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

Approvals:

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

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 2159.01 14.10 2474 76128 371907 63038513
Dyspnoea 1459.58 14.10 2778 75824 658535 62751885
Right ventricular failure 1324.01 14.10 569 78033 16619 63393801
Aspartate aminotransferase increased 931.15 14.10 821 77781 89456 63320964
Alanine aminotransferase increased 811.07 14.10 809 77793 102961 63307459
Fluid retention 759.70 14.10 613 77989 59073 63351347
Blood alkaline phosphatase increased 641.32 14.10 485 78117 42482 63367938
Liver function test abnormal 615.43 14.10 496 78106 47685 63362735
Drug ineffective 582.40 14.10 286 78316 1044479 62365941
Pulmonary hypertension 569.44 14.10 426 78176 36697 63373723
Transfusion 500.36 14.10 282 78320 14935 63395485
Cardiac failure 427.36 14.10 539 78063 88603 63321817
Pneumonia 372.39 14.10 1325 77277 455442 62954978
Hospitalisation 363.39 14.10 486 78116 84595 63325825
Dyspnoea exertional 360.30 14.10 408 78194 59894 63350526
Lung transplant 330.74 14.10 130 78472 2998 63407422
Blood bilirubin increased 324.20 14.10 308 78294 36832 63373588
Pulmonary oedema 323.95 14.10 369 78233 54504 63355916
Syncope 323.05 14.10 546 78056 116839 63293581
Hypervolaemia 299.59 14.10 262 78340 28151 63382269
Alopecia 299.52 14.10 34 78568 337502 63072918
Cardiac failure congestive 289.59 14.10 456 78146 91977 63318443
Infusion related reaction 279.00 14.10 5 78597 245516 63164904
Device related infection 271.67 14.10 228 78374 23164 63387256
Cardiac operation 266.38 14.10 113 78489 3185 63407235
Disease progression 265.11 14.10 514 78088 122244 63288176
Rash 263.70 14.10 187 78415 560684 62849736
Respiratory failure 246.69 14.10 448 78154 101410 63309010
Scleroderma 246.47 14.10 125 78477 5337 63405083
Oedema peripheral 238.92 14.10 641 77961 188870 63221550
Oxygen saturation decreased 234.32 14.10 405 78197 88180 63322240
Cardiac pacemaker insertion 232.84 14.10 110 78492 4016 63406404
Contraindicated product administered 226.95 14.10 10 78592 217638 63192782
Catheterisation cardiac 224.36 14.10 111 78491 4492 63405928
Concomitant disease aggravated 223.98 14.10 140 78462 8972 63401448
Pain in jaw 219.45 14.10 270 78332 43226 63367194
Treatment failure 218.50 14.10 6 78596 199037 63211383
Hypoxia 217.02 14.10 316 78286 59476 63350944
Drug hypersensitivity 215.71 14.10 59 78543 310628 63099792
Oedema 214.67 14.10 412 78190 97210 63313210
Pulmonary arterial pressure increased 212.61 14.10 99 78503 3496 63406924
Maternal exposure during pregnancy 203.26 14.10 19 78583 220043 63190377
Therapeutic product effect decreased 200.99 14.10 9 78593 193178 63217242
Drug intolerance 199.12 14.10 67 78535 308594 63101826
Rheumatoid arthritis 196.45 14.10 38 78564 253781 63156639
Off label use 192 14.10 339 78263 674123 62736297
Joint swelling 186.92 14.10 86 78516 327580 63082840
Arthropathy 182.01 14.10 35 78567 234757 63175663
Arthralgia 181.17 14.10 266 78336 569444 62840976
Product dose omission issue 174.35 14.10 661 77941 233652 63176768
Pain 171.38 14.10 419 78183 740209 62670211
Glossodynia 169.07 14.10 14 78588 178862 63231558
Dialysis 167.26 14.10 123 78479 10304 63400116
Gamma-glutamyltransferase increased 166.43 14.10 208 78394 33823 63376597
Chest pain 164.60 14.10 614 77988 215345 63195075
Toxicity to various agents 157.10 14.10 55 78547 247195 63163225
Pulmonary arterial hypertension 154.25 14.10 164 78438 22413 63388007
Neutropenia 154.13 14.10 18 78584 174987 63235433
Musculoskeletal stiffness 153.02 14.10 23 78579 184595 63225825
Completed suicide 150.80 14.10 7 78595 145666 63264754
Catheter site erythema 150.77 14.10 83 78519 4193 63406227
Catheter site pain 148.20 14.10 85 78517 4650 63405770
Cardiac disorder 139.12 14.10 236 78366 50580 63359840
Hypersensitivity 137.97 14.10 97 78505 292588 63117832
Catheter site infection 137.41 14.10 82 78520 4832 63405588
Condition aggravated 136.50 14.10 908 77694 401309 63009111
Haemoptysis 134.78 14.10 172 78430 28554 63381866
Catheter management 133.72 14.10 68 78534 2919 63407501
Pericardial effusion 130.17 14.10 173 78429 29885 63380535
Febrile neutropenia 128.37 14.10 4 78598 118445 63291975
Disease complication 123.47 14.10 66 78536 3143 63407277
Cough 123.27 14.10 699 77903 292044 63118376
Pericarditis 122.40 14.10 11 78591 131568 63278852
Chronic obstructive pulmonary disease 120.25 14.10 250 78352 62436 63347984
Discomfort 119.44 14.10 30 78572 167344 63243076
Flushing 115.35 14.10 274 78328 74813 63335607
Pulmonary hypertensive crisis 110.99 14.10 33 78569 311 63410109
Cyanosis 108.64 14.10 119 78483 16816 63393604
Cardioversion 107.86 14.10 45 78557 1215 63409205
Atrial fibrillation 106.32 14.10 352 78250 116284 63294136
Stomatitis 100.66 14.10 24 78578 138701 63271719
Urticaria 98.40 14.10 41 78561 165761 63244659
Nasal congestion 98.04 14.10 237 78365 65423 63344997
Congestive hepatopathy 97.97 14.10 55 78547 2887 63407533
Pruritus 97.76 14.10 187 78415 361266 63049154
Oxygen consumption increased 96.27 14.10 60 78542 3824 63406596
Therapeutic product effect incomplete 96.08 14.10 19 78583 125037 63285383
Mechanical ventilation 96.06 14.10 42 78560 1276 63409144
Tracheostomy 95.81 14.10 35 78567 655 63409765
Helicobacter infection 94.28 14.10 5 78597 92780 63317640
Ascites 93.28 14.10 175 78427 40553 63369867
Blood cholesterol increased 92.70 14.10 6 78596 94026 63316394
Finger amputation 91.38 14.10 32 78570 527 63409893
Cardiac ablation 91.26 14.10 42 78560 1443 63408977
Exercise tolerance decreased 90.78 14.10 66 78536 5431 63404989
Catheter site discharge 90.62 14.10 46 78556 1967 63408453
Stent placement 90.53 14.10 57 78545 3698 63406722
Dizziness 90.47 14.10 870 77732 429055 62981365
Pregnancy 89.04 14.10 162 78440 36674 63373746
Blister 87.47 14.10 26 78576 129788 63280632
Psoriasis 87.38 14.10 5 78597 86952 63323468
Cor pulmonale 86.86 14.10 45 78557 2009 63408411
Wound 86.72 14.10 47 78555 163216 63247204
Pulmonary veno-occlusive disease 85.87 14.10 37 78565 1084 63409336
Biopsy liver 85.41 14.10 28 78574 373 63410047
Atrial flutter 85.14 14.10 81 78521 9691 63400729
Duodenal ulcer perforation 84.69 14.10 6 78596 87203 63323217
Intentional product use issue 81.93 14.10 28 78574 127864 63282556
Fall 81.06 14.10 791 77811 391543 63018877
Mobility decreased 80.31 14.10 25 78577 121134 63289286
Lower respiratory tract infection 79.66 14.10 32 78570 132275 63278145
Palpitations 79.50 14.10 313 78289 112457 63297963
Systemic lupus erythematosus 79.25 14.10 85 78517 208833 63201587
Malignant neoplasm progression 78.75 14.10 6 78596 82115 63328305
Systemic scleroderma 77.19 14.10 33 78569 948 63409472
Hypertension 76.79 14.10 143 78459 279160 63131260
Epistaxis 75.87 14.10 230 78372 72495 63337925
Hypotension 75.23 14.10 586 78016 272018 63138402
Depression 74.47 14.10 80 78522 196412 63214008
Abdominal discomfort 74.28 14.10 181 78421 320704 63089716
Heart transplant 73.53 14.10 27 78575 513 63409907
Product use in unapproved indication 73.49 14.10 68 78534 179012 63231408
Device leakage 71.90 14.10 64 78538 7032 63403388
Catheter placement 71.48 14.10 41 78561 2243 63408177
Concomitant disease progression 71.35 14.10 40 78562 2094 63408326
Gastrointestinal haemorrhage 71.29 14.10 242 78360 80934 63329486
Catheter site swelling 69.97 14.10 35 78567 1450 63408970
Confusional state 69.50 14.10 116 78486 236264 63174156
Presyncope 68.17 14.10 123 78479 27662 63382758
Muscle injury 68.06 14.10 3 78599 65342 63345078
Atrial septal defect repair 67.79 14.10 21 78581 230 63410190
Drug abuse 67.59 14.10 6 78596 72512 63337908
Paraesthesia 67.54 14.10 57 78545 156909 63253511
Malaise 67.45 14.10 799 77803 415155 62995265
Intentional overdose 66.83 14.10 7 78595 74145 63336275
Fibromyalgia 64.38 14.10 11 78591 80409 63330011
Endotracheal intubation 64.19 14.10 40 78562 2548 63407872
Type 2 diabetes mellitus 63.17 14.10 4 78598 63864 63346556
Brain natriuretic peptide increased 62.97 14.10 52 78550 5161 63405259
Influenza 62.79 14.10 284 78318 108438 63301982
Impaired healing 61.39 14.10 25 78577 102517 63307903
Walking distance test abnormal 61.19 14.10 24 78578 550 63409870
Right ventricular dysfunction 60.55 14.10 34 78568 1785 63408635
Patent ductus arteriosus repair 59.56 14.10 12 78590 13 63410407
COVID-19 59.40 14.10 33 78569 113070 63297350
Hip fracture 59.39 14.10 120 78482 29354 63381066
Central venous catheterisation 59.05 14.10 38 78564 2561 63407859
Right-to-left cardiac shunt 59.02 14.10 19 78583 238 63410182
Transplant evaluation 58.73 14.10 29 78573 1168 63409252
Catheter site pruritus 58.30 14.10 35 78567 2085 63408335
Cardiomegaly 58.01 14.10 89 78513 17525 63392895
Respiratory distress 57.74 14.10 129 78473 33822 63376598
Osteoarthritis 57.48 14.10 23 78579 95320 63315100
Injection site pain 57.24 14.10 46 78556 129754 63280666
Hypoaesthesia 56.92 14.10 75 78527 168318 63242102
White blood cell count decreased 56.85 14.10 53 78549 139051 63271369
Catheter site haemorrhage 56.74 14.10 40 78562 3135 63407285
Hernia repair 56.38 14.10 31 78571 1562 63408858
Sudden death 54.51 14.10 66 78536 10383 63400037
Acute respiratory failure 54.19 14.10 127 78475 34358 63376062
Renal failure 54.12 14.10 288 78314 117364 63293056
Heart valve replacement 53.54 14.10 22 78580 571 63409849
Lung disorder 53.25 14.10 184 78418 62077 63348343
Overdose 53.01 14.10 39 78563 115039 63295381
Infusion site pain 52.44 14.10 83 78519 16786 63393634
Pulmonary haemorrhage 52.32 14.10 54 78548 7127 63403293
Abortion induced 52.30 14.10 64 78538 10178 63400242
Neutrophil count decreased 51.68 14.10 5 78597 56401 63354019
Catheter site inflammation 51.60 14.10 24 78578 845 63409575
