hydralazine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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 µM/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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 0.971 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.938 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 16.982 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 8.395 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 41 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 56.520 % High 1
herg hERG pIC50 4.361 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 17.298 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 23.768 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 16.570 % High 1
kinase-safety-class ACVR2B,AXL,BRAF,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,ERBB2,FLT3,GRK2,ITK,MAP3K21,MAPK7,MARK4,NTRK2,PDK2,PDK4,PRKDC,SIK2,SIK3,STK33,TEK,TTK 26
kinase-selectivity-class DYRK1B,EIF2AK3,GRK2 3
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 3.639 High 1
mh-clint Mouse hepatocyte intrinsic clearance 187.499 High 1
mppb Mouse plasma protein binding (% unbound) 42.070 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 1.528 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 36.790 % High 1
rh-clint Rat hepatocyte intrinsic clearance 92.897 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 90.680 % High 1
rppb Rat plasma protein binding (% unbound) 27.820 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 803.526 uM High 1

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 3390.73 12.44 674 36522 3319 90587932
Glomerulonephritis rapidly progressive 692.17 12.44 149 37047 1141 90590110
Pulmonary renal syndrome 607.52 12.44 117 37079 468 90590783
Cardiac failure congestive 444.40 12.44 349 36847 98345 90492906
Pulmonary alveolar haemorrhage 436.53 12.44 142 37054 5856 90585395
Glomerulonephritis 388.04 12.44 106 37090 2364 90588887
Gastrointestinal tract mucosal pigmentation 265.41 12.44 61 37135 648 90590603
Acute kidney injury 232.79 12.44 447 36749 319940 90271311
Lupus nephritis 221.56 12.44 81 37115 4751 90586500
Vasculitis 216.93 12.44 128 37068 22565 90568686
Lupus-like syndrome 196.82 12.44 162 37034 48684 90542567
Loss of employment 190.41 12.44 64 37132 2923 90588328
Blood pressure inadequately controlled 171.01 12.44 72 37124 6152 90585099
Acute febrile neutrophilic dermatosis 153.58 12.44 57 37139 3488 90587763
Premature delivery 150.82 12.44 126 37070 38636 90552615
Cardiac failure 113.57 12.44 179 37017 109317 90481934
Glossodynia 110.91 12.44 5 37191 321774 90269477
Hand deformity 107.72 12.44 3 37193 296359 90294892
Hepatic steatosis 107.69 12.44 102 37094 36843 90554408
Chronic kidney disease 105.21 12.44 116 37080 50075 90541176
Renal vasculitis 102.94 12.44 26 37170 422 90590829
Hyperkalaemia 101.18 12.44 129 37067 64835 90526416
Arthropathy 100.99 12.44 15 37181 366227 90225024
Exercise tolerance decreased 100.61 12.44 53 37143 7498 90583753
Rheumatoid arthritis 99.65 12.44 15 37181 362599 90228652
Synovitis 99.50 12.44 10 37186 329742 90261509
Serositis 99.14 12.44 32 37164 1285 90589966
Joint swelling 90.33 12.44 47 37149 503253 90087998
Diabetes mellitus inadequate control 90.31 12.44 69 37127 18615 90572636
Exposure during pregnancy 89.36 12.44 257 36939 238153 90353098
Infusion related reaction 87.37 12.44 31 37165 416749 90174502
Body mass index abnormal 85.61 12.44 25 37171 714 90590537
Renal impairment 83.68 12.44 153 37043 105268 90485983
Wound 82.16 12.44 13 37183 302967 90288284
Pericarditis 81.99 12.44 8 37188 270143 90321108
Alopecia 80.63 12.44 52 37144 495019 90096232
Alveolitis 79.84 12.44 34 37162 2987 90588264
Glomerulonephritis proliferative 79.43 12.44 19 37177 243 90591008
End stage renal disease 78.38 12.44 47 37149 8524 90582727
Treatment failure 78.13 12.44 15 37181 303913 90287338
Lower respiratory tract infection 77.19 12.44 7 37189 250652 90340599
Mental status changes 74.79 12.44 92 37104 44587 90546664
Death 74.43 12.44 377 36819 456174 90135077
Central nervous system lupus 74.38 12.44 26 37170 1337 90589914
General physical health deterioration 73.41 12.44 27 37169 355088 90236163
Impaired healing 70.89 12.44 7 37189 234192 90357059
Multiple drug therapy 70.83 12.44 41 37155 6968 90584283
BRASH syndrome 69.78 12.44 27 37169 1852 90589399
Blood pressure increased 69.47 12.44 208 36988 197009 90394242
Pulmonary oedema 69.26 12.44 105 37091 61975 90529276
Cerebrovascular accident 69.06 12.44 155 37041 123378 90467873
Dyspnoea 68.82 12.44 605 36591 880350 89710901
Pre-eclampsia 67.47 12.44 47 37149 11001 90580250
Lupus pneumonitis 67.01 12.44 14 37182 91 90591160
Psoriatic arthropathy 66.13 12.44 8 37188 228327 90362924
Antineutrophil cytoplasmic antibody 64.24 12.44 12 37184 39 90591212
Fibromyalgia 60.29 12.44 7 37189 206262 90384989
Atrial fibrillation 59.99 12.44 154 37042 133457 90457794
Renal failure 59.86 12.44 152 37044 130855 90460396
Premature baby 59.67 12.44 62 37134 25015 90566236
Respiratory failure 57.90 12.44 141 37055 118277 90472974
Shock 56.00 12.44 64 37132 28714 90562537
Musculoskeletal stiffness 55.70 12.44 26 37170 296506 90294745
Antineutrophil cytoplasmic antibody positive 55.48 12.44 18 37178 735 90590516
Inflammation 54.94 12.44 5 37191 178587 90412664
