{"id":"hydralazine","_fda":{"id":"004f0059-4ede-4748-9489-45e27c177424","set_id":"024ac6b8-5ce0-4435-9b11-b1806c511d7b","openfda":{"upc":["0382804081301"],"unii":["FD171B778Y"],"route":["ORAL"],"rxcui":["905225"],"spl_id":["004f0059-4ede-4748-9489-45e27c177424"],"brand_name":["Hydralazine Hydrochloride"],"spl_set_id":["024ac6b8-5ce0-4435-9b11-b1806c511d7b"],"package_ndc":["82804-081-30","82804-081-60","82804-081-90","82804-081-72"],"product_ndc":["82804-081"],"generic_name":["HYDRALAZINE HYDROCHLORIDE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["HYDRALAZINE HYDROCHLORIDE"],"manufacturer_name":["Proficient Rx LP"],"application_number":["ANDA040858"],"original_packager_product_ndc":["23155-833"]},"version":"2","warnings":["WARNINGS ​ In a few patients hydrALAZINE may produce a clinical picture simulating systemic lupus erythematosus including glomerulonephritis. In such patients hydrALAZINE should be discontinued unless the benefit-to-risk determination requires continued antihypertensive therapy with this drug. Symptoms and signs usually regress when the drug is discontinued but residua have been detected many years later. Long-term treatment with steroids may be necessary. (See PRECAUTIONS, Laboratory Tests .)"],"overdosage":["OVERDOSAGE Acute Toxicity: No deaths due to acute poisoning have been reported. Highest known dose survived: adults, 10 g orally. Oral LD 50 in rats: 173 and 187 mg/kg. Signs and Symptoms Signs and symptoms of overdosage include hypotension, tachycardia, headache, and generalized skin flushing. Complications can include myocardial ischemia and subsequent myocardial infarction, cardiac arrhythmia, and profound shock. Treatment There is no specific antidote. The gastric contents should be evacuated, taking adequate precautions against aspiration and for protection of the airway. An activated charcoal slurry may be instilled if conditions permit. These manipulations may have to be omitted or carried out after cardiovascular status has been stabilized, since they might precipitate cardiac arrhythmias or increase the depth of shock. Support of the cardiovascular system is of primary importance. Shock should be treated with plasma expanders. If possible, vasopressors should not be given, but if a vasopressor is required, care should be taken not to precipitate or aggravate cardiac arrhythmia. Tachycardia responds to beta blockers. Digitalization may be necessary, and renal function should be monitored and supported as required. No experience has been reported with extracorporeal or peritoneal dialysis."],"description":["DESCRIPTION HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is: HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition. Each tablet for oral administration contains 25 mg hydrALAZINE hydrochloride, USP. Tablets also contain magnesium stearate, microcrystalline cellulose, orange lake blend, silicon dioxide, and sodium starch glycolate. The orange lake blend consists of FD&C yellow #6. chemical-structure"],"precautions":["PRECAUTIONS General Myocardial stimulation produced by hydrALAZINE can cause anginal attacks and ECG changes of myocardial ischemia. The drug has been implicated in the production of myocardial infarction. It must, therefore, be used with caution in patients with suspected coronary artery disease. The “hyperdynamic” circulation caused by hydrALAZINE may accentuate specific cardiovascular inadequacies. For example, hydrALAZINE may increase pulmonary artery pressure in patients with mitral valvular disease. The drug may reduce the pressor responses to epinephrine. Postural hypotension may result from hydrALAZINE but is less common than with ganglionic blocking agents. It should be used with caution in patients with cerebral vascular accidents. In hypertensive patients with normal kidneys who are treated with hydrALAZINE, there is evidence of increased renal blood flow and a maintenance of glomerular filtration rate. In some instances where control values were below normal, improved renal function has been noted after administration of hydrALAZINE. However, as with any antihypertensive agent, hydrALAZINE should be used with caution in patients with advanced renal damage. Peripheral neuritis, evidenced by paresthesia, numbness, and tingling, has been observed. Published evidence suggests an antipyridoxine effect, and that pyridoxine should be added to the regimen if symptoms develop. Information for Patients Patients should be informed of possible side effects and advised to take the medication regularly and continuously as directed. Laboratory Tests Complete blood counts and antinuclear antibody titer determinations are indicated before and periodically during prolonged therapy with hydrALAZINE even though the patient is asymptomatic. These studies are also indicated if the patient develops arthralgia, fever, chest pain, continued malaise, or other unexplained signs