hydralazine ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antihypertensives, hydrazinephthalazine derivatives 1384 86-54-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • hydralazine
  • hydralazine hydrochloride
  • hydralazine HCl
A direct-acting vasodilator that is used as an antihypertensive agent.
  • Molecular weight: 160.18
  • Formula: C8H8N4
  • CLOGP: 1.17
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 2
  • TPSA: 63.83
  • ALOGS: -1.78
  • ROTB: 1

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.10 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 44.20 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 8 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 20.79 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 23 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.50 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 85 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.12 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Jan. 15, 1953 FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Anti-neutrophil cytoplasmic antibody positive vasculitis 1831.05 12.44 387 27378 2512 63458745
Glomerulonephritis rapidly progressive 532.62 12.44 116 27649 879 63460378
Pulmonary renal syndrome 382.27 12.44 77 27688 377 63460880
Cardiac failure congestive 353.07 12.44 305 27460 92128 63369129
Gastrointestinal tract mucosal pigmentation 223.18 12.44 52 27713 550 63460707
Glomerulonephritis 222.54 12.44 65 27700 1741 63459516
Lupus-like syndrome 196.52 12.44 107 27658 15188 63446069
Pulmonary alveolar haemorrhage 183.11 12.44 71 27694 4597 63456660
Acute kidney injury 158.52 12.44 353 27412 263062 63198195
Vasculitis 146.13 12.44 94 27671 18115 63443142
Loss of employment 128.16 12.44 45 27720 2199 63459058
Renal vasculitis 102.97 12.44 26 27739 394 63460863
Exposure during pregnancy 101.99 12.44 216 27549 155331 63305926
Premature delivery 95.82 12.44 90 27675 30191 63431066
Blood pressure inadequately controlled 93.50 12.44 45 27720 4933 63456324
Chronic kidney disease 83.27 12.44 101 27664 45297 63415960
Glomerulonephritis proliferative 83.14 12.44 19 27746 183 63461074
Alveolitis 78.94 12.44 34 27731 2881 63458376
End stage renal disease 78.21 12.44 44 27721 6649 63454608
Rheumatoid arthritis 74.75 12.44 11 27754 253808 63207449
Lupus nephritis 73.24 12.44 32 27733 2807 63458450
Cerebrovascular accident 68.43 12.44 148 27617 107876 63353381
Hypertension 62.76 12.44 265 27500 279038 63182219
Hepatic steatosis 61.07 12.44 69 27696 28700 63432557
Glossodynia 59.57 12.44 5 27760 178871 63282386
Pre-eclampsia 58.50 12.44 41 27724 9092 63452165
Joint swelling 57.77 12.44 36 27729 327630 63133627
Arthropathy 57.07 12.44 16 27749 234776 63226481
Death 55.93 12.44 316 27449 374065 63087192
Alopecia 54.30 12.44 41 27724 337495 63123762
Peritonitis bacterial 54.11 12.44 31 27734 4848 63456409
Synovitis 52.98 12.44 9 27756 186909 63274348
Low birth weight baby 52.78 12.44 35 27730 7094 63454163
Pulmonary oedema 51.73 12.44 89 27676 54784 63406473
Hypervolaemia 50.13 12.44 62 27703 28351 63432906
Hypoxia 49.96 12.44 92 27673 59700 63401557
Hyperkalaemia 49.90 12.44 87 27678 54116 63407141
Treatment failure 49.43 12.44 13 27752 199030 63262227
Renal failure 48.75 12.44 137 27628 117515 63343742
Dyspnoea 48.53 12.44 471 27294 660842 62800415
Blood pressure increased 48.04 12.44 168 27597 161894 63299363
Left ventricle outflow tract obstruction 47.06 12.44 13 27752 283 63460974
Atrial fibrillation 46.56 12.44 134 27631 116502 63344755
Diabetes mellitus inadequate control 46.01 12.44 44 27721 15082 63446175
Hospitalisation 45.46 12.44 109 27656 84972 63376285
Discomfort 45.41 12.44 9 27756 167365 63293892
BRASH syndrome 45.34 12.44 14 27751 455 63460802
Premature baby 44.46 12.44 50 27715 20685 63440572
Mental status changes 43.75 12.44 69 27696 39530 63421727
Pericarditis 42.93 12.44 4 27761 131575 63329682
Infusion related reaction 40.52 12.44 29 27736 245492 63215765
Pain 40.33 12.44 177 27588 740451 62720806
Pyrexia 39.94 12.44 92 27673 470386 62990871
Gastric disorder 39.75 12.44 64 27701 37305 63423952
Respiratory failure 39.66 12.44 116 27649 101742 63359515
