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

Stem definitionDrug idCAS RN
endothelin receptor antagonists 4337 177036-94-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • LU208075
  • LU 208075
  • ambrisentan
  • letairis
  • volibris
an endothelin receptor antagonist that is selective for the endothelin type-A (ETA) receptor
  • Molecular weight: 378.43
  • Formula: C22H22N2O4
  • CLOGP: 3.35
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 1
  • TPSA: 81.54
  • ALOGS: -3.88
  • ROTB: 7
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
7.50 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.06 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 5 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.38 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 90 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,MAP3K7,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PRKDC,STK33,TEK 26
kinase-selectivity-class AXL,EPHB4,ERBB2,GRK2,MAP2K6,PDK4,TEK 7
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
March 23, 2021 PMDA GlaxoSmithKline K.K.
June 20, 2019 EMA MYLAN SAS
June 15, 2007 FDA GILEAD

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
Dyspnoea 4779.02 18.30 5791 113374 875164 89634118
Death 2699.73 18.30 3150 116015 453401 90055881
Fluid retention 2571.62 18.30 1541 117624 86550 90422732
Pain in jaw 1924.71 18.30 1034 118131 46951 90462331
Nasal congestion 1848.44 18.30 1226 117939 82188 90427094
Headache 1835.53 18.30 3699 115466 859047 89650235
Pulmonary arterial hypertension 1450.79 18.30 702 118463 25485 90483797
Right ventricular failure 1258.06 18.30 578 118587 18627 90490655
Hypervolaemia 1199.76 18.30 665 118500 32092 90477190
Unevaluable event 1129.97 18.30 771 118394 54077 90455205
Flushing 1093.10 18.30 916 118249 87575 90421707
Pulmonary hypertension 1083.92 18.30 683 118482 41840 90467442
Dyspnoea exertional 1024.88 18.30 811 118354 71477 90437805
Oedema peripheral 996.73 18.30 1447 117718 256468 90252814
Oedema 834.08 18.30 1165 118000 199130 90310152
Hospitalisation 743.87 18.30 879 118286 127221 90382061
Drug ineffective 669.89 18.30 509 118656 1383789 89125493
Lung transplant 654.74 18.30 228 118937 3464 90505818
Chest pain 605.17 18.30 1312 117853 318333 90190949
Dizziness 604.49 18.30 1922 117243 587362 89921920
Catheterisation cardiac 582.16 18.30 226 118939 4730 90504552
Oxygen saturation decreased 582.00 18.30 712 118453 106771 90402511
Infusion site pain 579.17 18.30 347 118818 19391 90489891
Therapy interrupted 551.80 18.30 486 118679 49622 90459660
Syncope 546.28 18.30 768 118397 131895 90377387
Palpitations 508.15 18.30 754 118411 135974 90373308
Infusion related reaction 507.43 18.30 8 119157 416772 90092510
Diarrhoea 474.53 18.30 2457 116708 936733 89572549
Pneumonia 457.82 18.30 1852 117313 636207 89873075
Cardiac failure congestive 457.10 18.30 605 118560 98089 90411193
Peripheral swelling 448.16 18.30 1375 117790 411731 90097551
Hypotension 433.13 18.30 1166 117999 324231 90185051
Alopecia 419.64 18.30 73 119092 494998 90014284
Device related infection 403.62 18.30 307 118858 25479 90483803
Contraindicated product administered 378.05 18.30 9 119156 320130 90189152
Glossodynia 376.37 18.30 10 119155 321769 90187513
Respiratory failure 375.43 18.30 607 118558 117811 90391471
Cardiac failure 368.76 18.30 577 118588 108919 90400363
Cough 364.09 18.30 1189 117976 367773 90141509
Catheter site erythema 363.90 18.30 161 119004 4733 90504549
Arthropathy 350.45 18.30 37 119128 366205 90143077
Treatment failure 342.72 18.30 13 119152 303915 90205367
Rheumatoid arthritis 338.47 18.30 40 119125 362574 90146708
Hypoxia 327.73 18.30 439 118726 71960 90437322
Vascular device infection 319.51 18.30 198 118967 11754 90497528
Off label use 317.04 18.30 607 118558 1101645 89407637
Oxygen consumption increased 309.45 18.30 141 119024 4448 90504834
Product use in unapproved indication 309.10 18.30 39 119126 336197 90173085
Scleroderma 308.30 18.30 155 119010 6106 90503176
Therapeutic product effect decreased 302.61 18.30 15 119150 277556 90231726
Toxicity to various agents 300.21 18.30 20 119145 287826 90221456
Malaise 299.46 18.30 1540 117625 584446 89924836
Pericarditis 296.43 18.30 14 119151 270137 90239145
Stomatitis 286.73 18.30 19 119146 274679 90234603
Epistaxis 284.36 18.30 447 118718 84678 90424604
Infusion site infection 283.26 18.30 113 119052 2547 90506735
Maternal exposure during pregnancy 282.07 18.30 64 119101 359999 90149283
Central venous catheterisation 281.63 18.30 114 119051 2672 90506610
Infusion site erythema 280.86 18.30 192 118973 13478 90495804
Psoriatic arthropathy 279.33 18.30 4 119161 228331 90280951
Acute respiratory failure 264.62 18.30 304 118861 42614 90466668
Catheter site pruritus 263.37 18.30 103 119062 2199 90507083
Nausea 260.24 18.30 2407 116758 1107909 89401373
Helicobacter infection 258.12 18.30 9 119156 226841 90282441
Wound 257.97 18.30 44 119121 302936 90206346
Therapy change 256.35 18.30 151 119014 8171 90501111
Therapy cessation 254.15 18.30 275 118890 36086 90473196
Type 2 diabetes mellitus 242.64 18.30 5 119160 203239 90306043
Impaired healing 242.05 18.30 17 119148 234182 90275100
Drug hypersensitivity 239.12 18.30 158 119007 463451 90045831
Catheter site discharge 238.12 18.30 97 119068 2312 90506970
Blood cholesterol increased 237.55 18.30 8 119157 208004 90301278
Myalgia 232.00 18.30 627 118538 174498 90334784
Catheter site pain 231.18 18.30 123 119042 5456 90503826
Hepatic enzyme increased 228.78 18.30 94 119071 360642 90148640
Cardiac disorder 214.44 18.30 316 118849 56556 90452726
Musculoskeletal stiffness 212.52 18.30 63 119102 296469 90212813
Irritable bowel syndrome 211.67 18.30 16 119149 207432 90301850
C-reactive protein increased 210.64 18.30 6 119159 181383 90327899
Neutropenia 206.81 18.30 26 119139 224878 90284404
Catheter management 203.82 18.30 93 119072 2943 90506339
Discomfort 202.67 18.30 55 119110 274280 90235002
Hypertension 201.55 18.30 183 118982 457349 90051933
Rash 197.83 18.30 475 118690 795625 89713657
Chest discomfort 194.99 18.30 507 118658 137858 90371424
Osteoarthritis 194.41 18.30 17 119148 195713 90313569
Fibromyalgia 194.22 18.30 22 119143 206247 90303035
Catheter placement 194.01 18.30 85 119080 2439 90506843
Mobility decreased 189.52 18.30 48 119117 250686 90258596
Drug interaction 188.72 18.30 64 119101 276389 90232893
Haemoptysis 187.10 18.30 225 118940 33095 90476187
Pulmonary arterial pressure increased 184.20 18.30 94 119071 3822 90505460
Dermatitis contact 182.79 18.30 148 119017 13447 90495835
Febrile neutropenia 181.10 18.30 6 119159 158343 90350939
Pulmonary oedema 178.87 18.30 305 118860 61775 90447507
Injury 176.22 18.30 25 119140 197324 90311958
Liver injury 174.44 18.30 13 119152 170554 90338728
Systemic lupus erythematosus 172.53 18.30 134 119031 361762 90147520
Therapeutic product effect incomplete 172.12 18.30 25 119140 193871 90315411
Lower respiratory tract infection 169.40 18.30 59 119106 250600 90258682
Infusion site swelling 166.97 18.30 132 119033 11588 90497694
Device leakage 165.31 18.30 123 119042 9868 90499414
Joint range of motion decreased 163.23 18.30 3 119162 135640 90373642
Urticaria 161.90 18.30 106 119059 312628 90196654
Pain in extremity 160.78 18.30 1078 118087 449451 90059831
Hypersensitivity 160.53 18.30 218 118947 454459 90054823
Transfusion 160.03 18.30 153 119012 17335 90491947
Device alarm issue 159.70 18.30 68 119097 1817 90507465
Presyncope 159.64 18.30 203 118962 31602 90477680
Confusional state 158.95 18.30 164 119001 386041 90123241
Device dislocation 158.11 18.30 201 118964 31281 90478001
Blister 154.37 18.30 71 119094 254927 90254355
Complication associated with device 151.74 18.30 156 119009 19293 90489989
Sleep disorder due to general medical condition, insomnia type 150.35 18.30 4 119161 128690 90380592
Drug intolerance 149.68 18.30 223 118942 447368 90061914
Psoriasis 149.01 18.30 12 119153 147742 90361540
Catheter site infection 146.91 18.30 92 119073 5562 90503720
Device occlusion 146.30 18.30 111 119054 9171 90500111
Pericardial effusion 142.22 18.30 207 118958 36626 90472656
Exposure during pregnancy 135.81 18.30 72 119093 238338 90270944
Inflammation 133.37 18.30 35 119130 178557 90330725
General physical health deterioration 127.58 18.30 168 118997 354947 90154335
Heart rate increased 126.79 18.30 381 118784 112521 90396761
Catheter site rash 124.00 18.30 45 119120 775 90508507
Hypoaesthesia 123.05 18.30 139 119026 314071 90195211
Transplant evaluation 122.19 18.30 51 119114 1295 90507987
Feeling abnormal 120.42 18.30 487 118678 166748 90342534
Blood pressure decreased 118.62 18.30 287 118878 74608 90434674
White blood cell count decreased 116.95 18.30 37 119128 167072 90342210
Joint swelling 115.69 18.30 312 118853 502988 90006294
Abdominal distension 115.30 18.30 406 118759 130195 90379087
Lip dry 114.80 18.30 4 119161 100951 90408331
Catheter site haemorrhage 114.14 18.30 67 119098 3601 90505681
Malignant neoplasm progression 112.60 18.30 7 119158 106863 90402419