or symptoms. A positive antinuclear antibody titer requires that the physician carefully weigh the implications of the test results against the benefits to be derived from antihypertensive therapy with hydrALAZINE. Blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, and purpura, have been reported. If such abnormalities develop, therapy should be discontinued. Drug/Drug Interactions MAO inhibitors should be used with caution in patients receiving hydrALAZINE. When other potent parenteral antihypertensive drugs, such as diazoxide, are used in combination with hydrALAZINE, patients should be continuously observed for several hours for any excessive fall in blood pressure. Profound hypotensive episodes may occur when diazoxide injection and hydrALAZINE are used concomitantly. Drug/Food Interactions Administration of hydrALAZINE with food results in higher plasma levels. Carcinogenesis, Mutagenesis, Impairment of Fertility In a lifetime study in Swiss albino mice, there was a statistically significant increase in the incidence of lung tumors (adenomas and adenocarcinomas) of both male and female mice given hydrALAZINE continuously in their drinking water at a dosage of about 250 mg/kg per day (about 80 times the maximum recommended human dose). In a 2-year carcinogenicity study of rats given hydrALAZINE by gavage at dose levels of 15, 30, and 60 mg/kg/day (approximately 5 to 20 times the recommended human daily dosage), microscopic examination of the liver revealed a small, but statistically significant, increase in benign neoplastic nodules in male and female rats from the high-dose group and in female rats from the intermediate-dose group. Benign interstitial cell tumors of the testes were also significantly increased in male rats from the high-dose group. The tumors observed are common in aged rats and a significantly increased incidence was not observed until 18 months of treatment. HydrALAZINE was shown to be mutagenic in bacterial systems (Gene Mutation and DNA Repair) and in one of two rats and one rabbit hepatocyte in vitro DNA repair studies. Additional in vivo and in vitro studies using lymphoma cells, germinal cells, and fibroblasts from mice, bone marrow cells from chinese hamsters and fibroblasts from human cell lines did not demonstrate any mutagenic potential for hydrALAZINE. The extent to which these findings indicate a risk to man is uncertain. While longterm clinical observation has not suggested that human cancer is associated with hydrALAZINE use, epidemiologic studies have so far been insufficient to arrive at any conclusions. Pregnancy Teratogenic Effects Pregnancy Category C Animal studies indicate that hydrALAZINE is teratogenic in mice at 20 to 30 times the maximum daily human dose of 200 to 300 mg and possibly in rabbits at 10 to 15 times the maximum daily human dose, but that it is nonteratogenic in rats. Teratogenic effects observed were cleft palate and malformations of facial and cranial bones. There are no adequate and well-controlled studies in pregnant women. Although clinical experience does not include any positive evidence of adverse effects on the human fetus, hydrALAZINE should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus. Nursing Mothers Hydralazine has been shown to be excreted in breast milk. Pediatric Use Safety and effectiveness in pediatric patients have not been established in controlled clinical trials, although there is experience with the use of hydrALAZINE in pediatric patients. The usual recommended oral starting dosage is 0.75 mg/kg of body weight daily in four divided doses. Dosage may be increased gradually over the next 3 to 4 weeks to a maximum of 7.5 mg/kg or 200 mg daily."],"how_supplied":["HOW SUPPLIED HydrALAZINE Hydrochloride Tablets, USP are available as: 25 mg – Round, peach, core tablet, debossed EP over 102 on one side and plain on the reverse side. NDC 82804-081-30 Bottles of 30 NDC 82804-081-60 Bottles of 60 NDC 82804-081-90 Bottles of 90 NDC 82804-081-72 Bottles of 120 Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1-866-901-DRUG (3784) 51U000000426US01 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Revised: 11/2022 avet-logo"],"effective_time":"20250701","adverse_reactions":["ADVERSE REACTIONS Adverse reactions with hydrALAZINE are usually reversible when dosage is reduced. However, in some cases it may be necessary to discontinue the drug. The following adverse reactions have been observed, but there has not been enough systematic collection of data to support an estimate of their frequency. Common Headache, anorexia, nausea, vomiting, diarrhea, palpitations, tachycardia, angina pectoris. Less Frequent: Digestive: constipation, paralytic ileus. Cardiovascular: hypotension, paradoxical pressor response, edema. Respiratory: dyspnea. Neurologic: peripheral neuritis, evidenced by paresthesia, numbness, and tingling; dizziness; tremors; muscle cramps; psychotic reactions characterized by depression, disorientation, or anxiety. Genitourinary: difficulty in urination. Hematologic: blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, purpura; lymphadenopathy; splenomegaly. Hypersensitive Reactions: rash, urticaria, pruritus, fever, chills, arthralgia, eosinophilia, and rarely, hepatitis. Other: nasal congestion, flushing, lacrimation, conjunctivitis."],"contraindications":["CONTRAINDICATIONS Hypersensitivity to hydrALAZINE; coronary artery disease; mitral valvular rheumatic heart disease."