apixaban 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
blood coagulation factor XA inhibitors, antithrombotics 4298 503612-47-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • apixaban
  • eliquis
  • BMS 562247
  • BMS-562247
  • BMS-562247-01
Apixaban is a selective inhibitor of FXa. It does not require antithrombin III for antithrombotic activity. Apixaban inhibits free and clot-bound FXa, and prothrombinase activity. Apixaban has no direct effect on platelet aggregation, but indirectly inhibits platelet aggregation induced by thrombin. By inhibiting FXa, apixaban decreases thrombin generation and thrombus development.
  • Molecular weight: 459.51
  • Formula: C25H25N5O4
  • CLOGP: 1.99
  • LIPINSKI: 0
  • HAC: 9
  • HDO: 1
  • TPSA: 110.76
  • ALOGS: -3.83
  • ROTB: 5

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
10 mg O

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 0.30 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.80 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.13 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 12 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
May 18, 2011 EMA
Dec. 28, 2012 FDA BRISTOL MYERS SQUIBB

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
Death 1044.99 10.63 2236 108529 323143 50171216
Atrial fibrillation 961.25 10.63 1148 109617 100597 50393762
Gastrointestinal haemorrhage 931.36 10.63 966 109799 72355 50422004
Drug ineffective 640.76 10.63 517 110248 818816 49675543
Haemorrhage 614.24 10.63 668 110097 52773 50441586
Cerebral haemorrhage 614.05 10.63 494 110271 26558 50467801
Prescribed underdose 611.00 10.63 400 110365 15549 50478810
Cerebrovascular accident 588.80 10.63 871 109894 93809 50400550
Haemorrhage intracranial 570.64 10.63 349 110416 12025 50482334
Fall 530.84 10.63 1773 108992 333159 50161200
Haematoma 451.31 10.63 437 110328 30073 50464286
Thrombosis 415.52 10.63 560 110205 55273 50439086
Epistaxis 399.67 10.63 590 110175 63364 50430995
Cardiac failure 306.30 10.63 576 110189 75464 50418895
Subdural haematoma 292.76 10.63 236 110529 12711 50481648
Rheumatoid arthritis 256.13 10.63 64 110701 202486 50291873
Ischaemic stroke 252.03 10.63 237 110528 15711 50478648
Anaemia 248.54 10.63 1152 109613 251304 50243055
Exposure during pregnancy 244.42 10.63 4 110761 121011 50373348
Dyspnoea 238.66 10.63 2025 108740 545583 49948776
Pemphigus 238.51 10.63 5 110760 120161 50374198
Pulmonary embolism 237.36 10.63 619 110146 101085 50393274
Synovitis 231.78 10.63 9 110756 123856 50370503
Hospitalisation 224.67 10.63 474 110291 67463 50426896
Rectal haemorrhage 224.06 10.63 344 110421 38214 50456145
Intentional product use issue 223.02 10.63 509 110256 76409 50417950
Subarachnoid haemorrhage 221.81 10.63 186 110579 10590 50483769
Transfusion 217.89 10.63 199 110566 12706 50481653
Drug hypersensitivity 213.34 10.63 144 110621 250866 50243493
Cardiac disorder 212.17 10.63 356 110409 42623 50451736
Infusion related reaction 209.67 10.63 56 110709 169501 50324858
Cerebral infarction 203.85 10.63 244 110521 21360 50472999
Drug intolerance 200.96 10.63 115 110650 218989 50275370
Hand deformity 195.62 10.63 5 110760 100194 50394165
Systemic lupus erythematosus 192.74 10.63 37 110728 140585 50353774
Renal impairment 189.44 10.63 473 110292 75188 50419171
Glossodynia 185.02 10.63 19 110746 115550 50378809
Maternal exposure during pregnancy 184.34 10.63 60 110705 159718 50334641
Haematochezia 181.93 10.63 319 110446 39563 50454796
Therapeutic product effect decreased 179.81 10.63 39 110726 136011 50358348
Melaena 179.56 10.63 256 110509 26608 50467751
Pain 169.88 10.63 673 110092 578230 49916129
Atrial flutter 167.56 10.63 145 110620 8618 50485741
Completed suicide 165.99 10.63 42 110723 131847 50362512
Adverse event 155.99 10.63 315 110450 43448 50450911
Haematuria 155.13 10.63 233 110532 25380 50468979
Joint swelling 152.16 10.63 188 110577 245098 50249261
Dyspnoea exertional 151.73 10.63 342 110423 50891 50443468
Fluid retention 151.00 10.63 339 110426 50310 50444049
Deep vein thrombosis 146.85 10.63 422 110343 72882 50421477
Cardioversion 145.89 10.63 64 110701 1081 50493278
Haemoglobin decreased 138.76 10.63 599 110166 126617 50367742
Hypersensitivity 136.50 10.63 162 110603 214999 50279360
Pulmonary arterial hypertension 136.33 10.63 194 110571 20125 50474234
Product prescribing error 136.05 10.63 197 110568 20764 50473595
Labelled drug-drug interaction medication error 132.66 10.63 138 110627 10339 50484020
Treatment failure 125.02 10.63 73 110692 137564 50356795
Arthralgia 118.51 10.63 526 110239 438176 50056183
Hypotension 118.34 10.63 901 109864 234568 50259791
Hepatic enzyme increased 113.67 10.63 81 110684 137299 50357060
Internal haemorrhage 109.47 10.63 85 110680 4332 50490027
Haemorrhagic stroke 109.16 10.63 91 110674 5137 50489222
Embolic stroke 108.69 10.63 77 110688 3407 50490952
Intraventricular haemorrhage 107.90 10.63 61 110704 1809 50492550
Pericarditis 105.07 10.63 22 110743 78667 50415692
Haematemesis 102.90 10.63 203 110562 27522 50466837
Sensitisation 100.57 10.63 55 110710 1527 50492832
Head injury 100.41 10.63 185 110580 23835 50470524
Contraindicated product administered 96.73 10.63 110 110655 148848 50345511
Injection site pain 95.11 10.63 63 110702 110961 50383398
Shock haemorrhagic 91.74 10.63 102 110663 8242 50486117
Toxicity to various agents 91.65 10.63 206 110559 212293 50282066
Cardiac ablation 90.69 10.63 48 110717 1246 50493113
Atrial thrombosis 90.18 10.63 50 110715 1427 50492932
Subdural haemorrhage 88.65 10.63 62 110703 2687 50491672
Syncope 88.08 10.63 452 110313 102550 50391809
Pericardial haemorrhage 88.04 10.63 49 110716 1409 50492950
Musculoskeletal stiffness 87.71 10.63 91 110674 128390 50365969
Acute kidney injury 85.16 10.63 817 109948 227241 50267118
Upper gastrointestinal haemorrhage 83.36 10.63 136 110629 15899 50478460
Ejection fraction 82.65 10.63 44 110721 1156 50493203
Cardiac pacemaker insertion 81.32 10.63 66 110699 3587 50490772
Transient ischaemic attack 80.16 10.63 201 110564 32009 50462350
Stomatitis 79.64 10.63 63 110702 101281 50393078
Failure to suspend medication 79.31 10.63 17 110748 10 50494349
Impaired healing 79.03 10.63 27 110738 69759 50424600
Polycystic ovaries 77.72 10.63 55 110710 2429 50491930
Arthropathy 77.50 10.63 142 110623 157764 50336595
Dizziness 76.96 10.63 1123 109642 345246 50149113
Bradycardia 76.92 10.63 312 110453 64114 50430245
Cerebral mass effect 76.68 10.63 37 110728 785 50493574
Pyrexia 75.93 10.63 504 110261 379699 50114660
Hypervolaemia 75.22 10.63 170 110595 25329 50469030
Injection site erythema 75.03 10.63 35 110730 74901 50419458
Helicobacter infection 74.96 10.63 10 110755 49692 50444667
Haemorrhage subcutaneous 73.59 10.63 55 110710 2646 50491713
Post procedural haemorrhage 73.36 10.63 85 110680 7185 50487174
Folliculitis 72.83 10.63 3 110762 39222 50455137
Traumatic haemorrhage 71.73 10.63 30 110735 448 50493911
Discomfort 71.47 10.63 79 110686 108301 50386058
Alopecia 71.44 10.63 285 110480 244762 50249597
General physical health deterioration 69.74 10.63 542 110223 141892 50352467
Arrhythmia 69.48 10.63 194 110571 32938 50461421
Sinusitis 68.21 10.63 172 110593 170386 50323973
Therapeutic response decreased 67.77 10.63 11 110754 47220 50447139
Basal ganglia haemorrhage 67.68 10.63 30 110735 520 50493839
Swelling 66.87 10.63 221 110544 200651 50293708
Febrile neutropenia 66.84 10.63 69 110696 97598 50396761
Blood cholesterol increased 66.75 10.63 19 110746 55196 50439163
Therapeutic drug monitoring analysis not performed 66.57 10.63 32 110733 673 50493686
Product use issue 65.97 10.63 143 110622 149332 50345027
Injection site reaction 64.73 10.63 15 110750 50017 50444342
Lower respiratory tract infection 64.32 10.63 68 110697 95133 50399226
Cardiac failure congestive 61.13 10.63 354 110411 84028 50410331
Haemorrhoidal haemorrhage 60.82 10.63 56 110709 3611 50490748
Haemarthrosis 59.43 10.63 50 110715 2858 50491501
Dementia 57.99 10.63 116 110649 15881 50478478
Thrombectomy 57.70 10.63 19 110746 137 50494222
Pain in jaw 57.41 10.63 200 110565 38228 50456131
Pulmonary hypertension 57.11 10.63 182 110583 33235 50461124
Suicide attempt 56.89 10.63 21 110744 51711 50442648
Wound 56.60 10.63 90 110675 105704 50388655
Retroperitoneal haemorrhage 56.52 10.63 46 110719 2510 50491849
Cerebral ventricular rupture 56.49 10.63 20 110745 184 50494175
Depression 56.43 10.63 180 110585 165243 50329116
Thalamus haemorrhage 55.52 10.63 27 110738 583 50493776
Circumstance or information capable of leading to medication error 55.45 10.63 50 110715 3138 50491221
Abdominal discomfort 54.66 10.63 291 110474 231350 50263009
Cerebellar haemorrhage 54.09 10.63 34 110731 1229 50493130
Prescribed overdose 53.08 10.63 106 110659 14494 50479865
Spinal cord haemorrhage 52.00 10.63 19 110746 193 50494166
Blood test abnormal 50.89 10.63 90 110675 11229 50483130
Renal disorder 50.88 10.63 154 110611 27351 50467008
Blister 50.25 10.63 68 110697 85350 50409009
Irritable bowel syndrome 50.01 10.63 25 110740 51416 50442943
Traumatic haematoma 49.66 10.63 33 110732 1314 50493045
Pregnancy 49.62 10.63 4 110761 29573 50464786
Oedema peripheral 49.40 10.63 546 110219 157415 50336944
Faeces discoloured 48.11 10.63 108 110657 16016 50478343
Psoriasis 48.06 10.63 48 110717 68952 50425407
Diverticulum intestinal haemorrhagic 47.91 10.63 31 110734 1179 50493180
Creatinine renal clearance abnormal 47.91 10.63 21 110744 354 50494005
Eye haemorrhage 47.68 10.63 69 110696 7266 50487093
Contusion 47.42 10.63 413 110352 111770 50382589
Oxygen saturation decreased 47.14 10.63 298 110467 72950 50421409
Haemoptysis 47.14 10.63 143 110622 25430 50468929
Catheter site erythema 46.28 10.63 50 110715 3912 50490447
Injection site swelling 45.86 10.63 17 110748 41756 50452603
Abortion spontaneous 45.86 10.63 17 110748 41755 50452604
Drug interaction 45.71 10.63 651 110114 198970 50295389
Vascular device infection 45.48 10.63 52 110713 4332 50490027
Gastric haemorrhage 45.19 10.63 59 110706 5637 50488722
Catheter site haemorrhage 44.84 10.63 42 110723 2768 50491591
Gastrointestinal tract mucosal pigmentation 44.75 10.63 23 110742 561 50493798
Vascular pseudoaneurysm 44.13 10.63 31 110734 1353 50493006
Vaginal haemorrhage 44.05 10.63 136 110629 24415 50469944
Drug abuse 43.58 10.63 40 110725 59806 50434553
Injection site pruritus 43.44 10.63 17 110748 40394 50453965
Infection 42.62 10.63 214 110551 172740 50321619
Abdominal wall haematoma 42.31 10.63 40 110725 2668 50491691
Nephrectomy 42.23 10.63 25 110740 810 50493549
C-reactive protein increased 42.13 10.63 50 110715 66424 50427935
Rash 42.10 10.63 689 110076 436782 50057577
Anxiety 41.38 10.63 224 110541 177382 50316977
Muscle haemorrhage 41.15 10.63 41 110724 2917 50491442
Mobility decreased 40.90 10.63 70 110695 79878 50414481
Gastrointestinal ulcer haemorrhage 40.88 10.63 22 110743 591 50493768
Pulmonary thrombosis 40.61 10.63 65 110700 7476 50486883
Suicidal ideation 40.35 10.63 37 110728 55348 50439011
Lower gastrointestinal haemorrhage 39.41 10.63 61 110704 6818 50487541
Retroperitoneal haematoma 39.32 10.63 38 110727 2605 50491754
Rhinitis allergic 38.69 10.63 62 110703 7138 50487221
Splenic rupture 38.58 10.63 27 110738 1171 50493188
Cerebral haematoma 38.34 10.63 41 110724 3170 50491189
Anaphylactic reaction 38.34 10.63 37 110728 54018 50440341
COVID-19 37.94 10.63 202 110563 46460 50447899
Cerebrospinal fluid retention 37.64 10.63 12 110753 77 50494282
Traumatic intracranial haemorrhage 37.64 10.63 18 110747 374 50493985
Spontaneous haemorrhage 37.43 10.63 16 110749 253 50494106
Psoriatic arthropathy 37.23 10.63 29 110736 47003 50447356
Pericardial effusion 37.20 10.63 132 110633 25457 50468902
Seizure 36.95 10.63 133 110632 117741 50376618
Device expulsion 36.57 10.63 9 110756 28813 50465546
Orbital compartment syndrome 36.29 10.63 9 110756 18 50494341
Sleep disorder due to general medical condition, insomnia type 35.89 10.63 12 110753 31435 50462924
Haemangioma of spleen 35.35 10.63 9 110756 21 50494338
Infusion site haemorrhage 35.24 10.63 38 110727 2966 50491393
Infusion site pain 34.96 10.63 81 110684 12265 50482094
Listless 34.87 10.63 34 110731 2356 50492003
Haematoma muscle 34.75 10.63 21 110744 707 50493652
Multiple sclerosis relapse 34.64 10.63 26 110739 42938 50451421
Catheter management 34.53 10.63 36 110729 2703 50491656
Blood loss anaemia 34.40 10.63 63 110702 8076 50486283
Emotional distress 34.39 10.63 10 110755 28653 50465706
Hip arthroplasty 34.05 10.63 12 110753 30417 50463942
Alanine aminotransferase increased 33.84 10.63 91 110674 88268 50406091
Catheter site irritation 32.61 10.63 18 110747 509 50493850
Product monitoring error 32.49 10.63 35 110730 2729 50491630
Body temperature increased 32.36 10.63 14 110751 31327 50463032
Catheter site pruritus 32.29 10.63 30 110735 1957 50492402
Cardiac tamponade 32.28 10.63 43 110722 4189 50490170
Foetal exposure during pregnancy 32.00 10.63 10 110755 27349 50467010
Thirst decreased 31.72 10.63 14 110751 240 50494119
High frequency ablation 31.67 10.63 12 110753 136 50494223
Gingival bleeding 31.61 10.63 74 110691 11279 50483080
Malignant mediastinal neoplasm 31.47 10.63 18 110747 546 50493813
Conjunctival haemorrhage 31.40 10.63 36 110729 3008 50491351
Craniotomy 31.40 10.63 13 110752 189 50494170
Ocular retrobulbar haemorrhage 31.18 10.63 11 110754 100 50494259
Therapy change 30.87 10.63 47 110718 5178 50489181
