dabigatran etexilate ๐Ÿถ Veterinary Use | 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 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

DateAgencyCompanyOrphan
March 18, 2008 EMA BOEHRINGER INGELHEIM INTERNATIONAL GMBH
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 4609.59 15.00 1831 42873 79345 63364973
Ischaemic stroke 2437.97 15.00 776 43928 17181 63427137
Cerebrovascular accident 1607.59 15.00 979 43725 107045 63337273
Haemorrhage 1323.77 15.00 708 43996 60314 63384004
Melaena 1115.85 15.00 505 44199 29860 63414458
Rectal haemorrhage 1035.16 15.00 559 44145 48471 63395847
Haemorrhage intracranial 957.67 15.00 359 44345 13060 63431258
Cerebral haemorrhage 787.14 15.00 399 44305 30330 63413988
Lower gastrointestinal haemorrhage 692.68 15.00 246 44458 7644 63436674
Activated partial thromboplastin time prolonged 682.22 15.00 235 44469 6658 63437660
Cardiac tamponade 552.16 15.00 183 44521 4592 63439726
Subdural haematoma 493.51 15.00 228 44476 14100 63430218
Cerebral infarction 483.11 15.00 265 44439 23628 63420690
International normalised ratio increased 423.17 15.00 311 44393 46114 63398204
Haematoma 415.00 15.00 275 44429 34545 63409773
Fall 403.65 15.00 866 43838 391468 63052850
Shock haemorrhagic 393.18 15.00 174 44530 9721 63434597
Embolic stroke 386.30 15.00 132 44572 3644 63440674
Blood loss anaemia 385.96 15.00 167 44537 8834 63435484
Upper gastrointestinal haemorrhage 364.34 15.00 203 44501 18649 63425669
Coagulopathy 364.04 15.00 209 44495 20335 63423983
Procoagulant therapy 363.08 15.00 58 44646 0 63444318
Haematuria 325.14 15.00 221 44483 28936 63415382
Haematochezia 319.79 15.00 280 44424 53264 63391054
Transient ischaemic attack 319.60 15.00 242 44462 37511 63406807
Anaemia 316.63 15.00 661 44043 292769 63151549
Haemorrhagic stroke 307.07 15.00 125 44579 5667 63438651
Pericardial haemorrhage 278.40 15.00 84 44620 1535 63442783
Haematemesis 259.72 15.00 196 44508 30216 63414102
Thrombin time prolonged 245.85 15.00 46 44658 69 63444249
Acute kidney injury 244.75 15.00 559 44145 262856 63181462
Subarachnoid haemorrhage 236.29 15.00 139 44565 14144 63430174
Atrial thrombosis 231.63 15.00 75 44629 1743 63442575
Pain 229.98 15.00 118 44586 740510 62703808
Deep vein thrombosis 221.84 15.00 284 44420 83516 63360802
Haemoglobin decreased 218.82 15.00 378 44326 145107 63299211
Renal failure 213.82 15.00 333 44371 117319 63326999
Intestinal haemorrhage 210.71 15.00 85 44619 3762 63440556
Pulmonary embolism 201.99 15.00 323 44381 116361 63327957
Epistaxis 183.90 15.00 241 44463 72484 63371834
Hemiparesis 183.31 15.00 143 44561 23139 63421179
Cardiac failure 179.91 15.00 265 44439 88877 63355441
Hypovolaemic shock 162.43 15.00 82 44622 6159 63438159
Subdural haemorrhage 160.86 15.00 66 44638 3052 63441266
Drug hypersensitivity 146.66 15.00 22 44682 310665 63133653
Fatigue 142.21 15.00 256 44448 887772 62556546
Aortic dissection 133.06 15.00 51 44653 1967 63442351
Maternal exposure during pregnancy 133.03 15.00 5 44699 220057 63224261
Prothrombin time prolonged 129.76 15.00 82 44622 9482 63434836
Haemothorax 129.12 15.00 51 44653 2134 63442184
Renal impairment 128.05 15.00 226 44478 88129 63356189
Rheumatoid arthritis 124.41 15.00 16 44688 253803 63190515
Infusion related reaction 123.97 15.00 14 44690 245507 63198811
Haemoptysis 123.01 15.00 125 44579 28601 63415717
Systemic lupus erythematosus 122.13 15.00 6 44698 208912 63235406
Drug intolerance 120.64 15.00 34 44670 308627 63135691
Cerebral haematoma 118.68 15.00 56 44648 3627 63440691
Arthropathy 117.02 15.00 14 44690 234778 63209540
Rash 116.86 15.00 134 44570 560737 62883581
Head injury 113.30 15.00 117 44587 27279 63417039
Wound secretion 112.45 15.00 58 44646 4556 63439762
Coagulation time prolonged 111.50 15.00 41 44663 1407 63442911
Hemiplegia 109.46 15.00 73 44631 9250 63435068
Peripheral embolism 108.41 15.00 39 44665 1256 63443062
Arthralgia 107.30 15.00 147 44557 569563 62874755
Procedural haemorrhage 105.89 15.00 47 44657 2641 63441677
Gastric haemorrhage 105.10 15.00 62 44642 6336 63437982
Joint swelling 104.63 15.00 50 44654 327616 63116702
Therapeutic product effect decreased 102.77 15.00 9 44695 193178 63251140
Glossodynia 101.85 15.00 6 44698 178870 63265448
Faeces discoloured 100.90 15.00 92 44612 18417 63425901
Pyrexia 100.55 15.00 110 44594 470368 62973950
Drug ineffective 100.15 15.00 389 44315 1044376 62399942
Contraindicated product administered 99.08 15.00 17 44687 217631 63226687
Large intestinal haemorrhage 95.69 15.00 36 44668 1318 63443000
Post procedural haemorrhage 95.04 15.00 63 44641 7901 63436417
Musculoskeletal stiffness 94.51 15.00 10 44694 184608 63259710
Nasopharyngitis 92.17 15.00 32 44672 254225 63190093
Treatment failure 91.81 15.00 15 44689 199028 63245290
Condition aggravated 91.61 15.00 89 44615 402128 63042190
Hypersensitivity 91.39 15.00 46 44658 292639 63151679
Haemorrhoidal haemorrhage 90.69 15.00 49 44655 4230 63440088
Drug interaction 89.92 15.00 359 44345 228772 63215546
Pericardial effusion 86.02 15.00 106 44598 29952 63414366
Aphasia 84.35 15.00 110 44594 32890 63411428
Haemorrhagic transformation stroke 84.26 15.00 32 44672 1203 63443115
Creatinine renal clearance decreased 82.97 15.00 78 44626 16230 63428088
Alopecia 82.42 15.00 70 44634 337466 63106852
Gingival bleeding 81.51 15.00 69 44635 12518 63431800
Sinusitis 79.64 15.00 30 44674 226623 63217695
International normalised ratio abnormal 78.98 15.00 41 44663 3263 63441055
Traumatic haemorrhage 78.53 15.00 25 44679 549 63443769
Weight increased 78.43 15.00 43 44661 260749 63183569
Cerebral artery occlusion 75.09 15.00 27 44677 868 63443450
Mouth haemorrhage 74.58 15.00 51 44653 6732 63437586
Embolism 74.29 15.00 54 44650 7852 63436466
Swelling 73.69 15.00 52 44652 275326 63168992
Thrombosis 73.15 15.00 149 44555 64606 63379712
Thrombin time abnormal 72.44 15.00 12 44692 3 63444315
Discomfort 72.05 15.00 15 44689 167359 63276959
Pulmonary haemorrhage 71.95 15.00 51 44653 7130 63437188
Peripheral swelling 71.44 15.00 50 44654 265892 63178426
Death 71.21 15.00 479 44225 373902 63070416
Traumatic intracranial haemorrhage 69.59 15.00 22 44682 472 63443846
Headache 68.93 15.00 223 44481 633018 62811300
Anticoagulation drug level increased 68.42 15.00 18 44686 194 63444124
Product use issue 68.29 15.00 35 44669 220485 63223833
Splenic rupture 67.92 15.00 28 44676 1310 63443008
Dyspepsia 67.57 15.00 191 44513 102005 63342313
Wound 67.52 15.00 16 44688 163247 63281071
Hip fracture 67.30 15.00 93 44611 29381 63414937
Craniocerebral injury 67.29 15.00 35 44669 2797 63441521
Anxiety 66.66 15.00 35 44669 217506 63226812
Injection site pain 66.49 15.00 7 44697 129793 63314525
Intestinal ischaemia 65.65 15.00 49 44655 7419 63436899
Cerebral ischaemia 65.61 15.00 47 44657 6681 63437637
International normalised ratio 64.35 15.00 15 44689 93 63444225
Product dose omission issue 64.33 15.00 43 44661 234270 63210048
Cardiac valve replacement complication 63.71 15.00 16 44688 141 63444177
Peripheral ischaemia 61.65 15.00 40 44664 4838 63439480
Activated partial thromboplastin time abnormal 61.58 15.00 15 44689 115 63444203
Strangulated hernia 60.99 15.00 12 44692 27 63444291
Lower respiratory tract infection 60.92 15.00 10 44694 132297 63312021
Intracardiac thrombus 60.77 15.00 31 44673 2379 63441939
Product use in unapproved indication 60.76 15.00 25 44679 179055 63265263
Intra-abdominal haemorrhage 60.06 15.00 31 44673 2438 63441880
Colon cancer 59.59 15.00 52 44652 9826 63434492
Retroperitoneal haemorrhage 59.20 15.00 32 44672 2765 63441553
Infection 59.05 15.00 45 44659 229128 63215190
Pericarditis 58.28 15.00 11 44693 131568 63312750
Blood urine present 58.09 15.00 62 44642 15007 63429311
Puncture site haemorrhage 57.64 15.00 17 44687 286 63444032
Acute abdomen 57.17 15.00 26 44678 1547 63442771
Acute myocardial infarction 56.96 15.00 90 44614 32034 63412284
Stomatitis 56.56 15.00 14 44690 138711 63305607
Iron deficiency anaemia 56.45 15.00 70 44634 19899 63424419
Intentional product use issue 55.99 15.00 11 44693 127881 63316437
Haemarthrosis 55.54 15.00 32 44672 3129 63441189
Shock 55.02 15.00 75 44629 23388 63420930
Cerebral artery embolism 54.95 15.00 22 44682 954 63443364
Multiple organ dysfunction syndrome 54.20 15.00 122 44582 56630 63387688
Atrial fibrillation 54.17 15.00 193 44511 116443 63327875
Nausea 52.37 15.00 370 44334 854101 62590217
Haemorrhage subcutaneous 51.88 15.00 30 44674 2953 63441365
Gastritis erosive 51.70 15.00 39 44665 6000 63438318
Vaginal haemorrhage 51.51 15.00 79 44625 27408 63416910
Depression 51.36 15.00 38 44666 196454 63247864
Hepatic enzyme increased 50.51 15.00 41 44663 202287 63242031
Helicobacter infection 50.20 15.00 4 44700 92781 63351537
Femoral neck fracture 49.68 15.00 44 44660 8479 63435839
Neutropenia 49.54 15.00 31 44673 174974 63269344
Cardiac perforation 49.02 15.00 11 44693 56 63444262
Peripheral artery thrombosis 48.97 15.00 25 44679 1921 63442397
Cardiac failure congestive 48.21 15.00 159 44545 92274 63352044
Embolic cerebral infarction 48.20 15.00 17 44687 516 63443802
