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

Stem definitionDrug idCAS RN
blood coagulation factor XA inhibitors, antithrombotics 4897 480449-70-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • edoxaban tosylate
  • edoxaban
  • edoxaban tosilate
  • edoxaban tosilate hydrate
  • lixiana
  • DU-176b
  • savaysa
An orally active inhibitor of coagulation factor Xa (activated factor X) with anticoagulant activity. Edoxaban is administered as edoxaban tosylate. This agent has an elimination half-life of 9-11 hours and undergoes renal excretion.
  • Molecular weight: 548.06
  • Formula: C24H30ClN7O4S
  • CLOGP: 1.86
  • LIPINSKI: 2
  • HAC: 11
  • HDO: 3
  • TPSA: 136.63
  • ALOGS: -4.68
  • ROTB: 6
  • Status: ONP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
60 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 4 Hosey CM, Chan R, Benet LZ
Vd (Volume of distribution) 1.53 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 5.19 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.50 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 6.70 hours Lombardo F, Berellini G, Obach RS
S (Water solubility) 0.09 mg/mL Bocci G, Oprea TI, Benet LZ
BA (Bioavailability) 62 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 1.489 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 7.925 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 24.946 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 1.327 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 66.720 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 73.360 % High 1
herg hERG pIC50 4.593 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 1.503 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 6.166 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 56.470 % High 1
kinase-safety-class EIF2AK3,GRK2,PDK1,PDK2,PDK4 5
kinase-selectivity-class PDK1 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 17.947 High 1
mh-clint Mouse hepatocyte intrinsic clearance 3.972 High 1
mppb Mouse plasma protein binding (% unbound) 47.810 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 43.451 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 65.430 % High 1
rh-clint Rat hepatocyte intrinsic clearance 3.141 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 87.920 % High 1
rppb Rat plasma protein binding (% unbound) 49.770 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 578.096 uM High 1

Approvals:

DateAgencyCompanyOrphan
June 19, 2015 EMA Daiichi Sankyo Europe GmbH
Jan. 8, 2015 FDA DAIICHI SANKYO
April 22, 2011 PMDA DAIICHI SANKYO COMPANY, Limited

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
Anaemia 358.20 20.56 405 18726 352397 90256919
Cardiac failure 277.43 20.56 210 18921 109286 90500030
Cerebral infarction 262.66 20.56 123 19008 26473 90582843
Renal impairment 210.84 20.56 176 18955 105245 90504071
Atrial fibrillation 201.33 20.56 190 18941 133421 90475895
Gastrointestinal haemorrhage 185.27 20.56 153 18978 90095 90519221
Melaena 184.55 20.56 106 19025 34691 90574625
General physical health deterioration 184.01 20.56 294 18837 354821 90254495
Lymphatic fistula 135.70 20.56 36 19095 1425 90607891
Femoral hernia incarcerated 134.57 20.56 36 19095 1472 90607844
Arterial haemorrhage 133.33 20.56 40 19091 2483 90606833
Labelled drug-drug interaction medication error 130.36 20.56 63 19068 14519 90594797
Haematuria 130.32 20.56 85 19046 34852 90574464
Aortic valve stenosis 128.33 20.56 44 19087 4196 90605120
Pancreatic steatosis 126.90 20.56 35 19096 1607 90607709
Product monitoring error 125.35 20.56 44 19087 4500 90604816
Wound infection pseudomonas 124.10 20.56 36 19095 1987 90607329
Embolic stroke 118.36 20.56 41 19090 4031 90605285
Drug ineffective 112.41 20.56 78 19053 1384220 89225096
Haematochezia 110.83 20.56 103 19028 70810 90538506
Haemarthrosis 107.59 20.56 38 19093 3956 90605360
Seroma 105.41 20.56 35 19096 3025 90606291
Hyponatraemia 101.82 20.56 133 18998 133405 90475911
Tachyarrhythmia 99.91 20.56 39 19092 5367 90603949
Cerebral haemorrhage 95.76 20.56 70 19061 34452 90574864
Arrhythmia 95.74 20.56 76 19055 42256 90567060
Hyperkalaemia 93.20 20.56 90 19041 64874 90544442
Subarachnoid haemorrhage 90.80 20.56 53 19078 17851 90591465
Diverticulum intestinal 89.34 20.56 42 19089 9100 90600216
Hepatic cyst 89.23 20.56 38 19093 6530 90602786
Eructation 85.31 20.56 43 19088 10839 90598477
Streptococcal sepsis 84.88 20.56 31 19100 3553 90605763
Faecaloma 84.07 20.56 42 19089 10389 90598927
Anuria 83.54 20.56 47 19084 14771 90594545
Wound dehiscence 83.48 20.56 35 19096 5787 90603529