Infusion site discharge 110.34 18.30 57 119108 2378 90506904
Grip strength decreased 107.68 18.30 3 119162 92573 90416709
Wound infection 106.28 18.30 9 119156 106393 90402889
Sinus congestion 102.80 18.30 152 119013 27272 90482010
Intentional product use issue 102.41 18.30 81 119084 216811 90292471
Cardiac operation 101.95 18.30 64 119101 3885 90505397
Catheter site swelling 101.22 18.30 49 119116 1776 90507506
Anaemia 100.89 18.30 801 118364 352001 90157281
Dyspnoea at rest 100.09 18.30 68 119097 4723 90504559
Oxygen therapy 100.06 18.30 58 119107 3044 90506238
Obesity 99.92 18.30 11 119154 105496 90403786
Pruritus 99.66 18.30 371 118794 541154 89968128
Intentional overdose 96.35 18.30 7 119158 93827 90415455
Prescribed overdose 95.51 18.30 9 119156 97616 90411666
Infusion site haemorrhage 94.89 18.30 69 119096 5342 90503940
Sleep disorder 94.70 18.30 73 119092 197957 90311325
Delirium 93.65 18.30 13 119152 104346 90404936
Cor pulmonale 92.71 18.30 48 119117 2012 90507270
Dialysis 92.25 18.30 93 119072 11236 90498046
Drug-induced liver injury 91.99 18.30 7 119158 90311 90418971
Hot flush 91.04 18.30 225 118940 59263 90450019
Exercise tolerance decreased 90.67 18.30 77 119088 7474 90501808
Pulmonary hypertensive crisis 90.55 18.30 31 119134 446 90508836
Liver function test abnormal 90.52 18.30 204 118961 50641 90458641
Depression 89.89 18.30 161 119004 300440 90208842
Device infusion issue 89.14 18.30 51 119114 2611 90506671
Peripheral venous disease 86.92 18.30 6 119159 83915 90425367
Intentional dose omission 86.87 18.30 112 119053 17671 90491611
Anaphylactic reaction 85.80 18.30 8 119157 87516 90421766
Asthma 85.45 18.30 116 119049 242044 90267238
Prescribed underdose 85.20 18.30 3 119162 75016 90434266
Atrial flutter 83.39 18.30 86 119079 10672 90498610
Ill-defined disorder 82.41 18.30 73 119092 184818 90324464
Epilepsy 81.97 18.30 7 119158 82199 90427083
Gastrointestinal haemorrhage 81.75 18.30 283 118882 89965 90419317
Injection site discharge 80.60 18.30 39 119126 1412 90507870
Catheter site vesicles 79.21 18.30 27 119138 383 90508899
Chronic obstructive pulmonary disease 78.98 18.30 245 118920 73584 90435698
Injection site reaction 76.92 18.30 14 119151 92066 90417216
Arthralgia 76.33 18.30 656 118509 777866 89731416
Electrocardiogram QT prolonged 75.57 18.30 5 119160 72451 90436831
Pulmonary veno-occlusive disease 75.50 18.30 38 119127 1500 90507782
Dizziness postural 74.97 18.30 75 119090 8978 90500304
Night sweats 74.61 18.30 38 119127 128728 90380554
Drug abuse 74.50 18.30 10 119155 82337 90426945
Ascites 72.45 18.30 180 118985 47560 90461722
Thrombocytopenia 71.61 18.30 102 119063 208623 90300659
Device connection issue 71.59 18.30 32 119133 964 90508318
Gait inability 71.27 18.30 53 119112 146403 90362879
Infusion site pruritus 71.20 18.30 64 119101 6701 90502581
Mechanical ventilation 70.94 18.30 36 119129 1446 90507836
Overdose 70.60 18.30 62 119103 157647 90351635
Influenza 69.34 18.30 364 118801 138900 90370382
Product quality issue 68.60 18.30 11 119154 79314 90429968
Suicide attempt 68.58 18.30 9 119156 75390 90433892
Live birth 68.34 18.30 11 119154 79096 90430186
Brain natriuretic peptide increased 67.57 18.30 59 119106 5946 90503336
Pancytopenia 67.45 18.30 37 119128 120226 90389056
Paraesthesia 66.25 18.30 144 119021 250182 90259100
Walking distance test abnormal 65.96 18.30 26 119139 567 90508715
Fatigue 65.46 18.30 1981 117184 1152042 89357240
Leukopenia 64.14 18.30 26 119139 100684 90408598
Localised oedema 64.02 18.30 58 119107 6136 90503146
Catheter site irritation 63.81 18.30 26 119139 620 90508662
Transplant 63.77 18.30 30 119135 1019 90508263
Terminal state 63.68 18.30 42 119123 2776 90506506
Foot deformity 62.55 18.30 4 119161 59647 90449635
Medication error 62.40 18.30 17 119148 84635 90424647
Paracentesis 62.17 18.30 29 119136 966 90508316
Contusion 62.04 18.30 150 119015 251066 90258216
Sciatica 61.66 18.30 28 119137 101354 90407928
Autoimmune disorder 61.30 18.30 13 119152 76731 90432551
Catheter site inflammation 60.13 18.30 28 119137 929 90508353
Neuropathy peripheral 59.93 18.30 55 119110 136915 90372367
Infusion site cellulitis 59.70 18.30 21 119144 329 90508953
Vascular device occlusion 59.37 18.30 22 119143 403 90508879
Inappropriate schedule of product administration 58.99 18.30 66 119099 149867 90359415
Ear discomfort 57.45 18.30 69 119096 10131 90499151
Endotracheal intubation 56.96 18.30 42 119123 3322 90505960
Blood pressure increased 56.81 18.30 108 119057 197109 90312173
Blood pressure systolic increased 55.45 18.30 6 119159 58339 90450943
Blood potassium decreased 55.38 18.30 163 119002 47564 90461718
Upper respiratory tract congestion 55.32 18.30 36 119129 2326 90506956
Throat irritation 55.26 18.30 165 119000 48530 90460752
Infusion site induration 55.26 18.30 31 119134 1528 90507754
Disease complication 54.84 18.30 43 119122 3729 90505553
Bendopnoea 54.58 18.30 14 119151 66 90509216
Swelling 53.76 18.30 811 118354 418247 90091035
Hospice care 53.60 18.30 65 119100 9639 90499643
Hyponatraemia 53.40 18.30 58 119107 133480 90375802
Injection site infection 53.29 18.30 35 119130 2297 90506985
Chronic respiratory failure 52.78 18.30 37 119128 2704 90506578
Therapeutic response decreased 52.69 18.30 26 119139 89703 90419579
Lupus-like syndrome 52.05 18.30 3 119162 48843 90460439
Respiration abnormal 51.77 18.30 58 119107 7905 90501377
Multiple sclerosis relapse 50.69 18.30 5 119160 52300 90456982
Knee arthroplasty 50.54 18.30 23 119142 83159 90426123
Generalised oedema 50.17 18.30 90 119075 18963 90490319
Injection site pain 50.13 18.30 95 119070 173604 90335678
Acute kidney injury 49.84 18.30 234 118931 320153 90189129
Gastric disorder 49.74 18.30 125 119040 33259 90476023
Osteoporosis 49.51 18.30 33 119132 96498 90412784
Emergency care 49.38 18.30 29 119136 1560 90507722
Cognitive disorder 49.20 18.30 15 119150 69392 90439890
Haemorrhage 49.08 18.30 201 118964 69168 90440114
Hepatitis 48.88 18.30 16 119149 70723 90438559
Lactic acidosis 48.44 18.30 5 119160 50458 90458824
Joint stiffness 48.33 18.30 21 119144 78021 90431261
Sedation 48.31 18.30 4 119161 48167 90461115
Product dose omission issue 48.26 18.30 591 118574 291096 90218186
Sinus disorder 48.23 18.30 126 119039 34321 90474961
Intentional product misuse 48.20 18.30 29 119136 89575 90419707
Infusion site warmth 48.10 18.30 32 119133 2146 90507136
Atrial fibrillation 47.66 18.30 320 118845 133291 90375991
Treatment noncompliance 47.52 18.30 163 119002 51564 90457718
Hypothyroidism 46.77 18.30 7 119158 53120 90456162
Vomiting 46.37 18.30 1360 117805 786933 89722349
Drug ineffective for unapproved indication 46.18 18.30 15 119150 66629 90442653
Incorrect route of product administration 46.14 18.30 6 119159 50620 90458662
Arthritis 46.13 18.30 94 119071 167221 90342061
Infection 46.05 18.30 283 118882 361811 90147471
Oxygen saturation abnormal 45.99 18.30 41 119124 4247 90505035
Productive cough 45.88 18.30 212 118953 76851 90432431
Device related sepsis 45.88 18.30 43 119122 4750 90504532
Metapneumovirus infection 45.84 18.30 26 119139 1309 90507973
Device breakage 45.82 18.30 73 119092 13971 90495311
Immunodeficiency 45.03 18.30 3 119162 43231 90466051
Loss of personal independence in daily activities 44.25 18.30 69 119096 136036 90373246
Sickle cell anaemia 44.15 18.30 20 119145 622 90508660
Liver transplant 43.97 18.30 31 119134 2286 90506996
Neoplasm progression 43.78 18.30 4 119161 44482 90464800
Central venous catheter removal 43.20 18.30 18 119147 455 90508827
Cellulitis 42.91 18.30 235 118930 91102 90418180
Colitis ulcerative 42.76 18.30 13 119152 60253 90449029
No adverse event 42.56 18.30 18 119147 67964 90441318
Suicidal ideation 42.47 18.30 22 119143 73833 90435449
Sleep disorder due to a general medical condition 41.51 18.30 5 119160 44733 90464549
Injection site bruising 41.49 18.30 9 119156 52298 90456984
Catheter site cellulitis 41.46 18.30 16 119149 329 90508953
Oxygen consumption 41.38 18.30 12 119153 96 90509186
Coma 41.23 18.30 22 119143 72610 90436672
Accidental exposure to product 41.18 18.30 4 119161 42362 90466920
Ear congestion 41.12 18.30 35 119130 3407 90505875
Deep vein thrombosis 41.02 18.30 36 119129 91584 90417698
Product administration interrupted 40.85 18.30 65 119100 12427 90496855
Infusion site inflammation 40.84 18.30 18 119147 524 90508758
Wheezing 40.57 18.30 168 118997 237912 90271370
Application site pruritus 40.46 18.30 38 119127 4209 90505073
Memory impairment 40.33 18.30 129 119036 197115 90312167
Thrombosis in device 40.33 18.30 33 119132 3042 90506240
Muscular weakness 40.31 18.30 138 119027 206528 90302754
Cardiac failure high output 40.18 18.30 17 119148 447 90508835
Eczema 40.14 18.30 10 119155 52860 90456422
Renal disorder 39.89 18.30 125 119040 37734 90471548
Metabolic acidosis 39.52 18.30 12 119153 55664 90453618
Middle ear effusion 39.52 18.30 31 119134 2690 90506592
Swelling face 39.35 18.30 211 118954 81141 90428141
