dabigatran etexilate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 5 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 4.179 Moderate 0.79
caco2-efflux Caco-2 efflux ratio (BA/AB) 6.427 Moderate 0.79
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 12.445 10^-6 cm/s Moderate 0.79
dh-clint Dog hepatocyte intrinsic clearance 50.350 uL/min/10^6 cells Moderate 0.79
dppb Dog plasma protein binding (% unbound) 0.910 % Moderate 0.79
fcs-ppb Fetal calf serum protein binding (% unbound) 1.780 % Moderate 0.79
herg hERG pIC50 5.391 pIC50 Moderate 0.79
hh-clint Human hepatocyte intrinsic clearance 289.068 uL/min/10^6 cells Moderate 0.79
hlm-clint Human liver microsomal intrinsic clearance 292.415 uL/min/mg protein Moderate 0.79
hppb Human plasma protein binding (% unbound) 0.710 % Moderate 0.79
kinase-safety-class ACVR2A,ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GRK3,ITK,JAK2,MAP3K21,MAP3K7,MAPK10,MAPK12,MAPK7,MAPK9,MAPKAPK2,MARK4,MET,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TTK 44
kinase-selectivity-class AXL,GRK2,TEK 3
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 12.589 Moderate 0.79
mh-clint Mouse hepatocyte intrinsic clearance 274.789 Moderate 0.79
mppb Mouse plasma protein binding (% unbound) 0.750 Moderate 0.79
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 37.068 Moderate 0.79
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 1.510 % Moderate 0.79
rh-clint Rat hepatocyte intrinsic clearance 302.691 uL/min/10^6 cells Moderate 0.79
rh-fuinc Rat hepatocyte fraction unbound in incubation 7.390 % Moderate 0.79
rppb Rat plasma protein binding (% unbound) 0.840 % Moderate 0.79
solubility-dd Solubility at pH 7.4 in DMSO 1.107 uM Moderate 0.79

Approvals:

DateAgencyCompanyOrphan
Oct. 19, 2010 FDA BOEHRINGER INGELHEIM
March 18, 2008 EMA BOEHRINGER INGELHEIM INTERNATIONAL GMBH

