bosentan 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
endothelin receptor antagonists 392 147536-97-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • bosentan hydrate
  • bosentan monohydrate
  • stayveer
  • bosentan
  • actelion
  • tracleer
  • bosentan anhydrous
a specific and competitive antagonist at endothelin receptor types ETA and ETB, has a slightly higher affinity for ETA receptors than for ETB receptors, indicated for the treatment of pulmonary arterial hypertension
  • Molecular weight: 551.62
  • Formula: C27H29N5O6S
  • CLOGP: 3.87
  • LIPINSKI: 2
  • HAC: 11
  • HDO: 2
  • TPSA: 145.65
  • ALOGS: -4.79
  • ROTB: 10
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.25 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.00 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 2 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 6.47 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 50 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.29 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 2.10 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.04 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 4.10 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,AXL,BRAF,CDK9,EIF2AK3,ERBB2,GRK2,PDK1,PDK2,PDK4,PIK3CG,PRKDC 12
kinase-selectivity-class BRAF,GRK2 2
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 20.559 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
rat-kpuu-brain Rat brain Kpuu 0.012 % High 1

Approvals:

DateAgencyCompanyOrphan
Nov. 20, 2001 FDA ACTELION PHARMS LTD
May 14, 2002 EMA Janssen-Cilag International N.V.

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 2500.09 14.25 2520 78626 454031 90093270
Dyspnoea 1606.90 14.25 2835 78311 878120 89669181
Right ventricular failure 1462.21 14.25 575 80571 18630 90528671
Aspartate aminotransferase increased 1083.12 14.25 827 80319 102110 90445191
Alanine aminotransferase increased 956.80 14.25 815 80331 117523 90429778
Blood alkaline phosphatase increased 743.56 14.25 489 80657 47590 90499711
Liver function test abnormal 740.17 14.25 498 80648 50347 90496954
Fluid retention 730.78 14.25 616 80530 87475 90459826
Pulmonary hypertension 670.96 14.25 438 80708 42085 90505216
Transfusion 552.23 14.25 283 80863 17205 90530096
Cardiac failure 527.48 14.25 567 80579 108929 90438372
Drug ineffective 485.98 14.25 324 80822 1383974 89163327
Syncope 426.79 14.25 559 80587 132104 90415197
Dyspnoea exertional 421.61 14.25 415 80731 71873 90475428
Hospitalisation 395.44 14.25 529 80617 127571 90419730
Pulmonary oedema 395.19 14.25 374 80772 61706 90485595
Pneumonia 394.74 14.25 1360 79786 636699 89910602
Cardiac failure congestive 389.75 14.25 461 80685 98233 90449068
Blood bilirubin increased 370.56 14.25 309 80837 43161 90504140
Lung transplant 354.43 14.25 131 81015 3561 90543740
Hypervolaemia 352.39 14.25 267 80879 32490 90514811
Infusion related reaction 335.26 14.25 8 81138 416772 90130529
Alopecia 323.00 14.25 34 81112 495037 90052264
Device related infection 317.47 14.25 228 80918 25558 90521743
Respiratory failure 314.53 14.25 455 80691 117963 90429338
Disease progression 307.89 14.25 524 80622 156091 90391210
Oxygen saturation decreased 307.63 14.25 428 80718 107055 90440246
Pain in jaw 307.10 14.25 290 80856 47695 90499606
Cardiac operation 289.04 14.25 115 81031 3834 90543467
Catheterisation cardiac 286.82 14.25 122 81024 4834 90542467
Scleroderma 278.11 14.25 128 81018 6133 90541168
Hypoxia 272.31 14.25 330 80816 72069 90475232
Rash 269.32 14.25 193 80953 795907 89751394
Cardiac pacemaker insertion 260.07 14.25 110 81036 4297 90543004
Oedema peripheral 253.64 14.25 649 80497 257266 90290035
Pulmonary arterial pressure increased 248.73 14.25 103 81043 3813 90543488
Treatment failure 239.94 14.25 7 81139 303921 90243380
Drug hypersensitivity 239.83 14.25 60 81086 463549 90083752
Concomitant disease aggravated 238.19 14.25 141 81005 11377 90535924
Maternal exposure during pregnancy 236.60 14.25 24 81122 360039 90187262
Glossodynia 232.24 14.25 14 81132 321765 90225536
Contraindicated product administered 230.83 14.25 14 81132 320125 90227176
Product dose omission issue 224.37 14.25 671 80475 291016 90256285
Joint swelling 219.72 14.25 88 81058 503212 90044089
Arthropathy 212.92 14.25 36 81110 366206 90181095
Gamma-glutamyltransferase increased 210.30 14.25 212 80934 37740 90509561
Therapeutic product effect decreased 210.02 14.25 9 81137 277562 90269739
Drug intolerance 209.30 14.25 70 81076 447521 90099780
Rheumatoid arthritis 203.53 14.25 39 81107 362575 90184726
Off label use 201.61 14.25 430 80716 1101822 89445479
Pericarditis 197.22 14.25 11 81135 270140 90277161
Dialysis 196.65 14.25 124 81022 11205 90536096
Pulmonary arterial hypertension 196.33 14.25 173 80973 26014 90521287
Musculoskeletal stiffness 181.79 14.25 25 81121 296507 90250794
Cardiac disorder 181.68 14.25 239 80907 56633 90490668
Helicobacter infection 176.22 14.25 6 81140 226844 90320457
Duodenal ulcer perforation 171.38 14.25 6 81140 221282 90326019
Catheter site pain 169.50 14.25 88 81058 5491 90541810
Hypersensitivity 168.71 14.25 99 81047 454578 90092723
Catheter site erythema 168.50 14.25 84 81062 4810 90542491
Haemoptysis 168.12 14.25 177 80969 33143 90514158
Cough 167.56 14.25 714 80432 368248 90179053
Stomatitis 166.41 14.25 24 81122 274674 90272627
Pericardial effusion 165.43 14.25 184 80962 36649 90510652
Type 2 diabetes mellitus 162.90 14.25 4 81142 203240 90344061
Urticaria 162.53 14.25 40 81106 312694 90234607
Arthralgia 160.93 14.25 282 80864 778240 89769061
Blood cholesterol increased 159.84 14.25 6 81140 208006 90339295
Flushing 156.77 14.25 283 80863 88208 90459093
Atrial fibrillation 155.49 14.25 359 80787 133252 90414049
Catheter site infection 154.25 14.25 83 81063 5571 90541730
Catheter management 153.67 14.25 68 81078 2968 90544333
Chest pain 153.23 14.25 629 80517 319016 90228285
Discomfort 152.84 14.25 30 81116 274305 90272996
Pain 151.09 14.25 428 80718 995913 89551388
Chronic obstructive pulmonary disease 150.20 14.25 251 80895 73578 90473723
Blister 146.08 14.25 26 81120 254972 90292329
Muscle injury 143.42 14.25 3 81143 176651 90370650
Fibromyalgia 142.85 14.25 11 81135 206258 90341043
Mobility decreased 142.69 14.25 26 81120 250708 90296593
Wound 142.20 14.25 47 81099 302933 90244368
Neutropenia 135.39 14.25 20 81126 224884 90322417
Disease complication 133.59 14.25 66 81080 3706 90543595
Cyanosis 132.95 14.25 122 81024 19333 90527968
Hypotension 131.99 14.25 609 80537 324788 90222513
Impaired healing 131.74 14.25 25 81121 234174 90313127
Fall 129.43 14.25 805 80341 481005 90066296
Lower respiratory tract infection 128.40 14.25 33 81113 250626 90296675
Febrile neutropenia 123.63 14.25 4 81142 158345 90388956
Cardioversion 121.96 14.25 46 81100 1324 90545977
Epistaxis 121.00 14.25 248 80898 84877 90462424
Systemic lupus erythematosus 120.37 14.25 89 81057 361807 90185494
Nasal congestion 119.73 14.25 244 80902 83170 90464131
Product use in unapproved indication 119.38 14.25 77 81069 336159 90211142
Condition aggravated 118.15 14.25 924 80222 594621 89952680
Toxicity to various agents 118.03 14.25 55 81091 287791 90259510
Gastrointestinal haemorrhage 117.89 14.25 254 80892 89994 90457307
Ascites 117.36 14.25 177 80969 47563 90499738
Hypertension 115.54 14.25 144 81002 457388 90089913
Pulmonary hypertensive crisis 115.26 14.25 34 81112 443 90546858
Oedema 114.56 14.25 417 80729 199878 90347423
Congestive hepatopathy 113.19 14.25 55 81091 2978 90544323
Palpitations 113.04 14.25 323 80823 136405 90410896
Psoriasis 111.02 14.25 5 81141 147749 90399552
Pruritus 110.95 14.25 197 80949 541328 90005973
Oxygen consumption increased 110.40 14.25 62 81084 4527 90542774
Tracheostomy 109.12 14.25 36 81110 691 90546610
Joint range of motion decreased 107.44 14.25 3 81143 135640 90411661
Injury 106.95 14.25 23 81123 197326 90349975
Irritable bowel syndrome 106.83 14.25 27 81119 207421 90339880
Therapeutic product effect incomplete 106.30 14.25 22 81124 193874 90353427
Osteoarthritis 105.69 14.25 23 81123 195707 90351594
Mechanical ventilation 104.44 14.25 42 81104 1440 90545861
Bursitis 103.95 14.25 3 81143 131651 90415650
Atrial flutter 103.28 14.25 82 81064 10676 90536625
Catheter site discharge 103.09 14.25 48 81098 2361 90544940
Intentional product use issue 102.87 14.25 33 81113 216859 90330442
Dizziness 102.71 14.25 888 80258 588396 89958905
Completed suicide 102.53 14.25 7 81139 145051 90402250
Confusional state 102.33 14.25 117 81029 386088 90161213
Hypoaesthesia 102.25 14.25 79 81067 314131 90233170
Stent placement 101.69 14.25 57 81089 4146 90543155
Ill-defined disorder 101.32 14.25 21 81125 184870 90362431
Cor pulmonale 100.61 14.25 45 81101 2015 90545286
Cardiac ablation 98.78 14.25 42 81104 1662 90545639
Finger amputation 95.96 14.25 32 81114 636 90546665
Pulmonary veno-occlusive disease 92.79 14.25 39 81107 1499 90545802
Biopsy liver 92.74 14.25 28 81118 397 90546904
Exercise tolerance decreased 91.16 14.25 66 81080 7485 90539816
Anaemia 89.36 14.25 581 80565 352221 90195080
Renal failure 89.07 14.25 289 80857 130718 90416583
Depression 88.72 14.25 83 81063 300518 90246783
Abdominal discomfort 88.69 14.25 184 80962 477144 90070157
Heart transplant 86.60 14.25 29 81117 584 90546717
Presyncope 85.49 14.25 123 81023 31682 90515619
Brain natriuretic peptide increased 85.34 14.25 58 81088 5947 90541354
Sepsis 83.01 14.25 350 80796 179464 90367837
Paraesthesia 82.62 14.25 62 81084 250264 90297037
Concomitant disease progression 81.87 14.25 40 81106 2192 90545109
Respiratory distress 81.32 14.25 134 81012 38812 90508489
Cardiomegaly 80.63 14.25 92 81054 18833 90528468
Influenza 80.48 14.25 291 80855 138973 90408328
Catheter placement 80.10 14.25 41 81105 2483 90544818
Atrial septal defect repair 78.81 14.25 22 81124 232 90547069
Systemic scleroderma 78.53 14.25 35 81111 1554 90545747
Hip fracture 77.57 14.25 120 81026 32957 90514344
Cardiac arrest 75.44 14.25 236 80910 104699 90442602
Catheter site swelling 73.89 14.25 35 81111 1790 90545511
Malignant neoplasm progression 73.12 14.25 6 81140 106864 90440437
Device leakage 72.87 14.25 65 81081 9926 90537375
Walking distance test abnormal 71.83 14.25 25 81121 568 90546733
Sudden death 71.80 14.25 67 81079 10842 90536459
Central venous catheterisation 70.73 14.25 39 81107 2747 90544554
Hepatic function abnormal 70.71 14.25 139 81007 46149 90501152
Haemorrhage 70.55 14.25 177 80969 69192 90478109
Pregnancy 69.16 14.25 164 80982 61883 90485418
Endotracheal intubation 69.07 14.25 41 81105 3323 90543978
Viral infection 68.96 14.25 129 81017 41285 90506016
