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
S (Water solubility) 0.04 mg/mL Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Bocci G, Oprea TI, Benet LZ

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 1495.64 10.82 2828 137064 371553 62977577
Atrial fibrillation 1124.09 10.82 1334 138558 115302 63233828
Gastrointestinal haemorrhage 1054.56 10.82 1086 138806 80090 63269040
Drug ineffective 739.10 10.82 733 139159 1044032 62305098
Haemorrhage 700.94 10.82 765 139127 60257 63288873
Cerebral haemorrhage 698.06 10.82 563 139329 30166 63318964
Cerebrovascular accident 642.63 10.82 977 138915 107047 63242083
Haemorrhage intracranial 620.34 10.82 380 139512 13039 63336091
Fall 557.75 10.82 2013 137879 390321 62958809
Thrombosis 503.75 10.82 666 139226 64089 63285041
Haematoma 481.11 10.82 482 139410 34338 63314792
Epistaxis 466.99 10.82 682 139210 72043 63277087
Prescribed underdose 447.47 10.82 431 139461 29258 63319872
Subarachnoid haemorrhage 381.31 10.82 288 139604 13995 63335135
Pemphigus 378.43 10.82 5 139887 183721 63165409
Synovitis 358.00 10.82 12 139880 186906 63162224
Cardiac failure 349.34 10.82 670 139222 88472 63260658
Anaemia 345.91 10.82 1420 138472 292010 63057120
Subdural haematoma 334.82 10.82 267 139625 14061 63335069
Cardiac disorder 331.13 10.82 480 139412 50336 63298794
Hand deformity 321.36 10.82 6 139886 159451 63189679
Rheumatoid arthritis 318.73 10.82 83 139809 253736 63095394
Glossodynia 309.15 10.82 22 139870 178854 63170276
Exposure during pregnancy 308.90 10.82 7 139885 155540 63193590
Hospitalisation 307.33 10.82 618 139274 84463 63264667
Drug intolerance 301.35 10.82 152 139740 308509 63040621
Infusion related reaction 301.28 10.82 84 139808 245437 63103693
Ischaemic stroke 299.87 10.82 276 139616 17681 63331449
Dyspnoea 297.60 10.82 2476 137416 658837 62690293
Systemic lupus erythematosus 295.53 10.82 52 139840 208866 63140264
Pulmonary embolism 279.31 10.82 720 139172 115964 63233166
Drug hypersensitivity 269.08 10.82 177 139715 310510 63038620
Renal impairment 263.87 10.82 594 139298 87761 63261369
Maternal exposure during pregnancy 255.96 10.82 83 139809 219979 63129151
Therapeutic product effect decreased 254.55 10.82 57 139835 193130 63156000
Melaena 251.08 10.82 322 139570 30043 63319087
Joint swelling 245.04 10.82 217 139675 327449 63021681
Sensitisation 232.03 10.82 124 139768 3262 63345868
Cerebral infarction 227.50 10.82 272 139620 23621 63325509
Pain 221.23 10.82 863 139029 739765 62609365
Treatment failure 211.28 10.82 87 139805 198956 63150174
Rectal haemorrhage 210.03 10.82 383 139509 48647 63300483
Intentional product use issue 208.50 10.82 688 139204 127204 63221926
Transfusion 207.09 10.82 209 139683 15008 63334122
Haematochezia 205.43 10.82 399 139493 53145 63295985
Polycystic ovaries 199.95 10.82 124 139768 4347 63344783
Hepatic enzyme increased 199.78 10.82 98 139794 202230 63146900
Contraindicated product administered 197.99 10.82 117 139775 217531 63131599
Hypersensitivity 192.20 10.82 217 139675 292468 63056662
Ejection fraction 190.29 10.82 97 139795 2309 63346821
Atrial flutter 186.53 10.82 162 139730 9610 63339520
Pericardial haemorrhage 181.79 10.82 83 139809 1536 63347594
Completed suicide 176.42 10.82 51 139841 145622 63203508
Haematuria 173.49 10.82 264 139628 28893 63320237
Haemoglobin decreased 169.35 10.82 702 139190 144783 63204347
Arthropathy 168.86 10.82 161 139731 234631 63114499
Dyspnoea exertional 168.48 10.82 395 139497 59907 63289223
Product prescribing error 163.49 10.82 243 139649 26046 63323084
Helicobacter infection 161.43 10.82 11 139881 92774 63256356
Musculoskeletal stiffness 161.27 10.82 104 139788 184514 63164616
Deep vein thrombosis 159.71 10.82 476 139416 83324 63265806
Shock haemorrhagic 149.70 10.82 144 139748 9751 63339379
Transient ischaemic attack 145.60 10.82 282 139610 37471 63311659
Arthralgia 144.07 10.82 706 139186 569004 62780126
Fluid retention 142.38 10.82 368 139524 59318 63289812
Haematemesis 142.35 10.82 247 139645 30165 63318965
Pulmonary arterial hypertension 140.84 10.82 209 139683 22368 63326762
Cardioversion 139.61 10.82 64 139828 1196 63347934
Discomfort 138.55 10.82 100 139792 167274 63181856
Hypotension 137.83 10.82 1050 138842 271554 63077576
Folliculitis 136.39 10.82 4 139888 70313 63278817
Acute kidney injury 136.20 10.82 1020 138872 262395 63086735
Upper gastrointestinal haemorrhage 132.95 10.82 185 139707 18667 63330463
Swelling 132.03 10.82 254 139638 275124 63074006
Renal disorder 131.70 10.82 250 139642 32724 63316406
Product use issue 130.50 10.82 177 139715 220343 63128787
Internal haemorrhage 128.74 10.82 100 139792 5065 63344065
Wound 128.16 10.82 103 139789 163160 63185970
Blood test abnormal 128.02 10.82 165 139727 15464 63333666
Labelled drug-drug interaction medication error 126.66 10.82 152 139740 13247 63335883
Embolic stroke 125.55 10.82 87 139805 3689 63345441
Impaired healing 123.95 10.82 36 139856 102506 63246624
Haemorrhagic stroke 120.72 10.82 101 139791 5691 63343439
Atrial thrombosis 120.15 10.82 65 139827 1753 63347377
Blood cholesterol increased 117.41 10.82 31 139861 94001 63255129
Rhinitis allergic 117.41 10.82 137 139755 11590 63337540
Adverse event 115.92 10.82 370 139522 67189 63281941
Stomatitis 112.06 10.82 85 139807 138640 63210490
Intraventricular haemorrhage 110.83 10.82 65 139827 2055 63347075
Bradycardia 107.89 10.82 381 139511 72846 63276284
Psoriatic arthropathy 107.23 10.82 34 139858 91486 63257644
Head injury 104.85 10.82 204 139688 27192 63321938
Alopecia 104.38 10.82 387 139505 337149 63011981
Systemic infection 102.84 10.82 84 139808 4576 63344554
Sinusitis 100.16 10.82 219 139673 226434 63122696
Irritable bowel syndrome 99.47 10.82 29 139863 82383 63266747
Injection site pain 98.01 10.82 85 139807 129715 63219415
Lower respiratory tract infection 97.08 10.82 89 139803 132218 63216912
Arrhythmia 97.03 10.82 241 139651 37899 63311231
Blister 96.83 10.82 86 139806 129728 63219402
Palmoplantar keratoderma 95.71 10.82 58 139834 1949 63347181
Pericarditis 94.78 10.82 90 139802 131489 63217641
Syncope 93.78 10.82 508 139384 116877 63232253
Cardiospasm 93.24 10.82 56 139836 1851 63347279
Atrial tachycardia 92.67 10.82 76 139816 4164 63344966
Cardiac ablation 92.35 10.82 51 139841 1434 63347696
Drug interaction 90.88 10.82 836 139056 228295 63120835
Toxicity to various agents 89.09 10.82 265 139627 246985 63102145
Subdural haemorrhage 87.95 10.82 65 139827 3053 63346077
Therapeutic response decreased 87.60 10.82 15 139877 61510 63287620
Sleep disorder due to a general medical condition 86.53 10.82 120 139772 12068 63337062
Ejection fraction abnormal 86.20 10.82 52 139840 1733 63347397
Cardiac pacemaker insertion 84.04 10.82 71 139821 4055 63345075
Haemorrhage subcutaneous 83.72 10.82 62 139830 2921 63346209
Carotid artery occlusion 81.97 10.82 74 139818 4620 63344510
Mobility decreased 81.42 10.82 88 139804 121071 63228059
Injection site erythema 80.95 10.82 41 139851 83133 63265997
Hypervolaemia 80.29 10.82 187 139705 28226 63320904
Abdominal discomfort 80.10 10.82 399 139493 320486 63028644
Carpal tunnel syndrome 79.65 10.82 155 139737 20662 63328468
Cerebral mass effect 78.64 10.82 39 139853 874 63348256
Dizziness 77.91 10.82 1355 138537 428570 62920560
Malignant mediastinal neoplasm 74.71 10.82 44 139848 1402 63347728
Post procedural haemorrhage 74.71 10.82 90 139802 7874 63341256
Sleep terror 73.65 10.82 55 139837 2625 63346505
Haematoma muscle 73.33 10.82 40 139852 1097 63348033
Nephrectomy 73.00 10.82 44 139848 1464 63347666
General physical health deterioration 72.97 10.82 721 139171 200681 63148449
Depression 72.65 10.82 208 139684 196284 63152846
Pruritus genital 71.89 10.82 54 139838 2600 63346530
Basal ganglia haemorrhage 71.77 10.82 33 139859 621 63348509
Diverticulum intestinal haemorrhagic 71.60 10.82 44 139848 1517 63347613
C-reactive protein increased 70.30 10.82 63 139829 94644 63254486
Injection site reaction 69.88 10.82 21 139871 58503 63290627
Failure to suspend medication 69.82 10.82 17 139875 30 63349100
Haemarthrosis 69.80 10.82 57 139835 3104 63346026
Traumatic haemorrhage 69.44 10.82 31 139861 543 63348587
Psoriasis 69.28 10.82 54 139838 86903 63262227
Cerebral haematoma 68.16 10.82 60 139832 3623 63345507
Infection 68.02 10.82 267 139625 228906 63120224
Pyrexia 67.45 10.82 687 139205 469791 62879339
Pulmonary hypertension 67.05 10.82 207 139685 36916 63312214
Rash 66.74 10.82 854 139038 560017 62789113
Cerebral ventricular rupture 66.67 10.82 23 139869 193 63348937
Vaginal haemorrhage 66.06 10.82 170 139722 27317 63321813
Pregnancy 65.15 10.82 4 139888 36832 63312298
Retroperitoneal haemorrhage 65.07 10.82 52 139840 2745 63346385
COVID-19 64.69 10.82 449 139443 112654 63236476
Cardiac failure congestive 64.58 10.82 386 139506 92047 63257083
Type 2 diabetes mellitus 62.87 10.82 31 139861 63837 63285293
Dementia 62.46 10.82 132 139760 18662 63330468
Febrile neutropenia 62.32 10.82 103 139789 118346 63230784
Therapeutic drug monitoring analysis not performed 61.73 10.82 38 139854 1314 63347816
Ill-defined disorder 61.14 10.82 54 139838 81701 63267429
Hip arthroplasty 60.83 10.82 15 139877 47631 63301499
Hospice care 60.71 10.82 81 139811 7851 63341279
Hypothyroidism 60.37 10.82 219 139673 42413 63306717
Thrombectomy 60.05 10.82 20 139872 149 63348981
C-reactive protein abnormal 59.85 10.82 14 139878 46082 63303048
Pain in jaw 59.54 10.82 221 139671 43275 63305855
Oedema peripheral 59.01 10.82 658 139234 188853 63160277
Traumatic haematoma 58.46 10.82 38 139854 1447 63347683
Full blood count abnormal 58.34 10.82 178 139714 31539 63317591
Immunisation 58.24 10.82 35 139857 1158 63347972
Tension headache 57.70 10.82 64 139828 5122 63344008
Haemorrhoidal haemorrhage 56.81 10.82 58 139834 4221 63344909
Spinal cord haemorrhage 56.51 10.82 21 139871 223 63348907
Cerebellar haemorrhage 55.68 10.82 36 139856 1358 63347772
Eye haemorrhage 54.93 10.82 80 139812 8416 63340714
Faeces discoloured 54.70 10.82 124 139768 18385 63330745
Thalamus haemorrhage 54.38 10.82 28 139864 681 63348449
Sleep disorder due to general medical condition, insomnia type 53.47 10.82 24 139868 52193 63296937
Haemoptysis 52.64 10.82 161 139731 28565 63320565
Injection site pruritus 52.41 10.82 17 139875 45099 63304031
Traumatic intracranial haemorrhage 51.33 10.82 24 139868 470 63348660
Palpitations 51.17 10.82 424 139468 112346 63236784
Suicide attempt 50.89 10.82 36 139856 60882 63288248
Circumstance or information capable of leading to medication error 50.55 10.82 52 139840 3818 63345312
Conjunctival haemorrhage 50.15 10.82 50 139842 3537 63345593
Gastric haemorrhage 49.99 10.82 66 139826 6332 63342798
Spontaneous haemorrhage 49.86 10.82 25 139867 574 63348556
Hyponatraemia 49.32 10.82 418 139474 111482 63237648
Pulmonary thrombosis 49.24 10.82 77 139815 8625 63340505
Lower gastrointestinal haemorrhage 49.14 10.82 73 139819 7817 63341313
Suicidal ideation 48.17 10.82 40 139852 62381 63286749
Anosmia 47.89 10.82 67 139825 6793 63342337
Drug abuse 47.24 10.82 54 139838 72464 63276666
Mixed liver injury 46.87 10.82 55 139837 4680 63344450
Cardiac tamponade 46.50 10.82 55 139837 4720 63344410
Creatinine renal clearance abnormal 46.47 10.82 21 139871 379 63348751
Injury 46.16 10.82 56 139836 73191 63275939
Vascular device infection 46.04 10.82 68 139824 7244 63341886
Pericardial effusion 45.64 10.82 158 139734 29900 63319230
Retroperitoneal haematoma 45.21 10.82 43 139849 2870 63346260
Blood loss anaemia 44.61 10.82 75 139817 8926 63340204
Wound haemorrhage 44.60 10.82 40 139852 2476 63346654
Device expulsion 44.57 10.82 11 139881 34911 63314219
Multiple sclerosis relapse 44.10 10.82 26 139866 48452 63300678
Injection site swelling 44.01 10.82 25 139867 47547 63301583
Gastrointestinal ulcer haemorrhage 44.00 10.82 24 139868 658 63348472
Gastrointestinal tract mucosal pigmentation 43.95 10.82 23 139869 579 63348551
Blindness 43.93 10.82 126 139766 21573 63327557
Catheter site haemorrhage 43.91 10.82 44 139848 3131 63345999
Red blood cell sedimentation rate increased 43.82 10.82 21 139871 43961 63305169
Vascular pseudoaneurysm 43.31 10.82 32 139860 1502 63347628
Haemothorax 43.27 10.82 37 139855 2148 63346982
Urticaria 43.14 10.82 203 139689 165599 63183531
Catheter site erythema 42.88 10.82 50 139842 4226 63344904
Liver injury 42.86 10.82 42 139850 60478 63288652
Splenic rupture 42.55 10.82 30 139862 1308 63347822
Nasopharyngitis 42.51 10.82 357 139535 253900 63095230
Product monitoring error 42.30 10.82 51 139841 4465 63344665
Muscle haemorrhage 42.04 10.82 43 139849 3136 63345994
Joint range of motion decreased 41.80 10.82 10 139882 32418 63316712
Body temperature increased 41.49 10.82 15 139877 37177 63311953
Vasculitis 41.08 10.82 110 139782 18099 63331031
Oxygen saturation decreased 40.67 10.82 334 139558 88251 63260879
Spontaneous haematoma 40.52 10.82 25 139867 868 63348262
Premature delivery 39.70 10.82 9 139883 30272 63318858
Abortion spontaneous 39.27 10.82 28 139864 47167 63301963
Inflammation 39.25 10.82 76 139816 82197 63266933
Foetal exposure during pregnancy 39.02 10.82 11 139881 31951 63317179
Blood immunoglobulin E increased 38.58 10.82 45 139847 3804 63345326
Anaphylactic reaction 38.10 10.82 54 139838 66046 63283084
Abdominal wall haematoma 38.02 10.82 40 139852 3015 63346115
Limb injury 37.88 10.82 133 139759 25344 63323786
Heart rate increased 37.37 10.82 344 139548 93894 63255236
Cerebrospinal fluid retention 37.17 10.82 12 139880 80 63349050
Live birth 37.03 10.82 6 139886 25624 63323506
Listless 36.58 10.82 38 139854 2822 63346308
Emotional distress 36.53 10.82 13 139879 32536 63316594
Haemangioma of spleen 35.29 10.82 9 139883 21 63349109
Grip strength decreased 35.08 10.82 4 139888 22283 63326847
Infusion site haemorrhage 34.50 10.82 49 139843 5037 63344093
High frequency ablation 34.49 10.82 13 139879 144 63348986
Renal haemorrhage 34.35 10.82 23 139869 921 63348209
Catheter site pruritus 34.25 10.82 32 139860 2088 63347042
Sleep apnoea syndrome 34.16 10.82 141 139751 28992 63320138
Embolism 34.14 10.82 62 139830 7844 63341286
Facial pain 33.74 10.82 73 139819 10488 63338642
Knee arthroplasty 33.56 10.82 42 139850 54164 63294966
Thirst decreased 33.28 10.82 15 139877 269 63348861
Erythema 32.99 10.82 239 139653 175512 63173618
Burning sensation 32.88 10.82 219 139673 54188 63294942
Neovascular age-related macular degeneration 32.80 10.82 14 139878 219 63348911
Gastritis haemorrhagic 32.32 10.82 27 139865 1518 63347612
Joint stiffness 32.09 10.82 27 139865 41842 63307288
Seizure 31.85 10.82 167 139725 132467 63216663
Catheter site irritation 31.78 10.82 18 139874 532 63348598
Catheter management 31.76 10.82 36 139856 2951 63346179
Infusion site pain 31.33 10.82 95 139797 16774 63332356
Heart rate abnormal 31.14 10.82 46 139846 4901 63344229
Large intestinal haemorrhage 31.13 10.82 25 139867 1329 63347801
Craniotomy 31.11 10.82 14 139878 250 63348880
Contusion 30.79 10.82 483 139409 149561 63199569
Intracardiac thrombus 30.79 10.82 32 139860 2378 63346752
Bursitis 30.79 10.82 22 139870 37019 63312111