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 5262.96 16.19 1988 52419 88260 90485780
Ischaemic stroke 2562.02 16.19 816 53591 21350 90552690
Cerebrovascular accident 1775.89 16.19 1035 53372 122498 90451542
Haemorrhage 1525.74 16.19 771 53636 68598 90505442
Melaena 1371.56 16.19 580 53827 34217 90539823
Haemorrhage intracranial 1135.07 16.19 403 54004 14759 90559281
Rectal haemorrhage 969.92 16.19 609 53798 82135 90491905
Cerebral haemorrhage 871.98 16.19 422 53985 34100 90539940
Lower gastrointestinal haemorrhage 795.34 16.19 270 54137 8622 90565418
Activated partial thromboplastin time prolonged 780.81 16.19 258 54149 7567 90566473
Cardiac tamponade 619.76 16.19 200 54207 5432 90568608
Subdural haematoma 578.36 16.19 254 54153 16391 90557649
Fall 573.76 16.19 1031 53376 480779 90093261
International normalised ratio increased 568.43 16.19 354 54053 46962 90527078
Cerebral infarction 532.88 16.19 278 54129 26318 90547722
Coagulopathy 514.51 16.19 260 54147 23029 90551011
Haematoma 512.05 16.19 309 54098 38739 90535301
Upper gastrointestinal haemorrhage 471.29 16.19 244 54163 22732 90551308
Shock haemorrhagic 465.08 16.19 199 54208 12046 90561994
Embolic stroke 457.83 16.19 147 54260 3925 90570115
Anaemia 434.67 16.19 767 53640 352035 90222005
Blood loss anaemia 432.59 16.19 179 54228 9961 90564079
Haematuria 403.47 16.19 255 54152 34682 90539358
Procoagulant therapy 385.15 16.19 60 54347 0 90574040
Transient ischaemic attack 361.29 16.19 258 54149 42918 90531122
Acute kidney injury 353.11 16.19 664 53743 319723 90254317
Haemorrhagic stroke 347.55 16.19 135 54272 6361 90567679
Drug interaction 345.29 16.19 605 53802 275848 90298192
Haematochezia 338.79 16.19 305 54102 70608 90503432
Subarachnoid haemorrhage 329.85 16.19 177 54230 17727 90556313
Haemoglobin decreased 312.03 16.19 433 53974 161523 90412517
Deep vein thrombosis 302.69 16.19 322 54085 91298 90482742
Pericardial haemorrhage 301.11 16.19 89 54318 1787 90572253
Haematemesis 297.12 16.19 208 54199 33518 90540522
Thrombin time prolonged 291.22 16.19 52 54355 66 90573974
Renal failure 277.74 16.19 367 54040 130640 90443400
Pulmonary embolism 275.06 16.19 365 54042 130455 90443585
Cardiac failure 257.57 16.19 323 54084 109173 90464867
Atrial thrombosis 248.09 16.19 80 54327 2165 90571875
Pain 241.13 16.19 151 54256 996190 89577850
Epistaxis 241.06 16.19 276 54131 84849 90489191
Intestinal haemorrhage 236.41 16.19 92 54315 4355 90569685
Subdural haemorrhage 218.72 16.19 81 54326 3342 90570698
Hemiparesis 188.79 16.19 155 54252 31664 90542376
Infusion related reaction 187.99 16.19 17 54390 416763 90157277
Systemic lupus erythematosus 186.62 16.19 7 54400 361889 90212151
Maternal exposure during pregnancy 185.55 16.19 7 54400 360056 90213984
Drug hypersensitivity 175.51 16.19 33 54374 463576 90110464
Hypovolaemic shock 173.78 16.19 85 54322 7009 90567031
Prothrombin time prolonged 169.93 16.19 93 54314 9679 90564361
Arthropathy 167.70 16.19 14 54393 366228 90207812
Rash 167.09 16.19 140 54267 795960 89778080
Glossodynia 166.67 16.19 6 54401 321773 90252267
Coagulation time prolonged 165.65 16.19 55 54352 1635 90572405
Renal impairment 161.20 16.19 253 54154 105168 90468872
Rheumatoid arthritis 147.94 16.19 21 54386 362593 90211447
Drug intolerance 147.38 16.19 43 54364 447548 90126492
Hypotension 146.72 16.19 479 53928 324918 90249122
Haemothorax 146.39 16.19 55 54352 2363 90571677
Nasopharyngitis 143.74 16.19 34 54373 407070 90166970
Aortic dissection 142.78 16.19 54 54353 2363 90571677
Cerebral haematoma 141.04 16.19 63 54344 4226 90569814
Haemoptysis 140.99 16.19 134 54273 33186 90540854
Joint swelling 140.90 16.19 63 54344 503237 90070803
Head injury 140.75 16.19 130 54277 31058 90542982
Hypersensitivity 140.26 16.19 49 54358 454628 90119412
Faeces discoloured 139.51 16.19 110 54297 21210 90552830
Fatigue 138.96 16.19 305 54102 1153718 89420322
Wound secretion 128.89 16.19 62 54345 4928 90569112
Syncope 128.75 16.19 261 54146 132402 90441638
Therapeutic product effect decreased 128.73 16.19 10 54397 277561 90296479
Exposure during pregnancy 128.71 16.19 3 54404 238407 90335633
Atrial fibrillation 125.10 16.19 259 54148 133352 90440688
Procedural haemorrhage 122.66 16.19 52 54355 3072 90570968
Weight increased 122.24 16.19 49 54358 417878 90156162
Gastric haemorrhage 121.85 16.19 67 54340 7036 90567004
Treatment failure 120.72 16.19 19 54388 303909 90270131
Wound 117.98 16.19 20 54387 302960 90271080
Peripheral embolism 116.50 16.19 40 54367 1320 90572720
Contraindicated product administered 116.46 16.19 25 54382 320114 90253926
Stomatitis 114.16 16.19 15 54392 274683 90299357
Sinusitis 112.81 16.19 33 54374 343055 90230985
Musculoskeletal stiffness 112.36 16.19 21 54386 296511 90277529
Helicobacter infection 111.61 16.19 6 54401 226844 90347196
Duodenal ulcer perforation 111.60 16.19 5 54402 221283 90352757
Large intestinal haemorrhage 110.44 16.19 40 54367 1548 90572492
Alopecia 110.04 16.19 82 54325 494989 90079051
Swelling 108.82 16.19 58 54349 419000 90155040
Discomfort 107.04 16.19 18 54389 274317 90299723
Lower respiratory tract infection 105.82 16.19 13 54394 250646 90323394
Pericardial effusion 105.17 16.19 120 54287 36713 90537327
Irritable bowel syndrome 103.59 16.19 5 54402 207443 90366597
Post procedural haemorrhage 103.47 16.19 65 54342 8733 90565307
Impaired healing 101.72 16.19 11 54396 234188 90339852
Dementia 101.01 16.19 96 54311 23765 90550275
Traumatic intracranial haemorrhage 99.20 16.19 30 54377 653 90573387
Haemorrhoidal haemorrhage 99.07 16.19 53 54354 5270 90568770
Condition aggravated 98.53 16.19 128 54279 595417 89978623
Pyrexia 98.36 16.19 153 54254 660332 89913708
Infection 97.14 16.19 48 54359 362046 90211994
Anticoagulation drug level increased 96.99 16.19 25 54382 294 90573746
Product use in unapproved indication 95.74 16.19 41 54366 336195 90237845
Creatinine renal clearance decreased 95.56 16.19 84 54323 18815 90555225
Haemorrhagic transformation stroke 95.14 16.19 34 54373 1265 90572775
Thrombosis 94.66 16.19 163 54244 73088 90500952
Gastritis erosive 89.88 16.19 54 54353 6701 90567339
Hepatic enzyme increased 89.21 16.19 53 54354 360683 90213357
Aphasia 89.16 16.19 119 54288 42693 90531347
Pericarditis 88.76 16.19 26 54381 270125 90303915
Parkinsonism 88.66 16.19 71 54336 13994 90560046
Hemiplegia 88.13 16.19 75 54332 16085 90557955
Peripheral swelling 87.24 16.19 72 54335 413034 90161006
Gingival bleeding 87.13 16.19 72 54335 14831 90559209
Blood cholesterol decreased 85.44 16.19 35 54372 1896 90572144
Peripheral circulatory failure 84.60 16.19 33 54374 1571 90572469
Arthralgia 84.46 16.19 217 54190 778305 89795735
Blood cholesterol increased 82.58 16.19 13 54394 207999 90366041
Death 82.55 16.19 512 53895 456039 90118001
Cerebral artery occlusion 82.43 16.19 29 54378 1030 90573010
International normalised ratio abnormal 82.17 16.19 42 54365 3803 90570237
Ill-defined disorder 82.05 16.19 8 54399 184883 90389157
Wheezing 81.79 16.19 21 54386 238059 90335981
Traumatic haemorrhage 81.49 16.19 25 54382 572 90573468
Pulmonary haemorrhage 81.42 16.19 54 54353 7959 90566081
Thrombin time abnormal 80.75 16.19 13 54394 3 90574037
Mouth haemorrhage 78.52 16.19 54 54353 8447 90565593
Type 2 diabetes mellitus 77.81 16.19 14 54393 203230 90370810
Embolism 77.75 16.19 56 54351 9425 90564615
Drug ineffective 77 16.19 502 53905 1383796 89190244
Acute myocardial infarction 75.77 16.19 99 54308 34791 90539249
Splenic rupture 75.13 16.19 29 54378 1342 90572698
Sleep disorder 75.04 16.19 14 54393 198016 90376024
Intestinal ischaemia 74.06 16.19 53 54354 8830 90565210
Headache 73.94 16.19 268 54139 862478 89711562
Cardiac failure congestive 73.90 16.19 175 54232 98519 90475521
Asthma 73.05 16.19 27 54380 242133 90331907
Cardiac valve replacement complication 72.30 16.19 17 54390 132 90573908
Hip fracture 72.05 16.19 94 54313 32983 90541057
Cerebral ischaemia 71.92 16.19 48 54359 7148 90566892
Intra-abdominal haemorrhage 71.57 16.19 34 54373 2628 90571412
Intentional product use issue 71 16.19 21 54386 216871 90357169
Acute abdomen 69.71 16.19 29 54378 1634 90572406
Anxiety 69.15 16.19 51 54356 309721 90264319
Intracardiac thrombus 69 16.19 32 54375 2342 90571698
Off label use 68.91 16.19 385 54022 1101867 89472173
Injection site pain 68.62 16.19 11 54396 173688 90400352
Craniocerebral injury 67.52 16.19 35 54372 3263 90570777
International normalised ratio 67.29 16.19 15 54392 89 90573951
Cerebral mass effect 67.28 16.19 25 54382 1041 90572999
Hypoaesthesia 67.25 16.19 54 54353 314156 90259884
Activated partial thromboplastin time abnormal 66.97 16.19 16 54391 134 90573906
Product use issue 66.58 16.19 60 54347 329859 90244181
Blister 66.56 16.19 35 54372 254963 90319077
Gastric polyps 66.48 16.19 39 54368 4633 90569407
Product dose omission issue 66.44 16.19 47 54360 291640 90282400
Neuroglycopenia 66.18 16.19 25 54382 1090 90572950
Shock 66.16 16.19 84 54323 28694 90545346
Multiple drug therapy 65.86 16.19 45 54362 6964 90567076
Urticaria 65.38 16.19 55 54352 312679 90261361
Intraventricular haemorrhage 64.74 16.19 31 54376 2438 90571602
Peripheral ischaemia 64.47 16.19 41 54366 5626 90568414
Colon cancer 64.24 16.19 53 54354 10891 90563149
Retroperitoneal haemorrhage 63.96 16.19 33 54374 3047 90570993
Multiple organ dysfunction syndrome 63.36 16.19 132 54275 68204 90505836
Blood urine present 62.86 16.19 64 54343 17214 90556826
Strangulated hernia 62.59 16.19 12 54395 28 90574012
Diverticulum 61.56 16.19 54 54353 12059 90561981
Cerebral artery embolism 61.17 16.19 23 54384 990 90573050
Internal haemorrhage 60.99 16.19 41 54366 6179 90567861
Iron deficiency anaemia 60.73 16.19 73 54334 23589 90550451
Puncture site haemorrhage 60.04 16.19 18 54389 380 90573660
Microcytic anaemia 60.00 16.19 34 54373 3784 90570256
Vaginal haemorrhage 59.18 16.19 83 54324 31188 90542852
Night sweats 58.66 16.19 5 54402 128761 90445279
Hyperkalaemia 58.50 16.19 124 54283 64840 90509200
Completed suicide 57.71 16.19 9 54398 145049 90428991
Bursitis 57.62 16.19 6 54401 131648 90442392
Osteoarthritis 57.07 16.19 23 54384 195707 90378333
Femoral neck fracture 56.84 16.19 48 54359 10185 90563855
Liver injury 56.77 16.19 16 54391 170551 90403489
Haemarthrosis 55.93 16.19 33 54374 3961 90570079
Haemorrhage subcutaneous 55.42 16.19 31 54376 3365 90570675
Haematocrit decreased 55.23 16.19 94 54313 41738 90532302
Hyponatraemia 54.23 16.19 190 54217 133348 90440692
Neutropenia 54.22 16.19 34 54373 224870 90349170
Subcutaneous haematoma 53.54 16.19 25 54382 1858 90572182
Hypoglycaemia 53.53 16.19 125 54282 69723 90504317
Stupor 53.43 16.19 36 54371 5446 90568594
Anticoagulation drug level abnormal 53.00 16.19 13 54394 123 90573917
Colitis ischaemic 52.88 16.19 50 54357 12296 90561744
Peripheral artery thrombosis 52.69 16.19 26 54381 2184 90571856
Haemoperitoneum 51.65 16.19 30 54377 3498 90570542
Haemorrhagic cerebral infarction 51.60 16.19 18 54389 623 90573417
Atrioventricular block first degree 51.60 16.19 42 54365 8469 90565571
Coagulation test abnormal 51.30 16.19 20 54387 951 90573089
Cardiac perforation 50.77 16.19 11 54396 56 90573984
Paraesthesia 49.92 16.19 46 54361 250280 90323760
Sepsis 49.07 16.19 226 54181 179588 90394452
Therapy non-responder 49.01 16.19 11 54396 136693 90437347
Embolic cerebral infarction 48.69 16.19 17 54390 590 90573450
Hypercholesterolaemia 48.58 16.19 3 54404 100889 90473151
Myocardial infarction 48.52 16.19 157 54250 105815 90468225
Hypochromic anaemia 47.22 16.19 24 54383 2147 90571893
Blood creatinine increased 47.14 16.19 151 54256 101235 90472805
Anticoagulant-related nephropathy 46.95 16.19 9 54398 21 90574019
Ecchymosis 45.47 16.19 46 54361 12277 90561763
Musculoskeletal pain 45.43 16.19 23 54384 171228 90402812
Abdominal discomfort 45.05 16.19 142 54265 477186 90096854
Gait inability 44.71 16.19 16 54391 146440 90427600
Post procedural haematoma 44.62 16.19 20 54387 1352 90572688
Therapeutic product effect incomplete 44.45 16.19 31 54376 193865 90380175
Pulmonary fibrosis 44.32 16.19 6 54401 107497 90466543
Psoriasis 43.66 16.19 17 54390 147737 90426303
Gastric ulcer 43.48 16.19 67 54340 27381 90546659
Prothrombin time abnormal 43.06 16.19 15 54392 517 90573523
Bradycardia 42.79 16.19 129 54278 83718 90490322
Pelvic haematoma 41.96 16.19 16 54391 716 90573324
Disease progression 41.59 16.19 21 54386 156594 90417446
Sciatica 40.99 16.19 6 54401 101376 90472664
Wound haemorrhage 40.97 16.19 24 54383 2843 90571197
Conjunctival haemorrhage 40.84 16.19 27 54380 3957 90570083
Discoloured vomit 40.77 16.19 18 54389 1174 90572866
Overdose 40.66 16.19 195 54212 157514 90416526
Occult blood positive 40.60 16.19 27 54380 3996 90570044
Diabetes mellitus inadequate control 40.54 16.19 53 54354 18631 90555409
Inflammation 40.35 16.19 29 54378 178563 90395477
C-reactive protein increased 40.28 16.19 30 54377 181359 90392681
Dry mouth 40.15 16.19 31 54376 184028 90390012
Blood creatine increased 39.36 16.19 33 54374 6934 90567106
Skull fracture 39.21 16.19 18 54389 1287 90572753
Upper respiratory tract infection 39.20 16.19 14 54393 128304 90445736
Oesophagitis 39.10 16.19 50 54357 17199 90556841
Disseminated intravascular coagulation 39.03 16.19 56 54351 21482 90552558
Prescribed overdose 38.96 16.19 6 54401 97619 90476421
Bradyarrhythmia 38.90 16.19 22 54385 2439 90571601
Hypocoagulable state 38.68 16.19 19 54388 1580 90572460
Initial insomnia 38.53 16.19 37 54370 9273 90564767
Neuropathy peripheral 38.47 16.19 17 54390 136953 90437087
Blood urea increased 38.39 16.19 67 54340 30346 90543694
Ischaemia 38.30 16.19 29 54378 5266 90568774
Dysphagia 38.26 16.19 151 54256 112127 90461913
Gastric ulcer haemorrhage 38.22 16.19 29 54378 5282 90568758
Red blood cell sedimentation rate increased 38.19 16.19 3 54404 82592 90491448
Migraine 37.94 16.19 35 54372 190357 90383683
Petechiae 37.86 16.19 47 54360 15694 90558346
Small intestinal haemorrhage 37.79 16.19 21 54386 2250 90571790
Prothrombin time shortened 37.73 16.19 21 54386 2257 90571783
Atrial flutter 37.60 16.19 39 54368 10719 90563321
Pelvic fracture 37.50 16.19 46 54361 15173 90558867
Anticoagulation drug level above therapeutic 37.26 16.19 20 54387 2002 90572038
Pulmonary alveolar haemorrhage 37.21 16.19 30 54377 5968 90568072
Pruritus 37.12 16.19 183 54224 541342 90032698
Diverticulum intestinal haemorrhagic 36.95 16.19 19 54388 1742 90572298
Exsanguination 36.92 16.19 7 54400 15 90574025
Peritonitis 36.84 16.19 52 54355 19653 90554387
Liver function test increased 36.78 16.19 4 54403 84851 90489189
Ischaemic cerebral infarction 36.75 16.19 18 54389 1488 90572552
Incarcerated hernia 36.25 16.19 10 54397 155 90573885
Brain contusion 36.20 16.19 14 54393 651 90573389
Hiatus hernia 36.16 16.19 59 54348 25302 90548738
Bradykinesia 35.98 16.19 31 54376 6757 90567283
Muscle spasms 35.83 16.19 60 54347 251823 90322217
Wound infection 35.36 16.19 10 54397 106392 90467648
Hypertension 35.30 16.19 148 54259 457384 90116656
Obesity 34.91 16.19 10 54397 105497 90468543
Brain herniation 34.88 16.19 25 54382 4175 90569865
Gastritis 34.51 16.19 77 54330 41676 90532364
Vascular access site haemorrhage 34.25 16.19 10 54397 192 90573848
Arthritis 34.24 16.19 30 54377 167285 90406755
Activated partial thromboplastin time 33.88 16.19 6 54401 7 90574033
Gastritis haemorrhagic 33.72 16.19 18 54389 1782 90572258
Influenza 33.63 16.19 21 54386 139243 90434797
Chills 33.14 16.19 19 54388 131962 90442078
Renal infarct 32.66 16.19 17 54390 1598 90572442
Coagulation factor increased 32.63 16.19 6 54401 10 90574030
Oesophageal ulcer 32.60 16.19 26 54381 5093 90568947
Nausea 32.35 16.19 471 53936 1109845 89464195
Acute coronary syndrome 32.17 16.19 36 54371 10777 90563263
Rhinorrhoea 31.87 16.19 7 54400 88309 90485731
Prescribed underdose 31.37 16.19 4 54403 75015 90499025
Haemorrhoids 31.36 16.19 57 54350 26645 90547395
Femoral artery embolism 31.34 16.19 7 54400 42 90573998
Intracranial haematoma 31.31 16.19 11 54396 389 90573651
Basal ganglia haemorrhage 30.99 16.19 13 54394 748 90573292
Loss of personal independence in daily activities 30.87 16.19 22 54385 136083 90437957
Joint stiffness 30.68 16.19 5 54402 78037 90496003
Mesenteric artery embolism 30.21 16.19 6 54401 18 90574022
Heart transplant 30.18 16.19 12 54395 601 90573439
Intestinal infarction 29.83 16.19 14 54393 1053 90572987
Drug level increased 29.77 16.19 57 54350 27705 90546335
Phlebitis 29.76 16.19 29 54378 7401 90566639
Orthostatic intolerance 29.54 16.19 15 54392 1339 90572701
Urinary retention 29.41 16.19 68 54339 37676 90536364
Pain in extremity 29.30 16.19 155 54252 450374 90123666
Cardiac ablation 29.02 16.19 16 54391 1688 90572352
Drug abuse 28.77 16.19 7 54400 82340 90491700
Gastrointestinal necrosis 28.64 16.19 20 54387 3205 90570835
White blood cell count decreased 28.50 16.19 35 54372 167074 90406966
Cardiac failure chronic 28.35 16.19 25 54382 5621 90568419
Haemodynamic instability 28.15 16.19 35 54372 11704 90562336
Anticoagulation drug level below therapeutic 28.14 16.19 12 54395 719 90573321
Haemorrhagic arteriovenous malformation 28.09 16.19 8 54399 140 90573900
Normocytic anaemia 27.89 16.19 19 54388 2925 90571115
Peripheral venous disease 27.68 16.19 8 54399 83913 90490127
Infarction 27.50 16.19 19 54388 2994 90571046
Haemorrhagic disorder 27.43 16.19 13 54394 999 90573041
Hypotonia 27.29 16.19 34 54373 11392 90562648
Neutrophil count decreased 27.20 16.19 5 54402 71527 90502513
Memory impairment 27.12 16.19 48 54359 197196 90376844
Rib fracture 26.79 16.19 53 54354 26382 90547658
Femur fracture 26.49 16.19 74 54333 46008 90528032
Stress 26.40 16.19 8 54399 81387 90492653
Cardiogenic shock 25.95 16.19 50 54357 24418 90549622
Depression 25.88 16.19 93 54314 300508 90273532
Carotid artery occlusion 25.86 16.19 25 54382 6317 90567723
Cardiac arrest 25.78 16.19 128 54279 104807 90469233
Spontaneous haematoma 25.77 16.19 13 54394 1145 90572895
Abdominal wall haematoma 25.67 16.19 19 54388 3333 90570707
Haemorrhagic infarction 25.60 16.19 9 54398 319 90573721
Lacunar infarction 25.55 16.19 19 54388 3358 90570682
Oesophageal pain 25.29 16.19 21 54386 4353 90569687
Drug dependence 25.27 16.19 55 54352 29272 90544768
Dysarthria 25.18 16.19 81 54326 54401 90519639
Neck pain 25.10 16.19 19 54388 113944 90460096
Weight decreased 25.08 16.19 130 54277 379780 90194260
Cough 25.07 16.19 125 54282 368837 90205203
Diarrhoea 25.06 16.19 405 54002 938785 89635255
Prothrombin time 24.93 16.19 5 54402 16 90574024
Haemorrhagic diathesis 24.86 16.19 23 54384 5501 90568539
Rectal perforation 24.83 16.19 10 54397 518 90573522
Lower limb fracture 24.75 16.19 10 54397 85003 90489037
Mobility decreased 24.75 16.19 73 54334 250661 90323379
Prothrombin time ratio decreased 24.60 16.19 12 54395 983 90573057
Thrombotic stroke 24.44 16.19 10 54397 540 90573500
Diverticulitis intestinal haemorrhagic 24.29 16.19 7 54400 128 90573912
Ileus 24.28 16.19 39 54368 16507 90557533
Occult blood 24.25 16.19 13 54394 1298 90572742
Ear infection 24.24 16.19 6 54401 69769 90504271
Cerebellar haemorrhage 24.05 16.19 14 54393 1639 90572401
Knee arthroplasty 23.87 16.19 10 54397 83172 90490868
Hospitalisation 23.84 16.19 25 54382 128075 90445965
Adverse drug reaction 23.78 16.19 21 54386 116680 90457360
Appendicitis 23.73 16.19 30 54377 10201 90563839
Labelled drug-drug interaction medication error 23.67 16.19 36 54371 14546 90559494
Back pain 23.58 16.19 104 54303 317071 90256969
Haemoglobin abnormal 23.49 16.19 25 54382 7075 90566965
Illness 23.29 16.19 10 54397 81959 90492081
Haemorrhage urinary tract 23.29 16.19 12 54395 1105 90572935
Arterial haemorrhage 23.24 16.19 16 54391 2507 90571533
Duodenal ulcer haemorrhage 23.05 16.19 16 54391 2540 90571500
Gastrointestinal disorder 23.04 16.19 78 54329 256609 90317431
Inappropriate schedule of product administration 22.94 16.19 34 54373 149899 90424141
Pallor 22.82 16.19 58 54349 34107 90539933
Erosive oesophagitis 22.72 16.19 14 54393 1817 90572223
Rectal ulcer 22.63 16.19 13 54394 1485 90572555
Abdominal wall haemorrhage 22.58 16.19 7 54400 166 90573874
Nasal congestion 22.42 16.19 11 54396 83403 90490637
Therapeutic response decreased 22.40 16.19 13 54394 89716 90484324
Prothrombin level decreased 22.20 16.19 10 54397 684 90573356
Malignant neoplasm progression 22.06 16.19 19 54388 106851 90467189
Anuria 21.84 16.19 35 54372 14783 90559257
Uterine haemorrhage 21.80 16.19 20 54387 4732 90569308
Insomnia 21.51 16.19 115 54292 333359 90240681
Aortic thrombosis 21.47 16.19 12 54395 1300 90572740
Dyspepsia 21.39 16.19 197 54210 197963 90376077
Extradural haematoma 21.16 16.19 14 54393 2054 90571986
Lung disorder 21.03 16.19 36 54371 149847 90424193
Product administration error 21.02 16.19 48 54359 26375 90547665
Cardioversion 20.99 16.19 12 54395 1358 90572682
Glomerular filtration rate decreased 20.98 16.19 37 54370 16895 90557145
Vascular pseudoaneurysm 20.94 16.19 13 54394 1710 90572330
Post procedural haematuria 20.81 16.19 5 54402 43 90573997
COVID-19 20.67 16.19 44 54363 168799 90405241
Circulatory collapse 20.66 16.19 46 54361 24858 90549182
Injury 20.55 16.19 56 54351 197293 90376747
Brain stem haemorrhage 20.48 16.19 10 54397 821 90573219
Embolism arterial 20.41 16.19 11 54396 1110 90572930
Liver disorder 20.05 16.19 26 54381 121243 90452797
Cerebellar infarction 20.05 16.19 14 54393 2244 90571796
Splenic haematoma 20.04 16.19 6 54401 126 90573914
Muscle rigidity 20.01 16.19 33 54374 14276 90559764
Bleeding time prolonged 19.73 16.19 9 54398 634 90573406
Thoracic haemorrhage 19.70 16.19 5 54402 55 90573985
Arteriovenous malformation 19.58 16.19 12 54395 1543 90572497
Pharyngeal haemorrhage 19.56 16.19 9 54398 647 90573393
Lupus-like syndrome 19.49 16.19 3 54404 48843 90525197
Cerebral artery thrombosis 19.31 16.19 8 54399 446 90573594
Abdominal incarcerated hernia 19.26 16.19 3 54404 0 90574040
Thrombin time 19.26 16.19 3 54404 0 90574040
Sudden death 19.23 16.19 28 54379 10881 90563159
Anticoagulation drug level decreased 19.23 16.19 5 54402 61 90573979
Venous thrombosis 19.22 16.19 20 54387 5517 90568523
Retroperitoneal haematoma 19.12 16.19 16 54391 3352 90570688
Vomiting 19.03 16.19 346 54061 787947 89786093
Facial paresis 18.81 16.19 17 54390 3946 90570094
Product monitoring error 18.69 16.19 18 54389 4526 90569514
Acidosis 18.66 16.19 30 54377 12706 90561334
Micturition disorder 18.51 16.19 15 54392 3005 90571035
Feeling hot 18.50 16.19 12 54395 77996 90496044
Laryngitis 18.35 16.19 4 54403 50749 90523291
Influenza like illness 18.32 16.19 13 54394 80598 90493442
Back injury 18.30 16.19 3 54404 46619 90527421
Malaise 18.26 16.19 245 54162 585741 89988299
Chronic pigmented purpura 18.11 16.19 6 54401 177 90573863
Abortion spontaneous 18.11 16.19 5 54402 54051 90519989
Hepatitis acute 17.84 16.19 27 54380 10860 90563180
Tachyarrhythmia 17.83 16.19 19 54388 5387 90568653
Mucosal haemorrhage 17.75 16.19 11 54396 1442 90572598
Labelled drug-drug interaction issue 17.75 16.19 13 54394 2245 90571795
Colon neoplasm 17.67 16.19 9 54398 809 90573231
Hepatic failure 17.40 16.19 58 54349 39670 90534370
Stroke in evolution 17.32 16.19 5 54402 92 90573948
Hypertensive crisis 17.24 16.19 35 54372 17749 90556291
Injection site bruising 17.22 16.19 5 54402 52302 90521738
Muscle haemorrhage 17.17 16.19 15 54392 3331 90570709
Cardiac fibrillation 17.11 16.19 8 54399 596 90573444
Polyp 17.07 16.19 22 54385 7622 90566418
Blood potassium increased 16.85 16.19 38 54369 20711 90553329
Arterial thrombosis 16.78 16.19 11 54396 1589 90572451
Spinal cord haematoma 16.74 16.19 6 54401 225 90573815
Respiratory disorder 16.74 16.19 9 54398 64807 90509233
Venous thrombosis limb 16.73 16.19 15 54392 3447 90570593
Globulins decreased 16.68 16.19 7 54400 403 90573637
Adverse event 16.66 16.19 28 54379 117390 90456650
Brain stem stroke 16.55 16.19 7 54400 411 90573629
Ear pain 16.45 16.19 7 54400 57695 90516345
Duplicate therapy error 16.27 16.19 5 54402 115 90573925
Thrombotic cerebral infarction 16.26 16.19 6 54401 245 90573795
Atrial tachycardia 16.23 16.19 19 54388 5971 90568069
Lacunar stroke 16.21 16.19 6 54401 247 90573793