Disease progression 47.01 15.00 14 44690 122744 63321574
Intraventricular haemorrhage 46.96 15.00 25 44679 2095 63442223
Colitis ischaemic 46.57 15.00 47 44657 10661 63433657
Haemoperitoneum 46.17 15.00 27 44677 2714 63441604
Cerebral mass effect 45.99 15.00 19 44685 894 63443424
Microcytic anaemia 45.51 15.00 29 44675 3400 63440918
Back pain 43.93 15.00 74 44630 264071 63180247
Duodenal ulcer perforation 43.90 15.00 5 44699 87204 63357114
Pruritus 43.74 15.00 121 44583 361332 63082986
Internal haemorrhage 43.43 15.00 33 44671 5132 63439186
Irritable bowel syndrome 43.36 15.00 4 44700 82408 63361910
Toxicity to various agents 42.29 15.00 68 44636 247182 63197136
Diverticulum 42.15 15.00 47 44657 11944 63432374
Coagulation test abnormal 41.53 15.00 17 44687 781 63443537
Haemorrhagic cerebral infarction 41.33 15.00 16 44688 634 63443684
Hypocoagulable state 40.89 15.00 19 44685 1188 63443130
Impaired healing 40.55 15.00 11 44693 102531 63341787
Subcutaneous haematoma 40.15 15.00 21 44683 1697 63442621
Neuropathy peripheral 39.97 15.00 15 44689 113652 63330666
Hypotension 39.90 15.00 328 44376 272276 63172042
Chills 39.80 15.00 15 44689 113363 63330955
Syncope 39.78 15.00 176 44528 117209 63327109
Prothrombin time abnormal 37.84 15.00 14 44690 489 63443829
Mobility decreased 37.83 15.00 19 44685 121140 63323178
Wound haemorrhage 37.74 15.00 23 44681 2493 63441825
Therapeutic product effect incomplete 37.00 15.00 21 44683 125035 63319283
Off label use 36.99 15.00 301 44403 674161 62770157
Ecchymosis 36.47 15.00 42 44662 11052 63433266
Skull fracture 36.36 15.00 17 44687 1078 63443240
Ischaemic cerebral infarction 35.94 15.00 18 44686 1328 63442990
Exsanguination 35.81 15.00 7 44697 15 63444303
Ischaemia 34.73 15.00 28 44676 4744 63439574
Haematocrit decreased 34.73 15.00 82 44622 39258 63405060
Prothrombin time shortened 34.53 15.00 20 44684 1975 63442343
Overdose 34.16 15.00 166 44538 114912 63329406
Dysphagia 34.02 15.00 138 44566 88447 63355871
Type 2 diabetes mellitus 33.87 15.00 3 44701 63865 63380453
Ill-defined disorder 33.81 15.00 8 44696 81747 63362571
Post procedural haematoma 33.77 15.00 17 44687 1268 63443050
Small intestinal haemorrhage 33.65 15.00 20 44684 2072 63442246
Diverticulum intestinal haemorrhagic 33.43 15.00 18 44686 1543 63442775
Pelvic fracture 33.33 15.00 44 44660 13304 63431014
Mesenteric artery embolism 32.48 15.00 6 44698 8 63444310
Brain contusion 32.29 15.00 13 44691 572 63443746
Incarcerated hernia 32.25 15.00 9 44695 123 63444195
Blood cholesterol increased 32.08 15.00 13 44691 94019 63350299
Anticoagulation drug level above therapeutic 32.00 15.00 17 44687 1418 63442900
Gastric ulcer haemorrhage 31.97 15.00 27 44677 4881 63439437
Disseminated intravascular coagulation 31.89 15.00 52 44652 18999 63425319
Pelvic haematoma 31.78 15.00 13 44691 596 63443722
Activated partial thromboplastin time 31.68 15.00 6 44698 10 63444308
Coagulation factor increased 31.68 15.00 6 44698 10 63444308
Asthma 31.63 15.00 26 44678 127535 63316783
Skin haemorrhage 31.16 15.00 37 44667 10057 63434261
Influenza 31.11 15.00 19 44685 108703 63335615
Stress 31.08 15.00 5 44699 67162 63377156
Paraesthesia 30.96 15.00 39 44665 156927 63287391
Sepsis 30.87 15.00 199 44505 152924 63291394
Oesophagitis 30.78 15.00 45 44659 14963 63429355
Atrial flutter 30.46 15.00 36 44668 9736 63434582
Drug abuse 30.17 15.00 7 44697 72511 63371807
Discoloured vomit 30.06 15.00 14 44690 880 63443438
Oesophageal ulcer 29.86 15.00 25 44679 4465 63439853
Prothrombin time ratio decreased 29.85 15.00 12 44692 526 63443792
Brain herniation 29.83 15.00 23 44681 3654 63440664
Hypochromic anaemia 29.77 15.00 18 44686 1924 63442394
Femoral artery embolism 29.68 15.00 7 44697 46 63444272
Intracranial haematoma 29.33 15.00 11 44693 399 63443919
Blister 29.16 15.00 29 44675 129785 63314533
White blood cell count decreased 29.09 15.00 33 44671 139071 63305247
Petechiae 28.98 15.00 42 44662 13855 63430463
Peritonitis 28.95 15.00 47 44657 17107 63427211
Cardiogenic shock 28.74 15.00 48 44656 17884 63426434
Therapy non-responder 28.43 15.00 9 44695 75892 63368426
Contusion 28.43 15.00 192 44512 149852 63294466
Phlebitis 28.30 15.00 29 44675 6695 63437623
Myocardial infarction 28.15 15.00 142 44562 99751 63344567
COVID-19 28.11 15.00 23 44681 113080 63331238
Gastritis haemorrhagic 28.10 15.00 16 44688 1529 63442789
Gastric ulcer 27.95 15.00 56 44648 23981 63420337
Rhinorrhoea 27.95 15.00 6 44698 65571 63378747
Occult blood positive 27.71 15.00 22 44682 3648 63440670
Abdominal discomfort 27.66 15.00 124 44580 320761 63123557
Therapeutic response decreased 27.54 15.00 5 44699 61520 63382798
Bradycardia 27.27 15.00 113 44591 73114 63371204
Pulmonary alveolar haemorrhage 27.01 15.00 24 44680 4644 63439674
Osteoarthritis 26.81 15.00 17 44687 95326 63348992
Haemorrhagic arteriovenous malformation 26.62 15.00 8 44696 144 63444174
Neutrophil count decreased 26.55 15.00 4 44700 56402 63387916
Arterial haemorrhage 26.54 15.00 16 44688 1701 63442617
Cough 26.52 15.00 111 44593 292632 63151686
Heart transplant 26.40 15.00 11 44693 529 63443789
Gastrointestinal necrosis 26.03 15.00 19 44685 2779 63441539
Constipation 25.93 15.00 77 44627 224866 63219452
Diarrhoea 25.82 15.00 352 44352 715014 62729304
Haemodynamic instability 25.63 15.00 32 44672 9158 63435160
Anticoagulant-related nephropathy 25.49 15.00 5 44699 11 63444307
Hypoaesthesia 25.45 15.00 50 44654 168343 63275975
Upper respiratory tract infection 25.40 15.00 13 44691 82034 63362284
Sleep disorder 25.14 15.00 13 44691 81553 63362765
Intestinal infarction 25.01 15.00 13 44691 1037 63443281
Haemorrhage urinary tract 24.77 15.00 12 44692 824 63443494
Acute coronary syndrome 24.70 15.00 33 44671 10093 63434225
Basal ganglia haemorrhage 24.37 15.00 11 44693 643 63443675
Wheezing 24.30 15.00 19 44685 95576 63348742
Haemorrhagic diathesis 24.16 15.00 22 44682 4393 63439925
Night sweats 24.07 15.00 3 44701 48811 63395507
Gastritis 23.93 15.00 69 44635 37234 63407084
Conjunctival haemorrhage 23.91 15.00 20 44684 3567 63440751
Loss of personal independence in daily activities 23.91 15.00 20 44684 97270 63347048
Insomnia 23.87 15.00 75 44629 215177 63229141
Haemorrhoids 23.86 15.00 50 44654 22100 63422218
Psoriasis 23.78 15.00 16 44688 86941 63357377
Urticaria 23.56 15.00 51 44653 165751 63278567
Blood creatinine increased 23.45 15.00 123 44581 87721 63356597
Oesophageal pain 23.37 15.00 20 44684 3681 63440637
Lacunar infarction 23.35 15.00 19 44685 3261 63441057
Haemoglobin abnormal 23.35 15.00 23 44681 5065 63439253
Thrombotic stroke 23.26 15.00 10 44694 520 63443798
Rib fracture 23.18 15.00 50 44654 22547 63421771
Prothrombin time 22.88 15.00 5 44699 22 63444296
Infarction 22.48 15.00 17 44687 2624 63441694
Occult blood 22.40 15.00 13 44691 1288 63443030
Abdominal wall haematoma 22.39 15.00 18 44686 3037 63441281
Prothrombin level decreased 21.83 15.00 10 44694 605 63443713
Aortic thrombosis 21.67 15.00 12 44692 1087 63443231
Arthritis 21.63 15.00 30 44674 115891 63328427
Cerebellar haemorrhage 21.57 15.00 13 44691 1381 63442937
Haemorrhagic disorder 21.55 15.00 11 44693 845 63443473
C-reactive protein increased 21.44 15.00 21 44683 94686 63349632
Renal infarct 21.12 15.00 13 44691 1434 63442884
Migraine 21.08 15.00 25 44679 103321 63340997
Red blood cell sedimentation rate increased 20.97 15.00 3 44701 43979 63400339
Dysarthria 20.95 15.00 72 44632 42639 63401679
Nasal congestion 20.94 15.00 10 44694 65650 63378668
Pain in extremity 20.93 15.00 142 44562 331344 63112974
Cardiac ablation 20.81 15.00 13 44691 1472 63442846
Ileus 20.45 15.00 37 44667 14688 63429630
Cardiac failure chronic 20.33 15.00 20 44684 4398 63439920
Musculoskeletal pain 20.28 15.00 21 44683 92256 63352062
Embolism arterial 20.21 15.00 11 44693 963 63443355
Cardioversion 20.14 15.00 12 44692 1248 63443070
Influenza like illness 20.08 15.00 11 44693 66813 63377505
Post procedural haematuria 19.92 15.00 5 44699 44 63444274
Splenic haematoma 19.86 15.00 6 44698 110 63444208
Weight decreased 19.84 15.00 114 44590 276684 63167634
Injection site bruising 19.66 15.00 3 44701 41907 63402411
Arteriovenous malformation 19.30 15.00 12 44692 1348 63442970
Suicidal ideation 19.16 15.00 10 44694 62411 63381907
Diverticulitis intestinal haemorrhagic 19.10 15.00 6 44698 126 63444192
Duodenal ulcer haemorrhage 19.08 15.00 15 44689 2452 63441866
Road traffic accident 19.07 15.00 63 44641 36569 63407749
Extradural haematoma 19.05 15.00 13 44691 1709 63442609
Erosive oesophagitis 18.86 15.00 13 44691 1737 63442581
Malignant neoplasm progression 18.84 15.00 18 44686 82103 63362215
Abdominal incarcerated hernia 18.78 15.00 3 44701 0 63444318
Thrombotic cerebral infarction 18.59 15.00 6 44698 138 63444180
Hypertension 18.46 15.00 118 44586 279185 63165133
Inappropriate schedule of product administration 18.32 15.00 28 44676 103937 63340381
Spontaneous haematoma 18.30 15.00 10 44694 883 63443435
Rectal perforation 18.23 15.00 8 44696 437 63443881
Hospitalisation 17.98 15.00 20 44684 85061 63359257