Viral infection 51.38 14.10 127 78475 35536 63374884
Terminal state 50.94 14.10 33 78569 2249 63408171
Chronic respiratory failure 50.60 14.10 31 78571 1916 63408504
Electrocardiogram QT prolonged 50.25 14.10 7 78595 59523 63350897
Rhinovirus infection 50.21 14.10 43 78559 4486 63405934
Injection site reaction 49.12 14.10 7 78595 58517 63351903
Sepsis 47.75 14.10 339 78263 152784 63257636
Suicide attempt 47.32 14.10 9 78593 60909 63349511
Ill-defined disorder 47.23 14.10 21 78581 81734 63328686
Suicidal ideation 46.86 14.10 10 78592 62411 63348009
Anaphylactic reaction 46.83 14.10 12 78590 66088 63344332
Cardiac arrest 46.34 14.10 232 78370 92313 63318107
Angioplasty 46.29 14.10 26 78576 1366 63409054
Mucosal inflammation 46.23 14.10 3 78599 46925 63363495
Cognitive disorder 46.10 14.10 7 78595 55808 63354612
Device occlusion 45.80 14.10 51 78551 7336 63403084
Pulmonary resection 45.67 14.10 10 78592 21 63410399
Drug interaction 45.65 14.10 139 78463 228992 63181428
Neuropathy peripheral 45.63 14.10 44 78558 113623 63296797
Product use issue 45.21 14.10 132 78470 220388 63190032
Gout 45.03 14.10 68 78534 13203 63397217
Oxygen therapy 44.98 14.10 30 78572 2148 63408272
Headache 44.82 14.10 1062 77540 632179 62778241
Autoimmune hepatitis 44.80 14.10 54 78548 8456 63401964
Transplant 44.18 14.10 21 78581 777 63409643
Cardiac pacemaker replacement 43.73 14.10 17 78585 380 63410040
Haemorrhage 43.48 14.10 170 78432 60852 63349568
Tracheostomy malfunction 43.35 14.10 11 78591 53 63410367
Inappropriate schedule of product administration 43.20 14.10 39 78563 103926 63306494
Leg amputation 42.76 14.10 29 78573 2135 63408285
Pulmonary congestion 42.59 14.10 77 78525 17341 63393079
Mastectomy 42.43 14.10 26 78576 1607 63408813
Loss of personal independence in daily activities 42.24 14.10 35 78567 97255 63313165
Oxygen saturation abnormal 42.20 14.10 35 78567 3494 63406926
Heart rate increased 42.18 14.10 229 78373 94009 63316411
Anaemia 42.03 14.10 551 78051 292879 63117541
Heart and lung transplant 41.46 14.10 12 78590 102 63410318
Blood pressure systolic increased 41.39 14.10 5 78597 47392 63363028
Injection site erythema 41.23 14.10 26 78576 83148 63327272
Pleural effusion 40.71 14.10 225 78377 92985 63317435
Irritable bowel syndrome 40.52 14.10 26 78576 82386 63328034
Blood pressure increased 40.19 14.10 88 78514 161974 63248446
Hepatic function abnormal 40.17 14.10 119 78483 37023 63373397
Balloon atrial septostomy 40.12 14.10 11 78591 75 63410345
Coronary arterial stent insertion 40.10 14.10 31 78571 2798 63407622
Leukopenia 39.93 14.10 23 78579 77267 63333153
Renal disorder 39.89 14.10 110 78492 32864 63377556
Pulmonary vein stenosis 39.87 14.10 11 78591 77 63410343
Intentional product misuse 39.59 14.10 13 78589 60904 63349516
Cardiopulmonary failure 39.45 14.10 34 78568 3578 63406842
Device alarm issue 38.84 14.10 24 78578 1506 63408914
International normalised ratio increased 38.65 14.10 136 78466 46289 63364131
Right ventricular systolic pressure increased 38.47 14.10 17 78585 530 63409890
Chemotherapy 38.14 14.10 24 78578 1555 63408865
Bilirubin conjugated increased 37.89 14.10 30 78572 2804 63407616
Infusion site infection 37.75 14.10 25 78577 1769 63408651
Device related sepsis 37.71 14.10 35 78567 4059 63406361
Hip surgery 37.70 14.10 32 78570 3299 63407121
Acute kidney injury 37.52 14.10 183 78419 263232 63147188
Implantable defibrillator insertion 37.51 14.10 16 78586 457 63409963
Gastrointestinal tube insertion 37.34 14.10 21 78581 1106 63409314
Liver function test increased 37.28 14.10 107 78495 32704 63377716
Infusion site erythema 37.04 14.10 58 78544 11621 63398799
Adverse drug reaction 36.73 14.10 27 78575 79687 63330733
Injury 36.16 14.10 23 78579 73224 63337196
Wrong technique in product usage process 36.03 14.10 16 78586 62324 63348096
Pulmonary arterial pressure abnormal 35.97 14.10 16 78586 507 63409913
Dyspnoea at rest 35.89 14.10 34 78568 4045 63406375
Ventricular assist device insertion 35.29 14.10 8 78594 21 63410399
Complication associated with device 35.25 14.10 70 78532 16908 63393512
Unevaluable event 34.87 14.10 141 78461 51245 63359175
Bursitis 34.69 14.10 3 78599 37038 63373382
Infusion site discharge 34.65 14.10 17 78585 675 63409745
Right ventricular hypertrophy 34.40 14.10 17 78585 686 63409734
Sedation 34.12 14.10 4 78598 38805 63371615
Ventricular septal defect repair 34.09 14.10 7 78595 9 63410411
Sinusitis 33.71 14.10 155 78447 226498 63183922
Tricuspid valve repair 33.67 14.10 7 78595 10 63410410
Angioedema 33.42 14.10 9 78593 47956 63362464
Product quality issue 33.33 14.10 3 78599 35862 63374558
Hospice care 33.33 14.10 45 78557 7887 63402533
Upper limb fracture 33.29 14.10 73 78529 18895 63391525
Vascular device infection 33.06 14.10 43 78559 7269 63403151
Catheter removal 32.95 14.10 14 78588 396 63410024
Hyponatraemia 32.77 14.10 55 78547 111845 63298575
Scleroderma renal crisis 32.02 14.10 13 78589 327 63410093
Paracentesis 31.93 14.10 18 78584 952 63409468
Left ventricular failure 31.44 14.10 37 78565 5650 63404770
Generalised oedema 31.39 14.10 64 78538 15754 63394666
Red blood cell sedimentation rate increased 31.12 14.10 8 78594 43974 63366446
Pulmonary valve replacement 31.11 14.10 6 78596 4 63410416
Rhabdomyolysis 31.09 14.10 8 78594 43943 63366477
Therapy change 31.05 14.10 38 78564 6043 63404377
Hepatomegaly 30.92 14.10 54 78548 11835 63398585
Colon operation 30.89 14.10 13 78589 359 63410061
Gastritis hypertrophic 30.64 14.10 8 78594 44 63410376
Limb operation 30.62 14.10 31 78571 4000 63406420
Mineral supplementation 30.50 14.10 16 78586 733 63409687
Injection site pruritus 30.44 14.10 9 78593 45107 63365313
Hepatic cirrhosis 30.40 14.10 83 78519 24651 63385769
Abdominal distension 30.10 14.10 197 78405 86418 63324002
Deep vein thrombosis 29.67 14.10 36 78566 83764 63326656
Swollen tongue 29.59 14.10 4 78598 34796 63375624
Joint range of motion decreased 29.37 14.10 3 78599 32425 63377995
Systemic-pulmonary artery shunt 29.26 14.10 7 78595 25 63410395
Cardiac output decreased 29.22 14.10 17 78585 955 63409465
C-reactive protein increased 29.19 14.10 45 78557 94662 63315758
Pulmonary artery banding 29.10 14.10 6 78596 8 63410412
Muscle spasms 28.80 14.10 98 78504 156052 63254368
Blood pressure decreased 28.41 14.10 157 78445 64865 63345555
Therapeutic response decreased 28.13 14.10 21 78581 61504 63348916
Productive cough 27.87 14.10 153 78449 63055 63347365
Infected skin ulcer 27.62 14.10 23 78579 2309 63408111
Mouth ulceration 27.55 14.10 4 78598 32980 63377440
Somnolence 27.28 14.10 121 78481 178564 63231856
Cholecystectomy 27.13 14.10 48 78554 10629 63399791
Thrombocytopenia 27.11 14.10 96 78506 151061 63259359
Haemodynamic test abnormal 27.05 14.10 7 78595 37 63410383
Pulmonary artery dilatation 27.04 14.10 11 78591 278 63410142
Head injury 27.03 14.10 85 78517 27311 63383109
Lymphocyte count decreased 26.89 14.10 3 78599 30254 63380166
Catheter site related reaction 26.87 14.10 16 78586 939 63409481
Radiotherapy 26.78 14.10 12 78590 387 63410033
Bronchitis 26.72 14.10 254 78348 124681 63285739
Toe amputation 26.68 14.10 21 78581 1946 63408474
Platelet transfusion 26.65 14.10 15 78587 791 63409629
Tracheitis 26.64 14.10 15 78587 792 63409628
Biopsy kidney 26.54 14.10 9 78593 134 63410286
Plasma cell myeloma 26.45 14.10 6 78596 35899 63374521
Cellulitis 26.43 14.10 183 78419 81775 63328645
Medication error 26.38 14.10 16 78586 52268 63358152
Hypocalcaemia 26.13 14.10 4 78598 31709 63378711
Sleep study 26.13 14.10 6 78596 17 63410403
Depressed level of consciousness 26.13 14.10 23 78579 62055 63348365
Chest tube insertion 26.02 14.10 7 78595 44 63410376
Skin ulcer 26.00 14.10 114 78488 42931 63367489
Atrial tachycardia 25.82 14.10 29 78573 4211 63406209
Bone marrow failure 25.79 14.10 3 78599 29287 63381133
Treatment noncompliance 25.79 14.10 103 78499 37222 63373198
Pneumothorax 25.67 14.10 60 78542 16201 63394219
Skin operation 25.63 14.10 6 78596 19 63410401
Cardiac septal defect repair 25.54 14.10 5 78597 4 63410416
Rehabilitation therapy 25.42 14.10 19 78583 1631 63408789
Endothelial dysfunction 25.27 14.10 9 78593 156 63410264
Biopsy bone marrow 25.16 14.10 11 78591 334 63410086
Supraventricular tachycardia 25.13 14.10 55 78547 14216 63396204
Pulmonary artery therapeutic procedure 24.75 14.10 6 78596 23 63410397
Heart valve operation 24.66 14.10 9 78593 168 63410252
Prescribed overdose 24.58 14.10 6 78596 34147 63376273
Muscular weakness 24.50 14.10 74 78528 122279 63288141
Tracheostomy infection 24.35 14.10 6 78596 25 63410395
Chest discomfort 24.23 14.10 225 78377 109744 63300676
Loss of consciousness 24.21 14.10 238 78364 117883 63292537
Lung assist device therapy 24.17 14.10 8 78594 110 63410310
Mitral valve replacement 24.00 14.10 10 78592 269 63410151
Swelling 23.78 14.10 222 78380 275156 63135264
Pancytopenia 23.72 14.10 53 78549 96880 63313540
Blood potassium decreased 23.66 14.10 109 78493 41917 63368503
Exercise test abnormal 23.66 14.10 8 78594 118 63410302
Hepatic enzyme increased 23.64 14.10 150 78452 202178 63208242
Human metapneumovirus test positive 23.63 14.10 7 78595 65 63410355
Knee operation 23.59 14.10 33 78569 5980 63404440
Gastrostomy 23.53 14.10 13 78589 661 63409759
Coma 23.48 14.10 27 78575 64337 63346083
Aortic stenosis 23.45 14.10 30 78572 4990 63405430
Constipation 23.20 14.10 173 78429 224770 63185650
CREST syndrome 23.20 14.10 12 78590 534 63409886
Gangrene 23.13 14.10 33 78569 6090 63404330
Low cardiac output syndrome 23.07 14.10 11 78591 410 63410010
Cardiac index decreased 22.99 14.10 7 78595 72 63410348
Blood iron decreased 22.89 14.10 54 78548 14667 63395753
Internal haemorrhage 22.77 14.10 30 78572 5135 63405285
