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
Jan. 18, 2012 PMDA Bayer Yakuhin, Ltd.
July 1, 2011 FDA JANSSEN PHARMS
Sept. 30, 2008 EMA BAYER PHARMA AG

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 5623.70 10.65 2938 110566 77392 53158170
Pulmonary embolism 2348.79 10.65 1943 111561 112499 53123063
Deep vein thrombosis 1929.36 10.65 1516 111988 81397 53154165
Ischaemic stroke 1253.49 10.65 658 112846 17335 53218227
Haemorrhage 1150.57 10.65 967 112537 57020 53178542
Cerebral haemorrhage 1037.33 10.65 698 112806 29298 53206264
Cerebrovascular accident 1013.11 10.65 1182 112322 103992 53131570
Epistaxis 977.05 10.65 950 112554 67760 53167802
Haemorrhage intracranial 805.80 10.65 444 113060 12908 53222654
Upper gastrointestinal haemorrhage 805.05 10.65 487 113017 16943 53218619
Thrombosis 801.88 10.65 807 112697 59986 53175576
Heavy menstrual bleeding 689.92 10.65 441 113063 16935 53218627
Haematuria 684.65 10.65 531 112973 27858 53207704
Rectal haemorrhage 666.50 10.65 614 112890 40867 53194695
Vaginal haemorrhage 612.59 10.65 486 113018 26355 53209207
Haematoma 610.91 10.65 535 112969 33309 53202253
Haemoglobin decreased 589.27 10.65 1051 112453 136256 53099306
Cerebral infarction 556.53 10.65 442 113062 24002 53211560
Melaena 508.75 10.65 452 113052 28677 53206885
Lower gastrointestinal haemorrhage 499.27 10.65 267 113237 7299 53228263
Haemorrhagic stroke 439.41 10.65 224 113280 5534 53230028
Anaemia 436.31 10.65 1436 112068 275282 52960280
Embolic stroke 433.98 10.65 195 113309 3604 53231958
Rheumatoid arthritis 406.19 10.65 87 113417 314444 52921118
Atrial fibrillation 364.93 10.65 762 112742 110890 53124672
Internal haemorrhage 362.16 10.65 184 113320 4512 53231050
Subdural haematoma 340.82 10.65 262 113242 13551 53222011
Haematochezia 327.88 10.65 427 113077 41931 53193631
Atrial thrombosis 270.76 10.65 107 113397 1412 53234150
Blood loss anaemia 268.69 10.65 190 113314 8633 53226929
Incorrect dose administered 258.46 10.65 421 113083 50624 53184938
Intraventricular haemorrhage 238.21 10.65 106 113398 1912 53233650
Pericardial haemorrhage 235.73 10.65 98 113406 1485 53234077
Pain 234.69 10.65 571 112933 587827 52647735
Haemoptysis 230.05 10.65 291 113213 27748 53207814
Haemarthrosis 228.74 10.65 120 113384 3150 53232412
International normalised ratio increased 208.80 10.65 369 113135 47392 53188170
Post procedural haemorrhage 205.05 10.65 155 113349 7813 53227749
Haematemesis 203.71 10.65 288 113216 30569 53204993
Diverticulum intestinal haemorrhagic 198.97 10.65 82 113422 1214 53234348
Haemorrhoidal haemorrhage 198.81 10.65 117 113387 3861 53231701
Faeces discoloured 197.49 10.65 215 113289 17471 53218091
Infusion related reaction 197.27 10.65 45 113459 155912 53079650
Shock haemorrhagic 193.98 10.65 159 113345 9024 53226538
Synovitis 191.62 10.65 9 113495 107884 53127678
Haemorrhagic arteriovenous malformation 186.74 10.65 47 113457 107 53235455
Fall 172.09 10.65 1327 112177 357113 52878449
Therapeutic product effect decreased 167.66 10.65 32 113472 125623 53109939
Systemic lupus erythematosus 167.20 10.65 32 113472 125382 53110180
Transient ischaemic attack 166.55 10.65 284 113220 35441 53200121
Hand deformity 165.37 10.65 3 113501 84846 53150716
Gingival bleeding 161.32 10.65 163 113341 12145 53223417
Glossodynia 158.73 10.65 15 113489 100276 53135286
Subarachnoid haemorrhage 156.78 10.65 158 113346 11735 53223827
Drug intolerance 156.12 10.65 125 113379 205368 53030194
Labelled drug-drug interaction medication error 155.18 10.65 151 113353 10748 53224814
Basal ganglia haemorrhage 154.46 10.65 56 113448 573 53234989
Drug hypersensitivity 148.28 10.65 209 113295 265033 52970529
Uterine haemorrhage 145.22 10.65 95 113409 3792 53231770
Maternal exposure during pregnancy 145.05 10.65 75 113429 155564 53079998
Hemiplegia 144.05 10.65 125 113379 7675 53227887
Blood urine present 140.54 10.65 157 113347 13128 53222434
Cerebral haematoma 138.95 10.65 89 113415 3425 53232137
Creatinine renal clearance decreased 135.84 10.65 139 113365 10512 53225050
Joint swelling 133.00 10.65 183 113321 234455 53001107
Arthralgia 132.87 10.65 485 113019 439298 52796264
Embolic cerebral infarction 130.15 10.65 47 113457 475 53235087
Cerebellar haemorrhage 129.94 10.65 63 113441 1392 53234170
Subcutaneous haematoma 127.94 10.65 65 113439 1593 53233969
Abdominal wall haematoma 126.21 10.65 79 113425 2919 53232643
Toxicity to various agents 122.72 10.65 173 113331 219425 53016137
Muscle haemorrhage 114.26 10.65 78 113426 3345 53232217
Haemorrhagic transformation stroke 113.44 10.65 54 113450 1144 53234418
Hemiparesis 112.57 10.65 180 113324 21295 53214267
Arthropathy 111.25 10.65 83 113421 141370 53094192
Pyrexia 111.24 10.65 461 113043 402732 52832830
Dyspnoea exertional 110.18 10.65 311 113193 54689 53180873
Mouth haemorrhage 110.05 10.65 100 113404 6526 53229036
Anxiety 106.90 10.65 158 113346 196546 53039016
Thalamus haemorrhage 106.89 10.65 43 113461 596 53234966
Iron deficiency anaemia 106.10 10.65 162 113342 18418 53217144
Hypersensitivity 104.31 10.65 180 113324 210485 53025077
Gastrointestinal vascular malformation haemorrhagic 102.22 10.65 30 113474 144 53235418
Depression 99.49 10.65 147 113357 182905 53052657
Subdural haemorrhage 96.68 10.65 67 113437 2945 53232617
Drug interaction 88.83 10.65 782 112722 218547 53017015
Musculoskeletal stiffness 88.77 10.65 79 113425 123289 53112273
Prothrombin time prolonged 88.68 10.65 107 113397 9715 53225847
Injection site erythema 88.67 10.65 27 113477 77222 53158340
Dyspnoea 87.99 10.65 1741 111763 584491 52651071
Cardiac failure 87.94 10.65 389 113115 85455 53150107
Discomfort 87.44 10.65 47 113457 95425 53140137
Drug abuse 86.71 10.65 17 113487 65509 53170053
Contraindicated product administered 85.97 10.65 97 113407 135532 53100030
Retroperitoneal haemorrhage 85.06 10.65 61 113443 2833 53232729
Gastric ulcer haemorrhage 84.99 10.65 77 113427 5005 53230557
Hospitalisation 84.60 10.65 337 113167 70675 53164887
Alopecia 84.41 10.65 239 113265 234344 53001218
Sinusitis 84.36 10.65 143 113361 168421 53067141
Duodenal ulcer haemorrhage 84.36 10.65 57 113447 2403 53233159
Eye haemorrhage 82.83 10.65 92 113412 7642 53227920
Infection 79.10 10.65 154 113350 172051 53063511
Extradural haematoma 79.01 10.65 48 113456 1680 53233882
Cerebral artery embolism 78.90 10.65 38 113466 827 53234735
Embolism venous 78.63 10.65 59 113445 2940 53232622
Condition aggravated 78.60 10.65 345 113159 296789 52938773
Embolism 78.21 10.65 88 113416 7415 53228147
Wound haemorrhage 77.75 10.65 52 113452 2155 53233407
Splenic rupture 77.54 10.65 43 113461 1264 53234298
Post procedural haematoma 77.23 10.65 44 113460 1364 53234198
Injection site pain 76.43 10.65 77 113427 113314 53122248
Exposure during pregnancy 76.23 10.65 92 113412 124768 53110794
Small intestinal haemorrhage 74.99 10.65 50 113454 2061 53233501
Pulmonary thrombosis 74.90 10.65 89 113415 7952 53227610
Haemorrhage urinary tract 74.56 10.65 36 113468 788 53234774
Cerebral artery occlusion 74.11 10.65 38 113466 950 53234612
Swelling 73.79 10.65 188 113316 190917 53044645
Postmenopausal haemorrhage 73.39 10.65 50 113454 2137 53233425
Renal haemorrhage 73.21 10.65 36 113468 821 53234741
Treatment failure 72.82 10.65 100 113404 128303 53107259
Venous thrombosis 72.37 10.65 70 113434 4944 53230618
Product prescribing issue 71.49 10.65 40 113464 1197 53234365
Rheumatoid factor positive 71.33 10.65 4 113500 41194 53194368
Injection site reaction 70.44 10.65 12 113492 51154 53184408
Gastric haemorrhage 70.39 10.65 76 113428 6115 53229447
Peripheral embolism 70.07 10.65 40 113464 1245 53234317
Wound 69.07 10.65 56 113448 91501 53144061
Completed suicide 68.44 10.65 118 113386 138083 53097479
Haemorrhage subcutaneous 68.40 10.65 55 113449 3036 53232526
Febrile neutropenia 67.64 10.65 74 113430 104862 53130700
Product prescribing error 66.87 10.65 150 113354 22881 53212681
Activated partial thromboplastin time prolonged 65.54 10.65 78 113426 6981 53228581
Abnormal uterine bleeding 64.97 10.65 39 113465 1335 53234227
Cerebral ventricular rupture 64.80 10.65 22 113482 182 53235380
Cerebral ischaemia 64.12 10.65 75 113429 6590 53228972
Pericarditis 63.05 10.65 29 113475 64377 53171185
Pulmonary arterial hypertension 62.98 10.65 162 113342 26960 53208602
Weight increased 60.66 10.65 227 113277 204340 53031222
Treatment noncompliance 60.56 10.65 181 113323 32854 53202708
Gastritis haemorrhagic 59.70 10.65 38 113466 1446 53234116
Contusion 59.15 10.65 421 113083 110311 53125251
Haemothorax 58.58 10.65 43 113461 2071 53233491
Renal impairment 57.52 10.65 338 113166 82980 53152582
Venous thrombosis limb 56.04 10.65 48 113456 2895 53232667
Traumatic intracranial haemorrhage 56.02 10.65 23 113481 337 53235225
Coagulopathy 55.74 10.65 127 113377 19571 53215991
Gastric ulcer 55.73 10.65 141 113363 23228 53212334
Therapeutic response decreased 55.73 10.65 16 113488 47553 53188009
Incision site haemorrhage 55.66 10.65 26 113478 527 53235035
Psoriatic arthropathy 55.01 10.65 17 113487 48173 53187389
Transfusion 55.01 10.65 102 113402 13585 53221977
Occult blood positive 54.75 10.65 52 113452 3590 53231972
Pulmonary hypertension 54.51 10.65 189 113315 37081 53198481
Anaphylactic reaction 54.45 10.65 28 113476 58298 53177264
Therapeutic product effect incomplete 53.53 10.65 70 113434 91714 53143848
Acute kidney injury 53.50 10.65 797 112707 253071 52982491
Mobility decreased 53.47 10.65 50 113454 76221 53159341
Haematoma muscle 53.09 10.65 27 113477 663 53234899
Brain stem haemorrhage 52.82 10.65 28 113476 751 53234811
Nasopharyngitis 52.80 10.65 220 113284 192075 53043487
Pericardial effusion 52.42 10.65 152 113352 27126 53208436
Intracardiac thrombus 52.36 10.65 43 113461 2446 53233116
Loss of personal independence in daily activities 52.28 10.65 43 113461 69772 53165790
Folliculitis 52.18 10.65 4 113500 31705 53203857
Hepatic enzyme increased 51.95 10.65 120 113384 126075 53109487