Gastrointestinal tube insertion 30.78 10.63 22 110743 987 50493372
Haemothorax 30.64 10.63 29 110736 1937 50492422
Medication error 30.52 10.63 158 110607 35946 50458413
Surgery 30.43 10.63 139 110626 30066 50464293
Peripheral swelling 30.16 10.63 625 110140 205311 50289048
Ulcer haemorrhage 30.13 10.63 37 110728 3324 50491035
Type 2 diabetes mellitus 30.11 10.63 19 110746 34356 50460003
Hospice care 30.06 10.63 49 110716 5723 50488636
Extradural haematoma 29.81 10.63 26 110739 1561 50492798
Infusion site discharge 29.73 10.63 18 110747 608 50493751
Heavy menstrual bleeding 29.69 10.63 88 110677 15449 50478910
Subchondral insufficiency fracture 29.63 10.63 9 110756 48 50494311
Vena cava filter insertion 29.49 10.63 11 110754 119 50494240
Aspartate aminotransferase increased 29.37 10.63 81 110684 77917 50416442
Venous pressure jugular increased 29.24 10.63 17 110748 532 50493827
Red blood cell sedimentation rate increased 29.04 10.63 14 110751 29402 50464957
Pulmonary oedema 28.97 10.63 195 110570 48743 50445616
Subclavian vein thrombosis 28.92 10.63 27 110738 1772 50492587
Systemic infection 28.77 10.63 30 110735 2253 50492106
Right ventricular failure 28.47 10.63 88 110677 15805 50478554
Chloropsia 28.21 10.63 8 110757 32 50494327
Neovascular age-related macular degeneration 28.10 10.63 11 110754 137 50494222
Drug withdrawal syndrome 27.88 10.63 10 110755 25071 50469288
Ill-defined disorder 27.82 10.63 48 110717 54606 50439753
Renal haemorrhage 27.82 10.63 19 110746 792 50493567
Urticaria 27.69 10.63 168 110597 129393 50364966
Erythema 27.68 10.63 197 110568 146217 50348142
Neoplasm malignant 27.61 10.63 114 110651 23601 50470758
Antinuclear antibody negative 27.28 10.63 12 110753 204 50494155
Rectosigmoid cancer 27.27 10.63 11 110754 149 50494210
Ejection fraction abnormal 27.07 10.63 19 110746 828 50493531
Premature delivery 27.05 10.63 9 110756 23654 50470705
Lymphocyte count decreased 26.77 10.63 12 110753 26295 50468064
Limb injury 26.52 10.63 101 110664 20149 50474210
Vomiting 26.31 10.63 788 109977 459970 50034389
Intracardiac thrombus 26.23 10.63 28 110737 2161 50492198
Catheter site discharge 26.19 10.63 26 110739 1842 50492517
Diabetes mellitus 25.94 10.63 42 110723 48991 50445368
Erythromelalgia 25.81 10.63 10 110755 121 50494238
Rectal prolapse 25.74 10.63 25 110740 1724 50492635
Hepatic haemangioma rupture 25.63 10.63 5 110760 0 50494359
Wound haemorrhage 25.51 10.63 27 110738 2063 50492296
Cerebellar infarction 25.50 10.63 25 110740 1744 50492615
Heart rate abnormal 25.14 10.63 37 110728 3955 50490404
Hip fracture 25.14 10.63 118 110647 25813 50468546
Petechiae 24.99 10.63 72 110693 12440 50481919
Subcutaneous haematoma 24.86 10.63 23 110742 1492 50492867
Infarction 24.81 10.63 28 110737 2300 50492059
Ear haemorrhage 24.73 10.63 21 110744 1216 50493143
Embolism 24.62 10.63 50 110715 6918 50487441
White blood cell count increased 24.46 10.63 34 110731 42206 50452153
Agitation 24.43 10.63 50 110715 53334 50441025
Full blood count decreased 24.14 10.63 105 110660 22241 50472118
Cytomegalovirus infection 24.01 10.63 5 110760 17957 50476402
Catheter site pain 23.88 10.63 35 110730 3727 50490632
Sleep disorder due to a general medical condition 23.84 10.63 51 110714 7320 50487039
Meningorrhagia 23.75 10.63 9 110756 102 50494257
Spontaneous haematoma 23.66 10.63 17 110748 769 50493590
Cardiac fibrillation 23.61 10.63 14 110751 455 50493904
Somnolence 23.59 10.63 221 110544 154764 50339595
Palpitations 23.55 10.63 313 110452 94193 50400166
Catheterisation cardiac 23.39 10.63 36 110729 4004 50490355
Gastritis haemorrhagic 23.31 10.63 21 110744 1316 50493043
Embolic cerebral infarction 23.31 10.63 14 110751 466 50493893
Live birth 23.14 10.63 4 110761 16404 50477955
Post procedural haematoma 22.94 10.63 20 110745 1200 50493159
Antiphospholipid syndrome 22.92 10.63 22 110743 1495 50492864
Device pacing issue 22.85 10.63 8 110757 71 50494288
Gastrointestinal angiodysplasia 22.74 10.63 13 110752 394 50493965
Vascular device occlusion 22.64 10.63 7 110758 40 50494319
Joint stiffness 22.37 10.63 20 110745 30288 50464071
Urinary bladder haemorrhage 22.32 10.63 18 110747 969 50493390
Hemiparesis 22.27 10.63 95 110670 19953 50474406
Wrong strength 22.22 10.63 7 110758 43 50494316
Coombs positive haemolytic anaemia 22.14 10.63 12 110753 327 50494032
Gastrostomy 22.13 10.63 14 110751 512 50493847
Drug resistance 22.10 10.63 7 110758 18982 50475377
Therapeutic product effect incomplete 22.09 10.63 114 110651 91401 50402958
Gout 21.95 10.63 65 110700 11405 50482954
Insomnia 21.89 10.63 261 110504 174604 50319755
Bicytopenia 21.86 10.63 24 110741 1912 50492447
Mixed liver injury 21.76 10.63 32 110733 3419 50490940
Basal cell carcinoma 21.74 10.63 12 110753 23344 50471015
Caesarean section 21.65 10.63 4 110761 15635 50478724
Product dose omission issue 21.61 10.63 541 110224 183297 50311062
Mucosal inflammation 21.60 10.63 34 110731 40108 50454251
Paratonia 21.57 10.63 6 110759 22 50494337
Injury 21.40 10.63 47 110718 48878 50445481
Prerenal failure 21.34 10.63 21 110744 1472 50492887
Femoral neck fracture 21.05 10.63 49 110716 7441 50486918
Mental disorder 20.90 10.63 11 110754 21980 50472379
Prescription drug used without a prescription 20.82 10.63 22 110743 1678 50492681
Irritability 20.69 10.63 19 110746 28407 50465952
Muscle spasticity 20.60 10.63 6 110759 17178 50477181
Haematoma evacuation 20.41 10.63 9 110756 154 50494205
Herpes simplex reactivation 20.37 10.63 12 110753 385 50493974
Biliary sepsis 20.29 10.63 16 110749 834 50493525
Treatment noncompliance 20.22 10.63 124 110641 30026 50464333
Asthenia 20.14 10.63 872 109893 318170 50176189
Cerebral artery occlusion 20.12 10.63 16 110749 844 50493515
No adverse event 19.99 10.63 134 110631 33444 50460915
Injection site bruising 19.92 10.63 31 110734 36737 50457622
Rehabilitation therapy 19.76 10.63 19 110746 1294 50493065
Oxygen consumption increased 19.76 10.63 31 110734 3505 50490854
Injection site mass 19.69 10.63 5 110760 15675 50478684
Anal stenosis 19.68 10.63 11 110754 319 50494040
Iron deficiency anaemia 19.66 10.63 81 110684 16753 50477606
Cerebral artery embolism 19.63 10.63 15 110750 746 50493613
Joint range of motion decreased 19.55 10.63 8 110757 18504 50475855
Herpes zoster 19.54 10.63 84 110681 70702 50423657
Bone marrow failure 19.48 10.63 19 110746 27605 50466754
Large intestinal haemorrhage 19.41 10.63 18 110747 1171 50493188
Intestinal haemorrhage 19.35 10.63 29 110736 3151 50491208
Intentional overdose 19.26 10.63 71 110694 62433 50431926
Coagulation factor V level abnormal 19.26 10.63 5 110760 13 50494346
Tumour haemorrhage 19.26 10.63 19 110746 1336 50493023
Pyroglutamic acidosis 19.16 10.63 12 110753 431 50493928
Renal failure 19.15 10.63 334 110431 106299 50388060
Anal haemorrhage 19.15 10.63 21 110744 1671 50492688
Tooth disorder 19.09 10.63 104 110661 24124 50470235
Listeraemia 19.08 10.63 7 110758 72 50494287
Hyponatraemia 19.05 10.63 306 110459 95833 50398526
Osteonecrosis of jaw 19.01 10.63 26 110739 32500 50461859
Upper respiratory tract infection 18.93 10.63 77 110688 65821 50428538
Heart rate irregular 18.69 10.63 88 110677 19272 50475087
Respiratory arrest 18.56 10.63 23 110742 29986 50464373
Osteopenia 18.55 10.63 7 110758 17011 50477348
Accidental exposure to product 18.52 10.63 14 110751 23043 50471316
Ovarian cyst 18.49 10.63 4 110761 13992 50480367
Neutropenia 18.46 10.63 221 110544 147744 50346615
Nasal congestion 18.45 10.63 182 110583 50938 50443421
Reduced facial expression 18.41 10.63 20 110745 1574 50492785
Chills 18.31 10.63 130 110635 96557 50397802
Duodenal vascular ectasia 18.28 10.63 4 110761 3 50494356
Degenerative aortic valve disease 18.27 10.63 7 110758 82 50494277
Cardiac failure chronic 18.22 10.63 30 110735 3533 50490826
Pulmonary alveolar haemorrhage 18.08 10.63 32 110733 3995 50490364
Haemoperitoneum 18.03 10.63 25 110740 2530 50491829
Neutrophil count decreased 17.92 10.63 47 110718 45979 50448380
Palmar-plantar erythrodysaesthesia syndrome 17.75 10.63 11 110754 20087 50474272
Blood urine present 17.63 10.63 65 110700 12768 50481591
Craniocerebral injury 17.61 10.63 23 110742 2198 50492161
Catheter site rash 17.57 10.63 14 110751 741 50493618
Hypothyroidism 17.30 10.63 131 110634 33994 50460365
Acute respiratory failure 17.22 10.63 115 110650 28667 50465692
Carpal tunnel syndrome 17.21 10.63 78 110687 16815 50477544
Sinus node dysfunction 17.20 10.63 31 110734 3924 50490435
Nasopharyngitis 17.14 10.63 308 110457 192619 50301740
Infusion site swelling 17.03 10.63 44 110721 7132 50487227
Glomerular filtration rate abnormal 16.98 10.63 12 110753 529 50493830
Crying 16.91 10.63 12 110753 20404 50473955
Full blood count abnormal 16.84 10.63 98 110667 23290 50471069
Muscle abscess 16.64 10.63 10 110755 333 50494026
Hyperhidrosis 16.56 10.63 121 110644 89305 50405054
Posterior reversible encephalopathy syndrome 16.51 10.63 6 110759 14922 50479437
Granulomatous dermatitis 16.47 10.63 7 110758 109 50494250
Oesophageal food impaction 16.40 10.63 8 110757 174 50494185
Injection site warmth 16.34 10.63 5 110760 13861 50480498
Skin laceration 16.30 10.63 83 110682 18759 50475600
Premature baby 16.24 10.63 10 110755 18327 50476032
Occult blood positive 15.88 10.63 27 110738 3264 50491095
Brain stem haemorrhage 15.85 10.63 13 110752 717 50493642
Blood creatinine abnormal 15.83 10.63 24 110741 2634 50491725
Microcytic anaemia 15.81 10.63 26 110739 3058 50491301
Anti factor X activity increased 15.81 10.63 4 110761 9 50494350
Product quality issue 15.79 10.63 27 110738 30831 50463528
Muscle twitching 15.76 10.63 7 110758 15424 50478935
Progressive multifocal leukoencephalopathy 15.71 10.63 3 110762 11454 50482905
Splenic haemorrhage 15.64 10.63 8 110757 193 50494166
Thrombotic stroke 15.64 10.63 11 110754 481 50493878
Device infusion issue 15.53 10.63 17 110748 1350 50493009
Kyphosis 15.52 10.63 22 110743 2273 50492086
Sedation 15.47 10.63 27 110738 30583 50463776
Inflammation 15.42 10.63 68 110697 56844 50437515
Infusion site infection 15.38 10.63 18 110747 1537 50492822
Chemotherapy toxicity attenuation 15.38 10.63 3 110762 0 50494359
Basal ganglia haematoma 15.38 10.63 3 110762 0 50494359
Embolism venous 15.32 10.63 23 110742 2502 50491857
Haemorrhagic disorder 15.29 10.63 13 110752 754 50493605
Red cell distribution width abnormal 15.21 10.63 7 110758 133 50494226
Wrong drug 15.21 10.63 7 110758 133 50494226
Atrial appendage closure 14.99 10.63 4 110761 12 50494347
Grip strength decreased 14.97 10.63 4 110761 12117 50482242
Tendonitis 14.95 10.63 9 110756 16696 50477663
Oesophageal achalasia 14.94 10.63 10 110755 403 50493956
Lymphadenopathy 14.80 10.63 32 110733 33467 50460892
Influenza like illness 14.77 10.63 70 110695 57389 50436970
Ear congestion 14.74 10.63 20 110745 1983 50492376
Hepatotoxicity 14.70 10.63 23 110742 27203 50467156
Sinus tachycardia 14.70 10.63 15 110750 21339 50473020
Defaecation disorder 14.63 10.63 11 110754 534 50493825
Neurotoxicity 14.57 10.63 7 110758 14733 50479626
Blood creatine phosphokinase increased 14.50 10.63 22 110743 26345 50468014
Ataxia 14.49 10.63 6 110759 13780 50480579
Generalised tonic-clonic seizure 14.42 10.63 22 110743 26288 50468071
Disability 14.36 10.63 5 110760 12770 50481589
Fear 14.24 10.63 7 110758 14542 50479817
Impaired work ability 14.23 10.63 6 110759 13634 50480725
Cardiac ventricular disorder 14.03 10.63 7 110758 160 50494199
Metastases to liver 13.98 10.63 14 110751 20090 50474269
Subclavian artery thrombosis 13.95 10.63 7 110758 162 50494197
Blood glucose increased 13.94 10.63 95 110670 71229 50423130
Heart rate increased 13.88 10.63 242 110523 77008 50417351
Pleural effusion 13.86 10.63 253 110512 81201 50413158
Product administration error 13.83 10.63 82 110683 19617 50474742
Splenic haematoma 13.80 10.63 6 110759 99 50494260
Tremor 13.80 10.63 173 110592 114730 50379629
Fracture 13.77 10.63 73 110692 16760 50477599
Pneumonia 13.74 10.63 983 109782 377418 50116941
Paraesthesia 13.72 10.63 183 110582 120060 50374299
Head discomfort 13.65 10.63 54 110711 10965 50483394
Colon cancer 13.64 10.63 46 110719 8645 50485714
Orthopnoea 13.63 10.63 35 110730 5654 50488705
Device alarm issue 13.62 10.63 16 110749 1372 50492987
Aneurysm ruptured 13.58 10.63 10 110755 470 50493889
Haemorrhagic diathesis 13.56 10.63 28 110737 3920 50490439
Thrombophlebitis migrans 13.54 10.63 6 110759 104 50494255
Foreign body 13.48 10.63 19 110746 1952 50492407
Pallor 13.46 10.63 92 110673 23107 50471252
Pancreatitis 13.40 10.63 48 110717 42566 50451793
Ear pain 13.36 10.63 26 110739 28257 50466102
Thrombophlebitis 13.34 10.63 28 110737 3965 50490394
Aspiration pleural cavity 13.31 10.63 12 110753 753 50493606
Stroke volume decreased 13.31 10.63 3 110762 3 50494356
Bronchospasm 13.30 10.63 8 110757 14846 50479513
Aggression 13.25 10.63 16 110749 21100 50473259
Acne 13.22 10.63 14 110751 19581 50474778
Oxygen therapy 13.19 10.63 18 110747 1794 50492565
Psychotic disorder 13.19 10.63 17 110748 21795 50472564
Skull fracture 13.19 10.63 13 110752 913 50493446
Erysipelas 13.17 10.63 38 110727 6570 50487789
Joint effusion 13.15 10.63 6 110759 13015 50481344
Malignant melanoma 13.13 10.63 3 110762 10105 50484254
Bronchopulmonary dysplasia 13.11 10.63 8 110757 274 50494085
Tuberculosis 13.09 10.63 3 110762 10080 50484279
Arthritis 13.04 10.63 124 110641 86597 50407762
Bone density decreased 13.04 10.63 4 110761 11071 50483288
Mite allergy 12.99 10.63 10 110755 503 50493856