Infusion site abscess 22.64 14.10 9 78593 214 63410206
Anxiety 22.58 14.10 167 78435 217374 63193046
Orthopnoea 22.56 14.10 33 78569 6228 63404192
Amputation 22.56 14.10 9 78593 216 63410204
Hypercalcaemia 22.39 14.10 4 78598 28318 63382102
Mitral valve repair 22.18 14.10 9 78593 226 63410194
Hypokalaemia 22.09 14.10 61 78541 103743 63306677
Skin exfoliation 22.01 14.10 13 78589 43089 63367331
Catheter site rash 21.87 14.10 13 78589 760 63409660
Resuscitation 21.82 14.10 15 78587 1129 63409291
Carbon dioxide increased 21.82 14.10 16 78586 1334 63409086
Disturbance in attention 21.75 14.10 10 78592 38179 63372241
Psychotic disorder 21.75 14.10 3 78599 25709 63384711
Aortic valve replacement 21.69 14.10 13 78589 772 63409648
Blood culture positive 21.65 14.10 28 78574 4707 63405713
Pulmonary artery aneurysm 21.39 14.10 6 78596 45 63410375
Echocardiogram abnormal 21.32 14.10 16 78586 1382 63409038
Shoulder operation 21.27 14.10 20 78582 2357 63408063
Dry eye 21.24 14.10 12 78590 40749 63369671
Pulmonary vascular resistance abnormality 21.16 14.10 6 78596 47 63410373
Emotional distress 21.05 14.10 7 78595 32542 63377878
Therapeutic embolisation 21.04 14.10 8 78594 168 63410252
Contusion 20.90 14.10 105 78497 149939 63260481
Post procedural complication 20.69 14.10 57 78545 17017 63393403
Pulseless electrical activity 20.66 14.10 35 78567 7486 63402934
Arterial aneurysm repair 20.55 14.10 4 78598 3 63410417
Pericardial drainage 20.50 14.10 9 78593 276 63410144
Pericardiotomy 20.46 14.10 5 78597 20 63410400
Systemic sclerosis pulmonary 20.46 14.10 5 78597 20 63410400
Emergency care 20.29 14.10 14 78588 1060 63409360
Multiple sclerosis 20.25 14.10 3 78599 24369 63386051
Colitis ulcerative 19.95 14.10 4 78598 26087 63384333
Respiratory syncytial virus infection 19.73 14.10 33 78569 6985 63403435
Foot amputation 19.67 14.10 9 78593 305 63410115
Jaundice 19.63 14.10 80 78522 29171 63381249
Tracheostomy tube removal 19.54 14.10 4 78598 5 63410415
Endarterectomy 19.53 14.10 8 78594 206 63410214
Vasodilation procedure 19.39 14.10 5 78597 26 63410394
Infusion site cellulitis 19.38 14.10 8 78594 210 63410210
Vascular operation 19.36 14.10 7 78595 127 63410293
Respiratory tract haemorrhage 19.31 14.10 10 78592 446 63409974
Catheter site warmth 19.28 14.10 8 78594 213 63410207
Dysentery 19.28 14.10 13 78589 948 63409472
Generalised tonic-clonic seizure 19.19 14.10 6 78596 29010 63381410
N-terminal prohormone brain natriuretic peptide increased 18.99 14.10 18 78584 2143 63408277
Heart rate irregular 18.93 14.10 66 78536 22355 63388065
Primary biliary cholangitis 18.90 14.10 14 78588 1185 63409235
Osteoporosis 18.89 14.10 26 78576 57312 63353108
Haemoglobin decreased 18.67 14.10 268 78334 145217 63265203
Nocturnal dyspnoea 18.64 14.10 14 78588 1210 63409210
Alanine aminotransferase 18.51 14.10 6 78596 77 63410343
Orthostatic hypotension 18.34 14.10 11 78591 36149 63374271
Night sweats 18.33 14.10 20 78582 48794 63361626
Cataract operation 18.32 14.10 28 78574 5494 63404926
Cardiac failure acute 18.27 14.10 38 78564 9485 63400935
Cyst removal 18.26 14.10 10 78592 500 63409920
Pulmonary thrombosis 18.21 14.10 36 78566 8666 63401754
Gastric operation 18.15 14.10 9 78593 366 63410054
Product supply issue 18.12 14.10 16 78586 1739 63408681
Aortic valve repair 18.08 14.10 4 78598 9 63410411
Aspiration pleural cavity 18.04 14.10 12 78590 855 63409565
Oral herpes 17.96 14.10 5 78597 26069 63384351
Surgery 17.94 14.10 90 78512 35822 63374598
Full blood count decreased 17.91 14.10 5 78597 26019 63384401
Dysarthria 17.76 14.10 16 78586 42695 63367725
Staphylococcus test positive 17.75 14.10 23 78579 3873 63406547
Living in residential institution 17.72 14.10 10 78592 530 63409890
Cerebrovascular accident 17.64 14.10 208 78394 107816 63302604
Drug reaction with eosinophilia and systemic symptoms 17.57 14.10 10 78592 33826 63376594
Amnesia 17.52 14.10 26 78576 55559 63354861
Oesophageal haemorrhage 17.52 14.10 10 78592 542 63409878
Localised infection 17.48 14.10 79 78523 30131 63380289
Polycythaemia 17.46 14.10 12 78590 903 63409517
International normalised ratio abnormal 17.45 14.10 21 78581 3283 63407137
Splenomegaly 17.42 14.10 41 78561 11116 63399304
Blood pressure fluctuation 17.36 14.10 19 78583 46298 63364122
Injection site swelling 17.31 14.10 20 78582 47552 63362868
Ulcer haemorrhage 17.30 14.10 27 78575 5395 63405025
Extremity necrosis 17.24 14.10 15 78587 1598 63408822
Drug eruption 17.16 14.10 7 78595 28687 63381733
Dilatation ventricular 17.12 14.10 18 78584 2427 63407993
Phlebotomy 17.09 14.10 3 78599 0 63410420
Sterilisation 17.09 14.10 3 78599 0 63410420
Plasmapheresis 17.09 14.10 8 78594 286 63410134
Cholelithotomy 17.02 14.10 5 78597 45 63410375
Gait disturbance 16.97 14.10 145 78457 183033 63227387
Skin neoplasm excision 16.74 14.10 11 78591 768 63409652
Heart valve incompetence 16.72 14.10 19 78583 2795 63407625
Dry skin 16.61 14.10 28 78574 56859 63353561
Scleroderma associated digital ulcer 16.57 14.10 4 78598 15 63410405
Delirium 16.56 14.10 23 78579 50518 63359902
N-terminal prohormone brain natriuretic peptide 16.55 14.10 5 78597 50 63410370
Disease recurrence 16.50 14.10 7 78595 28023 63382397
Illness 16.41 14.10 22 78580 49037 63361383
Lip swelling 16.39 14.10 9 78593 31054 63379366
Polypectomy 16.37 14.10 11 78591 797 63409623
Collateral circulation 16.36 14.10 4 78598 16 63410404
Lactic acidosis 16.33 14.10 14 78588 38273 63372147
Carpal tunnel syndrome 16.32 14.10 3 78599 20814 63389606
Medical device change 16.18 14.10 8 78594 323 63410097
Localised oedema 16.08 14.10 26 78576 5352 63405068
Device infusion issue 16.08 14.10 16 78586 2022 63408398
Catheter site induration 16.04 14.10 5 78597 56 63410364
Agitation 16.03 14.10 31 78571 59726 63350694
Administration site infection 15.99 14.10 4 78598 18 63410402
Diabetic ketoacidosis 15.98 14.10 3 78599 20502 63389918
Gallbladder operation 15.96 14.10 17 78585 2326 63408094
Smooth muscle antibody positive 15.87 14.10 6 78596 124 63410296
Dehydration 15.82 14.10 302 78300 173052 63237368
Teething 15.81 14.10 4 78598 19 63410401
Body temperature decreased 15.78 14.10 3 78599 20316 63390104
Rash maculo-papular 15.76 14.10 10 78592 31886 63378534
Sopor 15.74 14.10 4 78598 22160 63388260
Drug withdrawal syndrome 15.68 14.10 7 78595 27187 63383233
Device connection issue 15.66 14.10 10 78592 665 63409755
Hypomagnesaemia 15.64 14.10 8 78594 28729 63381691
Liver disorder 15.64 14.10 117 78485 53570 63356850
Cardiac resynchronisation therapy 15.64 14.10 4 78598 20 63410400
Diuretic therapy 15.61 14.10 6 78596 130 63410290
Arteriovenous fistula operation 15.50 14.10 7 78595 230 63410190
Mixed connective tissue disease 15.48 14.10 9 78593 505 63409915
Colonoscopy 15.47 14.10 14 78588 1572 63408848
Vascular cauterisation 15.43 14.10 5 78597 64 63410356
Obesity 15.34 14.10 9 78593 29943 63380477
Aggression 15.29 14.10 5 78597 23493 63386927
Agranulocytosis 15.25 14.10 6 78596 25128 63385292
Rash pruritic 15.20 14.10 32 78570 59767 63350653
Caesarean section 15.14 14.10 51 78551 16981 63393439
Muscle twitching 15.07 14.10 3 78599 19665 63390755
Intestinal polypectomy 15.01 14.10 3 78599 3 63410417
Removal of transplanted organ 15.01 14.10 3 78599 3 63410417
Abnormal behaviour 14.96 14.10 4 78598 21422 63388998
Bone pain 14.96 14.10 28 78574 54613 63355807
Cataract 14.96 14.10 30 78572 57023 63353397
Dry mouth 14.94 14.10 48 78554 77815 63332605
Hyperthyroidism 14.91 14.10 46 78556 14627 63395793
Dyspnoea paroxysmal nocturnal 14.86 14.10 11 78591 930 63409490
Palliative care 14.81 14.10 9 78593 548 63409872
Catheter site abscess 14.76 14.10 4 78598 26 63410394
Walking disability 14.71 14.10 13 78589 1414 63409006
Hallucination, visual 14.67 14.10 3 78599 19295 63391125
Aneurysm repair 14.63 14.10 4 78598 27 63410393
Haemodynamic instability 14.60 14.10 34 78568 9156 63401264
Drug dependence 14.60 14.10 6 78596 24477 63385943
Cavopulmonary anastomosis 14.55 14.10 3 78599 4 63410416
Metastases to bone 14.54 14.10 4 78598 21015 63389405
Drug level increased 14.51 14.10 5 78597 22731 63387689
Thromboembolectomy 14.50 14.10 4 78598 28 63410392
Abdominal cavity drainage 14.44 14.10 8 78594 409 63410011
Laparoscopic surgery 14.38 14.10 4 78598 29 63410391
Encephalopathy 14.30 14.10 16 78586 38604 63371816
Rash erythematous 14.28 14.10 19 78583 42491 63367929
Lung neoplasm malignant 14.23 14.10 55 78547 19578 63390842
Cyanosis central 14.13 14.10 5 78597 85 63410335
Enterovirus infection 14.13 14.10 11 78591 1003 63409417

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 702.94 17.33 1137 24862 396912 34534020
Right ventricular failure 571.69 17.33 223 25776 8561 34922371
Fluid retention 415.21 17.33 255 25744 26632 34904300
Dyspnoea 386.59 17.33 856 25143 375926 34555006
Pulmonary hypertension 254.89 17.33 171 25828 20753 34910179
Aspartate aminotransferase increased 246.35 17.33 277 25722 67506 34863426
Lung transplant 231.54 17.33 78 25921 1946 34928986
Alanine aminotransferase increased 198.10 17.33 271 25728 80544 34850388
Catheterisation cardiac 177.72 17.33 69 25930 2608 34928324
Liver function test abnormal 169.18 17.33 158 25841 30916 34900016
Cardiac operation 160.99 17.33 67 25932 3040 34927892
Concomitant disease aggravated 139.08 17.33 73 25926 5628 34925304
Hospitalisation 136.57 17.33 189 25810 56713 34874219
Oxygen saturation decreased 134.05 17.33 182 25817 53636 34877296
Cardiac failure 127.80 17.33 237 25762 91011 34839921
Oedema 122.04 17.33 160 25839 45581 34885351
Drug ineffective 118.53 17.33 100 25899 456651 34474281
Blood alkaline phosphatase increased 110.67 17.33 126 25873 31049 34899883
Toxicity to various agents 107.15 17.33 12 25987 200350 34730582