Bleeding time prolonged 17.93 15.00 9 44695 667 63443651
Abdominal wall haemorrhage 17.89 15.00 6 44698 156 63444162
Multiple sclerosis relapse 17.71 15.00 6 44698 48472 63395846
Rectal ulcer 17.70 15.00 11 44693 1234 63443084
Hyperkalaemia 17.39 15.00 80 44624 54123 63390195
Appendicitis 17.35 15.00 25 44679 8204 63436114
Spinal cord haematoma 17.11 15.00 6 44698 179 63444139
Hypertensive crisis 17.04 15.00 35 44669 15251 63429067
Muscle spasms 16.89 15.00 55 44649 156095 63288223
Brain stem haemorrhage 16.87 15.00 9 44695 757 63443561
Herpes zoster 16.76 15.00 20 44684 82442 63361876
Tachyarrhythmia 16.61 15.00 18 44686 4432 63439886
Vomiting 16.52 15.00 286 44418 559331 62884987
Glomerular filtration rate decreased 16.45 15.00 32 44672 13409 63430909
Facial paresis 16.40 15.00 16 44688 3482 63440836
Surgery 16.29 15.00 59 44645 35853 63408465
Uterine haemorrhage 16.24 15.00 17 44687 4024 63440294
Arterial thrombosis 16.22 15.00 11 44693 1432 63442886
Brain stem stroke 16.17 15.00 7 44697 370 63443948
Cerebral artery thrombosis 16.12 15.00 7 44697 373 63443945
Muscle haemorrhage 15.78 15.00 15 44689 3164 63441154
Thoracic haemorrhage 15.66 15.00 4 44700 38 63444280
Joint stiffness 15.62 15.00 5 44699 41864 63402454
Vascular pseudoaneurysm 15.61 15.00 11 44693 1523 63442795
Duodenal ulcer 15.54 15.00 23 44681 7733 63436585
Polyp 15.52 15.00 21 44683 6500 63437818
Adverse drug reaction 15.51 15.00 20 44684 79694 63364624
Sudden death 15.47 15.00 27 44677 10422 63433896
Tongue haemorrhage 15.30 15.00 7 44697 422 63443896
Mucosal inflammation 15.19 15.00 7 44697 46921 63397397
Venous thrombosis 15.18 15.00 18 44686 4884 63439434
Vessel puncture site haemorrhage 15.09 15.00 5 44699 125 63444193
Cerebellar infarction 15.02 15.00 12 44692 2007 63442311
Thrombolysis 15.02 15.00 5 44699 127 63444191

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 2880.71 14.41 1720 49522 86757 34818932
Ischaemic stroke 2412.08 14.41 932 50310 17318 34888371
Cerebrovascular accident 1774.18 14.41 1251 49991 83560 34822129
Haemorrhage 1147.24 14.41 790 50452 50580 34855109
Haemorrhage intracranial 903.11 14.41 449 50793 15497 34890192
Rectal haemorrhage 862.84 14.41 604 50638 39645 34866044
Cerebral infarction 855.67 14.41 521 50721 26934 34878755
Cerebral haemorrhage 806.93 14.41 549 50693 34388 34871301
Melaena 777.05 14.41 539 50703 34841 34870848
Subdural haematoma 657.88 14.41 396 50846 20025 34885664
Cardiac tamponade 645.19 14.41 255 50987 5011 34900678
Atrial thrombosis 631.97 14.41 201 51041 2013 34903676
Embolic stroke 606.96 14.41 233 51009 4221 34901468
Haematuria 464.70 14.41 463 50779 49603 34856086
Fall 435.10 14.41 933 50309 201952 34703737
Activated partial thromboplastin time prolonged 414.13 14.41 218 51024 8477 34897212
Transient ischaemic attack 389.10 14.41 323 50919 27290 34878399
Lower gastrointestinal haemorrhage 388.77 14.41 215 51027 9237 34896452
Procoagulant therapy 366.55 14.41 68 51174 10 34905679
Shock haemorrhagic 336.84 14.41 209 51033 11145 34894544
Hemiparesis 328.78 14.41 233 51009 15545 34890144
Upper gastrointestinal haemorrhage 270.40 14.41 254 50988 25264 34880425
Blood loss anaemia 245.98 14.41 152 51090 8042 34897647
Coagulopathy 237.02 14.41 211 51031 19578 34886111
Thrombin time prolonged 236.02 14.41 55 51187 135 34905554
Pericardial haemorrhage 224.38 14.41 104 51138 3054 34902635
Haematoma 221.23 14.41 228 51014 25377 34880312
Haemorrhagic stroke 210.88 14.41 127 51115 6412 34899277
Subarachnoid haemorrhage 208.05 14.41 162 51080 12473 34893216
Aphasia 188.87 14.41 193 51049 21261 34884428
Haemothorax 178.89 14.41 95 51147 3757 34901932
Pulmonary embolism 177.08 14.41 400 50842 89346 34816343
Haematemesis 175.90 14.41 210 51032 27501 34878188
Aortic dissection 174.66 14.41 84 51158 2684 34903005
Deep vein thrombosis 173.63 14.41 329 50913 64919 34840770
Hemiplegia 159.32 14.41 109 51133 6863 34898826
Head injury 157.36 14.41 162 51080 17998 34887691
Epistaxis 152.83 14.41 292 50950 57959 34847730
Febrile neutropenia 152.37 14.41 13 51229 136836 34768853
Procedural haemorrhage 150.31 14.41 73 51169 2384 34903305
Haemorrhagic transformation stroke 149.69 14.41 63 51179 1460 34904229
Toxicity to various agents 142.16 14.41 58 51184 200304 34705385
Neutropenia 139.12 14.41 30 51212 156748 34748941
Subdural haemorrhage 135.06 14.41 74 51168 3117 34902572
Anaemia 129.06 14.41 678 50564 232657 34673032
Completed suicide 125.76 14.41 4 51238 98164 34807525
Pyrexia 121.65 14.41 188 51054 332825 34572864
International normalised ratio increased 121.36 14.41 235 51007 47092 34858597
Haemoptysis 120.89 14.41 198 51044 34808 34870881
Intracardiac thrombus 117.15 14.41 62 51180 2434 34903255
Cerebral haematoma 117.08 14.41 77 51165 4538 34901151
Brain contusion 111.89 14.41 43 51199 780 34904909
Drug abuse 111.41 14.41 9 51233 99087 34806602
Intestinal haemorrhage 110.39 14.41 67 51175 3429 34902260
Haematochezia 109.60 14.41 223 51019 46311 34859378
Post procedural haemorrhage 106.46 14.41 92 51150 8197 34897492
Product dose omission issue 105.97 14.41 23 51219 119688 34786001
Cardiac failure 103.97 14.41 332 50910 90916 34814773
Off label use 102.79 14.41 297 50945 419227 34486462
Peripheral embolism 101.82 14.41 43 51199 1005 34904684
Pericardial effusion 99.72 14.41 150 51092 24512 34881177
Disease progression 97.22 14.41 20 51222 108057 34797632
Colon cancer 93.54 14.41 87 51155 8534 34897155
Fatigue 93.23 14.41 259 50983 370394 34535295
Product use in unapproved indication 88.27 14.41 31 51211 117468 34788221
Gastric haemorrhage 84.32 14.41 89 51153 10172 34895517
Oesophageal pain 83.04 14.41 35 51207 814 34904875
Intraventricular haemorrhage 82.56 14.41 56 51186 3475 34902214
Road traffic accident 82.02 14.41 114 51128 17336 34888353
Traumatic intracranial haemorrhage 78.33 14.41 32 51210 686 34905003
Large intestinal haemorrhage 77.62 14.41 41 51201 1603 34904086
Anticoagulation drug level increased 76.23 14.41 29 51213 511 34905178
Faeces discoloured 75.68 14.41 101 51141 14777 34890912
Extradural haematoma 74.76 14.41 36 51206 1153 34904536
Activated partial thromboplastin time abnormal 74.29 14.41 21 51221 134 34905555
Hypovolaemic shock 73.99 14.41 70 51172 7015 34898674
Pancytopenia 73.38 14.41 24 51218 95133 34810556
Renal impairment 71.36 14.41 301 50941 94212 34811477
Pain 70.38 14.41 120 51122 204555 34701134
Nausea 69.05 14.41 261 50981 339647 34566042
Haemorrhagic infarction 68.72 14.41 26 51216 451 34905238
Pulmonary haemorrhage 68.51 14.41 80 51162 10224 34895465
Drug hypersensitivity 68.20 14.41 17 51225 80512 34825177
Depression 67.32 14.41 29 51213 97069 34808620
Cerebral artery occlusion 66.64 14.41 29 51213 731 34904958
Coagulation test abnormal 66.17 14.41 27 51215 577 34905112
Condition aggravated 65.78 14.41 113 51129 192083 34713606
Rash 64.96 14.41 144 51098 222608 34683081
Leukopenia 64.66 14.41 8 51234 62848 34842841
Diarrhoea 63.68 14.41 325 50917 389587 34516102
Embolism 62.72 14.41 67 51175 7762 34897927
Blood urine present 62.06 14.41 78 51164 10756 34894933
Embolic cerebral infarction 61.81 14.41 27 51215 687 34905002
Urinary bladder haemorrhage 61.69 14.41 36 51206 1713 34903976
Aortic aneurysm rupture 60.92 14.41 30 51212 1010 34904679
White blood cell count decreased 60.82 14.41 32 51210 95413 34810276
Contusion 60.67 14.41 152 51090 36212 34869477
Gingival bleeding 59.81 14.41 62 51180 6938 34898751
Cerebral mass effect 59.51 14.41 29 51213 954 34904735
Skull fracture 58.26 14.41 28 51214 893 34904796
Splenic rupture 57.76 14.41 33 51209 1508 34904181
Coagulation time prolonged 57.33 14.41 31 51211 1271 34904418
Wound secretion 56.97 14.41 40 51202 2625 34903064
Intentional product use issue 56.03 14.41 10 51232 59806 34845883
Dyspepsia 54.57 14.41 147 51095 36585 34869104
Surgery 54.24 14.41 84 51158 14073 34891616
Infusion related reaction 53.97 14.41 7 51235 53050 34852639
Tremor 53.64 14.41 27 51215 82560 34823129
Traumatic haemorrhage 52.94 14.41 25 51217 766 34904923
Renal failure 52.91 14.41 350 50892 130207 34775482
Haemoglobin decreased 52.77 14.41 330 50912 120442 34785247
Arthralgia 51.97 14.41 107 51135 169934 34735755
International normalised ratio abnormal 51.09 14.41 41 51201 3294 34902395
Anorectal discomfort 50.38 14.41 33 51209 1931 34903758
Cerebral artery embolism 50.19 14.41 25 51217 863 34904826
Neuropathy peripheral 50.04 14.41 30 51212 83233 34822456
Traumatic haemothorax 49.14 14.41 18 51224 284 34905405
Creatinine renal clearance decreased 48.50 14.41 40 51202 3341 34902348
Cardiac ablation 48.18 14.41 26 51216 1062 34904627
Chills 47.59 14.41 30 51212 81013 34824676
Incarcerated hernia 47.43 14.41 15 51227 147 34905542
Product use issue 46.89 14.41 17 51225 63199 34842490
Anxiety 46.80 14.41 46 51196 99382 34806307
Insomnia 46.72 14.41 50 51192 103857 34801832
Weight increased 46.19 14.41 41 51201 92992 34812697
Heart transplant 45.89 14.41 24 51218 919 34904770
Thrombosis 45.53 14.41 170 51072 50288 34855401
Embolism arterial 44.69 14.41 21 51221 636 34905053
Thrombin time abnormal 44.22 14.41 8 51234 0 34905689