Cardiopulmonary failure 68.11 14.25 44 81102 4144 90543157
Malaise 67.81 14.25 812 80334 585174 89962127
Transplant evaluation 67.65 14.25 30 81116 1316 90545985
International normalised ratio increased 67.39 14.25 138 81008 47178 90500123
Headache 67.05 14.25 1114 80032 861632 89685669
Acute respiratory failure 66.92 14.25 130 81016 42788 90504513
Infusion site pain 66.20 14.25 85 81061 19653 90527648
Catheter site pruritus 66.19 14.25 35 81111 2267 90545034
Chronic respiratory failure 65.85 14.25 37 81109 2704 90544597
Catheter site haemorrhage 65.80 14.25 41 81105 3627 90543674
Prescribed overdose 65.38 14.25 6 81140 97619 90449682
Heart rate increased 65.29 14.25 236 80910 112666 90434635
Abortion induced 65.09 14.25 66 81080 11822 90535479
Obesity 64.35 14.25 9 81137 105498 90441803
Patent ductus arteriosus repair 63.44 14.25 12 81134 13 90547288
Pleural effusion 62.99 14.25 232 80914 111759 90435542
Right-to-left cardiac shunt 62.70 14.25 19 81127 273 90547028
Right ventricular dysfunction 62.53 14.25 34 81112 2330 90544971
Pulmonary haemorrhage 62.18 14.25 54 81092 7959 90539342
Hernia repair 61.17 14.25 31 81115 1838 90545463
Night sweats 60.31 14.25 20 81126 128746 90418555
Unevaluable event 60.08 14.25 144 81002 54704 90492597
Intentional overdose 59.66 14.25 7 81139 93827 90453474
Peripheral venous disease 59.44 14.25 4 81142 83917 90463384
Product quality issue 58.56 14.25 3 81143 79322 90467979
Injection site reaction 58.22 14.25 7 81139 92073 90455228
Pulmonary congestion 57.95 14.25 79 81067 19354 90527947
Renal disorder 56.99 14.25 113 81033 37746 90509555
Catheter site inflammation 56.84 14.25 24 81122 933 90546368
Liver injury 56.58 14.25 42 81104 170525 90376776
Rhinovirus infection 56.27 14.25 45 81101 5918 90541383
Hepatic enzyme increased 55.11 14.25 154 80992 360582 90186719
C-reactive protein increased 54.77 14.25 49 81097 181340 90365961
Leg amputation 54.66 14.25 31 81115 2306 90544995
Sleep disorder 54.59 14.25 58 81088 197972 90349329
Terminal state 54.37 14.25 33 81113 2785 90544516
Dry mouth 54.06 14.25 51 81095 184008 90363293
Heart valve replacement 53.96 14.25 22 81124 782 90546519
Product use issue 53.29 14.25 137 81009 329782 90217519
Angioplasty 52.77 14.25 26 81120 1451 90545850
Drug abuse 52.71 14.25 6 81140 82341 90464960
Injection site pain 52.36 14.25 47 81099 173652 90373649
Autoimmune hepatitis 52.22 14.25 55 81091 10296 90537005
Device occlusion 51.67 14.25 52 81094 9230 90538071
Wound infection 50.76 14.25 16 81130 106386 90440915
Overdose 49.57 14.25 41 81105 157668 90389633
Gout 49.46 14.25 68 81078 16791 90530510
Coronary arterial stent insertion 49.07 14.25 31 81115 2809 90544492
Complication associated with device 49.06 14.25 73 81073 19376 90527925
Oxygen therapy 49.00 14.25 32 81114 3070 90544231
Cardiac pacemaker replacement 48.82 14.25 17 81129 387 90546914
Oxygen saturation abnormal 48.42 14.25 36 81110 4252 90543049
Transplant 48.32 14.25 22 81124 1027 90546274
Red blood cell sedimentation rate increased 48.19 14.25 8 81138 82587 90464714
Cellulitis 47.05 14.25 184 80962 91153 90456148
Right ventricular hypertrophy 46.90 14.25 20 81126 797 90546504
Tracheostomy malfunction 46.89 14.25 11 81135 53 90547248
Neutrophil count decreased 46.32 14.25 5 81141 71527 90475774
Muscle spasms 45.95 14.25 98 81048 251785 90295516
COVID-19 45.92 14.25 50 81096 168793 90378508
Right ventricular systolic pressure increased 45.90 14.25 18 81128 577 90546724
Anaphylactic reaction 45.80 14.25 11 81135 87513 90459788
Blood pressure decreased 45.38 14.25 159 80987 74736 90472565
Sinusitis 44.95 14.25 157 80989 342931 90204370
Upper limb fracture 44.71 14.25 74 81072 21504 90525797
Heart and lung transplant 44.60 14.25 12 81134 109 90547192
Infusion site erythema 44.49 14.25 58 81088 13612 90533689
Haemoglobin decreased 44.20 14.25 272 80874 161684 90385617
Mastectomy 44.19 14.25 26 81120 2073 90545228
Device alarm issue 44.08 14.25 25 81121 1860 90545441
Bilirubin conjugated increased 43.93 14.25 30 81116 3100 90544201
Balloon atrial septostomy 43.79 14.25 11 81135 74 90547227
Productive cough 43.62 14.25 160 80986 76903 90470398
Skin ulcer 43.01 14.25 120 81026 49955 90497346
Device related sepsis 42.75 14.25 35 81111 4758 90542543
Bronchitis 42.46 14.25 258 80888 152669 90394632
Pulmonary vein stenosis 42.34 14.25 11 81135 86 90547215
Electrocardiogram QT prolonged 42.31 14.25 7 81139 72449 90474852
Head injury 42.11 14.25 89 81057 31099 90516202
Chemotherapy 42.10 14.25 24 81122 1803 90545498
Loss of personal independence in daily activities 42.01 14.25 36 81110 136069 90411232
Dehydration 41.91 14.25 308 80838 194139 90353162
Intentional product misuse 41.81 14.25 14 81132 89590 90457711
Loss of consciousness 41.77 14.25 241 80905 139997 90407304
Generalised oedema 41.73 14.25 67 81079 18986 90528315
White blood cell count decreased 41.68 14.25 53 81093 167056 90380245
Mineral supplementation 41.64 14.25 18 81128 742 90546559
Therapy change 41.60 14.25 44 81102 8278 90539023
Pulmonary resection 41.37 14.25 10 81136 56 90547245
Hepatomegaly 40.99 14.25 55 81091 13271 90534030
Dyspnoea at rest 40.68 14.25 34 81112 4757 90542544
Suicide attempt 40.40 14.25 9 81137 75390 90471911
Hip surgery 40.32 14.25 32 81114 4163 90543138
Gastrointestinal tube insertion 40.31 14.25 21 81125 1319 90545982
Inflammation 40.18 14.25 61 81085 178531 90368770
Inappropriate schedule of product administration 40.11 14.25 45 81101 149888 90397413
Mucosal inflammation 40.08 14.25 3 81143 57622 90489679
Contusion 40.03 14.25 105 81041 251111 90296190
Cognitive disorder 39.88 14.25 7 81139 69400 90477901
Delirium 39.65 14.25 22 81124 104337 90442964
Live birth 39.37 14.25 11 81135 79096 90468205
Implantable defibrillator insertion 39.21 14.25 16 81130 570 90546731
Pulmonary arterial pressure abnormal 38.59 14.25 16 81130 594 90546707
Infusion site infection 38.53 14.25 26 81120 2634 90544667
Left ventricular failure 38.15 14.25 38 81108 6662 90540639
Muscular weakness 38.03 14.25 80 81066 206586 90340715
Catheter removal 37.89 14.25 14 81132 380 90546921
Ventricular assist device insertion 37.87 14.25 8 81138 21 90547280
Hospice care 37.71 14.25 45 81101 9659 90537642
Suicidal ideation 37.26 14.25 10 81136 73845 90473456
Adverse drug reaction 37.09 14.25 30 81116 116671 90430630
Paracentesis 37.00 14.25 18 81128 977 90546324
Cholecystectomy 36.90 14.25 49 81097 11706 90535595
Blood potassium decreased 36.77 14.25 110 81036 47617 90499684
Cardiac output decreased 36.58 14.25 18 81128 1002 90546299
Ventricular septal defect repair 36.36 14.25 7 81139 9 90547292
Chest discomfort 36.26 14.25 230 80916 138135 90409166
Limb operation 36.13 14.25 31 81115 4496 90542805
Scleroderma renal crisis 36.02 14.25 14 81132 438 90546863
Taste disorder 35.82 14.25 6 81140 61540 90485761
Amnesia 35.61 14.25 27 81119 108478 90438823
Jaundice 35.20 14.25 85 81061 32432 90514869
Medication error 34.93 14.25 16 81130 84636 90462665
Swelling 34.78 14.25 226 80920 418832 90128469
Leukopenia 34.43 14.25 24 81122 100686 90446615
Toe amputation 34.29 14.25 22 81124 2047 90545254
Autoimmune disorder 34.09 14.25 13 81133 76731 90470570
Cerebrovascular accident 34.03 14.25 208 80938 123325 90423976
Tricuspid valve repair 33.82 14.25 7 81139 16 90547285
Supraventricular tachycardia 33.82 14.25 56 81090 16280 90531021
N-terminal prohormone brain natriuretic peptide increased 33.74 14.25 25 81121 2937 90544364
Neuropathy peripheral 33.58 14.25 44 81102 136926 90410375
Pneumothorax 33.53 14.25 61 81085 19106 90528195
Blood pressure systolic increased 33.27 14.25 6 81140 58339 90488962
Vascular device infection 33.26 14.25 47 81099 11905 90535396
Gastritis hypertrophic 33.22 14.25 8 81138 44 90547257
Pulmonary valve replacement 32.48 14.25 6 81140 5 90547296
Localised infection 32.42 14.25 84 81062 33478 90513823
Angioedema 32.32 14.25 9 81137 64867 90482434
Gait inability 32.01 14.25 51 81095 146405 90400896
Gastrointestinal disorder 31.92 14.25 120 81026 256567 90290734
Systemic-pulmonary artery shunt 31.74 14.25 7 81139 24 90547277
Epilepsy 31.71 14.25 17 81129 82189 90465112
Infected skin ulcer 31.68 14.25 23 81123 2619 90544682
Echocardiogram abnormal 31.56 14.25 19 81127 1580 90545721
Colon operation 31.42 14.25 13 81133 480 90546821
Therapeutic response decreased 31.19 14.25 21 81125 89708 90457593
Pulmonary artery banding 31.04 14.25 6 81140 8 90547293
Injection site erythema 30.46 14.25 26 81120 98476 90448825
Orthopnoea 30.43 14.25 34 81112 6801 90540500
Catheter site related reaction 29.85 14.25 16 81130 1065 90546236
Wheezing 29.80 14.25 111 81035 237969 90309332
Haemodynamic test abnormal 29.79 14.25 7 81139 34 90547267
Sedation 29.63 14.25 4 81142 48167 90499134
Myocardial infarction 29.54 14.25 179 80967 105793 90441508
Tracheitis 29.51 14.25 15 81131 895 90546406
Platelet transfusion 29.32 14.25 16 81130 1104 90546197
Osteoporosis 29.22 14.25 26 81120 96505 90450796
Coeliac disease 29.18 14.25 3 81143 44607 90502694
Heart rate irregular 29.07 14.25 66 81080 24202 90523099
Post procedural complication 28.85 14.25 57 81089 18985 90528316
Colitis ulcerative 28.85 14.25 9 81137 60257 90487044
Chest tube insertion 28.84 14.25 7 81139 40 90547261
Sciatica 28.71 14.25 29 81117 101353 90445948
Knee operation 28.34 14.25 33 81113 6903 90540398
Asthma 28.33 14.25 116 81030 242044 90305257
Sleep study 28.07 14.25 6 81140 17 90547284
Rehabilitation therapy 27.89 14.25 19 81127 1955 90545346
Swollen tongue 27.83 14.25 4 81142 45952 90501349
Internal haemorrhage 27.79 14.25 31 81115 6189 90541112
Skin exfoliation 27.77 14.25 13 81133 67900 90479401
Musculoskeletal pain 27.71 14.25 71 81075 171180 90376121
Blood iron decreased 27.51 14.25 54 81092 17905 90529396
Blood culture positive 27.48 14.25 28 81118 5044 90542257
Blood pressure increased 27.34 14.25 88 81058 197129 90350172
Treatment noncompliance 27.28 14.25 105 81041 51622 90495679
Pulmonary vascular resistance abnormality 27.28 14.25 8 81138 102 90547199
Gastrostomy 27.21 14.25 14 81132 857 90546444
Cardiac septal defect repair 27.16 14.25 5 81141 4 90547297
Biopsy bone marrow 27.03 14.25 11 81135 389 90546912
Atrial tachycardia 27.02 14.25 30 81116 5960 90541341
Heart valve operation 26.93 14.25 9 81137 180 90547121
Exercise test abnormal 26.86 14.25 8 81138 108 90547193
Scleroderma associated digital ulcer 26.68 14.25 6 81140 23 90547278
Biopsy kidney 26.57 14.25 9 81137 188 90547113
Primary biliary cholangitis 26.28 14.25 16 81130 1358 90545943
Lung assist device therapy 26.27 14.25 8 81138 117 90547184