Splenic haemorrhage 51.75 10.65 19 113485 202 53235360
Pregnancy 51.64 10.65 4 113500 31437 53204125
Spinal cord haematoma 51.40 10.65 18 113486 165 53235397
Adrenal haemorrhage 51.22 10.65 23 113481 424 53235138
Anticoagulation drug level increased 50.78 10.65 19 113485 214 53235348
Psoriasis 50.20 10.65 67 113437 87022 53148540
Neutropenia 49.59 10.65 173 113331 159012 53076550
Suicidal ideation 49.51 10.65 34 113470 60477 53175085
Stomatitis 49.32 10.65 83 113421 98075 53137487
Urinary bladder haemorrhage 49.17 10.65 30 113474 1058 53234504
Multiple sclerosis relapse 49.13 10.65 17 113487 44836 53190726
Pharyngeal haemorrhage 48.94 10.65 24 113480 544 53235018
Cardioversion 48.65 10.65 31 113473 1182 53234380
Muscle injury 48.30 10.65 4 113500 29762 53205800
Cerebellar infarction 48.18 10.65 37 113467 1909 53233653
Sedation 48.12 10.65 4 113500 29671 53205891
Prothrombin time shortened 48.08 10.65 36 113468 1788 53233774
Impaired healing 47.52 10.65 40 113464 64165 53171397
Retinal haemorrhage 47.07 10.65 56 113448 5009 53230553
Abdominal discomfort 46.32 10.65 278 113226 220784 53014778
Pulmonary haemorrhage 46.16 10.65 65 113439 6868 53228694
Large intestinal haemorrhage 45.22 10.65 30 113474 1226 53234336
Seizure 45.03 10.65 134 113370 129375 53106187
Microcytic anaemia 44.66 10.65 45 113459 3340 53232222
Blood cholesterol increased 44.39 10.65 29 113475 52960 53182602
Dizziness 44.25 10.65 1070 112434 371189 52864373
Hypovolaemic shock 44.17 10.65 57 113447 5540 53230022
Ecchymosis 43.71 10.65 82 113422 11017 53224545
Injection site pruritus 43.46 10.65 17 113487 41572 53193990
Spontaneous haematoma 43.11 10.65 25 113479 802 53234760
Intra-abdominal haemorrhage 42.95 10.65 38 113466 2394 53233168
Oedema peripheral 42.34 10.65 552 112952 170235 53065327
Irritable bowel syndrome 42.15 10.65 20 113484 43612 53191950
Inflammation 41.79 10.65 36 113468 57100 53178462
Skin haemorrhage 41.48 10.65 61 113443 6706 53228856
Glomerular filtration rate decreased 41.45 10.65 87 113417 12680 53222882
Head injury 41.31 10.65 135 113369 25698 53209864
Retroperitoneal haematoma 41.30 10.65 40 113464 2830 53232732
Procedural haemorrhage 41.16 10.65 38 113466 2531 53233031
Cerebral mass effect 40.84 10.65 25 113479 887 53234675
Fatigue 40.56 10.65 1215 112289 729291 52506271
Agitation 40.42 10.65 39 113465 58587 53176975
Vascular pseudoaneurysm 40.17 10.65 30 113474 1484 53234078
Salpingo-oophorectomy unilateral 39.75 10.65 22 113482 644 53234918
Insomnia 39.31 10.65 235 113269 186837 53048725
Blister 39.19 10.65 67 113437 78686 53156876
Injection site swelling 38.99 10.65 21 113483 42607 53192955
Drug ineffective 38.81 10.65 1387 112117 815858 52419704
Suicide attempt 38.61 10.65 40 113464 58128 53177434
Device related thrombosis 38.60 10.65 28 113476 1324 53234238
Foetal exposure during pregnancy 38.29 10.65 13 113491 34702 53200860
Cardiac failure chronic 38.19 10.65 45 113459 3985 53231577
Hypertension 38.07 10.65 302 113202 225129 53010433
Labelled drug-disease interaction medication error 37.95 10.65 14 113490 151 53235411
Conjunctival haemorrhage 37.19 10.65 40 113464 3204 53232358
Pelvic venous thrombosis 36.34 10.65 29 113475 1583 53233979
Rash 36.33 10.65 700 112804 445491 52790071
High frequency ablation 36.25 10.65 14 113490 173 53235389
Traumatic haematoma 36.15 10.65 28 113476 1463 53234099
Coagulation factor X level increased 36.09 10.65 7 113497 0 53235562
Herpes zoster 35.89 10.65 64 113440 73955 53161607
Retinal artery occlusion 35.86 10.65 29 113475 1614 53233948
Fluid retention 35.81 10.65 218 113286 54183 53181379
Intra-abdominal haematoma 35.21 10.65 29 113475 1656 53233906
Subgaleal haematoma 35.03 10.65 11 113493 69 53235493
Alanine aminotransferase increased 34.06 10.65 97 113407 94998 53140564
Haemorrhagic cerebral infarction 33.98 10.65 20 113484 660 53234902
Ill-defined disorder 33.96 10.65 33 113471 49411 53186151
Product monitoring error 33.50 10.65 36 113468 2881 53232681
Hepatotoxicity 33.36 10.65 9 113495 27871 53207691
Sinusitis fungal 33.35 10.65 26 113478 1372 53234190
Gastrointestinal angiodysplasia 33.12 10.65 17 113487 426 53235136
Pulmonary alveolar haemorrhage 33.07 10.65 44 113460 4406 53231156
Pallor 32.82 10.65 123 113381 25059 53210503
Intentional overdose 32.68 10.65 58 113446 67147 53168415
Anovulatory cycle 32.24 10.65 12 113492 133 53235429
Gastrointestinal ulcer haemorrhage 32.14 10.65 19 113485 632 53234930
Gastrointestinal disorder 32.09 10.65 92 113412 89912 53145650
Duodenal ulcer 32.06 10.65 58 113446 7578 53227984
Helicobacter infection 31.90 10.65 22 113482 39047 53196515
Aphasia 31.89 10.65 140 113364 30638 53204924
Peripheral ischaemia 31.82 10.65 45 113459 4774 53230788
Abdominal wall haemorrhage 31.77 10.65 12 113492 139 53235423
Mesenteric artery embolism 31.76 10.65 7 113497 6 53235556
Traumatic haemorrhage 31.31 10.65 17 113487 479 53235083
Emotional distress 30.93 10.65 15 113489 32302 53203260
Gastritis erosive 30.77 10.65 48 113456 5558 53230004
Chills 30.62 10.65 117 113387 104731 53130831
Somnolence 30.53 10.65 220 113284 167514 53068048
Ischaemic cerebral infarction 30.46 10.65 24 113480 1286 53234276
Cardiac tamponade 30.44 10.65 43 113461 4557 53231005
Intestinal haemorrhage 30.28 10.65 37 113467 3403 53232159
Irritability 30.19 10.65 14 113490 30939 53204623
Chest wall haematoma 30.18 10.65 12 113492 161 53235401
Creatinine renal clearance abnormal 30.04 10.65 15 113489 354 53235208
Potentiating drug interaction 30.00 10.65 41 113463 4212 53231350
Ear haemorrhage 29.92 10.65 24 113480 1320 53234242
Arterial haemorrhage 29.88 10.65 27 113477 1749 53233813
Spinal cord haemorrhage 29.86 10.65 13 113491 222 53235340
Stress 29.86 10.65 47 113457 57037 53178525
Oesophageal haemorrhage 29.46 10.65 17 113487 540 53235022
Syncope 29.01 10.65 365 113139 111628 53123934
Hypersensitivity vasculitis 28.62 10.65 41 113463 4402 53231160
Cerebral artery thrombosis 28.07 10.65 15 113489 409 53235153
Renal infarct 27.98 10.65 24 113480 1450 53234112
Brain herniation 27.78 10.65 35 113469 3321 53232241
Peripheral artery thrombosis 27.72 10.65 27 113477 1923 53233639
Fluid overload 27.63 10.65 125 113379 27706 53207856
Injury 27.59 10.65 41 113463 50930 53184632
Deep vein thrombosis postoperative 27.54 10.65 21 113483 1072 53234490
Drug dependence 27.51 10.65 6 113498 21466 53214096
Toxic epidermal necrolysis 27.44 10.65 8 113496 23542 53212020
Dry eye 27.39 10.65 19 113485 33625 53201937
Basal cell carcinoma 27.29 10.65 8 113496 23461 53212101
Aggression 27.17 10.65 8 113496 23395 53212167
Type 2 diabetes mellitus 26.98 10.65 17 113487 31653 53203909
Gastrointestinal polyp haemorrhage 26.80 10.65 11 113493 161 53235401
International normalised ratio abnormal 26.76 10.65 33 113471 3064 53232498
Mood swings 26.66 10.65 3 113501 17483 53218079
Purpura 26.41 10.65 66 113438 10787 53224775
Aspartate aminotransferase increased 26.36 10.65 91 113413 83938 53151624
Haematoma infection 26.36 10.65 16 113488 559 53235003
Petechiae 26.32 10.65 76 113428 13529 53222033
Sputum increased 26.29 10.65 28 113476 2218 53233344
Lower respiratory tract infection 26.26 10.65 102 113402 90879 53144683
Nasal polyps 26.18 10.65 32 113472 2944 53232618
Joint stiffness 26.15 10.65 16 113488 30267 53205295
Right ventricular failure 26.01 10.65 87 113417 16756 53218806
C-reactive protein increased 26.00 10.65 67 113437 67819 53167743
Cytomegalovirus infection 25.99 10.65 5 113499 19534 53216028
Haemoperitoneum 25.91 10.65 30 113474 2607 53232955
Respiratory symptom 25.80 10.65 30 113474 2619 53232943
Cerebral thrombosis 25.79 10.65 25 113479 1770 53233792
Arterial injury 25.63 10.65 11 113493 181 53235381
Cardiac pacemaker insertion 25.59 10.65 36 113468 3801 53231761
Menometrorrhagia 25.51 10.65 19 113485 936 53234626
Intentional self-injury 25.34 10.65 11 113493 25273 53210289
Therapeutic response increased 25.24 10.65 13 113491 328 53235234
Arrhythmia 25.23 10.65 149 113355 36630 53198932
Atrial flutter 25.13 10.65 60 113444 9531 53226031
Injection site rash 24.88 10.65 3 113501 16576 53218986
Premature baby 24.44 10.65 6 113498 19795 53215767
Malignant neoplasm progression 24.15 10.65 75 113429 71466 53164096
Cardiac ablation 24.01 10.65 21 113483 1303 53234259
Diverticulum 23.96 10.65 67 113437 11712 53223850
Multiple sclerosis 23.94 10.65 14 113490 27139 53208423
Overdose 23.86 10.65 133 113371 107603 53127959
Premature delivery 23.67 10.65 13 113491 26091 53209471
Haemorrhagic erosive gastritis 23.47 10.65 12 113492 298 53235264
Crying 23.43 10.65 9 113495 22253 53213309
Thrombophlebitis superficial 23.42 10.65 40 113464 4995 53230567
Bone marrow failure 23.23 10.65 18 113486 30097 53205465
Blood pressure increased 22.86 10.65 190 113314 140289 53095273
Sleep disorder 22.62 10.65 58 113446 58812 53176750
Drug withdrawal syndrome 22.58 10.65 16 113488 28006 53207556
Brain stem infarction 22.57 10.65 17 113487 852 53234710
Ear pain 22.55 10.65 18 113486 29655 53205907
Diverticulitis intestinal haemorrhagic 22.49 10.65 9 113495 123 53235439
Sinus tachycardia 22.47 10.65 11 113493 23561 53212001
Mucosal haemorrhage 22.45 10.65 17 113487 859 53234703
Catheter management 22.44 10.65 29 113475 2823 53232739
Fibromyalgia 22.38 10.65 37 113467 44038 53191524
Tremor 21.87 10.65 167 113337 125569 53109993
Osteopenia 21.82 10.65 6 113498 18349 53217213
Spontaneous haemorrhage 21.67 10.65 11 113493 269 53235293
Injection site bruising 21.65 10.65 29 113475 37617 53197945
Oropharyngeal pain 21.64 10.65 94 113410 81174 53154388
Arthritis 21.45 10.65 104 113400 87194 53148368
Erythema 21.36 10.65 222 113282 156747 53078815
Bradyarrhythmia 21.36 10.65 24 113480 2019 53233543
Intracranial haematoma 21.21 10.65 12 113492 367 53235195
Hypoaesthesia 21.13 10.65 181 113323 132814 53102748
Drug resistance 21.12 10.65 8 113496 19954 53215608
Muscle spasticity 20.89 10.65 6 113498 17832 53217730
Underdose 20.87 10.65 96 113408 21426 53214136