Musculoskeletal stiffness 38.92 12.44 16 27749 184602 63276655
General physical health deterioration 38.51 12.44 20 27745 201382 63259875
Exercise tolerance decreased 38.32 12.44 26 27739 5471 63455786
Antineutrophil cytoplasmic antibody positive 37.38 12.44 13 27752 617 63460640
Generalised oedema 37.13 12.44 40 27725 15778 63445479
Norepinephrine increased 36.67 12.44 8 27757 61 63461196
Ventricular hyperkinesia 36.33 12.44 8 27757 64 63461193
Wound 36.32 12.44 13 27752 163250 63298007
Lower respiratory tract infection 34.08 12.44 8 27757 132299 63328958
Shock 33.30 12.44 46 27719 23417 63437840
Antineutrophil cytoplasmic antibody 31.40 12.44 6 27759 21 63461236
Cardiac failure 31.39 12.44 98 27667 89044 63372213
Sinusitis 31.02 12.44 32 27733 226621 63234636
Premature labour 30.02 12.44 32 27733 12472 63448785
Multiple drug therapy 29.68 12.44 19 27746 3627 63457630
Acute myocardial infarction 28.83 12.44 51 27714 32073 63429184
Myocardial infarction 28.24 12.44 102 27663 99791 63361466
Oedema peripheral 27.58 12.44 159 27606 189352 63271905
Vasculitis necrotising 27.38 12.44 10 27755 548 63460709
Pulseless electrical activity 27.00 12.44 24 27741 7497 63453760
Hypotension 26.02 12.44 206 27559 272398 63188859
Irritable bowel syndrome 25.60 12.44 3 27762 82409 63378848
Cutaneous vasculitis 25.53 12.44 20 27745 5249 63456008
Peripartum cardiomyopathy 25.53 12.44 7 27758 148 63461109
Completed suicide 25.09 12.44 128 27637 145545 63315712
Hyphaema 25.04 12.44 8 27757 291 63460966
Impaired healing 24.87 12.44 7 27758 102535 63358722
Swelling 24.84 12.44 52 27713 275326 63185931
Endometritis 24.73 12.44 11 27754 1007 63460250
Pleural effusion 24.52 12.44 93 27672 93117 63368140
Drug-induced liver injury 24.18 12.44 54 27711 40168 63421089
Nephritic syndrome 24.13 12.44 8 27757 328 63460929
Pulmonary haemorrhage 23.97 12.44 22 27743 7159 63454098
Gastrointestinal haemorrhage 23.89 12.44 84 27681 81092 63380165
Blood glucose decreased 23.82 12.44 37 27728 20915 63440342
Eclampsia 23.12 12.44 8 27757 374 63460883
Psoriatic arthropathy 22.66 12.44 6 27759 91514 63369743
Necrotising retinitis 22.53 12.44 8 27757 404 63460853
Orthopnoea 22.51 12.44 20 27745 6241 63455016
Cardiac arrest 22.45 12.44 90 27675 92455 63368802
Dialysis 22.11 12.44 25 27740 10402 63450855
Pernicious anaemia 22.07 12.44 9 27756 665 63460592
Renal impairment 21.49 12.44 86 27679 88269 63372988
Foetal growth restriction 21.15 12.44 21 27744 7532 63453725
Inflammation 21.13 12.44 5 27760 82268 63378989
Gastrointestinal disorder 20.99 12.44 16 27749 131223 63330034
Hypoperfusion 20.90 12.44 11 27754 1456 63459801
Monocytosis 20.11 12.44 8 27757 554 63460703
Hypertrophic cardiomyopathy 20.09 12.44 11 27754 1576 63459681
Hypersensitivity 19.71 12.44 64 27701 292621 63168636
Renal disorder 19.52 12.44 44 27721 32930 63428327
Drug abuse 19.45 12.44 4 27761 72514 63388743
Hypermagnesaemia 18.78 12.44 9 27756 977 63460280
Mitral valve incompetence 18.74 12.44 32 27733 19562 63441695
Corneal disorder 18.72 12.44 11 27754 1803 63459454
Respiratory distress 18.66 12.44 44 27721 33907 63427350
Hyperplasia adrenal 18.64 12.44 4 27761 28 63461229
Product dose omission issue 18.61 12.44 170 27595 234143 63227114
Autoimmune myocarditis 18.59 12.44 5 27760 98 63461159
HELLP syndrome 18.29 12.44 9 27756 1035 63460222
C3 glomerulopathy 18.13 12.44 3 27762 3 63461254
Proteinuria 17.96 12.44 31 27734 19114 63442143
Therapeutic product effect incomplete 17.85 12.44 17 27748 125039 63336218
Haemolytic uraemic syndrome 17.83 12.44 12 27753 2491 63458766
Haemodynamic instability 17.75 12.44 21 27744 9169 63452088
Suicidal ideation 17.68 12.44 3 27762 62418 63398839
Hypoglycaemia 17.54 12.44 62 27703 60003 63401254
Stillbirth 17.50 12.44 18 27747 6732 63454525
Dermatitis bullous 17.36 12.44 20 27745 8488 63452769
Blood cholesterol increased 17 12.44 10 27755 94022 63367235
Blister 17.00 12.44 19 27746 129795 63331462
Ulcerative keratitis 16.97 12.44 12 27753 2698 63458559
Fibromyalgia 16.88 12.44 7 27758 80413 63380844
Condition aggravated 16.82 12.44 105 27660 402112 63059145
Hypertensive urgency 16.56 12.44 6 27759 321 63460936
Stomatitis 16.38 12.44 22 27743 138703 63322554
