rivaroxaban Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
blood coagulation factor XA inhibitors, antithrombotics 4182 366789-02-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • xarelto
  • rivaroxaban
  • BAY 59-7939
A morpholine and thiophene derivative that functions as a FACTOR XA INHIBITOR and is used in the treatment and prevention of DEEP-VEIN THROMBOSIS and PULMONARY EMBOLISM. It is also used for the prevention of STROKE and systemic embolization in patients with non-valvular ATRIAL FIBRILLATION, and for the prevention of atherothrombotic events in patients after an ACUTE CORONARY SYNDROME.
  • Molecular weight: 435.88
  • Formula: C19H18ClN3O5S
  • CLOGP: 2.39
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 1
  • TPSA: 88.18
  • ALOGS: -4.64
  • ROTB: 5

  • Status: ONP

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

Drug dosage:

DoseUnitRoute
20 mg O

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 0.70 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 2.40 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.06 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 7 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
July 1, 2011 FDA JANSSEN PHARMS

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 5363.98 10.76 2878 103743 74495 46504946
Pulmonary embolism 2207.20 10.76 1889 104732 106696 46472745
Deep vein thrombosis 1793.57 10.76 1472 105149 78301 46501140
Ischaemic stroke 1203.99 10.76 640 105981 16082 46563359
Haemorrhage 1094.78 10.76 946 105675 53923 46525518
Cerebral haemorrhage 999.35 10.76 686 105935 27685 46551756
Cerebrovascular accident 957.79 10.76 1166 105455 99873 46479568
Epistaxis 917.78 10.76 920 105701 63385 46516056
Upper gastrointestinal haemorrhage 768.61 10.76 478 106143 16260 46563181
Haemorrhage intracranial 761.13 10.76 431 106190 12293 46567148
Thrombosis 714.50 10.76 755 105866 55314 46524127
Haematuria 653.79 10.76 520 106101 26338 46553103
Rectal haemorrhage 646.63 10.76 601 106020 37654 46541787
Haematoma 588.05 10.76 526 106095 31346 46548095
Vaginal haemorrhage 587.70 10.76 479 106142 25125 46554316
Cerebral infarction 527.58 10.76 433 106188 22933 46556508
Haemoglobin decreased 518.11 10.76 999 105622 127950 46451491
Lower gastrointestinal haemorrhage 478.75 10.76 263 106358 7057 46572384
Melaena 457.04 10.76 430 106191 27342 46552099
Haemorrhagic stroke 428.74 10.76 223 106398 5343 46574098
Embolic stroke 422.48 10.76 193 106428 3446 46575995
Anaemia 380.59 10.76 1365 105256 254414 46325027
Internal haemorrhage 344.60 10.76 179 106442 4276 46575165
Subdural haematoma 323.35 10.76 255 106366 12742 46566699
Atrial fibrillation 315.67 10.76 717 105904 102873 46476568
Rheumatoid arthritis 307.99 10.76 84 106537 240131 46339310
Haematochezia 302.68 10.76 400 106221 37093 46542348
Atrial thrombosis 265.19 10.76 106 106515 1338 46578103
Incorrect dose administered 255.41 10.76 409 106212 45141 46534300
Blood loss anaemia 250.51 10.76 185 106436 8372 46571069
Intraventricular haemorrhage 233.68 10.76 105 106516 1800 46577641
Haemoptysis 218.46 10.76 284 106337 25905 46553536
Pericardial haemorrhage 217.77 10.76 94 106527 1457 46577984
Haemarthrosis 216.52 10.76 115 106506 2878 46576563
Pain 199.23 10.76 503 106118 476445 46102996
Haemorrhoidal haemorrhage 195.78 10.76 116 106505 3604 46575837
Diverticulum intestinal haemorrhagic 193.31 10.76 81 106540 1162 46578279
International normalised ratio increased 188.80 10.76 364 106257 46519 46532922
Post procedural haemorrhage 185.34 10.76 146 106475 7280 46572161
Haemorrhagic arteriovenous malformation 183.43 10.76 47 106574 107 46579334
Shock haemorrhagic 182.49 10.76 154 106467 8470 46570971
Faeces discoloured 180.53 10.76 207 106414 16580 46562861
Haematemesis 180.06 10.76 272 106349 28534 46550907
Creatinine renal clearance decreased 176.92 10.76 138 106483 6782 46572659
Drug hypersensitivity 158.91 10.76 194 106427 243631 46335810
Gingival bleeding 157.47 10.76 162 106459 11477 46567964
Basal ganglia haemorrhage 152.98 10.76 56 106565 546 46578895
Transient ischaemic attack 151.69 10.76 280 106341 34623 46544818
Subarachnoid haemorrhage 148.66 10.76 154 106467 10999 46568442
Fall 144.35 10.76 1261 105360 327836 46251605
Toxicity to various agents 142.75 10.76 164 106457 211602 46367839
Hemiplegia 140.88 10.76 121 106500 6817 46572624
Uterine haemorrhage 140.46 10.76 93 106528 3524 46575917
Blood urine present 136.38 10.76 154 106467 12128 46567313
Cerebellar haemorrhage 131.12 10.76 63 106558 1266 46578175
Subcutaneous haematoma 125.74 10.76 65 106556 1536 46577905
Embolic cerebral infarction 125.17 10.76 46 106575 454 46578987
Cerebral haematoma 122.80 10.76 83 106538 3256 46576185
Labelled drug-drug interaction medication error 122.36 10.76 126 106495 8935 46570506
Abdominal wall haematoma 121.48 10.76 78 106543 2803 46576638
Infusion related reaction 121.14 10.76 40 106581 101168 46478273
Depression 115.39 10.76 131 106490 169973 46409468
Anxiety 115.09 10.76 148 106473 181809 46397632
Muscle haemorrhage 111.76 10.76 78 106543 3226 46576215
Haemorrhagic transformation stroke 111.02 10.76 54 106567 1116 46578325
Hemiparesis 108.07 10.76 177 106444 19892 46559549
Pyrexia 107.14 10.76 422 106199 348380 46231061
Arthralgia 106.44 10.76 450 106171 364153 46215288
Synovitis 105.90 10.76 9 106612 61066 46518375
Therapeutic product effect decreased 105.46 10.76 29 106592 82572 46496869
Gastrointestinal vascular malformation haemorrhagic 101.88 10.76 30 106591 134 46579307
Mouth haemorrhage 101.72 10.76 97 106524 6265 46573176
Thalamus haemorrhage 99.21 10.76 40 106581 517 46578924
Injection site erythema 99.09 10.76 24 106597 74403 46505038
Completed suicide 95.06 10.76 116 106505 145804 46433637
Iron deficiency anaemia 92.98 10.76 152 106469 17054 46562387
Subdural haemorrhage 92.14 10.76 66 106555 2846 46576595
Drug intolerance 91.53 10.76 121 106500 146928 46432513
Drug abuse 91.47 10.76 17 106604 63391 46516050
Dyspnoea exertional 89.93 10.76 286 106335 50003 46529438
Febrile neutropenia 85.97 10.76 55 106566 94572 46484869
Contusion 85.45 10.76 411 106210 87076 46492365
Prothrombin time prolonged 83.03 10.76 106 106515 9490 46569951
Eye haemorrhage 82.72 10.76 91 106530 6961 46572480
Injection site pain 82.34 10.76 74 106547 107078 46472363
Dyspnoea 82.23 10.76 1641 104980 513907 46065534
Maternal exposure during pregnancy 79.79 10.76 70 106551 102479 46476962
Extradural haematoma 79.16 10.76 46 106575 1377 46578064
Splenic rupture 77.90 10.76 43 106578 1164 46578277
Cerebral artery embolism 77.83 10.76 38 106583 792 46578649
Gastric ulcer haemorrhage 77.41 10.76 74 106547 4794 46574647
Duodenal ulcer haemorrhage 77.16 10.76 55 106566 2353 46577088
Haemorrhage urinary tract 76.42 10.76 36 106585 691 46578750
Post procedural haematoma 76.02 10.76 44 106577 1307 46578134
Small intestinal haemorrhage 75.95 10.76 50 106571 1876 46577565
Hospitalisation 75.59 10.76 316 106305 63069 46516372
Retroperitoneal haemorrhage 75.38 10.76 57 106564 2673 46576768
Systemic lupus erythematosus 74.14 10.76 28 106593 65152 46514289
Wound haemorrhage 73.78 10.76 51 106570 2076 46577365
Injection site reaction 73.07 10.76 11 106610 47838 46531603
Renal haemorrhage 72.89 10.76 36 106585 770 46578671
Cerebral artery occlusion 72.82 10.76 38 106583 916 46578525
Drug interaction 72.24 10.76 745 105876 202349 46377092
Cardiac failure 71.97 10.76 367 106254 79581 46499860
Postmenopausal haemorrhage 71.56 10.76 49 106572 1964 46577477
Exposure during pregnancy 71.54 10.76 85 106536 108127 46471314
Product prescribing error 71.48 10.76 148 106473 19899 46559542
Joint swelling 71.47 10.76 172 106449 165901 46413540
Musculoskeletal stiffness 71.39 10.76 71 106550 97922 46481519
Embolism 70.05 10.76 84 106537 7054 46572387
Venous thrombosis 67.54 10.76 68 106553 4694 46574747
Peripheral embolism 66.59 10.76 39 106582 1185 46578256
Embolism venous 66.27 10.76 51 106570 2456 46576985
Hand deformity 66.18 10.76 3 106618 34571 46544870
Neutropenia 65.08 10.76 144 106477 143060 46436381
Sinusitis 64.46 10.76 124 106497 129644 46449797
Condition aggravated 63.31 10.76 316 106305 244736 46334705
Treatment noncompliance 61.51 10.76 178 106443 29553 46549888
Cerebral ischaemia 61.36 10.76 74 106547 6251 46573190
Gastritis haemorrhagic 61.16 10.76 38 106583 1288 46578153
Gastric haemorrhage 60.15 10.76 71 106550 5863 46573578
Product prescribing issue 59.59 10.76 33 106588 899 46578542
Pulmonary thrombosis 58.19 10.76 78 106543 7324 46572117
Glossodynia 57.72 10.76 15 106606 44358 46535083
Haemorrhage subcutaneous 57.62 10.76 50 106571 2856 46576585
Deep vein thrombosis postoperative 57.25 10.76 21 106600 206 46579235
Therapeutic response decreased 57.25 10.76 14 106607 43131 46536310