Pulmonary arterial pressure increased 103.51 17.33 38 25961 1227 34929705
Transfusion 101.69 17.33 69 25930 8516 34922416
Pulmonary arterial hypertension 100.58 17.33 69 25930 8670 34922262
Condition aggravated 94.83 17.33 336 25663 191860 34739072
Hypervolaemia 88.10 17.33 90 25909 19619 34911313
Pulmonary hypertensive crisis 86.13 17.33 21 25978 152 34930780
Infusion site pain 84.61 17.33 46 25953 3805 34927127
Disease progression 82.26 17.33 220 25779 107857 34823075
Pain in jaw 82.11 17.33 72 25927 12968 34917964
Catheter management 79.00 17.33 29 25970 936 34929996
Catheter placement 76.68 17.33 27 25972 771 34930161
Cardiac failure congestive 75.32 17.33 181 25818 83089 34847843
Respiratory failure 74.68 17.33 213 25786 108359 34822573
Device related infection 73.95 17.33 77 25922 17160 34913772
Blood bilirubin increased 72.73 17.33 114 25885 38182 34892750
Heart transplant 72.28 17.33 27 25972 916 34930016
Oedema peripheral 70.10 17.33 222 25777 119590 34811342
Catheter site erythema 68.48 17.33 29 25970 1374 34929558
Syncope 66.39 17.33 183 25816 91268 34839664
Cor pulmonale 64.88 17.33 24 25975 792 34930140
Pulmonary vein stenosis 64.54 17.33 13 25986 32 34930900
Atrial septal defect repair 62.86 17.33 15 25984 98 34930834
Oxygen consumption increased 62.59 17.33 27 25972 1339 34929593
Dyspnoea exertional 62.48 17.33 114 25885 43165 34887767
Heart and lung transplant 62.34 17.33 14 25985 67 34930865
Tracheostomy 60.65 17.33 23 25976 814 34930118
Balloon atrial septostomy 60.64 17.33 11 25988 11 34930921
Neutropenia 59.78 17.33 21 25978 156757 34774175
Viral infection 58.77 17.33 69 25930 17554 34913378
Infusion site erythema 57.99 17.33 30 25969 2243 34928689
Catheter site infection 56.99 17.33 31 25968 2566 34928366
Cardiac pacemaker insertion 56.50 17.33 32 25967 2866 34928066
Mechanical ventilation 56.09 17.33 28 25971 1942 34928990
Hypoxia 55.53 17.33 125 25874 54970 34875962
Acute kidney injury 54.93 17.33 89 25910 304899 34626033
Cyanosis 52.92 17.33 56 25943 12708 34918224
Disease complication 52.77 17.33 30 25969 2706 34928226
Scleroderma 52.75 17.33 25 25974 1547 34929385
Haemoptysis 51.52 17.33 93 25906 34913 34896019
Respiratory distress 49.03 17.33 92 25907 35573 34895359
Malignant neoplasm progression 47.69 17.33 5 25994 88041 34842891
Brain natriuretic peptide increased 47.66 17.33 37 25962 5622 34925310
Overdose 47.26 17.33 6 25993 91053 34839879
Rhinovirus infection 47.24 17.33 33 25966 4266 34926666
Pulmonary oedema 46.96 17.33 107 25892 47422 34883510
Respiratory syncytial virus infection 46.80 17.33 34 25965 4675 34926257
Flushing 46.28 17.33 85 25914 32335 34898597
Pneumonia 45.63 17.33 440 25559 362187 34568745
Terminal state 45.11 17.33 31 25968 3903 34927029
Cardiac ablation 44.97 17.33 20 25979 1068 34929864
Catheter site pain 44.04 17.33 21 25978 1317 34929615
Central venous catheterisation 44.03 17.33 21 25978 1318 34929614
Liver function test increased 43.62 17.33 54 25945 14511 34916421
Pregnancy of partner 42.21 17.33 14 25985 332 34930600
Cardioversion 41.27 17.33 18 25981 917 34930015
Transplant evaluation 40.66 17.33 15 25984 491 34930441
Stent placement 40.17 17.33 32 25967 5046 34925886
Tracheitis 39.02 17.33 16 25983 698 34930234
Product use in unapproved indication 37.98 17.33 20 25979 117479 34813453
Patent ductus arteriosus repair 37.65 17.33 7 25992 9 34930923
Systemic scleroderma 37.29 17.33 13 25986 360 34930572
Biopsy liver 36.73 17.33 12 25987 271 34930661
Rhabdomyolysis 36.58 17.33 4 25995 68159 34862773
Concomitant disease progression 36.57 17.33 23 25976 2495 34928437
Cardiac disorder 36.04 17.33 91 25908 43035 34887897
Product administered to patient of inappropriate age 35.55 17.33 25 25974 3266 34927666
Exercise tolerance decreased 35.35 17.33 30 25969 5168 34925764
Swelling 34.99 17.33 89 25910 42277 34888655
Heart disease congenital 34.47 17.33 18 25981 1372 34929560
Infusion site infection 34.12 17.33 13 25986 466 34930466
Catheter site discharge 33.76 17.33 14 25985 629 34930303
Neuropathy peripheral 33.75 17.33 10 25989 83253 34847679
Complication associated with device 33.54 17.33 31 25968 5975 34924957
Catheter site swelling 33.08 17.33 12 25987 374 34930558
Ventricular septal defect repair 33.07 17.33 6 25993 6 34930926
White blood cell count decreased 32.73 17.33 15 25984 95430 34835502
Dialysis 32.67 17.33 41 25958 11167 34919765
Hyponatraemia 31.62 17.33 11 25988 82680 34848252
Tracheostomy infection 31.43 17.33 7 25992 32 34930900
Catheter removal 31.43 17.33 10 25989 207 34930725
Micrococcus test positive 30.99 17.33 6 25993 11 34930921
Headache 30.54 17.33 254 25745 200381 34730551
Nasal congestion 29.86 17.33 58 25941 22999 34907933
Chronic obstructive pulmonary disease 29.79 17.33 92 25907 48826 34882106
Product dose omission issue 29.77 17.33 171 25828 119540 34811392
Right ventricular systolic pressure increased 29.76 17.33 11 25988 362 34930570
Drug interaction 29.57 17.33 79 25920 225867 34705065
Pulmonary veno-occlusive disease 29.28 17.33 12 25987 523 34930409
Right-to-left cardiac shunt 29.11 17.33 8 25991 97 34930835
Rash 29.06 17.33 78 25921 222674 34708258
Cough 28.97 17.33 201 25798 149939 34780993
Infusion related reaction 28.76 17.33 3 25996 53054 34877878
Infusion site discharge 28.75 17.33 8 25991 102 34930830
Epistaxis 28.73 17.33 102 25897 58149 34872783
Right ventricular dysfunction 28.51 17.33 15 25984 1161 34929771
Infusion site haemorrhage 27.79 17.33 14 25985 990 34929942
No adverse event 27.67 17.33 56 25943 22871 34908061
Device occlusion 27.63 17.33 29 25970 6516 34924416
Confusional state 26.89 17.33 41 25958 144119 34786813
Congestive hepatopathy 26.86 17.33 17 25982 1864 34929068
Thrombocytopenia 26.75 17.33 47 25952 156200 34774732
Vascular resistance pulmonary increased 26.50 17.33 6 25993 30 34930902
Intentional product use issue 26.50 17.33 6 25993 59810 34871122
Pleural mass 26.43 17.33 7 25992 73 34930859
Hypertension 26.23 17.33 38 25961 136405 34794527
Endotracheal intubation 25.72 17.33 20 25979 3045 34927887
Endarterectomy 25.54 17.33 8 25991 157 34930775
Adenotonsillectomy 25.44 17.33 6 25993 37 34930895
Infusion site cellulitis 24.75 17.33 7 25992 95 34930837
High frequency ablation 24.69 17.33 8 25991 176 34930756
Retinal vascular disorder 24.47 17.33 8 25991 181 34930751
Haematuria 24.33 17.33 4 25995 50062 34880870
Transplant 24.28 17.33 12 25987 814 34930118
Chemotherapy 24.20 17.33 11 25988 618 34930314
Depression 24.12 17.33 22 25977 97076 34833856
Carbon dioxide increased 23.99 17.33 13 25986 1068 34929864
Catheter site pruritus 23.46 17.33 9 25990 329 34930603
Localised oedema 23.15 17.33 20 25979 3528 34927404
Viral upper respiratory tract infection 23.11 17.33 18 25981 2748 34928184
Right ventricular dilatation 23.07 17.33 11 25988 690 34930242
Acute myocardial infarction 22.60 17.33 6 25993 53713 34877219
Exercise test abnormal 22.58 17.33 4 25995 3 34930929
COVID-19 22.51 17.33 15 25984 77535 34853397
Gastrointestinal tube insertion 22.33 17.33 13 25986 1226 34929706
Biopsy lymph gland 22.29 17.33 6 25993 67 34930865
Biopsy lung 22.18 17.33 7 25992 141 34930791
Treatment failure 22.10 17.33 4 25995 46693 34884239
Pulmonary artery therapeutic procedure 22.05 17.33 4 25995 4 34930928
Respiratory disorder 22.00 17.33 46 25953 19218 34911714
Sudden death 21.87 17.33 40 25959 15161 34915771
Lung disorder 21.82 17.33 66 25933 34630 34896302
Drug hypersensitivity 21.52 17.33 17 25982 80512 34850420
Adverse event 21.47 17.33 45 25954 18832 34912100
Pulmonary haemorrhage 21.41 17.33 32 25967 10272 34920660
Hypoglycaemia 21.35 17.33 7 25992 54633 34876299
Normal newborn 20.87 17.33 7 25992 172 34930760
Choking sensation 20.76 17.33 12 25987 1117 34929815
Therapeutic product effect incomplete 20.60 17.33 6 25993 50535 34880397
Catheter site granuloma 20.53 17.33 5 25994 36 34930896
Oxygen therapy 20.51 17.33 11 25988 885 34930047
Left ventricular failure 20.32 17.33 22 25977 5122 34925810
Off label use 20.29 17.33 207 25792 419317 34511615
Infusion site swelling 20.17 17.33 16 25983 2508 34928424
Injection site erosion 19.85 17.33 6 25993 104 34930828
Cardiac flutter 19.84 17.33 14 25985 1839 34929093
Oxygen saturation abnormal 19.81 17.33 13 25986 1517 34929415
Radiotherapy to brain 19.64 17.33 5 25994 44 34930888
Influenza 19.58 17.33 81 25918 49585 34881347
Weight increased 19.38 17.33 127 25872 92906 34838026
Sickle cell anaemia 19.30 17.33 7 25992 218 34930714
Exposure via body fluid 19.19 17.33 6 25993 117 34930815
Catheter site irritation 19.19 17.33 6 25993 117 34930815
Ascites 19.19 17.33 77 25922 46494 34884438
Implantable defibrillator insertion 18.99 17.33 10 25989 775 34930157
Catheter site warmth 18.81 17.33 5 25994 53 34930879
Microcytic anaemia 18.72 17.33 15 25984 2385 34928547
Acute respiratory failure 18.67 17.33 58 25941 30870 34900062
Cavopulmonary anastomosis 18.61 17.33 3 25996 0 34930932
Spinal cord operation 18.61 17.33 3 25996 0 34930932
Oxygen consumption 18.61 17.33 3 25996 0 34930932
Cardiopulmonary bypass 18.61 17.33 3 25996 0 34930932
Infusion 18.61 17.33 3 25996 0 34930932
Mast cell activation syndrome 18.59 17.33 7 25992 243 34930689
Delirium 18.34 17.33 5 25994 43986 34886946
Aspiration pleural cavity 18.31 17.33 10 25989 834 34930098
Arthralgia 18.28 17.33 65 25934 169976 34760956
Cyanosis central 18.26 17.33 6 25993 138 34930794
Medical device change 18.26 17.33 6 25993 138 34930794
Hyperkalaemia 18.10 17.33 15 25984 69374 34861558
Tracheostomy malfunction 18.09 17.33 5 25994 62 34930870
Nasopharyngitis 18.06 17.33 101 25898 69867 34861065
Resuscitation 17.97 17.33 12 25987 1441 34929491
Device infusion issue 17.87 17.33 10 25989 875 34930057