Hip arthroplasty 39.15 18.30 26 119139 76182 90433100
Depressed level of consciousness 38.53 18.30 24 119141 72760 90436522
Mouth ulceration 38.27 18.30 4 119161 39970 90469312
Dizziness exertional 37.94 18.30 17 119148 515 90508767
Haemoglobin increased 37.93 18.30 48 119117 7433 90501849
Cardiac failure acute 37.54 18.30 61 119104 11868 90497414
Bradycardia 37.47 18.30 33 119132 83814 90425468
Taste disorder 37.42 18.30 17 119148 61529 90447753
Device malfunction 37.14 18.30 84 119081 20893 90488389
Right-to-left cardiac shunt 36.73 18.30 14 119151 278 90509004
Catheter site warmth 36.42 18.30 13 119152 213 90509069
Blood glucose increased 36.30 18.30 43 119122 95203 90414079
Intra-abdominal fluid collection 36.21 18.30 30 119135 2814 90506468
Ventilation perfusion mismatch 36.20 18.30 17 119148 575 90508707
Hepatotoxicity 36.13 18.30 8 119157 45834 90463448
Abortion spontaneous 36.01 18.30 13 119152 54043 90455239
Pregnancy test positive 35.61 18.30 12 119153 164 90509118
Dry eye 35.22 18.30 16 119149 57915 90451367
Nasal dryness 35.16 18.30 40 119125 5543 90503739
Infusion site irritation 35.11 18.30 22 119143 1331 90507951
Viral infection 35.02 18.30 127 119038 41287 90467995
Lower limb fracture 35.02 18.30 36 119129 84977 90424305
Infusion site vesicles 34.94 18.30 17 119148 623 90508659
Biopsy liver 34.91 18.30 15 119150 410 90508872
Alanine aminotransferase increased 34.78 18.30 64 119101 118274 90391008
Agitation 34.32 18.30 23 119142 67075 90442207
Product substitution issue 34.01 18.30 74 119091 17934 90491348
Nocturnal dyspnoea 33.85 18.30 22 119143 1418 90507864
Foetal exposure during pregnancy 32.88 18.30 8 119157 42967 90466315
Right ventricular dilatation 32.87 18.30 23 119142 1676 90507606
Catheter removal 32.67 18.30 14 119151 380 90508902
Heart transplant 32.62 18.30 16 119149 597 90508685
Oropharyngeal pain 32.55 18.30 261 118904 114926 90394356
Amnesia 32.50 18.30 58 119107 108447 90400835
Skin exfoliation 32.49 18.30 25 119140 67888 90441394
Plasma cell myeloma 32.43 18.30 7 119158 40821 90468461
Left ventricular failure 32.41 18.30 42 119123 6658 90502624
Pyrexia 32.10 18.30 644 118521 659841 89849441
Systemic scleroderma 31.88 18.30 22 119143 1567 90507715
Drug titration error 31.81 18.30 20 119145 1217 90508065
Sepsis 31.76 18.30 369 118796 179445 90329837
Pulmonary fibrosis 31.72 18.30 58 119107 107445 90401837
Bronchitis 31.71 18.30 324 118841 152603 90356679
Acute right ventricular failure 31.69 18.30 12 119153 234 90509048
Heart and lung transplant 31.57 18.30 10 119155 111 90509171
Bone marrow failure 31.43 18.30 3 119162 32218 90477064
Gastrointestinal disorder 31.38 18.30 203 118962 256484 90252798
Heart valve replacement 31.28 18.30 17 119148 787 90508495
Infusion site rash 31.21 18.30 26 119139 2457 90506825
Renal failure 30.81 18.30 285 118880 130722 90378560
Hypomagnesaemia 30.62 18.30 5 119160 35583 90473699
Right ventricular dysfunction 30.23 18.30 25 119140 2339 90506943
Head injury 30.16 18.30 100 119065 31088 90478194
Decreased activity 30.12 18.30 45 119120 8147 90501135
Respiratory distress 30.08 18.30 116 119049 38830 90470452
Loss of consciousness 29.98 18.30 299 118866 139939 90369343
Intracardiac pressure increased 29.72 18.30 8 119157 47 90509235
CREST syndrome 29.57 18.30 15 119150 602 90508680
Pulmonary thrombosis 29.41 18.30 49 119116 9733 90499549
Haemoglobin decreased 29.34 18.30 334 118831 161622 90347660
Catheter site related reaction 29.12 18.30 18 119147 1063 90508219
Pneumonitis 28.78 18.30 11 119154 44159 90465123
Paranasal sinus discomfort 28.60 18.30 38 119127 6172 90503110
Disability 28.53 18.30 9 119156 40736 90468546
Hyperkalaemia 28.51 18.30 26 119139 64938 90444344
Angioedema 28.43 18.30 26 119139 64850 90444432
Back injury 28.15 18.30 13 119152 46609 90462673
Pulmonary congestion 28.15 18.30 72 119093 19361 90489921
Hyperglycaemia 28.11 18.30 16 119149 50954 90458328
Basal cell carcinoma 28.05 18.30 5 119160 33384 90475898
Stevens-Johnson syndrome 27.97 18.30 3 119162 29373 90479909
Purulent discharge 27.91 18.30 35 119130 5370 90503912
Life support 27.90 18.30 11 119154 240 90509042
Infusion site oedema 27.66 18.30 18 119147 1163 90508119
Cardiac arrest 27.62 18.30 234 118931 104701 90404581
Hepatic cytolysis 27.38 18.30 4 119161 30912 90478370
Head discomfort 27.37 18.30 64 119101 16269 90493013
Catheter site scab 27.36 18.30 11 119154 253 90509029
Metastases to liver 27.28 18.30 3 119162 28804 90480478
Tracheostomy 27.25 18.30 15 119150 712 90508570
Drug withdrawal syndrome 27.17 18.30 3 119162 28720 90480562
Device programming error 27.16 18.30 11 119154 258 90509024
Disturbance in attention 27.13 18.30 14 119151 47095 90462187
White blood cell count increased 27.10 18.30 29 119136 67212 90442070
Hallucination 27.09 18.30 28 119137 65931 90443351
Pleural effusion 27.02 18.30 245 118920 111746 90397536
Nasopharyngitis 26.82 18.30 713 118452 406391 90102891
Road traffic accident 26.76 18.30 64 119101 107562 90401720
Walking aid user 26.41 18.30 7 119158 35499 90473783
Blood creatinine increased 26.24 18.30 59 119106 101327 90407955
Seasonal allergy 26.19 18.30 78 119087 22905 90486377
Right ventricular enlargement 26.16 18.30 13 119152 499 90508783
Product use issue 25.91 18.30 293 118872 329626 90179656
Emotional distress 25.84 18.30 8 119157 36654 90472628
Catheterisation cardiac abnormal 25.79 18.30 11 119154 295 90508987
Eye swelling 25.60 18.30 91 119074 29295 90479987
Infusion site haematoma 25.52 18.30 11 119154 303 90508979
Macular degeneration 25.51 18.30 9 119156 37961 90471321
Cardiac flutter 25.51 18.30 31 119134 4607 90504675
Biopsy lung 25.46 18.30 10 119155 216 90509066
Disease recurrence 25.17 18.30 9 119156 37644 90471638
Hypercalcaemia 25.00 18.30 7 119158 34233 90475049
Toxic epidermal necrolysis 24.99 18.30 6 119159 32522 90476760
Premature delivery 24.69 18.30 10 119155 38752 90470530
Dry skin 24.68 18.30 49 119116 88024 90421258
Stent placement 24.60 18.30 29 119136 4174 90505108
Dry mouth 24.35 18.30 142 119023 183917 90325365
Somnolence 24.23 18.30 168 118997 208916 90300366
Device use error 24.20 18.30 38 119127 7183 90502099
Gout 23.94 18.30 62 119103 16797 90492485
Infusion site abscess 23.65 18.30 11 119154 364 90508918
Vascular resistance pulmonary increased 23.61 18.30 7 119158 61 90509221
Skin irritation 23.56 18.30 54 119111 13549 90495733
Catheter site discolouration 23.44 18.30 8 119157 114 90509168
Echocardiogram 23.27 18.30 6 119159 29 90509253
Skin lesion 23.22 18.30 10 119155 37355 90471927
Hypoacusis 23.21 18.30 85 119080 27765 90481517
Joint dislocation 23.18 18.30 15 119150 44567 90464715
Tubulointerstitial nephritis 23.10 18.30 3 119162 25340 90483942
Feeling cold 23.03 18.30 84 119081 27381 90481901
Portopulmonary hypertension 23.00 18.30 8 119157 121 90509161
Pregnancy test 22.54 18.30 4 119161 0 90509282
Medical procedure 22.51 18.30 12 119153 534 90508748
Gastroenteritis viral 22.30 18.30 89 119076 30266 90479016
Respiratory tract congestion 22.29 18.30 83 119082 27327 90481955
Catheter site extravasation 22.17 18.30 11 119154 421 90508861
Hypoglycaemia 22.14 18.30 36 119129 69812 90439470
Systolic dysfunction 22.01 18.30 19 119146 1885 90507397
Pain 21.92 18.30 1079 118086 995262 89514020
Bedridden 21.90 18.30 49 119116 12099 90497183
Endarterectomy 21.88 18.30 9 119156 220 90509062
Injection site erythema 21.86 18.30 62 119103 98440 90410842
Injection site swelling 21.76 18.30 28 119137 59811 90449471
Abdominal cavity drainage 21.51 18.30 11 119154 449 90508833
Obstructive airways disorder 21.46 18.30 4 119161 25865 90483417
Pulmonary arterial pressure abnormal 21.27 18.30 12 119153 598 90508684
Seizure 21.13 18.30 116 119049 152513 90356769
Polyuria 20.98 18.30 43 119122 9997 90499285
Atrial septal defect repair 20.98 18.30 9 119156 245 90509037
Drug tolerance decreased 20.94 18.30 8 119157 32122 90477160
Gastritis hypertrophic 20.92 18.30 6 119159 46 90509236
Dermatitis atopic 20.87 18.30 3 119162 23469 90485813
Abdominal discomfort 20.66 18.30 474 118691 476854 90032428
Hemiparesis 20.61 18.30 8 119157 31811 90477471
Bone disorder 20.46 18.30 3 119162 23117 90486165
Faeces soft 20.44 18.30 36 119129 7475 90501807
Paraesthesia oral 20.44 18.30 8 119157 31651 90477631
Hallucination, visual 20.42 18.30 3 119162 23089 90486193
Mitral valve replacement 20.34 18.30 11 119154 504 90508778
Pulmonary vascular resistance abnormality 20.30 18.30 7 119158 103 90509179
Adrenal insufficiency 20.26 18.30 7 119158 29914 90479368
Hysterectomy 20.08 18.30 46 119119 11538 90497744
Psychotic disorder 19.98 18.30 8 119157 31222 90478060
Catheter site induration 19.97 18.30 6 119159 55 90509227
Cardiac output increased 19.91 18.30 11 119154 526 90508756
Encephalopathy 19.89 18.30 19 119146 46425 90462857
Ejection fraction decreased 19.86 18.30 5 119160 26248 90483034
Flatulence 19.80 18.30 107 119058 41260 90468022
Pulmonary arterial wedge pressure increased 19.74 18.30 10 119155 400 90508882
Biopsy kidney 19.70 18.30 8 119157 189 90509093