Neonatal hyponatraemia 16.27 12.44 4 27761 54 63461203
Acute respiratory failure 16.11 12.44 42 27723 34443 63426814
Acute febrile neutrophilic dermatosis 15.97 12.44 12 27753 2962 63458295
Treatment noncompliance 15.97 12.44 44 27721 37281 63423976
Primary hyperaldosteronism 15.94 12.44 4 27761 59 63461198
Jugular vein distension 15.80 12.44 8 27757 978 63460279
Urine output decreased 15.70 12.44 22 27743 11348 63449909
Small for dates baby 15.55 12.44 13 27752 3738 63457519
Drug intolerance 15.39 12.44 76 27689 308585 63152672
Serositis 15.22 12.44 7 27758 692 63460565
Acute hepatic failure 15.05 12.44 28 27737 18299 63442958
Cortisol increased 14.98 12.44 6 27759 423 63460834
Nephropathy 14.82 12.44 16 27749 6325 63454932
Systemic lupus erythematosus 14.53 12.44 45 27720 208873 63252384
Medication error 14.44 12.44 53 27712 52231 63409026
Contraindicated product administered 14.36 12.44 48 27717 217600 63243657
Nasopharyngitis 14.22 12.44 60 27705 254197 63207060
Phaeochromocytoma crisis 14.17 12.44 5 27760 248 63461009
Respiratory rate decreased 14.14 12.44 12 27753 3523 63457734
Haemorrhagic transformation stroke 14.11 12.44 8 27757 1227 63460030
Cardiac failure acute 14.01 12.44 19 27746 9504 63451753
Urinary tract infection 13.99 12.44 177 27588 264507 63196750
Phaeochromocytoma 13.88 12.44 6 27759 513 63460744
Umbilical cord vascular disorder 13.84 12.44 4 27761 103 63461154
Hepatic enzyme increased 13.78 12.44 44 27721 202284 63258973
Maternal exposure during pregnancy 13.77 12.44 152 27613 219910 63241347
Pericardial effusion 13.42 12.44 36 27729 30022 63431235
Bicuspid aortic valve 13.36 12.44 4 27761 117 63461140
Foetal death 13.34 12.44 20 27745 10960 63450297
Therapy cessation 13.12 12.44 36 27729 30421 63430836
Hypoglycaemia neonatal 13.02 12.44 7 27758 968 63460289
Glomerulonephritis membranous 12.95 12.44 6 27759 604 63460653
Fluid retention 12.87 12.44 56 27709 59630 63401627
Urticaria 12.79 12.44 34 27731 165768 63295489
Action tremor 12.77 12.44 5 27760 332 63460925
Hypothermia 12.75 12.44 22 27743 13559 63447698
Vitreous haemorrhage 12.66 12.44 9 27756 2041 63459216
Blood potassium increased 12.64 12.44 26 27739 18283 63442974
Hypertensive nephropathy 12.57 12.44 6 27759 646 63460611
Stag horn calculus 12.46 12.44 4 27761 148 63461109

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Anti-neutrophil cytoplasmic antibody positive vasculitis 909.88 12.72 187 19913 742 34936089
Lupus-like syndrome 275.33 12.72 90 20010 2666 34934165
Gastrointestinal tract mucosal pigmentation 262.04 12.72 60 20040 430 34936401
Glomerulonephritis rapidly progressive 259.73 12.72 63 20037 595 34936236
Cardiac failure congestive 239.21 12.72 266 19834 83004 34853827
Pulmonary renal syndrome 215.70 12.72 43 20057 140 34936691
Device interaction 96.31 12.72 28 20072 554 34936277
Acute kidney injury 91.06 12.72 381 19719 304607 34632224
Chronic kidney disease 85.85 12.72 112 19988 41098 34895733
Pulmonary alveolar haemorrhage 74.38 12.72 49 20051 7463 34929368
End stage renal disease 67.06 12.72 49 20051 8812 34928019
Glomerulonephritis 62.85 12.72 28 20072 1950 34934881
Vasculitis 58.59 12.72 50 20050 11246 34925585
Renal vasculitis 58.33 12.72 15 20085 183 34936648
Lupus nephritis 57.56 12.72 17 20083 356 34936475
Systemic lupus erythematosus 51.35 12.72 30 20070 3694 34933137
Myocardial infarction 48.09 12.72 166 19934 120919 34815912
Pulmonary oedema 41.16 12.72 87 20013 47442 34889389
Cerebrovascular accident 40.63 12.72 124 19976 84687 34852144
Lupus vasculitis 38.77 12.72 6 20094 0 34936831
Drug abuse 37.54 12.72 6 20094 99090 34837741
Premature baby 37.24 12.72 51 20049 19582 34917249
Hypertension 36.31 12.72 165 19935 136278 34800553
Hypotension 35.92 12.72 234 19866 221415 34715416
Peritonitis bacterial 35.74 12.72 29 20071 6081 34930750
Renal failure 34.82 12.72 158 19942 130399 34806432
Mental status changes 33.30 12.72 70 20030 38013 34898818
Apgar score low 32.77 12.72 14 20086 881 34935950
Low birth weight baby 31.17 12.72 30 20070 7875 34928956
General physical health deterioration 30.45 12.72 18 20082 128251 34808580
Lupus pneumonitis 29.67 12.72 7 20093 58 34936773
Completed suicide 28.58 12.72 122 19978 98046 34838785