Heart rate increased 17.81 17.33 75 25924 46268 34884664
Pancytopenia 17.79 17.33 27 25972 95130 34835802
Hallucination 17.79 17.33 8 25991 51490 34879442
Pneumothorax 17.76 17.33 42 25957 19050 34911882
Surgery 17.58 17.33 35 25964 14122 34916810
Faeces soft 17.48 17.33 17 25982 3491 34927441

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 2484.91 13.14 3216 92883 563298 79084991
Right ventricular failure 1669.85 13.14 729 95370 22768 79625521
Dyspnoea 1653.20 13.14 3350 92749 853675 78794614
Fluid retention 1168.49 13.14 835 95264 68974 79579315
Aspartate aminotransferase increased 958.22 13.14 999 95100 137642 79510647
Alanine aminotransferase increased 795.20 13.14 979 95120 161591 79486698
Pulmonary hypertension 751.49 13.14 552 95547 47528 79600761
Liver function test abnormal 660.90 13.14 578 95521 63897 79584392
Blood alkaline phosphatase increased 655.13 13.14 572 95527 63092 79585197
Transfusion 546.17 13.14 333 95766 20997 79627292
Lung transplant 524.54 13.14 200 95899 4361 79643928
Drug ineffective 516.23 13.14 336 95763 1080577 78567712
Cardiac failure 376.86 13.14 672 95427 154170 79494119
Catheterisation cardiac 359.41 13.14 163 95936 5565 79642724
Cardiac operation 357.39 13.14 156 95943 4856 79643433
Hypervolaemia 348.28 13.14 337 95762 42353 79605936
Dyspnoea exertional 346.39 13.14 474 95625 86599 79561690
Cardiac failure congestive 338.79 13.14 612 95487 141790 79506499
Device related infection 332.39 13.14 298 95801 33996 79614293
Syncope 329.16 13.14 691 95408 178758 79469531
Pneumonia 328.92 13.14 1617 94482 658629 78989660
Toxicity to various agents 323.02 13.14 59 96040 421481 79226808
Oedema 312.99 13.14 536 95563 119044 79529245
Blood bilirubin increased 310.62 13.14 391 95708 65841 79582448
Pulmonary oedema 294.59 13.14 442 95657 87812 79560477
Oxygen saturation decreased 292.25 13.14 543 95556 128504 79519785
Oedema peripheral 291.07 13.14 812 95287 251476 79396813
Disease progression 280.68 13.14 659 95440 183703 79464586
Cardiac pacemaker insertion 280.22 13.14 138 95961 5684 79642605
Pain in jaw 278.57 13.14 310 95789 45841 79602448
Concomitant disease aggravated 273.17 13.14 180 95919 12987 79635302
Pulmonary arterial pressure increased 271.26 13.14 125 95974 4430 79643859
Completed suicide 267.22 13.14 6 96093 245761 79402528
Febrile neutropenia 262.18 13.14 3 96096 230996 79417293
Off label use 257.81 13.14 437 95662 906778 78741511
Scleroderma 257.46 13.14 128 95971 5382 79642907
Hospitalisation 253.94 13.14 428 95671 93808 79554481
Infusion related reaction 252.76 13.14 5 96094 230232 79418057
Neutropenia 229.68 13.14 36 96063 287674 79360615
Respiratory failure 224.17 13.14 598 95501 180313 79467976
Rash 206.52 13.14 236 95863 578122 79070167
Catheter site erythema 205.01 13.14 108 95991 5132 79643157
Pulmonary arterial hypertension 194.75 13.14 204 95895 28162 79620127
Hypoxia 193.12 13.14 401 95698 102842 79545447
Pulmonary hypertensive crisis 192.56 13.14 51 96048 309 79647980
Condition aggravated 192.31 13.14 1144 94955 499980 79148309
Drug hypersensitivity 189.59 13.14 62 96037 298854 79349435
Product dose omission issue 184.37 13.14 686 95413 246851 79401438
Catheter site infection 183.99 13.14 110 95989 6685 79641604
Cardiac disorder 182.89 13.14 303 95796 65454 79582835
Catheter site pain 177.12 13.14 99 96000 5297 79642992
Catheter management 176.80 13.14 87 96012 3576 79644713
Treatment failure 175.00 13.14 7 96092 170479 79477810
Alopecia 173.58 13.14 34 96065 231321 79416968
Dialysis 170.17 13.14 156 95943 18306 79629983
Synovitis 166.50 13.14 3 96096 150731 79497558
Drug abuse 165.92 13.14 7 96092 162684 79485605
Chest pain 154.02 13.14 711 95388 281593 79366696
Contraindicated product administered 153.58 13.14 9 96090 157529 79490760
Therapeutic product effect decreased 152.04 13.14 12 96087 163851 79484438
Chronic obstructive pulmonary disease 150.70 13.14 324 95775 85095 79563194
Rheumatoid arthritis 147.48 13.14 35 96064 208435 79439854
Acute kidney injury 146.30 13.14 251 95848 519153 79129136
Disease complication 144.37 13.14 84 96015 4853 79643436
Flushing 142.38 13.14 323 95776 87945 79560344
Arthralgia 142.07 13.14 298 95801 571505 79076784
Haemoptysis 138.54 13.14 245 95854 55754 79592535
Drug intolerance 138.11 13.14 73 96026 264046 79384243
Cyanosis 138.10 13.14 161 95938 25021 79623268
Cor pulmonale 137.43 13.14 63 96036 2205 79646084
Oxygen consumption increased 135.85 13.14 81 96018 4898 79643391
Musculoskeletal stiffness 132.77 13.14 25 96074 174983 79473306
Drug interaction 131.79 13.14 185 95914 414998 79233291
Product use in unapproved indication 129.72 13.14 70 96029 250289 79398000
Heart transplant 128.52 13.14 53 96046 1428 79646861
Cough 128.25 13.14 818 95281 365971 79282318
Cardioversion 126.25 13.14 58 96041 2040 79646249
Catheter site discharge 124.56 13.14 60 96039 2352 79645937
Malignant neoplasm progression 123.29 13.14 11 96088 135979 79512310
Cardiac ablation 122.31 13.14 58 96041 2195 79646094
Catheter placement 121.20 13.14 63 96036 2911 79645378
Joint swelling 121.03 13.14 102 95997 288544 79359745
Overdose 120.68 13.14 36 96063 184170 79464119
Stent placement 118.20 13.14 82 96017 6438 79641851
Mechanical ventilation 116.81 13.14 60 96039 2704 79645585
Tracheostomy 115.43 13.14 47 96052 1225 79647064
Intentional product use issue 112.70 13.14 23 96076 152089 79496200
Infusion site pain 111.99 13.14 110 95989 14066 79634223
Maternal exposure during pregnancy 111.37 13.14 16 96083 136522 79511767
Stomatitis 111.24 13.14 21 96078 146736 79501553
Atrial septal defect repair 110.65 13.14 35 96064 425 79647864
COVID-19 110.47 13.14 27 96072 157647 79490642
Arthropathy 106.61 13.14 40 96059 177071 79471218
Pulmonary veno-occlusive disease 103.71 13.14 47 96052 1601 79646688
Viral infection 103.57 13.14 186 95913 42830 79605459
Nasal congestion 102.84 13.14 261 95838 76291 79571998
Pericardial effusion 102.59 13.14 193 95906 46044 79602245
Concomitant disease progression 101.31 13.14 59 96040 3414 79644875
Confusional state 99.55 13.14 143 95956 317854 79330435
Congestive hepatopathy 98.80 13.14 64 96035 4483 79643806
Gamma-glutamyltransferase increased 98.25 13.14 209 95890 54471 79593818
Therapeutic product effect incomplete 97.78 13.14 25 96074 141620 79506669
Intentional overdose 97.60 13.14 8 96091 105952 79542337
Urticaria 97.05 13.14 51 96048 185150 79463139
Neutrophil count decreased 95.92 13.14 4 96095 93955 79554334
Hypertension 94.86 13.14 158 95941 330834 79317455
Hypersensitivity 94.46 13.14 106 95993 262133 79386156
Pain 93.33 13.14 484 95615 703318 78944971
Biopsy liver 92.34 13.14 33 96066 595 79647694
Catheter site swelling 92.23 13.14 45 96054 1815 79646474
Exercise tolerance decreased 92.19 13.14 81 96018 8990 79639299
Rhabdomyolysis 91.72 13.14 9 96090 103122 79545167
Psoriasis 90.84 13.14 4 96095 89583 79558706
Pregnancy 90.25 13.14 135 95964 26716 79621573
Headache 89.04 13.14 1189 94910 652583 78995706
White blood cell count decreased 88.58 13.14 59 96040 188229 79460060
Epistaxis 87.89 13.14 315 95784 111200 79537089
Pruritus 87.10 13.14 219 95880 394429 79253860
Patent ductus arteriosus repair 86.95 13.14 18 96081 26 79648263
Heart and lung transplant 86.91 13.14 24 96075 174 79648115
Pulmonary vein stenosis 86.47 13.14 23 96076 142 79648147
Central venous catheterisation 85.83 13.14 52 96047 3237 79645052
Pericarditis 85.50 13.14 12 96087 104224 79544065
Finger amputation 85.46 13.14 32 96067 662 79647627
Transplant evaluation 83.98 13.14 41 96058 1656 79646633
Balloon atrial septostomy 83.35 13.14 21 96078 101 79648188
Systemic scleroderma 81.27 13.14 36 96063 1161 79647128
Dizziness 81.20 13.14 980 95119 525461 79122828
Brain natriuretic peptide increased 79.67 13.14 74 96025 8826 79639463
Glossodynia 77.85 13.14 15 96084 103322 79544967
Catheter site pruritus 77.83 13.14 43 96056 2248 79646041
Right-to-left cardiac shunt 76.83 13.14 23 96076 229 79648060
Respiratory distress 76.37 13.14 197 95902 58142 79590147
Hernia repair 76.13 13.14 41 96058 2037 79646252
Terminal state 76.01 13.14 56 96043 4833 79643456
Ascites 75.20 13.14 231 95868 75331 79572958
Influenza 74.70 13.14 332 95767 129274 79519015
Depression 74.43 13.14 91 96008 216699 79431590
Hyponatraemia 74.31 13.14 63 96036 177785 79470504
Intentional product misuse 73.43 13.14 13 96086 95152 79553137
Thrombocytopenia 72.88 13.14 130 95969 265129 79383160
Blood cholesterol increased 72.66 13.14 8 96091 83712 79564577
Right ventricular dysfunction 72.23 13.14 43 96056 2592 79645697
Complication associated with device 72.15 13.14 97 96002 17399 79630890
Infusion site erythema 72.12 13.14 72 96027 9388 79638901
Palpitations 70.48 13.14 321 95778 126289 79522000
Atrial flutter 70.22 13.14 107 95992 21518 79626771
Atrial fibrillation 70.05 13.14 443 95656 197443 79450846
Mobility decreased 69.58 13.14 30 96069 122145 79526144
Rhinovirus infection 69.03 13.14 65 96034 7888 79640401
Endotracheal intubation 69.00 13.14 52 96047 4645 79643644
Helicobacter infection 67.86 13.14 4 96095 69700 79578589
Hip fracture 67.73 13.14 128 95971 30633 79617656
Transplant 67.42 13.14 30 96069 978 79647311
Heart disease congenital 67.37 13.14 26 96073 586 79647703
Suicide attempt 66.96 13.14 10 96089 82922 79565367
Device occlusion 66.96 13.14 77 96022 11789 79636500
Device leakage 65.60 13.14 73 96026 10783 79637506
Malaise 63.72 13.14 884 95215 488985 79159304
Electrocardiogram QT prolonged 62.28 13.14 16 96083 90370 79557919
Lung disorder 62.14 13.14 226 95873 80331 79567958
Infusion site infection 62.08 13.14 34 96065 1747 79646542
Blood pressure systolic increased 61.85 13.14 5 96094 66981 79581308
Lower respiratory tract infection 61.42 13.14 40 96059 129180 79519109