Acute kidney injury 43.43 14.41 657 50585 304331 34601358
Vomiting 42.26 14.41 203 51039 247418 34658271
Intra-abdominal haemorrhage 42.13 14.41 32 51210 2372 34903317
Mucosal inflammation 42.04 14.41 4 51238 38618 34867071
Multiple injuries 41.81 14.41 29 51213 1866 34903823
Cerebellar haemorrhage 41.77 14.41 27 51215 1544 34904145
Mouth haemorrhage 41.69 14.41 45 51197 5274 34900415
Craniocerebral injury 41.46 14.41 36 51206 3227 34902462
Haemorrhoidal haemorrhage 41.32 14.41 38 51204 3673 34902016
Retroperitoneal haemorrhage 41.08 14.41 34 51208 2854 34902835
Muscle spasms 41.04 14.41 30 51212 74971 34830718
Drug ineffective 40.01 14.41 453 50789 456298 34449391
Malignant neoplasm progression 39.99 14.41 42 51200 88004 34817685
Strangulated hernia 39.56 14.41 9 51233 19 34905670
Neutrophil count decreased 39.18 14.41 13 51229 51091 34854598
Rheumatoid arthritis 38.99 14.41 5 51237 38233 34867456
Acute abdomen 38.69 14.41 28 51214 1927 34903762
Agitation 38.42 14.41 18 51224 57381 34848308
Oesophageal ulcer 38.38 14.41 35 51207 3346 34902343
Basal ganglia haemorrhage 37.88 14.41 21 51221 905 34904784
Pulmonary alveolar haemorrhage 36.68 14.41 50 51192 7462 34898227
Subarachnoid haematoma 36.47 14.41 14 51228 253 34905436
Dysarthria 36.36 14.41 123 51119 34659 34871030
Ischaemia 36.34 14.41 39 51203 4541 34901148
Alanine aminotransferase increased 36.20 14.41 39 51203 80776 34824913
Cough 36.04 14.41 107 51135 150033 34755656
Femur fracture 35.11 14.41 51 51191 8073 34897616
Injury 35.05 14.41 87 51155 20600 34885089
Renal infarct 35 14.41 23 51219 1353 34904336
Coagulation time shortened 34.87 14.41 13 51229 216 34905473
Cardiac valve replacement complication 34.73 14.41 9 51233 39 34905650
Somnolence 34.70 14.41 69 51173 111047 34794642
Acute myocardial infarction 34.40 14.41 163 51079 53556 34852133
Haemorrhage subcutaneous 34.39 14.41 28 51214 2296 34903393
Erythema 34.33 14.41 48 51194 88732 34816957
Joint swelling 34.02 14.41 23 51219 59867 34845822
International normalised ratio 33.85 14.41 9 51233 44 34905645
Activated partial thromboplastin time 33.16 14.41 6 51236 0 34905689
Creatinine renal clearance 33.16 14.41 6 51236 0 34905689
Arterial thrombosis 32.99 14.41 23 51219 1492 34904197
Haemorrhage urinary tract 32.96 14.41 25 51217 1849 34903840
Seizure 32.84 14.41 65 51177 104792 34800897
Cardioversion 32.33 14.41 19 51223 916 34904773
Stomatitis 32.27 14.41 11 51231 42503 34863186
Intracranial haematoma 32.12 14.41 15 51227 448 34905241
Platelet count decreased 31.95 14.41 81 51161 119636 34786053
Hemianopia 31.89 14.41 17 51225 677 34905012
Injection site pain 31.56 14.41 9 51233 38996 34866693
Femoral neck fracture 31.38 14.41 31 51211 3276 34902413
Drug intolerance 31.09 14.41 25 51217 59545 34846144
Intestinal ischaemia 30.91 14.41 47 51195 7747 34897942
Stress 30.87 14.41 4 51238 30343 34875346
Cerebral ischaemia 30.75 14.41 42 51200 6280 34899409
Elderly 30.73 14.41 6 51236 3 34905686
Haemoglobin abnormal 30.72 14.41 33 51209 3847 34901842
Musculoskeletal stiffness 30.69 14.41 15 51227 46665 34859024
Wound haemorrhage 30.60 14.41 25 51217 2060 34903629
Gastrointestinal motility disorder 29.82 14.41 27 51215 2557 34903132
Infection 29.65 14.41 55 51187 90860 34814829
Psoriasis 29.53 14.41 10 51232 38802 34866887
Prothrombin time prolonged 29.51 14.41 51 51191 9355 34896334
Neurologic neglect syndrome 29.33 14.41 11 51231 186 34905503
Thrombotic stroke 29.04 14.41 12 51230 265 34905424
Large intestine polyp 28.98 14.41 46 51196 7868 34897821
Nasopharyngitis 28.92 14.41 36 51206 69932 34835757
Weight decreased 28.62 14.41 147 51095 176154 34729535
Blood creatine phosphokinase increased 28.61 14.41 15 51227 44842 34860847
Cardiac perforation 28.57 14.41 9 51233 87 34905602
Iron deficiency anaemia 28.56 14.41 53 51189 10276 34895413
Cerebellar infarction 28.15 14.41 23 51219 1896 34903793
Rib fracture 28.12 14.41 64 51178 14336 34891353
Aggression 28.02 14.41 11 51231 38953 34866736
Peripheral artery thrombosis 27.91 14.41 25 51217 2335 34903354
C-reactive protein increased 27.86 14.41 23 51219 54075 34851614
Sinusitis 27.68 14.41 13 51229 41389 34864300
Asthma 27.60 14.41 14 51228 42642 34863047
Lumbar puncture 27.44 14.41 9 51233 100 34905589
Hyperhidrosis 27.24 14.41 43 51199 75649 34830040
COVID-19 27.02 14.41 45 51197 77505 34828184
Ecchymosis 26.95 14.41 41 51201 6762 34898927
Blood glucose increased 26.87 14.41 35 51207 66683 34839006
Infarction 26.48 14.41 26 51216 2727 34902962
Exsanguination 26.30 14.41 8 51234 68 34905621
Mesenteric artery embolism 26.20 14.41 8 51234 69 34905620
Hospitalisation 25.99 14.41 27 51215 56875 34848814
White blood cell count increased 25.89 14.41 14 51228 41137 34864552
Inappropriate schedule of product administration 25.80 14.41 32 51210 62264 34843425
Prothrombin time abnormal 25.34 14.41 15 51227 733 34904956
Hemianopia homonymous 25.32 14.41 15 51227 734 34904955
Anaphylactic reaction 25.14 14.41 8 51234 32293 34873396
Aspartate aminotransferase increased 24.87 14.41 38 51204 67745 34837944
Brain herniation 24.80 14.41 30 51212 3978 34901711
Gastrointestinal carcinoma 24.72 14.41 21 51221 1827 34903862
Gastric ulcer haemorrhage 24.62 14.41 35 51207 5431 34900258
Loss of personal independence in daily activities 24.47 14.41 9 51233 33170 34872519
Diverticulum intestinal haemorrhagic 24.43 14.41 24 51218 2518 34903171
Cholecystitis acute 24.37 14.41 38 51204 6401 34899288
Arteriovenous malformation 24.30 14.41 15 51227 791 34904898
Herpes zoster 24.26 14.41 10 51232 34389 34871300
Gastric cancer 24.24 14.41 38 51204 6431 34899258
Therapy non-responder 23.65 14.41 14 51228 39132 34866557
Thalamus haemorrhage 23.64 14.41 16 51226 989 34904700
Feeling abnormal 23.64 14.41 35 51207 63200 34842489
Rectal cancer 23.41 14.41 22 51220 2185 34903504
Thrombocytopenia 23.30 14.41 134 51108 156113 34749576
Therapeutic response decreased 23.28 14.41 7 51235 29306 34876383
Catheter site haemorrhage 23.27 14.41 22 51220 2202 34903487
Oxygen saturation decreased 22.97 14.41 27 51215 53791 34851898
Aortic aneurysm 22.92 14.41 38 51204 6741 34898948
Electrocardiogram QT prolonged 22.89 14.41 16 51226 40936 34864753
Urticaria 22.86 14.41 35 51207 62342 34843347
Diabetes mellitus 22.84 14.41 21 51221 46852 34858837
Pruritus 22.68 14.41 119 51123 141862 34763827
Peripheral swelling 22.64 14.41 49 51193 76492 34829197
Renal haemorrhage 22.51 14.41 18 51224 1439 34904250
Post procedural stroke 22.45 14.41 6 51236 30 34905659
Rhabdomyolysis 22.43 14.41 41 51201 68122 34837567
Dry skin 22.22 14.41 9 51233 31278 34874411
Productive cough 22.18 14.41 14 51228 37799 34867890
Drug interaction 22.14 14.41 459 50783 225487 34680202
Aneurysm ruptured 22.04 14.41 12 51230 499 34905190
Pulmonary contusion 21.83 14.41 7 51235 72 34905617
Cardiac pacemaker insertion 21.81 14.41 24 51218 2874 34902815
Venous thrombosis 21.72 14.41 26 51216 3409 34902280
Haemodynamic instability 21.64 14.41 45 51197 9478 34896211
Gastric ulcer 21.61 14.41 61 51181 15589 34890100
Subcutaneous haematoma 21.37 14.41 15 51227 984 34904705
Irritability 21.31 14.41 5 51237 24685 34881004
Orthopaedic procedure 21.25 14.41 5 51237 13 34905676
Skin haemorrhage 21.14 14.41 30 51212 4648 34901041
Arterial injury 21.01 14.41 11 51231 422 34905267
Colon neoplasm 20.71 14.41 11 51231 435 34905254
Traumatic haematoma 20.63 14.41 13 51229 711 34904978
Pneumonitis 20.63 14.41 12 51230 33866 34871823
Back pain 20.63 14.41 100 51142 121689 34784000
Coronary artery embolism 20.57 14.41 8 51234 150 34905539
Hyponatraemia 20.50 14.41 58 51184 82633 34823056
Dyskinesia 20.44 14.41 4 51238 22409 34883280
Blood pressure increased 20.26 14.41 64 51178 88038 34817651
Blood cholesterol increased 20.20 14.41 3 51239 20540 34885149
Myalgia 20.12 14.41 60 51182 84050 34821639
Microcytic anaemia 20.04 14.41 21 51221 2379 34903310
Gastrointestinal angiodysplasia 20.00 14.41 12 51230 601 34905088
Abnormal behaviour 19.76 14.41 6 51236 24963 34880726
Incarcerated inguinal hernia 19.65 14.41 8 51234 170 34905519
Osteoma 19.50 14.41 7 51235 104 34905585
Polycystic liver disease 19.43 14.41 7 51235 105 34905584
Haemorrhoids 19.34 14.41 56 51186 14519 34891170
Intentional product misuse 19.34 14.41 23 51219 45588 34860101
Pain in extremity 19.12 14.41 108 51134 126405 34779284
Angioedema 19.11 14.41 16 51226 37358 34868331
Splenic necrosis 18.74 14.41 7 51235 117 34905572
Factor V deficiency 18.71 14.41 5 51237 25 34905664
Lymphocyte count decreased 18.71 14.41 5 51237 22617 34883072
Arthropathy 18.69 14.41 8 51234 26899 34878790
Vision blurred 18.62 14.41 24 51218 45939 34859750
Small intestinal haemorrhage 18.62 14.41 19 51223 2087 34903602
Eye haemorrhage 18.56 14.41 27 51215 4278 34901411
Intestinal infarction 18.46 14.41 11 51231 544 34905145
Puncture site haemorrhage 18.41 14.41 9 51233 298 34905391
Ischaemic cerebral infarction 18.40 14.41 15 51227 1232 34904457
Gastritis erosive 18.40 14.41 32 51210 5900 34899789
Occult blood positive 18.35 14.41 26 51216 4022 34901667
Drug reaction with eosinophilia and systemic symptoms 18.32 14.41 13 51229 32999 34872690