Drug eruption 19.69 18.30 11 119154 35396 90473886
Sluggishness 19.47 18.30 31 119134 5928 90503354
Dysentery 19.43 18.30 14 119151 1068 90508214
Device physical property issue 19.40 18.30 21 119144 2755 90506527
Infusion site discolouration 19.35 18.30 14 119151 1075 90508207
Herpes zoster 19.26 18.30 62 119103 94582 90414700
Orthostatic hypotension 19.25 18.30 16 119149 41811 90467471
Blood pressure abnormal 19.01 18.30 63 119102 19582 90489700
Extra dose administered 19.00 18.30 39 119126 9079 90500203
Aphasia 18.94 18.30 17 119148 42795 90466487
Abdominal pain upper 18.93 18.30 572 118593 332102 90177180
Orthopnoea 18.91 18.30 33 119132 6802 90502480
Blood calcium decreased 18.88 18.30 8 119157 30174 90479108
Vasodilatation 18.74 18.30 21 119144 2863 90506419
Medical device change 18.67 18.30 9 119156 323 90508959
Gait disturbance 18.66 18.30 236 118929 260260 90249022
Premature baby 18.55 18.30 5 119160 25072 90484210
Nodule 18.50 18.30 6 119159 26680 90482602
Drug delivery system malfunction 18.49 18.30 15 119150 1366 90507916
Skin haemorrhage 18.40 18.30 3 119162 21377 90487905
Coordination abnormal 18.37 18.30 3 119162 21353 90487929
Nasal discomfort 18.32 18.30 29 119136 5519 90503763
Weight increased 18.32 18.30 697 118468 417230 90092052

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
Dyspnoea 1445.15 22.69 1768 32658 440853 42146056
Fluid retention 1091.35 22.69 525 33901 31094 42555815
Death 853.08 22.69 1425 33001 469760 42117149
Headache 656.95 22.69 882 33544 238487 42348422
Oedema 588.84 22.69 419 34007 51582 42535327
Pulmonary arterial hypertension 541.63 22.69 229 34197 9958 42576951
Pain in jaw 533.86 22.69 252 34174 14250 42572659
Nasal congestion 531.08 22.69 318 34108 29183 42557726
Right ventricular failure 459.22 22.69 200 34226 9355 42577554
Pulmonary hypertension 444.85 22.69 262 34164 23307 42563602
Peripheral swelling 400.70 22.69 426 34000 89844 42497065
Hypervolaemia 387.07 22.69 238 34188 22887 42564022
Oedema peripheral 342.46 22.69 482 33944 135594 42451315
Flushing 307.20 22.69 248 34178 36780 42550129
Lung transplant 242.68 22.69 86 34340 2300 42584609
Dyspnoea exertional 220.99 22.69 236 34190 49912 42536997
Unevaluable event 217.62 22.69 197 34229 34091 42552818
Therapy interrupted 216.90 22.69 164 34262 22086 42564823
Oxygen saturation decreased 184.83 22.69 244 34182 64443 42522466
Infusion site pain 183.95 22.69 89 34337 5306 42581603
Toxicity to various agents 170.19 22.69 3 34423 229133 42357776
Hospitalisation 170.06 22.69 252 34174 74078 42512831
Dizziness 169.58 22.69 513 33913 248741 42338168
Swelling 169.23 22.69 215 34211 54670 42532239
Drug interaction 151.07 22.69 19 34407 266980 42319929
Neutropenia 146.50 22.69 3 34423 199428 42387481
Catheterisation cardiac 145.73 22.69 62 34364 2732 42584177
Syncope 121.58 22.69 256 34170 99150 42487759
Cardiac failure congestive 107.62 22.69 223 34203 85379 42501530
Weight increased 107.28 22.69 256 34170 107727 42479182
Product use in unapproved indication 107.03 22.69 12 34414 184444 42402465
Pain in extremity 104.05 22.69 312 34114 150292 42436617
Therapy change 97.37 22.69 53 34373 4042 42582867
Catheter site erythema 91.33 22.69 39 34387 1734 42585175
Hypoxia 90.29 22.69 184 34242 69602 42517307
Catheter management 89.24 22.69 33 34393 999 42585910
Device related infection 86.71 22.69 94 34332 20185 42566724
Cardiac failure 85.02 22.69 233 34193 106623 42480286
Drug ineffective 84.43 22.69 247 34179 629950 41956959
Thrombocytopenia 83.53 22.69 25 34401 190254 42396655
Myalgia 80.95 22.69 214 34212 95866 42491043
Malaise 79.87 22.69 361 34065 211795 42375114
Respiratory failure 77.87 22.69 254 34172 127878 42459031
Acute respiratory failure 76.50 22.69 123 34303 38735 42548174
Catheter site pruritus 74.72 22.69 22 34404 318 42586591
Malignant neoplasm progression 74.54 22.69 3 34423 108397 42478512
Oxygen consumption increased 74.08 22.69 33 34393 1626 42585283
Central venous catheterisation 73.29 22.69 33 34393 1668 42585241
Diarrhoea 73.12 22.69 627 33799 460222 42126687
Hypotension 72.68 22.69 404 34022 257227 42329682
Infusion site erythema 67.56 22.69 40 34386 3582 42583327
Catheter site discharge 66.30 22.69 25 34401 800 42586109
Pulmonary veno-occlusive disease 65.17 22.69 23 34403 607 42586302
Therapy cessation 64.37 22.69 81 34345 20369 42566540
Device alarm issue 63.67 22.69 24 34402 767 42586142
Cough 63.23 22.69 298 34128 177805 42409104
Acute kidney injury 63.22 22.69 126 34300 367211 42219698
Chest pain 62.96 22.69 251 34175 139279 42447630
Vascular device infection 61.64 22.69 46 34380 6064 42580845
Transplant evaluation 61.46 22.69 21 34405 502 42586407
White blood cell count decreased 59.62 22.69 9 34417 110387 42476522
Cor pulmonale 59.05 22.69 23 34403 805 42586104
Liver transplant 56.25 22.69 32 34394 2659 42584250
Drug abuse 51.26 22.69 11 34415 104760 42482149
Infusion site infection 51.20 22.69 19 34407 581 42586328
Rhabdomyolysis 50.94 22.69 3 34423 78016 42508893
Pancytopenia 50.68 22.69 16 34410 117727 42469182
Epistaxis 50.42 22.69 143 34283 66683 42520226
Palpitations 49.90 22.69 120 34306 50677 42536232
Infusion site discharge 47.12 22.69 16 34410 375 42586534
Hyponatraemia 46.97 22.69 12 34414 101450 42485459
Catheter site rash 46.40 22.69 14 34412 221 42586688
Pneumonia 46.16 22.69 532 33894 421617 42165292
Overdose 45.84 22.69 14 34412 105250 42481659
Dermatitis contact 45.65 22.69 34 34392 4469 42582440
Abdominal discomfort 44.60 22.69 148 34278 75107 42511802
Confusional state 44.34 22.69 42 34384 167555 42419354
Fatigue 44.11 22.69 541 33885 435100 42151809
Transfusion 43.65 22.69 48 34378 10466 42576443
Infusion site haemorrhage 43.32 22.69 21 34405 1256 42585653
Complication associated with device 41.58 22.69 38 34388 6643 42580266
Pulmonary arterial pressure abnormal 41.32 22.69 14 34412 326 42586583
Dialysis 40.16 22.69 49 34377 11937 42574972
Paracentesis 40.10 22.69 15 34411 469 42586440
Catheter placement 39.66 22.69 18 34408 927 42585982
Pulmonary arterial pressure increased 39.63 22.69 21 34405 1517 42585392
Sinus congestion 38.26 22.69 37 34389 6943 42579966
Infusion site swelling 38.25 22.69 27 34399 3265 42583644
Infusion related reaction 37.76 22.69 3 34423 60803 42526106
C-reactive protein increased 37.16 22.69 4 34422 63556 42523353
Neuropathy peripheral 36.98 22.69 18 34408 101835 42485074
Feeling abnormal 36.77 22.69 132 34294 69654 42517255
Catheter site inflammation 36.67 22.69 12 34414 250 42586659
Hypertension 36.48 22.69 49 34377 167155 42419754
Platelet count decreased 35.18 22.69 36 34390 138545 42448364
Pulmonary hypertensive crisis 35.17 22.69 11 34415 197 42586712
Device occlusion 34.08 22.69 38 34388 8412 42578497
Therapeutic product effect incomplete 33.58 22.69 8 34418 70931 42515978
Therapy non-responder 33.46 22.69 107 34319 53252 42533657
Liver function test abnormal 33.41 22.69 78 34348 32313 42554596
Chest discomfort 33.23 22.69 120 34306 63496 42523413
Blood pressure decreased 33.03 22.69 113 34313 58219 42528690
Ventilation perfusion mismatch 33.02 22.69 10 34416 160 42586749
Device dislocation 32.94 22.69 36 34390 7795 42579114
Infusion site vesicles 32.46 22.69 10 34416 170 42586739
Nausea 31.55 22.69 472 33954 396327 42190582
Intentional product misuse 31.31 22.69 6 34420 61894 42525015
Cardiac operation 31.13 22.69 25 34401 3670 42583239
Off label use 30.81 22.69 349 34077 637986 41948923
Pyrexia 30.50 22.69 190 34236 393852 42193057
Abdominal distension 29.89 22.69 126 34300 71609 42515300
Treatment failure 29.77 22.69 7 34419 62617 42524292
Heart transplant 29.40 22.69 15 34411 1002 42585907
Internal haemorrhage 28.34 22.69 28 34398 5393 42581516
Electrocardiogram QT prolonged 28.07 22.69 3 34423 47942 42538967
Oxygen therapy 27.98 22.69 16 34410 1342 42585567
Inappropriate schedule of product administration 27.81 22.69 22 34404 95880 42491029
Plasma cell myeloma 27.80 22.69 3 34423 47575 42539334
Exercise tolerance decreased 27.47 22.69 29 34397 6037 42580872
Catheter site pain 27.09 22.69 17 34409 1690 42585219
Chronic respiratory failure 26.95 22.69 17 34409 1705 42585204
Faeces soft 26.85 22.69 26 34400 4886 42582023
Delirium 26.75 22.69 5 34421 52514 42534395
Suicide attempt 26.70 22.69 3 34423 46097 42540812
Hyperglycaemia 26.52 22.69 3 34423 45856 42541053
Pericardial effusion 26.45 22.69 67 34359 29208 42557701
Infusion site warmth 26.11 22.69 9 34417 221 42586688
Lactic acidosis 26.07 22.69 3 34423 45258 42541651
Catheterisation cardiac abnormal 25.86 22.69 7 34419 73 42586836
Nasopharyngitis 25.80 22.69 135 34291 83861 42503048
Pulmonary oedema 25.74 22.69 98 34328 53174 42533735
Intentional product use issue 25.60 22.69 13 34413 71820 42515089
Lung disorder 25.54 22.69 91 34335 47832 42539077
Feeding tube user 25.44 22.69 7 34419 78 42586831
Cardiac disorder 25.29 22.69 92 34334 48840 42538069
Stomatitis 25.19 22.69 5 34421 50324 42536585
Infusion site cellulitis 24.70 22.69 8 34418 161 42586748
Arterial catheterisation 24.49 22.69 4 34422 0 42586909