Mitral valve incompetence 79.61 20.56 53 19078 22471 90586845
Pseudomonal sepsis 79.37 20.56 31 19100 4271 90605045
Syncope 78.50 20.56 117 19014 132546 90476770
Aortic arteriosclerosis 77.25 20.56 36 19095 7648 90601668
Tachycardia 76.58 20.56 127 19004 157546 90451770
Nail bed inflammation 75.88 20.56 24 19107 1777 90607539
Tricuspid valve incompetence 75.65 20.56 46 19085 16685 90592631
Groin pain 72.29 20.56 40 19091 12173 90597143
Pallor 72.29 20.56 59 19072 34106 90575210
Nasal mucosal disorder 71.06 20.56 23 19108 1834 90607482
Inflammatory marker increased 71.03 20.56 36 19095 9178 90600138
Cardiovascular disorder 68.57 20.56 40 19091 13452 90595864
Cardiac failure chronic 67.99 20.56 30 19101 5616 90603700
Dyspnoea 67.95 20.56 365 18766 880590 89728726
Drug hypersensitivity 67.59 20.56 9 19122 463600 90145716
Acute kidney injury 67.14 20.56 183 18948 320204 90289112
Hypersensitivity 65.88 20.56 9 19122 454668 90154648
Escherichia infection 65.02 20.56 41 19090 15854 90593462
Maternal exposure during pregnancy 63.45 20.56 3 19128 360060 90249256
Left ventricular dysfunction 62.93 20.56 39 19092 14630 90594686
Arthropathy 61.61 20.56 4 19127 366238 90243078
Infusion related reaction 60.97 20.56 8 19123 416772 90192544
Postoperative wound infection 60.92 20.56 37 19094 13389 90595927
Atrial tachycardia 60.02 20.56 28 19103 5962 90603354
Oedema peripheral 59.79 20.56 153 18978 257762 90351554
Product prescribing error 59.49 20.56 50 19081 30095 90579221
Aplastic anaemia 58.76 20.56 36 19095 13233 90596083
Drug intolerance 57.90 20.56 12 19119 447579 90161737
Varicose vein 57.57 20.56 29 19102 7298 90602018
Heparin resistance 57.24 20.56 10 19121 47 90609269
Cardiospasm 57.18 20.56 23 19108 3423 90605893
Myelodysplastic syndrome 57.09 20.56 42 19089 20861 90588455
Palmoplantar keratoderma 56.79 20.56 23 19108 3484 90605832
Swelling 54.69 20.56 11 19120 419047 90190269
Pulmonary hypertension 53.73 20.56 55 19076 42468 90566848
Rheumatoid arthritis 52.93 20.56 7 19124 362607 90246709
Treatment failure 52.07 20.56 3 19128 303925 90305391
Sinusitis 51.59 20.56 6 19125 343082 90266234
Sleep terror 51.44 20.56 23 19108 4441 90604875
Bradycardia 51.08 20.56 75 19056 83772 90525544
Pruritus genital 50.98 20.56 23 19108 4535 90604781
Ischaemic stroke 50.54 20.56 40 19091 22126 90587190
Carotid artery occlusion 49.53 20.56 25 19106 6317 90602999
Nasopharyngitis 48.52 20.56 13 19118 407091 90202225
Pain 46.92 20.56 87 19044 996254 89613062
Systemic infection 46.85 20.56 22 19109 4753 90604563
Vascular device infection 46.82 20.56 30 19101 11922 90597394
Paronychia 46.77 20.56 26 19105 7980 90601336
Blindness 46.20 20.56 41 19090 26527 90582789
Shock haemorrhagic 46.15 20.56 30 19101 12215 90597101
Dehydration 45.71 20.56 116 19015 194331 90414985
Drug interaction 45.53 20.56 145 18986 276308 90333008
Osteopenia 45.07 20.56 38 19093 22964 90586352
Metastases to lymph nodes 44.95 20.56 29 19102 11660 90597656
Subdural haematoma 44.45 20.56 33 19098 16612 90592704
Upper gastrointestinal haemorrhage 43.06 20.56 37 19094 22939 90586377
Cardiogenic shock 43.03 20.56 38 19093 24430 90584886
Tension headache 42.82 20.56 24 19107 7485 90601831
Coronary artery disease 41.59 20.56 43 19088 33580 90575736
Internal haemorrhage 41.34 20.56 22 19109 6198 90603118
Thrombophlebitis migrans 41.30 20.56 10 19121 272 90609044
Urticaria 41.22 20.56 8 19123 312726 90296590
Joint swelling 41.07 20.56 28 19103 503272 90106044
Systemic lupus erythematosus 40.48 20.56 13 19118 361883 90247433
Haematoma 39.66 20.56 45 19086 39003 90570313
Aortic dissection 39.65 20.56 16 19115 2401 90606915
Cardiac failure acute 39.59 20.56 27 19104 11902 90597414
Urinary retention 39.19 20.56 44 19087 37700 90571616
Brain oedema 38.84 20.56 31 19100 17354 90591962
Mobility decreased 38.66 20.56 4 19127 250730 90358586
Hiatus hernia 37.99 20.56 36 19095 25325 90583991
Interstitial lung disease 37.67 20.56 62 19069 76343 90532973
Immunisation 37.51 20.56 15 19116 2198 90607118
Product dose omission issue 37.32 20.56 8 19123 291679 90317637
Therapeutic drug monitoring analysis not performed 37.15 20.56 13 19118 1316 90608000
Cerebrovascular accident 36.96 20.56 81 19050 123452 90485864
Anosmia 36.80 20.56 24 19107 9824 90599492
Exposure during pregnancy 36.25 20.56 4 19127 238406 90370910
Hepatic enzyme increased 35.28 20.56 16 19115 360720 90248596
Myocardial infarction 34.60 20.56 72 19059 105900 90503416
Metastases to central nervous system 34.41 20.56 29 19102 17513 90591803
Pleural effusion 34.15 20.56 74 19057 111917 90497399