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Although the precise mechanism of action of hydrALAZINE is not fully understood, the major effects are on the cardiovascular system. HydrALAZINE apparently lowers blood pressure by exerting a peripheral vasodilating effect through a direct relaxation of vascular smooth muscle. HydrALAZINE, by altering cellular calcium metabolism, interferes with the calcium movements within the vascular smooth muscle that are responsible for initiating or maintaining the contractile state. The peripheral vasodilating effect of hydrALAZINE results in decreased arterial blood pressure (diastolic more than systolic); decreased peripheral vascular resistance; and an increased heart rate, stroke volume, and cardiac output. The preferential dilatation of arterioles, as compared to veins, minimizes postural hypotension and promotes the increase in cardiac output. HydrALAZINE usually increases renin activity in plasma, presumably as a result of increased secretion of renin by the renal juxtaglomerular cells in response to reflex sympathetic discharge. This increase in renin activity leads to the production of angiotensin II, which then causes stimulation of aldosterone and consequent sodium reabsorption. HydrALAZINE also maintains or increases renal and cerebral blood flow. HydrALAZINE is rapidly absorbed after oral administration, and peak plasma levels are reached at 1 to 2 hours. Plasma levels of apparent hydrALAZINE decline with a half-life of 3 to 7 hours. Binding to human plasma protein is 87%. Plasma levels of hydrALAZINE vary widely among individuals. HydrALAZINE is subject to polymorphic acetylation; slow acetylators generally have higher plasma levels of hydrALAZINE and require lower doses to maintain control of blood pressure. HydrALAZINE undergoes extensive hepatic metabolism; it is excreted mainly in the form of metabolites in the urine."],"indications_and_usage":["INDICATIONS AND USAGE Essential hypertension, alone or as an adjunct."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Initiate therapy in gradually increasing dosages; adjust according to individual response. Start with 10 mg four times daily for the first 2 to 4 days, increase to 25 mg four times daily for the balance of the first week. For the second and subsequent weeks, increase dosage to 50 mg four times daily. For maintenance, adjust dosage to the lowest effective levels. The incidence of toxic reactions, particularly the L.E. cell syndrome, is high in the group of patients receiving large doses of hydrALAZINE hydrochloride tablets. In a few resistant patients, up to 300 mg of hydrALAZINE hydrochloride tablets daily may be required for a significant antihypertensive effect. In such cases, a lower dosage of hydrALAZINE hydrochloride tablets combined with a thiazide and/or reserpine or a beta blocker may be considered. However, when combining therapy, individual titration is essential to ensure the lowest possible therapeutic dose of each drug."],"spl_product_data_elements":["Hydralazine Hydrochloride Hydralazine Hydrochloride Hydralazine Hydrochloride HYDRALAZINE MICROCRYSTALLINE CELLULOSE 102 MICROCRYSTALLINE CELLULOSE 105 SODIUM STARCH GLYCOLATE TYPE A POTATO SILICON DIOXIDE MAGNESIUM STEARATE FD&C YELLOW NO. 6 Peach EP;102"],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 25 mg NDC 82804- 081 -30 HydrALAZINE Hydrochloride Tablets, USP 25 mg 30 Tablets Rx only ​ 82804-081-30"]},"safety":{"boxedWarnings":[],"commonSideEffects":[{"effect":"Headache","drugRate":"","severity":"common","organSystem":""},{"effect":"Anorexia","drugRate":"","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"","severity":"common","organSystem":""},{"effect":"Palpitations","drugRate":"","severity":"common","organSystem":""},{"effect":"Tachycardia","drugRate":"","severity":"common","organSystem":""},{"effect":"Angina pectoris","drugRate":"","severity":"common","organSystem":""}],"seriousAdverseEvents":[{"effect":"Agranulocytosis","drugRate":"","severity":"serious"},{"effect":"Blood dyscrasias","drugRate":"","severity":"serious"},{"effect":"Leukopenia","drugRate":"","severity":"serious"},{"effect":"Hepatitis","drugRate":"","severity":"serious"},{"effect":"Psychotic reactions","drugRate":"","severity":"serious"},{"effect":"Paralytic ileus","drugRate":"","severity":"serious"},{"effect":"Peripheral