dabigatran etexilate Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
thrombin inhibitors, antithrombotic agents 776 211915-06-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • BIBR 1048
  • BIBR-1048
  • dabigatran etexilate mesilate
  • dabigatran etexilate
  • pradaxa
  • dabigatran etexilate mesylate
  • dabigatran etexilate methanesulfonate
A THROMBIN inhibitor which acts by binding and blocking thrombogenic activity and the prevention of thrombus formation. It is used to reduce the risk of stroke and systemic EMBOLISM in patients with nonvalvular atrial fibrillation.
  • Molecular weight: 627.75
  • Formula: C34H41N7O5
  • CLOGP: 4.71
  • LIPINSKI: 2
  • HAC: 12
  • HDO: 3
  • TPSA: 151.53
  • ALOGS: -4.68
  • ROTB: 17

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.30 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 1.80 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 6.83 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

DateAgencyCompanyOrphan
Oct. 19, 2010 FDA BOEHRINGER INGELHEIM

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
Gastrointestinal haemorrhage 4291.33 14.69 1799 40976 78531 53227760
Ischaemic stroke 2230.07 14.69 749 42026 17244 53289047
Cerebrovascular accident 1465.85 14.69 959 41816 104215 53202076
Haemorrhage 1184.72 14.69 676 42099 57311 53248980
Melaena 999.86 14.69 481 42294 28648 53277643
Rectal haemorrhage 976.27 14.69 531 42244 40950 53265341
Haemorrhage intracranial 893.06 14.69 353 42422 12999 53293292
Cerebral haemorrhage 702.66 14.69 383 42392 29613 53276678
Lower gastrointestinal haemorrhage 653.08 14.69 241 42534 7325 53298966
Activated partial thromboplastin time prolonged 591.45 14.69 220 42555 6839 53299452
Cardiac tamponade 469.93 14.69 166 42609 4434 53301857
Subdural haematoma 440.19 14.69 217 42558 13596 53292695
Cerebral infarction 437.62 14.69 262 42513 24182 53282109
Embolic stroke 391.51 14.69 138 42637 3661 53302630
Blood loss anaemia 365.19 14.69 166 42609 8657 53297634
Shock haemorrhagic 365.09 14.69 168 42607 9015 53297276
Haematoma 362.14 14.69 263 42512 33581 53272710
International normalised ratio increased 354.58 14.69 299 42476 47462 53258829
Fall 336.86 14.69 826 41949 357614 52948677
Coagulopathy 334.14 14.69 204 42571 19494 53286797
Upper gastrointestinal haemorrhage 333.32 14.69 195 42580 17235 53289056
Haematochezia 322.29 14.69 269 42506 42089 53264202
Transient ischaemic attack 305.74 14.69 243 42532 35482 53270809
Haematuria 288.74 14.69 214 42561 28175 53278116
Haemorrhagic stroke 285.53 14.69 123 42652 5635 53300656
Pericardial haemorrhage 261.15 14.69 82 42693 1501 53304790
Procoagulant therapy 251.33 14.69 41 42734 0 53306291
Anaemia 249.21 14.69 628 42147 276090 53030201
Atrial thrombosis 243.58 14.69 77 42698 1442 53304849
Haematemesis 226.48 14.69 192 42583 30665 53275626
Thrombin time prolonged 223.25 14.69 43 42732 67 53306224
Subarachnoid haemorrhage 221.95 14.69 131 42644 11762 53294529
Deep vein thrombosis 213.16 14.69 296 42479 82617 53223674
Pain 201.70 14.69 111 42664 588287 52718004
Rheumatoid arthritis 198.38 14.69 14 42761 314517 52991774
Pulmonary embolism 197.81 14.69 340 42435 114102 53192189
Intestinal haemorrhage 195.60 14.69 81 42694 3359 53302932
Acute kidney injury 189.78 14.69 538 42237 253330 53052961
Haemoglobin decreased 186.96 14.69 368 42407 136939 53169352
Atrial fibrillation 179.05 14.69 321 42454 111331 53194960
Hemiparesis 168.69 14.69 139 42636 21336 53284955
Renal failure 167.95 14.69 323 42452 118129 53188162
Epistaxis 157.02 14.69 232 42543 68478 53237813
Hypovolaemic shock 155.01 14.69 80 42695 5517 53300774
Subdural haemorrhage 144.93 14.69 63 42712 2949 53303342
Drug hypersensitivity 143.48 14.69 21 42754 265221 53041070
Aortic dissection 134.54 14.69 51 42724 1669 53304622
Cardiac failure 131.45 14.69 242 42533 85602 53220689
Fatigue 128.55 14.69 245 42530 730261 52576030
Renal impairment 111.69 14.69 222 42553 83096 53223195
Wound secretion 109.93 14.69 58 42717 4185 53302106
Prothrombin time prolonged 108.79 14.69 78 42697 9744 53296547
Cerebral haematoma 108.32 14.69 54 42721 3460 53302831
Haemoptysis 106.94 14.69 122 42653 27917 53278374
Hemiplegia 105.37 14.69 70 42705 7730 53298561
Haemothorax 104.27 14.69 45 42730 2069 53304222
Maternal exposure during pregnancy 103.87 14.69 5 42770 155634 53150657
Peripheral embolism 103.76 14.69 39 42736 1246 53305045
Creatinine renal clearance decreased 103.13 14.69 78 42697 10573 53295718
Procedural haemorrhage 102.08 14.69 47 42728 2522 53303769
Pyrexia 101.90 14.69 104 42671 403089 52903202
Head injury 101.24 14.69 114 42661 25719 53280572
Coagulation time prolonged 99.04 14.69 38 42737 1286 53305005
Rash 98.81 14.69 128 42647 446063 52860228
Gastric haemorrhage 94.53 14.69 60 42715 6131 53300160
Infusion related reaction 89.94 14.69 10 42765 155947 53150344
Large intestinal haemorrhage 86.68 14.69 34 42741 1222 53305069
Arthralgia 85.70 14.69 138 42637 439645 52866646
Haemorrhoidal haemorrhage 85.36 14.69 48 42727 3930 53302361
Faeces discoloured 85.06 14.69 87 42688 17599 53288692
Drug ineffective 83.74 14.69 355 42420 816890 52489401
Dyspepsia 82.29 14.69 188 42587 77412 53228879
Post procedural haemorrhage 80.81 14.69 60 42715 7908 53298383
Systemic lupus erythematosus 80.66 14.69 5 42770 125409 53180882
Traumatic haemorrhage 78.93 14.69 25 42750 471 53305820
Drug intolerance 78.90 14.69 33 42742 205460 53100831
Aphasia 77.68 14.69 109 42666 30669 53275622
Haemorrhagic transformation stroke 77.67 14.69 31 42744 1167 53305124
Nasopharyngitis 75.25 14.69 30 42745 192265 53114026
Joint swelling 74.80 14.69 48 42727 234590 53071701
Anxiety 73.28 14.69 33 42742 196671 53109620