Eye haematoma 12.92 10.63 4 110761 23 50494336
Knee arthroplasty 12.92 10.63 38 110727 35808 50458551
Peptic ulcer 12.79 10.63 27 110738 3839 50490520
Prosthetic cardiac valve thrombosis 12.78 10.63 4 110761 24 50494335
Condition aggravated 12.77 10.63 526 110239 296532 50197827
Epidural haemorrhage 12.76 10.63 6 110759 120 50494239
Pruritus 12.64 10.63 500 110265 283068 50211291
Gastroenteritis aeromonas 12.64 10.63 4 110761 25 50494334
Electrocardiogram QT shortened 12.62 10.63 6 110759 123 50494236
Urinary tract infection bacterial 12.57 10.63 28 110737 4131 50490228
Weight increased 12.56 10.63 341 110424 201550 50292809
Stress 12.42 10.63 68 110697 53725 50440634
Mood swings 12.42 10.63 10 110755 15944 50478415
Gamma-glutamyltransferase abnormal 12.40 10.63 7 110758 207 50494152
Pharyngitis 12.38 10.63 12 110753 17491 50476868
Adrenal haemorrhage 12.38 10.63 9 110756 415 50493944
Catheter site warmth 12.31 10.63 7 110758 210 50494149
Splenomegaly 12.29 10.63 3 110762 9657 50484702
Intracranial tumour haemorrhage 12.28 10.63 6 110759 131 50494228
Pericardial drainage 12.22 10.63 7 110758 213 50494146
Rabbit syndrome 12.19 10.63 8 110757 312 50494047
Adenocarcinoma of colon 12.14 10.63 19 110746 2143 50492216
Skin haemorrhage 12.11 10.63 38 110727 6880 50487479
Malignant atrophic papulosis 12.10 10.63 3 110762 6 50494353
Gastric ulcer 12.07 10.63 84 110681 21221 50473138
Procedural haemorrhage 12.05 10.63 20 110745 2370 50491989
Chronic left ventricular failure 12.01 10.63 8 110757 320 50494039
Bone disorder 11.99 10.63 14 110751 18738 50475621
Metastases to bone 11.98 10.63 13 110752 17982 50476377
Joint dislocation 11.97 10.63 6 110759 12327 50482032
Osteoporosis 11.93 10.63 54 110711 44825 50449534
Immunodeficiency 11.91 10.63 9 110756 14819 50479540
Hepatic steatosis 11.88 10.63 22 110743 24362 50469997
Periorbital haematoma 11.86 10.63 11 110754 716 50493643
Pseudomonas infection 11.86 10.63 3 110762 9427 50484932
Colorectal cancer 11.83 10.63 15 110750 1392 50492967
Infusion site erythema 11.82 10.63 44 110721 8683 50485676
Kussmaul respiration 11.82 10.63 7 110758 227 50494132
Cutaneous lupus erythematosus 11.80 10.63 20 110745 2411 50491948
Microembolism 11.78 10.63 3 110762 7 50494352
Subdural haematoma evacuation 11.78 10.63 3 110762 7 50494352
Electrocardiogram QT prolonged 11.76 10.63 66 110699 51820 50442539
Uveitis 11.63 10.63 3 110762 9307 50485052
Foot deformity 11.59 10.63 15 110750 19195 50475164
Injection site rash 11.55 10.63 11 110754 16166 50478193
Dyspnoea at rest 11.52 10.63 25 110740 3622 50490737
Cardiac failure acute 11.51 10.63 42 110723 8208 50486151
Oral mucosa haematoma 11.50 10.63 3 110762 8 50494351
Manufacturing product shipping issue 11.48 10.63 5 110760 83 50494276
Anaemia vitamin B12 deficiency 11.47 10.63 8 110757 345 50494014
Hypercalcaemia 11.44 10.63 21 110744 23331 50471028
Intracranial haematoma 11.43 10.63 8 110757 347 50494012
Product storage error 11.39 10.63 55 110710 12169 50482190
Multiple sclerosis 11.37 10.63 17 110748 20476 50473883
Product dispensing error 11.36 10.63 44 110721 8847 50485512
Drug dependence 11.34 10.63 16 110749 19743 50474616
Obesity 11.30 10.63 12 110753 16763 50477596
Atelectasis 11.30 10.63 14 110751 18256 50476103
Malignant neoplasm progression 11.30 10.63 95 110670 68029 50426330
Mediastinal haematoma 11.26 10.63 5 110760 87 50494272
Atopic keratoconjunctivitis 11.24 10.63 3 110762 9 50494350
Cerebellar haematoma 11.23 10.63 8 110757 357 50494002
Product communication issue 11.21 10.63 8 110757 358 50494001
Hepatocellular injury 11.19 10.63 96 110669 25851 50468508
Shunt thrombosis 11.18 10.63 4 110761 38 50494321
Coronavirus test positive 11.11 10.63 10 110755 626 50493733
Toxic epidermal necrolysis 11.08 10.63 18 110747 20974 50473385
Listeria encephalitis 11.04 10.63 7 110758 257 50494102
Low density lipoprotein abnormal 11.02 10.63 6 110759 165 50494194
Cardiac operation 11.02 10.63 21 110744 2774 50491585
Peripheral embolism 11.02 10.63 13 110752 1120 50493239
Blood immunoglobulin E increased 10.92 10.63 19 110746 2340 50492019
Echocardiogram abnormal 10.91 10.63 13 110752 1132 50493227
Pulmonary mass 10.88 10.63 15 110750 18690 50475669
Vascular stenosis 10.82 10.63 7 110758 266 50494093
Gastrointestinal vascular malformation haemorrhagic 10.80 10.63 6 110759 172 50494187
Adrenal haematoma 10.78 10.63 3 110762 11 50494348
Catheter site swelling 10.78 10.63 14 110751 1330 50493029
Panic attack 10.77 10.63 16 110749 19326 50475033
Diarrhoea 10.75 10.63 1457 109308 587019 49907340
Anticoagulation drug level increased 10.70 10.63 6 110759 175 50494184
Dialysis 10.70 10.63 45 110720 9393 50484966
Prothrombin time ratio increased 10.68 10.63 5 110760 99 50494260
Thrombocytopenia 10.66 10.63 360 110405 127313 50367046
Fungal infection 10.63 10.63 32 110733 29933 50464426

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
Haemorrhage 872.33 11.45 905 97796 44167 29431659
Gastrointestinal haemorrhage 725.72 11.45 1095 97606 78438 29397388
Prescribed underdose 647.29 11.45 373 98328 7413 29468413
Atrial fibrillation 618.62 11.45 1194 97507 104452 29371374
Cerebral haemorrhage 593.26 11.45 623 98078 30803 29445023
Death 532.22 11.45 2399 96302 339685 29136141
Haemorrhage intracranial 494.97 11.45 401 98300 14141 29461685
Gastric haemorrhage 448.83 11.45 316 98385 8981 29466845
Cerebrovascular accident 442.01 11.45 863 97838 76048 29399778
Fall 358.71 11.45 1350 97351 175828 29299998
Subdural haematoma 324.24 11.45 350 98351 17843 29457983
Thrombosis 290.73 11.45 518 98183 42527 29433299
Haematuria 263.90 11.45 504 98197 43635 29432191
Intentional product use issue 261.18 11.45 491 98210 42007 29433819
Melaena 245.85 11.45 402 98299 30774 29445052
Haematoma 239.23 11.45 339 98362 22873 29452953
Drug ineffective 235.32 11.45 543 98158 362627 29113199
Transfusion 224.80 11.45 190 98511 7108 29468718
Toxicity to various agents 219.74 11.45 156 98545 173505 29302321
Epistaxis 206.11 11.45 501 98200 51203 29424623
Atrial thrombosis 199.73 11.45 108 98593 1885 29473941
Adverse event 198.49 11.45 250 98451 15041 29460785
Completed suicide 193.38 11.45 34 98667 90212 29385614
Drug abuse 182.72 11.45 25 98676 79858 29395968
Lower gastrointestinal haemorrhage 180.67 11.45 177 98524 8036 29467790
Ischaemic stroke 176.04 11.45 241 98460 15736 29460090
Labelled drug-drug interaction medication error 172.65 11.45 208 98493 11951 29463875
Haematochezia 163.26 11.45 373 98328 36610 29439216
Cardiac failure 161.35 11.45 606 98095 78681 29397145
Pulmonary embolism 149.16 11.45 577 98124 75957 29399869
Cerebral infarction 145.22 11.45 280 98421 24395 29451431
Haemorrhagic stroke 143.59 11.45 134 98567 5722 29470104
Anaemia 127.10 11.45 1122 97579 199829 29275997
Dyspnoea 121.31 11.45 1640 97061 325092 29150734
Cardioversion 120.60 11.45 58 98643 781 29475045
Pericardial haemorrhage 115.13 11.45 88 98613 2843 29472983
Embolic stroke 109.24 11.45 93 98608 3513 29472313
Upper gastrointestinal haemorrhage 106.79 11.45 230 98471 21684 29454142
Cardiac disorder 100.45 11.45 313 98388 36950 29438876
Post procedural haemorrhage 99.62 11.45 124 98577 7367 29468459
Internal haemorrhage 98.47 11.45 96 98605 4331 29471495
Contraindicated product administered 90.48 11.45 193 98508 18073 29457753
Traumatic haemorrhage 89.91 11.45 44 98657 617 29475209
Pyrexia 87.42 11.45 582 98119 287040 29188786
Rectal haemorrhage 86.55 11.45 283 98418 34266 29441560
Traumatic intracranial haemorrhage 86.33 11.45 42 98659 581 29475245
Haemoptysis 83.61 11.45 258 98443 30292 29445534
Shock haemorrhagic 80.48 11.45 127 98574 9424 29466402
Febrile neutropenia 80.44 11.45 158 98543 112082 29363744
Haemoglobin decreased 80 11.45 627 98074 107748 29368078
Foetal exposure during pregnancy 78.83 11.45 10 98691 33857 29441969
Hospitalisation 78.58 11.45 333 98368 45655 29430171
Product prescribing error 77.84 11.45 180 98521 17796 29458030
Transient ischaemic attack 77.65 11.45 211 98490 23059 29452767
Cerebral haematoma 77.11 11.45 83 98618 4213 29471613
Renal impairment 76.53 11.45 499 98202 80834 29394992
Subarachnoid haemorrhage 76.37 11.45 125 98576 9567 29466259
Blood urine present 75.77 11.45 125 98576 9630 29466196
Deep vein thrombosis 75.50 11.45 385 98316 57014 29418812
Fluid retention 75.02 11.45 210 98491 23350 29452476
Dizziness 75.01 11.45 964 97737 188720 29287106
Aortic valve stenosis 71.12 11.45 59 98642 2149 29473677
Leukopenia 69.12 11.45 50 98651 55153 29420673
Peripheral swelling 68.69 11.45 405 98296 63334 29412492
Intraventricular haemorrhage 68.37 11.45 65 98636 2841 29472985
Nausea 67.49 11.45 629 98072 288626 29187200
Head injury 67.41 11.45 159 98542 15922 29459904
Faeces discoloured 67.19 11.45 142 98559 13209 29462617
Alanine aminotransferase increased 65.84 11.45 84 98617 70860 29404966
Right atrial hypertrophy 64.64 11.45 33 98668 509 29475317
Suicidal ideation 64.39 11.45 18 98683 34698 29441128
Neutropenia 62.79 11.45 227 98474 131484 29344342
Vomiting 62.63 11.45 433 98268 211827 29263999
N-terminal prohormone brain natriuretic peptide increased 60.93 11.45 51 98650 1881 29473945
COVID-19 60.91 11.45 260 98441 35754 29440072
Diverticulum intestinal haemorrhagic 60.06 11.45 52 98649 2010 29473816
Drug hypersensitivity 59.42 11.45 85 98616 68321 29407505
Drug resistance 59.38 11.45 3 98698 21537 29454289
Seizure 58.49 11.45 141 98560 92982 29382844
General physical health deterioration 58.08 11.45 561 98140 102296 29373530
Urinary bladder haemorrhage 57.50 11.45 46 98655 1590 29474236
Contusion 56.90 11.45 230 98471 30865 29444961
Aggression 56.31 11.45 24 98677 35517 29440309
Arrhythmia 56.02 11.45 230 98471 31083 29444743
Infusion related reaction 55.92 11.45 39 98662 43847 29431979
Mucosal inflammation 55.66 11.45 18 98683 31577 29444249
Cerebral ventricular rupture 55.41 11.45 21 98680 149 29475677
Drug dependence 54.59 11.45 4 98697 20977 29454849
Surgery 53.26 11.45 120 98581 11659 29464167
Spinal cord haemorrhage 51.91 11.45 24 98677 294 29475532
Polypectomy 51.40 11.45 28 98673 496 29475330
Haematemesis 50.64 11.45 189 98512 24437 29451389
Pulmonary arterial hypertension 49.39 11.45 89 98612 7360 29468466
Haemothorax 49.12 11.45 59 98642 3377 29472449
Agitation 48.37 11.45 60 98641 51244 29424582
Cardiac ablation 48.26 11.45 30 98671 687 29475139
Aspartate aminotransferase increased 48.22 11.45 78 98623 59647 29416179
Depression 48.06 11.45 136 98565 85011 29390815
Thalamus haemorrhage 48.05 11.45 33 98668 899 29474927
Urogenital haemorrhage 47.56 11.45 26 98675 464 29475362
Dyspnoea exertional 46.73 11.45 243 98458 36247 29439579
Right ventricular hypertrophy 45.91 11.45 35 98666 1126 29474700
Toxic epidermal necrolysis 45.73 11.45 4 98697 18149 29457677
Prescribed overdose 45.61 11.45 94 98607 8589 29467237
Abdominal wall haematoma 45.31 11.45 40 98661 1587 29474239
Haemorrhage subcutaneous 45.25 11.45 45 98656 2080 29473746
High frequency ablation 44.19 11.45 18 98683 158 29475668
Gastrointestinal endoscopic therapy 43.71 11.45 10 98691 4 29475822
Bone marrow failure 42.75 11.45 19 98682 27430 29448396
Overdose 42.50 11.45 131 98570 79688 29396138
Cardiac amyloidosis 41.96 11.45 30 98671 873 29474953
Bronchial secretion retention 41.77 11.45 33 98668 1120 29474706
Failure to suspend medication 41.40 11.45 22 98679 370 29475456
Stomatitis 41.00 11.45 38 98663 37075 29438751
Procedural haemorrhage 40.78 11.45 44 98657 2239 29473587
White blood cell count increased 40.75 11.45 39 98662 37477 29438349
Iron deficiency anaemia 40.32 11.45 91 98610 8851 29466975
Gastrointestinal tube insertion 40.23 11.45 32 98669 1097 29474729
Drug withdrawal syndrome 40.22 11.45 6 98695 17978 29457848
Bronchial wall thickening 40.04 11.45 31 98670 1021 29474805
Rhabdomyolysis 39.83 11.45 90 98611 60718 29415108
Post procedural haematoma 39.28 11.45 35 98666 1406 29474420
Pulmonary function test abnormal 38.73 11.45 41 98660 2041 29473785
Atrial flutter 38.61 11.45 118 98583 13776 29462050
Spinal subarachnoid haemorrhage 38.56 11.45 12 98689 42 29475784
Haemoperitoneum 38.39 11.45 36 98665 1546 29474280
Brain stem haemorrhage 38.36 11.45 28 98673 842 29474984
Haematoma muscle 38.17 11.45 29 98672 928 29474898
Cerebellar haemorrhage 37.91 11.45 34 98667 1378 29474448
Anxiety 37.49 11.45 152 98549 85213 29390613
Blood loss anaemia 37.39 11.45 78 98623 7188 29468638
Mycotic allergy 37.19 11.45 18 98683 246 29475580
Neuroleptic malignant syndrome 37.02 11.45 5 98696 16143 29459683
Psychotic disorder 36.92 11.45 11 98690 20343 29455483
Gastrointestinal angiodysplasia 36.49 11.45 23 98678 540 29475286
Blood glucose increased 36.47 11.45 90 98611 58894 29416932
Cytomegalovirus infection 36.26 11.45 16 98685 23199 29452627
Cardiac pacemaker insertion 36.15 11.45 43 98658 2436 29473390
Musculoskeletal stiffness 35.10 11.45 44 98657 37414 29438412
Erythema 34.87 11.45 132 98569 75474 29400352
Large intestine polyp 34.82 11.45 71 98630 6438 29469388
Mite allergy 34.07 11.45 18 98683 299 29475527
Respiratory depression 34.01 11.45 3 98698 13520 29462306
Spontaneous haematoma 33.97 11.45 21 98680 476 29475350
Cardiac failure congestive 33.97 11.45 398 98303 76183 29399643
Cardiac failure chronic 33.96 11.45 70 98631 6397 29469429
Vascular pseudoaneurysm 33.83 11.45 37 98664 1912 29473914
Cerebral mass effect 33.61 11.45 26 98675 855 29474971
Conjunctivitis allergic 33.48 11.45 23 98678 627 29475199
Haematoma evacuation 33.24 11.45 15 98686 173 29475653
Suicide attempt 33.09 11.45 39 98662 34071 29441755