neuritis","drugRate":"","severity":"serious"},{"effect":"Hypotension","drugRate":"","severity":"serious"},{"effect":"Dyspnea","drugRate":"","severity":"serious"},{"effect":"Paradoxical pressor response","drugRate":"","severity":"serious"}]},"_chembl":null,"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=HYDRALAZINE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T05:59:28.939944+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T05:59:39.685602+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=HYDRALAZINE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T05:59:40.469258+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:59:26.726807+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:59:26.726861+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL276832/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T05:59:40.939417+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA040858","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:59:26.726872+00:00"}},"_dailymed":{"setId":"f3c806a4-b971-421c-bcb9-9979c6d7aaec","title":"HYDRALAZINE HYDROCHLORIDE INJECTION [MEITHEAL PHARMACEUTICALS INC.]"},"_scrapedAt":"2026-03-27T23:33:09.795Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T05:59:45.186328+00:00","fieldsConflicting":0,"overallConfidence":0.95},"trialDetails":[{"nctId":"NCT02627196","phase":"NA","title":"Baroreflex Activation Therapy for Heart Failure","status":"COMPLETED","sponsor":"CVRx, Inc.","startDate":"2016-04-19","conditions":"Heart Failure","enrollment":1090},{"nctId":"NCT03514108","phase":"PHASE4","title":"DANHEART (H-HeFT and Met-HeFT)","status":"COMPLETED","sponsor":"Henrik Wiggers","startDate":"2018-03-01","conditions":"Heart Failure, Diabetes","enrollment":1100},{"nctId":"NCT03814317","phase":"PHASE2","title":"Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension","status":"COMPLETED","sponsor":"University of Florida","startDate":"2020-01-30","conditions":"Sarcoidosis, Precapillary Pulmonary Hypertension, Interstitial Lung Disease","enrollment":5},{"nctId":"NCT07093151","phase":"NA","title":"Comparison of Post-Craniotomy Blood Pressure Targets","status":"NOT_YET_RECRUITING","sponsor":"Vanderbilt University Medical Center","startDate":"2026-03-01","conditions":"Intracranial Hemorrhage, Hypertensive, Craniotomy Tumor Removal Surgery","enrollment":500},{"nctId":"NCT01471834","phase":"NA","title":"Verification of the Efficacy and Safety of the BAROSTIM NEO System in the Treatment of Drug Resistant Hypertension","status":"ACTIVE_NOT_RECRUITING","sponsor":"CVRx, Inc.","startDate":"2011-06","conditions":"High Blood Pressure","enrollment":40},{"nctId":"NCT02446652","phase":"PHASE3","title":"Evaluation of TRANSKRIP ® Plus Chemotherapy in Recurrent-Persistent Cervical Cancer","status":"WITHDRAWN","sponsor":"National Institute of Cancerología","startDate":"2015-01-01","conditions":"Cervical Cancer","enrollment":""},{"nctId":"NCT06360601","phase":"PHASE1, PHASE2","title":"Intravenous Labetalol Versus Hydralazine in Preeclampsia","status":"RECRUITING","sponsor":"Tanta University","startDate":"2024-04-01","conditions":"Preeclampsia Severe","enrollment":40},{"nctId":"NCT02281838","phase":"PHASE2","title":"The Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial II","status":"TERMINATED","sponsor":"University of Alberta","startDate":"2011-08-01","conditions":"Intracerebral Hemorrhage","enrollment":142},{"nctId":"NCT06400784","phase":"PHASE4","title":"Hypertensive Heart Failure Treatment in SSA","status":"COMPLETED","sponsor":"University of Abuja","startDate":"2022-03-25","conditions":"A Feasibility Study on Hypertensive Heart Failure Treatment","enrollment":50},{"nctId":"NCT06218199","phase":"PHASE4","title":"Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts","status":"RECRUITING","sponsor":"Heart Center Research, LLC","startDate":"2021-07-08","conditions":"Heart Failure, Congestive","enrollment":80},{"nctId":"NCT06175663","phase":"","title":"Hyperintense: Midlife Hypertension and the Brain","status":"UNKNOWN","sponsor":"Radboud University Medical Center","startDate":"2021-07-06","conditions":"Hypertension, Small Vessel Cerebrovascular Disease","enrollment":130},{"nctId":"NCT04484350","phase":"PHASE2","title":"Blood Pressure Management in Stroke Following Endovascular Treatment","status":"COMPLETED","sponsor":"Hamilton Health Sciences Corporation","startDate":"2020-10-23","conditions":"Stroke, Acute, Vessels; Occlusion, Blood Pressure","enrollment":30},{"nctId":"NCT04116112","phase":"PHASE2","title":"Blood Pressure After Endovascular Stroke Therapy-II","status":"COMPLETED","sponsor":"University of Cincinnati","startDate":"2020-01-17","conditions":"Acute Stroke, Endovascular Thrombectomy","enrollment":120},{"nctId":"NCT02046395","phase":"PHASE4","title":"Effect of Renin-angiotensin-system Blockade on Urinary Free Light Chains in Patients With Type 2 Diabetes