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 3275.25 14.23 1935 60415 95791 42463194
Ischaemic stroke 2521.03 14.23 1016 61334 21217 42537768
Cerebrovascular accident 1827.04 14.23 1343 61007 95817 42463168
Haemorrhage 1448.68 14.23 971 61379 59592 42499393
Melaena 1029.65 14.23 664 61686 38082 42520903
Rectal haemorrhage 985.17 14.23 710 61640 48896 42510089
Haemorrhage intracranial 965.26 14.23 481 61869 16711 42542274
Cerebral haemorrhage 874.04 14.23 601 61749 38365 42520620
Cerebral infarction 864.69 14.23 549 61801 30620 42528365
Cardiac tamponade 761.17 14.23 305 62045 6235 42552750
Subdural haematoma 739.20 14.23 446 61904 22692 42536293
Atrial thrombosis 682.02 14.23 218 62132 2226 42556759
Embolic stroke 614.16 14.23 243 62107 4797 42554188
Haematuria 586.98 14.23 561 61789 57238 42501747
Fall 453.69 14.23 1034 61316 233486 42325499
Lower gastrointestinal haemorrhage 439.93 14.23 244 62106 10564 42548421
Transient ischaemic attack 405.47 14.23 360 61990 33379 42525606
Gastric haemorrhage 397.07 14.23 226 62124 10289 42548696
Activated partial thromboplastin time prolonged 381.65 14.23 256 62094 15647 42543338
Procoagulant therapy 372.20 14.23 69 62281 10 42558975
Shock haemorrhagic 353.14 14.23 246 62104 15996 42542989
Hemiparesis 331.39 14.23 243 62107 17133 42541852
Coagulopathy 316.22 14.23 261 62089 21901 42537084
Pericardial haemorrhage 296.50 14.23 131 62219 3438 42555547
Upper gastrointestinal haemorrhage 292.03 14.23 286 62064 30013 42528972
Blood loss anaemia 270.94 14.23 172 62178 9564 42549421
Haematoma 254.29 14.23 256 62094 27767 42531218
Thrombin time prolonged 246.74 14.23 57 62293 133 42558852
Subarachnoid haemorrhage 241.77 14.23 187 62163 14285 42544700
Off label use 219.21 14.23 375 61975 637960 41921025
Epistaxis 215.51 14.23 366 61984 66460 42492525
Haemorrhagic stroke 211.54 14.23 133 62217 7269 42551716
Haematemesis 193.92 14.23 230 62120 29969 42529016
Aortic dissection 193.33 14.23 93 62257 2979 42556006
Haemothorax 190.84 14.23 110 62240 5126 42553859
Febrile neutropenia 189.92 14.23 24 62326 185679 42373306
Aphasia 187.97 14.23 203 62147 23880 42535105
Head injury 172.15 14.23 180 62170 20402 42538583
Neutropenia 170.80 14.23 41 62309 199390 42359595
Cardiac failure 168.18 14.23 436 61914 106420 42452565
Deep vein thrombosis 168.07 14.23 357 61993 76600 42482385
Procedural haemorrhage 166.74 14.23 82 62268 2759 42556226
International normalised ratio increased 164.83 14.23 271 62079 47897 42511088
Hemiplegia 161.15 14.23 115 62235 7764 42551221
Anaemia 161.13 14.23 822 61528 279456 42279529
Subdural haemorrhage 156.15 14.23 84 62266 3417 42555568
Intracardiac thrombus 154.18 14.23 74 62276 2358 42556627
Drug interaction 149.90 14.23 778 61572 266221 42292764
Haemorrhagic transformation stroke 149.60 14.23 66 62284 1725 42557260
Haematochezia 147.63 14.23 288 62062 58148 42500837
Pyrexia 139.82 14.23 226 62124 393816 42165169
Product dose omission issue 137.61 14.23 29 62321 154336 42404649
Pulmonary embolism 137.59 14.23 436 61914 119176 42439809
Post procedural haemorrhage 131.38 14.23 109 62241 9203 42549782
Disease progression 130.09 14.23 26 62324 143630 42415355
Product use in unapproved indication 126.15 14.23 56 62294 184400 42374585
Haemoptysis 124.54 14.23 234 62116 45933 42513052
Intestinal haemorrhage 123.05 14.23 75 62275 3876 42555109
Brain contusion 118.20 14.23 47 62303 939 42558046
Pericardial effusion 115.72 14.23 176 62174 29099 42529886
Cerebral haematoma 110.41 14.23 80 62270 5530 42553455
Drug abuse 108.35 14.23 13 62337 104758 42454227
Dyspepsia 108.32 14.23 207 62143 41145 42517840
Heart transplant 106.53 14.23 44 62306 973 42558012
Haemoglobin decreased 104.56 14.23 427 61923 132044 42426941
Peripheral embolism 101.79 14.23 43 62307 1008 42557977
Traumatic intracranial haemorrhage 101.37 14.23 39 62311 711 42558274
Anticoagulation drug level increased 94.78 14.23 35 62315 567 42558418
Toxicity to various agents 94.38 14.23 118 62232 229018 42329967
Faeces discoloured 93.73 14.23 120 62230 16894 42542091
Completed suicide 92.62 14.23 15 62335 96450 42462535
Colon cancer 92.50 14.23 91 62259 9590 42549395
Intraventricular haemorrhage 91.88 14.23 62 62288 3822 42555163
Fatigue 91.54 14.23 329 62021 435312 42123673
Pain 89.91 14.23 137 62213 244711 42314274
Rash 87.96 14.23 170 62180 276784 42282201
Large intestinal haemorrhage 84.22 14.23 44 62306 1685 42557300
Cerebral artery occlusion 83.46 14.23 35 62315 805 42558180
Activated partial thromboplastin time abnormal 83.19 14.23 23 62327 134 42558851
Road traffic accident 82.93 14.23 120 62230 18973 42540012
Extradural haematoma 82.29 14.23 40 62310 1311 42557674
Oesophageal pain 79.90 14.23 36 62314 990 42557995
International normalised ratio abnormal 79.44 14.23 54 62296 3369 42555616
Renal impairment 78.92 14.23 345 62005 109883 42449102
Leukopenia 77.95 14.23 9 62341 74737 42484248
Pancytopenia 76.96 14.23 38 62312 117705 42441280
Urinary bladder haemorrhage 73.22 14.23 41 62309 1806 42557179
Drug hypersensitivity 73.05 14.23 27 62323 99362 42459623
Pulmonary haemorrhage 71.80 14.23 86 62264 11311 42547674
White blood cell count decreased 70.10 14.23 37 62313 110359 42448626
Haemorrhagic infarction 69.84 14.23 27 62323 499 42558486
Depression 69.72 14.23 38 62312 111325 42447660
Hypovolaemic shock 69.31 14.23 74 62276 8585 42550400
Condition aggravated 68.88 14.23 177 62173 260577 42298408
Coagulation time prolonged 68.49 14.23 36 62314 1396 42557589
Blood urine present 68.19 14.23 85 62265 11648 42547337
Acute kidney injury 67.58 14.23 827 61523 366510 42192475
Drug ineffective 66.79 14.23 596 61754 629601 41929384
Arthralgia 65.08 14.23 126 62224 205112 42353873
Aortic aneurysm rupture 64.67 14.23 32 62318 1091 42557894
Coagulation test abnormal 63.75 14.23 27 62323 637 42558348
Gingival bleeding 63.52 14.23 70 62280 8415 42550570
Neuropathy peripheral 63.40 14.23 35 62315 101818 42457167
Creatinine renal clearance decreased 63.20 14.23 48 62302 3565 42555420
Intentional product use issue 62.93 14.23 14 62336 71819 42487166
Embolic cerebral infarction 62.34 14.23 29 62321 860 42558125
Contusion 61.55 14.23 167 62183 41818 42517167
Haemorrhoidal haemorrhage 61.11 14.23 50 62300 4138 42554847
Splenic rupture 61.08 14.23 35 62315 1612 42557373
Diarrhoea 60.83 14.23 410 61940 460439 42098546
Embolism 59.98 14.23 69 62281 8694 42550291
Cerebral mass effect 59.47 14.23 32 62318 1302 42557683
Wound secretion 59.40 14.23 42 62308 2793 42556192
Infusion related reaction 59.39 14.23 9 62341 60797 42498188
Skull fracture 58.33 14.23 29 62321 999 42557986
Neutrophil count decreased 54.27 14.23 13 62337 63402 42495583
Weight increased 54.09 14.23 47 62303 107936 42451049
Renal failure 53.62 14.23 377 61973 143349 42415636
Injection site pain 53.25 14.23 10 62340 57788 42501197
Prothrombin time prolonged 52.48 14.23 67 62283 9402 42549583
Cardiac ablation 52.13 14.23 29 62321 1261 42557724
Malignant neoplasm progression 52.13 14.23 49 62301 108351 42450634
Cerebral artery embolism 51.87 14.23 27 62323 1026 42557959
Anorectal discomfort 50.97 14.23 35 62315 2220 42556765
Coagulation time shortened 50.91 14.23 17 62333 201 42558784
Traumatic haemothorax 50.55 14.23 20 62330 394 42558591
Cytokine release syndrome 50.01 14.23 4 62346 44523 42514462
Product use issue 49.79 14.23 25 62325 76726 42482259
Thrombin time abnormal 49.76 14.23 9 62341 0 42558985
Stress 49.57 14.23 4 62346 44208 42514777
Chills 49.51 14.23 39 62311 94027 42464958
Mucosal inflammation 48.93 14.23 7 62343 49367 42509618
Muscle spasms 48.76 14.23 33 62317 86011 42472974
Basal ganglia haemorrhage 48.68 14.23 26 62324 1042 42557943
Embolism arterial 48.43 14.23 24 62326 821 42558164
Nausea 48.40 14.23 361 61989 396438 42162547
Craniocerebral injury 48.18 14.23 42 62308 3792 42555193
Cerebellar haemorrhage 47.20 14.23 30 62320 1670 42557315
Surgery 47.11 14.23 89 62261 17527 42541458
Incarcerated hernia 47.10 14.23 15 62335 151 42558834
Traumatic haemorrhage 46.99 14.23 27 62323 1250 42557735
Acute abdomen 46.95 14.23 32 62318 2005 42556980
Oesophageal ulcer 46.88 14.23 41 62309 3718 42555267
Retroperitoneal haemorrhage 46.74 14.23 38 62312 3117 42555868
Inappropriate schedule of product administration 46.52 14.23 43 62307 95859 42463126
Acute myocardial infarction 46.21 14.23 188 62162 57977 42501008
Anxiety 45.73 14.23 64 62286 118496 42440489
Somnolence 45.24 14.23 86 62264 141019 42417966
Rheumatoid arthritis 44.52 14.23 5 62345 42435 42516550
Tremor 44.09 14.23 46 62304 96883 42462102
COVID-19 43.33 14.23 64 62286 115884 42443101
Subarachnoid haematoma 43.22 14.23 16 62334 261 42558724
Intra-abdominal haemorrhage 42.81 14.23 35 62315 2893 42556092
Diverticulum 42.81 14.23 54 62296 7487 42551498
Insomnia 42.53 14.23 67 62283 118186 42440799
Asthma 42.41 14.23 19 62331 62295 42496690
Syncope 42.00 14.23 269 62081 99137 42459848
Multiple injuries 41.76 14.23 29 62321 1873 42557112
Drug intolerance 41.50 14.23 34 62316 80390 42478595
Hospitalisation 41.46 14.23 29 62321 74301 42484684
Large intestine polyp 41.35 14.23 59 62291 9206 42549779
Cardiac valve replacement complication 40.99 14.23 10 62340 32 42558953
Erythema 40.70 14.23 60 62290 108733 42450252
Mouth haemorrhage 40.68 14.23 48 62302 6213 42552772
Nasopharyngitis 40.34 14.23 38 62312 83958 42475027
Cough 40.30 14.23 130 62220 177973 42381012
Musculoskeletal stiffness 40.28 14.23 17 62333 57748 42501237
Gastric ulcer haemorrhage 39.86 14.23 47 62303 6080 42552905
Pruritus 39.85 14.23 142 62208 188629 42370356
Haemorrhage urinary tract 39.35 14.23 29 62321 2057 42556928
Dry skin 39.27 14.23 11 62339 48327 42510658
Agitation 38.72 14.23 23 62327 64291 42494694
Activated partial thromboplastin time 38.70 14.23 7 62343 0 42558985
Dysarthria 38.49 14.23 137 62213 39670 42519315
Ischaemia 38.41 14.23 42 62308 5005 42553980
International normalised ratio 38.13 14.23 10 62340 46 42558939
Intestinal ischaemia 37.87 14.23 57 62293 9331 42549654
Loss of personal independence in daily activities 37.49 14.23 13 62337 49803 42509182
Strangulated hernia 36.61 14.23 9 62341 30 42558955
Stomatitis 36.42 14.23 14 62336 50315 42508670
Joint swelling 36.04 14.23 28 62322 67994 42490991
Platelet count decreased 35.81 14.23 95 62255 138486 42420499
Haemorrhoids 35.75 14.23 78 62272 17019 42541966
Cerebral ischaemia 35.09 14.23 47 62303 6912 42552073
Iron deficiency anaemia 35.02 14.23 66 62284 12973 42546012
Intracranial haematoma 34.78 14.23 17 62333 564 42558421
Anticoagulation drug level abnormal 34.77 14.23 12 62338 158 42558827
Wound haemorrhage 34.58 14.23 28 62322 2283 42556702
Haemodynamic instability 34.27 14.23 64 62286 12493 42546492
Arterial thrombosis 34.21 14.23 25 62325 1751 42557234
Seizure 34.00 14.23 79 62271 120482 42438503
Injury 33.94 14.23 90 62260 22226 42536759
Urogenital haemorrhage 33.82 14.23 18 62332 716 42558269
Cardioversion 33.75 14.23 20 62330 981 42558004
Weight decreased 33.70 14.23 173 62177 207775 42351210
Infection 33.60 14.23 71 62279 111997 42446988
Cytomegalovirus infection 33.40 14.23 4 62346 32302 42526683
Prothrombin time abnormal 33.38 14.23 19 62331 864 42558121
Femur fracture 33.25 14.23 55 62295 9757 42549228
Renal infarct 32.90 14.23 25 62325 1858 42557127
Diabetes mellitus 32.78 14.23 24 62326 60063 42498922
Ecchymosis 32.61 14.23 48 62302 7704 42551281
Arrhythmia 32.56 14.23 131 62219 40186 42518799
Sleep disorder 32.20 14.23 15 62335 48080 42510905
Alanine aminotransferase increased 31.86 14.23 50 62300 88356 42470629
Facial asymmetry 31.83 14.23 14 62336 363 42558622
Exsanguination 31.78 14.23 9 62341 58 42558927
Cerebellar infarction 31.49 14.23 26 62324 2179 42556806
Arteriovenous malformation 31.49 14.23 18 62332 825 42558160
Psoriasis 31.26 14.23 16 62334 48588 42510397
Sedation 30.95 14.23 4 62346 30471 42528514
Vomiting 30.93 14.23 273 62077 289450 42269535
Therapeutic response decreased 30.86 14.23 8 62342 37004 42521981
Peripheral artery thrombosis 30.82 14.23 28 62322 2669 42556316
Gastrointestinal motility disorder 30.81 14.23 29 62321 2892 42556093
Mesenteric artery embolism 30.77 14.23 9 62341 66 42558919
Creatinine renal clearance 30.75 14.23 6 62344 3 42558982
Elderly 30.75 14.23 6 62344 3 42558982