Drug reaction with eosinophilia and systemic symptoms 32.93 11.45 27 98674 27965 29447861
Hepatic function abnormal 32.89 11.45 50 98651 39209 29436617
Injection site pain 32.67 11.45 36 98665 32410 29443416
Emotional distress 32.58 11.45 4 98697 13891 29461935
Haemorrhage urinary tract 32.52 11.45 33 98668 1563 29474263
Obstruction 32.46 11.45 36 98665 1890 29473936
Catheter site haemorrhage 32.33 11.45 37 98664 2011 29473815
Therapeutic drug monitoring analysis not performed 31.72 11.45 20 98681 470 29475356
Haemorrhagic hepatic cyst 31.65 11.45 8 98693 9 29475817
Stevens-Johnson syndrome 31.64 11.45 8 98693 16489 29459337
Subdural haemorrhage 31.57 11.45 43 98658 2792 29473034
Abnormal behaviour 31.57 11.45 19 98682 23108 29452718
Splenic rupture 31.49 11.45 31 98670 1415 29474411
Spirometry abnormal 31.15 11.45 18 98683 359 29475467
Disease progression 31.07 11.45 154 98547 81762 29394064
Blood creatine phosphokinase increased 31.03 11.45 55 98646 40589 29435237
Therapy interrupted 30.98 11.45 79 98622 8307 29467519
Gout 30.86 11.45 125 98576 16786 29459040
Intentional self-injury 30.71 11.45 3 98698 12458 29463368
Pancytopenia 30.61 11.45 158 98543 83010 29392816
Cardiac tamponade 30.25 11.45 55 98646 4580 29471246
Pain 29.85 11.45 398 98303 171034 29304792
Neutrophil count decreased 29.74 11.45 63 98638 43504 29432322
Tooth disorder 29.40 11.45 84 98617 9445 29466381
Basal ganglia haemorrhage 29.30 11.45 23 98678 773 29475053
BRASH syndrome 29.27 11.45 13 98688 144 29475682
Osteonecrosis 29.13 11.45 5 98696 13514 29462312
Wound haemorrhage 29.12 11.45 33 98668 1774 29474052
Pulmonary alveolar haemorrhage 28.85 11.45 65 98636 6315 29469511
Muscle haemorrhage 28.73 11.45 45 98656 3317 29472509
Intracranial haematoma 28.65 11.45 17 98684 357 29475469
Neutrophil count increased 28.56 11.45 7 98694 14735 29461091
Circumstance or information capable of leading to medication error 28.33 11.45 30 98671 1494 29474332
Neurotoxicity 28.19 11.45 7 98694 14606 29461220
Proteinuria 27.84 11.45 9 98692 15795 29460031
Therapeutic response decreased 27.65 11.45 25 98676 24686 29451140
Haemarthrosis 27.45 11.45 40 98661 2766 29473060
Sedation 27.17 11.45 12 98689 17393 29458433
Haemorrhoids 26.97 11.45 93 98608 11564 29464262
Dust allergy 26.84 11.45 18 98683 471 29475355
Laryngeal haemorrhage 26.64 11.45 8 98693 24 29475802
Haemostasis 26.64 11.45 8 98693 24 29475802
Eye haemorrhage 26.53 11.45 46 98655 3690 29472136
Irritability 26.51 11.45 21 98680 22131 29453695
Gastrostomy 26.43 11.45 20 98681 636 29475190
Osteonecrosis of jaw 26.39 11.45 11 98690 16499 29459327
Serotonin syndrome 25.91 11.45 13 98688 17499 29458327
Peripheral artery occlusion 25.80 11.45 28 98673 1434 29474392
Cerebral thrombosis 25.46 11.45 22 98679 848 29474978
Duodenal ulcer haemorrhage 25.33 11.45 50 98651 4429 29471397
Hyperhidrosis 25.24 11.45 120 98581 64420 29411406
Therapeutic product effect decreased 25.16 11.45 37 98664 29414 29446412
Haemorrhoidal haemorrhage 25.13 11.45 40 98661 2989 29472837
Percutaneous coronary intervention 25.04 11.45 13 98688 208 29475618
Benign prostatic hyperplasia 25.01 11.45 91 98610 11619 29464207
Platypnoea 24.88 11.45 8 98693 32 29475794
Urethral haemorrhage 24.71 11.45 16 98685 394 29475432
Malignant neoplasm progression 24.61 11.45 145 98556 73714 29402112
Blood lactate dehydrogenase increased 24.55 11.45 17 98684 19192 29456634
Haemorrhagic disorder 24.55 11.45 18 98683 545 29475281
Aortic valve disease 24.55 11.45 24 98677 1086 29474740
Cardiac flutter 24.41 11.45 29 98672 1641 29474185
Haemorrhagic ascites 24.29 11.45 11 98690 128 29475698
Ulcer haemorrhage 24.17 11.45 35 98666 2406 29473420
Gastric ulcer 24.13 11.45 102 98599 13959 29461867
Peripheral artery stenosis 23.94 11.45 21 98680 826 29475000
Stress 23.74 11.45 22 98679 21468 29454358
Abdominal pain 23.63 11.45 314 98387 135043 29340783
Pericardial drainage 23.26 11.45 9 98692 68 29475758
Anaphylactic reaction 23.20 11.45 35 98666 27538 29448288
Nephropathy toxic 23.12 11.45 4 98697 10752 29465074
Traumatic haemothorax 22.92 11.45 13 98688 250 29475576
Hydrocephalus 22.91 11.45 47 98654 4280 29471546
Polyp 22.51 11.45 39 98662 3126 29472700
Renal haematoma 22.46 11.45 16 98685 463 29475363
Retroperitoneal haematoma 22.18 11.45 33 98668 2325 29473501
Glomerular filtration rate abnormal 22.15 11.45 19 98682 725 29475101
Multiple organ dysfunction syndrome 22.05 11.45 122 98579 62994 29412832
Catheter management 22.02 11.45 20 98681 824 29475002
Contraindicated product prescribed 22.01 11.45 14 98687 334 29475492
Gastrointestinal arteriovenous malformation 22.01 11.45 14 98687 334 29475492
Xyphoid retraction 22.00 11.45 11 98690 162 29475664
Lymphadenopathy 21.86 11.45 31 98670 25018 29450808
Upper respiratory tract infection 21.80 11.45 36 98665 27313 29448513
Splenic haematoma 21.58 11.45 11 98690 169 29475657
Rheumatoid arthritis 21.52 11.45 47 98654 32105 29443721
Blood pressure increased 21.47 11.45 151 98550 73652 29402174
Blood triglycerides increased 21.42 11.45 8 98693 12826 29463000
Muscle rigidity 21.37 11.45 3 98698 9408 29466418
Transcatheter aortic valve implantation 21.19 11.45 5 98696 3 29475823
Arteriovenous malformation 21.07 11.45 18 98683 683 29475143
Myoclonus 21.06 11.45 9 98692 13300 29462526
Staphylococcal infection 21.05 11.45 41 98660 29199 29446627
Hemiparesis 21.04 11.45 100 98601 14386 29461440
Extradural haematoma 20.97 11.45 22 98679 1084 29474742
Catheter site pruritus 20.90 11.45 13 98688 298 29475528
Tumour haemorrhage 20.87 11.45 33 98668 2452 29473374
Psoriasis 20.85 11.45 48 98653 32179 29443647
Ilium fracture 20.81 11.45 9 98692 93 29475733
Benign gastrointestinal neoplasm 20.77 11.45 10 98691 135 29475691
No adverse event 20.74 11.45 114 98587 17364 29458462
Hyperkaliuria 20.65 11.45 9 98692 95 29475731
Neoplasm progression 20.62 11.45 19 98682 18593 29457233
Prosthetic cardiac valve thrombosis 20.49 11.45 6 98695 16 29475810
Pulmonary thrombosis 20.38 11.45 58 98643 6507 29469319
Injection site reaction 20.37 11.45 6 98695 11182 29464644
Haemophagocytic lymphohistiocytosis 20.32 11.45 5 98696 10499 29465327
Amyloidosis 20.23 11.45 29 98672 1975 29473851
Metallosis of globe 20.08 11.45 5 98696 5 29475821
Infarction 20.08 11.45 32 98669 2394 29473432
Bladder irrigation 20.07 11.45 8 98693 66 29475760
Swelling face 20.02 11.45 23 98678 20327 29455499
Drug level fluctuating 19.96 11.45 15 98686 472 29475354
Graft versus host disease 19.80 11.45 4 98697 9624 29466202
Hypersensitivity 19.74 11.45 100 98601 52803 29423023
Respiratory arrest 19.68 11.45 35 98666 25798 29450028
Anti factor Xa activity decreased 19.61 11.45 5 98696 6 29475820
Low cardiac output syndrome 19.58 11.45 15 98686 486 29475340
Prostatic adenoma 19.49 11.45 10 98691 156 29475670
Colon cancer 19.42 11.45 63 98638 7592 29468234
Multiple sclerosis relapse 19.25 11.45 7 98694 11412 29464414
Prostatic haemorrhage 18.92 11.45 11 98690 222 29475604
Gastric ulcer haemorrhage 18.89 11.45 47 98654 4867 29470959
Clotting factor transfusion 18.82 11.45 4 98697 0 29475826
Coagulation factor V level abnormal 18.82 11.45 4 98697 0 29475826
Tremor 18.78 11.45 156 98545 73382 29402444
Pneumocystis jirovecii pneumonia 18.74 11.45 17 98684 16762 29459064
Intentional underdose 18.73 11.45 16 98685 607 29475219
Coagulation factor deficiency 18.64 11.45 8 98693 81 29475745
Somnolence 18.64 11.45 212 98489 93743 29382083
Gastric cancer 18.58 11.45 46 98655 4748 29471078
Discharge 18.57 11.45 10 98691 173 29475653
Haemobilia 18.52 11.45 12 98689 296 29475530
Sepsis 18.51 11.45 350 98351 142332 29333494
Blood cholesterol increased 18.39 11.45 15 98686 15580 29460246
Injection site erythema 18.31 11.45 12 98689 13944 29461882
Hypoglycaemia 18.26 11.45 91 98610 48255 29427571
Creatinine renal clearance decreased 18.21 11.45 35 98666 3039 29472787
Blood urea increased 18.08 11.45 42 98659 28070 29447756
Diabetes mellitus 18.06 11.45 70 98631 39761 29436065
Bone pain 18.00 11.45 21 98680 18431 29457395
Arthralgia 17.95 11.45 343 98358 139274 29336552
Chills 17.87 11.45 152 98549 71148 29404678
Sinusitis 17.83 11.45 57 98644 34293 29441533
Retroperitoneal haemorrhage 17.83 11.45 31 98670 2492 29473334
Anger 17.82 11.45 7 98694 10883 29464943
Wound haematoma 17.75 11.45 7 98694 56 29475770
Hepatitis C 17.72 11.45 4 98697 8906 29466920
Drug level increased 17.67 11.45 22 98679 18765 29457061
Lupus pneumonitis 17.54 11.45 7 98694 58 29475768
Abnormal loss of weight 17.53 11.45 38 98663 3596 29472230
Antiphospholipid syndrome 17.52 11.45 13 98688 401 29475425
Candida infection 17.52 11.45 15 98686 15210 29460616
Psoriatic arthropathy 17.49 11.45 14 98687 14677 29461149
Fear 17.49 11.45 5 98696 9499 29466327
Skin pressure mark 17.43 11.45 7 98694 59 29475767
Generalised tonic-clonic seizure 17.39 11.45 23 98678 19116 29456710
Mitral valve incompetence 17.34 11.45 89 98612 13204 29462622
Urticaria 17.32 11.45 109 98592 54551 29421275
Laryngeal discomfort 17.17 11.45 9 98692 147 29475679
Miosis 17.17 11.45 3 98698 8006 29467820
Progressive multifocal leukoencephalopathy 17.16 11.45 4 98697 8715 29467111
Oesophageal infection 17.13 11.45 11 98690 267 29475559
Bleeding time prolonged 17.08 11.45 15 98686 591 29475235
COVID-19 pneumonia 17.07 11.45 70 98631 9452 29466374
Hepatic haemorrhage 17.00 11.45 13 98688 420 29475406
Hallucination 16.98 11.45 84 98617 44628 29431198
Hypophosphataemia 16.92 11.45 3 98698 7921 29467905
Occult blood positive 16.90 11.45 38 98663 3686 29472140
Cardiovascular insufficiency 16.85 11.45 22 98679 1371 29474455
Amaurosis 16.78 11.45 15 98686 605 29475221
Disease recurrence 16.75 11.45 17 98684 15897 29459929
Chloasma 16.65 11.45 5 98696 15 29475811
Cerebral artery embolism 16.62 11.45 17 98684 813 29475013
Renal tubular necrosis 16.60 11.45 14 98687 14301 29461525
Mitral valve calcification 16.60 11.45 14 98687 522 29475304
Withdrawal syndrome 16.51 11.45 8 98693 10984 29464842
Hyperkinetic heart syndrome 16.49 11.45 8 98693 110 29475716
Intra-abdominal haemorrhage 16.47 11.45 27 98674 2068 29473758
Chest X-ray abnormal 16.43 11.45 38 98663 3756 29472070
Stent placement 16.36 11.45 41 98660 4265 29471561
Intentional product misuse 16.31 11.45 60 98641 34601 29441225
Vascular cauterisation 16.28 11.45 6 98695 39 29475787
Coma uraemic 16.02 11.45 6 98695 41 29475785
Agranulocytosis 16.00 11.45 27 98674 20313 29455513
Diastolic dysfunction 15.97 11.45 45 98656 5019 29470807
Hallucination, auditory 15.97 11.45 6 98695 9587 29466239
Intracardiac thrombus 15.96 11.45 28 98673 2267 29473559
Full blood count abnormal 15.89 11.45 95 98606 14918 29460908
Cardiogenic shock 15.79 11.45 114 98587 19076 29456750
Intestinal haemorrhage 15.78 11.45 33 98668 3046 29472780
Splenic haemorrhage 15.77 11.45 12 98689 385 29475441
Bronchiectasis 15.64 11.45 53 98648 6532 29469294
Hypertriglyceridaemia 15.60 11.45 3 98698 7472 29468354
Tumour lysis syndrome 15.59 11.45 14 98687 13870 29461956
Pulmonary hypertension 15.58 11.45 111 98590 18497 29457329
Product monitoring error 15.53 11.45 30 98671 2615 29473211
Traumatic haematoma 15.52 11.45 15 98686 669 29475157
Disturbance in attention 15.45 11.45 30 98671 21394 29454432
Dyskinesia 15.44 11.45 27 98674 20034 29455792
Aspergillus infection 15.44 11.45 8 98693 10573 29465253
Pathogen resistance 15.44 11.45 4 98697 8112 29467714
Catheter placement 15.41 11.45 15 98686 675 29475151
Bradycardia 15.39 11.45 306 98395 65323 29410503
Infective exacerbation of chronic obstructive airways disease 15.39 11.45 23 98678 1627 29474199
Oesophageal achalasia 15.36 11.45 11 98690 321 29475505
Radiation fibrosis - lung 15.36 11.45 5 98696 21 29475805
Mucosal haemorrhage 15.34 11.45 22 98679 1499 29474327
Factor V Leiden mutation 15.32 11.45 6 98695 47 29475779
Pain in jaw 15.22 11.45 78 98623 11563 29464263
Renal haemorrhage 15.20 11.45 20 98681 1256 29474570
Nipple exudate bloody 15.18 11.45 4 98697 6 29475820
Inguinal hernia 15.16 11.45 53 98648 6635 29469191
Renal mass 15.13 11.45 22 98679 1518 29474308
Hypoacusis 15.10 11.45 91 98610 14332 29461494
Systemic infection 15.09 11.45 26 98675 2075 29473751
Prostatic operation 15.06 11.45 11 98690 331 29475495
Craniocerebral injury 15.03 11.45 30 98671 2678 29473148
Fracture delayed union 15.00 11.45 6 98695 50 29475776
Transplant rejection 14.94 11.45 6 98695 9206 29466620
Haemorrhagic infarction 14.92 11.45 12 98689 418 29475408
Intentional overdose 14.85 11.45 72 98629 38456 29437370
Thrombectomy 14.84 11.45 7 98694 90 29475736
Mental status changes 14.81 11.45 63 98638 34864 29440962
Synovitis 14.79 11.45 9 98692 10881 29464945
Pneumonitis chemical 14.77 11.45 8 98693 140 29475686
Lymphopenia 14.77 11.45 14 98687 13519 29462307
Sinus node dysfunction 14.66 11.45 36 98665 3698 29472128
Product quality issue 14.55 11.45 19 98682 15876 29459950
Wound 14.52 11.45 79 98622 11984 29463842
Heart rate abnormal 14.40 11.45 22 98679 1587 29474239
Glomerular filtration rate decreased 14.40 11.45 75 98626 11191 29464635
Puncture site haematoma 14.38 11.45 8 98693 148 29475678
Anaphylactic shock 14.32 11.45 14 98687 13322 29462504
Conjunctival haemorrhage 14.30 11.45 29 98672 2619 29473207
Creatinine renal clearance abnormal 14.25 11.45 9 98692 212 29475614
Mitral valve thickening 14.21 11.45 11 98690 362 29475464
Diverticulum 14.20 11.45 50 98651 6282 29469544
Neoplasm malignant 14.19 11.45 101 98600 16824 29459002
Blood alkaline phosphatase increased 14.14 11.45 48 98653 28358 29447468