Tubulointerstitial nephritis 26.26 12.72 45 20055 20979 34915852
Hypervolaemia 25.70 12.72 43 20057 19666 34917165
Unresponsive to stimuli 25.66 12.72 52 20048 27517 34909314
Pulmonary haemorrhage 23.00 12.72 29 20071 10275 34926556
Proteinuria 22.11 12.72 39 20061 18603 34918228
Drug ineffective 21.65 12.72 164 19936 456587 34480244
Blood pressure increased 21.54 12.72 104 19996 87998 34848833
Glomerulonephritis proliferative 21.51 12.72 7 20093 204 34936627
Bradycardia foetal 21.36 12.72 8 20092 356 34936475
Human ehrlichiosis 21.19 12.72 8 20092 364 34936467
Histone antibody positive 20.57 12.72 4 20096 11 34936820
Cardiomegaly 20.55 12.72 34 20066 15404 34921427
Anencephaly 19.99 12.72 6 20094 133 34936698
Full blood count decreased 19.12 12.72 36 20064 18052 34918779
Blood glucose decreased 18.77 12.72 30 20070 13207 34923624
Troponin I increased 18.43 12.72 14 20086 2668 34934163
Pyrexia 17.99 12.72 115 19985 332898 34603933
Blood creatinine increased 17.66 12.72 104 19996 94872 34841959
Blood pressure abnormal 16.81 12.72 22 20078 8084 34928747
Pericardial effusion 16.73 12.72 41 20059 24621 34912210
Fluid retention 16.47 12.72 43 20057 26844 34909987
Nephrogenic anaemia 16.21 12.72 12 20088 2199 34934632
Rickets 15.47 12.72 4 20096 50 34936781
Death 15.33 12.72 317 19783 397732 34539099
C-reactive protein increased 15.25 12.72 6 20094 54092 34882739
Peripheral swelling 15.00 12.72 85 20015 76456 34860375
Renal disorder 14.84 12.72 40 20060 25440 34911391
Gastrointestinal haemorrhage 14.63 12.72 94 20006 88383 34848448
Chest pain 14.31 12.72 123 19977 126639 34810192
Off label use 14.09 12.72 164 19936 419360 34517471
Dialysis 14.01 12.72 24 20076 11184 34925647
Respiratory failure 13.68 12.72 108 19992 108464 34828367
Burkholderia test positive 13.47 12.72 8 20092 1015 34935816
Cholestatic liver injury 13.36 12.72 11 20089 2353 34934478
Suspected suicide 13.29 12.72 15 20085 4733 34932098
Mucosal inflammation 13.21 12.72 3 20097 38619 34898212
Foetal exposure timing unspecified 13.11 12.72 5 20095 234 34936597
Hospitalisation 13.06 12.72 66 20034 56836 34879995
Blood potassium increased 12.91 12.72 29 20071 16466 34920365
Cardiac disorder 12.84 12.72 54 20046 43072 34893759

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Anti-neutrophil cytoplasmic antibody positive vasculitis 2750.90 11.49 582 40391 3147 79700268
Glomerulonephritis rapidly progressive 737.87 11.49 171 40802 1477 79701938
Cardiac failure congestive 585.27 11.49 525 40448 141877 79561538
Pulmonary renal syndrome 576.68 11.49 118 40855 522 79702893
Gastrointestinal tract mucosal pigmentation 486.28 11.49 112 40861 938 79702477
Lupus-like syndrome 464.67 11.49 197 40776 13660 79689755
Pulmonary alveolar haemorrhage 244.81 11.49 119 40854 11338 79692077
Glomerulonephritis 242.36 11.49 84 40889 3349 79700066
Acute kidney injury 230.70 11.49 686 40287 518718 79184697
Vasculitis 192.75 11.49 134 40839 24968 79678447
Renal vasculitis 153.33 11.49 40 40933 585 79702830
Chronic kidney disease 122.04 11.49 160 40813 65994 79637421
Loss of employment 111.33 11.49 44 40929 2543 79700872
Lupus nephritis 108.28 11.49 45 40928 2963 79700452
Cerebrovascular accident 104.40 11.49 240 40733 155052 79548363
Premature delivery 103.04 11.49 90 40883 23377 79680038
End stage renal disease 100.33 11.49 68 40905 12152 79691263
Glomerulonephritis proliferative 99.55 11.49 26 40947 382 79703033
Device interaction 83.90 11.49 26 40947 724 79702691
Blood pressure inadequately controlled 82.87 11.49 47 40926 6130 79697285
Myocardial infarction 82.06 11.49 244 40729 183885 79519530
Pulmonary oedema 81.01 11.49 155 40818 88099 79615316
Mental status changes 78.67 11.49 131 40842 66828 79636587
Hypertension 77.48 11.49 356 40617 330636 79372779
Rheumatoid arthritis 71.19 11.49 11 40962 208459 79494956
Peritonitis bacterial 70.92 11.49 50 40923 9517 79693898
General physical health deterioration 68.23 11.49 28 40945 275210 79428205
Exposure during pregnancy 66.49 11.49 155 40818 100977 79602438
Alveolitis 64.84 11.49 35 40938 4145 79699270
Renal failure 63.38 11.49 237 40736 200731 79502684
Hypervolaemia 63.34 11.49 93 40880 42597 79660818