Anaphylactic reaction 56.86 10.76 25 106596 53087 46526354
Pulmonary arterial hypertension 56.33 10.76 158 106463 25770 46553671
Cerebral ventricular rupture 56.14 10.76 20 106601 179 46579262
Traumatic intracranial haemorrhage 55.91 10.76 23 106598 314 46579127
Infection 55.39 10.76 141 106480 133451 46445990
Haemothorax 55.31 10.76 42 106579 1982 46577459
Incision site haemorrhage 54.96 10.76 26 106595 504 46578937
Hypersensitivity 53.97 10.76 170 106451 150151 46429290
Multiple sclerosis relapse 53.36 10.76 15 106606 42110 46537331
Seizure 53.27 10.76 127 106494 122927 46456514
Psoriasis 52.74 10.76 61 106560 78543 46500898
Intracardiac thrombus 52.53 10.76 43 106578 2265 46577176
Venous thrombosis limb 52.25 10.76 47 106574 2816 46576625
Therapeutic product effect incomplete 52.06 10.76 61 106560 78092 46501349
Renal impairment 51.38 10.76 318 106303 74054 46505387
Adrenal haemorrhage 50.96 10.76 22 106599 341 46579100
Suicidal ideation 50.88 10.76 33 106588 56349 46523092
Activated partial thromboplastin time prolonged 50.24 10.76 70 106551 6819 46572622
Splenic haemorrhage 50.11 10.76 19 106602 206 46579235
Gastric ulcer 49.24 10.76 135 106486 21728 46557713
Occult blood positive 48.84 10.76 50 106571 3520 46575921
Pharyngeal haemorrhage 48.10 10.76 24 106597 525 46578916
Cardioversion 48.10 10.76 31 106590 1121 46578320
Urinary bladder haemorrhage 47.99 10.76 30 106591 1028 46578413
Haematoma muscle 47.89 10.76 25 106596 603 46578838
Insomnia 47.70 10.76 204 106417 164720 46414721
Cerebellar infarction 47.48 10.76 37 106584 1815 46577626
Brain stem haemorrhage 47.33 10.76 26 106595 697 46578744
Pregnancy 47.03 10.76 4 106617 27133 46552308
Injection site pruritus 47.02 10.76 16 106605 39727 46539714
Coagulopathy 46.51 10.76 119 106502 18380 46561061
Spinal cord haematoma 46.51 10.76 17 106604 165 46579276
Transfusion 46.37 10.76 97 106524 13134 46566307
Large intestinal haemorrhage 45.70 10.76 30 106591 1120 46578321
Arthropathy 45.57 10.76 77 106544 84623 46494818
Retinal haemorrhage 45.53 10.76 56 106565 4827 46574614
Weight increased 45.41 10.76 207 106414 164266 46415175
Spontaneous haematoma 44.62 10.76 25 106596 697 46578744
Psoriatic arthropathy 44.17 10.76 14 106607 36365 46543076
Pericardial effusion 43.59 10.76 143 106478 25400 46554041
Pulmonary hypertension 43.33 10.76 180 106441 35813 46543628
Pulmonary haemorrhage 42.89 10.76 63 106558 6442 46572999
Prothrombin time shortened 42.64 10.76 34 106587 1725 46577716
Suicide attempt 42.27 10.76 38 106583 54998 46524443
Intra-abdominal haemorrhage 42.03 10.76 38 106583 2292 46577149
Retroperitoneal haematoma 41.73 10.76 40 106581 2600 46576841
Agitation 41.68 10.76 39 106582 55376 46524065
Injection site swelling 41.58 10.76 20 106601 40307 46539134
Procedural haemorrhage 41.26 10.76 38 106583 2348 46577093
Herpes zoster 41.03 10.76 57 106564 67815 46511626
Loss of personal independence in daily activities 40.99 10.76 42 106579 57141 46522300
Contraindicated product administered 40.91 10.76 75 106546 79872 46499569
Somnolence 40.86 10.76 201 106420 156320 46423121
Treatment failure 40.33 10.76 96 106525 92991 46486450
Skin haemorrhage 40.21 10.76 58 106563 5833 46573608
Microcytic anaemia 39.89 10.76 42 106579 3056 46576385
Anticoagulation drug level increased 38.89 10.76 15 106606 171 46579270
Intentional overdose 38.80 10.76 55 106566 64889 46514552
Ecchymosis 38.78 10.76 79 106542 10497 46568944
Inflammation 38.28 10.76 33 106588 48748 46530693
Blood cholesterol increased 38.08 10.76 22 106599 39991 46539450
Sedation 38.05 10.76 4 106617 22906 46556535
Conjunctival haemorrhage 37.65 10.76 40 106581 2941 46576500
Mobility decreased 37.52 10.76 50 106571 60544 46518897
High frequency ablation 37.24 10.76 14 106607 148 46579293
Creatinine renal clearance abnormal 37.19 10.76 15 106606 194 46579247
Hypertension 37.17 10.76 279 106342 196077 46383364
Cardiac failure chronic 37.11 10.76 43 106578 3481 46575960
Head injury 36.85 10.76 132 106489 24504 46554937
Glomerular filtration rate decreased 36.71 10.76 82 106539 11612 46567829
Alanine aminotransferase increased 36.15 10.76 94 106527 88357 46491084
Acute kidney injury 36.13 10.76 747 105874 235108 46344333
Coagulation factor X level increased 35.59 10.76 7 106614 0 46579441
Traumatic haematoma 35.26 10.76 28 106593 1412 46578029
Emotional distress 35.23 10.76 13 106608 30694 46548747
Device related thrombosis 34.73 10.76 26 106595 1201 46578240
Subgaleal haematoma 34.67 10.76 11 106610 66 46579375
Labelled drug-disease interaction medication error 33.96 10.76 13 106608 145 46579296
Foetal exposure during pregnancy 33.66 10.76 14 106607 30733 46548708
Nasopharyngitis 33.50 10.76 210 106411 153788 46425653
Chills 33.47 10.76 110 106511 95922 46483519
Chest wall haematoma 33.24 10.76 12 106609 112 46579329
Traumatic haemorrhage 33.03 10.76 17 106604 398 46579043
Pulmonary alveolar haemorrhage 32.94 10.76 44 106577 4118 46575323
Rheumatoid factor positive 32.91 10.76 4 106617 20457 46558984
Pelvic venous thrombosis 32.72 10.76 28 106593 1569 46577872
Nausea 32.64 10.76 1263 105358 686191 45893250
Gastrointestinal angiodysplasia 32.27 10.76 17 106604 418 46579023
Haemorrhagic cerebral infarction 32.16 10.76 19 106602 587 46578854
Irritability 31.98 10.76 13 106608 28933 46550508
Abdominal wall haemorrhage 31.66 10.76 12 106609 130 46579311
Hypoglycaemia 31.51 10.76 47 106574 54302 46525139
Hepatotoxicity 31.50 10.76 9 106612 25000 46554441
Stress 31.45 10.76 43 106578 51508 46527933
Anovulatory cycle 31.41 10.76 12 106609 133 46579308
Mesenteric artery embolism 31.27 10.76 7 106614 6 46579435
Pallor 31.20 10.76 120 106501 23046 46556395
Gastrointestinal ulcer haemorrhage 31.09 10.76 19 106602 625 46578816
Hypovolaemic shock 31.04 10.76 48 106573 5135 46574306
Aggression 30.92 10.76 7 106614 22737 46556704
Overdose 30.79 10.76 124 106497 101855 46477586
Renal infarct 30.35 10.76 24 106597 1203 46578238
Intra-abdominal haematoma 30.21 10.76 27 106594 1604 46577837
Alopecia 30.15 10.76 232 106389 162182 46417259
Fatigue 30.03 10.76 1113 105508 607584 45971857
Toxic epidermal necrolysis 30.00 10.76 7 106614 22271 46557170
Vascular pseudoaneurysm 29.93 10.76 25 106596 1355 46578086
Peripheral ischaemia 29.83 10.76 44 106577 4515 46574926
Hypersensitivity vasculitis 29.46 10.76 42 106579 4179 46575262
Cardiac tamponade 29.16 10.76 43 106578 4411 46575030
Spinal cord haemorrhage 29.09 10.76 12 106609 165 46579276
Potentiating drug interaction 28.81 10.76 40 106581 3883 46575558
Brain herniation 28.72 10.76 35 106586 2988 46576453
Gastritis erosive 28.67 10.76 47 106574 5283 46574158
Basal cell carcinoma 28.47 10.76 6 106615 20481 46558960
Salpingo-oophorectomy unilateral 28.47 10.76 15 106606 369 46579072
Fluid retention 28.47 10.76 207 106414 50839 46528602
Aspartate aminotransferase increased 28.22 10.76 89 106532 78611 46500830
C-reactive protein increased 28.19 10.76 57 106564 58533 46520908
Intentional self-injury 28.12 10.76 10 106611 24156 46555285
Duodenal ulcer 27.76 10.76 55 106566 7163 46572278
Aphasia 27.71 10.76 134 106487 28433 46551008
Ear haemorrhage 27.56 10.76 23 106598 1245 46578196
Blood pressure increased 27.40 10.76 173 106448 126493 46452948
Drug dependence 27.31 10.76 6 106615 19895 46559546
Gastrointestinal polyp haemorrhage 27.16 10.76 11 106610 144 46579297
Arterial haemorrhage 27.09 10.76 26 106595 1692 46577749
Dry eye 27.01 10.76 18 106603 30304 46549137
Haematoma infection 26.97 10.76 16 106605 498 46578943
Injection site bruising 26.89 10.76 25 106596 35611 46543830
Malignant neoplasm progression 26.52 10.76 69 106552 64857 46514584
Intestinal haemorrhage 26.36 10.76 34 106587 3074 46576367
Oedema peripheral 26.14 10.76 511 106110 159195 46420246
Arterial injury 26.11 10.76 11 106610 160 46579281
Tremor 26.02 10.76 156 106465 115483 46463958
Purpura 26.01 10.76 65 106556 9893 46569548
Bone marrow failure 25.91 10.76 18 106603 29651 46549790
Crying 25.91 10.76 8 106613 21133 46558308
Cytomegalovirus infection 25.87 10.76 5 106616 18139 46561302
Therapeutic response increased 25.86 10.76 13 106608 289 46579152
Ischaemic cerebral infarction 25.86 10.76 22 106599 1223 46578218
Cerebral artery thrombosis 25.84 10.76 14 106607 365 46579076
Gait disturbance 25.79 10.76 210 106411 145053 46434388
Sinusitis fungal 25.73 10.76 19 106602 859 46578582
Haemoperitoneum 25.66 10.76 30 106591 2452 46576989
Injection site rash 25.65 10.76 3 106618 15810 46563631
Retinal artery occlusion 25.55 10.76 23 106598 1379 46578062
Petechiae 25.38 10.76 75 106546 12595 46566846
Dizziness 25.26 10.76 983 105638 339431 46240010
International normalised ratio abnormal 25.23 10.76 33 106588 3026 46576415
Abortion spontaneous 25.05 10.76 38 106583 43608 46535833
Swelling 24.95 10.76 174 106447 124337 46455104