Anastomotic infection 30.28 14.23 10 62340 114 42558871
C-reactive protein increased 30.23 14.23 29 62321 63531 42495454
Gastric ulcer 30.19 14.23 76 62274 18186 42540799
Occult blood positive 29.95 14.23 34 62316 4223 42554762
Cardiac perforation 29.77 14.23 9 62341 75 42558910
Rib fracture 29.56 14.23 71 62279 16500 42542485
Therapy non-responder 29.51 14.23 21 62329 53338 42505647
Bleeding time prolonged 29.49 14.23 16 62334 662 42558323
Gastrointestinal angiodysplasia 29.49 14.23 16 62334 662 42558323
Haemorrhage subcutaneous 29.32 14.23 27 62323 2619 42556366
Cardiac ventricular thrombosis 29.24 14.23 23 62327 1799 42557186
Thrombotic stroke 29.23 14.23 12 62338 261 42558724
Oxygen saturation decreased 29.07 14.23 31 62319 64656 42494329
Thrombocytopenia 28.77 14.23 162 62188 190117 42368868
Anticoagulation drug level decreased 28.72 14.23 11 62339 198 42558787
Haemorrhagic diathesis 28.66 14.23 29 62321 3160 42555825
Femoral neck fracture 28.57 14.23 33 62317 4176 42554809
Blood cholesterol increased 28.43 14.23 3 62347 26738 42532247
Neurologic neglect syndrome 28.42 14.23 11 62339 204 42558781
Sinusitis 28.34 14.23 17 62333 47275 42511710
Rectal cancer 28.14 14.23 25 62325 2315 42556670
Anticoagulant-related nephropathy 27.60 14.23 10 62340 153 42558832
Thrombosis 27.46 14.23 183 62167 68328 42490657
Mucosal haemorrhage 27.45 14.23 22 62328 1768 42557217
Haemoglobin abnormal 27.31 14.23 35 62315 4929 42554056
Hemianopia 27.26 14.23 17 62333 915 42558070
Drug ineffective for unapproved indication 27.10 14.23 17 62333 46146 42512839
Lumbar puncture 27.06 14.23 9 62341 105 42558880
Gastritis erosive 26.97 14.23 40 62310 6463 42552522
Influenza 26.62 14.23 31 62319 62144 42496841
Gastric cancer 26.56 14.23 41 62309 6862 42552123
Mucosal dryness 26.53 14.23 21 62329 1657 42557328
Productive cough 26.35 14.23 22 62328 51545 42507440
Diverticulum intestinal haemorrhagic 26.30 14.23 27 62323 2992 42555993
Infarction 26.19 14.23 27 62323 3008 42555977
Anaphylactic reaction 26.13 14.23 15 62335 42728 42516257
Gastrointestinal carcinoma 25.84 14.23 22 62328 1924 42557061
Aneurysm ruptured 25.39 14.23 14 62336 598 42558387
Blood glucose increased 25.32 14.23 43 62307 73656 42485329
Basilar artery occlusion 25.26 14.23 8 62342 79 42558906
Renal haemorrhage 25.04 14.23 20 62330 1599 42557386
Brain herniation 24.97 14.23 33 62317 4790 42554195
Wheezing 24.90 14.23 26 62324 54755 42504230
Peripheral swelling 24.76 14.23 60 62290 90210 42468775
Blood pressure increased 24.74 14.23 72 62278 101856 42457129
Urticaria 24.71 14.23 44 62306 73992 42484993
Feeling abnormal 24.64 14.23 40 62310 69746 42489239
White blood cell count increased 24.60 14.23 18 62332 45069 42513916
Thalamus haemorrhage 24.43 14.23 17 62333 1102 42557883
Myocardial infarction 24.34 14.23 283 62067 123726 42435259
Blood creatine phosphokinase increased 24.24 14.23 21 62329 48317 42510668
Hyperhidrosis 24.17 14.23 61 62289 90451 42468534
Arterial injury 24.07 14.23 12 62338 416 42558569
Pulmonary contusion 24.00 14.23 8 62342 94 42558891
Osteoma 24.00 14.23 8 62342 94 42558891
Pain in extremity 23.98 14.23 126 62224 150478 42408507
Pneumocystis jirovecii pneumonia 23.97 14.23 4 62346 25177 42533808
Myalgia 23.96 14.23 67 62283 96013 42462972
Full blood count abnormal 23.90 14.23 7 62343 29869 42529116
Aspartate aminotransferase increased 23.87 14.23 48 62302 77115 42481870
Hemianopia homonymous 23.81 14.23 15 62335 822 42558163
Eczema 23.81 14.23 10 62340 34076 42524909
Hyponatraemia 23.67 14.23 73 62277 101389 42457596
Polycystic liver disease 23.63 14.23 8 62342 99 42558886
Aggression 23.62 14.23 18 62332 44145 42514840
Irritability 23.61 14.23 6 62344 28122 42530863
Back pain 23.49 14.23 117 62233 141659 42417326
Ascites 23.47 14.23 29 62321 56649 42502336
Hypersensitivity 23.27 14.23 44 62306 72326 42486659
Lymphocyte count decreased 23.21 14.23 6 62344 27803 42531182
Splenic injury 23.17 14.23 6 62344 26 42558959
Aortic aneurysm 23.15 14.23 41 62309 7682 42551303
Venous thrombosis 23.07 14.23 29 62321 4006 42554979
Respiratory tract haemorrhage 23.07 14.23 18 62332 1391 42557594
Rhabdomyolysis 22.90 14.23 50 62300 77969 42481016
Neoplasm progression 22.82 14.23 7 62343 28993 42529992
Cardiac failure chronic 22.63 14.23 46 62304 9555 42549430
Catheter site haemorrhage 22.59 14.23 23 62327 2525 42556460
Small intestinal haemorrhage 22.45 14.23 22 62328 2306 42556679
Subcutaneous haematoma 22.43 14.23 16 62334 1079 42557906
Acute myeloid leukaemia 22.41 14.23 3 62347 22253 42536732
Splenic necrosis 22.41 14.23 8 62342 117 42558868
Pneumonitis 22.32 14.23 17 62333 41701 42517284
Dysphagia 22.16 14.23 182 62168 72537 42486448
Traumatic haematoma 22.14 14.23 14 62336 772 42558213
Suicidal ideation 21.72 14.23 23 62327 48138 42510847
Skull fractured base 21.50 14.23 9 62341 206 42558779
Splenic cyst 21.42 14.23 8 62342 134 42558851
Cataract 21.34 14.23 9 62341 30595 42528390
Post procedural stroke 21.27 14.23 6 62344 38 42558947
Cardiac pacemaker insertion 21.27 14.23 25 62325 3223 42555762
Atrial fibrillation 21.25 14.23 304 62046 139289 42419696
Cholecystitis acute 21.05 14.23 39 62311 7567 42551418
Haemoglobin urine present 20.99 14.23 8 62342 142 42558843
Constipation 20.99 14.23 145 62205 162146 42396839
Psychotic disorder due to a general medical condition 20.95 14.23 7 62343 83 42558902
Microcytic anaemia 20.94 14.23 24 62326 3011 42555974
Labelled drug-drug interaction medication error 20.88 14.23 60 62290 15522 42543463
Pneumonia 20.81 14.23 465 61885 421684 42137301
Pulmonary alveolar haemorrhage 20.78 14.23 58 62292 14758 42544227
Oesophagitis 20.71 14.23 59 62291 15188 42543797
Shock 20.69 14.23 91 62259 29030 42529955
Haematocrit increased 20.65 14.23 22 62328 2545 42556440
Herpes zoster 20.59 14.23 16 62334 38861 42520124
Neuralgia 20.53 14.23 6 62344 25641 42533344
Intentional product misuse 20.46 14.23 37 62313 61863 42497122
Coronary artery embolism 20.39 14.23 8 62342 154 42558831
Diabetic ketoacidosis 20.32 14.23 4 62346 22363 42536622
Puncture site haemorrhage 20.23 14.23 10 62340 340 42558645
Drug reaction with eosinophilia and systemic symptoms 20.23 14.23 19 62331 42056 42516929
Arthritis 20.22 14.23 19 62331 42046 42516939
Intestinal infarction 20.19 14.23 12 62338 592 42558393
Arthropathy 20.17 14.23 9 62341 29588 42529397
Left atrial dilatation 20.06 14.23 21 62329 2381 42556604
Feeling hot 19.72 14.23 5 62345 23477 42535508
Influenza like illness 19.71 14.23 11 62339 31829 42527156
Hypoxia 19.44 14.23 46 62304 69740 42489245
Non-compaction cardiomyopathy 19.44 14.23 6 62344 54 42558931
Colitis ulcerative 19.40 14.23 7 62343 26168 42532817
Candida infection 19.35 14.23 4 62346 21606 42537379
Prostate tenderness 19.34 14.23 6 62344 55 42558930
Factor V deficiency 19.24 14.23 5 62345 22 42558963
Neutrophil count increased 19.17 14.23 3 62347 19801 42539184
Urinary sediment present 19.13 14.23 9 62341 274 42558711
Eye haemorrhage 19.02 14.23 29 62321 4801 42554184
Cerebral thrombosis 18.99 14.23 14 62336 994 42557991
Haemoperitoneum 18.95 14.23 19 62331 2047 42556938
Peripheral ischaemia 18.89 14.23 34 62316 6451 42552534
Anticoagulation drug level below therapeutic 18.76 14.23 14 62336 1012 42557973
Haemarthrosis 18.64 14.23 26 62324 3972 42555013
Hepatic cytolysis 18.55 14.23 8 62342 26836 42532149
Dyskinesia 18.47 14.23 7 62343 25383 42533602
Toxic epidermal necrolysis 18.44 14.23 8 62342 26742 42532243
Colon neoplasm 18.32 14.23 11 62339 553 42558432
Blood pressure systolic increased 18.29 14.23 9 62341 27959 42531026
Bone pain 18.26 14.23 6 62344 23786 42535199
Lower respiratory tract infection 18.23 14.23 20 62330 41186 42517799
Cerebellar haematoma 18.17 14.23 8 62342 208 42558777
Abnormal behaviour 18.09 14.23 8 62342 26443 42532542
Colitis 18.08 14.23 25 62325 46547 42512438
Bacteraemia 18.05 14.23 7 62343 25033 42533952
Muscle haemorrhage 18.01 14.23 26 62324 4099 42554886
Respiratory depression 17.95 14.23 3 62347 18865 42540120
Anaphylactic shock 17.93 14.23 6 62344 23511 42535474
Gastritis 17.91 14.23 76 62274 23871 42535114
Prothrombin time ratio decreased 17.88 14.23 11 62339 578 42558407
Blood lactate dehydrogenase increased 17.66 14.23 8 62342 26073 42532912
Hallucination 17.59 14.23 36 62314 57471 42501514
Skin exfoliation 17.48 14.23 21 62329 41532 42517453
Colitis ischaemic 17.48 14.23 35 62315 7191 42551794
Encephalopathy 17.27 14.23 21 62329 41312 42517673
Prothrombin time shortened 17.19 14.23 16 62334 1573 42557412
Hypovolaemia 17.14 14.23 46 62304 11439 42547546
Intestinal mass 17.13 14.23 11 62339 623 42558362
Cerebral vascular occlusion 17.12 14.23 4 62346 10 42558975
Abdominal strangulated hernia 17.12 14.23 4 62346 10 42558975
Diverticulitis intestinal haemorrhagic 17.03 14.23 9 62341 353 42558632
Upper respiratory tract infection 17.02 14.23 22 62328 42151 42516834
Haematocrit decreased 16.97 14.23 98 62252 34810 42524175
Vision blurred 16.95 14.23 33 62317 53666 42505319
Bronchiectasis 16.84 14.23 3 62347 18016 42540969
Orthopaedic procedure 16.83 14.23 5 62345 39 42558946
Iliac artery embolism 16.59 14.23 3 62347 0 42558985
Anti factor VIII antibody test 16.59 14.23 3 62347 0 42558985
Inguinal hernia strangulated 16.59 14.23 3 62347 0 42558985
Gastrointestinal necrosis 16.56 14.23 25 62325 4103 42554882
Internal haemorrhage 16.54 14.23 29 62321 5392 42553593
Conjunctival haemorrhage 16.51 14.23 23 62327 3510 42555475
Gastritis haemorrhagic 16.48 14.23 16 62334 1658 42557327
Nightmare 16.43 14.23 8 62342 25004 42533981
Tumour lysis syndrome 16.39 14.23 6 62344 22225 42536760
Incarcerated inguinal hernia 16.38 14.23 8 62342 265 42558720
Pericardial fibrosis 16.26 14.23 7 62343 172 42558813
Cytopenia 16.17 14.23 3 62347 17494 42541491
Palmar-plantar erythrodysaesthesia syndrome 16.14 14.23 5 62345 20577 42538408
No adverse event 16.12 14.23 20 62330 39001 42519984
Putamen haemorrhage 16.11 14.23 8 62342 275 42558710
Disease recurrence 15.99 14.23 12 62338 29666 42529319
Myocarditis 15.97 14.23 4 62346 18934 42540051
Accidental exposure to product 15.91 14.23 5 62345 20388 42538597
Skin laceration 15.89 14.23 51 62299 14007 42544978
Mitral valve replacement 15.79 14.23 7 62343 185 42558800
Lacunar stroke 15.71 14.23 8 62342 290 42558695
Haemochromatosis 15.65 14.23 13 62337 1099 42557886
Brain oedema 15.61 14.23 56 62294 16271 42542714
Myoclonus 15.61 14.23 3 62347 17062 42541923
Gait disturbance 15.58 14.23 82 62268 97918 42461067
Aortic intramural haematoma 15.55 14.23 5 62345 52 42558933
Atrial flutter 15.51 14.23 58 62292 17193 42541792
Ulcer haemorrhage 15.46 14.23 21 62329 3129 42555856
Chest injury 15.34 14.23 16 62334 1806 42557179
Decreased appetite 15.29 14.23 195 62155 192942 42366043
Hypocalcaemia 15.26 14.23 13 62337 30160 42528825
Plasma cell myeloma 15.23 14.23 29 62321 47549 42511436
Carotid artery stenosis 15.20 14.23 28 62322 5408 42553577
Acute respiratory distress syndrome 15.19 14.23 13 62337 30095 42528890
Presyncope 15.18 14.23 69 62281 22318 42536667
Viral infection 15.07 14.23 7 62343 22476 42536509
Meningorrhagia 14.99 14.23 6 62344 122 42558863
Speech disorder 14.97 14.23 83 62267 29038 42529947
Haemorrhagic disorder 14.92 14.23 11 62339 781 42558204
Ischaemic cerebral infarction 14.87 14.23 15 62335 1628 42557357
Thrombotic cerebral infarction 14.85 14.23 9 62341 460 42558525
Right hemisphere deficit syndrome 14.82 14.23 4 62346 21 42558964
Duodenitis 14.77 14.23 28 62322 5528 42553457
Obstructive airways disorder 14.69 14.23 9 62341 24750 42534235
Muscle strain 14.63 14.23 25 62325 4552 42554433
Blood pressure systolic inspiratory decreased 14.51 14.23 3 62347 3 42558982
Mesenteric haemorrhage 14.51 14.23 4 62346 23 42558962
Lordosis 14.48 14.23 8 62342 343 42558642
Retroperitoneal haematoma 14.46 14.23 20 62330 3031 42555954
Coronary artery occlusion 14.40 14.23 42 62308 10955 42548030
Angioedema 14.39 14.23 25 62325 42452 42516533
Vascular stent occlusion 14.38 14.23 7 62343 230 42558755
Splenic lesion 14.38 14.23 8 62342 348 42558637
Paresis 14.37 14.23 18 62332 2478 42556507
Hypercoagulation 14.31 14.23 14 62336 1465 42557520
Osteonecrosis of jaw 14.28 14.23 5 62345 19044 42539941
Thoracic haemorrhage 14.27 14.23 7 62343 234 42558751

