rivaroxaban 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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: OFP

  • 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
BA (Bioavailability) 90 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 1.492 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 4.688 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 60.395 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 4.955 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 21.440 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 42.740 % High 1
herg hERG pIC50 4.412 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 9.204 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 16.827 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 18.710 % High 1
kinase-safety-class ACVR2B,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,JAK2,MAP3K7,MAPK7,MAPK9,MAPKAPK2,MET,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIK3CD,PRKDC,SIK2,SIK3,STK33,TEK,TTK 34
kinase-selectivity-class BRAF,EIF2AK3,GRK2,SIK2,TEK 5
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 8.299 High 1
mh-clint Mouse hepatocyte intrinsic clearance 27.353 High 1
mppb Mouse plasma protein binding (% unbound) 12.910 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 30.690 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1
pppb Pig plasma protein binding (% unbound) 31.720 % High 1
rh-clint Rat hepatocyte intrinsic clearance 15.704 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 88.980 % High 1
rppb Rat plasma protein binding (% unbound) 9.660 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 36.475 uM High 1

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 6666.39 10.78 3155 145963 87093 90392236
Pulmonary embolism 2570.57 10.78 1949 147169 128871 90350458
Haemorrhage 1511.90 10.78 1101 148017 68268 90411061
Ischaemic stroke 1447.70 10.78 714 148404 21452 90457877
Cerebral haemorrhage 1393.28 10.78 807 148311 33715 90445614
Deep vein thrombosis 1361.22 10.78 1160 147958 90460 90388869
Cerebrovascular accident 1325.23 10.78 1303 147815 122230 90357099
Epistaxis 1281.38 10.78 1086 148032 84039 90395290
Thrombosis 1017.97 10.78 893 148225 72358 90406971
Upper gastrointestinal haemorrhage 996.31 10.78 563 148555 22413 90456916
Haemorrhage intracranial 950.24 10.78 475 148643 14687 90464642
Haematuria 872.78 10.78 603 148515 34334 90444995
Haemoglobin decreased 872.13 10.78 1198 147920 160758 90318571
Heavy menstrual bleeding 846.98 10.78 487 148631 20043 90459286
Anaemia 835.08 10.78 1811 147307 350991 90128338
Haematoma 825.92 10.78 609 148509 38439 90440890
Melaena 823.50 10.78 581 148537 34216 90445113
Vaginal haemorrhage 762.97 10.78 532 148586 30739 90448590
Cerebral infarction 697.29 10.78 473 148645 26123 90453206
Rectal haemorrhage 618.14 10.78 721 148397 82023 90397306
Lower gastrointestinal haemorrhage 594.04 10.78 291 148827 8601 90470728
Embolic stroke 530.65 10.78 213 148905 3859 90475470
Haemorrhagic stroke 514.51 10.78 239 148879 6257 90473072
Hand deformity 470.14 10.78 3 149115 296359 90182970
Glossodynia 448.10 10.78 19 149099 321760 90157569
Subdural haematoma 440.96 10.78 298 148820 16347 90462982
Synovitis 438.47 10.78 26 149092 329726 90149603
Blood loss anaemia 422.08 10.78 242 148876 9898 90469431
Haematochezia 410.79 10.78 544 148574 70369 90408960
Systemic lupus erythematosus 408.05 10.78 56 149062 361840 90117489
Internal haemorrhage 404.87 10.78 200 148918 6020 90473309
Infusion related reaction 400.21 10.78 97 149021 416683 90062646
Haemoptysis 370.77 10.78 359 148759 32961 90446368
Atrial fibrillation 358.43 10.78 723 148395 132888 90346441
International normalised ratio increased 344.39 10.78 407 148711 46909 90432420
Haematemesis 337.54 10.78 343 148775 33383 90445946
Drug intolerance 331.78 10.78 161 148957 447430 90031899
Therapeutic product effect decreased 329.85 10.78 36 149082 277535 90201794
Fall 322.09 10.78 1605 147513 480205 89999124
Drug interaction 317.05 10.78 1088 148030 275365 90203964
Folliculitis 314.88 10.78 4 149114 204349 90274980
Labelled drug-drug interaction medication error 311.75 10.78 229 148889 14353 90464976
Pericarditis 311.15 10.78 39 149079 270112 90209217
Incorrect dose administered 304.37 10.78 500 148618 78430 90400899
Arthropathy 296.27 10.78 116 149002 366126 90113203
Atrial thrombosis 294.49 10.78 118 149000 2127 90477202
Wound 293.69 10.78 69 149049 302911 90176418
Pericardial haemorrhage 289.77 10.78 111 149007 1765 90477564
Faeces discoloured 288.06 10.78 256 148862 21064 90458265
Maternal exposure during pregnancy 275.25 10.78 124 148994 359939 90119390
Joint swelling 270.33 10.78 258 148860 503042 89976287
Intraventricular haemorrhage 270.23 10.78 114 149004 2355 90476974
Rheumatoid arthritis 264.73 10.78 133 148985 362481 90116848
Rheumatoid factor positive 261.66 10.78 4 149114 171646 90307683
Haemarthrosis 261.66 10.78 129 148989 3865 90475464
Muscle injury 261.65 10.78 6 149112 176648 90302681
Post procedural haemorrhage 260.86 10.78 169 148949 8629 90470700
Cerebral haematoma 255.86 10.78 130 148988 4159 90475170
Pain 251.48 10.78 823 148295 995518 89483811
Discomfort 251.41 10.78 70 149048 274265 90205064
Irritable bowel syndrome 251.32 10.78 25 149093 207423 90271906
Hypersensitivity 251.31 10.78 227 148891 454450 90024879
Hepatic enzyme increased 249.13 10.78 142 148976 360594 90118735
Gingival bleeding 246.48 10.78 201 148917 14702 90464627
Type 2 diabetes mellitus 244.90 10.78 25 149093 203219 90276110
Helicobacter infection 244.29 10.78 40 149078 226810 90252519
Cardiac failure 241.11 10.78 547 148571 108949 90370380
Shock haemorrhagic 241.01 10.78 183 148935 12062 90467267
Psoriatic arthropathy 237.71 10.78 44 149074 228291 90251038
Impaired healing 235.67 10.78 49 149069 234150 90245179
Blood cholesterol increased 225.50 10.78 36 149082 207976 90271353
Haemorrhoidal haemorrhage 224.11 10.78 128 148990 5195 90474134
Diverticulum intestinal haemorrhagic 218.73 10.78 89 149029 1672 90477657
Transient ischaemic attack 216.49 10.78 309 148809 42867 90436462
Product prescribing issue 216.47 10.78 145 148973 7834 90471495
Dyspnoea exertional 214.14 10.78 408 148710 71880 90407449
Swelling 213.26 10.78 225 148893 418833 90060496
Alopecia 204.98 10.78 311 148807 494760 89984569
Mobility decreased 201.70 10.78 80 149038 250654 90228675
Blister 200.84 10.78 84 149034 254914 90224415
Haemorrhagic arteriovenous malformation 200.60 10.78 47 149071 101 90479228
Acute kidney injury 198.13 10.78 1045 148073 319342 90159987
Drug hypersensitivity 197.99 10.78 285 148833 463324 90016005
Musculoskeletal stiffness 197.25 10.78 122 148996 296410 90182919
Fibromyalgia 195.84 10.78 49 149069 206220 90273109
Treatment failure 194.05 10.78 131 148987 303797 90175532
Contraindicated product administered 193.90 10.78 146 148972 319993 90159336
Iron deficiency anaemia 186.32 10.78 212 148906 23450 90455879
Prothrombin time prolonged 185.64 10.78 143 148975 9629 90469700
Ill-defined disorder 185.34 10.78 39 149079 184852 90294477
Subarachnoid haemorrhage 184.45 10.78 185 148933 17719 90461610
Injury 183.30 10.78 49 149069 197300 90282029
Coagulopathy 178.89 10.78 206 148912 23083 90456246
Basal ganglia haemorrhage 173.43 10.78 60 149058 701 90478628
Dyspnoea 173.15 10.78 2209 146909 878746 89600583
Stomatitis 171.89 10.78 121 148997 274577 90204752
Arthralgia 169.65 10.78 683 148435 777839 89701490
Uterine haemorrhage 167.83 10.78 102 149016 4650 90474679
Blood urine present 158.96 10.78 168 148950 17110 90462219
Infection 158.08 10.78 219 148899 361875 90117454
Subcutaneous haematoma 157.61 10.78 72 149046 1811 90477518
Embolic cerebral infarction 150.59 10.78 51 149067 556 90478773
Muscle haemorrhage 150.43 10.78 84 149034 3262 90476067
Cerebellar haemorrhage 150.41 10.78 67 149051 1586 90477743
Liver injury 149.84 10.78 47 149071 170520 90308809
Sinusitis 149.27 10.78 208 148910 342880 90136449
Abdominal wall haematoma 147.57 10.78 83 149035 3269 90476060
Bursitis 146.74 10.78 21 149097 131633 90347696
Lip dry 140.27 10.78 6 149112 100949 90378380
Exposure during pregnancy 140.15 10.78 112 149006 238298 90241031
Mouth haemorrhage 139.20 10.78 114 149004 8387 90470942
Renal impairment 136.80 10.78 433 148685 104988 90374341
Hemiplegia 136.16 10.78 150 148968 16010 90463319
Product prescribing error 135.58 10.78 205 148913 29940 90449389
Hemiparesis 135.54 10.78 211 148907 31608 90447721
Gastrointestinal disorder 133.65 10.78 135 148983 256552 90222777
Subdural haemorrhage 132.65 10.78 78 149040 3345 90475984
Joint range of motion decreased 131.11 10.78 31 149087 135612 90343717
Gastric ulcer haemorrhage 130.98 10.78 91 149027 5220 90474109
Haemorrhagic transformation stroke 125.77 10.78 55 149063 1244 90478085
Weight increased 125.63 10.78 317 148801 417610 90061719
C-reactive protein abnormal 125.41 10.78 28 149090 127401 90351928
Hypercholesterolaemia 125.23 10.78 11 149107 100881 90378448
Nasopharyngitis 122.21 10.78 309 148809 406795 90072534
Pulmonary arterial hypertension 120.50 10.78 180 148938 26007 90453322
Abdominal discomfort 118.04 10.78 397 148721 476931 90002398
Grip strength decreased 117.93 10.78 9 149109 92567 90386762
Thalamus haemorrhage 117.90 10.78 45 149073 708 90478621
Activated partial thromboplastin time prolonged 117.89 10.78 100 149018 7725 90471604
Cerebral ischaemia 116.78 10.78 96 149022 7100 90472229
Embolism venous 115.91 10.78 73 149045 3547 90475782
Creatinine renal clearance decreased 115.61 10.78 149 148969 18750 90460579
Inflammation 115.23 10.78 76 149042 178516 90300813
Duodenal ulcer haemorrhage 111.74 10.78 63 149055 2493 90476836
Death 111.62 10.78 1195 147923 455356 90023973
Condition aggravated 110.57 10.78 554 148564 594991 89884338
Sleep disorder 109.07 10.78 99 149019 197931 90281398
Retroperitoneal haemorrhage 108.49 10.78 66 149052 3014 90476315
Lower respiratory tract infection 105.96 10.78 155 148963 250504 90228825
Wound infection 105.47 10.78 23 149095 106379 90372950
Haemorrhage subcutaneous 105.04 10.78 67 149051 3329 90476000
Embolism 103.28 10.78 101 149017 9380 90469949
Gastrointestinal vascular malformation haemorrhagic 102.22 10.78 30 149088 195 90479134
Product use issue 101.64 10.78 247 148871 329672 90149657
Prescribed overdose 101.14 10.78 19 149099 97606 90381723
Postmenopausal haemorrhage 101.13 10.78 58 149060 2372 90476957
Pulmonary hypertension 99.79 10.78 218 148900 42305 90437024
Haemorrhage urinary tract 97.57 10.78 44 149074 1073 90478256
Injection site reaction 95.22 10.78 18 149100 92062 90387267
Post procedural haematoma 94.93 10.78 46 149072 1326 90478003
Syncope 94.75 10.78 451 148667 132212 90347117
Eye haemorrhage 93.67 10.78 99 149019 10081 90469248
Gastric haemorrhage 93.38 10.78 84 149034 7019 90472310
Extradural haematoma 93.20 10.78 52 149066 2016 90477313
Urticaria 92.54 10.78 239 148879 312495 90166834
Venous thrombosis 92.23 10.78 75 149043 5462 90473867
Splenic rupture 91.95 10.78 45 149073 1326 90478003
Pulmonary thrombosis 91.56 10.78 96 149022 9686 90469643
Wheezing 91.37 10.78 157 148961 237923 90241406
Autoimmune disorder 90.96 10.78 10 149108 76734 90402595
Therapeutic product effect incomplete 88.89 10.78 113 149005 193783 90285546
Transfusion 88.88 10.78 126 148992 17362 90461967
Gastric ulcer 88.86 10.78 161 148957 27287 90452042
Cerebral artery embolism 88.79 10.78 40 149078 973 90478356
Intestinal haemorrhage 88.70 10.78 67 149051 4380 90474949
Small intestinal haemorrhage 88.66 10.78 52 149066 2219 90477110
Night sweats 88.32 10.78 51 149067 128715 90350614
Anticoagulation drug level increased 87.87 10.78 29 149089 290 90479039
Hypovolaemic shock 87.60 10.78 81 149037 7013 90472316
Wound haemorrhage 87.28 10.78 56 149062 2811 90476518
Sciatica 87.14 10.78 29 149089 101353 90377976
Cerebral artery occlusion 87.09 10.78 40 149078 1019 90478310
Pyrexia 87.08 10.78 683 148435 659802 89819527
Peripheral embolism 86.34 10.78 43 149075 1317 90478012
C-reactive protein increased 86.00 10.78 103 149015 181286 90298043
Haemothorax 85.64 10.78 52 149066 2366 90476963
Hypoaesthesia 85.59 10.78 250 148868 313960 90165369
Hospitalisation 84.69 10.78 426 148692 127674 90351655
Hypertension 84.62 10.78 426 148692 457106 90022223
Anxiety 83.99 10.78 247 148871 309525 90169804
Depression 82.73 10.78 238 148880 300363 90178966
Pericardial effusion 82.12 10.78 185 148933 36648 90442681
Bradycardia 80.67 10.78 312 148806 83535 90395794
Ecchymosis 79.87 10.78 100 149018 12223 90467106
Peripheral venous disease 79.49 10.78 20 149098 83901 90395428
Renal haemorrhage 79.24 10.78 38 149080 1070 90478259
Pregnancy 79.12 10.78 6 149112 62041 90417288
Oedema peripheral 79.02 10.78 708 148410 257207 90222122
Intracardiac thrombus 78.85 10.78 49 149069 2325 90477004
Glomerular filtration rate decreased 78.78 10.78 117 149001 16815 90462514
Adrenal haemorrhage 77.29 10.78 30 149088 495 90478834
Hypotension 77.23 10.78 847 148271 324550 90154779
Therapeutic response decreased 76.53 10.78 26 149092 89703 90389626
Product monitoring error 74.53 10.78 61 149057 4483 90474846
Head injury 74.44 10.78 161 148957 31027 90448302
Adjustment disorder with depressed mood 73.77 10.78 5 149113 56748 90422581
Osteoarthritis 73.34 10.78 131 148987 195599 90283730
Therapy non-responder 73.30 10.78 70 149048 136634 90342695
Venous thrombosis limb 73.16 10.78 54 149064 3408 90475921
Abnormal uterine bleeding 73.15 10.78 44 149074 1968 90477361
Cardiac failure chronic 72.71 10.78 66 149052 5580 90473749
Incision site haemorrhage 72.55 10.78 30 149088 588 90478741
Pulmonary haemorrhage 72.09 10.78 77 149041 7936 90471393
Obesity 70.65 10.78 43 149075 105464 90373865
Occult blood positive 70.21 10.78 56 149062 3967 90475362
Pulmonary fibrosis 68.99 10.78 46 149072 107457 90371872
Intra-abdominal haemorrhage 68.92 10.78 47 149071 2615 90476714
Psoriasis 68.87 10.78 85 149033 147669 90331660
Cerebral mass effect 68.55 10.78 34 149084 1032 90478297
Cerebral ventricular rupture 68.53 10.78 22 149096 200 90479129
Treatment noncompliance 68.48 10.78 214 148904 51513 90427816
Drug abuse 68.28 10.78 25 149093 82322 90397007
Dizziness 67.91 10.78 1353 147765 587931 89891398
Retinal haemorrhage 67.69 10.78 64 149054 5700 90473629
Duodenal ulcer 67.55 10.78 81 149037 9471 90469858
Arrhythmia 67.38 10.78 187 148931 42145 90437184
Brain stem haemorrhage 67.13 10.78 31 149087 800 90478529
Migraine 66.43 10.78 133 148985 190259 90289070
Aphasia 66.06 10.78 187 148931 42625 90436704
Salpingo-oophorectomy unilateral 65.61 10.78 32 149086 936 90478393
Intentional product use issue 64.71 10.78 165 148953 216727 90262602
Gastritis haemorrhagic 64.50 10.78 39 149079 1761 90477568
Lupus-like syndrome 64.39 10.78 4 149114 48842 90430487
Microcytic anaemia 64.19 10.78 52 149066 3766 90475563
Road traffic accident 63.91 10.78 50 149068 107576 90371753
Cerebellar infarction 63.58 10.78 42 149076 2216 90477113
X-ray abnormal 62.11 10.78 3 149115 45421 90433908
Loss of personal independence in daily activities 61.66 10.78 80 149038 136025 90343304
Presyncope 61.38 10.78 151 148967 31654 90447675
Vascular pseudoaneurysm 60.89 10.78 37 149081 1686 90477643
Insomnia 60.75 10.78 312 148806 333162 90146167
Cardioversion 60.52 10.78 34 149084 1336 90477993
Asthenia 59.97 10.78 1221 147897 532530 89946799
Rash 59.79 10.78 936 148182 795164 89684165
Spinal cord haematoma 59.64 10.78 20 149098 211 90479118
Underdose 59.49 10.78 210 148908 53807 90425522
Cardiac tamponade 59.49 10.78 59 149059 5573 90473756
Device related thrombosis 59.10 10.78 39 149079 2054 90477275
Haematoma muscle 58.47 10.78 37 149081 1813 90477516
Dry mouth 58.06 10.78 136 148982 183923 90295406
Urinary bladder haemorrhage 57.91 10.78 32 149086 1217 90478112
Deep vein thrombosis postoperative 57.87 10.78 22 149096 70787 90408542
Joint stiffness 57.80 10.78 28 149090 78014 90401315
Coeliac disease 57.78 10.78 4 149114 44606 90434723
Gait inability 57.62 10.78 95 149023 146361 90332968
Peripheral ischaemia 57.35 10.78 58 149060 5609 90473720
Splenic haemorrhage 56.96 10.78 19 149099 197 90479132
Central nervous system haemorrhage 56.95 10.78 20 149098 245 90479084
Injection site erythema 56.94 10.78 47 149071 98455 90380874
Foot deformity 56.91 10.78 14 149104 59637 90419692
Sinusitis fungal 56.44 10.78 37 149081 1927 90477402
Large intestinal haemorrhage 55.86 10.78 34 149084 1554 90477775
Gastritis erosive 55.69 10.78 62 149056 6693 90472636
Pharyngeal haemorrhage 54.64 10.78 25 149093 631 90478698
Pulmonary alveolar haemorrhage 54.60 10.78 58 149060 5940 90473389
Prothrombin time shortened 53.77 10.78 38 149080 2240 90477089
Sedation 52.93 10.78 8 149110 48163 90431166
Diverticulum 52.52 10.78 81 149037 12032 90467297
Peripheral artery thrombosis 52.48 10.78 37 149081 2173 90477156
Red blood cell sedimentation rate increased 52.11 10.78 36 149082 82559 90396770
Haemorrhagic cerebral infarction 52.05 10.78 24 149094 617 90478712
Ear infection 51.72 10.78 25 149093 69750 90409579
Retroperitoneal haematoma 50.65 10.78 43 149075 3325 90476004
Traumatic intracranial haemorrhage 50.60 10.78 24 149094 659 90478670
Traumatic haemorrhage 50.51 10.78 23 149095 574 90478755
Hypervolaemia 50.46 10.78 143 148975 32614 90446715
Liver disorder 50.23 10.78 76 149042 121193 90358136
Potentiating drug interaction 50.21 10.78 54 149064 5608 90473721
Drug ineffective 49.45 10.78 1823 147295 1382475 89096854
Truncus arteriosus persistent 48.89 10.78 20 149098 381 90478948
Intra-abdominal haematoma 48.85 10.78 35 149083 2109 90477220
Petechiae 48.02 10.78 90 149028 15651 90463678
Procedural haemorrhage 47.22 10.78 40 149078 3084 90476245
Sputum increased 47.05 10.78 39 149079 2918 90476411
Retinal artery occlusion 47.04 10.78 35 149083 2236 90477093
Right ventricular failure 46.82 10.78 100 149018 19105 90460224
Onychomycosis 46.58 10.78 4 149114 37372 90441957
Fibrin D dimer increased 46.55 10.78 51 149067 5409 90473920
Conjunctival haemorrhage 46.33 10.78 44 149074 3940 90475389
Lower limb fracture 46.19 10.78 43 149075 84970 90394359
Confusional state 45.97 10.78 410 148708 385795 90093534
Musculoskeletal pain 45.33 10.78 138 148980 171113 90308216
Traumatic haematoma 44.84 10.78 31 149087 1764 90477565
Anovulatory cycle 44.75 10.78 15 149103 158 90479171
Laryngitis 44.52 10.78 14 149104 50739 90428590
Anaphylactic reaction 44.41 10.78 47 149071 87477 90391852
Spontaneous haematoma 43.86 10.78 26 149092 1132 90478197
Heart rate irregular 43.46 10.78 112 149006 24156 90455173
Pallor 43.07 10.78 139 148979 34026 90445303
Toxicity to various agents 42.47 10.78 288 148830 287558 90191771
Finger deformity 42.46 10.78 3 149115 32894 90446435
Rectal polyp 42.18 10.78 25 149093 1088 90478241