Hepatic function abnormal 33.53 20.56 45 19086 46243 90563073
Depression 33.25 20.56 11 19120 300590 90308726
Ventricular tachycardia 33.12 20.56 33 19098 24675 90584641
Angina pectoris 32.95 20.56 41 19090 39119 90570197
Alopecia 32.46 20.56 34 19097 495037 90114279
Fall 31.92 20.56 192 18939 481618 90127698
Product used for unknown indication 31.40 20.56 10 19121 757 90608559
Chorea 31.31 20.56 13 19118 2097 90607219
Electrocardiogram abnormal 31.10 20.56 22 19109 10276 90599040
Blister 30.63 20.56 8 19123 254990 90354326
Facial pain 30.51 20.56 24 19107 13158 90596158
Sopor 29.55 20.56 31 19100 24613 90584703
Malignant neoplasm progression 28.54 20.56 67 19064 106803 90502513
Gastroenteritis clostridial 28.46 20.56 9 19122 666 90608650
Haemorrhage subcutaneous 28.33 20.56 14 19117 3382 90605934
Product use issue 27.36 20.56 18 19113 329901 90279415
Rhonchi 27.01 20.56 13 19118 2965 90606351
Electrolyte imbalance 26.93 20.56 29 19102 23716 90585600
Rash 26.69 20.56 83 19048 796017 89813299
Pain of skin 26.35 20.56 24 19107 16058 90593258
Vasculitis 26.24 20.56 28 19103 22665 90586651
Injection site pain 26.19 20.56 3 19128 173696 90435620
Candida infection 26.04 20.56 34 19097 34023 90575293
BRASH syndrome 25.95 20.56 11 19120 1868 90607448
Joint dislocation 25.88 20.56 39 19092 44543 90564773
Liver injury 25.58 20.56 3 19128 170564 90438752
Arthritis 24.95 20.56 3 19128 167312 90442004
Cerebral artery embolism 24.87 20.56 9 19122 1004 90608312
Haemorrhage 24.86 20.56 49 19082 69320 90539996
Asthma 24.85 20.56 10 19121 242150 90367166
Sinus node dysfunction 24.77 20.56 15 19116 5397 90603919
Lower gastrointestinal haemorrhage 24.58 20.56 18 19113 8874 90600442
Hypokalaemia 24.56 20.56 72 19059 131044 90478272
Femoral neck fracture 24.48 20.56 19 19112 10214 90599102
Sleep disorder 24.19 20.56 6 19125 198024 90411292
Atrial thrombosis 24.07 20.56 11 19120 2234 90607082
Injury 24.07 20.56 6 19125 197343 90411973
Pneumonia aspiration 24.03 20.56 36 19095 40904 90568412
Transient ischaemic attack 23.98 20.56 37 19094 43139 90566177
Contraindicated product administered 23.29 20.56 20 19111 320119 90289197
Restlessness 23.27 20.56 33 19098 35687 90573629
Oesophageal mucosal tear 23.23 20.56 4 19127 17 90609299
Hallucination 22.92 20.56 46 19085 65913 90543403
Marasmus 22.81 20.56 8 19123 815 90608501
Lip swelling 22.73 20.56 34 19097 38576 90570740
Palpitations 22.73 20.56 72 19059 136656 90472660
Gastrointestinal disorder 22.67 20.56 13 19118 256674 90352642
Faeces discoloured 22.38 20.56 25 19106 21295 90588021
Haemorrhage intracranial 21.71 20.56 21 19110 15141 90594175
Glomerular filtration rate decreased 21.56 20.56 22 19109 16910 90592406
Atrial conduction time prolongation 21.30 20.56 4 19127 30 90609286
Skin fissures 21.16 20.56 24 19107 20785 90588531
Gastrointestinal angiodysplasia 20.99 20.56 7 19124 613 90608703
Psychotic symptom 20.92 20.56 10 19121 2246 90607070
Cholangitis 20.90 20.56 15 19116 7167 90602149
Polyneuropathy 20.85 20.56 23 19108 19318 90589998
Haemorrhagic cerebral infarction 20.76 20.56 7 19124 634 90608682
Acute on chronic liver failure 20.63 20.56 6 19125 334 90608982

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
Cerebral infarction 247.67 15.69 153 16420 31016 42573746
Cardiac failure 202.76 15.69 228 16345 106628 42498134
Renal impairment 185.31 15.69 221 16352 110007 42494755
Haematuria 173.16 15.69 158 16415 57641 42547121
Melaena 142.33 15.69 119 16454 38627 42566135
Anaemia 133.93 15.69 319 16254 279959 42324803
Embolic stroke 130.44 15.69 55 16518 4985 42599777
Atrial fibrillation 123.73 15.69 206 16367 139387 42465375
General physical health deterioration 102.98 15.69 199 16374 151047 42453715
Interstitial lung disease 93.65 15.69 133 16440 78329 42526433
Pelvic mass 82.03 15.69 19 16554 222 42604540
Product monitoring error 78.30 15.69 37 16536 4386 42600376
Drug ineffective 74.09 15.69 82 16491 630115 41974647
Gastrointestinal haemorrhage 71.89 15.69 133 16440 97593 42507169
Cerebral haemorrhage 66.73 15.69 79 16494 38887 42565875
Prostate cancer recurrent 61.53 15.69 21 16552 1062 42603700
Cardiac failure acute 60.92 15.69 47 16526 13586 42591176
Cardiac amyloidosis 59.04 15.69 24 16549 1981 42602781
Epistaxis 56.91 15.69 97 16476 66729 42538033
Malignant transformation 55.71 15.69 19 16554 959 42603803
Blood electrolytes abnormal 54.67 15.69 19 16554 1015 42603747
Haematochezia 54.00 15.69 88 16485 58348 42546414
Blood urea abnormal 52.89 15.69 19 16554 1119 42603643
Upper gastrointestinal haemorrhage 51.16 15.69 61 16512 30238 42574524
Oedema peripheral 50.35 15.69 141 16432 135935 42468827
