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
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 4373.14 14.91 1805 41104 71516 50490699
Ischaemic stroke 2293.77 14.91 753 42156 15195 50547020
Cerebrovascular accident 1509.02 14.91 959 41950 93721 50468494
Haemorrhage 1219.98 14.91 683 42226 52758 50509457
Melaena 1029.71 14.91 487 42422 26377 50535838
Rectal haemorrhage 993.21 14.91 534 42375 38024 50524191
Haemorrhage intracranial 899.96 14.91 353 42556 12021 50550194
Cerebral haemorrhage 719.69 14.91 383 42526 26669 50535546
Lower gastrointestinal haemorrhage 666.04 14.91 242 42667 6637 50555578
Activated partial thromboplastin time prolonged 619.00 14.91 225 42684 6177 50556038
Cardiac tamponade 482.08 14.91 168 42741 4064 50558151
Cerebral infarction 448.72 14.91 260 42649 21344 50540871
Subdural haematoma 444.99 14.91 218 42691 12729 50549486
Shock haemorrhagic 377.85 14.91 170 42739 8174 50554041
Haematoma 375.77 14.91 264 42645 30246 50531969
International normalised ratio increased 374.95 14.91 303 42606 42849 50519366
Blood loss anaemia 369.13 14.91 166 42743 7973 50554242
Embolic stroke 365.11 14.91 130 42779 3354 50558861
Fall 349.83 14.91 832 42077 334100 50228115
Upper gastrointestinal haemorrhage 343.65 14.91 197 42712 15838 50546377
Coagulopathy 341.18 14.91 204 42705 17740 50544475
Haematochezia 327.47 14.91 271 42638 39611 50522604
Transient ischaemic attack 309.44 14.91 240 42669 31970 50530245
Haematuria 297.75 14.91 214 42695 25399 50536816
Haemorrhagic stroke 293.67 14.91 124 42785 5104 50557111
Procoagulant therapy 279.41 14.91 46 42863 0 50562215
Anaemia 270.52 14.91 634 42275 251822 50310393
Pericardial haemorrhage 263.27 14.91 82 42827 1376 50560839
Haematemesis 241.40 14.91 195 42714 27530 50534685
Subarachnoid haemorrhage 235.18 14.91 134 42775 10642 50551573
Atrial thrombosis 233.25 14.91 75 42834 1402 50560813
Thrombin time prolonged 227.00 14.91 44 42865 66 50562149
Pain 215.05 14.91 112 42797 578791 49983424
Acute kidney injury 207.27 14.91 538 42371 227520 50334695
Deep vein thrombosis 201.14 14.91 278 42631 73026 50489189
Intestinal haemorrhage 200.78 14.91 82 42827 3098 50559117
Haemoglobin decreased 192.26 14.91 368 42541 126848 50435367
Pulmonary embolism 185.15 14.91 319 42590 101385 50460830
Renal failure 184.44 14.91 327 42582 106306 50455909
Hemiparesis 170.26 14.91 139 42770 19909 50542306
Epistaxis 164.21 14.91 235 42674 63719 50498496
Hypovolaemic shock 156.52 14.91 80 42829 5108 50557107
Cardiac failure 148.27 14.91 246 42663 75794 50486421
Subdural haemorrhage 147.08 14.91 63 42846 2686 50559529
Drug hypersensitivity 143.63 14.91 21 42888 250989 50311226
Fatigue 134.35 14.91 248 42661 707353 49854862
Aortic dissection 131.64 14.91 50 42859 1553 50560662
Rheumatoid arthritis 122.94 14.91 14 42895 202536 50359679
Haemothorax 121.74 14.91 50 42859 1916 50560299
Renal impairment 120.53 14.91 224 42685 75437 50486778
Prothrombin time prolonged 114.63 14.91 79 42830 8759 50553456
Maternal exposure during pregnancy 114.18 14.91 5 42904 159773 50402442
Wound secretion 112.66 14.91 58 42851 3759 50558456
Haemoptysis 110.55 14.91 122 42787 25451 50536764
Cerebral haematoma 110.07 14.91 54 42855 3157 50559058
Hemiplegia 107.75 14.91 71 42838 7310 50554905
Infusion related reaction 107.32 14.91 10 42899 169547 50392668
Peripheral embolism 106.42 14.91 39 42870 1094 50561121
Rash 104.27 14.91 131 42778 437340 50124875
Head injury 102.81 14.91 114 42795 23906 50538309
Procedural haemorrhage 102.81 14.91 47 42862 2343 50559872
Coagulation time prolonged 101.60 14.91 38 42871 1130 50561085
Drug ineffective 100.72 14.91 358 42551 818975 49743240
Pyrexia 99.03 14.91 106 42803 380097 50182118
Systemic lupus erythematosus 98.53 14.91 5 42904 140617 50421598
Gastric haemorrhage 96.04 14.91 60 42849 5636 50556579
Drug intolerance 96.03 14.91 33 42876 219071 50343144
Arthralgia 94.83 14.91 141 42768 438561 50123654
Creatinine renal clearance decreased 91.77 14.91 78 42831 11803 50550412
Joint swelling 89.90 14.91 48 42861 245238 50316977
Arthropathy 88.45 14.91 14 42895 157892 50404323
Faeces discoloured 87.73 14.91 87 42822 16037 50546178
Large intestinal haemorrhage 86.64 14.91 34 42875 1155 50561060
Haemorrhoidal haemorrhage 86.50 14.91 48 42861 3619 50558596
Therapeutic product effect decreased 86.15 14.91 8 42901 136042 50426173
Post procedural haemorrhage 85.02 14.91 61 42848 7209 50555006
Dyspepsia 82.17 14.91 189 42720 73908 50488307
Nasopharyngitis 81.23 14.91 31 42878 192896 50369319
Aphasia 79.47 14.91 109 42800 28385 50533830
Traumatic haemorrhage 78.46 14.91 25 42884 453 50561762
Haemorrhagic transformation stroke 78.31 14.91 31 42878 1078 50561137
Sinusitis 77.68 14.91 24 42885 170534 50391681
Musculoskeletal stiffness 77.62 14.91 9 42900 128472 50433743
Hypersensitivity 77.52 14.91 43 42866 215118 50347097
Contraindicated product administered 77.39 14.91 16 42893 148942 50413273
Glossodynia 75.33 14.91 6 42903 115563 50446652
Pericardial effusion 74.57 14.91 100 42809 25489 50536726
Condition aggravated 72.71 14.91 87 42822 296971 50265244
Injection site pain 71.71 14.91 6 42903 111018 50451197
Cerebral artery occlusion 71.25 14.91 27 42882 833 50561382
Treatment failure 71.05 14.91 15 42894 137622 50424593
Drug interaction 71.02 14.91 346 42563 199275 50362940
Weight increased 70.37 14.91 42 42867 201849 50360366
Product use issue 69.95 14.91 20 42889 149455 50412760
International normalised ratio abnormal 69.22 14.91 38 42871 2805 50559410
Embolism 69.21 14.91 53 42856 6915 50555300
Gingival bleeding 68.80 14.91 65 42844 11288 50550927
Pulmonary haemorrhage 68.07 14.91 51 42858 6441 50555774
Mouth haemorrhage 67.93 14.91 50 42859 6146 50556069
Anxiety 67.66 14.91 33 42876 177573 50384642
Headache 66.26 14.91 215 42694 506320 50055895
Splenic rupture 65.89 14.91 28 42881 1170 50561045
Peripheral swelling 64.82 14.91 48 42861 205888 50356327
Thrombin time abnormal 64.16 14.91 11 42898 3 50562212
International normalised ratio 64.13 14.91 15 42894 76 50562139
Anticoagulation drug level increased 63.18 14.91 17 42892 164 50562051
Alopecia 61.84 14.91 70 42839 244977 50317238
Hip fracture 61.73 14.91 92 42817 25839 50536376
Swelling 61.71 14.91 48 42861 200824 50361391
Product dose omission issue 61.63 14.91 40 42869 183798 50378417
Cardiac valve replacement complication 61.17 14.91 16 42893 137 50562078
Craniocerebral injury 60.54 14.91 32 42877 2189 50560026
Thrombosis 60.33 14.91 141 42768 55692 50506523
Activated partial thromboplastin time abnormal 60.00 14.91 15 42894 105 50562110
Intestinal ischaemia 59.78 14.91 48 42861 6709 50555506
Peripheral ischaemia 59.67 14.91 40 42869 4236 50557979
Cerebral ischaemia 58.82 14.91 45 42864 5863 50556352
Strangulated hernia 58.76 14.91 12 42897 27 50562188
Neutropenia 58.66 14.91 26 42883 147939 50414276
Depression 58.21 14.91 34 42875 165389 50396826
Intracardiac thrombus 58.15 14.91 31 42878 2158 50560057
Intra-abdominal haemorrhage 57.74 14.91 31 42878 2189 50560026
Nausea 57.57 14.91 357 42552 705041 49857174
Colon cancer 57.00 14.91 52 42857 8639 50553576
Puncture site haemorrhage 56.77 14.91 17 42892 248 50561967
Cerebral artery embolism 56.29 14.91 22 42887 739 50561476
Iron deficiency anaemia 55.62 14.91 70 42839 16764 50545451
Acute abdomen 54.47 14.91 26 42883 1430 50560785
Death 54.05 14.91 465 42444 324914 50237301
Retroperitoneal haemorrhage 53.65 14.91 31 42878 2525 50559690
Infection 52.26 14.91 42 42867 172912 50389303
Toxicity to various agents 52.20 14.91 62 42847 212437 50349778
Blood urine present 51.65 14.91 59 42850 12774 50549441
Discomfort 51.63 14.91 14 42895 108366 50453849
Gastritis erosive 50.88 14.91 39 42870 5095 50557120
Traumatic intracranial haemorrhage 50.23 14.91 17 42892 375 50561840
Shock 50.20 14.91 74 42835 20576 50541639
Haemarthrosis 49.95 14.91 31 42878 2877 50559338
Lower respiratory tract infection 49.90 14.91 10 42899 95191 50467024
Stomatitis 48.44 14.91 13 42896 101331 50460884
Acute myocardial infarction 48.24 14.91 88 42821 29185 50533030
Cardiac perforation 47.49 14.91 11 42898 53 50562162
Multiple organ dysfunction syndrome 46.80 14.91 120 42789 50217 50511998
Wound 46.19 14.91 16 42893 105778 50456437
Back pain 45.22 14.91 73 42836 219957 50342258
Peripheral artery thrombosis 45.21 14.91 24 42885 1656 50560559
Haemorrhage subcutaneous 44.40 14.91 28 42881 2673 50559542
Femoral neck fracture 43.71 14.91 42 42867 7448 50554767
Microcytic anaemia 43.40 14.91 29 42880 3055 50559160
Product use in unapproved indication 43.36 14.91 22 42887 115797 50446418