Colitis ischaemic 41.99 10.78 74 149044 12272 90467057
Pelvic venous thrombosis 41.81 10.78 31 149087 1970 90477359
Injection site pain 41.80 10.78 146 148972 173553 90305776
Liver function test increased 41.48 10.78 47 149071 84808 90394521
Spinal cord haemorrhage 41.39 10.78 16 149102 261 90479068
Product dose omission issue 41.31 10.78 692 148426 290995 90188334
Hemianopia 40.71 10.78 31 149087 2051 90477278
Orthopnoea 40.42 10.78 53 149065 6782 90472547
Bradyarrhythmia 40.29 10.78 33 149085 2428 90476901
Cerebral thrombosis 40.09 10.78 29 149089 1774 90477555
Cerebral artery thrombosis 40.03 10.78 18 149100 436 90478893
High frequency ablation 40.02 10.78 15 149103 224 90479105
Mesenteric artery embolism 39.90 10.78 9 149109 15 90479314
Peripheral artery occlusion 39.64 10.78 27 149091 1499 90477830
Hepatotoxicity 39.58 10.78 13 149105 45829 90433500
Arterial haemorrhage 39.57 10.78 33 149085 2490 90476839
Oesophageal haemorrhage 39.36 10.78 19 149099 543 90478786
Memory impairment 39.10 10.78 179 148939 197065 90282264
Polyp 38.73 10.78 55 149063 7589 90471740
Inappropriate schedule of product administration 38.66 10.78 397 148721 149536 90329793
Palpitations 38.63 10.78 369 148749 136359 90342970
Drug tolerance decreased 38.55 10.78 4 149114 32126 90447203
Muscle spasticity 38.50 10.78 6 149112 35316 90444013
Respiratory symptom 38.50 10.78 41 149077 4211 90475118
Congenital cardiovascular anomaly 38.43 10.78 18 149100 480 90478849
Multiple sclerosis relapse 38.38 10.78 19 149099 52286 90427043
Renal infarct 38.26 10.78 27 149091 1588 90477741
Subgaleal haematoma 38.23 10.78 11 149107 66 90479263
Labelled drug-disease interaction medication error 38.11 10.78 14 149104 197 90479132
Sleep disorder due to a general medical condition 38.08 10.78 13 149105 44725 90434604
Coagulation factor X level increased 37.88 10.78 7 149111 0 90479329
Incorrect route of product administration 37.74 10.78 18 149100 50608 90428721
Ischaemic cerebral infarction 37.60 10.78 26 149092 1480 90477849
Hypersensitivity vasculitis 37.47 10.78 40 149078 4119 90475210
Atrial flutter 37.26 10.78 65 149053 10693 90468636
Back injury 37.24 10.78 15 149103 46607 90432722
Abdominal wall haemorrhage 36.96 10.78 13 149105 160 90479169
Cardiac ablation 36.96 10.78 27 149091 1677 90477652
Ear haemorrhage 36.24 10.78 26 149092 1570 90477759
Creatinine renal clearance abnormal 36.04 10.78 17 149101 461 90478868
Haemoglobin abnormal 35.85 10.78 51 149067 7049 90472280
Lipase increased 35.74 10.78 65 149053 11046 90468283
Blood pressure decreased 35.55 10.78 228 148890 74667 90404662
Haemoperitoneum 35.50 10.78 36 149082 3492 90475837
Gastrointestinal ulcer haemorrhage 35.37 10.78 21 149097 917 90478412
Diastolic dysfunction 34.59 10.78 51 149067 7282 90472047
Joint dislocation 34.56 10.78 15 149103 44567 90434762
Walking aid user 34.52 10.78 8 149110 35498 90443831
Hysterectomy 33.81 10.78 65 149053 11519 90467810
Febrile neutropenia 33.64 10.78 140 148978 158209 90321120
Knee arthroplasty 33.61 10.78 53 149065 83129 90396200
Pruritus 33.42 10.78 659 148459 540866 89938463
International normalised ratio abnormal 32.93 10.78 36 149082 3809 90475520
Chest wall haematoma 32.87 10.78 13 149105 226 90479103
Cardiac failure congestive 32.83 10.78 276 148842 98418 90380911
Ear pain 32.77 10.78 28 149090 57674 90421655
Disability 32.73 10.78 13 149105 40732 90438597
Coagulation time prolonged 32.69 10.78 25 149093 1665 90477664
Haematoma infection 32.56 10.78 18 149100 685 90478644
Full blood count decreased 32.33 10.78 115 149003 29574 90449755
Cardiac pacemaker insertion 32.20 10.78 38 149080 4369 90474960
Colorectal cancer metastatic 31.99 10.78 19 149099 830 90478499
Gastrointestinal angiodysplasia 31.85 10.78 17 149101 603 90478726
Tricuspid valve incompetence 31.82 10.78 79 149039 16652 90462677
Myelosuppression 31.68 10.78 25 149093 53566 90425763
Contraindicated product prescribed 31.39 10.78 24 149094 1598 90477731
Hip arthroplasty 31.32 10.78 48 149070 76160 90403169
Normochromic normocytic anaemia 30.85 10.78 40 149078 5062 90474267
Cardiac septal defect 30.71 10.78 18 149100 767 90478562
Pain in jaw 30.59 10.78 158 148960 47827 90431502
Purpura 30.48 10.78 72 149046 14706 90464623
Brain herniation 30.33 10.78 36 149082 4164 90475165
Arteriovenous malformation 30.07 10.78 23 149095 1532 90477797
Change of bowel habit 30.01 10.78 27 149091 2256 90477073
Menometrorrhagia 29.77 10.78 21 149097 1234 90478095
Lung disorder 29.71 10.78 136 148982 149747 90329582
Muscle spasms 29.68 10.78 268 148850 251615 90227714
Vascular stent thrombosis 29.60 10.78 20 149098 1096 90478233
Product administration error 29.33 10.78 103 149015 26320 90453009
Arterial intramural haematoma 29.30 10.78 11 149107 165 90479164
Spontaneous haemorrhage 29.19 10.78 17 149101 716 90478613
Suicidal ideation 28.95 10.78 48 149070 73807 90405522
Brain stem infarction 28.93 10.78 18 149100 856 90478473
Product quality issue 28.01 10.78 55 149063 79270 90400059
Peripheral coldness 27.92 10.78 67 149051 13825 90465504
Cardiac failure acute 27.80 10.78 61 149057 11868 90467461
Cardiac murmur 27.61 10.78 79 149039 18115 90461214
Amnesia 27.60 10.78 89 149029 108416 90370913
Periorbital haematoma 27.60 10.78 17 149101 794 90478535
Paraplegia 27.59 10.78 31 149087 3381 90475948
Therapeutic response increased 27.38 10.78 14 149104 454 90478875
Arterial thrombosis 27.34 10.78 22 149096 1578 90477751
Product use in unapproved indication 27.32 10.78 389 148729 335847 90143482
Jaundice 27.28 10.78 116 149002 32401 90446928
Injection site swelling 27.27 10.78 35 149083 59804 90419525
Taste disorder 27.03 10.78 37 149081 61509 90417820
Spinal subdural haematoma 27.01 10.78 10 149108 144 90479185
Catheter management 27.00 10.78 29 149089 3007 90476322
Heart disease congenital 26.76 10.78 22 149096 1627 90477702
Toxic epidermal necrolysis 26.75 10.78 10 149108 32518 90446811
Renal vein thrombosis 26.59 10.78 15 149103 594 90478735
Renal failure 26.57 10.78 331 148787 130676 90348653
Hypercoagulation 26.53 10.78 25 149093 2217 90477112
Intracranial haematoma 26.44 10.78 13 149105 387 90478942
Plasma cell myeloma 26.41 10.78 135 148983 40693 90438636
Dry eye 26.28 10.78 34 149084 57897 90421432
Emphysema 25.92 10.78 60 149058 12095 90467234
Vascular purpura 25.75 10.78 22 149096 1716 90477613
Urethral haemorrhage 25.71 10.78 8 149110 65 90479264
Drug resistance 25.66 10.78 9 149109 30440 90448889
Duplicate therapy error 25.57 10.78 9 149109 111 90479218
Pemphigoid 25.55 10.78 50 149068 8976 90470353
Postoperative thrombosis 25.44 10.78 10 149108 171 90479158
Chronic gastritis 25.27 10.78 31 149087 3710 90475619
Product packaging quantity issue 25.22 10.78 21 149097 1581 90477748
Catheter site discharge 25.01 10.78 25 149093 2384 90476945
Hiatus hernia 24.89 10.78 95 149023 25266 90454063
Urogenital haemorrhage 24.86 10.78 11 149107 256 90479073
Thrombophlebitis 24.85 10.78 35 149083 4793 90474536
Coagulation test abnormal 24.80 10.78 17 149101 954 90478375
Trisomy 21 24.78 10.78 13 149105 445 90478884
Cardiac ventricular thrombosis 24.67 10.78 18 149100 1116 90478213
Respiratory disorder 24.60 10.78 43 149075 64773 90414556
Diverticulitis intestinal haemorrhagic 24.54 10.78 9 149109 126 90479203
Acute myocardial infarction 24.44 10.78 118 149000 34772 90444557
Respiratory tract haemorrhage 24.38 10.78 13 149105 460 90478869
Arthritis 24.36 10.78 168 148950 167147 90312182
Premature delivery 24.31 10.78 17 149101 38745 90440584
Arterial injury 24.29 10.78 12 149106 361 90478968
Subcapsular renal haematoma 24.29 10.78 12 149106 361 90478968
Pneumonia viral 23.92 10.78 48 149070 8775 90470554
Thrombocytosis 23.86 10.78 42 149076 6959 90472370
Asthma 23.82 10.78 269 148849 241891 90237438
Haemorrhagic erosive gastritis 23.73 10.78 13 149105 486 90478843
Shock 23.64 10.78 102 149016 28676 90450653
Pelvic haemorrhage 23.61 10.78 9 149109 141 90479188
Delirium 23.59 10.78 90 149028 104269 90375060
Hypochromic anaemia 23.41 10.78 23 149095 2148 90477181
Aortic valve calcification 23.40 10.78 14 149104 620 90478709
Circulatory collapse 23.39 10.78 92 149026 24812 90454517
Immunodeficiency 23.33 10.78 22 149096 43212 90436117
Exostosis 23.27 10.78 32 149086 53102 90426227
Dyspepsia 23.27 10.78 211 148907 197949 90281380
Protein S deficiency 23.26 10.78 6 149112 22 90479307
Procedural pain 23.17 10.78 13 149105 33347 90445982
Cerebral vascular occlusion 23.05 10.78 6 149112 23 90479306
Fluid retention 23.05 10.78 234 148884 87857 90391472
Peripheral arterial occlusive disease 23.05 10.78 33 149085 4588 90474741
Injection site pruritus 23.00 10.78 33 149085 53801 90425528
Post procedural pulmonary embolism 23.00 10.78 10 149108 223 90479106
Mucosal haemorrhage 22.78 10.78 19 149099 1434 90477895
Paraesthesia 22.73 10.78 283 148835 250043 90229286
Peritoneal haematoma 22.71 10.78 8 149110 99 90479230
Retinal vein thrombosis 22.70 10.78 13 149105 530 90478799
Haemorrhagic infarction 22.70 10.78 11 149107 317 90479012
Labelled drug-drug interaction issue 22.65 10.78 23 149095 2235 90477094
Haemorrhagic diathesis 22.64 10.78 36 149082 5488 90473841
Gastrointestinal polyp haemorrhage 22.63 10.78 12 149106 420 90478909
Arrhythmogenic right ventricular dysplasia 22.47 10.78 6 149112 26 90479303
Gait disturbance 22.36 10.78 298 148820 260198 90219131
Bleeding time abnormal 22.29 10.78 5 149113 8 90479321
Tumour haemorrhage 22.23 10.78 22 149096 2072 90477257
Colon cancer 22.23 10.78 53 149065 10891 90468438
Completed suicide 21.94 10.78 144 148974 144914 90334415
Irritability 21.89 10.78 16 149102 35646 90443683
Bladder disorder 21.70 10.78 52 149066 10720 90468609
Orthostatic heart rate response increased 21.65 10.78 4 149114 0 90479329
Oesophagitis haemorrhagic 21.44 10.78 12 149106 468 90478861
Chondrocalcinosis 21.34 10.78 19 149099 1566 90477763
Hydrocephalus 21.34 10.78 37 149081 6057 90473272
Intermenstrual bleeding 21.31 10.78 47 149071 9176 90470153
Epilepsy 21.21 10.78 67 149051 82139 90397190
Myocardial infarction 21.16 10.78 267 148851 105705 90373624
Quadriplegia 21.07 10.78 22 149096 2209 90477120
Traumatic fracture 21.05 10.78 14 149104 747 90478582
Gastritis 20.99 10.78 129 148989 41624 90437705
Diarrhoea haemorrhagic 20.97 10.78 51 149067 10612 90468717
Aortic occlusion 20.89 10.78 8 149110 127 90479202
Haemorrhagic hepatic cyst 20.85 10.78 6 149112 36 90479293
Pulmonary oedema 20.85 10.78 174 148944 61906 90417423
Foetal exposure during pregnancy 20.79 10.78 24 149094 42951 90436378
Rheumatoid nodule 20.72 10.78 4 149114 20162 90459167
Dyspnoea at rest 20.72 10.78 32 149086 4759 90474570
Antiphospholipid syndrome 20.72 10.78 22 149096 2252 90477077
Cerebellar haematoma 20.64 10.78 11 149107 389 90478940
Therapeutic procedure 20.54 10.78 15 149103 931 90478398
Hepatic cirrhosis 20.53 10.78 46 149072 63207 90416122
Radiculopathy 20.50 10.78 3 149115 18502 90460827
Interstitial lung disease 20.49 10.78 204 148914 76201 90403128
Mallory-Weiss syndrome 20.44 10.78 19 149099 1656 90477673
Putamen haemorrhage 20.40 10.78 9 149109 208 90479121
Breast haematoma 20.36 10.78 9 149109 209 90479120
Eosinophilia 20.35 10.78 97 149021 28436 90450893
Chronic gastrointestinal bleeding 20.29 10.78 8 149110 138 90479191
Catheter site erythema 20.21 10.78 32 149086 4862 90474467
Mesenteric haemorrhage 20.19 10.78 6 149112 41 90479288
Adverse reaction 20.04 10.78 12 149106 29700 90449629
Thrombotic stroke 19.92 10.78 12 149106 538 90478791
Affect lability 19.84 10.78 3 149115 18060 90461269
Pulmonary endarterectomy 19.72 10.78 8 149110 149 90479180
Incision site haematoma 19.70 10.78 7 149111 89 90479240
Fatigue 19.63 10.78 1634 147484 1152389 89326940
Endocarditis noninfective 19.56 10.78 7 149111 91 90479238
Gastric pH increased 19.48 10.78 6 149112 47 90479282
Lactic acidosis 19.45 10.78 146 148972 50317 90429012
Herpes zoster 19.28 10.78 85 149033 94559 90384770
Haemorrhoids 19.20 10.78 91 149027 26611 90452718
Hyperkalaemia 19.18 10.78 177 148941 64787 90414542
Thrombocytopenia 19.10 10.78 464 148654 208261 90271068
Cytomegalovirus infection 19.01 10.78 10 149108 26592 90452737
Anal haemorrhage 18.83 10.78 22 149096 2502 90476827
Cholestatic liver injury 18.77 10.78 27 149091 3770 90475559
Prosthetic cardiac valve thrombosis 18.74 10.78 6 149112 54 90479275
General physical health deterioration 18.73 10.78 443 148675 354672 90124657
Protein C deficiency 18.66 10.78 5 149113 22 90479307
Craniocerebral injury 18.62 10.78 25 149093 3273 90476056
Anastomotic ulcer haemorrhage 18.55 10.78 6 149112 56 90479273
Post procedural stroke 18.45 10.78 6 149112 57 90479272
Platelet aggregation inhibition 18.29 10.78 8 149110 181 90479148
Emotional distress 18.25 10.78 20 149098 36642 90442687
Rhinorrhoea 18.18 10.78 79 149039 88237 90391092
Anticoagulation drug level decreased 18.18 10.78 6 149112 60 90479269
Degenerative aortic valve disease 18.17 10.78 8 149110 184 90479145
Oral herpes 18.16 10.78 17 149101 33507 90445822
Tonic clonic movements 18.12 10.78 18 149100 1704 90477625
Catheter site infection 18.09 10.78 33 149085 5621 90473708
Exercise tolerance decreased 18.04 10.78 39 149079 7512 90471817
Intentional product misuse 17.94 10.78 81 149037 89523 90389806
Abnormal withdrawal bleeding 17.92 10.78 6 149112 63 90479266
Normal newborn 17.89 10.78 8 149110 23354 90455975
Vaginal discharge 17.74 10.78 5 149113 19459 90459870
Foetal death 17.68 10.78 6 149112 20717 90458612
Blood creatinine increased 17.58 10.78 249 148869 101137 90378192
Adverse drug reaction 17.57 10.78 116 149002 116585 90362744
Increased tendency to bruise 17.43 10.78 51 149067 11839 90467490
Blood blister 17.40 10.78 20 149098 2235 90477094
Blindness unilateral 17.40 10.78 39 149079 7697 90471632
Monoparesis 17.39 10.78 19 149099 2008 90477321
Myositis 17.35 10.78 9 149109 24119 90455210
Chromaturia 17.32 10.78 70 149048 19117 90460212
Therapeutic response shortened 17.26 10.78 8 149110 22871 90456458
Intracranial aneurysm 17.12 10.78 28 149090 4370 90474959
Uterine disorder 17.09 10.78 24 149094 3277 90476052
Catheter site pruritus 17.07 10.78 20 149098 2282 90477047
Withdrawal bleed 17.05 10.78 6 149112 74 90479255
Vena cava thrombosis 17.00 10.78 21 149097 2531 90476798
Coagulation factor X level abnormal 16.97 10.78 5 149113 33 90479296
Oral candidiasis 16.93 10.78 20 149098 35435 90443894
Dehydration 16.82 10.78 429 148689 194018 90285311
Facial paralysis 16.76 10.78 60 149058 15474 90463855
Splenic infarction 16.64 10.78 19 149099 2108 90477221
Retinal ischaemia 16.57 10.78 10 149108 450 90478879
Catheter site haemorrhage 16.57 10.78 25 149093 3643 90475686
Antineutrophil cytoplasmic antibody positive 16.49 10.78 12 149106 741 90478588
Cerebral ventricle collapse 16.48 10.78 5 149113 37 90479292
Renal haematoma 16.46 10.78 8 149110 232 90479097
Hyponatraemia 16.46 10.78 310 148808 133228 90346101
Crying 16.41 10.78 11 149107 25634 90453695
CHA2DS2-VASc annual stroke risk high 16.23 10.78 3 149115 0 90479329
Contraindication to surgery 16.23 10.78 3 149115 0 90479329
Right hemisphere deficit syndrome 16.23 10.78 3 149115 0 90479329
Emergency care examination 16.19 10.78 7 149111 154 90479175
Hypertensive crisis 16.14 10.78 65 149053 17719 90461610
Spinal cord compression 16.14 10.78 29 149089 4882 90474447
Ventricular arrhythmia 16.14 10.78 27 149091 4294 90475035
N-terminal prohormone brain natriuretic peptide increased 16.03 10.78 22 149096 2940 90476389
Mood swings 15.99 10.78 7 149111 20695 90458634
Jaundice acholuric 15.98 10.78 6 149112 90 90479239
Off label use 15.92 10.78 1580 147538 1100672 89378657
Osteopenia 15.92 10.78 9 149109 22993 90456336
Rhinitis allergic 15.89 10.78 4 149114 16781 90462548
White blood cell count increased 15.84 10.78 57 149061 67184 90412145
Post procedural haematuria 15.82 10.78 5 149113 43 90479286
Ventricle rupture 15.82 10.78 5 149113 43 90479286
Vertigo 15.74 10.78 180 148938 69631 90409698
Proctitis 15.74 10.78 3 149115 15256 90464073
Frequent bowel movements 15.69 10.78 45 149073 56890 90422439
Investigation 15.53 10.78 16 149102 1581 90477748
Macular degeneration 15.52 10.78 24 149094 37946 90441383
Gastrooesophageal reflux disease 15.49 10.78 187 148931 166150 90313179
Sensitisation 15.48 10.78 26 149092 4149 90475180
Skin haemorrhage 15.48 10.78 73 149045 21307 90458022
Hepatic haemorrhage 15.47 10.78 11 149107 655 90478674
Amaurosis 15.45 10.78 12 149106 818 90478511
Glomerular filtration rate 15.44 10.78 4 149114 15 90479314
Dizziness postural 15.41 10.78 41 149077 9012 90470317
Skin laceration 15.41 10.78 84 149034 25951 90453378
Neck pain 15.34 10.78 117 149001 113846 90365483
Nail disorder 15.33 10.78 48 149070 59019 90420310
Vascular graft infection 15.33 10.78 5 149113 48 90479281
Left ventricular dysfunction 15.27 10.78 56 149062 14613 90464716
Post procedural discharge 15.27 10.78 10 149108 520 90478809
Fasciotomy 15.23 10.78 4 149114 16 90479313
Dizziness exertional 15.23 10.78 10 149108 522 90478807
Prothrombin time abnormal 15.23 10.78 10 149108 522 90478807
Catarrh 15.23 10.78 16 149102 1618 90477711
Soft tissue haemorrhage 15.19 10.78 8 149110 276 90479053
Surgery 15.17 10.78 126 148992 44761 90434568
Abdominal pain upper 15.14 10.78 424 148694 332250 90147079
Pseudophaeochromocytoma 15.14 10.78 6 149112 105 90479224
Incorrect dosage administered 15.12 10.78 21 149097 2839 90476490
Atrioventricular block 15.08 10.78 40 149078 8775 90470554
Aggression 15.07 10.78 13 149105 26655 90452674
Urosepsis 15.01 10.78 72 149046 21160 90458169
Hemianopia homonymous 15.01 10.78 12 149106 853 90478476
Haematocrit decreased 14.99 10.78 119 148999 41713 90437616
Monoclonal gammopathy 14.89 10.78 12 149106 863 90478466
Exsanguination 14.86 10.78 4 149114 18 90479311
Conjunctival pallor 14.78 10.78 6 149112 112 90479217
Autoimmune nephritis 14.75 10.78 9 149109 413 90478916
Feeling hot 14.74 10.78 72 149046 77936 90401393
Meningorrhagia 14.73 10.78 7 149111 193 90479136
Catheterisation cardiac 14.70 10.78 28 149090 4928 90474401
Intracranial mass 14.67 10.78 14 149104 1261 90478068
Device loosening 14.67 10.78 12 149106 881 90478448
Injection site rash 14.64 10.78 11 149107 24162 90455167
Panniculitis 14.58 10.78 3 149115 14455 90464874
Injection site discomfort 14.56 10.78 31 149087 5909 90473420
Venous haemorrhage 14.51 10.78 8 149110 303 90479026
Pleural effusion 14.50 10.78 262 148856 111729 90367600
Paresis 14.45 10.78 20 149098 2694 90476635
Muscular weakness 14.43 10.78 246 148872 206420 90272909
Vascular graft occlusion 14.37 10.78 7 149111 204 90479125
Anti factor X activity increased 14.35 10.78 4 149114 21 90479308
Degenerative mitral valve disease 14.35 10.78 4 149114 21 90479308