Urticaria 20.68 10.65 187 113317 135698 53099864
Pelvic haemorrhage 20.65 10.65 9 113495 154 53235408
Product use issue 20.42 10.65 194 113310 139390 53096172
Foot deformity 20.40 10.65 7 113497 18561 53217001
Ventricle rupture 20.30 10.65 5 113499 10 53235552
Abortion spontaneous 20.28 10.65 43 113461 46592 53188970
Migraine 20.23 10.65 95 113409 80322 53155240
Injection site warmth 20.15 10.65 3 113501 14125 53221437
Serotonin syndrome 20.09 10.65 16 113488 26390 53209172
Oral herpes 20.01 10.65 10 113494 21169 53214393
Hypercoagulation 19.99 10.65 24 113480 2167 53233395
Arterial thrombosis 19.94 10.65 20 113484 1476 53234086
Presyncope 19.86 10.65 109 113395 26085 53209477
Neuralgia 19.53 10.65 13 113491 23508 53212054
Pruritus 19.50 10.65 476 113028 293356 52942206
Thrombocytosis 19.50 10.65 39 113465 5493 53230069
Gait disturbance 19.49 10.65 230 113274 158612 53076950
Product administration error 19.39 10.65 94 113410 21437 53214125
Osteomyelitis 19.32 10.65 14 113490 24221 53211341
Haemoglobin abnormal 19.31 10.65 35 113469 4579 53230983
Periorbital haematoma 19.26 10.65 15 113489 790 53234772
Urogenital haemorrhage 19.25 10.65 10 113494 257 53235305
Asthenia 19.15 10.65 904 112600 342686 52892876
Neutrophil count decreased 19.15 10.65 48 113456 49050 53186512
Heart rate irregular 19.09 10.65 90 113414 20294 53215268
Multiple organ dysfunction syndrome 19.06 10.65 58 113446 55619 53179943
Red blood cell sedimentation rate increased 18.95 10.65 19 113485 28038 53207524
Leukopenia 18.94 10.65 86 113418 73377 53162185
Rhinorrhoea 18.92 10.65 55 113449 53523 53182039
Nausea 18.90 10.65 1370 112134 754721 52480841
Platelet aggregation inhibition 18.85 10.65 8 113496 128 53235434
Generalised tonic-clonic seizure 18.83 10.65 20 113484 28738 53206824
Pulmonary endarterectomy 18.68 10.65 8 113496 131 53235431
Hepatic steatosis 18.65 10.65 17 113487 26242 53209320
Bradycardia 18.57 10.65 232 113272 70824 53164738
Female genital tract fistula 18.56 10.65 32 113472 4026 53231536
Post procedural pulmonary embolism 18.54 10.65 10 113494 278 53235284
Gastric pH increased 18.42 10.65 6 113498 43 53235519
Metabolic acidosis 18.33 10.65 39 113465 42203 53193359
Confusional state 18.20 10.65 297 113207 193924 53041638
Prosthetic cardiac valve thrombosis 18.18 10.65 5 113499 18 53235544
Body temperature increased 18.12 10.65 26 113478 32773 53202789
Ear infection 18.12 10.65 17 113487 25883 53209679
C-reactive protein abnormal 18.07 10.65 17 113487 25853 53209709
Dystonia 18.04 10.65 3 113501 13018 53222544
Fibrin D dimer increased 18.01 10.65 34 113470 4589 53230973
Orthopnoea 17.99 10.65 40 113464 6064 53229498
Breast haematoma 17.96 10.65 9 113495 214 53235348
Paraplegia 17.90 10.65 25 113479 2622 53232940
Swelling face 17.87 10.65 62 113442 57106 53178456
Anal haemorrhage 17.86 10.65 20 113484 1676 53233886
Quadriplegia 17.84 10.65 21 113483 1857 53233705
Normochromic normocytic anaemia 17.79 10.65 34 113470 4632 53230930
Hysterectomy 17.71 10.65 49 113455 8512 53227050
Polyp 17.71 10.65 39 113465 5875 53229687
Emergency care 17.68 10.65 15 113489 893 53234669
Subcapsular renal haematoma 17.67 10.65 10 113494 306 53235256
Toothache 17.63 10.65 8 113496 17906 53217656
Haemorrhagic infarction 17.61 10.65 10 113494 308 53235254
Arrhythmogenic right ventricular dysplasia 17.58 10.65 5 113499 21 53235541
Antineutrophil cytoplasmic antibody positive 17.36 10.65 12 113492 525 53235037
Product dose omission issue 17.34 10.65 532 112972 191088 53044474
Mucosal inflammation 17.34 10.65 41 113463 42743 53192819
Vascular stent thrombosis 17.28 10.65 15 113489 921 53234641
Thrombotic stroke 17.18 10.65 12 113492 534 53235028
Respiratory arrest 17.17 10.65 28 113476 33512 53202050
Urethral haemorrhage 17.13 10.65 6 113498 55 53235507
Haemorrhagic hepatic cyst 17.04 10.65 5 113499 24 53235538
Oesophagitis haemorrhagic 16.97 10.65 11 113493 432 53235130
Ulcer haemorrhage 16.90 10.65 29 113475 3635 53231927
Death 16.85 10.65 925 112579 356307 52879255
Mesenteric haemorrhage 16.85 10.65 6 113498 58 53235504
Post procedural stroke 16.76 10.65 6 113498 59 53235503
Catheter site discharge 16.66 10.65 21 113483 1993 53233569
Arteriovenous malformation 16.52 10.65 17 113487 1294 53234268
Photophobia 16.41 10.65 7 113497 16251 53219311
Coagulation time prolonged 16.38 10.65 17 113487 1307 53234255
Intentional product use issue 16.32 10.65 89 113415 72405 53163157
Tenderness 16.25 10.65 11 113493 19719 53215843
Throat tightness 16.24 10.65 14 113490 22202 53213360
Neuroleptic malignant syndrome 16.17 10.65 3 113501 12030 53223532
Depressed mood 16.14 10.65 34 113470 36930 53198632
Hypochromic anaemia 16.11 10.65 20 113484 1869 53233693
White blood cell count increased 15.95 10.65 48 113456 46197 53189365
Pain in jaw 15.89 10.65 144 113360 40525 53195037
Hypoglycaemia 15.87 10.65 68 113436 58945 53176617
Venous haemorrhage 15.86 10.65 8 113496 193 53235369
Influenza like illness 15.84 10.65 71 113433 60788 53174774
Intervertebral disc protrusion 15.83 10.65 14 113490 21931 53213631
Therapeutic procedure 15.81 10.65 14 113490 883 53234679
Blood glucose increased 15.80 10.65 98 113406 77263 53158299
Mania 15.79 10.65 3 113501 11826 53223736
Peritoneal haematoma 15.77 10.65 6 113498 71 53235491
Coagulation test abnormal 15.75 10.65 13 113491 745 53234817
Spinal subdural haematoma 15.74 10.65 7 113497 126 53235436
Carotid artery occlusion 15.73 10.65 24 113480 2725 53232837
Abnormal behaviour 15.71 10.65 14 113490 21852 53213710
Cerebral ventricle collapse 15.70 10.65 5 113499 33 53235529
Inappropriate schedule of product administration 15.69 10.65 235 113269 74643 53160919
Putamen haemorrhage 15.67 10.65 8 113496 198 53235364
Mallory-Weiss syndrome 15.65 10.65 18 113486 1553 53234009
Antiphospholipid syndrome 15.55 10.65 19 113485 1747 53233815
Influenza 15.51 10.65 129 113375 95250 53140312
Right hemisphere deficit syndrome 15.47 10.65 3 113501 0 53235562
Orthostatic heart rate response increased 15.47 10.65 3 113501 0 53235562
CHA2DS2-VASc annual stroke risk high 15.47 10.65 3 113501 0 53235562
Spinal cord injury thoracic 15.47 10.65 3 113501 0 53235562
Contraindication to surgery 15.47 10.65 3 113501 0 53235562
Procedural pain 15.40 10.65 6 113498 14711 53220851
Post procedural discharge 15.38 10.65 10 113494 395 53235167
Aortic valve calcification 15.33 10.65 10 113494 397 53235165
Post procedural haematuria 15.21 10.65 5 113499 37 53235525
Intentional product misuse 15.14 10.65 54 113450 49338 53186224
Stevens-Johnson syndrome 15.11 10.65 18 113486 24564 53210998
Cerebral vascular occlusion 15.10 10.65 4 113500 12 53235550
Cognitive disorder 15.07 10.65 47 113457 44731 53190831
Meningorrhagia 14.94 10.65 7 113497 143 53235419
Cerebellar haematoma 14.92 10.65 10 113494 416 53235146
Medical device site haemorrhage 14.87 10.65 5 113499 40 53235522
Rhabdomyolysis 14.86 10.65 46 113458 43877 53191685
Retinal vein thrombosis 14.81 10.65 10 113494 421 53235141
Rectal polyp 14.77 10.65 14 113490 964 53234598
Lymphocyte count decreased 14.76 10.65 23 113481 28029 53207533
White blood cell count decreased 14.60 10.65 182 113322 124293 53111269
Anaphylactic shock 14.59 10.65 15 113489 21878 53213684
Chronic gastrointestinal bleeding 14.46 10.65 7 113497 154 53235408
Chronic gastritis 14.41 10.65 22 113482 2500 53233062
Osteonecrosis of jaw 14.36 10.65 35 113469 36111 53199451
Withdrawal syndrome 14.31 10.65 12 113492 19289 53216273
Autoimmune nephritis 14.25 10.65 9 113495 338 53235224
Vulval haemorrhage 14.22 10.65 4 113500 16 53235546
Vascular device infection 14.20 10.65 30 113474 4391 53231171
Retinal ischaemia 14.20 10.65 9 113495 340 53235222
Bleeding varicose vein 14.13 10.65 8 113496 245 53235317
Respiratory tract haemorrhage 14.10 10.65 10 113494 456 53235106
Lipase increased 14.09 10.65 48 113456 9330 53226232
No adverse event 14.09 10.65 40 113464 39225 53196337
Myoclonus 14.08 10.65 8 113496 15756 53219806
Muscle rigidity 13.95 10.65 3 113501 10838 53224724
Traumatic fracture 13.90 10.65 11 113493 593 53234969
Protein S deficiency 13.89 10.65 5 113499 50 53235512
Rheumatoid nodule 13.88 10.65 4 113500 11860 53223702
Exsanguination 13.84 10.65 4 113500 18 53235544
Psychotic disorder 13.80 10.65 19 113485 24366 53211196
Monoparesis 13.80 10.65 17 113487 1577 53233985
Cholelithiasis 13.78 10.65 43 113461 40921 53194641
Splenic haematoma 13.75 10.65 6 113498 103 53235459
Duodenal polyp 13.70 10.65 6 113498 104 53235458
Jaundice acholuric 13.60 10.65 6 113498 106 53235456
Brain compression 13.58 10.65 9 113495 367 53235195
Coronary artery disease 13.58 10.65 32 113472 33405 53202157
Respiratory disorder 13.56 10.65 33 113471 34064 53201498
Catheter site pruritus 13.51 10.65 19 113485 2005 53233557
Anticoagulant therapy 13.50 10.65 4 113500 20 53235542
Pancytopenia 13.45 10.65 126 113378 90802 53144760
Incorrect dosage administered 13.43 10.65 18 113486 1815 53233747
Injection site urticaria 13.43 10.65 5 113499 12602 53222960
Pulmonary artery thrombosis 13.41 10.65 12 113492 767 53234795
Device expulsion 13.38 10.65 27 113477 29786 53205776
Degenerative mitral valve disease 13.33 10.65 4 113500 21 53235541
Ovarian cyst 13.28 10.65 8 113496 15261 53220301
Tooth abscess 13.26 10.65 6 113498 13452 53222110
Pulmonary haematoma 13.23 10.65 5 113499 58 53235504
Anastomotic ulcer haemorrhage 13.23 10.65 5 113499 58 53235504
Throat irritation 13.13 10.65 30 113474 31651 53203911
Dyspnoea at rest 13.12 10.65 27 113477 3880 53231682
Contraindicated product prescribed 13.09 10.65 12 113492 792 53234770
Thrombotic cerebral infarction 13.06 10.65 6 113498 117 53235445
Anger 13.05 10.65 5 113499 12385 53223177
Viral infection 13.04 10.65 31 113473 32264 53203298
Incorrect route of product administration 13.03 10.65 13 113491 19231 53216331
Catheter site erythema 13.00 10.65 28 113476 4154 53231408
Vena cava thrombosis 13.00 10.65 20 113484 2288 53233274