Caesarean section 26.23 14.25 54 81092 18523 90528778
Low cardiac output syndrome 26.19 14.25 11 81135 422 90546879
Pulseless electrical activity 26.16 14.25 36 81110 8896 90538405
Pulmonary artery therapeutic procedure 26.10 14.25 6 81140 26 90547275
Endothelial dysfunction 25.96 14.25 9 81137 202 90547099
Injection site pruritus 25.84 14.25 8 81138 53826 90493475
Cardiac index decreased 25.69 14.25 7 81139 67 90547234
Aortic stenosis 25.64 14.25 30 81116 6306 90540995
CREST syndrome 25.49 14.25 12 81134 605 90546696
Foot amputation 25.40 14.25 10 81136 324 90546977
Bronchopulmonary dysplasia 25.36 14.25 12 81134 612 90546689
Surgery 25.23 14.25 93 81053 44794 90502507
Catheter site rash 25.10 14.25 13 81133 807 90546494
Pulmonary thrombosis 25.08 14.25 37 81109 9745 90537556
Skin operation 25.07 14.25 6 81140 32 90547269
Resuscitation 24.55 14.25 15 81131 1281 90546020
Wrong technique in product usage process 24.54 14.25 17 81129 71554 90475747
Hyperthyroidism 24.43 14.25 52 81094 18258 90529043
Systemic sclerosis pulmonary 24.33 14.25 6 81140 37 90547264
Pulmonary artery dilatation 24.33 14.25 10 81136 363 90546938
Migraine 24.33 14.25 88 81058 190304 90356997
Human metapneumovirus test positive 24.18 14.25 7 81139 85 90547216
Mitral valve repair 24.09 14.25 9 81137 252 90547049
Amputation 23.99 14.25 9 81137 255 90547046
Illness 23.72 14.25 23 81123 81946 90465355
Staphylococcal infection 23.67 14.25 96 81050 48343 90498958
Staphylococcus test positive 23.56 14.25 24 81122 4321 90542980
Multiple organ dysfunction syndrome 23.40 14.25 122 81024 68214 90479087
Extremity necrosis 23.38 14.25 17 81129 1940 90545361
Aortic valve replacement 23.31 14.25 13 81133 936 90546365
Shoulder operation 23.27 14.25 20 81126 2906 90544395
Abdominal distension 23.25 14.25 198 80948 130403 90416898
Pericardial drainage 23.17 14.25 9 81137 281 90547020
Mouth ulceration 23.03 14.25 4 81142 39970 90507331
Cataract operation 23.00 14.25 28 81118 6135 90541166
Drug interaction 22.96 14.25 149 80997 276304 90270997
Hypocalcaemia 22.81 14.25 5 81141 42363 90504938
Anxiety 22.77 14.25 173 80973 309599 90237702
Dilatation ventricular 22.57 14.25 18 81128 2358 90544943
Splenomegaly 22.44 14.25 41 81105 12883 90534418
Dry eye 22.31 14.25 12 81134 57919 90489382
Prothrombin time prolonged 22.28 14.25 35 81111 9737 90537564
Haematocrit decreased 22.13 14.25 85 81061 41747 90505554
Pericardiotomy 22.07 14.25 5 81141 20 90547281
Respiratory tract haemorrhage 22.04 14.25 10 81136 463 90546838
Arterial aneurysm repair 21.84 14.25 4 81142 3 90547298
Dysentery 21.73 14.25 13 81133 1069 90546232
Frequent bowel movements 21.63 14.25 12 81134 56923 90490378
Catheter site warmth 21.62 14.25 8 81138 218 90547083
Infusion site cellulitis 21.53 14.25 9 81137 341 90546960
Tracheostomy infection 21.52 14.25 6 81140 63 90547238
Endarterectomy 21.52 14.25 8 81138 221 90547080
Lymphocyte count decreased 21.35 14.25 3 81143 35047 90512254
Vasodilation procedure 21.33 14.25 5 81141 24 90547277
Mitral valve replacement 21.23 14.25 10 81136 505 90546796
Galectin-3 increased 21.16 14.25 5 81141 25 90547276
Blood potassium increased 21.15 14.25 53 81093 20696 90526605
Vascular operation 21.14 14.25 7 81139 136 90547165
Drug-induced liver injury 21.14 14.25 30 81116 90288 90457013
Aspiration pleural cavity 21.02 14.25 12 81134 904 90546397
Infusion site abscess 20.93 14.25 9 81137 366 90546935
Cardiac failure acute 20.91 14.25 38 81108 11891 90535410
Tracheostomy tube removal 20.84 14.25 4 81142 5 90547296
Radiotherapy 20.79 14.25 12 81134 923 90546378
Nocturnal dyspnoea 20.68 14.25 14 81132 1426 90545875
Gastric operation 20.66 14.25 9 81137 378 90546923
Pulmonary artery aneurysm 20.57 14.25 6 81140 75 90547226
Cyst removal 20.55 14.25 10 81136 543 90546758
Therapeutic embolisation 20.50 14.25 8 81138 253 90547048
Respiratory syncytial virus infection 20.46 14.25 35 81111 10445 90536856
International normalised ratio abnormal 20.42 14.25 21 81125 3824 90543477
Oesophageal haemorrhage 20.40 14.25 10 81136 552 90546749
Hyponatraemia 20.36 14.25 57 81089 133481 90413820
Infusion site discharge 20.10 14.25 17 81129 2418 90544883
Device connection issue 20.09 14.25 12 81134 984 90546317
Dry skin 19.88 14.25 30 81116 88043 90459258
Alanine aminotransferase 19.81 14.25 6 81140 86 90547215
Insomnia 19.73 14.25 197 80949 333277 90214024
Localised oedema 19.72 14.25 26 81120 6168 90541133
Plasma cell myeloma 19.72 14.25 6 81140 40822 90506479
Thrombocytopenia 19.70 14.25 108 81038 208617 90338684
Carbon dioxide increased 19.53 14.25 15 81131 1860 90545441
Emergency care 19.43 14.25 14 81132 1575 90545726
Aortic valve repair 19.37 14.25 4 81142 9 90547292
Arrhythmia 19.19 14.25 82 81064 42250 90505051
Rhabdomyolysis 19.19 14.25 11 81135 51245 90496056
Bone marrow failure 19.06 14.25 3 81143 32218 90515083
Eczema 18.88 14.25 12 81134 52858 90494443
Device infusion issue 18.78 14.25 17 81129 2645 90544656
Lung neoplasm malignant 18.75 14.25 56 81090 24217 90523084
Acute kidney injury 18.65 14.25 190 80956 320197 90227104
Medical device change 18.64 14.25 8 81138 324 90546977
Living in residential institution 18.63 14.25 10 81136 668 90546633
Hypercalcaemia 18.52 14.25 4 81142 34236 90513065
Colonoscopy 18.30 14.25 14 81132 1726 90545575
Psychotic disorder 18.27 14.25 3 81143 31227 90516074
Depressed level of consciousness 18.23 14.25 23 81123 72761 90474540
Gallbladder operation 18.20 14.25 17 81129 2754 90544547
Interstitial lung disease 18.18 14.25 124 81022 76281 90471020
Plasmapheresis 18.17 14.25 8 81138 345 90546956
N-terminal prohormone brain natriuretic peptide 18.15 14.25 5 81141 50 90547251
Immunodeficiency 18.10 14.25 8 81138 43226 90504075
Sterilisation 18.06 14.25 3 81143 0 90547301
Blood glucose decreased 18.04 14.25 54 81092 23375 90523926
Gait disturbance 17.97 14.25 148 80998 260348 90286953
Hysterectomy 17.94 14.25 35 81111 11549 90535752
Walking disability 17.89 14.25 13 81133 1482 90545819
Polycythaemia 17.83 14.25 12 81134 1211 90546090
Disturbance in attention 17.79 14.25 10 81136 47099 90500202
Bacteraemia 17.75 14.25 52 81094 22248 90525053
Catheter site induration 17.64 14.25 5 81141 56 90547245
Hypoacusis 17.63 14.25 60 81086 27790 90519511
Haemodynamic instability 17.62 14.25 35 81111 11704 90535597
Infection 17.45 14.25 224 80922 361870 90185431
Smooth muscle antibody positive 17.42 14.25 6 81140 132 90547169
Infusion site induration 17.41 14.25 13 81133 1546 90545755
Cholelithotomy 17.40 14.25 5 81141 59 90547242
Vascular cauterisation 17.40 14.25 5 81141 59 90547242
Hernia 17.37 14.25 39 81107 14192 90533109
Heart valve incompetence 17.20 14.25 18 81128 3344 90543957
Cardiac flutter 17.19 14.25 21 81125 4617 90542684
Arteriovenous fistula operation 17.19 14.25 7 81139 248 90547053
Toxic epidermal necrolysis 17.19 14.25 4 81142 32524 90514777
Diuretic therapy 17.17 14.25 6 81140 138 90547163
Pulmonary arterial wedge pressure increased 17.02 14.25 8 81138 402 90546899
Polypectomy 17.00 14.25 11 81135 1039 90546262
Mixed connective tissue disease 16.98 14.25 9 81137 586 90546715
Rash erythematous 16.91 14.25 20 81126 65084 90482217
Decreased activity 16.85 14.25 28 81118 8164 90539137
Dyspnoea paroxysmal nocturnal 16.71 14.25 11 81135 1069 90546232
Arthritis 16.67 14.25 85 81061 167230 90380071
Aneurysm repair 16.61 14.25 4 81142 22 90547279
Hepatic failure 16.53 14.25 75 81071 39653 90507648
Vascular graft 16.49 14.25 10 81136 843 90546458
Infusion site swelling 16.47 14.25 34 81112 11686 90535615
Right ventricular dilatation 16.41 14.25 13 81133 1686 90545615
Deep vein thrombosis 16.40 14.25 36 81110 91584 90455717
Road traffic accident 16.36 14.25 46 81100 107580 90439721
Hepatic cancer 16.34 14.25 21 81125 4860 90542441
General physical health deterioration 16.26 14.25 222 80924 354893 90192408
Abdominal cavity drainage 16.14 14.25 8 81138 452 90546849
Palliative care 16.11 14.25 10 81136 878 90546423
Dizziness postural 16.08 14.25 29 81117 9024 90538277
Removal of transplanted organ 15.98 14.25 3 81143 3 90547298
Intestinal polypectomy 15.98 14.25 3 81143 3 90547298
Cardio-respiratory arrest 15.94 14.25 104 81042 63036 90484265
Procedural pain 15.94 14.25 5 81141 33355 90513946
Seasonal allergy 15.87 14.25 51 81095 22932 90524369
Biopsy 15.84 14.25 8 81138 471 90546830
Enterovirus infection 15.81 14.25 12 81134 1462 90545839
Cardiac resynchronisation therapy 15.78 14.25 4 81142 28 90547273
Skin graft 15.70 14.25 9 81137 683 90546618
Cytokine release syndrome 15.68 14.25 3 81143 27970 90519331
Administration site infection 15.66 14.25 4 81142 29 90547272
Laboratory test abnormal 15.64 14.25 9 81137 41845 90505456
Multiple sclerosis 15.58 14.25 3 81143 27837 90519464
Laparoscopic surgery 15.54 14.25 4 81142 30 90547271
Cavopulmonary anastomosis 15.52 14.25 3 81143 4 90547297
Cardiac failure chronic 15.41 14.25 22 81124 5624 90541677
Throat irritation 15.36 14.25 85 81061 48610 90498691
Generalised tonic-clonic seizure 15.35 14.25 6 81140 34897 90512404
Protein-losing gastroenteropathy 15.29 14.25 7 81139 331 90546970
Product supply issue 15.28 14.25 16 81130 2976 90544325
Tricuspid valve incompetence 15.27 14.25 41 81105 16690 90530611
Sudden cardiac death 15.25 14.25 14 81132 2218 90545083
Fracture treatment 15.25 14.25 5 81141 94 90547207
Feeling abnormal 15.19 14.25 222 80924 167013 90380288
Cyanosis central 15.11 14.25 5 81141 97 90547204
Visual impairment 15.10 14.25 64 81082 132301 90415000
Pancytopenia 15.08 14.25 56 81090 120207 90427094
Atrioventricular septal defect 15.04 14.25 7 81139 344 90546957
Drug tolerance decreased 15.02 14.25 5 81141 32125 90515176
Emotional distress 15.01 14.25 7 81139 36655 90510646
Rash pruritic 14.96 14.25 32 81114 82182 90465119
Ear tube insertion 14.96 14.25 5 81141 100 90547201
Drug reaction with eosinophilia and systemic symptoms 14.87 14.25 10 81136 42748 90504553
Oxygen consumption 14.83 14.25 5 81141 103 90547198
Respiratory tract infection viral 14.82 14.25 16 81130 3080 90544221
Phlebotomy 14.77 14.25 3 81143 6 90547295
Eye operation 14.76 14.25 15 81131 2694 90544607
Underdose 14.67 14.25 16 81130 54001 90493300
Heart disease congenital 14.62 14.25 12 81134 1637 90545664
Metapneumovirus infection 14.61 14.25 11 81135 1324 90545977
Poor peripheral circulation 14.56 14.25 18 81128 4007 90543294
Coma 14.31 14.25 27 81119 72605 90474696
Gangrene 14.30 14.25 34 81112 12842 90534459
Asthenia 14.28 14.25 599 80547 533152 90014149

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
Death 721.72 17.01 1158 25924 470027 42124226
Right ventricular failure 591.16 17.01 224 26858 9331 42584922