Aortic thrombosis 14.33 10.78 14 149104 1298 90478031
Post thrombotic syndrome 14.29 10.78 10 149108 580 90478749
Cor pulmonale acute 14.28 10.78 9 149109 438 90478891
Peptic ulcer haemorrhage 14.20 10.78 13 149105 1111 90478218
Coagulation factor VIII level increased 14.20 10.78 4 149114 22 90479307
Urine abnormality 14.16 10.78 36 149082 7701 90471628
Splenic haematoma 14.13 10.78 6 149112 126 90479203
Non-small cell lung cancer recurrent 14.13 10.78 6 149112 126 90479203
Dystonia 14.12 10.78 5 149113 16814 90462515
Poverty of speech 14.11 10.78 8 149110 320 90479009
Mania 14.10 10.78 3 149115 14121 90465208
Cardiac fibrillation 14.08 10.78 10 149108 594 90478735
Hip fracture 14.07 10.78 98 149020 32979 90446350
Pulmonary arterial pressure increased 14.01 10.78 24 149094 3892 90475437
Peripheral swelling 13.95 10.78 547 148571 412559 90066770
Pulmonary artery thrombosis 13.93 10.78 11 149107 768 90478561
Coordination abnormal 13.88 10.78 9 149109 21347 90457982
Anastomotic haemorrhage 13.83 10.78 5 149113 67 90479262
Emergency care 13.82 10.78 15 149103 1574 90477755
Oedema 13.80 10.78 239 148879 200056 90279273
Thrombectomy 13.75 10.78 7 149111 225 90479104
Neutropenia 13.74 10.78 274 148844 224630 90254699
Medical device site haemorrhage 13.70 10.78 5 149113 69 90479260
Vascular operation 13.67 10.78 6 149112 137 90479192
Furuncle 13.65 10.78 35 149083 7526 90471803
Non-pitting oedema 13.59 10.78 6 149112 139 90479190
Paracentesis 13.54 10.78 12 149106 983 90478346
Bone marrow failure 13.52 10.78 20 149098 32201 90447128
Bleeding time prolonged 13.52 10.78 10 149108 633 90478696
Vulval haemorrhage 13.50 10.78 4 149114 27 90479302
Catheter site irritation 13.48 10.78 10 149108 636 90478693
Tendon pain 13.44 10.78 23 149095 3725 90475604
Chest pain 13.44 10.78 649 148469 318996 90160333
Red blood cell sedimentation rate abnormal 13.43 10.78 12 149106 24192 90455137
Hypovolaemia 13.40 10.78 48 149070 12383 90466946
Generalised tonic-clonic seizure 13.39 10.78 23 149095 34880 90444449
Compartment syndrome 13.37 10.78 20 149098 2892 90476437
Adverse event 13.36 10.78 126 148992 117292 90362037
Duodenal polyp 13.33 10.78 7 149111 240 90479089
Protein induced by vitamin K absence or antagonist II increased 13.30 10.78 3 149115 5 90479324
Non-small cell lung cancer 13.30 10.78 25 149093 4356 90474973
Brain contusion 13.22 10.78 10 149108 655 90478674
Pseudomonas infection 13.22 10.78 4 149114 14861 90464468
Product complaint 13.21 10.78 3 149115 13497 90465832
Bleeding varicose vein 13.20 10.78 8 149110 363 90478966
Infective pericardial effusion 13.14 10.78 4 149114 30 90479299
Leriche syndrome 13.02 10.78 4 149114 31 90479298
Tenderness 13.00 10.78 15 149103 26853 90452476
Multiple sclerosis 12.98 10.78 16 149102 27824 90451505
Lymphostasis 12.95 10.78 3 149115 6 90479323
Manufacturing materials issue 12.95 10.78 3 149115 6 90479323
Osteorrhagia 12.95 10.78 3 149115 6 90479323
Hepatic infarction 12.94 10.78 10 149108 676 90478653
Intestinal ischaemia 12.93 10.78 38 149080 8845 90470484
Retinal artery embolism 12.91 10.78 5 149113 82 90479247
Brain compression 12.80 10.78 9 149109 526 90478803
Back disorder 12.74 10.78 14 149104 25617 90453712
No adverse event 12.70 10.78 63 149055 67919 90411410
Skin ulcer haemorrhage 12.70 10.78 8 149110 389 90478940
Ankylosing spondylitis 12.69 10.78 3 149115 13130 90466199
Thrombotic microangiopathy 12.68 10.78 5 149113 15738 90463591
Chronic obstructive pulmonary disease 12.67 10.78 181 148937 73648 90405681
Sedation complication 12.66 10.78 6 149112 16938 90462391
Laryngeal haemorrhage 12.63 10.78 3 149115 7 90479322
Vascular pseudoaneurysm ruptured 12.59 10.78 5 149113 88 90479241
Gastroduodenal haemorrhage 12.59 10.78 5 149113 88 90479241
Nasal polyps 12.59 10.78 43 149075 10837 90468492
Basilar artery thrombosis 12.57 10.78 6 149112 167 90479162
Injection site urticaria 12.54 10.78 7 149111 18004 90461325
Aortic aneurysm rupture 12.51 10.78 9 149109 546 90478783
Performance status decreased 12.47 10.78 24 149094 4256 90475073
Ruptured cerebral aneurysm 12.46 10.78 9 149109 549 90478780
Catheter site vesicles 12.46 10.78 8 149110 402 90478927
Haemorrhagic ovarian cyst 12.43 10.78 10 149108 717 90478612
Pelvic haematoma 12.37 10.78 10 149108 722 90478607
Computerised tomogram head abnormal 12.35 10.78 3 149115 8 90479321
Overdose 12.25 10.78 184 148934 157525 90321804
Portal vein thrombosis 12.25 10.78 20 149098 3118 90476211
Therapy partial responder 12.15 10.78 11 149107 22032 90457297
Brain natriuretic peptide abnormal 12.15 10.78 8 149110 420 90478909
Carotid artery occlusion 12.12 10.78 30 149088 6312 90473017
Osteoporosis 12.12 10.78 101 149017 96430 90382899
Leg amputation 12.11 10.78 17 149101 2320 90477009
Ventricular hypokinesia 12.10 10.78 27 149091 5314 90474015
Catheter site bruise 12.10 10.78 9 149109 575 90478754
Gastric mucosal hypertrophy 12.09 10.78 5 149113 98 90479231
Left ventricular failure 12.08 10.78 31 149087 6669 90472660
Retinal vascular occlusion 11.93 10.78 8 149110 433 90478896
Vascular device infection 11.92 10.78 45 149073 11907 90467422
Cerebral venous sinus thrombosis 11.90 10.78 17 149101 2359 90476970
Subclavian vein thrombosis 11.88 10.78 16 149102 2100 90477229
Optic nerve compression 11.85 10.78 3 149115 10 90479319
Pulmonary arterial pressure 11.78 10.78 4 149114 44 90479285
Nodule 11.76 10.78 16 149102 26670 90452659
Catheter site hypersensitivity 11.73 10.78 5 149113 106 90479223
Catheter site injury 11.72 10.78 7 149111 309 90479020
Cardiac arrest 11.71 10.78 240 148878 104695 90374634
Upper respiratory tract infection 11.66 10.78 145 148973 128173 90351156
Prothrombin time ratio decreased 11.59 10.78 11 149107 984 90478345
Limb injury 11.49 10.78 90 149028 31418 90447911
Infarction 11.49 10.78 19 149099 2994 90476335
Postpartum venous thrombosis 11.43 10.78 3 149115 12 90479317
Vascular stent insertion 11.43 10.78 3 149115 12 90479317
Extra dose administered 11.40 10.78 37 149081 9081 90470248
Colon neoplasm 11.40 10.78 10 149108 808 90478521
Anaemia macrocytic 11.37 10.78 24 149094 4548 90474781
Large intestinal ulcer haemorrhage 11.36 10.78 5 149113 115 90479214
Blood iron decreased 11.35 10.78 59 149059 17900 90461429
Musculoskeletal discomfort 11.28 10.78 66 149052 20925 90458404
Photophobia 11.27 10.78 11 149107 21258 90458071
Sinus disorder 11.22 10.78 25 149093 34422 90444907
Adrenal insufficiency 11.22 10.78 20 149098 29901 90449428
Aneurysm ruptured 11.22 10.78 9 149109 643 90478686
Implant site haemorrhage 11.20 10.78 5 149113 119 90479210
Burns second degree 11.16 10.78 15 149103 1965 90477364
Body temperature increased 11.14 10.78 37 149081 44673 90434656
Exposure to fungus 11.06 10.78 6 149112 220 90479109
Steroid dependence 11.02 10.78 16 149102 2253 90477076
Aortic intramural haematoma 11.01 10.78 5 149113 124 90479205
Wrong patient 11 10.78 10 149108 847 90478482
Proctalgia 10.92 10.78 34 149084 8164 90471165
Subacute hepatic failure 10.90 10.78 5 149113 127 90479202
Cerebral amyloid angiopathy 10.82 10.78 6 149112 230 90479099
Conjunctivitis 10.80 10.78 17 149101 26689 90452640
Osteoporotic fracture 10.79 10.78 24 149094 4712 90474617
Tracheal haemorrhage 10.79 10.78 6 149112 231 90479098

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 5083.96 11.53 3487 141127 94239 42382482
Haemorrhage 1564.69 11.53 1435 143179 59128 42417593
Haematuria 1495.97 11.53 1371 143243 56428 42420293
Cerebral haemorrhage 1265.04 11.53 1052 143562 37914 42438807
Epistaxis 1171.25 11.53 1283 143331 65543 42411178
Haemorrhage intracranial 1015.41 11.53 666 143948 16526 42460195
Cerebrovascular accident 983.08 11.53 1417 143197 95743 42380978
Pulmonary embolism 952.33 11.53 1561 143053 118051 42358670
Upper gastrointestinal haemorrhage 905.04 11.53 780 143834 29519 42447202
Ischaemic stroke 900.71 11.53 684 143930 21549 42455172
Deep vein thrombosis 856.29 11.53 1175 143439 75782 42400939
Cerebral infarction 748.95 11.53 710 143904 30459 42446262
Rectal haemorrhage 725.85 11.53 868 143746 48738 42427983
Melaena 701.04 11.53 757 143857 37989 42438732
Haematoma 682.16 11.53 643 143971 27380 42449341
Atrial thrombosis 562.71 11.53 236 144378 2208 42474513
Subdural haematoma 561.35 11.53 530 144084 22608 42454113
Lower gastrointestinal haemorrhage 524.63 11.53 371 144243 10437 42466284
Haemorrhagic stroke 509.61 11.53 316 144298 7086 42469635
Thrombosis 452.41 11.53 824 143790 67687 42409034
Gastric haemorrhage 442.32 11.53 331 144283 10184 42466537
Embolic stroke 424.50 11.53 245 144369 4795 42471926
Internal haemorrhage 397.61 11.53 241 144373 5180 42471541
Post procedural haemorrhage 378.08 11.53 287 144327 9025 42467696
Blood loss anaemia 371.07 11.53 289 144325 9447 42467274
Haemoptysis 352.38 11.53 592 144022 45575 42431146
Anaemia 332.19 11.53 1846 142768 278432 42198289
Haemoglobin decreased 313.23 11.53 1075 143539 131396 42345325
Drug abuse 293.41 11.53 15 144599 104756 42371965
Haematochezia 292.62 11.53 626 143988 57810 42418911
Transient ischaemic attack 274.03 11.53 445 144169 33294 42443427
Basal ganglia haemorrhage 265.68 11.53 109 144505 959 42475762
Blood urine present 247.46 11.53 249 144365 11484 42465237
Gingival bleeding 242.18 11.53 213 144401 8272 42468449
Diverticulum intestinal haemorrhagic 241.65 11.53 142 144472 2877 42473844
Cerebral haematoma 241.28 11.53 179 144435 5431 42471290
Pericardial haemorrhage 239.67 11.53 150 144464 3419 42473302
Labelled drug-drug interaction medication error 236.47 11.53 278 144336 15304 42461417
Haemarthrosis 233.77 11.53 154 144460 3844 42472877
Febrile neutropenia 227.79 11.53 178 144436 185525 42291196
Haemorrhagic arteriovenous malformation 226.81 11.53 74 144540 307 42476414
Toxicity to various agents 219.63 11.53 273 144341 228863 42247858
Fall 197.16 11.53 1416 143198 233104 42243617
Shock haemorrhagic 197.06 11.53 259 144355 15983 42460738
Haematemesis 187.56 11.53 354 144260 29845 42446876
Thalamus haemorrhage 183.04 11.53 85 144529 1034 42475687
Cerebellar haemorrhage 182.57 11.53 97 144517 1603 42475118
Product prescribing issue 179.38 11.53 163 144451 6610 42470111
Embolic cerebral infarction 178.74 11.53 78 144536 811 42475910
International normalised ratio increased 178.72 11.53 459 144155 47709 42429012
Pyrexia 173.31 11.53 719 143895 393323 42083398
Atrial fibrillation 171.87 11.53 930 143684 138663 42338058
Intraventricular haemorrhage 171.69 11.53 126 144488 3758 42472963
Disease progression 167.03 11.53 145 144469 143511 42333210
Haemorrhoidal haemorrhage 163.23 11.53 126 144488 4062 42472659
Prescribed underdose 158.59 11.53 185 144429 10097 42466624
Incorrect dose administered 155.12 11.53 463 144151 52511 42424210
Faeces discoloured 152.74 11.53 235 144379 16779 42459942
Contusion 151.54 11.53 396 144218 41589 42435132
Procedural haemorrhage 145.94 11.53 101 144513 2740 42473981
Cerebral artery embolism 141.85 11.53 70 144544 983 42475738
Subarachnoid haemorrhage 141.46 11.53 208 144406 14264 42462457
Creatinine renal clearance decreased 137.11 11.53 107 144507 3506 42473215
Gastric ulcer haemorrhage 134.67 11.53 133 144481 5994 42470727
Prothrombin time prolonged 133.90 11.53 163 144451 9306 42467415
Hemiparesis 132.72 11.53 223 144391 17153 42459568
Hemiplegia 132.06 11.53 148 144466 7731 42468990
Neutropenia 130.71 11.53 303 144311 199128 42277593
Wound haemorrhage 130.23 11.53 87 144527 2224 42474497
Foetal exposure during pregnancy 128.61 11.53 8 144606 47303 42429418
Cardioversion 127.32 11.53 64 144550 937 42475784
Sepsis 123.41 11.53 312 144302 199022 42277699
Anticoagulation drug level increased 121.62 11.53 53 144561 549 42476172
Gastrointestinal vascular malformation haemorrhagic 120.61 11.53 58 144556 767 42475954
Subcutaneous haematoma 119.06 11.53 63 144551 1032 42475689
Subdural haemorrhage 114.42 11.53 95 144519 3406 42473315
Mouth haemorrhage 114.28 11.53 123 144491 6138 42470583
Drug interaction 112.67 11.53 1392 143222 265607 42211114
Condition aggravated 108.14 11.53 486 144128 260268 42216453
Anxiety 107.51 11.53 147 144467 118413 42358308
Intracardiac thrombus 103.24 11.53 77 144537 2355 42474366
Cardiac tamponade 103.08 11.53 119 144495 6421 42470300
Splenic rupture 102.55 11.53 66 144548 1581 42475140
Retroperitoneal haemorrhage 101.84 11.53 85 144529 3070 42473651
Cerebral ventricular rupture 100.89 11.53 35 144579 182 42476539
Haemorrhage urinary tract 99.80 11.53 71 144543 2015 42474706
Drug hypersensitivity 99.76 11.53 114 144500 99275 42377446
Mucosal inflammation 96.96 11.53 24 144590 49350 42427371
Iron deficiency anaemia 95.17 11.53 164 144450 12875 42463846
Haemorrhagic transformation stroke 95.13 11.53 65 144549 1726 42474995
Occult blood positive 94.66 11.53 93 144521 4164 42472557
Myoglobin blood increased 92.42 11.53 86 144528 3596 42473125
Muscle haemorrhage 91.51 11.53 90 144524 4035 42472686
Traumatic intracranial haemorrhage 89.70 11.53 46 144568 704 42476017
Fractional exhaled nitric oxide increased 89.29 11.53 60 144554 1549 42475172
Haemothorax 88.86 11.53 99 144515 5137 42471584
Cardiac failure 88.24 11.53 643 143971 106213 42370508
Microcytic anaemia 88.23 11.53 77 144537 2958 42473763
Coagulopathy 87.18 11.53 216 144398 21946 42454775
Gastric ulcer 83.79 11.53 189 144425 18073 42458648
Pelvic venous thrombosis 83.16 11.53 47 144567 882 42475839
High frequency ablation 82.63 11.53 29 144585 157 42476564
Infusion related reaction 81.36 11.53 53 144561 60753 42415968
Aphasia 80.66 11.53 221 144393 23862 42452859
Therapeutic product effect incomplete 79.51 11.53 74 144540 70865 42405856
Post procedural haematoma 79.34 11.53 56 144558 1569 42475152
Drug dependence 78.83 11.53 5 144609 29089 42447632
Nausea 77.05 11.53 919 143695 395880 42080841
Agitation 77.03 11.53 63 144551 64251 42412470
Dyspnoea exertional 76.35 11.53 355 144259 49793 42426928
Underdose 75.93 11.53 172 144442 16494 42460227
Haemorrhagic diathesis 75.29 11.53 72 144542 3117 42473604
Large intestinal haemorrhage 73.97 11.53 55 144559 1674 42475047
Small intestinal haemorrhage 73.66 11.53 62 144552 2266 42474455
Neutrophil count decreased 73.64 11.53 64 144550 63351 42413370
Spinal cord haemorrhage 73.16 11.53 31 144583 298 42476423
Renal haemorrhage 72.64 11.53 53 144561 1566 42475155
Gastritis erosive 71.70 11.53 99 144515 6404 42470317
Brain stem haemorrhage 71.38 11.53 44 144570 975 42475746
Haemorrhage subcutaneous 70.69 11.53 64 144550 2582 42474139
Malignant neoplasm progression 70.68 11.53 165 144449 108235 42368486
Adrenal haemorrhage 69.59 11.53 30 144584 302 42476419
Drug intolerance 68.66 11.53 104 144510 80320 42396401
Brain natriuretic peptide increased 68.62 11.53 99 144515 6671 42470050
Pancytopenia 66.24 11.53 193 144421 117550 42359171
Premature baby 65.78 11.53 3 144611 23150 42453571
No adverse event 65.77 11.53 25 144589 38996 42437725
Abdominal wall haematoma 65.67 11.53 58 144556 2264 42474457
Vomiting 64.95 11.53 649 143965 289074 42187647
Duodenal ulcer haemorrhage 64.91 11.53 89 144525 5719 42471002
Tremor 62.82 11.53 148 144466 96781 42379940
Head injury 62.21 11.53 182 144432 20400 42456321
Therapy non-responder 61.78 11.53 54 144560 53305 42423416
Pulmonary haemorrhage 61.53 11.53 126 144488 11271 42465450
Infection 59.95 11.53 188 144426 111880 42364841
Dizziness 59.82 11.53 1182 143432 248072 42228649
Aggression 59.75 11.53 38 144576 44125 42432596
Sensation of foreign body 59.07 11.53 67 144547 3546 42473175
Haemorrhagic cerebral infarction 58.70 11.53 37 144577 854 42475867
Therapeutic response decreased 58.67 11.53 26 144588 36986 42439735
Multiple organ dysfunction syndrome 58.33 11.53 154 144460 96881 42379840
Cerebral hypoperfusion 58.13 11.53 39 144575 1004 42475717
Peripheral embolism 57.86 11.53 39 144575 1012 42475709
Cytomegalovirus infection 57.35 11.53 19 144595 32287 42444434
Leukopenia 56.98 11.53 104 144510 74642 42402079
Hypochromic anaemia 56.90 11.53 39 144575 1041 42475680
Arterial haemorrhage 56.89 11.53 41 144573 1188 42475533
Insomnia 56.71 11.53 208 144406 118045 42358676
Intentional product misuse 55.82 11.53 77 144537 61823 42414898
Completed suicide 55.81 11.53 156 144458 96309 42380412
Psychotic disorder 55.81 11.53 15 144599 29193 42447528
Overdose 55.31 11.53 178 144436 105086 42371635
Seizure 55.26 11.53 216 144398 120345 42356376
Chills 55.25 11.53 151 144463 93915 42382806
Hyponatraemia 55.12 11.53 169 144445 101293 42375428
Drug withdrawal syndrome 54.72 11.53 5 144609 21544 42455177
Off label use 54.66 11.53 1701 142913 636634 41840087
N-terminal prohormone brain natriuretic peptide abnormal 54.56 11.53 23 144591 218 42476503
Cytokine release syndrome 54.09 11.53 43 144571 44484 42432237
Urinary bladder haemorrhage 53.97 11.53 47 144567 1800 42474921
Diabetes mellitus 53.93 11.53 75 144539 60012 42416709
Plantar fasciitis 53.74 11.53 59 144555 3011 42473710
Bladder tamponade 53.68 11.53 31 144583 607 42476114
Bone marrow failure 52.85 11.53 23 144591 33070 42443651
Vascular pseudoaneurysm 52.55 11.53 55 144559 2657 42474064
Peripheral arterial occlusive disease 52.53 11.53 88 144526 6750 42469971
Eye haemorrhage 52.45 11.53 73 144541 4757 42471964
Hypoxia 52.40 11.53 98 144516 69688 42407033
Syncope 52.05 11.53 541 144073 98865 42377856
Gastrointestinal ulcer haemorrhage 51.81 11.53 33 144581 776 42475945
Myelosuppression 51.81 11.53 37 144577 40424 42436297
Gastritis haemorrhagic 51.76 11.53 44 144570 1630 42475091
Cerebral mass effect 51.69 11.53 40 144574 1294 42475427
Neurotoxicity 51.57 11.53 9 144605 23642 42453079
Deep vein thrombosis postoperative 51.43 11.53 12 144602 6 42476715
Cerebral ischaemia 51.40 11.53 88 144526 6871 42469850
Injection site pain 51.02 11.53 73 144541 57725 42418996
Asthma 50.88 11.53 83 144531 62231 42414490
Aspartate aminotransferase increased 50.65 11.53 117 144497 77046 42399675
Compartment syndrome 50.42 11.53 59 144555 3230 42473491
Duodenal ulcer 49.69 11.53 121 144493 12158 42464563
Urogenital haemorrhage 49.66 11.53 31 144583 703 42476018
Ecchymosis 49.51 11.53 92 144522 7660 42469061
Traumatic haemorrhage 48.85 11.53 38 144576 1239 42475482
Gastrointestinal polyp haemorrhage 48.67 11.53 27 144587 488 42476233
Peptic ulcer haemorrhage 48.58 11.53 30 144584 667 42476054
Suicidal ideation 48.56 11.53 55 144559 48106 42428615
Prostatic haemorrhage 48.54 11.53 22 144592 252 42476469
Cardiac ablation 48.51 11.53 38 144576 1252 42475469
Peripheral artery occlusion 48.46 11.53 44 144570 1782 42474939
Anticoagulation drug level decreased 47.50 11.53 20 144594 189 42476532
Inappropriate schedule of product administration 46.97 11.53 515 144099 95387 42381334
Drug ineffective for unapproved indication 46.24 11.53 53 144561 46110 42430611