Spontaneous haemorrhage 24.89 10.76 11 106610 181 46579260
Drug withdrawal syndrome 24.74 10.76 16 106605 27368 46552073
Cardiac pacemaker insertion 24.64 10.76 36 106585 3663 46575778
Multiple sclerosis 24.50 10.76 13 106608 24778 46554663
Joint stiffness 24.27 10.76 16 106605 27092 46552349
Mood swings 24.21 10.76 4 106617 16248 46563193
Oesophageal haemorrhage 24.07 10.76 15 106606 511 46578930
Discomfort 23.67 10.76 44 106577 46626 46532815
Cardiac ablation 23.63 10.76 21 106600 1238 46578203
Cerebral thrombosis 23.57 10.76 24 106597 1679 46577762
Haemorrhagic erosive gastritis 23.51 10.76 12 106609 276 46579165
Osteopenia 23.50 10.76 5 106616 16956 46562485
Sinus tachycardia 23.47 10.76 10 106611 21639 46557802
Arthritis 23.34 10.76 94 106527 77222 46502219
Stomatitis 23.26 10.76 79 106542 68218 46511223
Right ventricular failure 23.03 10.76 85 106536 16008 46563433
Hypoaesthesia 22.90 10.76 168 106453 118701 46460740
Menometrorrhagia 22.89 10.76 18 106603 895 46578546
Injury 22.79 10.76 41 106580 43986 46535455
Post procedural pulmonary embolism 22.76 10.76 10 106611 162 46579279
Mucosal haemorrhage 22.52 10.76 17 106604 795 46578646
Erythema 22.47 10.76 213 106408 142607 46436834
Diverticulitis intestinal haemorrhagic 22.07 10.76 9 106612 120 46579321
Swelling face 21.97 10.76 56 106565 53003 46526438
Premature baby 21.93 10.76 7 106614 18105 46561336
White blood cell count decreased 21.92 10.76 158 106463 112073 46467368
Brain stem infarction 21.74 10.76 17 106604 838 46578603
Osteomyelitis 21.73 10.76 12 106609 22371 46557070
Fibromyalgia 21.65 10.76 31 106590 36432 46543009
Thrombophlebitis superficial 21.55 10.76 40 106581 4963 46574478
Injection site warmth 21.41 10.76 3 106618 13769 46565672
Mucosal inflammation 21.36 10.76 35 106586 38941 46540500
Catheter management 21.28 10.76 29 106592 2766 46576675
Oropharyngeal pain 21.26 10.76 92 106529 74076 46505365
Premature delivery 21.19 10.76 12 106609 22057 46557384
Fluid overload 21.18 10.76 120 106501 27065 46552376
Arrhythmia 21.01 10.76 144 106477 34697 46544744
Oral herpes 20.95 10.76 9 106612 19381 46560060
Intracranial haematoma 20.90 10.76 12 106609 351 46579090
Blood glucose increased 20.84 10.76 89 106532 71924 46507517
Respiratory arrest 20.83 10.76 28 106593 33788 46545653
Peripheral artery thrombosis 20.62 10.76 23 106598 1786 46577655
Arterial thrombosis 20.56 10.76 20 106601 1324 46578117
Multiple organ dysfunction syndrome 20.33 10.76 56 106565 51654 46527787
Bradyarrhythmia 20.33 10.76 24 106597 1982 46577459
Product administration error 20.31 10.76 94 106527 19587 46559854
Lymphopenia 20.21 10.76 5 106616 15288 46564153
Atrial flutter 20.11 10.76 56 106565 9092 46570349
Leukopenia 20.06 10.76 84 106537 68259 46511182
Urogenital haemorrhage 20.04 10.76 9 106612 154 46579287
Neuralgia 20.00 10.76 12 106609 21371 46558070
Rhinorrhoea 19.97 10.76 50 106571 47615 46531826
Ventricle rupture 19.95 10.76 5 106616 10 46579431
Serotonin syndrome 19.47 10.76 16 106605 24204 46555237
Hypochromic anaemia 19.45 10.76 20 106601 1415 46578026
Abnormal behaviour 19.44 10.76 12 106609 21046 46558395
Generalised tonic-clonic seizure 19.34 10.76 20 106601 27102 46552339
Influenza like illness 19.33 10.76 67 106554 57503 46521938
Metabolic acidosis 19.28 10.76 37 106584 38743 46540698
Influenza 19.26 10.76 122 106499 89148 46490293
Lymphocyte count decreased 19.25 10.76 18 106603 25571 46553870
Hepatic steatosis 19.19 10.76 16 106605 24026 46555415
Thrombocytosis 19.10 10.76 38 106583 4964 46574477
Syncope 19.10 10.76 341 106280 104462 46474979
Toothache 19.08 10.76 7 106614 16585 46562856
Drug resistance 18.86 10.76 8 106613 17360 46562081
Vomiting 18.82 10.76 844 105777 451950 46127491
Ear infection 18.76 10.76 15 106606 22998 46556443
Throat tightness 18.72 10.76 12 106609 20627 46558814
Fibrin D dimer increased 18.68 10.76 33 106588 3940 46575501
Foot deformity 18.61 10.76 6 106615 15419 46564022
Intentional product misuse 18.56 10.76 51 106570 47077 46532364
Periorbital haematoma 18.52 10.76 15 106606 778 46578663
Back pain 18.51 10.76 353 106268 209686 46369755
Intervertebral disc protrusion 18.33 10.76 12 106609 20393 46559048
Cholelithiasis 18.29 10.76 38 106583 38643 46540798
Migraine 18.21 10.76 90 106531 69936 46509505
Pulmonary endarterectomy 18.19 10.76 8 106613 130 46579311
Respiratory symptom 18.12 10.76 23 106598 2047 46577394
Cerebral vascular occlusion 18.11 10.76 4 106617 3 46579438
White blood cell count increased 18.05 10.76 47 106574 44172 46535269
Urticaria 18.04 10.76 177 106444 117715 46461726
Procedural pain 18.03 10.76 4 106617 13175 46566266
Subcapsular renal haematoma 18.00 10.76 10 106611 274 46579167
Gastric pH increased 18.00 10.76 6 106615 43 46579398
Coronary artery disease 17.86 10.76 31 106590 33721 46545720
Neutrophil count decreased 17.85 10.76 46 106575 43380 46536061
Sputum increased 17.78 10.76 21 106600 1735 46577706
Antineutrophil cytoplasmic antibody positive 17.77 10.76 12 106609 470 46578971
Haemorrhagic infarction 17.62 10.76 10 106611 286 46579155
Rhabdomyolysis 17.53 10.76 44 106577 41865 46537576
Pancytopenia 17.46 10.76 118 106503 84940 46494501
Ear pain 17.26 10.76 15 106606 22077 46557364
Degenerative aortic valve disease 17.23 10.76 5 106616 21 46579420
Arrhythmogenic right ventricular dysplasia 17.23 10.76 5 106616 21 46579420
Pelvic haemorrhage 17.20 10.76 8 106613 149 46579292
Weight decreased 17.18 10.76 359 106262 210490 46368951
Putamen haemorrhage 16.96 10.76 8 106613 154 46579287
Nasal polyps 16.93 10.76 23 106598 2187 46577254
Stevens-Johnson syndrome 16.82 10.76 17 106604 23280 46556161
Urethral haemorrhage 16.81 10.76 6 106615 54 46579387
Diverticulum 16.72 10.76 60 106561 11146 46568295
Haemorrhagic hepatic cyst 16.69 10.76 5 106616 24 46579417
Thrombotic stroke 16.66 10.76 12 106609 522 46578919
Aortic valve calcification 16.63 10.76 11 106610 416 46579025
Ulcer haemorrhage 16.62 10.76 29 106592 3429 46576012
Product dose omission issue 16.58 10.76 503 106118 168017 46411424
Osteoarthritis 16.54 10.76 79 106542 61946 46517495
Post procedural stroke 16.34 10.76 6 106615 59 46579382
Oesophagitis haemorrhagic 16.33 10.76 11 106610 429 46579012
Quadriplegia 16.32 10.76 20 106601 1717 46577724
Dystonia 16.27 10.76 3 106618 11254 46568187
Urinary tract infection 16.24 10.76 381 106240 219885 46359556
Vision blurred 16.15 10.76 111 106510 79597 46499844
Ovarian cyst 16.10 10.76 6 106615 14081 46565360
Osteonecrosis of jaw 16.10 10.76 34 106587 34368 46545073
Retinal vein thrombosis 16.08 10.76 11 106610 440 46579001
Medical device site haemorrhage 16.05 10.76 5 106616 28 46579413
Breast haematoma 16.03 10.76 8 106613 175 46579266
Peritoneal haematoma 16.00 10.76 6 106615 63 46579378
Catheter site discharge 15.84 10.76 21 106600 1951 46577490
Withdrawal syndrome 15.84 10.76 11 106610 18123 46561318
Venous haemorrhage 15.75 10.76 8 106613 182 46579259
Platelet aggregation inhibition 15.74 10.76 7 106614 117 46579324
Emergency care 15.72 10.76 14 106607 828 46578613
Underdose 15.68 10.76 87 106534 19471 46559970
Muscle twitching 15.55 10.76 7 106614 14665 46564776
Hepatic enzyme increased 15.55 10.76 116 106505 81671 46497770
Depressed mood 15.53 10.76 33 106588 33286 46546155
Rash 15.52 10.76 661 105960 355851 46223590
Spinal subdural haematoma 15.52 10.76 7 106614 121 46579320
Paraplegia 15.51 10.76 23 106598 2371 46577070
Coagulation time prolonged 15.49 10.76 17 106604 1297 46578144
Respiratory tract haemorrhage 15.46 10.76 10 106611 364 46579077
Cerebellar haematoma 15.46 10.76 10 106611 364 46579077
Mania 15.44 10.76 3 106618 10843 46568598
Hypercoagulation 15.43 10.76 21 106600 2001 46577440
Anger 15.42 10.76 4 106617 11848 46567593
Neurotoxicity 15.41 10.76 6 106615 13711 46565730
Cerebral ventricle collapse 15.36 10.76 5 106616 33 46579408
Photophobia 15.32 10.76 7 106614 14537 46564904
Vascular stent thrombosis 15.31 10.76 14 106607 857 46578584
Drug ineffective 15.30 10.76 1337 105284 676501 45902940
Right hemisphere deficit syndrome 15.25 10.76 3 106618 0 46579441
Spinal cord injury thoracic 15.25 10.76 3 106618 0 46579441
CHA2DS2-VASc annual stroke risk high 15.25 10.76 3 106618 0 46579441
Orthostatic heart rate response increased 15.25 10.76 3 106618 0 46579441
Contraindication to surgery 15.25 10.76 3 106618 0 46579441
Tooth abscess 15.09 10.76 5 106616 12628 46566813
Tenderness 15.06 10.76 10 106611 16871 46562570
No adverse event 15.06 10.76 35 106586 34196 46545245
Carotid artery occlusion 15.06 10.76 24 106597 2635 46576806
Impaired healing 15.04 10.76 39 106582 36704 46542737
Diabetes mellitus 15.03 10.76 61 106560 50004 46529437
Inappropriate schedule of product administration 15.01 10.76 220 106401 64793 46514648
Therapeutic procedure 14.98 10.76 14 106607 881 46578560