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 5808.02 13.74 2840 93454 162678 110330327
Ischaemic stroke 4363.08 13.74 1558 94736 39705 110453300
Cerebrovascular accident 2356.48 13.74 1635 94659 179649 110313356
Melaena 2086.06 13.74 1072 95222 67685 110425320
Haemorrhage 2057.42 13.74 1234 95060 105458 110387547
Haemorrhage intracranial 1670.55 13.74 705 95589 28264 110464741
Cerebral haemorrhage 1543.12 13.74 861 95433 64107 110428898
Rectal haemorrhage 1497.24 13.74 1056 95238 118777 110374228
Cerebral infarction 1374.59 13.74 739 95555 51099 110441906
Cardiac tamponade 1280.86 13.74 450 95844 10857 110482148
Subdural haematoma 1161.78 13.74 588 95706 35866 110457139
Lower gastrointestinal haemorrhage 950.54 13.74 415 95879 18071 110474934
Embolic stroke 937.12 13.74 334 95960 8409 110484596
Haematuria 911.76 13.74 677 95617 82328 110410677
Activated partial thromboplastin time prolonged 835.19 13.74 402 95892 21966 110471039
Atrial thrombosis 801.76 13.74 250 96044 4096 110488909
Fall 799.18 13.74 1675 94619 601807 109891198
Shock haemorrhagic 771.46 13.74 406 95888 26841 110466164
Coagulopathy 697.51 13.74 438 95856 40473 110452532
Upper gastrointestinal haemorrhage 654.03 13.74 454 95840 49642 110443363
Drug interaction 595.62 13.74 1331 94963 498852 109994153
Haematoma 588.88 13.74 453 95841 58023 110434982
Transient ischaemic attack 563.42 13.74 458 95836 63524 110429481
Gastric haemorrhage 531.17 13.74 265 96029 15650 110477355
Subarachnoid haemorrhage 513.80 13.74 321 95973 29381 110463624
Blood loss anaemia 511.36 13.74 269 96025 17756 110475249
Pericardial haemorrhage 501.77 13.74 184 96110 5033 110487972
Anaemia 499.28 13.74 1314 94980 545772 109947233
Hemiparesis 492.83 13.74 363 95931 43540 110449465
Haemorrhagic stroke 449.57 13.74 226 96068 13563 110479442
International normalised ratio increased 445.44 13.74 459 95835 86313 110406692
Haematemesis 429.73 13.74 379 95915 58729 110434276
Thrombin time prolonged 427.97 13.74 91 96203 259 110492746
Haematochezia 406.41 13.74 502 95792 115022 110377983
Cardiac failure 395.70 13.74 638 95656 186988 110306017
Epistaxis 348.21 13.74 495 95799 129877 110363128
Haemoglobin decreased 344.90 13.74 705 95589 248022 110244983
Acute kidney injury 327.90 13.74 1254 95040 634176 109858829
Subdural haemorrhage 323.35 13.74 143 96151 6415 110486590
Deep vein thrombosis 304.86 13.74 483 95811 139404 110353601
Pain 301.41 13.74 235 96059 954720 109538285
Aortic dissection 300.72 13.74 125 96169 4808 110488197
Pulmonary embolism 290.28 13.74 602 95692 213872 110279133
Haemothorax 288.81 13.74 135 96159 6896 110486109
Procoagulant therapy 286.28 13.74 50 96244 19 110492986
Intestinal haemorrhage 274.14 13.74 132 96162 7209 110485796
Drug hypersensitivity 253.24 13.74 45 96249 454045 110038960
Cerebral haematoma 245.81 13.74 134 96160 9498 110483507
Infusion related reaction 245.34 13.74 24 96270 381138 110111867
Aphasia 244.75 13.74 279 96015 58718 110434287
Procedural haemorrhage 244.16 13.74 111 96183 5316 110487689
Haemoptysis 242.72 13.74 305 95989 71049 110421956
Renal failure 240.27 13.74 577 95717 225997 110267008
Head injury 237.90 13.74 237 96057 42780 110450225
Rash 229.85 13.74 226 96068 820738 109672267
Off label use 224.46 13.74 623 95671 1499562 108993443
Hypovolaemic shock 218.47 13.74 144 96150 14439 110478566
Faeces discoloured 215.93 13.74 202 96092 33746 110459259
Synovitis 214.62 13.74 5 96289 274087 110218918
Hemiplegia 210.87 13.74 168 96126 22614 110470391
Joint swelling 207.20 13.74 64 96230 442781 110050224
Post procedural haemorrhage 205.67 13.74 142 96152 15370 110477635
Renal impairment 204.16 13.74 484 95810 187961 110305044
Systemic lupus erythematosus 197.75 13.74 5 96289 254333 110238672
Maternal exposure during pregnancy 190.98 13.74 7 96287 254876 110238129
Arthropathy 190.64 13.74 16 96278 287506 110205499
Fatigue 190.63 13.74 493 95801 1215465 109277540
Febrile neutropenia 188.74 13.74 26 96268 316741 110176264
Nasopharyngitis 186.26 13.74 56 96238 394305 110098700
Drug intolerance 186.15 13.74 61 96233 406451 110086554
Pericardial effusion 185.77 13.74 239 96055 56978 110436027
Rheumatoid arthritis 184.77 13.74 22 96272 299591 110193414
Peripheral embolism 181.82 13.74 68 96226 1967 110491038
Anticoagulation drug level increased 178.89 13.74 56 96238 929 110492076
Pyrexia 176.38 13.74 321 95973 897944 109595061
Weight increased 175.28 13.74 73 96221 419571 110073434
Product use in unapproved indication 172.60 13.74 87 96207 447290 110045715
Hypersensitivity 172.44 13.74 68 96226 403930 110089075
Haemorrhagic transformation stroke 171.89 13.74 73 96221 2964 110490041
Coagulation time prolonged 171.37 13.74 72 96222 2845 110490160
Arthralgia 171.21 13.74 259 96035 779373 109713632
Cerebral artery occlusion 169.05 13.74 64 96230 1916 110491089
Traumatic intracranial haemorrhage 168.07 13.74 59 96235 1417 110491588
Syncope 166.53 13.74 469 95825 202067 110290938
Glossodynia 163.26 13.74 7 96287 221997 110271008
Intraventricular haemorrhage 161.34 13.74 84 96210 5423 110487582
Alopecia 157.96 13.74 60 96234 364693 110128312
Stomatitis 156.75 13.74 24 96270 270218 110222787
Intracardiac thrombus 154.10 13.74 75 96219 4193 110488812
Large intestinal haemorrhage 153.31 13.74 68 96226 3071 110489934
Neutropenia 151.92 13.74 68 96226 374552 110118453
Brain contusion 151.31 13.74 56 96238 1572 110491433
Atrial fibrillation 146.89 13.74 487 95807 229155 110263850
Sinusitis 145.85 13.74 39 96255 296649 110196356
Musculoskeletal stiffness 142.92 13.74 34 96260 279788 110213217
Completed suicide 139.49 13.74 22 96272 242359 110250646
Product dose omission issue 139.20 13.74 53 96241 321729 110171276
Prothrombin time prolonged 138.18 13.74 117 96177 17144 110475861
Hypotension 137.91 13.74 853 95441 522996 109970009
Therapeutic product effect decreased 136.55 13.74 24 96270 244292 110248713
Lower respiratory tract infection 135.62 13.74 24 96270 243082 110249923
Helicobacter infection 132.85 13.74 6 96288 181871 110311134
Condition aggravated 132.47 13.74 276 96018 734560 109758445
Folliculitis 131.43 13.74 3 96291 167650 110325355
Haemorrhoidal haemorrhage 126.32 13.74 82 96212 8011 110484994
Heart transplant 126.03 13.74 49 96245 1579 110491426
Pulmonary haemorrhage 124.52 13.74 108 96186 16348 110476657
Activated partial thromboplastin time abnormal 124.02 13.74 34 96260 344 110492661
International normalised ratio abnormal 123.44 13.74 74 96220 6283 110486722
Intentional product use issue 122.95 13.74 32 96262 247874 110245131
Craniocerebral injury 122.87 13.74 72 96222 5862 110487143
Irritable bowel syndrome 121.32 13.74 5 96289 164210 110328795
Asthma 119.10 13.74 35 96259 250256 110242749
Blood cholesterol increased 115.31 13.74 13 96281 184772 110308233
Peripheral swelling 114.23 13.74 110 96184 403924 110089081
Gingival bleeding 112.81 13.74 111 96183 19728 110473277
Wheezing 112.11 13.74 41 96253 255189 110237816
Embolic cerebral infarction 111.90 13.74 44 96250 1462 110491543
Acute myocardial infarction 111.83 13.74 234 96060 83543 110409462
Traumatic haemorrhage 109.95 13.74 46 96248 1798 110491207
Cerebral mass effect 107.32 13.74 49 96245 2370 110490635
Duodenal ulcer perforation 107.20 13.74 14 96280 177686 110315319
Swelling 107.10 13.74 89 96205 350952 110142053
Impaired healing 106.33 13.74 21 96273 196696 110296309
Discomfort 104.04 13.74 29 96265 214678 110278327
Contraindicated product administered 103.89 13.74 43 96251 248224 110244781
Sleep disorder 103.68 13.74 23 96271 198621 110294384
Hepatic enzyme increased 103.38 13.74 77 96217 320815 110172190
Colon cancer 102.94 13.74 97 96197 16346 110476659
Anticoagulation drug level abnormal 101.36 13.74 28 96266 292 110492713
Mouth haemorrhage 101.00 13.74 88 96206 13400 110479605
Disease progression 100.94 13.74 43 96251 243991 110249014
Splenic rupture 100.23 13.74 48 96246 2589 110490416
Infection 99.62 13.74 101 96193 362099 110130906
Blister 99.06 13.74 37 96257 227339 110265666
Anxiety 98.63 13.74 93 96201 344985 110148020
Urticaria 98.30 13.74 80 96214 318777 110174228
Injection site pain 98.27 13.74 18 96276 177904 110315101
Extradural haematoma 97.58 13.74 51 96243 3318 110489687
Cerebral artery embolism 97.55 13.74 44 96250 2068 110490937
Product use issue 95.10 13.74 79 96215 311616 110181389
Wound 94.29 13.74 43 96251 234394 110258611
Drug abuse 93.69 13.74 20 96274 177391 110315614
C-reactive protein abnormal 92.40 13.74 5 96289 129690 110363315
Embolism 92.36 13.74 91 96203 16198 110476807
Cardiac valve replacement complication 91.70 13.74 24 96270 200 110492805
Gastritis erosive 91.29 13.74 79 96215 11921 110481084
Thrombin time abnormal 90.95 13.74 16 96278 7 110492998
Nausea 89.45 13.74 670 95624 1235020 109257985
Intestinal ischaemia 87.34 13.74 88 96206 16091 110476914
Pericarditis 86.87 13.74 41 96253 219073 110273932
Muscle spasms 86.72 13.74 69 96225 278088 110214917
Coagulation test abnormal 86.05 13.74 37 96257 1549 110491456
Treatment failure 84.89 13.74 70 96224 277164 110215841
Night sweats 84.67 13.74 9 96285 133974 110359031
Aortic aneurysm rupture 83.73 13.74 35 96259 1365 110491640
Paraesthesia 83.22 13.74 71 96223 276450 110216555
Intra-abdominal haemorrhage 83.06 13.74 54 96240 5288 110487717
Musculoskeletal pain 82.76 13.74 28 96266 182995 110310010
Cerebral ischaemia 82.74 13.74 75 96219 12029 110480976
Creatinine renal clearance decreased 81.83 13.74 98 96196 21717 110471288
Bursitis 81.40 13.74 9 96285 129909 110363096
Acute abdomen 80.91 13.74 45 96249 3316 110489689
Blood urine present 79.81 13.74 102 96192 24143 110468862
Skull fracture 79.48 13.74 38 96256 2042 110490963
Diverticulum 79.36 13.74 82 96212 15444 110477561
Inflammation 78.40 13.74 35 96259 193203 110299802
Hypoaesthesia 78.28 13.74 95 96199 314128 110178877
Ill-defined disorder 78.23 13.74 20 96274 156833 110336172
Thrombosis 78.12 13.74 240 96054 108422 110384583
Gastric ulcer haemorrhage 77.90 13.74 67 96227 10027 110482978
Basal ganglia haemorrhage 76.76 13.74 36 96258 1852 110491153
Strangulated hernia 76.32 13.74 17 96277 64 110492941
Iron deficiency anaemia 75.71 13.74 114 96180 31445 110461560
Ischaemia 75.66 13.74 63 96231 9020 110483985
Microcytic anaemia 75.62 13.74 54 96240 6164 110486841
C-reactive protein increased 74.51 13.74 49 96245 217870 110275135
Headache 74.40 13.74 457 95837 881920 109611085
Urinary bladder haemorrhage 74.06 13.74 40 96254 2782 110490223
Type 2 diabetes mellitus 73.65 13.74 31 96263 177201 110315804
White blood cell count decreased 71.37 13.74 57 96237 229333 110263672
Therapy non-responder 71.24 13.74 24 96270 157283 110335722
Dysarthria 71.23 13.74 197 96097 83924 110409081
Puncture site haemorrhage 71.06 13.74 26 96268 706 110492299
Incarcerated hernia 70.47 13.74 23 96271 439 110492566
Cardiac perforation 70.10 13.74 18 96276 138 110492867
Internal haemorrhage 70.01 13.74 63 96231 10008 110482997
Dry mouth 69.67 13.74 44 96250 199904 110293101
Anticoagulant-related nephropathy 69.32 13.74 19 96275 192 110492813
Myelosuppression 69.25 13.74 3 96291 94337 110398668
Peripheral circulatory failure 68.80 13.74 33 96261 1786 110491219
Cerebellar haemorrhage 68.54 13.74 40 96254 3231 110489774
Ecchymosis 68.52 13.74 80 96214 17258 110475747
Haematocrit decreased 68.49 13.74 167 96127 65950 110427055
Shock 68.40 13.74 147 96147 53441 110439564
Peripheral artery thrombosis 68.33 13.74 43 96251 3981 110489024
Neuropathy peripheral 67.37 13.74 36 96258 179241 110313764
Haemodynamic instability 67.15 13.74 91 96203 22797 110470208
Peripheral ischaemia 66.87 13.74 64 96230 10994 110482011
Prothrombin time abnormal 66.58 13.74 29 96265 1253 110491752
Diarrhoea 66.20 13.74 654 95640 1138851 109354154
Pruritus 65.63 13.74 272 96022 581288 109911717
Surgery 65.53 13.74 124 96170 41159 110451846
Osteoarthritis 65.28 13.74 39 96255 182584 110310421
Vomiting 65.17 13.74 495 95799 910180 109582825
Cardiac ablation 64.82 13.74 36 96258 2646 110490359
Cough 64.69 13.74 197 96097 461444 110031561
Blood cholesterol decreased 64.39 13.74 36 96258 2680 110490325
Activated partial thromboplastin time 64.35 13.74 13 96281 26 110492979
Stress 64.25 13.74 8 96286 105340 110387665
Toxicity to various agents 63.89 13.74 210 96084 480345 110012660
Haemoperitoneum 63.71 13.74 46 96248 5342 110487663
Labelled drug-drug interaction medication error 63.51 13.74 101 96193 29201 110463804
Retroperitoneal haemorrhage 63.23 13.74 48 96246 6017 110486988
Lip dry 62.53 13.74 7 96287 100076 110392929
Traumatic haemothorax 62.48 13.74 24 96270 748 110492257