Fluid retention 421.73 17.01 258 26824 31361 42562892
Dyspnoea 408.31 17.01 877 26205 441744 42152509
Pulmonary hypertension 283.05 17.01 180 26902 23389 42570864
Aspartate aminotransferase increased 256.13 17.01 279 26803 76884 42517369
Lung transplant 230.99 17.01 78 27004 2308 42591945
Alanine aminotransferase increased 217.26 17.01 274 26808 88132 42506121
Catheterisation cardiac 196.46 17.01 72 27010 2722 42591531
Liver function test abnormal 187.01 17.01 159 26923 32232 42562021
Cardiac operation 163.32 17.01 68 27014 3627 42590626
Hospitalisation 146.59 17.01 207 26875 74123 42520130
Oxygen saturation decreased 140.86 17.01 189 26893 64498 42529755
Concomitant disease aggravated 139.98 17.01 73 27009 6513 42587740
Drug ineffective 134.88 17.01 122 26960 630075 41964178
Oedema 133.71 17.01 165 26917 51836 42542417
Cardiac failure 131.48 17.01 240 26842 106616 42487637
Blood alkaline phosphatase increased 121.03 17.01 127 26955 33470 42560783
Pulmonary arterial hypertension 110.42 17.01 73 27009 10114 42584139
Toxicity to various agents 106.52 17.01 11 27071 229125 42365128
Pulmonary arterial pressure increased 105.78 17.01 39 27043 1499 42592754
Pain in jaw 102.21 17.01 80 27002 14422 42579831
Transfusion 98.86 17.01 69 27013 10445 42583808
Cardiac failure congestive 96.17 17.01 185 26897 85417 42508836
Hypervolaemia 89.73 17.01 91 26991 23034 42571219
Pulmonary hypertensive crisis 85.57 17.01 21 27061 187 42594066
Infusion site pain 84.80 17.01 49 27033 5346 42588907
Catheter management 81.56 17.01 29 27053 1003 42593250
Blood bilirubin increased 79.29 17.01 115 26967 42137 42552116
Oedema peripheral 77.97 17.01 226 26856 135850 42458403
Device related infection 77.22 17.01 79 27003 20200 42574053
Respiratory failure 76.50 17.01 216 26866 127916 42466337
Catheter placement 76.37 17.01 27 27055 918 42593335
Syncope 76.17 17.01 184 26898 99222 42495031
Condition aggravated 75.81 17.01 347 26735 260407 42333846
Heart transplant 74.44 17.01 27 27055 990 42593263
Dyspnoea exertional 73.80 17.01 122 26960 50026 42544227
Cor pulmonale 68.22 17.01 24 27058 804 42593449
Neutropenia 68.18 17.01 21 27061 199410 42394843
Disease progression 66.90 17.01 222 26860 143434 42450819
Catheter site erythema 66.34 17.01 29 27053 1744 42592509
Pulmonary vein stenosis 66.02 17.01 13 27069 34 42594219
Heart and lung transplant 64.71 17.01 14 27068 66 42594187
Tracheostomy 62.95 17.01 24 27058 1013 42593240
Atrial septal defect repair 62.66 17.01 15 27067 119 42594134
Balloon atrial septostomy 62.37 17.01 11 27071 11 42594242
Hypoxia 62.04 17.01 137 26945 69649 42524604
Oxygen consumption increased 61.63 17.01 27 27055 1632 42592621
Cardiac pacemaker insertion 60.56 17.01 33 27049 3215 42591038
Scleroderma 59.84 17.01 27 27055 1751 42592502
Viral infection 58.80 17.01 72 27010 22411 42571842
Pulmonary oedema 58.40 17.01 114 26968 53158 42541095
Cyanosis 58.03 17.01 59 27023 14972 42579281
Acute kidney injury 58.02 17.01 90 26992 367247 42227006
Catheter site infection 56.58 17.01 31 27051 3052 42591201
Mechanical ventilation 56.42 17.01 28 27054 2249 42592004
Pneumonia 54.32 17.01 455 26627 421694 42172559
Disease complication 53.96 17.01 30 27052 3040 42591213
Brain natriuretic peptide increased 53.52 17.01 40 27042 6730 42587523
Respiratory distress 52.69 17.01 95 26987 41725 42552528
Liver function test increased 52.23 17.01 64 27018 19934 42574319
Malignant neoplasm progression 50.84 17.01 5 27077 108395 42485858
Product use in unapproved indication 50.72 17.01 27 27055 184429 42409824
Infusion site erythema 49.35 17.01 30 27052 3592 42590661
Flushing 47.78 17.01 85 26997 36943 42557310
Terminal state 46.25 17.01 31 27051 4392 42589861
Catheter site pain 45.31 17.01 22 27060 1685 42592568
Cardiac ablation 44.72 17.01 20 27062 1270 42592983
Right-to-left cardiac shunt 43.76 17.01 12 27070 171 42594082
Haemoptysis 43.72 17.01 93 26989 46074 42548179
Stent placement 43.11 17.01 32 27050 5328 42588925
Respiratory syncytial virus infection 43.07 17.01 36 27046 7116 42587137
Cardioversion 42.81 17.01 18 27064 983 42593270
Transplant evaluation 42.48 17.01 15 27067 508 42593745
Central venous catheterisation 42.39 17.01 21 27061 1680 42592573
Overdose 41.96 17.01 8 27074 105256 42488997
Rhinovirus infection 41.60 17.01 34 27048 6514 42587739
Pregnancy of partner 41.23 17.01 14 27068 421 42593832
Systemic scleroderma 41.04 17.01 15 27067 562 42593691
Concomitant disease progression 40.04 17.01 23 27059 2480 42591773
Pulmonary veno-occlusive disease 39.76 17.01 15 27067 615 42593638
Heart disease congenital 39.53 17.01 19 27063 1423 42592830
Patent ductus arteriosus repair 38.75 17.01 7 27075 9 42594244
Biopsy liver 38.72 17.01 12 27070 268 42593985
Cardiac disorder 37.88 17.01 91 26991 48841 42545412
Exercise tolerance decreased 37.50 17.01 31 27051 6035 42588218
Dialysis 37.35 17.01 42 27040 11944 42582309
Right ventricular dysfunction 36.92 17.01 18 27064 1391 42592862
Nasal congestion 35.86 17.01 66 27016 29435 42564818
Tracheitis 35.67 17.01 16 27066 1023 42593230
Rhabdomyolysis 35.54 17.01 4 27078 78015 42516238
Complication associated with device 34.89 17.01 31 27051 6650 42587603
Headache 34.47 17.01 265 26817 239104 42355149
Ventricular septal defect repair 34.02 17.01 6 27076 6 42594247
Infusion site infection 33.27 17.01 13 27069 587 42593666
Catheter removal 33.16 17.01 10 27072 203 42594050
Epistaxis 32.60 17.01 105 26977 66721 42527532
Catheter site discharge 32.52 17.01 14 27068 811 42593442
Hyponatraemia 32.35 17.01 12 27070 101450 42492803
Rash 32.30 17.01 81 27001 276873 42317380
Micrococcus test positive 32.29 17.01 6 27076 10 42594243
White blood cell count decreased 32.07 17.01 15 27067 110381 42483872
COVID-19 31.80 17.01 17 27065 115931 42478322
Cough 31.33 17.01 207 26875 177896 42416357
Product administered to patient of inappropriate age 30.83 17.01 25 27057 4736 42589517
Tracheostomy infection 30.80 17.01 7 27075 43 42594210
Drug interaction 30.43 17.01 79 27003 266920 42327333
Right ventricular systolic pressure increased 30.33 17.01 11 27071 403 42593850
Catheter site swelling 29.76 17.01 12 27070 589 42593664
Thrombocytopenia 29.60 17.01 47 27035 190232 42404021
Mast cell activation syndrome 28.62 17.01 10 27072 328 42593925
Catheter site pruritus 28.57 17.01 10 27072 330 42593923
Swelling 28.38 17.01 88 26994 54797 42539456
Injection site erosion 28.14 17.01 8 27074 131 42594122
Infusion related reaction 27.99 17.01 3 27079 60803 42533450
Neuropathy peripheral 27.83 17.01 15 27067 101838 42492415
Product dose omission issue 27.49 17.01 180 26902 154185 42440068
Off label use 27.32 17.01 267 26815 638068 41956185
Vascular resistance pulmonary increased 27.12 17.01 6 27076 32 42594221
Bronchopulmonary dysplasia 27.09 17.01 12 27070 745 42593508
Pleural mass 26.79 17.01 7 27075 82 42594171
Infusion site haemorrhage 26.69 17.01 14 27068 1263 42592990
Endarterectomy 26.64 17.01 8 27074 160 42594093
Treatment failure 26.63 17.01 4 27078 62620 42531633
Right ventricular dilatation 26.55 17.01 12 27070 781 42593472
Confusional state 26.44 17.01 41 27041 167556 42426697
Adverse event 26.39 17.01 51 27031 23589 42570664
Hypertension 26.28 17.01 41 27041 167163 42427090
Faeces soft 26.07 17.01 23 27059 4889 42589364
High frequency ablation 25.84 17.01 8 27074 178 42594075
Congestive hepatopathy 25.64 17.01 17 27065 2365 42591888
Intentional product use issue 25.55 17.01 7 27075 71826 42522427
Chronic obstructive pulmonary disease 25.38 17.01 93 26989 63021 42531232
Device occlusion 25.29 17.01 29 27053 8421 42585832
Endotracheal intubation 24.77 17.01 20 27062 3765 42590488
Retinal vascular disorder 24.59 17.01 8 27074 210 42594043
Transplant 24.43 17.01 12 27070 942 42593311
Carbon dioxide increased 23.92 17.01 13 27069 1259 42592994
Haematuria 23.88 17.01 4 27078 57795 42536458
Respiratory disorder 23.86 17.01 47 27035 22038 42572215
Adenotonsillectomy 23.82 17.01 6 27076 60 42594193
Biopsy lung 23.70 17.01 7 27075 132 42594121
Biopsy lymph gland 23.47 17.01 6 27076 64 42594189
Localised oedema 23.47 17.01 20 27062 4058 42590195
Viral upper respiratory tract infection 23.45 17.01 18 27064 3151 42591102
Chemotherapy 23.24 17.01 11 27071 796 42593457
Exercise test abnormal 23.21 17.01 4 27078 3 42594250
Depression 23.10 17.01 22 27060 111341 42482912
Pulmonary haemorrhage 22.80 17.01 32 27050 11365 42582888
Sudden death 22.51 17.01 39 27043 16590 42577663
Weight increased 22.40 17.01 131 26951 107852 42486401
Infusion site cellulitis 22.35 17.01 7 27075 162 42594091
Pulmonary artery therapeutic procedure 22.21 17.01 4 27078 5 42594248
Left ventricular failure 22.06 17.01 23 27059 6008 42588245
Stomatitis 21.90 17.01 3 27079 50326 42543927
Heart rate increased 21.86 17.01 79 27003 53176 42541077
Gastrointestinal tube insertion 21.84 17.01 13 27069 1497 42592756
Choking sensation 21.47 17.01 12 27070 1228 42593025
Drug hypersensitivity 21.37 17.01 19 27063 99370 42494883
Chest pain 20.89 17.01 156 26926 139374 42454879
Catheter site granuloma 20.85 17.01 5 27077 40 42594213
Ascites 20.71 17.01 81 27001 56597 42537656
Injection site injury 20.29 17.01 8 27074 370 42593883
Foetal exposure during pregnancy 20.16 17.01 3 27079 47308 42546945
Catheter site irritation 20.12 17.01 6 27076 117 42594136
Exposure via body fluid 20.12 17.01 6 27076 117 42594136
Implantable defibrillator insertion 20.05 17.01 10 27072 812 42593441
Therapeutic product effect incomplete 20.04 17.01 10 27072 70929 42523324
Portal hypertensive gastropathy 20.03 17.01 10 27072 813 42593440
Infusion site discharge 20.03 17.01 8 27074 383 42593870
Cardiac flutter 20.01 17.01 14 27068 2126 42592127
Acute respiratory failure 19.80 17.01 62 27020 38796 42555457
Radiotherapy to brain 19.59 17.01 5 27077 53 42594200
Medical device change 19.49 17.01 6 27076 131 42594122
Pancytopenia 19.34 17.01 28 27054 117715 42476538
Aspiration pleural cavity 19.20 17.01 10 27072 889 42593364
Pruritus 19.16 17.01 59 27023 188712 42405541
Renal haematoma 19.10 17.01 9 27073 645 42593608
Infusion 19.09 17.01 3 27079 0 42594253
Oxygen consumption 19.09 17.01 3 27079 0 42594253
Cardiopulmonary bypass 19.09 17.01 3 27079 0 42594253
Cavopulmonary anastomosis 19.09 17.01 3 27079 0 42594253
Spinal cord operation 19.09 17.01 3 27079 0 42594253
Tricuspid valve incompetence 19.04 17.01 29 27053 11084 42583169
Lactic acidosis 18.99 17.01 3 27079 45258 42548995
Influenza 18.91 17.01 84 26998 62091 42532162
Malaise 18.90 17.01 212 26870 211944 42382309
Delirium 18.90 17.01 5 27077 52514 42541739
Nasopharyngitis 18.80 17.01 104 26978 83892 42510361
