rivaroxaban 🐶 Veterinary Use | 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
S (Water solubility) 0.01 mg/mL Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Bocci G, Oprea TI, Benet LZ

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 6000.42 10.90 3039 126521 78137 63281325
Pulmonary embolism 2189.00 10.90 1849 127711 114835 63244627
Ischaemic stroke 1350.27 10.90 682 128878 17275 63342187
Haemorrhage 1290.88 10.90 1038 128522 59984 63299478
Cerebral haemorrhage 1185.69 10.90 754 128806 29975 63329487
Cerebrovascular accident 1164.61 10.90 1262 128298 106762 63252700
Deep vein thrombosis 1105.06 10.90 1091 128469 82709 63276753
Epistaxis 1068.59 10.90 1005 128555 71720 63287742
Upper gastrointestinal haemorrhage 865.60 10.90 517 129043 18335 63341127
Haemorrhage intracranial 846.18 10.90 453 129107 12966 63346496
Thrombosis 819.99 10.90 825 128735 63930 63295532
Haematuria 778.52 10.90 570 128990 28587 63330875
Heavy menstrual bleeding 758.23 10.90 465 129095 17308 63342154
Rectal haemorrhage 693.95 10.90 664 128896 48366 63311096
Haemoglobin decreased 686.69 10.90 1135 128425 144350 63215112
Haematoma 678.45 10.90 565 128995 34255 63325207
Vaginal haemorrhage 661.64 10.90 505 129055 26982 63332480
Melaena 625.63 10.90 509 129051 29856 63329606
Cerebral infarction 619.57 10.90 459 129101 23434 63336028
Anaemia 557.51 10.90 1582 127978 291848 63067614
Lower gastrointestinal haemorrhage 538.89 10.90 281 129279 7609 63351853
Embolic stroke 482.05 10.90 207 129353 3569 63355893
Haemorrhagic stroke 461.75 10.90 229 129331 5563 63353899
Haematochezia 380.99 10.90 507 129053 53037 63306425
Internal haemorrhage 378.82 10.90 193 129367 4972 63354490
Subdural haematoma 364.11 10.90 272 129288 14056 63345406
Synovitis 325.04 10.90 13 129547 186905 63172557
Blood loss anaemia 315.31 10.90 208 129352 8793 63350669
Hand deformity 308.74 10.90 3 129557 159454 63200008
Infusion related reaction 301.98 10.90 66 129494 245455 63114007
Haemoptysis 297.42 10.90 329 129231 28397 63331065
Glossodynia 290.33 10.90 19 129541 178857 63180605
Drug intolerance 278.76 10.90 141 129419 308520 63050942
Atrial thrombosis 276.81 10.90 113 129447 1705 63357757
Therapeutic product effect decreased 274.97 10.90 35 129525 193152 63166310
Incorrect dose administered 273.25 10.90 461 129099 59507 63299955
Systemic lupus erythematosus 265.47 10.90 52 129508 208866 63150596
Labelled drug-drug interaction medication error 264.14 10.90 219 129341 13180 63346282
Pain 263.68 10.90 715 128845 739913 62619549
Haematemesis 259.01 10.90 315 129245 30097 63329365
Rheumatoid arthritis 255.82 10.90 99 129461 253720 63105742
Pericardial haemorrhage 254.63 10.90 103 129457 1516 63357946
Intraventricular haemorrhage 253.55 10.90 111 129449 2009 63357453
International normalised ratio increased 248.48 10.90 384 129176 46041 63313421
Haemarthrosis 246.11 10.90 123 129437 3038 63356424
Faeces discoloured 234.35 10.90 236 129324 18273 63341189
Arthropathy 230.98 10.90 95 129465 234697 63124765
Post procedural haemorrhage 224.54 10.90 161 129399 7803 63351659
Atrial fibrillation 219.89 10.90 628 128932 116008 63243454
Maternal exposure during pregnancy 218.15 10.90 88 129472 219974 63139488
Haemorrhoidal haemorrhage 211.14 10.90 123 129437 4156 63355306
Fall 208.10 10.90 1441 128119 390893 62968569
Joint swelling 207.12 10.90 218 129342 327448 63032014
Shock haemorrhagic 199.78 10.90 164 129396 9731 63349731
Diverticulum intestinal haemorrhagic 194.08 10.90 84 129476 1477 63357985
Haemorrhagic arteriovenous malformation 189.29 10.90 47 129513 105 63359357
Arthralgia 188.40 10.90 569 128991 569141 62790321
Discomfort 182.81 10.90 57 129503 167317 63192145
Transient ischaemic attack 182.35 10.90 298 129262 37455 63322007
Gingival bleeding 180.84 10.90 172 129388 12415 63347047
Cerebral haematoma 176.80 10.90 104 129456 3579 63355883
Hypersensitivity 172.58 10.90 206 129354 292479 63066983
Wound 170.60 10.90 60 129500 163203 63196259
Alopecia 170.41 10.90 266 129294 337270 63022192
Hemiplegia 168.58 10.90 145 129415 9178 63350284
Product prescribing issue 166.96 10.90 90 129470 2609 63356853
Contraindicated product administered 163.62 10.90 123 129437 217525 63141937
Drug interaction 163.62 10.90 909 128651 228222 63131240
Basal ganglia haemorrhage 162.11 10.90 58 129502 596 63358866
Dyspnoea exertional 160.61 10.90 370 129190 59932 63299530
Pericarditis 158.38 10.90 37 129523 131542 63227920
Uterine haemorrhage 157.82 10.90 100 129460 3941 63355521
Drug hypersensitivity 153.81 10.90 248 129312 310439 63049023
Rheumatoid factor positive 153.30 10.90 4 129556 84402 63275060
Subarachnoid haemorrhage 152 10.90 166 129394 14117 63345345
Treatment failure 151.52 10.90 111 129449 198932 63160530
Swelling 147.71 10.90 208 129352 275170 63084292
Blood urine present 146.40 10.90 167 129393 14902 63344560
Subcutaneous haematoma 146.11 10.90 71 129489 1647 63357815
Cerebellar haemorrhage 141.24 10.90 65 129495 1329 63358133
Cardiac failure 138.86 10.90 449 129111 88693 63270769
Iron deficiency anaemia 138.76 10.90 187 129373 19782 63339680
Embolic cerebral infarction 138.68 10.90 49 129511 484 63358978
Abdominal wall haematoma 138.13 10.90 83 129477 2972 63356490
Musculoskeletal stiffness 135.34 10.90 107 129453 184511 63174951
Hemiparesis 132.21 10.90 198 129362 23084 63336378
Hepatic enzyme increased 129.52 10.90 133 129427 202195 63157267
Mouth haemorrhage 125.71 10.90 107 129453 6676 63352786
Folliculitis 125.25 10.90 4 129556 70313 63289149
Muscle haemorrhage 124.98 10.90 79 129481 3100 63356362
Prothrombin time prolonged 124.84 10.90 124 129436 9440 63350022
Dyspnoea 124.72 10.90 1966 127594 659347 62700115
Condition aggravated 121.36 10.90 418 129142 401799 62957663
Haemorrhagic transformation stroke 117.10 10.90 55 129505 1180 63358282
Acute kidney injury 115.75 10.90 926 128634 262489 63096973
Product prescribing error 111.68 10.90 196 129364 26093 63333369
Thalamus haemorrhage 111.13 10.90 45 129515 664 63358798
Infection 109.56 10.90 187 129373 228986 63130476
Subdural haemorrhage 109.07 10.90 72 129488 3046 63356416
Muscle injury 108.80 10.90 6 129554 65339 63294123
Coagulopathy 105.80 10.90 167 129393 20377 63339085
Exposure during pregnancy 105.61 10.90 97 129463 155450 63204012
Toxicity to various agents 101.43 10.90 221 129339 247029 63112433
Blood cholesterol increased 100.89 10.90 33 129527 93999 63265463
Sinusitis 100.25 10.90 194 129366 226459 63133003
Irritable bowel syndrome 99.50 10.90 23 129537 82389 63277073
Pulmonary arterial hypertension 99.39 10.90 171 129389 22406 63337056
Pyrexia 99.36 10.90 559 129001 469919 62889543
Creatinine renal clearance decreased 98.81 10.90 143 129417 16165 63343297
Haemorrhage urinary tract 97.48 10.90 43 129517 793 63358669
Anxiety 97.26 10.90 185 129375 217356 63142106
Embolism venous 96.41 10.90 67 129493 3087 63356375
Retroperitoneal haemorrhage 96.41 10.90 64 129496 2733 63356729
Gastric ulcer haemorrhage 96.27 10.90 80 129480 4828 63354634
Gastrointestinal vascular malformation haemorrhagic 95.85 10.90 30 129530 195 63359267
Mobility decreased 95.53 10.90 65 129495 121094 63238368
Blister 94.15 10.90 76 129484 129738 63229724
Duodenal ulcer haemorrhage 93.73 10.90 60 129500 2407 63357055
Impaired healing 92.17 10.90 47 129513 102495 63256967
Helicobacter infection 92.03 10.90 37 129523 92748 63266714
Drug ineffective 89.83 10.90 1548 128012 1043217 62316245
Abdominal discomfort 89.11 10.90 345 129215 320540 63038922
Postmenopausal haemorrhage 88.66 10.90 55 129505 2087 63357375
Eye haemorrhage 87.38 10.90 97 129463 8399 63351063
Stomatitis 86.71 10.90 93 129467 138632 63220830
Renal impairment 86.01 10.90 383 129177 87972 63271490
Hospitalisation 86.01 10.90 373 129187 84708 63274754
Post procedural haematoma 85.55 10.90 45 129515 1240 63358222
Embolism 84.32 10.90 92 129468 7814 63351648
Splenic rupture 83.84 10.90 45 129515 1293 63358169
Activated partial thromboplastin time prolonged 83.80 10.90 86 129474 6807 63352655
Cerebral ischaemia 83.71 10.90 85 129475 6643 63352819
Psoriatic arthropathy 83.68 10.90 41 129519 91479 63267983
Extradural haematoma 83.64 10.90 49 129511 1673 63357789
Small intestinal haemorrhage 82.27 10.90 52 129508 2040 63357422
Cerebral artery embolism 81.99 10.90 40 129520 936 63358526
Gastric haemorrhage 81.75 10.90 82 129478 6316 63353146
Nasopharyngitis 81.57 10.90 257 129303 254000 63105462
Haemorrhage subcutaneous 81.11 10.90 59 129501 2924 63356538
Venous thrombosis 80.13 10.90 72 129488 4830 63354632
Cerebral artery occlusion 79.17 10.90 38 129522 857 63358605
Ill-defined disorder 78.82 10.90 34 129526 81721 63277741
Drug abuse 78.59 10.90 25 129535 72493 63286969
Renal haemorrhage 77.25 10.90 38 129522 906 63358556
Pulmonary thrombosis 77.12 10.90 92 129468 8610 63350852
Peripheral embolism 76.82 10.90 42 129518 1253 63358209
Injection site erythema 76.44 10.90 37 129523 83137 63276325
Wound haemorrhage 75.86 10.90 53 129507 2463 63356999
Depression 73.83 10.90 184 129376 196308 63163154
Injection site reaction 73.35 10.90 15 129545 58509 63300953
Type 2 diabetes mellitus 72.89 10.90 20 129540 63848 63295614
Weight increased 72.62 10.90 280 129280 260512 63098950
Product use issue 71.35 10.90 222 129338 220298 63139164
Hypovolaemic shock 70.73 10.90 75 129485 6166 63353296
Pulmonary hypertension 69.98 10.90 200 129360 36923 63322539
Abnormal uterine bleeding 69.89 10.90 42 129518 1504 63357958
Therapeutic response decreased 68.86 10.90 20 129540 61505 63297957
Anticoagulation drug level increased 68.82 10.90 23 129537 189 63359273
Therapeutic product effect incomplete 68.42 10.90 93 129467 124963 63234499
Completed suicide 66.73 10.90 122 129438 145551 63213911
Transfusion 66.64 10.90 115 129445 15102 63344360
Intracardiac thrombus 66.28 10.90 48 129512 2362 63357100
Underdose 66.07 10.90 162 129398 27294 63332168
Intestinal haemorrhage 65.85 10.90 58 129502 3789 63355673
Gastric ulcer 65.64 10.90 149 129411 23888 63335574
Cerebral ventricular rupture 64.47 10.90 22 129538 194 63359268
Febrile neutropenia 63.88 10.90 89 129471 118360 63241102
Oedema peripheral 63.42 10.90 628 128932 188883 63170579
Fibromyalgia 62.25 10.90 44 129516 80376 63279086
Adrenal haemorrhage 61.96 10.90 26 129534 422 63359040
Salpingo-oophorectomy unilateral 61.93 10.90 32 129528 849 63358613
Haemothorax 61.19 10.90 44 129516 2141 63357321
Sedation 60.41 10.90 5 129555 38804 63320658
Gastrointestinal disorder 60.03 10.90 110 129450 131129 63228333
Spinal cord haematoma 59.78 10.90 20 129540 165 63359297
Product monitoring error 59.77 10.90 59 129501 4457 63355005
Gastritis haemorrhagic 59.75 10.90 38 129522 1507 63357955
Injection site pain 59.19 10.90 109 129451 129691 63229771
Treatment noncompliance 58.98 10.90 189 129371 37136 63322326
Venous thrombosis limb 58.93 10.90 49 129511 2959 63356503
Pericardial effusion 58.67 10.90 164 129396 29894 63329568
Intra-abdominal haemorrhage 58.58 10.90 45 129515 2424 63357038
Incision site haemorrhage 58.40 10.90 27 129533 558 63358904
Ecchymosis 58.25 10.90 91 129469 11003 63348459
Pulmonary haemorrhage 57.29 10.90 72 129488 7109 63352353
Brain stem haemorrhage 57.26 10.90 29 129531 737 63358725
Haematoma muscle 56.93 10.90 33 129527 1104 63358358
Retinal haemorrhage 56.82 10.90 60 129500 4909 63354553
Loss of personal independence in daily activities 56.68 10.90 69 129491 97221 63262241
Pregnancy 56.64 10.90 5 129555 36831 63322631
Occult blood positive 56.26 10.90 52 129508 3618 63355844
Inflammation 56.18 10.90 51 129509 82222 63277240
Duodenal ulcer 55.97 10.90 74 129486 7682 63351780
Cerebellar infarction 55.05 10.90 40 129520 1979 63357483
Dizziness 54.84 10.90 1204 128356 428721 62930741
Large intestinal haemorrhage 54.11 10.90 34 129526 1320 63358142
Urinary bladder haemorrhage 53.43 10.90 31 129529 1039 63358423
Splenic haemorrhage 53.39 10.90 19 129541 192 63359270
Head injury 53 10.90 149 129411 27247 63332215
Pharyngeal haemorrhage 52.78 10.90 25 129535 547 63358915
Anaphylactic reaction 52.71 10.90 35 129525 66065 63293397
Cerebral mass effect 52.47 10.90 29 129531 884 63358578
Injury 51.71 10.90 44 129516 73203 63286259
Syncope 51.63 10.90 413 129147 116972 63242490
Sinusitis fungal 51.57 10.90 37 129523 1794 63357668
Cardioversion 51.26 10.90 32 129528 1228 63358234
Rash 50.52 10.90 823 128737 560048 62799414
Lower respiratory tract infection 50.37 10.90 123 129437 132184 63227278
Traumatic intracranial haemorrhage 49.94 10.90 23 129537 471 63358991
Cardiac failure chronic 49.90 10.90 53 129507 4365 63355097
Multiple sclerosis relapse 48.60 10.90 19 129541 48459 63311003
C-reactive protein abnormal 48.01 10.90 17 129543 46079 63313383
Glomerular filtration rate decreased 48.00 10.90 93 129467 13348 63346114
Device related thrombosis 47.84 10.90 35 129525 1750 63357712
Microcytic anaemia 47.63 10.90 46 129514 3383 63356079
Prothrombin time shortened 46.54 10.90 36 129524 1959 63357503
Fatigue 46.48 10.90 1420 128140 886608 62472854
Hypertension 46.12 10.90 357 129203 278946 63080516
Sputum increased 45.99 10.90 39 129521 2420 63357042
Bradycardia 45.95 10.90 281 129279 72946 63286516
Vascular pseudoaneurysm 45.52 10.90 32 129528 1502 63357960
Peripheral artery thrombosis 45.15 10.90 35 129525 1911 63357551
Arterial haemorrhage 44.52 10.90 33 129527 1684 63357778
Retroperitoneal haematoma 44.13 10.90 41 129519 2872 63356590
Death 44.12 10.90 1037 128523 373344 62986118
Hepatotoxicity 43.40 10.90 11 129549 37030 63322432
Spontaneous haematoma 42.29 10.90 25 129535 868 63358594
Peripheral ischaemia 42.29 10.90 51 129509 4827 63354635
Anovulatory cycle 42.02 10.90 15 129545 153 63359309
Rectal polyp 41.86 10.90 28 129532 1211 63358251
Haemorrhagic cerebral infarction 41.12 10.90 22 129538 628 63358834
Suicidal ideation 41.08 10.90 40 129520 62381 63297081
Procedural haemorrhage 41.04 10.90 38 129522 2650 63356812
Joint stiffness 41.01 10.90 17 129543 41852 63317610
Intra-abdominal haematoma 40.87 10.90 32 129528 1773 63357689
Aphasia 40.76 10.90 154 129406 32846 63326616
C-reactive protein increased 40.16 10.90 83 129477 94624 63264838
Neutropenia 40.12 10.90 202 129358 174803 63184659
Labelled drug-disease interaction medication error 39.83 10.90 14 129546 136 63359326
Traumatic haematoma 39.53 10.90 29 129531 1456 63358006
Cerebral artery thrombosis 39.38 10.90 18 129542 362 63359100
Respiratory symptom 39.32 10.90 41 129519 3306 63356156
High frequency ablation 39.20 10.90 14 129546 143 63359319
Injection site pruritus 38.59 10.90 22 129538 45094 63314368
Liver injury 38.43 10.90 40 129520 60480 63298982
Diverticulum 38.07 10.90 79 129481 11912 63347550
Pulmonary alveolar haemorrhage 37.55 10.90 47 129513 4621 63354841
Pelvic venous thrombosis 37.35 10.90 30 129530 1725 63357737
Mesenteric artery embolism 37.11 10.90 8 129552 6 63359456
Hypervolaemia 37.10 10.90 135 129425 28278 63331184
Conjunctival haemorrhage 36.97 10.90 41 129519 3546 63355916
Injection site swelling 36.85 10.90 26 129534 47546 63311916
Fluid retention 36.79 10.90 228 129332 59458 63300004
Retinal artery occlusion 36.77 10.90 29 129531 1624 63357838
Cardiac tamponade 36.70 10.90 47 129513 4728 63354734
Insomnia 36.52 10.90 273 129287 214979 63144483
Coagulation factor X level increased 36.38 10.90 7 129553 0 63359462
Asthenia 36.26 10.90 1032 128528 382572 62976890
Therapy non-responder 36.16 10.90 62 129498 75839 63283623
Sleep disorder 35.85 10.90 70 129490 81496 63277966
Right ventricular failure 35.75 10.90 96 129464 17092 63342370
Contusion 35.58 10.90 465 129095 149579 63209883
Subgaleal haematoma 35.48 10.90 11 129549 69 63359393
Red blood cell sedimentation rate increased 35.45 10.90 23 129537 43959 63315503
Psoriasis 35.37 10.90 78 129482 86879 63272583
Potentiating drug interaction 35.27 10.90 44 129516 4312 63355150
Gastritis erosive 35.20 10.90 52 129508 5987 63353475
Traumatic haemorrhage 35.11 10.90 19 129541 555 63358907
Abdominal wall haemorrhage 35.07 10.90 13 129547 149 63359313
Polyp 34.95 10.90 54 129506 6467 63352995
Gastrointestinal ulcer haemorrhage 34.70 10.90 20 129540 662 63358800
Foetal exposure during pregnancy 34.66 10.90 11 129549 31951 63327511
Arrhythmia 34.61 10.90 162 129398 37978 63321484
Cerebral thrombosis 34.07 10.90 28 129532 1663 63357799
Herpes zoster 33.52 10.90 74 129486 82388 63277074