Therapeutic product effect decreased 72.59 14.69 8 42767 125647 53180644
Pericardial effusion 72.43 14.69 99 42676 27179 53279112
Arthropathy 72.38 14.69 13 42762 141440 53164851
Embolism 70.55 14.69 54 42721 7449 53298842
Sinusitis 69.82 14.69 24 42751 168540 53137751
Cerebral artery occlusion 69.08 14.69 27 42748 961 53305330
Injection site pain 68.69 14.69 6 42769 113385 53192906
Musculoskeletal stiffness 68.44 14.69 9 42766 123359 53182932
International normalised ratio abnormal 68.16 14.69 38 42737 3059 53303232
Condition aggravated 68.01 14.69 83 42692 297051 53009240
Pulmonary haemorrhage 67.62 14.69 51 42724 6882 53299409
Mouth haemorrhage 67.43 14.69 50 42725 6576 53299715
Hypersensitivity 67.27 14.69 43 42732 210622 53095669
Headache 66.73 14.69 215 42560 536606 52769685
Depression 66.18 14.69 32 42743 183020 53123271
Gingival bleeding 65.55 14.69 64 42711 12244 53294047
Splenic rupture 65.05 14.69 28 42747 1279 53305012
Weight increased 64.98 14.69 42 42733 204525 53101766
Thrombin time abnormal 64.78 14.69 11 42764 3 53306288
International normalised ratio 64.32 14.69 15 42760 80 53306211
Nausea 62.54 14.69 354 42421 755737 52550554
Contraindicated product administered 62.18 14.69 16 42759 135613 53170678
Neutropenia 62 14.69 25 42750 159160 53147131
Product dose omission issue 61.32 14.69 39 42736 191581 53114710
Drug interaction 60.99 14.69 341 42434 218988 53087303
Activated partial thromboplastin time abnormal 60.35 14.69 15 42760 109 53306182
Craniocerebral injury 59.92 14.69 32 42743 2366 53303925
Anticoagulation drug level increased 59.87 14.69 17 42758 216 53306075
Thrombosis 59.76 14.69 143 42632 60650 53245641
Hip fracture 59.64 14.69 92 42683 28165 53278126
Treatment failure 59.15 14.69 15 42760 128388 53177903
Glossodynia 58.91 14.69 6 42769 100285 53206006
Cardiac valve replacement complication 58.38 14.69 16 42759 177 53306114
Peripheral swelling 58.08 14.69 48 42727 206060 53100231
Intestinal ischaemia 57.73 14.69 48 42727 7454 53298837
Peripheral ischaemia 57.37 14.69 40 42735 4779 53301512
Intra-abdominal haemorrhage 56.71 14.69 31 42744 2401 53303890
Cerebral ischaemia 56.24 14.69 45 42730 6620 53299671
Intracardiac thrombus 56.04 14.69 31 42744 2458 53303833
Puncture site haemorrhage 55.91 14.69 17 42758 278 53306013
Product use issue 55.88 14.69 21 42754 139563 53166728
Strangulated hernia 54.89 14.69 12 42763 45 53306246
Cerebral artery embolism 54.75 14.69 22 42753 843 53305448
Colon cancer 54.04 14.69 52 42723 9773 53296518
Iron deficiency anaemia 53.25 14.69 70 42705 18510 53287781
Toxicity to various agents 52.73 14.69 59 42716 219539 53086752
Acute abdomen 52.65 14.69 26 42749 1632 53304659
Traumatic intracranial haemorrhage 52.58 14.69 17 42758 343 53305948
Retroperitoneal haemorrhage 51.69 14.69 31 42744 2863 53303428
Blood urine present 50.97 14.69 58 42717 13227 53293064
Gastritis erosive 49.77 14.69 39 42736 5567 53300724
Swelling 49.64 14.69 48 42727 191057 53115234
Alopecia 49.06 14.69 70 42705 234513 53071778
Cardiac perforation 46.96 14.69 11 42764 60 53306231
Embolic cerebral infarction 46.39 14.69 17 42758 505 53305786
Infection 46.20 14.69 42 42733 172163 53134128
Back pain 45.99 14.69 73 42702 234174 53072117
Haemarthrosis 45.75 14.69 30 42745 3240 53303051
Shock 45.59 14.69 73 42702 23066 53283225
Chills 45.03 14.69 14 42761 104834 53201457
Death 44.23 14.69 459 42316 356773 52949518
Neuropathy peripheral 43.92 14.69 14 42761 103173 53203118
Haemoperitoneum 43.89 14.69 27 42748 2610 53303681
Acute myocardial infarction 43.82 14.69 88 42687 33147 53273144
Multiple organ dysfunction syndrome 43.37 14.69 120 42655 55557 53250734
Lower respiratory tract infection 43.12 14.69 10 42765 90971 53215320
Peripheral artery thrombosis 43.12 14.69 24 42751 1926 53304365
Contusion 42.70 14.69 189 42586 110543 53195748
Microcytic anaemia 42.42 14.69 29 42746 3356 53302935
Haemorrhage subcutaneous 42.38 14.69 28 42747 3063 53303228
Stomatitis 42.34 14.69 13 42762 98145 53208146
Femoral neck fracture 41.70 14.69 42 42733 8341 53297950
Disease progression 41.34 14.69 15 42760 101905 53204386
Vaginal haemorrhage 40.19 14.69 75 42700 26766 53279525
Intraventricular haemorrhage 39.67 14.69 23 42752 1995 53304296
Colitis ischaemic 39.24 14.69 46 42729 10828 53295463
Pruritus 39.01 14.69 114 42661 293718 53012573
Discomfort 38.81 14.69 14 42761 95458 53210833
Haemorrhagic cerebral infarction 38.61 14.69 16 42759 664 53305627
Diverticulum 37.88 14.69 47 42728 11732 53294559
Wound haemorrhage 37.76 14.69 23 42752 2184 53304107
Hypocoagulable state 37.66 14.69 18 42757 1051 53305240
Cerebral mass effect 37.22 14.69 17 42758 895 53305396
Product use in unapproved indication 37.09 14.69 22 42753 112267 53194024
Asthma 36.49 14.69 21 42754 108951 53197340
Skull fracture 35.97 14.69 17 42758 968 53305323
Skin haemorrhage 35.68 14.69 35 42740 6732 53299559
Subcutaneous haematoma 35.55 14.69 20 42755 1638 53304653
Exsanguination 34.90 14.69 7 42768 15 53306276
Diverticulum intestinal haemorrhagic 34.38 14.69 18 42757 1278 53305013
Prothrombin time abnormal 34.33 14.69 13 42762 424 53305867
Ischaemic cerebral infarction 34.20 14.69 18 42757 1292 53304999
Influenza 33.95 14.69 17 42758 95362 53210929
Prothrombin time shortened 33.78 14.69 20 42755 1804 53304487
Coagulation test abnormal 33.70 14.69 15 42760 743 53305548
Drug abuse 33.55 14.69 6 42769 65520 53240771
Wound 33.07 14.69 16 42759 91541 53214750
White blood cell count decreased 32.61 14.69 31 42744 124444 53181847
Cardiac failure congestive 32.54 14.69 154 42621 92603 53213688
Intentional product use issue 32.37 14.69 9 42766 72485 53233806
Mesenteric artery embolism 32.14 14.69 6 42769 7 53306284