Oxygen saturation abnormal 18.67 17.01 13 27069 1958 42592295
Tracheostomy malfunction 18.66 17.01 5 27077 65 42594188
Infusion site swelling 18.65 17.01 16 27066 3276 42590977
Gamma-glutamyltransferase increased 18.58 17.01 54 27028 32443 42561810
Sickle cell anaemia 18.58 17.01 7 27075 286 42593967
Vascular device infection 18.34 17.01 21 27061 6089 42588164
Acute myocardial infarction 18.33 17.01 7 27075 58158 42536095
Infusion site scar 18.29 17.01 4 27078 20 42594233
Abdominal distension 18.23 17.01 92 26990 71643 42522610
Oxygen therapy 17.86 17.01 11 27071 1347 42592906
Catheter site mass 17.82 17.01 4 27078 23 42594230
Microcytic anaemia 17.70 17.01 15 27067 3020 42591233
Walking distance test abnormal 17.65 17.01 6 27076 181 42594072
Hernia repair 17.53 17.01 11 27071 1392 42592861
Cardiopulmonary failure 17.38 17.01 18 27064 4665 42589588
Pneumothorax 17.38 17.01 43 27039 23500 42570753
Cardiac arrest 17.38 17.01 124 26958 109196 42485057
Device infusion issue 17.24 17.01 10 27072 1098 42593155
Resuscitation 17.20 17.01 12 27070 1813 42592440
Normal newborn 17.01 17.01 7 27075 362 42593891
Fasciectomy 17.01 17.01 3 27079 3 42594250

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 2783.13 13.75 3263 95902 695606 109794528
Dyspnoea 1835.07 13.75 3421 95744 1103451 109386683
Right ventricular failure 1825.02 13.75 734 98431 25220 110464914
Fluid retention 1171.39 13.75 838 98327 93469 110396665
Aspartate aminotransferase increased 1100.87 13.75 1006 98159 158930 110331204
Alanine aminotransferase increased 947.95 13.75 987 98178 182786 110307348
Pulmonary hypertension 861.37 13.75 565 98600 54655 110435479
Liver function test abnormal 781.62 13.75 580 98585 68370 110421764
Blood alkaline phosphatase increased 760.29 13.75 577 98588 70358 110419776
Transfusion 585.32 13.75 334 98831 25138 110464996
Lung transplant 553.39 13.75 200 98965 5086 110485048
Drug ineffective 491.42 13.75 389 98776 1520151 108969983
Cardiac failure 474.82 13.75 705 98460 186921 110303213
Cardiac failure congestive 459.91 13.75 620 98545 150380 110339754
Catheterisation cardiac 441.49 13.75 177 98988 6014 110484120
Syncope 431.48 13.75 703 98462 201833 110288301
Dyspnoea exertional 413.44 13.75 488 98677 103572 110386562
Hypervolaemia 403.44 13.75 343 98822 49117 110441017
Cardiac operation 381.65 13.75 158 99007 5837 110484297
Device related infection 376.60 13.75 300 98865 39219 110450915
Pain in jaw 375.26 13.75 334 98831 50843 110439291
Pulmonary oedema 370.32 13.75 454 98711 100205 110389929
Pneumonia 368.51 13.75 1657 97508 875057 109615077
Oxygen saturation decreased 364.67 13.75 567 98598 156415 110333719
Blood bilirubin increased 364.38 13.75 393 98772 75579 110414555
Oedema peripheral 319.35 13.75 824 98341 327836 110162298
Off label use 317.48 13.75 538 98627 1499647 108990487
Pulmonary arterial pressure increased 309.14 13.75 130 99035 4997 110485137
Cardiac pacemaker insertion 308.73 13.75 138 99027 6163 110483971
Infusion related reaction 304.31 13.75 8 99157 381154 110108980
Disease progression 296.23 13.75 667 98498 243367 110246767
Scleroderma 288.88 13.75 132 99033 6209 110483925
Concomitant disease aggravated 288.57 13.75 181 98984 16183 110473951
Respiratory failure 281.06 13.75 606 98559 214726 110275408
Febrile neutropenia 267.79 13.75 3 99162 316764 110173370
Toxicity to various agents 255.30 13.75 59 99106 480496 110009638
Hospitalisation 255.01 13.75 458 98707 142035 110348099
Pulmonary arterial hypertension 237.62 13.75 212 98953 32356 110457778
Hypoxia 233.94 13.75 418 98747 129097 110361037
Synovitis 229.86 13.75 3 99162 274089 110216045
Drug hypersensitivity 225.35 13.75 64 99101 454026 110036108
Oedema 225.31 13.75 547 98618 209429 110280705
Catheter site erythema 223.89 13.75 109 99056 5919 110484215
Cardiac disorder 221.14 13.75 306 98859 75974 110414160
Rash 220.63 13.75 247 98918 820717 109669417
Neutropenia 217.75 13.75 37 99128 374583 110115551
Alopecia 216.54 13.75 34 99131 364719 110125415
Treatment failure 213.40 13.75 8 99157 277226 110212908
Product dose omission issue 212.45 13.75 703 98462 321079 110169055
Dialysis 206.52 13.75 158 99007 19461 110470673
Catheter site infection 200.27 13.75 111 99054 7889 110482245
Catheter management 199.76 13.75 87 99078 3648 110486486
Pulmonary hypertensive crisis 195.44 13.75 51 99114 406 110489728
Catheter site pain 193.76 13.75 101 99064 6345 110483789
Product use in unapproved indication 191.09 13.75 81 99084 447296 110042838
Completed suicide 190.03 13.75 6 99159 242375 110247759
Contraindicated product administered 181.82 13.75 10 99155 248257 110241877
Flushing 177.65 13.75 329 98836 104407 110385727
Therapeutic product effect decreased 172.44 13.75 12 99153 244304 110245830
Drug intolerance 169.78 13.75 76 99089 406436 110083698
Stomatitis 167.79 13.75 22 99143 270220 110219914
Chest pain 166.84 13.75 724 98441 375651 110114483
Cough 165.05 13.75 834 98331 460807 110029327
Musculoskeletal stiffness 163.98 13.75 27 99138 279795 110210339
Chronic obstructive pulmonary disease 163.16 13.75 325 98840 108833 110381301
Rheumatoid arthritis 162.60 13.75 35 99130 299578 110190556
Cyanosis 162.47 13.75 165 99000 29576 110460558
Condition aggravated 158.55 13.75 1164 98001 733672 109756462
Maternal exposure during pregnancy 157.64 13.75 21 99144 254862 110235272
Haemoptysis 154.87 13.75 250 98915 71104 110419030
Cor pulmonale 154.65 13.75 63 99102 2231 110487903
Disease complication 154.55 13.75 84 99081 5743 110484391
Joint swelling 152.86 13.75 105 99060 442740 110047394
Oxygen consumption increased 148.15 13.75 81 99084 5604 110484530
Urticaria 145.56 13.75 52 99113 318805 110171329
Glossodynia 145.46 13.75 15 99150 221989 110268145
Helicobacter infection 144.38 13.75 4 99161 181873 110308261
Pericarditis 143.06 13.75 15 99150 219099 110271035
Heart transplant 142.45 13.75 54 99111 1574 110488560
Arthropathy 141.67 13.75 41 99124 287481 110202653
Cardioversion 140.38 13.75 59 99106 2264 110487870
Type 2 diabetes mellitus 136.75 13.75 5 99160 177227 110312907
Catheter site discharge 135.65 13.75 62 99103 2917 110487217
Intentional product use issue 134.42 13.75 29 99136 247877 110242257
Duodenal ulcer perforation 133.79 13.75 6 99159 177694 110312440
Epistaxis 133.77 13.75 334 98831 130038 110360096
Blood cholesterol increased 133.58 13.75 8 99157 184777 110305357
Stent placement 132.55 13.75 82 99083 7152 110482982
Catheter placement 132.28 13.75 63 99102 3257 110486877
Gamma-glutamyltransferase increased 130.59 13.75 213 98952 61096 110429038
Pericardial effusion 130.39 13.75 205 98960 57012 110433122
Drug abuse 130.34 13.75 7 99158 177404 110312730
Infusion site pain 130.26 13.75 115 99050 17304 110472830
Nasal congestion 129.68 13.75 278 98887 98004 110392130
Cardiac ablation 129.03 13.75 58 99107 2624 110487510
Hypertension 128.73 13.75 161 99004 509923 109980211
Pulmonary veno-occlusive disease 127.95 13.75 54 99111 2094 110488040
Tracheostomy 127.68 13.75 49 99116 1478 110488656
Arthralgia 127.41 13.75 323 98842 779309 109710825
Hypersensitivity 123.88 13.75 108 99057 403890 110086244
Confusional state 123.49 13.75 143 99022 468537 110021597
Mechanical ventilation 123.42 13.75 60 99105 3247 110486887
Mobility decreased 122.33 13.75 31 99134 237391 110252743
Atrial septal defect repair 121.15 13.75 36 99129 481 110489653
Viral infection 120.55 13.75 190 98975 52949 110437185
Malignant neoplasm progression 116.43 13.75 11 99154 174556 110315578
Concomitant disease progression 115.52 13.75 59 99106 3551 110486583
Therapeutic product effect incomplete 113.82 13.75 30 99135 223775 110266359
Headache 113.48 13.75 1249 97916 881128 109609006
Fibromyalgia 113.38 13.75 11 99154 170898 110319236
Atrial fibrillation 109.59 13.75 452 98713 229190 110260944
Muscle injury 108.53 13.75 4 99161 140803 110349331
Congestive hepatopathy 108.09 13.75 64 99101 5156 110484978
Acute kidney injury 107.87 13.75 258 98907 635172 109854962
Psoriasis 107.82 13.75 4 99161 139989 110350145
Overdose 105.20 13.75 39 99126 233755 110256379
COVID-19 105.14 13.75 44 99121 245016 110245118
Pruritus 102.82 13.75 231 98934 581329 109908805
Brain natriuretic peptide increased 102.30 13.75 83 99082 11126 110479008
Lower respiratory tract infection 102.14 13.75 45 99120 243061 110247073
Biopsy liver 100.64 13.75 33 99132 620 110489514
Right-to-left cardiac shunt 100.12 13.75 28 99137 297 110489837
Bursitis 99.08 13.75 4 99161 129914 110360220
Impaired healing 96.97 13.75 28 99137 196689 110293445
Respiratory distress 96.87 13.75 200 98965 68674 110421460
Transplant evaluation 95.72 13.75 42 99123 1793 110488341
Catheter site swelling 95.35 13.75 45 99120 2279 110487855
Central venous catheterisation 95.32 13.75 53 99112 3789 110486345
Exercise tolerance decreased 94.92 13.75 82 99083 11985 110478149
Heart and lung transplant 93.58 13.75 24 99141 177 110489957
Pulmonary vein stenosis 93.50 13.75 23 99142 140 110489994
Dizziness 92.73 13.75 995 98170 697198 109792936
Catheter site pruritus 92.62 13.75 44 99121 2262 110487872
Blister 92.55 13.75 44 99121 227332 110262802
Patent ductus arteriosus repair 92.26 13.75 18 99147 26 110490108
Drug interaction 92.25 13.75 194 98971 499989 109990145
Joint range of motion decreased 92.07 13.75 4 99161 121828 110368306
Osteoarthritis 91.87 13.75 25 99140 182598 110307536
Hypoaesthesia 91.54 13.75 88 99077 314135 110175999
Neutrophil count decreased 91.30 13.75 4 99161 120937 110369197
Ascites 91.25 13.75 234 98931 92574 110397560
Fall 90.60 13.75 882 98283 602600 109887534
Balloon atrial septostomy 89.69 13.75 21 99144 100 110490034
Complication associated with device 89.52 13.75 100 99065 19973 110470161
Palpitations 89.45 13.75 330 98835 158882 110331252
Intentional overdose 89.29 13.75 8 99157 132493 110357641
Pain 89.03 13.75 498 98667 954457 109535677
Finger amputation 87.53 13.75 32 99133 841 110489293
Atrial flutter 86.84 13.75 108 99057 24154 110465980
Depression 86.62 13.75 94 99071 317241 110172893
Influenza 86.36 13.75 340 98825 168761 110321373
Discomfort 85.18 13.75 43 99122 214664 110275470
Wound 84.32 13.75 53 99112 234384 110255750
Terminal state 83.48 13.75 56 99109 5611 110484523
Systemic scleroderma 83.42 13.75 39 99126 1933 110488201
Hip fracture 82.95 13.75 128 99037 35023 110455111
Irritable bowel syndrome 81.63 13.75 23 99142 164192 110325942
Hernia repair 79.85 13.75 41 99124 2495 110487639
Ill-defined disorder 77.91 13.75 22 99143 156831 110333303
Right ventricular dysfunction 77.45 13.75 44 99121 3279 110486855
Heart rate increased 77.36 13.75 294 98871 143540 110346594
Infusion site erythema 75.85 13.75 72 99093 11887 110478247