Neuropathy peripheral 43.34 14.91 14 42895 96743 50465472
Chills 43.29 14.91 14 42895 96673 50465542
Haemoperitoneum 43.29 14.91 27 42882 2528 50559687
Embolic cerebral infarction 43.15 14.91 16 42893 464 50561751
Intraventricular haemorrhage 42.80 14.91 24 42885 1846 50560369
Disease progression 42.71 14.91 14 42895 95852 50466363
Atrial fibrillation 42.51 14.91 185 42724 101560 50460655
Colitis ischaemic 42.29 14.91 46 42863 9437 50552778
Hypocoagulable state 42.13 14.91 19 42890 917 50561298
Vaginal haemorrhage 41.98 14.91 75 42834 24476 50537739
Pruritus 40.07 14.91 116 42793 283452 50278763
Diverticulum 39.71 14.91 47 42862 10567 50551648
Haemorrhagic cerebral infarction 39.28 14.91 16 42893 600 50561615
Intentional product use issue 38.43 14.91 9 42900 76909 50485306
Cerebral mass effect 38.00 14.91 17 42892 805 50561410
Coagulation test abnormal 37.84 14.91 16 42893 660 50561555
Wound haemorrhage 37.73 14.91 23 42886 2067 50560148
Contusion 36.68 14.91 190 42719 111993 50450222
Subcutaneous haematoma 36.19 14.91 20 42889 1495 50560720
Skull fracture 36.06 14.91 17 42892 909 50561306
Pericarditis 35.93 14.91 11 42898 78678 50483537
Cardiac failure congestive 35.68 14.91 154 42755 84228 50477987
Ischaemic cerebral infarction 35.42 14.91 18 42891 1135 50561080
Skin haemorrhage 35.19 14.91 36 42873 6882 50555333
Prothrombin time abnormal 34.74 14.91 13 42896 387 50561828
Diverticulum intestinal haemorrhagic 34.59 14.91 18 42891 1192 50561023
Exsanguination 34.51 14.91 7 42902 15 50562200
Prothrombin time shortened 34.41 14.91 20 42889 1647 50560568
Influenza 33.52 14.91 17 42892 89521 50472694
Ischaemia 32.75 14.91 28 42881 4269 50557946
Hepatic enzyme increased 32.74 14.91 41 42868 137339 50424876
Upper respiratory tract infection 32.35 14.91 8 42901 65890 50496325
Anticoagulation drug level above therapeutic 32.27 14.91 17 42892 1155 50561060
Drug abuse 31.96 14.91 6 42903 59840 50502375
Stress 31.90 14.91 4 42905 53789 50508426
Mesenteric artery embolism 31.81 14.91 6 42903 7 50562208
Small intestinal haemorrhage 31.77 14.91 20 42889 1903 50560312
Post procedural haematoma 31.63 14.91 17 42892 1203 50561012
Ecchymosis 31.56 14.91 41 42868 10128 50552087
Pelvic haematoma 31.39 14.91 13 42896 509 50561706
Incarcerated hernia 31.37 14.91 9 42900 112 50562103
Prothrombin time ratio decreased 30.68 14.91 12 42897 404 50561811
Coagulation factor increased 30.57 14.91 6 42903 10 50562205
Mobility decreased 30.20 14.91 15 42894 79933 50482282
Irritable bowel syndrome 30.08 14.91 4 42905 51437 50510778
White blood cell count decreased 29.78 14.91 33 42876 116689 50445526
Gastric ulcer haemorrhage 29.74 14.91 27 42882 4457 50557758
Impaired healing 29.69 14.91 11 42898 69775 50492440
Brain herniation 29.57 14.91 23 42886 3069 50559146
Therapeutic response decreased 29.29 14.91 3 42906 47228 50514987
Therapeutic product effect incomplete 29.19 14.91 21 42888 91494 50470721
Haematocrit decreased 29.07 14.91 80 42829 34896 50527319
Pelvic fracture 29.04 14.91 42 42867 11478 50550737
Hypochromic anaemia 28.93 14.91 18 42891 1678 50560537
Intracranial haematoma 28.89 14.91 11 42898 344 50561871
Helicobacter infection 28.74 14.91 4 42905 49698 50512517
Oesophageal ulcer 28.64 14.91 25 42884 3920 50558295
Constipation 28.43 14.91 73 42836 185635 50376580
Femoral artery embolism 28.38 14.91 7 42902 46 50562169
Phlebitis 27.72 14.91 29 42880 5691 50556524
Brain contusion 27.61 14.91 12 42897 530 50561685
Disseminated intravascular coagulation 27.58 14.91 51 42858 17084 50545131
Gastritis haemorrhagic 27.49 14.91 16 42893 1321 50560894
Dysphagia 27.23 14.91 134 42775 77384 50484831
Cough 27.06 14.91 109 42800 241155 50321060
Heart transplant 27.02 14.91 11 42898 412 50561803
Diarrhoea 26.95 14.91 345 42564 588131 49974084
Road traffic accident 26.84 14.91 62 42847 24290 50537925
Hypotension 26.63 14.91 311 42598 235158 50327057
Asthma 26.58 14.91 22 42887 89315 50472900
Occult blood positive 26.22 14.91 22 42887 3269 50558946
Pulmonary alveolar haemorrhage 26.22 14.91 24 42885 4003 50558212
Overdose 26.02 14.91 159 42750 99568 50462647
Neutrophil count decreased 25.93 14.91 4 42905 46022 50516193
Rhinorrhoea 25.84 14.91 6 42903 51577 50510638
Insomnia 25.80 14.91 70 42839 174795 50387420
Paraesthesia 25.52 14.91 39 42870 120204 50442011
Sepsis 25.24 14.91 196 42713 132729 50429486
Atrial flutter 25.15 14.91 34 42875 8729 50553486
Petechiae 25.05 14.91 41 42868 12471 50549744
Oesophageal pain 24.99 14.91 20 42889 2782 50559433
Peritonitis 24.81 14.91 46 42863 15440 50546775
Gastric ulcer 24.32 14.91 55 42854 21250 50540965
Ill-defined disorder 24.31 14.91 8 42901 54646 50507569
Basal ganglia haemorrhage 24.24 14.91 11 42898 539 50561676
Conjunctival haemorrhage 23.54 14.91 20 42889 3024 50559191
Duodenal ulcer perforation 23.46 14.91 5 42904 45606 50516609
Myocardial infarction 23.26 14.91 142 42767 88885 50473330
Intestinal infarction 23.19 14.91 13 42896 999 50561216
Suicidal ideation 23.11 14.91 9 42900 55376 50506839
Arterial haemorrhage 22.78 14.91 15 42894 1542 50560673
Haemoglobin abnormal 22.52 14.91 23 42886 4389 50557826
Thrombotic stroke 22.19 14.91 10 42899 482 50561733
Cardiogenic shock 22.12 14.91 44 42865 15555 50546660
Off label use 22.11 14.91 277 42632 474149 50088066
Gastrointestinal necrosis 22.02 14.91 18 42891 2580 50559635
Prothrombin time 21.96 14.91 5 42904 22 50562193
Hypoaesthesia 21.89 14.91 47 42862 127210 50435005
Syncope 21.89 14.91 156 42753 102846 50459369
Psoriasis 21.78 14.91 16 42893 68984 50493231
Prothrombin level decreased 21.69 14.91 10 42899 508 50561707
Pain in extremity 21.64 14.91 139 42770 272726 50289489
Infarction 21.58 14.91 17 42892 2311 50559904
Osteoarthritis 21.54 14.91 16 42893 68590 50493625
Haemorrhoids 21.54 14.91 49 42860 19004 50543211
Haemorrhagic arteriovenous malformation 21.42 14.91 7 42902 138 50562077
Influenza like illness 21.37 14.91 11 42898 57448 50504767
Abdominal wall haematoma 21.36 14.91 18 42891 2690 50559525
Haemodynamic instability 21.32 14.91 30 42879 7994 50554221
Gastritis 21.30 14.91 69 42840 32914 50529301
Lacunar infarction 21.28 14.91 19 42890 3068 50559147
Weight decreased 21.16 14.91 106 42803 221139 50341076
Injection site bruising 21.16 14.91 3 42906 36765 50525450
Occult blood 21.07 14.91 13 42896 1194 50561021
Haemorrhagic diathesis 20.91 14.91 21 42888 3927 50558288
Cardiac failure chronic 20.83 14.91 20 42889 3543 50558672
Haemorrhage urinary tract 20.60 14.91 11 42898 768 50561447
Cerebellar haemorrhage 20.53 14.91 13 42896 1250 50560965
Acute coronary syndrome 20.52 14.91 32 42877 9342 50552873
COVID-19 20.45 14.91 7 42902 46655 50515560
Therapy non-responder 20.15 14.91 9 42900 51013 50511202
Urticaria 19.76 14.91 51 42858 129510 50432705
Embolism arterial 19.67 14.91 11 42898 842 50561373
Renal infarct 19.65 14.91 13 42896 1347 50560868
Post procedural haematuria 19.64 14.91 5 42904 38 50562177
Multiple sclerosis relapse 19.62 14.91 6 42903 42958 50519257
Arthritis 19.51 14.91 27 42882 86694 50475521
Thrombotic cerebral infarction 19.41 14.91 6 42903 98 50562117
Splenic haematoma 19.35 14.91 6 42903 99 50562116
Type 2 diabetes mellitus 19.33 14.91 3 42906 34372 50527843
Activated partial thromboplastin time 19.29 14.91 4 42905 10 50562205
Cardioversion 19.15 14.91 12 42897 1133 50561082
Rib fracture 19.09 14.91 47 42862 19174 50543041
Malignant neoplasm progression 18.79 14.91 18 42891 68106 50494109
Nasal congestion 18.69 14.91 10 42899 51110 50511105
Sleep disorder 18.45 14.91 13 42896 57270 50504945
Blood creatinine increased 18.35 14.91 119 42790 76041 50486174
Duodenal ulcer haemorrhage 18.34 14.91 15 42894 2151 50560064
Abdominal incarcerated hernia 18.22 14.91 3 42906 0 50562215
Glomerular filtration rate 18.22 14.91 3 42906 0 50562215
Aortic thrombosis 18.15 14.91 11 42898 978 50561237
Diverticulitis intestinal haemorrhagic 18.14 14.91 6 42903 123 50562092
Arteriovenous malformation 18.11 14.91 12 42897 1246 50560969
Oesophagitis 18.09 14.91 37 42872 13346 50548869
Herpes zoster 18.06 14.91 20 42889 70766 50491449
Haemorrhagic disorder 17.98 14.91 10 42899 757 50561458
Rectal perforation 17.92 14.91 8 42901 377 50561838
Extradural haematoma 17.83 14.91 13 42896 1574 50560641
Cardiac ablation 17.80 14.91 12 42897 1282 50560933
Brain stem stroke 17.80 14.91 7 42902 239 50561976
Musculoskeletal pain 17.76 14.91 21 42888 72156 50490059
Gastric cancer 17.75 14.91 17 42892 3001 50559214
Spontaneous haematoma 17.75 14.91 10 42899 776 50561439