Stress 32.04 14.69 4 42771 57080 53249211
Upper respiratory tract infection 31.95 14.69 8 42767 69089 53237202
Anticoagulation drug level above therapeutic 31.63 14.69 17 42758 1273 53305018
Small intestinal haemorrhage 31.09 14.69 20 42755 2091 53304200
Pelvic haematoma 31.07 14.69 13 42762 553 53305738
Coagulation factor increased 30.90 14.69 6 42769 10 53306281
Incarcerated hernia 30.57 14.69 9 42766 131 53306160
Ecchymosis 30.54 14.69 41 42734 11058 53295233
Psoriasis 30.29 14.69 16 42759 87073 53219218
Post procedural haematoma 30.24 14.69 17 42758 1391 53304900
Prothrombin time ratio decreased 30.11 14.69 12 42763 450 53305841
Ischaemia 29.90 14.69 27 42748 4681 53301610
Constipation 29.31 14.69 73 42702 198339 53107952
Diarrhoea 29.29 14.69 341 42434 625205 52681086
Cough 29.01 14.69 107 42668 256786 53049505
Intracranial haematoma 28.78 14.69 11 42764 368 53305923
Gastric ulcer haemorrhage 28.14 14.69 27 42748 5055 53301236
Hypochromic anaemia 28.07 14.69 18 42757 1871 53304420
Oesophageal ulcer 28.05 14.69 25 42750 4261 53302030
Femoral artery embolism 27.91 14.69 7 42768 53 53306238
Haematocrit decreased 27.63 14.69 79 42696 37252 53269039
Therapeutic response decreased 27.53 14.69 3 42772 47566 53258725
Insomnia 27.49 14.69 69 42706 187003 53119288
Brain contusion 27.26 14.69 12 42763 579 53305712
Phlebitis 27.17 14.69 29 42746 6158 53300133
Road traffic accident 27.03 14.69 62 42713 25569 53280722
Heart transplant 27 14.69 11 42764 437 53305854
Brain herniation 26.92 14.69 22 42753 3334 53302957
Gastritis haemorrhagic 26.77 14.69 16 42759 1468 53304823
Therapeutic product effect incomplete 26.29 14.69 21 42754 91763 53214528
Neutrophil count decreased 26.24 14.69 4 42771 49094 53257197
Atrial flutter 25.74 14.69 35 42740 9556 53296735
Paraesthesia 25.70 14.69 39 42736 127476 53178815
Occult blood positive 25.35 14.69 22 42753 3620 53302671
Pulmonary alveolar haemorrhage 25.32 14.69 24 42751 4426 53301865
Rhinorrhoea 25.16 14.69 6 42769 53572 53252719
Mobility decreased 25.10 14.69 15 42760 76256 53230035
Oesophageal pain 24.62 14.69 20 42755 3006 53303285
Dysphagia 24.59 14.69 133 42642 84264 53222027
Disseminated intravascular coagulation 24.55 14.69 51 42724 19668 53286623
Suicidal ideation 24.37 14.69 9 42766 60502 53245789
Pelvic fracture 24.34 14.69 39 42736 12325 53293966
Petechiae 24.21 14.69 41 42734 13564 53292727
Hepatic enzyme increased 24.10 14.69 40 42735 126155 53180136
Pericarditis 23.65 14.69 11 42764 64395 53241896
Hypotension 23.58 14.69 309 42466 253767 53052524
Impaired healing 23.52 14.69 11 42764 64194 53242097
Basal ganglia haemorrhage 23.41 14.69 11 42764 618 53305673
Conjunctival haemorrhage 23.40 14.69 20 42755 3224 53303067
Intestinal infarction 23.15 14.69 13 42762 1061 53305230
Gastrointestinal necrosis 22.79 14.69 19 42756 2961 53303330
Haemoglobin abnormal 22.73 14.69 23 42752 4591 53301700
Irritable bowel syndrome 22.32 14.69 4 42771 43628 53262663
Prothrombin time 22.23 14.69 5 42770 22 53306269
Gastric ulcer 21.91 14.69 54 42721 23315 53282976
Arterial haemorrhage 21.75 14.69 15 42760 1761 53304530
Weight decreased 21.51 14.69 106 42669 234842 53071449
Haemorrhagic diathesis 21.48 14.69 22 42753 4456 53301835
Influenza like illness 21.43 14.69 11 42764 60848 53245443
Haemorrhagic arteriovenous malformation 21.39 14.69 7 42768 147 53306144
Hypoaesthesia 21.17 14.69 47 42728 132948 53173343
Haemorrhoids 20.99 14.69 49 42726 20440 53285851
Abdominal wall haematoma 20.65 14.69 18 42757 2980 53303311
Haemorrhage urinary tract 20.60 14.69 11 42764 813 53305478
Pain in extremity 20.52 14.69 139 42636 284911 53021380
Sepsis 20.40 14.69 193 42582 146236 53160055
Cardiogenic shock 20.36 14.69 44 42731 17438 53288853
Osteoarthritis 20.34 14.69 16 42759 70470 53235821
Prothrombin level decreased 20.33 14.69 10 42765 622 53305669
Injection site bruising 20.27 14.69 3 42772 37643 53268648
Vomiting 20.24 14.69 279 42496 496860 52809431
Post procedural haematuria 20.04 14.69 5 42770 37 53306254
Syncope 20.01 14.69 156 42619 111837 53194454
Lacunar infarction 19.81 14.69 19 42756 3555 53302736
Myocardial infarction 19.79 14.69 142 42633 99212 53207079
Gastritis 19.76 14.69 69 42706 36165 53270126
Intentional overdose 19.72 14.69 15 42760 67190 53239101
Cardiac failure chronic 19.69 14.69 20 42755 4010 53302281
Activated partial thromboplastin time 19.52 14.69 4 42771 10 53306281
Neurologic neglect syndrome 19.48 14.69 12 42763 1163 53305128
Splenic haematoma 19.46 14.69 6 42769 103 53306188
Renal infarct 19.36 14.69 13 42762 1461 53304830
Acute coronary syndrome 19.33 14.69 32 42743 10392 53295899
Urticaria 19.28 14.69 51 42724 135834 53170457
Multiple sclerosis relapse 19.23 14.69 6 42769 44847 53261444
Rib fracture 19.16 14.69 47 42728 20231 53286060
Cardioversion 19.13 14.69 12 42763 1201 53305090
Occult blood 19.12 14.69 12 42763 1202 53305089
Helicobacter infection 19.10 14.69 4 42771 39065 53267226
Infarction 18.98 14.69 16 42759 2531 53303760
Ill-defined disorder 18.85 14.69 8 42767 49436 53256855
Thrombotic cerebral infarction 18.75 14.69 6 42769 117 53306174
Overdose 18.66 14.69 149 42626 107587 53198704
Thrombotic stroke 18.65 14.69 9 42766 537 53305754
Malignant neoplasm progression 18.52 14.69 18 42757 71523 53234768
Diverticulitis intestinal haemorrhagic 18.33 14.69 6 42769 126 53306165
Arteriovenous malformation 18.27 14.69 12 42763 1299 53304992
Nasal congestion 18.22 14.69 10 42765 53277 53253014
Cardiac ablation 18.17 14.69 12 42763 1312 53304979
Haemodynamic instability 18.15 14.69 28 42747 8566 53297725
Haemorrhagic disorder 17.86 14.69 10 42765 812 53305479
Spontaneous haematoma 17.80 14.69 10 42765 817 53305474