Vascular stent thrombosis 46.14 11.53 56 144558 3186 42473535
Product prescribing error 45.13 11.53 192 144422 25920 42450801
Cerebellar infarction 45.03 11.53 46 144568 2159 42474562
Catarrh 44.61 11.53 76 144538 5910 42470811
Sedation 44.37 11.53 24 144590 30451 42446270
White blood cell count decreased 44.31 11.53 208 144406 110188 42366533
Retroperitoneal haematoma 43.91 11.53 53 144561 2998 42473723
Vertigo 43.63 11.53 231 144383 34116 42442605
Puncture site haemorrhage 43.41 11.53 22 144592 328 42476393
Alanine aminotransferase increased 43.36 11.53 154 144460 88252 42388469
Cardiac ventricular thrombosis 42.76 11.53 41 144573 1781 42474940
Parosmia 42.67 11.53 86 144528 7605 42469116
Burns second degree 42.31 11.53 75 144539 6021 42470700
Anticoagulation drug level above therapeutic 42.29 11.53 48 144566 2542 42474179
Rheumatoid arthritis 42.21 11.53 49 144565 42391 42434330
Retinal vascular thrombosis 42.18 11.53 14 144600 62 42476659
Penile haemorrhage 42.14 11.53 32 144582 1006 42475715
Stomatitis 42.06 11.53 66 144548 50263 42426458
Respiratory depression 41.54 11.53 7 144607 18861 42457860
Hypophosphataemia 41.47 11.53 10 144604 20935 42455786
Peripheral ischaemia 41.46 11.53 77 144537 6408 42470313
Arthralgia 41.38 11.53 471 144143 204767 42271954
Haemorrhagic erosive gastritis 41.21 11.53 19 144595 227 42476494
Pancreatitis 40.87 11.53 52 144562 43216 42433505
Ear haemorrhage 40.65 11.53 32 144582 1062 42475659
Wound haematoma 40.62 11.53 13 144601 50 42476671
Leriche syndrome 40.39 11.53 15 144599 98 42476623
Haemoperitoneum 40.21 11.53 42 144572 2024 42474697
Coagulation test abnormal 39.85 11.53 26 144588 638 42476083
Irritability 39.73 11.53 23 144591 28105 42448616
Haemophagocytic lymphohistiocytosis 39.59 11.53 7 144607 18215 42458506
Drug resistance 39.23 11.53 35 144579 34213 42442508
Pneumonia 39.20 11.53 1112 143502 421037 42055684
Ureteric haemorrhage 39.12 11.53 18 144596 214 42476507
Depression 38.95 11.53 220 144394 111143 42365578
Lymphocyte count decreased 38.91 11.53 23 144591 27786 42448935
Death 38.89 11.53 1261 143353 469924 42006797
Cerebral artery occlusion 38.83 11.53 28 144586 812 42475909
Glomerular filtration rate decreased 38.79 11.53 133 144481 16218 42460503
Therapy partial responder 38.78 11.53 10 144604 20011 42456710
Pericardial effusion 38.64 11.53 199 144415 29076 42447645
Ischaemic cerebral infarction 38.61 11.53 37 144577 1606 42475115
Vitreous haemorrhage 38.37 11.53 47 144567 2700 42474021
Steroid dependence 38.29 11.53 76 144538 6646 42470075
Cardiac failure chronic 38.20 11.53 94 144520 9507 42467214
Neutrophil count increased 38.16 11.53 10 144604 19794 42456927
Venous thrombosis 38.00 11.53 57 144557 3978 42472743
Hypovolaemic shock 37.93 11.53 88 144526 8571 42468150
Post thrombotic syndrome 37.90 11.53 15 144599 119 42476602
Cerebral ventricle collapse 37.90 11.53 15 144599 119 42476602
Embolism venous 37.55 11.53 39 144575 1867 42474854
Lipoprotein (a) increased 36.93 11.53 20 144594 344 42476377
Incision site haemorrhage 36.87 11.53 23 144591 521 42476200
Systemic lupus erythematosus 36.80 11.53 91 144523 9233 42467488
Splenic haemorrhage 36.44 11.53 23 144591 532 42476189
Pain 36.36 11.53 598 144016 244250 42232471
Dyspnoea 36.32 11.53 1842 142772 440779 42035942
Rhabdomyolysis 36.23 11.53 139 144475 77880 42398841
Hyperthyroidism 36.10 11.53 119 144495 14222 42462499
Septic shock 36.04 11.53 174 144440 91498 42385223
Peripheral swelling 35.94 11.53 466 144148 89804 42386917
Cerebellar stroke 35.94 11.53 24 144590 613 42476108
Haematoma muscle 35.37 11.53 40 144574 2110 42474611
Brain stem infarction 35.20 11.53 32 144582 1298 42475423
Anaphylactic reaction 34.82 11.53 57 144557 42686 42434035
Spontaneous haematoma 34.43 11.53 25 144589 733 42475988
Incorrect route of product administration 34.15 11.53 20 144594 24285 42452436
Neurologic neglect syndrome 34.14 11.53 16 144598 199 42476522
Splenic haematoma 33.95 11.53 15 144599 161 42476560
Contraindicated product prescribed 33.92 11.53 24 144590 675 42476046
Paranoia 33.69 11.53 4 144610 14022 42462699
Polyp 33.62 11.53 58 144556 4556 42472165
Traumatic haematoma 33.62 11.53 25 144589 761 42475960
Anaphylactic shock 33.54 11.53 19 144595 23498 42453223
Conjunctival haemorrhage 33.40 11.53 50 144564 3483 42473238
Thrombotic stroke 33.39 11.53 17 144597 256 42476465
Sleep disorder due to a general medical condition 33.27 11.53 9 144605 17444 42459277
White blood cell count increased 33.24 11.53 64 144550 45023 42431698
Renal haematoma 33.00 11.53 23 144591 631 42476090
Putamen haemorrhage 32.82 11.53 17 144597 266 42476455
Abnormal behaviour 32.81 11.53 25 144589 26426 42450295
Renal infarct 32.63 11.53 36 144578 1847 42474874
Serotonin syndrome 32.61 11.53 24 144590 25821 42450900
Ascites 32.51 11.53 92 144522 56586 42420135
C-reactive protein increased 32.32 11.53 109 144505 63451 42413270
Sleep disorder 32.30 11.53 72 144542 48023 42428698
Venous thrombosis limb 32.23 11.53 40 144574 2329 42474392
Diarrhoea 32.14 11.53 1259 143355 459590 42017131
Injection site reaction 32.13 11.53 7 144607 15714 42461007
Gastrointestinal angiectasia 32.10 11.53 17 144597 279 42476442
Aneurysm ruptured 32.01 11.53 22 144592 590 42476131
Intestinal haemorrhage 31.90 11.53 52 144562 3899 42472822
Ulcer haemorrhage 31.83 11.53 46 144568 3104 42473617
Drug ineffective 31.74 11.53 1783 142831 628414 41848307
Sinusitis 31.60 11.53 71 144543 47221 42429500
Hypopnoea 31.18 11.53 77 144537 7805 42468916
Therapeutic product effect decreased 31.16 11.53 53 144561 39097 42437624
Colitis 31.05 11.53 70 144544 46502 42430219
Hypersensitivity 31.05 11.53 133 144481 72237 42404484
Abdominal pain 31.03 11.53 457 144157 190014 42286707
Labelled drug-drug interaction issue 30.94 11.53 34 144580 1737 42474984
Gingival pain 30.51 11.53 80 144534 8414 42468307
Hypophagia 30.33 11.53 28 144586 26928 42449793
Treatment noncompliance 30.08 11.53 225 144389 37447 42439274
Psoriasis 30.06 11.53 76 144538 48528 42428193
Pancreatitis acute 30.01 11.53 42 144572 33522 42443199
Chronic gastrointestinal bleeding 29.94 11.53 17 144597 322 42476399
Blood blister 29.93 11.53 37 144577 2146 42474575
Embolism 29.92 11.53 81 144533 8682 42468039
Arteriovenous malformation 29.91 11.53 24 144590 819 42475902
Respiratory failure 29.90 11.53 284 144330 127848 42348873
Accidental exposure to product 29.77 11.53 16 144598 20377 42456344
Mallory-Weiss syndrome 29.74 11.53 31 144583 1490 42475231
Labelled drug-disease interaction medication error 29.63 11.53 13 144601 137 42476584
Blood glucose increased 29.48 11.53 139 144475 73560 42403161
Contraindicated product administered 29.43 11.53 166 144448 25106 42451615
Vena cava thrombosis 29.07 11.53 31 144583 1530 42475191
Acute myeloid leukaemia 28.95 11.53 20 144594 22236 42454485
Renal tubular necrosis 28.92 11.53 13 144601 18341 42458380
Musculoskeletal stiffness 28.74 11.53 100 144514 57665 42419056
Aplastic anaemia 28.62 11.53 4 144610 12380 42464341
Pathogen resistance 28.17 11.53 3 144611 11447 42465274
Nephropathy toxic 28.02 11.53 11 144603 16827 42459894
Cerebral vascular occlusion 28.00 11.53 7 144607 7 42476714
Bacterial infection 27.92 11.53 32 144582 27847 42448874
Multiple sclerosis relapse 27.87 11.53 7 144607 14257 42462464
Aortic aneurysm rupture 27.74 11.53 26 144588 1097 42475624
Gastrointestinal angiodysplasia 27.74 11.53 21 144593 657 42476064
Brain natriuretic peptide abnormal 27.73 11.53 17 144597 373 42476348
Coagulation time prolonged 27.67 11.53 29 144585 1403 42475318
Fractured coccyx 27.64 11.53 13 144601 163 42476558
Spleen ischaemia 27.64 11.53 10 144604 60 42476661
Purpura 27.63 11.53 96 144518 11783 42464938
Medication error 27.61 11.53 200 144414 32954 42443767
Back pain 27.52 11.53 328 144286 141448 42335273
End stage renal disease 27.25 11.53 11 144603 16547 42460174
Pulmonary alveolar haemorrhage 27.21 11.53 111 144503 14705 42462016
Somnolence 27.18 11.53 327 144287 140778 42335943
Large intestine polyp 27.11 11.53 81 144533 9184 42467537
Neuroleptic malignant syndrome 27.01 11.53 20 144594 21452 42455269
Cardiac arrest 26.94 11.53 239 144375 109081 42367640
Intentional self-injury 26.87 11.53 9 144605 15193 42461528
Pharyngeal haemorrhage 26.65 11.53 22 144592 782 42475939
Peripheral artery bypass 26.58 11.53 10 144604 68 42476653
Schizophrenia 25.36 11.53 3 144611 10547 42466174
Platelet dysfunction 25.34 11.53 15 144599 308 42476413
Upper respiratory tract infection 25.27 11.53 67 144547 42106 42434615
Brain compression 25.23 11.53 13 144601 201 42476520
Blood creatine phosphokinase increased 25.19 11.53 82 144532 48256 42428465
Cytopenia 25.15 11.53 14 144600 17483 42459238
Speech disorder 25.02 11.53 177 144437 28944 42447777
Cytomegalovirus viraemia 24.83 11.53 3 144611 10374 42466347
Anal haemorrhage 24.82 11.53 39 144575 2834 42473887
Myocarditis 24.66 11.53 17 144597 18921 42457800
Bronchopulmonary aspergillosis 24.57 11.53 18 144596 19411 42457310
Encephalopathy 24.52 11.53 66 144548 41267 42435454
Constipation 24.51 11.53 395 144219 161896 42314825
Haemodialysis 24.46 11.53 3 144611 10257 42466464
Ischaemic nephropathy 24.37 11.53 10 144604 88 42476633
Periorbital haemorrhage 24.35 11.53 11 144603 125 42476596
Hyperphosphataemia 24.24 11.53 7 144607 12997 42463724
Skin exfoliation 24.16 11.53 67 144547 41486 42435235
Respiratory arrest 24.01 11.53 37 144577 28387 42448334
Tumour lysis syndrome 23.96 11.53 24 144590 22207 42454514
Therapeutic procedure 23.94 11.53 14 144600 281 42476440
Osteonecrosis 23.83 11.53 12 144602 15853 42460868
Haemorrhoids 23.81 11.53 118 144496 16979 42459742
Extradural haematoma 23.71 11.53 26 144588 1325 42475396
Intra-abdominal haematoma 23.63 11.53 28 144586 1553 42475168
Lymphopenia 23.56 11.53 23 144591 21540 42455181
Binocular eye movement disorder 23.55 11.53 14 144600 290 42476431
Bleeding varicose vein 23.47 11.53 15 144599 355 42476366
Mesenteric haemorrhage 23.45 11.53 7 144607 20 42476701
Bleeding time prolonged 23.42 11.53 19 144595 659 42476062
Parkinsonism 23.25 11.53 4 144610 10619 42466102
Dry skin 23.16 11.53 85 144529 48253 42428468
Haemorrhagic infarction 23.10 11.53 17 144597 509 42476212
Activated partial thromboplastin time prolonged 23.04 11.53 111 144503 15792 42460929
Pneumocystis jirovecii pneumonia 23.02 11.53 31 144583 25150 42451571
Emotional distress 22.95 11.53 13 144601 16080 42460641
Penis injury 22.90 11.53 13 144601 246 42476475
Presyncope 22.81 11.53 142 144472 22245 42454476
Product use in unapproved indication 22.80 11.53 465 144149 183991 42292730
Stiff person syndrome 22.71 11.53 12 144602 196 42476525
Product label issue 22.64 11.53 14 144600 312 42476409
Atrial flutter 22.58 11.53 117 144497 17134 42459587
Facial paresis 22.57 11.53 40 144574 3210 42473511
Anger 22.51 11.53 8 144606 13010 42463711
Lip discolouration 22.44 11.53 12 144602 201 42476520
Toxic epidermal necrolysis 22.42 11.53 35 144579 26715 42450006
Ulnar nerve injury 22.34 11.53 10 144604 111 42476610
Spinal cord haematoma 22.34 11.53 10 144604 111 42476610
Palpitations 22.25 11.53 267 144347 50530 42426191
Cardiac murmur 22.12 11.53 94 144520 12681 42464040
Haematospermia 22.10 11.53 14 144600 326 42476395
Mesenteric artery thrombosis 22.10 11.53 19 144595 715 42476006
Restlessness 22.01 11.53 41 144573 29208 42447513
Anticoagulation drug level abnormal 22.01 11.53 11 144603 159 42476562
Hepatotoxicity 21.99 11.53 32 144582 25135 42451586
Traumatic haemothorax 21.93 11.53 15 144599 399 42476322
Hypercoagulation 21.79 11.53 26 144588 1453 42475268
Embolism arterial 21.72 11.53 20 144594 825 42475896
Pulmonary arterial hypertension 21.71 11.53 80 144534 10107 42466614
Herpes zoster 21.64 11.53 64 144550 38813 42437908
Fungal infection 21.59 11.53 21 144593 19701 42457020
Spinal epidural haematoma 21.51 11.53 15 144599 412 42476309
Appendicitis 21.37 11.53 23 144591 20590 42456131
Hypersensitivity vasculitis 21.35 11.53 39 144575 3205 42473516
Diverticulitis intestinal haemorrhagic 21.30 11.53 14 144600 348 42476373
Skin haemorrhage 21.27 11.53 67 144547 7818 42468903
Brain herniation 21.11 11.53 49 144565 4774 42471947
Peripheral artery thrombosis 21.11 11.53 35 144579 2662 42474059
Pulmonary endarterectomy 21.02 11.53 9 144605 89 42476632
Night sweats 21.02 11.53 22 144592 19947 42456774
Withdrawal syndrome 20.98 11.53 12 144602 14763 42461958
Phlebitis deep 20.96 11.53 6 144608 14 42476707
Occult blood 20.92 11.53 21 144593 965 42475756
Dental care 20.92 11.53 14 144600 359 42476362
Oxygen saturation increased 20.90 11.53 13 144601 293 42476428
Dehydration 20.76 11.53 347 144267 141420 42335301
Haematoma infection 20.75 11.53 22 144592 1079 42475642
Tachycardia 20.72 11.53 231 144383 100856 42375865
Hydrocephalus 20.57 11.53 56 144558 6022 42470699
Weight increased 20.50 11.53 251 144363 107732 42368989
Antiphospholipid syndrome 20.46 11.53 17 144597 610 42476111
Retinal artery occlusion 20.45 11.53 31 144583 2184 42474537
Potentiating drug interaction 20.32 11.53 58 144556 6410 42470311
Influenza like illness 20.31 11.53 49 144565 31791 42444930
Dystonia 20.24 11.53 9 144605 12781 42463940
Exostosis 20.19 11.53 53 144561 5578 42471143
Decreased appetite 20.14 11.53 500 144114 192637 42284084
Alcohol poisoning 20.10 11.53 64 144550 7510 42469211
Enterocolitis infectious 20.10 11.53 29 144585 1954 42474767
Post procedural haematuria 20.04 11.53 12 144602 252 42476469
Osteonecrosis of jaw 20.03 11.53 21 144593 19028 42457693
Neuropathy peripheral 20.00 11.53 235 144379 101618 42375103
Lymphadenopathy 20.00 11.53 53 144561 33312 42443409
Diabetic ketoacidosis 19.98 11.53 28 144586 22339 42454382
Neutropenic sepsis 19.87 11.53 15 144599 15931 42460790
Catheter site haemorrhage 19.85 11.53 33 144581 2515 42474206
Blood thyroid stimulating hormone abnormal 19.84 11.53 14 144600 392 42476329
Hyperglycaemia 19.83 11.53 84 144530 45775 42430946
Lymphoma 19.81 11.53 12 144602 14309 42462412
Blood cholesterol increased 19.67 11.53 38 144576 26703 42450018
Pulmonary arterial pressure abnormal 19.64 11.53 13 144601 327 42476394
Hypertension 19.64 11.53 425 144189 166779 42309942
Mental status changes 19.57 11.53 75 144539 42040 42434681
Implant site haematoma 19.56 11.53 9 144605 107 42476614
Nodule 19.56 11.53 9 144605 12525 42464196
Arterial thrombosis 19.52 11.53 27 144587 1749 42474972
Oedema peripheral 19.50 11.53 602 144012 135474 42341247
Intracranial haematoma 19.47 11.53 16 144598 565 42476156
Ill-defined disorder 19.46 11.53 16 144598 16280 42460441
Sticky platelet syndrome 19.41 11.53 6 144608 20 42476701
Hyperhomocysteinaemia 19.38 11.53 12 144602 268 42476453
Platelet count decreased 19.38 11.53 342 144272 138239 42338482
Tumour haemorrhage 19.38 11.53 40 144574 3598 42473123
Candida infection 19.36 11.53 27 144587 21583 42455138
Injection site erythema 19.35 11.53 24 144590 20171 42456550
Vascular graft occlusion 19.14 11.53 16 144598 579 42476142
Intra-abdominal haemorrhage 19.01 11.53 35 144579 2893 42473828
Neoplasm progression 19.00 11.53 44 144570 28956 42447765
Gastrointestinal arteriovenous malformation 18.97 11.53 13 144601 347 42476374
Enzyme inhibition 18.96 11.53 8 144606 76 42476645
Synovitis 18.94 11.53 15 144599 15552 42461169
Vascular graft thrombosis 18.94 11.53 10 144604 163 42476558
Haemorrhagic disorder 18.92 11.53 18 144596 774 42475947
Hypercalcaemia 18.89 11.53 20 144594 18038 42458683
Myelodysplastic syndrome 18.84 11.53 30 144584 22715 42454006
Erythema 18.76 11.53 258 144356 108535 42368186
Coagulation factor X level increased 18.76 11.53 4 144610 0 42476721
Labelled drug-disease interaction issue 18.76 11.53 4 144610 0 42476721
Aortic surgery 18.76 11.53 4 144610 0 42476721
Dyskinesia 18.75 11.53 36 144578 25354 42451367
Disease recurrence 18.67 11.53 46 144568 29632 42447089
Renal impairment 18.65 11.53 498 144116 109730 42366991
Basal ganglia haematoma 18.56 11.53 7 144607 48 42476673
Fear 18.51 11.53 7 144607 10958 42465763
Blood triglycerides increased 18.50 11.53 16 144598 15880 42460841
Progressive multifocal leukoencephalopathy 18.44 11.53 8 144606 11528 42465193
Hypoglycaemia 18.43 11.53 123 144491 59731 42416990
Paralysis 18.34 11.53 59 144555 6961 42469760
Thrombotic microangiopathy 18.30 11.53 14 144600 14768 42461953
Viral infection 18.29 11.53 30 144584 22453 42454268
Vision blurred 18.27 11.53 107 144507 53592 42423129
Diffuse vasculitis 18.26 11.53 8 144606 84 42476637
Drug reaction with eosinophilia and systemic symptoms 18.24 11.53 77 144537 41998 42434723
Bladder neoplasm 18.22 11.53 24 144590 1483 42475238
Supine hypertension 18.18 11.53 13 144601 372 42476349
Bronchiectasis 18.18 11.53 114 144500 17905 42458816
Palmar-plantar erythrodysaesthesia syndrome 18.15 11.53 26 144588 20556 42456165
Bacteraemia 18.06 11.53 36 144578 25004 42451717
Dysphonia 17.90 11.53 161 144453 28289 42448432
Dysphagia 17.90 11.53 159 144455 72560 42404161
Myasthenia gravis 17.87 11.53 17 144597 16120 42460601
Post-traumatic amnestic disorder 17.86 11.53 7 144607 54 42476667
Product administration error 17.85 11.53 115 144499 18228 42458493
Oesophageal haemorrhage 17.85 11.53 23 144591 1391 42475330
Metabolic acidosis 17.82 11.53 103 144511 51755 42424966
Status epilepticus 17.74 11.53 16 144598 15562 42461159
Small intestinal obstruction 17.73 11.53 19 144595 17042 42459679
Renal embolism 17.65 11.53 9 144605 136 42476585
Rhinitis 17.64 11.53 84 144530 11893 42464828
Vascular access site occlusion 17.64 11.53 7 144607 56 42476665
Blood lactate dehydrogenase increased 17.55 11.53 39 144575 26042 42450679
Staphylococcal infection 17.51 11.53 67 144547 37576 42439145
Spinal osteoarthritis 17.49 11.53 4 144610 8682 42468039
Acute myocardial infarction 17.49 11.53 286 144328 57879 42418842
Hemianaesthesia 17.32 11.53 8 144606 96 42476625
Duodenitis haemorrhagic 17.32 11.53 8 144606 96 42476625
Respiratory distress 17.24 11.53 78 144536 41742 42434979
Rhinorrhoea 17.22 11.53 53 144561 31741 42444980
Subclavian vein thrombosis 17.19 11.53 19 144595 977 42475744
Hyperammonaemia 17.13 11.53 3 144611 7863 42468858
Blood pressure increased 17.12 11.53 243 144371 101685 42375036
Carotid artery aneurysm 17.12 11.53 7 144607 61 42476660
Psoriatic arthropathy 17.07 11.53 37 144577 24930 42451791
Middle insomnia 17.04 11.53 3 144611 7830 42468891
Extra dose administered 17.00 11.53 50 144564 5619 42471102
Haemodilution 16.87 11.53 6 144608 34 42476687
Salivary hypersecretion 16.85 11.53 8 144606 10935 42465786
Gravitational oedema 16.74 11.53 16 144598 692 42476029
Vocal cord inflammation 16.55 11.53 7 144607 67 42476654
Blood uric acid increased 16.51 11.53 17 144597 15530 42461191
Angioedema 16.46 11.53 81 144533 42396 42434325