Type 2 diabetes mellitus 54.45 12.44 9 37187 203235 90388016
Pyrexia 54.42 12.44 119 37077 660366 89930885
Peritonitis bacterial 54.26 12.44 31 37165 5140 90586111
Gliosis 54.07 12.44 16 37180 479 90590772
Low birth weight baby 52.55 12.44 38 37158 9429 90581822
Sinusitis 51.88 12.44 39 37157 343049 90248202
Discomfort 51.60 12.44 24 37172 274311 90316940
Treatment noncompliance 51.45 12.44 83 37113 51644 90539607
Haematuria 50.67 12.44 67 37129 34870 90556381
Monocytosis 50.58 12.44 18 37178 976 90590275
Hypervolaemia 49.34 12.44 64 37132 32693 90558558
Polyserositis 49.23 12.44 16 37180 657 90590594
Pouchitis 49.13 12.44 16 37180 661 90590590
Hypoxia 48.72 12.44 98 37098 72301 90518950
Blood cholesterol increased 47.98 12.44 13 37183 207999 90383252
Stomatitis 47.25 12.44 27 37169 274671 90316580
Blister 46.90 12.44 23 37173 254975 90336276
Swelling 46.90 12.44 62 37134 418996 90172255
Hospitalisation 46.88 12.44 137 37059 127963 90463288
Generalised oedema 45.13 12.44 47 37149 19006 90572245
Gout 44.33 12.44 44 37152 16815 90574436
Left ventricle outflow tract obstruction 43.01 12.44 13 37183 419 90590832
Ulcerative keratitis 42.52 12.44 23 37173 3430 90587821
Pleural effusion 42.16 12.44 121 37075 111870 90479381
Joint range of motion decreased 41.17 12.44 4 37192 135639 90455612
Hypotension 40.48 12.44 250 36946 325147 90266104
Hypertension 40.22 12.44 323 36873 457209 90134042
Vaccination site pain 39.94 12.44 12 37184 379 90590872
Cardiac tamponade 39.24 12.44 26 37170 5606 90585645
Nasopharyngitis 39.00 12.44 67 37129 407037 90184214
Liver injury 38.69 12.44 11 37185 170556 90420695
Premature menopause 38.61 12.44 16 37180 1313 90589938
Cutaneous vasculitis 37.95 12.44 28 37168 7165 90584086
Completed suicide 37.63 12.44 138 37058 144920 90446331
Norepinephrine increased 37.18 12.44 8 37188 61 90591190
Oedema peripheral 37.15 12.44 206 36990 257709 90333542
Ventricular hyperkinesia 37.06 12.44 8 37188 62 90591189
Acute myocardial infarction 36.09 12.44 57 37139 34833 90556418
Pathergy reaction 35.90 12.44 8 37188 73 90591178
C-reactive protein increased 35.46 12.44 15 37181 181374 90409877
Ovarian failure 35.34 12.44 16 37180 1627 90589624
Pericardial effusion 35.13 12.44 58 37138 36775 90554476
Ill-defined disorder 35.03 12.44 16 37180 184875 90406376
Exposure to SARS-CoV-2 34.92 12.44 18 37178 2434 90588817
Myocardial infarction 33.78 12.44 108 37088 105864 90485387
Sleep disorder 33.28 12.44 20 37176 198010 90393241
Urticaria 33.23 12.44 48 37148 312686 90278565
Proctectomy 32.97 12.44 9 37187 200 90591051
Cough 32.13 12.44 260 36936 368702 90222549
Depressed mood 31.45 12.44 66 37130 50156 90541095
Renal disorder 31.36 12.44 56 37140 37803 90553448
Nephritic syndrome 31.09 12.44 10 37186 397 90590854
Pulmonary haemorrhage 31.05 12.44 26 37170 7987 90583264
Lethargy 30.65 12.44 75 37121 63064 90528187
Gastrointestinal haemorrhage 30.63 12.44 94 37102 90154 90501097
Dialysis 30.59 12.44 30 37166 11299 90579952
Antiphospholipid syndrome 30.40 12.44 16 37180 2258 90588993
Endometritis 30.05 12.44 13 37183 1187 90590064
Premature labour 29.91 12.44 32 37164 13344 90577907
Osteoarthritis 29.89 12.44 22 37174 195708 90395543
Vasculitis necrotising 29.63 12.44 11 37185 673 90590578
Hypermagnesaemia 29.55 12.44 13 37183 1236 90590015
Dermatitis bullous 29.14 12.44 28 37168 10288 90580963
Eclampsia 29.11 12.44 10 37186 488 90590763
Lipoma 28.94 12.44 17 37179 2969 90588282
Gastric disorder 28.45 12.44 50 37146 33334 90557917
Orthopnoea 28.20 12.44 23 37173 6812 90584439
Cardiac arrest 28.20 12.44 101 37095 104834 90486417
Lower urinary tract symptoms 28.10 12.44 7 37189 107 90591144
Condition aggravated 27.69 12.44 138 37058 595407 89995844
Acidosis 27.66 12.44 30 37166 12706 90578545
Therapeutic product effect incomplete 26.85 12.44 24 37172 193872 90397379
Pulseless electrical activity 26.67 12.44 25 37171 8907 90582344
Venous thrombosis limb 26.62 12.44 17 37179 3445 90587806
Hypertensive urgency 25.98 12.44 10 37186 676 90590575
Pain 25.87 12.44 273 36923 996068 89595183
Migraine 25.85 12.44 24 37172 190368 90400883
Foetal growth restriction 25.63 12.44 25 37171 9355 90581896
Intentional product use issue 25.36 12.44 31 37165 216861 90374390
Cognitive disorder 25.16 12.44 74 37122 69333 90521918
Primary hyperaldosteronism 24.99 12.44 6 37190 78 90591173
Hepatic enzyme increased 24.96 12.44 71 37125 360665 90230586
Foreign body sensation in eyes 24.87 12.44 16 37180 3284 90587967
Dyspepsia 24.60 12.44 27 37169 198133 90393118
Somatic symptom disorder 24.25 12.44 16 37180 3425 90587826
Pulmonary fibrosis 24.25 12.44 7 37189 107496 90483755
Dry mouth 24.06 12.44 24 37172 184035 90407216
Ileostomy 24.02 12.44 13 37183 1941 90589310
Proteinuria 24.01 12.44 38 37158 23253 90567998
Cardiomegaly 23.98 12.44 34 37162 18891 90572360
Hyphaema 23.95 12.44 8 37188 358 90590893
Transient ischaemic attack 23.91 12.44 54 37142 43122 90548129
Blood glucose decreased 23.85 12.44 38 37158 23391 90567860
Peripartum cardiomyopathy 23.61 12.44 7 37189 211 90591040
Neoplasm skin 23.10 12.44 15 37181 3127 90588124
Prescribed overdose 22.69 12.44 6 37190 97619 90493632
Product dose omission issue 22.44 12.44 200 36996 291487 90299764
Medication error 22.34 12.44 81 37115 84571 90506680