Hallucination 24.40 22.69 8 34418 57499 42529410
Renal impairment 24.34 22.69 32 34394 110196 42476713
Blood pressure increased 24.17 22.69 28 34398 101900 42485009
Scleroderma 24.01 22.69 16 34410 1762 42585147
Drug hypersensitivity 23.90 22.69 27 34399 99362 42487547
Urinary retention 23.82 22.69 3 34423 42211 42544698
Swelling face 23.80 22.69 62 34364 27492 42559417
Portopulmonary hypertension 23.69 22.69 5 34421 15 42586894
Hyperhidrosis 23.55 22.69 23 34403 90489 42496420
Alanine aminotransferase increased 23.54 22.69 22 34404 88384 42498525
Depressed level of consciousness 23.53 22.69 5 34421 47965 42538944
Influenza 23.45 22.69 106 34320 62069 42524840
Catheter site discolouration 23.27 22.69 6 34420 51 42586858
Deep vein thrombosis 23.15 22.69 17 34409 76940 42509969
Acute myocardial infarction 23.13 22.69 9 34417 58156 42528753
Aggression 22.93 22.69 4 34422 44159 42542750
Seizure 22.74 22.69 39 34387 120522 42466387

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
Dyspnoea 5049.91 18.47 6184 118779 1100688 109363648
Fluid retention 3086.26 18.47 1686 123277 92621 110371715
Headache 2398.06 18.47 3862 121101 878515 109585821
Death 2379.42 18.47 3399 121564 695470 109768866
Pain in jaw 2240.81 18.47 1113 123850 50064 110414272
Nasal congestion 2174.47 18.47 1364 123599 96918 110367418
Pulmonary arterial hypertension 1561.84 18.47 754 124209 31814 110432522
Hypervolaemia 1289.30 18.47 763 124200 48697 110415639
Right ventricular failure 1284.16 18.47 614 124349 25340 110438996
Flushing 1251.31 18.47 998 123965 103738 110360598
Oedema 1237.71 18.47 1349 123614 208627 110255709
Unevaluable event 1221.69 18.47 787 124176 58440 110405896
Oedema peripheral 1166.17 18.47 1635 123328 327025 110137311
Dyspnoea exertional 1094.87 18.47 921 124042 103139 110361197
Pulmonary hypertension 974.79 18.47 666 124297 54554 110409782
Peripheral swelling 841.93 18.47 1579 123384 402455 110061881
Dizziness 726.23 18.47 2074 122889 696119 109768217
Lung transplant 630.51 18.47 234 124729 5052 110459284
Infusion site pain 586.81 18.47 318 124645 17101 110447235
Chest pain 569.71 18.47 1290 123673 375085 110089251
Catheterisation cardiac 559.65 18.47 224 124739 5967 110458369
Oxygen saturation decreased 540.68 18.47 771 124192 156211 110308125
Syncope 500.99 18.47 854 124109 201682 110262654
Diarrhoea 499.05 18.47 2568 122395 1136937 109327399
Palpitations 487.69 18.47 740 124223 158472 110305864
Drug ineffective 483.54 18.47 608 124355 1519932 108944404
Toxicity to various agents 458.08 18.47 20 124943 480535 109983801
Hospitalisation 416.24 18.47 648 124315 141845 110322491
Catheter site erythema 396.76 18.47 174 124789 5854 110458482
Infusion related reaction 391.53 18.47 8 124955 381154 110083182
Device related infection 375.02 18.47 330 124633 39189 110425147
Cough 365.30 18.47 1249 123714 460392 110003944
Drug interaction 358.46 18.47 66 124897 500117 109964219
Product use in unapproved indication 347.72 18.47 47 124916 447330 110017006
Malaise 335.57 18.47 1574 123389 670245 109794091
Neutropenia 328.22 18.47 25 124938 374595 110089741
Catheter site pruritus 323.19 18.47 115 124848 2191 110462145
Febrile neutropenia 320.02 18.47 8 124955 316759 110147577
Hypotension 319.07 18.47 1303 123660 522546 109941790
Myalgia 316.93 18.47 745 124218 221636 110242700
Central venous catheterisation 312.92 18.47 129 124834 3713 110460623
Oxygen consumption increased 310.31 18.47 144 124819 5541 110458795
Off label use 306.09 18.47 789 124174 1499396 108964940
Therapy interrupted 304.89 18.47 327 124636 49495 110414841
Nausea 302.54 18.47 2404 122559 1233286 109231050
Infusion site infection 276.18 18.47 102 124861 2170 110462166
Pain in extremity 268.03 18.47 1175 123788 485943 109978393
Cardiac failure congestive 262.60 18.47 548 124415 150452 110313884
Infusion site erythema 258.98 18.47 164 124799 11795 110452541
Hypoxia 258.70 18.47 498 124465 129017 110335319
Catheter site discharge 256.19 18.47 104 124859 2875 110461461
Catheter management 256.19 18.47 111 124852 3624 110460712
Cardiac failure 255.84 18.47 618 124345 187008 110277328
Contraindicated product administered 255.70 18.47 5 124958 248262 110216074
Treatment failure 244.20 18.47 18 124945 277216 110187120
Therapeutic product effect decreased 243.64 18.47 7 124956 244309 110220027
Acute respiratory failure 243.37 18.47 359 124604 74901 110389435
Epistaxis 241.88 18.47 486 124477 129886 110334450
Catheter site pain 237.67 18.47 125 124838 6321 110458015
Scleroderma 236.75 18.47 124 124839 6217 110458119
Vascular device infection 231.03 18.47 173 124790 16339 110447997
Stomatitis 228.47 18.47 21 124942 270221 110194115
Alopecia 227.59 18.47 65 124898 364688 110099648
Arthropathy 226.17 18.47 29 124934 287493 110176843
Catheter placement 225.54 18.47 98 124865 3222 110461114
Rheumatoid arthritis 217.81 18.47 38 124925 299575 110164761
Device alarm issue 205.58 18.47 84 124879 2362 110461974
C-reactive protein increased 204.43 18.47 10 124953 217909 110246427
Therapy change 203.85 18.47 132 124831 9865 110454471
Psoriatic arthropathy 202.45 18.47 4 124959 196757 110267579
Therapeutic product effect incomplete 201.54 18.47 13 124950 223792 110240544
Glossodynia 199.61 18.47 13 124950 221991 110242345
Acute kidney injury 198.86 18.47 256 124707 635174 109829162
Pericarditis 196.51 18.47 13 124950 219101 110245235
Therapy cessation 195.02 18.47 247 124716 44610 110419726
Pneumonia 190.41 18.47 1662 123301 875052 109589284
Hypertension 189.87 18.47 178 124785 509906 109954430
Chest discomfort 187.96 18.47 525 124438 173323 110291013
Swelling 185.46 18.47 837 124126 350204 110114132
Type 2 diabetes mellitus 184.82 18.47 3 124960 177229 110287107
Drug hypersensitivity 184.15 18.47 146 124817 453944 110010392
Respiratory failure 179.96 18.47 594 124369 214738 110249598
Complication associated with device 177.29 18.47 161 124802 19912 110444424
Blood cholesterol increased 174.87 18.47 8 124955 184777 110279559
Device dislocation 174.73 18.47 197 124766 31507 110432829
Confusional state 173.88 18.47 164 124799 468516 109995820
Feeling abnormal 171.60 18.47 521 124442 180190 110284146
Fatigue 170.44 18.47 2108 122855 1213850 109250486
Helicobacter infection 168.52 18.47 9 124954 181868 110282468
Pulmonary arterial pressure increased 168.21 18.47 92 124871 5035 110459301
Infusion site swelling 166.78 18.47 116 124847 9761 110454575
Impaired healing 164.35 18.47 16 124947 196701 110267635
Malignant neoplasm progression 163.76 18.47 8 124955 174559 110289777
Maternal exposure during pregnancy 157.87 18.47 46 124917 254837 110209499
Transfusion 155.48 18.47 167 124796 25305 110439031
Catheter site rash 153.88 18.47 54 124909 986 110463350
Thrombocytopenia 153.32 18.47 103 124860 348782 110115554
Musculoskeletal stiffness 148.62 18.47 65 124898 279757 110184579
Device occlusion 148.44 18.47 129 124834 15056 110449280
Transplant evaluation 147.37 18.47 61 124902 1774 110462562
Hepatic enzyme increased 146.09 18.47 91 124872 320801 110143535
White blood cell count decreased 144.65 18.47 40 124923 229350 110234986
Osteoarthritis 144.60 18.47 18 124945 182605 110281731
Cardiac disorder 144.58 18.47 287 124676 75993 110388343
Drug abuse 144.16 18.47 16 124947 177395 110286941
Liver injury 144.01 18.47 6 124957 150407 110313929
Pericardial effusion 143.52 18.47 243 124720 56974 110407362
Device leakage 142.29 18.47 129 124834 15919 110448417
Catheter site infection 139.89 18.47 96 124867 7904 110456432
Presyncope 139.37 18.47 220 124743 48667 110415669
Wound 136.82 18.47 47 124916 234390 110229946
Mobility decreased 136.16 18.47 49 124914 237373 110226963
Irritable bowel syndrome 130.46 18.47 16 124947 164199 110300137
Urticaria 128.59 18.47 103 124860 318754 110145582
Lower respiratory tract infection 128.25 18.47 57 124906 243049 110221287
Pancytopenia 127.66 18.47 39 124924 209574 110254762
Bursitis 124.99 18.47 5 124958 129913 110334423
Blood pressure decreased 123.79 18.47 347 124616 114744 110349592
Fibromyalgia 123.45 18.47 22 124941 170887 110293449
Neutrophil count decreased 122.28 18.47 3 124960 120938 110343398
Abdominal distension 122.02 18.47 455 124508 174648 110289688
Pulmonary oedema 121.82 18.47 317 124646 100342 110363994
Dermatitis contact 121.44 18.47 111 124852 13842 110450494
Sinus congestion 120.34 18.47 160 124803 30299 110434037
Joint range of motion decreased 119.58 18.47 4 124959 121828 110342508
Discomfort 116.99 18.47 48 124915 214659 110249677
Inflammation 115.80 18.47 37 124926 193201 110271135
Intentional overdose 115.50 18.47 9 124954 132492 110331844
Injury 115.38 18.47 29 124934 177236 110287100
Psoriasis 115.33 18.47 12 124951 139981 110324355
Overdose 113.94 18.47 61 124902 233733 110230603
Rash 110.27 18.47 515 124448 820449 109643887
Pulmonary veno-occlusive disease 106.74 18.47 51 124912 2097 110462239
Drug-induced liver injury 105.09 18.47 8 124955 120059 110344277
Infusion site discharge 104.65 18.47 49 124914 1924 110462412
Haemoptysis 103.61 18.47 241 124722 71113 110393223