Fall 61.42 13.14 875 95224 486754 79161535
Discomfort 60.92 13.14 38 96061 125579 79522710
Angioplasty 60.65 13.14 34 96065 1829 79646460
Pancytopenia 59.64 13.14 67 96032 165678 79482611
Anaphylactic reaction 59.30 13.14 14 96085 83729 79564560
Right ventricular systolic pressure increased 59.16 13.14 27 96072 935 79647354
Neuropathy peripheral 59.09 13.14 50 96049 141255 79507034
Catheter site haemorrhage 58.74 13.14 49 96050 5068 79643221
Presyncope 58.30 13.14 143 95956 40911 79607378
Duodenal ulcer perforation 58.29 13.14 6 96093 66205 79582084
Pulmonary haemorrhage 56.77 13.14 79 96020 14638 79633651
Walking distance test abnormal 55.98 13.14 24 96075 714 79647575
Abortion induced 55.85 13.14 55 96044 7054 79641235
Oxygen therapy 55.11 13.14 37 96062 2753 79645536
Liver function test increased 54.85 13.14 137 95962 39636 79608653
Catheter site inflammation 54.77 13.14 27 96072 1114 79647175
Ventricular septal defect repair 54.56 13.14 12 96087 27 79648262
Chemotherapy 54.32 13.14 31 96068 1726 79646563
Tracheostomy malfunction 54.12 13.14 16 96083 152 79648137
Suicidal ideation 53.59 13.14 13 96086 76327 79571962
Angioedema 53.28 13.14 13 96086 76022 79572267
Cognitive disorder 52.98 13.14 10 96089 69916 79578373
Acute respiratory failure 52.83 13.14 175 95924 59366 79588923
Hypoaesthesia 51.90 13.14 85 96014 179267 79469022
Catheter removal 51.81 13.14 22 96077 639 79647650
Oxygen saturation abnormal 50.79 13.14 43 96056 4539 79643750
Leg amputation 50.36 13.14 39 96060 3627 79644662
Blister 50.29 13.14 42 96057 119434 79528855
Heart rate increased 50.22 13.14 282 95817 120442 79527847
Depressed level of consciousness 50.05 13.14 27 96072 96625 79551664
Inappropriate schedule of product administration 49.19 13.14 53 96046 133575 79514714
Upper limb fracture 48.86 13.14 82 96017 17885 79630404
Implantable defibrillator insertion 48.78 13.14 24 96075 986 79647303
Sudden death 48.73 13.14 93 96006 22418 79625871
Gastrointestinal tube insertion 48.37 13.14 28 96071 1602 79646687
Injection site pain 48.35 13.14 51 96048 129787 79518502
Type 2 diabetes mellitus 48.22 13.14 6 96093 57116 79591173
Tracheitis 48.09 13.14 26 96073 1302 79646987
Respiratory syncytial virus infection 48.05 13.14 58 96041 9344 79638945
Chronic respiratory failure 47.85 13.14 35 96064 2987 79645302
Heart valve replacement 47.76 13.14 23 96076 901 79647388
Cardiac pacemaker replacement 47.43 13.14 19 96080 474 79647815
Delirium 46.27 13.14 22 96077 84605 79563684
Wrong technique in product usage process 45.59 13.14 16 96083 73859 79574430
C-reactive protein increased 45.50 13.14 53 96046 128974 79519315
Coma 45.38 13.14 33 96066 100616 79547673
Tracheostomy infection 45.13 13.14 12 96087 74 79648215
Fibromyalgia 45.08 13.14 11 96088 64329 79583960
Cardiopulmonary failure 45.05 13.14 48 96051 6753 79641536
Renal disorder 44.98 13.14 132 95967 41973 79606316
Pulmonary congestion 44.59 13.14 100 95999 27000 79621289
Deep vein thrombosis 44.47 13.14 48 96051 120871 79527418
Device alarm issue 44.40 13.14 29 96070 2060 79646229
Osteoarthritis 44.32 13.14 25 96074 87284 79561005
Aggression 43.89 13.14 5 96094 50953 79597336
Muscle injury 43.80 13.14 4 96095 48557 79599732
Pulmonary resection 43.47 13.14 11 96088 54 79648235
Hip surgery 43.35 13.14 34 96065 3221 79645068
Injection site reaction 43.33 13.14 7 96092 54778 79593511
Infusion site discharge 43.23 13.14 19 96080 601 79647688
Leukopenia 43.12 13.14 46 96053 116467 79531822
Mastectomy 42.96 13.14 23 96076 1129 79647160
Systemic-pulmonary artery shunt 42.68 13.14 10 96089 33 79648256
Sedation 42.49 13.14 6 96093 51889 79596400
Lymphocyte count decreased 42.38 13.14 4 96095 47285 79601004
Blood pressure increased 42.26 13.14 123 95976 211237 79437052
Lactic acidosis 42.13 13.14 16 96083 70343 79577946
Toxic epidermal necrolysis 42.08 13.14 3 96096 44578 79603711
Cardiomegaly 41.98 13.14 96 96003 26256 79622033
Paraesthesia 41.89 13.14 94 96005 176229 79472060
Hepatic cirrhosis 41.75 13.14 114 95985 34792 79613497
Endarterectomy 41.20 13.14 16 96083 367 79647922
Left ventricular failure 40.86 13.14 54 96045 9527 79638762
Haemorrhage 40.68 13.14 217 95882 90901 79557388
Impaired healing 40.49 13.14 28 96071 87627 79560662
Bronchitis 40.48 13.14 283 95816 130361 79517928
Gout 40.36 13.14 91 96008 24658 79623631
Pneumothorax 39.52 13.14 98 96001 28225 79620064
Drug reaction with eosinophilia and systemic symptoms 39.50 13.14 14 96085 64230 79584059
Gastrostomy 39.46 13.14 22 96077 1171 79647118
Pulmonary artery therapeutic procedure 38.81 13.14 9 96090 28 79648261
Cholecystectomy 38.45 13.14 52 96047 9380 79638909
Surgery 38.18 13.14 106 95993 32660 79615629
Dysarthria 37.87 13.14 17 96082 67605 79580684
Joint stiffness 37.82 13.14 3 96096 40827 79607462
Limb operation 37.66 13.14 32 96067 3394 79644895
Unevaluable event 37.14 13.14 149 95950 55436 79592853
Abdominal distension 36.96 13.14 259 95840 119391 79528898
Rash maculo-papular 36.63 13.14 11 96088 56067 79592222
Somnolence 36.44 13.14 156 95943 238825 79409464
Generalised oedema 36.26 13.14 85 96014 23624 79624665
Bronchopulmonary dysplasia 36.19 13.14 13 96086 238 79648051
Psychotic disorder 35.81 13.14 4 96095 41398 79606891
Skin exfoliation 35.64 13.14 11 96088 55089 79593200
Plasma cell myeloma 35.61 13.14 10 96089 53249 79595040
Carbon dioxide increased 35.59 13.14 26 96073 2214 79646075
Wound 35.56 13.14 53 96046 116126 79532163
Muscular weakness 35.54 13.14 89 96010 160640 79487649
Hypoglycaemia 35.53 13.14 42 96057 101552 79546737
Right ventricular hypertrophy 35.47 13.14 23 96076 1614 79646675
Cardiac output decreased 35.41 13.14 24 96075 1814 79646475
Catheter site warmth 35.31 13.14 13 96086 256 79648033
Renal failure 35.29 13.14 384 95715 200584 79447705
Hyperkalaemia 35.20 13.14 52 96047 114346 79533943
Mineral supplementation 34.82 13.14 18 96081 822 79647467
Lung assist device therapy 34.67 13.14 11 96088 135 79648154
Myelosuppression 34.59 13.14 4 96095 40292 79607997
Paracentesis 34.42 13.14 21 96078 1324 79646965
Device related sepsis 34.38 13.14 40 96059 6200 79642089
Pulmonary arterial pressure abnormal 33.96 13.14 17 96082 725 79647564
Infusion site abscess 33.80 13.14 12 96087 212 79648077
Blood potassium decreased 33.78 13.14 128 95971 46384 79601905
Coronary arterial stent insertion 33.73 13.14 39 96060 6005 79642284
Infusion site cellulitis 33.72 13.14 13 96086 292 79647997
Catheter site related reaction 33.65 13.14 20 96079 1202 79647087
Vascular resistance pulmonary increased 33.55 13.14 10 96089 98 79648191
Product supply issue 33.06 13.14 24 96075 2024 79646265
Product administered to patient of inappropriate age 32.97 13.14 37 96062 5516 79642773
Medication error 32.95 13.14 21 96078 68621 79579668
Localised oedema 32.65 13.14 44 96055 7908 79640381
Device infusion issue 32.51 13.14 25 96074 2301 79645988
Colon operation 32.48 13.14 14 96085 422 79647867
Swollen tongue 32.44 13.14 6 96093 42564 79605725
Head injury 32.41 13.14 109 95990 37260 79611029
Exercise test abnormal 32.38 13.14 9 96090 67 79648222
Anaphylactic shock 32.37 13.14 3 96096 35993 79612296
Vascular device infection 32.17 13.14 50 96049 10226 79638063
Pleural effusion 32.02 13.14 291 95808 144971 79503318
Agitation 31.99 13.14 44 96055 99671 79548618
Red blood cell sedimentation rate increased 31.90 13.14 8 96091 45934 79602355
Pregnancy of partner 31.84 13.14 12 96087 253 79648036
Encephalopathy 31.83 13.14 21 96078 67376 79580913
Cataract operation 31.56 13.14 35 96064 5150 79643139
Drug level increased 31.51 13.14 5 96094 39646 79608643
Pulmonary artery dilatation 31.50 13.14 14 96085 455 79647834
Hypotension 31.48 13.14 723 95376 439594 79208695
Cardiac septal defect repair 31.45 13.14 7 96092 17 79648272
Gallbladder operation 31.24 13.14 23 96076 1982 79646307
Loss of personal independence in daily activities 31.20 13.14 47 96052 102533 79545756
Incorrect route of product administration 31.18 13.14 3 96096 34926 79613363
Biopsy bone marrow 30.99 13.14 13 96086 366 79647923
Dyspnoea at rest 30.90 13.14 41 96058 7261 79641028
Gastritis hypertrophic 30.86 13.14 8 96091 44 79648245
Mitral valve repair 30.67 13.14 12 96087 281 79648008
Emergency care 30.53 13.14 18 96081 1066 79647223
Haematuria 30.47 13.14 23 96076 68813 79579476
Heart valve operation 30.30 13.14 11 96088 208 79648081
Hypercalcaemia 30.19 13.14 5 96094 38425 79609864
Mouth ulceration 30.15 13.14 5 96094 38389 79609900
Pneumonitis 30.07 13.14 18 96081 60842 79587447
Disease recurrence 30.02 13.14 8 96091 44101 79604188
Tubulointerstitial nephritis 29.98 13.14 5 96094 38230 79610059
Bone marrow failure 29.97 13.14 12 96087 51095 79597194
Constipation 29.81 13.14 209 95890 282841 79365448
Aortic valve replacement 29.78 13.14 19 96080 1296 79646993
Sickle cell anaemia 29.77 13.14 15 96084 649 79647640
Autoimmune hepatitis 29.71 13.14 52 96047 11731 79636558
Bursitis 29.69 13.14 4 96095 35840 79612449
Hallucination 29.40 13.14 36 96063 85709 79562580
Pulmonary artery banding 29.26 13.14 6 96093 8 79648281
Hyperglycaemia 29.26 13.14 25 96074 70310 79577979
Ill-defined disorder 29.17 13.14 22 96077 65853 79582436
Catheter site rash 29.12 13.14 17 96082 988 79647301
Cavopulmonary anastomosis 28.85 13.14 6 96093 9 79648280
Injection site erythema 28.79 13.14 31 96068 78166 79570123
Infusion site swelling 28.69 13.14 41 96058 7785 79640504
Aspiration pleural cavity 28.52 13.14 20 96079 1597 79646692
Cytomegalovirus infection 28.52 13.14 8 96091 42636 79605653
Micrococcus test positive 28.10 13.14 6 96093 11 79648278
Disturbance in attention 28.09 13.14 13 96086 50788 79597501
Radiotherapy 28.08 13.14 14 96085 592 79647697
Body temperature decreased 28.07 13.14 3 96096 32142 79616147