Mellitus","status":"COMPLETED","sponsor":"Tulane University School of Medicine","startDate":"2012-01","conditions":"Type 2 Diabetes, Hypertension","enrollment":28},{"nctId":"NCT02592499","phase":"NA","title":"Swedish Evaluation of Left Ventricular Assist Device as Permanent Treatment in End-stage Heart Failure","status":"UNKNOWN","sponsor":"Vastra Gotaland Region","startDate":"2016-06","conditions":"End-stage Heart Failure","enrollment":80},{"nctId":"NCT02305095","phase":"","title":"Genomic Response Analysis of Heart Failure Therapy in African Americans","status":"COMPLETED","sponsor":"University of Pittsburgh","startDate":"2015-05-01","conditions":"Heart Failure","enrollment":225},{"nctId":"NCT05633758","phase":"PHASE2","title":"Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure","status":"WITHDRAWN","sponsor":"Scripps Health","startDate":"2014-03","conditions":"Acute Decompensated Heart Failure","enrollment":""},{"nctId":"NCT03616730","phase":"","title":"NICOM in Pregnant Women With Heart Disease","status":"TERMINATED","sponsor":"Saint Luke's Health System","startDate":"2018-10-17","conditions":"Heart Diseases in Pregnancy, Congenital Heart Disease in Pregnancy","enrollment":100},{"nctId":"NCT05230901","phase":"PHASE3","title":"Effect of Antifibrotic Therapy on Regression of Myocardial Fibrosis After Transcatheter Aortic Valve Implantation (TAVI) in Aortic Stenosis Patients With High Fibrotic Burden","status":"RECRUITING","sponsor":"University Medical Center Goettingen","startDate":"2022-02-23","conditions":"Aortic Stenosis, Severe","enrollment":300},{"nctId":"NCT01516346","phase":"PHASE2","title":"Vasodilator Therapy for Heart Failure and Preserved Ejection Fraction","status":"COMPLETED","sponsor":"Corporal Michael J. Crescenz VA Medical Center","startDate":"2012-01","conditions":"Heart Failure, Congestive Heart Failure","enrollment":44},{"nctId":"NCT04842552","phase":"PHASE3","title":"Effect of Hydralazine on Alzheimer's Disease","status":"UNKNOWN","sponsor":"Shahid Sadoughi University of Medical Sciences and Health Services","startDate":"2021-08-02","conditions":"Alzheimer Disease","enrollment":424},{"nctId":"NCT04217135","phase":"PHASE4","title":"The Prognostic Impact of Using High-dose Hydralazine in Severe Systolic Heart Failure With Hemodynamically Significant Mitral Regurgitation","status":"UNKNOWN","sponsor":"Kaohsiung Veterans General Hospital.","startDate":"2017-01-01","conditions":"Systolic Heart Failure Stage D (Disorder), Mitral Regurgitation","enrollment":400},{"nctId":"NCT01422616","phase":"PHASE3","title":"Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED)","status":"COMPLETED","sponsor":"The George Institute","startDate":"2012-03","conditions":"Ischemic Stroke, High Blood Pressure","enrollment":4587},{"nctId":"NCT04191681","phase":"PHASE4","title":"Safety and Efficacy of ARNI After LVAD ImplanT (SEAL-IT) Study","status":"RECRUITING","sponsor":"The Cleveland Clinic","startDate":"2019-11-08","conditions":"Stage D Heart Failure","enrollment":50},{"nctId":"NCT04467931","phase":"","title":"ACEI or ARB and COVID-19 Severity and Mortality in US Veterans","status":"COMPLETED","sponsor":"University of Utah","startDate":"2020-01-19","conditions":"Hypertension, COVID","enrollment":22213},{"nctId":"NCT02228408","phase":"PHASE4","title":"Safety and Cardiovascular Efficacy of Hydralazine and Isosorbide Dinitrate in Dialysis-Dependent ESRD","status":"COMPLETED","sponsor":"Brigham and Women's Hospital","startDate":"2017-08-28","conditions":"Chronic Hemodialysis (ESRD)","enrollment":17},{"nctId":"NCT04206865","phase":"PHASE4","title":"Comparison of ARNI to Alternate Oral Vasodilator Therapies in Patients With Low Cardiac Output","status":"WITHDRAWN","sponsor":"The Cleveland Clinic","startDate":"2019-11-25","conditions":"Cardiogenic Shock","enrollment":""},{"nctId":"NCT04435210","phase":"NA","title":"Efficacy of Nifedipine Versus Hydralazine in Management of Severe Hypertension in Pregnancy","status":"COMPLETED","sponsor":"Adebayo Joshua Adeniyi","startDate":"2018-08-13","conditions":"Hypertension","enrollment":69},{"nctId":"NCT00283686","phase":"PHASE3","title":"HALT Progression of Polycystic Kidney Disease Study A","status":"COMPLETED","sponsor":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","startDate":"2006-01","conditions":"Kidney, Polycystic","enrollment":558},{"nctId":"NCT03423810","phase":"EARLY_PHASE1","title":"Assessing a Dose-Response Relationship of Hydralazine and Its Effects on DNA Methyltransferase 1 in Polycystic Kidney Disease Patients","status":"COMPLETED","sponsor":"University of Kansas Medical Center","startDate":"2018-04-23","conditions":"Polycystic Kidney Diseases","enrollment":14},{"nctId":"NCT00512759","phase":"PHASE4","title":"Goal-directed Afterload Reduction in Acute Congestive Cardiac Decompensation Study","status":"COMPLETED","sponsor":"University Hospital, Basel, Switzerland","startDate":"2007-12-10","conditions":"Acute