Myelosuppression 14.12 11.45 12 98689 12215 29463611
Anal ulcer haemorrhage 14.12 11.45 3 98698 0 29475826
Femoral artery embolism 14.12 11.45 3 98698 0 29475826
Therapeutic aspiration 14.12 11.45 3 98698 0 29475826
Gastritis haemorrhagic 14.06 11.45 19 98682 1224 29474602
Gastrointestinal neoplasm 14.01 11.45 8 98693 156 29475670
Anti factor X activity increased 13.96 11.45 6 98695 61 29475765
Pharyngeal haemorrhage 13.94 11.45 14 98687 655 29475171
Putamen haemorrhage 13.92 11.45 9 98692 221 29475605
Post procedural stroke 13.90 11.45 5 98696 30 29475796
Limb injury 13.89 11.45 65 98636 9290 29466536
Lymphocyte count decreased 13.89 11.45 27 98674 19244 29456582
Acute myeloid leukaemia 13.86 11.45 21 98680 16492 29459334
Depressed mood 13.72 11.45 21 98680 16427 29459399
Subcutaneous haematoma 13.71 11.45 16 98685 888 29474938
Atheroembolism 13.68 11.45 9 98692 228 29475598
Hepatic encephalopathy 13.63 11.45 14 98687 13021 29462805
Metabolic acidosis 13.59 11.45 72 98629 37590 29438236
Substance abuse 13.59 11.45 3 98698 6784 29469042
Intestinal perforation 13.56 11.45 5 98696 8081 29467745
Eosinophilia 13.54 11.45 34 98667 22127 29453699
Hepatic steatosis 13.54 11.45 18 98683 14928 29460898
Therapy change 13.50 11.45 28 98673 2570 29473256
Haemorrhagic cholecystitis 13.47 11.45 6 98695 67 29475759
Product prescribing issue 13.45 11.45 18 98683 1149 29474677
Catheter site irritation 13.37 11.45 7 98694 114 29475712
Arthropathy 13.36 11.45 120 98581 21434 29454392
Hypotension 13.33 11.45 784 97917 193570 29282256
Angioedema 13.27 11.45 58 98643 31857 29443969
Hepatic failure 13.27 11.45 57 98644 31455 29444371
Acidosis 13.21 11.45 8 98693 9697 29466129
Accidental exposure to product 13.11 11.45 10 98691 10743 29465083
Ventricular drainage 13.08 11.45 4 98697 13 29475813
Lung infiltration 13.08 11.45 12 98689 11767 29464059
Heart valve replacement 13.06 11.45 10 98691 324 29475502
Hirsutism 13.03 11.45 8 98693 179 29475647
Drug ineffective for unapproved indication 13.00 11.45 17 98684 14197 29461629
Schizophrenia 12.95 11.45 3 98698 6562 29469264
Catheter site erythema 12.93 11.45 18 98683 1193 29474633
Necrotising oesophagitis 12.90 11.45 12 98689 510 29475316
Skin exfoliation 12.89 11.45 36 98665 22609 29453217
Duodenal ulcer 12.86 11.45 63 98638 9175 29466651
Cardiac valve disease 12.86 11.45 29 98672 2819 29473007
Ruptured cerebral aneurysm 12.85 11.45 7 98694 124 29475702
Catheter site rash 12.84 11.45 8 98693 184 29475642
Hip fracture 12.83 11.45 69 98632 10423 29465403
Amaurosis fugax 12.80 11.45 12 98689 515 29475311
Pseudolymphoma 12.80 11.45 12 98689 515 29475311
Craniotomy 12.73 11.45 6 98695 77 29475749
Disseminated intravascular coagulation 12.73 11.45 30 98671 19950 29455876
Aortic stenosis 12.67 11.45 35 98666 3859 29471967
Cardiac arrest 12.67 11.45 205 98496 85386 29390440
Respiratory failure 12.66 11.45 238 98463 96893 29378933
Medical procedure 12.66 11.45 6 98695 78 29475748
Ataxia 12.66 11.45 13 98688 12090 29463736
Dizziness postural 12.57 11.45 43 98658 5324 29470502
Small intestinal haemorrhage 12.56 11.45 23 98678 1926 29473900
Pallor 12.49 11.45 116 98585 20908 29454918
Electrocardiogram abnormal 12.47 11.45 53 98648 7269 29468557
Gastrointestinal polyp 12.44 11.45 4 98697 16 29475810
Influenza like illness 12.42 11.45 41 98660 24429 29451397
Incarcerated inguinal hernia 12.40 11.45 6 98695 82 29475744
Spontaneous haemorrhage 12.39 11.45 8 98693 196 29475630
Respiratory distress 12.37 11.45 60 98641 32046 29443780
Insomnia 12.36 11.45 215 98486 88546 29387280
Gynaecomastia 12.31 11.45 6 98695 8211 29467615
Cholecystitis 12.29 11.45 62 98639 9135 29466691
Syncope 12.25 11.45 357 98344 81014 29394812
Cytomegalovirus viraemia 12.24 11.45 3 98698 6317 29469509
Palmar-plantar erythrodysaesthesia syndrome 12.16 11.45 19 98682 14740 29461086
Wrong dose 12.16 11.45 11 98690 451 29475375
Muscle rupture 12.16 11.45 23 98678 1974 29473852
Catheter site discharge 12.15 11.45 12 98689 550 29475276
Prostatectomy 12.15 11.45 8 98693 203 29475623
Oedema peripheral 12.14 11.45 441 98260 103116 29372710
Catheterisation cardiac 12.13 11.45 24 98677 2129 29473697
Myocardial infarction 12.10 11.45 278 98423 110018 29365808
Hypervolaemia 12.09 11.45 100 98601 17445 29458381
Cardiac resynchronisation therapy 12.05 11.45 3 98698 3 29475823
Splenomegaly 12.02 11.45 16 98685 13263 29462563
Incorrect route of product administration 11.99 11.45 11 98690 10790 29465036
Face oedema 11.99 11.45 10 98691 10273 29465553
Hypovolaemic shock 11.98 11.45 46 98655 6026 29469800
White blood cell count decreased 11.90 11.45 201 98500 83161 29392665
Fungal infection 11.88 11.45 17 98684 13668 29462158
Renal injury 11.80 11.45 10 98691 10192 29465634
Subdural hygroma 11.79 11.45 9 98692 290 29475536
Subdural haematoma evacuation 11.72 11.45 4 98697 20 29475806
Cerebral artery occlusion 11.68 11.45 13 98688 685 29475141
Polyneuropathy 11.67 11.45 14 98687 12138 29463688
Hypoaesthesia 11.66 11.45 118 98583 53349 29422477
Hernia 11.63 11.45 57 98644 8301 29467525
Large intestine perforation 11.60 11.45 5 98696 7351 29468475
Arteriovenous fistula 11.56 11.45 13 98688 693 29475133
Skull fracture 11.51 11.45 14 98687 812 29475014

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 1370.76 10.58 1737 172666 130575 64193754
Atrial fibrillation 1295.58 10.58 1930 172473 169159 64155170
Cerebral haemorrhage 1147.60 10.58 1014 173389 50076 64274253
Prescribed underdose 1094.32 10.58 654 173749 17361 64306968
Haemorrhage 1029.99 10.58 1169 173234 78182 64246147
Death 1009.03 10.58 3226 171177 479479 63844850
Haemorrhage intracranial 868.23 10.58 629 173774 23255 64301074
Fall 770.19 10.58 2674 171729 414152 63910177
Cerebrovascular accident 628.26 10.58 1241 173162 136342 64187987
Haematoma 611.01 10.58 688 173715 45562 64278767
Subdural haematoma 598.31 10.58 541 173862 27513 64296816
Drug ineffective 593.15 10.58 849 173554 839398 63484931
Gastric haemorrhage 517.30 10.58 367 174036 13114 64311215
Cardiac failure 458.92 10.58 1068 173335 131305 64193024
Epistaxis 452.33 10.58 889 173514 97242 64227087
Melaena 449.22 10.58 635 173768 52913 64271416
Anaemia 445.13 10.58 2113 172290 376567 63947762
Haematuria 427.95 10.58 662 173741 59809 64264520
Cerebral infarction 402.34 10.58 525 173878 40519 64283810
Completed suicide 375.82 10.58 75 174328 224339 64099990
Haematochezia 360.20 10.58 645 173758 65728 64258601
Intentional product use issue 356.54 10.58 793 173610 94571 64229758
Transfusion 352.53 10.58 331 174072 17663 64306666
Dyspnoea 352.09 10.58 3216 171187 715458 63608871
Thrombosis 345.02 10.58 656 173747 69986 64254343
Ischaemic stroke 335.00 10.58 403 174000 28632 64295697
Rectal haemorrhage 295.63 10.58 569 173834 61248 64263081
Toxicity to various agents 289.62 10.58 334 174069 363179 63961150
Subarachnoid haemorrhage 283.06 10.58 297 174106 18141 64306188
Drug hypersensitivity 273.95 10.58 151 174252 237664 64086665
Labelled drug-drug interaction medication error 255.78 10.58 307 174096 21755 64302574
Synovitis 243.23 10.58 5 174398 99085 64225244
Haemorrhagic stroke 230.19 10.58 201 174202 9750 64314579
Renal impairment 226.52 10.58 841 173562 134176 64190153
Infusion related reaction 226.15 10.58 81 174322 164386 64159943
Rheumatoid arthritis 222.39 10.58 83 174320 164211 64160118
Pulmonary embolism 222.09 10.58 883 173520 145473 64178856
Haemoglobin decreased 221.61 10.58 1079 173324 193984 64130345
Lower gastrointestinal haemorrhage 214.80 10.58 225 174178 13714 64310615
Upper gastrointestinal haemorrhage 211.49 10.58 358 174045 34862 64289467
Drug abuse 200.18 10.58 55 174348 132319 64192010
Cardiac disorder 198.29 10.58 455 173948 55361 64268968
Cardioversion 196.84 10.58 98 174305 1787 64322542
Pericardial haemorrhage 187.95 10.58 125 174278 4011 64320318
Product prescribing error 185.21 10.58 338 174065 34931 64289398
Embolic stroke 185.02 10.58 150 174253 6561 64317768
Hospitalisation 179.44 10.58 528 173875 74679 64249650
Atrial flutter 179.23 10.58 241 174162 19139 64305190
Atrial thrombosis 178.34 10.58 108 174295 2934 64321395
Intraventricular haemorrhage 177.91 10.58 121 174282 4032 64320297
Shock haemorrhagic 175.83 10.58 222 174181 16569 64307760
Maternal exposure during pregnancy 171.35 10.58 27 174376 95857 64228472
General physical health deterioration 168.25 10.58 1036 173367 203389 64120940
Drug intolerance 167.23 10.58 157 174246 187835 64136494
Dyspnoea exertional 166.80 10.58 508 173895 73222 64251107
Pain 163.03 10.58 857 173546 552654 63771675
Fluid retention 160.28 10.58 437 173966 59169 64265160
Haematemesis 160.21 10.58 377 174026 46622 64277707
Therapeutic product effect decreased 159.92 10.58 56 174347 115295 64209034
Internal haemorrhage 155.87 10.58 144 174259 7523 64316806
Hypersensitivity 155.68 10.58 181 174222 196271 64128058
Pulmonary arterial hypertension 151.17 10.58 257 174146 25110 64299219
Traumatic haemorrhage 149.39 10.58 69 174334 1057 64323272
Pemphigus 145.35 10.58 4 174399 60697 64263632
Arthralgia 144.40 10.58 660 173743 441600 63882729
Post procedural haemorrhage 142.47 10.58 172 174231 12259 64312070
Head injury 135.08 10.58 284 174119 32558 64291771
Haemoptysis 133.26 10.58 361 174042 48687 64275642
Transient ischaemic attack 133.13 10.58 338 174065 43844 64280485
Joint swelling 127.32 10.58 243 174160 215139 64109190
Arrhythmia 123.69 10.58 369 174034 52575 64271754
Cardiac ablation 119.85 10.58 69 174334 1703 64322626
Cerebral haematoma 119.78 10.58 121 174282 7064 64317265
Stomatitis 118.45 10.58 75 174328 109530 64214799
Traumatic intracranial haemorrhage 117.03 10.58 57 174346 989 64323340
Dizziness 116.50 10.58 1719 172684 428444 63895885
Deep vein thrombosis 115.84 10.58 577 173826 104605 64219724
Musculoskeletal stiffness 114.17 10.58 99 174304 123107 64201222
Systemic lupus erythematosus 112.26 10.58 35 174368 77577 64246752
Hypotension 111.73 10.58 1544 172859 379430 63944899
Cerebral mass effect 108.94 10.58 64 174339 1642 64322687
Injection site pain 108.83 10.58 85 174318 111323 64213006
Glossodynia 107.39 10.58 22 174381 64674 64259655
Cardiac pacemaker insertion 107.30 10.58 97 174306 4926 64319403
Subdural haemorrhage 106.64 10.58 99 174304 5204 64319125
Febrile neutropenia 105.49 10.58 218 174185 187439 64136890
Diverticulum intestinal haemorrhagic 105.08 10.58 80 174323 3189 64321140
Haemorrhage subcutaneous 104.72 10.58 90 174313 4271 64320058
Thalamus haemorrhage 101.46 10.58 60 174343 1559 64322770
Bradycardia 100.23 10.58 604 173799 117615 64206714
Cerebral ventricular rupture 100.06 10.58 39 174364 381 64323948
Pyrexia 98.83 10.58 1000 173403 557644 63766685
Faeces discoloured 97.22 10.58 215 174188 25514 64298815
Hepatic enzyme increased 96.29 10.58 126 174277 129817 64194512
Therapeutic drug monitoring analysis not performed 95.03 10.58 52 174351 1160 64323169
Syncope 90.90 10.58 733 173670 156902 64167427
Basal ganglia haemorrhage 90.45 10.58 53 174350 1353 64322976
Spinal cord haemorrhage 87.65 10.58 38 174365 497 64323832
Injection site erythema 87.33 10.58 41 174362 70759 64253570
Sinusitis 85.88 10.58 165 174238 145763 64178566
Sensitisation 85.20 10.58 55 174348 1676 64322653
Depression 84.70 10.58 236 174167 183055 64141274
Cerebellar haemorrhage 83.59 10.58 64 174339 2573 64321756
Acute kidney injury 83.10 10.58 1689 172714 447551 63876778
Vascular pseudoaneurysm 82.28 10.58 68 174335 3056 64321273
Prescribed overdose 80.35 10.58 173 174230 20158 64304171
Injection site reaction 79.27 10.58 15 174388 46649 64277680
Blood cholesterol increased 79.11 10.58 19 174384 50047 64274282
Anxiety 78.83 10.58 282 174121 202367 64121962
Treatment failure 77.92 10.58 122 174281 116694 64207635
Alanine aminotransferase increased 76.85 10.58 163 174240 138868 64185461
Blood loss anaemia 76.57 10.58 136 174267 13756 64310573
Haemarthrosis 76.29 10.58 82 174321 5147 64319182
Haemothorax 74.31 10.58 78 174325 4764 64319565
Polycystic ovaries 74.30 10.58 55 174348 2100 64322229
Oedema peripheral 74.04 10.58 882 173521 209435 64114894
Alopecia 73.14 10.58 218 174185 165472 64158857
Cardiac failure congestive 73.00 10.58 603 173800 129977 64194352
Hypervolaemia 71.37 10.58 247 174156 38038 64286291
Ejection fraction 71.15 10.58 44 174359 1242 64323087
Right atrial hypertrophy 71.07 10.58 33 174370 512 64323817
Abdominal wall haematoma 70.85 10.58 72 174331 4233 64320096
Splenic rupture 70.66 10.58 54 174349 2165 64322164
Suicidal ideation 69.89 10.58 47 174356 66495 64257834
Haematoma muscle 69.20 10.58 49 174354 1744 64322585
Aortic valve stenosis 68.90 10.58 73 174330 4507 64319822
Pericarditis 68.60 10.58 42 174361 62474 64261855
Suicide attempt 68.30 10.58 55 174348 70952 64253377
Failure to suspend medication 67.11 10.58 29 174374 376 64323953
Rash 66.42 10.58 858 173545 457691 63866638
Therapeutic response decreased 66.27 10.58 29 174374 52159 64272170
Seizure 65.72 10.58 231 174172 166661 64157668
Surgery 65.28 10.58 196 174207 28017 64296312
Erythema 64.62 10.58 273 174130 186797 64137532
Neutropenia 64.30 10.58 382 174021 239242 64085087
Serotonin syndrome 63.87 10.58 14 174389 39268 64285061
Haemorrhoidal haemorrhage 63.69 10.58 78 174325 5641 64318688
Pulmonary hypertension 63.51 10.58 258 174145 42881 64281448
Impaired healing 63.12 10.58 43 174360 60430 64263899
Vomiting 62.98 10.58 1080 173323 550037 63774292
Injection site pruritus 62.49 10.58 13 174390 37813 64286516