Prothrombin time shortened 18.29 14.41 16 51226 1448 34904241
Sleep disorder 18.22 14.41 12 51230 31676 34874013
Ascites 18.17 14.41 25 51217 46546 34859143
Haemoglobin urine present 18.11 14.41 7 51235 129 34905560
Mesenteric haemorrhage 18.07 14.41 4 51238 7 34905682
Splenic cyst 18.01 14.41 7 51235 131 34905558
Pneumonia 17.99 14.41 400 50842 362227 34543462
Influenza like illness 17.98 14.41 9 51233 27625 34878064
Splenic injury 17.95 14.41 5 51237 30 34905659
Urogenital haemorrhage 17.86 14.41 12 51230 733 34904956
Appendicitis 17.85 14.41 55 51187 14752 34890937
Cataract 17.85 14.41 8 51234 26178 34879511
Dysphagia 17.75 14.41 154 51088 62227 34843462
Diverticulum 17.66 14.41 35 51207 7124 34898565
Colitis ischaemic 17.62 14.41 33 51209 6442 34899247
Conjunctival haemorrhage 17.50 14.41 22 51220 3033 34902656
Syncope 17.48 14.41 208 51034 91243 34814446
Shock 17.43 14.41 76 51166 24103 34881586
Haemoperitoneum 17.22 14.41 17 51225 1795 34903894
Myocardial infarction 17.20 14.41 261 50981 120824 34784865
Influenza 17.13 14.41 29 51213 49637 34856052
Diverticulitis intestinal haemorrhagic 17.13 14.41 9 51233 348 34905341
Cerebral vascular occlusion 17.11 14.41 4 51238 10 34905679
Pneumocystis jirovecii pneumonia 16.99 14.41 4 51238 19706 34885983
Aortic intramural haematoma 16.82 14.41 5 51237 39 34905650
Gait disturbance 16.79 14.41 66 51176 85074 34820615
Cerebral thrombosis 16.78 14.41 13 51229 992 34904697
Peripheral ischaemia 16.76 14.41 30 51212 5657 34900032
Osteonecrosis of jaw 16.72 14.41 3 51239 17886 34887803
Internal haemorrhage 16.69 14.41 28 51214 5013 34900676
Thrombotic cerebral infarction 16.60 14.41 9 51233 371 34905318
Anti factor VIII antibody test 16.58 14.41 3 51239 0 34905689
Inguinal hernia strangulated 16.58 14.41 3 51239 0 34905689
Feeling hot 16.56 14.41 4 51238 19368 34886321
Drug ineffective for unapproved indication 16.55 14.41 7 51235 23708 34881981
Hypersensitivity 16.50 14.41 41 51201 60994 34844695
Wheezing 16.38 14.41 22 51220 41380 34864309
Neoplasm progression 16.07 14.41 7 51235 23293 34882396
Skull fractured base 15.92 14.41 7 51235 181 34905508
Upper respiratory tract infection 15.88 14.41 15 51227 33044 34872645
Urinary sediment present 15.88 14.41 8 51234 283 34905406
Muscle strain 15.80 14.41 24 51218 3952 34901737
Thoracic haemorrhage 15.71 14.41 7 51235 187 34905502
Blood lactate dehydrogenase increased 15.71 14.41 7 51235 22983 34882706
Suicidal ideation 15.44 14.41 22 51220 40366 34865323
Serotonin syndrome 15.40 14.41 5 51237 19928 34885761
Chest injury 15.25 14.41 15 51227 1576 34904113
Bacteraemia 15.14 14.41 5 51237 19712 34885977
Hip fracture 15.04 14.41 45 51197 11880 34893809
Abdominal strangulated hernia 14.97 14.41 4 51238 20 34905669
Ulcer haemorrhage 14.94 14.41 19 51223 2651 34903038
Haemarthrosis 14.87 14.41 21 51221 3238 34902451
Right hemisphere deficit syndrome 14.81 14.41 4 51238 21 34905668
Encephalopathy 14.77 14.41 18 51224 35301 34870388
Meningorrhagia 14.71 14.41 6 51236 128 34905561
Cerebellar haematoma 14.63 14.41 7 51235 221 34905468
Bone pain 14.61 14.41 6 51236 20680 34885009
Post procedural pulmonary embolism 14.50 14.41 4 51238 23 34905666
Candida infection 14.49 14.41 4 51238 17711 34887978

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
Gastrointestinal haemorrhage 4776.07 13.53 2468 73564 145251 79523105
Ischaemic stroke 4124.15 13.53 1445 74587 31686 79636670
Cerebrovascular accident 2124.23 13.53 1496 74536 153796 79514560
Melaena 1547.58 13.53 870 75162 60020 79608336
Haemorrhage 1525.85 13.53 996 75036 90122 79578234
Rectal haemorrhage 1451.24 13.53 904 75128 75396 79592960
Haemorrhage intracranial 1434.20 13.53 631 75401 25562 79642794
Cerebral haemorrhage 1363.15 13.53 786 75246 56887 79611469
Cerebral infarction 1290.42 13.53 700 75332 44976 79623380
Cardiac tamponade 1100.29 13.53 391 75641 8885 79659471
Subdural haematoma 992.57 13.53 519 75513 30915 79637441
Embolic stroke 853.37 13.53 310 75722 7516 79660840
Lower gastrointestinal haemorrhage 800.87 13.53 363 75669 15762 79652594
Activated partial thromboplastin time prolonged 785.71 13.53 345 75687 13883 79654473
Atrial thrombosis 737.38 13.53 230 75802 3426 79664930
Shock haemorrhagic 675.63 13.53 346 75686 19714 79648642
Haematuria 673.64 13.53 544 75488 68292 79600064
Fall 633.08 13.53 1417 74615 486212 79182144
Upper gastrointestinal haemorrhage 525.48 13.53 382 75650 40998 79627358
Hemiparesis 496.92 13.53 341 75691 33392 79634964
Transient ischaemic attack 495.51 13.53 407 75625 52288 79616068
Coagulopathy 479.14 13.53 342 75690 35664 79632692
Haematoma 467.60 13.53 392 75640 51803 79616553
Blood loss anaemia 441.35 13.53 239 75793 15259 79653097
Haemorrhagic stroke 432.26 13.53 211 75821 10835 79657521
Subarachnoid haemorrhage 402.70 13.53 265 75767 24200 79644156
Pericardial haemorrhage 398.43 13.53 153 75879 4342 79664014
Thrombin time prolonged 382.69 13.53 84 75948 258 79668098
Haematemesis 382.68 13.53 350 75682 51914 79616442
Anaemia 339.35 13.53 1062 74970 443953 79224403
Haematochezia 327.98 13.53 411 75621 87234 79581122
International normalised ratio increased 302.29 13.53 388 75644 84333 79584023
Aortic dissection 272.50 13.53 114 75918 4061 79664295
Procoagulant therapy 269.93 13.53 48 75984 19 79668337
Pulmonary embolism 257.34 13.53 530 75502 171124 79497232
Haemothorax 252.07 13.53 117 75915 5361 79662995
Pain 251.84 13.53 183 75849 703619 78964737
Subdural haemorrhage 248.96 13.53 119 75913 5829 79662527
Aphasia 248.80 13.53 263 75769 46469 79621887
Hemiplegia 241.40 13.53 160 75872 14779 79653577
Deep vein thrombosis 237.59 13.53 419 75613 120500 79547856
Intestinal haemorrhage 237.25 13.53 118 75914 6308 79662048
Cerebral haematoma 233.14 13.53 125 75907 7817 79660539
Cardiac failure 227.25 13.53 474 75558 154368 79513988
Epistaxis 225.03 13.53 391 75641 111124 79557232
Completed suicide 214.39 13.53 4 76028 245763 79422593
Haemoptysis 213.24 13.53 265 75767 55734 79612622
Hypovolaemic shock 211.83 13.53 137 75895 12139 79656217
Procedural haemorrhage 205.68 13.53 97 75935 4609 79663747
Head injury 200.14 13.53 211 75821 37158 79631198
Acute kidney injury 195.42 13.53 994 75038 518410 79149946
Haemoglobin decreased 195.17 13.53 558 75474 221561 79446795
Drug hypersensitivity 192.47 13.53 28 76004 298888 79369468
Renal failure 191.47 13.53 520 75512 200448 79467908
Fatigue 189.71 13.53 376 75656 929351 78739005
Arthralgia 175.68 13.53 172 75860 571631 79096725
Peripheral embolism 174.52 13.53 67 75965 1899 79666457
Pyrexia 169.16 13.53 241 75791 678468 78989888
Febrile neutropenia 167.95 13.53 14 76018 230985 79437371
Post procedural haemorrhage 167.86 13.53 124 75908 13620 79654736
Faeces discoloured 158.70 13.53 166 75866 28961 79639395
Infusion related reaction 156.77 13.53 18 76014 230219 79438137
Rash 155.61 13.53 194 75838 578164 79090192
Renal impairment 154.98 13.53 413 75619 157370 79510986
Haemorrhagic transformation stroke 154.15 13.53 67 75965 2625 79665731
Toxicity to various agents 151.25 13.53 109 75923 421431 79246925
Pericardial effusion 148.20 13.53 201 75831 46036 79622320
Gastric haemorrhage 147.16 13.53 119 75913 14931 79653425
Joint swelling 145.49 13.53 47 75985 288599 79379757
Drug interaction 143.82 13.53 777 75255 414406 79253950
Rheumatoid arthritis 140.18 13.53 17 76015 208453 79459903
Cerebral artery occlusion 139.79 13.53 55 75977 1667 79666689
Brain contusion 137.11 13.53 51 75981 1322 79667034
Anticoagulation drug level increased 136.79 13.53 44 75988 727 79667629
Intraventricular haemorrhage 135.31 13.53 74 75958 4813 79663543
Drug intolerance 134.89 13.53 42 75990 264077 79404279
Neutropenia 132.87 13.53 54 75978 287656 79380700
Large intestinal haemorrhage 132.45 13.53 61 75971 2744 79665612
Condition aggravated 131.71 13.53 171 75861 500953 79167403
Nausea 128.07 13.53 476 75556 956720 78711636
Synovitis 125.52 13.53 4 76028 150730 79517626
Product dose omission issue 120.04 13.53 43 75989 247494 79420862
Product use in unapproved indication 118.87 13.53 45 75987 250314 79418042
Arthropathy 117.71 13.53 15 76017 177096 79491260
Traumatic haemorrhage 116.79 13.53 45 75987 1288 79667068
Traumatic intracranial haemorrhage 116.44 13.53 44 75988 1193 79667163
Craniocerebral injury 115.09 13.53 68 75964 5128 79663228
Coagulation time prolonged 113.89 13.53 53 75979 2442 79665914
Off label use 113.69 13.53 463 75569 906752 78761604
Nasopharyngitis 113.45 13.53 50 75982 253831 79414525
Weight increased 112.81 13.53 62 75970 277324 79391032
Embolic cerebral infarction 111.69 13.53 43 75989 1228 79667128
Intracardiac thrombus 110.62 13.53 62 75970 4231 79664125
Activated partial thromboplastin time abnormal 110.17 13.53 31 76001 315 79668041
Maternal exposure during pregnancy 108.99 13.53 5 76027 136533 79531823
Pulmonary haemorrhage 108.50 13.53 99 75933 14618 79653738
Hypersensitivity 103.21 13.53 61 75971 262178 79406178
Drug abuse 102.90 13.53 16 76016 162675 79505681
Alopecia 102.67 13.53 46 75986 231309 79437047
Musculoskeletal stiffness 102.48 13.53 21 76011 174987 79493369