Drug abuse 56.89 11.49 8 40965 162683 79540732
Death 56.24 11.49 489 40484 566025 79137390
Hyperkalaemia 55.16 11.49 156 40817 114242 79589173
Pre-eclampsia 55.00 11.49 38 40935 7003 79696412
Pulmonary haemorrhage 52.03 11.49 50 40923 14667 79688748
Synovitis 51.35 11.49 8 40965 150726 79552689
Hypotension 50.60 11.49 393 40580 439924 79263491
Atrial fibrillation 50.11 11.49 218 40755 197668 79505747
Pyrexia 48.72 11.49 182 40791 678527 79024888
Arthropathy 47.26 11.49 16 40957 177095 79526320
Completed suicide 47.21 11.49 250 40723 245517 79457898
Treatment failure 44.46 11.49 16 40957 170470 79532945
Lupus pneumonitis 43.92 11.49 10 40963 79 79703336
Respiratory failure 43.30 11.49 196 40777 180715 79522700
Musculoskeletal stiffness 43.03 11.49 18 40955 174990 79528425
Proteinuria 42.81 11.49 67 40906 32435 79670980
Antineutrophil cytoplasmic antibody positive 41.88 11.49 18 40955 1288 79702127
Hepatic steatosis 41.88 11.49 72 40901 37666 79665749
Dyspnoea 41.67 11.49 644 40329 856381 78847034
Blood pressure increased 40.58 11.49 215 40758 211145 79492270
Shock 40.57 11.49 77 40896 43471 79659944
Blood glucose decreased 40.14 11.49 58 40915 26176 79677239
Gastric disorder 39.70 11.49 70 40903 37363 79666052
Pain 39.43 11.49 207 40766 703595 78999820
Joint swelling 38.86 11.49 55 40918 288591 79414824
Vasculitis necrotising 38.70 11.49 17 40956 1283 79702132
Lower respiratory tract infection 37.50 11.49 10 40963 129210 79574205
Sinusitis 36.75 11.49 28 40945 195473 79507942
Left ventricle outflow tract obstruction 36.64 11.49 12 40961 401 79703014
Infusion related reaction 36.10 11.49 39 40934 230198 79473217
Hypoxia 34.40 11.49 124 40849 103119 79600296
Antineutrophil cytoplasmic antibody 34.01 11.49 7 40966 32 79703383
Alopecia 33.25 11.49 42 40931 231313 79472102
Norepinephrine increased 33.10 11.49 8 40965 84 79703331
Gastrointestinal haemorrhage 33.09 11.49 157 40816 147562 79555853
Generalised oedema 32.80 11.49 50 40923 23659 79679756
BRASH syndrome 32.56 11.49 14 40959 1003 79702412
Premature labour 32.52 11.49 30 40943 8360 79695055
Acute myocardial infarction 32.31 11.49 100 40873 76936 79626479
Cardiac arrest 32.30 11.49 174 40799 171922 79531493
Hospitalisation 32.09 11.49 114 40859 94122 79609293
Inflammation 31.87 11.49 5 40968 93748 79609667
Pericardial effusion 30.52 11.49 71 40902 46166 79657249
Tubulointerstitial nephritis 30.08 11.49 63 40910 38172 79665243
Glossodynia 29.98 11.49 8 40965 103329 79600086
Psoriatic arthropathy 29.32 11.49 3 40970 77996 79625419
Lupus vasculitis 29.11 11.49 11 40962 563 79702852
Unresponsive to stimuli 28.78 11.49 78 40895 55710 79647705
Blood creatinine increased 28.57 11.49 156 40817 154901 79548514
Dialysis 28.51 11.49 41 40932 18421 79684994
Diabetes mellitus inadequate control 27.85 11.49 47 40926 24217 79679198
Discomfort 27.68 11.49 15 40958 125602 79577813
Maternal exposure during pregnancy 27.64 11.49 141 40832 136397 79567018
Nephrogenic anaemia 25.74 11.49 19 40954 3883 79699532
Therapeutic product effect incomplete 25.71 11.49 21 40952 141624 79561791
Endometritis 25.46 11.49 11 40962 797 79702618
Cardiomegaly 25.05 11.49 47 40926 26305 79677110
Multiple drug therapy 24.99 11.49 19 40954 4059 79699356
Nephritic syndrome 24.61 11.49 9 40964 420 79702995
Pulseless electrical activity 24.18 11.49 33 40940 14127 79689288
Pleural effusion 24.03 11.49 142 40831 145120 79558295
Suicidal ideation 23.94 11.49 5 40968 76335 79627080
Coronary artery disease 23.84 11.49 81 40892 65393 79638022
Acute respiratory failure 23.78 11.49 76 40897 59465 79643950
Ventricular hyperkinesia 23.78 11.49 8 40965 291 79703124
Small for dates baby 23.70 11.49 9 40964 467 79702948
Cutaneous vasculitis 23.60 11.49 25 40948 8227 79695188
Renal impairment 23.43 11.49 150 40823 157633 79545782
Stillbirth 23.30 11.49 18 40955 3937 79699478
Impaired healing 23.23 11.49 8 40965 87647 79615768
Haemoptysis 22.84 11.49 72 40901 55927 79647488
Orthopnoea 22.78 11.49 27 40946 10046 79693369
C-reactive protein increased 22.35 11.49 20 40953 129007 79574408
Hypertensive urgency 22.31 11.49 9 40964 549 79702866
Pericarditis 22.17 11.49 13 40960 104223 79599192