Systemic infection 50.25 15.69 29 16544 5176 42599586
Haemorrhage 47.77 15.69 85 16488 60478 42544284
Dehydration 44.90 15.69 139 16434 141628 42463134
Haematoma 43.38 15.69 54 16519 27969 42576793
Respiratory tract haemorrhage 41.95 15.69 17 16556 1392 42603370
Toxicity to various agents 40.89 15.69 19 16554 229117 42375645
Haemorrhage subcutaneous 40.39 15.69 20 16553 2626 42602136
Product dose omission issue 40.29 15.69 6 16567 154359 42450403
Drug interaction 38.60 15.69 205 16368 266794 42337968
Haematemesis 37.17 15.69 52 16521 30147 42574615
Urogenital haemorrhage 36.93 15.69 13 16560 721 42604041
Subdural haematoma 36.48 15.69 45 16528 23093 42581669
Cardiac failure chronic 36.27 15.69 30 16543 9571 42595191
Anticoagulant-related nephropathy 35.67 15.69 9 16564 154 42604608
Heparin resistance 35.51 15.69 9 16564 157 42604605
Shock haemorrhagic 34.76 15.69 37 16536 16205 42588557
Pneumonia aspiration 32.89 15.69 65 16508 50013 42554749
Hypovitaminosis 32.35 15.69 12 16561 774 42603988
Dysuria 31.70 15.69 49 16524 31047 42573715
Presyncope 31.27 15.69 41 16532 22346 42582416
Labelled drug-drug interaction medication error 30.73 15.69 34 16539 15548 42589214
Fluid intake reduced 29.98 15.69 19 16554 4013 42600749
Acute kidney injury 29.80 15.69 244 16329 367093 42237669
Ejection fraction 28.65 15.69 8 16565 205 42604557
Thalamus haemorrhage 28.24 15.69 12 16561 1107 42603655
Drug abuse 27.50 15.69 4 16569 104767 42499995
Electrocardiogram abnormal 26.99 15.69 26 16547 10119 42594643
Procedural failure 26.32 15.69 6 16567 65 42604697
Pseudarthrosis 25.17 15.69 6 16567 80 42604682
Anxiety 24.13 15.69 8 16565 118552 42486210
Dyspnoea 23.53 15.69 269 16304 442352 42162410
Faeces discoloured 23.51 15.69 31 16542 16983 42587779
Stress urinary incontinence 23.44 15.69 6 16567 109 42604653
Tracheal pain 23.18 15.69 5 16568 41 42604721
Varicella virus test positive 23.18 15.69 7 16566 238 42604524
Gastrointestinal stoma output decreased 22.85 15.69 6 16567 121 42604641
Peri-implantitis 22.67 15.69 6 16567 125 42604637
Atrioventricular block 22.54 15.69 23 16550 9592 42595170
Putamen haemorrhage 22.18 15.69 7 16566 276 42604486
Pallor 22.06 15.69 40 16533 28846 42575916
Cardiac tamponade 21.76 15.69 19 16554 6521 42598241
Loss of consciousness 21.68 15.69 82 16491 92272 42512490
Duodenal ulcer haemorrhage 21.63 15.69 18 16555 5790 42598972
Syncope 21.50 15.69 86 16487 99320 42505442
Monoplegia 21.43 15.69 12 16561 2022 42602740
Blood pressure decreased 21.09 15.69 60 16513 58272 42546490
Product prescribing error 21.02 15.69 37 16536 26075 42578687
Dizziness 20.94 15.69 167 16406 249087 42355675
Antithrombin III decreased 20.86 15.69 8 16565 566 42604196
Gastric haemorrhage 20.83 15.69 23 16550 10492 42594270
Hemiplegia 20.60 15.69 20 16553 7859 42596903
Aneurysm ruptured 20.36 15.69 8 16565 604 42604158
Sinus node dysfunction 20.21 15.69 16 16557 4796 42599966
Hydronephrosis 20.20 15.69 24 16549 11841 42592921
Ischaemic stroke 19.87 15.69 33 16540 22200 42582562
Haemothorax 19.03 15.69 16 16557 5220 42599542
Depression 18.68 15.69 10 16563 111353 42493409
Immobilisation syndrome 18.62 15.69 7 16566 469 42604293
Nasopharyngitis 18.30 15.69 5 16568 83991 42520771
Cholangitis acute 18.27 15.69 9 16564 1168 42603594
Medication error 18.21 15.69 40 16533 33114 42571648
Heart rate 17.75 15.69 4 16569 41 42604721
Eosinophil count decreased 17.45 15.69 13 16560 3563 42601199
Documented hypersensitivity to administered product 17.34 15.69 6 16567 316 42604446
Therapeutic drug monitoring analysis incorrectly performed 17.29 15.69 6 16567 319 42604443
Death 17.26 15.69 110 16463 471075 42133687
Drug intolerance 17.13 15.69 5 16568 80419 42524343
Endoscopy upper gastrointestinal tract 17.09 15.69 4 16569 49 42604713
Thrombophlebitis migrans 16.53 15.69 6 16567 364 42604398
Cerebral artery embolism 16.19 15.69 8 16565 1045 42603717
Helicobacter infection 16.15 15.69 11 16562 2621 42602141
Phrenic nerve paralysis 16.05 15.69 5 16568 189 42604573
Pulmonary alveolar haemorrhage 16.02 15.69 24 16549 14792 42589970
Therapeutic product effect incomplete 15.88 15.69 4 16569 70935 42533827

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
Cerebral infarction 531.03 15.85 279 34447 51559 110503014
Cardiac failure 475.65 15.85 425 34301 187201 110367372
Anaemia 474.92 15.85 711 34015 546375 110008198
Renal impairment 423.33 15.85 399 34327 188046 110366527
Haematuria 317.32 15.85 239 34487 82766 110471807
Atrial fibrillation 306.82 15.85 369 34357 229273 110325300
Melaena 305.90 15.85 217 34509 68540 110486033