Hypogammaglobulinaemia 16.40 11.53 10 144604 11881 42464840
Sinus tachycardia 16.40 11.53 28 144586 20625 42456096
Klebsiella infection 16.38 11.53 9 144605 11323 42465398
International normalised ratio abnormal 16.34 11.53 36 144578 3387 42473334
Hyperlipidaemia 16.33 11.53 30 144584 21486 42455235
Retinal artery thrombosis 16.33 11.53 5 144609 16 42476705
Hallucination 16.32 11.53 121 144493 57386 42419335
Immune reconstitution inflammatory syndrome 16.27 11.53 7 144607 10136 42466585
Laryngeal haematoma 16.26 11.53 9 144605 162 42476559
Prostate cancer 16.25 11.53 87 144527 44556 42432165
Hypertriglyceridaemia 16.22 11.53 7 144607 10119 42466602
Thrombophlebitis 16.22 11.53 39 144575 3887 42472834
Diabetes mellitus inadequate control 16.15 11.53 17 144597 15373 42461348
N-terminal prohormone brain natriuretic peptide increased 16.13 11.53 36 144578 3417 42473304
Lung diffusion disorder 16.11 11.53 9 144605 165 42476556
Nasal congestion 16.10 11.53 49 144565 29452 42447269
Frequent bowel movements 16.05 11.53 126 144488 21281 42455440
Electrocardiogram QRS complex abnormal 16.00 11.53 13 144601 452 42476269
Mediastinal haematoma 15.98 11.53 8 144606 116 42476605
Peritonitis 15.98 11.53 24 144590 18609 42458112
Foreign body in throat 15.95 11.53 14 144600 542 42476179
Product storage error 15.89 11.53 9 144605 11131 42465590
Hepatic function abnormal 15.86 11.53 106 144508 51461 42425260
Stent placement 15.81 11.53 47 144567 5313 42471408
Delusion 15.77 11.53 16 144598 14718 42462003
Blood glucose decreased 15.73 11.53 15 144599 14204 42462517
Intercepted product preparation error 15.70 11.53 3 144611 7386 42469335
Hemiataxia 15.68 11.53 6 144608 43 42476678
Hospitalisation 15.64 11.53 346 144268 73984 42402737
Tendonitis 15.60 11.53 7 144607 9887 42466834
Skin ulcer haemorrhage 15.55 11.53 9 144605 177 42476544
Pruritus 15.53 11.53 505 144109 188266 42288455
Basilar artery thrombosis 15.48 11.53 10 144604 241 42476480
Eosinophilic granulomatosis with polyangiitis 15.47 11.53 5 144609 8633 42468088
Thrombosis mesenteric vessel 15.34 11.53 8 144606 127 42476594
Hypertrophic osteoarthropathy 15.23 11.53 7 144607 83 42476638
Anastomotic ulcer haemorrhage 15.23 11.53 6 144608 47 42476674
Eye pruritus 15.19 11.53 10 144604 11402 42465319
Delirium 15.15 11.53 110 144504 52409 42424312
Hyperhidrosis 15.12 11.53 216 144398 90296 42386425
Haematotympanum 15.11 11.53 4 144610 6 42476715
Biopsy prostate 15.09 11.53 5 144609 22 42476699
Varicophlebitis 15.09 11.53 5 144609 22 42476699
Conjunctivitis 15.08 11.53 13 144601 12926 42463795
Anticoagulation drug level below therapeutic 15.06 11.53 18 144596 1008 42475713
Alopecia 15.02 11.53 50 144564 29226 42447495
Blood bilirubin increased 15.01 11.53 83 144531 42169 42434552
Intermittent claudication 15.01 11.53 29 144585 2486 42474235
Hypotension 14.92 11.53 1040 143574 256591 42220130
Body temperature increased 14.91 11.53 29 144585 20329 42456392
Postoperative thrombosis 14.91 11.53 6 144608 50 42476671
Myocardial infarction 14.90 11.53 314 144300 123695 42353026
Swollen joint count decreased 14.82 11.53 10 144604 260 42476461
Tender joint count decreased 14.82 11.53 10 144604 260 42476461
Gastrointestinal disorder 14.80 11.53 95 144519 46558 42430163
Suspected counterfeit product 14.76 11.53 11 144603 336 42476385
Uterine haemorrhage 14.74 11.53 4 144610 7 42476714
Subclavian artery thrombosis 14.74 11.53 4 144610 7 42476714
Large intestinal polypectomy 14.73 11.53 7 144607 90 42476631
Tuberculosis 14.63 11.53 8 144606 10091 42466630
Thalamic infarction 14.63 11.53 16 144598 813 42475908
Cardiac vein perforation 14.57 11.53 5 144609 25 42476696
Eye pain 14.54 11.53 22 144592 17008 42459713
Surgery 14.51 11.53 106 144508 17510 42459211
Impaired work ability 14.46 11.53 80 144534 12011 42464710
Injection site swelling 14.42 11.53 22 144592 16951 42459770
Forced expiratory volume decreased 14.42 11.53 4 144610 7626 42469095
Hepatic cytolysis 14.36 11.53 45 144569 26799 42449922
Colon cancer 14.33 11.53 68 144546 9613 42467108
Breath sounds abnormal 14.28 11.53 12 144602 12081 42464640
Diverticulum 14.25 11.53 57 144557 7484 42469237
Weight decreased 14.23 11.53 569 144045 207379 42269342
Intestinal haematoma 14.19 11.53 9 144605 210 42476511
Polyneuropathy 14.18 11.53 26 144588 18635 42458086
Pseudomonas infection 14.16 11.53 20 144594 15903 42460818
Mydriasis 14.15 11.53 6 144608 8764 42467957
Pancreatic neoplasm 14.15 11.53 17 144597 957 42475764
Clostridium difficile colitis 14.12 11.53 32 144582 21220 42455501
COVID-19 14.10 11.53 293 144321 115655 42361066
Cardio-respiratory arrest 14.08 11.53 129 144485 58507 42418214
Bronchial mucosa hyperaemia 14.07 11.53 3 144611 0 42476721
Muscle contusion 14.07 11.53 3 144611 0 42476721
Phlebectomy 14.07 11.53 3 144611 0 42476721
Spinal subdural haemorrhage 14.07 11.53 3 144611 0 42476721
Photophobia 14.02 11.53 5 144609 8114 42468607
Medical device site thrombosis 13.96 11.53 5 144609 29 42476692
Spontaneous haemorrhage 13.96 11.53 13 144601 544 42476177
Anticoagulant-related nephropathy 13.93 11.53 8 144606 155 42476566
Lacunar stroke 13.93 11.53 10 144604 288 42476433
Myositis 13.90 11.53 18 144596 14848 42461873
Secretion discharge 13.86 11.53 57 144557 7578 42469143
Soft tissue haemorrhage 13.84 11.53 8 144606 157 42476564
Dermatitis atopic 13.82 11.53 13 144601 12391 42464330
Bone hypertrophy 13.81 11.53 10 144604 292 42476429
Vascular rupture 13.79 11.53 9 144605 221 42476500
Carotid endarterectomy 13.78 11.53 6 144608 62 42476659
Hot flush 13.78 11.53 35 144579 22316 42454405
Hepatitis B 13.69 11.53 3 144611 6708 42470013
Intervertebral disc degeneration 13.67 11.53 4 144610 7363 42469358
Scar 13.62 11.53 3 144611 6685 42470036
Peripheral artery haematoma 13.61 11.53 6 144608 64 42476657
Oesophageal carcinoma 13.59 11.53 8 144606 9688 42467033
Ocular myasthenia 13.57 11.53 13 144601 564 42476157
Transfusion 13.55 11.53 71 144543 10443 42466278
Renal injury 13.53 11.53 13 144601 12267 42464454
Inappropriate antidiuretic hormone secretion 13.52 11.53 22 144592 16519 42460202
Jugular vein distension 13.48 11.53 14 144600 670 42476051
Peripheral artery stenosis 13.45 11.53 16 144598 891 42475830
Gastrointestinal ischaemia 13.43 11.53 10 144604 305 42476416
Genital haemorrhage 13.36 11.53 8 144606 168 42476553
Hepatitis C 13.32 11.53 9 144605 10124 42466597
Pollakiuria 13.30 11.53 36 144578 22469 42454252
Dry eye 13.27 11.53 20 144594 15486 42461235
Cyanosis 13.24 11.53 19 144595 15012 42461709
Influenza 13.17 11.53 141 144473 62034 42414687
Spinal subdural haematoma 13.14 11.53 6 144608 70 42476651
Ventricular fibrillation 13.13 11.53 55 144559 30068 42446653
Thinking abnormal 13.08 11.53 4 144610 7157 42469564
Hypernatraemia 13.07 11.53 9 144605 10023 42466698
Incorrect dosage administered 13.05 11.53 22 144592 1696 42475025
Chromaturia 13.05 11.53 96 144518 15893 42460828
Discomfort 12.99 11.53 43 144571 25176 42451545
Neurological symptom 12.97 11.53 9 144605 9982 42466739
Feeling abnormal 12.94 11.53 163 144451 69623 42407098
Hepatic steatosis 12.91 11.53 34 144580 21414 42455307
Herpes simplex 12.90 11.53 4 144610 7091 42469630
Hallucination, visual 12.89 11.53 33 144581 20987 42455734
Hallucination, auditory 12.89 11.53 19 144595 14845 42461876
Visual acuity reduced 12.85 11.53 25 144589 17525 42459196
Monoplegia 12.81 11.53 24 144590 2010 42474711
Renal vascular thrombosis 12.79 11.53 4 144610 14 42476707
Nasal abscess 12.79 11.53 4 144610 14 42476707
Metastases to bone 12.77 11.53 19 144595 14790 42461931
Full blood count abnormal 12.75 11.53 55 144559 29821 42446900
Blood test abnormal 12.72 11.53 15 144599 12891 42463830
Urethral haemorrhage 12.71 11.53 12 144602 511 42476210
BK virus infection 12.67 11.53 7 144607 8777 42467944
Intestinal perforation 12.59 11.53 11 144603 10863 42465858
Paresis cranial nerve 12.57 11.53 6 144608 78 42476643
Maternal exposure during pregnancy 12.57 11.53 4 144610 6974 42469747
Tonsillar ulcer 12.56 11.53 8 144606 188 42476533
Hypothyroidism 12.54 11.53 61 144553 32023 42444698
Myopathy 12.52 11.53 17 144597 13744 42462977
Spinal epidural haemorrhage 12.49 11.53 5 144609 41 42476680
Perforated ulcer 12.48 11.53 9 144605 261 42476460
Tongue haemorrhage 12.40 11.53 14 144600 737 42475984
Pharyngeal haematoma 12.37 11.53 6 144608 81 42476640
Limb injury 12.31 11.53 87 144527 14218 42462503
Oedema genital 12.29 11.53 12 144602 533 42476188
Vitamin D deficiency 12.28 11.53 6 144608 8067 42468654
Oropharyngeal pain 12.28 11.53 89 144525 42421 42434300
Medical device site haemorrhage 12.26 11.53 7 144607 134 42476587
Malnutrition 12.21 11.53 19 144595 14523 42462198
Therapeutic product ineffective 12.21 11.53 17 144597 1108 42475613
Depressed level of consciousness 12.19 11.53 104 144510 47866 42428855
Aspergillus infection 12.09 11.53 22 144592 15815 42460906
Oral pain 12.04 11.53 15 144599 12581 42464140
Cerebral amyloid angiopathy 12.02 11.53 9 144605 277 42476444
Coronary artery thrombosis 12.02 11.53 25 144589 2261 42474460
Prosthetic cardiac valve stenosis 12 11.53 4 144610 18 42476703
Scrotal haemorrhage 12.00 11.53 3 144611 3 42476718
Coital bleeding 12.00 11.53 3 144611 3 42476718
Echocardiogram 12.00 11.53 3 144611 3 42476718
Throat tightness 12.00 11.53 9 144605 9590 42467131
Device issue 11.98 11.53 17 144597 13492 42463229
Respiratory symptom 11.95 11.53 12 144602 11094 42465627
Flushing 11.95 11.53 75 144539 36953 42439768
Muscle rigidity 11.90 11.53 14 144600 12045 42464676
Leukocytosis 11.89 11.53 56 144558 29652 42447069
Atrial septal defect 11.88 11.53 6 144608 7913 42468808
Splenomegaly 11.87 11.53 25 144589 17022 42459699
Fistula 11.86 11.53 6 144608 7906 42468815
Cerebellar haematoma 11.86 11.53 8 144606 208 42476513
Left ventricular dilatation 11.85 11.53 15 144599 891 42475830
Miosis 11.84 11.53 17 144597 13429 42463292
Subcapsular renal haematoma 11.84 11.53 12 144602 558 42476163
Cardiac amyloidosis 11.82 11.53 23 144591 1982 42474739
Blood calcium increased 11.81 11.53 7 144607 8447 42468274
Erectile dysfunction 11.81 11.53 44 144570 24869 42451852
Inflammation 11.75 11.53 67 144547 33780 42442941
Dialysis 11.74 11.53 14 144600 11972 42464749
Electrocardiogram QT prolonged 11.72 11.53 105 144509 47840 42428881
Ventricle rupture 11.72 11.53 5 144609 49 42476672
Immune effector cell-associated neurotoxicity syndrome 11.66 11.53 9 144605 9452 42467269
Application site haematoma 11.63 11.53 5 144609 50 42476671
Catheter site cellulitis 11.60 11.53 7 144607 149 42476572
Angiodysplasia 11.58 11.53 14 144600 793 42475928

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 10109.55 10.86 5654 245271 159864 110178510
Cerebral haemorrhage 2506.57 10.86 1658 249267 63310 110275064
Pulmonary embolism 2242.43 10.86 2594 248331 211880 110126494
Haematuria 2197.94 10.86 1684 249241 81321 110257053
Haemorrhage 2165.65 10.86 1853 249072 104839 110233535
Ischaemic stroke 2046.94 10.86 1235 249690 40028 110298346
Epistaxis 1996.62 10.86 1933 248992 128439 110209935
Upper gastrointestinal haemorrhage 1913.90 10.86 1271 249654 48825 110289549
Melaena 1555.71 10.86 1272 249653 67485 110270889
Haemorrhage intracranial 1548.53 10.86 910 250015 28059 110310315
Cerebrovascular accident 1481.92 10.86 1938 248987 179346 110159028
Deep vein thrombosis 1422.28 10.86 1669 249256 138218 110200156
Cerebral infarction 1398.69 10.86 1064 249861 50774 110287600
Rectal haemorrhage 1245.10 10.86 1446 249479 118387 110219987
Anaemia 1215.07 10.86 3339 247586 543747 109794627
Haematoma 1206.93 10.86 1026 249899 57450 110280924
Lower gastrointestinal haemorrhage 1127.68 10.86 633 250292 17853 110320521
Haemoglobin decreased 1039.74 10.86 1953 248972 246774 110091600
Subdural haematoma 991.54 10.86 752 250173 35702 110302672
Haemorrhagic stroke 934.10 10.86 506 250419 13283 110325091
Embolic stroke 818.67 10.86 399 250526 8344 110330030
Blood loss anaemia 813.18 10.86 508 250417 17517 110320857
Internal haemorrhage 776.73 10.86 403 250522 9668 110328706
Thrombosis 773.64 10.86 1087 249838 107575 110230799
Haemoptysis 699.22 10.86 836 250089 70518 110267856
Haematochezia 655.24 10.86 1039 249886 114485 110223889
Atrial thrombosis 640.28 10.86 272 250653 4074 110334300
Gastric haemorrhage 581.54 10.86 393 250532 15522 110322852
Labelled drug-drug interaction medication error 543.62 10.86 484 250441 28818 110309556
Haematemesis 515.27 10.86 653 250272 58455 110279919
Heavy menstrual bleeding 513.40 10.86 368 250557 15997 110322377
Atrial fibrillation 505.33 10.86 1399 249526 228243 110110131
Post procedural haemorrhage 500.87 10.86 355 250570 15157 110323217
Pericardial haemorrhage 497.21 10.86 241 250684 4976 110333398
Diverticulum intestinal haemorrhagic 487.27 10.86 231 250694 4532 110333842
Cerebral haematoma 486.96 10.86 292 250633 9340 110329034
Synovitis 478.37 10.86 38 250887 274054 110064320
Hand deformity 477.95 10.86 3 250922 218503 110119871
Vaginal haemorrhage 470.78 10.86 417 250508 24657 110313717
Drug interaction 470.10 10.86 2311 248614 497872 109840502
Infusion related reaction 467.34 10.86 142 250783 381020 109957354
Shock haemorrhagic 448.71 10.86 421 250504 26826 110311548
Intraventricular haemorrhage 443.80 10.86 227 250698 5280 110333094
Fall 428.57 10.86 2583 248342 600899 109737475
Drug intolerance 417.69 10.86 200 250725 406312 109932062
Haemorrhagic arteriovenous malformation 413.48 10.86 118 250807 464 110337910
Basal ganglia haemorrhage 412.75 10.86 157 250768 1731 110336643
Glossodynia 407.13 10.86 24 250901 221980 110116394
Product prescribing issue 400.17 10.86 287 250638 12485 110325889
Faeces discoloured 393.62 10.86 434 250491 33514 110304860
International normalised ratio increased 392.96 10.86 706 250219 86066 110252308
Drug hypersensitivity 380.17 10.86 285 250640 453805 109884569
Haemarthrosis 375.22 10.86 224 250701 7105 110331269
Transient ischaemic attack 368.91 10.86 580 250345 63402 110274972
Duodenal ulcer perforation 364.15 10.86 8 250917 177692 110160682
Haemorrhoidal haemorrhage 362.27 10.86 227 250698 7866 110330508
Incorrect dose administered 352.07 10.86 747 250178 102894 110235480
Therapeutic product effect decreased 350.51 10.86 65 250860 244251 110094123
Folliculitis 349.78 10.86 6 250919 167647 110170727
Maternal exposure during pregnancy 344.56 10.86 78 250847 254805 110083569
Gingival bleeding 341.08 10.86 314 250611 19525 110318849
Cardiac failure 339.01 10.86 1066 249859 186560 110151814
Cerebellar haemorrhage 329.60 10.86 157 250768 3114 110335260
Embolic cerebral infarction 328.39 10.86 125 250800 1381 110336993
Subarachnoid haemorrhage 324.27 10.86 368 250557 29334 110309040
Hypersensitivity 323.64 10.86 265 250660 403733 109934641
Pericarditis 306.47 10.86 62 250863 219052 110119322
Thalamus haemorrhage 306.27 10.86 128 250797 1836 110336538
Arthropathy 294.38 10.86 142 250783 287380 110050994
Prothrombin time prolonged 290.54 10.86 270 250655 16991 110321383
Rheumatoid arthritis 288.89 10.86 160 250765 299453 110038921
Rheumatoid factor positive 282.06 10.86 3 250922 131637 110206737
Alopecia 281.42 10.86 248 250677 364505 109973869
Pain 277.15 10.86 1171 249754 953784 109384590
Muscle injury 275.04 10.86 10 250915 140797 110197577
Drug abuse 272.77 10.86 39 250886 177372 110161002
Gastric ulcer haemorrhage 271.67 10.86 207 250718 9887 110328487
Coagulopathy 271.48 10.86 396 250529 40515 110297859
Helicobacter infection 263.83 10.86 47 250878 181830 110156544
Discomfort 262.97 10.86 80 250845 214627 110123747
Psoriatic arthropathy 262.34 10.86 62 250863 196699 110141675
Iron deficiency anaemia 261.39 10.86 340 250585 31219 110307155
Hemiparesis 258.64 10.86 402 250523 43501 110294873
Stomatitis 258.09 10.86 146 250779 270096 110068278
Irritable bowel syndrome 257.43 10.86 34 250891 164181 110174193
Subcutaneous haematoma 255.88 10.86 129 250796 2907 110335467
Fibromyalgia 254.91 10.86 41 250884 170868 110167506
Joint swelling 254.14 10.86 382 250543 442463 109895911
Systemic lupus erythematosus 250.76 10.86 132 250793 254206 110084168
Blood urine present 248.87 10.86 291 250634 23954 110314420
Hemiplegia 248.24 10.86 282 250643 22500 110315874
Blood cholesterol increased 240.94 10.86 61 250864 184724 110153650
Dyspnoea exertional 236.63 10.86 642 250283 103418 110234956
Ill-defined disorder 235.34 10.86 37 250888 156816 110181558
Acute kidney injury 232.71 10.86 2332 248593 633098 109705276
Subdural haemorrhage 230.21 10.86 158 250767 6400 110331974
Gastrointestinal vascular malformation haemorrhagic 226.77 10.86 85 250840 897 110337477
Arthralgia 226.60 10.86 955 249970 778677 109559697
Mobility decreased 225.65 10.86 129 250796 237293 110101081
Hepatic enzyme increased 224.45 10.86 238 250687 320654 110017720
Musculoskeletal stiffness 218.51 10.86 188 250737 279634 110058740
Muscle haemorrhage 216.67 10.86 155 250770 6714 110331660
Haemorrhagic transformation stroke 212.80 10.86 114 250811 2923 110335451
Sinusitis 209.79 10.86 218 250707 296470 110041904
Impaired healing 207.73 10.86 93 250832 196624 110141750
Cerebral artery embolism 205.60 10.86 99 250826 2013 110336361
Anticoagulation drug level increased 204.90 10.86 79 250846 906 110337468
Infection 204.31 10.86 316 250609 361884 109976490
Type 2 diabetes mellitus 201.40 10.86 75 250850 177157 110161217
Bursitis 198.67 10.86 29 250896 129889 110208485
Wound 194.89 10.86 148 250777 234289 110104085
Abdominal wall haematoma 194.50 10.86 135 250790 5570 110332804
Exposure during pregnancy 193.38 10.86 69 250856 167355 110171019
Blister 191.00 10.86 142 250783 227234 110111140
Retroperitoneal haemorrhage 189.34 10.86 136 250789 5929 110332445
Swelling 188.83 10.86 316 250609 350725 109987649
Anxiety 187.13 10.86 309 250616 344769 109993605
Dyspnoea 184.93 10.86 3529 247396 1103343 109235031
Lip dry 182.88 10.86 11 250914 100072 110238302
Duodenal ulcer haemorrhage 180.16 10.86 148 250777 7889 110330485
Occult blood positive 179.37 10.86 143 250782 7302 110331072
Mouth haemorrhage 178.51 10.86 185 250740 13303 110325071
Gastric ulcer 177.63 10.86 322 250603 39505 110298869
Gastrointestinal disorder 175.34 10.86 174 250751 241778 110096596
Pyrexia 175.33 10.86 1256 249669 897009 109441365
Condition aggravated 175.06 10.86 966 249959 733870 109604504
Splenic rupture 173.67 10.86 95 250830 2542 110335832
Wound haemorrhage 173.08 10.86 117 250808 4621 110333753
Haemothorax 171.43 10.86 136 250789 6895 110331479
Syncope 169.61 10.86 907 250018 201629 110136745
Nasopharyngitis 164.51 10.86 411 250514 393950 109944424
Small intestinal haemorrhage 161.49 10.86 111 250814 4507 110333867
Inflammation 159.31 10.86 123 250802 193115 110145259
Therapeutic product effect incomplete 158.69 10.86 164 250761 223641 110114733