Ocular retrobulbar haemorrhage 30.64 10.82 11 139881 105 63349025
Surgery 30.41 10.82 158 139734 35754 63313376
Post procedural haematoma 30.13 10.82 24 139868 1261 63347869
Alanine aminotransferase increased 30.05 10.82 122 139770 103648 63245482
Gout 29.77 10.82 80 139812 13191 63335939
Muscle spasticity 29.55 10.82 6 139886 21788 63327342
Antinuclear antibody negative 29.47 10.82 13 139879 221 63348909
Subchondral insufficiency fracture 29.42 10.82 9 139883 49 63349081
Neoplasm malignant 29.29 10.82 137 139755 29724 63319406
Heavy menstrual bleeding 29.25 10.82 96 139796 17677 63331453
Therapy change 29.25 10.82 50 139842 6031 63343099
Cardiac failure chronic 29.14 10.82 42 139850 4376 63344754
Pulmonary oedema 29.12 10.82 214 139678 54659 63294471
Arthritis 28.94 10.82 144 139748 115777 63233353
Obesity 28.78 10.82 15 139877 29937 63319193
Weight increased 28.76 10.82 403 139489 260389 63088741
Drug withdrawal syndrome 28.63 10.82 12 139880 27182 63321948
Duplicate therapy error 28.57 10.82 10 139882 88 63349042
Gastrointestinal angiodysplasia 28.49 10.82 16 139876 465 63348665
Gastrointestinal tube insertion 28.48 10.82 22 139870 1105 63348025
Vascular device occlusion 28.40 10.82 11 139881 132 63348998
Medication error 28.38 10.82 205 139687 52079 63297051
Gingival bleeding 28.36 10.82 76 139816 12511 63336619
Venous pressure jugular increased 28.36 10.82 17 139875 560 63348570
Defaecation disorder 28.35 10.82 19 139873 762 63348368
Hip fracture 28.02 10.82 134 139758 29340 63319790
Infusion site discharge 27.96 10.82 18 139874 674 63348456
Cytomegalovirus infection 27.93 10.82 6 139886 20946 63328184
Subcutaneous haematoma 27.89 10.82 26 139866 1692 63347438
Extradural haematoma 27.84 10.82 26 139866 1696 63347434
Pulmonary fibrosis 27.76 10.82 28 139864 39781 63309349
Subclavian vein thrombosis 27.64 10.82 27 139865 1863 63347267
Vena cava filter insertion 27.61 10.82 11 139881 143 63348987
Chloropsia 27.58 10.82 8 139884 35 63349095
Right ventricular failure 27.54 10.82 92 139800 17096 63332034
Eye haematoma 27.50 10.82 9 139883 63 63349067
Renal failure 27.36 10.82 387 139505 117265 63231865
Femoral neck fracture 27.33 10.82 59 139833 8464 63340666
Sinus node dysfunction 27.27 10.82 42 139850 4643 63344487
Rectosigmoid cancer 27.20 10.82 11 139881 149 63348981
Hepatotoxicity 27.05 10.82 25 139867 37016 63312114
Antiphospholipid syndrome 26.98 10.82 26 139866 1764 63347366
Pain of skin 26.97 10.82 71 139821 11563 63337567
Orbital compartment syndrome 26.80 10.82 9 139883 69 63349061
Full blood count decreased 26.72 10.82 121 139771 25903 63323227
Infarction 26.68 10.82 31 139861 2610 63346520
Petechiae 26.50 10.82 79 139813 13818 63335312
Somnolence 26.31 10.82 259 139633 178426 63170704
Catheter site discharge 26.21 10.82 27 139865 1986 63347144
Cerebellar infarction 26.14 10.82 27 139865 1992 63347138
Ear haemorrhage 25.73 10.82 23 139869 1417 63347713
Red blood cell sedimentation rate abnormal 25.70 10.82 6 139886 19776 63329354
Hepatic haemangioma rupture 25.60 10.82 5 139887 0 63349130
Thrombocytopenia 25.35 10.82 471 139421 150686 63198444
Condition aggravated 25.21 10.82 684 139208 401533 62947597
Nasal congestion 25.18 10.82 238 139654 65422 63283708
Tumour haemorrhage 25.17 10.82 24 139868 1607 63347523
Cardiac fibrillation 25.13 10.82 15 139877 490 63348640
Urinary bladder haemorrhage 25.12 10.82 20 139872 1050 63348080
Peripheral swelling 25.04 10.82 765 139127 265177 63083953
Product use in unapproved indication 24.95 10.82 263 139629 178817 63170313
Rehabilitation therapy 24.93 10.82 24 139868 1626 63347504
Gastrointestinal disorder 24.84 10.82 178 139714 131061 63218069
Irritability 24.84 10.82 20 139872 31674 63317456
Acute respiratory failure 24.70 10.82 145 139747 34340 63314790
Caesarean section 24.58 10.82 4 139888 17028 63332102
Erythromelalgia 24.49 10.82 10 139882 139 63348991
Embolic cerebral infarction 24.38 10.82 15 139877 518 63348612
Treatment noncompliance 24.24 10.82 153 139739 37172 63311958
Anxiety 24.03 10.82 336 139556 217205 63131925
White blood cell count increased 23.91 10.82 44 139848 48517 63300613
Coombs positive haemolytic anaemia 23.78 10.82 13 139879 358 63348772
Catheterisation cardiac 23.67 10.82 39 139853 4564 63344566
Mental disorder 23.43 10.82 14 139878 25905 63323225
Tachycardia 23.35 10.82 378 139514 117778 63231352
Diarrhoea 23.27 10.82 1853 138039 713513 62635617
Duodenal vascular ectasia 23.26 10.82 5 139887 3 63349127
Aspartate aminotransferase increased 23.19 10.82 111 139781 90166 63258964
Fracture 23.13 10.82 95 139797 19489 63329641
Disability 22.98 10.82 6 139886 18341 63330789
Rectal prolapse 22.98 10.82 25 139867 1958 63347172
Calciphylaxis 22.94 10.82 31 139861 3041 63346089
Sleep disorder 22.93 10.82 97 139795 81469 63267661
No adverse event 22.85 10.82 163 139729 41242 63307888
Blood urine present 22.69 10.82 79 139813 14990 63334140
Foot deformity 22.56 10.82 17 139875 27836 63321294
Bone marrow failure 22.31 10.82 19 139873 29271 63319859
Haemorrhagic disorder 22.27 10.82 17 139875 839 63348291
Haemorrhage subepidermal 22.15 10.82 5 139887 5 63349125
Osteopenia 22.04 10.82 8 139884 19777 63329353
Tooth disorder 21.88 10.82 121 139771 28036 63321094
Intestinal haemorrhage 21.71 10.82 34 139858 3813 63345317
Respiratory arrest 21.60 10.82 24 139868 32621 63316509
Upper respiratory tract infection 21.59 10.82 100 139792 81947 63267183
Paratonia 21.53 10.82 6 139886 22 63349108
Agitation 21.52 10.82 64 139828 59693 63289437
Basal cell carcinoma 21.52 10.82 18 139874 27973 63321157
Adrenal haemorrhage 21.50 10.82 13 139879 435 63348695
Oxygen consumption increased 21.46 10.82 34 139858 3850 63345280
Pleural effusion 21.43 10.82 306 139586 92904 63256226
Lymphocyte count decreased 21.42 10.82 21 139871 30236 63318894
Hypoaesthesia 21.21 10.82 253 139639 168140 63180990
Device pacing issue 21.19 10.82 8 139884 89 63349041
Paraesthesia oral 21.09 10.82 8 139884 19248 63329882
Chest pain 21.06 10.82 624 139268 215335 63133795
Injection site urticaria 21.00 10.82 3 139889 14070 63335060
Haemoperitoneum 20.99 10.82 28 139864 2713 63346417
Osteonecrosis of jaw 20.93 10.82 28 139864 35095 63314035
Incorrect route of product administration 20.68 10.82 18 139874 27434 63321696
Heart rate irregular 20.64 10.82 101 139791 22320 63326810
Iron deficiency anaemia 20.61 10.82 93 139799 19876 63329254
Joint effusion 20.58 10.82 6 139886 17054 63332076
Gastrointestinal vascular malformation haemorrhagic 20.54 10.82 10 139882 215 63348915
Premature baby 20.50 10.82 10 139882 20725 63328405
Echocardiogram abnormal 20.50 10.82 20 139872 1378 63347752
Nephropathy 20.45 10.82 44 139848 6297 63342833
Ovarian cyst 20.39 10.82 5 139887 15940 63333190
Cerebral artery embolism 20.30 10.82 17 139875 959 63348171
Joint dislocation 20.27 10.82 8 139884 18792 63330338
Wrong strength 20.26 10.82 7 139885 59 63349071
Osteoporosis 20.22 10.82 62 139830 57276 63291854
Vomiting 20.12 10.82 1018 138874 558599 62790531
Blood creatinine abnormal 20.08 10.82 29 139863 3027 63346103
Hypercholesterolaemia 20.04 10.82 11 139881 21323 63327807
Injection site mass 20.02 10.82 8 139884 18648 63330482
Peripheral embolism 19.88 10.82 19 139873 1276 63347854
Central nervous system lupus 19.86 10.82 13 139879 501 63348629
Bone density decreased 19.86 10.82 4 139888 14608 63334522
Gait disturbance 19.84 10.82 284 139608 182894 63166236
Anti factor X activity increased 19.81 10.82 5 139887 11 63349119
Reduced facial expression 19.73 10.82 23 139869 1943 63347187
Paraesthesia 19.70 10.82 236 139656 156730 63192400
Influenza like illness 19.70 10.82 78 139814 66746 63282384
Therapy non-responder 19.69 10.82 93 139799 75808 63273322
Haematoma evacuation 19.59 10.82 9 139883 169 63348961
Cerebral artery occlusion 19.47 10.82 16 139876 879 63348251
Brain stem haemorrhage 19.46 10.82 15 139877 751 63348379
Accidental exposure to product 19.42 10.82 19 139873 27386 63321744
Hemiparesis 19.41 10.82 102 139790 23180 63325950
Sedation 19.26 10.82 35 139857 38774 63310356
Coagulation factor V level abnormal 19.22 10.82 5 139887 13 63349117
Crying 19.22 10.82 14 139878 23329 63325801
Asthenia 19.19 10.82 1031 138861 382573 62966557
Aneurysm ruptured 19.19 10.82 13 139879 531 63348599
Ulcer haemorrhage 19.09 10.82 39 139853 5383 63343747
Infusion site swelling 19.07 10.82 56 139836 9714 63339416
Listeraemia 19.03 10.82 7 139885 72 63349058
Product quality issue 19.02 10.82 31 139861 35834 63313296
Catheter site pain 19.02 10.82 36 139856 4699 63344431
Prerenal failure 18.99 10.82 21 139871 1675 63347455
Device alarm issue 18.98 10.82 20 139872 1510 63347620
Biliary sepsis 18.92 10.82 16 139876 915 63348215
Gastrostomy 18.90 10.82 14 139878 660 63348470
Meningorrhagia 18.76 10.82 9 139883 187 63348943
Herpes simplex reactivation 18.68 10.82 13 139879 555 63348575
Cutaneous vasculitis 18.67 10.82 38 139854 5231 63343899
Chronic sinusitis 18.57 10.82 3 139889 12840 63336290
Drug resistance 18.57 10.82 14 139878 22919 63326211
Chronic left ventricular failure 18.37 10.82 12 139880 461 63348669
Immunodeficiency 18.23 10.82 11 139881 20243 63328887
Injection site bruising 18.06 10.82 41 139851 41869 63307261
Uveitis 18.00 10.82 3 139889 12550 63336580
Embolism venous 17.97 10.82 28 139864 3126 63346004
Impaired work ability 17.94 10.82 8 139884 17467 63331663
Drug tolerance decreased 17.93 10.82 8 139884 17465 63331665
Oesophageal food impaction 17.89 10.82 9 139883 208 63348922
Diabetes mellitus 17.85 10.82 63 139829 55747 63293383
Breast cancer female 17.84 10.82 4 139888 13555 63335575
Posterior reversible encephalopathy syndrome 17.71 10.82 8 139884 17337 63331793
Prescription drug used without a prescription 17.70 10.82 24 139868 2362 63346768
Lip dry 17.67 10.82 6 139886 15464 63333666
Blood pressure systolic abnormal 17.51 10.82 4 139888 13382 63335748
Dehydration 17.47 10.82 503 139389 172851 63176279
Orthopnoea 17.46 10.82 41 139851 6220 63342910
Troponin abnormal 17.32 10.82 6 139886 51 63349079
Skin laceration 17.26 10.82 97 139795 22611 63326519
Catheter site rash 17.20 10.82 14 139878 759 63348371
Cardiac failure acute 17.10 10.82 53 139839 9470 63339660
Exostosis 17.08 10.82 9 139883 17853 63331277
Atrioventricular block 17.05 10.82 46 139846 7601 63341529
Herpes zoster 17.02 10.82 109 139783 82353 63266777
Ventricular tachycardia 16.98 10.82 88 139804 19891 63329239
Pulmonary alveolar haemorrhage 16.94 10.82 34 139858 4634 63344496
Chills 16.82 10.82 164 139728 113214 63235916
Bicytopenia 16.80 10.82 24 139868 2481 63346649
Fungal infection 16.78 10.82 35 139857 36839 63312291
Skull fracture 16.68 10.82 16 139876 1079 63348051
Acne 16.68 10.82 16 139876 23277 63325853
Kyphosis 16.54 10.82 24 139868 2516 63346614
Insomnia 16.50 10.82 355 139537 214897 63134233
Anal stenosis 16.40 10.82 11 139881 442 63348688
Mucosal inflammation 16.37 10.82 51 139841 46877 63302253
Oxygen therapy 16.30 10.82 22 139870 2156 63346974
Microcytic anaemia 16.24 10.82 28 139864 3401 63345729
Glomerular filtration rate abnormal 16.19 10.82 14 139878 825 63348305
Skin haemorrhage 16.15 10.82 54 139838 10040 63339090
Multiple sclerosis 16.03 10.82 18 139874 24354 63324776
Craniocerebral injury 15.94 10.82 25 139867 2807 63346323
Muscle abscess 15.93 10.82 10 139882 358 63348772
Gastric ulcer 15.90 10.82 99 139793 23938 63325192
Sinus tachycardia 15.88 10.82 18 139874 24250 63324880
Tendonitis 15.85 10.82 12 139880 19603 63329527
Ear pain 15.84 10.82 35 139857 36083 63313047
Haemorrhagic diathesis 15.83 10.82 32 139860 4383 63344747
Post procedural pulmonary embolism 15.74 10.82 9 139883 271 63348859
Plasma cell myeloma 15.74 10.82 134 139758 35771 63313359
Product storage error 15.70 10.82 70 139822 14886 63334244
Oesophageal achalasia 15.70 10.82 11 139881 475 63348655
Basal ganglia haematoma 15.36 10.82 3 139889 0 63349130
Chemotherapy toxicity attenuation 15.36 10.82 3 139889 0 63349130
Haemorrhagic hepatic cyst 15.28 10.82 5 139887 35 63349095
Splenic haemorrhage 15.23 10.82 8 139884 203 63348927
Pyroglutamic acidosis 15.19 10.82 12 139880 623 63348507
Gastritis erosive 15.18 10.82 38 139854 6001 63343129
Product dose omission issue 15.14 10.82 646 139246 233667 63115463
Anal haemorrhage 15.12 10.82 21 139871 2115 63347015
Peripheral artery thrombosis 15.09 10.82 20 139872 1926 63347204
Thrombophlebitis migrans 15.07 10.82 7 139885 135 63348995
Night sweats 15.02 10.82 56 139836 48758 63300372
Thrombophlebitis 14.89 10.82 31 139861 4337 63344793
Progressive multifocal leukoencephalopathy 14.87 10.82 5 139887 12966 63336164
Occult blood positive 14.86 10.82 28 139864 3642 63345488
Thrombotic stroke 14.84 10.82 11 139881 519 63348611
Drug level changed 14.81 10.82 8 139884 215 63348915
Intentional product misuse 14.81 10.82 202 139690 60715 63288415
Tricuspid valve repair 14.72 10.82 4 139888 13 63349117
Pancreatitis 14.62 10.82 57 139835 48998 63300132
Blood creatine phosphokinase increased 14.61 10.82 28 139864 30402 63318728
Generalised tonic-clonic seizure 14.55 10.82 26 139866 28990 63320140
Red cell distribution width abnormal 14.48 10.82 7 139885 148 63348982
Degenerative aortic valve disease 14.48 10.82 7 139885 148 63348982
Mediastinal haematoma 14.47 10.82 6 139886 87 63349043
Deformity 14.30 10.82 4 139888 11680 63337450
Anticoagulation drug level decreased 14.29 10.82 5 139887 44 63349086
Haemophagocytic lymphohistiocytosis 14.25 10.82 3 139889 10624 63338506
Granulomatous dermatitis 14.23 10.82 7 139885 154 63348976
Laryngitis 14.20 10.82 10 139882 16957 63332173
Erysipelas 14.20 10.82 44 139848 7861 63341269
Intra-abdominal haemorrhage 14.18 10.82 22 139870 2447 63346683
Osteoarthritis 14.11 10.82 138 139754 95205 63253925
Ecchymosis 14.05 10.82 55 139837 11039 63338091
Injection site warmth 14.03 10.82 8 139884 15187 63333943
Ataxia 14.03 10.82 8 139884 15187 63333943
Metastases to liver 13.93 10.82 19 139873 23620 63325510
Blood calcium decreased 13.90 10.82 23 139869 26428 63322702
Oral candidiasis 13.76 10.82 18 139874 22780 63326350
Aggression 13.73 10.82 19 139873 23479 63325651
Kidney rupture 13.72 10.82 5 139887 50 63349080
Ear infection 13.70 10.82 41 139851 38172 63310958
Foreign body 13.66 10.82 21 139871 2317 63346813
Vascular stenosis 13.65 10.82 9 139883 351 63348779
Hypokalaemia 13.62 10.82 312 139580 103492 63245638
Fear 13.59 10.82 9 139883 15757 63333373
Staphylococcal infection 13.58 10.82 46 139846 41210 63307920
Subclavian artery thrombosis 13.53 10.82 7 139885 172 63348958
Skin pressure mark 13.53 10.82 4 139888 19 63349111
Head discomfort 13.49 10.82 62 139830 13353 63335777
Cardiac ventricular disorder 13.46 10.82 7 139885 174 63348956
Hepatic steatosis 13.35 10.82 27 139865 28742 63320388
Splenomegaly 13.32 10.82 4 139888 11153 63337977
Stroke volume decreased 13.29 10.82 3 139889 3 63349127
Jejunostomy 13.29 10.82 3 139889 3 63349127
Mesenteric haematoma 13.29 10.82 3 139889 3 63349127
Stress 13.24 10.82 90 139802 67077 63282053
Infusion site infection 13.24 10.82 18 139874 1776 63347354
Peritoneal neoplasm 13.22 10.82 5 139887 56 63349074
Cerebral artery thrombosis 13.21 10.82 9 139883 371 63348759