General physical health deterioration 269.37 15.85 480 34246 424815 110129758
Gastrointestinal haemorrhage 242.57 15.85 279 34447 165239 110389334
Embolic stroke 226.95 15.85 90 34636 8653 110545920
Product monitoring error 194.35 15.85 81 34645 8846 110545727
Drug ineffective 161.27 15.85 145 34581 1520395 109034178
Cerebral haemorrhage 158.03 15.85 144 34582 64824 110489749
Haematochezia 154.64 15.85 186 34540 115338 110439235
Labelled drug-drug interaction medication error 140.79 15.85 97 34629 29205 110525368
Interstitial lung disease 122.90 15.85 183 34543 139151 110415422
Lymphatic fistula 120.72 15.85 36 34690 1459 110553114
Femoral hernia incarcerated 120.39 15.85 36 34690 1473 110553100
Arterial haemorrhage 115.74 15.85 44 34682 3775 110550798
Pancreatic steatosis 109.57 15.85 35 34691 1787 110552786
Cardiac failure acute 109.34 15.85 77 34649 24001 110530572
Wound infection pseudomonas 103.80 15.85 36 34690 2375 110552198
Aortic valve stenosis 103.54 15.85 47 34679 6303 110548270
Oedema peripheral 103.12 15.85 280 34446 328380 110226193
Acute kidney injury 98.92 15.85 428 34298 635002 109919571
Systemic infection 95.21 15.85 51 34675 9768 110544805
Dehydration 93.60 15.85 244 34482 279267 110275306
Upper gastrointestinal haemorrhage 93.46 15.85 96 34630 50000 110504573
Cardiac failure chronic 91.64 15.85 56 34670 13755 110540818
Drug intolerance 89.88 15.85 11 34715 406501 110148072
Drug hypersensitivity 89.66 15.85 17 34709 454073 110100500
Seroma 89.23 15.85 35 34691 3266 110551307
Syncope 86.21 15.85 194 34532 202342 110352231
Haemarthrosis 85.22 15.85 43 34683 7286 110547287
Pallor 83.97 15.85 96 34630 56371 110498202
Heparin resistance 83.85 15.85 19 34707 252 110554321
Tachyarrhythmia 83.18 15.85 44 34682 8217 110546356
Dyspnoea 79.99 15.85 607 34119 1106265 109448308
Hepatic cyst 79.92 15.85 42 34684 7741 110546832
Subdural haematoma 79.38 15.85 76 34650 36378 110518195
Shock haemorrhagic 77.44 15.85 66 34660 27181 110527392
Arrhythmia 75.57 15.85 101 34625 69474 110485099
Product prescribing error 74.19 15.85 86 34640 51245 110503328
Synovitis 73.10 15.85 3 34723 274089 110280484
Diverticulum intestinal 71.38 15.85 45 34681 11674 110542899
Nasopharyngitis 71.28 15.85 18 34708 394343 110160230
Sinusitis 70.82 15.85 6 34720 296682 110257891
Prostate cancer recurrent 68.38 15.85 21 34705 941 110553632
Haematoma 68.33 15.85 88 34638 58388 110496185
Arthropathy 68.12 15.85 6 34720 287516 110267057
Infusion related reaction 67.74 15.85 18 34708 381144 110173429
Nail bed inflammation 67.38 15.85 25 34701 2005 110552568
Maternal exposure during pregnancy 67.27 15.85 3 34723 254880 110299693
Hyperkalaemia 66.84 15.85 138 34588 135658 110418915
Rheumatoid arthritis 66.47 15.85 8 34718 299605 110254968
Haemorrhage subcutaneous 65.87 15.85 33 34693 5506 110549067
Product dose omission issue 65.77 15.85 11 34715 321771 110232802
Nasal mucosal disorder 65.48 15.85 24 34702 1859 110552714
Swelling 65.44 15.85 15 34711 351026 110203547
Hypersensitivity 64.74 15.85 23 34703 403975 110150598
Haemorrhage 64.18 15.85 118 34608 106574 110447999
Tricuspid valve incompetence 64.14 15.85 56 34670 23817 110530756
Streptococcal sepsis 62.63 15.85 31 34695 5041 110549532
Cardiac amyloidosis 62.62 15.85 26 34700 2811 110551762
Groin pain 62.41 15.85 46 34680 15382 110539191
Mitral valve incompetence 62.40 15.85 64 34662 33265 110521308
Drug interaction 62.34 15.85 316 34410 499867 110054706
Hyponatraemia 61.87 15.85 179 34547 217474 110337099
Pain 61.63 15.85 130 34596 954825 109599748
Pneumonia aspiration 60.84 15.85 99 34627 81134 110473439
Electrocardiogram abnormal 60.84 15.85 49 34677 18660 110535913
Lower respiratory tract infection 60.62 15.85 4 34722 243102 110311471
Wound dehiscence 59.88 15.85 35 34691 7927 110546646
Eructation 59.32 15.85 43 34683 14014 110540559
Aortic arteriosclerosis 59.21 15.85 39 34687 10899 110543674
Musculoskeletal stiffness 58.45 15.85 9 34717 279813 110274760
Tachycardia 58.36 15.85 180 34546 226465 110328108
Urinary retention 57.81 15.85 89 34637 69594 110484979
Presyncope 56.23 15.85 73 34653 48814 110505759
Ischaemic stroke 56.08 15.85 67 34659 41196 110513377
Subarachnoid haemorrhage 55.54 15.85 57 34669 29645 110524928
Discomfort 55.14 15.85 3 34723 214704 110339869
Varicose vein 53.50 15.85 31 34695 6909 110547664
Faecaloma 52.67 15.85 41 34685 14867 110539706
Pelvic mass 52.37 15.85 19 34707 1430 110553143
Dysuria 51.48 15.85 78 34648 60153 110494420
Malignant transformation 51.42 15.85 19 34707 1506 110553067
Thrombophlebitis migrans 51.24 15.85 16 34710 758 110553815