Renal infarct 33.51 10.90 26 129534 1421 63358041
Petechiae 33.44 10.90 82 129478 13815 63345647
Dry eye 33.29 10.90 21 129539 40740 63318722
Spinal cord haemorrhage 33.21 10.90 14 129546 230 63359232
Foot deformity 33.16 10.90 8 129552 27845 63331617
Ischaemic cerebral infarction 32.96 10.90 25 129535 1321 63358141
Intentional product use issue 32.61 10.90 142 129418 127750 63231712
Gastrointestinal angiodysplasia 32.46 10.90 17 129543 464 63358998
Creatinine renal clearance abnormal 32.43 10.90 16 129544 384 63359078
Presyncope 31.33 10.90 126 129434 27659 63331803
Hypersensitivity vasculitis 30.86 10.90 40 129520 4072 63355390
Pallor 30.86 10.90 134 129426 30434 63329028
Hysterectomy 30.65 10.90 63 129497 9436 63350026
Bradyarrhythmia 30.56 10.90 29 129531 2086 63357376
Bursitis 30.36 10.90 19 129541 37022 63322440
Fibrin D dimer increased 30.28 10.90 44 129516 4990 63354472
Oesophageal haemorrhage 30.27 10.90 17 129543 535 63358927
Prescribed overdose 30.16 10.90 16 129544 34137 63325325
Seizure 29.87 10.90 154 129406 132480 63226982
Ear haemorrhage 29.34 10.90 24 129536 1416 63358046
Irritability 29.26 10.90 14 129546 31680 63327782
Cardiac pacemaker insertion 29.21 10.90 39 129521 4087 63355375
Urticaria 28.73 10.90 209 129351 165593 63193869
Chest wall haematoma 28.42 10.90 12 129548 198 63359264
Purpura 28.27 10.90 68 129492 11317 63348145
Skin haemorrhage 28.03 10.90 63 129497 10031 63349431
Pruritus 27.82 10.90 545 129015 360908 62998554
Menometrorrhagia 27.75 10.90 20 129540 977 63358485
Lipase increased 27.73 10.90 62 129498 9838 63349624
Emotional distress 27.66 10.90 16 129544 32533 63326929
Hypotension 27.59 10.90 740 128820 271864 63087598
Haematoma infection 27.45 10.90 17 129543 643 63358819
Hypoaesthesia 27.41 10.90 216 129344 168177 63191285
Coagulation time prolonged 27.15 10.90 23 129537 1425 63358037
Atrial flutter 27.15 10.90 61 129499 9711 63349751
Cytomegalovirus infection 27.03 10.90 5 129555 20947 63338515
Toxic epidermal necrolysis 26.97 10.90 9 129551 25325 63334137
Ear infection 26.91 10.90 23 129537 38190 63321272
Brain stem infarction 26.66 10.90 18 129542 791 63358671
Cardiac ablation 26.65 10.90 23 129537 1462 63358000
Alanine aminotransferase increased 26.59 10.90 115 129445 103655 63255807
Oral herpes 26.50 10.90 10 129550 26064 63333398
Muscle spasticity 26.46 10.90 6 129554 21788 63337674
Product administration error 26.41 10.90 103 129457 22294 63337168
Brain herniation 26.41 10.90 35 129525 3642 63355820
Spontaneous haemorrhage 26.37 10.90 16 129544 583 63358879
Therapeutic response increased 26.35 10.90 14 129546 394 63359068
International normalised ratio abnormal 26.15 10.90 33 129527 3271 63356191
Haemoperitoneum 25.98 10.90 30 129530 2711 63356751
Diastolic dysfunction 25.88 10.90 47 129513 6424 63353038
Orthopnoea 25.71 10.90 46 129514 6215 63353247
Normochromic normocytic anaemia 25.71 10.90 39 129521 4597 63354865
Haemoglobin abnormal 25.70 10.90 41 129519 5047 63354415
Drug dependence 25.54 10.90 9 129551 24474 63334988
Heart rate irregular 25.54 10.90 102 129458 22319 63337143
Duplicate therapy error 25.46 10.90 9 129551 89 63359373
Injection site rash 25.34 10.90 4 129556 18805 63340657
Arterial thrombosis 25.19 10.90 22 129538 1421 63358041
Knee arthroplasty 25.16 10.90 45 129515 54161 63305301
Peripheral artery occlusion 25.13 10.90 21 129539 1277 63358185
Arterial injury 24.75 10.90 12 129548 277 63359185
Gastrointestinal polyp haemorrhage 24.68 10.90 11 129549 208 63359254
Drug resistance 24.67 10.90 8 129552 22925 63336537
Premature baby 24.60 10.90 6 129554 20729 63338733
Periorbital haematoma 24.58 10.90 17 129543 777 63358685
Mood swings 24.32 10.90 4 129556 18244 63341218
Change of bowel habit 24.23 10.90 26 129534 2167 63357295
Premature delivery 24.18 10.90 16 129544 30265 63329197
Inappropriate schedule of product administration 24.13 10.90 321 129239 103644 63255818
Aggression 23.90 10.90 9 129551 23489 63335973
Sciatica 23.76 10.90 21 129539 34303 63325159
Hypercholesterolaemia 23.75 10.90 7 129553 21327 63338135
Crying 23.64 10.90 9 129551 23334 63336128
Grip strength decreased 23.58 10.90 8 129552 22279 63337183
Intracranial haematoma 23.50 10.90 13 129547 397 63359065
Chronic gastritis 23.49 10.90 29 129531 2812 63356650
Basal cell carcinoma 23.44 10.90 14 129546 27977 63331485
Nasal polyps 23.06 10.90 43 129517 5996 63353466
Osteopenia 22.94 10.90 6 129554 19779 63339683
Drug tolerance decreased 22.91 10.90 4 129556 17469 63341993
Diverticulitis intestinal haemorrhagic 22.85 10.90 9 129551 123 63359339
Ear pain 22.79 10.90 24 129536 36094 63323368
Aortic valve calcification 22.71 10.90 14 129546 525 63358937
Myelosuppression 22.61 10.90 10 129550 23693 63335769
Full blood count decreased 22.50 10.90 109 129451 25915 63333547
Urethral haemorrhage 22.43 10.90 7 129553 45 63359417
Peripheral coldness 22.40 10.90 65 129495 12100 63347362
Rheumatoid nodule 22.33 10.90 4 129556 17151 63342311
Catheter management 22.33 10.90 29 129531 2958 63356504
Urogenital haemorrhage 22.22 10.90 11 129549 266 63359196
Coagulation test abnormal 22.19 10.90 16 129544 782 63358680
Migraine 22.15 10.90 122 129438 103224 63256238
Chest pain 22.05 10.90 587 128973 215372 63144090
Hypercoagulation 21.78 10.90 24 129536 2061 63357401
Haemorrhagic erosive gastritis 21.77 10.90 13 129547 460 63359002
Pelvic haemorrhage 21.68 10.90 9 129551 142 63359320
Peritoneal haematoma 21.48 10.90 8 129552 93 63359369
Vascular stent thrombosis 21.43 10.90 17 129543 960 63358502
Mucosal haemorrhage 21.42 10.90 18 129542 1103 63358359
Hypochromic anaemia 21.41 10.90 23 129537 1919 63357543
Cerebral vascular occlusion 21.38 10.90 6 129554 25 63359437
Retinal vein thrombosis 21.35 10.90 13 129547 477 63358985
Tricuspid valve incompetence 21.27 10.90 72 129488 14549 63344913
Incorrect route of product administration 21.26 10.90 15 129545 27437 63332025
Lupus-like syndrome 21.19 10.90 3 129557 15292 63344170
Arrhythmogenic right ventricular dysplasia 21.19 10.90 6 129554 26 63359436
Rhinorrhoea 21.19 10.90 66 129494 65511 63293951
Cognitive disorder 21.14 10.90 52 129508 55763 63303699
Chills 21.07 10.90 140 129420 113238 63246224
Vascular purpura 20.85 10.90 20 129540 1458 63358004
Protein S deficiency 20.83 10.90 6 129554 28 63359434
Orthostatic heart rate response increased 20.79 10.90 4 129556 0 63359462
Central nervous system haemorrhage 20.50 10.90 9 129551 164 63359298
Thrombocytosis 20.46 10.90 40 129520 5778 63353684
Aspartate aminotransferase increased 20.22 10.90 105 129455 90172 63269290
Paraplegia 20.07 10.90 26 129534 2646 63356816
Oropharyngeal pain 20.00 10.90 112 129448 94375 63265087
Hip arthroplasty 19.99 10.90 42 129518 47604 63311858
Emphysema 19.71 10.90 58 129502 10880 63348582
Cardiac failure acute 19.61 10.90 53 129507 9470 63349992
Drug withdrawal syndrome 19.60 10.90 16 129544 27178 63332284
Prosthetic cardiac valve thrombosis 19.58 10.90 6 129554 36 63359426
Antiphospholipid syndrome 19.38 10.90 21 129539 1769 63357693
Traumatic fracture 19.37 10.90 14 129546 687 63358775
Prescribed underdose 19.30 10.90 115 129445 29574 63329888
Quadriplegia 19.29 10.90 21 129539 1779 63357683
Post procedural pulmonary embolism 19.19 10.90 10 129550 270 63359192
Hiatus hernia 19.07 10.90 91 129469 21503 63337959
Mesenteric haemorrhage 19.04 10.90 6 129554 40 63359422
Putamen haemorrhage 19.04 10.90 9 129551 196 63359266
Catheter site discharge 19.03 10.90 22 129538 1991 63357471
Bone marrow failure 19.00 10.90 19 129541 29271 63330191
Platelet aggregation inhibition 18.84 10.90 8 129552 134 63359328
Injection site warmth 18.82 10.90 4 129556 15191 63344271
Therapeutic procedure 18.82 10.90 15 129545 853 63358609
Pulmonary endarterectomy 18.78 10.90 8 129552 135 63359327
Palpitations 18.76 10.90 329 129231 112441 63247021
Oesophagitis haemorrhagic 18.64 10.90 12 129548 486 63358976
Haemorrhagic infarction 18.64 10.90 10 129550 287 63359175
Breast haematoma 18.59 10.90 9 129551 207 63359255
Cerebellar haematoma 18.56 10.90 11 129549 384 63359078
Gastric pH increased 18.55 10.90 6 129554 44 63359418
Subcapsular renal haematoma 18.48 10.90 10 129550 292 63359170
Erythema 18.47 10.90 250 129310 175501 63183961
Gait disturbance 18.39 10.90 263 129297 182915 63176547
Arthritis 18.25 10.90 150 129410 115771 63243691
Degenerative aortic valve disease 18.16 10.90 8 129552 147 63359315
Overdose 18.08 10.90 149 129411 114929 63244533
Body temperature increased 18.06 10.90 30 129530 37162 63322300
Anal haemorrhage 17.97 10.90 22 129538 2114 63357348
Thrombotic stroke 17.96 10.90 12 129548 518 63358944
Bladder disorder 17.64 10.90 49 129511 8897 63350565
Tonic clonic movements 17.62 10.90 18 129542 1417 63358045
Protein C deficiency 17.60 10.90 5 129555 22 63359440
Osteoarthritis 17.58 10.90 118 129442 95225 63264237
Photophobia 17.53 10.90 7 129553 17628 63341834
Cholestatic liver injury 17.46 10.90 24 129536 2586 63356876
Anastomotic ulcer haemorrhage 17.38 10.90 6 129554 55 63359407
Post procedural stroke 17.38 10.90 6 129554 55 63359407
Lip dry 17.36 10.90 5 129555 15465 63343997
Cardiac murmur 17.22 10.90 67 129493 14485 63344977
Intervertebral disc protrusion 17.03 10.90 14 129546 23695 63335767
Pain in jaw 16.96 10.90 149 129411 43347 63316115
Mallory-Weiss syndrome 16.74 10.90 18 129542 1503 63357959
Abnormal withdrawal bleeding 16.74 10.90 6 129554 62 63359400
Neuralgia 16.61 10.90 17 129543 25909 63333553
Arteriovenous malformation 16.59 10.90 17 129543 1343 63358119
Female genital tract fistula 16.51 10.90 43 129517 7516 63351946
Generalised tonic-clonic seizure 16.45 10.90 21 129539 28995 63330467
Dystonia 16.39 10.90 4 129556 13815 63345647
Haemorrhagic diathesis 16.32 10.90 31 129529 4384 63355078
Cardiac ventricular thrombosis 16.28 10.90 12 129548 607 63358855
Antineutrophil cytoplasmic antibody positive 16.09 10.90 12 129548 618 63358844
Emergency care 16.04 10.90 15 129545 1059 63358403
Ventricle rupture 16.04 10.90 5 129555 32 63359430
Anticoagulant therapy 16.04 10.90 5 129555 32 63359430
Intracranial aneurysm 16.04 10.90 28 129532 3711 63355751
Neutrophil count decreased 16.03 10.90 60 129500 56346 63303116
Pulmonary fibrosis 15.95 10.90 36 129524 39773 63319689
Respiratory disorder 15.94 10.90 35 129525 39047 63320415
Cerebral ventricle collapse 15.91 10.90 5 129555 33 63359429
Night sweats 15.86 10.90 49 129511 48765 63310697
Mania 15.85 10.90 3 129557 12364 63347098
Product dose omission issue 15.81 10.90 606 128954 233707 63125755
Catheter site erythema 15.78 10.90 30 129530 4246 63355216
Monoparesis 15.75 10.90 18 129542 1609 63357853
Duodenal polyp 15.68 10.90 7 129553 133 63359329
Confusional state 15.66 10.90 365 129195 236015 63123447
Haemorrhagic hepatic cyst 15.66 10.90 5 129555 35 63359427
Abortion spontaneous 15.60 10.90 47 129513 47148 63312314
Contraindication to surgery 15.59 10.90 3 129557 0 63359462
CHA2DS2-VASc annual stroke risk high 15.59 10.90 3 129557 0 63359462
Right hemisphere deficit syndrome 15.59 10.90 3 129557 0 63359462
Chronic gastrointestinal bleeding 15.54 10.90 7 129553 136 63359326
Sleep disorder due to a general medical condition 15.53 10.90 3 129557 12185 63347277
Dyspnoea at rest 15.52 10.90 29 129531 4050 63355412
Malignant neoplasm progression 15.46 10.90 101 129459 82020 63277442
Sinus tachycardia 15.45 10.90 16 129544 24252 63335210
Incorrect dosage administered 15.38 10.90 20 129540 2043 63357419
Spinal subdural haematoma 15.35 10.90 7 129553 140 63359322
Mucosal inflammation 15.32 10.90 47 129513 46881 63312581
Anti factor X activity increased 15.27 10.90 4 129556 12 63359450
Procedural pain 15.16 10.90 13 129547 21556 63337906
Contraindicated product prescribed 15.15 10.90 16 129544 1309 63358153
Medical device site haemorrhage 15.08 10.90 5 129555 40 63359422
Lymphocyte count decreased 15.07 10.90 24 129536 30233 63329229
Influenza like illness 14.81 10.90 78 129482 66746 63292716
Blood pressure decreased 14.77 10.90 200 129360 64822 63294640
Non-small cell lung cancer recurrent 14.73 10.90 6 129554 90 63359372
Suicide attempt 14.71 10.90 69 129491 60849 63298613
Muscle spasms 14.70 10.90 227 129333 155923 63203539
Respiratory tract haemorrhage 14.68 10.90 10 129550 446 63359016
Jaundice acholuric 14.67 10.90 6 129554 91 63359371
Post procedural haematuria 14.66 10.90 5 129555 44 63359418
Glomerular filtration rate 14.58 10.90 4 129556 15 63359447
Craniocerebral injury 14.55 10.90 23 129537 2809 63356653
Multiple sclerosis 14.49 10.90 17 129543 24355 63335107
Vena cava thrombosis 14.46 10.90 20 129540 2167 63357295
Thrombectomy 14.42 10.90 7 129553 162 63359300
Vulval haemorrhage 14.38 10.90 4 129556 16 63359446
Retinal ischaemia 14.38 10.90 9 129551 347 63359115
Vascular graft infection 14.37 10.90 5 129555 47 63359415
Throat irritation 14.32 10.90 35 129525 37612 63321850
Intermenstrual bleeding 14.26 10.90 42 129518 7884 63351578
Thrombophlebitis 14.13 10.90 29 129531 4339 63355123
Blood calcium decreased 14.13 10.90 20 129540 26431 63333031
Sensitisation 14.06 10.90 25 129535 3361 63356101
Tumour haemorrhage 14.05 10.90 17 129543 1614 63357848
Postoperative thrombosis 14.04 10.90 7 129553 172 63359290
Catheter site infection 14.02 10.90 31 129529 4883 63354579
Exsanguination 14.00 10.90 4 129556 18 63359444
Uterine disorder 13.94 10.90 24 129536 3145 63356317
Autoimmune disorder 13.82 10.90 9 129551 17168 63342294
Colon cancer 13.81 10.90 48 129512 9830 63349632
Peripheral arterial occlusive disease 13.72 10.90 28 129532 4173 63355289
Affect lability 13.68 10.90 3 129557 11148 63348314
Muscle twitching 13.65 10.90 12 129548 19656 63339806
Splenic haematoma 13.63 10.90 6 129554 110 63359352
Aortic occlusion 13.63 10.90 6 129554 110 63359352
Osteomyelitis 13.57 10.90 20 129540 26000 63333462
Influenza 13.57 10.90 149 129411 108573 63250889
Intentional product misuse 13.56 10.90 71 129489 60846 63298616
Mesenteric haematoma 13.52 10.90 3 129557 3 63359459
Degenerative mitral valve disease 13.50 10.90 4 129556 21 63359441
Post procedural discharge 13.44 10.90 10 129550 513 63358949
Catheter site pruritus 13.44 10.90 19 129541 2101 63357361
Meningorrhagia 13.44 10.90 7 129553 189 63359273
Blood glucose increased 13.36 10.90 108 129452 83648 63275814
Coagulation factor VIII level increased 13.34 10.90 4 129556 22 63359440
Injection site urticaria 13.33 10.90 6 129554 14067 63345395
Cor pulmonale acute 13.32 10.90 9 129551 396 63359066
Haemorrhoids 13.26 10.90 84 129476 22066 63337396
Venous haemorrhage 13.25 10.90 8 129552 289 63359173
Colitis ischaemic 13.24 10.90 50 129510 10658 63348804
Nodule 13.23 10.90 14 129546 21012 63338450
Brain compression 13.22 10.90 9 129551 401 63359061
Prothrombin time ratio decreased 13.19 10.90 10 129550 528 63358934
Psychotic disorder 13.18 10.90 20 129540 25692 63333770
Tenderness 13.16 10.90 16 129544 22562 63336900
Intentional self-injury 13.15 10.90 20 129540 25667 63333795
Pharyngitis 13.14 10.90 13 129547 20130 63339332
Epidural haemorrhage 13.11 10.90 6 129554 121 63359341
Catarrh 13.11 10.90 16 129544 1533 63357929
Agitation 13.10 10.90 70 129490 59687 63299775
Blood blister 13.09 10.90 18 129542 1940 63357522
Swelling face 13.02 10.90 76 129484 63399 63296063
Circulatory collapse 13.01 10.90 83 129477 21855 63337607
Toothache 12.98 10.90 12 129548 19187 63340275
Autoimmune nephritis 12.98 10.90 9 129551 413 63359049
Bleeding varicose vein 12.98 10.90 8 129552 300 63359162
Injection site discomfort 12.97 10.90 29 129531 4601 63354861
Disability 12.97 10.90 11 129549 18336 63341126
Carpal tunnel syndrome 12.94 10.90 14 129546 20803 63338659
Withdrawal syndrome 12.94 10.90 13 129547 19984 63339478
White blood cell count increased 12.94 10.90 53 129507 48508 63310954
Viral infection 12.91 10.90 34 129526 35629 63323833
Jaundice 12.89 10.90 103 129457 29148 63330314
Shock 12.84 10.90 87 129473 23376 63336086
Vascular operation 12.80 10.90 6 129554 128 63359334
Intracranial mass 12.79 10.90 14 129546 1193 63358269
Rhinitis allergic 12.78 10.90 4 129556 11723 63347739
Pulmonary artery thrombosis 12.75 10.90 11 129549 699 63358763
Respiratory arrest 12.69 10.90 30 129530 32615 63326847
Blood pressure fluctuation 12.69 10.90 50 129510 46267 63313195
Bone density decreased 12.68 10.90 7 129553 14605 63344857