Endotracheal intubation 74.78 13.75 54 99111 6090 110484044
Lip dry 73.34 13.75 4 99161 100079 110390055
Intentional product misuse 73.14 13.75 15 99150 132889 110357245
White blood cell count decreased 73.12 13.75 59 99106 229331 110260803
Hypotension 72.96 13.75 754 98411 523095 109967039
Heart disease congenital 72.87 13.75 26 99139 636 110489498
Transplant 72.47 13.75 31 99134 1243 110488891
Device occlusion 71.78 13.75 78 99087 15107 110475027
Injury 71.07 13.75 35 99130 177230 110312904
Cardiopulmonary failure 71.03 13.75 58 99107 7845 110482289
Presyncope 69.97 13.75 143 99022 48744 110441390
Rhabdomyolysis 69.65 13.75 12 99153 120389 110369745
C-reactive protein increased 69.52 13.75 56 99109 217863 110272271
Pulmonary haemorrhage 68.32 13.75 79 99086 16377 110473757
Angioplasty 68.31 13.75 34 99131 1937 110488197
Catheter site haemorrhage 67.76 13.75 50 99115 5830 110484304
Rhinovirus infection 67.31 13.75 67 99098 11722 110478412
Walking distance test abnormal 66.20 13.75 25 99140 721 110489413
Abortion induced 66.15 13.75 56 99109 7963 110482171
Myelosuppression 65.48 13.75 5 99160 94335 110395799
Acute respiratory failure 65.12 13.75 181 98984 75079 110415055
Renal failure 64.43 13.75 385 98780 226189 110263945
Right ventricular systolic pressure increased 64.09 13.75 27 99138 1042 110489092
Infusion site infection 63.74 13.75 34 99131 2238 110487896
Sudden death 63.50 13.75 93 99072 24302 110465832
Chronic respiratory failure 63.40 13.75 41 99124 3862 110486272
Anaphylactic reaction 62.69 13.75 13 99152 114287 110375847
Malaise 61.76 13.75 894 98271 670925 109819209
Cardiomegaly 61.74 13.75 101 99064 29029 110461105
Delirium 61.61 13.75 22 99143 135003 110355131
Device leakage 61.59 13.75 74 99091 15974 110474160
Systemic lupus erythematosus 61.28 13.75 83 99082 254255 110235879
Thrombocytopenia 61.24 13.75 139 99026 348746 110141388
Bronchitis 61.16 13.75 291 98874 156741 110333393
Unevaluable event 60.99 13.75 152 99013 59075 110431059
Upper limb fracture 60.81 13.75 84 99081 20804 110469330
Leg amputation 60.50 13.75 41 99124 4177 110485957
Suicide attempt 60.48 13.75 10 99155 103384 110386750
Catheter site inflammation 60.24 13.75 27 99138 1213 110488921
Haemorrhage 59.78 13.75 221 98944 106471 110383663
Peripheral venous disease 59.71 13.75 4 99161 84113 110406021
Gastrointestinal haemorrhage 59.66 13.75 300 98865 165218 110324916
Ventricular septal defect repair 59.05 13.75 12 99153 24 110490110
Pregnancy 58.97 13.75 137 99028 50930 110439204
Hyponatraemia 58.79 13.75 65 99100 217588 110272546
Renal disorder 58.52 13.75 134 99031 49345 110440789
Pulmonary congestion 58.51 13.75 102 99063 30864 110459270
Catheter removal 58.40 13.75 22 99143 630 110489504
Tracheostomy malfunction 57.79 13.75 16 99149 163 110489971
Chemotherapy 57.09 13.75 31 99134 2115 110488019
Oxygen saturation abnormal 56.45 13.75 44 99121 5567 110484567
Oxygen therapy 56.33 13.75 39 99126 4114 110486020
Night sweats 55.94 13.75 25 99140 133958 110356176
Bronchopulmonary dysplasia 54.91 13.75 17 99148 263 110489871
Paraesthesia 54.57 13.75 103 99062 276418 110213716
Obesity 54.28 13.75 17 99148 113334 110376800
Injection site reaction 53.49 13.75 8 99157 89062 110401072
Blood pressure systolic increased 53.33 13.75 6 99159 82985 110407149
Electrocardiogram QT prolonged 52.79 13.75 16 99149 108944 110381190
Cardiac pacemaker replacement 52.60 13.75 19 99146 482 110489652
Dry mouth 52.60 13.75 61 99104 199887 110290247
Implantable defibrillator insertion 51.61 13.75 24 99141 1175 110488959
Left ventricular failure 51.23 13.75 57 99108 11332 110478802
Cytokine release syndrome 50.93 13.75 3 99162 70303 110419831
Device alarm issue 50.67 13.75 30 99135 2416 110487718
Angioedema 50.44 13.75 13 99152 98487 110391647
Injection site pain 50.44 13.75 51 99114 177871 110312263
Prescribed overdose 50.06 13.75 9 99156 87572 110402562
Pleural effusion 49.89 13.75 301 98864 177408 110312726
Inappropriate schedule of product administration 49.51 13.75 66 99099 203571 110286563
Gastrointestinal tube insertion 49.46 13.75 28 99137 2073 110488061
Right ventricular hypertrophy 49.01 13.75 26 99139 1693 110488441
Tracheitis 48.98 13.75 26 99139 1695 110488439
Heart valve replacement 48.58 13.75 23 99142 1173 110488961
Joint stiffness 48.31 13.75 3 99162 67240 110422894
Respiratory syncytial virus infection 47.91 13.75 62 99103 14422 110475712
Pancytopenia 47.91 13.75 71 99094 209542 110280592
Cognitive disorder 47.89 13.75 10 99155 87501 110402633
Cardiac arrest 47.06 13.75 320 98845 196433 110293701
Suicidal ideation 46.97 13.75 13 99152 93924 110396210
Cholecystectomy 46.75 13.75 53 99112 10756 110479378
Pneumothorax 46.74 13.75 100 99065 35185 110454949
Blood potassium decreased 46.67 13.75 130 99035 53984 110436150
Skin exfoliation 45.99 13.75 11 99154 87640 110402494
Head injury 45.99 13.75 112 99053 42905 110447229
Systemic-pulmonary artery shunt 45.86 13.75 10 99155 32 110490102
Mineral supplementation 45.77 13.75 20 99145 845 110489289
Neuropathy peripheral 45.76 13.75 56 99109 179221 110310913
Surgery 45.76 13.75 109 99056 41174 110448960
Incorrect route of product administration 45.60 13.75 3 99162 64058 110426076
Hip surgery 45.09 13.75 34 99131 4096 110486038
Endarterectomy 45.09 13.75 16 99149 385 110489749
Red blood cell sedimentation rate increased 44.86 13.75 8 99157 78294 110411840
Muscular weakness 44.39 13.75 98 99067 248370 110241764
Coronary arterial stent insertion 44.12 13.75 39 99126 5876 110484258
Product quality issue 44.06 13.75 8 99157 77291 110412843
Mastectomy 43.49 13.75 23 99142 1488 110488646
Generalised oedema 42.97 13.75 89 99076 30615 110459519
Sedation 42.44 13.75 6 99159 69677 110420457
Cardiac output decreased 41.88 13.75 25 99140 2044 110488090
Muscle spasms 41.71 13.75 120 99045 278037 110212097
Cellulitis 41.66 13.75 223 98942 125793 110364341
Limb operation 41.45 13.75 32 99133 3992 110486142
Pulmonary artery therapeutic procedure 41.22 13.75 9 99156 29 110490105
Tracheostomy infection 41.19 13.75 12 99153 149 110489985
Sleep disorder 40.96 13.75 72 99093 198572 110291562
Medication error 40.45 13.75 22 99143 105344 110384790
Gastrostomy 40.15 13.75 22 99143 1528 110488606
Paracentesis 39.42 13.75 21 99144 1379 110488755
Lactic acidosis 39.24 13.75 17 99148 92794 110397340
Device related sepsis 39.18 13.75 41 99124 7606 110482528
Taste disorder 38.97 13.75 6 99159 65381 110424753
Wound infection 38.72 13.75 19 99146 96446 110393688
Leukopenia 38.48 13.75 46 99119 148745 110341389
Loss of consciousness 38.21 13.75 304 98861 196002 110294132
Depressed level of consciousness 38.17 13.75 27 99138 112251 110377883
Colitis ulcerative 38.13 13.75 11 99154 77352 110412782
Localised oedema 37.82 13.75 44 99121 9179 110480955
Lymphocyte count decreased 37.13 13.75 4 99161 57239 110432895
Loss of personal independence in daily activities 37.10 13.75 48 99117 149972 110340162
Carbon dioxide increased 36.92 13.75 26 99139 2818 110487316
Epilepsy 36.92 13.75 22 99143 100187 110389947
Lung assist device therapy 36.74 13.75 11 99154 151 110489983
Therapy change 36.58 13.75 45 99120 9952 110480182
Cataract operation 36.51 13.75 35 99130 5848 110484286
Catheter site warmth 36.36 13.75 13 99152 320 110489814
Aggression 36.29 13.75 5 99160 59205 110430929
Exercise test abnormal 36.28 13.75 9 99156 57 110490077
Dyspnoea at rest 36.22 13.75 41 99124 8305 110481829
Catheter site related reaction 35.92 13.75 20 99145 1434 110488700
Faeces soft 35.55 13.75 47 99118 11163 110478971
Vascular resistance pulmonary increased 35.51 13.75 10 99155 109 110490025
Wrong technique in product usage process 35.37 13.75 17 99148 87331 110402803
Device infusion issue 35.33 13.75 26 99139 3019 110487115
Heart rate irregular 35.33 13.75 88 99077 34186 110455948
Autoimmune hepatitis 35.05 13.75 54 99111 14750 110475384
Swollen tongue 34.94 13.75 6 99159 60356 110429778
Gout 34.70 13.75 91 99074 36475 110453659
Pulmonary arterial pressure abnormal 34.69 13.75 17 99148 936 110489198
International normalised ratio increased 34.65 13.75 162 99003 86610 110403524
Orthopnoea 34.63 13.75 46 99119 10975 110479159
Pulmonary resection 34.46 13.75 11 99154 189 110489945
Extremity necrosis 34.37 13.75 28 99137 3774 110486360
Coma 34.31 13.75 33 99132 117836 110372298
Sepsis 34.23 13.75 446 98719 326900 110163234
Blood culture positive 33.81 13.75 41 99124 8935 110481199
Infusion site swelling 33.80 13.75 43 99122 9834 110480300
Right ventricular dilatation 33.76 13.75 23 99142 2364 110487770
Gallbladder operation 33.70 13.75 23 99142 2370 110487764
Cardiac septal defect repair 33.51 13.75 7 99158 17 110490117
Pregnancy of partner 33.39 13.75 12 99153 300 110489834
Drug-induced liver injury 33.36 13.75 35 99130 120032 110370102
Skin ulcer 33.30 13.75 129 99036 63516 110426618
Catheter site rash 33.29 13.75 17 99148 1023 110489111
Drug reaction with eosinophilia and systemic symptoms 33.21 13.75 16 99149 82079 110408055
Gastritis hypertrophic 33.21 13.75 8 99157 44 110490090
Heart valve operation 33.19 13.75 11 99154 214 110489920
Dysarthria 33.12 13.75 17 99148 84104 110406030
Colon operation 33.12 13.75 14 99151 545 110489589
Viral upper respiratory tract infection 32.68 13.75 43 99122 10165 110479969
Aspiration pleural cavity 32.61 13.75 20 99145 1717 110488417
Anaphylactic shock 32.44 13.75 4 99161 51542 110438592
Product administered to patient of inappropriate age 32.39 13.75 38 99127 7998 110482136
Infusion site cellulitis 32.38 13.75 13 99152 443 110489691
Rash maculo-papular 32.34 13.75 13 99152 74209 110415925
Deep vein thrombosis 32.33 13.75 47 99118 139840 110350294
Live birth 32.24 13.75 11 99154 69473 110420661
Scleroderma renal crisis 32.22 13.75 16 99149 907 110489227
Biopsy bone marrow 32.00 13.75 13 99152 457 110489677
Vascular device infection 31.99 13.75 55 99110 16457 110473677
Psychotic disorder 31.94 13.75 4 99161 50933 110439201
Mitral valve repair 31.58 13.75 12 99153 352 110489782
Cardiac flutter 31.55 13.75 32 99133 5725 110484409
Aortic valve replacement 31.24 13.75 19 99146 1607 110488527
Sickle cell anaemia 31.20 13.75 15 99150 792 110489342
Toe amputation 31.16 13.75 28 99137 4310 110485824
Injection site erosion 31.05 13.75 10 99155 177 110489957
Pulmonary artery banding 31.03 13.75 6 99159 8 110490126
Pulmonary artery dilatation 30.88 13.75 14 99151 646 110489488
Hepatic function abnormal 30.87 13.75 160 99005 89135 110400999
Infusion site abscess 30.69 13.75 12 99153 381 110489753
Pulmonary thrombosis 30.65 13.75 49 99116 13814 110476320
Cavopulmonary anastomosis 30.62 13.75 6 99159 9 110490125