Arthritis 62.46 13.74 34 96260 167552 110325453
Depression 62.41 13.74 113 96181 317222 110175783
Chills 62.30 13.74 45 96249 190535 110302470
Leukopenia 61.86 13.74 26 96268 148765 110344240
Cardiac failure congestive 61.75 13.74 278 96016 150722 110342283
Gait inability 61.42 13.74 21 96273 136355 110356650
Pain in extremity 61.27 13.74 218 96076 486900 110006105
Multiple drug therapy 59.43 13.74 52 96242 7962 110485043
Dementia 59.02 13.74 102 96192 31571 110461434
Intracranial haematoma 59 13.74 25 96269 1009 110491996
Psoriasis 58.94 13.74 24 96270 139969 110353036
Oesophageal pain 58.89 13.74 43 96251 5082 110487923
Occult blood positive 58.64 13.74 50 96244 7395 110485610
Gastric polyps 58.22 13.74 44 96250 5479 110487526
Migraine 58.13 13.74 39 96255 171613 110321392
Neutrophil count decreased 57.35 13.74 17 96277 120924 110372081
Atrial flutter 57.29 13.74 87 96207 24175 110468830
Diverticulum intestinal haemorrhagic 57.09 13.74 41 96253 4722 110488283
Neuroglycopenia 56.95 13.74 25 96269 1101 110491904
Haemorrhage urinary tract 56.54 13.74 34 96260 2902 110490103
Myocardial infarction 56.30 13.74 322 95972 191761 110301244
Haemoglobin abnormal 55.97 13.74 53 96241 8985 110484020
Haemorrhage subcutaneous 55.91 13.74 43 96251 5496 110487509
Colitis ischaemic 55.81 13.74 73 96221 17677 110475328
Subcutaneous haematoma 55.49 13.74 34 96260 3002 110490003
Injection site erythema 55.41 13.74 8 96286 94168 110398837
Cardiac failure chronic 55.04 13.74 64 96230 13747 110479258
Femoral neck fracture 54.77 13.74 61 96233 12506 110480499
Cerebellar infarction 54.73 13.74 38 96256 4149 110488856
International normalised ratio 54.44 13.74 14 96280 108 110492897
Insomnia 54.06 13.74 149 96145 360441 110132564
Sciatica 54.02 13.74 8 96286 92391 110400614
Gastric ulcer 54.02 13.74 112 96182 39715 110453290
Haemorrhoids 53.98 13.74 105 96189 35567 110457438
Loss of personal independence in daily activities 53.67 13.74 32 96262 149988 110343017
Small intestinal haemorrhage 53.64 13.74 39 96255 4579 110488426
Subarachnoid haematoma 53.27 13.74 17 96277 301 110492704
Rib fracture 53.06 13.74 101 96193 33669 110459336
Brain herniation 53.03 13.74 51 96243 8812 110484193
Wound haemorrhage 52.74 13.74 39 96255 4699 110488306
Influenza 52.62 13.74 42 96252 169059 110323946
Liver injury 52.53 13.74 33 96261 150380 110342625
Renal infarct 52.01 13.74 34 96260 3361 110489644
Exsanguination 51.78 13.74 13 96281 90 110492915
Pulmonary alveolar haemorrhage 51.52 13.74 75 96219 20075 110472930
Inappropriate schedule of product administration 51.29 13.74 61 96233 203576 110289429
Anorectal discomfort 50.57 13.74 36 96258 4090 110488915
Hypercholesterolaemia 50.56 13.74 9 96285 90828 110402177
Anticoagulation drug level decreased 50.42 13.74 16 96278 278 110492727
Haemorrhagic diathesis 50.30 13.74 46 96248 7462 110485543
Haemorrhagic cerebral infarction 50.18 13.74 25 96269 1470 110491535
Mobility decreased 49.92 13.74 81 96213 237341 110255664
Drug ineffective 49.17 13.74 982 95312 1519558 108973447
Coagulation time shortened 49.07 13.74 17 96277 392 110492613
Liver function test increased 48.80 13.74 9 96285 88539 110404466
Feeling hot 48.64 13.74 10 96284 91096 110401909
Arrhythmia 48.45 13.74 152 96142 69423 110423582
Mucosal haemorrhage 48.12 13.74 31 96263 2989 110490016
Prescribed overdose 48.05 13.74 9 96285 87572 110405433
Oesophageal ulcer 47.98 13.74 46 96248 7918 110485087
Embolism arterial 47.81 13.74 26 96268 1833 110491172
Multiple organ dysfunction syndrome 47.56 13.74 259 96035 151451 110341554
Conjunctival haemorrhage 47.11 13.74 42 96252 6591 110486414
Peritonitis 46.95 13.74 94 96200 32513 110460492
Infarction 46.93 13.74 38 96256 5231 110487774
Pancytopenia 45.50 13.74 70 96224 209543 110283462
Malignant neoplasm progression 45.36 13.74 51 96243 174516 110318489
Wound infection 44.94 13.74 14 96280 96451 110396554
Hypocoagulable state 44.54 13.74 28 96266 2587 110490418
Cardiac ventricular thrombosis 44.54 13.74 30 96264 3117 110489888
Oesophagitis 44.03 13.74 85 96209 28630 110464375
Urinary retention 43.79 13.74 147 96147 69536 110423469
Pulmonary fibrosis 43.77 13.74 17 96277 102025 110390980
Wound secretion 43.75 13.74 41 96253 6860 110486145
Peripheral venous disease 43.35 13.74 10 96284 84107 110408898
Erythema 43.25 13.74 121 96173 291326 110201679
Upper respiratory tract infection 42.92 13.74 31 96263 131297 110361708
Drug level increased 42.64 13.74 114 96180 47605 110445400
Anticoagulation drug level above therapeutic 42.53 13.74 34 96260 4596 110488409
Intestinal infarction 42.43 13.74 22 96272 1408 110491597
Obesity 42.23 13.74 23 96271 113328 110379677
Hip fracture 42.10 13.74 94 96200 35057 110457948
Hypertension 41.95 13.74 266 96028 509818 109983187
Ischaemic cerebral infarction 41.50 13.74 28 96266 2917 110490088
Joint stiffness 41.26 13.74 5 96289 67238 110425767
Red blood cell sedimentation rate increased 40.97 13.74 9 96285 78293 110414712
Discoloured vomit 40.52 13.74 24 96270 1993 110491012
Malaise 40.40 13.74 382 95912 671437 109821568
Dysphagia 40.20 13.74 250 96044 153350 110339655
Ear infection 40.18 13.74 4 96290 62728 110430277
Cardioversion 39.89 13.74 25 96269 2298 110490707
Autoimmune disorder 39.86 13.74 5 96289 65478 110427527
Large intestine polyp 39.72 13.74 57 96237 15060 110477945
Aortic aneurysm 39.64 13.74 46 96248 9858 110483147
Gastritis haemorrhagic 39.61 13.74 28 96266 3145 110489860
Nasal congestion 39.54 13.74 18 96276 98264 110394741
Gastrointestinal angiodysplasia 39.49 13.74 20 96274 1218 110491787
Parkinsonism 39.45 13.74 70 96224 22117 110470888
Catheter site haemorrhage 39.34 13.74 36 96258 5844 110487161
Back pain 39.06 13.74 178 96116 370818 110122187
Weight decreased 39.04 13.74 243 96051 467814 110025191
Hospitalisation 38.83 13.74 40 96254 142453 110350552
Acute coronary syndrome 38.65 13.74 71 96223 23041 110469964
Multiple injuries 38.56 13.74 29 96265 3585 110489420
Thrombotic stroke 38.26 13.74 17 96277 771 110492234
Bradycardia 38.15 13.74 249 96045 155268 110337737
Mucosal inflammation 38.07 13.74 18 96276 96123 110396882
Urogenital haemorrhage 38.02 13.74 18 96276 946 110492059
Respiratory tract haemorrhage 37.95 13.74 23 96271 1991 110491014
Femur fracture 37.50 13.74 104 96190 44365 110448640
Gastrointestinal necrosis 37.47 13.74 37 96257 6603 110486402
Anaphylactic reaction 37.33 13.74 27 96267 114273 110378732
Cytokine release syndrome 36.95 13.74 8 96286 70298 110422707
COVID-19 36.90 13.74 101 96193 244959 110248046
Hiatus hernia 36.70 13.74 77 96217 27529 110465476
Adverse event 36.46 13.74 25 96269 108784 110384221
Facial paresis 36.25 13.74 35 96259 6078 110486927
Haemarthrosis 36.19 13.74 38 96256 7291 110485714
Gastritis 36.18 13.74 116 96178 53583 110439422
Arteriovenous malformation 36.05 13.74 22 96272 1929 110491076
Carotid artery occlusion 35.92 13.74 43 96251 9522 110483483
Anticoagulation drug level below therapeutic 35.80 13.74 21 96273 1713 110491292
Gastric cancer 35.74 13.74 46 96248 10962 110482043
Bleeding time prolonged 35.70 13.74 19 96275 1283 110491722
Dyspepsia 35.46 13.74 286 96008 190679 110302326
Arterial thrombosis 35.45 13.74 26 96268 3093 110489912
Memory impairment 35.34 13.74 74 96220 196870 110296135
Therapeutic response decreased 35.34 13.74 20 96274 96479 110396526
Disseminated intravascular coagulation 35.25 13.74 97 96197 41189 110451816
Pelvic fracture 35.20 13.74 52 96242 14102 110478903
Cardiogenic shock 35.19 13.74 120 96174 57218 110435787
Presyncope 35.14 13.74 108 96186 48779 110444226
Prescribed underdose 35.11 13.74 7 96287 65167 110427838
Hypochromic anaemia 34.85 13.74 26 96268 3175 110489830
Injection site swelling 34.65 13.74 6 96288 61784 110431221
Lung disorder 34.59 13.74 65 96229 179982 110313023
Stupor 34.11 13.74 39 96255 8226 110484779
Gastrointestinal disorder 34.03 13.74 103 96191 241849 110251156
Prothrombin time shortened 33.97 13.74 27 96267 3619 110489386
Anastomotic infection 33.78 13.74 10 96284 136 110492869
Lacunar stroke 33.71 13.74 14 96280 537 110492468
Blood pressure increased 33.54 13.74 114 96180 258259 110234746
Thalamus haemorrhage 33.38 13.74 21 96273 1943 110491062
Illness 33.13 13.74 15 96279 82156 110410849
Rectal cancer 33.06 13.74 27 96267 3762 110489243
Colitis ulcerative 32.99 13.74 13 96281 77350 110415655
Hypoglycaemia 32.94 13.74 193 96101 115911 110377094
Influenza like illness 32.84 13.74 18 96276 88394 110404611
Appendicitis 32.84 13.74 75 96219 28389 110464616
Hemianopia homonymous 32.77 13.74 19 96275 1516 110491489
Bradyarrhythmia 32.60 13.74 30 96264 4904 110488101
Abdominal discomfort 32.56 13.74 205 96089 393653 110099352
Myalgia 32.48 13.74 93 96201 222288 110270717
Coronary artery embolism 32.38 13.74 12 96282 338 110492667
Cholecystitis acute 32.29 13.74 53 96241 15729 110477276
Ileus 32.22 13.74 78 96216 30651 110462354
Colon neoplasm 32.04 13.74 16 96278 946 110492059
Circulatory collapse 31.86 13.74 96 96198 42897 110450108
Diabetes mellitus inadequate control 31.68 13.74 76 96218 29699 110463306
Brain oedema 31.61 13.74 78 96216 31020 110461985
Post procedural stroke 31.59 13.74 9 96285 106 110492899
Lower limb fracture 31.58 13.74 13 96281 75335 110417670
Diverticulitis intestinal haemorrhagic 31.34 13.74 13 96281 497 110492508
Anuria 31.32 13.74 67 96227 24274 110468731
Pulmonary contusion 31.29 13.74 10 96284 178 110492827
Cytomegalovirus infection 31.17 13.74 5 96289 54439 110438566
Renal haemorrhage 30.87 13.74 22 96272 2503 110490502
Pelvic haematoma 30.73 13.74 16 96278 1033 110491972
Agitation 30.50 13.74 32 96262 113019 110379986
Haemorrhagic infarction 30.24 13.74 15 96279 874 110492131
Ear pain 30.22 13.74 5 96289 53221 110439784
Overdose 30.22 13.74 324 95970 233470 110259535
Lumbar puncture 30.19 13.74 11 96283 295 110492710
Petechiae 29.79 13.74 64 96230 23253 110469752
Blood creatine increased 29.62 13.74 43 96251 11478 110481527
Prothrombin time ratio decreased 29.54 13.74 18 96276 1574 110491431
Oropharyngeal pain 29.52 13.74 45 96249 135231 110357774
Traumatic haematoma 29.38 13.74 21 96273 2400 110490605
Muscle haemorrhage 29.35 13.74 33 96261 6836 110486169
Exostosis 29.25 13.74 3 96291 45953 110447052
Drug ineffective for unapproved indication 29.01 13.74 28 96266 102810 110390195
Aortic thrombosis 28.97 13.74 20 96274 2163 110490842
Mesenteric artery embolism 28.83 13.74 8 96286 85 110492920
Psychotic disorder 28.45 13.74 5 96289 50932 110442073
Duodenal ulcer haemorrhage 28.34 13.74 35 96259 8002 110485003
Full blood count abnormal 28.22 13.74 7 96287 56045 110436960
Vascular access site haemorrhage 28.07 13.74 10 96284 251 110492754
Back injury 27.94 13.74 4 96290 47395 110445610
Eczema 27.92 13.74 14 96280 72279 110420726
Taste disorder 27.86 13.74 11 96283 65376 110427629
NIH stroke scale abnormal 27.74 13.74 6 96288 19 110492986
Accidental exposure to product 27.73 13.74 5 96289 50003 110443002
Knee arthroplasty 27.55 13.74 11 96283 64937 110428068
Skull fractured base 27.54 13.74 11 96283 381 110492624
Normocytic anaemia 27.51 13.74 31 96263 6436 110486569
Haemorrhagic disorder 27.39 13.74 18 96276 1795 110491210
Paresis 27.35 13.74 27 96267 4817 110488188
Bronchitis 27.34 13.74 60 96234 156972 110336033
Brain stem haemorrhage 27.27 13.74 18 96276 1808 110491197
Blood creatinine increased 27.25 13.74 261 96033 182628 110310377
Somnolence 27.13 13.74 150 96144 297299 110195706
Retroperitoneal haematoma 27.13 13.74 30 96264 6101 110486904
Initial insomnia 27.04 13.74 39 96255 10350 110482655
Osteoma 27.01 13.74 8 96286 109 110492896
Cardiac arrest 26.99 13.74 276 96018 196477 110296528
Venous thrombosis 26.77 13.74 35 96259 8470 110484535
Vascular pseudoaneurysm 26.77 13.74 25 96269 4165 110488840
Flushing 26.77 13.74 31 96263 104705 110388300
Arterial haemorrhage 26.76 13.74 24 96270 3795 110489210
Aneurysm ruptured 26.73 13.74 15 96279 1125 110491880
Basilar artery occlusion 26.71 13.74 10 96284 290 110492715
Lacunar infarction 26.52 13.74 30 96264 6256 110486749
Pharyngeal haemorrhage 26.34 13.74 16 96278 1391 110491614
Hemianopia 26.22 13.74 21 96273 2847 110490158
Prostate tenderness 26.17 13.74 7 96287 64 110492941
Femoral artery embolism 26.17 13.74 7 96287 64 110492941
Dry eye 26.16 13.74 8 96286 55785 110437220
Facial asymmetry 26.16 13.74 14 96280 956 110492049
Spontaneous haematoma 26.11 13.74 18 96276 1943 110491062
Hypovolaemia 26 13.74 58 96236 21616 110471389
Facial paralysis 25.97 13.74 62 96232 24152 110468853
Coagulation factor increased 25.88 13.74 7 96287 67 110492938
Bone marrow failure 25.88 13.74 9 96285 57839 110435166