Myoclonus 14.97 10.76 7 106614 14345 46565096
Antiphospholipid syndrome 14.95 10.76 19 106602 1693 46577748
Post procedural discharge 14.91 10.76 10 106611 387 46579054
Viral infection 14.90 10.76 29 106592 30206 46549235
Chronic gastrointestinal bleeding 14.88 10.76 7 106614 134 46579307
Throat irritation 14.88 10.76 27 106594 28874 46550567
Post procedural haematuria 14.86 10.76 5 106616 37 46579404
Muscle spasms 14.84 10.76 195 106426 122918 46456523
Mallory-Weiss syndrome 14.81 10.76 18 106603 1532 46577909
Anal haemorrhage 14.81 10.76 18 106603 1533 46577908
Duodenal polyp 14.71 10.76 6 106615 80 46579361
Psychotic disorder 14.69 10.76 18 106603 22603 46556838
Spinal osteoarthritis 14.61 10.76 7 106614 14144 46565297
Constipation 14.60 10.76 295 106326 173802 46405639
Hyperglycaemia 14.53 10.76 37 106584 35034 46544407
Meningorrhagia 14.51 10.76 7 106614 142 46579299
Arteriovenous malformation 14.40 10.76 16 106605 1237 46578204
Anaphylactic shock 14.40 10.76 15 106606 20259 46559182
Retinal ischaemia 14.38 10.76 9 106612 309 46579132
Traumatic fracture 14.29 10.76 11 106610 530 46578911
Blood creatine phosphokinase increased 14.18 10.76 26 106595 27698 46551743
Autoimmune nephritis 14.18 10.76 9 106612 317 46579124
Exsanguination 14.14 10.76 4 106617 15 46579426
Coagulation test abnormal 14.14 10.76 12 106609 665 46578776
Sleep disorder 14.05 10.76 57 106564 46738 46532703
Red blood cell sedimentation rate increased 14.05 10.76 19 106602 22870 46556571
Musculoskeletal pain 14.04 10.76 98 106523 70030 46509411
Splenic haematoma 13.90 10.76 6 106615 93 46579348
Polyp 13.89 10.76 34 106587 5109 46574332
Lacunar stroke 13.84 10.76 6 106615 94 46579347
Injection site urticaria 13.84 10.76 5 106616 11962 46567479
C-reactive protein abnormal 13.73 10.76 17 106604 21253 46558188
Muscle rigidity 13.67 10.76 3 106618 9958 46569483
Protein S deficiency 13.64 10.76 5 106616 49 46579392
Prosthetic cardiac valve thrombosis 13.56 10.76 4 106617 18 46579423
Anticoagulant therapy 13.56 10.76 4 106617 18 46579423
Pulmonary artery thrombosis 13.55 10.76 12 106609 704 46578737
Headache 13.51 10.76 926 105695 477426 46102015
Osteonecrosis 13.30 10.76 24 106597 25720 46553721
Pseudomonas infection 13.27 10.76 3 106618 9755 46569686
Panic attack 13.26 10.76 16 106605 20226 46559215
Pain in jaw 13.23 10.76 140 106481 38232 46541209
Brain compression 13.20 10.76 9 106612 358 46579083
Jaundice acholuric 13.19 10.76 6 106615 106 46579335
Thrombectomy 13.15 10.76 7 106614 176 46579265
Heart rate irregular 13.15 10.76 80 106541 18511 46560930
Device expulsion 13.07 10.76 27 106594 27515 46551926
Degenerative mitral valve disease 13.06 10.76 4 106617 21 46579420
Haemoglobin abnormal 13.03 10.76 30 106591 4333 46575108
Central nervous system lesion 12.99 10.76 3 106618 9612 46569829
Mydriasis 12.92 10.76 4 106617 10549 46568892
Peritonitis 12.91 10.76 17 106604 20697 46558744
Anastomotic ulcer haemorrhage 12.89 10.76 5 106616 58 46579383
Pulmonary haematoma 12.89 10.76 5 106616 58 46579383
Muscle spasticity 12.86 10.76 5 106616 11435 46568006
Hyperlipidaemia 12.85 10.76 14 106607 18525 46560916
Type 2 diabetes mellitus 12.71 10.76 16 106605 19859 46559582
Chronic gastritis 12.67 10.76 21 106600 2382 46577059
Acute respiratory distress syndrome 12.66 10.76 19 106602 21903 46557538
Lymphadenopathy 12.62 10.76 37 106584 33451 46545990
Pharyngitis 12.50 10.76 13 106608 17570 46561871
Anticoagulation drug level decreased 12.47 10.76 4 106617 25 46579416
Epidural haemorrhage 12.47 10.76 6 106615 121 46579320
Accidental exposure to product 12.44 10.76 18 106603 21063 46558378
Staphylococcal infection 12.44 10.76 41 106580 35730 46543711
Anaemia macrocytic 12.43 10.76 22 106599 2631 46576810
Disease progression 12.37 10.76 141 106480 91159 46488282
Dehydration 12.30 10.76 274 106347 159266 46420175
Medication error 12.21 10.76 116 106505 30795 46548646
Peripheral artery occlusion 12.19 10.76 14 106607 1123 46578318
Abdominal discomfort 12.12 10.76 258 106363 150907 46428534
Breast cancer 12.12 10.76 58 106563 45460 46533981
Pelvic haematoma 12.08 10.76 10 106611 535 46578906
Incorrect dosage administered 12.06 10.76 17 106604 1674 46577767
Incision site haematoma 12.04 10.76 5 106616 70 46579371
Thirst 12.01 10.76 5 106616 10971 46568470
Catheter site bruise 11.99 10.76 8 106613 307 46579134
Infarction 11.99 10.76 20 106601 2281 46577160
Lymphostasis 11.97 10.76 3 106618 6 46579435
Osteorrhagia 11.97 10.76 3 106618 6 46579435
Monoparesis 11.96 10.76 16 106605 1499 46577942
Brain contusion 11.91 10.76 10 106611 546 46578895
Intracranial aneurysm 11.90 10.76 24 106597 3166 46576275
Osteoporosis 11.86 10.76 50 106571 40558 46538883
Vascular purpura 11.85 10.76 15 106606 1331 46578110
Infective pericardial effusion 11.85 10.76 4 106617 30 46579411
Tonic clonic movements 11.84 10.76 14 106607 1158 46578283
Hysterectomy 11.82 10.76 42 106579 7764 46571677
Basilar artery thrombosis 11.79 10.76 6 106615 137 46579304
Spinal cord compression 11.75 10.76 26 106595 3658 46575783
Retinal artery embolism 11.73 10.76 5 106616 75 46579366
Nodule 11.71 10.76 11 106610 15594 46563847
Infective pulmonary exacerbation of cystic fibrosis 11.70 10.76 5 106616 10802 46568639
Post thrombotic syndrome 11.69 10.76 10 106611 560 46578881
Hyperhidrosis 11.68 10.76 139 106482 89169 46490272
Laryngeal haemorrhage 11.66 10.76 3 106618 7 46579434
Bursitis 11.65 10.76 17 106604 19825 46559616
Female genital tract fistula 11.65 10.76 24 106597 3215 46576226
Haemorrhagic diathesis 11.64 10.76 26 106595 3682 46575759
Respiratory depression 11.58 10.76 6 106615 11594 46567847
Central nervous system haemorrhage 11.56 10.76 6 106615 143 46579298
Ventricular tachycardia 11.55 10.76 13 106608 16954 46562487
Status epilepticus 11.53 10.76 9 106612 13970 46565471
Hypercholesterolaemia 11.46 10.76 6 106615 11524 46567917
Ataxia 11.45 10.76 9 106612 13921 46565520
Cataract 11.44 10.76 59 106562 45356 46534085
Hypercalcaemia 11.44 10.76 19 106602 21027 46558414
Vena cava thrombosis 11.43 10.76 19 106602 2160 46577281
Carotid artery thrombosis 11.42 10.76 11 106610 719 46578722
Emotional disorder 11.41 10.76 7 106614 12317 46567124
Cardio-respiratory arrest 11.34 10.76 85 106536 59784 46519657
Oral candidiasis 11.33 10.76 14 106607 17518 46561923
Presyncope 11.32 10.76 95 106526 24359 46555082
Craniocerebral injury 11.30 10.76 19 106602 2181 46577260
Body temperature increased 11.28 10.76 25 106596 24836 46554605
Tumour haemorrhage 11.26 10.76 15 106606 1400 46578041
Cerebellar ischaemia 11.21 10.76 4 106617 36 46579405
Haemorrhagic ovarian cyst 11.20 10.76 10 106611 593 46578848
Contraindication to medical treatment 11.20 10.76 10 106611 593 46578848
Cardiac ventricular thrombosis 11.20 10.76 9 106612 462 46578979
Angioedema 11.15 10.76 49 106572 39293 46540148
Cerebral amyloid angiopathy 11.12 10.76 6 106615 155 46579286
Anti factor X activity increased 11.11 10.76 3 106618 9 46579432
Right atrial enlargement 11.11 10.76 5 106616 86 46579355
Pharyngeal oedema 11.10 10.76 10 106611 14461 46564980
Uveitis 11.08 10.76 3 106618 8638 46570803
Tracheal haemorrhage 11.05 10.76 6 106615 157 46579284
Cognitive disorder 11.03 10.76 45 106576 36838 46542603
Investigation 11.02 10.76 16 106605 1618 46577823
Orthopnoea 11.02 10.76 34 106587 5846 46573595
Catheter site hypersensitivity 11.01 10.76 5 106616 88 46579353
Blindness unilateral 11.00 10.76 32 106589 5325 46574116
Carpal tunnel syndrome 10.97 10.76 12 106609 15847 46563594
Paresis 10.95 10.76 18 106603 2028 46577413
Proteinuria 10.93 10.76 13 106608 16540 46562901
Vascular operation 10.85 10.76 5 106616 91 46579350
Catheter site haemorrhage 10.85 10.76 21 106600 2688 46576753
Confusional state 10.84 10.76 280 106341 159612 46419829
Pruritus 10.81 10.76 448 106173 241904 46337537
Blood blister 10.77 10.76 16 106605 1652 46577789

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 4703.75 11.84 3097 96103 80349 29772929
Deep vein thrombosis 1816.24 11.84 1543 97657 58958 29794320
Haemorrhage 1457.73 11.84 1212 97988 44867 29808411
Haematuria 1376.20 11.84 1159 98041 43675 29809603
Pulmonary embolism 1314.84 11.84 1450 97750 76685 29776593
Epistaxis 1134.18 11.84 1119 98081 51862 29801416
Cerebral haemorrhage 1062.15 11.84 876 98324 32011 29821267
Haemorrhage intracranial 967.37 11.84 609 98591 14423 29838855
Ischaemic stroke 925.51 11.84 610 98590 15665 29837613
Upper gastrointestinal haemorrhage 826.60 11.84 641 98559 21387 29831891
Cerebrovascular accident 818.84 11.84 1184 98016 82293 29770985
Cerebral infarction 753.65 11.84 655 98545 25718 29827560
Rectal haemorrhage 634.49 11.84 676 98524 34263 29819015
Atrial thrombosis 592.09 11.84 226 98974 1655 29851623
Thrombosis 571.97 11.84 702 98498 41529 29811749