Epistaxis 50.08 15.85 120 34606 130252 110424321
Anuria 49.71 15.85 49 34677 24292 110530281
Bradycardia 49.19 15.85 133 34593 155384 110399189
Cardiovascular disorder 48.69 15.85 47 34679 22713 110531860
Alopecia 48.63 15.85 27 34699 364726 110189847
Pseudomonal sepsis 48.35 15.85 32 34694 9014 110545559
Angina pectoris 48.12 15.85 77 34649 62218 110492355
Left ventricular dysfunction 47.43 15.85 47 34679 23446 110531127
Blood urea abnormal 47.42 15.85 19 34707 1875 110552698
Inflammatory marker increased 47.27 15.85 38 34688 14431 110540142
Haematemesis 46.95 15.85 74 34652 59034 110495539
Toxicity to various agents 46.93 15.85 49 34677 480506 110074067
Mobility decreased 46.59 15.85 9 34717 237413 110317160
Postoperative wound infection 46.49 15.85 39 34687 15714 110538859
Urticaria 46.42 15.85 21 34705 318836 110235737
Depression 46.04 15.85 21 34705 317314 110237259
Joint swelling 45.72 15.85 43 34683 442802 110111771
Blood electrolytes abnormal 45.45 15.85 19 34707 2089 110552484
Anticoagulant-related nephropathy 45.30 15.85 11 34715 200 110554373
Faeces discoloured 44.30 15.85 54 34672 33894 110520679
Duodenal ulcer perforation 44.07 15.85 3 34723 177697 110376876
Systemic lupus erythematosus 43.33 15.85 13 34713 254325 110300248
Hepatic function abnormal 43.05 15.85 90 34636 89205 110465368
Treatment failure 42.36 15.85 17 34709 277217 110277356
Sinus node dysfunction 41.22 15.85 29 34697 9018 110545555
Anxiety 41.22 15.85 29 34697 345049 110209524
Type 2 diabetes mellitus 41.16 15.85 4 34722 177228 110377345
Exposure during pregnancy 41.02 15.85 3 34723 167421 110387152
Hepatic enzyme increased 41.00 15.85 25 34701 320867 110233706
Pulmonary hypertension 40.94 15.85 67 34659 55153 110499420
Asthma 40.50 15.85 14 34712 250277 110304296
Fall 40.08 15.85 325 34401 603157 109951416
Urogenital haemorrhage 39.98 15.85 14 34712 950 110553623
Escherichia infection 39.71 15.85 43 34683 23773 110530800
Respiratory tract haemorrhage 39.59 15.85 17 34709 1997 110552576
Putamen haemorrhage 39.18 15.85 12 34714 533 110554040
Internal haemorrhage 38.44 15.85 29 34697 10042 110544531
Gastrointestinal disorder 38.35 15.85 14 34712 241938 110312635
Gastric haemorrhage 38.14 15.85 35 34691 15880 110538693
Paronychia 38.12 15.85 30 34696 11051 110543522
Colon cancer 37.16 15.85 35 34691 16408 110538165
Therapeutic product effect incomplete 37.12 15.85 12 34714 223793 110330780
Thalamus haemorrhage 36.72 15.85 16 34710 1948 110552625
Injection site pain 36.52 15.85 6 34720 177916 110376657
Carotid artery occlusion 35.31 15.85 27 34699 9538 110545035
Aortic dissection 35.30 15.85 21 34705 4912 110549661
Hormone-dependent prostate cancer 35.14 15.85 9 34717 205 110554368
Blood pressure decreased 34.96 15.85 97 34629 114994 110439579
Blister 34.64 15.85 14 34712 227362 110327211
Atrioventricular block 34.51 15.85 34 34692 16843 110537730
Sleep disorder 34.11 15.85 10 34716 198634 110355939
Atrial tachycardia 34.08 15.85 26 34700 9152 110545421
Product used for unknown indication 33.50 15.85 15 34711 1948 110552625
Helicobacter infection 33.42 15.85 8 34718 181869 110372704
Osteopenia 33.41 15.85 38 34688 22171 110532402
Diverticulum intestinal haemorrhagic 33.36 15.85 20 34706 4743 110549830
Headache 32.84 15.85 154 34572 882223 109672350
Cerebral artery embolism 32.45 15.85 15 34711 2097 110552476
Wheezing 32.44 15.85 20 34706 255210 110299363
Aplastic anaemia 32.26 15.85 39 34687 24269 110530304
Injury 32.18 15.85 8 34718 177257 110377316
Metastases to lymph nodes 32.08 15.85 31 34695 15001 110539572
Metastases to nervous system 31.96 15.85 9 34717 297 110554276
Hypovitaminosis 30.94 15.85 13 34713 1447 110553126
Decreased appetite 30.88 15.85 255 34471 475591 110078982
Haemothorax 30.79 15.85 22 34704 7009 110547564
Intentional overdose 30.74 15.85 3 34723 132498 110422075
Therapeutic drug monitoring analysis not performed 30.56 15.85 14 34712 1917 110552656
Malignant neoplasm progression 30.49 15.85 122 34604 174445 110380128
Myelodysplastic syndrome 29.86 15.85 47 34679 37437 110517136
Arthralgia 29.63 15.85 135 34591 779497 109775076
Hypoaesthesia 29.59 15.85 33 34693 314190 110240383
Intentional product use issue 29.38 15.85 21 34705 247885 110306688
Rash 28.96 15.85 146 34580 820818 109733755
Electrolyte imbalance 28.91 15.85 46 34680 36982 110517591
Liver injury 28.88 15.85 6 34720 150407 110404166
Night sweats 28.68 15.85 4 34722 133979 110420594
Cholangitis 28.13 15.85 30 34696 16305 110538268
Procedural failure 27.57 15.85 7 34719 154 110554419
Endocarditis noninfective 27.50 15.85 8 34718 297 110554276