Generalised tonic-clonic seizure 27.98 13.14 9 96090 43901 79604388
Diabetic ketoacidosis 27.81 13.14 4 96095 34118 79614171
Cardiac flutter 27.70 13.14 32 96067 4922 79643367
Gastrointestinal haemorrhage 27.68 13.14 286 95813 147433 79500856
Therapy change 27.47 13.14 39 96060 7360 79640929
Therapeutic embolisation 27.46 13.14 13 96086 490 79647799
Anxiety 27.41 13.14 181 95918 248331 79399958
Gastric operation 27.40 13.14 11 96088 276 79648013
Human metapneumovirus test positive 27.26 13.14 10 96089 195 79648094
Viral upper respiratory tract infection 26.99 13.14 43 96056 8983 79639306
Joint range of motion decreased 26.89 13.14 4 96095 33278 79615011
Blood creatine phosphokinase increased 26.87 13.14 24 96075 66066 79582223
Stevens-Johnson syndrome 26.85 13.14 7 96092 39159 79609130
Acute myocardial infarction 26.77 13.14 32 96067 77004 79571285
Mitral valve replacement 26.66 13.14 12 96087 402 79647887
Hospice care 26.60 13.14 46 96053 10278 79638011
Sopor 26.60 13.14 4 96095 33006 79615283
Blood culture positive 26.37 13.14 41 96058 8388 79639901
Hallucination, visual 26.29 13.14 4 96095 32725 79615564
Chest tube insertion 26.23 13.14 9 96090 143 79648146
Nocturnal dyspnoea 26.12 13.14 19 96080 1607 79646682
Orthopnoea 26.11 13.14 45 96054 10028 79638261
Oxygen consumption 26.09 13.14 8 96091 87 79648202
Pulmonary valve replacement 26.04 13.14 6 96093 18 79648271
Irritable bowel syndrome 26.04 13.14 22 96077 62219 79586070
Vascular operation 25.95 13.14 9 96090 148 79648141
Metabolic acidosis 25.89 13.14 37 96062 82492 79565797
Cellulitis 25.85 13.14 222 95877 108838 79539451
Extremity necrosis 25.85 13.14 25 96074 3136 79645153
Ventricular assist device insertion 25.44 13.14 7 96092 50 79648239
Scleroderma renal crisis 25.26 13.14 13 96086 588 79647701
Treatment noncompliance 25.07 13.14 127 95972 52141 79596148
Injury 25.05 13.14 34 96065 77462 79570827
Eye operation 25.01 13.14 21 96078 2192 79646097
Biopsy kidney 24.99 13.14 9 96090 166 79648123
Cardiac arrest 24.96 13.14 317 95782 171779 79476510
Knee operation 24.92 13.14 33 96066 5833 79642456
Haemodynamic test abnormal 24.86 13.14 7 96092 55 79648234
Toe amputation 24.84 13.14 27 96072 3884 79644405
Bilirubin conjugated increased 24.83 13.14 32 96067 5507 79642782
Arteriovenous fistula operation 24.74 13.14 11 96088 358 79647931
Tricuspid valve repair 24.71 13.14 6 96093 24 79648265
Skin operation 24.71 13.14 6 96093 24 79648265
Hysterectomy 24.69 13.14 34 96065 6238 79642051
Altered state of consciousness 24.56 13.14 11 96088 43811 79604478
Gangrene 24.49 13.14 41 96058 8923 79639366
Acute myeloid leukaemia 24.30 13.14 4 96095 30881 79617408
Medical device change 24.23 13.14 12 96087 500 79647789
Colitis ulcerative 24.22 13.14 6 96093 34736 79613553
Emotional distress 24.08 13.14 9 96090 39960 79608329
Restlessness 24.05 13.14 13 96086 46479 79601810
Faeces soft 24.00 13.14 39 96060 8284 79640005
Product prescribing error 23.96 13.14 12 96087 44801 79603488
Muscle spasms 23.70 13.14 119 95980 174611 79473678
Pulmonary thrombosis 23.58 13.14 48 96051 12123 79636166
Orthostatic hypotension 23.31 13.14 20 96079 56144 79592145
Right ventricular dilatation 23.27 13.14 19 96080 1907 79646382
Adenotonsillectomy 23.27 13.14 7 96092 71 79648218
Hypokalaemia 23.21 13.14 92 96007 143948 79504341
Drug eruption 23.14 13.14 12 96087 43923 79604366
Aortic valve repair 23.13 13.14 5 96094 10 79648279
Injection site pruritus 23.10 13.14 11 96088 42272 79606017
Therapy non-responder 22.99 13.14 190 95909 92115 79556174
Hypocalcaemia 22.98 13.14 16 96083 49908 79598381
Injection site erosion 22.93 13.14 8 96091 134 79648155
Hernia diaphragmatic repair 22.89 13.14 4 96095 0 79648289
Bradycardia 22.86 13.14 85 96014 135472 79512817
Neutrophil count increased 22.71 13.14 4 96095 29392 79618897
Spinal operation 22.69 13.14 37 96062 7880 79640409
Pericardial drainage 22.58 13.14 11 96088 442 79647847
Pleural mass 22.44 13.14 7 96092 81 79648208
Abnormal behaviour 22.28 13.14 8 96091 36413 79611876
Tricuspid valve incompetence 22.21 13.14 63 96036 19649 79628640
Blood iron decreased 22.16 13.14 54 96045 15380 79632909
Heart rate irregular 22.15 13.14 88 96011 32591 79615698
Prescribed overdose 22.05 13.14 9 96090 37874 79610415
Ulcer haemorrhage 22.01 13.14 31 96068 5807 79642482
Systemic sclerosis pulmonary 21.95 13.14 5 96094 14 79648275
Pulmonary artery aneurysm 21.95 13.14 8 96091 153 79648136
Vasodilation procedure 21.91 13.14 6 96093 42 79648247
Thromboembolectomy 21.84 13.14 7 96092 89 79648200
Tonsillectomy 21.83 13.14 12 96087 621 79647668
Lip swelling 21.81 13.14 11 96088 40900 79607389
Staphylococcal infection 21.53 13.14 132 95967 58163 79590126
Vascular cauterisation 21.42 13.14 7 96092 95 79648194
Pancreatitis acute 21.41 13.14 17 96082 49587 79598702
Heart valve incompetence 21.40 13.14 23 96076 3268 79645021
Biopsy lung 21.37 13.14 9 96090 256 79648033
Serotonin syndrome 21.30 13.14 14 96085 45013 79603276
Catheter site abscess 21.21 13.14 6 96093 48 79648241
Phlebotomy 21.15 13.14 7 96092 99 79648190
Device expulsion 21.15 13.14 3 96096 25858 79622431
Catheter site induration 20.99 13.14 6 96093 50 79648239
Low cardiac output syndrome 20.98 13.14 14 96085 1031 79647258
Poor peripheral circulation 20.95 13.14 24 96075 3659 79644630
Loss of consciousness 20.91 13.14 301 95798 167642 79480647
Prostate cancer 20.88 13.14 7 96092 33261 79615028
Labelled drug-drug interaction medication error 20.85 13.14 4 96095 27646 79620643
Sleep study 20.79 13.14 5 96094 19 79648270
Aneurysm repair 20.68 13.14 6 96093 53 79648236
Rectal prolapse repair 20.66 13.14 4 96095 3 79648286
Sinus bradycardia 20.48 13.14 3 96096 25244 79623045
Pulmonary artery stenosis 20.36 13.14 7 96092 112 79648177
Catheter site granuloma 20.30 13.14 6 96093 57 79648232
Atrioventricular septal defect 20.25 13.14 7 96092 114 79648175
Blood pressure fluctuation 20.19 13.14 31 96068 67114 79581175
Platelet transfusion 20.05 13.14 19 96080 2323 79645966
Colitis 20.04 13.14 36 96063 73271 79575018
Withdrawal syndrome 20.00 13.14 4 96095 26850 79621439
Sarcoidosis 20.00 13.14 36 96063 8299 79639990
Lymphopenia 19.94 13.14 6 96093 30551 79617738
Product quality issue 19.85 13.14 8 96091 33932 79614357
Disorientation 19.83 13.14 28 96071 62748 79585541
Skin lesion 19.81 13.14 13 96086 41831 79606458
Lung neoplasm malignant 19.78 13.14 76 96023 27716 79620573
Cor pulmonale chronic 19.76 13.14 9 96090 310 79647979
Dysphagia 19.68 13.14 78 96021 122058 79526231
Tracheostomy tube removal 19.65 13.14 4 96095 5 79648284
Infusion site irritation 19.60 13.14 12 96087 761 79647528
Hyperhidrosis 19.51 13.14 105 95994 151387 79496902
Respiratory disorder 19.45 13.14 106 95993 44750 79603539
Dizziness postural 19.43 13.14 43 96056 11506 79636783
Congenital arterial malformation 19.36 13.14 5 96094 27 79648262
Osteoporosis 19.32 13.14 22 96077 54090 79594199
Polyneuropathy 19.29 13.14 3 96096 24148 79624141
Arterial aneurysm repair 19.23 13.14 4 96095 6 79648283
Polypectomy 19.19 13.14 14 96085 1190 79647099
Protein-losing gastroenteropathy 19.17 13.14 11 96088 619 79647670
Infusion site haemorrhage 19.10 13.14 23 96076 3697 79644592
Hepatomegaly 19.05 13.14 58 96041 18816 79629473
Drug withdrawal syndrome 19.02 13.14 9 96090 34709 79613580
Colonoscopy 19.01 13.14 17 96082 1930 79646359
Cyst removal 19.00 13.14 10 96089 474 79647815
Accidental exposure to product 18.96 13.14 7 96092 31315 79616974
Dry skin 18.94 13.14 33 96066 67962 79580327
Injection site discharge 18.92 13.14 12 96087 810 79647479
Renal impairment 18.90 13.14 112 95987 157671 79490618
Rash pruritic 18.85 13.14 36 96063 71593 79576696
Illness 18.78 13.14 17 96082 46494 79601795
Collateral circulation 18.74 13.14 6 96093 76 79648213
Adverse drug reaction 18.70 13.14 32 96067 66360 79581929
Oral herpes 18.64 13.14 5 96094 27449 79620840
Basal cell carcinoma 18.54 13.14 11 96088 37364 79610925
Systemic lupus erythematosus 18.50 13.14 79 96020 121070 79527219
Drug-induced liver injury 18.50 13.14 32 96067 66085 79582204
Supraventricular tachycardia 18.40 13.14 62 96037 21208 79627081
Skin ulcer 18.37 13.14 120 95979 54030 79594259
Pulmonary arterial wedge pressure increased 18.24 13.14 10 96089 515 79647774
Dry eye 18.14 13.14 11 96088 36920 79611369
Amnesia 18.12 13.14 30 96069 63027 79585262
Status epilepticus 18.10 13.14 4 96095 25037 79623252
Blood creatinine increased 18.08 13.14 111 95988 154946 79493343
Resuscitation 17.78 13.14 18 96081 2386 79645903
Urinary incontinence 17.68 13.14 14 96085 40895 79607394
Drug dependence 17.56 13.14 14 96085 40755 79607534
Drug resistance 17.56 13.14 15 96084 42198 79606091
Aortic stenosis 17.51 13.14 32 96067 7463 79640826
Productive cough 17.49 13.14 173 95926 88158 79560131
Shoulder operation 17.48 13.14 19 96080 2733 79645556
Smooth muscle antibody positive 17.39 13.14 7 96092 177 79648112
Venous operation 17.36 13.14 4 96095 12 79648277
Dyskinesia 17.33 13.14 17 96082 44756 79603533
Hyperlipidaemia 17.25 13.14 5 96094 26088 79622201
Tremor 17.21 13.14 127 95972 169956 79478333
Pulmonary valve repair 17.17 13.14 3 96096 0 79648289
Arterial switch operation 17.17 13.14 3 96096 0 79648289
Dilatation ventricular 17.12 13.14 23 96076 4121 79644168
Localised infection 17.11 13.14 90 96009 37485 79610804
Catheterisation cardiac abnormal 17.11 13.14 8 96091 293 79647996
Gastrointestinal surgery 17.11 13.14 8 96091 293 79647996
Seasonal allergy 17.11 13.14 51 96048 16355 79631934
High frequency ablation 17.06 13.14 8 96091 295 79647994
Radiotherapy to brain 17.06 13.14 5 96094 46 79648243
Myoclonus 17.05 13.14 6 96093 27654 79620635
Pulmonary fibrosis 17.00 13.14 101 95998 44011 79604278
Cerebral infarction 16.93 13.14 18 96081 45658 79602631