Protein induced by vitamin K absence or antagonist II increased 12.66 10.90 3 129557 5 63359457
Investigation 12.66 10.90 16 129544 1589 63357873
Catheter site haemorrhage 12.62 10.90 23 129537 3152 63356310
Headache 12.58 10.90 1117 128443 632124 62727338
Post thrombotic syndrome 12.57 10.90 10 129550 567 63358895
Retinal artery embolism 12.52 10.90 5 129555 71 63359391
Breast cancer female 12.50 10.90 6 129554 13553 63345909
Accidental exposure to product 12.49 10.90 23 129537 27382 63332080
White blood cell count decreased 12.49 10.90 204 129356 138900 63220562
Anaemia macrocytic 12.46 10.90 24 129536 3430 63356032
Brain contusion 12.45 10.90 10 129550 575 63358887
Uveitis 12.45 10.90 5 129555 12548 63346914
Joint range of motion decreased 12.45 10.90 30 129530 32398 63327064
Stress 12.44 10.90 83 129477 67084 63292378
Joint dislocation 12.42 10.90 12 129548 18788 63340674
Oral candidiasis 12.41 10.90 17 129543 22781 63336681
Cardiac failure congestive 12.41 10.90 261 129299 92172 63267290
Basilar artery thrombosis 12.39 10.90 6 129554 138 63359324
Thrombotic cerebral infarction 12.39 10.90 6 129554 138 63359324
Stoma site haemorrhage 12.37 10.90 13 129547 1058 63358404
Vascular graft occlusion 12.36 10.90 7 129553 224 63359238
Lactic acidosis 12.36 10.90 126 129434 38161 63321301
Wheezing 12.33 10.90 130 129430 95465 63263997
Osteorrhagia 12.31 10.90 3 129557 6 63359456
Lymphostasis 12.31 10.90 3 129557 6 63359456
Injection site bruising 12.29 10.90 44 129516 41866 63317596
Infective pericardial effusion 12.29 10.90 4 129556 30 63359432
Incision site haematoma 12.27 10.90 5 129555 75 63359387
Paresis 12.25 10.90 20 129540 2510 63356952
Tremor 12.19 10.90 193 129367 132046 63227416
Leukopenia 12.17 10.90 100 129460 77190 63282272
Throat tightness 12.15 10.90 20 129540 24867 63334595
Blindness unilateral 12.12 10.90 34 129526 6207 63353255
Pelvic haematoma 12.10 10.90 10 129550 599 63358863
Aortic thrombosis 12.09 10.90 13 129547 1086 63358376
Adjustment disorder with depressed mood 12.01 10.90 3 129557 10201 63349261
Ulcer haemorrhage 12.00 10.90 31 129529 5391 63354071
Laryngeal haemorrhage 11.99 10.90 3 129557 7 63359455
Ovarian cyst 11.97 10.90 9 129551 15936 63343526
Pseudomonas infection 11.91 10.90 4 129556 11209 63348253
Myoclonus 11.86 10.90 9 129551 15859 63343603
Panic attack 11.81 10.90 17 129543 22314 63337148
Extra dose administered 11.76 10.90 34 129526 6316 63353146
Cerebral amyloid angiopathy 11.72 10.90 6 129554 156 63359306
Spinal cord compression 11.64 10.90 26 129534 4122 63355340
Abnormal behaviour 11.64 10.90 16 129544 21410 63338052
Skin ulcer haemorrhage 11.62 10.90 8 129552 363 63359099
Infarction 11.62 10.90 20 129540 2621 63356841
Carotid artery occlusion 11.61 10.90 28 129532 4666 63354796
Tracheal haemorrhage 11.58 10.90 6 129554 160 63359302
Somnolence 11.52 10.90 277 129283 178408 63181054
Vascular device infection 11.52 10.90 37 129523 7275 63352187
Splenic infarction 11.50 10.90 16 129544 1743 63357719
Acute myocardial infarction 11.48 10.90 108 129452 32016 63327446
Steroid dependence 11.47 10.90 16 129544 1748 63357714
Lacunar stroke 11.45 10.90 6 129554 164 63359298
Manufacturing materials issue 11.45 10.90 3 129557 9 63359453
Postpartum venous thrombosis 11.45 10.90 3 129557 9 63359453
Atrioventricular block 11.43 10.90 38 129522 7609 63351853
Device expulsion 11.38 10.90 35 129525 34887 63324575
Therapeutic response shortened 11.36 10.90 5 129555 11883 63347579
Blood pressure increased 11.36 10.90 248 129312 161814 63197648
Brain natriuretic peptide abnormal 11.30 10.90 8 129552 380 63359082
Aortic intramural haematoma 11.30 10.90 5 129555 93 63359369
Increased tendency to bruise 11.22 10.90 47 129513 10505 63348957
Contraindication to medical treatment 11.19 10.90 10 129550 666 63358796
Hepatic infarction 11.14 10.90 10 129550 670 63358792
Hypertensive crisis 11.11 10.90 61 129499 15225 63344237
Furuncle 11.06 10.90 34 129526 6532 63352930
Cholelithiasis 11.05 10.90 49 129511 43876 63315586
Neurotoxicity 11.05 10.90 11 129549 16979 63342483
Monoclonal immunoglobulin present 11.04 10.90 11 129549 840 63358622
Hypercalcaemia 11.03 10.90 26 129534 28296 63331166
Feeling hot 11.03 10.90 59 129501 50295 63309167
Soft tissue haemorrhage 11.02 10.90 7 129553 277 63359185
Diarrhoea haemorrhagic 11.00 10.90 42 129518 9000 63350462
Computerised tomogram head abnormal 10.99 10.90 3 129557 11 63359451
Chondrocalcinosis 10.97 10.90 11 129549 847 63358615
Pulmonary arterial pressure 10.94 10.90 4 129556 44 63359418
Aortic aneurysm rupture 10.92 10.90 9 129551 537 63358925
Catheterisation cardiac 10.90 10.90 27 129533 4576 63354886

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 4780.99 11.50 3268 118985 85209 34749469
Haemorrhage 1513.60 11.50 1328 120925 50042 34784636
Haematuria 1402.64 11.50 1258 120995 48808 34785870
Epistaxis 1160.83 11.50 1214 121039 57037 34777641
Cerebral haemorrhage 1144.02 11.50 960 121293 33977 34800701
Pulmonary embolism 1031.71 11.50 1413 120840 88333 34746345
Haemorrhage intracranial 991.19 11.50 645 121608 15301 34819377
Ischaemic stroke 935.42 11.50 655 121598 17595 34817083
Cerebrovascular accident 887.81 11.50 1277 120976 83534 34751144
Upper gastrointestinal haemorrhage 851.22 11.50 709 121544 24809 34809869
Deep vein thrombosis 782.12 11.50 1049 121204 64199 34770479
Cerebral infarction 756.42 11.50 684 121569 26771 34807907
Rectal haemorrhage 653.77 11.50 754 121499 39495 34795183
Haematoma 626.20 11.50 597 121656 25008 34809670
Melaena 590.08 11.50 672 121581 34708 34799970
Atrial thrombosis 568.14 11.50 233 122020 1981 34832697
Thrombosis 526.15 11.50 759 121494 49699 34784979
Subdural haematoma 514.27 11.50 484 121769 19937 34814741
Lower gastrointestinal haemorrhage 514.10 11.50 352 121901 9100 34825578
Haemorrhagic stroke 497.97 11.50 301 121952 6238 34828440
Embolic stroke 429.42 11.50 239 122014 4215 34830463
Gastric haemorrhage 427.37 11.50 325 121928 9936 34824742
Internal haemorrhage 391.47 11.50 235 122018 4806 34829872
Post procedural haemorrhage 375.20 11.50 276 121977 8013 34826665
Haemoptysis 352.27 11.50 518 121735 34488 34800190
Blood loss anaemia 337.85 11.50 258 121995 7936 34826742
Anaemia 319.34 11.50 1634 120619 231701 34602977
Transient ischaemic attack 310.74 11.50 431 121822 27182 34807496
Drug abuse 288.09 11.50 14 122239 99082 34735596
Haemoglobin decreased 255.91 11.50 965 121288 119807 34714871
Diverticulum intestinal haemorrhagic 249.40 11.50 138 122115 2404 34832274
Blood urine present 248.51 11.50 244 122009 10590 34824088
Basal ganglia haemorrhage 246.28 11.50 100 122153 826 34833852
Gingival bleeding 244.69 11.50 200 122053 6800 34827878
Haemarthrosis 240.36 11.50 147 122106 3112 34831566
Pericardial haemorrhage 236.89 11.50 144 122109 3014 34831664
Labelled drug-drug interaction medication error 229.20 11.50 272 121981 14667 34820011
Haemorrhagic arteriovenous malformation 222.92 11.50 74 122179 316 34834362
Haematochezia 215.49 11.50 492 121761 46042 34788636
Toxicity to various agents 215.40 11.50 230 122023 200132 34634546
Cerebral haematoma 207.34 11.50 153 122100 4462 34830216
Pyrexia 204.31 11.50 549 121704 332464 34502214
Fall 204.27 11.50 1310 120943 201575 34633103
Shock haemorrhagic 203.39 11.50 224 122029 11130 34823548
Febrile neutropenia 184.95 11.50 126 122127 136723 34697955
Incorrect dose administered 183.86 11.50 425 121828 40090 34794588
Embolic cerebral infarction 182.70 11.50 75 122178 639 34834039
Thalamus haemorrhage 173.54 11.50 80 122173 925 34833753
Cerebellar haemorrhage 172.79 11.50 92 122161 1479 34833199
Intraventricular haemorrhage 165.27 11.50 120 122133 3411 34831267
Haemorrhoidal haemorrhage 159.93 11.50 120 122133 3591 34831087
Haematemesis 152.24 11.50 314 121939 27397 34807281
Procedural haemorrhage 149.16 11.50 98 122155 2359 34832319
Faeces discoloured 146.46 11.50 218 122035 14660 34820018
Cerebral artery embolism 144.99 11.50 68 122185 820 34833858
Product prescribing issue 142.33 11.50 91 122162 2088 34832590
Contusion 140.95 11.50 359 121894 36005 34798673
International normalised ratio increased 139.69 11.50 423 121830 46904 34787774
Subarachnoid haemorrhage 135.81 11.50 193 122060 12442 34822236
Hemiplegia 134.40 11.50 143 122110 6829 34827849
Atrial fibrillation 130.19 11.50 802 121451 121591 34713087
Gastrointestinal vascular malformation haemorrhagic 130.04 11.50 57 122196 580 34834098
Creatinine renal clearance decreased 127.50 11.50 101 122152 3280 34831398
Disease progression 125.23 11.50 116 122137 107961 34726717
Wound haemorrhage 123.75 11.50 82 122171 2003 34832675
Gastric ulcer haemorrhage 123.29 11.50 122 122131 5344 34829334
Cardioversion 120.78 11.50 61 122192 874 34833804
Mouth haemorrhage 120.49 11.50 119 122134 5200 34829478
Neutropenia 119.77 11.50 229 122024 156549 34678129
Hemiparesis 119.32 11.50 205 122048 15573 34819105
Cardiac tamponade 112.27 11.50 114 122139 5152 34829526
Foetal exposure during pregnancy 111.90 11.50 5 122248 38096 34796582
Sepsis 106.07 11.50 269 121984 166292 34668386
Subcutaneous haematoma 105.65 11.50 57 122196 942 34833736
Iron deficiency anaemia 105.48 11.50 154 122099 10175 34824503
Condition aggravated 103.65 11.50 336 121917 191860 34642818
Retroperitoneal haemorrhage 97.76 11.50 81 122172 2807 34831871
Intracardiac thrombus 97.22 11.50 76 122177 2420 34832258
Prescribed underdose 96.81 11.50 137 122116 8796 34825882
Haemorrhage urinary tract 95.32 11.50 67 122186 1807 34832871
Subdural haemorrhage 94.72 11.50 83 122170 3108 34831570
Cerebral ventricular rupture 93.62 11.50 33 122220 175 34834503
Anticoagulation drug level increased 93.29 11.50 43 122210 497 34834181
Haemorrhagic transformation stroke 93.07 11.50 61 122192 1462 34833216
Microcytic anaemia 91.15 11.50 72 122181 2328 34832350
Muscle haemorrhage 89.50 11.50 86 122167 3632 34831046
Anxiety 89.03 11.50 131 122122 99297 34735381
Depression 88.84 11.50 126 122127 96972 34737706
Splenic rupture 87.60 11.50 59 122194 1482 34833196
Traumatic intracranial haemorrhage 87.39 11.50 45 122208 673 34834005
Drug hypersensitivity 84.63 11.50 94 122159 80435 34754243
Haemothorax 83.23 11.50 84 122169 3768 34830910
Prothrombin time prolonged 82.96 11.50 131 122122 9275 34825403
High frequency ablation 82.08 11.50 29 122224 155 34834523
Occult blood positive 79.75 11.50 84 122169 3964 34830714
Completed suicide 79.72 11.50 138 122115 98030 34736648
Mucosal inflammation 76.92 11.50 20 122233 38602 34796076
Infusion related reaction 76.88 11.50 45 122208 53012 34781666
Abdominal wall haematoma 76.06 11.50 58 122195 1779 34832899
Drug interaction 75.69 11.50 1159 121094 224787 34609891
Haemorrhagic diathesis 75.19 11.50 69 122184 2747 34831931
Aphasia 75.15 11.50 204 122049 21250 34813428
Renal haemorrhage 73.90 11.50 52 122201 1405 34833273
Small intestinal haemorrhage 73.23 11.50 60 122193 2046 34832632
Large intestinal haemorrhage 72.71 11.50 54 122199 1590 34833088
Pelvic venous thrombosis 72.31 11.50 38 122215 594 34834084
Nausea 72.14 11.50 801 121452 339107 34495571
Neutrophil count decreased 70.36 11.50 46 122207 51058 34783620
Fractional exhaled nitric oxide increased 70.21 11.50 45 122208 1037 34833641
Myoglobin blood increased 69.15 11.50 68 122185 2955 34831723
Brain stem haemorrhage 68.62 11.50 42 122211 890 34833788
Agitation 68.36 11.50 60 122193 57339 34777339
Haemorrhage subcutaneous 68.08 11.50 60 122193 2264 34832414
Cardiac failure 66.56 11.50 546 121707 90702 34743976
Gastritis erosive 65.80 11.50 92 122161 5840 34828838
Drug dependence 65.57 11.50 5 122248 24212 34810466
Spinal cord haemorrhage 65.40 11.50 29 122224 304 34834374
Gastric ulcer 65.34 11.50 159 122094 15491 34819187
Post procedural haematoma 64.99 11.50 49 122204 1477 34833201
Coagulopathy 63.24 11.50 182 122071 19607 34815071
Head injury 62.92 11.50 172 122081 17988 34816690
Duodenal ulcer haemorrhage 62.05 11.50 82 122171 4931 34829747
Traumatic haemorrhage 61.73 11.50 37 122216 754 34833924
Hypochromic anaemia 60.80 11.50 39 122214 900 34833778
Therapeutic response decreased 60.67 11.50 14 122239 29299 34805379
Pulmonary haemorrhage 60.42 11.50 120 122133 10184 34824494
Pancytopenia 59.49 11.50 155 122098 95002 34739676
Dyspnoea exertional 59.46 11.50 304 121949 42975 34791703
Malignant neoplasm progression 58.48 11.50 139 122114 87907 34746771
Seizure 58.05 11.50 181 122072 104676 34730002
Aggression 57.95 11.50 32 122221 38932 34795746
Haemorrhagic cerebral infarction 55.96 11.50 36 122217 835 34833843
Brain natriuretic peptide increased 55.80 11.50 83 122170 5576 34829102
Overdose 55.65 11.50 150 122103 90909 34743769
Arterial haemorrhage 55.55 11.50 36 122217 846 34833832
Adrenal haemorrhage 55.42 11.50 23 122230 202 34834476
Rhabdomyolysis 55.15 11.50 96 122157 68067 34766611
Bladder tamponade 54.75 11.50 30 122223 512 34834166
Pulmonary alveolar haemorrhage 54.70 11.50 96 122157 7416 34827262
Gastritis haemorrhagic 53.97 11.50 43 122210 1408 34833270
N-terminal prohormone brain natriuretic peptide abnormal 53.63 11.50 22 122231 187 34834491
Inappropriate schedule of product administration 53.33 11.50 387 121866 61909 34772769
Gastrointestinal ulcer haemorrhage 53.03 11.50 33 122220 721 34833957
Cerebral ischaemia 52.94 11.50 86 122167 6236 34828442
Drug intolerance 52.80 11.50 79 122174 59491 34775187
Tremor 52.79 11.50 133 122120 82454 34752224
Penile haemorrhage 52.41 11.50 31 122222 616 34834062
Multiple organ dysfunction syndrome 52.35 11.50 119 122134 76447 34758231
Leukopenia 52.25 11.50 87 122166 62769 34771909
Peripheral embolism 52.22 11.50 37 122216 1011 34833667
Gastrointestinal polyp haemorrhage 52.06 11.50 25 122228 319 34834359
Insomnia 51.62 11.50 188 122065 103719 34730959
Drug withdrawal syndrome 51.23 11.50 5 122248 19829 34814849
Eye haemorrhage 51.11 11.50 69 122184 4236 34830442
Vomiting 51.06 11.50 587 121666 247034 34587644
Hyponatraemia 50.68 11.50 136 122117 82555 34752123
Infection 50.27 11.50 157 122096 90758 34743920
Psychotic disorder 49.97 11.50 12 122241 24440 34810238
Bone marrow failure 49.69 11.50 20 122233 29233 34805445
Aspartate aminotransferase increased 49.11 11.50 102 122151 67681 34766997
Product prescribing error 49.06 11.50 184 122069 22743 34811935
Urinary bladder haemorrhage 48.94 11.50 44 122209 1705 34832973
Prostatic haemorrhage 48.45 11.50 22 122231 245 34834433
Urogenital haemorrhage 48.38 11.50 31 122222 714 34833964
Chills 47.65 11.50 136 122117 80907 34753771
Cytomegalovirus infection 47.54 11.50 16 122237 26119 34808559
Suicidal ideation 47.15 11.50 43 122210 40345 34794333
Ecchymosis 47.04 11.50 85 122168 6718 34827960
Rheumatoid arthritis 46.71 11.50 39 122214 38199 34796479
Retroperitoneal haematoma 46.51 11.50 52 122201 2626 34832052
Deep vein thrombosis postoperative 46.49 11.50 11 122242 6 34834672
Cardiac ablation 46.48 11.50 35 122218 1053 34833625
Cerebral ventricle collapse 46.36 11.50 15 122238 58 34834620
Compartment syndrome 46.36 11.50 55 122198 2963 34831715
Vascular pseudoaneurysm 46.35 11.50 47 122206 2120 34832558
Cerebellar infarction 45.46 11.50 44 122209 1875 34832803
Therapy non-responder 45.31 11.50 42 122211 39104 34795574
Neutrophil count increased 45.15 11.50 4 122249 17142 34817536
Sensation of foreign body 44.88 11.50 52 122201 2731 34831947
Activated partial thromboplastin time prolonged 44.79 11.50 96 122157 8599 34826079
White blood cell count decreased 44.61 11.50 177 122076 95268 34739410
Alanine aminotransferase increased 44.36 11.50 140 122113 80675 34754003
Pain 43.81 11.50 481 121772 204194 34630484
Plantar fasciitis 43.64 11.50 45 122208 2071 34832607
Somnolence 43.55 11.50 220 122033 110896 34723782
No adverse event 43.55 11.50 13 122240 22914 34811764
Treatment noncompliance 43.32 11.50 204 122049 27896 34806782
Lymphocyte count decreased 42.66 11.50 13 122240 22609 34812069
Vascular stent thrombosis 42.65 11.50 52 122201 2883 34831795
Ischaemic cerebral infarction 42.26 11.50 35 122218 1212 34833466
Dizziness 42.22 11.50 1031 121222 217490 34617188
Blood glucose increased 42.20 11.50 108 122145 66610 34768068
Duodenal ulcer 42.10 11.50 104 122149 10228 34824450
Therapeutic product effect incomplete 41.96 11.50 70 122183 50471 34784207
Irritability 41.74 11.50 17 122236 24673 34810005
Pneumonia 41.31 11.50 960 121293 361667 34473011