Injury 22.25 12.44 29 37167 197320 90393931
Urinary tract infection 22.22 12.44 207 36989 305425 90285826
Haemorrhoidal haemorrhage 22.15 12.44 18 37178 5305 90585946
Wound infection 22.11 12.44 8 37188 106394 90484857
Hypercholesterolaemia 21.98 12.44 7 37189 100885 90490366
Clostridium test positive 21.92 12.44 18 37178 5383 90585868
Night sweats 21.64 12.44 13 37183 128753 90462498
Jugular vein distension 21.49 12.44 10 37186 1083 90590168
Ileostomy closure 21.32 12.44 7 37189 297 90590954
Subdural haematoma 21.23 12.44 30 37166 16615 90574636
Mitral valve incompetence 20.85 12.44 35 37161 22489 90568762
Necrotising retinitis 20.78 12.44 8 37188 541 90590710
Corneal disorder 20.78 12.44 12 37184 2030 90589221
Pernicious anaemia 20.54 12.44 9 37187 847 90590404
HELLP syndrome 20.47 12.44 10 37186 1207 90590044
Suicidal ideation 20.38 12.44 3 37193 73852 90517399
Blood potassium increased 20.23 12.44 33 37163 20716 90570535
Lung disorder 20.22 12.44 19 37177 149864 90441387
Peritonitis 20.11 12.44 32 37164 19673 90571578
Hypertensive emergency 19.86 12.44 12 37184 2205 90589046
Acute respiratory failure 19.79 12.44 50 37146 42868 90548383
Respiratory distress 19.69 12.44 47 37149 38899 90552352
Hypersensitivity 19.63 12.44 108 37088 454569 90136682
Urine output decreased 19.57 12.44 25 37171 12578 90578673
Hypoperfusion 19.54 12.44 11 37185 1773 90589478
Red blood cell sedimentation rate increased 19.34 12.44 5 37191 82590 90508661
Stillbirth 18.79 12.44 19 37177 7424 90583827
Obesity 18.66 12.44 10 37186 105497 90485754
Wheezing 18.65 12.44 44 37152 238036 90353215
Hyperplasia adrenal 18.42 12.44 4 37192 32 90591219
Blood glucose increased 17.86 12.44 82 37114 95164 90496087
Vulvovaginal mycotic infection 17.57 12.44 17 37179 6297 90584954
Urinary incontinence 17.57 12.44 44 37152 37522 90553729
Drug abuse 17.44 12.44 6 37190 82341 90508910
Psoriasis 17.39 12.44 21 37175 147733 90443518
Blood creatinine increased 17.35 12.44 85 37111 101301 90489950
Hypertrophic cardiomyopathy 17.28 12.44 11 37185 2217 90589034
Haemolytic uraemic syndrome 17.26 12.44 12 37184 2799 90588452
Posterior reversible encephalopathy syndrome 17.17 12.44 32 37164 22307 90568944
SARS-CoV-2 test positive 17.16 12.44 22 37174 11106 90580145
Vascular hyalinosis 17.11 12.44 4 37192 46 90591205
Haemorrhagic transformation stroke 16.97 12.44 9 37187 1290 90589961
Hypoglycaemia 16.90 12.44 65 37131 69783 90521468
Prescribed underdose 16.71 12.44 5 37191 75014 90516237
Glomerular filtration rate decreased 16.60 12.44 27 37169 16905 90574346
Lupus vasculitis 16.59 12.44 7 37189 601 90590650
Hepatic cirrhosis 16.49 12.44 3 37193 63250 90528001
Drug intolerance 16.35 12.44 112 37084 447479 90143772
Haemodynamic instability 16.23 12.44 22 37174 11717 90579534
Eye inflammation 16.19 12.44 18 37178 7833 90583418
Phaeochromocytoma crisis 16.17 12.44 6 37190 367 90590884
Systemic lupus erythematosus 16.14 12.44 85 37111 361811 90229440
Neonatal hyponatraemia 16.07 12.44 4 37192 61 90591190
Pregnancy 16.06 12.44 3 37193 62044 90529207
Pulmonary hypertension 16.05 12.44 46 37150 42477 90548774
Neutropenia 15.74 12.44 44 37152 224860 90366391
Musculoskeletal pain 15.64 12.44 29 37167 171222 90420029
Respiratory rate decreased 15.59 12.44 13 37183 3970 90587281
Bradycardia 15.59 12.44 72 37124 83775 90507476
Ascites 15.52 12.44 49 37147 47691 90543560
Tubulointerstitial nephritis 15.51 12.44 33 37163 25310 90565941
Maternal exposure during pregnancy 15.39 12.44 220 36976 359843 90231408
Iliac artery stenosis 15.15 12.44 4 37192 78 90591173
Lower limb fracture 15.12 12.44 8 37188 85005 90506246
Haemoglobin decreased 15.10 12.44 116 37080 161840 90429411
Memory impairment 15.01 12.44 37 37159 197207 90394044
Periumbilical abscess 15.01 12.44 5 37191 222 90591029
Nail disorder 14.98 12.44 3 37193 59064 90532187
Chronic obstructive pulmonary disease 14.93 12.44 65 37131 73764 90517487
Bullous haemorrhagic dermatosis 14.69 12.44 5 37191 237 90591014
Adverse event 14.56 12.44 16 37180 117402 90473849
Haemoptysis 14.52 12.44 38 37158 33282 90557969
Catheter site abscess 14.44 12.44 5 37191 250 90591001
Joint stiffness 14.39 12.44 7 37189 78035 90513216
Cortisol increased 14.39 12.44 6 37190 500 90590751
Therapy cessation 14.37 12.44 40 37156 36321 90554930
Autoimmune myocarditis 14.19 12.44 5 37191 263 90590988
Paranasal sinus discomfort 14.14 12.44 15 37181 6195 90585056
Azotaemia 14.14 12.44 14 37182 5334 90585917
Umbilical cord vascular disorder 13.98 12.44 4 37192 106 90591145
Throat clearing 13.92 12.44 12 37184 3835 90587416
Nephrogenic anaemia 13.92 12.44 10 37186 2456 90588795
Intestinal anastomosis 13.80 12.44 7 37189 915 90590336
Nephritis 13.71 12.44 11 37185 3184 90588067
Blood pressure abnormal 13.70 12.44 27 37169 19618 90571633
Symptom recurrence 13.62 12.44 12 37184 3947 90587304
Blood sodium decreased 13.61 12.44 33 37163 27580 90563671
Infection 13.52 12.44 90 37106 362004 90229247
Postoperative hypertension 13.50 12.44 3 37193 27 90591224
Ventilation perfusion mismatch 13.48 12.44 6 37190 586 90590665
Methaemoglobinaemia 13.48 12.44 12 37184 4003 90587248
Conjunctival oedema 13.47 12.44 7 37189 962 90590289
Vitreous haemorrhage 13.36 12.44 10 37186 2616 90588635
Leukopenia 13.31 12.44 13 37183 100697 90490554