Haematoma 551.26 11.84 527 98673 23426 29829852
Subdural haematoma 505.46 11.84 453 98747 18519 29834759
Lower gastrointestinal haemorrhage 492.73 11.84 314 98886 7590 29845688
Embolic stroke 467.47 11.84 232 98968 3390 29849888
Melaena 459.90 11.84 552 98648 31885 29821393
Haemorrhagic stroke 458.98 11.84 274 98926 5873 29847405
Internal haemorrhage 404.57 11.84 225 98975 4197 29849081
Post procedural haemorrhage 370.09 11.84 263 98937 7647 29845631
Gastric haemorrhage 355.97 11.84 276 98924 9191 29844087
Transient ischaemic attack 321.86 11.84 407 98793 24793 29828485
Haemoptysis 311.49 11.84 446 98754 30632 29822646
Blood loss anaemia 262.31 11.84 211 98989 7416 29845862
Anaemia 258.99 11.84 1364 97836 206628 29646650
Diverticulum intestinal haemorrhagic 255.05 11.84 129 99071 1966 29851312
Blood urine present 251.03 11.84 230 98970 9670 29843608
Haemarthrosis 247.52 11.84 142 99058 2817 29850461
Toxicity to various agents 241.50 11.84 144 99056 177039 29676239
Gingival bleeding 239.21 11.84 186 99014 6218 29847060
Haemorrhagic arteriovenous malformation 225.65 11.84 73 99127 302 29852976
Haematochezia 224.53 11.84 405 98795 33817 29819461
Haemoglobin decreased 222.98 11.84 856 98344 113242 29740036
Basal ganglia haemorrhage 216.48 11.84 88 99112 775 29852503
Pyrexia 210.76 11.84 411 98789 294078 29559200
Pericardial haemorrhage 209.86 11.84 127 99073 2791 29850487
Drug abuse 199.95 11.84 20 99180 82052 29771226
Incorrect dose administered 192.76 11.84 363 98837 31323 29821955
Shock haemorrhagic 189.76 11.84 197 99003 9668 29843610
Fall 185.96 11.84 1132 98068 180740 29672538
Atrial fibrillation 179.23 11.84 771 98429 107353 29745925
Cerebellar haemorrhage 178.40 11.84 89 99111 1315 29851963
Thalamus haemorrhage 171.77 11.84 77 99123 881 29852397
Labelled drug-drug interaction medication error 170.38 11.84 192 99008 10346 29842932
Cerebral haematoma 164.02 11.84 129 99071 4385 29848893
Embolic cerebral infarction 160.72 11.84 67 99133 633 29852645
Haemorrhoidal haemorrhage 159.59 11.84 110 99090 3040 29850238
Intraventricular haemorrhage 158.70 11.84 108 99092 2922 29850356
Febrile neutropenia 157.90 11.84 78 99122 106615 29746663
Contusion 155.03 11.84 329 98871 30951 29822327
Procedural haemorrhage 145.96 11.84 93 99107 2245 29851033
Subarachnoid haemorrhage 141.21 11.84 169 99031 9717 29843561
Gastrointestinal vascular malformation haemorrhagic 134.94 11.84 55 99145 488 29852790
Cerebral artery embolism 134.33 11.84 64 99136 850 29852428
Haematemesis 126.84 11.84 273 98927 25930 29827348
International normalised ratio increased 123.23 11.84 393 98807 47346 29805932
Wound haemorrhage 120.98 11.84 75 99125 1723 29851555
Faeces discoloured 120.79 11.84 187 99013 13759 29839519
Hemiplegia 119.17 11.84 128 99072 6533 29846745
Creatinine renal clearance decreased 119.06 11.84 95 99105 3298 29849980
Cardioversion 113.30 11.84 56 99144 810 29852468
Gastric ulcer haemorrhage 111.07 11.84 111 99089 5203 29848075
Hemiparesis 109.81 11.84 185 99015 14617 29838661
Haemorrhagic transformation stroke 105.89 11.84 60 99140 1161 29852117
Neutropenia 105.62 11.84 164 99036 128376 29724902
Mouth haemorrhage 105.23 11.84 105 99095 4912 29848366
Iron deficiency anaemia 103.06 11.84 138 99062 8886 29844392
Subcutaneous haematoma 101.71 11.84 54 99146 914 29852364
Depression 101.53 11.84 90 99110 90347 29762931
Foetal exposure during pregnancy 101.21 11.84 5 99195 36866 29816412
Cardiac tamponade 97.05 11.84 97 99103 4547 29848731
Intracardiac thrombus 93.37 11.84 72 99128 2376 29850902
Retroperitoneal haemorrhage 93.10 11.84 75 99125 2640 29850638
Completed suicide 92.63 11.84 116 99084 99376 29753902
Drug hypersensitivity 91.32 11.84 57 99143 68462 29784816
Muscle haemorrhage 88.00 11.84 83 99117 3620 29849658
Haemorrhage urinary tract 86.24 11.84 59 99141 1610 29851668
Subdural haemorrhage 85.30 11.84 73 99127 2799 29850479
Sepsis 85.16 11.84 228 98972 146167 29707111
Anxiety 84.48 11.84 104 99096 89767 29763511
Splenic rupture 83.42 11.84 56 99144 1480 29851798
Cerebral ventricular rupture 82.28 11.84 27 99173 118 29853160
High frequency ablation 81.00 11.84 28 99172 148 29853130
Anticoagulation drug level increased 78.15 11.84 37 99163 484 29852794
Abdominal wall haematoma 77.15 11.84 55 99145 1606 29851672
Small intestinal haemorrhage 74.71 11.84 59 99141 2017 29851261
Disease progression 74.46 11.84 93 99107 79781 29773497
Condition aggravated 74.07 11.84 223 98977 137643 29715635
Pancytopenia 73.23 11.84 105 99095 84947 29768331
Aphasia 72.63 11.84 183 99017 19256 29834022
Microcytic anaemia 72.22 11.84 59 99141 2119 29851159
Renal haemorrhage 71.56 11.84 48 99152 1267 29852011
Traumatic intracranial haemorrhage 70.77 11.84 37 99163 606 29852672
Large intestinal haemorrhage 70.68 11.84 51 99149 1518 29851760
Nausea 70.43 11.84 637 98563 296320 29556958
Brain stem haemorrhage 69.15 11.84 40 99160 806 29852472
Pelvic venous thrombosis 68.53 11.84 34 99166 496 29852782
Infusion related reaction 67.37 11.84 25 99175 40539 29812739
Haemorrhagic diathesis 66.79 11.84 63 99137 2748 29850530
Product prescribing error 66.18 11.84 161 99039 16572 29836706
Drug interaction 65.49 11.84 975 98225 198593 29654685
Occult blood positive 65.06 11.84 71 99129 3689 29849589
Traumatic haemorrhage 65.01 11.84 35 99165 610 29852668
Post procedural haematoma 64.53 11.84 48 99152 1499 29851779
Agitation 64.11 11.84 51 99149 54022 29799256
Insomnia 64.11 11.84 133 99067 93203 29760075
Haemorrhage subcutaneous 62.68 11.84 55 99145 2182 29851096
Pulmonary haemorrhage 62.62 11.84 112 99088 9280 29843998
Rhabdomyolysis 62.48 11.84 71 99129 63509 29789769
Head injury 62.30 11.84 159 99041 16861 29836417
Tremor 61.99 11.84 96 99104 75267 29778011
Haemothorax 61.38 11.84 67 99133 3482 29849796
Seizure 61.36 11.84 148 99052 98327 29754951
Neutrophil count decreased 61.30 11.84 32 99168 42422 29810856
Inappropriate schedule of product administration 60.89 11.84 277 98923 39451 29813827
Overdose 60.64 11.84 117 99083 84220 29769058
Bladder tamponade 59.76 11.84 29 99171 402 29852876
Rheumatoid arthritis 59.56 11.84 31 99169 41166 29812112
Somnolence 58.28 11.84 148 99052 96615 29756663
Drug dependence 58.08 11.84 3 99197 21292 29831986
Prothrombin time prolonged 57.05 11.84 107 99093 9196 29844082
Spinal cord haemorrhage 57.05 11.84 26 99174 310 29852968
Gastritis haemorrhagic 56.77 11.84 40 99160 1146 29852132
Product prescribing issue 56.68 11.84 35 99165 798 29852480
Adrenal haemorrhage 56.38 11.84 22 99178 172 29853106
Gastric ulcer 56.12 11.84 142 99058 14979 29838299
Vomiting 55.82 11.84 463 98737 219355 29633923
Mucosal inflammation 55.55 11.84 16 99184 30478 29822800
Gastrointestinal polyp haemorrhage 55.10 11.84 24 99176 255 29853023
Death 54.35 11.84 845 98355 356438 29496840
Duodenal ulcer haemorrhage 54.19 11.84 72 99128 4600 29848678
Gastritis erosive 53.91 11.84 79 99121 5534 29847744
Haemorrhagic cerebral infarction 53.42 11.84 33 99167 753 29852525
Compartment syndrome 53.20 11.84 53 99147 2474 29850804
Pneumonia 52.76 11.84 785 98415 333521 29519757
Peripheral embolism 52.62 11.84 34 99166 841 29852437
Arterial haemorrhage 51.81 11.84 32 99168 730 29852548
Gastrointestinal ulcer haemorrhage 51.19 11.84 30 99170 620 29852658
White blood cell count decreased 50.85 11.84 128 99072 83819 29769459
Eye haemorrhage 50.69 11.84 62 99138 3645 29849633
Prostatic haemorrhage 50.54 11.84 20 99180 163 29853115
Penile haemorrhage 50.15 11.84 29 99171 584 29852694
Aggression 50.13 11.84 30 99170 36877 29816401
Bone marrow failure 50.06 11.84 18 99182 29767 29823511
Treatment noncompliance 49.60 11.84 190 99010 25063 29828215
Cerebral ventricle collapse 49.34 11.84 15 99185 48 29853230
Psoriasis 49.25 11.84 41 99159 42465 29810813
Urinary bladder haemorrhage 49.10 11.84 42 99158 1609 29851669
Blood glucose increased 49.06 11.84 80 99120 61450 29791828
Blood creatine phosphokinase increased 48.73 11.84 44 99156 43804 29809474
Weight decreased 48.44 11.84 297 98903 150624 29702654
Ischaemic cerebral infarction 48.38 11.84 33 99167 896 29852382
Chills 48.05 11.84 105 99095 72233 29781045
Pain 47.81 11.84 355 98845 172286 29680992
Drug withdrawal syndrome 47.75 11.84 5 99195 19804 29833474
Leukopenia 47.66 11.84 70 99130 56089 29797189
White blood cell count increased 47.55 11.84 37 99163 39636 29813642
Aspartate aminotransferase increased 47.33 11.84 86 99114 63336 29789942
Malignant neoplasm progression 47.14 11.84 106 99094 72181 29781097
Deep vein thrombosis postoperative 47.08 11.84 11 99189 6 29853272
Cerebral ischaemia 46.65 11.84 78 99122 6122 29847156
Dehydration 46.26 11.84 231 98969 123308 29729970
Cytomegalovirus infection 45.83 11.84 11 99189 23663 29829615
Suicidal ideation 45.45 11.84 32 99168 36082 29817196