Emergency care 30.57 13.75 18 99147 1435 110488699
Anaemia 30.53 13.75 673 98492 546413 109943721
Staphylococcal infection 30.48 13.75 134 99031 69810 110420324
Abdominal distension 30.25 13.75 264 98901 174839 110315295
Hospice care 30.24 13.75 46 99119 12427 110477707
Micrococcus test positive 30.23 13.75 6 99159 10 110490124
Blood pressure increased 30.23 13.75 124 99041 258249 110231885
Tubulointerstitial nephritis 30.13 13.75 6 99159 54278 110435856
Toxic epidermal necrolysis 29.99 13.75 7 99158 56720 110433414
Hepatomegaly 29.88 13.75 62 99103 21352 110468782
Tricuspid valve incompetence 29.73 13.75 66 99099 23807 110466327
Liver injury 29.68 13.75 56 99109 150357 110339777
Abdominal discomfort 29.61 13.75 219 98946 393639 110096495
Bilirubin conjugated increased 29.47 13.75 32 99133 6192 110483942
Autoimmune disorder 29.31 13.75 11 99154 65472 110424662
Therapeutic embolisation 29.15 13.75 13 99152 577 110489557
Plasma cell myeloma 29.14 13.75 10 99155 62926 110427208
Amnesia 28.98 13.75 31 99134 105377 110384757
Chest tube insertion 28.97 13.75 9 99156 141 110489993
Oxygen consumption 28.77 13.75 8 99157 83 110490051
Nocturnal dyspnoea 28.76 13.75 19 99146 1856 110488278
Gastric operation 28.69 13.75 11 99154 331 110489803
Medical device change 28.49 13.75 12 99153 463 110489671
Anxiety 28.33 13.75 187 98978 344891 110145243
Wheezing 28.32 13.75 125 99040 255105 110235029
Osteoporosis 28.28 13.75 22 99143 87130 110403004
Coeliac disease 28.06 13.75 3 99162 43184 110446950
Arteriovenous fistula operation 28.02 13.75 11 99154 353 110489781
Knee operation 27.97 13.75 33 99132 6989 110483145
Human metapneumovirus test positive 27.93 13.75 10 99155 247 110489887
Lung neoplasm malignant 27.91 13.75 80 99085 33762 110456372
Infusion site discharge 27.88 13.75 19 99146 1954 110488180
Inflammation 27.78 13.75 85 99080 193153 110296981
Pneumocystis jirovecii pneumonia 27.68 13.75 3 99162 42732 110447402
Illness 27.62 13.75 20 99145 82151 110407983
Pulmonary valve replacement 27.56 13.75 6 99159 19 110490115
Disease recurrence 27.56 13.75 10 99155 60774 110429360
Ventricular assist device insertion 27.49 13.75 7 99158 50 110490084
Mouth ulceration 27.40 13.75 5 99160 48133 110442001
Blood pressure decreased 27.39 13.75 187 98978 114904 110375230
Haemodynamic test abnormal 27.37 13.75 7 99158 51 110490083
Hysterectomy 27.26 13.75 35 99130 8079 110482055
Tricuspid valve repair 27.10 13.75 6 99159 21 110490113
Vascular operation 27.06 13.75 9 99156 177 110489957
Drug level increased 27.06 13.75 5 99160 47714 110442420
Eye operation 27.02 13.75 21 99144 2646 110487488
Feeling abnormal 26.95 13.75 264 98901 180447 110309687
Localised infection 26.52 13.75 92 99073 42956 110447178
N-terminal prohormone brain natriuretic peptide increased 26.45 13.75 30 99135 6091 110484043
Cytomegalovirus infection 26.36 13.75 8 99157 54436 110435698
Product supply issue 26.34 13.75 24 99141 3762 110486372
Hypercalcaemia 26.22 13.75 5 99160 46652 110443482
Contusion 26.06 13.75 114 99051 233247 110256887
Dry skin 26.04 13.75 35 99130 107618 110382516
Somnolence 25.53 13.75 159 99006 297290 110192844
Supraventricular tachycardia 25.48 13.75 63 99102 24359 110465775
Mitral valve replacement 25.31 13.75 12 99153 614 110489520
Hepatic enzyme increased 25.29 13.75 176 98989 320716 110169418
Pneumonitis 25.24 13.75 19 99146 76512 110413622
Pericardial drainage 25.13 13.75 11 99154 467 110489667
Pulmonary arterial wedge pressure increased 24.95 13.75 12 99153 634 110489500
Blood iron decreased 24.93 13.75 54 99111 19160 110470974
Adverse drug reaction 24.85 13.75 35 99130 105524 110384610
Generalised tonic-clonic seizure 24.78 13.75 9 99156 54671 110435463
Diabetic ketoacidosis 24.74 13.75 4 99161 42054 110448080
Treatment noncompliance 24.68 13.75 130 99035 72860 110417274
Musculoskeletal pain 24.57 13.75 83 99082 182940 110307194
Encephalopathy 24.40 13.75 22 99143 81033 110409101
Biopsy kidney 24.32 13.75 9 99156 245 110489889
Poor peripheral circulation 24.23 13.75 24 99141 4173 110485961
Gait inability 24.17 13.75 54 99111 136322 110353812
Phlebotomy 24.17 13.75 7 99158 85 110490049
Vascular cauterisation 24.17 13.75 7 99158 85 110490049
Hernia diaphragmatic repair 24.07 13.75 4 99161 0 110490134
Low cardiac output syndrome 24.06 13.75 14 99151 1092 110489042
Protein-losing gastroenteropathy 23.86 13.75 13 99152 893 110489241
Adenotonsillectomy 23.80 13.75 7 99158 90 110490044
Vasodilation procedure 23.79 13.75 6 99159 41 110490093
Disturbance in attention 23.71 13.75 13 99152 61982 110428152
Aortic valve repair 23.70 13.75 5 99160 13 110490121
Altered state of consciousness 23.66 13.75 11 99154 57615 110432519
Biopsy lung 23.50 13.75 9 99156 270 110489864
Hyperglycaemia 23.42 13.75 25 99140 85065 110405069
Haematuria 23.28 13.75 24 99141 82981 110407153
Sinusitis 23.24 13.75 163 99002 296525 110193609
Frequent bowel movements 23.19 13.75 18 99147 71372 110418762
Gastrointestinal disorder 23.08 13.75 125 99040 241827 110248307
Accidental exposure to product 23.06 13.75 8 99157 50000 110440134
General physical health deterioration 23.01 13.75 257 98908 425038 110065096
Pleural mass 23.00 13.75 7 99158 102 110490032
Dilatation ventricular 22.97 13.75 23 99142 4052 110486082
Asthma 22.95 13.75 131 99034 250160 110239974
Body temperature decreased 22.92 13.75 3 99162 36932 110453202
Arrhythmia 22.90 13.75 123 99042 69452 110420682
Renal haematoma 22.87 13.75 13 99152 970 110489164
Hallucination, visual 22.78 13.75 4 99161 39601 110450533
Productive cough 22.77 13.75 178 98987 114127 110376007
Pulmonary artery aneurysm 22.64 13.75 8 99157 190 110489944
Atrioventricular septal defect 22.63 13.75 7 99158 108 110490026
Stevens-Johnson syndrome 22.51 13.75 7 99158 46894 110443240
Systemic sclerosis pulmonary 22.47 13.75 5 99160 18 110490116
Injection site erythema 22.40 13.75 31 99134 94145 110395989
Dry eye 22.38 13.75 11 99154 55782 110434352
Bone marrow failure 22.31 13.75 12 99153 57836 110432298
Hyperkalaemia 22.29 13.75 56 99109 135740 110354394
Aneurysm repair 22.24 13.75 6 99159 55 110490079
Product use issue 22.15 13.75 176 98989 311519 110178615
Colitis 22.09 13.75 36 99129 102287 110387847
Tonsillectomy 22.07 13.75 12 99153 821 110489313
Pulmonary vascular resistance abnormality 22.03 13.75 8 99157 206 110489928
Spinal operation 21.85 13.75 37 99128 10935 110479199
Platelet transfusion 21.70 13.75 19 99146 2827 110487307
Sleep study 21.68 13.75 5 99160 22 110490112
Hallucination 21.60 13.75 36 99129 101396 110388738
Acute myeloid leukaemia 21.60 13.75 4 99161 38106 110452028
Catheter site induration 21.60 13.75 6 99159 62 110490072
Colonoscopy 21.45 13.75 17 99148 2203 110487931
Heart valve incompetence 21.45 13.75 22 99143 3987 110486147
Sciatica 21.39 13.75 31 99134 92368 110397766
Cyst removal 21.35 13.75 10 99155 498 110489636
Skin operation 21.26 13.75 6 99159 66 110490068
Infusion site induration 21.24 13.75 14 99151 1362 110488772
Thromboembolectomy 21.22 13.75 7 99158 134 110490000
Pulmonary artery stenosis 21.22 13.75 7 99158 134 110490000
Dizziness postural 21.21 13.75 43 99122 14566 110475568
Galectin-3 increased 21.15 13.75 5 99160 25 110490109
Venous operation 20.99 13.75 5 99160 26 110490108
Tracheostomy tube removal 20.83 13.75 4 99161 5 110490129
Chest discomfort 20.80 13.75 243 98922 173605 110316529
Injection site pruritus 20.72 13.75 10 99155 51248 110438886
Seasonal allergy 20.71 13.75 51 99114 19671 110470463
Metabolic acidosis 20.69 13.75 36 99129 99708 110390426
Underdose 20.67 13.75 16 99149 63538 110426596
Infusion site haemorrhage 20.66 13.75 23 99142 4575 110485559
Hypocalcaemia 20.58 13.75 17 99148 65349 110424785
Hypoglycaemia 20.55 13.75 46 99119 116058 110374076
Caesarean section 20.46 13.75 41 99124 13776 110476358
Arterial aneurysm repair 20.41 13.75 4 99161 6 110490128
Serotonin syndrome 20.40 13.75 14 99151 59139 110430995
Congenital arterial malformation 20.39 13.75 5 99160 30 110490104
Sopor 20.36 13.75 4 99161 36542 110453592
Gastroenteritis viral 20.34 13.75 68 99097 31158 110458976
Radiotherapy 20.24 13.75 14 99151 1474 110488660
Immunodeficiency 20.13 13.75 5 99160 38833 110451301
Agitation 19.84 13.75 45 99120 113006 110377128
Restlessness 19.83 13.75 13 99152 56246 110433888
Device connection issue 19.76 13.75 13 99152 1261 110488873
Device dislocation 19.74 13.75 68 99097 31636 110458498
Polypectomy 19.74 13.75 14 99151 1535 110488599
Premature baby 19.64 13.75 23 99142 4832 110485302
Gallbladder disorder 19.61 13.75 52 99113 20977 110469157
Medical device implantation 19.47 13.75 10 99155 609 110489525
Liver function test increased 19.39 13.75 141 99024 88407 110401727
Pulseless electrical activity 19.39 13.75 45 99120 16712 110473422
Cor pulmonale chronic 19.37 13.75 9 99156 440 110489694
Rectal prolapse repair 19.36 13.75 4 99161 9 110490125
Smooth muscle antibody positive 19.33 13.75 7 99158 179 110489955
Dehydration 19.27 13.75 355 98810 279156 110210978
Resuscitation 19.25 13.75 18 99147 2915 110487219
Hepatic cirrhosis 19.25 13.75 115 99050 67511 110422623
Catheter site granuloma 19.19 13.75 6 99159 96 110490038
Respiratory tract infection viral 19.19 13.75 25 99140 5853 110484281
Eczema 19.06 13.75 22 99143 72271 110417863
Rash pruritic 18.92 13.75 37 99128 98032 110392102
Gastrointestinal surgery 18.82 13.75 8 99157 316 110489818
Catheterisation cardiac abnormal 18.79 13.75 8 99157 317 110489817
CREST syndrome 18.76 13.75 9 99156 473 110489661
Echocardiogram abnormal 18.70 13.75 17 99148 2657 110487477
Biopsy lymph gland 18.64 13.75 6 99159 106 110490028
Shoulder operation 18.61 13.75 19 99146 3426 110486708
Diuretic therapy 18.53 13.75 7 99158 202 110489932
Blood creatine phosphokinase increased 18.46 13.75 23 99142 73054 110417080
Sudden cardiac death 18.44 13.75 24 99141 5613 110484521
Atrial tachycardia 18.35 13.75 31 99134 9147 110480987
Radiotherapy to brain 18.33 13.75 5 99160 48 110490086
Primary biliary cholangitis 18.32 13.75 13 99152 1426 110488708
Posterior reversible encephalopathy syndrome 18.26 13.75 4 99161 33857 110456277
Infusion site irritation 18.25 13.75 12 99153 1163 110488971
Post procedural complication 18.22 13.75 59 99106 26599 110463535
Spinal fracture 18.18 13.75 53 99112 22580 110467554
Blood glucose decreased 18.14 13.75 63 99102 29425 110460709
Pulmonary valve repair 18.05 13.75 3 99162 0 110490134
Arterial switch operation 18.05 13.75 3 99162 0 110490134
Device expulsion 18.03 13.75 3 99162 30888 110459246
Product prescribing error 17.90 13.75 12 99153 51319 110438815
High frequency ablation 17.79 13.75 8 99157 362 110489772