COVID-19 62.48 10.58 344 174059 64796 64259533
Drug resistance 62.43 10.58 10 174393 35092 64289237
Gastrointestinal angiodysplasia 62.22 10.58 36 174367 897 64323432
Muscle haemorrhage 61.72 10.58 77 174326 5676 64318653
Aspartate aminotransferase increased 61.66 10.58 146 174257 119642 64204687
Traumatic haematoma 61.31 10.58 47 174356 1893 64322436
Mucosal inflammation 60.79 10.58 48 174355 62536 64261793
Psoriasis 60.11 10.58 63 174340 71640 64252689
High frequency ablation 59.06 10.58 24 174379 264 64324065
Post procedural haematoma 58.41 10.58 49 174354 2249 64322080
Catheter site haemorrhage 58.38 10.58 67 174336 4524 64319805
Nasopharyngitis 58.37 10.58 302 174101 195771 64128558
Drug dependence 58.11 10.58 10 174393 33302 64291027
White blood cell count increased 56.48 10.58 57 174346 65957 64258372
Emotional distress 56.30 10.58 14 174389 36024 64288305
Pulmonary alveolar haemorrhage 55.83 10.58 97 174306 9641 64314688
Cardiac tamponade 55.78 10.58 88 174315 8076 64316253
Anaphylactic reaction 55.71 10.58 62 174341 68602 64255727
Arthropathy 55.68 10.58 156 174247 120811 64203518
Nausea 55.14 10.58 1662 172741 784138 63540191
Product use issue 54.51 10.58 218 174185 151497 64172832
Spontaneous haematoma 54.37 10.58 37 174366 1234 64323095
Injection site swelling 54.07 10.58 22 174381 41331 64282998
Thrombectomy 53.74 10.58 22 174381 247 64324082
Urinary bladder haemorrhage 53.62 10.58 47 174356 2291 64322038
Muscle injury 53.20 10.58 5 174398 26432 64297897
Adverse event 52.54 10.58 229 174174 39260 64285069
Folliculitis 52.53 10.58 9 174394 30068 64294261
Mobility decreased 52.30 10.58 95 174308 85745 64238584
C-reactive protein abnormal 52.28 10.58 8 174395 29039 64295290
Brain stem haemorrhage 52.17 10.58 39 174364 1512 64322817
Retroperitoneal haematoma 52.06 10.58 64 174339 4647 64319682
Hemiparesis 50.95 10.58 187 174216 29640 64294689
Helicobacter infection 50.83 10.58 20 174383 38342 64285987
Infection 50.50 10.58 293 174110 184587 64139742
Haematoma evacuation 50.45 10.58 22 174381 292 64324037
Swelling 50.41 10.58 242 174161 159976 64164353
Bone marrow failure 50.18 10.58 34 174369 47918 64276411
Urogenital haemorrhage 50.09 10.58 28 174375 652 64323677
Cytomegalovirus infection 49.94 10.58 19 174384 37180 64287149
Agitation 49.32 10.58 103 174300 88264 64236065
Cardiac failure chronic 49.17 10.58 88 174315 8953 64315376
Retroperitoneal haemorrhage 48.81 10.58 63 174340 4805 64319524
Iron deficiency anaemia 48.70 10.58 150 174253 21739 64302590
Right ventricular hypertrophy 48.48 10.58 35 174368 1285 64323044
Lower respiratory tract infection 48.14 10.58 116 174287 94498 64229831
Gastric ulcer 47.87 10.58 185 174218 30049 64294280
Psoriatic arthropathy 47.59 10.58 29 174374 43252 64281077
Toxic epidermal necrolysis 46.64 10.58 21 174382 37145 64287184
Neutrophil count decreased 46.52 10.58 86 174317 77110 64247219
Haemoperitoneum 46.22 10.58 55 174348 3860 64320469
Product monitoring error 46.17 10.58 65 174338 5389 64318940
Multiple sclerosis relapse 46.02 10.58 27 174376 41108 64283221
Blood urine present 45.86 10.58 131 174272 18209 64306120
Infarction 45.71 10.58 55 174348 3905 64320424
Drug withdrawal syndrome 45.44 10.58 14 174389 31277 64293052
Abortion spontaneous 45.08 10.58 7 174396 25136 64299193
Extradural haematoma 44.48 10.58 45 174358 2631 64321698
Pain in jaw 44.42 10.58 223 174180 40532 64283797
Catheter management 44.42 10.58 50 174353 3305 64321024
Catheter site erythema 44.37 10.58 60 174343 4789 64319540
Leukopenia 44.08 10.58 134 174269 101108 64223221
Irritable bowel syndrome 44.02 10.58 23 174380 37346 64286983
Blister 43.83 10.58 96 174307 80871 64243458
Urticaria 43.77 10.58 227 174176 147090 64177239
Pericardial effusion 43.65 10.58 216 174187 39038 64285291
Osteonecrosis of jaw 43.35 10.58 27 174376 39798 64284531
Mite allergy 43.24 10.58 26 174377 697 64323632
Aggression 42.99 10.58 37 174366 46195 64278134
Spinal subarachnoid haemorrhage 42.55 10.58 13 174390 55 64324274
Bleeding time prolonged 42.54 10.58 31 174372 1155 64323174
Upper respiratory tract infection 42.18 10.58 83 174320 72702 64251627
White blood cell count decreased 42.11 10.58 252 174151 157585 64166744
Catheter site pruritus 41.08 10.58 39 174364 2109 64322220
Spontaneous haemorrhage 40.66 10.58 21 174382 415 64323914
Systemic infection 40.35 10.58 54 174349 4267 64320062
Vascular device infection 40.01 10.58 65 174338 6115 64318214
Gout 39.78 10.58 138 174265 21275 64303054
Abdominal discomfort 39.74 10.58 309 174094 182013 64142316
Sleep disorder due to a general medical condition 39.58 10.58 76 174327 8158 64316171
Procedural haemorrhage 39.50 10.58 53 174350 4199 64320130
Dementia 38.72 10.58 134 174269 20632 64303697
Polypectomy 38.68 10.58 27 174376 939 64323390
Irritability 38.52 10.58 26 174377 36720 64287609
Blood glucose increased 38.42 10.58 136 174267 97937 64226392
Pallor 37.99 10.58 206 174197 38575 64285754
Gastrointestinal endoscopic therapy 37.82 10.58 12 174391 59 64324270
Posterior reversible encephalopathy syndrome 37.67 10.58 8 174395 22938 64301391
Hydrocephalus 37.64 10.58 71 174332 7520 64316809
Discomfort 37.43 10.58 104 174299 80774 64243555
Conjunctival haemorrhage 36.93 10.58 56 174347 4965 64319364
Colon cancer 36.85 10.58 96 174307 12643 64311686
Neurotoxicity 36.78 10.58 14 174389 27390 64296939
Sedation 36.38 10.58 35 174368 41427 64282902
Benign prostatic hyperplasia 36.22 10.58 78 174325 9087 64315242
Cerebrospinal fluid retention 35.97 10.58 12 174391 71 64324258
Sleep disorder due to general medical condition, insomnia type 35.97 10.58 13 174390 26257 64298072
Percutaneous coronary intervention 35.92 10.58 18 174385 333 64323996
Haemorrhagic disorder 35.91 10.58 30 174373 1369 64322960
Blood test abnormal 35.88 10.58 96 174307 12847 64311482
Diabetes mellitus 35.83 10.58 79 174324 66395 64257934
Catheter site irritation 35.81 10.58 21 174382 537 64323792
Transplant rejection 35.80 10.58 3 174400 17398 64306931
Haemorrhagic hepatic cyst 35.73 10.58 11 174392 48 64324281
Respiratory arrest 35.64 10.58 55 174348 52930 64271399
Intracranial haematoma 35.57 10.58 24 174379 789 64323540
Pulmonary thrombosis 35.42 10.58 84 174319 10434 64313895
Fear 35.31 10.58 6 174397 20165 64304164
Sinus node dysfunction 35.28 10.58 65 174338 6763 64317566
Overdose 34.97 10.58 270 174133 159296 64165033
Tumour haemorrhage 34.70 10.58 45 174358 3448 64320881
Subcutaneous haematoma 34.59 10.58 38 174365 2445 64321884
Somnolence 34.44 10.58 368 174035 203277 64121052
Ulcer haemorrhage 34.33 10.58 51 174352 4441 64319888
Medication error 34.20 10.58 242 174161 49724 64274605
N-terminal prohormone brain natriuretic peptide increased 34.04 10.58 45 174358 3514 64320815
Muscle spasticity 33.95 10.58 3 174400 16666 64307663
Injection site bruising 33.95 10.58 29 174374 36344 64287985
Large intestine polyp 33.77 10.58 84 174319 10753 64313576
Hyperhidrosis 33.55 10.58 199 174204 124721 64199608
Nephrectomy 33.44 10.58 29 174374 1393 64322936
Stress 33.40 10.58 71 174332 60463 64263866
Vena cava filter insertion 33.26 10.58 13 174390 128 64324201
Insomnia 33.25 10.58 358 174045 197478 64126851
Paraesthesia 33.18 10.58 220 174183 134302 64190027
C-reactive protein increased 33.06 10.58 138 174265 94771 64229558
Psychotic disorder 32.97 10.58 27 174376 34551 64289778
Eye haemorrhage 32.87 10.58 71 174332 8289 64316040
Lymphocyte count decreased 32.73 10.58 37 174366 40662 64283667
Gastrointestinal tract mucosal pigmentation 32.73 10.58 24 174379 903 64323426
Splenic haematoma 32.73 10.58 16 174387 280 64324049
Orbital compartment syndrome 32.61 10.58 9 174394 24 64324305
Catheterisation cardiac 32.57 10.58 52 174351 4821 64319508
Full blood count abnormal 32.55 10.58 163 174240 29594 64294735
Gastrointestinal tube insertion 32.54 10.58 29 174374 1445 64322884
Intentional overdose 32.45 10.58 129 174274 89815 64234514
Haemorrhage urinary tract 31.62 10.58 34 174369 2135 64322194
Hypoaesthesia 31.61 10.58 233 174170 138875 64185454
Device expulsion 31.52 10.58 9 174394 21127 64303202
Premature delivery 31.52 10.58 6 174397 18583 64305746
Craniocerebral injury 31.32 10.58 47 174356 4129 64320200
Heart rate abnormal 31.30 10.58 52 174351 4983 64319346
Haemangioma of spleen 31.27 10.58 8 174395 14 64324315
Blood creatine phosphokinase increased 31.23 10.58 70 174333 58488 64265841
Limb injury 31.03 10.58 136 174267 23369 64300960
Wound haemorrhage 30.70 10.58 42 174361 3389 64320940
Gastric ulcer haemorrhage 30.70 10.58 68 174335 8075 64316254
Progressive multifocal leukoencephalopathy 30.67 10.58 6 174397 18226 64306103
Bronchial secretion retention 30.66 10.58 36 174367 2491 64321838
Tremor 30.55 10.58 255 174148 147975 64176354
Contusion 30.53 10.58 455 173948 113510 64210819
Craniotomy 30.49 10.58 16 174387 327 64324002
Asthenia 30.48 10.58 1432 172971 426612 63897717
Mania 30.45 10.58 4 174399 16282 64308047
Drug interaction 30.36 10.58 1232 173171 360851 63963478
Red blood cell sedimentation rate increased 30.27 10.58 24 174379 31211 64293118
Pulmonary function test abnormal 30.25 10.58 40 174363 3124 64321205
Occult blood positive 30.18 10.58 58 174345 6229 64318100
Generalised tonic-clonic seizure 30.17 10.58 38 174365 39819 64284510
Ocular retrobulbar haemorrhage 29.94 10.58 12 174391 127 64324202
Duodenal ulcer haemorrhage 29.94 10.58 58 174345 6267 64318062
Body temperature increased 29.85 10.58 33 174370 36633 64287696
Bronchial wall thickening 29.76 10.58 31 174372 1876 64322453
Ear haemorrhage 29.67 10.58 31 174372 1883 64322446
Herpes zoster 29.57 10.58 112 174291 79075 64245254
Clotting factor transfusion 29.50 10.58 6 174397 0 64324329
Oesophageal achalasia 29.31 10.58 20 174383 670 64323659
Right ventricular failure 28.93 10.58 125 174278 21346 64302983
Gastrointestinal ulcer haemorrhage 28.90 10.58 24 174379 1086 64323243
Gingival bleeding 28.70 10.58 97 174306 14757 64309572
Intentional self-injury 28.55 10.58 22 174381 29022 64295307
Neuroleptic malignant syndrome 28.54 10.58 16 174387 24980 64299349
Cerebral artery occlusion 28.46 10.58 28 174375 1583 64322746
Cerebral artery embolism 28.41 10.58 28 174375 1586 64322743
Mallory-Weiss syndrome 28.40 10.58 35 174368 2548 64321781
Therapy change 28.05 10.58 57 174346 6377 64317952
Thirst decreased 27.89 10.58 14 174389 260 64324069
Skin pressure mark 27.85 10.58 10 174393 76 64324253
Skull fracture 27.62 10.58 27 174376 1514 64322815
Intracardiac thrombus 27.57 10.58 42 174361 3739 64320590
Neutrophil count increased 27.49 10.58 17 174386 25157 64299172
Chills 27.45 10.58 238 174165 137026 64187303
Glomerular filtration rate decreased 27.19 10.58 115 174288 19457 64304872
Stevens-Johnson syndrome 26.61 10.58 32 174371 34217 64290112
Platypnoea 26.54 10.58 8 174395 32 64324297
Obstruction 26.45 10.58 38 174365 3210 64321119
Renal disorder 26.40 10.58 175 174228 35190 64289139
Hepatotoxicity 26.38 10.58 42 174361 39920 64284409
Osteopenia 26.38 10.58 5 174398 15535 64308794
Malignant mediastinal neoplasm 26.36 10.58 17 174386 517 64323812
Subchondral insufficiency fracture 26.33 10.58 9 174394 58 64324271
Glomerular filtration rate abnormal 26.28 10.58 24 174379 1235 64323094
Conjunctivitis allergic 26.26 10.58 22 174381 1008 64323321
Renal haematoma 26.19 10.58 19 174384 703 64323626
Listless 26.07 10.58 38 174365 3252 64321077
Ear pain 26.06 10.58 18 174385 25118 64299211
Mental disorder 26.03 10.58 20 174383 26425 64297904
Blood pressure increased 25.97 10.58 320 174083 172232 64152097
Inflammation 25.94 10.58 90 174313 65210 64259119
Pneumocystis jirovecii pneumonia 25.83 10.58 22 174381 27612 64296717
Benign gastrointestinal neoplasm 25.78 10.58 11 174392 138 64324191
Osteonecrosis 25.75 10.58 23 174380 28206 64296123
Infusion site pain 25.74 10.58 74 174329 10323 64314006
Palmar-plantar erythrodysaesthesia syndrome 25.67 10.58 24 174379 28795 64295534
Catheter site discharge 25.66 10.58 31 174372 2210 64322119
Circumstance or information capable of leading to medication error 25.64 10.58 38 174365 3302 64321027
Haemobilia 25.63 10.58 15 174388 382 64323947
Mixed liver injury 25.63 10.58 50 174353 5431 64318898
Rhinitis allergic 25.58 10.58 63 174340 8015 64316314
Pruritus 25.57 10.58 646 173757 311754 64012575
Rectosigmoid cancer 25.49 10.58 13 174390 250 64324079
Haemophagocytic lymphohistiocytosis 25.35 10.58 8 174395 17601 64306728
Diverticulum 25.34 10.58 86 174317 13112 64311217
Arteriovenous malformation 25.28 10.58 26 174377 1550 64322779
Spirometry abnormal 25.19 10.58 17 174386 559 64323770
Nephropathy toxic 25.14 10.58 8 174395 17506 64306823
Prostatic adenoma 25.02 10.58 10 174393 105 64324224
Oxygen saturation decreased 24.96 10.58 418 173985 106758 64217571
No adverse event 24.86 10.58 147 174256 28414 64295915
Pericardial drainage 24.82 10.58 14 174389 332 64323997
Proteinuria 24.80 10.58 23 174380 27700 64296629
Tenderness 24.71 10.58 11 174392 19591 64304738
Laryngeal haemorrhage 24.62 10.58 8 174395 43 64324286
Hepatic haemangioma rupture 24.58 10.58 5 174398 0 64324329
Fungal infection 24.55 10.58 34 174369 34217 64290112
Prosthetic cardiac valve thrombosis 24.47 10.58 8 174395 44 64324285
Skin exfoliation 24.47 10.58 53 174350 44832 64279497
Anti factor X activity increased 24.45 10.58 9 174394 74 64324255
Graft versus host disease 24.42 10.58 4 174399 13809 64310520
Cardiac failure acute 24.25 10.58 98 174305 16246 64308083
Gastric cancer 24.23 10.58 54 174349 6439 64317890