Neck pain 25.88 13.74 42 96252 123088 110369917
Thrombotic cerebral infarction 25.84 13.74 13 96281 781 110492224
Neoplasm progression 25.72 13.74 12 96282 64583 110428422
Herpes zoster 25.68 13.74 34 96260 108345 110384660
Speech disorder 25.64 13.74 114 96180 61455 110431550
Hydrocephalus 25.63 13.74 38 96256 10337 110482668
Gait disturbance 25.54 13.74 140 96154 278068 110214937
Lymphocyte count decreased 25.45 13.74 9 96285 57234 110435771
Arterial injury 25.23 13.74 13 96281 821 110492184
Serotonin syndrome 25.12 13.74 10 96284 59143 110433862
Lupus-like syndrome 25.11 13.74 3 96291 40789 110452216
Decreased appetite 25.10 13.74 279 96015 475567 110017438
No adverse event 24.69 13.74 17 96277 73822 110419183
Bacterial infection 24.68 13.74 5 96289 46031 110446974
Injection site bruising 24.68 13.74 7 96287 51256 110441749
Duodenitis 24.64 13.74 35 96259 9161 110483844
Gastrointestinal motility disorder 24.56 13.74 31 96263 7245 110485760
Frequent bowel movements 24.46 13.74 16 96278 71374 110421631
Micturition disorder 24.35 13.74 25 96269 4673 110488332
Pneumocystis jirovecii pneumonia 24.30 13.74 4 96290 42731 110450274
Inguinal hernia strangulated 24.19 13.74 4 96290 0 110493005
Blood pressure systolic increased 24.11 13.74 22 96272 82969 110410036
Cerebral artery thrombosis 23.84 13.74 16 96278 1652 110491353
Abdominal wall haematoma 23.68 13.74 27 96267 5678 110487327
Immunodeficiency 23.56 13.74 3 96291 38835 110454170
Thoracic haemorrhage 23.54 13.74 9 96285 277 110492728
Polycystic liver disease 23.53 13.74 8 96286 174 110492831
Rhinorrhoea 23.53 13.74 33 96261 102633 110390372
Vaginal haemorrhage 23.52 13.74 61 96233 25013 110467992
Platelet count decreased 23.39 13.74 112 96182 230331 110262674
Aortic intramural haematoma 23.03 13.74 8 96286 186 110492819
Cardiac failure acute 23.02 13.74 59 96235 24019 110468986
Splenic necrosis 22.99 13.74 8 96286 187 110492818
Carotid artery stenosis 22.99 13.74 34 96260 9229 110483776
Atrioventricular block first degree 22.91 13.74 43 96251 14182 110478823
Spinal cord haematoma 22.72 13.74 9 96285 305 110492700
Alanine aminotransferase increased 22.56 13.74 83 96211 183690 110309315
Haemochromatosis 22.41 13.74 15 96279 1542 110491463
Prothrombin time 22.41 13.74 5 96289 19 110492986
Hyperkalaemia 22.35 13.74 198 96096 135598 110357407
Incarcerated inguinal hernia 22.34 13.74 9 96285 319 110492686
Confusional state 22.33 13.74 281 96013 468399 110024606
Creatinine renal clearance 22.32 13.74 6 96288 56 110492949
Left atrial dilatation 22.28 13.74 21 96273 3539 110489466
Multiple sclerosis relapse 22.16 13.74 8 96286 50232 110442773
Non-compaction cardiomyopathy 22.13 13.74 6 96288 58 110492947
Ventricular tachycardia 21.89 13.74 94 96200 49915 110443090
Postrenal failure 21.83 13.74 12 96282 864 110492141
Pneumonia aspiration 21.74 13.74 133 96161 81100 110411905
Red blood cell abnormality 21.68 13.74 12 96282 876 110492129
Stroke in evolution 21.53 13.74 7 96287 132 110492873
Ruptured cerebral aneurysm 21.52 13.74 11 96283 683 110492322
Cardiac pacemaker insertion 21.52 13.74 27 96267 6274 110486731
Monoparesis 21.40 13.74 23 96271 4530 110488475
Procedural pain 20.97 13.74 3 96291 35562 110457443
Putamen haemorrhage 20.96 13.74 10 96284 535 110492470
Neuralgia 20.91 13.74 8 96286 48470 110444535
Hepatic cytolysis 20.75 13.74 11 96283 55042 110437963
Candida infection 20.58 13.74 8 96286 48001 110445004
Gastrointestinal vascular malformation haemorrhagic 20.55 13.74 12 96282 970 110492035
Bone pain 20.48 13.74 16 96278 65117 110427888
Liver disorder 20.39 13.74 60 96234 142183 110350822
Product administration error 20.35 13.74 75 96219 37142 110455863
Skin exfoliation 20.26 13.74 28 96266 87623 110405382
Neutrophil count increased 20.25 13.74 3 96291 34649 110458356
Drug reaction with eosinophilia and systemic symptoms 20.23 13.74 25 96269 82070 110410935
Rash pruritic 20.10 13.74 34 96260 98035 110394970
Laryngitis 20.03 13.74 6 96288 42405 110450600
Therapy partial responder 19.92 13.74 4 96290 37057 110455948
Osteorrhagia 19.80 13.74 4 96290 8 110492997
Splenic haemorrhage 19.80 13.74 11 96283 809 110492196
Haematocrit increased 19.79 13.74 23 96271 4936 110488069
Mesenteric haemorrhage 19.79 13.74 6 96288 89 110492916
Suicidal ideation 19.78 13.74 32 96262 93905 110399100
Splenic cyst 19.77 13.74 8 96286 287 110492718
Polyp 19.73 13.74 33 96261 9947 110483058
Dry skin 19.69 13.74 40 96254 107613 110385392
Muscular weakness 19.67 13.74 131 96163 248337 110244668
Blood glucose increased 19.64 13.74 55 96239 132441 110360564
Cerebellar haematoma 19.52 13.74 10 96284 624 110492381
Psychotic disorder due to a general medical condition 19.48 13.74 8 96286 298 110492707
Anaemia megaloblastic 19.44 13.74 11 96283 838 110492167
Blood urea increased 19.40 13.74 97 96197 54860 110438145
Oxygen saturation decreased 19.21 13.74 71 96223 156911 110336094
Mucosal dryness 19.11 13.74 21 96273 4242 110488763
Thyroid haemorrhage 19.08 13.74 6 96288 101 110492904
Prostatic specific antigen abnormal 18.87 13.74 10 96284 669 110492336
Post procedural haematuria 18.83 13.74 8 96286 325 110492680
Coagulation factor V level decreased 18.82 13.74 10 96284 673 110492332
Splenic haematoma 18.74 13.74 8 96286 329 110492676
Acute myeloid leukaemia 18.73 13.74 5 96289 38105 110454900
Tachyarrhythmia 18.63 13.74 29 96265 8232 110484773
Renal embolism 18.51 13.74 7 96287 209 110492796
Blood pressure systolic inspiratory decreased 18.41 13.74 4 96290 13 110492992
Hepatic cirrhosis 18.40 13.74 19 96275 67607 110425398
Seizure 18.33 13.74 115 96179 221070 110271935
Brain stem infarction 18.19 13.74 15 96279 2119 110490886
Respiratory depression 18.18 13.74 3 96291 31998 110461007
Pain in jaw 18.18 13.74 11 96283 51166 110441839
Orthostatic intolerance 18.14 13.74 15 96279 2126 110490879
Thrombin time 18.14 13.74 3 96291 0 110493005
Diabetes mellitus 18.11 13.74 37 96257 99344 110393661
High frequency ablation 18.02 13.74 8 96286 362 110492643
Oedema 18.01 13.74 108 96186 209868 110283137
Atrioventricular block complete 17.96 13.74 48 96246 20034 110472971
Abdominal wall haemorrhage 17.90 13.74 10 96284 743 110492262
Pericardial fibrosis 17.85 13.74 7 96287 231 110492774
Occult blood 17.84 13.74 14 96280 1842 110491163
Orthopaedic procedure 17.82 13.74 7 96287 232 110492773
Abortion spontaneous 17.81 13.74 4 96290 34278 110458727
Cataract 17.77 13.74 26 96268 79459 110413546
Body temperature increased 17.76 13.74 13 96281 54700 110438305
Mechanical ileus 17.66 13.74 12 96282 1265 110491740
Gastroenteritis viral 17.58 13.74 3 96291 31223 110461782
Brain stem stroke 17.56 13.74 10 96284 771 110492234
Facial nerve disorder 17.55 13.74 10 96284 772 110492233
Quadrantanopia 17.54 13.74 7 96287 242 110492763
Myositis 17.50 13.74 3 96291 31113 110461892
Cystitis 17.47 13.74 19 96275 66017 110426988
Haemoglobin 17.46 13.74 6 96288 135 110492870
Thrombosis mesenteric vessel 17.41 13.74 7 96287 247 110492758
Post procedural haematoma 17.35 13.74 16 96278 2623 110490382
Aspartate aminotransferase increased 17.26 13.74 76 96218 159860 110333145
Swelling face 17.14 13.74 34 96260 92287 110400718
Pneumonitis 17.14 13.74 25 96269 76506 110416499
Erosive oesophagitis 17.13 13.74 17 96277 3052 110489953
Dyskinesia 17.00 13.74 12 96282 51434 110441571
Contraindication to medical treatment 16.95 13.74 12 96282 1351 110491654
Hepatitis acute 16.93 13.74 45 96249 18721 110474284
Aortic dissection rupture 16.89 13.74 5 96289 68 110492937
White blood cell count increased 16.86 13.74 37 96257 96805 110396200
Splenic injury 16.82 13.74 7 96287 270 110492735
Diarrhoea haemorrhagic 16.72 13.74 40 96254 15599 110477406
Encephalopathy 16.70 13.74 28 96266 81027 110411978
IgA nephropathy 16.65 13.74 17 96277 3156 110489849
Bradykinesia 16.62 13.74 32 96262 10756 110482249
Nodule 16.57 13.74 4 96290 32627 110460378
Productive cough 16.54 13.74 48 96246 114257 110378748
Vascular stent occlusion 16.51 13.74 7 96287 283 110492722
Cerebral thrombosis 16.40 13.74 15 96279 2433 110490572
Atrial tachycardia 16.37 13.74 29 96265 9149 110483856
Adverse drug reaction 16.26 13.74 43 96251 105516 110387489
Amnesia 16.19 13.74 43 96251 105365 110387640
Lordosis 16.14 13.74 8 96286 465 110492540
Hypothyroidism 16.14 13.74 24 96270 72875 110420130
Pericardial drainage 16.07 13.74 8 96286 470 110492535
Traumatic renal injury 16.06 13.74 3 96291 3 110493002
Intestinal mass 16.05 13.74 12 96282 1470 110491535
Vision blurred 16.01 13.74 58 96236 128964 110364041
Hypercoagulation 15.99 13.74 17 96277 3309 110489696
Diverticulum intestinal 15.94 13.74 33 96261 11686 110481319
Drug eruption 15.86 13.74 14 96280 53645 110439360
Hypertensive crisis 15.83 13.74 52 96242 24320 110468685
Anaphylactic shock 15.78 13.74 13 96281 51533 110441472
Bronchiectasis 15.78 13.74 6 96288 36487 110456518
Mesenteric artery thrombosis 15.72 13.74 10 96284 943 110492062
Contusion 15.69 13.74 288 96006 233073 110259932
Pelvic haemorrhage 15.68 13.74 6 96288 185 110492820
Periorbital haemorrhage 15.64 13.74 7 96287 323 110492682
Gastric occult blood positive 15.60 13.74 3 96291 4 110493001
Extravasation blood 15.53 13.74 8 96286 505 110492500
Osteonecrosis 15.53 13.74 5 96289 33736 110459269
Coagulation time abnormal 15.44 13.74 6 96288 193 110492812
Abdominal strangulated hernia 15.44 13.74 5 96289 93 110492912
Angina pectoris 15.42 13.74 100 96194 62195 110430810
Device related thrombosis 15.42 13.74 17 96277 3445 110489560
Toxic epidermal necrolysis 15.36 13.74 16 96278 56711 110436294
Hot flush 15.35 13.74 21 96273 66015 110426990
Hyperlipidaemia 15.32 13.74 6 96288 35842 110457163
Therapeutic product effect incomplete 15.30 13.74 123 96171 223682 110269323
Urethral haemorrhage 15.27 13.74 8 96286 523 110492482
Skin haemorrhage 15.26 13.74 52 96242 24775 110468230
Adrenal insufficiency 15.21 13.74 9 96285 42381 110450624
Anti factor VIII antibody test 15.20 13.74 3 96291 5 110493000
Haemoglobin increased 15.17 13.74 28 96266 9119 110483886
Vessel puncture site haemorrhage 15.16 13.74 6 96288 203 110492802
Oesophageal carcinoma 15.15 13.74 32 96262 11492 110481513
Burning sensation 15.12 13.74 23 96271 69189 110423816
Laparotomy 15.06 13.74 8 96286 538 110492467
Myoclonus 14.99 13.74 5 96289 32993 110460012
Pseudomonas infection 14.99 13.74 3 96291 27850 110465155
Rectal perforation 14.95 13.74 10 96284 1027 110491978
Sepsis 14.94 13.74 382 95912 326964 110166041
Ascites 14.92 13.74 37 96257 92771 110400234
Mallory-Weiss syndrome 14.92 13.74 16 96278 3145 110489860
Hepatotoxicity 14.91 13.74 20 96274 63380 110429625
Osteonecrosis of jaw 14.84 13.74 12 96282 48005 110445000
Colitis 14.78 13.74 43 96251 102280 110390725
Intracranial mass 14.78 13.74 14 96280 2374 110490631
Drug tolerance decreased 14.75 13.74 3 96291 27537 110465468
Thrombectomy 14.73 13.74 7 96287 371 110492634
Glomerular filtration rate decreased 14.71 13.74 57 96237 28899 110464106
Irritability 14.71 13.74 12 96282 47797 110445208
Splenic embolism 14.70 13.74 6 96288 220 110492785
Pharyngeal mass 14.69 13.74 7 96287 373 110492632
Eye haemorrhage 14.68 13.74 32 96262 11742 110481263
Cardiac myxoma 14.63 13.74 6 96288 223 110492782
Meningorrhagia 14.57 13.74 7 96287 380 110492625
Contraindication to surgery 14.54 13.74 3 96291 7 110492998
Body temperature decreased 14.49 13.74 7 96287 36928 110456077
Fracture 14.44 13.74 51 96243 24737 110468268
General physical health deterioration 14.44 13.74 272 96022 425023 110067982
Spinal epidural haematoma 14.44 13.74 12 96282 1713 110491292
Coronary artery occlusion 14.41 13.74 38 96256 15734 110477271
Haematocrit abnormal 14.39 13.74 12 96282 1721 110491284
Blood pressure fluctuation 14.38 13.74 27 96267 74797 110418208
Electrocardiogram T wave biphasic 14.33 13.74 6 96288 235 110492770
Adverse reaction 14.32 13.74 4 96290 29590 110463415
Subdural hygroma 14.28 13.74 8 96286 598 110492407
Epidural haemorrhage 14.14 13.74 7 96287 406 110492599
Antiphospholipid syndrome 14.13 13.74 14 96280 2509 110490496
Endocarditis 14.08 13.74 34 96260 13337 110479668
Neuroleptic malignant syndrome 14.07 13.74 6 96288 34053 110458952
Oral candidiasis 14.06 13.74 11 96283 44749 110448256
Basilar artery thrombosis 14.06 13.74 7 96287 411 110492594
Venous thrombosis limb 14.05 13.74 20 96274 5245 110487760
Gastrointestinal erosion 14.03 13.74 10 96284 1138 110491867
Splenic lesion 13.93 13.74 8 96286 627 110492378
Cerebral vascular occlusion 13.90 13.74 4 96290 49 110492956
Impaired work ability 13.90 13.74 3 96291 26416 110466589
Carotid arterial embolus 13.82 13.74 4 96290 50 110492955