Migraine 17.79 14.69 23 42752 80394 53225897
Aortic thrombosis 17.70 14.69 11 42764 1083 53305208
Herpes zoster 17.61 14.69 20 42755 73999 53232292
Abdominal wall haemorrhage 17.54 14.69 6 42769 145 53306146
Sleep disorder 17.45 14.69 13 42762 58857 53247434
Arthritis 17.30 14.69 27 42748 87271 53219020
Gastric cancer 17.29 14.69 17 42758 3280 53303011
Brain stem stroke 17.28 14.69 7 42768 274 53306017
Internal haemorrhage 17.17 14.69 20 42755 4676 53301615
Musculoskeletal pain 17.16 14.69 21 42754 75179 53231112
Oesophagitis 17.16 14.69 37 42738 14640 53291651
Rectal perforation 17.15 14.69 8 42767 442 53305849
Cerebellar haemorrhage 17.14 14.69 12 42763 1443 53304848
Therapy non-responder 17.11 14.69 9 42766 49111 53257180
Blood creatinine increased 16.96 14.69 119 42656 82543 53223748
Somnolence 16.93 14.69 73 42702 167661 53138630
Embolism arterial 16.84 14.69 11 42764 1180 53305111
Muscle spasms 16.64 14.69 54 42721 134741 53171550
Loss of personal independence in daily activities 16.46 14.69 19 42756 69796 53236495
Spinal cord haematoma 16.41 14.69 6 42769 177 53306114
Leukopenia 16.26 14.69 21 42754 73442 53232849
Blood glucose increased 16.23 14.69 23 42752 77338 53228953
Rectal ulcer 16.20 14.69 11 42764 1259 53305032
Dysarthria 16.19 14.69 70 42705 40498 53265793
Mucosal inflammation 16.19 14.69 7 42768 42777 53263514
Blood pressure increased 16.18 14.69 58 42717 140421 53165870
Peritonitis 16.15 14.69 46 42729 21641 53284650
Off label use 16.14 14.69 274 42501 471938 52834353
Hospitalisation 16.03 14.69 20 42755 70992 53235299
Type 2 diabetes mellitus 15.99 14.69 3 42772 31667 53274624
Carotid artery occlusion 15.97 14.69 15 42760 2734 53303557
Inappropriate schedule of product administration 15.97 14.69 22 42753 74856 53231435
Hot flush 15.90 14.69 9 42766 47151 53259140
Bronchitis 15.87 14.69 42 42733 111857 53194434
Depressed mood 15.75 14.69 5 42770 36959 53269332
COVID-19 15.70 14.69 5 42770 36883 53269408
Brain stem haemorrhage 15.64 14.69 9 42766 770 53305521
Pancytopenia 15.42 14.69 31 42744 90897 53215394
Duodenal ulcer haemorrhage 15.41 14.69 14 42761 2446 53303845
Extradural haematoma 15.29 14.69 12 42763 1716 53304575
Lymphadenopathy 15.28 14.69 5 42770 36250 53270041
Hypertensive crisis 15.20 14.69 35 42740 14471 53291820
Venous thrombosis limb 15.10 14.69 15 42760 2928 53303363
Erosive oesophagitis 15.10 14.69 12 42763 1747 53304544
Phlebitis deep 15.10 14.69 3 42772 6 53306285
Polyp 15.00 14.69 21 42754 5893 53300398
Globulins decreased 14.86 14.69 6 42769 233 53306058
Myalgia 14.79 14.69 56 42719 133435 53172856
Facial paresis 14.74 14.69 16 42759 3464 53302827
Anaphylactic reaction 14.72 14.69 15 42760 58311 53247980
Tongue haemorrhage 14.71 14.69 7 42768 405 53305886

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
Gastrointestinal haemorrhage 2749.41 14.55 1672 47103 85210 32379541
Ischaemic stroke 2276.08 14.55 890 47885 16686 32448065
Cerebrovascular accident 1644.67 14.55 1214 47561 85106 32379645
Haemorrhage 1092.11 14.55 762 48013 48686 32416065
Haemorrhage intracranial 865.60 14.55 439 48336 15448 32449303
Cerebral infarction 821.62 14.55 513 48262 27101 32437650
Rectal haemorrhage 819.33 14.55 574 48201 36849 32427902
Cerebral haemorrhage 742.04 14.55 525 48250 34222 32430529
Melaena 726.96 14.55 518 48257 34147 32430604
Atrial thrombosis 632.00 14.55 197 48578 1790 32462961
Embolic stroke 628.19 14.55 230 48545 3544 32461207
Subdural haematoma 594.03 14.55 371 48404 19582 32445169
Cardiac tamponade 565.42 14.55 231 48544 4844 32459907
Haematuria 428.86 14.55 441 48334 47920 32416831
Fall 392.81 14.55 890 47885 195311 32269440
Transient ischaemic attack 378.70 14.55 312 48463 25482 32439269
Lower gastrointestinal haemorrhage 367.72 14.55 204 48571 8613 32456138
Activated partial thromboplastin time prolonged 367.41 14.55 201 48574 8254 32456497
Shock haemorrhagic 321.85 14.55 200 48575 10445 32454306
Hemiparesis 307.96 14.55 225 48550 15382 32449369
Upper gastrointestinal haemorrhage 264.53 14.55 246 48529 23603 32441148
Blood loss anaemia 239.17 14.55 149 48626 7813 32456938
Deep vein thrombosis 229.89 14.55 372 48403 63341 32401410
Procoagulant therapy 222.22 14.55 42 48733 10 32464741
Coagulopathy 221.08 14.55 204 48571 19373 32445378
Subarachnoid haemorrhage 211.96 14.55 153 48622 10258 32454493
Pulmonary embolism 210.10 14.55 417 48358 83242 32381509
Pericardial haemorrhage 208.93 14.55 99 48676 2987 32461764
Thrombin time prolonged 206.97 14.55 49 48726 128 32464623
Haemorrhagic stroke 206.71 14.55 126 48649 6352 32458399
Haematoma 202.15 14.55 220 48555 25464 32439287
Aphasia 179.08 14.55 187 48588 20641 32444110
Haemothorax 177.77 14.55 95 48680 3717 32461034
Aortic dissection 165.93 14.55 80 48695 2510 32462241
Hemiplegia 153.37 14.55 108 48667 6960 32457791
Haematemesis 150.18 14.55 196 48579 27439 32437312
Epistaxis 143.21 14.55 281 48494 55574 32409177
Head injury 141.93 14.55 153 48622 17510 32447241
Haemorrhagic transformation stroke 138.30 14.55 58 48717 1300 32463451
Procedural haemorrhage 133.01 14.55 68 48707 2425 32462326
Febrile neutropenia 132.53 14.55 13 48762 119553 32345198
Toxicity to various agents 130.47 14.55 52 48723 177989 32286762
Pyrexia 130.40 14.55 174 48601 319794 32144957
Neutropenia 124.79 14.55 30 48745 142145 32322606
Haematochezia 121.45 14.55 214 48561 38994 32425757
Completed suicide 120.79 14.55 4 48771 92513 32372238
Intracardiac thrombus 115.23 14.55 62 48713 2459 32462292
Subdural haemorrhage 115.11 14.55 66 48709 2967 32461784
Haemoptysis 114.37 14.55 191 48584 33334 32431417
Cerebral haematoma 112.55 14.55 77 48698 4734 32460017