Heart Failure","enrollment":781},{"nctId":"NCT03967496","phase":"","title":"Assessment of Immediate Postoperative Delirium (IPD) in Adult Patients: Incidence and Etiologic Factors","status":"COMPLETED","sponsor":"Sultan Qaboos University","startDate":"2019-01-01","conditions":"Delirium, Anesthesia; Adverse Effect","enrollment":402},{"nctId":"NCT01720160","phase":"NA","title":"BAROSTIM® Hope for Heart Failure Study","status":"UNKNOWN","sponsor":"CVRx, Inc.","startDate":"2012-11","conditions":"Heart Failure","enrollment":98},{"nctId":"NCT02620384","phase":"PHASE3","title":"Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure (MELT-HF)--A Single Center Pilot Study.","status":"TERMINATED","sponsor":"Aultman Health Foundation","startDate":"2015-10-01","conditions":"Acute Decompensated Heart Failure","enrollment":147},{"nctId":"NCT00204984","phase":"NA","title":"Heart and Blood Pressure Study: The Effect of Aortic Impedance on Myocardial Relaxation","status":"COMPLETED","sponsor":"University of Wisconsin, Madison","startDate":"2005-05","conditions":"High Blood Pressure","enrollment":17},{"nctId":"NCT02050529","phase":"PHASE2","title":"Randomized Controlled Trial of Labetalol Versus Hydralazine for Severe Hypertension in Obstetric Patients.","status":"COMPLETED","sponsor":"Dow University of Health Sciences","startDate":"2012-10","conditions":"Hypertension, Pregnancy Induced, Hydralazine Adverse Reaction, Pre-eclampsia","enrollment":190},{"nctId":"NCT03105934","phase":"NA","title":"Repeatability of OCT and IV-US in Pulmonary Arterial Hypertension","status":"COMPLETED","sponsor":"Hospital Universitari Vall d'Hebron Research Institute","startDate":"2016-04","conditions":"Pulmonary Arterial Hypertension","enrollment":20},{"nctId":"NCT03147092","phase":"EARLY_PHASE1","title":"Matão Controlling Hypertension (MatCH Study): Rationale and Design","status":"UNKNOWN","sponsor":"Centro Neurológico de Pesquisa e Reabiitação, Brazil","startDate":"2018-02-01","conditions":"Hypertension, Blood Pressure","enrollment":15000},{"nctId":"NCT02933593","phase":"NA","title":"Changes in Central Arterial Pressure When Comparing ACOG Hypertensive Urgency Protocols","status":"WITHDRAWN","sponsor":"St. Louis University","startDate":"2016-08","conditions":"Hypertension","enrollment":""},{"nctId":"NCT00223717","phase":"PHASE1","title":"Treatment of Supine Hypertension in Autonomic Failure","status":"COMPLETED","sponsor":"Vanderbilt University","startDate":"2001-01","conditions":"Hypertension","enrollment":152},{"nctId":"NCT00000620","phase":"PHASE3","title":"Action to Control Cardiovascular Risk in Diabetes (ACCORD)","status":"COMPLETED","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","startDate":"1999-09","conditions":"Atherosclerosis, Cardiovascular Diseases, Hypercholesterolemia","enrollment":10251},{"nctId":"NCT02522208","phase":"PHASE1","title":"Pharmacodynamic and Pharmacokinetic Study of BiDil Extended-release Capsules and Commercial BiDil Tablets","status":"COMPLETED","sponsor":"Arbor Pharmaceuticals, Inc.","startDate":"2015-09","conditions":"Heart Failure","enrollment":12},{"nctId":"NCT00996060","phase":"PHASE1","title":"Use of Hydralazine and Valproic Acid in Advanced Solid Tumor Malignancies","status":"COMPLETED","sponsor":"New Mexico Cancer Research Alliance","startDate":"2008-07","conditions":"Lung Cancer","enrollment":29},{"nctId":"NCT01822808","phase":"PHASE3","title":"Bi Treatment With Hydralazine/Nitrates Versus Placebo in Africans Admitted With Acute Heart Failure","status":"UNKNOWN","sponsor":"University of Cape Town","startDate":"2013-01","conditions":"Acute Heart Failure, Left Ventricular Dysfunction","enrollment":500},{"nctId":"NCT01587313","phase":"PHASE1","title":"A Comparison of Various Combinations of BiDil Capsules and BiDil Tablets in Healthy Human Volunteers","status":"COMPLETED","sponsor":"Arbor Pharmaceuticals, Inc.","startDate":"2012-04","conditions":"Healthy","enrollment":36},{"nctId":"NCT00575978","phase":"PHASE1, PHASE2","title":"Hydralazine as Demethylating Agent in Breast Cancer","status":"WITHDRAWN","sponsor":"University of Arkansas","startDate":"2004-06","conditions":"Breast Cancer","enrollment":""},{"nctId":"NCT00575640","phase":"PHASE1, PHASE2","title":"Hydralazine as a Demethylating Agent in Rectal Cancer","status":"WITHDRAWN","sponsor":"University of Arkansas","startDate":"2004-11","conditions":"Rectal Cancer","enrollment":""},{"nctId":"NCT00952081","phase":"PHASE4","title":"A Pilot Study to Evaluate Efficacy and Safety of Clevidipine in Neurosurgical Patients","status":"COMPLETED","sponsor":"NYU Langone Health","startDate":"2009-07","conditions":"Hypertension, Brain Tumor, Epilepsy","enrollment":22},{"nctId":"NCT02343393","phase":"PHASE3","title":"Nitrates In Combination With Hydralazine in cardiorEnal Syndrome (NICHE) Study","status":"UNKNOWN","sponsor":"National University