Delirium 102.86 18.47 15 124948 135010 110329326
General physical health deterioration 102.08 18.47 204 124759 425091 110039245
Sleep disorder due to general medical condition, insomnia type 101.84 18.47 4 124959 105639 110358697
Hot flush 101.38 18.47 228 124735 65808 110398528
Weight increased 100.50 18.47 814 124149 418830 110045506
Infusion site haemorrhage 99.41 18.47 63 124900 4535 110459801
Catheter site haemorrhage 99.14 18.47 69 124894 5811 110458525
Intentional product use issue 97.55 18.47 82 124881 247824 110216512
Dyspnoea at rest 96.24 18.47 78 124885 8268 110456068
Hyponatraemia 95.92 18.47 64 124899 217589 110246747
Dialysis 94.88 18.47 114 124849 19505 110444831
Paracentesis 94.04 18.47 41 124922 1359 110462977
Leukopenia 93.68 18.47 26 124937 148765 110315571
Electrocardiogram QT prolonged 93.31 18.47 8 124955 108952 110355384
Heart rate increased 92.99 18.47 365 124598 143469 110320867
Epilepsy 92.68 18.47 5 124958 100204 110364132
Lip dry 92.54 18.47 5 124958 100078 110364258
Pulmonary hypertensive crisis 92.38 18.47 30 124933 427 110463909
Catheter site inflammation 92.13 18.47 39 124924 1201 110463135
Exercise tolerance decreased 91.62 18.47 89 124874 11978 110452358
Catheter site swelling 91.21 18.47 47 124916 2277 110462059
Obesity 90.14 18.47 11 124952 113340 110350996
Blister 89.71 18.47 75 124888 227301 110237035
Anaphylactic reaction 88.70 18.47 12 124951 114288 110350048
Exposure during pregnancy 87.12 18.47 40 124923 167384 110296952
Oxygen therapy 85.08 18.47 55 124908 4098 110460238
Asthma 83.24 18.47 96 124867 250195 110214141
Systemic lupus erythematosus 81.97 18.47 100 124863 254238 110210098
Dizziness postural 80.87 18.47 91 124872 14518 110449818
Wound infection 80.15 18.47 8 124955 96457 110367879
Suicide attempt 79.89 18.47 11 124952 103383 110360953
Drug intolerance 79.85 18.47 217 124746 406295 110058041
Lactic acidosis 78.96 18.47 7 124956 92804 110371532
Intentional dose omission 78.58 18.47 105 124858 19975 110444361
Cardiac operation 77.66 18.47 60 124903 5935 110458401
Grip strength decreased 77.40 18.47 3 124960 80171 110384165
Neuropathy peripheral 77.27 18.47 54 124909 179223 110285113
Inappropriate schedule of product administration 76.90 18.47 70 124893 203567 110260769
Nasopharyngitis 76.26 18.47 730 124233 393631 110070705
Terminal state 76.22 18.47 58 124905 5609 110458727
Metabolic acidosis 76.15 18.47 11 124952 99733 110364603
Intentional product misuse 75.21 18.47 28 124935 132876 110331460
Medication error 75.14 18.47 14 124949 105352 110358984
Catheter site vesicles 74.52 18.47 25 124938 396 110463940
Walking distance test abnormal 74.45 18.47 29 124934 717 110463619
Hypersensitivity 73.96 18.47 223 124740 403775 110060561
Injection site discharge 73.57 18.47 35 124928 1425 110462911
Brain natriuretic peptide increased 72.86 18.47 76 124887 11133 110453203
Hypoaesthesia 72.58 18.47 154 124809 314069 110150267
Device connection issue 71.81 18.47 33 124930 1241 110463095
Blood pressure systolic increased 71.31 18.47 6 124957 82985 110381351
Liver function test abnormal 71.30 18.47 205 124758 68745 110395591
Catheter site irritation 71.06 18.47 27 124936 623 110463713
Rash maculo-papular 70.90 18.47 3 124960 74219 110390117
Peripheral venous disease 69.82 18.47 7 124956 84110 110380226
Influenza 69.73 18.47 376 124587 168725 110295611
Cor pulmonale 69.33 18.47 39 124924 2255 110462081
Sinus disorder 69.19 18.47 129 124834 32599 110431737
Device infusion issue 69.04 18.47 43 124920 3002 110461334
Blood pressure increased 69.01 18.47 116 124847 258257 110206079
Infusion site pruritus 69.00 18.47 52 124911 4956 110459380
Product administration interrupted 67.10 18.47 73 124890 11219 110453117
Coma 66.41 18.47 25 124938 117844 110346492
Hepatitis 66.32 18.47 11 124952 90043 110374293
Liver transplant 66.25 18.47 49 124914 4540 110459796
Prescribed overdose 66.07 18.47 10 124953 87571 110376765
Product dose omission issue 65.86 18.47 603 124360 321179 110143157
Device breakage 64.94 18.47 79 124884 13690 110450646
Infusion site warmth 64.28 18.47 34 124929 1739 110462597
Product quality issue 62.70 18.47 7 124956 77292 110387044
Gastric disorder 62.58 18.47 125 124838 33232 110431104
Upper respiratory tract congestion 61.91 18.47 40 124923 2977 110461359
Depression 61.84 18.47 170 124793 317165 110147171
Hypocalcaemia 61.27 18.47 3 124960 65363 110398973
Infusion site cellulitis 61.11 18.47 22 124941 434 110463902
Injection site reaction 61.07 18.47 13 124950 89057 110375279
Drug ineffective for unapproved indication 61.05 18.47 20 124943 102818 110361518
Localised oedema 60.79 18.47 63 124900 9160 110455176
Bradycardia 60.47 18.47 52 124911 155465 110308871
Neoplasm progression 60.44 18.47 3 124960 64592 110399744
Throat irritation 60.07 18.47 164 124799 53388 110410948
Hyperkalaemia 59.72 18.47 40 124923 135756 110328580
Deep vein thrombosis 59.14 18.47 43 124920 139844 110324492
Hypothyroidism 58.14 18.47 7 124956 72892 110391444
Prescribed underdose 58.01 18.47 4 124959 65170 110399166
Infusion site induration 57.41 18.47 29 124934 1347 110462989
Agitation 57.29 18.47 28 124935 113023 110351313
Live birth 57.11 18.47 6 124957 69478 110394858
Alanine aminotransferase increased 56.35 18.47 75 124888 183698 110280638
Mechanical ventilation 56.21 18.47 39 124924 3268 110461068
Ear discomfort 55.44 18.47 66 124897 11183 110453153
Hyperglycaemia 55.20 18.47 14 124949 85076 110379260
Depressed level of consciousness 55.11 18.47 29 124934 112249 110352087
Chronic respiratory failure 54.83 18.47 41 124922 3862 110460474
Swelling face 53.87 18.47 227 124736 92094 110372242
Cognitive disorder 53.77 18.47 16 124947 87495 110376841
Colitis ulcerative 53.64 18.47 11 124952 77352 110386984
Pruritus 53.50 18.47 411 124552 581149 109883187
Nail disorder 53.23 18.47 3 124960 57932 110406404
Ascites 53.23 18.47 227 124736 92581 110371755
Night sweats 53.07 18.47 44 124919 133939 110330397
Eczema 52.86 18.47 9 124954 72284 110392052
Suicidal ideation 52.79 18.47 20 124943 93917 110370419
Joint swelling 52.38 18.47 290 124673 442555 110021781
Treatment noncompliance 51.92 18.47 191 124772 72799 110391537
Hallucination 51.58 18.47 25 124938 101407 110362929
Hospice care 51.55 18.47 67 124896 12406 110451930
Incorrect route of product administration 51.46 18.47 6 124957 64055 110400281
Paraesthesia 51.03 18.47 152 124811 276369 110187967
Pneumonitis 50.80 18.47 12 124951 76519 110387817
Sleep disorder 50.48 18.47 92 124871 198552 110265784
Emergency care 50.25 18.47 27 124936 1426 110462910
Central venous catheter removal 49.95 18.47 20 124943 533 110463803
Endotracheal intubation 49.84 18.47 47 124916 6097 110458239
Seizure 49.73 18.47 110 124853 221075 110243261
Lymphocyte count decreased 49.57 18.47 4 124959 57239 110407097
Pulmonary arterial pressure abnormal 48.49 18.47 23 124940 930 110463406
Atrial flutter 48.03 18.47 93 124870 24169 110440167
Hypomagnesaemia 47.65 18.47 6 124957 60364 110403972
Vomiting 47.61 18.47 1356 123607 909319 109555017
Bone marrow failure 47.53 18.47 5 124958 57843 110406493
Hepatic cytolysis 47.25 18.47 4 124959 55049 110409287
Blood creatinine increased 47.10 18.47 84 124879 182805 110281531
Bendopnoea 46.90 18.47 12 124951 67 110464269
Pyrexia 46.74 18.47 724 124239 897541 109566795
Hepatotoxicity 46.12 18.47 8 124955 63392 110400944
Ventilation perfusion mismatch 46.04 18.47 21 124942 776 110463560
Ear congestion 46.00 18.47 36 124927 3629 110460707
Plasma cell myeloma 45.65 18.47 8 124955 62928 110401408
Abdominal pain upper 45.42 18.47 598 124365 348513 110115823
Head discomfort 45.41 18.47 79 124884 18921 110445415
Injection site infection 45.06 18.47 31 124932 2562 110461774
Right ventricular dilatation 44.97 18.47 30 124933 2357 110461979
Catheterisation cardiac abnormal 44.76 18.47 16 124947 309 110464027
Drug dependence 44.73 18.47 3 124960 50017 110414319
Drug titration error 44.42 18.47 26 124937 1621 110462715
Metapneumovirus infection 44.33 18.47 30 124933 2414 110461922
Infusion site vesicles 43.97 18.47 19 124944 616 110463720
Pulmonary embolism 43.97 18.47 112 124851 214362 110249974
Middle ear effusion 43.92 18.47 31 124932 2670 110461666
Toxic epidermal necrolysis 43.90 18.47 6 124957 56721 110407615
Hypoglycaemia 43.72 18.47 40 124923 116064 110348272
Thrombosis in device 43.69 18.47 41 124922 5286 110459050
Oropharyngeal pain 43.62 18.47 282 124681 134994 110329342
Infusion site rash 43.07 18.47 29 124934 2314 110462022
Therapeutic response decreased 43.00 18.47 28 124935 96471 110367865
Mouth ulceration 42.71 18.47 3 124960 48135 110416201
Right ventricular dysfunction 42.48 18.47 33 124930 3290 110461046
Multiple sclerosis relapse 42.17 18.47 4 124959 50236 110414100
Sleep disorder due to a general medical condition 41.57 18.47 5 124958 52107 110412229
Stevens-Johnson syndrome 41.39 18.47 3 124960 46898 110417438
Nocturnal dyspnoea 41.31 18.47 26 124937 1849 110462487
Nasal dryness 41.30 18.47 41 124922 5665 110458671