Joint dislocation 27.42 15.85 43 34683 34147 110520426
Hydronephrosis 27.17 15.85 33 34693 20632 110533941
Anticoagulation drug level abnormal 27.12 15.85 8 34718 312 110554261
Product use issue 26.94 15.85 35 34691 311660 110242913
Glomerular filtration rate decreased 26.89 15.85 39 34687 28917 110525656
Tachypnoea 26.80 15.85 46 34680 39349 110515224
Ill-defined disorder 26.74 15.85 8 34718 156845 110397728
Pleural effusion 26.23 15.85 118 34608 177591 110376982
Immobilisation syndrome 26.21 15.85 10 34716 866 110553707
Pulmonary alveolar haemorrhage 26.20 15.85 32 34694 20118 110534455
Vascular device infection 26.12 15.85 29 34697 16483 110538090
Arthritis 26.04 15.85 10 34716 167576 110386997
Duodenal ulcer haemorrhage 26.02 15.85 21 34705 8016 110546557
Hormone-refractory prostate cancer 25.84 15.85 10 34716 900 110553673
Brain natriuretic peptide increased 25.60 15.85 24 34702 11185 110543388
Cardiac tamponade 25.42 15.85 24 34702 11283 110543290
Cardiospasm 25.17 15.85 17 34709 4950 110549623
Haemorrhagic diathesis 25.12 15.85 20 34706 7488 110547085
Coagulation time prolonged 25.09 15.85 14 34712 2903 110551670
Metastases to central nervous system 24.58 15.85 33 34693 22784 110531789
BRASH syndrome 24.45 15.85 15 34711 3708 110550865
Thirst 24.31 15.85 32 34694 21675 110532898
Blood chromogranin A increased 24.23 15.85 9 34717 724 110553849
Sopor 23.98 15.85 42 34684 36504 110518069
Hiatus hernia 23.94 15.85 36 34690 27570 110527003
Palmoplantar keratoderma 23.92 15.85 17 34709 5370 110549203
Small intestinal haemorrhage 23.87 15.85 16 34710 4602 110549971
Chorea 23.75 15.85 14 34712 3221 110551352
Aneurysm ruptured 23.66 15.85 10 34716 1130 110553443
Brain oedema 23.41 15.85 38 34688 31060 110523513
Loss of personal independence in daily activities 23.23 15.85 9 34717 150011 110404562
Tracheal pain 23.09 15.85 5 34721 53 110554520
Endoscopy upper gastrointestinal tract 23.09 15.85 6 34720 145 110554428
Pulmonary toxicity 22.78 15.85 28 34698 17718 110536855
Haemorrhage intracranial 22.63 15.85 36 34690 28933 110525640
Psoriasis 22.35 15.85 8 34718 139985 110414588
Fluid intake reduced 22.08 15.85 18 34708 6968 110547605
Oesophageal mucosal tear 22.04 15.85 4 34722 15 110554558
Lung disorder 21.66 15.85 15 34711 180032 110374541
Anticoagulation drug level increased 21.65 15.85 9 34717 976 110553597
Loss of consciousness 21.63 15.85 120 34606 196186 110358387
Vertebrobasilar insufficiency 21.61 15.85 7 34719 374 110554199
Haemoptysis 21.53 15.85 60 34666 71294 110483279
Varicella virus test positive 21.24 15.85 7 34719 395 110554178
Cerebral artery occlusion 21.23 15.85 11 34715 1969 110552604
Road traffic accident 21.21 15.85 4 34722 107394 110447179
Pruritus genital 21.03 15.85 17 34709 6505 110548068
Pneumonia bacterial 21.02 15.85 33 34693 26228 110528345
Peri-implantitis 20.99 15.85 6 34720 209 110554364
Embolic cerebral infarction 20.99 15.85 10 34716 1496 110553077
Sleep terror 20.83 15.85 17 34709 6593 110547980
Obesity 20.79 15.85 5 34721 113346 110441227
Acute on chronic liver failure 20.68 15.85 7 34719 429 110554144
Renal infarct 20.58 15.85 13 34713 3382 110551191
Transient ischaemic attack 20.50 15.85 55 34671 63927 110490646
Influenza 20.46 15.85 14 34712 169087 110385486
Wound infection 20.37 15.85 3 34723 96462 110458111
Drug eruption 20.17 15.85 49 34677 53610 110500963
Oliguria 20.12 15.85 27 34699 18630 110535943
Coma 20.11 15.85 6 34720 117863 110436710
Palpitations 20.06 15.85 101 34625 159111 110395462
Atrial thrombosis 19.96 15.85 14 34712 4332 110550241
Marasmus 19.89 15.85 10 34716 1681 110552892
Gastrointestinal stoma output decreased 19.73 15.85 6 34720 260 110554313
Pulmonary fibrosis 19.73 15.85 4 34722 102038 110452535
Injection site erythema 19.72 15.85 3 34723 94173 110460400
Pain in extremity 19.29 15.85 83 34643 487035 110067538
Post procedural haemorrhage 19.15 15.85 24 34702 15488 110539085
Haemorrhagic infarction 19.12 15.85 8 34718 881 110553692
Product use in unapproved indication 19.11 15.85 74 34652 447303 110107270
Embolism arterial 18.99 15.85 10 34716 1849 110552724
Lower gastrointestinal haemorrhage 18.80 15.85 26 34700 18460 110536113
Hypercholesterolaemia 18.78 15.85 3 34723 90834 110463739
Balanoposthitis 18.76 15.85 9 34717 1367 110553206
Cholangitis acute 18.72 15.85 10 34716 1903 110552670
Off label use 18.53 15.85 346 34380 1499839 109054734
Pericarditis 18.52 15.85 25 34701 219089 110335484
Osteoarthritis 18.51 15.85 18 34708 182605 110371968
Hypotension 18.41 15.85 248 34478 523601 110030972
Contraindicated product administered 18.40 15.85 31 34695 248236 110306337