Splenic haematoma 13.19 10.82 6 139886 110 63349020
Dropped head syndrome 13.17 10.82 7 139885 182 63348948
Drug dependence 13.14 10.82 21 139871 24462 63324668
Anhedonia 12.99 10.82 4 139888 10970 63338160
Schizophrenia 12.96 10.82 3 139889 9949 63339181
Adrenal haematoma 12.89 10.82 4 139888 23 63349107
Hyperkalaemia 12.88 10.82 179 139713 54024 63295106
Periorbital haematoma 12.86 10.82 12 139880 782 63348348
Product administration error 12.84 10.82 89 139803 22308 63326822
Mite allergy 12.71 10.82 11 139881 649 63348481
Bone disorder 12.71 10.82 17 139875 21309 63327821
Wrong drug 12.70 10.82 7 139885 196 63348934
Glomerular filtration rate decreased 12.70 10.82 61 139831 13380 63335750
Epidural haemorrhage 12.67 10.82 6 139886 121 63349009
Traumatic haemothorax 12.67 10.82 6 139886 121 63349009
Catheter site swelling 12.67 10.82 16 139876 1469 63347661
Polyserositis 12.65 10.82 9 139883 398 63348732
Dialysis 12.65 10.82 51 139841 10376 63338754
Tremor 12.62 10.82 210 139682 132029 63217101
Intracranial haematoma 12.59 10.82 9 139883 401 63348729
Infusion site erythema 12.51 10.82 55 139837 11624 63337506
Product communication issue 12.44 10.82 11 139881 668 63348462
Anticoagulation drug level increased 12.42 10.82 7 139885 205 63348925
Electrocardiogram QT shortened 12.41 10.82 6 139886 127 63349003
Dry eye 12.38 10.82 47 139845 40714 63308416
Ear congestion 12.38 10.82 22 139870 2737 63346393
Injection site rash 12.25 10.82 14 139878 18795 63330335
Cystitis 12.23 10.82 71 139821 54920 63294210
Bronchospasm 12.22 10.82 12 139880 17268 63331862
Blood pressure systolic decreased 12.21 10.82 40 139852 7357 63341773
Catheter site warmth 12.15 10.82 7 139885 214 63348916
Pruritus 12.11 10.82 662 139230 360791 62988339
Scleral haemorrhage 12.10 10.82 4 139888 29 63349101
Gastroenteritis aeromonas 12.10 10.82 4 139888 29 63349101
Skin irritation 12.10 10.82 48 139844 9693 63339437
Sinus rhythm 12.09 10.82 12 139880 844 63348286
Malignant atrophic papulosis 12.08 10.82 3 139889 6 63349124
Ankylosing spondylitis 12.07 10.82 4 139888 10470 63338660
Aspiration pleural cavity 11.96 10.82 12 139880 855 63348275
Mood altered 11.94 10.82 9 139883 14734 63334396
Atrial appendage closure 11.87 10.82 4 139888 31 63349099
Rabbit syndrome 11.87 10.82 8 139884 324 63348806
Throat tightness 11.86 10.82 23 139869 24864 63324266
Microembolism 11.76 10.82 3 139889 7 63349123
Feeling hot 11.75 10.82 64 139828 50290 63298840
Colon cancer 11.73 10.82 48 139844 9830 63339300
Tuberculosis 11.72 10.82 5 139887 11206 63337924
COVID-19 pneumonia 11.67 10.82 62 139830 14147 63334983
Pulmonary artery occlusion 11.65 10.82 4 139888 33 63349097
Electrolyte imbalance 11.64 10.82 80 139812 19996 63329134
Sprue-like enteropathy 11.59 10.82 11 139881 732 63348398
Emergency care 11.51 10.82 13 139879 1061 63348069
Procedural haemorrhage 11.50 10.82 21 139871 2667 63346463
Inferior vena cava dilatation 11.50 10.82 5 139887 82 63349048
Left ventricular failure 11.49 10.82 33 139859 5654 63343476
Oral mucosa haematoma 11.48 10.82 3 139889 8 63349122
Lactic acidosis 11.47 10.82 132 139760 38155 63310975
Abdominal pain 11.46 10.82 529 139363 292927 63056203
Cholestasis 11.43 10.82 107 139785 29327 63319803
Hot flush 11.40 10.82 66 139826 51093 63298037
Product dispensing error 11.40 10.82 49 139843 10256 63338874
Pallor 11.32 10.82 110 139782 30458 63318672
Cerebral amyloid angiopathy 11.29 10.82 6 139886 156 63348974
Cardiac ventricular thrombosis 11.29 10.82 10 139882 609 63348521
Manufacturing product shipping issue 11.28 10.82 5 139887 86 63349044
Adenocarcinoma of colon 11.28 10.82 20 139872 2484 63346646
Intercepted medication error 11.25 10.82 10 139882 612 63348518
Pneumonia 11.25 10.82 1160 138732 455607 62893523
Kussmaul respiration 11.24 10.82 7 139885 247 63348883
Morbid thoughts 11.23 10.82 10 139882 613 63348517
Psychotic disorder 11.21 10.82 25 139867 25687 63323443
Panic attack 11.20 10.82 20 139872 22311 63326819
Hypercalcaemia 11.19 10.82 29 139863 28293 63320837
Eye pruritus 11.18 10.82 75 139817 18596 63330534
Hypercoagulation 11.18 10.82 18 139874 2067 63347063
Therapeutic product effect incomplete 11.16 10.82 201 139691 124855 63224275
Prosthetic cardiac valve thrombosis 11.16 10.82 4 139888 38 63349092
Inappropriate antidiuretic hormone secretion 11.06 10.82 65 139827 15397 63333733
Listeria encephalitis 11.00 10.82 7 139885 257 63348873
Eye pain 10.97 10.82 38 139854 33816 63315314
Arterial haemorrhage 10.86 10.82 16 139876 1701 63347429

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 929.94 11.56 1029 124071 50341 34781490
Gastrointestinal haemorrhage 782.44 11.56 1247 123853 87230 34744601
Atrial fibrillation 739.99 11.56 1460 123640 120933 34710898
Death 686.48 11.56 3023 122077 395026 34436805
Prescribed underdose 643.20 11.56 400 124700 8533 34823298
Cerebral haemorrhage 639.05 11.56 704 124396 34233 34797598
Gastric haemorrhage 563.99 11.56 388 124712 9873 34821958
Haemorrhage intracranial 547.32 11.56 455 124645 15491 34816340
Cerebrovascular accident 487.05 11.56 991 124109 83820 34748011
Fall 350.46 11.56 1545 123555 201340 34630491
Subdural haematoma 341.61 11.56 393 124707 20028 34811803
Drug ineffective 328.46 11.56 719 124381 456032 34375799
Haematuria 324.64 11.56 616 124484 49450 34782381
Thrombosis 318.77 11.56 614 124486 49844 34781987
Melaena 290.80 11.56 483 124617 34897 34796934
Intentional product use issue 282.34 11.56 646 124454 59170 34772661
Haematoma 278.54 11.56 398 124702 25207 34806624
Toxicity to various agents 248.95 11.56 211 124889 200151 34631680
Epistaxis 242.32 11.56 599 124501 57652 34774179
Drug abuse 234.41 11.56 37 125063 99059 34732772
Adverse event 231.64 11.56 311 124789 18566 34813265
Atrial thrombosis 216.82 11.56 121 124979 2093 34829738
Transfusion 211.15 11.56 203 124897 8382 34823449
Ischaemic stroke 210.81 11.56 292 124808 17958 34813873
Lower gastrointestinal haemorrhage 196.51 11.56 204 124896 9248 34822583
Cardiac failure 191.79 11.56 739 124361 90509 34741322
Completed suicide 183.85 11.56 61 125039 98107 34733724
Haematochezia 182.47 11.56 468 124632 46066 34785765
Labelled drug-drug interaction medication error 171.00 11.56 238 124862 14701 34817130
Subarachnoid haemorrhage 168.68 11.56 217 124883 12418 34819413
Anaemia 166.09 11.56 1412 123688 231923 34599908
Pulmonary embolism 162.45 11.56 694 124406 89052 34742779
Haemorrhagic stroke 159.63 11.56 154 124946 6385 34825446
Cerebral infarction 155.12 11.56 319 124781 27136 34804695
Dyspnoea 150.80 11.56 2030 123070 374752 34457079
Transient ischaemic attack 137.73 11.56 305 124795 27308 34804523
Upper gastrointestinal haemorrhage 127.43 11.56 282 124818 25236 34806595
Shock haemorrhagic 122.71 11.56 176 124924 11178 34820653
Pericardial haemorrhage 120.71 11.56 96 125004 3062 34828769
Cardioversion 116.55 11.56 60 125040 875 34830956
Hospitalisation 115.50 11.56 456 124644 56446 34775385
Post procedural haemorrhage 111.64 11.56 143 124957 8146 34823685
N-terminal prohormone brain natriuretic peptide increased 106.93 11.56 84 125016 2631 34829200
Cardiospasm 104.00 11.56 67 125033 1521 34830310
Embolic stroke 101.45 11.56 101 124999 4353 34827478
Internal haemorrhage 99.78 11.56 106 124994 4935 34826896
Foetal exposure during pregnancy 95.25 11.56 12 125088 38089 34793742
Cardiac disorder 95.21 11.56 355 124745 42771 34789060
Palmoplantar keratoderma 93.71 11.56 68 125032 1885 34829946
Haemoptysis 91.79 11.56 305 124795 34701 34797130
Haemoglobin decreased 91.60 11.56 742 124358 120030 34711801
Atrial tachycardia 91.15 11.56 87 125013 3558 34828273
Pyrexia 91.06 11.56 759 124341 332254 34499577
Aortic valve stenosis 90.36 11.56 76 125024 2627 34829204
Rectal haemorrhage 90.26 11.56 333 124767 39916 34791915
Right atrial hypertrophy 89.92 11.56 48 125052 757 34831074
Peripheral swelling 88.13 11.56 521 124579 76020 34755811
Cerebral haematoma 87.75 11.56 95 125005 4520 34827311
Pruritus genital 86.39 11.56 68 125032 2136 34829695
Febrile neutropenia 86.18 11.56 230 124870 136619 34695212
Deep vein thrombosis 85.60 11.56 460 124640 64788 34767043
Suicidal ideation 81.18 11.56 22 125078 40366 34791465
Traumatic intracranial haemorrhage 80.73 11.56 43 125057 675 34831156
Drug hypersensitivity 80.39 11.56 102 124998 80427 34751404
Product prescribing error 80.10 11.56 221 124879 22706 34809125
Mucosal inflammation 79.61 11.56 20 125080 38602 34793229
Traumatic haemorrhage 79.56 11.56 44 125056 747 34831084
Dizziness 77.22 11.56 1153 123947 217368 34614463
Sleep terror 77.12 11.56 65 125035 2253 34829578
Head injury 76.75 11.56 188 124912 17972 34813859
Blood urine present 76.01 11.56 138 124962 10696 34821135
Alanine aminotransferase increased 74.96 11.56 108 124992 80707 34751124
Contraindicated product administered 74.00 11.56 206 124894 21275 34810556
Fluid retention 73.84 11.56 238 124862 26649 34805182
Intraventricular haemorrhage 73.01 11.56 76 125024 3455 34828376
Seizure 72.41 11.56 168 124932 104689 34727142
Renal impairment 72.34 11.56 582 124518 93931 34737900
Tension headache 71.17 11.56 70 125030 2972 34828859
COVID-19 69.72 11.56 496 124604 77054 34754777
Immunisation 69.45 11.56 45 125055 1032 34830799
Carotid artery occlusion 69.44 11.56 76 125024 3661 34828170
Aggression 68.16 11.56 27 125073 38937 34792894
Diverticulum intestinal haemorrhagic 66.10 11.56 62 125038 2480 34829351
Right ventricular hypertrophy 65.96 11.56 50 125050 1484 34830347
Arrhythmia 65.53 11.56 278 124822 35530 34796301
Neutropenia 65.05 11.56 314 124786 156464 34675367
Nausea 64.86 11.56 843 124257 339065 34492766
Drug dependence 64.67 11.56 6 125094 24211 34807620
Mycotic allergy 64.41 11.56 35 125065 573 34831258
Dyspnoea exertional 64.32 11.56 316 124784 42963 34788868
Faeces discoloured 63.91 11.56 155 124945 14723 34817108
Bronchial secretion retention 63.70 11.56 49 125051 1487 34830344
Cardiac amyloidosis 63.33 11.56 45 125055 1206 34830625
Drug resistance 62.82 11.56 9 125091 25918 34805913
Leukopenia 62.32 11.56 80 125020 62776 34769055
Agitation 62.31 11.56 68 125032 57331 34774500
Haemothorax 60.82 11.56 72 125028 3780 34828051
Aspartate aminotransferase increased 60.50 11.56 93 125007 67690 34764141
Anosmia 59.91 11.56 73 125027 3951 34827880
Mite allergy 59.71 11.56 35 125065 667 34831164
Spirometry abnormal 58.71 11.56 35 125065 689 34831142
Facial pain 58.10 11.56 69 125031 3635 34828196
Bronchial wall thickening 57.52 11.56 44 125056 1324 34830507
Overdose 57.31 11.56 153 124947 90906 34740925
General physical health deterioration 56.77 11.56 705 124395 127564 34704267
Conjunctivitis allergic 56.74 11.56 41 125059 1129 34830702
Cerebral ventricular rupture 56.65 11.56 23 125077 185 34831646
Urinary bladder haemorrhage 56.05 11.56 48 125052 1701 34830130
Pulmonary function test abnormal 55.45 11.56 57 125043 2553 34829278
Thalamus haemorrhage 55.19 11.56 38 125062 967 34830864
Depression 54.65 11.56 172 124928 96926 34734905
Abdominal wall haematoma 54.01 11.56 48 125052 1789 34830042
Contusion 53.66 11.56 265 124835 36099 34795732
Stomatitis 53.60 11.56 44 125056 42470 34789361
Vomiting 52.12 11.56 601 124499 247020 34584811
Dust allergy 51.51 11.56 35 125065 871 34830960
Infusion related reaction 50.08 11.56 70 125030 52987 34778844
Polypectomy 50.02 11.56 29 125071 541 34831290
Haemorrhage subcutaneous 49.82 11.56 51 125049 2273 34829558
Injection site pain 49.63 11.56 40 125060 38965 34792866
Spinal cord haemorrhage 49.26 11.56 24 125076 309 34831522
Procedural haemorrhage 49.22 11.56 52 125048 2405 34829426
Haematemesis 49.05 11.56 213 124887 27498 34804333
Pulmonary arterial hypertension 48.70 11.56 101 124999 8638 34823193
Cardiac ablation 47.97 11.56 36 125064 1052 34830779
Drug withdrawal syndrome 47.78 11.56 7 125093 19827 34812004
Subdural haemorrhage 47.69 11.56 58 125042 3133 34828698
Cytomegalovirus infection 47.57 11.56 17 125083 26118 34805713
Haemoperitoneum 46.74 11.56 44 125056 1768 34830063
Rhabdomyolysis 46.40 11.56 110 124990 68053 34763778
Respiratory depression 46.26 11.56 3 125097 16242 34815589
Cardiac failure chronic 46.20 11.56 93 125007 7786 34824045
Cardiac failure congestive 46.00 11.56 478 124622 82792 34749039
Disease progression 45.64 11.56 215 124885 107862 34723969
High frequency ablation 45.54 11.56 19 125081 165 34831666
Stress 45.46 11.56 26 125074 30321 34801510
Multiple organ dysfunction syndrome 44.95 11.56 133 124967 76433 34755398
Prescribed overdose 44.75 11.56 110 124990 10537 34821294
Cerebral mass effect 44.40 11.56 33 125067 950 34830881
Neuroleptic malignant syndrome 43.97 11.56 6 125094 17928 34813903
Obstruction 43.22 11.56 51 125049 2668 34829163
Toxic epidermal necrolysis 43.10 11.56 12 125088 21634 34810197
Gastrointestinal endoscopic therapy 43.01 11.56 10 125090 4 34831827
Psychotic disorder 42.67 11.56 17 125083 24435 34807396
Blood creatine phosphokinase increased 42.52 11.56 59 125041 44798 34787033
Haemorrhagic disorder 42.50 11.56 28 125072 661 34831170
Erythema 42.12 11.56 169 124931 88611 34743220
Sedation 41.17 11.56 12 125088 20994 34810837
Atrial flutter 41.08 11.56 136 124964 15438 34816393
Therapy interrupted 40.13 11.56 124 124976 13573 34818258
Bone marrow failure 39.79 11.56 28 125072 29225 34802606
Surgery 39.48 11.56 126 124974 14031 34817800
Emotional distress 39.39 11.56 4 125096 15022 34816809
Pain of skin 39.33 11.56 75 125025 6034 34825797
Post procedural haematoma 39.26 11.56 37 125063 1489 34830342
Therapeutic product effect decreased 39.00 11.56 40 125060 34703 34797128
Musculoskeletal stiffness 38.88 11.56 67 125033 46613 34785218
Therapeutic response decreased 38.64 11.56 29 125071 29284 34802547
Haemorrhagic hepatic cyst 38.52 11.56 10 125090 12 34831819
Hepatic function abnormal 38.50 11.56 62 125038 44301 34787530
Cerebellar haemorrhage 38.34 11.56 37 125063 1534 34830297
Blood loss anaemia 38.04 11.56 88 125012 8106 34823725
Gastrointestinal angiodysplasia 38.03 11.56 25 125075 588 34831243
Coagulation factor deficiency 37.86 11.56 16 125084 144 34831687
Spinal subarachnoid haemorrhage 37.74 11.56 12 125088 42 34831789
Failure to suspend medication 37.68 11.56 22 125078 416 34831415
Gastrointestinal tube insertion 37.68 11.56 33 125067 1206 34830625
Pancytopenia 37.47 11.56 194 124906 94963 34736868
Systemic infection 37.34 11.56 67 125033 5145 34826686
Haematoma muscle 36.79 11.56 34 125066 1334 34830497
Abnormal behaviour 36.54 11.56 22 125078 24947 34806884
Iron deficiency anaemia 36.50 11.56 100 125000 10229 34821602
Urogenital haemorrhage 35.88 11.56 26 125074 719 34831112
Neurotoxicity 35.83 11.56 10 125090 18000 34813831
Blood lactate dehydrogenase increased 35.44 11.56 19 125081 22971 34808860
White blood cell count increased 35.25 11.56 58 125042 41093 34790738
Intentional self-injury 35.25 11.56 4 125096 13767 34818064
Somnolence 35.07 11.56 243 124857 110873 34720958
Brain stem haemorrhage 34.91 11.56 28 125072 904 34830927
Diastolic dysfunction 34.73 11.56 72 125028 6155 34825676
Blood cholesterol increased 34.69 11.56 15 125085 20528 34811303
Haemorrhage urinary tract 34.62 11.56 38 125062 1836 34829995