Sinusitis 99.95 13.53 31 76001 195470 79472886
Gingival bleeding 98.17 13.53 98 75934 16178 79652178
Systemic lupus erythematosus 98.14 13.53 4 76028 121145 79547211
Mouth haemorrhage 97.81 13.53 82 75950 10817 79657539
Colon cancer 96.11 13.53 92 75940 14431 79653925
Therapeutic product effect decreased 95.24 13.53 20 76012 163843 79504513
Haemorrhoidal haemorrhage 93.70 13.53 66 75966 6729 79661627
Anxiety 93.37 13.53 61 75971 248451 79419905
Disease progression 92.88 13.53 30 76002 184332 79484024
Intentional product use issue 91.70 13.53 17 76015 152095 79516261
Embolism 91.45 13.53 88 75944 13894 79654462
Splenic rupture 90.84 13.53 45 75987 2384 79665972
Cerebral artery embolism 88.90 13.53 41 75991 1850 79666506
International normalised ratio abnormal 88.90 13.53 60 75972 5708 79662648
Depression 88.78 13.53 48 75984 216742 79451614
Cerebral mass effect 88.59 13.53 41 75991 1865 79666491
Product use issue 88.08 13.53 45 75987 209777 79458579
Extradural haematoma 86.47 13.53 46 75986 2830 79665526
Peripheral swelling 86.25 13.53 78 75954 269539 79398817
Prothrombin time prolonged 84.43 13.53 92 75940 16807 79651549
Contraindicated product administered 82.29 13.53 24 76008 157514 79510842
Stomatitis 81.11 13.53 20 76012 146737 79521619
Cardiac valve replacement complication 79.51 13.53 22 76010 209 79668147
Thrombosis 79.35 13.53 217 75815 83883 79584473
Acute myocardial infarction 78.98 13.53 205 75827 76831 79591525
Coagulation test abnormal 78.73 13.53 34 75998 1311 79667045
Thrombin time abnormal 77.72 13.53 14 76018 7 79668349
Strangulated hernia 77.50 13.53 17 76015 52 79668304
Injection site pain 77.21 13.53 15 76017 129823 79538533
Cerebral ischaemia 76.14 13.53 72 75960 11123 79657233
Skull fracture 75.67 13.53 36 75996 1744 79666612
Intestinal ischaemia 74.74 13.53 77 75955 13193 79655163
Aortic aneurysm rupture 73.40 13.53 32 76000 1263 79667093
Glossodynia 73.07 13.53 7 76025 103330 79565026
Intra-abdominal haemorrhage 71.83 13.53 48 75984 4492 79663864
Chills 70.85 13.53 32 76000 160202 79508154
Acute abdomen 69.34 13.53 41 75991 3096 79665260
Blood urine present 68.86 13.53 93 75939 21204 79647152
Diarrhoea 68.72 13.53 525 75507 879964 78788392
Incarcerated hernia 67.92 13.53 22 76010 372 79667984
Headache 67.83 13.53 357 75675 653415 79014941
Cardiac perforation 67.59 13.53 18 76014 146 79668210
Lower respiratory tract infection 66.91 13.53 20 76012 129200 79539156
Ischaemia 66.84 13.53 58 75974 8017 79660339
Puncture site haemorrhage 65.68 13.53 24 76008 591 79667765
Cough 65.63 13.53 159 75873 366630 79301726
Creatinine renal clearance decreased 64.54 13.53 85 75947 18917 79649439
Road traffic accident 64.33 13.53 134 75898 43530 79624826
Vomiting 63.40 13.53 374 75658 665454 79002902
White blood cell count decreased 63.20 13.53 52 75980 188236 79480120
Heart transplant 63.10 13.53 30 76002 1451 79666905
Iron deficiency anaemia 62.46 13.53 98 75934 25574 79642782
Dysarthria 62.31 13.53 173 75859 67449 79600907
Surgery 62.28 13.53 112 75920 32654 79635702
Infection 61.82 13.53 84 75948 241628 79426728
Neuropathy peripheral 61.26 13.53 29 76003 141276 79527080
Microcytic anaemia 60.86 13.53 46 75986 5228 79663128
Traumatic haemothorax 60.58 13.53 22 76010 532 79667824
Discomfort 60.55 13.53 22 76010 125595 79542761
Peripheral artery thrombosis 60.40 13.53 39 75993 3444 79664912
Peripheral ischaemia 58.99 13.53 58 75974 9399 79658957
Cerebellar haemorrhage 58.94 13.53 36 75996 2884 79665472
Treatment failure 58.57 13.53 46 75986 170440 79497916
Activated partial thromboplastin time 58.32 13.53 12 76020 24 79668332
Oesophageal pain 57.70 13.53 41 75991 4238 79664118
Haemoperitoneum 57.15 13.53 41 75991 4302 79664054
Basal ganglia haemorrhage 56.74 13.53 29 76003 1642 79666714
Pruritus 56.68 13.53 190 75842 394458 79273898
Pancytopenia 56.59 13.53 45 75987 165700 79502656
Pulmonary alveolar haemorrhage 56.59 13.53 62 75970 11395 79656961
Ecchymosis 56.31 13.53 71 75961 15135 79653221
Syncope 56.07 13.53 327 75705 179122 79489234
Hepatic enzyme increased 55.82 13.53 55 75977 182555 79485801
Haemorrhage subcutaneous 55.62 13.53 42 75990 4767 79663589
Insomnia 55.17 13.53 93 75939 245077 79423279
Asthma 55.16 13.53 30 76002 135065 79533291
Haemoglobin abnormal 55.05 13.53 49 75983 7005 79661351
Internal haemorrhage 54.78 13.53 54 75978 8779 79659577
Swelling 54.72 13.53 76 75956 216635 79451721
Stress 54.71 13.53 6 76026 79606 79588750
Shock 54.33 13.53 125 75907 43423 79624933
Leukopenia 53.52 13.53 22 76010 116491 79551865
Back pain 53.50 13.53 133 75899 304047 79364309
International normalised ratio 53.41 13.53 14 76018 106 79668250
Urinary bladder haemorrhage 53.07 13.53 32 76000 2504 79665852
Retroperitoneal haemorrhage 52.94 13.53 43 75989 5427 79662929
Femoral neck fracture 52.77 13.53 56 75976 9928 79658428
Intracranial haematoma 52.54 13.53 23 76009 917 79667439
Gastritis erosive 52.36 13.53 58 75974 10789 79657567
Prothrombin time abnormal 52.06 13.53 24 76008 1082 79667274
Dyspepsia 51.62 13.53 223 75809 108464 79559892
Haemorrhage urinary tract 51.37 13.53 31 76001 2430 79665926
Cardiac ablation 51.25 13.53 30 76002 2223 79666133
Helicobacter infection 51.24 13.53 4 76028 69700 79598656
Colitis ischaemic 51.08 13.53 68 75964 15291 79653065
Diverticulum intestinal haemorrhagic 50.81 13.53 37 75995 3974 79664382
Gastric ulcer haemorrhage 50.15 13.53 52 75980 8975 79659381
Mobility decreased 50.07 13.53 27 76005 122148 79546208
Blister 49.55 13.53 26 76006 119450 79548906
Drug ineffective 49.46 13.53 730 75302 1080183 78588173
Haemodynamic instability 48.89 13.53 71 75961 17311 79651045
Injection site erythema 48.73 13.53 8 76024 78189 79590167
Rib fracture 48.68 13.53 92 75940 27855 79640501
Wound haemorrhage 47.37 13.53 36 75996 4125 79664231
Anorectal discomfort 47.31 13.53 34 75998 3577 79664779
Hypocoagulable state 47.15 13.53 28 76004 2131 79666225
Brain herniation 46.98 13.53 46 75986 7417 79660939
Paraesthesia 46.37 13.53 60 75972 176263 79492093
Neutrophil count decreased 46.06 13.53 16 76016 93943 79574413
Exsanguination 44.98 13.53 12 76020 98 79668258
Embolism arterial 44.85 13.53 24 76008 1494 79666862
Cerebellar infarction 44.74 13.53 33 75999 3614 79664742
Urticaria 44.73 13.53 67 75965 185134 79483222
Irritable bowel syndrome 44.58 13.53 4 76028 62237 79606119
Muscle spasms 44.38 13.53 61 75971 174669 79493687
Pain in extremity 44.21 13.53 188 75844 364350 79304006
C-reactive protein increased 44.08 13.53 35 75997 128992 79539364
Multiple organ dysfunction syndrome 43.48 13.53 228 75804 120018 79548338
Blood cholesterol increased 43.26 13.53 13 76019 83707 79584649
Therapy non-responder 43.09 13.53 17 76015 92288 79576068
Myalgia 43.08 13.53 69 75963 185572 79482784
Ischaemic cerebral infarction 43.01 13.53 28 76004 2507 79665849
Small intestinal haemorrhage 43 13.53 34 75998 4129 79664227
Pericarditis 42.76 13.53 23 76009 104213 79564143
Haemorrhagic cerebral infarction 42.63 13.53 23 76009 1456 79666900
Contusion 42.56 13.53 265 75767 148511 79519845
Infarction 42.21 13.53 35 75997 4547 79663809
Renal infarct 41.49 13.53 28 76004 2663 79665693
Hip fracture 41.39 13.53 91 75941 30670 79637686
Atrial flutter 41.20 13.53 74 75958 21551 79646805
Psoriasis 41.00 13.53 17 76015 89570 79578786
Subarachnoid haematoma 40.99 13.53 14 76018 281 79668075
Influenza 40.81 13.53 38 75994 129568 79538788
Subcutaneous haematoma 40.69 13.53 28 76004 2749 79665607
Mucosal inflammation 40.41 13.53 11 76021 75569 79592787
Musculoskeletal pain 39.96 13.53 24 76008 102330 79566026
Malignant neoplasm progression 39.25 13.53 43 75989 135947 79532409
Peritonitis 38.93 13.53 84 75948 27952 79640404
Oesophageal ulcer 38.43 13.53 40 75992 6935 79661421
Arthritis 38.20 13.53 32 76000 114848 79553508
Cardioversion 37.64 13.53 24 76008 2074 79666282
Thrombotic stroke 37.56 13.53 17 76015 734 79667622
Loss of personal independence in daily activities 37.39 13.53 26 76006 102554 79565802
Multiple injuries 37.08 13.53 29 76003 3466 79664890
Occult blood positive 37.07 13.53 39 75993 6844 79661512
Wheezing 36.97 13.53 34 75998 116630 79551726
Appendicitis 36.89 13.53 69 75963 20725 79647631
Wound secretion 36.84 13.53 37 75995 6151 79662205
Diverticulum 36.42 13.53 57 75975 14839 79653517
Intestinal infarction 36.35 13.53 20 76012 1316 79667040
Anticoagulation drug level abnormal 36.10 13.53 8 76024 26 79668330
Wound 35.48 13.53 35 75997 116144 79552212
Skin haemorrhage 35.25 13.53 50 75982 11931 79656425
Therapeutic response decreased 35.24 13.53 10 76022 66843 79601513
Erythema 35.19 13.53 103 75929 223187 79445169
Upper respiratory tract infection 34.72 13.53 22 76010 91146 79577210
Herpes zoster 34.72 13.53 23 76009 93060 79575296
Blood glucose increased 34.70 13.53 35 75997 114940 79553416
Pelvic fracture 34.54 13.53 50 75982 12154 79656202
Anticoagulant-related nephropathy 34.35 13.53 9 76023 68 79668288
Agitation 34.12 13.53 27 76005 99688 79568668
Aortic aneurysm 33.79 13.53 41 75991 8405 79659951
Cholecystitis acute 33.63 13.53 52 75980 13399 79654957