Haemorrhagic transformation stroke 22.14 11.49 15 40958 2677 79700738
Eclampsia 22.12 11.49 7 40966 209 79703206
Oedema peripheral 22.00 11.49 212 40761 252076 79451339
Pernicious anaemia 21.73 11.49 9 40964 587 79702828
Condition aggravated 21.47 11.49 160 40813 500964 79202451
Dermatitis bullous 21.07 11.49 31 40942 14214 79689201
Off label use 20.68 11.49 335 40638 906880 78796535
Hypoglycaemia 20.62 11.49 105 40868 101489 79601926
Hepatic function abnormal 20.57 11.49 6 40967 73101 79630314
Urticaria 20.53 11.49 40 40933 185161 79518254
Peripartum cardiomyopathy 20.25 11.49 6 40967 143 79703272
Wound 20.14 11.49 18 40955 116161 79587254
Drug-induced liver injury 20.00 11.49 77 40896 66040 79637375
Blood cholesterol increased 19.95 11.49 9 40964 83711 79619704
Neutropenia 19.38 11.49 79 40894 287631 79415784
Acute febrile neutrophilic dermatosis 19.35 11.49 16 40957 3856 79699559
Umbilical cord vascular disorder 19.31 11.49 4 40969 19 79703396
Human ehrlichiosis 18.93 11.49 8 40965 549 79702866
Chest pain 18.91 11.49 225 40748 282079 79421336
Fibromyalgia 18.62 11.49 5 40968 64335 79639080
Suspected suicide 18.59 11.49 25 40948 10551 79692864
Treatment noncompliance 18.45 11.49 64 40909 52204 79651211
Exercise tolerance decreased 18.38 11.49 23 40950 9048 79694367
Cardiac failure acute 18.29 11.49 34 40939 18895 79684520
Histone antibody positive 17.94 11.49 5 40968 95 79703320
Mitral valve incompetence 17.91 11.49 43 40930 28522 79674893
Angioedema 17.89 11.49 82 40891 75953 79627462
Cholestatic liver injury 17.87 11.49 17 40956 4924 79698491
Hypocomplementaemia 17.84 11.49 6 40967 218 79703197
Gastrointestinal disorder 17.74 11.49 22 40951 122183 79581232
Irritable bowel syndrome 17.71 11.49 5 40968 62236 79641179
Microscopic polyangiitis 17.69 11.49 7 40966 406 79703009
Cardiac failure 17.61 11.49 138 40835 154704 79548711
Hypertensive emergency 17.12 11.49 13 40960 2772 79700643
Fluid retention 16.96 11.49 76 40897 69733 79633682
Hyperplasia adrenal 16.82 11.49 4 40969 39 79703376
Drug reaction with eosinophilia and systemic symptoms 16.79 11.49 6 40967 64238 79639177
Nasopharyngitis 16.30 11.49 71 40902 253810 79449605
Foetal death 15.67 11.49 20 40953 8024 79695391
Serositis 15.63 11.49 8 40965 850 79702565
Foetal growth restriction 15.53 11.49 11 40962 2108 79701307
Cardiac disorder 15.53 11.49 71 40902 65686 79637729
Plasma cell myeloma 15.28 11.49 61 40912 53198 79650217
Hyphaema 15.24 11.49 8 40965 896 79702519
Azotaemia 15.22 11.49 20 40953 8256 79695159
Febrile neutropenia 15.20 11.49 64 40909 230935 79472480
Blood potassium increased 15.16 11.49 41 40932 29234 79674181
Focal segmental glomerulosclerosis 15.11 11.49 13 40960 3308 79700107
Hypertensive crisis 14.93 11.49 33 40940 20737 79682678
Depression 14.93 11.49 59 40914 216731 79486684
Kidney transplant rejection 14.73 11.49 22 40951 10224 79693191
Product dose omission issue 14.73 11.49 193 40780 247344 79456071
Troponin I increased 14.71 11.49 15 40958 4723 79698692
Renal aneurysm 14.65 11.49 5 40968 190 79703225
Hypertensive encephalopathy 14.61 11.49 8 40965 974 79702441
Pulmonary hypertension 14.55 11.49 56 40917 48024 79655391
Phaeochromocytoma 14.46 11.49 7 40966 660 79702755
Lethargy 14.43 11.49 81 40892 81211 79622204
Renal disorder 14.38 11.49 51 40922 42054 79661361
Hypertensive nephropathy 14.37 11.49 8 40965 1006 79702409
Blood pressure abnormal 14.34 11.49 29 40944 17140 79686275
Monocytosis 14.30 11.49 8 40965 1016 79702399
Swelling 14.28 11.49 60 40913 216651 79486764
Erythema 14.00 11.49 63 40910 223227 79480188
Product use in unapproved indication 13.76 11.49 74 40899 250285 79453130
Anaemia 13.71 11.49 312 40661 444703 79258712
Malignant neoplasm progression 13.70 11.49 31 40942 135959 79567456
Hypoperfusion 13.39 11.49 11 40962 2628 79700787
Urine output decreased 13.37 11.49 29 40944 17993 79685422
Full blood count decreased 13.33 11.49 37 40936 26782 79676633
HELLP syndrome 13.21 11.49 7 40966 799 79702616
Psoriasis 13.13 11.49 16 40957 89571 79613844
Hepatic enzyme increased 13.02 11.49 49 40924 182561 79520854
Glomerular filtration rate decreased 12.99 11.49 33 40940 22669 79680746
Necrotising retinitis 12.85 11.49 8 40965 1237 79702178