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 anticoagulant
CHEBI has role CHEBI:50266 prodrug
CHEBI has role CHEBI:65232 EC 3.4.21.5 (thrombin) inhibitor
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:38070 anti-arrhythmia drug
CHEBI has role CHEBI:73336 vulnerary
CHEBI has role CHEBI:77020 EC 1.10.99.2 [ribosyldihydronicotinamide dehydrogenase (quinone)] inhibitor

Related Drugs by ATC class:

B01AE Direct thrombin inhibitors 5 drugs
argatrobanbivalirudindesirudinlepirudinximelagatran

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




🐶 Veterinary Drug Use

None

🐶 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)

None

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 Enzyme IC50 6.26 CHEMBL

External reference:

IDSource
4030255 VUID
N0000181837 NUI
D07082 KEGG_DRUG
872728-81-9 SECONDARY_CAS_RN
1037041 RXNORM
C1571583 UMLSCUI
CHEBI:70746 CHEBI
CHEMBL539697 ChEMBL_ID
CHEMBL1615369 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
A1IO4 PDB_CHEM_ID
CHEMBL48361 ChEMBL_ID
211914-51-1 SECONDARY_CAS_RN
216210 PUBCHEM_CID
6380 IUPHAR_LIGAND_ID
8027 INN_ID
4030254 VANDF
4030255 VANDF
I0VM4M70GC UNII
CHEBI:70752 CHEBI
2E18WX195X INXIGHT DRUGS
I0VM4M70GC INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Dabigatran Etexilate HUMAN PRESCRIPTION DRUG LABEL 1 0378-0265 CAPSULE 75 mg ORAL ANDA 29 sections
Dabigatran Etexilate HUMAN PRESCRIPTION DRUG LABEL 1 0378-0266 CAPSULE 150 mg ORAL ANDA 29 sections
Pradaxa HUMAN PRESCRIPTION DRUG LABEL 1 0597-0108 CAPSULE 110 mg ORAL NDA 32 sections
Pradaxa HUMAN PRESCRIPTION DRUG LABEL 1 0597-0355 CAPSULE 75 mg ORAL NDA 32 sections
Pradaxa HUMAN PRESCRIPTION DRUG LABEL 1 0597-0360 CAPSULE 150 mg ORAL NDA 32 sections
Pradaxa HUMAN PRESCRIPTION DRUG LABEL 1 0597-0425 PELLET 20 mg ORAL NDA 33 sections
Pradaxa HUMAN PRESCRIPTION DRUG LABEL 1 0597-0430 PELLET 30 mg ORAL NDA 33 sections
Pradaxa HUMAN PRESCRIPTION DRUG LABEL 1 0597-0435 PELLET 40 mg ORAL NDA 33 sections
Pradaxa HUMAN PRESCRIPTION DRUG LABEL 1 0597-0440 PELLET 50 mg ORAL NDA 33 sections
Pradaxa HUMAN PRESCRIPTION DRUG LABEL 1 0597-0445 PELLET 110 mg ORAL NDA 33 sections
Pradaxa HUMAN PRESCRIPTION DRUG LABEL 1 0597-0450 PELLET 150 mg ORAL NDA 33 sections
Dabigatran Etexilate Human Prescription Drug Label 1 0904-7253 CAPSULE, COATED PELLETS 75 mg ORAL ANDA 28 sections
Dabigatran Etexilate Human Prescription Drug Label 1 0904-7254 CAPSULE, COATED PELLETS 110 mg ORAL ANDA 28 sections
Dabigatran Etexilate Human Prescription Drug Label 1 0904-7255 CAPSULE, COATED PELLETS 150 mg ORAL ANDA 28 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
Dabigatran Etexilate HUMAN PRESCRIPTION DRUG LABEL 1 31722-666 CAPSULE 110 mg ORAL ANDA 28 sections
DABIGATRAN HUMAN PRESCRIPTION DRUG LABEL 1 42291-033 CAPSULE 75 mg ORAL ANDA 27 sections
DABIGATRAN HUMAN PRESCRIPTION DRUG LABEL 1 42291-034 CAPSULE 150 mg ORAL ANDA 27 sections
Dabigatran etexilate HUMAN PRESCRIPTION DRUG LABEL 1 43598-453 CAPSULE 110 mg ORAL ANDA 27 sections
Dabigatran etexilate HUMAN PRESCRIPTION DRUG LABEL 1 43598-641 CAPSULE 150 mg ORAL ANDA 27 sections
Dabigatran etexilate HUMAN PRESCRIPTION DRUG LABEL 1 43598-642 CAPSULE 75 mg ORAL ANDA 27 sections
Dabigatran Etexilate Human Prescription Drug Label 1 46708-634 CAPSULE 75 mg ORAL ANDA 28 sections
Dabigatran Etexilate Human Prescription Drug Label 1 46708-635 CAPSULE 110 mg ORAL ANDA 28 sections
Dabigatran Etexilate Human Prescription Drug Label 1 46708-636 CAPSULE 150 mg ORAL ANDA 28 sections
Pradaxa HUMAN PRESCRIPTION DRUG LABEL 1 50090-3617 CAPSULE 150 mg ORAL NDA 32 sections
DABIGATRAN Human Prescription Drug Label 1 50090-7530 CAPSULE 150 mg ORAL ANDA 27 sections
DABIGATRAN Human Prescription Drug Label 1 50090-7531 CAPSULE 75 mg ORAL ANDA 27 sections
Dabigatran Etexilate Human Prescription Drug Label 1 50090-7656 CAPSULE, COATED PELLETS 75 mg ORAL ANDA 27 sections