Cardiac tamponade 158.56 10.86 160 250765 11147 110327227
Weight increased 157.99 10.86 460 250465 419184 109919190
Toxicity to various agents 157.12 10.86 561 250364 479994 109858380
Haemorrhage subcutaneous 156.62 10.86 117 250808 5422 110332952
Microcytic anaemia 155.32 10.86 122 250803 6096 110332278
Febrile neutropenia 154.36 10.86 303 250622 316464 110021910
Haemorrhage urinary tract 150.98 10.86 90 250835 2846 110335528
Cerebral ventricular rupture 150.65 10.86 52 250873 423 110337951
Sleep disorder 149.58 10.86 138 250787 198506 110139868
Aphasia 149.42 10.86 379 250546 58618 110279756
Pulmonary haemorrhage 148.44 10.86 185 250740 16271 110322103
Cerebral ischaemia 147.71 10.86 159 250766 11945 110326429
Injury 145.91 10.86 113 250812 177152 110161222
Treatment failure 145.89 10.86 253 250672 276981 110061393
Joint range of motion decreased 144.50 10.86 48 250877 121784 110216590
Uterine haemorrhage 143.93 10.86 93 250832 3401 110334973
Night sweats 143.55 10.86 62 250863 133921 110204453
Grip strength decreased 142.96 10.86 10 250915 80164 110258210
Procedural haemorrhage 141.02 10.86 109 250816 5318 110333056
Renal haemorrhage 139.30 10.86 81 250844 2444 110335930
C-reactive protein abnormal 138.98 10.86 60 250865 129635 110208739
Post procedural haematoma 135.98 10.86 81 250844 2558 110335816
Gastritis erosive 133.22 10.86 150 250775 11850 110326524
Product prescribing error 132.34 10.86 332 250593 50999 110287375
Sciatica 131.56 10.86 25 250900 92374 110246000
Traumatic intracranial haemorrhage 131.13 10.86 65 250860 1411 110336963
Brain stem haemorrhage 129.22 10.86 69 250856 1757 110336617
Injection site reaction 129.18 10.86 23 250902 89047 110249327
Renal impairment 129.04 10.86 800 250125 187645 110150729
Hypovolaemic shock 128.44 10.86 162 250763 14421 110323953
Duodenal ulcer 128.16 10.86 188 250737 19326 110319048
Ecchymosis 127.07 10.86 176 250749 17162 110321212
Cardioversion 126.78 10.86 74 250851 2249 110336125
C-reactive protein increased 125.81 10.86 187 250738 217732 110120642
Activated partial thromboplastin time prolonged 125.07 10.86 200 250725 22168 110316206
Peripheral embolism 124.93 10.86 70 250855 1965 110336409
Insomnia 123.85 10.86 412 250513 360178 109978196
Peripheral venous disease 123.57 10.86 21 250904 84096 110254278
Large intestinal haemorrhage 123.06 10.86 81 250844 3058 110335316
Intracardiac thrombus 122.57 10.86 91 250834 4177 110334197
Liver injury 122.38 10.86 97 250828 150316 110188058
Therapy non-responder 122.36 10.86 106 250819 157201 110181173
Adrenal haemorrhage 120.21 10.86 51 250874 761 110337613
Cardiac failure chronic 117.81 10.86 151 250774 13660 110324714
Haemorrhagic cerebral infarction 115.77 10.86 60 250865 1435 110336939
Vascular pseudoaneurysm 115.13 10.86 87 250838 4103 110334271
Hypercholesterolaemia 114.56 10.86 32 250893 90805 110247569
Cerebral mass effect 113.70 10.86 70 250855 2349 110336025
Hypoaesthesia 113.49 10.86 351 250574 313872 110024502
Pericardial effusion 113.42 10.86 336 250589 56881 110281493
Depression 112.84 10.86 357 250568 316978 110021396
Gastritis haemorrhagic 112.68 10.86 77 250848 3096 110335278
Wound infection 112.67 10.86 39 250886 96426 110241948
Osteoarthritis 112.09 10.86 150 250775 182473 110155901
Prescribed overdose 112.06 10.86 30 250895 87551 110250823
Pulmonary arterial hypertension 111.99 10.86 236 250689 32332 110306042
Wheezing 111.91 10.86 259 250666 254971 110083403
Creatinine renal clearance decreased 111.09 10.86 187 250738 21628 110316746
Urticaria 109.70 10.86 364 250561 318493 110019881
Head injury 109.61 10.86 277 250648 42740 110295634
Embolism venous 109.46 10.86 91 250834 4932 110333442
Therapeutic response decreased 109.33 10.86 41 250884 96458 110241916
Autoimmune disorder 108.98 10.86 11 250914 65472 110272902
Cerebellar infarction 108.59 10.86 84 250841 4103 110334271
Glomerular filtration rate decreased 108.02 10.86 217 250708 28739 110309635
Lower respiratory tract infection 107.96 10.86 245 250680 242861 110095513
Hypertension 107.84 10.86 696 250229 509388 109828986
Obesity 107.06 10.86 62 250863 113289 110225085
Myelosuppression 107.02 10.86 40 250885 94300 110244074
Dry mouth 106.51 10.86 181 250744 199767 110138607
Extradural haematoma 106.21 10.86 76 250849 3293 110335081
Underdose 103.75 10.86 349 250576 63205 110275169
Hypotension 103.31 10.86 1716 249209 522133 109816241
Intestinal haemorrhage 103.16 10.86 104 250821 7237 110331137
Bradycardia 100.73 10.86 651 250274 154866 110183508
Dizziness 100.23 10.86 2178 248747 696015 109642359
Cerebral artery occlusion 100.01 10.86 60 250865 1920 110336454
Peripheral artery occlusion 99.64 10.86 69 250856 2836 110335538
Product use issue 95.82 10.86 373 250552 311322 110027052
Pregnancy 95.18 10.86 5 250920 51062 110287312
Retroperitoneal haematoma 91.96 10.86 90 250835 6041 110332333
Bone erosion 91.56 10.86 3 250922 46368 110292006
Eye haemorrhage 90.03 10.86 122 250803 11652 110326722
Peripheral ischaemia 89.80 10.86 118 250807 10940 110327434
Spinal cord haemorrhage 89.38 10.86 38 250887 570 110337804
Haematoma muscle 88.93 10.86 74 250851 4016 110334358
Pelvic venous thrombosis 88.63 10.86 63 250862 2701 110335673
Pulmonary hypertension 88.17 10.86 301 250624 54919 110283455
Oedema peripheral 87.76 10.86 1135 249790 327525 110010849
Urinary bladder haemorrhage 87.45 10.86 63 250862 2759 110335615
Pulmonary alveolar haemorrhage 87.42 10.86 161 250764 19989 110318385
Contraindicated product administered 87.04 10.86 281 250644 247986 110090388
Traumatic haemorrhage 85.76 10.86 53 250872 1791 110336583
Transfusion 84.60 10.86 182 250743 25290 110313084
Neutropenia 83.87 10.86 502 250423 374118 109964256
Haemorrhagic diathesis 83.60 10.86 94 250831 7414 110330960
Psoriasis 81.89 10.86 119 250806 139874 110198500
High frequency ablation 81.72 10.86 31 250894 339 110338035
Abdominal discomfort 81.38 10.86 541 250384 393317 109945057
Injection site pain 80.86 10.86 177 250748 177745 110160629
Arterial haemorrhage 80.77 10.86 68 250857 3751 110334623
Postmenopausal haemorrhage 80.67 10.86 51 250874 1795 110336579
Sedation 79.96 10.86 29 250896 69654 110268720
Adjustment disorder with depressed mood 79.63 10.86 5 250920 43878 110294496
Anaphylactic reaction 78.48 10.86 86 250839 114214 110224160
Embolism 78.16 10.86 136 250789 16153 110322221
Rash 78 10.86 1352 249573 819612 109518762
Potentiating drug interaction 77.66 10.86 113 250812 11530 110326844
Presyncope 77.63 10.86 266 250659 48621 110289753
Lower limb fracture 77.37 10.86 37 250888 75311 110263063
Venous thrombosis 77.33 10.86 96 250829 8409 110329965
Prescribed underdose 77.29 10.86 323 250602 64851 110273523
Inappropriate schedule of product administration 76.98 10.86 753 250172 202884 110135490
Peptic ulcer haemorrhage 76.53 10.86 42 250883 1131 110337243
Incision site haemorrhage 76.33 10.86 41 250884 1057 110337317
Injection site erythema 76.26 10.86 61 250864 94115 110244259
Ischaemic cerebral infarction 76.20 10.86 59 250866 2886 110335488
Gastrointestinal ulcer haemorrhage 75.66 10.86 47 250878 1603 110336771
Atrial flutter 75.64 10.86 169 250756 24093 110314281
Coeliac disease 75.25 10.86 6 250919 43181 110295193
Catarrh 75.20 10.86 88 250837 7247 110331127
Onychomycosis 74.32 10.86 3 250922 38528 110299846
Hypochromic anaemia 73.96 10.86 60 250865 3141 110335233
Arrhythmia 73.48 10.86 333 250592 69242 110269132
Haemoperitoneum 73.28 10.86 75 250850 5313 110333061
Gait inability 73.03 10.86 123 250802 136253 110202121
Memory impairment 72.50 10.86 218 250707 196726 110141648
Diverticulum 72.39 10.86 128 250797 15398 110322976
Asthma 71.59 10.86 308 250617 249983 110088391
Completed suicide 70.72 10.86 296 250629 242085 110096289
Sleep disorder due to a general medical condition 70.26 10.86 16 250909 52096 110286278
Lupus-like syndrome 70.16 10.86 6 250919 40786 110297588
Peripheral arterial occlusive disease 69.20 10.86 95 250830 9185 110329189
Conjunctival haemorrhage 68.71 10.86 80 250845 6553 110331821
Abnormal uterine bleeding 68.34 10.86 42 250883 1405 110336969
Burns second degree 68.25 10.86 86 250839 7647 110330727
Spinal cord haematoma 68.24 10.86 26 250899 288 110338086
Traumatic haematoma 68.14 10.86 51 250874 2370 110336004
Peripheral artery thrombosis 67.82 10.86 63 250862 3961 110334413
Foot deformity 67.16 10.86 14 250911 48466 110289908
Red blood cell sedimentation rate increased 66.88 10.86 48 250877 78254 110260120
Anticoagulation drug level decreased 66.26 10.86 25 250900 269 110338105
Steroid dependence 65.13 10.86 88 250837 8381 110329993
Intra-abdominal haemorrhage 64.88 10.86 70 250855 5272 110333102
Musculoskeletal pain 64.24 10.86 207 250718 182816 110155558
Mucosal inflammation 64.18 10.86 74 250851 96067 110242307
Vascular stent thrombosis 64.13 10.86 62 250863 4099 110334275
Compartment syndrome 64.11 10.86 73 250852 5837 110332537
Intentional product use issue 63.82 10.86 317 250608 247589 110090785
Splenic haemorrhage 63.76 10.86 33 250892 787 110337587
Cardiac ablation 63.51 10.86 51 250874 2631 110335743
Pulmonary fibrosis 63.43 10.86 83 250842 101959 110236415
Cardiac murmur 63.17 10.86 159 250766 24469 110313905
Retinal artery occlusion 63.04 10.86 62 250863 4187 110334187
Polyp 62.45 10.86 94 250831 9886 110328488
Finger deformity 62.44 10.86 3 250922 33089 110305285
Gastrointestinal polyp haemorrhage 62.21 10.86 32 250893 753 110337621
Parosmia 61.89 10.86 109 250816 13071 110325303
Pharyngeal haemorrhage 61.80 10.86 39 250886 1368 110337006
Contraindicated product prescribed 61.65 10.86 47 250878 2246 110336128
Urogenital haemorrhage 61.48 10.86 34 250891 930 110337444
Multiple sclerosis relapse 60.97 10.86 19 250906 50221 110288153
Incorrect route of product administration 60.54 10.86 35 250890 64026 110274348
Drug resistance 60.51 10.86 26 250899 56348 110282026
Venous thrombosis limb 60.48 10.86 67 250858 5198 110333176
N-terminal prohormone brain natriuretic peptide abnormal 60.47 10.86 24 250901 299 110338075
Ear infection 59.68 10.86 34 250891 62698 110275676
Deep vein thrombosis postoperative 59.53 10.86 30 250895 59261 110279113
Laryngitis 59.26 10.86 12 250913 42399 110295975
Road traffic accident 59.24 10.86 95 250830 107303 110231071
Arteriovenous malformation 59.19 10.86 43 250882 1908 110336466
Spontaneous haematoma 58.99 10.86 43 250882 1918 110336456
Retinal haemorrhage 58.76 10.86 89 250836 9412 110328962
Pruritus 58.66 10.86 947 249978 580613 109757761
Cytomegalovirus infection 58.61 10.86 25 250900 54419 110283955
Neutrophil count decreased 58.58 10.86 116 250809 120825 110217549
Disease progression 58.36 10.86 320 250605 243714 110094660
Migraine 58.28 10.86 197 250728 171455 110166919
Pulmonary thrombosis 57.93 10.86 109 250816 13754 110324620
Salpingo-oophorectomy unilateral 57.68 10.86 31 250894 800 110337574
Acute myocardial infarction 57.51 10.86 356 250569 83421 110254953
Cerebral ventricle collapse 57.49 10.86 20 250905 167 110338207
Muscle spasms 57.46 10.86 382 250543 277775 110060599
Intentional product misuse 57.31 10.86 136 250789 132768 110205606
Treatment noncompliance 57.10 10.86 321 250604 72669 110265705
Renal infarct 56.93 10.86 53 250872 3342 110335032
Leriche syndrome 56.79 10.86 19 250906 139 110338235
Haemorrhagic erosive gastritis 56.61 10.86 30 250895 752 110337622
Off label use 56.22 10.86 2808 248117 1497377 108840997
Coagulation time prolonged 55.72 10.86 49 250876 2868 110335506
Back injury 55.63 10.86 19 250906 47380 110290994
Coagulation test abnormal 55.17 10.86 38 250887 1548 110336826
Purpura 54.94 10.86 150 250775 24238 110314136
Ear haemorrhage 54.65 10.86 45 250880 2406 110335968
Hypopnoea 54.59 10.86 95 250830 11285 110327089
Product monitoring error 54.33 10.86 83 250842 8844 110329530
Labelled drug-drug interaction issue 53.82 10.86 56 250869 4045 110334329
Drug dependence 53.80 10.86 23 250902 49997 110288377
Brain herniation 53.37 10.86 82 250843 8781 110329593
Hypersensitivity vasculitis 53.22 10.86 72 250853 6865 110331509
Hydrocephalus 52.91 10.86 89 250836 10286 110328088
Hepatotoxicity 52.68 10.86 40 250885 63360 110275014
Liver function test increased 52.04 10.86 75 250850 88473 110249901
Liver disorder 51.95 10.86 158 250767 142085 110196289
Haematoma infection 51.87 10.86 37 250888 1595 110336779
Joint stiffness 51.44 10.86 46 250879 67197 110271177
Bone marrow failure 51.35 10.86 34 250891 57814 110280560
Gastrointestinal angiodysplasia 51.11 10.86 33 250892 1205 110337169
Suicidal ideation 50.96 10.86 84 250841 93853 110244521
Labelled drug-disease interaction medication error 50.92 10.86 22 250903 344 110338030
Chronic gastrointestinal bleeding 50.56 10.86 24 250901 472 110337902
Hospitalisation 50.02 10.86 519 250406 141974 110196400
Puncture site haemorrhage 49.95 10.86 27 250898 705 110337669
Penile haemorrhage 49.75 10.86 29 250896 879 110337495
Product administration error 49.36 10.86 191 250734 37026 110301348
Myoglobin blood increased 48.86 10.86 54 250871 4178 110334196
Hemianopia 48.53 10.86 45 250880 2823 110335551
Fractional exhaled nitric oxide increased 48.48 10.86 27 250898 749 110337625
Muscle spasticity 48.47 10.86 11 250914 35904 110302470
Putamen haemorrhage 48.41 10.86 24 250901 521 110337853
Paraesthesia 48.37 10.86 398 250527 276123 110062251
Loss of personal independence in daily activities 48.35 10.86 176 250749 149844 110188530
Vitreous haemorrhage 48.32 10.86 56 250869 4564 110333810
Prothrombin time shortened 48.23 10.86 50 250875 3596 110334778
Cerebral vascular occlusion 48.00 10.86 13 250912 40 110338334
Renal haematoma 47.62 10.86 29 250896 954 110337420
Taste disorder 47.36 10.86 47 250878 65340 110273034
Interstitial lung disease 47.27 10.86 504 250421 138830 110199544
Therapy partial responder 46.83 10.86 13 250912 37048 110301326
Intra-abdominal haematoma 46.62 10.86 48 250877 3424 110334950
Product use in unapproved indication 46.59 10.86 724 250201 446653 109891721
Intracranial haematoma 46.27 10.86 29 250896 1005 110337369
Neurotoxicity 46.05 10.86 19 250906 42188 110296186
Toxic epidermal necrolysis 45.60 10.86 37 250888 56690 110281684
Brain natriuretic peptide increased 45.44 10.86 87 250838 11122 110327252
Overdose 45.35 10.86 327 250598 233467 110104907
Brain stem infarction 45.13 10.86 38 250887 2096 110336278
Mesenteric artery embolism 44.94 10.86 14 250911 79 110338295
Drug tolerance decreased 44.87 10.86 5 250920 27535 110310839
Respiratory depression 44.83 10.86 9 250916 31992 110306382
Hyperthyroidism 44.53 10.86 157 250768 29104 110309270
Bladder tamponade 44.32 10.86 25 250900 711 110337663
Rhinorrhoea 44.31 10.86 105 250820 102561 110235813
Transplant rejection 43.98 10.86 3 250922 24564 110313810
Vomiting 43.85 10.86 1657 249268 909018 109429356
Palpitations 43.79 10.86 553 250372 158659 110179715
Asthenia 43.50 10.86 1945 248980 687054 109651320
Device related thrombosis 43.16 10.86 46 250879 3416 110334958
Dry eye 42.88 10.86 38 250887 55755 110282619
Splenic haematoma 42.81 10.86 19 250906 318 110338056
Aortic aneurysm rupture 42.80 10.86 31 250894 1369 110337005
Nausea 42.76 10.86 2331 248594 1233359 109105015
Tumour haemorrhage 42.63 10.86 56 250869 5189 110333185
Pallor 42.63 10.86 246 250679 56221 110282153
Bleeding time prolonged 42.50 10.86 30 250895 1272 110337102
Haemorrhagic infarction 42.49 10.86 26 250899 863 110337511
Anal haemorrhage 42.01 10.86 54 250871 4898 110333476
Anticoagulation drug level above therapeutic 41.68 10.86 52 250873 4578 110333796
Post thrombotic syndrome 41.17 10.86 23 250902 642 110337732
Prostatic haemorrhage 41.15 10.86 16 250909 188 110338186
Gingival pain 40.78 10.86 102 250823 15634 110322740
Coagulation factor X level increased 40.73 10.86 8 250917 0 110338374
Mesenteric haemorrhage 40.51 10.86 13 250912 82 110338292
Aggression 40.14 10.86 45 250880 59165 110279209
Irritability 39.93 10.86 30 250895 47779 110290595
Vertigo 39.82 10.86 335 250590 86535 110251839
Aspartate aminotransferase increased 39.73 10.86 207 250718 159729 110178645
Bleeding varicose vein 39.67 10.86 23 250902 690 110337684
Gastrointestinal angiectasia 39.25 10.86 19 250906 391 110337983
No adverse event 39.15 10.86 67 250858 73772 110264602
Herpes zoster 39.13 10.86 121 250804 108258 110230116
Anovulatory cycle 39.13 10.86 14 250911 128 110338246
Psychotic disorder 38.78 10.86 35 250890 50902 110287472
Chills 38.70 10.86 263 250662 190317 110148057
Feeling hot 38.67 10.86 94 250831 91012 110247362
Right ventricular failure 38.42 10.86 138 250787 25816 110312558
Lipoprotein (a) decreased 38.39 10.86 11 250914 44 110338330
Agitation 38.19 10.86 130 250795 112921 110225453
Diverticulitis intestinal haemorrhagic 38.15 10.86 20 250905 490 110337884
Schizophrenia 38.12 10.86 3 250922 21823 110316551
Rectal polyp 38.00 10.86 30 250895 1510 110336864
Tricuspid valve incompetence 37.99 10.86 130 250795 23743 110314631
White blood cell count increased 37.97 10.86 104 250821 96738 110241636
Vena cava thrombosis 37.64 10.86 43 250882 3451 110334923
Drug ineffective 37.22 10.86 2959 247966 1517581 108820793
Lymphocyte count decreased 37.20 10.86 45 250880 57198 110281176
Central nervous system haemorrhage 37.14 10.86 19 250906 442 110337932
Large intestine polyp 37.11 10.86 96 250829 15021 110323353
Subgaleal haematoma 37.01 10.86 13 250912 112 110338262
Drug ineffective for unapproved indication 37.00 10.86 115 250810 102723 110235651
Brain natriuretic peptide abnormal 36.99 10.86 24 250901 884 110337490
Fibrin D dimer increased 36.98 10.86 74 250851 9771 110328603
Facial paralysis 36.92 10.86 130 250795 24084 110314290
Oral herpes 36.61 10.86 18 250907 36062 110302312
Oesophageal haemorrhage 36.42 10.86 32 250893 1871 110336503
Emotional distress 36.36 10.86 29 250896 44818 110293556
Arterial thrombosis 36.36 10.86 40 250885 3079 110335295
Penis injury 36.32 10.86 13 250912 119 110338255
Gastrooesophageal reflux disease 36.23 10.86 249 250676 179727 110158647
Bradyarrhythmia 36.03 10.86 50 250875 4884 110333490
Mesenteric artery thrombosis 35.93 10.86 24 250901 929 110337445
Colitis ischaemic 35.90 10.86 105 250820 17645 110320729
Drug withdrawal syndrome 35.66 10.86 21 250904 38033 110300341
Injection site swelling 35.66 10.86 53 250872 61737 110276637
Heart rate irregular 35.41 10.86 163 250762 34111 110304263
Leukopenia 35.07 10.86 196 250729 148595 110189779
Thrombotic stroke 35.01 10.86 22 250903 766 110337608
Haemorrhoids 34.91 10.86 167 250758 35505 110302869
Spinal subdural haematoma 34.64 10.86 15 250910 236 110338138
Orthopnoea 34.61 10.86 77 250848 10944 110327430
Ear pain 34.42 10.86 42 250883 53184 110285190
Amnesia 34.40 10.86 123 250802 105285 110233089
Abdominal pain upper 34.32 10.86 571 250354 348540 109989834