Retinal vascular thrombosis 41.23 11.50 14 122239 65 34834613
White blood cell count increased 41.09 11.50 50 122203 41101 34793577
Vitreous haemorrhage 41.08 11.50 46 122207 2327 34832351
Ear haemorrhage 40.76 11.50 31 122222 947 34833731
Injection site pain 40.44 11.50 46 122207 38959 34795719
Pericardial effusion 40.20 11.50 182 122071 24480 34810198
Wound haematoma 39.44 11.50 13 122240 54 34834624
Haematoma muscle 39.44 11.50 35 122218 1333 34833345
Conjunctival haemorrhage 39.41 11.50 51 122202 3004 34831674
Spontaneous haematoma 39.24 11.50 24 122229 508 34834170
Haemorrhagic erosive gastritis 39.21 11.50 18 122235 206 34834472
Neurotoxicity 38.49 11.50 8 122245 18002 34816676
Cerebral mass effect 38.43 11.50 30 122223 953 34833725
Asthma 38.35 11.50 56 122197 42600 34792078
Anticoagulation drug level above therapeutic 38.32 11.50 42 122211 2074 34832604
Hypoxia 38.17 11.50 85 122168 55010 34779668
Cardiac ventricular thrombosis 38.15 11.50 32 122221 1128 34833550
Hypovolaemic shock 37.39 11.50 79 122174 7006 34827672
Splenic haemorrhage 37.33 11.50 22 122231 434 34834244
Diabetes mellitus 37.02 11.50 67 122186 46806 34787872
Venous thrombosis 36.21 11.50 52 122201 3383 34831295
Pancreatitis 36.01 11.50 50 122203 38841 34795837
Cerebral artery occlusion 35.96 11.50 26 122227 734 34833944
Peptic ulcer haemorrhage 35.58 11.50 23 122230 538 34834140
Respiratory depression 35.17 11.50 7 122246 16238 34818440
Arthralgia 35.03 11.50 403 121850 169638 34665040
Venous thrombosis limb 34.72 11.50 39 122214 1980 34832698
Haemoperitoneum 34.63 11.50 37 122216 1775 34832903
Embolism venous 34.49 11.50 34 122219 1482 34833196
Syncope 34.41 11.50 479 121774 90972 34743706
Dyspnoea 34.36 11.50 1628 120625 375154 34459524
Death 34.35 11.50 1096 121157 396953 34437725
Renal haematoma 34.32 11.50 22 122231 507 34834171
Haemophagocytic lymphohistiocytosis 34.23 11.50 3 122250 12970 34821708
Drug reaction with eosinophilia and systemic symptoms 34.15 11.50 39 122214 32973 34801705
Cardiac failure chronic 33.91 11.50 81 122172 7798 34826880
Puncture site haemorrhage 33.82 11.50 18 122235 289 34834389
Abnormal behaviour 33.66 11.50 23 122230 24946 34809732
Anaphylactic reaction 33.59 11.50 38 122215 32263 34802415
Brain stem infarction 33.43 11.50 31 122222 1251 34833427
Putamen haemorrhage 33.26 11.50 17 122236 250 34834428
Skin haemorrhage 33.05 11.50 59 122194 4619 34830059
Glomerular filtration rate decreased 32.87 11.50 110 122143 12851 34821827
Weight decreased 32.84 11.50 427 121826 175874 34658804
Intestinal haemorrhage 32.65 11.50 50 122203 3446 34831232
Splenic haematoma 32.65 11.50 15 122238 172 34834506
Aneurysm ruptured 32.53 11.50 21 122232 490 34834188
Constipation 32.53 11.50 314 121939 136668 34698010
Loss of personal independence in daily activities 32.41 11.50 41 122212 33138 34801540
Peripheral swelling 32.15 11.50 409 121844 76132 34758546
Ulcer haemorrhage 32.01 11.50 43 122210 2627 34832051
Anticoagulation drug level decreased 31.95 11.50 13 122240 108 34834570
Coagulation test abnormal 31.67 11.50 22 122231 582 34834096
Diarrhoea 31.65 11.50 1082 121171 388830 34445848
Incision site haemorrhage 31.30 11.50 21 122232 524 34834154
Blood creatine phosphokinase increased 31.24 11.50 69 122184 44788 34789890
Gastrointestinal angiectasia 30.57 11.50 17 122236 299 34834379
Sinusitis 30.23 11.50 62 122191 41340 34793338
Psoriasis 30.18 11.50 56 122197 38756 34795922
Blood blister 30.17 11.50 33 122220 1626 34833052
Sedation 30.16 11.50 18 122235 20988 34813690
Stomatitis 29.93 11.50 65 122188 42449 34792229
Thrombotic stroke 29.84 11.50 16 122237 261 34834417
Underdose 29.82 11.50 111 122142 13669 34821009
Post thrombotic syndrome 29.77 11.50 13 122240 131 34834547
Cytokine release syndrome 29.62 11.50 22 122231 22855 34811823
Renal tubular necrosis 29.58 11.50 9 122244 15671 34819007
Dehydration 29.57 11.50 301 121952 129668 34705010
Mesenteric haemorrhage 29.47 11.50 7 122246 4 34834674
Peripheral artery occlusion 29.32 11.50 33 122220 1679 34832999
Osteonecrosis 29.10 11.50 8 122245 14882 34819796
Neurologic neglect syndrome 28.85 11.50 14 122239 183 34834495
Paranoia 28.79 11.50 4 122249 12064 34822614
Abdominal pain 28.76 11.50 401 121852 163217 34671461
Hypophagia 28.72 11.50 25 122228 23997 34810681
Intentional product misuse 28.71 11.50 74 122179 45537 34789141
Hypersensitivity 28.62 11.50 113 122140 60922 34773756
Septic shock 28.26 11.50 142 122111 71692 34762986
Arteriovenous malformation 28.10 11.50 23 122230 783 34833895
C-reactive protein increased 28.10 11.50 96 122157 54002 34780676
Traumatic haematoma 28.10 11.50 22 122231 702 34833976
Brain natriuretic peptide abnormal 28.08 11.50 17 122236 353 34834325
Therapeutic product effect decreased 28.03 11.50 49 122204 34694 34799984
Embolism 27.97 11.50 75 122178 7754 34826924
Cerebral vascular occlusion 27.79 11.50 7 122246 7 34834671
Mallory-Weiss syndrome 27.76 11.50 29 122224 1355 34833323
Emotional distress 27.68 11.50 9 122244 15017 34819661
Intentional self-injury 27.67 11.50 7 122246 13764 34820914
Therapeutic procedure 27.63 11.50 14 122239 202 34834476
Fractured coccyx 27.63 11.50 13 122240 158 34834520
Injection site reaction 27.42 11.50 6 122247 13027 34821651
Polyp 27.38 11.50 49 122204 3843 34830835
Colitis 27.17 11.50 57 122196 37693 34796985
Respiratory arrest 27.03 11.50 35 122218 28008 34806670
Aortic aneurysm rupture 26.83 11.50 25 122228 1015 34833663
Purpura 26.58 11.50 88 122165 10223 34824455
Hepatotoxicity 26.13 11.50 22 122231 21463 34813215
Back pain 26.10 11.50 286 121967 121503 34713175
Cardiac arrest 26.08 11.50 213 122040 95946 34738732
Periorbital haemorrhage 26.08 11.50 11 122242 101 34834577
Ascites 26.02 11.50 80 122173 46491 34788187
Traumatic haemothorax 25.86 11.50 15 122238 287 34834391
Anal haemorrhage 25.69 11.50 38 122215 2540 34832138
Large intestine polyp 25.49 11.50 73 122180 7841 34826837
Toxic epidermal necrolysis 25.31 11.50 23 122230 21623 34813055
Extra dose administered 25.10 11.50 48 122205 3961 34830717
Mesenteric artery thrombosis 25.07 11.50 17 122236 432 34834246
Bronchopulmonary aspergillosis 24.93 11.50 10 122243 14649 34820029
Intentional product use issue 24.83 11.50 116 122137 59700 34774978
Accidental exposure to product 24.79 11.50 7 122246 12795 34821883
Penis injury 24.74 11.50 14 122239 255 34834423
Labelled drug-disease interaction medication error 24.42 11.50 11 122242 120 34834558
Bleeding varicose vein 24.21 11.50 15 122238 325 34834353
Decreased appetite 24.10 11.50 423 121830 165969 34668709
Peripheral ischaemia 23.97 11.50 58 122195 5629 34829049
Multiple sclerosis relapse 23.95 11.50 8 122245 13125 34821553
Pulmonary arterial hypertension 23.80 11.50 76 122177 8663 34826015
Brain compression 23.75 11.50 12 122241 172 34834506
Dental care 23.63 11.50 14 122239 279 34834399
Retinal artery occlusion 23.59 11.50 31 122222 1854 34832824
Stress 23.41 11.50 44 122209 30303 34804375
Herpes zoster 23.07 11.50 54 122199 34345 34800333
Pathogen resistance 22.96 11.50 3 122250 9479 34825199
Contraindicated product administered 22.92 11.50 141 122112 21340 34813338
Pharyngeal haemorrhage 22.86 11.50 20 122233 747 34833931
Hydrocephalus 22.74 11.50 54 122199 5178 34829500
Haemorrhoids 22.59 11.50 106 122147 14469 34820209
Hypercalcaemia 22.57 11.50 13 122240 15455 34819223
Neutropenic sepsis 22.44 11.50 10 122243 13757 34820921
Pancreatitis acute 22.42 11.50 40 122213 28101 34806577
Drug resistance 22.37 11.50 35 122218 25892 34808786
Metastases to bone 22.35 11.50 7 122246 11963 34822715
Myocardial infarction 22.26 11.50 294 121959 120791 34713887
Osteonecrosis of jaw 22.15 11.50 18 122235 17871 34816807
Hypercoagulation 22.04 11.50 25 122228 1283 34833395
Pulmonary arterial pressure abnormal 21.89 11.50 12 122241 205 34834473
Acute myeloid leukaemia 21.86 11.50 19 122234 18251 34816427
Haemorrhagic infarction 21.84 11.50 16 122237 461 34834217
Synovitis 21.72 11.50 11 122242 14055 34820623
Candida infection 21.71 11.50 18 122235 17697 34816981
Haematospermia 21.60 11.50 14 122239 329 34834349
Progressive multifocal leukoencephalopathy 21.57 11.50 4 122249 9760 34824918
Aplastic anaemia 21.43 11.50 4 122249 9712 34824966
Neuropathy peripheral 21.42 11.50 187 122066 83076 34751602
Obstructive airways disorder 21.38 11.50 109 122144 15385 34819293
Influenza like illness 21.37 11.50 40 122213 27594 34807084
Ill-defined disorder 21.30 11.50 11 122242 13898 34820780
Therapy partial responder 21.12 11.50 4 122249 9612 34825066
Intra-abdominal haematoma 21.10 11.50 25 122228 1345 34833333
Diverticulitis intestinal haemorrhagic 21.09 11.50 14 122239 343 34834335
Neuroleptic malignant syndrome 21.04 11.50 19 122234 17915 34816763
Peripheral artery thrombosis 20.99 11.50 33 122220 2327 34832351
Blood lactate dehydrogenase increased 20.84 11.50 30 122223 22960 34811718
Phlebitis deep 20.78 11.50 6 122247 14 34834664
Nephropathy toxic 20.74 11.50 9 122244 12579 34822099
Staphylococcal infection 20.73 11.50 53 122200 32707 34801971
Hallucination 20.71 11.50 101 122152 51397 34783281
Myocarditis 20.68 11.50 11 122242 13671 34821007
Immune reconstitution inflammatory syndrome 20.67 11.50 3 122250 8756 34825922
Upper respiratory tract infection 20.52 11.50 54 122199 33005 34801673
Lymphoma 20.52 11.50 9 122244 12498 34822180
Platelet count decreased 20.45 11.50 295 121958 119422 34715256
Stiff person syndrome 20.41 11.50 9 122244 93 34834585
Anger 20.38 11.50 8 122245 11876 34822802
Potentiating drug interaction 20.17 11.50 50 122203 4927 34829751
Serotonin syndrome 20.13 11.50 24 122229 19909 34814769
Tumour lysis syndrome 20.10 11.50 18 122235 17041 34817637
Vena cava thrombosis 19.99 11.50 23 122230 1199 34833479
Blood thyroid stimulating hormone abnormal 19.97 11.50 14 122239 376 34834302
Hyperglycaemia 19.87 11.50 71 122182 39409 34795269
Aspergillus infection 19.82 11.50 9 122244 12245 34822433
Hypersensitivity vasculitis 19.74 11.50 39 122214 3296 34831382
Hypertriglyceridaemia 19.69 11.50 3 122250 8445 34826233
Catheter site haemorrhage 19.64 11.50 31 122222 2193 34832485
Pneumocystis jirovecii pneumonia 19.62 11.50 24 122229 19686 34814992
Lymphopenia 19.53 11.50 17 122236 16318 34818360
Prostate cancer 19.49 11.50 72 122181 39577 34795101
Hospitalisation 19.39 11.50 293 121960 56609 34778069
Renal infarct 19.38 11.50 24 122229 1352 34833326
Injection site swelling 19.38 11.50 8 122245 11519 34823159
Embolism arterial 19.32 11.50 17 122236 640 34834038
Ureteric haemorrhage 19.30 11.50 9 122244 107 34834571
Bleeding time prolonged 19.30 11.50 17 122236 641 34834037
Brain herniation 19.22 11.50 43 122210 3965 34830713
Tumour haemorrhage 19.21 11.50 36 122217 2926 34831752
Product administration error 19.18 11.50 110 122143 16234 34818444
COVID-19 19.14 11.50 176 122077 77374 34757304
Blood triglycerides increased 19.14 11.50 13 122240 14146 34820532
Arterial thrombosis 19.09 11.50 25 122228 1490 34833188
Product label issue 19.01 11.50 12 122241 269 34834409
Implant site haematoma 19.01 11.50 8 122245 73 34834605
Carotid artery aneurysm 19.00 11.50 7 122246 43 34834635
Platelet dysfunction 18.97 11.50 12 122241 270 34834408
Dysphagia 18.88 11.50 134 122119 62247 34772431
Withdrawal syndrome 18.85 11.50 10 122243 12445 34822233
Extradural haematoma 18.81 11.50 22 122231 1167 34833511
Coagulation time prolonged 18.81 11.50 23 122230 1279 34833399
Parkinsonism 18.71 11.50 3 122250 8135 34826543
Diabetes mellitus inadequate control 18.69 11.50 12 122241 13452 34821226
Haematotympanum 18.64 11.50 4 122249 0 34834678
Coagulation factor X level increased 18.64 11.50 4 122249 0 34834678
Hyperhomocysteinaemia 18.62 11.50 11 122242 218 34834460
Cardio-respiratory arrest 18.61 11.50 115 122138 55158 34779520
Oesophageal haemorrhage 18.58 11.50 23 122230 1295 34833383
Anaphylactic shock 18.57 11.50 17 122236 15924 34818754
Musculoskeletal stiffness 18.51 11.50 92 122161 46588 34788090
Injection site erythema 18.46 11.50 17 122236 15882 34818796
Vascular pseudoaneurysm ruptured 18.46 11.50 8 122245 79 34834599
Delirium 18.44 11.50 85 122168 43906 34790772
Oxygen saturation increased 18.40 11.50 12 122241 285 34834393
Anastomotic ulcer haemorrhage 18.38 11.50 6 122247 24 34834654
Respiratory failure 18.38 11.50 268 121985 108304 34726374
Gastrointestinal angiodysplasia 18.31 11.50 16 122237 597 34834081
Subclavian vein thrombosis 18.29 11.50 19 122234 882 34833796
Angioedema 18.29 11.50 68 122185 37306 34797372
Cyanosis 18.24 11.50 11 122242 12753 34821925
Electrocardiogram QRS complex abnormal 18.23 11.50 13 122240 359 34834319
Cytopenia 18.13 11.50 11 122242 12712 34821966
Encephalopathy 18.12 11.50 63 122190 35256 34799422
Fear 18.06 11.50 7 122246 10469 34824209
Diffuse vasculitis 18.03 11.50 8 122245 84 34834594
Hypophosphataemia 17.98 11.50 8 122245 11018 34823660
Blood bilirubin increased 17.89 11.50 71 122182 38225 34796453
Postoperative thrombosis 17.82 11.50 6 122247 27 34834651
Vascular access site occlusion 17.76 11.50 7 122246 53 34834625
Bladder neoplasm 17.64 11.50 23 122230 1365 34833313
Cerebral amyloid angiopathy 17.57 11.50 9 122244 133 34834545
Conjunctivitis 17.55 11.50 6 122247 9699 34824979
Dystonia 17.48 11.50 8 122245 10837 34823841
Hypogammaglobulinaemia 17.47 11.50 3 122250 7737 34826941
Night sweats 17.41 11.50 21 122232 17331 34817347
Respiratory distress 17.38 11.50 65 122188 35600 34799078
Post-traumatic amnestic disorder 17.32 11.50 7 122246 57 34834621
Spinal osteoarthritis 17.30 11.50 3 122250 7680 34826998
Lymphadenopathy 17.28 11.50 47 122206 28416 34806262
Lung diffusion disorder 17.28 11.50 9 122244 138 34834540
Hepatic function abnormal 17.27 11.50 88 122165 44275 34790403
Facial paresis 17.27 11.50 35 122218 3014 34831664
Pseudomonas infection 17.23 11.50 11 122242 12371 34822307
Small intestinal obstruction 17.14 11.50 16 122237 14850 34819828
Chronic gastrointestinal bleeding 17.12 11.50 12 122241 322 34834356
Oedema peripheral 17.09 11.50 544 121709 119268 34715410
Viral infection 16.98 11.50 22 122231 17601 34817077
Skin exfoliation 16.88 11.50 45 122208 27387 34807291
Intestinal haematoma 16.87 11.50 8 122245 99 34834579
Fatigue 16.84 11.50 1094 121159 369559 34465119
Febrile bone marrow aplasia 16.83 11.50 4 122249 8205 34826473
Rhinorrhoea 16.65 11.50 41 122212 25627 34809051
Myelosuppression 16.63 11.50 26 122227 19239 34815439
Splenomegaly 16.59 11.50 17 122236 15100 34819578
Intra-abdominal haemorrhage 16.57 11.50 30 122223 2374 34832304
Lacunar stroke 16.54 11.50 10 122243 207 34834471
Mediastinal haematoma 16.53 11.50 8 122245 104 34834574
Blood pressure increased 16.52 11.50 213 122040 87889 34746789
Cytomegalovirus viraemia 16.51 11.50 3 122250 7427 34827251
Stent placement 16.51 11.50 47 122206 5031 34829647
Duodenitis haemorrhagic 16.46 11.50 8 122245 105 34834573
N-terminal prohormone brain natriuretic peptide increased 16.38 11.50 32 122221 2683 34831995
Supine hypertension 16.34 11.50 12 122241 347 34834331
Renal embolism 16.33 11.50 8 122245 107 34834571
Weight increased 16.33 11.50 228 122025 92805 34741873
Restlessness 16.30 11.50 41 122212 25441 34809237
Spinal cord haematoma 16.26 11.50 8 122245 108 34834570
Acidosis 16.25 11.50 9 122244 10936 34823742
Tachycardia 16.24 11.50 204 122049 84568 34750110
Metabolic acidosis 16.24 11.50 88 122165 43592 34791086
International normalised ratio abnormal 16.24 11.50 36 122217 3299 34831379
Renal impairment 16.17 11.50 439 121814 94074 34740604
Vocal cord inflammation 16.16 11.50 7 122246 69 34834609
Gastrointestinal arteriovenous malformation 16.14 11.50 12 122241 354 34834324
Haemodilution 16.13 11.50 6 122247 38 34834640
Neoplasm progression 16.09 11.50 36 122217 23264 34811414
Cholestasis 15.99 11.50 45 122208 26903 34807775
Renal vein thrombosis 15.95 11.50 9 122244 163 34834515
Sleep disorder 15.94 11.50 57 122196 31631 34803047
Vascular graft thrombosis 15.85 11.50 9 122244 165 34834513
Skin ulcer haemorrhage 15.81 11.50 9 122244 166 34834512
Secretion discharge 15.76 11.50 51 122202 5854 34828824
Hypoglycaemia 15.75 11.50 119 122134 54521 34780157
Biopsy prostate 15.73 11.50 5 122248 18 34834660
Mental status changes 15.71 11.50 74 122179 38009 34796669
Laryngeal haematoma 15.71 11.50 9 122244 168 34834510
Intestinal perforation 15.70 11.50 6 122247 9054 34825624