Loss of personal independence in daily activities 17.65 14.91 20 42889 70030 50492185
Abdominal wall haemorrhage 17.45 14.91 6 42903 139 50562076
Migraine 17.37 14.91 23 42886 75257 50486958
Abdominal discomfort 17.35 14.91 120 42789 231521 50330694
Internal haemorrhage 17.25 14.91 20 42889 4397 50557818
Blood cholesterol increased 17.17 14.91 13 42896 55202 50507013
Dysarthria 17.15 14.91 70 42839 37333 50524882
Blister 16.91 14.91 29 42880 85389 50476826
Vomiting 16.89 14.91 282 42627 460476 50101739
Rectal ulcer 16.87 14.91 11 42898 1112 50561103
Neurologic neglect syndrome 16.51 14.91 12 42897 1446 50560769
Sedation 16.49 14.91 3 42906 30607 50531608
Hospitalisation 16.46 14.91 20 42889 67917 50494298
Carotid artery occlusion 16.46 14.91 15 42894 2488 50559727
Spinal cord haematoma 16.45 14.91 6 42903 166 50562049
Bradycardia 16.35 14.91 102 42807 64324 50497891
Blood pressure increased 16.30 14.91 58 42851 133074 50429141
Hypertensive crisis 16.19 14.91 35 42874 13119 50549096
Mucosal inflammation 15.98 14.91 7 42902 40135 50522080
Brain stem haemorrhage 15.71 14.91 9 42900 721 50561494
C-reactive protein increased 15.66 14.91 20 42889 66454 50495761
Hot flush 15.63 14.91 9 42900 44160 50518055
Red blood cell sedimentation rate increased 15.59 14.91 3 42906 29413 50532802
Erosive oesophagitis 15.59 14.91 12 42897 1577 50560638
Arterial thrombosis 15.59 14.91 11 42898 1266 50560949
Thoracic haemorrhage 15.53 14.91 4 42905 32 50562183
Inappropriate schedule of product administration 15.53 14.91 23 42886 71808 50490407
Pallor 15.40 14.91 49 42860 23150 50539065
Cerebral artery thrombosis 15.37 14.91 7 42902 346 50561869
Facial paresis 15.31 14.91 16 42893 3136 50559079
Leukopenia 15.21 14.91 21 42888 67507 50494708
Muscle spasms 15.17 14.91 55 42854 125498 50436717
Bronchitis 15.13 14.91 42 42867 104117 50458098
Depressed mood 15.09 14.91 5 42904 34018 50528197
Polyp 15.08 14.91 21 42888 5541 50556674
Tachyarrhythmia 15.06 14.91 18 42891 4087 50558128
Globulins decreased 15.01 14.91 6 42903 214 50562001
Tongue haemorrhage 14.96 14.91 7 42902 368 50561847
Phlebitis deep 14.93 14.91 3 42906 6 50562209

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 2759.11 14.05 1681 47208 77852 29447786
Ischaemic stroke 2320.66 14.05 903 47986 15074 29510564
Cerebrovascular accident 1676.00 14.05 1219 47670 75692 29449946
Haemorrhage 1093.74 14.05 764 48125 44308 29481330
Haemorrhage intracranial 862.02 14.05 439 48450 14103 29511535
Cerebral infarction 816.23 14.05 508 48381 24167 29501471
Rectal haemorrhage 815.07 14.05 576 48313 33973 29491665
Cerebral haemorrhage 755.28 14.05 530 48359 30896 29494742
Melaena 738.11 14.05 521 48368 30655 29494983
Embolic stroke 627.62 14.05 233 48656 3373 29522265
Atrial thrombosis 620.79 14.05 199 48690 1794 29523844
Subdural haematoma 599.99 14.05 374 48515 17819 29507819
Cardiac tamponade 584.53 14.05 237 48652 4398 29521240
Haematuria 433.99 14.05 445 48444 43694 29481944
Fall 408.17 14.05 901 47988 176277 29349361
Activated partial thromboplastin time prolonged 387.94 14.05 209 48680 7533 29518105
Transient ischaemic attack 378.22 14.05 311 48578 22959 29502679
Lower gastrointestinal haemorrhage 362.74 14.05 204 48685 8009 29517629
Shock haemorrhagic 329.04 14.05 202 48687 9349 29516289
Hemiparesis 303.42 14.05 225 48664 14261 29511377
Upper gastrointestinal haemorrhage 265.75 14.05 248 48641 21666 29503972
Procoagulant therapy 247.63 14.05 47 48842 7 29525631
Blood loss anaemia 240.93 14.05 150 48739 7116 29518522
Coagulopathy 217.76 14.05 203 48686 17704 29507934
Haematoma 213.48 14.05 226 48663 22986 29502652
Subarachnoid haemorrhage 210.72 14.05 154 48735 9538 29516100
Thrombin time prolonged 207.65 14.05 50 48839 126 29525512
Haemorrhagic stroke 207.16 14.05 126 48763 5730 29519908
Pericardial haemorrhage 204.63 14.05 99 48790 2832 29522806
Pulmonary embolism 180.83 14.05 394 48495 76140 29449498
Aphasia 178.44 14.05 188 48701 19010 29506628
Haemothorax 178.37 14.05 95 48794 3341 29522297
Deep vein thrombosis 173.03 14.05 327 48562 57072 29468566
Aortic dissection 164.85 14.05 80 48809 2304 29523334
Haematemesis 156.16 14.05 198 48691 24428 29501210
Hemiplegia 152.98 14.05 109 48780 6485 29519153
Toxicity to various agents 145.10 14.05 53 48836 173608 29352030
Head injury 143.28 14.05 154 48735 15927 29509711
Haemorrhagic transformation stroke 141.68 14.05 60 48829 1246 29524392
Epistaxis 139.30 14.05 281 48608 51423 29474215
Febrile neutropenia 138.29 14.05 13 48876 112227 29413411
Procedural haemorrhage 132.43 14.05 68 48821 2215 29523423
Completed suicide 130.92 14.05 4 48885 90242 29435396
Neutropenia 128.63 14.05 30 48859 131681 29393957
Pyrexia 125.48 14.05 176 48713 287446 29238192
Anaemia 116.86 14.05 646 48243 200305 29325333
Intracardiac thrombus 115.04 14.05 62 48827 2233 29523405
Haematochezia 114.24 14.05 213 48676 36770 29488868
Haemoptysis 113.79 14.05 191 48698 30359 29495279
Cerebral haematoma 113.68 14.05 77 48812 4219 29521419
Subdural haemorrhage 113.29 14.05 66 48823 2769 29522869
Intestinal haemorrhage 105.69 14.05 65 48824 3014 29522624
International normalised ratio increased 105.31 14.05 229 48660 44143 29481495
Brain contusion 104.50 14.05 41 48848 694 29524944
Cardiac failure 100.68 14.05 324 48565 78963 29446675
Peripheral embolism 99.04 14.05 43 48846 951 29524687
Drug abuse 99.03 14.05 9 48880 79874 29445764
Product dose omission issue 98.02 14.05 20 48869 96363 29429275
Post procedural haemorrhage 97.01 14.05 88 48801 7403 29518235
Pericardial effusion 96.04 14.05 145 48744 21063 29504575
Colon cancer 91.52 14.05 86 48803 7569 29518069
Fatigue 88.14 14.05 252 48637 316569 29209069
Oesophageal pain 82.81 14.05 35 48854 723 29524915
Gastric haemorrhage 79.24 14.05 87 48802 9210 29516428
Disease progression 79.24 14.05 19 48870 81897 29443741
Large intestinal haemorrhage 76.34 14.05 41 48848 1466 29524172
Renal impairment 75.51 14.05 300 48589 81033 29444605
Anticoagulation drug level increased 75.35 14.05 29 48860 465 29525173
Road traffic accident 74.18 14.05 109 48780 15452 29510186
Hypovolaemic shock 74.09 14.05 69 48820 6003 29519635
Pain 73.48 14.05 106 48783 171326 29354312
Pancytopenia 71.72 14.05 24 48865 83144 29442494
Faeces discoloured 71.72 14.05 99 48790 13252 29512386
Product use in unapproved indication 69.97 14.05 28 48861 86847 29438791
Traumatic intracranial haemorrhage 68.84 14.05 29 48860 594 29525044
Drug hypersensitivity 67.88 14.05 15 48874 68391 29457247
Depression 67.67 14.05 28 48861 85119 29440519
Pulmonary haemorrhage 67.58 14.05 80 48809 9190 29516448
Extradural haematoma 67.22 14.05 34 48855 1072 29524566
Rash 66.10 14.05 134 48755 189685 29335953
Cerebral artery occlusion 65.66 14.05 29 48860 669 29524969
Diarrhoea 65.19 14.05 306 48583 332392 29193246
Nausea 64.64 14.05 253 48636 289002 29236636
Leukopenia 63.85 14.05 8 48881 55195 29470443
Intraventricular haemorrhage 62.75 14.05 46 48843 2860 29522778
Dyspepsia 62.01 14.05 147 48742 29978 29495660
Embolism 61.33 14.05 66 48823 6830 29518808
Haemorrhagic infarction 61.18 14.05 24 48865 406 29525232
Coagulation test abnormal 61.12 14.05 25 48864 474 29525164
Blood urine present 61.12 14.05 78 48811 9677 29515961
Contusion 61.08 14.05 149 48740 30946 29494692
White blood cell count decreased 60.67 14.05 31 48858 83331 29442307
Urinary bladder haemorrhage 59.91 14.05 36 48853 1600 29524038
Gingival bleeding 57.81 14.05 62 48827 6391 29519247
Wound secretion 57.36 14.05 40 48849 2298 29523340
Tremor 57.12 14.05 25 48864 73513 29452125
Aortic aneurysm rupture 56.94 14.05 29 48860 928 29524710
Off label use 56.35 14.05 281 48608 300519 29225119
Cerebral mass effect 56.24 14.05 28 48861 853 29524785
Splenic rupture 56.03 14.05 33 48856 1413 29524225
Coagulation time prolonged 55.97 14.05 31 48858 1179 29524459
Embolic cerebral infarction 55.54 14.05 25 48864 604 29525034
Skull fracture 54.95 14.05 27 48862 799 29524839
Traumatic haemorrhage 54.35 14.05 25 48864 636 29525002
Anorectal discomfort 52.58 14.05 33 48856 1586 29524052
Activated partial thromboplastin time abnormal 51.76 14.05 14 48875 64 29525574
Surgery 51.15 14.05 79 48810 11700 29513938
Chills 49.70 14.05 28 48861 71272 29454366
Infusion related reaction 49.22 14.05 7 48882 43879 29481759
Cerebral artery embolism 48.94 14.05 25 48864 805 29524833
Insomnia 48.65 14.05 45 48844 88716 29436922
Condition aggravated 48.60 14.05 106 48783 146189 29379449
Neuropathy peripheral 47.94 14.05 29 48860 70998 29454640
Creatinine renal clearance decreased 47.62 14.05 40 48849 3034 29522604