Hypomagnesaemia 16.82 13.14 19 96080 46892 79601397
Renal haematoma 16.56 13.14 11 96088 804 79647485
Diuretic therapy 16.53 13.14 7 96092 202 79648087
Biopsy lymph gland 16.45 13.14 6 96093 115 79648174
Liver disorder 16.42 13.14 146 95953 72271 79576018
Retinal vascular disorder 16.41 13.14 8 96091 322 79647967
Diplopia 16.39 13.14 10 96089 33456 79614833
CREST syndrome 16.30 13.14 9 96090 470 79647819
Device connection issue 16.28 13.14 12 96087 1036 79647253
Administration site infection 16.28 13.14 4 96095 17 79648272
Mixed connective tissue disease 16.25 13.14 8 96091 329 79647960
Catheter site vesicles 16.21 13.14 8 96091 331 79647958
Gastroenteritis viral 16.14 13.14 66 96033 24765 79623524
Atrial tachycardia 16.10 13.14 30 96069 7103 79641186
Blood triglycerides increased 15.96 13.14 3 96096 21037 79627252
Spinal fracture 15.95 13.14 53 96046 18001 79630288
Colectomy 15.93 13.14 20 96079 3354 79644935
Pericardiotomy 15.92 13.14 4 96095 19 79648270
Trisomy 21 15.79 13.14 5 96094 61 79648228
Hypothermia 15.72 13.14 4 96095 22742 79625547
Catheter site mass 15.71 13.14 5 96094 62 79648227
Pulmonary capillary haemangiomatosis 15.71 13.14 5 96094 62 79648227
Dry mouth 15.63 13.14 54 96045 87965 79560324
Cardiac resynchronisation therapy 15.57 13.14 5 96094 64 79648225
Infusion site induration 15.43 13.14 12 96087 1123 79647166
Ear tube insertion 15.39 13.14 6 96093 139 79648150
Clubbing 15.38 13.14 10 96089 705 79647584
Cardiac failure acute 15.35 13.14 54 96045 18875 79629414
Agranulocytosis 15.33 13.14 19 96080 45011 79603278
Urinary retention 15.31 13.14 28 96071 56602 79591687
Device dislocation 15.30 13.14 67 96032 25903 79622386
Delusion 15.30 13.14 3 96096 20420 79627869
N-terminal prohormone brain natriuretic peptide 15.29 13.14 5 96094 68 79648221
Pulmonary vein occlusion 15.23 13.14 6 96093 143 79648146
Removal of transplanted organ 15.09 13.14 3 96096 3 79648286
Fasciectomy 15.09 13.14 3 96096 3 79648286
Cardiopulmonary bypass 15.09 13.14 3 96096 3 79648286
Injection site mass 15.05 13.14 3 96096 20181 79628108
Lung operation 15.03 13.14 7 96092 254 79648035
Pulmonary vascular resistance abnormality 15.00 13.14 6 96093 149 79648140
Product use issue 15.00 13.14 171 95928 209651 79438638
Cyanosis central 14.93 13.14 7 96092 258 79648031
Injection site swelling 14.91 13.14 21 96078 47111 79601178
Brain tumour operation 14.90 13.14 5 96094 74 79648215
Oral pain 14.89 13.14 10 96089 31788 79616501
Dysentery 14.82 13.14 12 96087 1190 79647099
Therapeutic response decreased 14.78 13.14 37 96062 66816 79581473
Night sweats 14.77 13.14 25 96074 52070 79596219
Dialysis related complication 14.76 13.14 7 96092 265 79648024
Device physical property issue 14.73 13.14 17 96082 2613 79645676
Sepsis 14.71 13.14 427 95672 269001 79379288
Jugular vein distension 14.68 13.14 13 96086 1457 79646832
Throat irritation 14.67 13.14 92 96007 40854 79607435
Peripheral artery stent insertion 14.63 13.14 3 96096 4 79648285
Catheter site irritation 14.51 13.14 9 96090 584 79647705
Right atrial dilatation 14.46 13.14 10 96089 781 79647508
International normalised ratio increased 14.45 13.14 161 95938 84560 79563729
Sudden cardiac death 14.41 13.14 24 96075 5201 79643088
Blood pressure decreased 14.32 13.14 183 95916 99283 79549006
Nasopharyngitis 14.31 13.14 404 95695 253477 79394812
Skin graft 14.27 13.14 11 96088 1016 79647273
Alanine aminotransferase 14.23 13.14 6 96093 171 79648118
Muscle twitching 14.22 13.14 6 96093 24758 79623531
Decreased activity 14.21 13.14 32 96067 8662 79639627
Leukocytosis 14.11 13.14 19 96080 43436 79604853
Blood glucose increased 14.09 13.14 81 96018 114894 79533395
Erythema 14.07 13.14 187 95912 223103 79425186
Skin neoplasm excision 14.05 13.14 11 96088 1039 79647250
Laparoscopic surgery 14.03 13.14 4 96095 33 79648256
Abdominal discomfort 14.03 13.14 215 95884 250512 79397777
Chest discomfort 13.98 13.14 239 95860 137805 79510484
Renal stone removal 13.89 13.14 6 96093 182 79648107
Intestinal adhesion lysis 13.88 13.14 3 96096 6 79648283
Varicose vein operation 13.88 13.14 3 96096 6 79648283
Internal haemorrhage 13.87 13.14 32 96067 8801 79639488
Pregnancy on oral contraceptive 13.86 13.14 10 96089 835 79647454
Thrombectomy 13.85 13.14 7 96092 305 79647984
Pulseless electrical activity 13.81 13.14 43 96056 14117 79634172
Creatinine renal clearance decreased 13.80 13.14 3 96096 18999 79629290
Diabetes mellitus inadequate control 13.74 13.14 6 96093 24258 79624031
Contusion 13.69 13.14 114 95985 148662 79499627
Choking sensation 13.64 13.14 20 96079 3886 79644403
Incorrect dose administered 13.61 13.14 47 96052 76583 79571706
COVID-19 pneumonia 13.61 13.14 9 96090 28840 79619449
Brain operation 13.57 13.14 9 96090 656 79647633
Breast operation 13.56 13.14 7 96092 319 79647970
Ejection fraction decreased 13.53 13.14 13 96086 34564 79613725
Colostomy 13.51 13.14 11 96088 1100 79647189
Dyspnoea paroxysmal nocturnal 13.49 13.14 15 96084 2213 79646076
Echocardiogram abnormal 13.49 13.14 15 96084 2213 79646076
Insomnia 13.46 13.14 211 95888 244959 79403330
Disseminated intravascular coagulation 13.43 13.14 14 96085 35828 79612461
Gait disturbance 13.36 13.14 173 95926 207333 79440956
Pulmonary arterial pressure 13.35 13.14 4 96095 40 79648249
N-terminal prohormone brain natriuretic peptide increased 13.33 13.14 22 96077 4733 79643556
Hypothyroidism 13.21 13.14 27 96072 52365 79595924
Full blood count decreased 13.15 13.14 8 96091 26811 79621478

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:35674 antihypertensive drugs
CHEBI has role CHEBI:51451 ERA

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
125MG TRACLEER ACTELION N021290 Nov. 20, 2001 RX TABLET ORAL Sept. 5, 2024 FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
62.5MG TRACLEER ACTELION N021290 Nov. 20, 2001 RX TABLET ORAL Sept. 5, 2024 FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
32MG TRACLEER ACTELION N209279 Sept. 5, 2017 RX TABLET, FOR SUSPENSION ORAL Sept. 5, 2024 TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) IN PEDIATRIC PATIENTS AGED 3 YRS AND OLDER WITH IDIOPATHIC OR CONGENITAL PAH TO IMPROVE PULMONARY VASCULAR RESISTANCE (PVR), WHICH IS EXPECTED TO RESULT IN AN IMPROVEMENT IN EXERCISE ABILITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Endothelin-1 receptor GPCR ANTAGONIST Ki 8.19 CHEMBL CHEMBL
Endothelin B receptor GPCR ANTAGONIST Ki 7.10 CHEMBL CHEMBL
Nuclear receptor subfamily 1 group I member 2 Nuclear hormone receptor WOMBAT-PK
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
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
4021289 VANDF
7195 INN_ID
157212-55-0 SECONDARY_CAS_RN
009514 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Bosentan HUMAN PRESCRIPTION DRUG LABEL 1 0054-0520 TABLET 62.50 mg ORAL ANDA 25 sections
Bosentan HUMAN PRESCRIPTION DRUG LABEL 1 0054-0521 TABLET 125 mg ORAL ANDA 25 sections
bosentan HUMAN PRESCRIPTION DRUG LABEL 1 0591-2511 TABLET, FILM COATED 62.50 mg ORAL ANDA 27 sections
bosentan HUMAN PRESCRIPTION DRUG LABEL 1 0591-2512 TABLET, FILM COATED 125 mg ORAL ANDA 27 sections
Bosentan Human Prescription Drug Label 1 46708-383 TABLET, FILM COATED 62.50 mg ORAL ANDA 26 sections
Bosentan Human Prescription Drug Label 1 46708-384 TABLET, FILM COATED 125 mg ORAL ANDA 26 sections
Bosentan Human Prescription Drug Label 1 47335-038 TABLET, FILM COATED 62.50 mg ORAL ANDA 27 sections
Bosentan Human Prescription Drug Label 1 47335-039 TABLET, FILM COATED 125 mg ORAL ANDA 27 sections
Bosentan HUMAN PRESCRIPTION DRUG LABEL 1 47781-270 TABLET, FILM COATED 62.50 mg ORAL ANDA 27 sections
Bosentan HUMAN PRESCRIPTION DRUG LABEL 1 47781-271 TABLET, FILM COATED 125 mg ORAL ANDA 27 sections
Bosentan HUMAN PRESCRIPTION DRUG LABEL 1 49884-058 TABLET, FILM COATED 62.50 mg ORAL ANDA 26 sections
Bosentan HUMAN PRESCRIPTION DRUG LABEL 1 49884-058 TABLET, FILM COATED 62.50 mg ORAL ANDA 26 sections
Bosentan HUMAN PRESCRIPTION DRUG LABEL 1 49884-058 TABLET, FILM COATED 62.50 mg ORAL ANDA 26 sections
Bosentan HUMAN PRESCRIPTION DRUG LABEL 1 49884-059 TABLET, FILM COATED 125 mg ORAL ANDA 26 sections
Bosentan HUMAN PRESCRIPTION DRUG LABEL 1 49884-059 TABLET, FILM COATED 125 mg ORAL ANDA 26 sections
Bosentan HUMAN PRESCRIPTION DRUG LABEL 1 49884-059 TABLET, FILM COATED 125 mg ORAL ANDA 26 sections
Bosentan HUMAN PRESCRIPTION DRUG LABEL 1 65162-873 TABLET, FILM COATED 62.50 mg ORAL ANDA 23 sections
Bosentan HUMAN PRESCRIPTION DRUG LABEL 1 65162-873 TABLET, FILM COATED 62.50 mg ORAL ANDA 23 sections
Bosentan HUMAN PRESCRIPTION DRUG LABEL 1 65162-874 TABLET, FILM COATED 125 mg ORAL ANDA 23 sections
Bosentan HUMAN PRESCRIPTION DRUG LABEL 1 65162-874 TABLET, FILM COATED 125 mg ORAL ANDA 23 sections
Tracleer HUMAN PRESCRIPTION DRUG LABEL 1 66215-101 TABLET, FILM COATED 62.50 mg ORAL NDA 30 sections
Tracleer HUMAN PRESCRIPTION DRUG LABEL 1 66215-101 TABLET, FILM COATED 62.50 mg ORAL NDA 30 sections
Tracleer HUMAN PRESCRIPTION DRUG LABEL 1 66215-101 TABLET, FILM COATED 62.50 mg ORAL NDA 30 sections
Tracleer HUMAN PRESCRIPTION DRUG LABEL 1 66215-101 TABLET, FILM COATED 62.50 mg ORAL NDA 30 sections
Tracleer HUMAN PRESCRIPTION DRUG LABEL 1 66215-102 TABLET, FILM COATED 125 mg ORAL NDA 30 sections
Tracleer HUMAN PRESCRIPTION DRUG LABEL 1 66215-102 TABLET, FILM COATED 125 mg ORAL NDA 30 sections
Tracleer HUMAN PRESCRIPTION DRUG LABEL 1 66215-102 TABLET, FILM COATED 125 mg ORAL NDA 30 sections
Tracleer HUMAN PRESCRIPTION DRUG LABEL 1 66215-102 TABLET, FILM COATED 125 mg ORAL NDA 30 sections
Tracleer HUMAN PRESCRIPTION DRUG LABEL 1 66215-103 TABLET, SOLUBLE 32 mg ORAL NDA 30 sections
Tracleer HUMAN PRESCRIPTION DRUG LABEL 1 66215-103 TABLET, SOLUBLE 32 mg ORAL NDA 30 sections