Therapy non-responder 12.96 10.65 57 113447 49063 53186499
Mydriasis 12.92 10.65 4 113500 11322 53224240
Weight decreased 12.88 10.65 391 113113 234557 53001005
Accidental exposure to product 12.85 10.65 19 113485 23655 53211907
Panic attack 12.83 10.65 16 113488 21402 53214160
Back pain 12.80 10.65 390 113114 233857 53001705
Epidural haemorrhage 12.78 10.65 6 113498 123 53235439
Pharyngitis 12.65 10.65 13 113491 18967 53216595
Diastolic dysfunction 12.64 10.65 34 113470 5810 53229752
Lacunar stroke 12.61 10.65 6 113498 127 53235435
Incision site haematoma 12.58 10.65 5 113499 67 53235495
Thrombectomy 12.55 10.65 7 113497 208 53235354
Anaemia macrocytic 12.55 10.65 22 113482 2804 53232758
Constipation 12.45 10.65 324 113180 198088 53037474
Muscle twitching 12.44 10.65 10 113494 16416 53219146
Craniocerebral injury 12.43 10.65 20 113484 2378 53233184
Acute respiratory distress syndrome 12.40 10.65 19 113485 23313 53212249
Extra dose administered 12.39 10.65 32 113472 5338 53230224
Blood blister 12.38 10.65 17 113487 1754 53233808
Blood creatine phosphokinase increased 12.37 10.65 27 113477 28958 53206604
Pelvic haematoma 12.37 10.65 10 113494 556 53235006
Headache 12.37 10.65 979 112525 535842 52699720
Cardiac failure acute 12.34 10.65 45 113459 9047 53226515
Thrombophlebitis 12.28 10.65 29 113475 4574 53230988
Bursitis 12.26 10.65 18 113486 22474 53213088
Lymphadenopathy 12.24 10.65 38 113466 36217 53199345
Basilar artery thrombosis 12.20 10.65 6 113498 137 53235425
Retinal artery embolism 12.19 10.65 5 113499 73 53235489
Osteorrhagia 12.18 10.65 3 113501 6 53235556
Manufacturing materials issue 12.18 10.65 3 113501 6 53235556
Lymphostasis 12.18 10.65 3 113501 6 53235556
Peritonitis 12.17 10.65 17 113487 21670 53213892
Respiratory depression 12.17 10.65 6 113498 12800 53222762
Peripheral artery occlusion 12.14 10.65 14 113490 1211 53234351
Infective pericardial effusion 12.12 10.65 4 113500 30 53235532
Cholestatic liver injury 12.10 10.65 20 113484 2431 53233131
Vision blurred 12.08 10.65 120 113384 85484 53150078
Postoperative thrombosis 12.08 10.65 6 113498 140 53235422
Blindness unilateral 12.07 10.65 33 113471 5694 53229868
Spinal cord compression 12.02 10.65 26 113478 3868 53231694
Post thrombotic syndrome 11.99 10.65 10 113494 581 53234981
Brain contusion 11.99 10.65 10 113494 581 53234981
Colon cancer 11.99 10.65 47 113457 9778 53225784
Vascular purpura 11.88 10.65 15 113489 1426 53234136
Hypercholesterolaemia 11.87 10.65 6 113498 12620 53222942
Medication error 11.87 10.65 124 113380 36241 53199321
Laryngeal haemorrhage 11.87 10.65 3 113501 7 53235555
Investigation 11.85 10.65 16 113488 1625 53233937
Lymphopenia 11.85 10.65 11 113493 16832 53218730
Hypercalcaemia 11.85 10.65 21 113483 24327 53211235
Catheter site haemorrhage 11.84 10.65 22 113482 2933 53232629
Catheter site bruise 11.84 10.65 8 113496 337 53235225
Chondrocalcinosis 11.83 10.65 10 113494 592 53234970
Central nervous system haemorrhage 11.81 10.65 6 113498 147 53235415
Anticoagulation drug level decreased 11.79 10.65 4 113500 33 53235529
Soft tissue haemorrhage 11.78 10.65 7 113497 235 53235327
Spinal osteoarthritis 11.76 10.65 9 113495 15148 53220414
Haemorrhagic diathesis 11.71 10.65 28 113476 4450 53231112
Intracranial aneurysm 11.64 10.65 24 113480 3455 53232107
Osteoarthritis 11.61 10.65 95 113409 70391 53165171
Infarction 11.54 10.65 20 113484 2527 53233035
Extrapyramidal disorder 11.50 10.65 6 113498 12396 53223166
Cerebellar ischaemia 11.49 10.65 4 113500 36 53235526
Hypotension 11.40 10.65 655 112849 253421 52982141
Pseudomonas infection 11.34 10.65 4 113500 10424 53225138
Tumour haemorrhage 11.30 10.65 15 113489 1499 53234063
Chronic sinusitis 11.30 10.65 33 113471 5912 53229650
Tonic clonic movements 11.28 10.65 14 113490 1308 53234254
Affect lability 11.26 10.65 3 113501 9372 53226190
Hyperlipidaemia 11.25 10.65 15 113489 19500 53216062
Brain natriuretic peptide abnormal 11.24 10.65 8 113496 367 53235195
Tracheal haemorrhage 11.18 10.65 6 113498 165 53235397
Osteonecrosis 11.14 10.65 25 113479 26550 53209012
Ataxia 11.12 10.65 9 113495 14728 53220834
Cerebral amyloid angiopathy 11.12 10.65 6 113498 167 53235395
Anti factor X activity increased 11.09 10.65 3 113501 10 53235552
Infective pulmonary exacerbation of cystic fibrosis 10.95 10.65 5 113499 11151 53224411
Contraindication to medical treatment 10.95 10.65 10 113494 657 53234905
Carpal tunnel syndrome 10.93 10.65 13 113491 17754 53217808
Breast cancer 10.89 10.65 61 113443 49297 53186265
Degenerative aortic valve disease 10.86 10.65 5 113499 98 53235464
Peptostreptococcus infection 10.86 10.65 4 113500 43 53235519
Neurotoxicity 10.82 10.65 10 113494 15339 53220223
Brain stem stroke 10.82 10.65 7 113497 274 53235288
Tuberculosis 10.81 10.65 5 113499 11066 53224496
Myelosuppression 10.77 10.65 7 113497 12821 53222741
Right atrial enlargement 10.77 10.65 5 113499 100 53235462
Muscle spasms 10.76 10.65 212 113292 134583 53100979
Vascular stent insertion 10.66 10.65 3 113501 12 53235550

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 4710.70 11.94 3136 103432 83746 32323212
Deep vein thrombosis 1833.06 11.94 1579 104989 62134 32344824
Haemorrhage 1485.61 11.94 1257 105311 48191 32358767
Haematuria 1382.57 11.94 1195 105373 47166 32359792
Pulmonary embolism 1294.54 11.94 1479 105089 82180 32324778
Epistaxis 1143.38 11.94 1146 105422 54709 32352249
Cerebral haemorrhage 1085.56 11.94 904 105664 33843 32373115
Haemorrhage intracranial 974.35 11.94 622 105946 15265 32391693
Ischaemic stroke 931.35 11.94 628 105940 16948 32390010
Upper gastrointestinal haemorrhage 825.65 11.94 659 105909 23190 32383768
Cerebrovascular accident 816.40 11.94 1197 105371 85123 32321835
Cerebral infarction 743.32 11.94 660 105908 26954 32380004
Rectal haemorrhage 638.16 11.94 697 105871 36726 32370232
Thrombosis 596.03 11.94 742 105826 45012 32361946
Atrial thrombosis 592.98 11.94 229 106339 1758 32405200
Haematoma 580.73 11.94 557 106011 25127 32381831
Subdural haematoma 507.38 11.94 462 106106 19491 32387467
Lower gastrointestinal haemorrhage 505.41 11.94 331 106237 8486 32398472
Embolic stroke 466.57 11.94 234 106334 3540 32403418
Melaena 465.50 11.94 571 105997 34094 32372864
Haemorrhagic stroke 463.74 11.94 280 106288 6198 32400760
Internal haemorrhage 390.74 11.94 225 106343 4547 32402411
Gastric haemorrhage 380.75 11.94 291 106277 9585 32397373
Post procedural haemorrhage 372.56 11.94 268 106300 8032 32398926
Transient ischaemic attack 327.14 11.94 413 106155 25381 32381577
Haemoptysis 314.85 11.94 464 106104 33061 32373897
Blood loss anaemia 279.55 11.94 222 106346 7740 32399218
Anaemia 278.77 11.94 1456 105112 222168 32184790
Blood urine present 251.35 11.94 235 106333 10250 32396708
Diverticulum intestinal haemorrhagic 250.68 11.94 129 106439 2065 32404893
Haemoglobin decreased 239.26 11.94 898 105670 118773 32288185
Pericardial haemorrhage 232.82 11.94 138 106430 2948 32404010
Haemarthrosis 230.99 11.94 142 106426 3248 32403710
Gingival bleeding 228.86 11.94 187 106381 6794 32400164
Basal ganglia haemorrhage 226.62 11.94 91 106477 783 32406175
Haemorrhagic arteriovenous malformation 225.64 11.94 73 106495 306 32406652
Toxicity to various agents 219.98 11.94 158 106410 177883 32229075
Haematochezia 217.07 11.94 429 106139 38779 32368179
Atrial fibrillation 209.04 11.94 846 105722 115858 32291100
Pyrexia 204.72 11.94 468 106100 319500 32087458
Fall 201.37 11.94 1213 105355 194988 32211970
Incorrect dose administered 193.57 11.94 383 106185 34645 32372313
Drug abuse 189.20 11.94 21 106547 80222 32326736
Shock haemorrhagic 185.99 11.94 201 106367 10444 32396514
Labelled drug-drug interaction medication error 183.75 11.94 215 106353 12198 32394760
Cerebellar haemorrhage 173.25 11.94 89 106479 1419 32405539
Cerebral haematoma 170.71 11.94 135 106433 4676 32402282
Thalamus haemorrhage 168.42 11.94 77 106491 936 32406022
Intraventricular haemorrhage 162.36 11.94 111 106457 3059 32403899
Embolic cerebral infarction 162.13 11.94 67 106501 625 32406333
Haemorrhoidal haemorrhage 162.08 11.94 112 106456 3142 32403816
Contusion 154.56 11.94 340 106228 33128 32373830
Febrile neutropenia 154.35 11.94 101 106467 119465 32287493
Subarachnoid haemorrhage 145.31 11.94 175 106393 10236 32396722
Procedural haemorrhage 143.82 11.94 94 106474 2399 32404559
Gastrointestinal vascular malformation haemorrhagic 133.89 11.94 56 106512 540 32406418
Haematemesis 133.60 11.94 286 106282 27349 32379609
Cerebral artery embolism 132.41 11.94 64 106504 889 32406069
International normalised ratio increased 129.39 11.94 404 106164 48631 32358327
Wound haemorrhage 124.66 11.94 79 106489 1909 32405049
Faeces discoloured 124.14 11.94 195 106373 14682 32392276
Hemiplegia 119.18 11.94 131 106437 6937 32400021
Creatinine renal clearance decreased 118.64 11.94 96 106472 3438 32403520
Gastric ulcer haemorrhage 114.31 11.94 115 106453 5492 32401466
Neutropenia 114.21 11.94 181 106387 141994 32264964
Foetal exposure during pregnancy 113.96 11.94 5 106563 41296 32365662
Cardioversion 113.86 11.94 57 106511 858 32406100
Hemiparesis 111.88 11.94 191 106377 15416 32391542
Cardiac tamponade 108.84 11.94 107 106461 4968 32401990
Iron deficiency anaemia 108.40 11.94 146 106422 9555 32397403
Subcutaneous haematoma 103.51 11.94 55 106513 943 32406015
Mouth haemorrhage 103.44 11.94 106 106462 5175 32401783
Depression 102.62 11.94 100 106468 96960 32309998
Retroperitoneal haemorrhage 101.72 11.94 80 106488 2748 32404210
Haemorrhagic transformation stroke 100.54 11.94 60 106508 1298 32405660
Intracardiac thrombus 94.33 11.94 73 106495 2448 32404510
Sepsis 92.82 11.94 243 106325 158591 32248367
Haemorrhage urinary tract 90.60 11.94 61 106507 1638 32405320
Muscle haemorrhage 87.34 11.94 84 106484 3795 32403163
Subdural haemorrhage 86.52 11.94 75 106493 2958 32404000
Anxiety 85.11 11.94 114 106454 95891 32311067
High frequency ablation 81.29 11.94 28 106540 148 32406810