Serotonin syndrome 34.55 11.56 14 125086 19919 34811912
Myelosuppression 34.27 11.56 13 125087 19252 34812579
Pulmonary alveolar haemorrhage 34.14 11.56 80 125020 7432 34824399
Factor V Leiden mutation 34.06 11.56 13 125087 87 34831744
Spontaneous haematoma 33.74 11.56 22 125078 510 34831321
Neutrophil count decreased 33.57 11.56 84 125016 51020 34780811
Sleep disorder due to a general medical condition 33.49 11.56 64 125036 5157 34826674
Splenic rupture 33.36 11.56 34 125066 1507 34830324
Gout 33.32 11.56 147 124953 19106 34812725
BRASH syndrome 33.22 11.56 22 125078 524 34831307
Cardiac pacemaker insertion 32.90 11.56 46 125054 2852 34828979
Poisoning 32.72 11.56 3 125097 12223 34819608
Catheter site haemorrhage 32.55 11.56 40 125060 2184 34829647
Haematoma evacuation 32.16 11.56 15 125085 174 34831657
Cardiac tamponade 31.89 11.56 63 125037 5203 34826628
Irritability 31.81 11.56 25 125075 24665 34807166
Suicide attempt 31.80 11.56 57 125043 39059 34792772
Vascular pseudoaneurysm 31.75 11.56 39 125061 2128 34829703
Intracranial haematoma 31.47 11.56 20 125080 443 34831388
Neutrophil count increased 31.46 11.56 11 125089 17135 34814696
Large intestine polyp 31.40 11.56 80 125020 7834 34823997
Sepsis 30.94 11.56 415 124685 166146 34665685
Chest X-ray abnormal 30.82 11.56 56 125044 4342 34827489
Hypoglycaemia 30.58 11.56 97 125003 54543 34777288
Tooth disorder 30.48 11.56 97 125003 10785 34821046
Osteonecrosis of jaw 30.31 11.56 13 125087 17876 34813955
Upper respiratory tract infection 29.83 11.56 45 125055 33014 34798817
Full blood count abnormal 29.67 11.56 139 124961 18529 34813302
Haemorrhoidal haemorrhage 29.57 11.56 50 125050 3661 34828170
Atheroembolism 29.52 11.56 17 125083 313 34831518
Pericarditis 29.22 11.56 100 125000 11545 34820286
Duodenal ulcer haemorrhage 29.19 11.56 59 125041 4954 34826877
Psoriasis 28.56 11.56 60 125040 38752 34793079
Injection site reaction 28.34 11.56 6 125094 13027 34818804
Cardiac flutter 28.21 11.56 34 125066 1819 34830012
Muscle haemorrhage 28.19 11.56 49 125051 3669 34828162
Wound haemorrhage 28.12 11.56 36 125064 2049 34829782
Gastrointestinal arteriovenous malformation 27.89 11.56 17 125083 349 34831482
Proteinuria 27.88 11.56 16 125084 18626 34813205
Stevens-Johnson syndrome 27.87 11.56 16 125084 18623 34813208
Therapeutic drug monitoring analysis not performed 27.86 11.56 20 125080 545 34831286
Staphylococcal infection 27.30 11.56 47 125053 32713 34799118
Nephropathy toxic 26.96 11.56 6 125094 12582 34819249
Basal ganglia haemorrhage 26.83 11.56 24 125076 902 34830929
Ulcer haemorrhage 26.83 11.56 40 125060 2630 34829201
Retroperitoneal haematoma 26.74 11.56 40 125060 2638 34829193
Product use in unapproved indication 26.71 11.56 280 124820 117219 34714612
Osteonecrosis 26.56 11.56 10 125090 14880 34816951
Drug level increased 26.47 11.56 24 125076 22072 34809759
Diabetes mellitus 26.37 11.56 83 125017 46790 34785041
Injection site erythema 26.23 11.56 12 125088 15887 34815944
Blood triglycerides increased 26.13 11.56 9 125091 14150 34817681
Benign prostatic hyperplasia 26.09 11.56 112 124988 14383 34817448
Tremor 25.85 11.56 181 124919 82406 34749425
Rheumatoid arthritis 25.78 11.56 62 125038 38176 34793655
Blood pressure increased 25.70 11.56 197 124903 87905 34743926
Pain 25.61 11.56 548 124552 204127 34627704
Respiratory arrest 25.47 11.56 38 125062 28005 34803826
Eye haemorrhage 25.46 11.56 51 125049 4254 34827577
Lymphadenopathy 25.43 11.56 39 125061 28424 34803407
Laryngeal haemorrhage 25.38 11.56 8 125092 27 34831804
Candida infection 25.38 11.56 16 125084 17699 34814132
Gastric ulcer 25.22 11.56 117 124983 15533 34816298
Posterior reversible encephalopathy syndrome 25.20 11.56 3 125097 9951 34821880
Cerebral thrombosis 25.15 11.56 24 125076 981 34830850
Eye pruritus 24.98 11.56 71 125029 7418 34824413
Hallucination, auditory 24.89 11.56 6 125094 11911 34819920
Graft versus host disease 24.84 11.56 4 125096 10565 34821266
Abdominal pain 24.45 11.56 425 124675 163193 34668638
Circumstance or information capable of leading to medication error 24.44 11.56 31 125069 1748 34830083
Low cardiac output syndrome 24.35 11.56 19 125081 589 34831242
Platypnoea 24.33 11.56 8 125092 32 34831799
Haemorrhoids 24.25 11.56 110 124990 14465 34817366
Psychomotor hyperactivity 24.12 11.56 3 125097 9619 34822212
Urticaria 24.08 11.56 128 124972 62249 34769582
Mania 23.75 11.56 3 125097 9508 34822323
Anti factor Xa activity decreased 23.68 11.56 6 125094 6 34831825
Arteriovenous malformation 23.58 11.56 21 125079 785 34831046
Haemarthrosis 23.48 11.56 42 125058 3217 34828614
Swelling face 23.31 11.56 29 125071 23076 34808755
Vasculitis 23.27 11.56 91 125009 11205 34820626
Percutaneous coronary intervention 23.18 11.56 13 125087 227 34831604
Hepatic steatosis 23.15 11.56 19 125081 18343 34813488
Hypersensitivity 23.14 11.56 126 124974 60909 34770922
Lymphopenia 23.06 11.56 15 125085 16320 34815511
Bone pain 23.01 11.56 24 125076 20662 34811169
Traumatic haemothorax 22.94 11.56 14 125086 288 34831543
Anger 22.90 11.56 7 125093 11877 34819954
Tachyarrhythmia 22.86 11.56 44 125056 3564 34828267
Urethral haemorrhage 22.80 11.56 16 125084 420 34831411
Coagulation factor V level abnormal 22.74 11.56 8 125092 41 34831790
Haemorrhagic ascites 22.69 11.56 11 125089 140 34831691
Hepatitis C 22.49 11.56 4 125096 9826 34822005
Aortic valve disease 22.48 11.56 25 125075 1226 34830605
Fear 22.42 11.56 5 125095 10471 34821360
Glomerular filtration rate abnormal 22.34 11.56 21 125079 842 34830989
Aspergillus infection 22.25 11.56 8 125092 12246 34819585
Gastrostomy 22.22 11.56 20 125080 758 34831073
Peripheral artery occlusion 22.21 11.56 29 125071 1683 34830148
Renal haematoma 22.21 11.56 17 125083 512 34831319
Peripheral artery stenosis 22.16 11.56 21 125079 851 34830980
Prohormone brain natriuretic peptide increased 22.00 11.56 9 125091 74 34831757
No adverse event 21.97 11.56 149 124951 22778 34809053
Anastomotic infection 21.83 11.56 10 125090 111 34831720
Extradural haematoma 21.78 11.56 24 125076 1165 34830666
Neoplasm progression 21.72 11.56 31 125069 23269 34808562
Polyp 21.71 11.56 45 125055 3847 34827984
Drug ineffective for unapproved indication 21.67 11.56 32 125068 23683 34808148
Miosis 21.55 11.56 4 125096 9531 34822300
Haemobilia 21.54 11.56 15 125085 389 34831442
Multiple sclerosis relapse 21.53 11.56 10 125090 13123 34818708
Blood urea increased 21.46 11.56 48 125052 30316 34801515
Gastric ulcer haemorrhage 21.43 11.56 55 125045 5411 34826420
Hospice care 21.42 11.56 64 125036 6876 34824955
Pathogen resistance 21.38 11.56 4 125096 9478 34822353
Abnormal loss of weight 21.32 11.56 46 125054 4044 34827787
Xyphoid retraction 21.27 11.56 11 125089 162 34831669
Withdrawal syndrome 21.18 11.56 9 125091 12446 34819385
Ejection fraction decreased 21.13 11.56 129 124971 19025 34812806
Bleeding time prolonged 20.97 11.56 18 125082 640 34831191
Transcatheter aortic valve implantation 20.84 11.56 5 125095 3 34831828
Antiphospholipid syndrome 20.81 11.56 16 125084 485 34831346
Malignant neoplasm progression 20.75 11.56 208 124892 87838 34743993
Colon cancer 20.73 11.56 73 125027 8548 34823283
Anaphylactic shock 20.71 11.56 16 125084 15925 34815906
Muscle rigidity 20.63 11.56 6 125094 10512 34821319
Anaphylactic reaction 20.51 11.56 54 125046 32247 34799584
Respiratory tract haemorrhage 20.48 11.56 24 125076 1246 34830585
Splenic haematoma 20.47 11.56 11 125089 176 34831655
Bradycardia 20.30 11.56 381 124719 75037 34756794
Progressive multifocal leukoencephalopathy 20.23 11.56 5 125095 9759 34822072
Amyloidosis 20.19 11.56 31 125069 2092 34829739
Platelet distribution width increased 20.17 11.56 10 125090 134 34831697
Chills 20.13 11.56 189 124911 80854 34750977
Pericardial drainage 20.13 11.56 9 125091 94 34831737
Benign gastrointestinal neoplasm 20.11 11.56 10 125090 135 34831696
Renal tubular necrosis 20.04 11.56 16 125084 15664 34816167
Hyperkaliuria 20.04 11.56 9 125091 95 34831736
Mitral valve incompetence 20.01 11.56 106 124994 14837 34816994
Creatinine renal clearance decreased 19.93 11.56 40 125060 3341 34828490
Generalised tonic-clonic seizure 19.91 11.56 28 125072 21146 34810685
Hemiparesis 19.83 11.56 110 124990 15668 34816163
Product quality issue 19.82 11.56 19 125081 17016 34814815
Pulmonary thrombosis 19.82 11.56 65 125035 7342 34824489
Metallosis of globe 19.73 11.56 5 125095 5 34831826
Hepatotoxicity 19.62 11.56 29 125071 21456 34810375
Hypoacusis 19.40 11.56 112 124988 16189 34815642
Bladder irrigation 19.32 11.56 8 125092 68 34831763
Prostatic haemorrhage 19.32 11.56 12 125088 255 34831576
Diverticulum 19.31 11.56 63 125037 7096 34824735
Nightmare 19.27 11.56 14 125086 14377 34817454
Retroperitoneal haemorrhage 19.26 11.56 36 125064 2852 34828979
Infarction 19.22 11.56 35 125065 2718 34829113
Blindness 19.19 11.56 105 124995 14881 34816950
Oedema peripheral 19.18 11.56 563 124537 119249 34712582
Incorrect route of product administration 19.16 11.56 15 125085 14830 34817001
Prosthetic cardiac valve thrombosis 19.09 11.56 6 125094 20 34831811
Catheter site pruritus 19.08 11.56 13 125087 325 34831506
Diplopia 18.94 11.56 114 124986 16729 34815102
Hepatic haemorrhage 18.90 11.56 15 125085 477 34831354
Muscle twitching 18.87 11.56 80 125020 10218 34821613
Myoclonus 18.85 11.56 15 125085 14710 34817121
Contraindicated product prescribed 18.84 11.56 14 125086 403 34831428
Schizophrenia 18.82 11.56 4 125096 8662 34823169
Psoriatic arthropathy 18.79 11.56 26 125074 19772 34812059
Tumour lysis syndrome 18.74 11.56 20 125080 17039 34814792
Depressed mood 18.71 11.56 25 125075 19292 34812539
Anxiety 18.70 11.56 247 124853 99181 34732650
Palpitations 18.61 11.56 222 124878 39764 34792067
Pneumocystis jirovecii pneumonia 18.60 11.56 26 125074 19684 34812147
Catheter management 18.58 11.56 20 125080 945 34830886
Clotting factor transfusion 18.55 11.56 4 125096 0 34831831
Lymphocyte count decreased 18.35 11.56 33 125067 22589 34809242
Ventricular tachycardia 18.34 11.56 160 124940 26419 34805412
Drug level fluctuating 18.29 11.56 15 125085 500 34831331
Transplant rejection 18.27 11.56 7 125093 10304 34821527
Prostatic adenoma 18.23 11.56 10 125090 167 34831664
Hepatic failure 18.15 11.56 63 125037 34468 34797363
Hypertriglyceridaemia 18.15 11.56 4 125096 8444 34823387
White blood cell count decreased 17.99 11.56 237 124863 95208 34736623
Duodenal ulcer 17.96 11.56 79 125021 10253 34821578
Intracardiac thrombus 17.77 11.56 32 125068 2464 34829367
Substance abuse 17.72 11.56 3 125097 7638 34824193
Bacterial infection 17.65 11.56 21 125079 17042 34814789
Hypervolaemia 17.65 11.56 126 124974 19583 34812248
Hepatic encephalopathy 17.53 11.56 16 125084 14669 34817162
Haemorrhagic cholecystitis 17.53 11.56 8 125092 88 34831743
Drug reaction with eosinophilia and systemic symptoms 17.50 11.56 60 125040 32952 34798879
Splenomegaly 17.43 11.56 17 125083 15100 34816731
Tumour haemorrhage 17.41 11.56 35 125065 2927 34828904
Intra-abdominal haemorrhage 17.34 11.56 31 125069 2373 34829458
Acute myeloid leukaemia 17.34 11.56 24 125076 18246 34813585
Mucosal haemorrhage 17.28 11.56 25 125075 1600 34830231
Platelet count decreased 17.23 11.56 313 124787 119404 34712427
Occult blood positive 17.20 11.56 42 125058 4006 34827825
Synovitis 17.18 11.56 15 125085 14051 34817780
Paranoia 17.15 11.56 11 125089 12057 34819774
Product monitoring error 17.09 11.56 44 125056 4337 34827494
Sinusitis 17.09 11.56 83 125017 41319 34790512
Lupus pneumonitis 17.06 11.56 7 125093 58 34831773
Cytomegalovirus viraemia 17.05 11.56 3 125097 7427 34824404
Gastrointestinal polyp 16.96 11.56 7 125093 59 34831772
Intervertebral disc degeneration 16.89 11.56 56 125044 6361 34825470
Wound haematoma 16.86 11.56 7 125093 60 34831771
Putamen haemorrhage 16.83 11.56 11 125089 256 34831575
Intentional underdose 16.81 11.56 16 125084 652 34831179
Glomerular filtration rate decreased 16.72 11.56 91 125009 12870 34818961
Dementia 16.72 11.56 95 125005 13653 34818178
COVID-19 pneumonia 16.69 11.56 111 124989 16856 34814975
Renal mass 16.68 11.56 26 125074 1778 34830053
Appendicitis 16.67 11.56 17 125083 14790 34817041
Pancreatitis 16.61 11.56 77 125023 38814 34793017
Skin pressure mark 16.56 11.56 7 125093 63 34831768
Helicobacter test false negative 16.56 11.56 7 125093 63 34831768
Aplastic anaemia 16.55 11.56 7 125093 9709 34822122
Dizziness postural 16.41 11.56 54 125046 6110 34825721
Hypoaesthesia 16.26 11.56 141 124959 61303 34770528
Dyskinesia 16.19 11.56 35 125065 22378 34809453
Hypotension 16.15 11.56 958 124142 220691 34611140
Liver function test abnormal 16.12 11.56 57 125043 31017 34800814
Fungal infection 16.08 11.56 20 125080 15915 34815916
Ilium fracture 16.06 11.56 9 125091 157 34831674
Adrenal haemorrhage 16.00 11.56 10 125090 215 34831616
Hydrocephalus 15.92 11.56 48 125052 5184 34826647
Respiratory failure 15.89 11.56 283 124817 108289 34723542
Vascular cauterisation 15.87 11.56 6 125094 39 34831792
Limb injury 15.71 11.56 83 125017 11606 34820225
Haemophagocytic lymphohistiocytosis 15.65 11.56 14 125086 12959 34818872
Blood alkaline phosphatase increased 15.64 11.56 58 125042 31117 34800714
Coma uraemic 15.62 11.56 6 125094 41 34831790
Ataxia 15.49 11.56 16 125084 13837 34817994
Mental disorder 15.44 11.56 19 125081 15190 34816641
Oesophageal infection 15.38 11.56 11 125089 298 34831533
Hyperkinetic heart syndrome 15.34 11.56 8 125092 120 34831711
Gastroduodenal haemorrhage 15.33 11.56 9 125091 172 34831659
Therapy non-responder 15.28 11.56 80 125020 39066 34792765
Accidental exposure to product 15.22 11.56 14 125086 12788 34819043
Dry mouth 15.21 11.56 56 125044 30109 34801722
Disease recurrence 15.16 11.56 34 125066 21456 34810375
Skin exfoliation 15.13 11.56 49 125051 27383 34804448
Mitral valve thickening 15.11 11.56 12 125088 382 34831449
Haemorrhagic infarction 15.10 11.56 13 125087 464 34831367
Chloasma 15.01 11.56 5 125095 21 34831810
Radiation fibrosis - lung 15.01 11.56 5 125095 21 34831810
Gastritis haemorrhagic 14.96 11.56 22 125078 1429 34830402
Haemostasis 14.94 11.56 8 125092 127 34831704
Nipple exudate bloody 14.90 11.56 4 125096 6 34831825
Renal haemorrhage 14.89 11.56 22 125078 1435 34830396
Neoplasm malignant 14.89 11.56 122 124978 19783 34812048
Mitral valve calcification 14.86 11.56 14 125086 563 34831268
Gynaecomastia 14.85 11.56 9 125091 10171 34821660
C-reactive protein increased 14.83 11.56 123 124977 53975 34777856
Mental status changes 14.77 11.56 78 125022 38005 34793826
Pharyngitis 14.74 11.56 5 125095 7939 34823892
Transaminases increased 14.73 11.56 48 125052 26775 34805056
Cerebral artery embolism 14.69 11.56 17 125083 871 34830960
Amaurosis fugax 14.68 11.56 14 125086 572 34831259
Subcutaneous haematoma 14.67 11.56 18 125082 981 34830850
Fracture delayed union 14.60 11.56 6 125094 50 34831781
Metabolic acidosis 14.53 11.56 94 125006 43586 34788245
Amaurosis 14.50 11.56 15 125085 677 34831154
Skin lesion 14.49 11.56 36 125064 21925 34809906
Restlessness 14.42 11.56 45 125055 25437 34806394
Conjunctival haemorrhage 14.39 11.56 33 125067 3022 34828809