Hypochromic anaemia 45.32 11.84 30 99170 774 29852504
Haemorrhagic erosive gastritis 45.05 11.84 17 99183 120 29853158
Conjunctival haemorrhage 45.01 11.84 50 99150 2650 29850628
Embolism venous 44.83 11.84 36 99164 1261 29852017
Skin haemorrhage 44.58 11.84 56 99144 3384 29849894
Asthma 44.29 11.84 33 99167 36141 29817137
Multiple organ dysfunction syndrome 43.97 11.84 90 99110 63397 29789881
Therapeutic response decreased 43.94 11.84 13 99187 24336 29828942
Thrombophlebitis superficial 43.77 11.84 49 99151 2620 29850658
Cardiac ventricular thrombosis 43.15 11.84 29 99171 768 29852510
Cerebellar infarction 43.09 11.84 41 99159 1808 29851470
Hyponatraemia 42.64 11.84 100 99100 67102 29786176
Splenic haemorrhage 42.04 11.84 22 99178 361 29852917
Venous thrombosis 40.88 11.84 52 99148 3182 29850096
N-terminal prohormone brain natriuretic peptide abnormal 40.61 11.84 15 99185 99 29853179
Vitreous haemorrhage 40.32 11.84 42 99158 2068 29851210
Vascular stent thrombosis 40.12 11.84 44 99156 2299 29850979
Pericardial effusion 39.82 11.84 157 99043 20987 29832291
Neutrophil count increased 39.28 11.84 3 99197 15320 29837958
Infection 39.26 11.84 130 99070 77944 29775334
Retinal vascular thrombosis 39.04 11.84 13 99187 60 29853218
Ecchymosis 38.74 11.84 74 99126 6448 29846830
Coagulopathy 38.72 11.84 142 99058 18345 29834933
Wound haematoma 38.70 11.84 13 99187 62 29853216
Irritability 38.61 11.84 14 99186 23036 29830242
Hypoxia 38.35 11.84 62 99138 47792 29805486
Peripheral swelling 37.91 11.84 338 98862 60736 29792542
Psychotic disorder 37.90 11.84 12 99188 21503 29831775
Hypovolaemic shock 37.68 11.84 73 99127 6427 29846851
Alanine aminotransferase increased 37.13 11.84 124 99076 74152 29779126
Vascular pseudoaneurysm 36.77 11.84 39 99161 1961 29851317
Duodenal ulcer 36.76 11.84 93 99107 9808 29843470
Diabetes mellitus 36.68 11.84 51 99149 41814 29811464
Hypophagia 36.42 11.84 14 99186 22222 29831056
Splenic haematoma 35.95 11.84 15 99185 142 29853136
Ear haemorrhage 35.81 11.84 27 99173 861 29852417
Urogenital haemorrhage 35.77 11.84 16 99184 182 29853096
Retroperitoneal haematoma 35.68 11.84 43 99157 2489 29850789
Spontaneous haematoma 35.38 11.84 22 99178 508 29852770
Peptic ulcer haemorrhage 35.00 11.84 21 99179 454 29852824
Gastrointestinal angiectasia 34.88 11.84 17 99183 238 29853040
Diarrhoea 34.85 11.84 842 98358 333261 29520017
Arteriovenous malformation 34.73 11.84 23 99177 594 29852684
Lymphocyte count decreased 34.70 11.84 10 99190 19045 29834233
Brain stem infarction 34.38 11.84 31 99169 1275 29852003
Extra dose administered 34.28 11.84 45 99155 2841 29850437
Activated partial thromboplastin time prolonged 33.85 11.84 78 99122 7750 29845528
Intestinal haemorrhage 33.60 11.84 47 99153 3154 29850124
Renal haematoma 33.58 11.84 21 99179 490 29852788
Putamen haemorrhage 33.22 11.84 16 99184 218 29853060
Abnormal behaviour 33.18 11.84 22 99178 25601 29827677
Incision site haemorrhage 33.17 11.84 21 99179 501 29852777
Haematoma muscle 33.15 11.84 22 99178 570 29852708
Myocardial infarction 33.01 11.84 262 98938 125363 29727915
Anticoagulation drug level above therapeutic 32.93 11.84 35 99165 1764 29851514
Venous thrombosis limb 32.69 11.84 35 99165 1779 29851499
Anal haemorrhage 32.52 11.84 34 99166 1681 29851597
Osteonecrosis 32.22 11.84 7 99193 16128 29837150
No adverse event 31.98 11.84 9 99191 17410 29835868
Cardio-respiratory arrest 31.95 11.84 91 99109 57215 29796063
Lung diffusion disorder 31.71 11.84 8 99192 9 29853269
Pancreatitis 31.43 11.84 45 99155 36445 29816833
Blood thyroid stimulating hormone abnormal 31.24 11.84 14 99186 160 29853118
Therapy non-responder 31.03 11.84 31 99169 29422 29823856
Cardiac ablation 30.73 11.84 21 99179 572 29852706
Drug intolerance 30.68 11.84 65 99135 45226 29808052
Thrombotic stroke 30.44 11.84 16 99184 265 29853013
Therapeutic procedure 30.35 11.84 14 99186 172 29853106
Ulcer haemorrhage 30.25 11.84 39 99161 2419 29850859
Puncture site haemorrhage 30.18 11.84 17 99183 325 29852953
Pruritus genital 30.17 11.84 19 99181 449 29852829
Cardiac arrest 30.13 11.84 182 99018 92668 29760610
Neurotoxicity 30.11 11.84 4 99196 13178 29840100
Drug reaction with eosinophilia and systemic symptoms 30.00 11.84 30 99170 28458 29824820
Hypersensitivity 29.97 11.84 86 99114 53942 29799336
Dizziness 29.64 11.84 850 98350 194059 29659219
Anticoagulation drug level decreased 29.38 11.84 10 99190 50 29853228
Fractured coccyx 29.21 11.84 13 99187 146 29853132
Coronary artery disease 29.16 11.84 77 99123 49635 29803643
Therapeutic product effect decreased 29.06 11.84 32 99168 29044 29824234
Confusional state 28.96 11.84 296 98904 134538 29718740
Pulmonary alveolar haemorrhage 28.93 11.84 66 99134 6515 29846763
Haemorrhoids 28.64 11.84 97 99103 12044 29841234
Fatigue 28.45 11.84 827 98373 319846 29533432
Respiratory arrest 28.37 11.84 33 99167 29225 29824053
Decreased appetite 28.27 11.84 339 98861 149571 29703707
Brain natriuretic peptide abnormal 28.02 11.84 13 99187 162 29853116
Hyperkalaemia 27.91 11.84 118 99082 65892 29787386
Respiratory failure 27.79 11.84 207 98993 100435 29752843
Renal tubular necrosis 27.78 11.84 8 99192 15243 29838035
Blood urea increased 27.72 11.84 38 99162 31343 29821935
Injection site pain 27.49 11.84 36 99164 30274 29823004
Emotional distress 27.40 11.84 9 99191 15756 29837522
Blood blister 27.35 11.84 29 99171 1458 29851820
Sedation 27.33 11.84 10 99190 16363 29836915
Embolism 27.24 11.84 67 99133 6942 29846336
Glomerular filtration rate decreased 27.00 11.84 91 99109 11271 29842007
Post thrombotic syndrome 26.87 11.84 12 99188 136 29853142
Hypocalcaemia 26.82 11.84 19 99181 21357 29831921
Intentional self-injury 26.76 11.84 6 99194 13526 29839752
Anaphylactic reaction 26.67 11.84 32 99168 27950 29825328
Bleeding varicose vein 26.34 11.84 15 99185 293 29852985
Hydrocephalus 26.31 11.84 49 99151 4188 29849090
Periorbital haemorrhage 26.29 11.84 11 99189 105 29853173
Hospitalisation 25.83 11.84 242 98958 44077 29809201
Cerebral artery occlusion 25.78 11.84 21 99179 751 29852527
Coagulation test abnormal 25.74 11.84 17 99183 437 29852841
Mesenteric artery thrombosis 25.70 11.84 17 99183 438 29852840
Aortic aneurysm rupture 25.57 11.84 24 99176 1040 29852238
Osteonecrosis of jaw 25.47 11.84 15 99185 18603 29834675
Constipation 25.43 11.84 245 98955 112661 29740617
Mesenteric haemorrhage 25.23 11.84 6 99194 4 29853274
Toxic epidermal necrolysis 25.19 11.84 14 99186 17926 29835352
Stomatitis 24.83 11.84 54 99146 37225 29816053
Pulmonary arterial pressure abnormal 24.62 11.84 12 99188 168 29853110
Colitis 24.62 11.84 40 99160 30780 29822498
Myocardial strain 24.51 11.84 10 99190 89 29853189
Neurologic neglect syndrome 24.50 11.84 12 99188 170 29853108
Aneurysm ruptured 24.43 11.84 17 99183 477 29852801
Metabolic acidosis 24.35 11.84 55 99145 37406 29815872
Peritonitis 24.29 11.84 21 99179 21354 29831924
Product administration error 24.10 11.84 103 99097 14274 29839004
Mallory-Weiss syndrome 23.84 11.84 26 99174 1350 29851928
Penis injury 23.77 11.84 13 99187 234 29853044
Platelet dysfunction 23.65 11.84 12 99188 184 29853094
Angioedema 23.58 11.84 49 99151 34335 29818943
C-reactive protein increased 23.52 11.84 70 99130 43403 29809875
Paranoia 23.49 11.84 3 99197 10185 29843093
Hypertension 23.41 11.84 273 98927 121081 29732197
Traumatic haematoma 23.41 11.84 19 99181 676 29852602
Pharyngeal haemorrhage 23.34 11.84 19 99181 679 29852599
Sinusitis 23.31 11.84 47 99153 33298 29819980
Acute respiratory distress syndrome 23.28 11.84 26 99174 23446 29829832
Intentional product misuse 23.27 11.84 50 99150 34617 29818661
Haemorrhagic infarction 23.18 11.84 15 99185 372 29852906
Renal failure 23.03 11.84 295 98905 128671 29724607
Dyspnoea exertional 22.96 11.84 198 99002 35232 29818046
Injection site reaction 22.89 11.84 4 99196 10756 29842522
Retinal artery occlusion 22.76 11.84 28 99172 1656 29851622
Diabetes mellitus inadequate control 22.69 11.84 7 99193 12755 29840523
Septic shock 22.61 11.84 121 99079 63486 29789792
Peritonitis bacterial 22.59 11.84 5 99195 11373 29841905
Renal infarct 22.52 11.84 23 99177 1106 29852172
Restlessness 22.45 11.84 25 99175 22574 29830704
Hepatic function abnormal 22.37 11.84 68 99132 41877 29811401
Oxygen saturation increased 22.25 11.84 12 99188 210 29853068
Electrocardiogram QRS complex abnormal 22.13 11.84 13 99187 270 29853008
Polyp 21.84 11.84 39 99161 3227 29850051
Hyperglycaemia 21.82 11.84 53 99147 35147 29818131
Pancreatitis acute 21.82 11.84 32 99168 25663 29827615
Dysphagia 21.78 11.84 105 99095 56593 29796685
Palmar-plantar erythrodysaesthesia syndrome 21.77 11.84 11 99189 14859 29838419
Staphylococcal infection 21.64 11.84 42 99158 30182 29823096
Hypercoagulation 21.63 11.84 22 99178 1053 29852225
Product label issue 21.61 11.84 12 99188 223 29853055