Impaired healing 33.60 13.53 21 76011 87634 79580722
Anaphylactic reaction 33.59 13.53 19 76013 83724 79584632
Sleep disorder 33.57 13.53 20 76012 85657 79582699
Alanine aminotransferase increased 33.57 13.53 65 75967 162505 79505851
Hemianopia homonymous 33.56 13.53 19 76013 1322 79667034
Catheter site haemorrhage 33.07 13.53 32 76000 5085 79663271
Conjunctival haemorrhage 32.97 13.53 34 75998 5831 79662525
Blood pressure increased 32.94 13.53 98 75934 211262 79457094
Coagulation time shortened 32.89 13.53 13 76019 399 79667957
Nasal congestion 32.73 13.53 16 76016 76536 79591820
Inappropriate schedule of product administration 32.59 13.53 48 75984 133580 79534776
Prothrombin time shortened 32.56 13.53 26 76006 3202 79665154
Arterial thrombosis 32.36 13.53 24 76008 2650 79665706
Influenza like illness 32.19 13.53 14 76018 71693 79596663
Anticoagulation drug level above therapeutic 32.00 13.53 27 76005 3593 79664763
Weight decreased 31.89 13.53 203 75829 354995 79313361
COVID-19 31.73 13.53 64 75968 157610 79510746
Haematocrit decreased 31.60 13.53 129 75903 61183 79607173
Gastric ulcer 31.48 13.53 87 75945 33818 79634538
Cardiac failure congestive 31.43 13.53 238 75794 142164 79526192
Feeling hot 31.36 13.53 9 76023 59725 79608631
Ileus 31.34 13.53 74 75958 26137 79642219
Injection site swelling 31.27 13.53 4 76028 47128 79621228
Duodenal ulcer perforation 31.22 13.53 12 76020 66199 79602157
Thalamus haemorrhage 31.02 13.53 20 76012 1762 79666594
Facial paresis 31 13.53 32 76000 5494 79662862
Dysphagia 30.93 13.53 211 75821 121925 79546431
Atrial fibrillation 30.74 13.53 306 75726 197580 79470776
Gastric cancer 30.72 13.53 43 75989 10136 79658220
Somnolence 30.35 13.53 121 75911 238860 79429496
Drug ineffective for unapproved indication 30.28 13.53 6 76026 51232 79617124
Pulmonary contusion 30.26 13.53 9 76023 113 79668243
Myocardial infarction 30.20 13.53 288 75744 183841 79484515
Haemorrhagic diathesis 30.18 13.53 33 75999 6051 79662305
C-reactive protein abnormal 30.02 13.53 5 76027 48362 79619994
Lumbar puncture 29.99 13.53 10 76022 186 79668170
Cytomegalovirus infection 29.85 13.53 3 76029 42641 79625715
Haemarthrosis 29.66 13.53 32 76000 5780 79662576
Serotonin syndrome 29.45 13.53 4 76028 45023 79623333
Aortic thrombosis 29.44 13.53 19 76013 1676 79666680
Discoloured vomit 29.26 13.53 18 76014 1460 79666896
Hemianopia 29.11 13.53 19 76013 1709 79666647
Night sweats 28.97 13.53 7 76025 52088 79616268
Arterial haemorrhage 28.81 13.53 22 76010 2539 79665817
Hypoaesthesia 28.79 13.53 82 75950 179270 79489086
Thrombotic cerebral infarction 28.77 13.53 13 76019 559 79667797
Coronary artery embolism 28.67 13.53 11 76021 311 79668045
Oesophagitis 28.42 13.53 68 75964 24221 79644135
Prothrombin time ratio decreased 28.39 13.53 15 76017 910 79667446
Haemorrhoids 28.30 13.53 76 75956 29052 79639304
Mesenteric artery embolism 28.28 13.53 8 76024 83 79668273
Acute coronary syndrome 27.85 13.53 62 75970 21071 79647285
Disseminated intravascular coagulation 27.56 13.53 86 75946 35756 79632600
Diverticulitis intestinal haemorrhagic 27.47 13.53 12 76020 476 79667880
Gastrointestinal necrosis 27.28 13.53 30 76002 5535 79662821
Cardiogenic shock 27.25 13.53 95 75937 41819 79626537
NIH stroke scale abnormal 27.19 13.53 6 76026 19 79668337
Platelet count decreased 27.03 13.53 95 75937 194569 79473787
Lymphocyte count decreased 27.00 13.53 6 76026 47283 79621073
Oropharyngeal pain 26.94 13.53 39 75993 109314 79559042
Constipation 26.84 13.53 159 75873 282891 79385465
Femoral artery embolism 26.82 13.53 7 76025 52 79668304
Brain oedema 26.67 13.53 68 75964 25195 79643161
Colon neoplasm 26.67 13.53 14 76018 838 79667518
Rectal cancer 26.61 13.53 24 76008 3489 79664867
Post procedural stroke 26.50 13.53 8 76024 106 79668250
Mucosal haemorrhage 26.45 13.53 21 76011 2565 79665791
Arteriovenous malformation 26.38 13.53 18 76014 1743 79666613
Psychotic disorder 26.33 13.53 4 76028 41398 79626958
Bone marrow failure 26.28 13.53 8 76024 51099 79617257
Malaise 26.20 13.53 320 75712 489549 79178807
Incarcerated inguinal hernia 26.01 13.53 9 76023 188 79668168
Joint stiffness 25.84 13.53 4 76028 40826 79627530
Cerebral artery thrombosis 25.82 13.53 15 76017 1096 79667260
Drug dependence 25.78 13.53 4 76028 40765 79627591
Creatinine renal clearance 25.72 13.53 6 76026 26 79668330
Tremor 25.68 13.53 80 75952 170003 79498353
Lacunar infarction 25.61 13.53 30 76002 5927 79662429
Bronchitis 25.46 13.53 54 75978 130590 79537766
Aneurysm ruptured 25.18 13.53 14 76018 940 79667416
Sedation 25.15 13.53 9 76023 51886 79616470
Cardiac failure chronic 25.02 13.53 41 75991 11094 79657262
Anuria 24.86 13.53 59 75973 20904 79647452
Aspartate aminotransferase increased 24.83 13.53 60 75972 138581 79529775
Hydrocephalus 24.52 13.53 36 75996 8864 79659492
Neurologic neglect syndrome 24.30 13.53 21 76011 2886 79665470
Flushing 24.28 13.53 29 76003 88239 79580117
Duodenal ulcer haemorrhage 24.26 13.53 32 76000 7131 79661225
Coagulation factor increased 24.21 13.53 7 76025 79 79668277
Pneumonia aspiration 24.21 13.53 127 75905 66840 79601516
Gastritis haemorrhagic 23.86 13.53 20 76012 2637 79665719
Pelvic haematoma 23.83 13.53 13 76019 841 79667515
Inguinal hernia strangulated 23.83 13.53 4 76028 0 79668356
Injection site bruising 23.82 13.53 5 76027 40997 79627359
Hospitalisation 23.82 13.53 33 75999 94203 79574153
Migraine 23.80 13.53 29 76003 87464 79580892
Traumatic haematoma 23.72 13.53 18 76014 2058 79666298
Gastrointestinal angiodysplasia 23.70 13.53 14 76018 1055 79667301
Ill-defined disorder 23.61 13.53 17 76015 65858 79602498
Inflammation 23.53 13.53 33 75999 93720 79574636
Gastrointestinal motility disorder 23.33 13.53 29 76003 6093 79662263
Bone pain 23.30 13.53 12 76020 55730 79612626
Hypochromic anaemia 23.25 13.53 20 76012 2731 79665625
Vision blurred 23.04 13.53 41 75991 105857 79562499
Venous thrombosis 22.89 13.53 31 76001 7085 79661271
Monoparesis 22.77 13.53 22 76010 3489 79664867
Arterial injury 22.77 13.53 12 76020 724 79667632
Paresis 22.70 13.53 24 76008 4237 79664119
Multiple sclerosis relapse 22.67 13.53 8 76024 46525 79621831
Osteoarthritis 22.65 13.53 30 76002 87279 79581077
Feeling abnormal 22.57 13.53 77 75955 159122 79509234
Seizure 22.48 13.53 98 75934 188736 79479620
Spontaneous haematoma 22.41 13.53 15 76017 1407 79666949
Renal haemorrhage 22.39 13.53 18 76014 2238 79666118
Large intestine polyp 22.33 13.53 42 75990 12666 79655690
Hypothyroidism 22.32 13.53 11 76021 52381 79615975
Osteoma 22.15 13.53 7 76025 109 79668247
Femur fracture 22.07 13.53 84 75948 38568 79629788
Dry mouth 22.07 13.53 31 76001 87988 79580368
Gastrointestinal vascular malformation haemorrhagic 21.95 13.53 12 76020 780 79667576
Cytokine release syndrome 21.73 13.53 4 76028 35994 79632362
Spinal cord haematoma 21.63 13.53 9 76023 316 79668040
Gait disturbance 21.60 13.53 113 75919 207393 79460963
Hypotension 21.58 13.53 561 75471 439756 79228600
Skull fractured base 21.47 13.53 9 76023 322 79668034
Dyskinesia 21.30 13.53 8 76024 44765 79623591
Vaginal haemorrhage 21.27 13.53 57 75975 21760 79646596
Carotid artery occlusion 21.16 13.53 31 76001 7616 79660740
Thoracic haemorrhage 21.13 13.53 8 76024 218 79668138
Suicidal ideation 21.09 13.53 25 76007 76315 79592041
Hyperhidrosis 20.98 13.53 74 75958 151418 79516938
Vascular pseudoaneurysm 20.92 13.53 21 76011 3489 79664867
Angioedema 20.89 13.53 25 76007 76010 79592346
Pain in jaw 20.73 13.53 9 76023 46142 79622214
Oxygen saturation decreased 20.70 13.53 59 75973 128988 79539368
Haemochromatosis 20.70 13.53 14 76018 1336 79667020
Prothrombin time 20.68 13.53 5 76027 26 79668330
Blood pressure systolic increased 20.66 13.53 20 76012 66966 79601390
Red blood cell sedimentation rate increased 20.57 13.53 9 76023 45933 79622423
Hypertension 20.53 13.53 209 75823 330783 79337573
Facial paralysis 20.49 13.53 55 75977 21017 79647339
Ear infection 20.41 13.53 4 76028 34428 79633928
Neoplasm progression 20.34 13.53 12 76020 51670 79616686
Petechiae 20.32 13.53 54 75978 20511 79647845
Mesenteric haemorrhage 20.12 13.53 6 76026 76 79668280
Drug reaction with eosinophilia and systemic symptoms 20.02 13.53 19 76013 64225 79604131
Bacterial infection 19.94 13.53 3 76029 31277 79637079
Aortic intramural haematoma 19.89 13.53 7 76025 154 79668202
Occult blood 19.82 13.53 15 76017 1708 79666648
Osteonecrosis 19.78 13.53 3 76029 31092 79637264
Cardiac pacemaker insertion 19.70 13.53 26 76006 5796 79662560
Post procedural haematuria 19.69 13.53 8 76024 264 79668092
Intentional overdose 19.66 13.53 45 75987 105915 79562441
Full blood count abnormal 19.65 13.53 7 76025 40467 79627889
Candida infection 19.62 13.53 6 76026 38208 79630148
Urogenital haemorrhage 19.60 13.53 12 76020 965 79667391
Haemorrhagic infarction 19.46 13.53 11 76021 763 79667593
Polycystic liver disease 19.40 13.53 7 76025 166 79668190
Prescribed overdose 19.36 13.53 6 76026 37877 79630479
Splenic necrosis 19.17 13.53 7 76025 172 79668184
Liver function test increased 19.10 13.53 7 76025 39766 79628590