Thrombectomy 14.31 11.56 7 125093 91 34831740
Disseminated intravascular coagulation 14.21 11.56 36 125064 21780 34810051
Post transplant lymphoproliferative disorder 14.21 11.56 3 125097 6525 34825306
Pseudomonas infection 14.18 11.56 14 125086 12368 34819463
Discharge 14.18 11.56 11 125089 338 34831493
Syncope 14.16 11.56 428 124672 91023 34740808
Subdural hygroma 14.15 11.56 11 125089 339 34831492
Subdural haematoma evacuation 14.15 11.56 5 125095 26 34831805
Bronchiectasis 14.15 11.56 71 125029 9730 34822101
Blood phosphorus increased 14.09 11.56 5 125095 7716 34824115
Peritonitis 14.07 11.56 23 125077 16342 34815489
Bronchopulmonary aspergillosis allergic 14.07 11.56 17 125083 912 34830919
Laryngeal discomfort 14.06 11.56 9 125091 202 34831629
Increased tendency to bruise 14.03 11.56 39 125061 4022 34827809
Craniocerebral injury 14.02 11.56 34 125066 3229 34828602
Intentional overdose 14.01 11.56 95 125005 43579 34788252
Wrong patient received product 14.00 11.56 30 125070 2624 34829207
Inflammation 13.96 11.56 53 125047 28242 34803589
Cardiac arrest 13.96 11.56 251 124849 95908 34735923
Pulmonary hypertension 13.94 11.56 125 124975 20799 34811032
Infection 13.94 11.56 235 124865 90680 34741151
Traumatic haematoma 13.93 11.56 15 125085 709 34831122
Femoral artery embolism 13.91 11.56 3 125097 0 34831831
Anal ulcer haemorrhage 13.91 11.56 3 125097 0 34831831
Therapeutic aspiration 13.91 11.56 3 125097 0 34831831
Spontaneous hyphaema 13.91 11.56 3 125097 0 34831831
Factor Xa activity increased 13.91 11.56 3 125097 0 34831831
Intestinal varices haemorrhage 13.91 11.56 3 125097 0 34831831
Puncture site haematoma 13.81 11.56 8 125092 149 34831682
Splinter haemorrhages 13.72 11.56 7 125093 100 34831731
Heart rate abnormal 13.71 11.56 24 125076 1807 34830024
Orbital haemorrhage 13.70 11.56 5 125095 29 34831802
Liver disorder 13.70 11.56 66 125034 32931 34798900
Normochromic normocytic anaemia 13.68 11.56 40 125060 4247 34827584
Drug eruption 13.62 11.56 32 125068 19866 34811965
Renal injury 13.60 11.56 12 125088 11183 34820648
Splenic haemorrhage 13.57 11.56 12 125088 444 34831387
Anti factor X activity increased 13.56 11.56 6 125094 61 34831770
Intestinal haemorrhage 13.52 11.56 35 125065 3461 34828370
Impaired work ability 13.50 11.56 4 125096 6926 34824905
Tendonitis 13.45 11.56 8 125092 9132 34822699
Post procedural stroke 13.42 11.56 5 125095 31 34831800
Hemiparaesthesia 13.36 11.56 7 125093 106 34831725
Tuberculosis 13.35 11.56 7 125093 8570 34823261
Therapy partial responder 13.34 11.56 9 125091 9607 34822224
Respiratory distress 13.31 11.56 74 125026 35591 34796240
Vision blurred 13.29 11.56 103 124997 45860 34785971
Brain oedema 13.27 11.56 18 125082 13803 34818028
Injection site swelling 13.24 11.56 13 125087 11514 34820317
Increased appetite 13.23 11.56 5 125095 7424 34824407
Lung infiltration 13.23 11.56 16 125084 12889 34818942
Klebsiella infection 13.22 11.56 7 125093 8524 34823307
Pharyngeal haemorrhage 13.22 11.56 15 125085 752 34831079
Palmar-plantar erythrodysaesthesia syndrome 13.18 11.56 25 125075 16770 34815061
Bronchopulmonary aspergillosis 13.18 11.56 20 125080 14639 34817192
Hypophosphataemia 13.18 11.56 12 125088 11014 34820817
Therapy change 13.15 11.56 32 125068 3045 34828786
Stent placement 13.08 11.56 44 125056 5034 34826797
Productive cough 13.08 11.56 199 124901 37614 34794217
Acute generalised exanthematous pustulosis 13.04 11.56 4 125096 6772 34825059
Gastrointestinal neoplasm 13.01 11.56 8 125092 167 34831664
Aplasia pure red cell 12.98 11.56 3 125097 6129 34825702
Mood swings 12.98 11.56 6 125094 7895 34823936
Normocytic anaemia 12.95 11.56 27 125073 2317 34829514
Sinus node dysfunction 12.94 11.56 39 125061 4210 34827621
Blood sodium decreased 12.92 11.56 24 125076 16227 34815604
Oesophageal achalasia 12.91 11.56 11 125089 387 34831444
Incarcerated inguinal hernia 12.88 11.56 8 125092 170 34831661
Influenza like illness 12.84 11.56 53 125047 27581 34804250
Spinal epidural haematoma 12.84 11.56 10 125090 309 34831522
Hyperhidrosis 12.82 11.56 192 124908 75500 34756331
Catheter site irritation 12.81 11.56 7 125093 116 34831715
Ventricular drainage 12.80 11.56 4 125096 13 34831818
Cognitive disorder 12.79 11.56 158 124942 28535 34803296
Catheter placement 12.74 11.56 15 125085 783 34831048
Overflow diarrhoea 12.67 11.56 5 125095 37 34831794
Ventricular fibrillation 12.66 11.56 41 125059 22913 34808918
Wrong dose 12.58 11.56 13 125087 586 34831245
Skull fracture 12.58 11.56 16 125084 905 34830926
Enterococcal infection 12.53 11.56 9 125091 9297 34822534
Idiopathic interstitial pneumonia 12.52 11.56 8 125092 179 34831652
Hepatitis B 12.52 11.56 3 125097 5980 34825851
Small intestinal haemorrhage 12.52 11.56 25 125075 2081 34829750
Cardiovascular insufficiency 12.49 11.56 22 125078 1665 34830166
Escherichia infection 12.44 11.56 7 125093 8238 34823593
Heart rate increased 12.42 11.56 234 124866 46109 34785722
Creatinine renal clearance abnormal 12.42 11.56 9 125091 249 34831582
Mixed liver injury 12.41 11.56 30 125070 2843 34828988
Thromboembolectomy 12.34 11.56 5 125095 40 34831791
Subcapsular renal haematoma 12.31 11.56 11 125089 413 34831418
Prostatic operation 12.31 11.56 11 125089 413 34831418
Pneumonia fungal 12.28 11.56 5 125095 7095 34824736
Myelodysplastic syndrome 12.28 11.56 32 125068 19176 34812655
Infective exacerbation of chronic obstructive airways disease 12.26 11.56 23 125077 1828 34830003
Pneumonitis chemical 12.25 11.56 8 125092 186 34831645
Product complaint 12.23 11.56 3 125097 5887 34825944
Hirsutism 12.21 11.56 8 125092 187 34831644
Post procedural haematuria 12.17 11.56 8 125092 188 34831643
Speech disorder 12.10 11.56 49 125051 25637 34806194
Face oedema 12.10 11.56 14 125086 11502 34820329
Vasculitic rash 12.06 11.56 16 125084 943 34830888
Periorbital haematoma 12.03 11.56 10 125090 340 34831491
Nervous system disorder 11.99 11.56 21 125079 14522 34817309
Electrocardiogram abnormal 11.98 11.56 65 125035 9182 34822649
Right atrial pressure increased 11.87 11.56 6 125094 84 34831747
Polyneuropathy 11.84 11.56 22 125078 14874 34816957
Body temperature increased 11.83 11.56 28 125072 17340 34814491
Hyperammonaemia 11.83 11.56 4 125096 6363 34825468
Gingival bleeding 11.77 11.56 53 125047 6947 34824884
BK virus infection 11.77 11.56 3 125097 5735 34826096
Eosinophilia 11.75 11.56 51 125049 26171 34805660
Haemorrhagic cerebral infarction 11.69 11.56 15 125085 856 34830975
Cerebral artery occlusion 11.66 11.56 14 125086 746 34831085
Ruptured cerebral aneurysm 11.64 11.56 7 125093 140 34831691
Hepatitis 11.64 11.56 45 125055 23859 34807972

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
Death 1611.40 10.37 4338 220413 562176 78957461
Atrial fibrillation 1566.10 10.37 2330 222421 195556 79324081
Gastrointestinal haemorrhage 1538.76 10.37 1986 222765 145733 79373904
Cerebral haemorrhage 1276.55 10.37 1156 223595 56517 79463120
Haemorrhage 1193.37 10.37 1376 223375 89742 79429895
Haemorrhage intracranial 960.57 10.37 705 224046 25488 79494149
Prescribed underdose 894.32 10.37 709 224042 28805 79490832
Fall 782.24 10.37 3075 221676 484554 79035083
Drug ineffective 746.51 10.37 1189 223562 1079724 78439913
Cerebrovascular accident 692.26 10.37 1421 223330 153871 79365766
Haematoma 682.56 10.37 788 223963 51407 79468230
Subdural haematoma 658.07 10.37 611 224140 30823 79488814
Gastric haemorrhage 643.76 10.37 445 224306 14605 79505032
Anaemia 601.50 10.37 2664 222087 442351 79077286
Melaena 573.40 10.37 780 223971 60110 79459527
Epistaxis 557.64 10.37 1071 223680 110444 79409193
Cardiac failure 536.41 10.37 1281 223470 153561 79366076
Subarachnoid haemorrhage 526.55 10.37 483 224268 23982 79495655
Haematuria 516.89 10.37 792 223959 68044 79451593
Thrombosis 440.50 10.37 824 223927 83276 79436361
Dyspnoea 431.62 10.37 3986 220765 853039 78666598
Cerebral infarction 431.33 10.37 586 224165 45090 79474547
Ischaemic stroke 406.11 10.37 484 224267 32647 79486990
Haematochezia 404.43 10.37 814 223937 86831 79432806
Completed suicide 379.18 10.37 111 224640 245656 79273981
Intentional product use issue 375.73 10.37 1110 223641 151002 79368635
Drug hypersensitivity 370.44 10.37 190 224561 298726 79220911
Synovitis 363.43 10.37 14 224737 150720 79368917
Transfusion 333.96 10.37 354 224397 20976 79498661
Infusion related reaction 304.11 10.37 134 224617 230103 79289534
Toxicity to various agents 302.41 10.37 450 224301 421090 79098547
Rheumatoid arthritis 292.08 10.37 111 224640 208359 79311278
Renal impairment 291.62 10.37 1043 223708 156740 79362897
Rectal haemorrhage 287.78 10.37 653 224098 75647 79443990
Hospitalisation 285.39 10.37 741 224010 93495 79426142
Upper gastrointestinal haemorrhage 278.57 10.37 453 224298 40927 79478710
Cardiac disorder 277.75 10.37 589 224162 65168 79454469
Drug intolerance 276.98 10.37 204 224547 263915 79255722
Shock haemorrhagic 274.20 10.37 310 224441 19750 79499887
Pericardial haemorrhage 273.82 10.37 166 224585 4329 79515308
Haemoglobin decreased 264.63 10.37 1283 223468 220836 79298801
Exposure during pregnancy 264.14 10.37 4 224747 101128 79418509
Pulmonary embolism 262.29 10.37 1068 223683 170586 79349051
Pemphigus 259.83 10.37 4 224747 99578 79420059
Labelled drug-drug interaction medication error 253.84 10.37 350 224401 27300 79492337
Haemorrhagic stroke 253.22 10.37 226 224525 10820 79508817
Transient ischaemic attack 252.11 10.37 497 224254 52198 79467439
Therapeutic product effect decreased 249.02 10.37 76 224675 163787 79355850
Lower gastrointestinal haemorrhage 244.28 10.37 263 224488 15862 79503775
Drug abuse 242.69 10.37 78 224673 162613 79357024
Maternal exposure during pregnancy 237.16 10.37 48 224703 136490 79383147
Joint swelling 230.21 10.37 285 224466 288361 79231276
Hypersensitivity 223.01 10.37 246 224505 261993 79257644
Product prescribing error 214.78 10.37 423 224328 44390 79475247
Atrial thrombosis 204.83 10.37 128 224623 3528 79516109
Dyspnoea exertional 202.20 10.37 622 224129 86451 79433186
Glossodynia 200.19 10.37 27 224724 103310 79416327
Pain 200.09 10.37 1165 223586 702637 78817000
Systemic lupus erythematosus 197.51 10.37 49 224702 121100 79398537
Embolic stroke 195.20 10.37 168 224583 7658 79511979
Atrial flutter 192.91 10.37 270 224481 21355 79498282
Cardiospasm 191.08 10.37 118 224633 3183 79516454
Haematemesis 190.08 10.37 441 224310 51823 79467814
Intraventricular haemorrhage 189.23 10.37 136 224615 4751 79514886
Cardioversion 188.74 10.37 100 224651 1998 79517639
Musculoskeletal stiffness 184.91 10.37 134 224617 174874 79344763
Palmoplantar keratoderma 183.14 10.37 120 224631 3596 79516041
Sensitisation 178.17 10.37 113 224638 3198 79516439
General physical health deterioration 175.56 10.37 1352 223399 273886 79245751
Internal haemorrhage 172 10.37 165 224586 8668 79510969
Duodenal ulcer perforation 171.29 10.37 3 224748 66208 79453429
Stomatitis 170.44 10.37 101 224650 146656 79372981
Atrial tachycardia 169.60 10.37 149 224602 6984 79512653
Hepatic enzyme increased 165.68 10.37 162 224589 182448 79337189
Polycystic ovaries 164.55 10.37 113 224638 3666 79515971
Arrhythmia 161.59 10.37 458 224293 60814 79458823
Cerebral haematoma 159.67 10.37 151 224600 7791 79511846
Post procedural haemorrhage 157.34 10.37 194 224557 13550 79506087
Carotid artery occlusion 152.99 10.37 145 224606 7502 79512135
Blood cholesterol increased 152.71 10.37 26 224725 83694 79435943
Head injury 152.32 10.37 330 224421 37039 79482598
Sleep terror 152.21 10.37 115 224636 4343 79515294
Fluid retention 151.32 10.37 487 224264 69322 79450315
Haemoptysis 151.02 10.37 422 224329 55577 79464060
Pruritus genital 149.36 10.37 114 224637 4372 79515265
Pulmonary arterial hypertension 148.50 10.37 278 224473 28088 79491549
Arthralgia 147.51 10.37 975 223776 570828 78948809
Ejection fraction 143.91 10.37 86 224665 2183 79517454
Traumatic haemorrhage 141.44 10.37 71 224680 1262 79518375
Treatment failure 140.43 10.37 164 224587 170322 79349315
Diverticulum intestinal haemorrhagic 135.90 10.37 103 224648 3908 79515729
Bradycardia 134.21 10.37 744 224007 134813 79384824
Injection site pain 133.79 10.37 102 224649 129736 79389901
Acute kidney injury 132.56 10.37 2127 222624 517277 79002360
Hypotension 131.29 10.37 1852 222899 438465 79081172
Deep vein thrombosis 128.73 10.37 677 224074 120242 79399395
Systemic infection 128.69 10.37 148 224603 9604 79510033
Tension headache 127.90 10.37 128 224623 7083 79512554
Subdural haemorrhage 127.11 10.37 117 224634 5831 79513806
Arthropathy 126.83 10.37 189 224562 176922 79342715
Traumatic intracranial haemorrhage 125.74 10.37 64 224687 1173 79518464
Helicobacter infection 124.19 10.37 23 224728 69681 79449956
Cerebral mass effect 122.86 10.37 73 224678 1833 79517804
Immunisation 121.73 10.37 76 224675 2091 79517546
Sinusitis 120.29 10.37 230 224521 195271 79324366
Haemorrhage subcutaneous 119.46 10.37 103 224648 4706 79514931
Sleep disorder due to a general medical condition 116.69 10.37 171 224580 14106 79505531
Swelling 116.59 10.37 275 224476 216436 79303201
Muscle injury 115.36 10.37 5 224746 48556 79471081
Dizziness 114.08 10.37 2100 222651 524341 78995296
Folliculitis 113.34 10.37 12 224739 55368 79464269
Cerebral ventricular rupture 112.38 10.37 44 224707 416 79519221
Cardiac ablation 111.63 10.37 73 224678 2180 79517457
Anosmia 109.66 10.37 130 224621 8714 79510923
Thalamus haemorrhage 109.03 10.37 66 224685 1716 79517921
Depression 108.89 10.37 285 224466 216505 79303132
Psoriatic arthropathy 106.74 10.37 43 224708 77956 79441681
Impaired healing 106.54 10.37 57 224694 87598 79432039
Cardiac pacemaker insertion 104.47 10.37 104 224647 5718 79513919
Nasopharyngitis 103.77 10.37 367 224384 253514 79266123
Febrile neutropenia 103.30 10.37 321 224430 230678 79288959
Injection site erythema 102.39 10.37 46 224705 78151 79441486
Faeces discoloured 101.78 10.37 242 224509 28885 79490752
Haematoma muscle 101.77 10.37 73 224678 2542 79517095
Product use issue 100.75 10.37 282 224469 209540 79310097
Haemothorax 100.42 10.37 99 224652 5379 79514258
Pyrexia 98.82 10.37 1334 223417 677375 78842262
Rash 97.65 10.37 1101 223650 577257 78942380
Right atrial hypertrophy 96.59 10.37 46 224705 725 79518912
Therapeutic response decreased 96.25 10.37 34 224717 66819 79452818
Blister 96.16 10.37 117 224634 119359 79400278
Injection site reaction 95.64 10.37 19 224732 54766 79464871
Syncope 95.25 10.37 846 223905 178603 79341034
Oedema peripheral 93.55 10.37 1105 223646 251183 79268454
COVID-19 92.98 10.37 761 223990 156913 79362724
Mobility decreased 92.78 10.37 125 224626 122050 79397587
Basal ganglia haemorrhage 92.35 10.37 58 224693 1613 79518024
Discomfort 91.92 10.37 132 224619 125485 79394152
Infection 89.95 10.37 363 224388 241349 79278288
Cerebellar haemorrhage 88.09 10.37 70 224681 2850 79516787
Lower respiratory tract infection 87.62 10.37 143 224608 129077 79390560
Blood loss anaemia 87.57 10.37 157 224594 15341 79504296
Facial pain 86.92 10.37 138 224613 12212 79507425
Spinal cord haemorrhage 86.74 10.37 39 224712 535 79519102
Suicidal ideation 86.57 10.37 54 224697 76286 79443351