Coronary artery disease 13.30 12.44 37 37159 33586 90557665
Phaeochromocytoma 13.25 12.44 6 37190 611 90590640
Urine protein/creatinine ratio increased 13.19 12.44 7 37189 1005 90590246
Abortion spontaneous 13.19 12.44 3 37193 54053 90537198
Metabolic encephalopathy 13.11 12.44 15 37181 6737 90584514
Superimposed pre-eclampsia 13.04 12.44 3 37193 32 90591219
Small for dates baby 13.04 12.44 13 37183 4994 90586257
Action tremor 13.03 12.44 5 37191 335 90590916
Road traffic accident 12.98 12.44 15 37181 107611 90483640
Lacrimation increased 12.97 12.44 32 37164 27030 90564221
Stag horn calculus 12.78 12.44 4 37192 145 90591106
Hypertensive nephropathy 12.70 12.44 6 37190 672 90590579
Bicuspid aortic valve 12.65 12.44 4 37192 150 90591101
Hypoglycaemia neonatal 12.51 12.44 7 37189 1115 90590136

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 1706.68 12.90 344 24615 1184 42595192
Lupus-like syndrome 503.06 12.90 148 24811 3006 42593370
Glomerulonephritis rapidly progressive 407.47 12.90 97 24862 823 42595553
Pulmonary renal syndrome 349.28 12.90 68 24891 184 42596192
Gastrointestinal tract mucosal pigmentation 314.24 12.90 72 24887 507 42595869
Glomerulonephritis 279.99 12.90 90 24869 2476 42593900
Cardiac failure congestive 239.13 12.90 272 24687 85330 42511046
Pulmonary alveolar haemorrhage 165.67 12.90 105 24854 14711 42581665
Acute kidney injury 126.71 12.90 486 24473 366851 42229525
Antineutrophil cytoplasmic antibody 120.78 12.90 21 24938 21 42596355
Lupus nephritis 107.41 12.90 30 24929 501 42595875
Device interaction 95.61 12.90 28 24931 558 42595818
End stage renal disease 90.27 12.90 76 24883 16482 42579894
Chronic kidney disease 80.99 12.90 118 24841 47123 42549253
Vasculitis 75.63 12.90 72 24887 18322 42578054
Acute febrile neutrophilic dermatosis 66.92 12.90 29 24930 1855 42594521
Renal vasculitis 59.84 12.90 16 24943 225 42596151
Completed suicide 59.15 12.90 156 24803 96309 42500067
Systemic lupus erythematosus 55.41 12.90 45 24914 9279 42587097
Pulmonary haemorrhage 51.45 12.90 47 24912 11350 42585026
Myocardial infarction 50.87 12.90 174 24785 123835 42472541
Cerebrovascular accident 47.70 12.90 145 24814 97015 42499361
Lupus vasculitis 45.11 12.90 7 24952 0 42596376
Hypotension 44.35 12.90 280 24679 257351 42339025
Pulmonary oedema 43.19 12.90 96 24863 53176 42543200
Renin increased 43.09 12.90 12 24947 198 42596178
Pericardial effusion 41.52 12.90 67 24892 29208 42567168
Pleuropericarditis 41.42 12.90 13 24946 330 42596046
Low birth weight baby 40.98 12.90 39 24920 9916 42586460
Premature baby 39.90 12.90 58 24901 23095 42573281
Peritonitis bacterial 38.21 12.90 32 24927 6883 42589493
Unresponsive to stimuli 38.06 12.90 67 24892 31336 42565040
Overlap syndrome 37.22 12.90 12 24947 333 42596043
Drug abuse 37.11 12.90 8 24951 104763 42491613
Renal failure 36.70 12.90 174 24785 143552 42452824
Mental status changes 36.53 12.90 78 24881 42037 42554339
Hypervolaemia 34.27 12.90 54 24905 23071 42573305
Hypertension 34.04 12.90 190 24769 167014 42429362
General physical health deterioration 33.32 12.90 24 24935 151222 42445154
Suspected suicide 32.84 12.90 28 24931 6171 42590205
Apgar score low 31.51 12.90 14 24945 951 42595425
Ventricular asystole 30.59 12.90 10 24949 290 42596086
Primary biliary cholangitis 29.78 12.90 10 24949 316 42596060
Lupus pneumonitis 29.33 12.90 7 24952 60 42596316
Trigemino-cardiac reflex 28.51 12.90 10 24949 361 42596015
Sinus bradycardia 25.28 12.90 37 24922 14816 42581560
Pyrexia 23.57 12.90 135 24824 393907 42202469
Blood pressure increased 22.87 12.90 119 24840 101809 42494567
Proteinuria 22.80 12.90 45 24914 22938 42573438
Death 22.20 12.90 393 24566 470792 42125584
Hypertensive emergency 21.88 12.90 12 24947 1285 42595091
Bradycardia foetal 21.17 12.90 8 24951 358 42596018
Acute respiratory failure 20.96 12.90 60 24899 38798 42557578
Blood glucose decreased 20.78 12.90 33 24926 14186 42582190
Febrile neutropenia 20.76 12.90 49 24910 185654 42410722
Cardiomegaly 20.61 12.90 36 24923 16730 42579646
Histone antibody positive 20.49 12.90 4 24955 11 42596365
Hospitalisation 20.43 12.90 92 24867 74238 42522138
Hepatic function abnormal 20.29 12.90 3 24956 51564 42544812
Respiratory failure 19.99 12.90 136 24823 127996 42468380
Haemoptysis 19.97 12.90 66 24893 46101 42550275
Anencephaly 19.88 12.90 6 24953 133 42596243
Glomerulonephritis proliferative 19.79 12.90 7 24952 259 42596117
Blood creatinine increased 19.76 12.90 121 24838 109882 42486494
Hypertensive crisis 19.70 12.90 27 24932 10179 42586197
Peripheral swelling 19.29 12.90 104 24855 90166 42506210
Tubulointerstitial nephritis 19.28 12.90 51 24908 31497 42564879
Dialysis 19.17 12.90 29 24930 11957 42584419
Full blood count decreased 18.89 12.90 39 24920 20521 42575855
Human ehrlichiosis 18.63 12.90 8 24951 500 42595876
C-reactive protein increased 18.54 12.90 7 24952 63553 42532823
Chest pain 18.26 12.90 142 24817 139388 42456988
Drug ineffective 18.22 12.90 260 24699 629937 41966439
Eosinophilic pleural effusion 18.14 12.90 7 24952 332 42596044
Antineutrophil cytoplasmic antibody positive 17.77 12.90 17 24942 4348 42592028
Pulmonary embolism 16.41 12.90 28 24931 119584 42476792
Troponin I increased 16.24 12.90 14 24945 3132 42593244
Neutropenia 16.23 12.90 61 24898 199370 42397006