Embolism arterial 47.57 14.05 21 48868 484 29525154
Renal failure 46.26 14.05 345 48544 118254 29407384
Traumatic haemothorax 45.76 14.05 17 48872 246 29525392
Vomiting 45.22 14.05 189 48700 212071 29313567
Thrombosis 45.02 14.05 165 48724 42880 29482758
Intentional product use issue 44.91 14.05 8 48881 42490 29483148
Anxiety 44.78 14.05 45 48844 85320 29440318
Arthralgia 44.06 14.05 104 48785 139513 29386125
Strangulated hernia 43.50 14.05 9 48880 7 29525631
Cardiac ablation 43.45 14.05 22 48867 695 29524943
Weight increased 43.05 14.05 38 48851 76629 29449009
Haemoglobin decreased 42.68 14.05 316 48573 108059 29417579
Intra-abdominal haemorrhage 42.63 14.05 32 48857 2063 29523575
Product use issue 42.36 14.05 16 48873 51428 29474210
Incarcerated hernia 41.92 14.05 14 48875 145 29525493
Muscle spasms 40.63 14.05 29 48860 65053 29460585
Neutrophil count decreased 40.39 14.05 11 48878 43556 29482082
Haemorrhoidal haemorrhage 40.03 14.05 36 48853 2993 29522645
Malignant neoplasm progression 39.81 14.05 38 48851 73821 29451817
Retroperitoneal haemorrhage 39.44 14.05 33 48856 2490 29523148
Cerebellar haemorrhage 39.01 14.05 26 48863 1386 29524252
Agitation 38.96 14.05 18 48871 51286 29474352
Acute abdomen 38.50 14.05 28 48861 1719 29523919
Basal ganglia haemorrhage 38.49 14.05 21 48868 775 29524863
Mucosal inflammation 37.98 14.05 4 48885 31591 29494047
Thrombin time abnormal 37.85 14.05 7 48882 0 29525638
Mouth haemorrhage 37.76 14.05 43 48846 4737 29520901
Oesophageal ulcer 37.19 14.05 35 48854 3085 29522553
Acute kidney injury 36.80 14.05 629 48260 264638 29261000
International normalised ratio abnormal 36.78 14.05 34 48855 2929 29522709
Drug intolerance 36.69 14.05 17 48872 48362 29477276
Alanine aminotransferase increased 36.52 14.05 38 48851 70906 29454732
Rheumatoid arthritis 36.36 14.05 5 48884 32147 29493491
Renal infarct 36.12 14.05 23 48866 1134 29524504
Multiple injuries 35.93 14.05 27 48862 1743 29523895
Dysarthria 35.32 14.05 122 48767 30789 29494849
Ischaemia 35.17 14.05 39 48850 4173 29521465
Seizure 34.74 14.05 63 48826 93060 29432578
Erythema 34.08 14.05 45 48844 75561 29450077
Coagulation time shortened 33.92 14.05 13 48876 206 29525432
Haemorrhage urinary tract 33.86 14.05 25 48864 1571 29524067
Pulmonary alveolar haemorrhage 33.79 14.05 47 48842 6333 29519305
Platelet count decreased 33.78 14.05 77 48812 104595 29421043
Cardiac valve replacement complication 33.66 14.05 9 48880 39 29525599
Intracranial haematoma 33.45 14.05 15 48874 359 29525279
International normalised ratio 32.95 14.05 9 48880 43 29525595
C-reactive protein increased 32.88 14.05 16 48873 44247 29481391
Heart transplant 32.74 14.05 19 48870 791 29524847
Femoral neck fracture 32.56 14.05 31 48858 2772 29522866
Activated partial thromboplastin time 32.44 14.05 6 48883 0 29525638
Creatinine renal clearance 32.44 14.05 6 48883 0 29525638
Cardioversion 32.12 14.05 19 48870 820 29524818
Cough 32.08 14.05 105 48784 126622 29399016
Somnolence 32.06 14.05 67 48822 93888 29431750
Femur fracture 31.92 14.05 48 48841 6943 29518695
Large intestine polyp 31.60 14.05 46 48843 6463 29519175
Haemorrhage subcutaneous 31.58 14.05 27 48862 2098 29523540
Stomatitis 31.47 14.05 11 48878 37102 29488536
Blood creatine phosphokinase increased 31.26 14.05 14 48875 40630 29485008
Joint swelling 31.12 14.05 22 48867 49608 29476030
Wound haemorrhage 31.11 14.05 25 48864 1782 29523856
Gastrointestinal motility disorder 31.07 14.05 27 48862 2145 29523493
Hemianopia 30.95 14.05 17 48872 636 29525002
Injection site pain 30.44 14.05 8 48881 32438 29493200
Neurologic neglect syndrome 30.41 14.05 11 48878 147 29525491
Acute myocardial infarction 30.21 14.05 159 48730 48279 29477359
Gastrointestinal carcinoma 30.16 14.05 21 48868 1203 29524435
Elderly 30.01 14.05 6 48883 3 29525635
Craniocerebral injury 29.67 14.05 29 48860 2679 29522959
Nasopharyngitis 29.54 14.05 33 48856 59632 29466006
Gastric cancer 29.50 14.05 38 48851 4756 29520882
Arterial thrombosis 29.47 14.05 22 48867 1406 29524232
Aggression 29.35 14.05 11 48878 35530 29490108
Iron deficiency anaemia 28.20 14.05 52 48837 8890 29516748
Weight decreased 28.13 14.05 141 48748 150764 29374874
Thrombotic stroke 27.99 14.05 12 48877 257 29525381
Oesophageal carcinoma 27.92 14.05 36 48853 4511 29521127
Drug ineffective 27.83 14.05 428 48461 362742 29162896
Cardiac perforation 27.78 14.05 9 48880 84 29525554
Blood glucose increased 27.73 14.05 34 48855 58950 29466688
Appendicitis 27.62 14.05 51 48838 8728 29516910
White blood cell count increased 27.20 14.05 14 48875 37502 29488136
Lumbar puncture 27.14 14.05 9 48880 91 29525547
Infarction 26.62 14.05 26 48863 2400 29523238
Psoriasis 26.56 14.05 10 48879 32217 29493421
Intestinal ischaemia 26.45 14.05 43 48846 6649 29518989
Diverticulum intestinal haemorrhagic 26.26 14.05 24 48865 2038 29523600
Prothrombin time prolonged 26.16 14.05 50 48839 8782 29516856
Rib fracture 26.09 14.05 62 48827 12656 29512982
Ascites 26.06 14.05 14 48875 36605 29489033
Infection 25.96 14.05 55 48834 76696 29448942
Cerebral ischaemia 25.81 14.05 39 48850 5664 29519974
Ecchymosis 25.71 14.05 41 48848 6239 29519399
Musculoskeletal stiffness 25.68 14.05 15 48874 37443 29488195
Peripheral artery thrombosis 25.67 14.05 24 48865 2098 29523540
Mesenteric artery embolism 25.57 14.05 8 48881 66 29525572
Asthma 25.50 14.05 12 48877 33837 29491801
Anaphylactic reaction 25.48 14.05 7 48882 27566 29498072
Aspartate aminotransferase increased 25.46 14.05 37 48852 59688 29465950
Cerebellar infarction 25.03 14.05 22 48867 1775 29523863
Pulmonary contusion 24.89 14.05 7 48882 38 29525600
Hyperhidrosis 24.66 14.05 43 48846 64497 29461141
Sinusitis 24.64 14.05 13 48876 34337 29491301
Hemianopia homonymous 24.41 14.05 15 48874 694 29524944
Back pain 24.34 14.05 87 48802 102197 29423441
Gastric ulcer haemorrhage 24.25 14.05 35 48854 4879 29520759
Feeling abnormal 23.93 14.05 33 48856 54412 29471226
Rhabdomyolysis 23.70 14.05 40 48849 60768 29464870
Herpes zoster 23.67 14.05 10 48879 30042 29495596
Cholecystitis acute 23.55 14.05 36 48853 5283 29520355
Injury 23.37 14.05 77 48812 18969 29506669
Abnormal behaviour 23.07 14.05 5 48884 23122 29502516
Thrombocytopenia 22.88 14.05 130 48759 134693 29390945
Stress 22.80 14.05 4 48885 21486 29504152
Electrocardiogram QT prolonged 22.68 14.05 16 48873 36121 29489517
Brain herniation 22.67 14.05 29 48860 3604 29522034
Catheter site haemorrhage 22.56 14.05 22 48867 2026 29523612
Urticaria 22.19 14.05 35 48854 54625 29471013
Hospitalisation 22.15 14.05 26 48863 45962 29479676
Peripheral swelling 22.12 14.05 45 48844 63694 29461944
Arteriovenous malformation 22.04 14.05 14 48875 687 29524951
Diabetes mellitus 22.03 14.05 20 48869 39811 29485827
Post procedural stroke 21.91 14.05 6 48883 29 29525609
Irritability 21.67 14.05 5 48884 22147 29503491
Cerebral vascular occlusion 21.63 14.05 4 48885 0 29525638
Therapeutic response decreased 21.51 14.05 7 48882 24704 29500934
Aneurysm ruptured 21.30 14.05 12 48877 472 29525166
Colon neoplasm 21.26 14.05 11 48878 364 29525274
Vision blurred 21.26 14.05 21 48868 40155 29485483
Myalgia 21.10 14.05 58 48831 73961 29451677
Skin haemorrhage 21.09 14.05 28 48861 3609 29522029
Subcutaneous haematoma 21.09 14.05 15 48874 889 29524749
Pneumonitis 21.03 14.05 10 48879 28034 29497604
Oxygen saturation decreased 21.01 14.05 26 48863 44911 29480727
Haemoglobin abnormal 20.95 14.05 26 48863 3135 29522503
Haemorrhoids 20.93 14.05 54 48835 11603 29514035
Subarachnoid haematoma 20.83 14.05 7 48882 74 29525564
Dyskinesia 20.71 14.05 4 48885 20057 29505581
Thalamus haemorrhage 20.68 14.05 15 48874 917 29524721
Renal haemorrhage 20.59 14.05 17 48872 1259 29524379
Incarcerated inguinal hernia 20.26 14.05 7 48882 81 29525557
Rectal cancer 20.24 14.05 20 48869 1872 29523766
Gastric ulcer 20.16 14.05 60 48829 14001 29511637
Traumatic haematoma 19.88 14.05 13 48876 671 29524967
Venous thrombosis 19.87 14.05 25 48864 3057 29522581
Coronary artery embolism 19.84 14.05 8 48881 146 29525492
Ischaemic cerebral infarction 19.67 14.05 15 48874 990 29524648
Gastrointestinal angiodysplasia 19.61 14.05 12 48877 551 29525087
Dry skin 19.60 14.05 7 48882 23300 29502338
Arterial injury 19.52 14.05 10 48879 324 29525314
Haemodynamic instability 19.51 14.05 42 48847 8031 29517607
Influenza like illness 19.50 14.05 8 48881 24462 29501176
Productive cough 19.41 14.05 14 48875 31245 29494393
Aortic aneurysm 19.40 14.05 36 48853 6184 29519454
Loss of personal independence in daily activities 19.19 14.05 9 48880 25431 29500207