Hypercoagulation 34.26 10.86 40 250885 3286 110335088
Blood blister 34.19 10.86 43 250882 3816 110334558
Thrombophlebitis 34.13 10.86 62 250863 7617 110330757
Nail disorder 34.11 10.86 49 250876 57886 110280488
Sinusitis fungal 33.66 10.86 36 250889 2684 110335690
Injection site pruritus 33.62 10.86 40 250885 51218 110287156
Cardiac pacemaker insertion 33.40 10.86 55 250870 6246 110332128
Alanine aminotransferase increased 33.28 10.86 262 250663 183511 110154863
Subcapsular renal haematoma 33.26 10.86 23 250902 943 110337431
Oesophagitis haemorrhagic 33.20 10.86 20 250905 645 110337729
Haemophagocytic lymphohistiocytosis 33.17 10.86 15 250910 31544 110306830
Wound haematoma 32.75 10.86 13 250912 162 110338212
Fatigue 32.60 10.86 2348 248577 1213610 109124764
Mallory-Weiss syndrome 32.53 10.86 38 250887 3123 110335251
Tremor 32.28 10.86 298 250627 201934 110136440
Cardiac failure acute 32.28 10.86 124 250801 23954 110314420
Duplicate therapy error 32.23 10.86 17 250908 422 110337952
Aneurysm ruptured 32.05 10.86 24 250901 1116 110337258
Facial paresis 31.92 10.86 53 250872 6060 110332314
N-terminal prohormone brain natriuretic peptide increased 31.87 10.86 53 250872 6068 110332306
Circulatory collapse 31.61 10.86 186 250739 42807 110295567
Spleen ischaemia 31.58 10.86 10 250915 60 110338314
Haematotoxicity 31.55 10.86 5 250920 21077 110317297
Hypervolaemia 31.36 10.86 206 250719 49254 110289120
Neck pain 31.35 10.86 158 250767 122972 110215402
Petechiae 31.19 10.86 120 250805 23197 110315177
Cytokine release syndrome 31.06 10.86 71 250854 70235 110268139
Product quality issue 31.06 10.86 82 250843 77217 110261157
Cardiac ventricular thrombosis 31.01 10.86 37 250888 3110 110335264
Normal newborn 31.00 10.86 6 250919 21890 110316484
Abdominal wall haemorrhage 30.91 10.86 20 250905 733 110337641
Anastomotic ulcer haemorrhage 30.86 10.86 12 250913 141 110338233
Ureteric haemorrhage 30.86 10.86 12 250913 141 110338233
Muscular weakness 30.86 10.86 388 250537 248080 110090294
Brain compression 30.72 10.86 20 250905 741 110337633
Gastritis 30.69 10.86 218 250707 53481 110284893
Confusional state 30.65 10.86 819 250106 467861 109870513
Alcohol poisoning 30.59 10.86 65 250860 8955 110329419
Haemoglobin abnormal 30.50 10.86 65 250860 8973 110329401
International normalised ratio abnormal 30.40 10.86 53 250872 6304 110332070
Craniocerebral injury 30.39 10.86 51 250874 5883 110332491
Serotonin syndrome 30.16 10.86 55 250870 59098 110279276
Blood pressure decreased 30.05 10.86 396 250529 114695 110223679
Pancreatitis 29.96 10.86 110 250815 93423 110244951
Menometrorrhagia 29.86 10.86 21 250904 885 110337489
Periorbital haematoma 29.63 10.86 22 250903 1010 110337364
Osteopenia 29.58 10.86 7 250918 22202 110316172
Cytomegalovirus viraemia 29.52 10.86 3 250922 17761 110320613
Chondrocalcinosis 29.51 10.86 29 250896 1956 110336418
Catheter site haemorrhage 29.40 10.86 50 250875 5830 110332544
Disability 29.30 10.86 16 250909 30207 110308167
Colon cancer 29.26 10.86 93 250832 16350 110322024
Embolism arterial 29.22 10.86 28 250897 1831 110336543
Nodule 29.20 10.86 19 250906 32612 110305762
Knee arthroplasty 29.18 10.86 65 250860 64883 110273491
Chest wall haematoma 29.08 10.86 17 250908 518 110337856
Anaphylactic shock 28.99 10.86 45 250880 51501 110286873
Cerebellar haematoma 28.92 10.86 18 250907 616 110337758
Affect lability 28.86 10.86 4 250921 18633 110319741
Chronic gastritis 28.37 10.86 47 250878 5364 110333010
Dyspepsia 28.11 10.86 287 250638 190678 110147696
Renal vein thrombosis 27.94 10.86 22 250903 1103 110337271
Haemorrhagic disorder 27.92 10.86 27 250898 1786 110336588
Oropharyngeal pain 27.80 10.86 186 250739 135090 110203284
Upper respiratory tract infection 27.78 10.86 179 250746 131149 110207225
Periorbital haemorrhage 27.75 10.86 14 250911 316 110338058
Accidental overdose 27.65 10.86 207 250718 51627 110286747
Lung disorder 27.58 10.86 268 250657 179779 110158595
Dystonia 27.54 10.86 12 250913 25793 110312581
Vascular graft thrombosis 27.42 10.86 13 250912 255 110338119
Diarrhoea haemorrhagic 27.42 10.86 88 250837 15551 110322823
Rhinitis allergic 27.39 10.86 4 250921 17918 110320456
Vaginal discharge 27.36 10.86 4 250921 17904 110320470
Haematospermia 27.28 10.86 13 250912 258 110338116
Ischaemic nephropathy 27.16 10.86 10 250915 100 110338274
Spinal epidural haematoma 27.15 10.86 26 250899 1699 110336675
Antiphospholipid syndrome 27.09 10.86 31 250894 2492 110335882
Delirium 27.08 10.86 187 250738 134838 110203536
Hysterectomy 26.97 10.86 58 250867 8056 110330318
Pathogen resistance 26.88 10.86 4 250921 17668 110320706
Accidental exposure to product 26.86 10.86 45 250880 49963 110288411
Stent placement 26.72 10.86 54 250871 7180 110331194
White blood cell count decreased 26.72 10.86 363 250562 229027 110109347
Retinal vascular thrombosis 26.66 10.86 12 250913 208 110338166
Urethral haemorrhage 26.59 10.86 16 250909 515 110337859
Blood phosphorus increased 26.53 10.86 3 250922 16337 110322037
Creatinine renal clearance abnormal 26.51 10.86 18 250907 716 110337658
Peripheral artery bypass 26.23 10.86 10 250915 111 110338263
Paraplegia 26.22 10.86 49 250876 6151 110332223
Paranoia 26.20 10.86 9 250916 22365 110316009
Cerebral thrombosis 26.15 10.86 30 250895 2418 110335956
Incorrect dosage administered 26.09 10.86 38 250887 3880 110334494
Thrombotic microangiopathy 26.05 10.86 17 250908 29132 110309242
Lacunar stroke 26.04 10.86 16 250909 535 110337839
Pemphigoid 26.02 10.86 101 250824 19606 110318768
Premature delivery 25.87 10.86 19 250906 30613 110307761
Intentional self-injury 25.86 10.86 28 250897 37401 110300973
Malignant neoplasm progression 25.84 10.86 262 250663 174305 110164069
Endocarditis noninfective 25.82 10.86 13 250912 292 110338082
Immunodeficiency 25.80 10.86 30 250895 38808 110299566
Seizure 25.77 10.86 350 250575 220835 110117539
Mucosal haemorrhage 25.73 10.86 33 250892 2987 110335387
Traumatic haemothorax 25.69 10.86 18 250907 754 110337620
Respiratory disorder 25.55 10.86 80 250845 71302 110267072
Drug use disorder 25.49 10.86 5 250920 18069 110320305
Lymphadenopathy 25.44 10.86 68 250857 63767 110274607
Epilepsy 25.28 10.86 129 250796 100080 110238294
Procedural pain 25.26 10.86 26 250899 35539 110302835
Sedation complication 25.02 10.86 7 250918 19848 110318526
Hypophosphataemia 25.02 10.86 23 250902 33159 110305215
Panniculitis 24.96 10.86 3 250922 15579 110322795
Influenza 24.95 10.86 254 250671 168847 110169527
Epstein-Barr virus infection 24.77 10.86 6 250919 18732 110319642
Post procedural haematuria 24.74 10.86 13 250912 320 110338054
Post-traumatic amnestic disorder 24.72 10.86 8 250917 52 110338322
Pulmonary endarterectomy 24.70 10.86 12 250913 249 110338125
Basilar artery thrombosis 24.64 10.86 14 250911 404 110337970
Withdrawal syndrome 24.57 10.86 21 250904 31359 110307015
Catheter management 24.55 10.86 36 250889 3699 110334675
Photophobia 24.47 10.86 14 250911 25757 110312617
Osteoporosis 24.44 10.86 108 250817 87044 110251330
Platelet dysfunction 24.35 10.86 15 250910 504 110337870
Oral candidiasis 24.30 10.86 40 250885 44720 110293654
Vascular purpura 24.28 10.86 36 250889 3735 110334639
Adverse event 24.21 10.86 146 250779 108663 110229711
Hip arthroplasty 24.15 10.86 57 250868 55756 110282618
Exercise tolerance decreased 24.04 10.86 71 250854 11996 110326378
Radiculopathy 24.03 10.86 7 250918 19329 110319045
Anticoagulant-related nephropathy 23.96 10.86 11 250914 200 110338174
Anti factor X activity increased 23.92 10.86 9 250916 96 110338278
Hemianopia homonymous 23.90 10.86 23 250902 1512 110336862
Duodenitis haemorrhagic 23.83 10.86 10 250915 145 110338229
Red blood cell sedimentation rate abnormal 23.72 10.86 13 250912 24496 110313878
Soft tissue haemorrhage 23.71 10.86 14 250911 435 110337939
Shock 23.69 10.86 205 250720 53383 110284991
Conjunctivitis 23.66 10.86 25 250900 33767 110304607
Intracranial mass 23.41 10.86 28 250897 2360 110336014
Diverticulum intestinal 23.39 10.86 69 250856 11650 110326724
Postoperative thrombosis 23.38 10.86 11 250914 212 110338162
Bronchopulmonary aspergillosis 23.36 10.86 20 250905 29843 110308531
Bleeding time abnormal 23.35 10.86 6 250919 14 110338360
Hiatus hernia 23.33 10.86 124 250801 27482 110310892
Hyperhomocysteinaemia 23.25 10.86 16 250909 651 110337723
Joint dislocation 23.16 10.86 26 250899 34164 110304210
Oedema 23.14 10.86 336 250589 209640 110128734
Rhinitis 23.13 10.86 107 250818 22438 110315936
Neuroleptic malignant syndrome 22.96 10.86 26 250899 34033 110304341
Adverse reaction 22.93 10.86 20 250905 29574 110308800
Chromaturia 22.87 10.86 129 250796 29231 110309143
Aortic surgery 22.85 10.86 7 250918 37 110338337
Pharyngeal haematoma 22.83 10.86 10 250915 162 110338212
Body temperature increased 22.78 10.86 57 250868 54656 110283718
Neutrophil count increased 22.77 10.86 27 250898 34625 110303749
Ventricle rupture 22.76 10.86 9 250916 111 110338263
Infusion site reaction 22.72 10.86 6 250919 17676 110320698
Sputum increased 22.53 10.86 44 250881 5707 110332667
Prothrombin level decreased 22.48 10.86 24 250901 1786 110336588
Bacterial infection 22.42 10.86 44 250881 45992 110292382
Viral infection 22.41 10.86 55 250870 53084 110285290
Phlebitis deep 22.27 10.86 6 250919 18 110338356
Angioedema 22.00 10.86 132 250793 98368 110240006
Occult blood 21.98 10.86 24 250901 1832 110336542
Arterial intramural haematoma 21.85 10.86 11 250914 247 110338127
Quadriplegia 21.84 10.86 36 250889 4091 110334283
Hypertriglyceridaemia 21.70 10.86 5 250920 16149 110322225
Lactic acidosis 21.65 10.86 313 250612 92498 110245876
Retinal vein thrombosis 21.63 10.86 16 250909 730 110337644
Cardiac failure congestive 21.54 10.86 471 250454 150529 110187845
Back pain 21.53 10.86 659 250266 370337 109968037
Foetal death 21.48 10.86 5 250920 16040 110322334
Prothrombin time abnormal 21.47 10.86 20 250905 1262 110337112
Laryngeal haematoma 21.38 10.86 10 250915 190 110338184
Pulmonary artery thrombosis 21.25 10.86 22 250903 1580 110336794
Oxygen saturation increased 21.22 10.86 16 250909 752 110337622
Parkinsonism 21.14 10.86 12 250913 22175 110316199
Medical device site haemorrhage 21.10 10.86 10 250915 196 110338178
Coronary artery stenosis 21.09 10.86 74 250851 13684 110324690
Mydriasis 21.09 10.86 12 250913 22145 110316229
Supine hypertension 21.07 10.86 13 250912 438 110337936
Cerebral amyloid angiopathy 20.98 10.86 14 250911 541 110337833
Coronary artery thrombosis 20.94 10.86 31 250894 3213 110335161
Herpes simplex 20.93 10.86 5 250920 15759 110322615
Constipation 20.89 10.86 635 250290 357151 109981223
Implant site haematoma 20.87 10.86 10 250915 201 110338173
Product packaging quantity issue 20.85 10.86 23 250902 1776 110336598
Diabetes mellitus 20.74 10.86 136 250789 99245 110239129
Erythema 20.72 10.86 503 250422 290944 110047430
Hypercalcaemia 20.71 10.86 47 250878 46610 110291764
Aplastic anaemia 20.63 10.86 15 250910 24293 110314081
Skin haemorrhage 20.63 10.86 111 250814 24716 110313658
Therapeutic response shortened 20.59 10.86 22 250903 29561 110308813
Neuralgia 20.58 10.86 50 250875 48428 110289946
Intermittent claudication 20.56 10.86 33 250892 3668 110334706
Hemianaesthesia 20.55 10.86 13 250912 458 110337916
Monoparesis 20.54 10.86 37 250888 4516 110333858
Cerebral artery thrombosis 20.51 10.86 22 250903 1646 110336728
Vascular pseudoaneurysm ruptured 20.51 10.86 14 250911 562 110337812
Exsanguination 20.50 10.86 8 250917 95 110338279
Jaundice 20.42 10.86 215 250710 59021 110279353
Tender joint count decreased 20.39 10.86 11 250914 286 110338088
Haematotympanum 20.38 10.86 6 250919 27 110338347
Multiple sclerosis 20.36 10.86 17 250908 25681 110312693
Sepsis 20.36 10.86 576 250349 326770 110011604
Multiple organ dysfunction syndrome 20.32 10.86 233 250692 151477 110186897
Renal failure 20.30 10.86 665 250260 225909 110112465
Sudden death 20.22 10.86 109 250816 24286 110314088
Pseudomonas infection 20.19 10.86 20 250905 27833 110310541
Contusion 20.16 10.86 682 250243 232679 110105695
Skin ulcer haemorrhage 20.16 10.86 14 250911 578 110337796
Throat tightness 20.04 10.86 28 250897 33461 110304913
Throat irritation 19.89 10.86 59 250866 53493 110284881
Left ventricular failure 19.89 10.86 64 250861 11325 110327049
Anticoagulation drug level below therapeutic 19.80 10.86 22 250903 1712 110336662
Monoplegia 19.77 10.86 38 250887 4871 110333503
Haemorrhagic hepatic cyst 19.76 10.86 7 250918 62 110338312
Protein C deficiency 19.70 10.86 6 250919 31 110338343
Vascular graft occlusion 19.69 10.86 15 250910 716 110337658
Post procedural stroke 19.65 10.86 8 250917 107 110338267
Subclavian vein thrombosis 19.64 10.86 28 250897 2804 110335570
Anticoagulation drug level abnormal 19.62 10.86 11 250914 309 110338065
Spinal cord compression 19.62 10.86 49 250876 7503 110330871
Basal ganglia haematoma 19.56 10.86 7 250918 64 110338310
Troponin increased 19.50 10.86 125 250800 29641 110308733
Proctitis 19.49 10.86 7 250918 16920 110321454
Mood swings 19.46 10.86 14 250911 22798 110315576
Thrombocytosis 19.44 10.86 60 250865 10384 110327990
Colitis 19.40 10.86 144 250781 102179 110236195
Gastrointestinal erosion 19.40 10.86 18 250907 1130 110337244
Product label issue 19.24 10.86 17 250908 1001 110337373
Crying 19.05 10.86 18 250907 25610 110312764
Splenic infarction 19.04 10.86 35 250890 4339 110334035
Eye pruritus 19.02 10.86 28 250897 32747 110305627
Pneumocystis jirovecii pneumonia 19.01 10.86 43 250882 42692 110295682
Traumatic fracture 19.00 10.86 18 250907 1160 110337214
Diffuse vasculitis 19 10.86 8 250917 117 110338257
Hepatic haemorrhage 18.93 10.86 19 250906 1315 110337059
Hypogammaglobulinaemia 18.92 10.86 11 250914 20065 110318309
Sneezing 18.88 10.86 27 250898 31957 110306417
Incision site haematoma 18.82 10.86 9 250916 180 110338194
Post procedural pulmonary embolism 18.82 10.86 10 250915 252 110338122
Left ventricular dysfunction 18.82 10.86 104 250821 23389 110314985
Injection site warmth 18.72 10.86 8 250917 17397 110320977
Renal tubular necrosis 18.72 10.86 25 250900 30450 110307924
Peripheral artery stenosis 18.69 10.86 19 250906 1335 110337039
Ventricular hypokinesia 18.67 10.86 62 250863 11152 110327222
Myositis 18.63 10.86 26 250899 31090 110307284
Thrombotic cerebral infarction 18.59 10.86 15 250910 779 110337595
Catheter site discharge 18.56 10.86 28 250897 2951 110335423
Substance abuse 18.55 10.86 3 250922 12460 110325914
Conjunctival pallor 18.51 10.86 9 250916 187 110338187
Anger 18.51 10.86 10 250915 18997 110319377
Hyperphosphataemia 18.48 10.86 7 250918 16374 110322000
Encephalopathy 18.43 10.86 108 250817 80947 110257427
Abnormal behaviour 18.42 10.86 38 250887 39001 110299373
Coordination abnormal 18.42 10.86 18 250907 25210 110313164
Status epilepticus 18.29 10.86 27 250898 31544 110306830
Paralysis 18.24 10.86 77 250848 15523 110322851
Tenderness 18.23 10.86 24 250901 29413 110308961
Lymphopenia 18.21 10.86 40 250885 40130 110298244
Gait disturbance 18.21 10.86 486 250439 277722 110060652
Percutaneous coronary intervention 18.18 10.86 12 250913 455 110337919
Walking aid user 18.18 10.86 18 250907 25057 110313317
Atrio-oesophageal fistula 18.13 10.86 4 250921 3 110338371
Mental disorder 18.10 10.86 38 250887 38753 110299621
Swollen joint count decreased 18.06 10.86 11 250914 362 110338012
Hemiataxia 18.04 10.86 6 250919 43 110338331
Hepatic haematoma 18.01 10.86 16 250909 949 110337425
Progressive multifocal leukoencephalopathy 18.00 10.86 18 250907 24938 110313436
Venous haemorrhage 17.95 10.86 11 250914 366 110338008
Change of bowel habit 17.92 10.86 27 250898 2842 110335532
Bladder neoplasm 17.86 10.86 22 250903 1912 110336462
Increased tendency to bruise 17.82 10.86 63 250862 11695 110326679
Labelled drug-disease interaction issue 17.80 10.86 7 250918 85 110338289
Catheter site pruritus 17.79 10.86 24 250901 2282 110336092
Meningorrhagia 17.69 10.86 11 250914 376 110337998
Renal embolism 17.68 10.86 9 250916 207 110338167
Ulnar nerve injury 17.68 10.86 10 250915 286 110338088
Acute coronary syndrome 17.65 10.86 101 250824 23011 110315363
Aortic aneurysm 17.61 10.86 56 250869 9848 110328526
Blood glucose increased 17.55 10.86 204 250721 132292 110206082
Sticky platelet syndrome 17.45 10.86 5 250920 20 110338354
Influenza like illness 17.45 10.86 123 250802 88289 110250085
Enzyme inhibition 17.45 10.86 8 250917 145 110338229
Pulmonary arterial pressure increased 17.45 10.86 37 250888 5090 110333284
Extra dose administered 17.45 10.86 64 250861 12095 110326279
Mania 17.43 10.86 13 250912 20783 110317591
Stenosis 17.43 10.86 29 250896 3322 110335052
Duodenitis 17.27 10.86 53 250872 9143 110329231
Abnormal withdrawal bleeding 17.26 10.86 6 250919 50 110338324
Pneumonia fungal 17.16 10.86 6 250919 14748 110323626
Angiodysplasia 17.06 10.86 19 250906 1483 110336891
Death 17.04 10.86 1823 249102 697046 109641328
Dry skin 17.01 10.86 159 250766 107494 110230880
Hyperammonaemia 17.01 10.86 5 250920 13727 110324647
Skin laceration 17 10.86 133 250792 33620 110304754
Therapeutic procedure 16.99 10.86 16 250909 1024 110337350
Aortic valve calcification 16.98 10.86 15 250910 883 110337491
Blood test abnormal 16.96 10.86 24 250901 28530 110309844
Withdrawal bleed 16.95 10.86 6 250919 53 110338321
Perforated ulcer 16.95 10.86 14 250911 752 110337622
Headache 16.85 10.86 1749 249176 880628 109457746
Blood calcium decreased 16.82 10.86 35 250890 35810 110302564
Spontaneous haemorrhage 16.77 10.86 17 250908 1191 110337183
Mediastinal haematoma 16.76 10.86 9 250916 232 110338142
Cardiac amyloidosis 16.73 10.86 26 250899 2811 110335563
Contraindication to surgery 16.71 10.86 4 250921 6 110338368
Brain stem stroke 16.71 10.86 14 250911 767 110337607
Foreign body in throat 16.69 10.86 16 250909 1047 110337327
Sarcoidosis 16.68 10.86 4 250921 12575 110325799
Stiff person syndrome 16.59 10.86 13 250912 647 110337727
Cerebrospinal fluid retention 16.59 10.86 7 250918 103 110338271
Pulmonary infarction 16.56 10.86 32 250893 4119 110334255
Cardiac vein perforation 16.55 10.86 5 250920 25 110338349
Arthritis 16.48 10.86 274 250651 167312 110171062
Acute myeloid leukaemia 16.42 10.86 39 250886 38071 110300303
CHA2DS2-VASc annual stroke risk high 16.39 10.86 5 250920 26 110338348
Dental care 16.36 10.86 16 250909 1073 110337301
Macular degeneration 16.35 10.86 15 250910 21644 110316730
Thrombosis mesenteric vessel 16.31 10.86 9 250916 245 110338129
Blindness unilateral 16.20 10.86 54 250871 9732 110328642
Fractured coccyx 16.19 10.86 17 250908 1241 110337133
Colorectal cancer metastatic 16.18 10.86 19 250906 1570 110336804
Amaurosis 16.18 10.86 19 250906 1570 110336804
Sinus disorder 16.18 10.86 31 250894 32697 110305677