Hospital, Singapore","startDate":"2015-01","conditions":"Cardio-Renal Syndrome","enrollment":100},{"nctId":"NCT01255475","phase":"PHASE2, PHASE3","title":"Blood Pressure Reduction in Heart Failure","status":"COMPLETED","sponsor":"University of Sao Paulo","startDate":"2011-01","conditions":"Heart Failure, Cardiac Failure, Congestive Heart Failure","enrollment":21},{"nctId":"NCT00607477","phase":"NA","title":"Pilot Study of the Treatment of Vascular Endothelial Growth Factor(VEGF)Signaling Pathway Inhibitor-Induced Hypertension","status":"TERMINATED","sponsor":"University of Chicago","startDate":"2008-01","conditions":"Treatment Induced Hypertension","enrollment":2},{"nctId":"NCT00716079","phase":"NA","title":"The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial","status":"COMPLETED","sponsor":"The George Institute","startDate":"2008-09","conditions":"Intracerebral Hemorrhage, Stroke, Hypertension","enrollment":2839},{"nctId":"NCT01248169","phase":"","title":"Impedance Cardiographic (ICG) Assessment of Pregnant Women With Severe Hypertension to Assess Impact of Standard Therapy","status":"COMPLETED","sponsor":"University of Mississippi Medical Center","startDate":"2009-12","conditions":"Pregnancy; Proteinuria, With Hypertension (Severe Pre-eclampsia), Delivery; Proteinuria, With Gestational Hypertension (Pre-eclampsia, Severe), Pregnancy; Hypertension, Gestational Hypertension, With Albuminuria (Severe Pre-eclampsia)","enrollment":30},{"nctId":"NCT00000499","phase":"PHASE2","title":"Systolic Hypertension in the Elderly Program (SHEP) (Pilot Study)","status":"COMPLETED","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","startDate":"1980-09","conditions":"Cardiovascular Diseases, Heart Diseases, Hypertension","enrollment":""},{"nctId":"NCT01538875","phase":"PHASE3","title":"Hydralazine Versus Labetalol for the Management of Hypertensive Disorders of Pregnancy","status":"COMPLETED","sponsor":"Saint Thomas Hospital, Panama","startDate":"2012-07","conditions":"Hypertension, Pregnancy Induced","enrollment":261},{"nctId":"NCT00661895","phase":"PHASE4","title":"Black Education and Treatment of Hypertension (BEAT HTN)","status":"COMPLETED","sponsor":"Creighton University","startDate":"2005-08","conditions":"Hypertension","enrollment":99},{"nctId":"NCT00582777","phase":"PHASE2, PHASE3","title":"African American Study of Kidney Disease and Hypertension ABPM Pilot Study","status":"COMPLETED","sponsor":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","startDate":"2007-11","conditions":"Hypertensive Renal Disease","enrollment":180},{"nctId":"NCT00963976","phase":"PHASE2","title":"Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial","status":"COMPLETED","sponsor":"University of Alberta","startDate":"2007-01","conditions":"Intracerebral Hemorrhage","enrollment":74},{"nctId":"NCT01356875","phase":"PHASE2","title":"Treatment of Myelodysplastic Syndromes Comparing Hydralazine/Ac. Valproic and Supportive Care in Patients Not Candidates, Refractory and/or Intolerant to Intensive Chemotherapy","status":"UNKNOWN","sponsor":"Basque Health Service","startDate":"2011-09","conditions":"Myelodysplastic Syndrome","enrollment":42},{"nctId":"NCT01041963","phase":"PHASE4","title":"The Effect of Enalapril and Losartan on Peritoneal Membrane in Continuous Ambulatory Peritoneal Dialysis Patients","status":"UNKNOWN","sponsor":"Chulalongkorn University","startDate":"2009-06","conditions":"Continuous Ambulatory Peritoneal Dialysis","enrollment":90},{"nctId":"NCT00599235","phase":"NA","title":"Sildenafil and Exercise Capacity in Hypertension","status":"COMPLETED","sponsor":"University of Edinburgh","startDate":"2007-03","conditions":"Hypertension","enrollment":30},{"nctId":"NCT00621075","phase":"","title":"Correlation OF Hemodynamics in Pulmonary Hypertension With Perfusion Lung Scans","status":"COMPLETED","sponsor":"Northwell Health","startDate":"2007-04","conditions":"Pulmonary Arterial Hypertension","enrollment":50},{"nctId":"NCT00311974","phase":"PHASE4","title":"The Effect of Dihydralazine on Kidney Function and Hormones in Healthy Individuals","status":"COMPLETED","sponsor":"Regional Hospital Holstebro","startDate":"2006-04","conditions":"Healthy","enrollment":16},{"nctId":"NCT00532818","phase":"PHASE3","title":"Hydralazine Valproate for Cervical Cancer","status":"UNKNOWN","sponsor":"National Institute of Cancerología","startDate":"2007-07","conditions":"Metastatic Cervical Cancer","enrollment":143},{"nctId":"NCT00772499","phase":"PHASE4","title":"Vascular Improvement With Olmesartan Medoxomil Study","status":"COMPLETED","sponsor":"Daiichi Sankyo","startDate":"2002-11","conditions":"Hypertension","enrollment":100},{"nctId":"NCT00226096","phase":"NA","title":"Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage","status":"COMPLETED","sponsor":"The George Institute","startDate":"2005-11","conditions":"CVA (Cerebrovascular Accident), Cerebral Hemorrhage, Intracranial