Pneumonia 19.17 14.05 394 48495 319778 29205860
Exsanguination 19.12 14.05 6 48883 50 29525588
Cardiac pacemaker insertion 19.07 14.05 22 48867 2457 29523181
Therapy non-responder 18.99 14.05 14 48875 30897 29494741
Urogenital haemorrhage 18.51 14.05 11 48878 479 29525159
Pain in extremity 18.45 14.05 107 48782 110326 29415312
Cataract 18.35 14.05 7 48882 22371 29503267
Intestinal infarction 18.16 14.05 11 48878 496 29525142
Puncture site haemorrhage 18.14 14.05 9 48880 272 29525366
Factor V deficiency 18.12 14.05 5 48884 25 29525613
Drug reaction with eosinophilia and systemic symptoms 18.09 14.05 12 48877 27980 29497658
Pruritus 18.07 14.05 116 48773 116733 29408905
Hypersensitivity 17.80 14.05 38 48851 52865 29472773
Diverticulum 17.72 14.05 35 48854 6297 29519341
Angioedema 17.68 14.05 16 48873 31899 29493739
Osteonecrosis of jaw 17.67 14.05 3 48886 16507 29509131
Lymphocyte count decreased 17.61 14.05 5 48884 19266 29506372
Mesenteric haemorrhage 17.59 14.05 4 48885 7 29525631
Shock 17.50 14.05 76 48813 21328 29504310
Haemoperitoneum 17.44 14.05 17 48872 1565 29524073
Blood pressure increased 17.40 14.05 63 48826 73740 29451898
Splenic injury 17.35 14.05 5 48884 30 29525608
Colitis ischaemic 17.29 14.05 33 48856 5790 29519848
Prothrombin time shortened 17.27 14.05 16 48873 1382 29524256
Hyponatraemia 17.12 14.05 56 48833 67577 29458061
Cerebral thrombosis 17.06 14.05 13 48876 857 29524781
Gait disturbance 17.04 14.05 63 48826 73286 29452352
Thrombotic cerebral infarction 16.93 14.05 9 48880 315 29525323
Orthopaedic procedure 16.93 14.05 4 48885 9 29525629
Hyperglycaemia 16.93 14.05 19 48870 34268 29491370
Diverticulitis intestinal haemorrhagic 16.75 14.05 9 48880 322 29525316
Inappropriate schedule of product administration 16.65 14.05 30 48859 44442 29481196
Peripheral ischaemia 16.44 14.05 30 48859 5089 29520549
Blood cholesterol increased 16.33 14.05 3 48886 15592 29510046
Abdominal discomfort 16.24 14.05 135 48754 47768 29477870
Inguinal hernia strangulated 16.22 14.05 3 48886 0 29525638
Anti factor VIII antibody test 16.22 14.05 3 48886 0 29525638
Occult blood positive 16.20 14.05 25 48864 3699 29521939
Small intestinal haemorrhage 16.19 14.05 18 48871 1931 29523707
Eye haemorrhage 16.14 14.05 25 48864 3711 29521927
Right hemisphere deficit syndrome 16.10 14.05 4 48885 12 29525626
Pneumocystis jirovecii pneumonia 16.00 14.05 4 48885 16775 29508863
Hallucination 16.00 14.05 31 48858 44681 29480957
Influenza 15.90 14.05 28 48861 41853 29483785
Muscle strain 15.76 14.05 24 48865 3509 29522129
Arthropathy 15.69 14.05 8 48881 21546 29504092
Aortic dissection rupture 15.63 14.05 4 48885 14 29525624
Microcytic anaemia 15.59 14.05 18 48871 2013 29523625
Internal haemorrhage 15.57 14.05 27 48862 4400 29521238
Encephalopathy 15.55 14.05 17 48872 31026 29494612
Confusional state 15.47 14.05 136 48753 127741 29397897
Gastritis erosive 15.32 14.05 30 48859 5363 29520275
Intentional product misuse 15.23 14.05 21 48868 34640 29490998
Microvillous inclusion disease 15.22 14.05 5 48884 49 29525589
Serotonin syndrome 15.17 14.05 5 48884 17507 29508131
Tachycardia 15.04 14.05 65 48824 72345 29453293
Sleep disorder 15.03 14.05 11 48878 24375 29501263
Hypertension 15.01 14.05 122 48767 116492 29409146
Thoracic haemorrhage 14.94 14.05 7 48882 186 29525452
Upper respiratory tract infection 14.81 14.05 14 48875 27335 29498303
Conjunctival haemorrhage 14.77 14.05 20 48869 2628 29523010
Bone pain 14.75 14.05 6 48883 18446 29507192
Post procedural pulmonary embolism 14.66 14.05 4 48885 19 29525619
Myocardial infarction 14.66 14.05 260 48629 110036 29415602
Lymphadenopathy 14.55 14.05 12 48877 25037 29500601
Abdominal strangulated hernia 14.49 14.05 4 48885 20 29525618
Ulcer haemorrhage 14.48 14.05 19 48870 2422 29523216
Laboratory test abnormal 14.40 14.05 6 48883 18179 29507459
Toxic epidermal necrolysis 14.36 14.05 6 48883 18147 29507491
Hip fracture 14.31 14.05 44 48845 10448 29515190
Cerebellar haematoma 14.31 14.05 7 48882 205 29525433
Suicidal ideation 14.31 14.05 22 48867 34694 29490944
Meningorrhagia 14.19 14.05 6 48883 124 29525514
Feeling hot 14.18 14.05 4 48885 15484 29510154
Blood lactate dehydrogenase increased 14.18 14.05 7 48882 19202 29506436
Dysphagia 14.18 14.05 146 48743 54780 29470858
NIH stroke scale abnormal 14.15 14.05 3 48886 3 29525635
Carotid artery occlusion 14.14 14.05 17 48872 1984 29523654
Oesophageal irritation 14.09 14.05 5 48884 63 29525575

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 4489.86 13.68 2409 69911 129903 64296509
Ischaemic stroke 3903.79 13.68 1398 70922 27637 64398775
Cerebrovascular accident 1960.38 13.68 1448 70872 136135 64290277
Melaena 1427.26 13.68 835 71485 52713 64373699
Haemorrhage 1391.47 13.68 949 71371 78402 64348010
Rectal haemorrhage 1361.72 13.68 853 71467 60964 64365448
Haemorrhage intracranial 1344.71 13.68 616 71704 23268 64403144
Cerebral haemorrhage 1249.98 13.68 754 71566 50336 64376076
Cerebral infarction 1202.75 13.68 681 71639 40363 64386049
Cardiac tamponade 968.22 13.68 359 71961 7805 64418607
Subdural haematoma 882.86 13.68 488 71832 27566 64398846
Embolic stroke 843.41 13.68 308 72012 6403 64420009
Lower gastrointestinal haemorrhage 751.37 13.68 349 71971 13590 64412822
Atrial thrombosis 733.90 13.68 228 72092 2814 64423598
Activated partial thromboplastin time prolonged 706.37 13.68 326 71994 12505 64413907
Shock haemorrhagic 646.05 13.68 334 71986 16457 64409955
Haematuria 606.53 13.68 519 71801 59952 64366460
Fall 562.34 13.68 1357 70963 415469 64010943
Upper gastrointestinal haemorrhage 504.84 13.68 373 71947 34847 64391565
Transient ischaemic attack 475.43 13.68 395 71925 43787 64382625
Hemiparesis 457.21 13.68 329 71991 29498 64396914
Coagulopathy 439.45 13.68 330 71990 31590 64394822
Haematoma 431.43 13.68 381 71939 45869 64380543
Blood loss anaemia 421.38 13.68 236 72084 13656 64412756
Haemorrhagic stroke 414.84 13.68 209 72111 9742 64416670
Subarachnoid haemorrhage 399.19 13.68 252 72068 18186 64408226
Pericardial haemorrhage 362.39 13.68 146 72174 3990 64422422
Haematemesis 343.42 13.68 338 71982 46661 64379751
Thrombin time prolonged 337.52 13.68 77 72243 240 64426172
Haematochezia 334.44 13.68 392 71928 65981 64360431
Anaemia 287.85 13.68 1005 71315 377675 64048737
Aortic dissection 265.48 13.68 111 72209 3341 64423071
International normalised ratio increased 254.68 13.68 375 71945 78792 64347620
Pulmonary embolism 245.87 13.68 521 71799 145835 64280577
Haemothorax 244.68 13.68 116 72204 4726 64421686
Pain 238.49 13.68 165 72155 553346 63873066
Hemiplegia 235.85 13.68 158 72162 12610 64413802
Aphasia 232.08 13.68 257 72063 40649 64385763
Completed suicide 231.49 13.68 4 72316 224410 64202002
Procoagulant therapy 227.85 13.68 41 72279 11 64426401
Deep vein thrombosis 223.15 13.68 413 71907 104769 64321643
Intestinal haemorrhage 221.60 13.68 113 72207 5401 64421011
Cerebral haematoma 220.41 13.68 123 72197 7062 64419350
Subdural haemorrhage 211.15 13.68 108 72212 5195 64421217
Hypovolaemic shock 206.52 13.68 134 72186 10132 64416280
Cardiac failure 195.96 13.68 448 71872 131925 64294487
Epistaxis 194.10 13.68 374 71946 97757 64328655
Haemoptysis 192.98 13.68 256 72064 48792 64377620
Procedural haemorrhage 185.14 13.68 92 72228 4160 64422252
Drug hypersensitivity 182.88 13.68 25 72295 237790 64188622
Head injury 177.14 13.68 201 72119 32641 64393771
Fatigue 173.76 13.68 363 71957 748367 63678045
Toxicity to various agents 170.58 13.68 98 72222 363415 64062997
Pyrexia 170.09 13.68 227 72093 558417 63867995
Peripheral embolism 169.82 13.68 67 72253 1730 64424682
Haemoglobin decreased 162.96 13.68 535 71785 194528 64231884
Renal failure 162.38 13.68 510 71810 181178 64245234
Febrile neutropenia 158.74 13.68 14 72306 187643 64238769
Acute kidney injury 155.92 13.68 947 71373 448293 63978119
Arthralgia 152.31 13.68 163 72157 442097 63984315
Renal impairment 151.34 13.68 411 71909 134606 64291806
Post procedural haemorrhage 148.07 13.68 118 72202 12313 64414099
Haemorrhagic transformation stroke 144.99 13.68 65 72255 2324 64424088
Faeces discoloured 143.06 13.68 160 72160 25569 64400843
Rash 139.78 13.68 186 72134 458363 63968049
Neutropenia 136.63 13.68 49 72271 239575 64186837
Gastric haemorrhage 135.58 13.68 116 72204 13365 64413047
Cerebral artery occlusion 134.71 13.68 55 72265 1556 64424856
Pericardial effusion 132.04 13.68 190 72130 39064 64387348
Infusion related reaction 131.97 13.68 15 72305 164452 64261960
Rheumatoid arthritis 131.79 13.68 15 72305 164279 64262133