Anaemia 112.45 14.55 644 48131 222980 32241771
Intestinal haemorrhage 105.94 14.55 65 48710 3314 32461437
Peripheral embolism 103.19 14.55 43 48732 948 32463803
Brain contusion 102.35 14.55 41 48734 814 32463937
International normalised ratio increased 99.23 14.55 224 48551 48811 32415940
Post procedural haemorrhage 94.64 14.55 87 48688 8213 32456538
Pericardial effusion 93.51 14.55 142 48633 22860 32441891
Product dose omission issue 93.25 14.55 20 48755 102555 32362196
Fatigue 89.39 14.55 252 48523 350449 32114302
Cardiac failure 87.27 14.55 319 48456 91354 32373397
Colon cancer 86.02 14.55 85 48690 8781 32455970
Oesophageal pain 84.10 14.55 35 48740 769 32463982
Gastric haemorrhage 80.11 14.55 86 48689 9790 32454961
Drug abuse 78.56 14.55 13 48762 80230 32384521
Large intestinal haemorrhage 77.56 14.55 41 48734 1568 32463183
Anticoagulation drug level increased 76.16 14.55 29 48746 500 32464251
Disease progression 74.85 14.55 19 48756 86843 32377908
Faeces discoloured 72.36 14.55 100 48675 14777 32449974
Pain 72.20 14.55 106 48669 187450 32277301
Depression 71.58 14.55 28 48747 97032 32367719
Renal impairment 71.26 14.55 300 48475 91672 32373079
Pancytopenia 71.21 14.55 24 48751 91211 32373540
Hypovolaemic shock 70.63 14.55 68 48707 6804 32457947
Road traffic accident 70.21 14.55 107 48668 17274 32447477
Pulmonary haemorrhage 68.21 14.55 79 48696 9778 32454973
Rash 67.97 14.55 132 48643 209201 32255550
Extradural haematoma 66.72 14.55 34 48741 1204 32463547
Traumatic intracranial haemorrhage 65.69 14.55 28 48747 654 32464097
Nausea 65.50 14.55 254 48521 320595 32144156
Drug hypersensitivity 65.30 14.55 15 48760 73385 32391366
Product use in unapproved indication 64.56 14.55 25 48750 87179 32377572
Blood urine present 64.27 14.55 79 48696 10406 32454345
Cerebral artery occlusion 64.26 14.55 29 48746 780 32463971
Diarrhoea 63.97 14.55 306 48469 364496 32100255
Intraventricular haemorrhage 63.16 14.55 46 48729 3124 32461627
Leukopenia 62.88 14.55 8 48767 60114 32404637
Haemorrhagic infarction 62.80 14.55 24 48751 418 32464333
Embolism 62.68 14.55 66 48709 7348 32457403
Coagulation test abnormal 62.51 14.55 25 48750 494 32464257
Dyspepsia 62.43 14.55 147 48628 32908 32431843
Contusion 61.22 14.55 147 48628 33321 32431430
Urinary bladder haemorrhage 60.29 14.55 36 48739 1746 32463005
White blood cell count decreased 59.90 14.55 31 48744 91167 32373584
Gingival bleeding 58.76 14.55 62 48713 6919 32457832
Tremor 57.41 14.55 25 48750 81252 32383499
Wound secretion 56.38 14.55 40 48735 2607 32462144
Embolic cerebral infarction 55.58 14.55 25 48750 667 32464084
Splenic rupture 55.50 14.55 33 48742 1588 32463163
Cerebral mass effect 55.47 14.55 27 48748 865 32463886
Coagulation time prolonged 54.81 14.55 31 48744 1357 32463394
Traumatic haemorrhage 54.40 14.55 25 48750 702 32464049
Skull fracture 54.02 14.55 27 48748 917 32463834
Anorectal discomfort 53.47 14.55 34 48741 1846 32462905
Insomnia 50.11 14.55 46 48729 100302 32364449
Thrombosis 49.34 14.55 166 48609 45588 32419163
Chills 49.15 14.55 28 48747 78056 32386695
Rheumatoid arthritis 48.90 14.55 5 48770 44539 32420212
Surgery 48.69 14.55 76 48699 12523 32452228
Cerebral artery embolism 47.97 14.55 25 48750 928 32463823
Anxiety 47.95 14.55 44 48731 95961 32368790
Infusion related reaction 47.84 14.55 6 48769 45593 32419158
Cardiac ablation 47.41 14.55 22 48753 632 32464119
Vomiting 47.01 14.55 188 48587 235369 32229382
Aortic aneurysm rupture 46.93 14.55 26 48749 1093 32463658
Activated partial thromboplastin time abnormal 46.66 14.55 13 48762 76 32464675
Neuropathy peripheral 46.49 14.55 29 48746 76953 32387798
Embolism arterial 46.46 14.55 21 48754 567 32464184
Condition aggravated 46.38 14.55 103 48672 155558 32309193
Creatinine renal clearance decreased 46.15 14.55 40 48735 3494 32461257
Intra-abdominal haemorrhage 43.20 14.55 32 48743 2231 32462520
Traumatic haemothorax 43.06 14.55 16 48759 257 32464494
Haemorrhoidal haemorrhage 42.83 14.55 37 48738 3217 32461534
Strangulated hernia 42.82 14.55 9 48766 10 32464741
Haemoglobin decreased 42.39 14.55 316 48459 119355 32345396
Atrial fibrillation 42.39 14.55 310 48465 116394 32348357
Weight increased 42.18 14.55 38 48737 83625 32381126
Renal failure 42.07 14.55 345 48430 134133 32330618
Arthralgia 40.42 14.55 103 48672 148345 32316406
Psoriasis 39.88 14.55 10 48765 46113 32418638
Agitation 39.79 14.55 18 48757 57218 32407533
Off label use 39.66 14.55 283 48492 306037 32158714
Neutrophil count decreased 39.28 14.55 11 48764 47128 32417623
Muscle spasms 39.21 14.55 29 48746 70389 32394362
Retroperitoneal haemorrhage 38.95 14.55 33 48742 2795 32461956
Intentional product use issue 38.80 14.55 8 48767 42203 32422548
Incarcerated hernia 38.68 14.55 14 48761 208 32464543
Basal ganglia haemorrhage 38.56 14.55 21 48754 853 32463898
Thrombin time abnormal 38.53 14.55 7 48768 0 32464751
Acute abdomen 37.70 14.55 28 48747 1960 32462791
Seizure 37.69 14.55 61 48714 103793 32360958
Mouth haemorrhage 37.67 14.55 43 48732 5238 32459513
Product use issue 37.63 14.55 16 48759 52761 32411990
Cerebellar haemorrhage 37.33 14.55 25 48750 1483 32463268
Renal infarct 36.84 14.55 23 48752 1209 32463542
Malignant neoplasm progression 36.84 14.55 38 48737 78458 32386293
Alanine aminotransferase increased 36.83 14.55 38 48737 78441 32386310
Oesophageal ulcer 36.76 14.55 35 48740 3453 32461298
International normalised ratio abnormal 36.57 14.55 34 48741 3255 32461496
Dysarthria 36.26 14.55 121 48654 33080 32431671
Mucosal inflammation 36.06 14.55 4 48771 33430 32431321
Somnolence 35.79 14.55 63 48712 103734 32361017
Acute kidney injury 34.97 14.55 626 48149 292842 32171909
Ischaemia 34.96 14.55 39 48736 4633 32460118