Aspergillus infection 21.29 11.84 4 99196 10210 29843068
Loss of personal independence in daily activities 21.19 11.84 24 99176 21511 29831767
Cerebral amyloid angiopathy 21.14 11.84 9 99191 90 29853188
Dental care 21.14 11.84 12 99188 233 29853045
Phlebitis deep 21.10 11.84 6 99194 14 29853264
Herpes zoster 21.10 11.84 42 99158 29901 29823377
Intra-abdominal haematoma 21.04 11.84 24 99176 1310 29851968
Delirium 20.87 11.84 67 99133 40564 29812714
Malnutrition 20.86 11.84 6 99194 11443 29841835
Haematospermia 20.82 11.84 14 99186 371 29852907
Intra-abdominal haemorrhage 20.79 11.84 30 99170 2072 29851206
Neutropenic sepsis 20.75 11.84 6 99194 11403 29841875
Supine hypertension 20.61 11.84 12 99188 245 29853033
Brain compression 20.57 11.84 11 99189 189 29853089
Hepatitis C 20.51 11.84 9 99191 13196 29840082
Cardiac failure 20.45 11.84 389 98811 83029 29770249
Candida infection 20.15 11.84 13 99187 15349 29837929
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits 20.12 11.84 5 99195 5 29853273
Occult blood 20.10 11.84 12 99188 257 29853021
Acute myeloid leukaemia 20.08 11.84 18 99182 17988 29835290
Catheter site haemorrhage 20.04 11.84 30 99170 2142 29851136
Pseudomonas infection 20.03 11.84 5 99195 10477 29842801
Anastomotic ulcer haemorrhage 20.02 11.84 6 99194 18 29853260
Postoperative thrombosis 20.02 11.84 6 99194 18 29853260
Arterial thrombosis 20.01 11.84 24 99176 1382 29851896
Arthralgia 19.90 11.84 323 98877 135468 29717810
Electrocardiogram QT prolonged 19.90 11.84 57 99143 35778 29817500
Large intestine polyp 19.88 11.84 58 99142 6651 29846627
Dystonia 19.87 11.84 4 99196 9723 29843555
Psoriatic arthropathy 19.78 11.84 14 99186 15747 29837531
Lacunar stroke 19.62 11.84 9 99191 109 29853169
Peripheral artery occlusion 19.47 11.84 24 99176 1422 29851856
Peripheral artery thrombosis 19.42 11.84 30 99170 2202 29851076
Hallucination 19.34 11.84 90 99110 48969 29804309
Haemoperitoneum 19.22 11.84 24 99176 1441 29851837
Adverse event 19.21 11.84 101 99099 15240 29838038
Prescribed underdose 19.20 11.84 63 99137 7696 29845582
Abdominal pain 19.12 11.84 325 98875 135329 29717949
Basilar artery thrombosis 19.06 11.84 9 99191 117 29853161
Diverticulitis intestinal haemorrhagic 18.96 11.84 13 99187 356 29852922
Neuropathy peripheral 18.95 11.84 146 99054 70329 29782949
Lymphopenia 18.88 11.84 10 99190 13153 29840125
Haematotympanum 18.85 11.84 4 99196 0 29853278
Coagulation factor X level increased 18.85 11.84 4 99196 0 29853278
Lung infiltration 18.82 11.84 9 99191 12550 29840728
Tachycardia 18.79 11.84 155 99045 73584 29779694
Purpura 18.76 11.84 74 99126 9893 29843385
Myocarditis 18.70 11.84 5 99195 10006 29843272
Therapeutic product effect incomplete 18.65 11.84 54 99146 33780 29819498
Hyperhomocysteinaemia 18.64 11.84 10 99190 173 29853105
Post-traumatic amnestic disorder 18.60 11.84 7 99193 49 29853229
Back pain 18.56 11.84 234 98966 102362 29750916
Mental status changes 18.45 11.84 62 99138 37017 29816261
Blood bilirubin increased 18.41 11.84 61 99139 36575 29816703
Vena cava thrombosis 18.34 11.84 20 99180 1038 29852240
Ill-defined disorder 18.19 11.84 6 99194 10478 29842800
Blood lactate dehydrogenase increased 18.14 11.84 25 99175 20576 29832702
Brain herniation 18.12 11.84 39 99161 3701 29849577
Oesophageal haemorrhage 18.11 11.84 21 99179 1167 29852111
Hepatotoxicity 18.10 11.84 20 99180 18125 29835153
Extradural haematoma 18.09 11.84 21 99179 1168 29852110
Encephalopathy 18.05 11.84 51 99149 32154 29821124
Abdominal wall haemorrhage 18.02 11.84 7 99193 54 29853224
Contraindicated product administered 17.97 11.84 108 99092 17123 29836155
Tumour haemorrhage 17.96 11.84 31 99169 2497 29850781
Chronic gastrointestinal bleeding 17.92 11.84 11 99189 248 29853030
Ascites 17.92 11.84 60 99140 35861 29817417
Progressive multifocal leukoencephalopathy 17.81 11.84 4 99196 9009 29844269
Cough 17.70 11.84 301 98899 125341 29727937
Hypophosphataemia 17.68 11.84 3 99197 8242 29845036
Peripheral ischaemia 17.65 11.84 48 99152 5286 29847992
Hemiataxia 17.63 11.84 6 99194 30 29853248
Intentional overdose 17.62 11.84 74 99126 41407 29811871
Multiple sclerosis relapse 17.52 11.84 7 99193 10855 29842423
Duodenitis haemorrhagic 17.51 11.84 8 99192 96 29853182
Disseminated intravascular coagulation 17.50 11.84 29 99171 22142 29831136
Tongue haemorrhage 17.47 11.84 14 99186 489 29852789
Perforated ulcer 17.46 11.84 9 99191 143 29853135
Fear 17.42 11.84 7 99193 10818 29842460
Hepatic encephalopathy 17.30 11.84 13 99187 14179 29839099
Poisoning 17.30 11.84 8 99192 11374 29841904
Lymphoma 17.20 11.84 6 99194 10115 29843163
Respiratory distress 17.19 11.84 54 99146 32918 29820360
Accidental exposure to product 17.19 11.84 6 99194 10109 29843169
Therapeutic product ineffective 17.16 11.84 15 99185 592 29852686
Injection site swelling 17.15 11.84 4 99196 8776 29844502
Bladder neoplasm 17.11 11.84 20 99180 1121 29852157
Hypersensitivity vasculitis 17.10 11.84 38 99162 3685 29849593
Pneumocystis jirovecii pneumonia 16.93 11.84 19 99181 17101 29836177
Blood triglycerides increased 16.88 11.84 13 99187 14004 29839274
Haemodilution 16.87 11.84 6 99194 35 29853243
Anaphylactic shock 16.82 11.84 13 99187 13980 29839298
Spinal cord haematoma 16.81 11.84 8 99192 106 29853172
Labelled drug-disease interaction medication error 16.81 11.84 8 99192 106 29853172
Cholestasis 16.73 11.84 36 99164 24914 29828364
Platelet count decreased 16.71 11.84 249 98951 105880 29747398
Plasma cell myeloma 16.70 11.84 106 99094 53356 29799922
Bronchopulmonary aspergillosis 16.66 11.84 10 99190 12274 29841004
Diabetic ketoacidosis 16.64 11.84 17 99183 15969 29837309
International normalised ratio abnormal 16.63 11.84 34 99166 3112 29850166
Hyperlipidaemia 16.62 11.84 13 99187 13894 29839384
Anger 16.62 11.84 8 99192 11112 29842166
Surgery 16.55 11.84 79 99121 11472 29841806
Facial paresis 16.51 11.84 32 99168 2818 29850460
Hypoglycaemia 16.49 11.84 100 99100 50881 29802397
Vascular graft thrombosis 16.46 11.84 9 99191 162 29853116
Stress 16.41 11.84 26 99174 20209 29833069
Embolism arterial 16.40 11.84 14 99186 535 29852743
Disorganised speech 16.40 11.84 14 99186 535 29852743
Bleeding time prolonged 16.37 11.84 15 99185 630 29852648
Depressed level of consciousness 16.35 11.84 68 99132 38154 29815124
Influenza like illness 16.31 11.84 38 99162 25567 29827711
Hepatic steatosis 16.25 11.84 15 99185 14778 29838500
Neuroleptic malignant syndrome 16.21 11.84 18 99182 16277 29837001
Subarachnoid haematoma 16.18 11.84 7 99193 73 29853205
Acidosis 16.03 11.84 7 99193 10294 29842984
Subclavian vein thrombosis 15.90 11.84 17 99183 863 29852415
Pulmonary arterial hypertension 15.87 11.84 67 99133 9234 29844044
Biopsy prostate 15.79 11.84 5 99195 19 29853259
Renal embolism 15.69 11.84 8 99192 124 29853154
Post procedural haematuria 15.62 11.84 9 99191 180 29853098
Thrombophlebitis 15.50 11.84 31 99169 2793 29850485
Withdrawal syndrome 15.48 11.84 9 99191 11241 29842037
Hypernatraemia 15.45 11.84 3 99197 7481 29845797
Colitis ulcerative 15.42 11.84 15 99185 14419 29838859
Hypertrophic osteoarthropathy 15.39 11.84 7 99193 83 29853195
Cardiac valve replacement complication 15.37 11.84 6 99194 47 29853231
Skin ulcer haemorrhage 15.30 11.84 8 99192 131 29853147
Renal injury 15.28 11.84 10 99190 11719 29841559
Myopathy 15.24 11.84 8 99192 10578 29842700
Varicose vein ruptured 15.21 11.84 5 99195 22 29853256
Upper respiratory tract infection 15.04 11.84 44 99156 27432 29825846
Blood potassium increased 14.96 11.84 19 99181 16194 29837084
Brief psychotic disorder with marked stressors 14.93 11.84 8 99192 138 29853140
Post procedural oedema 14.83 11.84 4 99196 7 29853271
Uterine haemorrhage 14.83 11.84 4 99196 7 29853271
Renal vein thrombosis 14.83 11.84 8 99192 140 29853138
Thrombotic microangiopathy 14.81 11.84 5 99195 8605 29844673
Syncope 14.78 11.84 377 98823 84526 29768752
Limb injury 14.75 11.84 64 99136 8927 29844351
Myositis 14.71 11.84 8 99192 10369 29842909
Left ventricular dilatation 14.70 11.84 14 99186 618 29852660
Mobility decreased 14.69 11.84 41 99159 25958 29827320
Retinal artery thrombosis 14.69 11.84 5 99195 25 29853253
Fungal infection 14.69 11.84 14 99186 13586 29839692
Gout 14.68 11.84 103 99097 17212 29836066
Potentiating drug interaction 14.66 11.84 41 99159 4590 29848688
Suicide attempt 14.65 11.84 67 99133 36630 29816648
Cerebral microhaemorrhage 14.65 11.84 6 99194 54 29853224
Carotid artery occlusion 14.60 11.84 25 99175 2000 29851278
Mania 14.60 11.84 6 99194 9148 29844130
Delusion 14.59 11.84 11 99189 11978 29841300
Intestinal perforation 14.57 11.84 5 99195 8514 29844764
Presyncope 14.49 11.84 97 99103 15959 29837319
Melanaemia 14.49 11.84 4 99196 8 29853270
Hyperbilirubinaemia 14.48 11.84 21 99179 16921 29836357