Anticoagulation drug level increased 131.23 13.68 43 72277 636 64425776
Brain contusion 123.44 13.68 48 72272 1191 64425221
Joint swelling 122.85 13.68 44 72276 215338 64211074
Nausea 122.70 13.68 461 71859 785339 63641073
Large intestinal haemorrhage 122.54 13.68 59 72261 2488 64423924
Traumatic haemorrhage 117.09 13.68 45 72275 1081 64425331
Drug intolerance 116.81 13.68 33 72287 187959 64238453
Product dose omission issue 109.00 13.68 41 72279 194706 64231706
Intracardiac thrombus 108.59 13.68 62 72258 3719 64422693
Drug interaction 106.80 13.68 733 71587 361350 64065062
Intraventricular haemorrhage 105.79 13.68 63 72257 4090 64422322
Pulmonary haemorrhage 104.58 13.68 99 72221 13010 64413402
Condition aggravated 100.76 13.68 164 72156 372262 64054150
Embolic cerebral infarction 99.75 13.68 40 72280 1079 64425333
Weight increased 99.26 13.68 58 72262 213290 64213122
Drug abuse 99.17 13.68 15 72305 132359 64294053
Nasopharyngitis 99.01 13.68 48 72272 196025 64230387
Coagulation time prolonged 98.09 13.68 48 72272 2098 64424314
Craniocerebral injury 97.74 13.68 60 72260 4116 64422296
Depression 95.43 13.68 43 72277 183248 64243164
Synovitis 93.89 13.68 4 72316 99086 64327326
Product use in unapproved indication 92.64 13.68 41 72279 176577 64249835
Traumatic intracranial haemorrhage 91.89 13.68 37 72283 1009 64425403
Colon cancer 91.83 13.68 91 72229 12648 64413764
Embolism 89.31 13.68 88 72232 12147 64414265
Anxiety 88.86 13.68 59 72261 202590 64223822
Gingival bleeding 88.86 13.68 96 72224 14758 64411654
Cerebral artery embolism 88.76 13.68 41 72279 1573 64424839
Product use issue 88.19 13.68 30 72290 151685 64274727
Splenic rupture 87.78 13.68 45 72275 2174 64424238
Hypersensitivity 87.77 13.68 56 72264 196396 64230016
Mouth haemorrhage 87.73 13.68 79 72241 9740 64416672
Arthropathy 87.71 13.68 15 72305 120952 64305460
Haemorrhoidal haemorrhage 87.38 13.68 63 72257 5656 64420756
Maternal exposure during pregnancy 87.24 13.68 5 72315 95879 64330533
Sinusitis 86.32 13.68 28 72292 145900 64280512
Activated partial thromboplastin time abnormal 82.61 13.68 24 72296 231 64426181
Injection site pain 82.59 13.68 13 72307 111395 64315017
Disease progression 80.66 13.68 29 72291 141651 64284761
Musculoskeletal stiffness 79.59 13.68 20 72300 123186 64303226
Cerebral mass effect 77.50 13.68 38 72282 1668 64424744
Extradural haematoma 77.17 13.68 44 72276 2632 64423780
Peripheral swelling 76.50 13.68 73 72247 209080 64217332
Cardiac valve replacement complication 76.36 13.68 22 72298 205 64426207
Strangulated hernia 76.29 13.68 17 72303 46 64426366
Alopecia 75.70 13.68 46 72274 165644 64260768
Road traffic accident 74.45 13.68 128 72192 30617 64395795
Therapeutic product effect decreased 73.98 13.68 19 72301 115332 64311080
Chills 73.34 13.68 31 72289 137233 64289179
Creatinine renal clearance decreased 72.26 13.68 85 72235 14336 64412076
Skull fracture 72.03 13.68 35 72285 1506 64424906
Thrombosis 71.17 13.68 207 72113 70435 64355977
Prothrombin time prolonged 71.07 13.68 88 72232 15653 64410759
Systemic lupus erythematosus 70.75 13.68 4 72316 77608 64348804
Intra-abdominal haemorrhage 69.94 13.68 48 72272 3983 64422429
Coagulation test abnormal 69.68 13.68 31 72289 1088 64425324
Diarrhoea 69.10 13.68 501 71819 722203 63704209
Stomatitis 68.50 13.68 19 72301 109586 64316826
Cerebral ischaemia 67.83 13.68 69 72251 9893 64416519
Dyspepsia 67.58 13.68 221 72099 80091 64346321
Aortic aneurysm rupture 67.51 13.68 31 72289 1173 64425239
Acute abdomen 67.18 13.68 41 72279 2783 64423629
Acute myocardial infarction 66.16 13.68 200 72120 69518 64356894
Cardiac perforation 65.70 13.68 18 72302 137 64426275
Vomiting 65.55 13.68 357 71963 550760 63875652
International normalised ratio abnormal 65.13 13.68 50 72270 4938 64421474
Blood urine present 64.94 13.68 91 72229 18249 64408163
Intentional product use issue 64.52 13.68 14 72306 95350 64331062
Intestinal ischaemia 64.50 13.68 72 72248 11477 64414935
Puncture site haemorrhage 64.16 13.68 24 72296 534 64425878
Thrombin time abnormal 64.03 13.68 12 72308 7 64426405
Ischaemia 63.92 13.68 58 72262 7220 64419192
Off label use 63.72 13.68 432 71888 632374 63794038
White blood cell count decreased 62.63 13.68 51 72269 157786 64268626
Headache 62.39 13.68 344 71976 529123 63897289
Cough 62.04 13.68 156 72164 301992 64124420
Oesophageal pain 61.74 13.68 41 72279 3222 64423190
Incarcerated hernia 61.44 13.68 21 72299 356 64426056
Iron deficiency anaemia 60.88 13.68 97 72223 21792 64404620
Neuropathy peripheral 60.48 13.68 28 72292 117497 64308915
Traumatic haemothorax 60.23 13.68 21 72299 379 64426033
Back pain 58.79 13.68 120 72200 250051 64176361
Pancytopenia 58.50 13.68 45 72275 143264 64283148
Contraindicated product administered 58.16 13.68 24 72296 107805 64318607
Peripheral artery thrombosis 57.33 13.68 38 72282 2977 64423435
Basal ganglia haemorrhage 57.03 13.68 29 72291 1377 64425035
Peripheral ischaemia 56.99 13.68 58 72262 8320 64418092
Dysarthria 55.97 13.68 170 72150 59236 64367176
Leukopenia 55.48 13.68 22 72298 101220 64325192
Injection site erythema 55.42 13.68 7 72313 70793 64355619
Insomnia 55.42 13.68 85 72235 197751 64228661
Haemoperitoneum 55.01 13.68 41 72279 3874 64422538
Cerebellar haemorrhage 54.46 13.68 35 72285 2602 64423810
Contusion 53.31 13.68 261 72059 113704 64312708
Microcytic anaemia 53.05 13.68 43 72277 4595 64421817
International normalised ratio 52.89 13.68 14 72306 92 64426320
Lower respiratory tract infection 52.77 13.68 20 72300 94594 64331818
Diverticulum intestinal haemorrhagic 52.22 13.68 37 72283 3232 64423180
Intracranial haematoma 52.16 13.68 23 72297 790 64425622
Pulmonary alveolar haemorrhage 51.47 13.68 59 72261 9679 64416733
Surgery 51.45 13.68 104 72216 28109 64398303
Urinary bladder haemorrhage 50.69 13.68 32 72288 2306 64424106
Ecchymosis 50.28 13.68 70 72250 13952 64412460
Stress 49.86 13.68 5 72315 60529 64365883
Swelling 49.68 13.68 64 72256 160154 64266258
Shock 49.55 13.68 123 72197 38117 64388295
Infection 49.36 13.68 82 72238 184798 64241614
Anorectal discomfort 49.22 13.68 34 72286 2851 64423561
Glossodynia 49.20 13.68 7 72313 64689 64361723
Pruritus 48.66 13.68 183 72137 312217 64114195
Heart transplant 48.42 13.68 25 72295 1226 64425186
Wound haemorrhage 48.36 13.68 36 72284 3395 64423017
Colitis ischaemic 48.15 13.68 67 72253 13347 64413065
Femoral neck fracture 48.05 13.68 54 72266 8670 64417742
Haemorrhage urinary tract 47.81 13.68 30 72290 2139 64424273
Gastric ulcer haemorrhage 47.60 13.68 52 72268 8091 64418321
Gastritis erosive 47.15 13.68 56 72264 9539 64416873
Retroperitoneal haemorrhage 47.14 13.68 41 72279 4827 64421585
Neutrophil count decreased 47.09 13.68 14 72306 77182 64349230
Asthma 47.00 13.68 24 72296 95201 64331211
Haemorrhage subcutaneous 46.88 13.68 39 72281 4322 64422090
Activated partial thromboplastin time 45.73 13.68 10 72310 24 64426388
Embolism arterial 45.58 13.68 24 72296 1226 64425186
Myalgia 45.53 13.68 67 72253 158550 64267862
Hypocoagulable state 44.33 13.68 27 72293 1826 64424586
Ischaemic cerebral infarction 44.03 13.68 28 72292 2044 64424368
Brain herniation 44.03 13.68 45 72275 6488 64419924
Cardiac ablation 42.85 13.68 26 72294 1746 64424666
Haemodynamic instability 42.74 13.68 67 72253 14845 64411567
Pain in extremity 42.50 13.68 185 72135 302900 64123512
C-reactive protein increased 42.43 13.68 27 72293 94882 64331530
Rib fracture 41.93 13.68 87 72233 23951 64402461
Infarction 41.71 13.68 35 72285 3925 64422487
Malignant neoplasm progression 41.70 13.68 39 72281 112832 64313580
Haemorrhagic cerebral infarction 41.68 13.68 23 72297 1291 64425121
Haemoglobin abnormal 41.63 13.68 42 72278 5962 64420450
Drug ineffective 41.56 13.68 678 71642 839569 63586843
Influenza 41.54 13.68 35 72285 106496 64319916
Gastric cancer 40.66 13.68 43 72277 6450 64419962
Cerebellar infarction 40.58 13.68 32 72288 3287 64423125
Mobility decreased 40.36 13.68 23 72297 85817 64340595
Appendicitis 40.33 13.68 62 72258 13507 64412905
Renal infarct 40.16 13.68 28 72292 2383 64424029
Treatment failure 40.14 13.68 43 72277 116773 64309639
Muscle spasms 40.05 13.68 60 72260 140963 64285449
Discomfort 39.00 13.68 21 72299 80857 64345555
Mucosal inflammation 38.81 13.68 11 72309 62573 64363839
Skin haemorrhage 38.76 13.68 48 72272 8537 64417875
Small intestinal haemorrhage 38.57 13.68 33 72287 3800 64422612
Tremor 38.40 13.68 67 72253 148163 64278249
Multiple organ dysfunction syndrome 38.32 13.68 219 72101 101194 64325218
Hip fracture 38.14 13.68 90 72230 27009 64399403