Splenic rupture 81.22 11.94 56 106512 1565 32405393
Cerebral ventricular rupture 80.07 11.94 28 106540 156 32406802
Drug hypersensitivity 79.47 11.94 74 106494 73326 32333632
Condition aggravated 78.66 11.94 255 106313 155406 32251552
Anticoagulation drug level increased 77.98 11.94 37 106531 492 32406466
Microcytic anaemia 76.26 11.94 61 106507 2148 32404810
Aphasia 75.92 11.94 193 106375 20635 32386323
Abdominal wall haematoma 75.25 11.94 55 106513 1689 32405269
Disease progression 75.12 11.94 105 106463 86757 32320201
Traumatic intracranial haemorrhage 74.75 11.94 39 106529 643 32406315
Infusion related reaction 74.63 11.94 28 106540 45571 32361387
Product prescribing issue 74.44 11.94 47 106521 1128 32405830
Small intestinal haemorrhage 74.36 11.94 59 106509 2053 32404905
Pelvic venous thrombosis 71.49 11.94 36 106532 549 32406409
Renal haemorrhage 71.48 11.94 49 106519 1356 32405602
Large intestinal haemorrhage 70.01 11.94 51 106517 1558 32405400
Completed suicide 69.40 11.94 123 106445 92394 32314564
Haemorrhagic diathesis 68.69 11.94 65 106503 2877 32404081
Nausea 67.72 11.94 699 105869 320150 32086808
Agitation 67.69 11.94 53 106515 57183 32349775
Drug interaction 67.40 11.94 1046 105522 217139 32189819
Brain stem haemorrhage 67.02 11.94 41 106527 929 32406029
Traumatic haemorrhage 66.87 11.94 37 106531 690 32406268
Haemothorax 66.61 11.94 72 106496 3740 32403218
Occult blood positive 66.16 11.94 74 106494 3995 32402963
Head injury 64.71 11.94 164 106404 17499 32389459
Seizure 64.41 11.94 154 106414 103700 32303258
Rheumatoid arthritis 63.99 11.94 33 106535 44511 32362447
Post procedural haematoma 63.42 11.94 48 106520 1556 32405402
Insomnia 62.08 11.94 149 106419 100199 32306759
Haemorrhage subcutaneous 61.93 11.94 56 106512 2337 32404621
Pulmonary haemorrhage 60.82 11.94 113 106455 9744 32397214
Rhabdomyolysis 59.47 11.94 80 106488 67185 32339773
Neutrophil count decreased 59.17 11.94 41 106527 47098 32359860
Mucosal inflammation 59.11 11.94 18 106550 33416 32373542
Tremor 58.34 11.94 111 106457 81166 32325792
Drug dependence 58.33 11.94 5 106563 23479 32383479
Prothrombin time prolonged 57.92 11.94 110 106458 9645 32397313
Pancytopenia 57.60 11.94 134 106434 91101 32315857
Spinal cord haemorrhage 57.31 11.94 26 106542 310 32406648
Gastric ulcer 57.10 11.94 146 106422 15663 32391295
Aggression 55.37 11.94 30 106538 39359 32367599
Adrenal haemorrhage 55.32 11.94 22 106546 184 32406774
Gastrointestinal polyp haemorrhage 55.03 11.94 25 106543 299 32406659
Compartment syndrome 54.64 11.94 54 106514 2523 32404435
N-terminal prohormone brain natriuretic peptide abnormal 54.51 11.94 22 106546 192 32406766
Penile haemorrhage 54.45 11.94 31 106537 612 32406346
Bladder tamponade 54.38 11.94 29 106539 501 32406457
Overdose 53.29 11.94 130 106438 86947 32320011
Gastritis erosive 53.07 11.94 81 106487 5946 32401012
Prostatic haemorrhage 53.07 11.94 22 106546 207 32406751
Duodenal ulcer haemorrhage 52.75 11.94 73 106495 4901 32402057
Gastritis haemorrhagic 52.55 11.94 40 106528 1308 32405650
Product prescribing error 52.47 11.94 163 106405 19554 32387404
Haemorrhagic cerebral infarction 52.27 11.94 33 106535 792 32406166
Vomiting 52.18 11.94 507 106061 235050 32171908
Arterial haemorrhage 52.01 11.94 33 106535 799 32406159
Psoriasis 51.70 11.94 45 106523 46078 32360880
Inappropriate schedule of product administration 51.09 11.94 290 106278 45535 32361423
Somnolence 51.03 11.94 172 106396 103625 32303333
Aspartate aminotransferase increased 51.00 11.94 87 106481 66342 32340616
Eye haemorrhage 50.63 11.94 64 106504 3933 32403025
Blood glucose increased 50.50 11.94 85 106483 65156 32341802
Multiple organ dysfunction syndrome 50.47 11.94 95 106473 69759 32337199
Gastrointestinal ulcer haemorrhage 50.18 11.94 30 106538 651 32406307
Cerebral ischaemia 49.74 11.94 81 106487 6286 32400672
Death 49.52 11.94 920 105648 381597 32025361
Bone marrow failure 49.20 11.94 19 106549 30385 32376573
Peripheral embolism 49.09 11.94 34 106534 957 32406001
Blood creatine phosphokinase increased 49.02 11.94 46 106522 45430 32361528
Urinary bladder haemorrhage 48.69 11.94 43 106525 1739 32405219
Drug withdrawal syndrome 48.40 11.94 5 106563 20226 32386732
Cytomegalovirus infection 48.21 11.94 12 106556 25452 32381506
Asthma 48.18 11.94 44 106524 44021 32362937
Suicidal ideation 47.96 11.94 33 106535 38050 32368908
Therapeutic response decreased 47.58 11.94 13 106555 25907 32381051
Hyponatraemia 47.38 11.94 109 106459 74404 32332554
Deep vein thrombosis postoperative 47.20 11.94 11 106557 6 32406952
Thrombophlebitis superficial 47 11.94 52 106516 2773 32404185
Leukopenia 46.84 11.94 78 106490 60044 32346914
Embolism venous 46.57 11.94 38 106530 1377 32405581
Urogenital haemorrhage 46.28 11.94 26 106542 500 32406458
Cerebral ventricle collapse 45.78 11.94 15 106553 66 32406892
Treatment noncompliance 45.26 11.94 193 106375 27009 32379949
Haemorrhagic erosive gastritis 45.23 11.94 17 106551 120 32406838
Pneumonia 44.85 11.94 858 105710 354394 32052564
Coagulopathy 44.15 11.94 153 106415 19424 32387534
Hypochromic anaemia 43.93 11.94 30 106538 825 32406133
Malignant neoplasm progression 43.59 11.94 123 106445 78373 32328585
White blood cell count increased 43.32 11.94 43 106525 41359 32365599
Conjunctival haemorrhage 43.16 11.94 50 106518 2805 32404153
Chills 42.89 11.94 123 106445 77961 32328997
Skin haemorrhage 42.64 11.94 57 106511 3702 32403256
Retinal vascular thrombosis 42.48 11.94 14 106554 63 32406895
Ischaemic cerebral infarction 42.13 11.94 32 106536 1043 32405915
Alanine aminotransferase increased 42.10 11.94 125 106443 78354 32328604
Infection 41.89 11.94 140 106428 84575 32322383
Cerebellar infarction 41.75 11.94 42 106526 2005 32404953
Psychotic disorder 41.41 11.94 12 106556 23008 32383950
Pericardial effusion 41.25 11.94 167 106401 22835 32384123
Splenic haemorrhage 40.90 11.94 22 106546 387 32406571
Peripheral swelling 40.79 11.94 372 106196 67973 32338985
Irritability 40.57 11.94 15 106553 24639 32382319
Ecchymosis 40.54 11.94 77 106491 6751 32400207
Cerebral mass effect 40.47 11.94 29 106539 863 32406095
White blood cell count decreased 40.27 11.94 158 106410 91040 32315918
Cardiac ventricular thrombosis 40.23 11.94 29 106539 871 32406087
Pain 40.10 11.94 407 106161 187149 32219809
Vascular stent thrombosis 39.16 11.94 45 106523 2502 32404456
Hypovolaemic shock 38.97 11.94 76 106492 6796 32400162
Vitreous haemorrhage 38.96 11.94 42 106526 2175 32404783
Dehydration 38.95 11.94 255 106313 128703 32278255
Wound haematoma 38.83 11.94 13 106555 62 32406896
Retroperitoneal haematoma 38.75 11.94 46 106522 2649 32404309
Neutrophil count increased 38.51 11.94 4 106564 16110 32390848
Drug reaction with eosinophilia and systemic symptoms 38.50 11.94 30 106538 32455 32374503
Venous thrombosis 38.45 11.94 52 106516 3415 32403543
Vascular pseudoaneurysm 38.19 11.94 41 106527 2113 32404845
No adverse event 36.91 11.94 10 106558 20043 32386915
Ear haemorrhage 36.59 11.94 28 106540 923 32406035
Lymphocyte count decreased 36.21 11.94 12 106556 21107 32385851
Duodenal ulcer 36.15 11.94 95 106473 10360 32396598
Pulmonary alveolar haemorrhage 35.84 11.94 75 106493 7054 32399904
Hypoxia 35.83 11.94 73 106495 52059 32354899
Activated partial thromboplastin time prolonged 35.77 11.94 83 106485 8372 32398586
Dizziness 35.33 11.94 918 105650 208700 32198258
Pancreatitis 35.12 11.94 44 106524 38107 32368851
Weight decreased 35.08 11.94 358 106210 164460 32242498
Spontaneous haematoma 34.95 11.94 22 106546 525 32406433
Anticoagulation drug level decreased 34.90 11.94 12 106556 63 32406895
Diabetes mellitus 34.81 11.94 59 106509 45114 32361844
Brain stem infarction 34.52 11.94 31 106537 1282 32405676
Gastrointestinal angiectasia 34.49 11.94 17 106551 247 32406711
Peptic ulcer haemorrhage 34.40 11.94 21 106547 474 32406484
Intestinal haemorrhage 33.47 11.94 48 106520 3331 32403627
Abnormal behaviour 33.23 11.94 23 106545 26443 32380515
Splenic haematoma 33.20 11.94 15 106553 177 32406781
Renal haematoma 33.19 11.94 21 106547 506 32406452
Drug intolerance 33.14 11.94 72 106496 50163 32356795
Osteonecrosis 33.13 11.94 7 106561 16615 32390343
Neurotoxicity 32.95 11.94 5 106563 15065 32391893
Blood blister 32.88 11.94 33 106535 1571 32405387
Injection site pain 32.71 11.94 36 106532 33022 32373936
Incision site haemorrhage 32.61 11.94 21 106547 522 32406436
Arteriovenous malformation 32.22 11.94 23 106545 680 32406278
Extra dose administered 31.76 11.94 47 106521 3356 32403602
Hypophagia 31.75 11.94 19 106549 23604 32383354
Putamen haemorrhage 31.43 11.94 16 106552 250 32406708
Cardiac ablation 31.37 11.94 22 106546 632 32406326
Anticoagulation drug level above therapeutic 31.35 11.94 35 106533 1885 32405073
Venous thrombosis limb 31.00 11.94 35 106533 1909 32405049
Aneurysm ruptured 30.89 11.94 20 106548 502 32406456
Therapy non-responder 30.75 11.94 37 106531 32617 32374341
Pruritus genital 30.73 11.94 21 106547 578 32406380
Puncture site haemorrhage 30.25 11.94 17 106551 327 32406631
Thrombotic stroke 30.23 11.94 16 106552 272 32406686
Therapeutic procedure 29.92 11.94 14 106554 180 32406778
Mesenteric haemorrhage 29.92 11.94 7 106561 4 32406954
Cardiac arrest 29.90 11.94 190 106378 96586 32310372
Ulcer haemorrhage 29.87 11.94 40 106528 2602 32404356
Decreased appetite 29.58 11.94 361 106207 160452 32246506
Haemorrhoids 29.46 11.94 101 106467 12752 32394206
Renal tubular necrosis 29.35 11.94 8 106560 15970 32390988
Dyspnoea exertional 29.06 11.94 223 106345 38738 32368220
Glomerular filtration rate decreased 28.78 11.94 100 106468 12711 32394247
Fractured coccyx 28.73 11.94 13 106555 154 32406804
Cardio-respiratory arrest 28.72 11.94 91 106477 55898 32351060
Anaphylactic reaction 28.61 11.94 34 106534 30138 32376820
Toxic epidermal necrolysis 28.48 11.94 16 106552 20577 32386381
Emotional distress 28.42 11.94 9 106559 16297 32390661
Embolism 28.37 11.94 70 106498 7344 32399614