Eye swelling 40.91 18.47 105 124858 32943 110431393
Pancreatitis acute 40.91 18.47 9 124954 60265 110404071
Catheter site warmth 40.66 18.47 15 124948 318 110464018
Psychotic disorder 40.35 18.47 5 124958 50932 110413404
Foot deformity 40.32 18.47 4 124959 48476 110415860
Catheter removal 40.26 18.47 18 124945 634 110463702
Platelet count decreased 40.16 18.47 130 124833 230313 110234023
Application site pruritus 39.97 18.47 35 124928 4125 110460211
Vascular device occlusion 39.69 18.47 18 124945 656 110463680
Transplant 39.43 18.47 22 124941 1252 110463084
Catheter site discolouration 39.21 18.47 12 124951 139 110464197
Somnolence 38.97 18.47 188 124775 297261 110167075
Multiple organ dysfunction syndrome 38.77 18.47 70 124893 151640 110312696
Injection site pain 38.76 18.47 90 124873 177832 110286504
Intra-abdominal fluid collection 38.49 18.47 33 124930 3781 110460555
Faeces soft 38.43 18.47 55 124908 11155 110453181
Autoimmune disorder 38.40 18.47 13 124950 65470 110398866
Aggression 37.91 18.47 10 124953 59200 110405136
No adverse event 37.85 18.47 18 124945 73821 110390515
Blood glucose increased 37.71 18.47 57 124906 132439 110331897
Disease recurrence 37.55 18.47 11 124952 60773 110403563
Right-to-left cardiac shunt 37.34 18.47 14 124949 311 110464025
Dizziness exertional 37.29 18.47 18 124945 757 110463579
Skin exfoliation 36.97 18.47 27 124936 87624 110376712
Basal cell carcinoma 36.97 18.47 4 124959 45266 110419070
Pneumocystis jirovecii pneumonia 36.96 18.47 3 124960 42732 110421604
Ill-defined disorder 36.93 18.47 76 124887 156777 110307559
White blood cell count increased 36.89 18.47 33 124930 96809 110367527
Device related sepsis 36.26 18.47 44 124919 7603 110456733
Gait inability 35.69 18.47 62 124901 136314 110328022
Disseminated intravascular coagulation 35.43 18.47 3 124960 41283 110423053
Generalised oedema 35.40 18.47 95 124868 30609 110433727
Heart valve replacement 35.24 18.47 20 124943 1176 110463160
Feeling cold 35.08 18.47 101 124862 33886 110430450
Productive cough 34.86 18.47 235 124728 114070 110350266
Angioedema 34.69 18.47 36 124927 98464 110365872
Sciatica 34.59 18.47 32 124931 92367 110371969
Jaundice 34.32 18.47 12 124951 59224 110405112
Lymphopenia 34.25 18.47 3 124960 40167 110424169
Loss of personal independence in daily activities 34.22 18.47 74 124889 149946 110314390
Proteinuria 34.09 18.47 3 124960 40015 110424321
Adrenal insufficiency 33.98 18.47 4 124959 42386 110421950
Renal disorder 33.95 18.47 128 124835 49351 110414985
Hallucination, visual 33.65 18.47 3 124960 39602 110424734
Diabetic ketoacidosis 33.63 18.47 4 124959 42054 110422282
Life support 32.95 18.47 14 124949 435 110463901
Gamma-glutamyltransferase increased 32.90 18.47 14 124949 61295 110403041
Oxygen saturation abnormal 32.86 18.47 36 124927 5575 110458761
Immunodeficiency 32.84 18.47 3 124960 38835 110425501
Osteoporosis 32.84 18.47 30 124933 87122 110377214
Urinary retention 32.74 18.47 19 124944 69664 110394672
Wheezing 32.46 18.47 163 124800 255067 110209269
Lupus-like syndrome 32.32 18.47 4 124959 40788 110423548
Bedridden 32.32 18.47 56 124907 13369 110450967
Paranasal sinus discomfort 32.26 18.47 38 124925 6367 110457969
CREST syndrome 32.00 18.47 14 124949 468 110463868
Emotional distress 31.88 18.47 6 124957 44841 110419495
Disease complication 31.75 18.47 36 124927 5791 110458545
Arthritis 31.72 18.47 91 124872 167495 110296841
Encephalopathy 31.63 18.47 27 124936 81028 110383308
Hypercalcaemia 31.60 18.47 7 124956 46650 110417686
Blood potassium decreased 31.52 18.47 133 124830 53981 110410355
Gastroenteritis viral 31.47 18.47 92 124871 31134 110433202
Oxygen consumption 31.35 18.47 9 124954 82 110464254
Seasonal allergy 31.28 18.47 69 124894 19653 110444683
Orthostatic hypotension 31.22 18.47 18 124945 66231 110398105
Altered state of consciousness 31.18 18.47 13 124950 57613 110406723
Obstructive airways disorder 31.10 18.47 7 124956 46142 110418194
Biopsy liver 30.92 18.47 15 124948 638 110463698
Cerebral infarction 30.91 18.47 10 124953 51828 110412508
Drug eruption 30.87 18.47 11 124952 53648 110410688
Body temperature decreased 30.84 18.47 3 124960 36932 110427404
Medical procedure 30.78 18.47 14 124949 514 110463822
Sickle cell anaemia 30.75 18.47 16 124947 791 110463545
Tracheostomy 30.73 18.47 20 124943 1507 110462829
Respiration abnormal 30.55 18.47 46 124917 9763 110454573
Taste disorder 30.48 18.47 18 124945 65369 110398967
Ejection fraction decreased 30.08 18.47 5 124958 40875 110423461
Diabetes mellitus 30.01 18.47 41 124922 99340 110364996
Catheter site cellulitis 29.66 18.47 14 124949 560 110463776
Internal haemorrhage 29.64 18.47 46 124917 10025 110454311
Haematuria 29.61 18.47 30 124933 82975 110381361
Drug withdrawal syndrome 29.51 18.47 4 124959 38050 110426286
Aphasia 29.30 18.47 15 124948 58982 110405354
Catheter site scab 29.19 18.47 11 124952 248 110464088
Muscular weakness 29.19 18.47 163 124800 248305 110216031
Prostate cancer 29.08 18.47 4 124959 37637 110426699
Medical device change 28.97 18.47 13 124950 462 110463874
Vascular resistance pulmonary increased 28.97 18.47 9 124954 110 110464226
Product prescribing error 28.72 18.47 11 124952 51320 110413016
Injection site bruising 28.66 18.47 11 124952 51252 110413084
Intracardiac pressure increased 28.34 18.47 7 124956 33 110464303
Viral infection 28.20 18.47 127 124836 53012 110411324
Cardiac failure high output 28.09 18.47 13 124950 497 110463839
Pulmonary fibrosis 27.98 18.47 45 124918 101997 110362339
Atrial septal defect repair 27.92 18.47 13 124950 504 110463832
Blood pressure fluctuation 27.90 18.47 26 124937 74798 110389538
Infection 27.88 18.47 268 124695 361932 110102404
Infusion site irritation 27.67 18.47 17 124946 1158 110463178
Vasculitis 27.28 18.47 4 124959 35869 110428467
Colitis 27.24 18.47 46 124917 102277 110362059
Heart transplant 27.20 18.47 19 124944 1609 110462727
Cellulitis 27.20 18.47 239 124724 125777 110338559
Rhinorrhoea 27.19 18.47 204 124759 102462 110361874
Dysarthria 27.16 18.47 33 124930 84088 110380248
Drug delivery system malfunction 27.03 18.47 16 124947 1019 110463317
Contusion 26.91 18.47 154 124809 233207 110231129
Metastases to liver 26.78 18.47 4 124959 35382 110428954
Coronary artery disease 26.63 18.47 25 124938 71665 110392671
Acute right ventricular failure 26.57 18.47 12 124951 433 110463903
Renal impairment 26.52 18.47 116 124847 188329 110276007
Blood pressure abnormal 26.48 18.47 70 124893 22354 110441982
Infusion site discolouration 26.43 18.47 15 124948 882 110463454
Abdominal cavity drainage 26.22 18.47 15 124948 896 110463440
Pulmonary capillary haemangiomatosis 25.96 18.47 8 124955 95 110464241
Cardiac output increased 25.85 18.47 13 124950 598 110463738
Disorientation 25.84 18.47 25 124938 70646 110393690
Skin lesion 25.83 18.47 13 124950 51618 110412718
Loss of consciousness 25.81 18.47 337 124626 195969 110268367
Feeding tube user 25.76 18.47 9 124954 162 110464174
Gastrointestinal haemorrhage 25.60 18.47 293 124670 165225 110299111
Infusion site inflammation 25.58 18.47 12 124951 473 110463863
Joint stiffness 25.51 18.47 23 124940 67220 110397116
Anaemia 25.36 18.47 803 124160 546283 109918053
Nasal discomfort 25.23 18.47 33 124930 6148 110458188
Device physical property issue 25.15 18.47 26 124937 3768 110460568
Osteonecrosis 25.11 18.47 4 124959 33737 110430599
Device issue 25.08 18.47 91 124872 34444 110429892
Infusion site abscess 24.75 18.47 11 124952 382 110463954
Hypokalaemia 24.66 18.47 114 124849 182334 110282002
Gout 24.60 18.47 94 124869 36472 110427864
Device malfunction 24.52 18.47 74 124889 25484 110438852
Tumour lysis syndrome 24.46 18.47 3 124960 30798 110433538
Catheter site related reaction 24.37 18.47 17 124946 1437 110462899
Heart and lung transplant 24.34 18.47 9 124954 192 110464144
Bronchitis 24.30 18.47 278 124685 156754 110307582
Aspartate aminotransferase increased 24.02 18.47 96 124867 159840 110304496
Hepatic function abnormal 23.91 18.47 40 124923 89255 110375081
Head injury 23.72 18.47 104 124859 42913 110421423
Catheter site extravasation 23.70 18.47 12 124951 560 110463776
Herpes zoster 23.46 18.47 55 124908 108324 110356012
Sinus bradycardia 23.10 18.47 3 124960 29480 110434856
Retching 23.02 18.47 67 124896 22615 110441721
Respiratory tract congestion 23 18.47 82 124881 30775 110433561
Echocardiogram 22.95 18.47 6 124957 37 110464299
Acute myocardial infarction 22.92 18.47 37 124926 83740 110380596
Dysentery 22.91 18.47 16 124947 1355 110462981
Sluggishness 22.88 18.47 35 124928 7532 110456804
Decreased activity 22.87 18.47 43 124920 10931 110453405
Generalised tonic-clonic seizure 22.86 18.47 17 124946 54663 110409673
Myelodysplastic syndrome 22.76 18.47 7 124956 37477 110426859
Mitral valve replacement 22.68 18.47 12 124951 614 110463722
Catheter site dryness 22.68 18.47 6 124957 39 110464297
Portopulmonary hypertension 22.60 18.47 8 124955 150 110464186
Hypoalbuminaemia 22.57 18.47 3 124960 28971 110435365
Hypoacusis 22.48 18.47 89 124874 35102 110429234