Pulmonary endarterectomy 15.57 11.50 7 122246 76 34834602
Poisoning 15.51 11.50 12 122241 12214 34822464
Hypertension 15.51 11.50 361 121892 136082 34698596
Presyncope 15.50 11.50 117 122136 18942 34815736
Enterocolitis infectious 15.49 11.50 24 122229 1671 34833007
Malnutrition 15.47 11.50 13 122240 12696 34821982
Hypertrophic osteoarthropathy 15.41 11.50 7 122246 78 34834600
Occult blood 15.32 11.50 17 122236 851 34833827
Delusion 15.29 11.50 13 122240 12622 34822056
Mobility decreased 15.28 11.50 54 122199 30074 34804604
Fungal infection 15.24 11.50 20 122233 15915 34818763
Dyskinesia 15.17 11.50 35 122218 22378 34812300
Colon cancer 15.09 11.50 65 122188 8556 34826122
Hemiataxia 15.05 11.50 6 122247 47 34834631
Vascular graft occlusion 15.03 11.50 14 122239 568 34834110
Peripheral arterial occlusive disease 15.02 11.50 50 122203 5824 34828854
Thalamic infarction 15.02 11.50 16 122237 765 34833913
Gravitational oedema 15.01 11.50 15 122238 665 34834013
Polyneuropathy 14.97 11.50 18 122235 14878 34819800
Retinal artery thrombosis 14.94 11.50 5 122248 22 34834656
Diabetic ketoacidosis 14.94 11.50 25 122228 18007 34816671
Tongue haemorrhage 14.87 11.50 14 122239 576 34834102
Confusional state 14.87 11.50 387 121866 143773 34690905
Post procedural haematuria 14.86 11.50 9 122244 187 34834491
Vision blurred 14.77 11.50 97 122156 45866 34788812
Hepatic steatosis 14.71 11.50 26 122227 18336 34816342
Visual acuity reduced 14.71 11.50 21 122232 16128 34818550
Fistula 14.70 11.50 3 122250 6837 34827841
Extrapyramidal disorder 14.69 11.50 14 122239 12866 34821812
Therapeutic product ineffective 14.63 11.50 16 122237 788 34833890
Atrial flutter 14.63 11.50 99 122154 15475 34819203
Subclavian artery thrombosis 14.62 11.50 4 122249 7 34834671
Uterine haemorrhage 14.62 11.50 4 122249 7 34834671
Post procedural oedema 14.62 11.50 4 122249 7 34834671
Subcapsular renal haematoma 14.58 11.50 12 122241 412 34834266
Feeling abnormal 14.55 11.50 146 122107 63089 34771589
Perforated ulcer 14.53 11.50 9 122244 195 34834483
Genital haemorrhage 14.53 11.50 9 122244 195 34834483
Surgery 14.52 11.50 92 122161 14065 34820613
Sinus tachycardia 14.44 11.50 24 122229 17336 34817342
Cardiac vein perforation 14.43 11.50 5 122248 25 34834653
Electrocardiogram QT prolonged 14.42 11.50 84 122169 40868 34793810
Blood glucose decreased 14.39 11.50 15 122238 13222 34821456
Soft tissue haemorrhage 14.37 11.50 8 122245 141 34834537
Tendonitis 14.34 11.50 7 122246 9133 34825545
Urethral haemorrhage 14.28 11.50 12 122241 424 34834254
Peritonitis 14.20 11.50 22 122231 16343 34818335
Renal injury 14.19 11.50 11 122242 11184 34823494
Palmar-plantar erythrodysaesthesia syndrome 14.18 11.50 23 122230 16772 34817906
Hemianaesthesia 14.13 11.50 7 122246 96 34834582
Thrombotic microangiopathy 14.05 11.50 10 122243 10620 34824058
Oral candidiasis 14.00 11.50 13 122240 12097 34822581
Muscle contusion 13.98 11.50 3 122250 0 34834678
Aortic surgery 13.98 11.50 3 122250 0 34834678
Phlebectomy 13.98 11.50 3 122250 0 34834678
Prostatic varices 13.98 11.50 3 122250 0 34834678
Gastrointestinal ischaemia 13.90 11.50 9 122244 211 34834467
Gout 13.90 11.50 115 122138 19138 34815540
Monoplegia 13.88 11.50 22 122231 1562 34833116
Myopathy 13.84 11.50 12 122241 11542 34823136
Myelodysplastic syndrome 13.82 11.50 29 122224 19179 34815499
Glomerular filtration rate abnormal 13.71 11.50 16 122237 847 34833831
Anal fissure haemorrhage 13.66 11.50 4 122249 10 34834668
Upper gastrointestinal perforation 13.66 11.50 4 122249 10 34834668
Intracranial haematoma 13.66 11.50 12 122241 451 34834227
Lung infiltration 13.61 11.50 15 122238 12890 34821788
Body temperature increased 13.55 11.50 25 122228 17343 34817335
Disease recurrence 13.42 11.50 35 122218 21455 34813223
Intervertebral disc degeneration 13.41 11.50 3 122250 6414 34828264
Tonsillar ulcer 13.39 11.50 8 122245 162 34834516
Psoriatic arthropathy 13.33 11.50 31 122222 19767 34814911
Diverticulum 13.33 11.50 55 122198 7104 34827574
Hepatitis C 13.32 11.50 9 122244 9821 34824857
Oesophageal carcinoma 13.32 11.50 8 122245 9296 34825382
Spinal subdural haematoma 13.20 11.50 6 122247 67 34834611
Incorrect dosage administered 13.10 11.50 19 122234 1247 34833431
Pancreatic neoplasm 13.05 11.50 16 122237 892 34833786
Haemorrhagic disorder 13.04 11.50 14 122239 675 34834003
Peripheral artery haematoma 13.04 11.50 6 122247 69 34834609
Dialysis 13.00 11.50 12 122241 11196 34823482
Salivary hypersecretion 12.99 11.50 7 122246 8637 34826041
Transfusion 12.99 11.50 62 122191 8523 34826155
Hyperthyroidism 12.98 11.50 72 122181 10494 34824184
Paresis cranial nerve 12.89 11.50 6 122247 71 34834607
Basilar artery thrombosis 12.89 11.50 9 122244 240 34834438
Interstitial lung disease 12.85 11.50 309 121944 64973 34769705
Incorrect route of product administration 12.84 11.50 20 122233 14825 34819853
Macular ischaemia 12.82 11.50 6 122247 72 34834606
Tuberculosis 12.81 11.50 7 122246 8570 34826108
Myositis 12.76 11.50 14 122239 12056 34822622
Hyperhidrosis 12.75 11.50 187 122066 75505 34759173
Cerebral microhaemorrhage 12.75 11.50 6 122247 73 34834605
Idiopathic interstitial pneumonia 12.69 11.50 8 122245 179 34834499
Blood calcium decreased 12.67 11.50 10 122243 10074 34824604
Limb injury 12.64 11.50 77 122176 11612 34823066
Creatinine renal clearance abnormal 12.60 11.50 9 122244 249 34834429
Erectile dysfunction 12.59 11.50 34 122219 20603 34814075
Rales 12.59 11.50 68 122185 9815 34824863
Hypernatraemia 12.58 11.50 7 122246 8483 34826195
Thinking abnormal 12.56 11.50 3 122250 6134 34828544
Depressed level of consciousness 12.49 11.50 93 122160 42748 34791930
Oedema genital 12.46 11.50 12 122241 508 34834170
Catheter site cellulitis 12.40 11.50 7 122246 127 34834551
Bacteraemia 12.39 11.50 32 122221 19685 34814993
Large intestinal polypectomy 12.39 11.50 6 122247 78 34834600
Acute myocardial infarction 12.37 11.50 260 121993 53459 34781219
Drug ineffective for unapproved indication 12.37 11.50 42 122211 23673 34811005
Spinal epidural haemorrhage 12.34 11.50 5 122248 41 34834637
Vascular rupture 12.34 11.50 8 122245 188 34834490
Device malfunction 12.27 11.50 11 122242 10410 34824268
Multiple sclerosis 12.20 11.50 4 122249 6641 34828037
Mydriasis 12.20 11.50 5 122248 7232 34827446
Vitamin D deficiency 12.10 11.50 4 122249 6604 34828074
Cachexia 12.06 11.50 5 122248 7181 34827497
Hypocalcaemia 12.01 11.50 44 122209 24245 34810433
Blood urea increased 11.95 11.50 60 122193 30304 34804374
Echocardiogram 11.91 11.50 3 122250 3 34834675
Status epilepticus 11.89 11.50 16 122237 12598 34822080
Hyperkalaemia 11.84 11.50 171 122082 69218 34765460
Left ventricular dilatation 11.82 11.50 14 122239 753 34833925
Disseminated intravascular coagulation 11.82 11.50 38 122215 21778 34812900
Blood potassium increased 11.79 11.50 25 122228 16470 34818208
Eye pain 11.78 11.50 18 122235 13444 34821234
Anticoagulant-related nephropathy 11.75 11.50 5 122248 47 34834631
Cardiac assistance device user 11.71 11.50 4 122249 19 34834659
Anal abscess 11.71 11.50 4 122249 6469 34828209
Blood cholesterol increased 11.68 11.50 35 122218 20508 34814170
Basal ganglia haematoma 11.66 11.50 5 122248 48 34834630
Thrombophlebitis 11.64 11.50 31 122222 3191 34831487
Product storage error 11.60 11.50 7 122246 8115 34826563
Urinary incontinence 11.58 11.50 31 122222 18843 34815835
Hepatic encephalopathy 11.58 11.50 21 122232 14664 34820014
Lip discolouration 11.58 11.50 7 122246 145 34834533
Application site haematoma 11.57 11.50 5 122248 49 34834629
Pollakiuria 11.56 11.50 33 122220 19641 34815037
Tardive dyskinesia 11.52 11.50 3 122250 5787 34828891

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Gastrointestinal haemorrhage 9022.53 10.48 5334 207072 142385 79389597
Cerebral haemorrhage 2121.87 10.48 1520 210886 56153 79475829
Pulmonary embolism 2003.97 10.48 2375 210031 169279 79362703
Ischaemic stroke 1950.19 10.48 1172 211234 31959 79500023
Haematuria 1925.03 10.48 1540 210866 67296 79464686
Haemorrhage 1860.77 10.48 1702 210704 89416 79442566
Epistaxis 1725.58 10.48 1789 210617 109726 79422256
Upper gastrointestinal haemorrhage 1673.69 10.48 1156 211250 40224 79491758
Haemorrhage intracranial 1396.57 10.48 870 211536 25323 79506659
Cerebral infarction 1278.80 10.48 1023 211383 44653 79487329
Rectal haemorrhage 1266.78 10.48 1272 211134 75028 79456954
Cerebrovascular accident 1209.46 10.48 1762 210644 153530 79378452
Melaena 1206.64 10.48 1119 211287 59771 79472211
Deep vein thrombosis 1114.52 10.48 1488 210918 119431 79412551
Lower gastrointestinal haemorrhage 1041.68 10.48 606 211800 15519 79516463
Haematoma 997.09 10.48 940 211466 51255 79480727
Anaemia 905.03 10.48 2920 209486 442095 79089887
Haemorrhagic stroke 901.28 10.48 484 211922 10562 79521420
Subdural haematoma 830.94 10.48 681 211725 30753 79501229
Haemoglobin decreased 783.38 10.48 1787 210619 220332 79311650
Embolic stroke 764.70 10.48 387 212019 7439 79524543
Internal haemorrhage 743.04 10.48 395 212011 8438 79523544
Thrombosis 685.80 10.48 976 211430 83124 79448858
Blood loss anaemia 659.50 10.48 447 211959 15051 79516931
Atrial thrombosis 620.37 10.48 265 212141 3391 79528591
Haemoptysis 609.69 10.48 749 211657 55250 79476732
Gastric haemorrhage 526.31 10.48 385 212021 14665 79517317
Haematochezia 514.20 10.48 874 211532 86771 79445211
Heavy menstrual bleeding 473.24 10.48 351 212055 13660 79518322
Labelled drug-drug interaction medication error 471.43 10.48 468 211938 27182 79504800
Diverticulum intestinal haemorrhagic 462.33 10.48 222 212184 3789 79528193
Pericardial haemorrhage 444.18 10.48 224 212182 4271 79527711
Post procedural haemorrhage 443.46 10.48 335 212071 13409 79518573
Vaginal haemorrhage 418.49 10.48 394 212012 21423 79510559
Intraventricular haemorrhage 409.49 10.48 218 212188 4669 79527313
Shock haemorrhagic 397.72 10.48 369 212037 19691 79512291
Haematemesis 397.40 10.48 587 211819 51677 79480305
Haemorrhagic arteriovenous malformation 392.22 10.48 118 212288 477 79531505
Basal ganglia haemorrhage 368.11 10.48 146 212260 1525 79530457
Cerebral haematoma 364.18 10.48 240 212166 7702 79524280
Haemarthrosis 358.37 10.48 212 212194 5600 79526382
Incorrect dose administered 345.39 10.48 682 211724 75948 79456034
Transient ischaemic attack 343.27 10.48 551 211855 52144 79479838
Haemorrhoidal haemorrhage 337.75 10.48 216 212190 6579 79525403
Faeces discoloured 332.24 10.48 399 212007 28728 79503254
Fall 328.31 10.48 2322 210084 485307 79046675
Infusion related reaction 327.11 10.48 103 212303 230134 79301848
Synovitis 315.94 10.48 22 212384 150712 79381270
Embolic cerebral infarction 311.58 10.48 120 212286 1151 79530831
Cerebellar haemorrhage 304.70 10.48 151 212255 2769 79529213
Drug intolerance 304.30 10.48 162 212244 263957 79268025
Drug abuse 303.22 10.48 38 212368 162653 79369329
Atrial fibrillation 295.83 10.48 1176 211230 196710 79335272
Product prescribing issue 293.35 10.48 164 212242 3881 79528101
Hemiplegia 290.74 10.48 272 212134 14667 79517315
Thalamus haemorrhage 282.12 10.48 123 212283 1659 79530323
Subarachnoid haemorrhage 277.17 10.48 334 212072 24131 79507851
Drug hypersensitivity 276.40 10.48 234 212172 298682 79233300
Gingival bleeding 270.99 10.48 272 212134 16004 79515978
International normalised ratio increased 265.87 10.48 652 211754 84069 79447913
Pain 263.51 10.48 976 211430 702826 78829156
Toxicity to various agents 262.43 10.48 450 211956 421090 79110892
Hand deformity 260.40 10.48 3 212403 103916 79428066
Therapeutic product effect decreased 259.73 10.48 59 212347 163804 79368178
Rheumatoid arthritis 250.36 10.48 121 212285 208349 79323633
Hemiparesis 246.56 10.48 372 212034 33361 79498621
Drug interaction 244.47 10.48 1916 210490 413267 79118715
Pyrexia 238.72 10.48 965 211441 677744 78854238
Blood urine present 233.53 10.48 286 212120 21011 79510971
Gastrointestinal vascular malformation haemorrhagic 227.61 10.48 84 212322 708 79531274
Subcutaneous haematoma 227.39 10.48 122 212284 2655 79529327
Iron deficiency anaemia 216.57 10.48 303 212103 25369 79506613
Gastric ulcer haemorrhage 214.55 10.48 184 212222 8843 79523139
Arthralgia 213.76 10.48 793 211613 571010 78960972
Hypersensitivity 211.30 10.48 232 212174 262007 79269975
Cardiac failure 203.67 10.48 885 211521 153957 79378025
Haemorrhagic transformation stroke 200.29 10.48 111 212295 2581 79529401
Glossodynia 197.81 10.48 22 212384 103315 79428667
Maternal exposure during pregnancy 197.59 10.48 59 212347 136479 79395503
Condition aggravated 195.83 10.48 682 211724 500442 79031540
Cerebral artery embolism 194.98 10.48 97 212309 1794 79530188
Arthropathy 193.32 10.48 116 212290 176995 79354987
Abdominal wall haematoma 191.83 10.48 134 212272 4739 79527243
Febrile neutropenia 190.94 10.48 200 212206 230799 79301183
Subdural haemorrhage 187.50 10.48 143 212263 5805 79526177
Alopecia 186.01 10.48 205 212201 231150 79300832
Muscle haemorrhage 184.51 10.48 145 212261 6155 79525827
Anxiety 178.87 10.48 240 212166 248272 79283710
Prothrombin time prolonged 174.16 10.48 220 212186 16679 79515303
Mouth haemorrhage 170.26 10.48 176 212230 10723 79521259
Joint swelling 169.69 10.48 319 212087 288327 79243655
Retroperitoneal haemorrhage 169.12 10.48 130 212276 5340 79526642
Systemic lupus erythematosus 168.78 10.48 56 212350 121093 79410889
Coagulopathy 167.68 10.48 325 212081 35681 79496301
Discomfort 163.26 10.48 65 212341 125552 79406430
Completed suicide 158.64 10.48 256 212150 245511 79286471
Anticoagulation drug level increased 158.18 10.48 64 212342 707 79531275
Dyspnoea exertional 154.50 10.48 547 211859 86526 79445456
Duodenal ulcer haemorrhage 154.17 10.48 138 212268 7025 79524957
Duodenal ulcer perforation 153.61 10.48 5 212401 66206 79465776
Wound haemorrhage 153.56 10.48 110 212296 4051 79527931
Small intestinal haemorrhage 148.94 10.48 108 212298 4055 79527927
Splenic rupture 148.18 10.48 88 212318 2341 79529641
Infection 147.51 10.48 261 212145 241451 79290531
Uterine haemorrhage 146.06 10.48 93 212313 2810 79529172
Rheumatoid factor positive 144.53 10.48 3 212403 59836 79472146
Occult blood positive 143.01 10.48 130 212276 6753 79525229
Haemorrhage urinary tract 139.37 10.48 85 212321 2376 79529606
Haemothorax 139.10 10.48 116 212290 5362 79526620
Sinusitis 138.42 10.48 191 212215 195310 79336672
Cerebral ventricular rupture 136.68 10.48 50 212356 410 79531572
Neutropenia 134.74 10.48 360 212046 287350 79244632
Cardiac tamponade 132.81 10.48 143 212263 9133 79522849
Dyspnoea 132.69 10.48 3099 209307 853926 78678056
Microcytic anaemia 132.51 10.48 111 212295 5163 79526819
Procedural haemorrhage 130.73 10.48 105 212301 4601 79527381
Depression 130.55 10.48 236 212170 216554 79315428
Renal haemorrhage 130.54 10.48 79 212327 2177 79529805
Pericarditis 130.51 10.48 57 212349 104179 79427803
Haemorrhage subcutaneous 128.73 10.48 105 212301 4704 79527278
Acute kidney injury 127.10 10.48 2015 210391 517389 79014593
Musculoskeletal stiffness 126.91 10.48 168 212238 174840 79357142
Activated partial thromboplastin time prolonged 126.11 10.48 172 212234 14056 79517926
Gastric ulcer 126.10 10.48 279 212127 33626 79498356
Stomatitis 125.85 10.48 123 212283 146634 79385348
Traumatic intracranial haemorrhage 123.26 10.48 62 212344 1175 79530807
Pulmonary haemorrhage 123.08 10.48 173 212233 14544 79517438
Folliculitis 122.34 10.48 6 212400 55374 79476608
Nasopharyngitis 117.86 10.48 319 212087 253562 79278420
Brain stem haemorrhage 117.21 10.48 66 212340 1584 79530398
Large intestinal haemorrhage 117.16 10.48 80 212326 2725 79529257
Exposure during pregnancy 116.40 10.48 62 212344 101070 79430912
Aphasia 116.32 10.48 330 212076 46402 79485580
Cerebral ischaemia 115.77 10.48 146 212260 11049 79520933
Product prescribing error 111.10 10.48 316 212090 44497 79487485
Post procedural haematoma 110.03 10.48 73 212333 2369 79529613
Gastritis haemorrhagic 109.13 10.48 75 212331 2582 79529400
Peripheral embolism 109.03 10.48 67 212339 1899 79530083
Mobility decreased 108.73 10.48 99 212307 122076 79409906
Cardioversion 107.52 10.48 68 212338 2030 79529952
Intracardiac thrombus 107.13 10.48 90 212316 4203 79527779
Hypovolaemic shock 105.19 10.48 146 212260 12130 79519852
Prescribed underdose 101.01 10.48 235 212171 29279 79502703