Gastrointestinal haemorrhage 16 12.90 105 24854 97621 42498755
Blood pressure abnormal 15.72 12.90 24 24935 9974 42586402
Mucosal inflammation 15.15 12.90 5 24954 49369 42547007
Microsporidia infection 14.99 12.90 9 24950 1143 42595233
Rickets 14.98 12.90 4 24955 56 42596320
Nephrogenic anaemia 14.36 12.90 12 24947 2574 42593802
Musculoskeletal stiffness 14.31 12.90 8 24951 57757 42538619
Hypocomplementaemia 14.20 12.90 4 24955 69 42596307
Off label use 13.98 12.90 277 24682 638058 41958318
Renal disorder 13.96 12.90 43 24916 28937 42567439
Vasculitis necrotising 13.59 12.90 8 24951 980 42595396
Blood potassium increased 13.46 12.90 32 24927 18504 42577872
Azotaemia 13.45 12.90 17 24942 5927 42590449
Faecal volume decreased 13.38 12.90 5 24954 217 42596159
Blood pressure inadequately controlled 13.28 12.90 12 24947 2856 42593520
Burkholderia test positive 13.14 12.90 8 24951 1042 42595334
Withdrawal hypertension 13.10 12.90 5 24954 230 42596146
Cardiac disorder 13.02 12.90 60 24899 48872 42547504
Rash maculo-papular 13.00 12.90 3 24956 37500 42558876
Renal transplant 12.94 12.90 11 24948 2414 42593962

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 5078.40 12.15 1022 52967 4395 110530915
Glomerulonephritis rapidly progressive 1090.71 12.15 246 53743 1969 110533341
Pulmonary renal syndrome 921.77 12.15 181 53808 660 110534650
Cardiac failure congestive 680.12 12.15 574 53415 150426 110384884
Glomerulonephritis 632.95 12.15 186 53803 4544 110530766
Gastrointestinal tract mucosal pigmentation 581.05 12.15 133 53856 1144 110534166
Lupus-like syndrome 561.69 12.15 310 53679 40482 110494828
Pulmonary alveolar haemorrhage 556.27 12.15 246 53743 19904 110515406
Acute kidney injury 350.79 12.15 880 53109 634550 109900760
Lupus nephritis 296.23 12.15 104 53885 4541 110530769
Vasculitis 276.00 12.15 188 53801 35685 110499625
Acute febrile neutrophilic dermatosis 188.75 12.15 76 53913 4860 110530450
Antineutrophil cytoplasmic antibody 185.20 12.15 33 53956 58 110535252
Loss of employment 172.47 12.15 64 53925 3280 110532030
Renal vasculitis 155.58 12.15 41 53948 660 110534650
Blood pressure inadequately controlled 153.93 12.15 75 53914 7558 110527752
Premature delivery 153.36 12.15 124 53865 30508 110504802
Chronic kidney disease 137.87 12.15 178 53811 76113 110459197
End stage renal disease 129.37 12.15 97 53892 21376 110513934
Mental status changes 112.35 12.15 161 53828 75961 110459349
Cerebrovascular accident 111.14 12.15 262 53727 181022 110354288
General physical health deterioration 105.36 12.15 38 53951 425257 110110053
Synovitis 100.66 12.15 9 53980 274083 110261227
Pulmonary oedema 100.40 12.15 178 53811 100481 110434829
Lupus pneumonitis 100.12 12.15 21 53968 114 110535196
Rheumatoid arthritis 99.58 12.15 14 53975 299599 110235711
Hyperkalaemia 98.62 12.15 210 53779 135586 110399724
Myocardial infarction 96.13 12.15 257 53732 191826 110343484
Serositis 95.74 12.15 34 53955 1535 110533775
Glomerulonephritis proliferative 95.42 12.15 26 53963 478 110534832
Pulmonary haemorrhage 93.97 12.15 72 53917 16384 110518926
Completed suicide 91.28 12.15 293 53696 242088 110293222
Arthropathy 85.54 12.15 18 53971 287504 110247806
Death 85.12 12.15 608 53381 698261 109837049
Device interaction 84.63 12.15 26 53963 741 110534569
Pericardial effusion 84.40 12.15 121 53868 57096 110478214
Infusion related reaction 83.26 12.15 41 53948 381121 110154189
Treatment failure 81.16 12.15 18 53971 277216 110258094
Glossodynia 79.63 12.15 8 53981 221996 110313314
Psoriatic arthropathy 79.42 12.15 4 53985 196757 110338553
Hepatic steatosis 76.07 12.15 106 53883 48725 110486585
Peritonitis bacterial 75.80 12.15 53 53936 10480 110524830
Body mass index abnormal 75.73 12.15 25 53964 903 110534407
Renal failure 74.75 12.15 262 53727 226312 110308998
Inflammation 74.72 12.15 5 53984 193233 110342077
Joint swelling 74.50 12.15 64 53925 442781 110092529
Hypervolaemia 73.54 12.15 105 53884 49355 110485955
Hypotension 72.81 12.15 471 53518 523378 110011932
Lower respiratory tract infection 72.76 12.15 15 53974 243091 110292219
Respiratory failure 71.03 12.15 249 53740 215083 110320227
Central nervous system lupus 70.16 12.15 26 53963 1327 110533983
Renal impairment 67.49 12.15 224 53765 188221 110347089
Musculoskeletal stiffness 65.94 12.15 27 53962 279795 110255515
Exercise tolerance decreased 64.99 12.15 51 53938 12016 110523294
Alveolitis 64.55 12.15 35 53954 4404 110530906
Fibromyalgia 64.42 12.15 5 53984 170904 110364406
Irritable bowel syndrome 64.23 12.15 4 53985 164211 110371099
Impaired healing 63.48 12.15 10 53979 196707 110338603
Dyspnoea 62.24 12.15 818 53171 1106054 109429256
Cardiac failure 61.90 12.15 217 53772 187409 110347901
Pyrexia 61.81 12.15 228 53761 898037 109637273
Multiple drug therapy 61.61 12.15 42 53947 7972 110527338
BRASH syndrome 61.61 12.15 32 53957 3691 110531619
Blood pressure increased 61.05 12.15 269 53720 258104 110277206
Pre-eclampsia 61.03 12.15 43 53946 8607 110526703
Alopecia 60.99 12.15 53 53936 364700 110170610
Antineutrophil cytoplasmic antibody positive 60.16 12.15 35 53954 5041 110530269
Hypertension 58.12 12.15 437 53552 509647 110025663
Atrial fibrillation 58.03 12.15 244 53745 229398 110305912
Wound 57.92 12.15 21 53968 234416 110300894
Diabetes mellitus inadequate control 57.77 12.15 72 53917 29703 110505607
