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 | 2025-11-30 |
| hydralazine hcl | ANDA | 2019-04-30 |
| hydralazine hydrochloride | ANDA | 2026-09-17 |
| hydralazine hydrocloride | 2006-09-19 | |
| isosorbide dinitrate and hydralazine hydrochloride | ANDA | 2025-06-03 |
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
76 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 | 4 | 4 | 4 | 12 | 25 |
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | 3 | 3 | 7 | 5 | 18 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | 1 | 2 | — | 3 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | 1 | 1 | — | 2 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | 1 | — | 2 |
| Cardiogenic shock | D012770 | — | R57.0 | — | — | — | 1 | — | 1 |
| Low cardiac output | D002303 | — | — | — | — | — | 1 | — | 1 |
| Continuous ambulatory peritoneal dialysis | D010531 | — | — | — | — | — | 1 | — | 1 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | — | — | 1 | — | 1 |
| Systolic heart failure | D054143 | EFO_1001207 | I50.20 | — | — | — | 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 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 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | 1 | 3 | — | — | 2 | 5 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | 2 | — | — | 2 | 4 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 2 | — | — | 2 | 4 |
| Cerebral hemorrhage | D002543 | — | — | — | 2 | — | — | 2 | 4 |
| 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 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pure autonomic failure | D054970 | — | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Pulmonary arterial hypertension | D000081029 | — | — | — | — | — | — | 3 | 3 |
| Covid-19 | D000086382 | — | U07.1 | — | — | — | — | 2 | 2 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | — | — | — | 1 | 1 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | — | — | 1 | 1 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | — | — | 1 | 1 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 1 | 1 |
| Down syndrome | D004314 | EFO_0001064 | Q90 | — | — | — | — | 1 | 1 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | — | — | 1 | 1 |
| Mucocutaneous lymph node syndrome | D009080 | EFO_0004246 | M30.3 | — | — | — | — | 1 | 1 |
| Hyperaldosteronism | D006929 | — | E26 | — | — | — | — | 1 | 1 |
Show 26 more
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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Safety
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Adverse Events
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7,672 adverse events reported
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