Duodenal ulcer 24.23 10.58 90 174313 14345 64309984
Xyphoid retraction 24.20 10.58 11 174392 162 64324167
Joint range of motion decreased 24.16 10.58 11 174392 19332 64304997
Palpitations 24.14 10.58 407 173996 104081 64220248
Neoplasm malignant 24.08 10.58 131 174272 24557 64299772
Ill-defined disorder 24.03 10.58 52 174351 44000 64280329
Renal haemorrhage 23.97 10.58 28 174375 1927 64322402
Lymphadenopathy 23.93 10.58 57 174346 46629 64277700
Cardiac amyloidosis 23.90 10.58 24 174379 1391 64322938
Hospice care 23.65 10.58 59 174344 7566 64316763
Splenic haemorrhage 23.62 10.58 17 174386 621 64323708
Neovascular age-related macular degeneration 23.47 10.58 12 174391 232 64324097
Accidental exposure to product 23.43 10.58 22 174381 26342 64297987
Catheter site rash 23.42 10.58 20 174383 941 64323388
Infusion site haemorrhage 23.27 10.58 30 174373 2285 64322044
Peripheral artery stenosis 23.21 10.58 22 174381 1187 64323142
Type 2 diabetes mellitus 23.18 10.58 35 174368 33985 64290344
Tendonitis 23.13 10.58 13 174390 20269 64304060
Intestinal haemorrhage 23.03 10.58 48 174355 5466 64318863
Traumatic haemothorax 22.93 10.58 14 174389 386 64323943
Anal haemorrhage 22.82 10.58 36 174367 3304 64321025
Crying 22.74 10.58 13 174390 20077 64304252
Respiratory depression 22.74 10.58 18 174385 23425 64300904
Cardiac fibrillation 22.54 10.58 19 174384 878 64323451
Petechiae 22.51 10.58 105 174298 18521 64305808
Bladder irrigation 22.48 10.58 8 174395 59 64324270
Pulmonary oedema 22.20 10.58 317 174086 78357 64245972
Haemorrhagic ascites 22.12 10.58 12 174391 263 64324066
Joint stiffness 21.98 10.58 30 174373 30374 64293955
Haemorrhagic diathesis 21.88 10.58 47 174356 5467 64318862
Impaired work ability 21.76 10.58 7 174396 15212 64309117
Ventricular drainage 21.74 10.58 6 174397 16 64324313
Oxygen consumption increased 21.67 10.58 42 174361 4539 64319790
Abnormal loss of weight 21.65 10.58 56 174347 7344 64316985
Grip strength decreased 21.63 10.58 3 174400 11721 64312608
Intra-abdominal haemorrhage 21.62 10.58 39 174364 3992 64320337
Amyloidosis 21.52 10.58 30 174373 2464 64321865
Injection site warmth 21.48 10.58 5 174398 13457 64310872
Pyroglutamic acidosis 21.46 10.58 17 174386 719 64323610
Staphylococcal infection 21.40 10.58 68 174335 50610 64273719
Ataxia 21.36 10.58 17 174386 22067 64302262
Drug reaction with eosinophilia and systemic symptoms 21.35 10.58 75 174328 54142 64270187
Puncture site haematoma 21.20 10.58 10 174393 161 64324168
Rhabdomyolysis 21.14 10.58 153 174250 91573 64232756
Metallosis of globe 21.13 10.58 5 174398 5 64324324
BRASH syndrome 21.11 10.58 13 174390 364 64323965
Large intestinal haemorrhage 21.04 10.58 30 174373 2517 64321812
Hepatic steatosis 21.03 10.58 32 174371 30975 64293354
Urethral haemorrhage 20.93 10.58 13 174390 370 64323959
Wrong dose 20.87 10.58 21 174382 1220 64323109
Gastrostomy 20.85 10.58 19 174384 975 64323354
Embolic cerebral infarction 20.80 10.58 20 174383 1099 64323230
Gastritis haemorrhagic 20.71 10.58 28 174375 2234 64322095
Fracture 20.70 10.58 103 174300 18652 64305677
COVID-19 pneumonia 20.66 10.58 94 174309 16410 64307919
Tooth disorder 20.61 10.58 117 174286 22285 64302044
Caesarean section 20.53 10.58 3 174400 11271 64313058
Periorbital haematoma 20.52 10.58 18 174385 878 64323451
Transcatheter aortic valve implantation 20.50 10.58 7 174396 45 64324284
Peripheral artery occlusion 20.40 10.58 27 174376 2111 64322218
Atheroembolism 20.32 10.58 11 174392 240 64324089
Paratonia 20.31 10.58 6 174397 22 64324307
Malignant neoplasm progression 20.28 10.58 201 174202 112670 64211659
Extrapyramidal disorder 20.27 10.58 14 174389 19538 64304791
Erythromelalgia 20.25 10.58 10 174393 179 64324150
Gastrointestinal arteriovenous malformation 20.13 10.58 18 174385 901 64323428
Subdural haematoma evacuation 20.11 10.58 7 174396 48 64324281
Contraindicated product prescribed 20.09 10.58 20 174383 1147 64323182
Ovarian cyst 19.91 10.58 3 174400 11015 64313314
Cardiogenic shock 19.87 10.58 153 174250 32274 64292055
Aortic valve disease 19.84 10.58 23 174380 1570 64322759
Candida infection 19.83 10.58 34 174369 31385 64292944
Device alarm issue 19.80 10.58 25 174378 1865 64322464
Hypovolaemic shock 19.80 10.58 67 174336 10199 64314130
Abnormal behaviour 19.77 10.58 38 174365 33584 64290745
Blood calcium decreased 19.72 10.58 24 174379 25530 64298799
Acne 19.66 10.58 20 174383 23061 64301268
Acute hepatic failure 19.66 10.58 25 174378 26087 64298242
Oropharyngeal pain 19.63 10.58 150 174253 88717 64235612
Pharyngeal haemorrhage 19.59 10.58 20 174383 1182 64323147
Aortic aneurysm rupture 19.56 10.58 20 174383 1184 64323145
Dyskinesia 19.47 10.58 49 174354 39339 64284990
Pathogen resistance 19.35 10.58 5 174398 12538 64311791
Meningorrhagia 19.31 10.58 11 174392 266 64324063
Conjunctivitis 19.27 10.58 16 174387 20338 64303991
Pharyngitis 19.26 10.58 14 174389 19025 64305304
Disease recurrence 19.07 10.58 35 174368 31475 64292854
Product quality issue 19.03 10.58 32 174371 29767 64294562
Putamen haemorrhage 18.99 10.58 13 174390 438 64323891
Hip fracture 18.98 10.58 132 174271 26967 64297362
Anaphylactic shock 18.97 10.58 33 174370 30295 64294034
Influenza like illness 18.92 10.58 94 174309 61608 64262721
Blood triglycerides increased 18.92 10.58 14 174389 18852 64305477
Immunodeficiency 18.88 10.58 10 174393 16114 64308215
Aplastic anaemia 18.87 10.58 7 174396 13913 64310416
Lymphopenia 18.87 10.58 25 174378 25632 64298697
Prostatic operation 18.86 10.58 10 174393 209 64324120
Catheter site pain 18.82 10.58 39 174364 4423 64319906
Ilium fracture 18.82 10.58 10 174393 210 64324119
Subdural hygroma 18.80 10.58 13 174390 445 64323884
Peripheral swelling 18.75 10.58 717 173686 208436 64115893
Arthritis 18.74 10.58 141 174262 83673 64240656
Subclavian vein thrombosis 18.74 10.58 27 174376 2287 64322042
Throat tightness 18.68 10.58 21 174382 23139 64301190
Therapy interrupted 18.66 10.58 105 174298 19931 64304398
Infusion site discharge 18.61 10.58 14 174389 548 64323781
Ejection fraction abnormal 18.61 10.58 21 174382 1392 64322937
Poisoning 18.58 10.58 19 174384 21860 64302469
Hemiplegia 18.50 10.58 76 174327 12692 64311637
Disability 18.49 10.58 5 174398 12167 64312162
Photophobia 18.44 10.58 12 174391 17281 64307048
Pseudomonas infection 18.28 10.58 13 174390 17870 64306459
Intracranial mass 18.27 10.58 25 174378 2018 64322311
Pancytopenia 18.23 10.58 275 174128 143034 64181295
Haemorrhagic cerebral infarction 18.11 10.58 20 174383 1294 64323035
Amaurosis fugax 18.06 10.58 16 174387 791 64323538
Hepatic function abnormal 18.04 10.58 101 174302 64212 64260117
Creatinine renal clearance abnormal 18.04 10.58 13 174390 476 64323853
Hyperkaliuria 17.98 10.58 9 174394 166 64324163
Aspergillus infection 17.97 10.58 11 174392 16368 64307961
Orthopnoea 17.96 10.58 60 174343 9074 64315255
Injury 17.93 10.58 84 174319 55908 64268421
Renal tubular necrosis 17.89 10.58 20 174383 22090 64302239
Microcytic anaemia 17.79 10.58 39 174364 4599 64319730
Anti factor Xa activity decreased 17.69 10.58 5 174398 15 64324314
Infective exacerbation of chronic obstructive airways disease 17.66 10.58 27 174376 2411 64321918
Brain herniation 17.65 10.58 48 174355 6485 64317844
Hypersensitivity vasculitis 17.60 10.58 49 174354 6712 64317617
Mucosal haemorrhage 17.58 10.58 26 174377 2255 64322074
Muscle rigidity 17.47 10.58 13 174390 17460 64306869
Hyperkinetic heart syndrome 17.47 10.58 8 174395 120 64324209
Mood swings 17.47 10.58 13 174390 17455 64306874
Haemorrhoids 17.45 10.58 118 174285 23883 64300446
Therapeutic aspiration 17.45 10.58 5 174398 16 64324313
Gastrointestinal polyp 17.38 10.58 6 174397 40 64324289
Anal stenosis 17.37 10.58 11 174392 324 64324005
Acute respiratory failure 17.35 10.58 209 174194 49725 64274604
Face oedema 17.33 10.58 25 174378 24736 64299593
Stent placement 17.17 10.58 43 174360 5528 64318801
Coma uraemic 17.13 10.58 6 174397 42 64324287
Hepatic encephalopathy 17.11 10.58 19 174384 21047 64303282
Infusion site erythema 17.09 10.58 49 174354 6824 64317505
Mycotic allergy 16.99 10.58 17 174386 981 64323348
Vascular device occlusion 16.89 10.58 6 174397 44 64324285
Foot deformity 16.87 10.58 12 174391 16492 64307837
Lupus pneumonitis 16.83 10.58 7 174396 82 64324247
Rectal prolapse 16.78 10.58 22 174381 1704 64322625
Small intestinal haemorrhage 16.76 10.58 34 174369 3799 64320530
Product use in unapproved indication 16.73 10.58 357 174046 176261 64148068
Antiphospholipid syndrome 16.69 10.58 21 174382 1561 64322768
Listeraemia 16.68 10.58 7 174396 84 64324245
Multiple sclerosis 16.60 10.58 16 174387 18925 64305404
Enthesopathy 16.58 10.58 3 174400 9635 64314694
Coagulation factor deficiency 16.54 10.58 7 174396 86 64324243
Muscle spasms 16.47 10.58 275 174128 140748 64183581
Hallucination, auditory 16.43 10.58 13 174390 16926 64307403
Abdominal pain 16.43 10.58 684 173719 311691 64012638
Cerebellar infarction 16.40 10.58 31 174372 3288 64321041
Hypoacusis 16.38 10.58 123 174280 25744 64298585
Low cardiac output syndrome 16.29 10.58 15 174388 780 64323549
Dust allergy 16.22 10.58 17 174386 1036 64323293
Dermatitis exfoliative 16.21 10.58 4 174399 10348 64313981
Carpal tunnel syndrome 16.13 10.58 85 174318 15743 64308586
Gastrointestinal disorder 16.01 10.58 160 174243 89549 64234780
Wrong patient received product 16.01 10.58 33 174370 3729 64320600
Tachyarrhythmia 16.01 10.58 44 174359 5982 64318347
Sinus tachycardia 15.94 10.58 40 174363 32148 64292181
Cardiac valve disease 15.91 10.58 40 174363 5155 64319174
Infective pulmonary exacerbation of cystic fibrosis 15.87 10.58 6 174397 11790 64312539
Peritonitis 15.86 10.58 27 174376 24996 64299333
Incorrect route of product administration 15.84 10.58 24 174379 23274 64301055
Cardiac flutter 15.81 10.58 35 174368 4154 64320175
Angioedema 15.80 10.58 100 174303 61721 64262608
Cerebellar haematoma 15.77 10.58 13 174390 582 64323747
Vision blurred 15.74 10.58 162 174241 90154 64234175
Product commingling 15.72 10.58 7 174396 98 64324231
Mitral valve thickening 15.57 10.58 11 174392 390 64323939
Electrocardiogram abnormal 15.57 10.58 75 174328 13406 64310923
Basal cell carcinoma 15.53 10.58 38 174365 30800 64293529
Therapeutic product effect incomplete 15.52 10.58 192 174211 103290 64221039
Subarachnoid haematoma 15.47 10.58 7 174396 102 64324227
Adrenal insufficiency 15.45 10.58 23 174380 22464 64301865
Wound haematoma 15.45 10.58 8 174395 159 64324170
Cytomegalovirus viraemia 15.44 10.58 5 174398 10823 64313506
Skin laceration 15.41 10.58 116 174287 24301 64300028
Injection site rash 15.38 10.58 12 174391 15730 64308599
Venous pressure jugular increased 15.34 10.58 18 174385 1245 64323084
Platelet count decreased 15.31 10.58 341 174062 167370 64156959
Tumour lysis syndrome 15.28 10.58 18 174385 19422 64304907
Hyperammonaemia 15.18 10.58 4 174399 9900 64314429
Catheter placement 15.09 10.58 26 174377 2567 64321762
Ruptured cerebral aneurysm 14.99 10.58 12 174391 515 64323814
Blood lactate dehydrogenase increased 14.96 10.58 43 174360 33035 64291294
Pleural effusion 14.92 10.58 448 173955 126111 64198218
Epidural haemorrhage 14.88 10.58 8 174395 172 64324157
Degenerative aortic valve disease 14.88 10.58 7 174396 112 64324217
Blood urea increased 14.88 10.58 65 174338 44088 64280241
Blood pressure systolic increased 14.79 10.58 76 174327 49377 64274952
Panniculitis 14.77 10.58 3 174400 8876 64315453
Cryotherapy 14.75 10.58 3 174400 0 64324329
Traumatic intracranial haematoma 14.75 10.58 3 174400 0 64324329
Chemotherapy toxicity attenuation 14.75 10.58 3 174400 0 64324329
Anal ulcer haemorrhage 14.75 10.58 3 174400 0 64324329
Eye haematoma 14.71 10.58 7 174396 115 64324214
Uveitis 14.70 10.58 8 174395 12700 64311629
Scar 14.70 10.58 9 174394 13389 64310940
Duodenal vascular ectasia 14.68 10.58 4 174399 10 64324319
Echocardiogram abnormal 14.67 10.58 21 174382 1768 64322561
Injection site mass 14.67 10.58 15 174388 17255 64307074
Acute generalised exanthematous pustulosis 14.66 10.58 10 174393 14048 64310281
Large intestinal polypectomy 14.65 10.58 9 174394 251 64324078
Infusion site swelling 14.61 10.58 40 174363 5425 64318904
Vaginal haemorrhage 14.61 10.58 96 174307 19248 64305081
Hypertriglyceridaemia 14.58 10.58 6 174397 11199 64313130
Intestinal perforation 14.55 10.58 12 174391 15301 64309028
Mydriasis 14.54 10.58 12 174391 15300 64309029
Amnesia 14.54 10.58 74 174329 48195 64276134
Muscle twitching 14.50 10.58 18 174385 18980 64305349
Oesophageal infection 14.49 10.58 12 174391 541 64323788
Helicobacter test positive 14.46 10.58 16 174387 1038 64323291
Bronchiectasis 14.45 10.58 76 174327 14064 64310265
Post transplant lymphoproliferative disorder 14.35 10.58 4 174399 9540 64314789
Emergency care 14.34 10.58 15 174388 912 64323417
Bladder neoplasm 14.34 10.58 19 174384 1487 64322842
Femoral artery aneurysm 14.32 10.58 8 174395 186 64324143
Agranulocytosis 14.31 10.58 54 174349 38175 64286154
Gastrointestinal polyp haemorrhage 14.31 10.58 11 174392 445 64323884
Intentional product misuse 14.16 10.58 126 174277 72169 64252160
Defaecation disorder 14.16 10.58 11 174392 452 64323877
Chloasma 14.16 10.58 5 174398 36 64324293
Haemorrhagic cholecystitis 14.15 10.58 6 174397 74 64324255
Anger 14.15 10.58 13 174390 15728 64308601
Disease progression 14.12 10.58 284 174119 141396 64182933
Normocytic anaemia 14.11 10.58 29 174374 3270 64321059
Haemostasis 14.10 10.58 9 174394 269 64324060
Anticoagulation drug level decreased 14.09 10.58 7 174396 127 64324202