Sinusitis 56.10 12.15 38 53951 296650 110238660
Exposure during pregnancy 53.82 12.15 192 53797 167232 110368078
Pericarditis 53.50 12.15 20 53969 219094 110316216
Proteinuria 52.35 12.15 80 53909 39938 110495372
Shock 51.16 12.15 93 53896 53495 110481815
Blood cholesterol increased 50.18 12.15 14 53975 184771 110350539
C-reactive protein increased 49.78 12.15 22 53967 217897 110317413
Drug abuse 49.01 12.15 13 53976 177398 110357912
Pleural effusion 48.99 12.15 194 53795 177515 110357795
Vasculitis necrotising 45.85 12.15 20 53969 1563 110533747
Unresponsive to stimuli 45.53 12.15 98 53891 63692 110471618
Treatment noncompliance 45.24 12.15 106 53883 72884 110462426
Gliosis 45.19 12.15 16 53973 716 110534594
Cardiomegaly 45.01 12.15 63 53926 29067 110506243
Type 2 diabetes mellitus 43.56 12.15 16 53973 177216 110358094
Urticaria 43.54 12.15 55 53934 318802 110216508
Gastrointestinal haemorrhage 43.47 12.15 178 53811 165340 110369970
Polyserositis 43.29 12.15 17 53972 1017 110534293
Blood glucose decreased 42.95 12.15 62 53927 29426 110505884
Cardiac tamponade 42.78 12.15 39 53950 11268 110524042
Nasopharyngitis 42.39 12.15 80 53909 394281 110141029
Stomatitis 41.93 12.15 42 53947 270200 110265110
Haemoptysis 41.39 12.15 101 53888 71253 110464057
Sleep disorder 40.93 12.15 23 53966 198621 110336689
Ovarian failure 40.70 12.15 16 53973 960 110534350
Haematuria 40.42 12.15 110 53879 82895 110452415
Lupus vasculitis 40.03 12.15 14 53975 604 110534706
Blood creatinine increased 39.88 12.15 186 53803 182703 110352607
Premature menopause 39.69 12.15 16 53973 1026 110534284
Hospitalisation 39.62 12.15 156 53833 142337 110392973
Gout 39.49 12.15 67 53922 36499 110498811
Hypertensive emergency 39.44 12.15 23 53966 3328 110531982
Dialysis 38.96 12.15 48 53941 19571 110515739
Acute respiratory failure 38.93 12.15 102 53887 75158 110460152
Acute myocardial infarction 38.79 12.15 109 53880 83668 110451642
Renin increased 38.67 12.15 12 53977 354 110534956
Monocytosis 37.82 12.15 18 53971 1722 110533588
Epilepsy 37.57 12.15 3 53986 100206 110435104
Joint range of motion decreased 37.53 12.15 7 53982 121825 110413485
Tubulointerstitial nephritis 37.15 12.15 82 53907 54202 110481108
Swelling 37.03 12.15 72 53917 350969 110184341
Suspected suicide 36.52 12.15 41 53948 15158 110520152
Osteoarthritis 36.41 12.15 22 53967 182601 110352709
Discomfort 36.10 12.15 31 53958 214676 110320634
Generalised oedema 35.49 12.15 58 53931 30646 110504664
Oedema peripheral 35.38 12.15 278 53711 328382 110206928
Pouchitis 35.17 12.15 16 53973 1381 110533929
Pleuropericarditis 35.16 12.15 13 53976 659 110534651
Cardiac arrest 35.06 12.15 189 53800 196564 110338746
Myelosuppression 34.88 12.15 3 53986 94337 110440973
Vaccination site pain 34.10 12.15 12 53977 527 110534783
Left ventricle outflow tract obstruction 34.02 12.15 12 53977 531 110534779
Condition aggravated 33.86 12.15 215 53774 734621 109800689
Norepinephrine increased 33.51 12.15 8 53981 84 110535226
Therapeutic product effect incomplete 33.34 12.15 36 53953 223769 110311541
Ventricular asystole 32.78 12.15 11 53978 418 110534892
Ill-defined disorder 32.54 12.15 18 53971 156835 110378475
Pain 32.46 12.15 304 53685 954651 109580659
Hypoxia 32.21 12.15 137 53852 129378 110405932
Cutaneous vasculitis 31.72 12.15 35 53954 12694 110522616
Premature labour 31.55 12.15 30 53959 9142 110526168
Nephritic syndrome 30.96 12.15 11 53978 497 110534813
Lethargy 30.64 12.15 108 53881 93468 110441842
Endometritis 30.49 12.15 13 53976 961 110534349
Liver injury 30.15 12.15 18 53971 150395 110384915
Migraine 29.82 12.15 24 53965 171628 110363682
Ulcerative keratitis 29.76 12.15 22 53967 4744 110530566
Hypertensive crisis 29.48 12.15 47 53942 24325 110510985
Gastric disorder 29.47 12.15 56 53933 33301 110502009
Blister 29.21 12.15 41 53948 227335 110307975
Exposure to SARS-CoV-2 29.08 12.15 18 53971 2901 110532409
Lung disorder 29.06 12.15 27 53962 180020 110355290
Dry mouth 28.86 12.15 33 53956 199915 110335395
Hypertensive urgency 28.34 12.15 13 53976 1144 110534166
Trigemino-cardiac reflex 27.96 12.15 10 53979 461 110534849
Suicidal ideation 27.67 12.15 6 53983 93931 110441379
Azotaemia 27.35 12.15 29 53960 10056 110525254
Product use in unapproved indication 27.24 12.15 119 53870 447258 110088052
Dermatitis bullous 27.22 12.15 38 53951 17491 110517819
Pulmonary fibrosis 27.20 12.15 8 53981 102034 110433276
Dyspepsia 27.05 12.15 32 53957 190933 110344377
Orthopnoea 26.94 12.15 30 53959 10991 110524319
Proctectomy 26.90 12.15 9 53980 339 110534971
Metabolic encephalopathy 26.85 12.15 30 53959 11030 110524280
Neutropenia 26.40 12.15 94 53895 374526 110160784
Lipoma 26.38 12.15 19 53970 3936 110531374
Eclampsia 26.31 12.15 9 53980 363 110534947
Antiphospholipid syndrome 26.26 12.15 16 53973 2507 110532803
Nephrogenic anaemia 26.07 12.15 20 53969 4557 110530753
Musculoskeletal pain 25.57 12.15 31 53958 182992 110352318
Renal disorder 25.53 12.15 67 53922 49412 110485898
Clostridium test positive 25.51 12.15 29 53960 10864 110524446
Coronary artery disease 25.45 12.15 85 53904 71605 110463705
Stillbirth 25.10 12.15 19 53970 4245 110531065
Hypercholesterolaemia 24.44 12.15 7 53982 90830 110444480
Subdural haematoma 23.75 12.15 54 53935 36400 110498910