Emotional distress 17.75 13.75 9 99156 44838 110445296
Neoplasm malignant 17.60 13.75 73 99092 37070 110453064
Lymphopenia 17.56 13.75 7 99158 40163 110449971
Internal haemorrhage 17.52 13.75 32 99133 10039 110480095
Constipation 17.50 13.75 221 98944 357565 110132569
Pulmonary vein occlusion 17.50 13.75 6 99159 130 110490004
Lip swelling 17.46 13.75 12 99153 50655 110439479
Drug resistance 17.33 13.75 15 99150 56359 110433775
Migraine 17.31 13.75 87 99078 171565 110318569
Right atrial dilatation 17.27 13.75 11 99154 1009 110489125
Laboratory test abnormal 17.21 13.75 9 99156 44070 110446064
Drug ineffective for unapproved indication 17.20 13.75 42 99123 102796 110387338
Portal hypertensive gastropathy 17.14 13.75 14 99151 1894 110488240
Cardiac failure acute 17.10 13.75 54 99111 24024 110466110
Pericardiotomy 17.09 13.75 4 99161 19 110490115
Device physical property issue 17.08 13.75 19 99146 3775 110486359
Sarcoidosis 17.06 13.75 36 99129 12543 110477591
Retinal vascular disorder 17.03 13.75 8 99157 401 110489733
N-terminal prohormone brain natriuretic peptide 17.02 13.75 5 99160 64 110490070
Clubbing 17.01 13.75 10 99155 795 110489339
Hypokalaemia 16.99 13.75 95 99070 182353 110307781
Jugular vein distension 16.97 13.75 13 99152 1603 110488531
Neutrophil count increased 16.94 13.75 5 99160 34647 110455487
Sinus bradycardia 16.91 13.75 3 99162 29480 110460654
Gangrene 16.88 13.75 42 99123 16299 110473835
Haemoglobin decreased 16.83 13.75 315 98850 248412 110241722
Polyneuropathy 16.83 13.75 4 99161 32008 110458126
Catheter site vesicles 16.81 13.75 8 99157 413 110489721
Insomnia 16.80 13.75 225 98940 360365 110129769
Skin lesion 16.79 13.75 13 99152 51618 110438516
Decreased activity 16.77 13.75 33 99132 10941 110479193
Ear tube insertion 16.77 13.75 6 99159 148 110489986
Mixed connective tissue disease 16.74 13.75 8 99157 417 110489717
Orthostatic hypotension 16.58 13.75 21 99144 66228 110423906
Dysentery 16.57 13.75 12 99153 1359 110488775
Colectomy 16.49 13.75 20 99145 4358 110485776
Status epilepticus 16.49 13.75 4 99161 31567 110458567
Therapeutic response decreased 16.46 13.75 39 99126 96460 110393674
Catheter site mass 16.42 13.75 5 99160 73 110490061
Skin graft 16.42 13.75 11 99154 1100 110489034
Thrombosis in device 16.38 13.75 22 99143 5305 110484829
Choking sensation 16.28 13.75 20 99145 4416 110485718
Blood potassium increased 16.27 13.75 66 99099 33183 110456951
Foot amputation 16.26 13.75 11 99154 1117 110489017
Staphylococcus test positive 16.22 13.75 26 99139 7344 110482790
Catheter site irritation 16.22 13.75 9 99156 641 110489493
Collateral circulation 15.99 13.75 5 99160 80 110490054
Hernia 15.98 13.75 46 99119 19454 110470680
Removal of transplanted organ 15.98 13.75 3 99162 3 110490131
Fasciectomy 15.98 13.75 3 99162 3 110490131
Injection site discharge 15.90 13.75 12 99153 1448 110488686
Procedural pain 15.87 13.75 6 99159 35559 110454575
Throat irritation 15.85 13.75 92 99073 53460 110436674
Administration site infection 15.78 13.75 4 99161 28 110490106
Arthritis 15.74 13.75 87 99078 167499 110322635
Prostate cancer 15.74 13.75 7 99158 37634 110452500
Dyspnoea paroxysmal nocturnal 15.74 13.75 15 99150 2487 110487647
Heart sounds abnormal 15.74 13.75 12 99153 1470 110488664
Pregnancy on oral contraceptive 15.70 13.75 10 99155 918 110489216
Peripheral artery stent insertion 15.52 13.75 3 99162 4 110490130
Haematocrit decreased 15.48 13.75 107 99058 66010 110424124
Trisomy 21 15.45 13.75 5 99160 90 110490044
Dialysis related complication 15.44 13.75 7 99158 323 110489811
Visual impairment 15.41 13.75 65 99100 134363 110355771
Drug tolerance decreased 15.37 13.75 3 99162 27537 110462597
Renal stone removal 15.36 13.75 6 99159 190 110489944
Cardiac resynchronisation therapy 15.29 13.75 5 99160 93 110490041
Impaired quality of life 15.29 13.75 4 99161 30013 110460121
Microcytic anaemia 15.17 13.75 23 99142 6195 110483939
Brain tumour operation 15.10 13.75 5 99160 97 110490037
Pulmonary capillary haemangiomatosis 15.05 13.75 5 99160 98 110490036
Fracture treatment 14.86 13.75 5 99160 102 110490032
Dysphagia 14.84 13.75 79 99086 153521 110336613
Neuralgia 14.78 13.75 13 99152 48465 110441669
Intestinal adhesion lysis 14.76 13.75 3 99162 6 110490128
Cardiopulmonary bypass 14.76 13.75 3 99162 6 110490128
Labelled drug-drug interaction medication error 14.75 13.75 4 99161 29298 110460836
Aneurysm 14.66 13.75 19 99146 4427 110485707
Oral herpes 14.64 13.75 7 99158 36073 110454061
Cyanosis central 14.64 13.75 7 99158 365 110489769
Lung operation 14.62 13.75 7 99158 366 110489768
Scleroderma associated digital ulcer 14.61 13.75 4 99161 39 110490095
Ankle fracture 14.58 13.75 45 99120 19774 110470360
Drug dependence 14.56 13.75 14 99151 50006 110440128
Jaundice 14.54 13.75 97 99068 59139 110430995
Thrombectomy 14.53 13.75 7 99158 371 110489763
Pulmonary arterial pressure 14.52 13.75 4 99161 40 110490094
Drug eruption 14.51 13.75 16 99149 53643 110436491
Paraesthesia oral 14.50 13.75 6 99159 33665 110456469
Hyperlipidaemia 14.48 13.75 7 99158 35841 110454293
Varicose vein operation 14.45 13.75 3 99162 7 110490127
Diplopia 14.34 13.75 10 99155 41884 110448250
Hypomagnesaemia 14.23 13.75 20 99145 60350 110429784
Acute myocardial infarction 14.18 13.75 34 99131 83743 110406391
Pancreatitis acute 14.17 13.75 20 99145 60254 110429880
Tooth extraction 14.07 13.75 34 99131 12957 110477177
Diet noncompliance 14.06 13.75 8 99157 598 110489536
Injection site swelling 14.04 13.75 21 99144 61769 110428365
Myoclonus 14.02 13.75 6 99159 32992 110457142
Univentricular heart 13.90 13.75 3 99162 9 110490125
Colostomy 13.87 13.75 11 99154 1427 110488707
Alanine aminotransferase 13.83 13.75 6 99159 249 110489885
Device breakage 13.82 13.75 35 99130 13734 110476400

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C02KX01 CARDIOVASCULAR SYSTEM
ANTIHYPERTENSIVES
OTHER ANTIHYPERTENSIVES
Antihypertensives for pulmonary arterial hypertension
FDA MoA N0000175364 Endothelin Receptor Antagonists
FDA EPC N0000175581 Endothelin Receptor Antagonist
MeSH PA D000959 Antihypertensive Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D065128 Endothelin Receptor Antagonists
FDA MoA N0000185507 Cytochrome P450 2C9 Inducers
FDA MoA N0000190118 Cytochrome P450 3A Inducers
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:39456 antiglaucoma drug
CHEBI has role CHEBI:49201 anti-ulcer drug
CHEBI has role CHEBI:51451 endothelin receptor antagonist
CHEBI has role CHEBI:62868 hepatoprotective agent
CHEBI has role CHEBI:65023 anti-asthmatic agent
CHEBI has role CHEBI:233423 antifibrotic agent

Related Drugs by ATC class:

C02KX Antihypertensives for pulmonary arterial hypertension 6 drugs
ambrisentanmacitentanriociguatsitaxentansotatercept-csrktadalafil

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

DiseaseRelationSNOMED_IDDOID
Pulmonary arterial hypertension indication 11399002
Pulmonary hypertension indication 70995007 DOID:6432
Systemic sclerosis indication 89155008 DOID:418
Hyperbilirubinemia contraindication 14783006 DOID:2741
Pulmonary edema contraindication 19242006 DOID:11396
Hepatic failure contraindication 59927004
Pulmonary veno-occlusive disease contraindication 89420002 DOID:5453
Liver function tests abnormal contraindication 166603001
Decompensated cardiac failure contraindication 195111005
Disease of liver contraindication 235856003 DOID:409
Drug-induced hepatitis contraindication 235876009
Edema contraindication 267038008
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Breastfeeding (mother) contraindication 413712001




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.84 acidic
pKa2 2.87 Basic
pKa3 1.44 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
32MG BOSENTAN NATCO PHARMA LTD A213154 Feb. 5, 2025 RX TABLET, FOR SUSPENSION ORAL Feb. 14, 2026 PATENT CHALLENGE

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Endothelin B receptor GPCR ANTAGONIST Ki 7.10 CHEMBL CHEMBL
Endothelin-1 receptor GPCR ANTAGONIST Ki 8.19 CHEMBL CHEMBL
Nuclear receptor subfamily 1 group I member 2 Nuclear hormone receptor WOMBAT-PK
Deoxyhypusine synthase Enzyme IC50 4.22 CHEMBL
Bile salt export pump Transporter IC50 4.42 CHEMBL
Endothelin-1 receptor GPCR Ki 8.19 CHEMBL
Endothelin-1 receptor GPCR IC50 8.12 CHEMBL
Bile salt export pump Transporter IC50 4.51 CHEMBL
Endothelin B receptor GPCR IC50 7.02 CHEMBL

External reference:

IDSource
D01227 KEGG_DRUG
157212-55-0 SECONDARY_CAS_RN
1468845 RXNORM
C0252643 UMLSCUI
CHEBI:51450 CHEBI
CHEMBL957 ChEMBL_ID
D000077300 MESH_DESCRIPTOR_UI
DB00559 DRUGBANK_ID
3494 IUPHAR_LIGAND_ID
Q326023R30 UNII
104865 PUBCHEM_CID
16217 MMSL
230939 MMSL
33033 MMSL
42472 MMSL
d04782 MMSL
1268952004 SNOMEDCT_US
385558007 SNOMEDCT_US
385559004 SNOMEDCT_US
725734005 SNOMEDCT_US
K86 PDB_CHEM_ID
7195 INN_ID
4021289 VANDF
009514 NDDF
Q326023R30 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
bosentan HUMAN PRESCRIPTION DRUG LABEL 1 0591-2511 TABLET, FILM COATED 62.50 mg ORAL ANDA 28 sections
bosentan HUMAN PRESCRIPTION DRUG LABEL 1 0591-2511 TABLET, FILM COATED 62.50 mg ORAL ANDA 28 sections
bosentan HUMAN PRESCRIPTION DRUG LABEL 1 0591-2512 TABLET, FILM COATED 125 mg ORAL ANDA 28 sections
bosentan HUMAN PRESCRIPTION DRUG LABEL 1 0591-2512 TABLET, FILM COATED 125 mg ORAL ANDA 28 sections
Bosentan Human Prescription Drug Label 1 47335-038 TABLET, FILM COATED 62.50 mg ORAL ANDA 28 sections
Bosentan Human Prescription Drug Label 1 47335-039 TABLET, FILM COATED 125 mg ORAL ANDA 28 sections
Tracleer HUMAN PRESCRIPTION DRUG LABEL 1 66215-101 TABLET, FILM COATED 62.50 mg ORAL NDA 31 sections
Tracleer HUMAN PRESCRIPTION DRUG LABEL 1 66215-102 TABLET, FILM COATED 125 mg ORAL NDA 31 sections
Tracleer HUMAN PRESCRIPTION DRUG LABEL 1 66215-232 TABLET, FOR SUSPENSION 32 mg ORAL NDA 31 sections
Bosentan Human Prescription Drug Label 1 68180-340 TABLET, FOR SUSPENSION 32 mg ORAL ANDA 29 sections
Bosentan Human Prescription Drug Label 1 68180-340 TABLET, FOR SUSPENSION 32 mg ORAL ANDA 29 sections
Bosentan HUMAN PRESCRIPTION DRUG LABEL 1 68382-446 TABLET, COATED 62.50 mg ORAL ANDA 26 sections
Bosentan HUMAN PRESCRIPTION DRUG LABEL 1 68382-447 TABLET, COATED 125 mg ORAL ANDA 26 sections
bosentan HUMAN PRESCRIPTION DRUG LABEL 1 70710-1508 TABLET, FOR SUSPENSION 32 mg ORAL ANDA 26 sections
Bosentan HUMAN PRESCRIPTION DRUG LABEL 1 70771-1017 TABLET 62.50 mg ORAL ANDA 2 sections
Bosentan HUMAN PRESCRIPTION DRUG LABEL 1 70771-1018 TABLET 125 mg ORAL ANDA 2 sections
bosentan HUMAN PRESCRIPTION DRUG LABEL 1 70771-1908 TABLET, FOR SUSPENSION 32 mg ORAL ANDA 1 sections