Therapeutic response decreased 100.19 10.48 27 212379 66826 79465156
Haemorrhagic cerebral infarction 99.25 10.48 57 212349 1422 79530560
Ecchymosis 98.98 10.48 159 212247 15047 79516935
Cerebellar infarction 98.40 10.48 80 212326 3567 79528415
Gastritis erosive 97.46 10.48 132 212274 10715 79521267
Pulmonary arterial hypertension 97.23 10.48 226 212180 28140 79503842
Therapeutic product effect incomplete 96.66 10.48 142 212264 141503 79390479
Muscle injury 96.39 10.48 9 212397 48552 79483430
Duodenal ulcer 95.58 10.48 163 212243 16206 79515776
Hepatic enzyme increased 95.23 10.48 216 212190 182394 79349588
Pulmonary alveolar haemorrhage 94.80 10.48 134 212272 11323 79520659
Ill-defined disorder 94.31 10.48 29 212377 65846 79466136
Weight increased 94.28 10.48 399 212007 276987 79254995
Creatinine renal clearance decreased 93.99 10.48 176 212230 18826 79513156
Syncope 93.38 10.48 806 211600 178643 79353339
Adrenal haemorrhage 92.34 10.48 41 212365 579 79531403
Underdose 91.35 10.48 243 212163 32908 79499074
Extradural haematoma 90.33 10.48 69 212337 2807 79529175
Injection site erythema 89.90 10.48 48 212358 78149 79453833
Pericardial effusion 89.44 10.48 299 212107 45938 79486044
Head injury 89.24 10.48 260 212146 37109 79494873
Cerebral artery occlusion 88.72 10.48 56 212350 1666 79530316
Vascular pseudoaneurysm 88.45 10.48 74 212332 3436 79528546
Blister 88.33 10.48 113 212293 119363 79412619
Injection site reaction 88.23 10.48 19 212387 54766 79477216
Haematoma muscle 87.15 10.48 65 212341 2550 79529432
Anaphylactic reaction 87.00 10.48 58 212348 83685 79448297
Blood cholesterol increased 86.95 10.48 58 212348 83662 79448320
Eye haemorrhage 86.55 10.48 118 212288 9639 79522343
Swelling 86.43 10.48 292 212114 216419 79315563
Irritable bowel syndrome 86.27 10.48 29 212377 62212 79469770
Embolism venous 85.99 10.48 79 212327 4160 79527822
Retroperitoneal haematoma 85.38 10.48 87 212319 5210 79526772
Injection site pain 83.95 10.48 135 212271 129703 79402279
Arterial haemorrhage 83.88 10.48 63 212343 2498 79529484
Cerebral mass effect 83.52 10.48 56 212350 1850 79530132
Cardiac failure chronic 83.06 10.48 124 212282 11011 79520971
Dizziness 82.80 10.48 1909 210497 524532 79007450
Insomnia 82.48 10.48 354 212052 244816 79287166
Psoriatic arthropathy 81.05 10.48 54 212352 77945 79454037
Traumatic haemorrhage 80.55 10.48 48 212358 1285 79530697
Treatment failure 79.99 10.48 213 212193 170273 79361709
Intestinal haemorrhage 79.85 10.48 92 212314 6334 79525648
High frequency ablation 79.28 10.48 30 212376 273 79531709
Fibromyalgia 79.25 10.48 36 212370 64304 79467678
Haemorrhagic diathesis 77.11 10.48 88 212318 5996 79525986
Helicobacter infection 76.93 10.48 45 212361 69659 79462323
Loss of personal independence in daily activities 76.89 10.48 96 212310 102484 79429498
Gastrointestinal ulcer haemorrhage 76.68 10.48 46 212360 1247 79530735
Sedation 75.83 10.48 22 212384 51873 79480109
Urinary bladder haemorrhage 75.63 10.48 59 212347 2477 79529505
Renal impairment 75.55 10.48 696 211710 157087 79374895
Postmenopausal haemorrhage 73.83 10.48 48 212358 1504 79530478
Neutrophil count decreased 73.54 10.48 85 212321 93874 79438108
Hypochromic anaemia 73.50 10.48 60 212346 2691 79529291
Spinal cord haemorrhage 72.99 10.48 34 212372 540 79531442
Mucosal inflammation 72.44 10.48 57 212349 75523 79456459
Drug dependence 70.18 10.48 12 212394 40757 79491225
Wound 69.42 10.48 127 212279 116052 79415930
Ischaemic cerebral infarction 69.23 10.48 56 212350 2479 79529503
Pelvic venous thrombosis 69.05 10.48 53 212353 2172 79529810
Therapy non-responder 68.54 10.48 87 212319 92218 79439764
Abnormal uterine bleeding 68.41 10.48 40 212366 1033 79530949
Glomerular filtration rate decreased 68.30 10.48 172 212234 22530 79509452
Oedema peripheral 68.17 10.48 996 211410 251292 79280690
C-reactive protein increased 67.76 10.48 152 212254 128875 79403107
Venous thrombosis 67.62 10.48 89 212317 7027 79524955
Nausea 66.47 10.48 1993 210413 955203 78576779
Rash 66.16 10.48 1113 211293 577245 78954737
Impaired healing 65.73 10.48 82 212324 87573 79444409
Multiple sclerosis relapse 65.69 10.48 21 212385 46512 79485470
Transfusion 64.59 10.48 162 212244 21168 79510814
Suicidal ideation 64.25 10.48 65 212341 76275 79455707
Abdominal discomfort 64.01 10.48 398 212008 250329 79281653
Conjunctival haemorrhage 63.06 10.48 78 212328 5787 79526195
Inflammation 62.96 10.48 95 212311 93658 79438324
Gastrointestinal disorder 62.52 10.48 146 212260 122059 79409923
Cytomegalovirus infection 62.45 10.48 18 212388 42626 79489356
Aspartate aminotransferase increased 62.20 10.48 177 212229 138464 79393518
Cerebral ventricle collapse 61.93 10.48 20 212386 107 79531875
Overdose 61.30 10.48 267 212139 183939 79348043
Potentiating drug interaction 61.25 10.48 95 212311 8724 79523258
Gastrointestinal polyp haemorrhage 60.86 10.48 29 212377 486 79531496
Bone marrow failure 60.78 10.48 30 212376 51077 79480905
Splenic haemorrhage 60.58 10.48 32 212374 674 79531308
Peripheral artery occlusion 60.52 10.48 52 212354 2505 79529477
Spontaneous haematoma 60.45 10.48 41 212365 1381 79530601
Incision site haemorrhage 60.20 10.48 37 212369 1049 79530933
Alanine aminotransferase increased 60.16 10.48 226 212180 162344 79369638
Embolism 60.02 10.48 122 212284 13860 79518122
Hepatotoxicity 59.79 10.48 31 212375 51321 79480661
Peripheral artery thrombosis 59.43 10.48 59 212347 3424 79528558
Myelosuppression 59.03 10.48 17 212389 40279 79491703
Contusion 58.01 10.48 629 211777 148147 79383835
Fatigue 57.96 10.48 1963 210443 927764 78604218
Seizure 57.92 10.48 282 212124 188552 79343430
Peripheral ischaemia 57.64 10.48 96 212310 9361 79522621
Hospitalisation 57.50 10.48 439 211967 93797 79438185
Product use issue 57.28 10.48 326 212080 209496 79322486
Haemoperitoneum 57.06 10.48 64 212342 4279 79527703
N-terminal prohormone brain natriuretic peptide abnormal 57.01 10.48 23 212383 252 79531730
Traumatic haematoma 56.99 10.48 46 212360 2030 79529952
Penile haemorrhage 56.71 10.48 28 212378 509 79531473
White blood cell count decreased 56.70 10.48 283 212123 188005 79343977
Spinal cord haematoma 56.60 10.48 24 212382 301 79531681
Retinal artery occlusion 56.58 10.48 56 212350 3238 79528744
Treatment noncompliance 56.32 10.48 282 212124 51986 79479996
Disease progression 56.15 10.48 276 212130 184086 79347896
Pregnancy 56.00 10.48 4 212402 26847 79505135
Urogenital haemorrhage 55.98 10.48 34 212372 943 79531039
Diverticulum 55.86 10.48 123 212283 14773 79517209
Peptic ulcer haemorrhage 55.86 10.48 34 212372 947 79531035
Hypertension 55.67 10.48 588 211818 330404 79201578
Herpes zoster 55.39 10.48 102 212304 92981 79439001
Compartment syndrome 55.30 10.48 68 212338 5014 79526968
Toxic epidermal necrolysis 54.81 10.48 25 212381 44556 79487426
Aggression 54.69 10.48 34 212372 50924 79481058
Vascular stent thrombosis 54.53 10.48 58 212348 3652 79528330
Intentional product use issue 54.01 10.48 215 212191 151897 79380085
Pharyngeal haemorrhage 53.70 10.48 37 212369 1279 79530703
Leukopenia 53.56 10.48 147 212259 116366 79415616
Chills 53.47 10.48 232 212174 160002 79371980
Tremor 53.32 10.48 252 212154 169831 79362151
Intra-abdominal haemorrhage 53.08 10.48 63 212343 4477 79527505
Pulmonary hypertension 52.93 10.48 261 212145 47819 79484163
Psoriasis 52.57 10.48 99 212307 89488 79442494
Bradycardia 51.88 10.48 571 211835 134986 79396996
Polyp 51.71 10.48 84 212322 8023 79523959
Lymphocyte count decreased 51.52 10.48 31 212375 47258 79484724
Haemorrhagic erosive gastritis 50.98 10.48 29 212377 710 79531272
Venous thrombosis limb 50.72 10.48 61 212345 4396 79527586
Irritability 50.70 10.48 23 212383 41121 79490861
Salpingo-oophorectomy unilateral 50.32 10.48 30 212376 804 79531178
Inappropriate schedule of product administration 50.28 10.48 561 211845 133067 79398915
Drug resistance 49.87 10.48 25 212381 42188 79489794
Injection site swelling 49.82 10.48 32 212374 47100 79484882
Cardiac ablation 49.66 10.48 44 212362 2209 79529773
Presyncope 49.65 10.48 229 212177 40825 79491157
Purpura 48.69 10.48 138 212268 19389 79512593
Contraindicated product administered 48.45 10.48 235 212171 157303 79374679
Drug withdrawal syndrome 48.42 10.48 16 212390 34702 79497280
Emotional distress 48.24 10.48 23 212383 39946 79492036
Respiratory depression 47.85 10.48 8 212398 27622 79504360
Red blood cell sedimentation rate increased 47.47 10.48 32 212374 45910 79486072
Atrial flutter 47.41 10.48 146 212260 21479 79510503
Ear haemorrhage 47.30 10.48 42 212364 2115 79529867
Retinal haemorrhage 46.89 10.48 81 212325 8136 79523846
Pulmonary thrombosis 46.21 10.48 101 212305 12070 79519912
Putamen haemorrhage 45.97 10.48 24 212382 493 79531489
Vitreous haemorrhage 45.87 10.48 53 212353 3660 79528322
Brain herniation 45.81 10.48 76 212330 7387 79524595
Sleep disorder 45.74 10.48 100 212306 85577 79446405
Product administration error 45.68 10.48 187 212219 31659 79500323
Rhinorrhoea 45.58 10.48 83 212323 75991 79455991
Cerebral vascular occlusion 45.23 10.48 13 212393 43 79531939
Skin haemorrhage 45.00 10.48 99 212307 11882 79520100
Agitation 44.94 10.48 127 212279 99588 79432394
Hypersensitivity vasculitis 44.37 10.48 72 212334 6871 79525111
Foot deformity 43.92 10.48 6 212400 24068 79507914
Coagulation test abnormal 43.86 10.48 33 212373 1312 79530670
Labelled drug-disease interaction medication error 43.67 10.48 20 212386 305 79531677
Prothrombin time shortened 43.15 10.48 48 212358 3180 79528802
Hypoaesthesia 43.05 10.48 290 212116 179062 79352920
Bladder tamponade 42.92 10.48 24 212382 568 79531414
Psychotic disorder 42.56 10.48 29 212377 41373 79490609
Constipation 42.40 10.48 516 211890 282534 79249448
Product monitoring error 42.20 10.48 81 212325 8825 79523157
Arteriovenous malformation 42.06 10.48 36 212370 1725 79530257
Neurotoxicity 41.95 10.48 17 212389 32501 79499481
Injection site pruritus 41.65 10.48 31 212375 42252 79489730
Oral herpes 41.30 10.48 11 212395 27443 79504539
Gastrointestinal angiodysplasia 41.16 10.48 29 212377 1040 79530942
Prostatic haemorrhage 40.95 10.48 16 212390 160 79531822
Renal haematoma 40.73 10.48 26 212380 789 79531193
Splenic haematoma 40.66 10.48 19 212387 304 79531678
Mesenteric haemorrhage 40.34 10.48 13 212393 69 79531913
Anal haemorrhage 40.30 10.48 53 212353 4181 79527801
Pancytopenia 40.28 10.48 267 212139 165478 79366504
Coagulation time prolonged 40.25 10.48 41 212365 2454 79529528
Lower respiratory tract infection 40.17 10.48 192 212214 129028 79402954
Intentional product misuse 40.15 10.48 125 212281 95040 79436942
Brain stem infarction 40.02 10.48 37 212369 1964 79530018
Anticoagulation drug level decreased 39.85 10.48 16 212390 173 79531809
Hydrocephalus 39.81 10.48 79 212327 8821 79523161
Coagulation factor X level increased 39.45 10.48 8 212398 0 79531982
Bleeding varicose vein 39.27 10.48 23 212383 596 79531386
Mesenteric artery embolism 39.01 10.48 13 212393 78 79531904
Malignant neoplasm progression 38.34 10.48 209 212197 135781 79396201
Aortic aneurysm rupture 38.34 10.48 30 212376 1265 79530717
Arrhythmia 38.25 10.48 287 212119 60985 79470997
Sepsis 38.17 10.48 497 211909 268931 79263051
Blood glucose increased 38.02 10.48 167 212239 114808 79417174
Somnolence 37.97 10.48 430 211976 238551 79293431
Oropharyngeal pain 37.91 10.48 156 212250 109197 79422785
Dry eye 37.79 10.48 26 212380 36905 79495077
Renal infarct 37.67 10.48 41 212365 2650 79529332
Anovulatory cycle 37.53 10.48 14 212392 122 79531860
Rectal polyp 37.46 10.48 33 212373 1644 79530338
Penis injury 37.03 10.48 14 212392 127 79531855
Prescribed overdose 37.02 10.48 28 212378 37855 79494127
Haemorrhagic infarction 36.97 10.48 24 212382 750 79531232
Migraine 36.85 10.48 115 212291 87378 79444604
Puncture site haemorrhage 36.78 10.48 22 212384 593 79531389
C-reactive protein abnormal 36.51 10.48 45 212361 48322 79483660
Back pain 36.46 10.48 580 211826 303600 79228382
Joint stiffness 36.41 10.48 33 212373 40797 79491185
Brain natriuretic peptide abnormal 36.33 10.48 24 212382 773 79531209
Bone erosion 36.25 10.48 3 212403 17844 79514138
Urticaria 36.19 10.48 317 212089 184884 79347098
Device related thrombosis 36.04 10.48 40 212366 2643 79529339
Multiple organ dysfunction syndrome 36.03 10.48 181 212225 120065 79411917
Diverticulitis intestinal haemorrhagic 35.97 10.48 20 212386 468 79531514
Mesenteric artery thrombosis 35.91 10.48 22 212384 620 79531362
Sciatica 35.88 10.48 22 212384 33200 79498782
COVID-19 35.85 10.48 259 212147 157415 79374567
Gastrointestinal angiectasia 35.68 10.48 19 212387 407 79531575
Anticoagulation drug level above therapeutic 35.52 10.48 46 212360 3574 79528408
Intra-abdominal haematoma 35.27 10.48 41 212365 2850 79529132
White blood cell count increased 35.17 10.48 93 212313 74540 79457442
Intracranial haematoma 35.03 10.48 25 212381 915 79531067
Osteopenia 34.90 10.48 4 212402 18360 79513622
Bursitis 34.38 10.48 27 212379 35817 79496165
Grip strength decreased 34.37 10.48 8 212398 21861 79510121
Neutrophil count increased 33.84 10.48 18 212388 29378 79502604
Subgaleal haematoma 33.63 10.48 13 212393 126 79531856
Type 2 diabetes mellitus 33.62 10.48 63 212343 57059 79474923
Tumour haemorrhage 33.60 10.48 48 212358 4096 79527886
Bradyarrhythmia 33.58 10.48 48 212358 4098 79527884
Haematoma infection 33.25 10.48 30 212376 1543 79530439
Post thrombotic syndrome 33.05 10.48 21 212385 632 79531350
Arterial thrombosis 32.75 10.48 38 212368 2636 79529346
Pruritus 32.61 10.48 801 211605 393847 79138135
Ulcer haemorrhage 32.60 10.48 57 212349 5781 79526201
Injury 32.54 10.48 102 212304 77394 79454588
Anastomotic ulcer haemorrhage 32.53 10.48 12 212394 101 79531881
Peripheral arterial occlusive disease 31.89 10.48 69 212337 8189 79523793
Drug ineffective 31.57 10.48 2466 209940 1078447 78453535
Sinusitis fungal 31.21 10.48 35 212371 2339 79529643
Vomiting 31.12 10.48 1453 210953 664375 78867607
Respiratory symptom 31.05 10.48 50 212356 4741 79527241
Wound haematoma 31.02 10.48 13 212393 158 79531824
Hypercalcaemia 30.90 10.48 34 212372 38396 79493586
Hypercoagulation 30.82 10.48 39 212367 2961 79529021
Chronic gastrointestinal bleeding 30.78 10.48 18 212388 465 79531517
Stress 30.54 10.48 109 212297 79503 79452479
Influenza 30.38 10.48 211 212195 129395 79402587
Intentional self-injury 30.37 10.48 25 212381 32394 79499588
Oesophageal haemorrhage 30.28 10.48 30 212376 1737 79530245
Lymphadenopathy 30.23 10.48 60 212346 53187 79478795
Brain compression 29.99 10.48 19 212387 569 79531413
Oesophagitis haemorrhagic 29.95 10.48 20 212386 656 79531326
Subcapsular renal haematoma 29.73 10.48 21 212385 756 79531226
Dystonia 29.60 10.48 10 212396 21389 79510593
Abdominal wall haemorrhage 29.48 10.48 20 212386 674 79531308
Night sweats 29.32 10.48 59 212347 52036 79479946
Hypotension 29.15 10.48 1443 210963 438874 79093108
Asthenia 29.09 10.48 1653 210753 510036 79021946
Cardiac pacemaker insertion 28.89 10.48 54 212352 5768 79526214
Body temperature increased 28.87 10.48 46 212360 44374 79487608
Lacunar stroke 28.87 10.48 16 212390 372 79531610
Haemophagocytic lymphohistiocytosis 28.85 10.48 11 212395 21826 79510156
Menometrorrhagia 28.81 10.48 20 212386 700 79531282
Injection site warmth 28.71 10.48 3 212403 14804 79517178
Withdrawal syndrome 28.70 10.48 18 212388 26836 79505146
Blood blister 28.68 10.48 38 212368 3019 79528963
Interstitial lung disease 28.60 10.48 440 211966 112160 79419822
Traumatic haemothorax 28.50 10.48 18 212388 536 79531446
Respiratory arrest 28.44 10.48 70 212336 57480 79474502
Abnormal behaviour 28.44 10.48 33 212373 36388 79495594
Periorbital haemorrhage 28.23 10.48 14 212392 257 79531725
Bleeding time prolonged 28.20 10.48 25 212381 1256 79530726
Bronchopulmonary aspergillosis 28.20 10.48 12 212394 22282 79509700
Ear infection 28.20 10.48 30 212376 34402 79497580
Muscle spasticity 28.07 10.48 11 212395 21464 79510518
Thrombotic stroke 28.05 10.48 20 212386 731 79531251
Blood calcium decreased 28.04 10.48 26 212380 31793 79500189
Aneurysm ruptured 28.03 10.48 22 212384 932 79531050
Haematotoxicity 28.00 10.48 4 212402 15515 79516467
Arthritis 27.93 10.48 185 212221 114695 79417287
Tricuspid valve incompetence 27.68 10.48 115 212291 19597 79512385
Erythema 27.68 10.48 423 211983 222867 79309115