Renal embolism 19.09 13.53 7 76025 174 79668182
Respiratory tract haemorrhage 19.07 13.53 15 76017 1808 79666548
Pneumonitis 18.97 13.53 18 76014 60842 79607514
Blood creatine phosphokinase increased 18.95 13.53 21 76011 66069 79602287
Type 2 diabetes mellitus 18.87 13.53 16 76016 57106 79611250
Pneumocystis jirovecii pneumonia 18.81 13.53 4 76028 32504 79635852
Orthopaedic procedure 18.76 13.53 7 76025 183 79668173
Memory impairment 18.73 13.53 50 75982 111684 79556672
Coagulation factor V level decreased 18.71 13.53 10 76022 621 79667735
Pharyngeal haemorrhage 18.65 13.53 13 76019 1303 79667053
Prostatic specific antigen abnormal 18.61 13.53 9 76023 452 79667904
Mesenteric artery thrombosis 18.55 13.53 10 76022 632 79667724
Osteonecrosis of jaw 18.53 13.53 9 76023 43217 79625139
Productive cough 18.50 13.53 35 75997 88296 79580060
Retroperitoneal haematoma 18.46 13.53 24 76008 5273 79663083
Polyp 18.42 13.53 30 76002 8077 79660279
Splenic haematoma 18.37 13.53 8 76024 315 79668041
Haemoglobin 18.23 13.53 6 76026 107 79668249
Brain stem haemorrhage 18.18 13.53 14 76018 1636 79666720
Muscle haemorrhage 18.11 13.53 26 76006 6274 79662082
Dry skin 18.01 13.53 23 76009 67972 79600384
Splenic haemorrhage 17.66 13.53 10 76022 696 79667660
Encephalopathy 17.64 13.53 23 76009 67374 79600982
Putamen haemorrhage 17.64 13.53 9 76023 508 79667848
Drug eruption 17.57 13.53 10 76022 43925 79624431
Brain stem stroke 17.49 13.53 10 76022 709 79667647
Acute myeloid leukaemia 17.47 13.53 4 76028 30881 79637475
Adverse event 17.41 13.53 19 76013 60195 79608161
Heart rate decreased 17.39 13.53 25 76007 70291 79598065
Hot flush 17.37 13.53 16 76016 54861 79613495
Cardiac ventricular thrombosis 17.29 13.53 14 76018 1759 79666597
Ear pain 17.17 13.53 5 76027 32864 79635492
Cystitis 17.14 13.53 15 76017 52717 79615639
White blood cell count increased 17.06 13.53 28 76004 74605 79593751
Lacunar stroke 16.96 13.53 8 76024 380 79667976
Cardiac myxoma 16.93 13.53 6 76026 135 79668221
Ruptured cerebral aneurysm 16.91 13.53 9 76023 554 79667802
Dry eye 16.91 13.53 7 76025 36924 79631432
Circulatory collapse 16.89 13.53 76 75956 37592 79630764
Anticoagulation drug level below therapeutic 16.87 13.53 13 76019 1520 79666836
Bleeding time prolonged 16.64 13.53 12 76020 1269 79667087
Haemorrhagic disorder 16.54 13.53 13 76019 1565 79666791
Splenic cyst 16.53 13.53 7 76025 257 79668099
Aortic dissection rupture 16.51 13.53 5 76027 67 79668289
Blood pressure fluctuation 16.48 13.53 24 76008 67121 79601235
Cataract 16.46 13.53 21 76011 62099 79606257
Mouth ulceration 16.45 13.53 8 76024 38386 79629970
Diabetic ketoacidosis 16.40 13.53 6 76026 34116 79634240
Prescribed underdose 16.34 13.53 4 76028 29510 79638846
Electrocardiogram QT prolonged 16.27 13.53 39 75993 90347 79578009
Hepatotoxicity 16.22 13.53 15 76017 51337 79617019
Bursitis 16.08 13.53 7 76025 35837 79632519
Fungal infection 16.00 13.53 10 76022 41738 79626618
Gastritis 15.98 13.53 89 75943 47904 79620452
Aggression 15.96 13.53 15 76017 50943 79617413
Accidental exposure to product 15.93 13.53 5 76027 31317 79637039
Cerebellar haematoma 15.88 13.53 9 76023 627 79667729
Neuralgia 15.82 13.53 6 76026 33378 79634978
Brain stem infarction 15.81 13.53 14 76018 1987 79666369
Traumatic renal injury 15.79 13.53 3 76029 3 79668353
Knee arthroplasty 15.71 13.53 11 76021 43237 79625119
Thrombosis mesenteric vessel 15.70 13.53 6 76026 168 79668188
Intentional product misuse 15.64 13.53 43 75989 95122 79573234
Eye haemorrhage 15.62 13.53 31 76001 9726 79658630
High frequency ablation 15.60 13.53 7 76025 296 79668060
Irritability 15.57 13.53 10 76022 41134 79627222
Open globe injury 15.52 13.53 5 76027 83 79668273
Depressed mood 15.51 13.53 14 76018 48466 79619890
Eczema 15.34 13.53 10 76022 40808 79627548
Abdominal wall haematoma 15.33 13.53 21 76011 4852 79663504
Body temperature increased 15.23 13.53 12 76020 44408 79623948
Mechanical ileus 15.22 13.53 10 76022 909 79667447
Rhabdomyolysis 15.22 13.53 49 75983 103082 79565274
Rhinorrhoea 15.19 13.53 31 76001 76043 79592313
Abdominal wall haemorrhage 15.15 13.53 9 76023 685 79667671
Meningorrhagia 15.09 13.53 7 76025 320 79668036
Anti factor VIII antibody test 14.93 13.53 3 76029 5 79668351
Gastric occult blood positive 14.93 13.53 3 76029 5 79668351
Subdural hygroma 14.91 13.53 8 76024 501 79667855
Abdominal strangulated hernia 14.89 13.53 5 76027 95 79668261
Pharyngeal mass 14.87 13.53 7 76025 331 79668025
Abdominal discomfort 14.85 13.53 160 75872 250567 79417789
Facial nerve disorder 14.82 13.53 9 76023 713 79667643
Gastrointestinal disorder 14.80 13.53 63 75969 122142 79546214
Vessel puncture site haemorrhage 14.77 13.53 6 76026 198 79668158
Basilar artery occlusion 14.68 13.53 6 76026 201 79668155
Hallucination 14.65 13.53 38 75994 85707 79582649
Overdose 14.65 13.53 252 75780 183954 79484402
Death 14.60 13.53 670 75362 565844 79102512
Decreased appetite 14.60 13.53 234 75798 342184 79326172
Splenic embolism 14.55 13.53 6 76026 206 79668150
Gait inability 14.52 13.53 21 76011 58896 79609460
Quadrantanopia 14.49 13.53 6 76026 208 79668148
Muscle twitching 14.43 13.53 3 76029 24761 79643595
Intracranial mass 14.36 13.53 14 76018 2245 79666111
Hypertensive crisis 14.31 13.53 48 75984 20722 79647634
Contraindication to surgery 14.26 13.53 3 76029 7 79668349
Epidural haemorrhage 14.18 13.53 6 76026 220 79668136
Toxic epidermal necrolysis 14.11 13.53 13 76019 44568 79623788
Ascites 14.09 13.53 32 76000 75530 79592826
Oesophageal carcinoma 14.02 13.53 32 76000 11052 79657304
Basilar artery thrombosis 14.00 13.53 7 76025 378 79667978
Osteorrhagia 13.98 13.53 3 76029 8 79668348
Diabetes mellitus 13.97 13.53 34 75998 78356 79590000
Sinus tachycardia 13.92 13.53 9 76023 36899 79631457
Muscular weakness 13.82 13.53 93 75939 160636 79507720
Carotid arterial embolus 13.77 13.53 4 76028 46 79668310
Speech disorder 13.74 13.53 94 75938 54351 79614005
Vascular stent occlusion 13.73 13.53 6 76026 238 79668118
Venous thrombosis limb 13.71 13.53 19 76013 4438 79663918
Urethral haemorrhage 13.64 13.53 7 76025 400 79667956

FDA Adverse Event Reporting System (Pediatric)

None

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 anticoagulants
CHEBI has role CHEBI:50266 Prodrugs
CHEBI has role CHEBI:65232 thrombin inhibitors
CHEBI has role CHEBI:77020 NAD(P)H:quinone oxidoreductase-2 inhibitors

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

DiseaseRelationSNOMED_IDDOID
Pulmonary embolism indication 59282003 DOID:9477
Deep vein thrombosis indication 128053003
Prevention of systemic embolism indication 414086009
Prevention of deep vein thrombosis indication 439993001
Prevention of stroke indication
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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 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
1037041 RXNORM
4030254 VANDF
4030255 VANDF
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
8028 INN_ID
2E18WX195X UNII
135565674 PUBCHEM_CID
DB14726 DRUGBANK_ID
136711 MMSL
25762 MMSL
360089 MMSL
41106 MMSL
41303 MMSL
d07137 MMSL
012668 NDDF
012669 NDDF
698871007 SNOMEDCT_US
700029008 SNOMEDCT_US
700039002 SNOMEDCT_US
714788005 SNOMEDCT_US
C2348066 UMLSCUI
8027 INN_ID
211914-51-1 SECONDARY_CAS_RN
216210 PUBCHEM_CID
6380 IUPHAR_LIGAND_ID
I0VM4M70GC UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Pradaxa HUMAN PRESCRIPTION DRUG LABEL 1 0597-0108 CAPSULE 110 mg ORAL NDA 33 sections
Pradaxa HUMAN PRESCRIPTION DRUG LABEL 1 0597-0108 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 0597-0355 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 0597-0360 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 0597-0425 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 0597-0430 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 0597-0435 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 0597-0440 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 0597-0445 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 0597-0450 PELLET 150 mg ORAL NDA 33 sections
PRADAXA HUMAN PRESCRIPTION DRUG LABEL 1 21695-899 CAPSULE 150 mg ORAL NDA 27 sections
Dabigatran Etexilate HUMAN PRESCRIPTION DRUG LABEL 1 31722-621 CAPSULE 75 mg ORAL ANDA 28 sections
Dabigatran Etexilate HUMAN PRESCRIPTION DRUG LABEL 1 31722-621 CAPSULE 75 mg ORAL ANDA 28 sections
Dabigatran Etexilate HUMAN PRESCRIPTION DRUG LABEL 1 31722-622 CAPSULE 150 mg ORAL ANDA 28 sections
Dabigatran Etexilate HUMAN PRESCRIPTION DRUG LABEL 1 31722-622 CAPSULE 150 mg ORAL ANDA 28 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 32 sections
Pradaxa HUMAN PRESCRIPTION DRUG LABEL 1 50090-4480 CAPSULE 150 mg ORAL NDA 32 sections
Dabigatran Etexilate HUMAN PRESCRIPTION DRUG LABEL 1 60687-744 CAPSULE 75 mg ORAL ANDA 28 sections
Dabigatran Etexilate HUMAN PRESCRIPTION DRUG LABEL 1 60687-752 CAPSULE 150 mg ORAL ANDA 28 sections
Pradaxa HUMAN PRESCRIPTION DRUG LABEL 1 63629-8242 CAPSULE 150 mg ORAL NDA 32 sections
Dabigatran Etexilate Human Prescription Drug Label 1 67877-474 CAPSULE, COATED PELLETS 75 mg ORAL ANDA 28 sections