Large intestinal ulcer haemorrhage 16.15 10.86 10 250915 339 110338035
Coronary artery embolism 16.13 10.86 10 250915 340 110338034
Ventricular arrhythmia 16.11 10.86 55 250870 10032 110328342
Gastrointestinal arteriovenous malformation 16.06 10.86 15 250910 950 110337424
Inhibitory drug interaction 16.03 10.86 35 250890 4912 110333462
Extremity necrosis 16.02 10.86 30 250895 3772 110334602
Vascular access site occlusion 16 10.86 7 250918 113 110338261
Osteorrhagia 15.99 10.86 4 250921 8 110338366
Facial bones fracture 15.91 10.86 35 250890 4936 110333438
Catheterisation cardiac 15.91 10.86 40 250885 6151 110332223
Intestinal haematoma 15.89 10.86 10 250915 349 110338025
Gastric pH increased 15.87 10.86 6 250919 65 110338309
Peritoneal haematoma 15.86 10.86 9 250916 259 110338115
Language disorder 15.82 10.86 30 250895 3808 110334566
Vision blurred 15.81 10.86 202 250723 128820 110209554
Brain contusion 15.81 10.86 19 250906 1609 110336765
Abdominal pain 15.79 10.86 978 249947 512011 109826363
Surgery 15.75 10.86 153 250772 41130 110297244
Fluid retention 15.70 10.86 301 250624 94006 110244368
Normochromic normocytic anaemia 15.70 10.86 65 250860 12992 110325382
Peripheral artery haematoma 15.67 10.86 7 250918 119 110338255
Infarction 15.64 10.86 36 250889 5233 110333141
Aortic intramural haematoma 15.64 10.86 8 250917 186 110338188
Henoch-Schonlein purpura 15.59 10.86 29 250896 3628 110334746
Extrapyramidal disorder 15.48 10.86 26 250899 28841 110309533
Plasma cell myeloma 15.38 10.86 214 250711 62722 110275652
Post procedural oedema 15.36 10.86 7 250918 125 110338249
Exposure to toxic agent 15.36 10.86 5 250920 12853 110325521
Osteomyelitis 15.34 10.86 38 250887 36562 110301812
Thoracic haemorrhage 15.32 10.86 9 250916 277 110338097
Intestinal ischaemia 15.30 10.86 75 250850 16104 110322270
Spinal subdural haemorrhage 15.27 10.86 3 250922 0 110338374
Bronchial mucosa hyperaemia 15.27 10.86 3 250922 0 110338374
Orthostatic heart rate response increased 15.27 10.86 3 250922 0 110338374
Scrotal haemorrhage 15.27 10.86 3 250922 0 110338374
Blood product transfusion dependent 15.22 10.86 11 250914 484 110337890
Cardiovascular insufficiency 15.19 10.86 27 250898 3261 110335113
Carotid artery occlusion 15.14 10.86 52 250873 9513 110328861
Medication error 15.14 10.86 329 250596 105037 110233337
Posterior reversible encephalopathy syndrome 15.12 10.86 34 250891 33827 110304547
Hypertrophic osteoarthropathy 15.11 10.86 7 250918 130 110338244
Lung diffusion disorder 15.09 10.86 9 250916 285 110338089
Atrioventricular block 15.08 10.86 77 250848 16800 110321574
Platelet aggregation inhibition 15.04 10.86 8 250917 202 110338172
Tongue haemorrhage 15.00 10.86 16 250909 1189 110337185
Haematoma evacuation 15.00 10.86 10 250915 386 110337988
Cerebral venous sinus thrombosis 14.98 10.86 25 250900 2870 110335504
Application site haematoma 14.96 10.86 6 250919 77 110338297
Haemodialysis 14.95 10.86 11 250914 17708 110320666
Scar 14.88 10.86 10 250915 16871 110321503
Manufacturing materials issue 14.85 10.86 4 250921 12 110338362
Food allergy 14.84 10.86 14 250911 19934 110318440
Haemodilution 14.83 10.86 7 250918 136 110338238
Bone density decreased 14.83 10.86 9 250916 16033 110322341
Peripheral coldness 14.80 10.86 82 250843 18458 110319916
Oedema genital 14.76 10.86 12 250913 630 110337744
Respiratory arrest 14.73 10.86 75 250850 58224 110280150
Implant site haemorrhage 14.73 10.86 8 250917 211 110338163
Ocular myasthenia 14.72 10.86 13 250912 765 110337609
Lacrimation increased 14.71 10.86 30 250895 30920 110307454
Coagulation time shortened 14.70 10.86 10 250915 399 110337975
Electrocardiogram QRS complex abnormal 14.66 10.86 13 250912 769 110337605
Dyspnoea at rest 14.66 10.86 47 250878 8299 110330075
Gastroduodenal haemorrhage 14.65 10.86 9 250916 301 110338073
Cardiac fibrillation 14.60 10.86 15 250910 1067 110337307
Pulmonary haematoma 14.60 10.86 7 250918 141 110338233
Acute respiratory failure 14.58 10.86 246 250679 75014 110263360
Prothrombin time ratio decreased 14.52 10.86 18 250907 1574 110336800
Degenerative aortic valve disease 14.49 10.86 8 250917 218 110338156
Cytopenia 14.48 10.86 29 250896 30087 110308287
Neutropenic sepsis 14.45 10.86 30 250895 30716 110307658
Subarachnoid haematoma 14.43 10.86 9 250916 309 110338065
Reversible ischaemic neurological deficit 14.35 10.86 5 250920 42 110338332
Oesophageal ulcer haemorrhage 14.33 10.86 14 250911 938 110337436
Pulmonary arterial pressure abnormal 14.31 10.86 14 250911 939 110337435
Arrhythmogenic right ventricular dysplasia 14.30 10.86 6 250919 87 110338287
Aortic thrombosis 14.29 10.86 21 250904 2162 110336212
Spondylitis 14.28 10.86 4 250921 11334 110327040
Emergency care 14.18 10.86 17 250908 1436 110336938
Uveitis 14.18 10.86 17 250908 21693 110316681
Therapeutic product ineffective 14.17 10.86 23 250902 2581 110335793
Eosinophilia 14.16 10.86 197 250728 57739 110280635
Basal ganglia stroke 14.11 10.86 8 250917 230 110338144
Pancreatic neoplasm 14.06 10.86 19 250906 1810 110336564
Spinal osteoarthritis 14.06 10.86 15 250910 20168 110318206
Subclavian artery thrombosis 14.04 10.86 5 250920 45 110338329
Palmar-plantar erythrodysaesthesia syndrome 13.97 10.86 47 250878 40978 110297396
Deformity 13.94 10.86 3 250922 10157 110328217
Gastrointestinal toxicity 13.92 10.86 4 250921 11144 110327230
Septic pulmonary embolism 13.91 10.86 9 250916 330 110338044
Eye irritation 13.81 10.86 35 250890 33417 110304957
Tuberculosis 13.79 10.86 12 250913 17762 110320612
Immune reconstitution inflammatory syndrome 13.78 10.86 10 250915 16216 110322158
Osteonecrosis of jaw 13.77 10.86 59 250866 47958 110290416
Paresis cranial nerve 13.76 10.86 5 250920 48 110338326
Varicose vein ruptured 13.64 10.86 7 250918 164 110338210
Injection site rash 13.60 10.86 20 250905 23399 110314975
Prosthetic cardiac valve stenosis 13.59 10.86 4 250921 18 110338356
Portal vein thrombosis 13.56 10.86 41 250884 7017 110331357
Tendonitis 13.52 10.86 24 250901 26059 110312315
Gravitational oedema 13.51 10.86 19 250906 1879 110336495
Pancytopenia 13.49 10.86 367 250558 209246 110129128
Retinal artery thrombosis 13.49 10.86 6 250919 101 110338273
Pustular psoriasis 13.48 10.86 7 250918 13598 110324776
Generalised tonic-clonic seizure 13.45 10.86 71 250854 54609 110283765
Cerebral microhaemorrhage 13.43 10.86 10 250915 461 110337913
SAPHO syndrome 13.43 10.86 11 250914 584 110337790
Intracranial aneurysm 13.41 10.86 33 250892 5007 110333367
Hepatic steatosis 13.40 10.86 61 250864 48770 110289604
Aortic occlusion 13.35 10.86 9 250916 354 110338020
Aphthous ulcer 13.33 10.86 17 250908 21119 110317255
Pain in jaw 13.32 10.86 176 250749 51001 110287373
Dissociation 13.31 10.86 3 250922 9839 110328535
Fear 13.28 10.86 20 250905 23173 110315201
Thrombosis in device 13.25 10.86 34 250891 5293 110333081
Immunosuppressant drug level increased 13.25 10.86 5 250920 11719 110326655
Factor Xa activity increased 13.24 10.86 4 250921 20 110338354
Diabetes mellitus inadequate control 13.21 10.86 30 250895 29745 110308629
Transient epileptic amnesia 13.20 10.86 3 250922 3 110338371
Plantar fasciitis 13.15 10.86 33 250892 5068 110333306
Ocular retrobulbar haemorrhage 13.12 10.86 7 250918 178 110338196
Vascular operation 13.08 10.86 7 250918 179 110338195
Ventricular drainage 13.08 10.86 4 250921 21 110338353
Dyslalia 13.07 10.86 16 250909 1381 110336993
Eosinophilic granulomatosis with polyangiitis 13.04 10.86 4 250921 10682 110327692
Adverse drug reaction 13.03 10.86 165 250760 105394 110232980
Thrombectomy 13.02 10.86 9 250916 369 110338005
Cor pulmonale acute 13.01 10.86 12 250913 748 110337626
Therapeutic response increased 13.00 10.86 11 250914 611 110337763
Varicophlebitis 12.99 10.86 5 250920 57 110338317
Mitral valve incompetence 12.95 10.86 124 250801 33205 110305169
Speech disorder 12.95 10.86 204 250721 61365 110277009
Pelvic haemorrhage 12.91 10.86 7 250918 184 110338190
Glomerular filtration rate abnormal 12.90 10.86 21 250904 2362 110336012
Renal vascular thrombosis 12.88 10.86 6 250919 113 110338261
End stage renal disease 12.80 10.86 18 250907 21455 110316919
Melanaemia 12.77 10.86 5 250920 60 110338314
Nephropathy toxic 12.75 10.86 27 250898 27451 110310923
Coronary artery occlusion 12.75 10.86 70 250855 15702 110322672
Peritonitis bacterial 12.75 10.86 4 250921 10529 110327845
Jugular vein distension 12.74 10.86 17 250908 1599 110336775
Akathisia 12.74 10.86 12 250913 17101 110321273
Myelodysplastic syndrome 12.73 10.86 43 250882 37441 110300933
Osteonecrosis 12.66 10.86 37 250888 33704 110304670
Blood pressure increased 12.62 10.86 469 250456 257904 110080470
Dizziness postural 12.60 10.86 66 250859 14543 110323831
Jaundice acholuric 12.60 10.86 6 250919 119 110338255
Breast haematoma 12.57 10.86 7 250918 194 110338180
Pulmonary artery dilatation 12.43 10.86 11 250914 649 110337725
Blood triglycerides increased 12.42 10.86 22 250903 23904 110314470
Poisoning 12.37 10.86 30 250895 29075 110309299
Bronchiectasis 12.37 10.86 132 250793 36361 110302013
Injection site bruising 12.36 10.86 67 250858 51196 110287178
Blood thyroid stimulating hormone abnormal 12.34 10.86 14 250911 1115 110337259
Tracheal haemorrhage 12.30 10.86 12 250913 802 110337572
Catheter site injury 12.30 10.86 8 250917 296 110338078
Vulval haemorrhage 12.23 10.86 4 250921 27 110338347
Duodenogastric reflux 12.23 10.86 7 250918 205 110338169
Bacteraemia 12.21 10.86 52 250873 42338 110296036
Gastrointestinal ischaemia 12.20 10.86 10 250915 531 110337843
Rales 12.20 10.86 97 250828 24642 110313732
Product storage error 12.19 10.86 19 250906 21709 110316665
Panic attack 12.17 10.86 30 250895 28910 110309464
Thirst 12.16 10.86 19 250906 21688 110316686
Pseudophaeochromocytoma 12.16 10.86 6 250919 129 110338245
Catheter site vesicles 12.14 10.86 9 250916 412 110337962
Tumour lysis syndrome 12.13 10.86 33 250892 30768 110307606
Chronic obstructive pulmonary disease 12.10 10.86 329 250596 108829 110229545
Diastolic dysfunction 12.09 10.86 58 250867 12346 110326028
Psychiatric symptom 12.08 10.86 3 250922 9210 110329164
Arterial injury 12.06 10.86 12 250913 822 110337552
Encephalitis 12.04 10.86 15 250910 18824 110319550
Aspergillus infection 12.03 10.86 25 250900 25591 110312783
Back disorder 12.02 10.86 18 250907 20904 110317470
Vertebral artery thrombosis 11.99 10.86 3 250922 6 110338368
Optic nerve compression 11.99 10.86 4 250921 29 110338345
Myocarditis 11.99 10.86 32 250893 30023 110308351
Pulmonary tuberculosis 11.94 10.86 3 250922 9136 110329238
Uterine disorder 11.92 10.86 20 250905 2306 110336068
Blood calcium increased 11.91 10.86 14 250911 18026 110320348
Radiation proctitis 11.90 10.86 7 250918 216 110338158
Thalamic infarction 11.88 10.86 15 250910 1337 110337037
Subclavian vein occlusion 11.87 10.86 4 250921 30 110338344
Gastrointestinal tract mucosal discolouration 11.87 10.86 4 250921 30 110338344
Pulmonary microemboli 11.87 10.86 4 250921 30 110338344
Cardiac valve replacement complication 11.87 10.86 7 250918 217 110338157
Device use error 11.84 10.86 3 250922 9086 110329288
Aortic dissection 11.77 10.86 31 250894 4902 110333472
Emphysema 11.75 10.86 81 250844 19675 110318699
Hypertensive crisis 11.71 10.86 95 250830 24277 110314097
Hepatitis C 11.69 10.86 7 250918 12566 110325808
Adrenal thrombosis 11.68 10.86 3 250922 7 110338367
Muscle rigidity 11.68 10.86 23 250902 24008 110314366
Sinus node dysfunction 11.65 10.86 46 250879 9001 110329373
Impaired work ability 11.64 10.86 101 250824 26318 110312056
Tachycardia induced cardiomyopathy 11.64 10.86 7 250918 225 110338149
Appendicitis 11.58 10.86 30 250895 28434 110309940
Ankylosing spondylitis 11.56 10.86 11 250914 15601 110322773
Hot flush 11.55 10.86 95 250830 65941 110272433
Monocyte count increased 11.55 10.86 8 250917 13285 110325089
Coagulation factor X level abnormal 11.54 10.86 4 250921 33 110338341
Spinal epidural haemorrhage 11.53 10.86 8 250917 330 110338044
Breast cancer female 11.51 10.86 7 250918 12461 110325913
Oesophageal ulcer 11.49 10.86 42 250883 7922 110330452
Cataract 11.47 10.86 120 250805 79365 110259009
Middle insomnia 11.43 10.86 18 250907 20484 110317890
Disorganised speech 11.43 10.86 24 250901 3279 110335095
Blood creatinine increased 11.43 10.86 516 250409 182373 110156001
Skin burning sensation 11.39 10.86 20 250905 21805 110316569
Cerebellar stroke 11.38 10.86 12 250913 880 110337494
Sinus tachycardia 11.38 10.86 57 250868 44436 110293938
Basal ganglia infarction 11.36 10.86 11 250914 729 110337645
Peritonitis 11.35 10.86 37 250888 32570 110305804
Haematocrit decreased 11.34 10.86 212 250713 65905 110272469
Pancreatitis acute 11.34 10.86 85 250840 60189 110278185
Left ventricular dilatation 11.28 10.86 15 250910 1407 110336967
Anastomotic haemorrhage 11.27 10.86 8 250917 342 110338032
Emergency care examination 11.26 10.86 7 250918 239 110338135
Intermenstrual bleeding 11.24 10.86 38 250887 6896 110331478
Dysarthria 11.24 10.86 260 250665 83861 110254513
BK virus infection 11.24 10.86 8 250917 13098 110325276
Lymphostasis 11.23 10.86 4 250921 36 110338338
Subdural hygroma 11.22 10.86 10 250915 596 110337778
Hepatitis acute 11.20 10.86 77 250848 18689 110319685
Myopathy 11.19 10.86 25 250900 24935 110313439
Scoliosis 11.15 10.86 3 250922 8730 110329644
Bone hypertrophy 11.14 10.86 11 250914 746 110337628
Pericardial drainage 11.13 10.86 9 250916 469 110337905
Brief psychotic disorder with marked stressors 11.07 10.86 8 250917 352 110338022
Injection site induration 11.07 10.86 6 250919 11377 110326997
COVID-19 11.06 10.86 449 250476 244611 110093763
Infective pericardial effusion 11.04 10.86 4 250921 38 110338336
Mesenteric haematoma 11.04 10.86 5 250920 88 110338286
Pre-eclampsia 10.99 10.86 3 250922 8647 110329727
Hypophagia 10.99 10.86 72 250853 52554 110285820
Retinal artery embolism 10.99 10.86 6 250919 160 110338214
Fasciotomy 10.99 10.86 5 250920 89 110338285
Nipple exudate bloody 10.99 10.86 5 250920 89 110338285
Echocardiogram 10.95 10.86 4 250921 39 110338335
Stent-graft endoleak 10.95 10.86 4 250921 39 110338335
Antiphospholipid antibodies positive 10.94 10.86 12 250913 921 110337453
Hyperlipidaemia 10.93 10.86 43 250882 35805 110302569
Hip fracture 10.93 10.86 125 250800 35026 110303348
Movement disorder 10.89 10.86 44 250881 36360 110302014
Limb injury 10.89 10.86 132 250793 37504 110300870

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
ATC B01AF51 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 D006401 Hematologic Agents
MeSH PA D011480 Protease Inhibitors
MeSH PA D015842 Serine Proteinase Inhibitors
MeSH PA D065427 Factor Xa Inhibitors
FDA MoA N0000175635 Factor Xa Inhibitors
FDA EPC N0000175637 Factor Xa Inhibitor
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:38070 anti-arrhythmia drug
CHEBI has role CHEBI:50249 anticoagulant
CHEBI has role CHEBI:62868 hepatoprotective agent
CHEBI has role CHEBI:68581 EC 3.4.21.6 (coagulation factor Xa) inhibitor
CHEBI has role CHEBI:74518 anti-obesity agent
CHEBI has role CHEBI:75835 anti-anaemic agent

Related Drugs by ATC class:

B01AF Direct factor Xa inhibitors 4 drugs

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 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

Orange Book exclusivity data (new drug applications)

None

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
DB06228 DRUGBANK_ID
9NDF7JZ4M3 UNII
1114195 RXNORM
159029 MMSL
26019 MMSL
341714 MMSL
d07356 MMSL
012873 NDDF
442031002 SNOMEDCT_US
442539005 SNOMEDCT_US
C1739768 UMLSCUI
D000069552 MESH_DESCRIPTOR_UI
8428 INN_ID
9875401 PUBCHEM_CID
9NDF7JZ4M3 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Rivaroxaban Human Prescription Drug Label 1 14445-147 TABLET, FILM COATED 2.50 mg ORAL ANDA 26 sections
Rivaroxaban Human Prescription Drug Label 1 14445-148 TABLET, FILM COATED 10 mg ORAL ANDA 26 sections
Rivaroxaban Human Prescription Drug Label 1 14445-183 TABLET, FILM COATED 15 mg ORAL ANDA 26 sections
Rivaroxaban Human Prescription Drug Label 1 14445-184 TABLET, FILM COATED 20 mg ORAL ANDA 26 sections
RIVAROXABAN HUMAN PRESCRIPTION DRUG LABEL 1 31722-496 TABLET, FILM COATED 2.50 mg ORAL ANDA 25 sections
Rivaroxaban Human Prescription Drug Label 1 33342-488 TABLET, FILM COATED 2.50 mg ORAL ANDA 29 sections
RIVAROXABAN HUMAN PRESCRIPTION DRUG LABEL 1 42571-345 TABLET 2.50 mg ORAL ANDA 29 sections
Rivaroxaban HUMAN PRESCRIPTION DRUG LABEL 1 43598-981 TABLET 2.50 mg ORAL ANDA 29 sections
RIVAROXABAN Human Prescription Drug Label 1 46708-346 TABLET, FILM COATED 10 mg ORAL ANDA 29 sections
RIVAROXABAN Human Prescription Drug Label 1 46708-347 TABLET, FILM COATED 15 mg ORAL ANDA 29 sections
RIVAROXABAN Human Prescription Drug Label 1 46708-348 TABLET, FILM COATED 20 mg ORAL ANDA 29 sections
RIVAROXABAN Human Prescription Drug Label 1 46708-683 TABLET, FILM COATED 2.50 mg ORAL ANDA 29 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50090-3625 TABLET, FILM COATED 10 mg ORAL NDA 34 sections
XARELTO HUMAN PRESCRIPTION DRUG LABEL 1 50090-3639 TABLET, FILM COATED 20 mg ORAL NDA 33 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50090-4468 TABLET, FILM COATED 20 mg ORAL NDA 34 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50090-4469 TABLET, FILM COATED 10 mg ORAL NDA 34 sections
Rivaroxaban HUMAN PRESCRIPTION DRUG LABEL 1 50228-513 TABLET, FILM COATED 2.50 mg ORAL ANDA 20 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50458-575 GRANULE, FOR SUSPENSION 155 mg ORAL NDA 35 sections
XARELTO HUMAN PRESCRIPTION DRUG LABEL 1 50458-577 TABLET, FILM COATED 2.50 mg ORAL NDA 35 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50458-578 TABLET, FILM COATED 15 mg ORAL NDA 35 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50458-579 TABLET, FILM COATED 20 mg ORAL NDA 35 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50458-580 TABLET, FILM COATED 10 mg ORAL NDA 35 sections
Rivaroxaban HUMAN PRESCRIPTION DRUG LABEL 1 51672-4228 TABLET, COATED 2.50 mg ORAL ANDA 33 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 55154-1422 TABLET, FILM COATED 10 mg ORAL NDA 34 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 55154-1423 TABLET, FILM COATED 20 mg ORAL NDA 34 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 55154-1424 TABLET, FILM COATED 15 mg ORAL NDA 34 sections
rivaroxaban HUMAN PRESCRIPTION DRUG LABEL 1 55488-0540 TABLET, FILM COATED 10 mg ORAL ANDA 34 sections
rivaroxaban HUMAN PRESCRIPTION DRUG LABEL 1 55488-0541 TABLET, FILM COATED 15 mg ORAL ANDA 34 sections
rivaroxaban HUMAN PRESCRIPTION DRUG LABEL 1 55488-0542 TABLET, FILM COATED 20 mg ORAL ANDA 34 sections
Rivaroxaban Human Prescription Drug Label 1 59651-849 TABLET, FILM COATED 2.50 mg ORAL ANDA 29 sections