Urticaria 37.79 13.68 67 72253 147250 64279162
Blood glucose increased 37.29 13.68 33 72287 98040 64328372
Hepatic enzyme increased 37.18 13.68 55 72265 129888 64296524
Subcutaneous haematoma 37.13 13.68 27 72293 2456 64423956
Agitation 37.02 13.68 27 72293 88340 64338072
Wound secretion 37.02 13.68 37 72283 5195 64421217
Psoriasis 37.01 13.68 17 72303 71686 64354726
Oesophageal ulcer 36.90 13.68 40 72280 6170 64420242
Exsanguination 36.86 13.68 10 72310 73 64426339
Erythema 36.51 13.68 99 72221 186971 64239441
Upper respiratory tract infection 36.43 13.68 18 72302 72767 64353645
Cardioversion 36.43 13.68 24 72296 1861 64424551
Thrombotic stroke 36.05 13.68 17 72303 684 64425728
Paraesthesia 35.58 13.68 60 72260 134462 64291950
Injection site swelling 35.17 13.68 3 72317 41350 64385062
Musculoskeletal pain 35.16 13.68 24 72296 81270 64345142
Alanine aminotransferase increased 34.97 13.68 64 72256 138967 64287445
Atrial flutter 34.81 13.68 71 72249 19309 64407103
Anticoagulation drug level abnormal 34.81 13.68 8 72312 26 64426386
Herpes zoster 34.75 13.68 23 72297 79164 64347248
Diverticulum 34.68 13.68 57 72263 13141 64413271
Therapeutic response decreased 34.62 13.68 8 72312 52180 64374232
Influenza like illness 34.47 13.68 13 72307 61689 64364723
Multiple injuries 34.42 13.68 29 72291 3270 64423142
Syncope 33.99 13.68 297 72023 157338 64269074
Intestinal infarction 33.97 13.68 20 72300 1271 64425141
Somnolence 33.19 13.68 117 72203 203528 64222884
Occult blood positive 33.07 13.68 38 72282 6249 64420163
Peritonitis 32.95 13.68 81 72239 24942 64401470
Anaphylactic reaction 32.86 13.68 18 72302 68646 64357766
Hemianopia homonymous 32.52 13.68 19 72301 1190 64425222
Blister 32.30 13.68 26 72294 80941 64345471
Neurologic neglect syndrome 32.24 13.68 21 72299 1597 64424815
Therapy non-responder 31.93 13.68 17 72303 65882 64360530
Pulmonary contusion 31.72 13.68 9 72311 79 64426333
Prothrombin time shortened 31.71 13.68 26 72294 2823 64423589
Coagulation time shortened 31.67 13.68 13 72307 373 64426039
Internal haemorrhage 31.65 13.68 41 72279 7626 64418786
Catheter site haemorrhage 31.62 13.68 32 72288 4559 64421853
Carotid artery occlusion 31.40 13.68 30 72290 3987 64422425
Wound 31.22 13.68 24 72296 76453 64349959
Platelet count decreased 31.06 13.68 91 72229 167620 64258792
Pelvic fracture 31.02 13.68 48 72272 10515 64415897
Blood pressure increased 30.97 13.68 95 72225 172457 64253955
Arterial thrombosis 30.95 13.68 24 72296 2406 64424006
Arthritis 30.91 13.68 29 72291 83785 64342627
Bone marrow failure 30.54 13.68 8 72312 47944 64378468
Lumbar puncture 30.51 13.68 10 72310 148 64426264
Serotonin syndrome 30.46 13.68 4 72316 39278 64387134
Sedation 30.35 13.68 5 72315 41457 64384955
Anticoagulation drug level above therapeutic 30.20 13.68 26 72294 3019 64423393
Facial paresis 29.93 13.68 32 72288 4860 64421552
Cholecystitis acute 29.76 13.68 49 72271 11311 64415101
Weight decreased 29.68 13.68 193 72127 285546 64140866
Helicobacter infection 29.52 13.68 4 72316 38358 64388054
Aspartate aminotransferase increased 29.37 13.68 56 72264 119732 64306680
Conjunctival haemorrhage 29.24 13.68 32 72288 4989 64421423
Oesophageal carcinoma 28.97 13.68 31 72289 4712 64421700
Aortic aneurysm 28.95 13.68 39 72281 7535 64418877
Thrombotic cerebral infarction 28.89 13.68 13 72307 469 64425943
Prothrombin time ratio decreased 28.63 13.68 15 72305 758 64425654
Aortic thrombosis 28.59 13.68 19 72301 1495 64424917
NIH stroke scale abnormal 28.53 13.68 6 72314 11 64426401
Irritable bowel syndrome 28.51 13.68 4 72316 37365 64389047
Hypoaesthesia 28.37 13.68 72 72248 139036 64287376
Feeling hot 28.36 13.68 8 72312 45655 64380757
Hemianopia 28.31 13.68 19 72301 1520 64424892
Vision blurred 28.06 13.68 36 72284 90280 64336132
Nasal congestion 28.02 13.68 16 72304 59642 64366770
Gastric ulcer 27.98 13.68 86 72234 30148 64396264
Coronary artery embolism 27.84 13.68 11 72309 285 64426127
Mesenteric artery embolism 27.82 13.68 8 72312 74 64426338
Lymphocyte count decreased 27.47 13.68 6 72314 40693 64385719
Thalamus haemorrhage 27.43 13.68 19 72301 1600 64424812
Prothrombin time abnormal 27.18 13.68 15 72305 842 64425570
Cardiogenic shock 27.05 13.68 89 72231 32338 64394074
Oropharyngeal pain 27.02 13.68 36 72284 88831 64337581
Flushing 26.96 13.68 29 72291 78619 64347793
Haemorrhagic diathesis 26.80 13.68 32 72288 5482 64420930
Haemorrhoids 26.77 13.68 73 72247 23928 64402484
Colon neoplasm 26.62 13.68 14 72306 713 64425699
Incarcerated inguinal hernia 26.58 13.68 8 72312 88 64426324
Seizure 26.45 13.68 97 72223 166795 64259617
Creatinine renal clearance 26.23 13.68 6 72314 19 64426393
Diverticulitis intestinal haemorrhagic 26.13 13.68 12 72308 454 64425958
Multiple sclerosis relapse 25.94 13.68 7 72313 41128 64385284
Femoral artery embolism 25.70 13.68 7 72313 52 64426360
Psychotic disorder 25.69 13.68 4 72316 34574 64391838
Bronchitis 25.65 13.68 52 72268 108691 64317721
Loss of personal independence in daily activities 25.64 13.68 26 72294 72428 64353984
Injection site bruising 25.30 13.68 5 72315 36368 64390044
Post procedural stroke 25.29 13.68 8 72312 105 64426307
Malaise 25.08 13.68 304 72016 395943 64030469
Haemarthrosis 24.84 13.68 30 72290 5199 64421213
Ileus 24.77 13.68 69 72251 22897 64403515
Pneumonitis 24.39 13.68 13 72307 50352 64376060
Aneurysm ruptured 24.38 13.68 14 72306 849 64425563
Gastrointestinal necrosis 24.31 13.68 29 72291 4963 64421449
Dyskinesia 24.28 13.68 7 72313 39381 64387031
Cerebral artery thrombosis 24.23 13.68 15 72305 1044 64425368
Pelvic haematoma 24.23 13.68 13 72307 690 64425722
Blood cholesterol increased 24.13 13.68 13 72307 50053 64376359
Arterial haemorrhage 24.08 13.68 20 72300 2211 64424201
Sleep disorder 24.04 13.68 19 72301 59690 64366722
Rectal cancer 23.94 13.68 22 72298 2784 64423628
Acute coronary syndrome 23.85 13.68 61 72259 19249 64407163
Gastritis haemorrhagic 23.84 13.68 20 72300 2242 64424170
Constipation 23.76 13.68 155 72165 229182 64197230
Feeling abnormal 23.65 13.68 74 72246 133528 64292884
Inappropriate schedule of product administration 23.63 13.68 42 72278 92244 64334168
Myocardial infarction 23.59 13.68 287 72033 165534 64260878
Lacunar infarction 23.49 13.68 30 72290 5502 64420910
Bone pain 23.45 13.68 12 72308 47560 64378852
Gastrointestinal motility disorder 23.45 13.68 29 72291 5150 64421262
Suicidal ideation 23.41 13.68 24 72296 66518 64359894
Ascites 23.40 13.68 21 72299 61980 64364432
Gastrointestinal angiodysplasia 23.36 13.68 14 72306 919 64425493
Arteriovenous malformation 23.25 13.68 17 72303 1559 64424853
Inguinal hernia strangulated 23.18 13.68 4 72316 0 64426412
Wheezing 23.14 13.68 34 72286 80545 64345867
Blood creatine phosphokinase increased 23.11 13.68 19 72301 58539 64367873
Monoparesis 23.10 13.68 22 72298 2912 64423500
Coagulation factor increased 23.09 13.68 7 72313 79 64426333
Hypochromic anaemia 23.04 13.68 20 72300 2348 64424064
Brain oedema 22.52 13.68 65 72255 22010 64404402
Dysphagia 22.37 13.68 200 72120 106612 64319800
Gait disturbance 22.36 13.68 108 72212 172047 64254365
Large intestine polyp 22.25 13.68 42 72278 10795 64415617
Traumatic haematoma 22.22 13.68 18 72302 1922 64424490
Impaired healing 22.21 13.68 21 72299 60452 64365960
Intentional overdose 22.08 13.68 42 72278 89902 64336510
Pain in jaw 22.08 13.68 9 72311 40746 64385666
Duodenal ulcer haemorrhage 21.82 13.68 31 72289 6294 64420118
Spontaneous haematoma 21.73 13.68 15 72305 1256 64425156
Gastrointestinal vascular malformation haemorrhagic 21.66 13.68 12 72308 679 64425733
Venous thrombosis 21.61 13.68 31 72289 6350 64420062
Osteonecrosis 21.59 13.68 3 72317 28226 64398186
Aortic dissection rupture 21.58 13.68 5 72315 17 64426395
Joint stiffness 21.53 13.68 4 72316 30400 64396012
Pericarditis 21.48 13.68 23 72297 62493 64363919
Subarachnoid haematoma 21.46 13.68 7 72313 102 64426310
Oxygen saturation decreased 21.44 13.68 56 72264 107120 64319292
Haematocrit decreased 21.28 13.68 119 72201 54536 64371876
Osteonecrosis of jaw 21.25 13.68 9 72311 39816 64386596
Night sweats 21.15 13.68 7 72313 36039 64390373
Diabetic ketoacidosis 20.97 13.68 4 72316 29841 64396571
Arterial injury 20.94 13.68 11 72309 559 64425853
Drug reaction with eosinophilia and systemic symptoms 20.90 13.68 18 72302 54199 64372213
Hot flush 20.87 13.68 13 72307 46222 64380190
Brain stem stroke 20.87 13.68 10 72310 417 64425995
Cardiac failure congestive 20.80 13.68 231 72089 130349 64296063
Spinal cord haematoma 20.69 13.68 9 72311 299 64426113
Anuria 20.48 13.68 57 72263 18907 64407505