Hypersensitivity 28.16 11.94 96 106472 57662 32349296
Myocardial infarction 27.97 11.94 270 106298 125406 32281552
Diarrhoea 27.93 11.94 948 105620 363854 32043104
Sedation 27.70 11.94 13 106555 18513 32388445
Septic shock 27.67 11.94 124 106444 68865 32338093
Intentional self-injury 27.40 11.94 6 106562 13894 32393064
Cardiac failure 27.25 11.94 437 106131 91236 32315722
Cerebral artery occlusion 27.20 11.94 22 106546 787 32406171
Confusional state 27.19 11.94 319 106249 142796 32264162
Stomatitis 27.08 11.94 57 106511 40172 32366786
Respiratory failure 27.03 11.94 223 106345 106959 32299999
Anal haemorrhage 27.03 11.94 34 106534 2079 32404879
Respiratory arrest 26.96 11.94 33 106535 28875 32378083
Brain natriuretic peptide abnormal 26.94 11.94 16 106552 343 32406615
Loss of personal independence in daily activities 26.79 11.94 29 106539 26804 32380154
Colitis 26.48 11.94 44 106524 33907 32373051
Haematoma muscle 26.41 11.94 24 106544 1008 32405950
Bleeding varicose vein 26.31 11.94 15 106553 297 32406661
Therapeutic product effect decreased 26.29 11.94 38 106530 30979 32375979
Blood thyroid stimulating hormone abnormal 26.09 11.94 14 106554 245 32406713
Peritonitis 25.98 11.94 21 106547 22309 32384649
Blood urea increased 25.94 11.94 41 106527 32232 32374726
Periorbital haemorrhage 25.86 11.94 11 106557 111 32406847
Penis injury 25.74 11.94 14 106554 252 32406706
Mesenteric artery thrombosis 25.73 11.94 17 106551 442 32406516
Peripheral artery occlusion 25.69 11.94 29 106539 1581 32405377
Post thrombotic syndrome 25.67 11.94 12 106556 154 32406804
Peritonitis bacterial 25.45 11.94 5 106563 12491 32394467
Coronary artery disease 25.35 11.94 81 106487 49625 32357333
Polyp 25.19 11.94 43 106525 3469 32403489
Osteonecrosis of jaw 24.95 11.94 16 106552 19150 32387808
Injection site reaction 24.93 11.94 4 106564 11565 32395393
Pharyngeal haemorrhage 24.79 11.94 20 106548 713 32406245
Mallory-Weiss syndrome 24.78 11.94 27 106541 1415 32405543
Aortic aneurysm rupture 24.75 11.94 24 106544 1095 32405863
Neurologic neglect syndrome 24.55 11.94 12 106556 171 32406787
Hydrocephalus 24.54 11.94 50 106518 4615 32402343
Myocardial strain 24.51 11.94 10 106558 90 32406868
Sinusitis 24.44 11.94 52 106516 36508 32370450
Constipation 23.87 11.94 282 106286 126091 32280867
Coagulation test abnormal 23.84 11.94 17 106551 502 32406456
Hyperglycaemia 23.72 11.94 57 106511 38334 32368624
Retinal artery occlusion 23.59 11.94 29 106539 1732 32405226
Respiratory depression 23.55 11.94 7 106561 13204 32393754
Prescribed underdose 23.42 11.94 72 106496 8587 32398371
Traumatic haematoma 23.30 11.94 20 106548 778 32406180
Psoriatic arthropathy 23.12 11.94 15 106553 17845 32389113
Pulmonary arterial pressure abnormal 23.04 11.94 12 106556 197 32406761
Abdominal pain 23.04 11.94 348 106220 149181 32257777
Delirium 23.01 11.94 71 106497 43975 32362983
Aspergillus infection 22.81 11.94 5 106563 11569 32395389
Therapeutic product effect incomplete 22.78 11.94 65 106503 41276 32365682
Intentional product misuse 22.69 11.94 53 106515 35998 32370960
Paranoia 22.68 11.94 4 106564 10795 32396163
Hospitalisation 22.67 11.94 253 106315 48718 32358240
Product administration error 22.34 11.94 106 106462 15519 32391439
Dental care 22.29 11.94 13 106555 269 32406689
Hepatic function abnormal 22.22 11.94 74 106494 44766 32362192
Dystonia 22.17 11.94 4 106564 10619 32396339
Staphylococcal infection 21.80 11.94 46 106522 32393 32374565
Purpura 21.80 11.94 80 106488 10445 32396513
Pancreatitis acute 21.71 11.94 35 106533 27300 32379658
Back pain 21.68 11.94 246 106322 110807 32296151
Diabetes mellitus inadequate control 21.62 11.94 9 106559 13759 32393199
Herpes zoster 21.62 11.94 46 106522 32295 32374663
Product label issue 21.53 11.94 12 106556 227 32406731
Haemorrhagic infarction 21.51 11.94 15 106553 427 32406531
Diverticulitis intestinal haemorrhagic 21.50 11.94 14 106554 355 32406603
Oesophageal haemorrhage 21.44 11.94 23 106545 1184 32405774
Arthralgia 21.35 11.94 350 106218 148098 32258860
Peripheral ischaemia 21.33 11.94 54 106514 5757 32401201
Stress 21.29 11.94 28 106540 23754 32383204
Cardiac failure chronic 21.28 11.94 62 106506 7178 32399780
Phlebitis deep 21.17 11.94 6 106562 14 32406944
Acute myeloid leukaemia 21.13 11.94 19 106549 19155 32387803
Platelet dysfunction 21.07 11.94 12 106556 237 32406721
Renal infarct 21.05 11.94 23 106545 1209 32405749
Hyperkalaemia 20.99 11.94 138 106430 69612 32337346
Hepatitis C 20.97 11.94 9 106559 13509 32393449
Hallucination 20.84 11.94 95 106473 52524 32354434
Synovitis 20.84 11.94 5 106563 10873 32396085
Palmar-plantar erythrodysaesthesia syndrome 20.70 11.94 13 106555 15736 32391222
Candida infection 20.57 11.94 15 106553 16788 32390170
Electrocardiogram QRS complex abnormal 20.55 11.94 13 106555 313 32406645
Intra-abdominal haematoma 20.54 11.94 24 106544 1359 32405599
Hyperhomocysteinaemia 20.52 11.94 11 106557 192 32406766
Large intestine polyp 20.50 11.94 61 106507 7145 32399813
Haematospermia 20.44 11.94 14 106554 387 32406571
Neutropenic sepsis 20.44 11.94 8 106560 12691 32394267
Brain compression 20.37 11.94 11 106557 195 32406763
Lymphopenia 20.32 11.94 11 106557 14445 32392513
Hepatotoxicity 20.32 11.94 20 106548 19317 32387641
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits 20.17 11.94 5 106563 5 32406953
Oxygen saturation increased 20.13 11.94 12 106556 259 32406699
Traumatic haemothorax 20.05 11.94 12 106556 261 32406697
Angioedema 20.03 11.94 57 106511 36232 32370726
Colitis ulcerative 19.88 11.94 16 106552 17035 32389923
Bleeding time prolonged 19.88 11.94 17 106551 658 32406300
Accidental exposure to product 19.85 11.94 6 106562 11196 32395762
Brain herniation 19.78 11.94 41 106527 3830 32403128
Haemoperitoneum 19.78 11.94 26 106542 1661 32405297
Hypercoagulation 19.72 11.94 22 106546 1184 32405774
Multiple sclerosis relapse 19.67 11.94 7 106561 11774 32395184
Encephalopathy 19.51 11.94 53 106515 34204 32372754
Hypertension 19.48 11.94 309 106259 131441 32275517
Postoperative thrombosis 19.39 11.94 6 106562 21 32406937
Intra-abdominal haemorrhage 19.34 11.94 30 106538 2233 32404725
Vena cava thrombosis 19.33 11.94 21 106547 1097 32405861
Carotid artery aneurysm 19.31 11.94 7 106561 44 32406914
Cholestasis 19.31 11.94 37 106531 26996 32379962
Catheter site haemorrhage 19.22 11.94 30 106538 2245 32404713
Bladder neoplasm 19.15 11.94 23 106545 1341 32405617
Progressive multifocal leukoencephalopathy 19.02 11.94 4 106564 9527 32397431
Fatigue 18.98 11.94 948 105620 349753 32057205
Pulmonary arterial hypertension 18.97 11.94 73 106495 9748 32397210
C-reactive protein increased 18.96 11.94 87 106481 48015 32358943
Coagulation factor X level increased 18.90 11.94 4 106564 0 32406958
Haematotympanum 18.90 11.94 4 106564 0 32406958
Peripheral artery thrombosis 18.83 11.94 30 106538 2285 32404673
Hypertriglyceridaemia 18.82 11.94 3 106565 8716 32398242
Dysphagia 18.82 11.94 121 106447 61355 32345603
Hypocalcaemia 18.80 11.94 29 106539 23025 32383933
Anastomotic ulcer haemorrhage 18.77 11.94 6 106562 24 32406934
Restlessness 18.71 11.94 33 106535 24848 32382110
Post-traumatic amnestic disorder 18.67 11.94 7 106561 49 32406909
Influenza like illness 18.65 11.94 38 106530 27102 32379856
Drug resistance 18.62 11.94 29 106539 22936 32384022
Syncope 18.58 11.94 406 106162 89718 32317240
Blood bilirubin increased 18.54 11.94 65 106503 38719 32368239
Neuroleptic malignant syndrome 18.49 11.94 18 106550 17477 32389481
Lung diffusion disorder 18.45 11.94 8 106560 85 32406873
Fear 18.43 11.94 7 106561 11312 32395646
Bronchopulmonary aspergillosis 18.40 11.94 11 106557 13676 32393282
Limb injury 18.40 11.94 74 106494 10085 32396873
Anger 18.35 11.94 8 106560 11896 32395062
Ill-defined disorder 18.31 11.94 8 106560 11881 32395077
Metabolic acidosis 18.28 11.94 70 106498 40629 32366329
Arterial thrombosis 18.27 11.94 24 106544 1532 32405426
Contraindicated product administered 18.23 11.94 116 106452 18960 32387998
Pneumocystis jirovecii pneumonia 18.17 11.94 21 106547 18849 32388109
Skin ulcer haemorrhage 18.06 11.94 9 106559 134 32406824
Cytokine release syndrome 18.03 11.94 11 106557 13524 32393434
Malnutrition 18.02 11.94 9 106559 12369 32394589
Tachycardia 17.97 11.94 169 106399 78919 32328039
Blood triglycerides increased 17.96 11.94 13 106555 14606 32392352
Hepatic steatosis 17.76 11.94 16 106552 16117 32390841
Renal failure 17.74 11.94 322 106246 134156 32272802
Embolism arterial 17.71 11.94 15 106553 573 32406385
Hypersensitivity vasculitis 17.67 11.94 38 106530 3643 32403315
Duodenitis haemorrhagic 17.59 11.94 8 106560 96 32406862
Extradural haematoma 17.58 11.94 21 106547 1217 32405741
Respiratory distress 17.58 11.94 58 106510 35188 32371770
Tumour haemorrhage 17.55 11.94 32 106536 2719 32404239
Lacunar stroke 17.49 11.94 9 106559 144 32406814
N-terminal prohormone brain natriuretic peptide increased 17.45 11.94 27 106541 2005 32404953
Hypernatraemia 17.40 11.94 3 106565 8230 32398728
Withdrawal syndrome 17.37 11.94 9 106559 12113 32394845
Neuropathy peripheral 17.27 11.94 165 106403 76817 32330141
Blood lactate dehydrogenase increased 17.24 11.94 28 106540 21777 32385181
Injection site swelling 17.23 11.94 5 106563 9579 32397379
Diabetic ketoacidosis 17.22 11.94 20 106548 17912 32389046
Disseminated intravascular coagulation 17.19 11.94 31 106537 23145 32383813
Hypoglycaemia 17.18 11.94 106 106462 54276 32352682
Acidosis 17.18 11.94 7 106561 10839 32396119
Mental status changes 17.18 11.94 66 106502 38271 32368687
Lymphoma 17.06 11.94 7 106561 10793 32396165
Erythema 17.04 11.94 182 106386 82923 32324035
International normalised ratio abnormal 17 11.94 35 106533 3254 32403704
Chronic gastrointestinal bleeding 16.99 11.94 11 106557 276 32406682
Surgery 16.95 11.94 84 106484 12515 32394443
Haemodilution 16.93 11.94 6 106562 35 32406923
Nephropathy toxic 16.93 11.94 9 106559 11937 32395021
Adverse event 16.89 11.94 102 106466 16370 32390588