Ventricular hyperkinesia 23.62 12.15 8 53981 313 110534997
Glomerular filtration rate decreased 23.61 12.15 47 53942 28909 110506401
Haemorrhagic transformation stroke 23.55 12.15 16 53973 3021 110532289
Peripheral venous disease 23.54 12.15 6 53983 84111 110451199
Intentional product use issue 23.49 12.15 54 53935 247852 110287458
Sinus bradycardia 23.02 12.15 47 53942 29436 110505874
Somatic symptom disorder 22.97 12.15 16 53973 3143 110532167
Nephritis 22.92 12.15 21 53968 6105 110529205
Acidosis 22.65 12.15 40 53949 22491 110512819
Pulseless electrical activity 22.62 12.15 34 53955 16723 110518587
Hepatic enzyme increased 22.28 12.15 81 53908 320811 110214499
Chest pain 21.78 12.15 280 53709 376095 110159215
Angioedema 21.33 12.15 100 53889 98400 110436910
Febrile neutropenia 21.31 12.15 81 53908 316686 110218624
Small for dates baby 21.27 12.15 9 53980 653 110534657
Hypoglycaemia 20.99 12.15 112 53877 115992 110419318
Obesity 20.77 12.15 15 53974 113336 110421974
Hepatitis 20.70 12.15 9 53980 90045 110445265
Neoplasm skin 20.48 12.15 15 53974 3189 110532121
Blood potassium increased 20.28 12.15 48 53941 33201 110502109
Mitral valve incompetence 20.21 12.15 48 53941 33281 110502029
Anaemia 20.14 12.15 377 53612 546709 109988601
Pernicious anaemia 19.91 12.15 9 53980 765 110534545
Vascular hyalinosis 19.66 12.15 6 53983 167 110535143
C3 glomerulopathy 19.53 12.15 6 53983 171 110535139
Ileostomy 19.50 12.15 13 53976 2379 110532931
Pathergy reaction 19.49 12.15 5 53984 72 110535238
Hypocomplementaemia 19.42 12.15 7 53982 330 110534980
Wheezing 19.36 12.15 62 53927 255168 110280142
Red blood cell sedimentation rate increased 19.35 12.15 7 53982 78295 110457015
Psoriasis 19.25 12.15 24 53965 139969 110395341
Cardiac disorder 19.20 12.15 81 53908 76199 110459111
Drug intolerance 19.17 12.15 118 53871 406394 110128916
Umbilical cord vascular disorder 19.03 12.15 4 53985 22 110535288
Injury 18.99 12.15 36 53953 177229 110358081
Peripartum cardiomyopathy 18.93 12.15 6 53983 190 110535120
Maternal exposure during pregnancy 18.92 12.15 199 53790 254684 110280626
Depressed mood 18.90 12.15 69 53920 60740 110474570
Hypertensive encephalopathy 18.87 12.15 10 53979 1201 110534109
Haemoglobin decreased 18.85 12.15 195 53794 248532 110286778
Hypermagnesaemia 18.73 12.15 11 53978 1612 110533698
Ileostomy closure 18.73 12.15 7 53982 366 110534944
Cough 18.71 12.15 323 53666 461318 110073992
Bradycardia 18.66 12.15 135 53854 155382 110379928
Posterior reversible encephalopathy syndrome 18.65 12.15 47 53942 33814 110501496
Transient ischaemic attack 18.55 12.15 71 53918 63911 110471399
Night sweats 18.39 12.15 23 53966 133960 110401350
Haemorrhoidal haemorrhage 18.04 12.15 21 53968 8072 110527238
Depression 17.76 12.15 87 53902 317248 110218062
Foreign body sensation in eyes 17.76 12.15 14 53975 3320 110531990
Venous thrombosis limb 17.69 12.15 17 53972 5248 110530062
Plasma cell myeloma 17.56 12.15 69 53920 62867 110472443
Antinuclear antibody 17.48 12.15 7 53982 441 110534869
Road traffic accident 17.45 12.15 16 53973 107382 110427928
Human ehrlichiosis 17.41 12.15 8 53981 707 110534603
Vulvovaginal mycotic infection 17.39 12.15 17 53972 5360 110529950
Primary biliary cholangitis 17.26 12.15 10 53979 1429 110533881
Kidney transplant rejection 17.16 12.15 25 53964 11962 110523348
Urine output decreased 17.10 12.15 33 53956 19843 110515467
Premature baby 16.93 12.15 16 53973 4839 110530471
Hyphaema 16.86 12.15 9 53980 1098 110534212
Prescribed overdose 16.83 12.15 11 53978 87570 110447740
Primary hyperaldosteronism 16.83 12.15 6 53983 274 110535036
Blood urea increased 16.77 12.15 62 53927 54895 110480415
Foetal growth restriction 16.66 12.15 13 53976 3037 110532273
Lower urinary tract symptoms 16.66 12.15 7 53982 499 110534811
Blood pressure abnormal 16.63 12.15 35 53954 22389 110512921
Pulmonary hypertension 16.61 12.15 62 53927 55158 110480152
Microscopic polyangiitis 16.56 12.15 7 53982 506 110534804
Hyperplasia adrenal 16.50 12.15 4 53985 45 110535265
Throat clearing 16.50 12.15 15 53974 4318 110530992
Nail disorder 16.47 12.15 4 53985 57931 110477379
Eosinophilic pleural effusion 16.37 12.15 7 53982 521 110534789
Drug reaction with eosinophilia and systemic symptoms 16.20 12.15 10 53979 82085 110453225
Jugular vein distension 16.19 12.15 10 53979 1606 110533704
Wound infection 16.12 12.15 14 53975 96451 110438859
Cardiac failure acute 16.05 12.15 36 53953 24042 110511268
Injection site reaction 16.04 12.15 12 53977 89058 110446252
HELLP syndrome 15.86 12.15 8 53981 868 110534442
Contusion 15.84 12.15 179 53810 233182 110302128
Malignant neoplasm progression 15.76 12.15 39 53950 174528 110360782
Histone antibody positive 15.55 12.15 5 53984 166 110535144
Respiratory rate decreased 15.24 12.15 17 53972 6241 110529069
Focal segmental glomerulosclerosis 15.10 12.15 14 53975 4131 110531179
Hepatic function abnormal 14.87 12.15 13 53976 89282 110446028
Product dose omission issue 14.83 12.15 230 53759 321552 110213758
Haemodialysis 14.74 12.15 29 53960 17690 110517620
Microsporidia infection 14.66 12.15 9 53980 1430 110533880
Hypertensive nephropathy 14.58 12.15 8 53981 1030 110534280
Urinary tract infection 14.57 12.15 232 53757 326050 110209260
Cholestatic liver injury 14.57 12.15 18 53971 7358 110527952