Haemorrhage urinary tract 34.64 14.55 25 48750 1674 32463077
Heart transplant 34.24 14.55 19 48756 801 32463950
Erythema 33.88 14.55 45 48730 83060 32381691
International normalised ratio 33.81 14.55 9 48766 43 32464708
Intracranial haematoma 33.81 14.55 15 48760 387 32464364
Blood creatine phosphokinase increased 33.70 14.55 13 48762 45463 32419288
Asthma 33.66 14.55 12 48763 44053 32420698
Cardiac valve replacement complication 33.64 14.55 9 48766 44 32464707
Pulmonary alveolar haemorrhage 33.29 14.55 47 48728 7082 32457669
Multiple injuries 33.23 14.55 26 48749 1967 32462784
Platelet count decreased 33.16 14.55 77 48698 114514 32350237
Drug intolerance 33.08 14.55 17 48758 50218 32414533
Coagulation time shortened 33.07 14.55 13 48762 245 32464506
Activated partial thromboplastin time 33.02 14.55 6 48769 0 32464751
Creatinine renal clearance 33.02 14.55 6 48769 0 32464751
Cardioversion 32.30 14.55 19 48756 896 32463855
C-reactive protein increased 32.09 14.55 16 48759 48086 32416665
Femoral neck fracture 31.99 14.55 31 48744 3125 32461626
Arterial thrombosis 31.96 14.55 23 48752 1533 32463218
Gastrointestinal carcinoma 31.81 14.55 21 48754 1216 32463535
Gastrointestinal motility disorder 31.53 14.55 27 48748 2320 32462431
Hemianopia 31.30 14.55 17 48758 687 32464064
Wound haemorrhage 31.14 14.55 25 48750 1963 32462788
Cough 30.77 14.55 106 48669 138711 32326040
Stomatitis 30.65 14.55 11 48764 40218 32424533
Neurologic neglect syndrome 29.87 14.55 11 48764 172 32464579
Aggression 29.62 14.55 11 48764 39378 32425373
Appendicitis 29.23 14.55 50 48725 8887 32455864
Craniocerebral injury 29.19 14.55 29 48746 3014 32461737
Blood glucose increased 29.04 14.55 33 48742 65208 32399543
Weight decreased 28.90 14.55 138 48637 164680 32300071
Elderly 28.87 14.55 6 48769 6 32464745
White blood cell count increased 28.80 14.55 13 48762 41389 32423362
Iron deficiency anaemia 28.79 14.55 52 48723 9649 32455102
Femur fracture 28.65 14.55 46 48729 7762 32456989
Gastric cancer 28.64 14.55 38 48737 5399 32459352
Large intestine polyp 28.59 14.55 44 48731 7162 32457589
Oesophageal carcinoma 28.43 14.55 33 48742 4093 32460658
Thrombotic stroke 28.32 14.55 12 48763 276 32464475
Cardiac perforation 28.18 14.55 9 48766 89 32464662
Plasma cell myeloma 28.05 14.55 27 48748 57587 32407164
Joint swelling 27.91 14.55 22 48753 51713 32413038
Acute myocardial infarction 27.67 14.55 159 48616 54990 32409761
Haemorrhage subcutaneous 27.11 14.55 25 48750 2368 32462383
Aspartate aminotransferase increased 27.04 14.55 36 48739 66393 32398358
Injection site pain 27.01 14.55 8 48767 33050 32431701
Infection 26.92 14.55 54 48721 84661 32380090
Lumbar puncture 26.76 14.55 9 48766 106 32464645
Nasopharyngitis 26.55 14.55 34 48741 63753 32400998
Prothrombin time prolonged 26.08 14.55 50 48725 9705 32455046
Mesenteric artery embolism 25.92 14.55 8 48767 70 32464681
Infarction 25.89 14.55 26 48749 2737 32462014
Ascites 25.87 14.55 14 48761 40177 32424574
Peripheral artery thrombosis 25.87 14.55 24 48751 2291 32462460
Intestinal ischaemia 25.46 14.55 42 48733 7249 32457502
Cerebral ischaemia 25.43 14.55 39 48736 6328 32458423
Rib fracture 25.38 14.55 61 48714 13828 32450923
Anaphylactic reaction 25.21 14.55 7 48768 30165 32434586
Hemianopia homonymous 25.02 14.55 15 48760 733 32464018
Diverticulum intestinal haemorrhagic 25.01 14.55 23 48752 2171 32462580
Ecchymosis 24.74 14.55 40 48735 6788 32457963
Hyperhidrosis 24.70 14.55 43 48732 71125 32393626
Cerebellar infarction 24.40 14.55 22 48753 2025 32462726
Abnormal behaviour 24.36 14.55 5 48770 26461 32438290
Rhabdomyolysis 23.93 14.55 40 48735 67225 32397526
Exsanguination 23.92 14.55 7 48768 50 32464701
Brain herniation 23.45 14.55 29 48746 3842 32460909
Musculoskeletal stiffness 23.40 14.55 15 48760 39249 32425502
Diabetes mellitus 23.38 14.55 20 48755 45153 32419598
Pulmonary contusion 23.34 14.55 7 48768 55 32464696
Feeling abnormal 23.34 14.55 34 48741 60389 32404362
Gastric ulcer haemorrhage 23.32 14.55 35 48740 5572 32459179
Arteriovenous malformation 23.26 14.55 14 48761 689 32464062
Sinusitis 23.15 14.55 13 48762 36547 32428204
Back pain 23.14 14.55 87 48688 110966 32353785
Cholecystitis acute 23.05 14.55 36 48739 5934 32458817
Stress 22.93 14.55 4 48771 23778 32440973
Post procedural stroke 22.84 14.55 6 48769 27 32464724
Herpes zoster 22.74 14.55 10 48765 32331 32432420
Thrombocytopenia 22.71 14.55 130 48645 148169 32316582
Dyskinesia 22.70 14.55 4 48771 23599 32441152
Skin haemorrhage 22.51 14.55 28 48747 3731 32461020
Electrocardiogram QT prolonged 22.48 14.55 16 48759 39625 32425126
Catheter site haemorrhage 22.41 14.55 22 48753 2253 32462498
Cerebral vascular occlusion 22.02 14.55 4 48771 0 32464751
Irritability 21.99 14.55 5 48770 24649 32440102
Colon neoplasm 21.78 14.55 11 48764 382 32464369
Urticaria 21.63 14.55 35 48740 59579 32405172
Hospitalisation 21.54 14.55 25 48750 48946 32415805
Aneurysm ruptured 21.54 14.55 12 48763 510 32464241
Drug ineffective 21.53 14.55 426 48349 383051 32081700
Subarachnoid haematoma 21.50 14.55 7 48768 74 32464677
Haemoglobin abnormal 21.42 14.55 26 48749 3379 32461372
Vision blurred 21.17 14.55 21 48754 44165 32420586
Subcutaneous haematoma 21.07 14.55 15 48760 983 32463768
Haemorrhoids 20.91 14.55 54 48721 12799 32451952
Thalamus haemorrhage 20.87 14.55 15 48760 998 32463753
Injury 20.77 14.55 77 48698 22168 32442583
Renal haemorrhage 20.60 14.55 17 48758 1388 32463363
Peripheral swelling 20.51 14.55 45 48730 68300 32396451
Pneumonia 20.43 14.55 393 48382 354859 32109892
Productive cough 20.38 14.55 13 48762 34103 32430648
Gastric ulcer 20.36 14.55 61 48714 15748 32449003