Bradycardia 12.85 11.49 116 40857 135441 79567974
Gastric ileus 12.83 11.49 3 40970 27 79703388
Injection site pain 12.75 11.49 30 40943 129808 79573607
Nephritis 12.47 11.49 13 40960 4201 79699214
Hypertrophic cardiomyopathy 12.39 11.49 10 40963 2330 79701085
Osteoarthritis 12.38 11.49 16 40957 87293 79616122
Respiratory distress 12.33 11.49 61 40912 58278 79645137
Metabolic encephalopathy 12.24 11.49 19 40954 9128 79694287
Gout 12.16 11.49 34 40939 24715 79678700
Stomatitis 12.08 11.49 37 40936 146720 79556695
Phaeochromocytoma crisis 11.99 11.49 5 40968 332 79703083
Drug intolerance 11.93 11.49 83 40890 264036 79439379
Renal tubular necrosis 11.91 11.49 34 40939 25005 79678410
Myelosuppression 11.91 11.49 3 40970 40293 79663122
Coronary arterial stent insertion 11.73 11.49 15 40958 6029 79697386
Primary hyperaldosteronism 11.72 11.49 4 40969 152 79703263
Jugular vein distension 11.64 11.49 8 40965 1462 79701953
Chronic left ventricular failure 11.63 11.49 7 40966 1019 79702396

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C02DB02 CARDIOVASCULAR SYSTEM
ANTIHYPERTENSIVES
ARTERIOLAR SMOOTH MUSCLE, AGENTS ACTING ON
Hydrazinophthalazine derivatives
ATC C02LG02 CARDIOVASCULAR SYSTEM
ANTIHYPERTENSIVES
ANTIHYPERTENSIVES AND DIURETICS IN COMBINATION
Hydrazinophthalazine derivatives and diuretics
FDA PE N0000175379 Arteriolar Vasodilation
FDA EPC N0000175564 Arteriolar Vasodilator
MeSH PA D000959 Antihypertensive Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D014665 Vasodilator Agents
CHEBI has role CHEBI:35620 vasodilator agents
CHEBI has role CHEBI:35674 antihypertensive drugs

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Hypertensive disorder indication 38341003 DOID:10763
Chronic heart failure indication 48447003
Anuria contraindication 2472002 DOID:2983
Suicidal thoughts contraindication 6471006
Peptic ulcer contraindication 13200003 DOID:750
Hypercholesterolemia contraindication 13644009
Chronic disease of respiratory system contraindication 17097001
Secondary angle-closure glaucoma contraindication 21571006
Myocardial infarction contraindication 22298006 DOID:5844
Electroconvulsive therapy contraindication 23835007
Hypovolemia contraindication 28560003
Dehydration contraindication 34095006
Hyperthyroidism contraindication 34486009 DOID:7998
Depressive disorder contraindication 35489007
Hyperuricemia contraindication 35885006 DOID:1920
Hypokalemia contraindication 43339004
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Sympathectomy contraindication 57071006
Ulcerative colitis contraindication 64766004 DOID:8577
Hypercalcemia contraindication 66931009 DOID:12678
Hyperparathyroidism contraindication 66999008 DOID:13543
Benign intracranial hypertension contraindication 68267002 DOID:11459
Hypochloremic alkalosis contraindication 70134007
Hepatic coma contraindication 72836002 DOID:12550
Diabetes mellitus contraindication 73211009 DOID:9351
Injury of head contraindication 82271004
Epilepsy contraindication 84757009 DOID:1826
Hyponatremia contraindication 89627008
Gout contraindication 90560007 DOID:13189
Kidney disease contraindication 90708001 DOID:557
Increased intestinal motility contraindication 102624003
Hypomagnesemia contraindication 190855004
Acute pancreatitis contraindication 197456007 DOID:2913
Cerebrovascular accident contraindication 230690007
Hypertrophic cardiomyopathy contraindication 233873004 DOID:11984
Lupus erythematosus and erythema multiforme-like syndrome contraindication 238926009
Calculus in biliary tract contraindication 266474003
Anemia contraindication 271737000 DOID:2355
Cerebral hemorrhage contraindication 274100004
Neonatal hyperbilirubinemia contraindication 281610001
Disorder of coronary artery contraindication 414024009
Myocardial infarction in recovery phase contraindication 418044006
Slow acetylator due to N-acetyltransferase enzyme variant contraindication 425079005
Azotemia contraindication 445009001
Malabsorption States contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 6.81 Basic
pKa2 3.26 Basic
pKa3 2.62 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Ryanodine receptor 2 Ion channel BLOCKER SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