Foot deformity 14.48 12.15 3 53986 48477 110486833
Methaemoglobinaemia 14.42 12.15 20 53969 9148 110526162
Urinary incontinence 14.15 12.15 54 53935 48533 110486777
Back injury 14.02 12.15 3 53986 47396 110487914
Cholestasis 13.98 12.15 7 53982 64511 110470799
Urine protein/creatinine ratio increased 13.92 12.15 9 53980 1564 110533746
Hip arthroplasty 13.78 12.15 5 53984 55808 110479502
Paraesthesia 13.70 12.15 79 53910 276442 110258868
Hepatic cirrhosis 13.68 12.15 8 53981 67618 110467692
Ventilation perfusion mismatch 13.62 12.15 7 53982 790 110534520
Troponin I increased 13.60 12.15 15 53974 5437 110529873
Cognitive disorder 13.55 12.15 81 53908 87430 110447880
Memory impairment 13.47 12.15 50 53939 196894 110338416
Coma 13.46 12.15 23 53966 117846 110417464
Phaeochromocytoma crisis 13.30 12.15 6 53983 508 110534802
Gastric ileus 13.30 12.15 3 53986 24 110535286
Autoimmune hepatitis 13.26 12.15 25 53964 14779 110520531
Phaeochromocytoma 13.23 12.15 7 53982 838 110534472
Catheter site abscess 13.17 12.15 5 53984 273 110535037
Full blood count decreased 13.16 12.15 40 53949 32059 110503251
Eye inflammation 12.94 12.15 19 53970 9152 110526158
Chronic left ventricular failure 12.93 12.15 8 53981 1288 110534022
Peritonitis 12.78 12.15 40 53949 32567 110502743
Prescribed underdose 12.78 12.15 8 53981 65166 110470144
Multiple injuries 12.77 12.15 12 53977 3602 110531708
Renal aneurysm 12.77 12.15 5 53984 297 110535013
Intestinal anastomosis 12.53 12.15 7 53982 934 110534376
Periumbilical abscess 12.52 12.15 5 53984 313 110534997
Lower limb fracture 12.51 12.15 11 53978 75337 110459973
Renal artery stenosis 12.46 12.15 12 53977 3714 110531596
Respiratory tract infection 12.45 12.15 10 53979 71607 110463703
Vomiting 12.44 12.15 344 53645 910331 109624979
Incorrect route of product administration 12.37 12.15 8 53981 64053 110471257
Medication error 12.37 12.15 91 53898 105275 110430035
Subcapsular renal haematoma 12.36 12.15 7 53982 959 110534351
Postoperative hypertension 12.28 12.15 3 53986 35 110535275
Parathyroid scan abnormal 12.20 12.15 3 53986 36 110535274
Essential hypertension 12.17 12.15 17 53972 7830 110527480

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:35526 hypoglycemic agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35620 vasodilator agent
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:145947 antiatherosclerotic agent
CHEBI has role CHEBI:66981 ophthalmology drug

Related Drugs by ATC class:

C02DB Hydrazinophthalazine derivatives 3 drugs
cadralazinedihydralazineendralazine
C02LG Hydrazinophthalazine derivatives and diuretics 2 drugs
dihydralazinepicodralazine

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




🐶 Veterinary Drug Use

None

🐶 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
Myeloperoxidase Enzyme IC50 6.05 CHEMBL
Aldehyde oxidase Enzyme IC50 5.41 CHEMBL
Peroxisomal acyl-coenzyme A oxidase 1 Enzyme IC50 6.38 CHEMBL
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
Arachidonate 15-lipoxygenase Enzyme IC50 5.44 DRUG MATRIX

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
26NAK24LS8 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0404-9787 INJECTION 20 mg INTRAVENOUS 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 0641-6231 INJECTION, SOLUTION 20 mg INTRAMUSCULAR ANDA 18 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7447 TABLET 10 mg ORAL ANDA 12 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7448 TABLET 25 mg ORAL ANDA 12 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7449 TABLET 50 mg ORAL ANDA 12 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7450 TABLET 100 mg ORAL ANDA 12 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 12 sections
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 23155-002 TABLET, FILM COATED 25 mg ORAL ANDA 12 sections
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 23155-003 TABLET, FILM COATED 50 mg ORAL ANDA 12 sections
HYDRALAZINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 23155-004 TABLET, FILM COATED 100 mg ORAL ANDA 12 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 23155-832 TABLET 10 mg ORAL ANDA 12 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 23155-833 TABLET 25 mg ORAL ANDA 12 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 23155-834 TABLET 50 mg ORAL ANDA 12 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 23155-835 TABLET 100 mg ORAL ANDA 12 sections
BiDil Human Prescription Drug Label 2 24338-010 TABLET, FILM COATED 37.50 mg ORAL NDA 29 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 31722-519 TABLET 10 mg ORAL ANDA 19 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 31722-520 TABLET 25 mg ORAL ANDA 19 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 31722-521 TABLET 50 mg ORAL ANDA 19 sections
Hydralazine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 31722-522 TABLET 100 mg ORAL ANDA 19 sections
Hydralazine Hydrochloride Human Prescription Drug Label 1 33342-374 TABLET 10 mg ORAL ANDA 21 sections
Hydralazine Hydrochloride Human Prescription Drug Label 1 33342-375 TABLET 25 mg ORAL ANDA 21 sections
Hydralazine Hydrochloride Human Prescription Drug Label 1 33342-376 TABLET 50 mg ORAL ANDA 21 sections
Hydralazine Hydrochloride Human Prescription Drug Label 1 33342-377 TABLET 100 mg ORAL ANDA 21 sections