Pallor 27.67 10.48 228 212178 49834 79482148
Right ventricular failure 27.63 10.48 130 212276 23367 79508615
Periorbital haematoma 27.63 10.48 22 212384 952 79531030
Mallory-Weiss syndrome 27.61 10.48 36 212370 2816 79529166
Oral candidiasis 27.57 10.48 23 212383 29605 79502377
Osteoarthritis 27.56 10.48 129 212277 87180 79444802
Muscle spasms 27.50 10.48 315 212091 174415 79357567
Acute myocardial infarction 27.42 10.48 320 212086 76716 79455266
Hysterectomy 27.25 10.48 55 212351 6217 79525765
Dry mouth 27.23 10.48 131 212275 87888 79444094
Pseudomonas infection 26.84 10.48 11 212395 20892 79511090
Osteonecrosis 26.71 10.48 26 212380 31069 79500913
Chest wall haematoma 26.70 10.48 16 212390 433 79531549
Angioedema 26.64 10.48 108 212298 75927 79456055
Creatinine renal clearance abnormal 26.51 10.48 17 212389 520 79531462
Conjunctivitis 26.45 10.48 18 212388 25697 79506285
Immune reconstitution inflammatory syndrome 26.34 10.48 3 212403 13838 79518144
Blood pressure increased 26.33 10.48 400 212006 210960 79321022
Mood swings 26.29 10.48 10 212396 19870 79512112
Large intestine polyp 26.20 10.48 84 212322 12624 79519358
Therapy partial responder 26.11 10.48 7 212399 17390 79514592
Photophobia 26.04 10.48 11 212395 20517 79511465
Accidental exposure to product 25.98 10.48 27 212379 31295 79500687
Weight decreased 25.89 10.48 734 211672 354464 79177518
Incorrect route of product administration 25.84 10.48 33 212373 34896 79497086
Haemorrhoids 25.83 10.48 149 212257 28979 79503003
Retinal vascular thrombosis 25.80 10.48 12 212394 190 79531792
Memory impairment 25.65 10.48 183 212223 111551 79420431
Urethral haemorrhage 25.49 10.48 15 212391 392 79531590
Haematospermia 25.35 10.48 13 212393 257 79531725
Serotonin syndrome 25.33 10.48 51 212355 44976 79487006
Paranoia 25.32 10.48 10 212396 19422 79512560
Crying 25.25 10.48 15 212391 23028 79508954
Pathogen resistance 25.18 10.48 4 212402 14338 79517644
Osteonecrosis of jaw 25.15 10.48 48 212358 43178 79488804
Cerebral artery thrombosis 25.09 10.48 22 212384 1089 79530893
Incorrect dosage administered 25.05 10.48 34 212372 2765 79529217
Cerebral amyloid angiopathy 24.97 10.48 14 212392 333 79531649
Akathisia 24.92 10.48 3 212403 13256 79518726
Viral infection 24.83 10.48 48 212358 42968 79489014
Feeling hot 24.81 10.48 79 212327 59655 79472327
Premature delivery 24.71 10.48 16 212390 23451 79508531
Cardiac failure acute 24.70 10.48 108 212298 18821 79513161
Upper respiratory tract infection 24.67 10.48 142 212264 91026 79440956
Lymphopenia 24.61 10.48 27 212379 30530 79501452
Wheezing 24.45 10.48 196 212210 116468 79415514
Hypervolaemia 24.44 10.48 196 212210 42494 79489488
Chronic gastritis 24.40 10.48 41 212365 4027 79527955
International normalised ratio abnormal 24.37 10.48 50 212356 5718 79526264
Osteomyelitis 24.37 10.48 31 212375 32834 79499148
Vascular pseudoaneurysm ruptured 24.36 10.48 11 212395 162 79531820
Autoimmune disorder 24.34 10.48 7 212399 16605 79515377
Asthma 24.32 10.48 236 212170 134859 79397123
Pancreatitis 24.28 10.48 97 212309 68478 79463504
Cerebellar haematoma 23.90 10.48 17 212389 619 79531363
Spinal subdural haematoma 23.88 10.48 12 212394 227 79531755
Cytomegalovirus viraemia 23.86 10.48 3 212403 12818 79519164
Influenza like illness 23.80 10.48 104 212302 71603 79460379
Nodule 23.77 10.48 16 212390 22978 79509004
Anger 23.77 10.48 8 212398 17154 79514828
Neuroleptic malignant syndrome 23.72 10.48 23 212383 27536 79504446
Anti factor X activity increased 23.68 10.48 9 212397 83 79531899
Cytokine release syndrome 23.66 10.48 37 212369 35961 79496021
Hypertriglyceridaemia 23.66 10.48 3 212403 12737 79519245
Petechiae 23.61 10.48 113 212293 20452 79511530
Catheter site haemorrhage 23.59 10.48 46 212360 5071 79526911
Post-traumatic amnestic disorder 23.47 10.48 8 212398 52 79531930
Facial paresis 23.46 10.48 48 212358 5478 79526504
Neuralgia 23.22 10.48 33 212373 33351 79498631
Progressive multifocal leukoencephalopathy 23.15 10.48 13 212393 20587 79511395
Sputum increased 23.15 10.48 43 212363 4570 79527412
Rhabdomyolysis 23.15 10.48 170 212236 102961 79429021
Fluid retention 23.11 10.48 286 212120 69523 79462459
Blood creatine phosphokinase increased 23.08 10.48 94 212312 65996 79465986
Cardiac ventricular thrombosis 23.07 10.48 26 212380 1747 79530235
Poisoning 23.05 10.48 20 212386 25252 79506730
Embolism arterial 22.79 10.48 24 212382 1494 79530488
Ventricle rupture 22.78 10.48 9 212397 93 79531889
Mental disorder 22.72 10.48 30 212376 31272 79500710
Vena cava thrombosis 22.69 10.48 33 212373 2862 79529120
Haemodialysis 22.63 10.48 10 212396 18158 79513824
Vision blurred 22.61 10.48 177 212229 105721 79426261
Renal tubular necrosis 22.61 10.48 20 212386 25019 79506963
Mucosal haemorrhage 22.52 10.48 31 212375 2555 79529427
Sinus tachycardia 22.35 10.48 40 212366 36868 79495114
Thrombotic microangiopathy 22.28 10.48 13 212393 20156 79511826
N-terminal prohormone brain natriuretic peptide increased 22.23 10.48 43 212363 4712 79527270
Duodenitis haemorrhagic 22.22 10.48 10 212396 146 79531836
Facial paralysis 22.21 10.48 113 212293 20959 79511023
Colon cancer 22.20 10.48 87 212319 14436 79517546
Throat tightness 22.10 10.48 25 212381 27882 79504100
Aplastic anaemia 22.07 10.48 10 212396 17895 79514087
Abdominal pain 21.98 10.48 832 211574 388737 79143245
Lupus-like syndrome 21.92 10.48 5 212401 13852 79518130
Craniocerebral injury 21.90 10.48 45 212361 5151 79526831
Hypogammaglobulinaemia 21.88 10.48 4 212402 12947 79519035
Anaphylactic shock 21.81 10.48 39 212367 35957 79496025
Hypophagia 21.78 10.48 56 212350 45311 79486671
Quadriplegia 21.68 10.48 35 212371 3325 79528657
Aspergillus infection 21.67 10.48 12 212394 19149 79512833
Vascular graft thrombosis 21.66 10.48 11 212395 213 79531769
Diverticulum intestinal 21.63 10.48 61 212345 8544 79523438
Extra dose administered 21.50 10.48 60 212346 8355 79523627
Drug reaction with eosinophilia and systemic symptoms 21.43 10.48 93 212313 64151 79467831
Liver injury 21.39 10.48 78 212328 56536 79475446
Phlebitis deep 21.32 10.48 6 212400 18 79531964
Stent placement 21.31 10.48 51 212355 6469 79525513
Orthopnoea 21.15 10.48 67 212339 10006 79521976
Multiple sclerosis 21.10 10.48 17 212389 22265 79509717
Intracranial mass 21.07 10.48 28 212378 2231 79529751
Basilar artery thrombosis 21.04 10.48 13 212393 372 79531610
Vascular purpura 20.99 10.48 33 212373 3065 79528917
Sleep disorder due to a general medical condition 20.95 10.48 6 212400 14271 79517711
Heart rate irregular 20.92 10.48 154 212252 32525 79499457
Laryngeal haematoma 20.80 10.48 10 212396 171 79531811
Catheter management 20.76 10.48 36 212370 3627 79528355
Haemoglobin abnormal 20.75 10.48 53 212353 7001 79524981
CHA2DS2-VASc annual stroke risk high 20.73 10.48 5 212401 6 79531976
Normochromic normocytic anaemia 20.64 10.48 56 212350 7671 79524311
Neutropenic sepsis 20.62 10.48 25 212381 27039 79504943
Gait disturbance 20.60 10.48 409 211997 207097 79324885
Confusional state 20.49 10.48 668 211738 317329 79214653
Basal cell carcinoma 20.46 10.48 43 212363 37332 79494650
Contraindicated product prescribed 20.32 10.48 24 212382 1697 79530285
Rhinitis allergic 20.28 10.48 4 212402 12265 79519717
Hemianopia 20.24 10.48 24 212382 1704 79530278
Thrombophlebitis 20.11 10.48 49 212357 6286 79525696
Antiphospholipid syndrome 20.09 10.48 25 212381 1866 79530116
Pharyngitis 20.05 10.48 18 212388 22357 79509625
Mydriasis 20.02 10.48 11 212395 17632 79514350
Haematotympanum 19.99 10.48 6 212400 24 79531958
Lip dry 19.98 10.48 8 212398 15410 79516572
Cognitive disorder 19.96 10.48 107 212299 69819 79462163
Panic attack 19.94 10.48 21 212385 24195 79507787
Soft tissue haemorrhage 19.92 10.48 13 212393 410 79531572
Drug tolerance decreased 19.90 10.48 5 212401 12973 79519009
Pneumocystis jirovecii pneumonia 19.89 10.48 35 212371 32473 79499509
Cerebral thrombosis 19.87 10.48 28 212378 2359 79529623
Hiatus hernia 19.86 10.48 118 212288 23194 79508788
Mania 19.85 10.48 12 212394 18248 79513734
Diabetes mellitus 19.68 10.48 125 212281 78265 79453717
Circulatory collapse 19.46 10.48 169 212237 37499 79494483
Injection site rash 19.23 10.48 12 212394 17942 79514040
Arrhythmogenic right ventricular dysplasia 18.91 10.48 6 212400 30 79531952
Dysphagia 18.90 10.48 221 212185 121915 79410067
Skin ulcer haemorrhage 18.84 10.48 14 212392 546 79531436
Pulmonary endarterectomy 18.79 10.48 10 212396 214 79531768
Oral pain 18.77 10.48 35 212371 31763 79500219
Encephalopathy 18.76 10.48 104 212302 67293 79464689
Exsanguination 18.75 10.48 8 212398 102 79531880
Traumatic fracture 18.69 10.48 18 212388 1006 79530976
Oxygen saturation increased 18.69 10.48 14 212392 553 79531429
Monoplegia 18.67 10.48 36 212370 3935 79528047
Thrombotic cerebral infarction 18.58 10.48 14 212392 558 79531424
Hepatic steatosis 18.57 10.48 46 212360 37692 79494290
Throat irritation 18.56 10.48 52 212354 40894 79491088
Aphthous ulcer 18.50 10.48 11 212395 16878 79515104
Post procedural stroke 18.47 10.48 8 212398 106 79531876
Retinal vein thrombosis 18.43 10.48 15 212391 670 79531312
Tumour lysis syndrome 18.36 10.48 22 212384 23917 79508065
Colitis 18.35 10.48 117 212289 73190 79458792
Implant site haematoma 18.31 10.48 9 212397 162 79531820
Protein C deficiency 18.29 10.48 6 212400 34 79531948
Adverse drug reaction 18.18 10.48 103 212303 66289 79465693
Fear 18.18 10.48 19 212387 21967 79510015
Status epilepticus 18.17 10.48 24 212382 25017 79506965
Coeliac disease 18.15 10.48 4 212402 11347 79520635
Knee arthroplasty 18.10 10.48 57 212349 43191 79488791
Hemianopia homonymous 18.03 10.48 20 212386 1321 79530661
Monoparesis 17.96 10.48 33 212373 3478 79528504
Affect lability 17.93 10.48 4 212402 11255 79520727
Anticoagulant-related nephropathy 17.92 10.48 7 212399 70 79531912
Blood phosphorus increased 17.91 10.48 3 212403 10344 79521638
Staphylococcal infection 17.89 10.48 87 212319 58208 79473774
Tenderness 17.84 10.48 22 212384 23620 79508362
Therapeutic procedure 17.81 10.48 16 212390 818 79531164
Subclavian vein thrombosis 17.81 10.48 27 212379 2430 79529552
No adverse event 17.78 10.48 46 212360 37146 79494836
Meningorrhagia 17.77 10.48 11 212395 316 79531666
Diffuse vasculitis 17.77 10.48 8 212398 117 79531865
Oesophageal ulcer haemorrhage 17.68 10.48 14 212392 601 79531381
Disability 17.58 10.48 12 212394 17108 79514874
Hyperhomocysteinaemia 17.56 10.48 13 212393 504 79531478
Medical device site haemorrhage 17.55 10.48 9 212397 178 79531804
Atrio-oesophageal fistula 17.49 10.48 4 212402 3 79531979
Supine hypertension 17.49 10.48 12 212394 412 79531570
Pulmonary artery thrombosis 17.42 10.48 20 212386 1372 79530610
Post procedural oedema 17.33 10.48 7 212399 77 79531905
Product use in unapproved indication 17.31 10.48 521 211885 249838 79282144
Extrapyramidal disorder 17.22 10.48 21 212385 22658 79509324
Vascular access site occlusion 17.17 10.48 7 212399 79 79531903
Lung diffusion disorder 17.15 10.48 9 212397 187 79531795
Tendonitis 17.13 10.48 23 212383 23807 79508175
Encephalitis 17.05 10.48 9 212397 14751 79517231
Platelet dysfunction 17.04 10.48 12 212394 430 79531552
Paraplegia 17.03 10.48 40 212366 5013 79526969
Ear pain 17.02 10.48 39 212367 32830 79499152
Uveitis 17.02 10.48 12 212394 16818 79515164
Post procedural haematuria 16.97 10.48 10 212396 262 79531720
Venous haemorrhage 16.97 10.48 11 212395 343 79531639
Blood pressure fluctuation 16.89 10.48 107 212299 67038 79464944
Fractured coccyx 16.86 10.48 17 212389 1005 79530977
Diabetes mellitus inadequate control 16.86 10.48 24 212382 24240 79507742
Respiratory disorder 16.81 10.48 62 212344 44794 79487188
Catheter site discharge 16.77 10.48 26 212380 2386 79529596
Headache 16.66 10.48 1507 210899 652265 78879717
Injection site induration 16.66 10.48 3 212403 9816 79522166
Pharyngeal haematoma 16.58 10.48 8 212398 138 79531844
Monocyte count increased 16.56 10.48 4 212402 10657 79521325
Parkinsonism 16.54 10.48 12 212394 16572 79515410
Peritoneal haematoma 16.52 10.48 9 212397 202 79531780
Dental care 16.50 10.48 16 212390 902 79531080
Breast cancer female 16.48 10.48 5 212401 11456 79520526
Febrile bone marrow aplasia 16.48 10.48 7 212399 13013 79518969
Post procedural pulmonary embolism 16.48 10.48 10 212396 277 79531705
Delirium 16.45 10.48 145 212261 84482 79447500
Abnormal withdrawal bleeding 16.42 10.48 6 212400 49 79531933
Prothrombin time ratio decreased 16.40 10.48 16 212390 909 79531073
Neuropathy peripheral 16.39 10.48 271 212135 141034 79390948
Tardive dyskinesia 16.35 10.48 4 212402 10567 79521415
Perforated ulcer 16.32 10.48 14 212392 673 79531309
Miosis 16.31 10.48 11 212395 15778 79516204
Generalised tonic-clonic seizure 16.26 10.48 61 212345 43849 79488133
Metabolic acidosis 16.23 10.48 141 212265 82388 79449594
Hypocalcaemia 16.21 10.48 73 212333 49851 79482131
Spinal epidural haemorrhage 16.18 10.48 8 212398 146 79531836
Cardio-respiratory arrest 16.15 10.48 198 212208 108312 79423670
Hemianaesthesia 16.15 10.48 12 212394 468 79531514
Gastric pH increased 16.11 10.48 6 212400 52 79531930
Gastrointestinal erosion 16.11 10.48 17 212389 1061 79530921
Contraindication to surgery 16.07 10.48 4 212402 6 79531976
Intestinal haematoma 16.02 10.48 9 212397 215 79531767
Brain contusion 15.97 10.48 19 212387 1354 79530628
Platelet aggregation inhibition 15.89 10.48 8 212398 152 79531830
Cerebrospinal fluid retention 15.88 10.48 7 212399 97 79531885
Fibrin D dimer increased 15.88 10.48 55 212351 8599 79523383
Aortic intramural haematoma 15.84 10.48 8 212398 153 79531829
Injection site bruising 15.81 10.48 56 212350 40946 79491036
Angiodysplasia 15.80 10.48 17 212389 1085 79530897
Brain stem stroke 15.77 10.48 14 212392 705 79531277
Cardiac vein perforation 15.76 10.48 5 212401 25 79531957
Muscle twitching 15.76 10.48 26 212380 24738 79507244
Osteorrhagia 15.70 10.48 4 212402 7 79531975
Immunodeficiency 15.66 10.48 21 212385 21747 79510235
Bone density decreased 15.62 10.48 8 212398 13339 79518643
Laryngitis 15.49 10.48 12 212394 16027 79515955
Troponin increased 15.48 10.48 96 212310 19159 79512823
Basal ganglia stroke 15.47 10.48 8 212398 161 79531821
Mesenteric haematoma 15.44 10.48 5 212401 27 79531955
Stiff person syndrome 15.42 10.48 10 212396 312 79531670
Haemorrhagic disorder 15.40 10.48 20 212386 1558 79530424
Bladder neoplasm 15.39 10.48 21 212385 1716 79530266
Joint range of motion decreased 15.28 10.48 42 212364 33240 79498742
Thinking abnormal 15.24 10.48 8 212398 13153 79518829
Tongue haemorrhage 15.23 10.48 16 212390 993 79530989
Electrocardiogram QRS complex abnormal 15.22 10.48 13 212393 621 79531361
Scar 15.15 10.48 11 212395 15185 79516797
Septic shock 15.08 10.48 233 212173 122568 79409414
Factor Xa activity increased 15.03 10.48 4 212402 9 79531973
Blood product transfusion dependent 15.01 10.48 11 212395 420 79531562
Anticoagulant therapy 15.00 10.48 5 212401 30 79531952
Brain natriuretic peptide increased 15.00 10.48 55 212351 8845 79523137
Renal embolism 14.95 10.48 8 212398 173 79531809
Aortic valve calcification 14.94 10.48 14 212392 756 79531226
Adjustment disorder with depressed mood 14.94 10.48 3 212403 9083 79522899
Proteinuria 14.93 10.48 41 212365 32461 79499521
Diarrhoea 14.93 10.48 2087 210319 878402 78653580
Hypercholesterolaemia 14.93 10.48 24 212382 23071 79508911
Acute myeloid leukaemia 14.92 10.48 38 212368 30847 79501135
Carpal tunnel syndrome 14.92 10.48 18 212388 19510 79512472
Amaurosis fugax 14.86 10.48 15 212391 888 79531094
Cholecystitis chronic 14.84 10.48 4 212402 9902 79522080
Product label issue 14.80 10.48 14 212392 765 79531217
Orthostatic heart rate response increased 14.79 10.48 3 212403 0 79531982
Spinal subdural haemorrhage 14.79 10.48 3 212403 0 79531982
Paraesthesia 14.77 10.48 357 212049 175966 79356016
Facial bones fracture 14.76 10.48 38 212368 5044 79526938
Peritonitis 14.73 10.48 33 212373 28003 79503979
Cardiac murmur 14.73 10.48 82 212324 15742 79516240
Glomerular filtration rate abnormal 14.72 10.48 20 212386 1628 79530354
Bacterial infection 14.72 10.48 39 212367 31241 79500741
Postoperative thrombosis 14.71 10.48 8 212398 179 79531803
Pharyngeal oedema 14.69 10.48 13 212393 16259 79515723
Shock 14.66 10.48 179 212227 43369 79488613
Chondrocalcinosis 14.63 10.48 16 212390 1040 79530942
Myopathy 14.63 10.48 20 212386 20543 79511439