Pneumonitis 20.13 14.55 10 48765 30124 32434627
Ischaemic cerebral infarction 20.07 14.55 15 48760 1060 32463691
Coronary artery embolism 20.01 14.55 8 48767 158 32464593
Hallucination 19.94 14.55 30 48745 52589 32412162
Drug reaction with eosinophilia and systemic symptoms 19.93 14.55 12 48763 32473 32432278
Aortic aneurysm 19.92 14.55 36 48739 6683 32458068
Therapeutic response decreased 19.89 14.55 7 48768 25913 32438838
Influenza like illness 19.71 14.55 8 48767 27132 32437619
Oxygen saturation decreased 19.64 14.55 26 48749 48073 32416678
Cardiac pacemaker insertion 19.52 14.55 22 48753 2643 32462108
Venous thrombosis 19.46 14.55 25 48750 3442 32461309
Arterial injury 19.44 14.55 10 48765 361 32464390
Myalgia 19.39 14.55 60 48715 81170 32383581
Traumatic haematoma 19.20 14.55 13 48762 785 32463966
Gastrointestinal angiodysplasia 19.05 14.55 12 48763 641 32464110
Osteonecrosis of jaw 18.98 14.55 3 48772 19163 32445588
Angioedema 18.86 14.55 16 48759 36273 32428478
Urogenital haemorrhage 18.77 14.55 11 48764 515 32464236
Dry skin 18.74 14.55 7 48768 24971 32439780
Haemodynamic instability 18.64 14.55 41 48734 8770 32455981
Intestinal infarction 18.05 14.55 11 48764 554 32464197
Mesenteric haemorrhage 17.98 14.55 4 48771 7 32464744
Factor V deficiency 17.98 14.55 5 48770 29 32464722
Rectal cancer 17.92 14.55 20 48755 2377 32462374
Haemoperitoneum 17.91 14.55 17 48758 1670 32463081
Hypertension 17.83 14.55 120 48655 131630 32333121
Loss of personal independence in daily activities 17.78 14.55 9 48766 26824 32437927
Diverticulum 17.71 14.55 35 48740 6947 32457804
Colitis ischaemic 17.65 14.55 33 48742 6287 32458464
Splenic injury 17.56 14.55 5 48770 32 32464719
Hyperglycaemia 17.54 14.55 19 48756 38372 32426379
Pruritus 17.53 14.55 117 48658 128585 32336166
Abdominal discomfort 17.50 14.55 137 48638 52487 32412264
Therapy non-responder 17.46 14.55 14 48761 32640 32432111
Lymphocyte count decreased 17.46 14.55 5 48770 21114 32443637
Hypersensitivity 17.35 14.55 38 48737 57720 32407031
Orthopaedic procedure 17.31 14.55 4 48771 9 32464742
Puncture site haemorrhage 17.25 14.55 9 48766 335 32464416
Confusional state 17.13 14.55 135 48640 142980 32321771
Hyponatraemia 17.11 14.55 56 48719 74457 32390294
Blood cholesterol increased 17.09 14.55 3 48772 17754 32446997
Thrombotic cerebral infarction 17.03 14.55 9 48766 344 32464407
Prothrombin time shortened 16.79 14.55 16 48759 1580 32463171
Pain in extremity 16.74 14.55 107 48668 118794 32345957
Eye haemorrhage 16.69 14.55 25 48750 3972 32460779
Diverticulitis intestinal haemorrhagic 16.65 14.55 9 48766 360 32464391
Blood lactate dehydrogenase increased 16.54 14.55 6 48769 21799 32442952
Incarcerated inguinal hernia 16.52 14.55 6 48769 90 32464661
Inguinal hernia strangulated 16.51 14.55 3 48772 0 32464751
Pneumocystis jirovecii pneumonia 16.49 14.55 4 48771 18866 32445885
Small intestinal haemorrhage 16.44 14.55 18 48757 2094 32462657
Occult blood positive 16.36 14.55 25 48750 4044 32460707
Cataract 16.19 14.55 8 48767 24175 32440576
Gait disturbance 16.09 14.55 64 48711 80344 32384407
Aortic dissection rupture 16.02 14.55 4 48771 14 32464737
Internal haemorrhage 16.01 14.55 27 48748 4745 32460006
Muscle strain 15.99 14.55 24 48751 3821 32460930
Blood pressure increased 15.99 14.55 63 48712 79291 32385460
Shock 15.88 14.55 75 48700 24039 32440712
Peripheral ischaemia 15.80 14.55 30 48745 5781 32458970
Tachycardia 15.80 14.55 63 48712 79025 32385726
Influenza 15.78 14.55 28 48747 45986 32418765
Encephalopathy 15.60 14.55 17 48758 34240 32430511
Microvillous inclusion disease 15.52 14.55 5 48770 51 32464700
Intentional product misuse 15.22 14.55 19 48756 36032 32428719
Conjunctival haemorrhage 15.11 14.55 20 48755 2835 32461916
Toxic epidermal necrolysis 15.07 14.55 6 48769 20587 32444164
Post procedural pulmonary embolism 15.05 14.55 4 48771 19 32464732
Gastritis erosive 15.03 14.55 30 48745 5997 32458754
Serotonin syndrome 14.95 14.55 5 48770 19112 32445639
Sleep disorder 14.90 14.55 11 48764 26741 32438010
Cerebral thrombosis 14.86 14.55 12 48763 950 32463801
Ulcer haemorrhage 14.75 14.55 19 48756 2623 32462128
Monoparesis 14.73 14.55 16 48759 1845 32462906
Thoracic haemorrhage 14.71 14.55 7 48768 213 32464538

Pharmacologic Action:

SourceCodeDescription
ATC B01AE07 BLOOD AND BLOOD FORMING ORGANS
ANTITHROMBOTIC AGENTS
ANTITHROMBOTIC AGENTS
Direct thrombin inhibitors
FDA MoA N0000009963 Thrombin Inhibitors
FDA EPC N0000175518 Direct Thrombin Inhibitor
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
CHEBI has role CHEBI:50249 anticoagulante
CHEBI has role CHEBI:50266 Prodrugs
CHEBI has role CHEBI:65232 EC 3.4.21.5 inhibitor
CHEBI has role CHEBI:77020 NRH:quinone oxidoreductase 2 inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Prevention of deep vein thrombosis indication 439993001
Prevention of Thromboembolism with Chronic Atrial Fibrillation indication
Acute hemorrhage contraindication 8573003
Acute nephropathy contraindication 58574008
Blood coagulation disorder contraindication 64779008 DOID:1247
Anemia contraindication 271737000 DOID:2355
Cerebral hemorrhage contraindication 274100004

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 5.35 Basic
pKa2 2.31 Basic
pKa3 1.61 Basic
pKa4 0.55 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 110MG BASE PRADAXA BOEHRINGER INGELHEIM N022512 Nov. 20, 2015 RX CAPSULE ORAL 9034822 Jan. 20, 2031 METHOD OF REVERSING THE ANTICOAGULANT EFFECT OF DABIGATRAN USING IDARUCIZUMAB
EQ 150MG BASE PRADAXA BOEHRINGER INGELHEIM N022512 Oct. 19, 2010 RX CAPSULE ORAL 9034822 Jan. 20, 2031 METHOD OF REVERSING THE ANTICOAGULANT EFFECT OF DABIGATRAN USING IDARUCIZUMAB