Ascites 16.87 11.94 71 106497 40120 32366838
Metastases to bone 16.82 11.94 7 106561 10703 32396255
Spinal cord haematoma 16.82 11.94 8 106560 107 32406851
Supine hypertension 16.69 11.94 12 106556 359 32406599
Tongue haemorrhage 16.63 11.94 14 106554 530 32406428
Perforated ulcer 16.60 11.94 9 106559 161 32406797
Night sweats 16.49 11.94 17 106551 16071 32390887
Poisoning 16.42 11.94 8 106560 11150 32395808
Presyncope 16.41 11.94 105 106463 17196 32389762
Vascular graft thrombosis 16.40 11.94 9 106559 165 32406793
Suicide attempt 16.40 11.94 67 106501 38177 32368781
Cerebral amyloid angiopathy 16.31 11.94 8 106560 115 32406843
Dyskinesia 16.26 11.94 33 106535 23570 32383388
Pulmonary endarterectomy 16.25 11.94 7 106561 73 32406885
Hypercalcaemia 16.25 11.94 13 106555 13881 32393077
Therapeutic product ineffective 16.17 11.94 15 106553 647 32406311
Subarachnoid haematoma 16.17 11.94 7 106561 74 32406884
Gout 16.15 11.94 111 106457 18617 32388341
Ureteric haemorrhage 16.12 11.94 8 106560 118 32406840
Hepatic encephalopathy 16.12 11.94 15 106553 14880 32392078
Facial paresis 16.11 11.94 32 106536 2899 32404059
Occult blood 16.08 11.94 13 106555 465 32406493
Myocarditis 16.03 11.94 9 106559 11581 32395377
Depressed level of consciousness 16.03 11.94 74 106494 40773 32366185
Rhinorrhoea 15.95 11.94 32 106536 22954 32384004
Labelled drug-disease interaction medication error 15.89 11.94 8 106560 122 32406836
Biopsy prostate 15.84 11.94 5 106563 19 32406939
Basilar artery thrombosis 15.79 11.94 9 106559 178 32406780
Pseudomonas infection 15.78 11.94 10 106558 12046 32394912
Renal embolism 15.77 11.94 8 106560 124 32406834
Oral candidiasis 15.71 11.94 10 106558 12017 32394941
Post procedural haematuria 15.71 11.94 9 106559 180 32406778
Implant site haematoma 15.69 11.94 7 106561 80 32406878
Vascular access site occlusion 15.65 11.94 6 106562 45 32406913
Cyanosis 15.64 11.94 11 106557 12542 32394416
Serotonin syndrome 15.63 11.94 24 106544 19093 32387865
Mania 15.61 11.94 6 106562 9626 32397332
Platelet count decreased 15.55 11.94 273 106295 114318 32292640
Hemiataxia 15.54 11.94 6 106562 46 32406912
Cardiac valve replacement complication 15.43 11.94 6 106562 47 32406911
Plasma cell myeloma 15.38 11.94 118 106450 57496 32349462
Lymphadenopathy 15.35 11.94 42 106526 27040 32379918
Subclavian vein thrombosis 15.33 11.94 17 106551 909 32406049
Intestinal perforation 15.29 11.94 5 106563 8870 32398088
Hypophosphataemia 15.29 11.94 5 106563 8870 32398088
Anaphylactic shock 15.28 11.94 16 106552 15018 32391940
Splenomegaly 15.18 11.94 15 106553 14462 32392496
Cytopenia 15.14 11.94 7 106561 10057 32396901
Carotid artery occlusion 15.12 11.94 26 106542 2110 32404848
Upper respiratory tract infection 15.04 11.94 48 106520 29425 32377533
Abdominal wall haemorrhage 15.03 11.94 7 106561 89 32406869
Blood pressure increased 15.00 11.94 177 106391 79177 32327781
Conjunctivitis 14.88 11.94 5 106563 8721 32398237
Uterine haemorrhage 14.87 11.94 4 106564 7 32406951
Subclavian artery thrombosis 14.87 11.94 4 106564 7 32406951
Post procedural oedema 14.87 11.94 4 106564 7 32406951
Potentiating drug interaction 14.83 11.94 43 106525 4965 32401993
Blood potassium increased 14.82 11.94 20 106548 16784 32390174
Retinal artery thrombosis 14.74 11.94 5 106563 25 32406933
Cardiac vein perforation 14.74 11.94 5 106563 25 32406933
Klebsiella infection 14.74 11.94 4 106564 8008 32398950
Mobility decreased 14.69 11.94 46 106522 28363 32378595
Myelodysplastic syndrome 14.68 11.94 27 106541 20011 32386947
Polyneuropathy 14.67 11.94 13 106555 13202 32393756
Vocal cord inflammation 14.61 11.94 6 106562 55 32406903
Idiopathic interstitial pneumonia 14.56 11.94 8 106560 147 32406811
Small intestinal obstruction 14.55 11.94 15 106553 14181 32392777
Melanaemia 14.53 11.94 4 106564 8 32406950
Cardiac assistance device user 14.53 11.94 4 106564 8 32406950
Hypertrophic osteoarthropathy 14.50 11.94 7 106561 97 32406861
Renal injury 14.45 11.94 11 106557 12044 32394914
Gastrointestinal angiodysplasia 14.43 11.94 14 106554 639 32406319
Delusion 14.43 11.94 13 106555 13095 32393863
Varicose vein ruptured 14.43 11.94 5 106563 27 32406931
Transfusion 14.40 11.94 57 106511 7711 32399247
Gastrointestinal arteriovenous malformation 14.34 11.94 11 106557 364 32406594
Lung infiltration 14.29 11.94 13 106555 13035 32393923
Electrocardiogram QT prolonged 14.29 11.94 74 106494 39567 32367391
Skin exfoliation 14.27 11.94 39 106529 25118 32381840
Intentional overdose 14.25 11.94 79 106489 41522 32365436
Tumour lysis syndrome 14.21 11.94 16 106552 14531 32392427
Thalamic infarction 14.20 11.94 14 106554 652 32406306
Aortic surgery 14.17 11.94 3 106565 0 32406958
Phlebectomy 14.17 11.94 3 106565 0 32406958
Prostatic varices 14.17 11.94 3 106565 0 32406958
Peripheral arterial occlusive disease 14.09 11.94 46 106522 5663 32401295
Visual acuity reduced 14.08 11.94 20 106548 16425 32390533
Cerebral microhaemorrhage 13.98 11.94 6 106562 62 32406896
Thrombophlebitis 13.93 11.94 31 106537 3041 32403917
Atrial septal defect 13.91 11.94 3 106565 7022 32399936
Mediastinal haematoma 13.83 11.94 7 106561 108 32406850
Hepatic cytolysis 13.83 11.94 5 106563 8328 32398630
Nasopharyngitis 13.77 11.94 138 106430 63649 32343309
Body temperature increased 13.72 11.94 19 106549 15772 32391186
Multiple sclerosis 13.72 11.94 4 106564 7640 32399318
Intentional product use issue 13.48 11.94 82 106486 42129 32364829
Left ventricular dilatation 13.43 11.94 14 106554 697 32406261
Renal vein thrombosis 13.33 11.94 8 106560 175 32406783
Tuberculosis 13.24 11.94 6 106562 8723 32398235
Disorganised speech 13.13 11.94 14 106554 716 32406242
Blood glucose decreased 13.10 11.94 15 106553 13519 32393439
Dose calculation error 13.10 11.94 5 106563 37 32406921
Hyperlipidaemia 13.08 11.94 17 106551 14494 32392464
Cytomegalovirus viraemia 13.07 11.94 3 106565 6724 32400234
Generalised oedema 13.01 11.94 13 106555 12470 32394488
Vision blurred 13 11.94 88 106480 44098 32362860
Aplastic anaemia 12.97 11.94 4 106564 7369 32399589
Hyperhidrosis 12.97 11.94 160 106408 71008 32335950
Eye pain 12.92 11.94 14 106554 12934 32394024
Hyperbilirubinaemia 12.89 11.94 24 106544 17706 32389252
Subcapsular renal haematoma 12.88 11.94 11 106557 425 32406533
Gravitational oedema 12.81 11.94 13 106555 627 32406331
Myopathy 12.78 11.94 11 106557 11330 32395628
Macular ischaemia 12.77 11.94 6 106562 78 32406880
Vascular rupture 12.71 11.94 8 106560 191 32406767
Vascular graft occlusion 12.66 11.94 13 106555 636 32406322
Dialysis 12.66 11.94 11 106557 11277 32395681
Fungal infection 12.62 11.94 19 106549 15236 32391722
Thyroiditis 12.59 11.94 23 106545 1957 32405001
Myositis 12.54 11.94 11 106557 11224 32395734
Monoplegia 12.51 11.94 20 106548 1528 32405430
Antiphospholipid syndrome 12.49 11.94 11 106557 443 32406515
Cough 12.45 11.94 353 106215 138464 32268494
Weight increased 12.43 11.94 196 106372 83467 32323491
Injection site erythema 12.40 11.94 18 106550 14650 32392308
Stiff person syndrome 12.35 11.94 7 106561 137 32406821
Urethral haemorrhage 12.33 11.94 11 106557 451 32406507
Hydronephrosis 12.32 11.94 8 106560 9515 32397443
Ocular retrobulbar haemorrhage 12.32 11.94 4 106564 17 32406941
Factor V Leiden mutation 12.32 11.94 4 106564 17 32406941
Blood calcium decreased 12.28 11.94 9 106559 10048 32396910
Depressed mood 12.25 11.94 26 106542 18274 32388684
Paresis cranial nerve 12.25 11.94 6 106562 86 32406872
Pollakiuria 12.24 11.94 27 106541 18717 32388241
Thrombotic microangiopathy 12.23 11.94 8 106560 9474 32397484
Tonsillar ulcer 12.21 11.94 8 106560 205 32406753
Sinus tachycardia 12.13 11.94 22 106546 16392 32390566
Feeling abnormal 12.11 11.94 133 106435 60290 32346668
Protein C deficiency 12.10 11.94 3 106565 3 32406955
Severe invasive streptococcal infection 12.10 11.94 3 106565 3 32406955
Anal fissure haemorrhage 12.10 11.94 3 106565 3 32406955
Echocardiogram 12.10 11.94 3 106565 3 32406955
Urinary incontinence 12.08 11.94 26 106542 18181 32388777
Ventricle rupture 12.07 11.94 5 106563 47 32406911
Brief psychotic disorder with marked stressors 11.97 11.94 8 106560 212 32406746
Post procedural pulmonary embolism 11.96 11.94 4 106564 19 32406939
Haematoma infection 11.96 11.94 16 106552 1040 32405918

Pharmacologic Action:

SourceCodeDescription
ATC B01AF01 BLOOD AND BLOOD FORMING ORGANS
ANTITHROMBOTIC AGENTS
ANTITHROMBOTIC AGENTS
Direct factor Xa inhibitors
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
FDA MoA N0000175635 Factor Xa Inhibitors
FDA EPC N0000175637 Factor Xa Inhibitor
CHEBI has role CHEBI:50249 anticoagulante
CHEBI has role CHEBI:68581 coagulation factor Xa inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Nonvalvular atrial fibrillation indication 49436004 DOID:0060224
Prevention of pulmonary embolism indication 59282003 DOID:9477
Pulmonary embolism indication 59282003 DOID:9477
Deep venous thrombosis indication 128053003
Prevention of stroke caused by a clot in a blood vessel in the brain indication 135875009
Prevention of systemic embolism caused by a clot in a blood vessel indication 414086009
Prevention of venous thromboembolism from re-occuring indication 429098002
Prevention of venous thromboembolism in undergoing surgery indication 429098002
Prevention of deep vein thrombosis indication 439993001
Prevention of atherothrombotic events at high risk of ischaemic events indication
Prevention of atherothrombotic events after an acute coronary syndrome indication
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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL 7157456 Aug. 28, 2024 TREATMENT OF DEEP VEIN THROMBOSIS (DVT)
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL 7157456 Aug. 28, 2024 TREATMENT OF PULMONARY EMBOLISM (PE)
15MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 7157456 Aug. 28, 2024 TREATMENT OF DEEP VEIN THROMBOSIS (DVT)
15MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 7157456 Aug. 28, 2024 TREATMENT OF PULMONARY EMBOLISM (PE)