Hysterectomy 22.41 18.47 36 124927 8078 110456258
Cardiac flutter 22.37 18.47 30 124933 5727 110458609
Therapy partial responder 22.36 18.47 7 124956 37054 110427282
Surgery 22.16 18.47 99 124864 41184 110423152
Hepatocellular injury 22.15 18.47 15 124948 50627 110413709
Right ventricular enlargement 22.10 18.47 14 124949 1007 110463329
Hemiparesis 22.05 18.47 11 124952 43892 110420444
Back pain 22.03 18.47 562 124401 370434 110093902
Lower limb fracture 21.84 18.47 32 124931 75316 110389020
Renal tubular necrosis 21.83 18.47 4 124959 30471 110433865
Gastritis hypertrophic 21.82 18.47 6 124957 46 110464290
Infusion site oedema 21.81 18.47 16 124947 1464 110462872
Memory impairment 21.63 18.47 132 124831 196812 110267524
Biopsy lung 21.48 18.47 9 124954 270 110464066
Dry skin 21.45 18.47 57 124906 107596 110356740
Disturbance in attention 21.45 18.47 23 124940 61972 110402364
Skin irritation 21.40 18.47 53 124910 16266 110448070
Stent placement 21.23 18.47 33 124930 7201 110457135
Toxic skin eruption 21.08 18.47 3 124960 27512 110436824
Therapy non-responder 21.08 18.47 271 124692 157036 110307300
Amnesia 20.86 18.47 56 124907 105352 110358984
Flatulence 20.83 18.47 115 124848 52034 110412302
Sickle cell disease 20.76 18.47 8 124955 192 110464144
Withdrawal syndrome 20.67 18.47 5 124958 31375 110432961
Hepatic steatosis 20.65 18.47 15 124948 48816 110415520
Cardiac failure acute 20.59 18.47 67 124896 24011 110440325
Left ventricular failure 20.55 18.47 42 124921 11347 110452989
Pregnancy test positive 20.52 18.47 7 124956 117 110464219
Cor pulmonale acute 20.51 18.47 12 124951 748 110463588
Haemorrhage 20.32 18.47 197 124766 106495 110357841
Orthopnoea 20.31 18.47 41 124922 10980 110453356
Hip arthroplasty 20.11 18.47 20 124943 55793 110408543
Dry eye 20.09 18.47 20 124943 55773 110408563
Peritonitis 19.96 18.47 6 124957 32601 110431735
Systemic scleroderma 19.77 18.47 17 124946 1955 110462381
Abortion spontaneous 19.77 18.47 7 124956 34275 110430061
Ischaemic stroke 19.74 18.47 11 124952 41252 110423084
Blood calcium decreased 19.53 18.47 8 124955 35837 110428499
Annuloplasty 19.49 18.47 4 124959 6 110464330
Back injury 19.47 18.47 15 124948 47384 110416952
Myocarditis 19.39 18.47 5 124958 30050 110434286
Pulmonary artery dilatation 19.35 18.47 11 124952 649 110463687
Paraesthesia oral 19.20 18.47 7 124956 33664 110430672
Diabetes mellitus inadequate control 19.12 18.47 5 124958 29770 110434566
Drug titration 19.10 18.47 5 124958 31 110464305
Dermatitis atopic 19.07 18.47 3 124960 25538 110438798
Mineral supplementation 19.07 18.47 12 124951 853 110463483
Subarachnoid haemorrhage 19.05 18.47 5 124958 29697 110434639
Dyskinesia 19.04 18.47 18 124945 51428 110412908
Blood albumin decreased 19.03 18.47 4 124959 27648 110436688
Blood iron decreased 18.78 18.47 56 124907 19158 110445178
Pulmonary endarterectomy 18.70 18.47 8 124955 253 110464083
Extra dose administered 18.67 18.47 42 124921 12117 110452219
Labelled drug-drug interaction medication error 18.66 18.47 5 124958 29297 110435039
Arteriosclerosis coronary artery 18.64 18.47 3 124960 25115 110439221
Oral candidiasis 18.60 18.47 14 124949 44746 110419590
Leukocytosis 18.59 18.47 20 124943 53808 110410528
Senile dementia 18.58 18.47 8 124955 257 110464079
Chemotherapy 18.53 18.47 17 124946 2129 110462207
Thrombotic microangiopathy 18.52 18.47 5 124958 29144 110435192
Vasodilatation 18.50 18.47 22 124941 3722 110460614

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C02KX02 CARDIOVASCULAR SYSTEM
ANTIHYPERTENSIVES
OTHER ANTIHYPERTENSIVES
Antihypertensives for pulmonary arterial hypertension
ATC C02KX52 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
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:65023 anti-asthmatic agent
CHEBI has role CHEBI:75835 anti-anaemic agent
CHEBI has role CHEBI:233423 antifibrotic agent

Related Drugs by ATC class:

C02KX Antihypertensives for pulmonary arterial hypertension 6 drugs
bosentanmacitentanriociguatsitaxentansotatercept-csrktadalafil

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

DiseaseRelationSNOMED_IDDOID
Pulmonary arterial hypertension indication 11399002
Body fluid retention contraindication 43498006
Chronic heart failure contraindication 48447003
Oligozoospermia contraindication 88311004
Pulmonary veno-occlusive disease contraindication 89420002 DOID:5453
Liver function tests abnormal contraindication 166603001
Edema contraindication 267038008
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
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 3.3 acidic
pKa2 2.68 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG LETAIRIS GILEAD N022081 June 15, 2007 RX TABLET ORAL 8377933 Dec. 11, 2027 FOR THE TREATMENT OF PULMONARY HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL
10MG LETAIRIS GILEAD N022081 June 15, 2007 RX TABLET ORAL 9474752 Dec. 11, 2027 FOR THE TREATMENT OF PULMONARY HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL
5MG LETAIRIS GILEAD N022081 June 15, 2007 RX TABLET ORAL 8377933 Dec. 11, 2027 FOR THE TREATMENT OF PULMONARY HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL
5MG LETAIRIS GILEAD N022081 June 15, 2007 RX TABLET ORAL 9474752 Dec. 11, 2027 FOR THE TREATMENT OF PULMONARY HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL
10MG LETAIRIS GILEAD N022081 June 15, 2007 RX TABLET ORAL 9549926 Oct. 14, 2031 FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL, WHEREIN THE WEIGHT RATIO OF AMBRISENTAN TO TADALAFIL IS ABOUT 1:2 TO ABOUT 1:3
5MG LETAIRIS GILEAD N022081 June 15, 2007 RX TABLET ORAL 9549926 Oct. 14, 2031 FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL, WHEREIN THE WEIGHT RATIO OF AMBRISENTAN TO TADALAFIL IS ABOUT 1:2 TO ABOUT 1:3

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Endothelin-1 receptor GPCR ANTAGONIST Ki 9.65 WOMBAT-PK DRUG LABEL
Endothelin B receptor GPCR ANTAGONIST Ki 6.98 WOMBAT-PK

External reference:

IDSource
4026238 VUID
N0000179774 NUI
D07077 KEGG_DRUG
4026238 VANDF
C1176329 UMLSCUI
CHEBI:135949 CHEBI
CHEMBL1111 ChEMBL_ID
DB06403 DRUGBANK_ID
C467894 MESH_SUPPLEMENTAL_RECORD_UI
3951 IUPHAR_LIGAND_ID
8128 INN_ID
HW6NV07QEC UNII
6918493 PUBCHEM_CID
358274 RXNORM
111024 MMSL
23940 MMSL
313847 MMSL
d06841 MMSL
012216 NDDF
427735003 SNOMEDCT_US
428159003 SNOMEDCT_US
A1D5J PDB_CHEM_ID
HW6NV07QEC INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ambrisentan HUMAN PRESCRIPTION DRUG LABEL 1 0378-4270 TABLET, FILM COATED 5 mg ORAL ANDA 30 sections
Ambrisentan HUMAN PRESCRIPTION DRUG LABEL 1 0378-4271 TABLET, FILM COATED 10 mg ORAL ANDA 30 sections
Ambrisentan HUMAN PRESCRIPTION DRUG LABEL 1 0591-2405 TABLET, FILM COATED 5 mg ORAL ANDA 28 sections
Ambrisentan HUMAN PRESCRIPTION DRUG LABEL 1 0591-2406 TABLET, FILM COATED 10 mg ORAL ANDA 28 sections
AMBRISENTAN HUMAN PRESCRIPTION DRUG LABEL 1 42794-051 TABLET, FILM COATED 5 mg ORAL ANDA 19 sections
AMBRISENTAN HUMAN PRESCRIPTION DRUG LABEL 1 42794-052 TABLET, FILM COATED 10 mg ORAL ANDA 19 sections
ambrisentan Human Prescription Drug Label 1 47335-236 TABLET, FILM COATED 5 mg ORAL ANDA 30 sections
ambrisentan Human Prescription Drug Label 1 47335-237 TABLET, FILM COATED 10 mg ORAL ANDA 30 sections
ambrisentan Human Prescription Drug Label 1 50090-7670 TABLET, FILM COATED 10 mg ORAL ANDA 29 sections
ambrisentan Human Prescription Drug Label 1 50090-7671 TABLET, FILM COATED 5 mg ORAL ANDA 29 sections
Ambrisentan HUMAN PRESCRIPTION DRUG LABEL 1 51407-594 TABLET, FILM COATED 5 mg ORAL ANDA 30 sections
Ambrisentan HUMAN PRESCRIPTION DRUG LABEL 1 51407-595 TABLET, FILM COATED 10 mg ORAL ANDA 30 sections
ambrisentan Human Prescription Drug Label 1 59651-494 TABLET, FILM COATED 5 mg ORAL ANDA 29 sections
ambrisentan Human Prescription Drug Label 1 59651-495 TABLET, FILM COATED 10 mg ORAL ANDA 29 sections
Ambrisentan HUMAN PRESCRIPTION DRUG LABEL 1 60505-4552 TABLET, FILM COATED 5 mg ORAL ANDA 30 sections
Ambrisentan HUMAN PRESCRIPTION DRUG LABEL 1 60505-4553 TABLET, FILM COATED 10 mg ORAL ANDA 30 sections
Letairis HUMAN PRESCRIPTION DRUG LABEL 1 61958-0801 TABLET, FILM COATED 5 mg ORAL NDA 34 sections
Letairis HUMAN PRESCRIPTION DRUG LABEL 1 61958-0802 TABLET, FILM COATED 10 mg ORAL NDA 34 sections
Ambrisentan HUMAN PRESCRIPTION DRUG LABEL 1 69097-386 TABLET, FILM COATED 5 mg ORAL ANDA 28 sections
Ambrisentan HUMAN PRESCRIPTION DRUG LABEL 1 69097-387 TABLET, FILM COATED 10 mg ORAL ANDA 28 sections
Ambrisentan HUMAN PRESCRIPTION DRUG LABEL 1 70710-1179 TABLET, FILM COATED 5 mg ORAL ANDA 24 sections
Ambrisentan HUMAN PRESCRIPTION DRUG LABEL 1 70710-1180 TABLET, FILM COATED 10 mg ORAL ANDA 24 sections
Ambrisentan HUMAN PRESCRIPTION DRUG LABEL 1 70771-1363 TABLET, FILM COATED 5 mg ORAL ANDA 2 sections
Ambrisentan HUMAN PRESCRIPTION DRUG LABEL 1 70771-1364 TABLET, FILM COATED 10 mg ORAL ANDA 2 sections
Ambrisentan HUMAN PRESCRIPTION DRUG LABEL 1 82009-141 TABLET, FILM COATED 5 mg ORAL ANDA 24 sections
Ambrisentan HUMAN PRESCRIPTION DRUG LABEL 1 82009-142 TABLET, FILM COATED 10 mg ORAL ANDA 24 sections