Hypercalcaemia 14.09 10.58 41 174362 31375 64292954
Mouth ulceration 14.07 10.58 43 174360 32401 64291928
Endocarditis noninfective 14.02 10.58 8 174395 194 64324135
Thromboembolectomy 14.01 10.58 6 174397 76 64324253
Tuberculosis 13.97 10.58 9 174394 13029 64311300
Kyphosis 13.93 10.58 24 174379 2369 64321960
Thrombotic stroke 13.93 10.58 13 174390 688 64323641
Oral candidiasis 13.86 10.58 26 174377 23186 64301143
Occult blood 13.83 10.58 18 174385 1384 64322945
Malignant melanoma 13.82 10.58 9 174394 12955 64311374
Hepatic necrosis 13.81 10.58 3 174400 8470 64315859
Cholecystitis chronic 13.77 10.58 4 174399 9283 64315046
Splenomegaly 13.72 10.58 17 174386 17944 64306385
Eye pain 13.66 10.58 42 174361 31583 64292746
Dry eye 13.66 10.58 37 174366 28982 64295347
Electrocardiogram QT prolonged 13.64 10.58 143 174260 79305 64245024
Biliary sepsis 13.57 10.58 18 174385 1410 64322919
Blood sodium decreased 13.57 10.58 38 174365 29444 64294885
Exostosis 13.53 10.58 7 174396 11431 64312898
Aspiration pleural cavity 13.50 10.58 18 174385 1417 64322912
Blood pressure systolic abnormal 13.47 10.58 5 174398 9937 64314392
Acidosis 13.43 10.58 17 174386 17778 64306551
Mood altered 13.43 10.58 14 174389 15965 64308364
Cerebral ischaemia 13.42 10.58 58 174345 9904 64314425
Myoclonus 13.41 10.58 30 174373 25088 64299241
Prerenal failure 13.40 10.58 28 174375 3194 64321135
Prostatic haemorrhage 13.39 10.58 7 174396 142 64324187
Embolism 13.37 10.58 67 174336 12168 64312161
Device pacing issue 13.35 10.58 6 174397 86 64324243
Coagulation factor V level abnormal 13.27 10.58 4 174399 16 64324313
Polyp 13.27 10.58 44 174359 6629 64317700
Ankylosing spondylitis 13.25 10.58 3 174400 8231 64316098
Bronchospasm 13.20 10.58 24 174379 21658 64302671
Bone pain 13.18 10.58 75 174328 47497 64276832
Graft haemorrhage 13.16 10.58 6 174397 89 64324240
Herpes simplex 13.14 10.58 6 174397 10530 64313799
Inguinal hernia 13.12 10.58 39 174364 5542 64318787
Vascular cauterisation 13.10 10.58 6 174397 90 64324239
Microembolism 13.09 10.58 5 174398 46 64324283
May-Thurner syndrome 13.08 10.58 4 174399 17 64324312
Metastases to bone 13.00 10.58 22 174381 20413 64303916
Hepatic haemorrhage 12.98 10.58 14 174389 882 64323447
Central nervous system lesion 12.94 10.58 8 174395 11841 64312488
Tooth abscess 12.93 10.58 11 174392 13815 64310514
Panic attack 12.93 10.58 23 174380 20930 64303399
Carotid artery stenosis 12.90 10.58 49 174354 7892 64316437
Rehabilitation therapy 12.90 10.58 18 174385 1480 64322849
Atrial appendage closure 12.89 10.58 4 174399 18 64324311
Hepatomegaly 12.88 10.58 16 174387 16866 64307463
Amaurosis 12.88 10.58 15 174388 1029 64323300
Cerebral amyloid angiopathy 12.87 10.58 9 174394 314 64324015
Cerebral thrombosis 12.86 10.58 22 174381 2160 64322169
Sedation complication 12.76 10.58 6 174397 10348 64313981
Poor venous access 12.73 10.58 9 174394 12408 64311921
Intracranial tumour haemorrhage 12.72 10.58 10 174393 418 64323911
Femoral neck fracture 12.70 10.58 52 174351 8672 64315657
Aortic stenosis 12.68 10.58 42 174361 6323 64318006
Orthostatic hypotension 12.66 10.58 187 174216 46551 64277778
Angiocardiogram 12.65 10.58 8 174395 235 64324094
Hyperlipidaemia 12.63 10.58 27 174376 22949 64301380
Intervertebral disc protrusion 12.60 10.58 22 174381 20169 64304160
Wrong strength 12.60 10.58 7 174396 161 64324168
Radiation fibrosis - lung 12.55 10.58 5 174398 52 64324277
Red cell distribution width increased 12.51 10.58 9 174394 12300 64312029
Concomitant disease aggravated 12.47 10.58 63 174340 11479 64312850
Brain contusion 12.37 10.58 16 174387 1223 64323106
Anticoagulation drug level increased 12.36 10.58 12 174391 667 64323662
Cardiovascular insufficiency 12.34 10.58 24 174379 2600 64321729
Condition aggravated 12.33 10.58 854 173549 371572 63952757
Drug eruption 12.30 10.58 53 174350 36083 64288246
Adrenal haemorrhage 12.26 10.58 11 174392 553 64323776
Joint effusion 12.26 10.58 11 174392 13462 64310867
Hot flush 12.22 10.58 74 174329 46161 64278168
Post procedural haematuria 12.21 10.58 8 174395 250 64324079
Diastolic dysfunction 12.21 10.58 52 174351 8823 64315506
Necrotising oesophagitis 12.20 10.58 12 174391 678 64323651
Salivary hypersecretion 12.13 10.58 9 174394 12104 64312225
Subcapsular renal haematoma 12.13 10.58 12 174391 683 64323646
Product packaging quantity issue 12.12 10.58 14 174389 952 64323377
Skin lesion 12.11 10.58 54 174349 36428 64287901
Cardio-respiratory arrest 12.10 10.58 190 174213 98203 64226126
Blood pressure decreased 12.08 10.58 312 174091 85887 64238442
Tongue disorder 12.06 10.58 9 174394 12071 64312258
Pneumonitis chemical 12.06 10.58 9 174394 348 64323981
Factor V inhibition 12.06 10.58 9 174394 348 64323981
Hernia repair 12.02 10.58 19 174384 1746 64322583
Tricuspid valve repair 11.94 10.58 4 174399 24 64324305
Bone density decreased 11.91 10.58 6 174397 9946 64314383
Obstructive airways disorder 11.85 10.58 105 174298 23080 64301249
Catatonia 11.83 10.58 3 174400 7617 64316712
Gastroenteritis aeromonas 11.81 10.58 4 174399 25 64324304
Myiasis 11.81 10.58 4 174399 25 64324304
Walking distance test abnormal 11.80 10.58 12 174391 706 64323623
Treatment noncompliance 11.79 10.58 174 174229 43308 64281021
Catheter site swelling 11.74 10.58 18 174385 1612 64322717
Electrolyte imbalance 11.73 10.58 112 174291 25131 64299198
Heavy menstrual bleeding 11.72 10.58 64 174339 12013 64312316
Torsade de pointes 11.70 10.58 18 174385 17345 64306984
Iron metabolism disorder 11.67 10.58 4 174399 26 64324303
Drug ineffective for unapproved indication 11.64 10.58 44 174359 31089 64293240
Aortic intramural haematoma 11.60 10.58 6 174397 119 64324210
Heart valve operation 11.60 10.58 7 174396 189 64324140
Renal mass 11.58 10.58 24 174379 2723 64321606
Nystagmus 11.57 10.58 5 174398 9063 64315266
Blood iron decreased 11.55 10.58 64 174339 12078 64312251
Mesenteric haematoma 11.55 10.58 4 174399 27 64324302
Interstitial lung disease 11.53 10.58 346 174057 97386 64226943
Drug half-life increased 11.51 10.58 6 174397 121 64324208
Cerebral ventricle collapse 11.51 10.58 6 174397 121 64324208
Acquired cardiac septal defect 11.47 10.58 3 174400 6 64324323
Ecchymosis 11.46 10.58 71 174332 13951 64310378
Cardiac pacemaker replacement 11.45 10.58 9 174394 376 64323953
Swollen tongue 11.45 10.58 52 174351 34902 64289427
Chronic left ventricular failure 11.44 10.58 12 174391 732 64323597
Obesity 11.44 10.58 24 174379 20538 64303791
Left atrial enlargement 11.37 10.58 14 174389 1018 64323311
Mixed dementia 11.37 10.58 8 174395 282 64324047
Blood chloride decreased 11.35 10.58 3 174400 7413 64316916
Amylase increased 11.35 10.58 6 174397 9679 64314650
Hypercholesterolaemia 11.28 10.58 15 174388 15358 64308971
Injection site induration 11.28 10.58 5 174398 8927 64315402
Muscle rupture 11.26 10.58 26 174377 3174 64321155
Arterial haemorrhage 11.23 10.58 21 174382 2210 64322119
Pancreatitis 11.19 10.58 105 174298 59502 64264827
Depressed mood 11.18 10.58 65 174338 40947 64283382
Eosinophil count increased 11.16 10.58 13 174390 14099 64310230
Arterial thrombosis 11.16 10.58 22 174381 2408 64321921
Factor Xa activity increased 11.15 10.58 3 174400 7 64324322
Throat irritation 11.12 10.58 48 174355 32663 64291666
Dyspnoea at rest 11.08 10.58 40 174363 6289 64318040
Thinking abnormal 11.05 10.58 9 174394 11547 64312782
Nipple exudate bloody 11.04 10.58 5 174398 73 64324256
Brain compression 11.01 10.58 10 174393 511 64323818
Heart rate irregular 10.99 10.58 118 174285 27295 64297034
Paranoia 10.97 10.58 17 174386 16335 64307994
Clot retraction 10.96 10.58 4 174399 32 64324297
Pulmonary tuberculosis 10.96 10.58 3 174400 7241 64317088
Adrenal haematoma 10.96 10.58 6 174397 134 64324195
Escherichia infection 10.93 10.58 15 174388 15153 64309176
Red cell distribution width abnormal 10.88 10.58 7 174396 212 64324117
Macroangiopathy 10.88 10.58 6 174397 136 64324193
Hyperkalaemia 10.86 10.58 354 174049 100775 64223554
Erythema multiforme 10.84 10.58 16 174387 15685 64308644
Metastases to lymph nodes 10.82 10.58 5 174398 8712 64315617
Myelosuppression 10.76 10.58 31 174372 23799 64300530
Cardiorenal syndrome 10.73 10.58 15 174388 1235 64323094
Disturbance in attention 10.72 10.58 66 174337 41008 64283321
Enterocolitis 10.71 10.58 10 174393 12008 64312321
Blood viscosity decreased 10.69 10.58 5 174398 79 64324250
Injection site haemorrhage 10.66 10.58 32 174371 24246 64300083
Emotional disorder 10.65 10.58 11 174392 12596 64311733
Prostatectomy 10.65 10.58 6 174397 142 64324187
Coronavirus test positive 10.64 10.58 13 174390 938 64323391
Elephantiasis 10.61 10.58 3 174400 9 64324320
Blood culture positive 10.59 10.58 4 174399 7864 64316465
Dysgeusia 10.58 10.58 79 174324 46968 64277361

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC B01AF02 BLOOD AND BLOOD FORMING ORGANS
ANTITHROMBOTIC AGENTS
ANTITHROMBOTIC AGENTS
Direct factor Xa inhibitors
MeSH PA D000925 Anticoagulants
MeSH PA D000991 Antithrombins
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D065427 Factor Xa Inhibitors
MeSH PA D006401 Hematologic Agents
MeSH PA D011480 Protease Inhibitors
MeSH PA D015842 Serine Proteinase Inhibitors
FDA MoA N0000175635 Factor Xa Inhibitors
FDA EPC N0000175637 Factor Xa Inhibitor
CHEBI has role CHEBI:50249 anticoagulants
CHEBI has role CHEBI:68581 factor Xa inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Arterial embolus and thrombosis indication 266262004
Myocardial Reinfarction Prevention indication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.89 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
2.5MG ELIQUIS BRISTOL MYERS SQUIBB N202155 Dec. 28, 2012 RX TABLET ORAL 6967208 Nov. 21, 2026 PROPHYLAXIS OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM
2.5MG ELIQUIS BRISTOL MYERS SQUIBB N202155 Dec. 28, 2012 RX TABLET ORAL 6967208 Nov. 21, 2026 PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT)
2.5MG ELIQUIS BRISTOL MYERS SQUIBB N202155 Dec. 28, 2012 RX TABLET ORAL 6967208 Nov. 21, 2026 PROPHYLAXIS OF PULMONARY EMBOLISM
2.5MG ELIQUIS BRISTOL MYERS SQUIBB N202155 Dec. 28, 2012 RX TABLET ORAL 6967208 Nov. 21, 2026 REDUCE THE RISK OF RECURRENT DEEP VEIN THROMBOSIS (DVT)
2.5MG ELIQUIS BRISTOL MYERS SQUIBB N202155 Dec. 28, 2012 RX TABLET ORAL 6967208 Nov. 21, 2026 REDUCE THE RISK OF RECURRENT PULMONARY EMBOLISM
2.5MG ELIQUIS BRISTOL MYERS SQUIBB N202155 Dec. 28, 2012 RX TABLET ORAL 6967208 Nov. 21, 2026 REDUCING THE RISK OF STROKE
2.5MG ELIQUIS BRISTOL MYERS SQUIBB N202155 Dec. 28, 2012 RX TABLET ORAL 6967208 Nov. 21, 2026 REDUCING THE RISK OF STROKE AND SYSTEMIC EMBOLISM
2.5MG ELIQUIS BRISTOL MYERS SQUIBB N202155 Dec. 28, 2012 RX TABLET ORAL 6967208 Nov. 21, 2026 TREATMENT OF DEEP VEIN THROMBOSIS (DVT)
2.5MG ELIQUIS BRISTOL MYERS SQUIBB N202155 Dec. 28, 2012 RX TABLET ORAL 6967208 Nov. 21, 2026 TREATMENT OF PULMONARY EMBOLISM (PE)
5MG ELIQUIS BRISTOL MYERS SQUIBB N202155 Dec. 28, 2012 RX TABLET ORAL 6967208 Nov. 21, 2026 REDUCING THE RISK OF STROKE
5MG ELIQUIS BRISTOL MYERS SQUIBB N202155 Dec. 28, 2012 RX TABLET ORAL 6967208 Nov. 21, 2026 REDUCING THE RISK OF STROKE AND SYSTEMIC EMBOLISM
5MG ELIQUIS BRISTOL MYERS SQUIBB N202155 Dec. 28, 2012 RX TABLET ORAL 6967208 Nov. 21, 2026 TREATMENT OF DEEP VEIN THROMBOSIS (DVT)
5MG ELIQUIS BRISTOL MYERS SQUIBB N202155 Dec. 28, 2012 RX TABLET ORAL 6967208 Nov. 21, 2026 TREATMENT OF PULMONARY EMBOLISM (PE)

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 10.10 CHEMBL CHEMBL
Prothrombin Enzyme Ki 5.51 CHEMBL
Coagulation factor X Enzyme Ki 9.77 CHEMBL

External reference:

IDSource
4031957 VUID
N0000186136 NUI
D03213 KEGG_DRUG
4031957 VANDF
CHEBI:72296 CHEBI
GG2 PDB_CHEM_ID
CHEMBL231779 ChEMBL_ID
C522181 MESH_SUPPLEMENTAL_RECORD_UI
6390 IUPHAR_LIGAND_ID
8626 INN_ID
DB06605 DRUGBANK_ID
3Z9Y7UWC1J UNII
10182969 PUBCHEM_CID
1364430 RXNORM
185767 MMSL
28142 MMSL
d07804 MMSL
013857 NDDF
698090000 SNOMEDCT_US
703906002 SNOMEDCT_US
C1831808 UMLSCUI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ELIQUIS HUMAN PRESCRIPTION DRUG LABEL 1 0003-0893 TABLET, FILM COATED 2.50 mg ORAL NDA 30 sections
ELIQUIS HUMAN PRESCRIPTION DRUG LABEL 1 0003-0894 TABLET, FILM COATED 5 mg ORAL NDA 30 sections
apixaban Human Prescription Drug Label 1 14445-149 TABLET, FILM COATED 2.50 mg ORAL ANDA 29 sections
apixaban Human Prescription Drug Label 1 14445-150 TABLET, FILM COATED 5 mg ORAL ANDA 29 sections
ELIQUIS HUMAN PRESCRIPTION DRUG LABEL 1 50090-1436 TABLET, FILM COATED 2.50 mg ORAL NDA 29 sections
ELIQUIS HUMAN PRESCRIPTION DRUG LABEL 1 50090-1437 TABLET, FILM COATED 5 mg ORAL NDA 29 sections
ELIQUIS HUMAN PRESCRIPTION DRUG LABEL 1 55154-0612 TABLET, FILM COATED 2.50 mg ORAL NDA 30 sections
ELIQUIS HUMAN PRESCRIPTION DRUG LABEL 1 55154-0612 TABLET, FILM COATED 2.50 mg ORAL NDA 30 sections
ELIQUIS HUMAN PRESCRIPTION DRUG LABEL 1 55154-0613 TABLET, FILM COATED 5 mg ORAL NDA 30 sections
ELIQUIS HUMAN PRESCRIPTION DRUG LABEL 1 55154-0613 TABLET, FILM COATED 5 mg ORAL NDA 30 sections
ELIQUIS HUMAN PRESCRIPTION DRUG LABEL 1 63629-7747 TABLET, FILM COATED 5 mg ORAL NDA 28 sections
ELIQUIS HUMAN PRESCRIPTION DRUG LABEL 1 63629-8432 TABLET, FILM COATED 2.50 mg ORAL NDA 28 sections
ELIQUIS HUMAN PRESCRIPTION DRUG LABEL 1 67296-1673 TABLET, FILM COATED 5 mg ORAL NDA 31 sections
ELIQUIS HUMAN PRESCRIPTION DRUG LABEL 1 70518-1861 TABLET, FILM COATED 5 mg ORAL NDA 30 sections
ELIQUIS HUMAN PRESCRIPTION DRUG LABEL 1 70518-1861 TABLET, FILM COATED 5 mg ORAL NDA 30 sections