Anal haemorrhage 18.32 15.85 14 34712 4938 110549635
Injection site reaction 18.28 15.85 3 34723 89067 110465506
Ventricular arrhythmia 18.21 15.85 19 34707 10068 110544505
Disseminated intravascular coagulation 18.04 15.85 40 34686 41246 110513327
Rhinorrhoea 17.93 15.85 5 34721 102661 110451912
Altered state of consciousness 17.92 15.85 49 34677 57577 110496996
Haemobilia 17.92 15.85 7 34719 646 110553927
Soft tissue mass 17.84 15.85 9 34717 1524 110553049
Duodenal ulcer 17.71 15.85 26 34700 19488 110535085
Restlessness 17.66 15.85 48 34678 56211 110498362
Gastroenteritis clostridial 17.64 15.85 8 34718 1070 110553503
Coagulation test abnormal 17.55 15.85 9 34717 1577 110552996
Pruritus 17.45 15.85 109 34617 581451 109973122
Inflammation 17.42 15.85 21 34705 193217 110361356
Cardiomegaly 17.23 15.85 32 34694 29098 110525475
Rhonchi 17.22 15.85 13 34713 4505 110550068
Tension headache 17.16 15.85 18 34708 9600 110544973
Insomnia 17.15 15.85 57 34669 360533 110194040
Prothrombin time prolonged 17.14 15.85 24 34702 17237 110537336
Cerebrovascular accident 16.86 15.85 106 34620 181178 110373395
Blindness 16.77 15.85 36 34690 36323 110518250
Gastrointestinal angiodysplasia 16.58 15.85 8 34718 1230 110553343
Stomatitis 16.36 15.85 38 34688 270204 110284369
Monoplegia 16.26 15.85 13 34713 4896 110549677
Occult blood 16.22 15.85 9 34717 1847 110552726
Bleeding time prolonged 16.20 15.85 8 34718 1294 110553279
Muscle spasms 16.14 15.85 40 34686 278117 110276456
Cerebellar haemorrhage 16.11 15.85 11 34715 3260 110551313
Urosepsis 16.06 15.85 32 34694 30643 110523930
Hypokalaemia 15.94 15.85 105 34621 182343 110372230
Postrenal failure 15.93 15.85 7 34719 869 110553704
Eosinophil count decreased 15.93 15.85 14 34712 6004 110548569
Circulatory collapse 15.88 15.85 39 34687 42954 110511619

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC B01AF03 BLOOD AND BLOOD FORMING ORGANS
ANTITHROMBOTIC AGENTS
ANTITHROMBOTIC AGENTS
Direct factor Xa inhibitors
MeSH PA D000925 Anticoagulants
MeSH PA D000991 Antithrombins
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D006401 Hematologic Agents
MeSH PA D011480 Protease Inhibitors
MeSH PA D015842 Serine Proteinase Inhibitors
MeSH PA D065427 Factor Xa Inhibitors
FDA MoA N0000175635 Factor Xa Inhibitors
FDA EPC N0000175637 Factor Xa Inhibitor
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:38070 anti-arrhythmia drug
CHEBI has role CHEBI:50249 anticoagulant
CHEBI has role CHEBI:50427 platelet aggregation inhibitor
CHEBI has role CHEBI:62868 hepatoprotective agent
CHEBI has role CHEBI:68581 EC 3.4.21.6 (coagulation factor Xa) inhibitor

Related Drugs by ATC class:

B01AF Direct factor Xa inhibitors 4 drugs
acetylsalicylic acidapixabanbetrixabanrivaroxaban

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

DiseaseRelationSNOMED_IDDOID
Pulmonary embolism indication 59282003 DOID:9477
Embolism indication 414086009
Ischemic stroke indication 422504002
Prevention of deep vein thrombosis indication 439993001




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.7 acidic
pKa2 12.4 acidic
pKa3 6.8 Basic
pKa4 3.01 Basic
pKa5 2.14 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 15MG BASE SAVAYSA DAIICHI SANKYO INC N206316 Jan. 8, 2015 RX TABLET ORAL Oct. 18, 2026 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
EQ 30MG BASE SAVAYSA DAIICHI SANKYO INC N206316 Jan. 8, 2015 RX TABLET ORAL Oct. 18, 2026 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
EQ 60MG BASE SAVAYSA DAIICHI SANKYO INC N206316 Jan. 8, 2015 RX TABLET ORAL Oct. 18, 2026 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Coagulation factor X Enzyme INHIBITOR Ki 9.25 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
Prothrombin Enzyme Ki 5.22 CHEMBL

External reference:

IDSource
D09546 KEGG_DRUG
480449-71-6 SECONDARY_CAS_RN
4034081 VANDF
CHEBI:85974 CHEBI
CHEMBL1269025 ChEMBL_ID
CHEMBL2105682 ChEMBL_ID
C552171 MESH_SUPPLEMENTAL_RECORD_UI
7575 IUPHAR_LIGAND_ID
DB09075 DRUGBANK_ID
1599538 RXNORM
232451 MMSL
30841 MMSL
30865 MMSL
d08338 MMSL
015852 NDDF
015853 NDDF
1162278009 SNOMEDCT_US
712778008 SNOMEDCT_US
714687009 SNOMEDCT_US
C2975435 UMLSCUI
8982 INN_ID
10280735 PUBCHEM_CID
NDU3J18APO UNII
NDU3J18APO INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
SAVAYSA HUMAN PRESCRIPTION DRUG LABEL 1 65597-201 TABLET, FILM COATED 15 mg ORAL NDA 33 sections
SAVAYSA HUMAN PRESCRIPTION DRUG LABEL 1 65597-202 TABLET, FILM COATED 30 mg ORAL NDA 33 sections
SAVAYSA HUMAN PRESCRIPTION DRUG LABEL 1 65597-203 TABLET, FILM COATED 60 mg ORAL NDA 33 sections