Occult blood 20.41 13.68 15 72305 1387 64425025
Hospitalisation 20.39 13.68 33 72287 75174 64351238
Thoracic haemorrhage 20.12 13.68 8 72312 211 64426201
Renal haemorrhage 20.02 13.68 17 72303 1938 64424474
Prothrombin time 19.88 13.68 5 72315 26 64426386
Pneumonia aspiration 19.82 13.68 124 72196 59147 64367265
Encephalopathy 19.81 13.68 22 72298 58797 64367615
White blood cell count increased 19.81 13.68 27 72293 65987 64360425
Cardiac failure chronic 19.77 13.68 36 72284 9005 64417407
Orthopaedic procedure 19.74 13.68 7 72313 133 64426279
Respiratory tract haemorrhage 19.65 13.68 15 72305 1469 64424943
Mouth ulceration 19.57 13.68 6 72314 32438 64393974
Haemochromatosis 19.38 13.68 14 72306 1260 64425152
Mesenteric haemorrhage 19.31 13.68 6 72314 74 64426338
Polyp 19.15 13.68 30 72290 6643 64419769
Hypertension 19.13 13.68 192 72128 259069 64167343
Rhabdomyolysis 19.06 13.68 47 72273 91679 64334733
Productive cough 19.03 13.68 33 72287 73170 64353242
Hydrocephalus 18.89 13.68 32 72288 7559 64418853
Hyperhidrosis 18.88 13.68 74 72246 124846 64301566
Angioedema 18.84 13.68 25 72295 61796 64364616
Pneumocystis jirovecii pneumonia 18.80 13.68 4 72316 27630 64398782
Hypothyroidism 18.79 13.68 11 72309 40446 64385966
Disseminated intravascular coagulation 18.78 13.68 79 72241 32269 64394143
Femur fracture 18.77 13.68 82 72238 34053 64392359
Haemorrhagic infarction 18.75 13.68 11 72309 694 64425718
Acute myeloid leukaemia 18.63 13.68 4 72316 27459 64398953
Candida infection 18.61 13.68 6 72314 31413 64394999
Cataract 18.59 13.68 18 72302 51244 64375168
Mesenteric artery thrombosis 18.56 13.68 10 72310 535 64425877
Migraine 18.44 13.68 26 72294 62651 64363761
Drug ineffective for unapproved indication 18.35 13.68 6 72314 31127 64395285
Renal embolism 18.30 13.68 7 72313 166 64426246
Haemoglobin 18.29 13.68 6 72314 89 64426323
Bacterial infection 18.28 13.68 3 72317 24947 64401465
Lacunar stroke 18.27 13.68 8 72312 270 64426142
Aggression 18.25 13.68 15 72305 46217 64380195
C-reactive protein abnormal 18.21 13.68 5 72315 29042 64397370
Cardiac ventricular thrombosis 18.03 13.68 14 72306 1406 64425006
Abdominal wall haemorrhage 17.92 13.68 9 72311 416 64425996
Skull fractured base 17.90 13.68 8 72312 284 64426128
Electrocardiogram QT prolonged 17.89 13.68 39 72281 79409 64347003
Neoplasm progression 17.83 13.68 12 72308 40952 64385460
Pharyngeal haemorrhage 17.81 13.68 13 72307 1189 64425223
Mucosal haemorrhage 17.76 13.68 17 72303 2264 64424148
Coagulation factor V level decreased 17.68 13.68 10 72310 589 64425823
Retroperitoneal haematoma 17.61 13.68 24 72296 4687 64421725
Accidental exposure to product 17.57 13.68 4 72316 26360 64400052
Putamen haemorrhage 17.42 13.68 9 72311 442 64425970
Lymphadenopathy 17.39 13.68 16 72304 46670 64379742
Petechiae 17.25 13.68 53 72267 18573 64407839
Hyperglycaemia 17.24 13.68 26 72294 60942 64365470
Blood pressure systolic increased 17.21 13.68 18 72302 49435 64376977
Splenic haemorrhage 17.09 13.68 10 72310 628 64425784
Irritability 17.05 13.68 10 72310 36736 64389676
Hepatotoxicity 17.01 13.68 12 72308 39950 64386462
Brain stem haemorrhage 16.94 13.68 14 72306 1537 64424875
Osteomyelitis 16.83 13.68 5 72315 27582 64398830
Cardiac myxoma 16.68 13.68 6 72314 119 64426293
Cystitis 16.65 13.68 14 72306 42661 64383751
Vascular pseudoaneurysm 16.63 13.68 19 72301 3105 64423307
Depressed mood 16.57 13.68 13 72307 40999 64385413
Drug eruption 16.53 13.68 10 72310 36126 64390286
Liver function test increased 16.52 13.68 7 72313 30963 64395449
Urogenital haemorrhage 16.50 13.68 10 72310 670 64425742
Dry skin 16.30 13.68 20 72300 51141 64375271
Decreased appetite 16.22 13.68 220 72100 281069 64145343
Hypomagnesaemia 16.20 13.68 11 72309 37365 64389047
Ruptured cerebral aneurysm 16.10 13.68 9 72311 518 64425894
Osteoarthritis 16.06 13.68 29 72291 63307 64363105
Vaginal haemorrhage 16.05 13.68 53 72267 19291 64407121
Microvillous inclusion disease 15.92 13.68 5 72315 64 64426348
Facial paralysis 15.77 13.68 52 72268 18914 64407498
Thrombosis mesenteric vessel 15.73 13.68 6 72314 141 64426271
Post procedural haematuria 15.59 13.68 7 72313 251 64426161
Memory impairment 15.49 13.68 47 72273 85635 64340777
Full blood count abnormal 15.44 13.68 7 72313 29750 64396662
Neurosurgery 15.42 13.68 4 72316 24 64426388
Hallucination 15.36 13.68 37 72283 72751 64353661
Traumatic renal injury 15.31 13.68 3 72317 3 64426409
Illness 15.29 13.68 3 72317 21935 64404477
Burning sensation 15.22 13.68 20 72300 49644 64376768
Cerebral vascular occlusion 15.15 13.68 4 72316 26 64426386
Meningorrhagia 15.12 13.68 7 72313 270 64426142
Cerebellar haematoma 15.09 13.68 9 72311 586 64425826
Heart rate decreased 15.08 13.68 24 72296 55043 64371369
Pharyngeal mass 15.07 13.68 7 72313 272 64426140
Dry mouth 15.02 13.68 28 72292 60390 64366022
Cardiac pacemaker insertion 15.00 13.68 23 72297 5000 64421412
Fungal infection 14.95 13.68 10 72310 34241 64392171
Open globe injury 14.95 13.68 5 72315 79 64426333
Blood calcium decreased 14.93 13.68 5 72315 25549 64400863
Varicose vein ruptured 14.90 13.68 5 72315 80 64426332
High frequency ablation 14.86 13.68 7 72313 281 64426131
Atrial fibrillation 14.85 13.68 272 72048 170817 64255595
Spontaneous haemorrhage 14.85 13.68 8 72312 428 64425984
Withdrawal syndrome 14.81 13.68 4 72316 23488 64402924
Mechanical ileus 14.80 13.68 9 72311 607 64425805
Dry eye 14.79 13.68 7 72313 29012 64397400
Type 2 diabetes mellitus 14.76 13.68 10 72310 34010 64392402
Paresis 14.76 13.68 19 72301 3513 64422899
Ear infection 14.72 13.68 4 72316 23400 64403012
Abdominal wall haematoma 14.71 13.68 21 72299 4284 64422128
Splenic haematoma 14.67 13.68 7 72313 289 64426123
Diabetes mellitus 14.66 13.68 33 72287 66441 64359971
Anticoagulation drug level below therapeutic 14.66 13.68 12 72308 1300 64425112
Sinus tachycardia 14.60 13.68 9 72311 32179 64394233
Epidural haemorrhage 14.56 13.68 6 72314 174 64426238
Ear pain 14.54 13.68 5 72315 25131 64401281
Myoclonus 14.53 13.68 5 72315 25113 64401299
Subdural hygroma 14.48 13.68 8 72312 450 64425962
Gastric occult blood positive 14.45 13.68 3 72317 5 64426407
Anti factor VIII antibody test 14.45 13.68 3 72317 5 64426407
Abnormal behaviour 14.43 13.68 10 72310 33612 64392800
Laparotomy 14.43 13.68 7 72313 300 64426112
Neuroleptic malignant syndrome 14.41 13.68 5 72315 24991 64401421
Restlessness 14.39 13.68 14 72306 39771 64386641
Basilar artery thrombosis 14.35 13.68 7 72313 304 64426108
Body temperature increased 14.34 13.68 12 72308 36654 64389758
Splenic embolism 14.30 13.68 6 72314 182 64426230
Abdominal strangulated hernia 14.30 13.68 5 72315 91 64426321
Oesophagitis 14.29 13.68 55 72265 21575 64404837
Ill-defined disorder 14.27 13.68 17 72303 44035 64382377
Iliac artery embolism 14.09 13.68 3 72317 6 64426406
Facial nerve disorder 14.09 13.68 9 72311 662 64425750
Quadrantanopia 14.03 13.68 6 72314 191 64426221
Ulcer haemorrhage 14.02 13.68 21 72299 4471 64421941
Muscle haemorrhage 13.99 13.68 24 72296 5729 64420683
Haemorrhagic disorder 13.99 13.68 12 72308 1387 64425025
Duodenal ulcer perforation 13.96 13.68 11 72309 34614 64391798
Staphylococcal infection 13.96 13.68 22 72298 50656 64375756
Inflammation 13.93 13.68 33 72287 65267 64361145
Basilar artery occlusion 13.92 13.68 6 72314 195 64426217
Bladder cancer 13.90 13.68 35 72285 10939 64415473
Neuralgia 13.84 13.68 6 72314 26178 64400234
Blood pressure fluctuation 13.83 13.68 23 72297 51848 64374564
Red blood cell sedimentation rate increased 13.80 13.68 9 72311 31226 64395186
Contraindication to surgery 13.78 13.68 3 72317 7 64426405
Nervousness 13.77 13.68 8 72312 29548 64396864
Vascular stent occlusion 13.77 13.68 6 72314 200 64426212

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 (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




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
6380 IUPHAR_LIGAND_ID
8028 INN_ID
211914-51-1 SECONDARY_CAS_RN
2E18WX195X UNII
135565674 PUBCHEM_CID
216210 PUBCHEM_CID
DB14726 DRUGBANK_ID
136711 MMSL
25762 MMSL
d07137 MMSL
012668 NDDF
012669 NDDF
698871007 SNOMEDCT_US
700029008 SNOMEDCT_US
700039002 SNOMEDCT_US
714788005 SNOMEDCT_US
C2348066 UMLSCUI
8027 INN_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 0597-0355 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 0597-0425 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 31722-622 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 31 sections
Pradaxa HUMAN PRESCRIPTION DRUG LABEL 1 63629-8242 CAPSULE 150 mg ORAL NDA 32 sections