Cyanosis 14.46 11.84 11 99189 11924 29841354
Splenomegaly 14.41 11.84 14 99186 13466 29839812
Drug resistance 14.39 11.84 28 99172 20105 29833173
Metastases to bone 14.35 11.84 7 99193 9651 29843627
Thalamic infarction 14.35 11.84 14 99186 637 29852641
Generalised oedema 14.34 11.84 11 99189 11874 29841404
Gastrointestinal arteriovenous malformation 14.21 11.84 11 99189 365 29852913
Visual acuity reduced 14.18 11.84 19 99181 15827 29837451
Blood pressure increased 14.17 11.84 161 99039 71767 29781511
Prostatic varices 14.14 11.84 3 99197 0 29853278
Aortic surgery 14.14 11.84 3 99197 0 29853278
Phlebectomy 14.14 11.84 3 99197 0 29853278
Severe invasive streptococcal infection 14.14 11.84 3 99197 0 29853278
Blood calcium decreased 14.11 11.84 7 99193 9555 29843723
Gait disturbance 14.11 11.84 169 99031 74608 29778670
Injection site erythema 14.07 11.84 15 99185 13819 29839459
Vision blurred 14.06 11.84 81 99119 41735 29811543
Duodenitis 14.02 11.84 37 99163 4003 29849275
Subcapsular renal haematoma 13.98 11.84 11 99189 374 29852904
Nephropathy toxic 13.96 11.84 9 99191 10630 29842648
Mediastinal haematoma 13.88 11.84 7 99193 106 29853172
Rhinorrhoea 13.87 11.84 30 99170 20724 29832554
Klebsiella infection 13.73 11.84 3 99197 6884 29846394
Small intestinal obstruction 13.68 11.84 15 99185 13644 29839634
Oral candidiasis 13.68 11.84 10 99190 11061 29842217
Factor V Leiden mutation 13.60 11.84 4 99196 11 29853267
Serotonin syndrome 13.57 11.84 24 99176 17867 29835411
Nasopharyngitis 13.53 11.84 127 99073 58722 29794556
Urinary incontinence 13.51 11.84 22 99178 16918 29836360
Dialysis 13.50 11.84 10 99190 10986 29842292
Blood glucose decreased 13.45 11.84 14 99186 13039 29840239
Night sweats 13.43 11.84 17 99183 14511 29838767
Hypercalcaemia 13.33 11.84 13 99187 12482 29840796
Gastrointestinal angiodysplasia 13.30 11.84 12 99188 494 29852784
Pulmonary endarterectomy 13.28 11.84 6 99194 70 29853208
Feeling abnormal 13.26 11.84 122 99078 56634 29796644
Gravitational oedema 13.22 11.84 13 99187 597 29852681
Atrial septal defect 13.19 11.84 3 99197 6698 29846580
Anuria 13.16 11.84 9 99191 10307 29842971
Conjunctivitis 13.16 11.84 5 99195 7995 29845283
Erythema 13.14 11.84 179 99021 77272 29776006
Intentional product use issue 13.12 11.84 69 99131 36371 29816907
Idiopathic interstitial pneumonia 13.10 11.84 7 99193 120 29853158
Cardiac failure chronic 13.09 11.84 46 99154 5817 29847461
Antiphospholipid syndrome 13.09 11.84 11 99189 411 29852867
Dose calculation error 13.05 11.84 5 99195 37 29853241
Vascular rupture 13.01 11.84 8 99192 181 29853097
Thyroiditis 12.94 11.84 21 99179 1608 29851670
Multiple sclerosis 12.89 11.84 4 99196 7263 29846015
Haematoma infection 12.85 11.84 16 99184 958 29852320
Hypomagnesaemia 12.83 11.84 22 99178 16576 29836702
Pulmonary oedema 12.82 11.84 89 99111 43886 29809392
Peripheral arterial occlusive disease 12.82 11.84 42 99158 5126 29848152
Depressed mood 12.77 11.84 23 99177 17006 29836272
Skin exfoliation 12.76 11.84 37 99163 23135 29830143
Macular ischaemia 12.71 11.84 6 99194 78 29853200
Myelodysplastic syndrome 12.67 11.84 27 99173 18751 29834527
Dyskinesia 12.66 11.84 34 99166 21800 29831478
Lymphadenopathy 12.65 11.84 40 99160 24336 29828942
Spontaneous haemorrhage 12.63 11.84 8 99192 191 29853087
Implant site haematoma 12.57 11.84 6 99194 80 29853198
Hyperhidrosis 12.51 11.84 152 99048 66938 29786340
Urethral haemorrhage 12.50 11.84 11 99189 438 29852840
Monoplegia 12.41 11.84 19 99181 1384 29851894
Hemianaesthesia 12.38 11.84 6 99194 83 29853195
Tonsillar ulcer 12.34 11.84 8 99192 199 29853079
Stiff person syndrome 12.28 11.84 7 99193 137 29853141
Ocular retrobulbar haemorrhage 12.28 11.84 4 99196 17 29853261
Cytokine release syndrome 12.24 11.84 9 99191 9924 29843354
Paresis cranial nerve 12.19 11.84 6 99194 86 29853192
Disorientation 12.17 11.84 58 99142 31360 29821918
Neoplasm progression 12.09 11.84 26 99174 17997 29835281
Anal fissure haemorrhage 12.07 11.84 3 99197 3 29853275
Echocardiogram 12.07 11.84 3 99197 3 29853275
Transient epileptic amnesia 12.07 11.84 3 99197 3 29853275
Protein C deficiency 12.07 11.84 3 99197 3 29853275
Catheter site cellulitis 12.06 11.84 7 99193 142 29853136
Ventricle rupture 12.01 11.84 5 99195 47 29853231
Tumour lysis syndrome 12.00 11.84 15 99185 12870 29840408
Body temperature increased 11.97 11.84 19 99181 14761 29838517
Apnoea 11.93 11.84 3 99197 6255 29847023
Tooth socket haemorrhage 11.92 11.84 4 99196 19 29853259
Post procedural pulmonary embolism 11.92 11.84 4 99196 19 29853259
Hallucination, visual 11.88 11.84 22 99178 16091 29837187
Mucosal haemorrhage 11.86 11.84 19 99181 1439 29851839

Pharmacologic Action:

SourceCodeDescription
ATC B01AF01 BLOOD AND BLOOD FORMING ORGANS
ANTITHROMBOTIC AGENTS
ANTITHROMBOTIC AGENTS
Direct factor Xa inhibitors
FDA MoA N0000175635 Factor Xa Inhibitors
FDA EPC N0000175637 Factor Xa Inhibitor
MeSH PA D000925 Anticoagulants
MeSH PA D000991 Antithrombins
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D065427 Factor Xa Inhibitors
MeSH PA D006401 Hematologic Agents
MeSH PA D011480 Protease Inhibitors
MeSH PA D015842 Serine Proteinase Inhibitors
CHEBI has role CHEBI:50249 anticoagulante
CHEBI has role CHEBI:68581 coagulation factor xa inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Prevention of deep vein thrombosis indication 439993001
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Blood coagulation disorder contraindication 64779008 DOID:1247
Kidney disease contraindication 90708001 DOID:557
Local anesthetic intrathecal block contraindication 231249005
Disease of liver contraindication 235856003 DOID:409
Procedure on spine contraindication 238181003
Lumbar puncture contraindication 277762005
Significant Bleeding contraindication
Placement of Epidural Catheter contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 10.89 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
2.5MG XARELTO JANSSEN PHARMS N022406 Oct. 11, 2018 RX TABLET ORAL Oct. 11, 2021 RIVAROXABAN IN COMBINULLTION WITH ASPIRIN, IS INDICATED TO REDUCE THE RISK OF MAJOR CV EVENTS (CV DEATH, MI, AND STROKE) IN PATIENTS WITH CHRONIC CORONULLRY ARTERY DISEASE (CAD) OR PERIPHERAL ARTERY DISEASE (PAD)
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL Oct. 11, 2022 PROPHYLAXIS OF VENOUS THROMBOEMBOLISM IN ACUTELY ILL MEDICAL PATIENTS AT RISK FOR THROMBOEMBOLIC COMPLICATIONS NOT AT HIGH RISK OF BLEEDING
15MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL Oct. 11, 2022 PROPHYLAXIS OF VENOUS THROMBOEMBOLISM IN ACUTELY ILL MEDICAL PATIENTS AT RISK FOR THROMBOEMBOLIC COMPLICATIONS NOT AT HIGH RISK OF BLEEDING
2.5MG XARELTO JANSSEN PHARMS N022406 Oct. 11, 2018 RX TABLET ORAL Oct. 11, 2022 PROPHYLAXIS OF VENOUS THROMBOEMBOLISM IN ACUTELY ILL MEDICAL PATIENTS AT RISK FOR THROMBOEMBOLIC COMPLICATIONS NOT AT HIGH RISK OF BLEEDING
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL Oct. 11, 2022 PROPHYLAXIS OF VENOUS THROMBOEMBOLISM IN ACUTELY ILL MEDICAL PATIENTS AT RISK FOR THROMBOEMBOLIC COMPLICATIONS NOT AT HIGH RISK OF BLEEDING

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Coagulation factor X Enzyme INHIBITOR Ki 9.40 CHEMBL CHEMBL
Suppressor of tumorigenicity 14 protein Enzyme Ki 5.47 CHEMBL
Coagulation factor X Enzyme IC50 6.29 CHEMBL

External reference:

IDSource
D07086 KEGG_DRUG
4030906 VANDF
C1739768 UMLSCUI
CHEBI:68579 CHEBI
RIV PDB_CHEM_ID
CHEMBL198362 ChEMBL_ID
D000069552 MESH_DESCRIPTOR_UI
9875401 PUBCHEM_CID
6388 IUPHAR_LIGAND_ID
8428 INN_ID
DB06228 DRUGBANK_ID
9NDF7JZ4M3 UNII
1114195 RXNORM
159029 MMSL
26019 MMSL
d07356 MMSL
012873 NDDF
442031002 SNOMEDCT_US
442539005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50090-3625 TABLET, FILM COATED 10 mg ORAL NDA 32 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50090-3639 TABLET, FILM COATED 20 mg ORAL NDA 31 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50090-4468 TABLET, FILM COATED 20 mg ORAL NDA 32 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50090-4469 TABLET, FILM COATED 10 mg ORAL NDA 32 sections
XARELTO HUMAN PRESCRIPTION DRUG LABEL 1 50458-577 TABLET, FILM COATED 2.50 mg ORAL NDA 32 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50458-578 TABLET, FILM COATED 15 mg ORAL NDA 32 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50458-579 TABLET, FILM COATED 20 mg ORAL NDA 32 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50458-580 TABLET, FILM COATED 10 mg ORAL NDA 32 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 55154-1422 TABLET, FILM COATED 10 mg ORAL NDA 32 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 55154-1423 TABLET, FILM COATED 20 mg ORAL NDA 32 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 55154-1424 TABLET, FILM COATED 15 mg ORAL NDA 32 sections