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 7157456 Aug. 28, 2024 TREATMENT OF DEEP VEIN THROMBOSIS (DVT)
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 7157456 Aug. 28, 2024 TREATMENT OF PULMONARY EMBOLISM (PE)
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL 9415053 Nov. 13, 2024 PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT)
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL 9415053 Nov. 13, 2024 PROPHYLAXIS OF THROMBOEMBOLIC DISEASES IN PEDIATRIC PATIENTS AGED 2 YEARS AND OLDER WITH CONGENITAL HEART DISEASE WHO HAVE UNDERGONE THE FONTAN PROCEDURE AND A BODY WEIGHT OF >=50 KG
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL 9415053 Nov. 13, 2024 PROPHYLAXIS OF VENOUS THROMBOEMBOLISM IN ACUTELY ILL MEDICAL PATIENTS AT RISK FOR THROMBOEMBOLIC COMPLICATIONS NOT AT HIGH RISK OF BLEEDING
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL 9415053 Nov. 13, 2024 REDUCTION IN THE RISK OF RECURRENCE OF DEEP VEIN THROMBOSIS (DVT) AND/OR PULMONARY EMBOLISM (PE) IN PATIENTS AT CONTINUED RISK FOR RECURRENT DVT AND/OR AFTER COMPLETION OF INITIAL TREATMENT LASTING AT LEAST 6 MONTHS
15MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9415053 Nov. 13, 2024 REDUCING THE RISK OF STROKE AND SYSTEMIC EMBOLISM
15MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9415053 Nov. 13, 2024 TREATMENT OF DEEP VEIN THROMBOSIS (DVT)
15MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9415053 Nov. 13, 2024 TREATMENT OF PULMONARY EMBOLISM (PE)
15MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9415053 Nov. 13, 2024 TREATMENT OF VENOUS THROMBOEMBOLISM (VTE) AND THE REDUCTION IN THE RISK OF RECURRENT VTE IN PEDIATRIC PATIENTS FROM BIRTH TO LESS THAN 18 YEARS WITH A BODY WEIGHT OF 30 KG TO 49.9 KG AFTER AT LEAST 5 DAYS OF INITIAL PARENTERAL ANTICOAGULANT TREATMENT
2.5MG XARELTO JANSSEN PHARMS N022406 Oct. 11, 2018 RX TABLET ORAL 9415053 Nov. 13, 2024 REDUCTION OF RISK OF MAJOR CARDIOVASCULAR EVENTS (CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION AND STROKE) IN PATIENTS WITH CAD
2.5MG XARELTO JANSSEN PHARMS N022406 Oct. 11, 2018 RX TABLET ORAL 9415053 Nov. 13, 2024 REDUCTION OF RISK OF MAJOR CARDIOVASCULAR EVENTS (CV DEATH, MI, AND STROKE) IN CHRONIC CAD OR PAD
2.5MG XARELTO JANSSEN PHARMS N022406 Oct. 11, 2018 RX TABLET ORAL 9415053 Nov. 13, 2024 REDUCTION OF RISK OF MAJOR THROMBOTIC VASCULAR EVENTS (MYOCARDIAL INFARCTION, ISCHEMIC STROKE, ACUTE LIMB ISCHEMIA, AND MAJOR AMPUTATION OF VASCULAR ETIOLOGY) IN PATIENTS WITH PAD
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9415053 Nov. 13, 2024 REDUCING THE RISK OF STROKE AND SYSTEMIC EMBOLISM
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9415053 Nov. 13, 2024 TREATMENT OF DEEP VEIN THROMBOSIS (DVT)
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9415053 Nov. 13, 2024 TREATMENT OF PULMONARY EMBOLISM (PE)
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9415053 Nov. 13, 2024 TREATMENT OF VENOUS THROMBOEMBOLISM (VTE) AND THE REDUCTION IN THE RISK OF RECURRENT VTE IN PEDIATRIC PATIENTS FROM BIRTH TO LESS THAN 18 YEARS WITH A BODY WEIGHT OF >=50 KG AFTER AT LEAST 5 DAYS OF INITIAL PARENTERAL ANTICOAGULANT TREATMENT
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL 9539218 Feb. 17, 2034 AFTER COMPLETION OF INITIAL TREATMENT LASTING AT LEAST 6 MONTHS, TO REDUCE THE RISK OF RECURRENCE OF DEEP VEIN THROMBOSIS AND/OR PULMONARY EMBOLISM IN CERTAIN PATIENTS WITH ONCE DAILY, RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST 5 CONSECUTIVE DAYS
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL 9539218 Feb. 17, 2034 PROPHYLAXIS OF DEEP VEIN THROMBOSIS, WHICH MAY LEAD TO PULMONARY EMBOLISM IN PATIENTS UNDERGOING KNEE OR HIP REPLACEMENT SURGERY, WITH ONCE DAILY, RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST FIVE CONSECUTIVE DAYS
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL 9539218 Feb. 17, 2034 PROPHYLAXIS OF PE, DVT AND/OR STROKE IN PEDIATRIC PATIENTS (>=50 KG) AGED 2 YEARS AND OLDER WITH CONGENITAL HEART DISEASE AFTER FONTAN PROCEDURE WITH ONCE DAILY, RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST 5 CONSECUTIVE DAYS
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL 9539218 Feb. 17, 2034 PROPHYLAXIS OF VENOUS THROMBOEMBOLISM IN ACUTELY ILL MEDICAL PATIENTS AT RISK FOR THROMBOEMBOLIC COMPLICATIONS NOT AT HIGH RISK OF BLEEDING WITH ONCE DAILY, RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST 5 CONSECUTIVE DAYS
15MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9539218 Feb. 17, 2034 REDUCE THE RISK OF STROKE IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION WITH ONCE DAILY, RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST FIVE CONSECUTIVE DAYS
15MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9539218 Feb. 17, 2034 TREATMENT OF DVT AND/OR PE AND REDUCTION IN RISK OF RECURRENT DVT AND/OR PE IN PEDIATRIC PATIENTS (30-49.9 KG) ONCE DAILY WITH RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST 5 CONSECUTIVE DAYS AFTER AT LEAST 5 DAYS PARENTERAL ANTICOAGULANT TREATMENT
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9539218 Feb. 17, 2034 REDUCE THE RISK OF STROKE IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION WITH ONCE DAILY, RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST FIVE CONSECUTIVE DAYS
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9539218 Feb. 17, 2034 TREATMENT OF DEEP VEIN THROMBOSIS WITH ONCE DAILY, RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST FIVE CONSECUTIVE DAYS
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9539218 Feb. 17, 2034 TREATMENT OF DVT AND/OR PE AND REDUCTION IN THE RISK OF RECURRENT DVT AND/OR PE IN PEDIATRIC PATIENTS (>=50 KG) ONCE DAILY WITH RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST 5 CONSECUTIVE DAYS AFTER AT LEAST 5 DAYS PARENTERAL ANTICOAGULANT TREATMENT
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9539218 Feb. 17, 2034 TREATMENT OF PULMONARY EMBOLISM WITH ONCE DAILY, RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST FIVE CONSECUTIVE DAYS
2.5MG XARELTO JANSSEN PHARMS N022406 Oct. 11, 2018 RX TABLET ORAL 10828310 Jan. 31, 2039 REDUCTION OF RISK OF CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION, AND STROKE IN PATIENTS WITH CAD BY ADMINISTERING CLINICALLY PROVEN EFFECTIVE AMOUNTS THAT ARE 2.5 MG RIVAROXABAN TWICE DAILY AND 75-100 MG ASPIRIN DAILY
2.5MG XARELTO JANSSEN PHARMS N022406 Oct. 11, 2018 RX TABLET ORAL 10828310 Jan. 31, 2039 REDUCTION OF RISK OF MYOCARDIAL INFARCTION AND ISCHEMIC STROKE IN PATIENTS WITH PAD BY ADMINISTERING CLINICALLY PROVEN EFFECTIVE AMOUNTS THAT ARE 2.5 MG RIVAROXABAN TWICE DAILY AND 75-100 MG ASPIRIN DAILY

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
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
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL April 11, 2023 PEDIATRIC EXCLUSIVITY
15MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL April 11, 2023 PEDIATRIC EXCLUSIVITY
2.5MG XARELTO JANSSEN PHARMS N022406 Oct. 11, 2018 RX TABLET ORAL April 11, 2023 PEDIATRIC EXCLUSIVITY
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL April 11, 2023 PEDIATRIC EXCLUSIVITY
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL Aug. 23, 2024 INDICATED TO REDUCE THE RISK OF MAJOR THROMBOTIC VASCULAR EVENTS (MYOCARDIAL INFARCTION, ISCHEMIC STROKE, ACUTE LIMB ISCHEMIA, AND MAJOR AMPUTATION OF VASCULAR ETIOLOGY) IN PATIENTS WITH PAD, INCLUDING PATIENTS WHO HAVE RECENTLY UNDERGONE A LOWER EXTREMITY REVASCULARIZATION PROCEDURE DUE TO SYMPTOMATIC PAD
15MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL Aug. 23, 2024 INDICATED TO REDUCE THE RISK OF MAJOR THROMBOTIC VASCULAR EVENTS (MYOCARDIAL INFARCTION, ISCHEMIC STROKE, ACUTE LIMB ISCHEMIA, AND MAJOR AMPUTATION OF VASCULAR ETIOLOGY) IN PATIENTS WITH PAD, INCLUDING PATIENTS WHO HAVE RECENTLY UNDERGONE A LOWER EXTREMITY REVASCULARIZATION PROCEDURE DUE TO SYMPTOMATIC PAD
2.5MG XARELTO JANSSEN PHARMS N022406 Oct. 11, 2018 RX TABLET ORAL Aug. 23, 2024 INDICATED TO REDUCE THE RISK OF MAJOR THROMBOTIC VASCULAR EVENTS (MYOCARDIAL INFARCTION, ISCHEMIC STROKE, ACUTE LIMB ISCHEMIA, AND MAJOR AMPUTATION OF VASCULAR ETIOLOGY) IN PATIENTS WITH PAD, INCLUDING PATIENTS WHO HAVE RECENTLY UNDERGONE A LOWER EXTREMITY REVASCULARIZATION PROCEDURE DUE TO SYMPTOMATIC PAD
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL Aug. 23, 2024 INDICATED TO REDUCE THE RISK OF MAJOR THROMBOTIC VASCULAR EVENTS (MYOCARDIAL INFARCTION, ISCHEMIC STROKE, ACUTE LIMB ISCHEMIA, AND MAJOR AMPUTATION OF VASCULAR ETIOLOGY) IN PATIENTS WITH PAD, INCLUDING PATIENTS WHO HAVE RECENTLY UNDERGONE A LOWER EXTREMITY REVASCULARIZATION PROCEDURE DUE TO SYMPTOMATIC PAD
1MG/ML XARELTO JANSSEN PHARMS N215859 Dec. 20, 2021 RX FOR SUSPENSION ORAL Dec. 20, 2024 NEW PRODUCT
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL Feb. 23, 2025 PEDIATRIC EXCLUSIVITY
15MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL Feb. 23, 2025 PEDIATRIC EXCLUSIVITY
2.5MG XARELTO JANSSEN PHARMS N022406 Oct. 11, 2018 RX TABLET ORAL Feb. 23, 2025 PEDIATRIC EXCLUSIVITY
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL Feb. 23, 2025 PEDIATRIC EXCLUSIVITY
1MG/ML XARELTO JANSSEN PHARMS N215859 Dec. 20, 2021 RX FOR SUSPENSION ORAL June 20, 2025 PEDIATRIC EXCLUSIVITY

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

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 50458-575 GRANULE, FOR SUSPENSION 155 mg ORAL NDA 35 sections
XARELTO HUMAN PRESCRIPTION DRUG LABEL 1 50458-577 TABLET, FILM COATED 2.50 mg ORAL NDA 35 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50458-578 TABLET, FILM COATED 15 mg ORAL NDA 35 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50458-579 TABLET, FILM COATED 20 mg ORAL NDA 35 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50458-580 TABLET, FILM COATED 10 mg ORAL NDA 35 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