | 2 | — | — | 3 |
| Polycystic kidney diseases | D007690 | — | Q61.3 | 1 | — | 1 | — | — | 2 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 1 | 1 | — | — | 2 |
| Syndrome | D013577 | — | — | — | 1 | 1 | — | — | 2 |
| Hypercholesterolemia | D006937 | — | — | — | — | 1 | — | — | 1 |
| Coronary disease | D003327 | — | — | — | — | 1 | — | — | 1 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | 1 | — | — | 1 |
Show 9 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemorrhage | D006470 | MP_0001914 | R58 | — | 2 | — | — | 2 | 4 |
| Cerebral hemorrhage | D002543 | — | — | — | 2 | — | — | 2 | 4 |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | 1 | 2 | — | — | 1 | 3 |
| Blood pressure | D001794 | EFO_0004325 | — | 1 | 1 | — | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 2 | — | — | — | 2 |
| Thrombectomy | D017131 | — | — | — | 2 | — | — | — | 2 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 1 | — | — | 1 | 2 |
| Eclampsia | D004461 | — | O15 | — | 1 | — | — | 1 | 2 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | 1 | — | — | — | 1 |
| Preleukemia | D011289 | — | — | — | 1 | — | — | — | 1 |
Show 4 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pure autonomic failure | D054970 | — | — | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Lung neoplasms | D008175 | — | C34.90 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | — | U07.1 | — | — | — | — | 1 | 1 |
| Delirium | D003693 | — | R41.0 | — | — | — | — | 1 | 1 |
| Emergence delirium | D000071257 | — | — | — | — | — | — | 1 | 1 |
| Intracranial hemorrhages | D020300 | EFO_0000551 | I62 | — | — | — | — | 1 | 1 |
| Hypertensive crisis | D000096003 | — | I16 | — | — | — | — | 1 | 1 |
| Proteinuria | D011507 | — | R80 | — | — | — | — | 1 | 1 |
| Albuminuria | D000419 | EFO_0004285 | R80.9 | — | — | — | — | 1 | 1 |
| Congenital heart defects | D006330 | — | Q24.9 | — | — | — | — | 1 | 1 |
| Cerebrovascular disorders | D002561 | EFO_0003763 | I60-I69 | — | — | — | — | 1 | 1 |
| Cerebral small vessel diseases | D059345 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Hydralazine |
| INN | hydralazine |
| 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 class | antihypertensives (hydrazine-phthalazines); antiarrhythmic/antianginal/antihypertensive agents, phthalazine like structure |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | NNc1nncc2ccccc12 |
Identifiers
| PDB | — |
| CAS-ID | 86-54-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL276832 |
| ChEBI ID | 5775 |
| PubChem CID | 3637 |
| DrugBank | DB01275 |
| UNII ID | 26NAK24LS8 (ChemIDplus, GSRS) |
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Hydralazine
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Hydralazine
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Hydrochlorothiazide
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Hydralazine
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Hydrochlorothiazide
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Reserpine
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Hydralazine
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Isosorbide dinitrate
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Trends
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Safety
Black-box Warning
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Adverse Events
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6,663 adverse events reported
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