Irritable bowel syndrome 85.68 10.37 34 224717 62207 79457430
Aortic valve stenosis 84.88 10.37 89 224662 5205 79514432
Therapeutic drug monitoring analysis not performed 84.55 10.37 58 224693 1878 79517759
Alanine aminotransferase increased 82.94 10.37 212 224539 162358 79357279
Cardiac failure congestive 80.59 10.37 681 224070 141721 79377916
Hypervolaemia 80.29 10.37 284 224467 42406 79477231
Serotonin syndrome 79.90 10.37 15 224736 45012 79474625
Blood test abnormal 79.85 10.37 163 224588 17547 79502090
Psoriasis 79.47 10.37 81 224670 89506 79430131
Full blood count abnormal 79.36 10.37 273 224478 40201 79479436
Vascular pseudoaneurysm 78.84 10.37 71 224680 3439 79516198
N-terminal prohormone brain natriuretic peptide increased 78.14 10.37 81 224670 4674 79514963
Haemarthrosis 78.03 10.37 89 224662 5723 79513914
C-reactive protein abnormal 77.96 10.37 20 224731 48347 79471290
Injection site pruritus 77.39 10.37 13 224738 42270 79477367
Splenic rupture 77.09 10.37 60 224691 2369 79517268
Erythema 75.33 10.37 348 224403 222942 79296695
Renal disorder 73.17 10.37 273 224478 41832 79477805
Abdominal wall haematoma 72.96 10.37 79 224672 4794 79514843
Rhinitis allergic 72.82 10.37 127 224624 12142 79507495
Cardiac tamponade 72.78 10.37 109 224642 9167 79510470
Cardiac failure chronic 72.35 10.37 120 224631 11015 79508622
Mite allergy 71.28 10.37 44 224707 1186 79518451
Mucosal inflammation 70.91 10.37 65 224686 75515 79444122
Spontaneous haematoma 70.27 10.37 46 224705 1376 79518261
Vasculitis 69.47 10.37 191 224560 24911 79494726
Right ventricular hypertrophy 69.04 10.37 48 224703 1589 79518048
Seizure 68.11 10.37 287 224464 188547 79331090
Palpitations 67.72 10.37 598 224153 126012 79393625
Pain of skin 67.67 10.37 136 224615 14477 79505160
Traumatic haematoma 67.46 10.37 52 224699 2024 79517613
Urticaria 67.09 10.37 281 224470 184920 79334717
Alopecia 67.03 10.37 380 224371 230975 79288662
Haemorrhoidal haemorrhage 66.89 10.37 89 224662 6706 79512931
Gastrointestinal angiodysplasia 66.46 10.37 40 224711 1029 79518608
Drug dependence 65.44 10.37 17 224734 40752 79478885
Aspartate aminotransferase increased 65.29 10.37 188 224563 138453 79381184
Drug resistance 65.14 10.37 19 224732 42194 79477443
Pulmonary hypertension 64.69 10.37 288 224463 47792 79471845
Muscle haemorrhage 64.31 10.37 84 224667 6216 79513421
Ejection fraction abnormal 64.17 10.37 54 224697 2386 79517251
Post procedural haematoma 64.13 10.37 54 224697 2388 79517249
High frequency ablation 63.67 10.37 26 224725 277 79519360
Emotional distress 63.52 10.37 17 224734 39952 79479685
Malignant mediastinal neoplasm 63.24 10.37 43 224708 1372 79518265
Retroperitoneal haematoma 62.62 10.37 76 224675 5221 79514416
Cytomegalovirus infection 62.57 10.37 21 224730 42623 79477014
Pulmonary alveolar haemorrhage 62.11 10.37 114 224637 11343 79508294
Adverse event 61.91 10.37 334 224417 59880 79459757
Failure to suspend medication 61.59 10.37 29 224722 445 79519192
C-reactive protein increased 61.47 10.37 174 224577 128853 79390784
Blindness 60.57 10.37 197 224554 28186 79491451
Ill-defined disorder 60.22 10.37 58 224693 65817 79453820
Suicide attempt 59.82 10.37 88 224663 82844 79436793
Injection site swelling 59.73 10.37 29 224722 47103 79472534
Haemorrhagic disorder 59.01 10.37 43 224708 1535 79518102
Drug interaction 58.50 10.37 1558 223193 413625 79106012
Carpal tunnel syndrome 58.49 10.37 153 224598 19375 79500262
Hypoaesthesia 58.44 10.37 283 224468 179069 79340568
Multiple sclerosis relapse 58.41 10.37 29 224722 46504 79473133
Surgery 58.23 10.37 214 224537 32552 79487085
Catheter site haemorrhage 58.20 10.37 72 224679 5045 79514592
Nephrectomy 58.09 10.37 48 224703 2067 79517570
Sleep disorder due to general medical condition, insomnia type 58.00 10.37 25 224726 43531 79476106
Inflammation 57.89 10.37 110 224641 93643 79425994
Haemoperitoneum 57.45 10.37 66 224685 4277 79515360
Vomiting 56.48 10.37 1437 223314 664391 78855246
Urinary bladder haemorrhage 56.37 10.37 51 224700 2485 79517152
Retroperitoneal haemorrhage 55.94 10.37 73 224678 5397 79514240
Anaphylactic reaction 55.53 10.37 94 224657 83649 79435988
Product monitoring error 55.23 10.37 94 224657 8812 79510825
Spirometry abnormal 54.80 10.37 34 224717 925 79518712
Product use in unapproved indication 54.25 10.37 448 224303 249911 79269726
Red blood cell sedimentation rate increased 54.19 10.37 31 224720 45911 79473726
Bone marrow failure 54.11 10.37 39 224712 51068 79468569
Nausea 54.03 10.37 2179 222572 955017 78564620
Gout 53.92 10.37 173 224578 24576 79495061
Sedation 53.14 10.37 41 224710 51854 79467783
Blood urine present 53.04 10.37 156 224595 21141 79498496
Thrombectomy 52.95 10.37 23 224728 289 79519348
Brain stem haemorrhage 52.90 10.37 41 224710 1609 79518028
Upper respiratory tract infection 52.83 10.37 111 224640 91057 79428580
Gastric ulcer 52.52 10.37 212 224539 33693 79485944
Mixed liver injury 52.40 10.37 84 224667 7494 79512143
Neutropenia 52.33 10.37 538 224213 287172 79232465
Spontaneous haemorrhage 51.90 10.37 31 224720 786 79518851
Dementia 51.58 10.37 170 224581 24489 79495148
Stress 51.29 10.37 91 224660 79521 79440116
Drug withdrawal syndrome 51.11 10.37 17 224734 34701 79484936
Haemorrhagic hepatic cyst 51.04 10.37 15 224736 51 79519586
Agitation 50.86 10.37 130 224621 99585 79420052
Somnolence 50.71 10.37 430 224321 238551 79281086
Conjunctival haemorrhage 50.48 10.37 72 224679 5793 79513844
Overdose 50.45 10.37 308 224443 183898 79335739
Conjunctivitis allergic 49.27 10.37 40 224711 1680 79517957
Pericardial effusion 49.25 10.37 259 224492 45978 79473659
Haematoma evacuation 48.92 10.37 22 224729 302 79519335
Aggression 48.79 10.37 43 224708 50915 79468722
Muscle spasticity 48.52 10.37 3 224748 21472 79498165
Osteonecrosis of jaw 48.42 10.37 31 224720 43195 79476442
Dystonia 48.32 10.37 3 224748 21396 79498241
Type 2 diabetes mellitus 48.03 10.37 54 224697 57068 79462569
White blood cell count increased 47.46 10.37 86 224665 74547 79445090
Hepatotoxicity 47.18 10.37 45 224706 51307 79468330
Injury 46.91 10.37 92 224659 77404 79442233
Cardiac amyloidosis 46.91 10.37 40 224711 1800 79517837
Procedural haemorrhage 46.88 10.37 62 224689 4644 79514993
Grip strength decreased 46.70 10.37 4 224747 21865 79497772
Infarction 46.63 10.37 61 224690 4521 79515116
Hemiparesis 46.09 10.37 203 224548 33530 79486107
Wound 46.06 10.37 170 224581 116009 79403628
Iron deficiency anaemia 45.90 10.37 168 224583 25504 79494133
Bleeding time prolonged 45.86 10.37 34 224717 1247 79518390
Premature delivery 45.75 10.37 6 224745 23461 79496176
Hospice care 45.34 10.37 94 224657 10230 79509407
Wound haemorrhage 44.86 10.37 57 224694 4104 79515533
Sinus node dysfunction 44.77 10.37 79 224672 7622 79512015
Irritability 44.08 10.37 31 224720 41113 79478524
Extradural haematoma 43.72 10.37 47 224704 2829 79516808
Respiratory arrest 43.56 10.37 59 224692 57491 79462146
Anxiety 43.43 10.37 469 224282 248043 79271594
Ventricular tachycardia 43.37 10.37 233 224518 41702 79477935
Device expulsion 43.03 10.37 10 224741 25851 79493786
Joint range of motion decreased 42.91 10.37 20 224731 33262 79486375
Mycotic allergy 42.82 10.37 35 224716 1484 79518153
Arthritis 42.40 10.37 173 224578 114707 79404930
White blood cell count decreased 42.11 10.37 334 224417 187954 79331683
Posterior reversible encephalopathy syndrome 42.10 10.37 11 224740 26270 79493367
Urogenital haemorrhage 42.03 10.37 29 224722 948 79518689
Spinal subarachnoid haemorrhage 42.01 10.37 13 224738 55 79519582
Limb injury 41.33 10.37 179 224572 29349 79490288
Toxic epidermal necrolysis 41.04 10.37 39 224712 44542 79475095
Intracranial haematoma 40.67 10.37 28 224723 912 79518725
Dust allergy 40.41 10.37 34 224717 1502 79518135
Pulmonary function test abnormal 40.37 10.37 54 224697 4090 79515547
Transplant rejection 40.32 10.37 4 224747 19433 79500204
Gastrointestinal disorder 40.27 10.37 192 224559 122013 79397624
Pulmonary thrombosis 40.24 10.37 99 224652 12072 79507565
Fear 39.71 10.37 7 224744 21979 79497658
Body temperature increased 39.57 10.37 40 224711 44380 79475257
Eye haemorrhage 39.56 10.37 86 224665 9671 79509966
Blood creatine phosphokinase increased 39.53 10.37 79 224672 66011 79453626
Red blood cell sedimentation rate abnormal 39.37 10.37 6 224745 20957 79498680
Sleep apnoea syndrome 39.31 10.37 205 224546 36273 79483364
Catheter management 39.21 10.37 50 224701 3613 79516024
Benign prostatic hyperplasia 38.98 10.37 95 224656 11517 79508120
Catheter site erythema 38.88 10.37 60 224691 5180 79514457
Obstruction 38.81 10.37 56 224695 4554 79515083
Contraindicated product administered 38.78 10.37 272 224479 157266 79362371
Live birth 38.51 10.37 4 224747 18740 79500897
Atheroembolism 38.50 10.37 19 224732 325 79519312
Bronchial wall thickening 38.12 10.37 42 224709 2599 79517038
Pain in jaw 37.73 10.37 241 224510 45910 79473727
Abortion spontaneous 37.62 10.37 18 224733 29489 79490148
Catheter site pruritus 37.60 10.37 39 224712 2252 79517385
Myelosuppression 37.39 10.37 35 224716 40261 79479376
Gastrointestinal endoscopic therapy 37.33 10.37 12 224739 59 79519578
Heart rate increased 37.13 10.37 511 224240 120213 79399424
Liver injury 37.11 10.37 64 224687 56550 79463087
Neutrophil count decreased 36.91 10.37 138 224613 93821 79425816
Tremor 36.53 10.37 305 224446 169778 79349859
Subcutaneous haematoma 36.40 10.37 42 224709 2735 79516902
Heart rate abnormal 36.34 10.37 63 224688 5994 79513643
Tumour haemorrhage 35.86 10.37 51 224700 4093 79515544
Colon cancer 35.80 10.37 106 224645 14417 79505220
Diabetes mellitus 35.66 10.37 108 224643 78282 79441355
Fungal infection 35.61 10.37 39 224712 41709 79477928
Abdominal discomfort 35.54 10.37 495 224256 250232 79269405
Neurotoxicity 35.50 10.37 24 224727 32494 79487143
Dehydration 35.37 10.37 933 223818 247254 79272383
Haemorrhage urinary tract 35.29 10.37 39 224712 2422 79517215
Lymphocyte count decreased 35.26 10.37 49 224702 47240 79472397
Neuroleptic malignant syndrome 34.85 10.37 17 224734 27542 79492095
Gastric ulcer haemorrhage 34.83 10.37 78 224673 8949 79510688
Mania 34.81 10.37 5 224746 18255 79501382
Duodenal ulcer haemorrhage 34.77 10.37 68 224683 7095 79512542
Bronchial secretion retention 34.77 10.37 50 224701 4054 79515583
Polypectomy 34.49 10.37 28 224723 1176 79518461
Large intestine polyp 34.48 10.37 96 224655 12612 79507025
Generalised tonic-clonic seizure 34.27 10.37 44 224707 43866 79475771
Injection site bruising 34.21 10.37 39 224712 40963 79478674
Coagulation factor deficiency 34.05 10.37 14 224737 152 79519485
Incorrect route of product administration 34.01 10.37 29 224722 34900 79484737
Psychotic disorder 33.88 10.37 40 224711 41362 79478275
Herpes zoster 33.83 10.37 141 224610 92942 79426695
Catheter site irritation 33.82 10.37 21 224730 572 79519065
Eye pruritus 33.78 10.37 131 224620 20439 79499198
Tachyarrhythmia 33.69 10.37 66 224685 6896 79512741
Catheterisation cardiac 33.61 10.37 59 224692 5669 79513968
Duodenal ulcer 33.48 10.37 112 224639 16257 79503380
Leukopenia 33.38 10.37 192 224559 116321 79403316
Intracardiac thrombus 33.05 10.37 50 224701 4243 79515394
Mental disorder 32.99 10.37 24 224727 31278 79488359
Adrenal haemorrhage 32.96 10.37 21 224730 599 79519038
Glomerular filtration rate decreased 32.84 10.37 139 224612 22563 79497074
Cerebrospinal fluid retention 32.84 10.37 12 224739 92 79519545
Osteopenia 32.83 10.37 6 224745 18358 79501279
Haematotoxicity 32.70 10.37 3 224748 15516 79504121
Percutaneous coronary intervention 32.62 10.37 18 224733 391 79519246
Schizophrenia 32.50 10.37 3 224748 15437 79504200
Paraesthesia 32.32 10.37 329 224422 175994 79343643
Progressive multifocal leukoencephalopathy 32.29 10.37 9 224742 20591 79499046
Hip arthroplasty 32.08 10.37 32 224719 35724 79483913
Disability 31.92 10.37 5 224746 17115 79502522
Vena cava filter insertion 31.88 10.37 13 224738 138 79519499
Sleep disorder 31.62 10.37 129 224622 85548 79434089
Cardiac failure acute 31.45 10.37 121 224630 18808 79500829
Large intestinal haemorrhage 31.15 10.37 39 224712 2766 79516871
Renal haemorrhage 31.06 10.37 35 224716 2221 79517416
Haemangioma of spleen 30.94 10.37 8 224743 14 79519623
Gastrointestinal tube insertion 30.89 10.37 30 224721 1600 79518037
Haemobilia 30.88 10.37 19 224732 509 79519128
Splenic haematoma 30.78 10.37 16 224735 307 79519330
Gastrointestinal ulcer haemorrhage 30.72 10.37 27 224724 1266 79518371
Occult blood positive 30.61 10.37 63 224688 6820 79512817
Skull fracture 30.48 10.37 31 224720 1749 79517888
Dry mouth 30.36 10.37 136 224615 87883 79431754
Hepatic steatosis 30.30 10.37 37 224714 37701 79481936
Ulcer haemorrhage 30.28 10.37 57 224694 5781 79513856
Blood calcium decreased 30.28 10.37 27 224724 31792 79487845
No adverse event 30.27 10.37 194 224557 36998 79482639
Foot deformity 30.22 10.37 15 224736 24059 79495578
Hydrocephalus 30.07 10.37 73 224678 8827 79510810
Skin pressure mark 30.03 10.37 11 224740 85 79519552
Ear pain 29.97 10.37 29 224722 32840 79486797
Immunodeficiency 29.78 10.37 12 224739 21756 79497881
Aplastic anaemia 29.64 10.37 7 224744 17898 79501739
Gastritis haemorrhagic 29.60 10.37 37 224714 2620 79517017
Intra-abdominal haemorrhage 29.59 10.37 49 224702 4491 79515146
Clotting factor transfusion 29.25 10.37 6 224745 0 79519637
Prescribed overdose 29.24 10.37 195 224556 37688 79481949
Gastrointestinal tract mucosal pigmentation 29.20 10.37 24 224727 1026 79518611
Diverticulum 28.78 10.37 100 224651 14796 79504841
Disease progression 28.67 10.37 357 224394 184005 79335632
Gingival bleeding 28.66 10.37 106 224645 16170 79503467
Craniocerebral injury 28.54 10.37 52 224699 5144 79514493
Thirst decreased 28.38 10.37 15 224736 298 79519339
Listless 28.36 10.37 44 224707 3817 79515820
Impaired work ability 28.34 10.37 10 224741 19671 79499966
Oesophageal achalasia 28.26 10.37 21 224730 773 79518864
Tendonitis 28.22 10.37 16 224735 23814 79495823
Therapy non-responder 28.14 10.37 149 224602 92156 79427481
Respiratory depression 28.07 10.37 22 224729 27608 79492029
Crying 27.97 10.37 15 224736 23028 79496609
Chills 27.73 10.37 303 224448 159931 79359706
Craniotomy 27.71 10.37 17 224734 453 79519184
Diastolic dysfunction 27.70 10.37 80 224671 10731 79508906
Cerebral artery occlusion 27.70 10.37 29 224722 1693 79517944
Ocular retrobulbar haemorrhage 27.68 10.37 12 224739 150 79519487
Traumatic haemothorax 27.57 10.37 18 224733 536 79519101
Therapy change 27.51 10.37 63 224688 7336 79512301
Staphylococcal infection 27.47 10.37 79 224672 58216 79461421
Eye haematoma 27.26 10.37 12 224739 156 79519481
Vascular device infection 27.26 10.37 77 224674 10199 79509438
Arteriovenous malformation 27.16 10.37 29 224722 1732 79517905
Anaphylactic shock 27.14 10.37 37 224714 35959 79483678
Exostosis 27.11 10.37 7 224744 16851 79502786
Product complaint 27.04 10.37 3 224748 13346 79506291
Pallor 27.03 10.37 237 224514 49825 79469812
Glomerular filtration rate abnormal 26.95 10.37 28 224723 1620 79518017
Prohormone brain natriuretic peptide increased 26.86 10.37 14 224737 270 79519367