Hemorrhages","enrollment":404},{"nctId":"NCT00684489","phase":"NA","title":"Renin-Guided Therapeutics in the Management of Untreated, Uncontrolled, or Complicated Hypertension","status":"COMPLETED","sponsor":"Medical University of South Carolina","startDate":"2003-09","conditions":"Hypertension","enrollment":52},{"nctId":"NCT00533299","phase":"PHASE3","title":"Hydralazine Valproate for Ovarian Cancer","status":"UNKNOWN","sponsor":"National Institute of Cancerología","startDate":"2007-08","conditions":"Ovarian Cancer","enrollment":211},{"nctId":"NCT00404508","phase":"PHASE2","title":"A Phase II Study of Epigenetic Therapy to Overcome Chemotherapy Resistance in Refractory Solid Tumors","status":"COMPLETED","sponsor":"National Institute of Cancerología","startDate":"2005-09","conditions":"Refractory Solid Tumors","enrollment":15},{"nctId":"NCT00404326","phase":"PHASE2","title":"Hydralazine and Valproate Plus Cisplatin Chemoradiation in Cervical Cancer","status":"COMPLETED","sponsor":"National Institute of Cancerología","startDate":"2005-05","conditions":"Cervical Cancer","enrollment":18},{"nctId":"NCT00395655","phase":"PHASE2","title":"Hydralazine and Valproate Added to Chemotherapy for Breast Cancer","status":"TERMINATED","sponsor":"National Institute of Cancerología","startDate":"2005-06","conditions":"Locally Advanced Breast Cancer","enrollment":43},{"nctId":"NCT00047775","phase":"PHASE4","title":"African-American Heart Failure Trial","status":"COMPLETED","sponsor":"Nitromed","startDate":"2001-05","conditions":"Congestive Heart Failure","enrollment":1100}],"_emaApprovals":[],"_faersSignals":[{"count":2919,"reaction":"CHRONIC KIDNEY DISEASE"},{"count":2753,"reaction":"ACUTE KIDNEY INJURY"},{"count":2390,"reaction":"RENAL FAILURE"},{"count":2084,"reaction":"DYSPNOEA"},{"count":2038,"reaction":"FATIGUE"},{"count":1851,"reaction":"DIARRHOEA"},{"count":1765,"reaction":"NAUSEA"},{"count":1723,"reaction":"DEATH"},{"count":1632,"reaction":"END STAGE RENAL DISEASE"},{"count":1607,"reaction":"HYPERTENSION"}],"administration":{"route":"Oral"},"crossReferences":{"chemblId":"CHEMBL276832"},"_approvalHistory":[{"date":"20130129","type":"SUPPL","sponsor":"PLIVA","applicationNumber":"ANDA089097"},{"date":"20010529","type":"SUPPL","sponsor":"PLIVA","applicationNumber":"ANDA089097"},{"date":"20000707","type":"SUPPL","sponsor":"PLIVA","applicationNumber":"ANDA089097"},{"date":"19920224","type":"SUPPL","sponsor":"PLIVA","applicationNumber":"ANDA089097"},{"date":"19870423","type":"SUPPL","sponsor":"PLIVA","applicationNumber":"ANDA089097"},{"date":"19851218","type":"ORIG","sponsor":"PLIVA","applicationNumber":"ANDA089097"},{"date":"20011011","type":"SUPPL","sponsor":"PLIVA","applicationNumber":"ANDA089097"},{"date":"20140911","type":"SUPPL","sponsor":"PLIVA","applicationNumber":"ANDA089097"},{"date":"20010606","type":"SUPPL","sponsor":"PLIVA","applicationNumber":"ANDA089097"},{"date":"19940511","type":"SUPPL","sponsor":"PLIVA","applicationNumber":"ANDA089097"},{"date":"20101101","type":"SUPPL","sponsor":"PLIVA","applicationNumber":"ANDA089097"},{"date":"19851218","type":"ORIG","sponsor":"PLIVA","applicationNumber":"ANDA089098"},{"date":"20130129","type":"SUPPL","sponsor":"PLIVA","applicationNumber":"ANDA089098"},{"date":"20010529","type":"SUPPL","sponsor":"PLIVA","applicationNumber":"ANDA089098"},{"date":"20101101","type":"SUPPL","sponsor":"PLIVA","applicationNumber":"ANDA089098"},{"date":"20000707","type":"SUPPL","sponsor":"PLIVA","applicationNumber":"ANDA089098"},{"date":"19870423","type":"SUPPL","sponsor":"PLIVA","applicationNumber":"ANDA089098"},{"date":"20011011","type":"SUPPL","sponsor":"PLIVA","applicationNumber":"ANDA089098"},{"date":"20140911","type":"SUPPL","sponsor":"PLIVA","applicationNumber":"ANDA089098"},{"date":"20010615","type":"SUPPL","sponsor":"PLIVA","applicationNumber":"ANDA089098"},{"date":"19940511","type":"SUPPL","sponsor":"PLIVA","applicationNumber":"ANDA089098"},{"date":"20250717","type":"ORIG","sponsor":"BAXTER HLTHCARE CORP","applicationNumber":"ANDA219797"},{"date":"20100226","type":"ORIG","sponsor":"HERITAGE PHARMS INC","applicationNumber":"ANDA040858"},{"date":"20231006","type":"SUPPL","sponsor":"HERITAGE PHARMS INC","applicationNumber":"ANDA040858"},{"date":"20181030","type":"SUPPL","sponsor":"CADILA PHARMS LTD","applicationNumber":"ANDA203845"},{"date":"20140918","type":"ORIG","sponsor":"CADILA PHARMS LTD","applicationNumber":"ANDA203845"},{"date":"20181030","type":"SUPPL","sponsor":"CADILA PHARMS LTD","applicationNumber":"ANDA203845"}],"publicationCount":4832,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"approved","brandName":"HYDRALAZINE","genericName":"HYDRALAZINE","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"1953","aiSummary":"","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T05:59:45.186328+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":false,"safety":true,"trials":true,"score":2}}