EQ 75MG BASE PRADAXA BOEHRINGER INGELHEIM N022512 Oct. 19, 2010 RX CAPSULE ORAL 9034822 Jan. 20, 2031 METHOD OF REVERSING THE ANTICOAGULANT EFFECT OF DABIGATRAN USING IDARUCIZUMAB

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 110MG BASE PRADAXA BOEHRINGER INGELHEIM N022512 Nov. 20, 2015 RX CAPSULE ORAL June 21, 2024 TREATMENT OF VENOUS THROMBOEMBOLIC EVENTS (VTE) IN PEDIATRIC PATIENTS 8 TO LESS THAN 18 YEARS OF AGE WHO HAVE BEEN TREATED WITH A PARENTERAL ANTICOAGULANT FOR AT LEAST 5 DAYS AND TO REDUCE THE RISK OF RECURRENCE OF VTE IN PEDIATRIC PATIENTS 8 TO LESS THAN 18 YEARS OF AGE WHO HAVE BEEN PREVIOUSLY TREATED
EQ 150MG BASE PRADAXA BOEHRINGER INGELHEIM N022512 Oct. 19, 2010 RX CAPSULE ORAL June 21, 2024 TREATMENT OF VENOUS THROMBOEMBOLIC EVENTS (VTE) IN PEDIATRIC PATIENTS 8 TO LESS THAN 18 YEARS OF AGE WHO HAVE BEEN TREATED WITH A PARENTERAL ANTICOAGULANT FOR AT LEAST 5 DAYS AND TO REDUCE THE RISK OF RECURRENCE OF VTE IN PEDIATRIC PATIENTS 8 TO LESS THAN 18 YEARS OF AGE WHO HAVE BEEN PREVIOUSLY TREATED
EQ 75MG BASE PRADAXA BOEHRINGER INGELHEIM N022512 Oct. 19, 2010 RX CAPSULE ORAL June 21, 2024 TREATMENT OF VENOUS THROMBOEMBOLIC EVENTS (VTE) IN PEDIATRIC PATIENTS 8 TO LESS THAN 18 YEARS OF AGE WHO HAVE BEEN TREATED WITH A PARENTERAL ANTICOAGULANT FOR AT LEAST 5 DAYS AND TO REDUCE THE RISK OF RECURRENCE OF VTE IN PEDIATRIC PATIENTS 8 TO LESS THAN 18 YEARS OF AGE WHO HAVE BEEN PREVIOUSLY TREATED
EQ 110MG BASE/PACKET PRADAXA BOEHRINGER INGELHEIM N214358 June 21, 2021 RX PELLETS ORAL June 21, 2024 NEW PRODUCT
EQ 150MG BASE/PACKET PRADAXA BOEHRINGER INGELHEIM N214358 June 21, 2021 RX PELLETS ORAL June 21, 2024 NEW PRODUCT
EQ 20MG BASE/PACKET PRADAXA BOEHRINGER INGELHEIM N214358 June 21, 2021 RX PELLETS ORAL June 21, 2024 NEW PRODUCT
EQ 30MG BASE/PACKET PRADAXA BOEHRINGER INGELHEIM N214358 June 21, 2021 RX PELLETS ORAL June 21, 2024 NEW PRODUCT
EQ 40MG BASE/PACKET PRADAXA BOEHRINGER INGELHEIM N214358 June 21, 2021 RX PELLETS ORAL June 21, 2024 NEW PRODUCT
EQ 50MG BASE/PACKET PRADAXA BOEHRINGER INGELHEIM N214358 June 21, 2021 RX PELLETS ORAL June 21, 2024 NEW PRODUCT
EQ 110MG BASE PRADAXA BOEHRINGER INGELHEIM N022512 Nov. 20, 2015 RX CAPSULE ORAL Dec. 21, 2024 PEDIATRIC EXCLUSIVITY
EQ 150MG BASE PRADAXA BOEHRINGER INGELHEIM N022512 Oct. 19, 2010 RX CAPSULE ORAL Dec. 21, 2024 PEDIATRIC EXCLUSIVITY
EQ 75MG BASE PRADAXA BOEHRINGER INGELHEIM N022512 Oct. 19, 2010 RX CAPSULE ORAL Dec. 21, 2024 PEDIATRIC EXCLUSIVITY
EQ 110MG BASE/PACKET PRADAXA BOEHRINGER INGELHEIM N214358 June 21, 2021 RX PELLETS ORAL Dec. 21, 2024 PEDIATRIC EXCLUSIVITY
EQ 150MG BASE/PACKET PRADAXA BOEHRINGER INGELHEIM N214358 June 21, 2021 RX PELLETS ORAL Dec. 21, 2024 PEDIATRIC EXCLUSIVITY
EQ 20MG BASE/PACKET PRADAXA BOEHRINGER INGELHEIM N214358 June 21, 2021 RX PELLETS ORAL Dec. 21, 2024 PEDIATRIC EXCLUSIVITY
EQ 30MG BASE/PACKET PRADAXA BOEHRINGER INGELHEIM N214358 June 21, 2021 RX PELLETS ORAL Dec. 21, 2024 PEDIATRIC EXCLUSIVITY
EQ 40MG BASE/PACKET PRADAXA BOEHRINGER INGELHEIM N214358 June 21, 2021 RX PELLETS ORAL Dec. 21, 2024 PEDIATRIC EXCLUSIVITY
EQ 50MG BASE/PACKET PRADAXA BOEHRINGER INGELHEIM N214358 June 21, 2021 RX PELLETS ORAL Dec. 21, 2024 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Prothrombin Enzyme INHIBITOR Ki 8.35 CHEMBL CHEMBL
Plasminogen Enzyme Ki 5.77 CHEMBL
Coagulation factor X Enzyme Ki 5.42 CHEMBL
Tissue-type plasminogen activator Enzyme Ki 4.34 CHEMBL
Vitamin K-dependent protein C Enzyme Ki 4.68 CHEMBL
Solute carrier family 22 member 2 Transporter IC50 5.33 CHEMBL
Multidrug and toxin extrusion protein 1 Transporter IC50 5.09 CHEMBL
Multidrug and toxin extrusion protein 2 Transporter IC50 4.60 CHEMBL
Trypsin Enzyme Ki 7.30 CHEMBL
Serine protease hepsin Enzyme Ki 6.08 CHEMBL
Ribosyldihydronicotinamide dehydrogenase [quinone] Enzyme IC50 4.96 CHEMBL
Thrombin Unclassified IC50 6.26 CHEMBL

External reference:

IDSource
4030255 VUID
N0000181837 NUI
D07082 KEGG_DRUG
872728-81-9 SECONDARY_CAS_RN
211914-51-1 SECONDARY_CAS_RN
C1571583 UMLSCUI
CHEBI:70746 CHEBI
CHEBI:70752 CHEBI
CHEMBL539697 ChEMBL_ID
CHEMBL1615369 ChEMBL_ID
CHEMBL48361 ChEMBL_ID
D000069604 MESH_DESCRIPTOR_UI
DB06695 DRUGBANK_ID
6379 IUPHAR_LIGAND_ID
6380 IUPHAR_LIGAND_ID
8028 INN_ID
8027 INN_ID
2E18WX195X UNII
135565674 PUBCHEM_CID
216210 PUBCHEM_CID
DB14726 DRUGBANK_ID
I0VM4M70GC UNII
1037041 RXNORM
136711 MMSL
25762 MMSL
d07137 MMSL
012668 NDDF
012669 NDDF
698871007 SNOMEDCT_US
700029008 SNOMEDCT_US
700039002 SNOMEDCT_US
714788005 SNOMEDCT_US
4030254 VANDF
4030255 VANDF
C2348066 UMLSCUI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Pradaxa HUMAN PRESCRIPTION DRUG LABEL 1 0597-0108 CAPSULE 110 mg ORAL NDA 33 sections
Pradaxa HUMAN PRESCRIPTION DRUG LABEL 1 0597-0355 CAPSULE 75 mg ORAL NDA 33 sections
Pradaxa HUMAN PRESCRIPTION DRUG LABEL 1 0597-0360 CAPSULE 150 mg ORAL NDA 33 sections
Pradaxa HUMAN PRESCRIPTION DRUG LABEL 1 0597-0425 PELLET 20 mg ORAL NDA 33 sections
Pradaxa HUMAN PRESCRIPTION DRUG LABEL 1 0597-0430 PELLET 30 mg ORAL NDA 33 sections
Pradaxa HUMAN PRESCRIPTION DRUG LABEL 1 0597-0435 PELLET 40 mg ORAL NDA 33 sections
Pradaxa HUMAN PRESCRIPTION DRUG LABEL 1 0597-0440 PELLET 50 mg ORAL NDA 33 sections
Pradaxa HUMAN PRESCRIPTION DRUG LABEL 1 0597-0445 PELLET 110 mg ORAL NDA 33 sections
Pradaxa HUMAN PRESCRIPTION DRUG LABEL 1 0597-0450 PELLET 150 mg ORAL NDA 33 sections
PRADAXA HUMAN PRESCRIPTION DRUG LABEL 1 21695-899 CAPSULE 150 mg ORAL NDA 27 sections
Pradaxa HUMAN PRESCRIPTION DRUG LABEL 1 50090-3617 CAPSULE 150 mg ORAL NDA 32 sections
Pradaxa HUMAN PRESCRIPTION DRUG LABEL 1 50090-4480 CAPSULE 150 mg ORAL NDA 31 sections
Pradaxa HUMAN PRESCRIPTION DRUG LABEL 1 63629-8242 CAPSULE 150 mg ORAL NDA 32 sections