Anti factor X activity increased 26.78 10.37 10 224741 82 79519555
Drug ineffective for unapproved indication 26.75 10.37 66 224685 51172 79468465
Hypothyroidism 26.74 10.37 245 224506 52147 79467490
Lymphadenopathy 26.70 10.37 70 224681 53177 79466460
Graft versus host disease 26.67 10.37 5 224746 15021 79504616
Hypercholesterolaemia 26.65 10.37 16 224735 23079 79496558
Anhedonia 26.35 10.37 5 224746 14893 79504744
Device pacing issue 26.31 10.37 11 224740 125 79519512
Platypnoea 26.21 10.37 8 224743 32 79519605
Sedation complication 26.19 10.37 6 224745 15663 79503974
Throat tightness 26.17 10.37 24 224727 27883 79491754
Joint stiffness 26 10.37 47 224704 40783 79478854
Defaecation disorder 25.98 10.37 19 224732 682 79518955
Proteinuria 25.96 10.37 32 224719 32470 79487167
Fracture 25.94 10.37 126 224625 21675 79497962
Accidental exposure to product 25.91 10.37 30 224721 31292 79488345
Bursitis 25.88 10.37 38 224713 35806 79483831
Extrapyramidal disorder 25.76 10.37 16 224735 22663 79496974
BRASH syndrome 25.70 10.37 22 224729 995 79518642
Neutrophil count increased 25.58 10.37 27 224724 29369 79490268
Ear haemorrhage 25.58 10.37 31 224720 2126 79517511
Renal haematoma 25.58 10.37 20 224731 795 79518842
Osteonecrosis 25.49 10.37 30 224721 31065 79488572
Abnormal loss of weight 25.47 10.37 66 224685 8310 79511327
Cerebral artery embolism 25.46 10.37 29 224722 1862 79517775
Subchondral insufficiency fracture 25.46 10.37 9 224742 62 79519575
Benign gastrointestinal neoplasm 25.34 10.37 11 224740 138 79519499
Neoplasm malignant 25.32 10.37 165 224586 31645 79487992
Vaginal haemorrhage 25.18 10.37 125 224626 21692 79497945
Skin exfoliation 25.00 10.37 76 224675 55024 79464613
Pathogen resistance 24.98 10.37 5 224746 14337 79505300
Caesarean section 24.93 10.37 3 224748 12532 79507105
Pneumocystis jirovecii pneumonia 24.93 10.37 33 224718 32475 79487162
Neovascular age-related macular degeneration 24.81 10.37 15 224736 389 79519248
Knee arthroplasty 24.76 10.37 53 224698 43195 79476442
Pericarditis 24.66 10.37 182 224569 104054 79415583
Tooth disorder 24.62 10.37 142 224609 26091 79493546
Electrocardiogram abnormal 24.62 10.37 103 224648 16634 79503003
Right ventricular failure 24.60 10.37 131 224620 23366 79496271
Gastrointestinal arteriovenous malformation 24.59 10.37 21 224730 947 79518690
Poisoning 24.58 10.37 21 224730 25251 79494386
Condition aggravated 24.56 10.37 1158 223593 499966 79019671
Mallory-Weiss syndrome 24.53 10.37 35 224716 2817 79516820
Panniculitis 24.51 10.37 3 224748 12368 79507269
Product quality issue 24.48 10.37 36 224715 33904 79485733
Blood pressure systolic abnormal 24.43 10.37 9 224742 17238 79502399
Muscle spasms 24.38 10.37 346 224405 174384 79345253
Hepatic haemangioma rupture 24.37 10.37 5 224746 0 79519637
Prostatic adenoma 24.29 10.37 10 224741 109 79519528
Medication error 24.23 10.37 298 224453 68344 79451293
Mucosal haemorrhage 24.13 10.37 33 224718 2553 79517084
Rectosigmoid cancer 24.08 10.37 13 224738 270 79519367
Ankylosing spondylitis 24.08 10.37 3 224748 12202 79507435
Cutaneous vasculitis 24.05 10.37 64 224687 8188 79511449
Influenza like illness 24.01 10.37 112 224639 71595 79448042
Haemorrhagic diathesis 23.96 10.37 53 224698 6031 79513606
Diplopia 23.89 10.37 169 224582 33297 79486340
Orbital compartment syndrome 23.88 10.37 9 224742 76 79519561
COVID-19 pneumonia 23.79 10.37 151 224600 28698 79490939
Xyphoid retraction 23.77 10.37 11 224740 162 79519475
Lip dry 23.68 10.37 7 224744 15411 79504226
Haemorrhagic ascites 23.66 10.37 13 224738 280 79519357
Acute respiratory failure 23.45 10.37 264 224487 59277 79460360
Therapy interrupted 23.40 10.37 160 224591 31181 79488456
Laryngeal haemorrhage 23.15 10.37 8 224743 51 79519586
Petechiae 23.15 10.37 117 224634 20448 79499189
Intestinal haemorrhage 23.11 10.37 54 224697 6372 79513265
Transcatheter aortic valve implantation 23.02 10.37 8 224743 52 79519585
Inappropriate schedule of product administration 23.00 10.37 253 224498 133375 79386262
Amyloidosis 22.97 10.37 33 224718 2673 79516964
Ataxia 22.93 10.37 22 224729 25017 79494620
Ovarian cyst 22.92 10.37 4 224747 12651 79506986
Bronchiectasis 22.89 10.37 124 224627 22262 79497375
Factor V Leiden mutation 22.84 10.37 11 224740 178 79519459
Catheter site discharge 22.84 10.37 31 224720 2381 79517256
Haemophagocytic lymphohistiocytosis 22.68 10.37 17 224734 21820 79497817
Oxygen consumption increased 22.65 10.37 46 224705 4933 79514704
Prosthetic cardiac valve thrombosis 22.64 10.37 8 224743 55 79519582
Muscle twitching 22.56 10.37 133 224618 24631 79495006
Acne 22.53 10.37 26 224725 27164 79492473
Ear infection 22.50 10.37 39 224712 34393 79485244
Aspergillus infection 22.49 10.37 13 224738 19148 79500489
Anastomotic infection 22.45 10.37 10 224741 134 79519503
Lymphopenia 22.45 10.37 32 224719 30525 79489112
Blood lactate dehydrogenase increased 22.43 10.37 48 224703 39122 79480515
Stevens-Johnson syndrome 22.42 10.37 48 224703 39118 79480519
Coagulation factor V level abnormal 22.40 10.37 8 224743 57 79519580
Platelet distribution width increased 22.38 10.37 10 224741 135 79519502
Duodenal vascular ectasia 22.37 10.37 6 224745 13 79519624
Calciphylaxis 22.34 10.37 39 224712 3731 79515906
Multiple sclerosis 22.31 10.37 18 224733 22264 79497373
Circumstance or information capable of leading to medication error 22.31 10.37 40 224711 3908 79515729
Abnormal behaviour 22.24 10.37 43 224708 36378 79483259
Injection site warmth 22.24 10.37 7 224744 14800 79504837
Antiphospholipid syndrome 22.14 10.37 27 224724 1864 79517773
Pleural effusion 22.11 10.37 551 224200 144711 79374926
Bladder irrigation 21.93 10.37 8 224743 61 79519576
Catheter site rash 21.93 10.37 20 224731 985 79518652
Ecchymosis 21.91 10.37 93 224658 15113 79504524
Uveitis 21.87 10.37 10 224741 16820 79502817
Intentional self-injury 21.85 10.37 36 224715 32383 79487254
Oral candidiasis 21.79 10.37 31 224720 29597 79490040
Vision blurred 21.79 10.37 192 224559 105706 79413931
Anti factor Xa activity decreased 21.77 10.37 6 224745 15 79519622
Amaurosis fugax 21.74 10.37 19 224732 884 79518753
Hypovolaemic shock 21.66 10.37 80 224671 12196 79507441
Subdural hygroma 21.64 10.37 15 224736 494 79519143
Device alarm issue 21.55 10.37 28 224723 2061 79517576
Embolic cerebral infarction 21.52 10.37 22 224729 1249 79518388
Ventricular drainage 21.50 10.37 6 224745 16 79519621
Splenic haemorrhage 21.46 10.37 17 224734 689 79518948
Putamen haemorrhage 21.43 10.37 15 224736 502 79519135
Infusion site haemorrhage 21.42 10.37 38 224713 3682 79515955
Wrong patient received product 21.41 10.37 43 224708 4575 79515062
Hypoacusis 21.38 10.37 152 224599 29998 79489639
Dry eye 21.36 10.37 45 224706 36886 79482751
Respiratory tract haemorrhage 21.30 10.37 26 224725 1797 79517840
Photophobia 21.29 10.37 16 224735 20512 79499125
Cytomegalovirus viraemia 21.25 10.37 5 224746 12816 79506821
Abdominal pain 21.17 10.37 890 223861 388679 79130958
Wrong dose 21.17 10.37 25 224726 1669 79517968
Asthenia 21.12 10.37 1695 223056 509994 79009643
Nephropathy toxic 21.07 10.37 16 224735 20403 79499234
Peripheral artery stenosis 20.95 10.37 22 224729 1289 79518348
Metallosis of globe 20.92 10.37 5 224746 5 79519632
Pharyngeal haemorrhage 20.88 10.37 22 224729 1294 79518343
Rash papular 20.81 10.37 119 224632 21797 79497840
Pericardial drainage 20.80 10.37 14 224737 439 79519198
Rhabdomyolysis 20.77 10.37 188 224563 102943 79416694
Peripheral swelling 20.77 10.37 944 223807 268673 79250964
Orthopnoea 20.67 10.37 69 224682 10004 79509633
Infusion site pain 20.66 10.37 87 224664 14089 79505548
Hepatic function abnormal 20.65 10.37 121 224630 72986 79446651
Bone density decreased 20.61 10.37 6 224745 13341 79506296
Cardiac fibrillation 20.55 10.37 19 224732 952 79518685
Embolism 20.53 10.37 86 224665 13896 79505741
Periorbital haematoma 20.50 10.37 19 224732 955 79518682
Hypercalcaemia 20.45 10.37 49 224702 38381 79481256
Haemorrhagic cerebral infarction 20.45 10.37 23 224728 1456 79518181
Atrioventricular block 20.33 10.37 86 224665 13955 79505682
Subdural haematoma evacuation 20.31 10.37 8 224743 77 79519560
Echocardiogram abnormal 20.14 10.37 28 224723 2200 79517437
Paratonia 20.07 10.37 6 224745 22 79519615
Puncture site haematoma 20.06 10.37 10 224741 175 79519462
Muscle rigidity 19.99 10.37 16 224735 19866 79499771
Post transplant lymphoproliferative disorder 19.96 10.37 4 224747 11460 79508177
Breast cancer female 19.95 10.37 4 224747 11457 79508180
Injection site rash 19.94 10.37 13 224738 17941 79501696
Paraesthesia oral 19.93 10.37 17 224734 20454 79499183
Blood triglycerides increased 19.84 10.37 18 224733 21022 79498615
Aortic stenosis 19.72 10.37 56 224695 7439 79512198
Urethral haemorrhage 19.71 10.37 13 224738 394 79519243
Blood immunoglobulin E increased 19.61 10.37 48 224703 5834 79513803
Blood pressure increased 19.53 10.37 450 224301 210910 79308727
Subclavian vein thrombosis 19.46 10.37 29 224722 2428 79517209
Dyskinesia 19.44 10.37 63 224688 44710 79474927
Infective pulmonary exacerbation of cystic fibrosis 19.43 10.37 6 224745 12845 79506792
Low cardiac output syndrome 19.37 10.37 19 224732 1026 79518611
Obesity 19.32 10.37 44 224707 35081 79484556
Splenomegaly 19.28 10.37 18 224733 20736 79498901
Disease recurrence 19.19 10.37 62 224689 44047 79475590
Haemorrhoids 19.02 10.37 144 224607 28984 79490653
Osteoarthritis 18.99 10.37 156 224595 87153 79432484
Erythromelalgia 18.86 10.37 10 224741 200 79519437
Contusion 18.84 10.37 551 224200 148225 79371412
Haemorrhagic cholecystitis 18.82 10.37 8 224743 95 79519542
Renal tubular necrosis 18.61 10.37 26 224725 25013 79494624
Candida infection 18.59 10.37 51 224700 38163 79481474
Purpura 18.52 10.37 106 224645 19421 79500216
Intentional overdose 18.48 10.37 200 224551 105760 79413877
Dermatitis exfoliative 18.39 10.37 4 224747 10825 79508812
Hip fracture 18.39 10.37 149 224602 30612 79489025
Blood pressure systolic increased 18.33 10.37 112 224639 66874 79452763
Tuberculosis 18.29 10.37 10 224741 15188 79504449
Helicobacter test false negative 18.18 10.37 7 224744 63 79519574
Injection site mass 18.18 10.37 18 224733 20166 79499471
Pruritus 18.14 10.37 918 223833 393730 79125907
Peritonitis 18.10 10.37 32 224719 28004 79491633
Peripheral artery thrombosis 18.06 10.37 34 224717 3449 79516188
Subcapsular renal haematoma 18.01 10.37 16 224735 761 79518876
Chest X-ray abnormal 17.99 10.37 56 224695 7827 79511810
Cognitive disorder 17.97 10.37 287 224464 69639 79449998
Anal haemorrhage 17.95 10.37 38 224713 4196 79515441
Herpes simplex 17.88 10.37 6 224745 12181 79507456
Gastrointestinal vascular malformation haemorrhagic 17.75 10.37 16 224735 776 79518861
Hypercoagulation 17.73 10.37 31 224720 2969 79516668
Aortic aneurysm rupture 17.67 10.37 20 224731 1275 79518362
Eye pain 17.65 10.37 51 224700 37527 79482110
Mouth haemorrhage 17.56 10.37 69 224682 10830 79508807
Microcytic anaemia 17.54 10.37 43 224708 5231 79514406
Bone pain 17.54 10.37 89 224662 55653 79463984
Multiple organ dysfunction syndrome 17.52 10.37 236 224515 120010 79399627
Hyperkaliuria 17.49 10.37 9 224742 169 79519468
Hypertriglyceridaemia 17.46 10.37 7 224744 12733 79506904
Angiocardiogram 17.42 10.37 10 224741 235 79519402
Face oedema 17.37 10.37 33 224718 28103 79491534
Lip swelling 17.31 10.37 184 224567 40727 79478910
Pseudomonas infection 17.31 10.37 20 224731 20883 79498754
Central nervous system lesion 17.28 10.37 8 224743 13360 79506277
Gastrostomy 17.27 10.37 19 224732 1174 79518463
Therapeutic aspiration 17.24 10.37 5 224746 16 79519621
Small intestinal haemorrhage 17.23 10.37 37 224714 4126 79515511
Central nervous system lupus 17.23 10.37 13 224738 490 79519147
Peripheral artery occlusion 17.21 10.37 28 224723 2529 79517108
Meningorrhagia 17.20 10.37 11 224740 316 79519321
Hyperkalaemia 17.13 10.37 433 224318 113965 79405672
Tenderness 17.13 10.37 25 224726 23617 79496020
Venous pressure jugular increased 17.12 10.37 20 224731 1320 79518317
Hepatic encephalopathy 17.08 10.37 26 224725 24140 79495497
Anticoagulation drug level decreased 16.98 10.37 9 224742 180 79519457
Aortic valve disease 16.96 10.37 24 224727 1917 79517720
Cerebellar infarction 16.95 10.37 34 224717 3613 79516024
Coma uraemic 16.89 10.37 6 224745 42 79519595
Infusion site discharge 16.88 10.37 14 224737 606 79519031
Scar 16.88 10.37 11 224740 15185 79504452
Pharyngitis 16.87 10.37 23 224728 22352 79497285
Liver disorder 16.86 10.37 127 224624 72290 79447347
Throat irritation 16.83 10.37 59 224692 40887 79478750
Mitral valve thickening 16.80 10.37 12 224739 415 79519222
Skin lesion 16.73 10.37 61 224690 41783 79477854
Wheezing 16.72 10.37 439 224312 116225 79403412
Basal cell carcinoma 16.64 10.37 52 224699 37323 79482314
Gastrointestinal polyp 16.64 10.37 8 224743 129 79519508
Pulmonary oedema 16.63 10.37 345 224406 87909 79431728
Hyperkinetic heart syndrome 16.58 10.37 8 224743 130 79519507
Pancreatitis 16.57 10.37 119 224632 68456 79451181
Electrolyte imbalance 16.57 10.37 146 224605 30735 79488902
Lupus pneumonitis 16.55 10.37 7 224744 82 79519555
Prostatic operation 16.52 10.37 10 224741 260 79519377
Creatinine renal clearance abnormal 16.47 10.37 13 224738 524 79519113
Drug tolerance decreased 16.42 10.37 8 224743 12970 79506667
Listeraemia 16.40 10.37 7 224744 84 79519553
Bronchospasm 16.39 10.37 28 224723 24831 79494806
Tooth abscess 16.35 10.37 13 224738 16197 79503440
Deep vein thrombosis postoperative 16.30 10.37 5 224746 10747 79508890
Polyarthritis 16.25 10.37 7 224744 12195 79507442
Panic attack 16.22 10.37 27 224724 24189 79495448
Obstructive pancreatitis 16.16 10.37 16 224735 874 79518763
Cholecystitis chronic 16.15 10.37 4 224747 9902 79509735
Intervertebral disc protrusion 16.13 10.37 26 224725 23595 79496042
Cardiogenic shock 16.13 10.37 185 224566 41729 79477908
Brain herniation 16.10 10.37 52 224699 7411 79512226
Pulmonary artery occlusion 16.09 10.37 6 224745 49 79519588
Cardiac flutter 16.07 10.37 40 224711 4914 79514723
Thromboembolectomy 16.04 10.37 7 224744 89 79519548
Chronic left ventricular failure 16.01 10.37 17 224734 1009 79518628
Mouth ulceration 16.00 10.37 55 224696 38339 79481298
Mood altered 15.98 10.37 16 224735 17831 79501806
Ilium fracture 15.96 10.37 10 224741 277 79519360
Dyspepsia 15.95 10.37 213 224538 108474 79411163
Ruptured cerebral aneurysm 15.93 10.37 13 224738 550 79519087
Normocytic anaemia 15.84 10.37 36 224715 4171 79515466
Arterial haemorrhage 15.84 10.37 27 224724 2534 79517103
Anger 15.81 10.37 15 224736 17147 79502490
Gastroduodenal haemorrhage 15.74 10.37 10 224741 284 79519353
Drug eruption 15.68 10.37 67 224684 43868 79475769
Polyserositis 15.67 10.37 14 224737 671 79518966
Paranoia 15.66 10.37 19 224732 19413 79500224
Intracranial mass 15.56 10.37 25 224726 2234 79517403
Hypersensitivity vasculitis 15.55 10.37 49 224702 6894 79512743
Palmar-plantar erythrodysaesthesia syndrome 15.54 10.37 45 224706 33089 79486548
Infusion site swelling 15.52 10.37 53 224698 7773 79511864
Tricuspid valve repair 15.48 10.37 5 224746 25 79519612
BK virus infection 15.48 10.37 3 224748 8801 79510836