Voltage-dependent L-type calcium channel subunit alpha-1C Ion channel WOMBAT-PK
DNA (cytosine-5)-methyltransferase 1 Enzyme WOMBAT-PK
DNA (cytosine-5)-methyltransferase 3A Enzyme WOMBAT-PK
DNA (cytosine-5)-methyltransferase 3B Enzyme WOMBAT-PK
Aspartate aminotransferase, cytoplasmic Enzyme Ki 4.83 CHEMBL
Aldehyde oxidase Enzyme IC50 5.41 CHEMBL
Myeloperoxidase Enzyme IC50 6.05 CHEMBL
Arachidonate 15-lipoxygenase Enzyme IC50 5.44 DRUG MATRIX
Acetylcholinesterase Enzyme Ki 5.15 CHEMBL
Cholinesterase Enzyme Ki 5.72 CHEMBL
Lactoperoxidase Enzyme IC50 5.92 CHEMBL
Ryanodine receptor 2 Ion channel IC50 7.15 SCIENTIFIC LITERATURE

External reference:

IDSource
4019778 VUID
N0000147869 NUI
D01302 KEGG_DRUG
304-20-1 SECONDARY_CAS_RN
4017880 VANDF
4019778 VANDF
C0020223 UMLSCUI
CHEBI:5775 CHEBI
HLZ PDB_CHEM_ID
CHEMBL276832 ChEMBL_ID
DB01275 DRUGBANK_ID
CHEMBL542541 ChEMBL_ID
D006830 MESH_DESCRIPTOR_UI
3637 PUBCHEM_CID
1 INN_ID
7326 IUPHAR_LIGAND_ID
26NAK24LS8 UNII
5470 RXNORM
4833 MMSL
896 MMSL
d00132 MMSL
000632 NDDF
004489 NDDF
22696000 SNOMEDCT_US
28662003 SNOMEDCT_US
387125005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9875 INJECTION 20 mg INTRAVENOUS ANDA 12 sections
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9875 INJECTION 20 mg INTRAVENOUS ANDA 12 sections
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9986 INJECTION 20 mg INTRAVENOUS ANDA 11 sections
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9986 INJECTION 20 mg INTRAVENOUS ANDA 11 sections
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9994 INJECTION, SOLUTION 20 mg INTRAMUSCULAR ANDA 12 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0517-0901 INJECTION, SOLUTION 20 mg INTRAMUSCULAR ANDA 19 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-7973 TABLET 100 mg ORAL ANDA 9 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-7973 TABLET 100 mg ORAL ANDA 9 sections
HydrALAZINE hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0641-6231 INJECTION, SOLUTION 20 mg INTRAMUSCULAR ANDA 18 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6440 TABLET, FILM COATED 10 mg ORAL ANDA 10 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6440 TABLET, FILM COATED 10 mg ORAL ANDA 10 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6441 TABLET, FILM COATED 25 mg ORAL ANDA 10 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6441 TABLET, FILM COATED 25 mg ORAL ANDA 10 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6442 TABLET, FILM COATED 50 mg ORAL ANDA 10 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6442 TABLET, FILM COATED 50 mg ORAL ANDA 10 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6443 TABLET, FILM COATED 100 mg ORAL ANDA 10 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6443 TABLET, FILM COATED 100 mg ORAL ANDA 10 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 17478-934 INJECTION 20 mg INTRAVENOUS ANDA 19 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 17478-934 INJECTION 20 mg INTRAVENOUS ANDA 19 sections
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 21695-679 TABLET 10 mg ORAL ANDA 11 sections
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 21695-680 TABLET 25 mg ORAL ANDA 11 sections
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 21695-694 TABLET 50 mg ORAL ANDA 11 sections
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 21695-695 TABLET 100 mg ORAL ANDA 11 sections
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 23155-001 TABLET, FILM COATED 10 mg ORAL ANDA 10 sections
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 23155-001 TABLET, FILM COATED 10 mg ORAL ANDA 10 sections
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 23155-002 TABLET, FILM COATED 25 mg ORAL ANDA 10 sections
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 23155-002 TABLET, FILM COATED 25 mg ORAL ANDA 10 sections
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 23155-003 TABLET, FILM COATED 50 mg ORAL ANDA 10 sections
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 23155-003 TABLET, FILM COATED 50 mg ORAL ANDA 10 sections
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 23155-004 TABLET, FILM COATED 100 mg ORAL ANDA 10 sections