Product storage error 14.60 10.48 13 212393 16213 79515769
Hot flush 14.56 10.48 86 212320 54791 79477191
Hypophosphataemia 14.54 10.48 19 212387 19894 79512088
Hypertrophic osteoarthropathy 14.50 10.48 7 212399 121 79531861
Subclavian artery thrombosis 14.47 10.48 5 212401 34 79531948
Alanine aminotransferase abnormal 14.43 10.48 3 212403 8864 79523118
Rales 14.41 10.48 97 212309 19904 79512078
Thirst 14.40 10.48 17 212389 18602 79513380
Application site haematoma 14.39 10.48 6 212400 72 79531910
Off label use 14.39 10.48 2159 210247 905056 78626926
Palmar-plantar erythrodysaesthesia syndrome 14.34 10.48 43 212363 33091 79498891
Peripheral artery haematoma 14.34 10.48 7 212399 124 79531858
Drug ineffective for unapproved indication 14.30 10.48 79 212327 51159 79480823
Emergency care 14.28 10.48 16 212390 1068 79530914
Aortic thrombosis 14.28 10.48 20 212386 1675 79530307
Coordination abnormal 14.27 10.48 15 212391 17297 79514685
Pulmonary haematoma 14.24 10.48 7 212399 126 79531856
Change of bowel habit 14.22 10.48 26 212380 2731 79529251
Dyskinesia 14.22 10.48 66 212340 44707 79487275
Pulmonary arterial pressure increased 14.22 10.48 35 212371 4520 79527462
Ovarian cyst 14.20 10.48 8 212398 12647 79519335
Hepatitis C 14.18 10.48 7 212399 11918 79520064
Myoclonus 14.18 10.48 33 212373 27627 79504355
Hypoglycaemia 14.15 10.48 188 212218 101406 79430576
Cataract 14.13 10.48 102 212304 62018 79469964
Pancreatitis acute 14.10 10.48 76 212330 49528 79482454
Tongue disorder 14.08 10.48 10 212396 13965 79518017
Peritonitis bacterial 14.08 10.48 4 212402 9563 79522419
Occult blood 14.03 10.48 20 212386 1703 79530279
Procedural pain 13.99 10.48 25 212381 23059 79508923
Stenosis 13.98 10.48 24 212382 2398 79529584
Manufacturing materials issue 13.97 10.48 4 212402 13 79531969
Diarrhoea haemorrhagic 13.97 10.48 71 212335 13163 79518819
Coronary artery stenosis 13.90 10.48 68 212338 12416 79519566
Tuberculosis 13.89 10.48 12 212394 15186 79516796
Thrombocytosis 13.79 10.48 52 212354 8474 79523508
Spinal epidural haematoma 13.74 10.48 18 212388 1414 79530568
Female genital tract fistula 13.72 10.48 41 212365 5934 79526048
Oedema genital 13.69 10.48 12 212394 594 79531388
Vascular graft occlusion 13.68 10.48 13 212393 715 79531267
Paresis cranial nerve 13.67 10.48 5 212401 41 79531941
Nipple exudate bloody 13.62 10.48 6 212400 83 79531899
Hepatic haematoma 13.62 10.48 14 212392 847 79531135
Exercise tolerance decreased 13.59 10.48 54 212352 9017 79522965
Spinal osteoarthritis 13.58 10.48 15 212391 16912 79515070
Diabetic ketoacidosis 13.57 10.48 46 212360 34076 79497906
Enterococcal infection 13.56 10.48 13 212393 15647 79516335
Mediastinal haematoma 13.53 10.48 8 212398 211 79531771
Pulmonary microemboli 13.53 10.48 4 212402 15 79531967
Obesity 13.53 10.48 48 212358 35077 79496905
Carotid artery occlusion 13.52 10.48 48 212358 7599 79524383
Mucormycosis 13.51 10.48 3 212403 8466 79523516
Muscle rigidity 13.49 10.48 20 212386 19862 79512120
Blood triglycerides increased 13.47 10.48 22 212384 21018 79510964
Pulmonary fibrosis 13.44 10.48 66 212340 44046 79487936
Duplicate therapy error 13.40 10.48 9 212397 298 79531684
Eye pain 13.40 10.48 53 212353 37525 79494457
Peripheral artery stenosis 13.40 10.48 17 212389 1294 79530688
Depressed mood 13.39 10.48 75 212331 48405 79483577
Hemiataxia 13.36 10.48 5 212401 44 79531938
Vulval haemorrhage 13.33 10.48 4 212402 16 79531966
Pancreatic neoplasm 13.32 10.48 18 212388 1458 79530524
Thoracic haemorrhage 13.30 10.48 8 212398 218 79531764
Acidosis 13.29 10.48 20 212386 19742 79512240
Henoch-Schonlein purpura 13.28 10.48 25 212381 2685 79529297
Incision site haematoma 13.27 10.48 7 212399 147 79531835
Percutaneous coronary intervention 13.26 10.48 10 212396 399 79531583
Aortic aneurysm 13.24 10.48 51 212355 8395 79523587
Bacteraemia 13.22 10.48 44 212362 32780 79499202
Exposure to toxic agent 13.16 10.48 4 212402 9154 79522828
Middle insomnia 13.16 10.48 14 212392 16055 79515927
Sneezing 13.16 10.48 20 212386 19663 79512319
Vascular operation 13.14 10.48 7 212399 150 79531832
Endocarditis noninfective 13.14 10.48 8 212398 223 79531759
Lymphostasis 13.14 10.48 4 212402 17 79531965
Catarrh 13.13 10.48 22 212384 2156 79529826
Granuloma 13.11 10.48 3 212403 8294 79523688
Intervertebral disc protrusion 13.08 10.48 27 212379 23594 79508388
Reversible ischaemic neurological deficit 13.07 10.48 5 212401 47 79531935
Central nervous system haemorrhage 13.04 10.48 9 212397 312 79531670
Lacrimation increased 13.04 10.48 25 212381 22452 79509530
Infarction 13.04 10.48 34 212372 4548 79527434
Muscular weakness 13.04 10.48 327 212079 160402 79371580
Intentional overdose 13.02 10.48 201 212205 105759 79426223
Product packaging quantity issue 13.02 10.48 17 212389 1332 79530650
Dry skin 13.00 10.48 117 212289 67878 79464104
Blood pressure decreased 12.97 10.48 352 212054 99114 79432868
Posterior reversible encephalopathy syndrome 12.96 10.48 32 212374 26249 79505733
Ventricular drainage 12.95 10.48 4 212402 18 79531964
Ocular retrobulbar haemorrhage 12.94 10.48 7 212399 155 79531827
Immunosuppressant drug level increased 12.87 10.48 4 212402 9023 79522959
Catheterisation cardiac 12.86 10.48 39 212367 5689 79526293
Idiopathic interstitial pneumonia 12.79 10.48 8 212398 234 79531748
Tracheal haemorrhage 12.78 10.48 12 212394 650 79531332
Amnesia 12.72 10.48 107 212299 62950 79469032
Transient epileptic amnesia 12.72 10.48 3 212403 3 79531979
Stent removal 12.72 10.48 3 212403 3 79531979
Eye pruritus 12.72 10.48 22 212384 20548 79511434
Large intestinal ulcer haemorrhage 12.72 10.48 9 212397 325 79531657
Pneumonia fungal 12.71 10.48 7 212399 11203 79520779
Pelvic haemorrhage 12.70 10.48 7 212399 161 79531821
Nervousness 12.65 10.48 46 212360 33369 79498613
Duodenal polyp 12.62 10.48 9 212397 329 79531653
Cerebral microhaemorrhage 12.61 10.48 8 212398 240 79531742
Colitis ischaemic 12.61 10.48 77 212329 15282 79516700
Dental caries 12.53 10.48 8 212398 11812 79520170
Tooth socket haemorrhage 12.51 10.48 6 212400 102 79531880
Atelectasis 12.48 10.48 44 212362 32213 79499769
Upper gastrointestinal perforation 12.45 10.48 4 212402 21 79531961
Spontaneous haemorrhage 12.41 10.48 13 212393 804 79531178
Duodenitis 12.40 10.48 48 212358 7919 79524063
Blood thyroid stimulating hormone abnormal 12.36 10.48 14 212392 946 79531036
Device expulsion 12.35 10.48 32 212374 25829 79506153
Catheter site pruritus 12.32 10.48 22 212384 2269 79529713
Retinal artery thrombosis 12.31 10.48 6 212400 106 79531876
Intermittent claudication 12.27 10.48 28 212378 3443 79528539
Cor pulmonale acute 12.27 10.48 12 212394 684 79531298
Gastrointestinal arteriovenous malformation 12.27 10.48 14 212392 954 79531028
Osteoporosis 12.23 10.48 89 212317 54023 79477959
Visual acuity reduced 12.22 10.48 39 212367 29430 79502552
Gastroenteritis 12.20 10.48 48 212358 34034 79497948
Intracranial aneurysm 12.18 10.48 33 212373 4517 79527465
Prosthetic cardiac valve thrombosis 12.14 10.48 5 212401 58 79531924
Spinal cord compression 12.12 10.48 41 212365 6336 79525646
Fistula 12.09 10.48 10 212396 12930 79519052
Salivary hypersecretion 12.09 10.48 12 212394 14212 79517770
Therapeutic response increased 12.09 10.48 11 212395 572 79531410
Acute coronary syndrome 12.08 10.48 97 212309 21036 79510946
Movement disorder 12.07 10.48 35 212371 27224 79504758
Basal ganglia haematoma 12.06 10.48 5 212401 59 79531923
Acne 11.98 10.48 35 212371 27155 79504827
Gastritis 11.97 10.48 187 212219 47806 79484176
Hypoxia 11.97 10.48 198 212208 103045 79428937
Tender joint count decreased 11.93 10.48 7 212399 182 79531800
Haemorrhagic hepatic cyst 11.92 10.48 5 212401 61 79531921
Myocarditis 11.90 10.48 25 212381 21708 79510274
Swollen joint count decreased 11.86 10.48 7 212399 184 79531798
Peripheral coldness 11.83 10.48 78 212328 15892 79516090
Degenerative aortic valve disease 11.83 10.48 7 212399 185 79531797
Photosensitivity reaction 11.82 10.48 24 212382 21103 79510879
Breast cancer 11.82 10.48 48 212358 33733 79498249
Blindness unilateral 11.81 10.48 48 212358 8098 79523884
Eosinophil count increased 11.80 10.48 17 212389 17088 79514894
Jaundice acholuric 11.77 10.48 6 212400 117 79531865
Breast haematoma 11.76 10.48 7 212399 187 79531795
Gout 11.74 10.48 109 212297 24640 79507342
Device difficult to use 11.72 10.48 11 212395 13374 79518608
Blood lactate dehydrogenase increased 11.71 10.48 59 212347 39111 79492871
Arterial injury 11.70 10.48 12 212394 724 79531258
Cardiac resynchronisation therapy 11.70 10.48 5 212401 64 79531918
Melanaemia 11.70 10.48 5 212401 64 79531918
Stevens-Johnson syndrome 11.70 10.48 59 212347 39107 79492875
Aortic occlusion 11.69 10.48 7 212399 189 79531793
Left ventricular dysfunction 11.69 10.48 90 212316 19271 79512711
Depressed level of consciousness 11.66 10.48 184 212222 96468 79435514
Increased tendency to bruise 11.65 10.48 57 212349 10407 79521575
Inhibitory drug interaction 11.62 10.48 32 212374 4421 79527561
Pulmonary arterial pressure abnormal 11.62 10.48 12 212394 730 79531252
Enteritis 11.62 10.48 13 212393 14570 79517412
Cardiovascular insufficiency 11.61 10.48 25 212381 2956 79529026
Nephropathy toxic 11.60 10.48 23 212383 20396 79511586
Non-small cell lung cancer recurrent 11.55 10.48 6 212400 122 79531860
Tachycardia induced cardiomyopathy 11.53 10.48 7 212399 194 79531788
Coronary artery disease 11.52 10.48 115 212291 65359 79466623
Chest pain 11.51 10.48 887 211519 281417 79250565
Language disorder 11.45 10.48 26 212380 3188 79528794
Injection site discomfort 11.44 10.48 35 212371 5131 79526851
Gastroduodenal haemorrhage 11.38 10.48 8 212398 286 79531696
Subarachnoid haematoma 11.35 10.48 8 212398 287 79531695
Swelling face 11.35 10.48 128 212278 71084 79460898
Myelodysplastic syndrome 11.28 10.48 42 212364 30259 79501723
Emotional disorder 11.27 10.48 13 212393 14374 79517608
Gastrointestinal tract mucosal discolouration 11.24 10.48 4 212402 30 79531952
Myalgia 11.23 10.48 393 212013 185248 79346734
Intestinal ischaemia 11.20 10.48 67 212339 13203 79518779
Renal vascular thrombosis 11.17 10.48 5 212401 72 79531910
Dyslalia 11.11 10.48 14 212392 1058 79530924
Hypoacusis 11.09 10.48 42 212364 30108 79501874
Neck pain 11.08 10.48 138 212268 75279 79456703
Therapeutic product ineffective 11.04 10.48 19 212387 1903 79530079
Large intestine erosion 11.02 10.48 4 212402 32 79531950
Brief psychotic disorder with marked stressors 11.02 10.48 8 212398 301 79531681
Varicose vein ruptured 11.00 10.48 6 212400 135 79531847
Thrombectomy 10.95 10.48 8 212398 304 79531678
Acute respiratory failure 10.94 10.48 221 212185 59320 79472662
Sensitisation 10.93 10.48 26 212380 3285 79528697
Infective pericardial effusion 10.91 10.48 4 212402 33 79531949
Gastroenteritis viral 10.91 10.48 32 212374 24799 79507183
Aortic dissection 10.89 10.48 30 212376 4145 79527837
Gastrointestinal toxicity 10.85 10.48 4 212402 8105 79523877
Feeling abnormal 10.82 10.48 332 212074 158867 79373115
Left ventricular dilatation 10.82 10.48 14 212392 1087 79530895
Mental status changes 10.81 10.48 120 212286 66839 79465143
Palpitations 10.79 10.48 426 211980 126184 79405798
Cholelithiasis 10.79 10.48 89 212317 52575 79479407
Epidural haemorrhage 10.78 10.48 7 212399 219 79531763
Gastric mucosal lesion 10.77 10.48 13 212393 940 79531042
Prothrombin time abnormal 10.77 10.48 14 212392 1092 79530890
Delusion 10.76 10.48 24 212382 20399 79511583
Hyperaesthesia 10.75 10.48 10 212396 12212 79519770
Ankylosing spondylitis 10.72 10.48 10 212396 12195 79519787
Parosmia 10.71 10.48 42 212364 6972 79525010
Cytopenia 10.70 10.48 24 212382 20359 79511623
Retinal artery embolism 10.69 10.48 6 212400 143 79531839
Acute respiratory distress syndrome 10.69 10.48 71 212335 43996 79487986
Musculoskeletal pain 10.68 10.48 200 212206 102154 79429828
Myoglobin blood increased 10.68 10.48 25 212381 3126 79528856
Haematoma evacuation 10.68 10.48 8 212398 316 79531666
Demyelination 10.67 10.48 4 212402 8019 79523963
Device malfunction 10.66 10.48 26 212380 21422 79510560
Biopsy prostate 10.66 10.48 3 212403 9 79531973
Cardiac valve replacement complication 10.64 10.48 7 212399 224 79531758
Hip arthroplasty 10.60 10.48 54 212352 35702 79496280
Hyperglycaemia 10.60 10.48 128 212278 70207 79461775
Cardiac fibrillation 10.58 10.48 13 212393 958 79531024
Bronchitis 10.54 10.48 266 212140 130378 79401604
Left ventricular failure 10.53 10.48 52 212354 9529 79522453
Skull fractured base 10.53 10.48 8 212398 323 79531659
Chronic kidney disease 10.50 10.48 119 212287 66035 79465947
Lymphoma 10.50 10.48 19 212387 17441 79514541
Cholestatic liver injury 10.50 10.48 33 212373 4908 79527074
Nasal polyps 10.49 10.48 43 212363 7284 79524698
Wound infection 10.48 10.48 31 212375 23960 79508022

FDA Adverse Event Reporting System (Pediatric)

None

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 anticoagulants
CHEBI has role CHEBI:68581 factor Xa inhibitors

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

DiseaseRelationSNOMED_IDDOID
Nonvalvular atrial fibrillation indication 49436004 DOID:0060224
Pulmonary embolism indication 59282003 DOID:9477
Prevention of pulmonary embolism indication 59282003 DOID:9477
Deep venous thrombosis indication 128053003
Stroke prevention indication 135875009
Prevention of stroke caused by a clot in a blood vessel in the brain indication 135875009
Prevention of atherothrombotic events after an acute coronary syndrome indication 394659003
Prevention of systemic embolism caused by a clot in a blood vessel indication 414086009
Venous thromboembolic disease indication 429098002
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 in symptomatic peripheral artery disease indication 840580004
Peripheral arterial disease indication 840580004
Prevention of atherothrombotic events at high risk of ischaemic events 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




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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 March 10, 2023 REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM GALILEO TRIAL
15MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL March 10, 2023 REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM GALILEO TRIAL
2.5MG XARELTO JANSSEN PHARMS N022406 Oct. 11, 2018 RX TABLET ORAL March 10, 2023 REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM GALILEO TRIAL
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL March 10, 2023 REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM GALILEO TRIAL
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 Sept. 10, 2023 PEDIATRIC EXCLUSIVITY
15MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL Sept. 10, 2023 PEDIATRIC EXCLUSIVITY
2.5MG XARELTO JANSSEN PHARMS N022406 Oct. 11, 2018 RX TABLET ORAL Sept. 10, 2023 PEDIATRIC EXCLUSIVITY
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL Sept. 10, 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
1114195 RXNORM
159029 MMSL
26019 MMSL
d07356 MMSL
012873 NDDF
442031002 SNOMEDCT_US
442539005 SNOMEDCT_US
C1739768 UMLSCUI
D000069552 MESH_DESCRIPTOR_UI
9875401 PUBCHEM_CID

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 50458-575 GRANULE, FOR SUSPENSION 155 mg ORAL NDA 35 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50458-575 GRANULE, FOR SUSPENSION 155 mg ORAL NDA 35 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50458-575 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 50458-577 TABLET, FILM COATED 2.50 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 50458-577 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 50458-578 TABLET, FILM COATED 15 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 50458-578 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 50458-579 TABLET, FILM COATED 20 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 50458-579 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 50458-580 TABLET, FILM COATED 10 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 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 55154-1422 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 55154-1423 TABLET, FILM COATED 20 mg ORAL NDA 32 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 55154-1423 TABLET, FILM COATED 20 mg ORAL NDA 32 sections