Infective exacerbation of chronic obstructive airways disease 15.47 10.37 28 224723 2756 79516881
Mood swings 15.43 10.37 20 224731 19860 79499777
Dizziness postural 15.40 10.37 69 224682 11480 79508157
Nightmare 15.39 10.37 31 224720 25830 79493807
Troponin T increased 15.39 10.37 32 224719 3490 79516147
Klebsiella infection 15.37 10.37 13 224738 15707 79503930
Catatonia 15.36 10.37 3 224748 8753 79510884
Duplicate therapy error 15.34 10.37 10 224741 297 79519340
Pyroglutamic acidosis 15.34 10.37 17 224734 1059 79518578
Infusion site erythema 15.33 10.37 60 224691 9400 79510237
Mitral valve incompetence 15.30 10.37 135 224616 28430 79491207
Cushingoid 15.30 10.37 4 224747 9548 79510089
Endocarditis noninfective 15.29 10.37 9 224742 222 79519415
Cytomegalovirus infection reactivation 15.26 10.37 3 224748 8713 79510924
Emergency care 15.23 10.37 17 224734 1067 79518570
Aneurysm ruptured 15.23 10.37 16 224735 938 79518699
Optic neuritis 15.22 10.37 4 224747 9516 79510121
Cardiac valve disease 15.21 10.37 43 224708 5698 79513939
Mesenteric haematoma 15.17 10.37 5 224746 27 79519610
Wound haematoma 14.96 10.37 8 224743 163 79519474
Factor Xa activity increased 14.81 10.37 4 224747 9 79519628
Laryngitis 14.80 10.37 14 224737 16025 79503612
Prostatic haemorrhage 14.74 10.37 8 224743 168 79519469
Blood urea increased 14.73 10.37 79 224672 48711 79470926
Product commingling 14.66 10.37 7 224744 111 79519526
Rehabilitation therapy 14.65 10.37 22 224729 1855 79517782
Sinus tachycardia 14.62 10.37 54 224697 36854 79482783
Cryotherapy 14.62 10.37 3 224748 0 79519637
Chemotherapy toxicity attenuation 14.62 10.37 3 224748 0 79519637
Anal ulcer haemorrhage 14.62 10.37 3 224748 0 79519637
Traumatic intracranial haematoma 14.62 10.37 3 224748 0 79519637
Stent placement 14.59 10.37 46 224705 6474 79513163
Cerebellar haematoma 14.55 10.37 13 224738 623 79519014
Obstructive airways disorder 14.51 10.37 144 224607 31315 79488322
Bladder neoplasm 14.48 10.37 21 224730 1716 79517921
Tachycardia 14.47 10.37 626 224125 177142 79342495
Red cell distribution width increased 14.42 10.37 13 224738 15229 79504408
Hepatic haemorrhage 14.42 10.37 16 224735 998 79518639
Large intestinal polypectomy 14.41 10.37 10 224741 330 79519307
Hot flush 14.37 10.37 93 224658 54784 79464853
Femoral neck fracture 14.34 10.37 61 224690 9923 79509714
Conjunctivitis 14.32 10.37 32 224719 25683 79493954
Feeling hot 14.27 10.37 104 224647 59630 79460007
Joint dislocation 14.25 10.37 16 224735 16923 79502714
Normochromic normocytic anaemia 14.18 10.37 51 224700 7676 79511961
Pancytopenia 14.17 10.37 357 224394 165388 79354249
Cardiac ventricular thrombosis 14.15 10.37 21 224730 1752 79517885
Onychomycosis 14.14 10.37 3 224748 8258 79511379
Escherichia infection 14.11 10.37 18 224733 17999 79501638
Joint effusion 14.11 10.37 18 224733 17996 79501641
Vascular device occlusion 14.10 10.37 10 224741 342 79519295
Oropharyngeal pain 14.05 10.37 220 224531 109133 79410504
Immunosuppressant drug level increased 14.04 10.37 4 224747 9023 79510614
Treatment noncompliance 13.99 10.37 216 224535 52052 79467585
Nail disorder 13.97 10.37 8 224743 11844 79507793
Chloasma 13.95 10.37 5 224746 36 79519601
Hallucination, auditory 13.92 10.37 23 224728 20670 79498967
Helicobacter test positive 13.91 10.37 18 224733 1320 79518317
Peripheral arterial occlusive disease 13.89 10.37 53 224698 8205 79511432
Peripheral embolism 13.88 10.37 22 224729 1944 79517693
Depressed mood 13.82 10.37 80 224671 48400 79471237
Chest pain 13.79 10.37 948 223803 281356 79238281
Gastrointestinal toxicity 13.76 10.37 3 224748 8106 79511531
Hyponatraemia 13.75 10.37 623 224128 177225 79342412
Cardio-respiratory arrest 13.71 10.37 219 224532 108291 79411346
Blood bilirubin increased 13.66 10.37 120 224631 66112 79453525
Hepatomegaly 13.63 10.37 20 224731 18854 79500783
Kyphosis 13.62 10.37 26 224725 2665 79516972
Renal infarct 13.62 10.37 26 224725 2665 79516972
Salivary hypersecretion 13.62 10.37 12 224739 14212 79505425
Radiculopathy 13.56 10.37 4 224747 8820 79510817
Cerebral ischaemia 13.53 10.37 65 224686 11130 79508507
Femoral artery aneurysm 13.49 10.37 8 224743 200 79519437
Splinter haemorrhages 13.48 10.37 7 224744 134 79519503
Hemiplegia 13.46 10.37 80 224671 14859 79504778
Dysgeusia 13.44 10.37 100 224651 57077 79462560
Insomnia 13.32 10.37 560 224191 244610 79275027
Night sweats 13.28 10.37 89 224662 52006 79467631
Anal stenosis 13.27 10.37 11 224740 476 79519161
Therapeutic drug monitoring analysis incorrectly performed 13.24 10.37 13 224738 703 79518934
Contraindicated product prescribed 13.18 10.37 20 224731 1701 79517936
Appendicitis 13.18 10.37 24 224727 20770 79498867
Pulmonary tuberculosis 13.17 10.37 3 224748 7862 79511775
Renal injury 13.17 10.37 17 224734 16910 79502727
Tumour lysis syndrome 13.16 10.37 30 224721 23909 79495728
Cardiac pacemaker replacement 13.15 10.37 11 224740 482 79519155
Visual acuity reduced 13.12 10.37 41 224710 29428 79490209
Mediastinal haematoma 13.11 10.37 8 224743 211 79519426
Skin laceration 13.08 10.37 132 224619 28830 79490807
Renal mass 13.04 10.37 29 224722 3311 79516326
Adrenal haematoma 13.03 10.37 7 224744 144 79519493
Swelling face 12.99 10.37 133 224618 71079 79448558
Carotid artery stenosis 12.96 10.37 54 224697 8704 79510933
Enterococcal infection 12.95 10.37 15 224736 15645 79503992
Withdrawal syndrome 12.94 10.37 36 224715 26818 79492819
Catheter site pain 12.94 10.37 39 224712 5357 79514280
Graft haemorrhage 12.93 10.37 6 224745 89 79519548
Inguinal hernia 12.92 10.37 44 224707 6444 79513193
Haemorrhage subepidermal 12.91 10.37 4 224747 17 79519620
Microembolism 12.89 10.37 5 224746 46 79519591
Epidural haemorrhage 12.88 10.37 8 224743 218 79519419
Disturbance in attention 12.87 10.37 208 224543 50593 79469044
Euphoric mood 12.83 10.37 3 224748 7723 79511914
Swollen tongue 12.81 10.37 69 224682 42501 79477136
Bipolar disorder 12.78 10.37 3 224748 7704 79511933
Emotional disorder 12.76 10.37 13 224738 14374 79505263
Hepatitis C 12.75 10.37 9 224742 11916 79507721
Acute generalised exanthematous pustulosis 12.74 10.37 18 224733 17236 79502401
Gastrointestinal polyp haemorrhage 12.73 10.37 11 224740 504 79519133
Mucormycosis 12.73 10.37 4 224747 8465 79511172
Thrombotic stroke 12.71 10.37 13 224738 738 79518899
Aspiration pleural cavity 12.68 10.37 19 224732 1598 79518039
Macroangiopathy 12.65 10.37 7 224744 153 79519484
Blood culture positive 12.63 10.37 4 224747 8425 79511212
Injection site discolouration 12.56 10.37 3 224748 7611 79512026
Vertebrobasilar stroke 12.55 10.37 3 224748 3 79519634
Spontaneous hyphaema 12.55 10.37 3 224748 3 79519634
Intestinal varices haemorrhage 12.55 10.37 3 224748 3 79519634
Vascular cauterisation 12.52 10.37 6 224745 96 79519541
Arterial thrombosis 12.52 10.37 25 224726 2649 79516988
Injection site induration 12.50 10.37 6 224745 9813 79509824
Neck pain 12.49 10.37 144 224607 75273 79444364
Oxygen saturation decreased 12.49 10.37 463 224288 128584 79391053
Neuralgia 12.48 10.37 50 224701 33334 79486303
Embolism venous 12.48 10.37 33 224718 4206 79515431
Hepatic necrosis 12.47 10.37 5 224746 9095 79510542
Heart rate irregular 12.46 10.37 144 224607 32535 79487102
Product administration error 12.45 10.37 141 224610 31705 79487932
Hemiparaesthesia 12.44 10.37 8 224743 232 79519405
Anticoagulation drug level increased 12.43 10.37 13 224738 758 79518879
Dyspnoea at rest 12.40 10.37 47 224704 7255 79512382
Metastases to lung 12.40 10.37 20 224731 18143 79501494
Haemorrhagic infarction 12.39 10.37 13 224738 761 79518876
Idiopathic interstitial pneumonia 12.38 10.37 8 224743 234 79519403
Lung infiltration 12.36 10.37 29 224722 22883 79496754
Encephalitis 12.36 10.37 14 224737 14746 79504891
Immune-mediated myositis 12.32 10.37 29 224722 3438 79516199
Malignant melanoma 12.32 10.37 14 224737 14727 79504910
Viral infection 12.25 10.37 71 224680 42945 79476692
Injection site haemorrhage 12.25 10.37 39 224712 27831 79491806
Rectal prolapse 12.22 10.37 22 224729 2156 79517481
Fear of injection 12.22 10.37 3 224748 7471 79512166
Left atrial enlargement 12.22 10.37 16 224735 1187 79518450
Vascular purpura 12.21 10.37 27 224724 3071 79516566
Bronchopulmonary aspergillosis 12.20 10.37 28 224723 22266 79497371
Thrombotic microangiopathy 12.15 10.37 24 224727 20145 79499492
Radiation fibrosis - lung 12.10 10.37 5 224746 55 79519582
Intestinal perforation 12.07 10.37 19 224732 17407 79502230
Blood chloride decreased 12.04 10.37 4 224747 8173 79511464
Mental impairment 12.04 10.37 22 224729 19014 79500623
Brain contusion 12.03 10.37 17 224734 1356 79518281
Oesophageal infection 12.02 10.37 12 224739 662 79518975
Polyp 12.01 10.37 50 224701 8057 79511580
Cerebral thrombosis 12.00 10.37 23 224728 2364 79517273
Tongue disorder 11.98 10.37 13 224738 13962 79505675
Thrombophlebitis migrans 11.98 10.37 10 224741 437 79519200
Asthma 11.96 10.37 480 224271 134615 79385022
Cerebral amyloid angiopathy 11.95 10.37 9 224742 338 79519299
Alanine aminotransferase abnormal 11.95 10.37 5 224746 8862 79510775
Respiratory rate increased 11.93 10.37 27 224724 21573 79498064
Neuropathy peripheral 11.91 10.37 305 224446 141000 79378637
Catheter placement 11.82 10.37 26 224725 2948 79516689
Skin hyperpigmentation 11.81 10.37 3 224748 7300 79512337
Platelet count decreased 11.80 10.37 439 224312 194225 79325412
Tinnitus 11.79 10.37 183 224568 44150 79475487
May-Thurner syndrome 11.78 10.37 4 224747 24 79519613
Occult blood 11.78 10.37 19 224732 1704 79517933
Lupus-like syndrome 11.76 10.37 13 224738 13844 79505793
Weight increased 11.64 10.37 651 224100 276735 79242902
Metastases to bone 11.58 10.37 33 224718 24394 79495243
Wrong strength 11.56 10.37 7 224744 182 79519455
Thinking abnormal 11.55 10.37 12 224739 13149 79506488
Odynophagia 11.53 10.37 9 224742 11318 79508319
Post procedural haematuria 11.53 10.37 8 224743 264 79519373
Tendon disorder 11.53 10.37 3 224748 7183 79512454
Cardiorenal syndrome 11.52 10.37 18 224733 1571 79518066
Gastric cancer 11.52 10.37 58 224693 10121 79509516
Pulmonary haemorrhage 11.50 10.37 76 224675 14641 79504996
Peripheral ischaemia 11.50 10.37 55 224696 9402 79510235
Degenerative aortic valve disease 11.46 10.37 7 224744 185 79519452
Eyelid oedema 11.44 10.37 13 224738 13674 79505963
Skin fissures 11.39 10.37 12 224739 13061 79506576
Antinuclear antibody positive 11.38 10.37 4 224747 7886 79511751
Acquired cardiac septal defect 11.34 10.37 3 224748 6 79519631
Acute hepatic failure 11.32 10.37 45 224706 30068 79489569
Chronic sinusitis 11.30 10.37 12 224739 13014 79506623
Pneumonia fungal 11.29 10.37 9 224742 11201 79508436
Amylase increased 11.29 10.37 9 224742 11200 79508437
Biliary sepsis 11.28 10.37 18 224733 1599 79518038
Cerebral ventricle collapse 11.27 10.37 6 224745 121 79519516
Gait disturbance 11.26 10.37 474 224277 207032 79312605
Superficial siderosis of central nervous system 11.26 10.37 4 224747 28 79519609
Tachypnoea 11.23 10.37 139 224612 31924 79487713
Aplasia 11.21 10.37 4 224747 7816 79511821
Factor V inhibition 11.21 10.37 9 224742 372 79519265
Tachycardia induced cardiomyopathy 11.17 10.37 7 224744 194 79519443
Diverticulum intestinal 11.16 10.37 51 224700 8554 79511083
Blood pressure decreased 11.16 10.37 363 224388 99103 79420534
Hypogammaglobulinaemia 11.15 10.37 12 224739 12939 79506698
Miosis 11.14 10.37 17 224734 15772 79503865
Post procedural pulmonary embolism 11.14 10.37 8 224743 279 79519358
Orbital haemorrhage 11.14 10.37 4 224747 29 79519608
Gastroenteritis aeromonas 11.14 10.37 4 224747 29 79519608
Walking distance test abnormal 11.11 10.37 12 224739 726 79518911
Therapy partial responder 11.10 10.37 20 224731 17377 79502260
Rectal ulcer haemorrhage 11.09 10.37 8 224743 281 79519356
Sexual dysfunction 11.08 10.37 4 224747 7759 79511878
Mixed dementia 11.04 10.37 8 224743 283 79519354
Bleeding varicose vein 11 10.37 11 224740 608 79519029
Coordination abnormal 10.96 10.37 20 224731 17292 79502345
Feeling jittery 10.95 10.37 12 224739 12829 79506808
Subarachnoid haematoma 10.94 10.37 8 224743 287 79519350
Cardiotoxicity 10.92 10.37 11 224740 12228 79507409
Oesophageal food impaction 10.92 10.37 9 224742 386 79519251
Loss of personal independence in daily activities 10.90 10.37 372 224379 102208 79417429
Enthesopathy 10.86 10.37 10 224741 11598 79508039
Cardiac pacemaker evaluation 10.85 10.37 6 224745 131 79519506
Streptococcal endocarditis 10.85 10.37 6 224745 131 79519506
Amaurosis 10.81 10.37 15 224736 1176 79518461
Clot retraction 10.80 10.37 4 224747 32 79519605
Blood creatinine abnormal 10.79 10.37 34 224717 4783 79514854
Haemostasis 10.78 10.37 9 224742 393 79519244
Tenosynovitis 10.74 10.37 17 224734 15537 79504100
Urinary occult blood positive 10.73 10.37 7 224744 208 79519429
Catheter site swelling 10.71 10.37 19 224732 1841 79517796
Arteriosclerotic retinopathy 10.69 10.37 4 224747 33 79519604
Skin haemorrhage 10.69 10.37 64 224687 11917 79507720
Drug level decreased 10.66 10.37 15 224736 14387 79505250
Skin irritation 10.65 10.37 61 224690 11179 79508458
Erythema multiforme 10.64 10.37 21 224730 17630 79502007
Ileus paralytic 10.64 10.37 7 224744 9613 79510024
Heart valve operation 10.62 10.37 7 224744 212 79519425
Myoclonus 10.61 10.37 41 224710 27619 79492018
Eosinophil count increased 10.61 10.37 20 224731 17085 79502552
Full blood count decreased 10.60 10.37 119 224632 26700 79492937
Elephantiasis 10.49 10.37 3 224748 9 79519628
Blood viscosity decreased 10.49 10.37 5 224746 79 79519558
Atrial appendage closure 10.49 10.37 4 224747 35 79519602
Pulmonary endarterectomy 10.47 10.37 7 224744 217 79519420
Bone disorder 10.47 10.37 24 224727 19089 79500548
Intracranial tumour haemorrhage 10.43 10.37 10 224741 525 79519112
Arteriospasm coronary 10.40 10.37 3 224748 6713 79512924
Blood alkaline phosphatase increased 10.37 10.37 122 224629 63542 79456095

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 | Suggest Off label Use Form| |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
1364430 RXNORM
185767 MMSL
28142 MMSL
d07804 MMSL
013857 NDDF
698090000 SNOMEDCT_US
703906002 SNOMEDCT_US
C1831808 UMLSCUI
10182969 PUBCHEM_CID

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 0003-0893 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
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 50090-6451 TABLET, FILM COATED 2.50 mg ORAL NDA 30 sections
ELIQUIS HUMAN PRESCRIPTION DRUG LABEL 1 50090-6454 TABLET, FILM COATED 5 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 55154-0612 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 55154-0612 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 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
ELIQUIS HUMAN PRESCRIPTION DRUG LABEL 1 70518-1861 TABLET, FILM COATED 5 mg ORAL NDA 30 sections
ELIQUIS HUMAN PRESCRIPTION DRUG LABEL 1 71610-662 TABLET, FILM COATED 5 mg ORAL NDA 30 sections
ELIQUIS HUMAN PRESCRIPTION DRUG LABEL 1 71610-662 TABLET, FILM COATED 5 mg ORAL NDA 30 sections
ELIQUIS HUMAN PRESCRIPTION DRUG LABEL 1 82982-054 TABLET, FILM COATED 5 mg ORAL NDA 30 sections