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

Stem definitionDrug idCAS RN
endothelin receptor antagonists 4809 441798-33-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • opsumit
  • ACT-064992
  • macitentan
an endothelin receptor antagonist that prevents the binding of ET-1 to both ETA and ETB receptors, macitentan displays high affinity and sustained occupancy of the ET receptors in human pulmonary arterial smooth muscle cells
  • Molecular weight: 588.28
  • Formula: C19H20Br2N6O4S
  • CLOGP: 3.90
  • LIPINSKI: 1
  • HAC: 10
  • HDO: 2
  • TPSA: 128.22
  • ALOGS: -4.94
  • ROTB: 9
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
10 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Bocci G, Oprea TI, Benet LZ
BA (Bioavailability) 0.74 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 3.218 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 1.445 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 47.424 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 4.920 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 0.670 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 1.610 % High 1
herg hERG pIC50 5.009 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 12.677 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 35.892 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 0.420 % High 1
kinase-safety-class ACVR2B,AXL,BRAF,CAMK2B,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,ERBB2,GRK2,ITK,MAP3K21,MAPK7,PDK1,PDK2,PDK4,PIK3CD,PIK3CG,PRKDC 20
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 2.570 High 1
mh-clint Mouse hepatocyte intrinsic clearance 27.164 High 1
mppb Mouse plasma protein binding (% unbound) 0.770 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 10.990 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 1.130 % High 1
rh-clint Rat hepatocyte intrinsic clearance 27.669 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 14.660 % High 1
rppb Rat plasma protein binding (% unbound) 0.620 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 4.864 uM High 1

Approvals:

DateAgencyCompanyOrphan
Dec. 20, 2013 EMA
Oct. 18, 2013 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
Dyspnoea 4130.91 15.17 6576 166863 874379 89580629
Hospitalisation 3372.92 15.17 2417 171022 125683 90329325
Fluid retention 3335.67 15.17 2084 171355 86007 90369001
Death 2684.66 15.17 3800 169639 452751 90002257
Pain in jaw 1854.31 15.17 1151 172288 46834 90408174
Dyspnoea exertional 1811.19 15.17 1325 172114 70963 90384045
Right ventricular failure 1550.11 15.17 750 172689 18455 90436553
Drug ineffective 1528.80 15.17 389 173050 1383909 89071099
Hypervolaemia 1378.49 15.17 830 172609 31927 90423081
Headache 1366.87 15.17 4174 169265 858572 89596436
Pulmonary hypertension 1343.87 15.17 899 172540 41624 90413384
Nasal congestion 1303.16 15.17 1160 172279 82254 90372754
Transfusion 1265.40 15.17 634 172805 16854 90438154
Oxygen saturation decreased 1223.55 15.17 1255 172184 106228 90348780
Off label use 944.59 15.17 468 172971 1101784 89353224
Hypotension 796.93 15.17 1855 171584 323542 90131466
Pneumonia 770.57 15.17 2822 170617 635237 89819771
Pulmonary oedema 764.86 15.17 757 172682 61323 90393685
Product dose omission issue 754.07 15.17 1699 171740 289988 90165020
Infusion related reaction 745.61 15.17 10 173429 416770 90038238
Lung transplant 713.65 15.17 268 173171 3424 90451584
Cough 680.03 15.17 1889 171550 367073 90087935
Catheter management 670.20 15.17 243 173196 2793 90452215
Pulmonary arterial hypertension 639.41 15.17 473 172966 25714 90429294
Oedema peripheral 638.29 15.17 1477 171962 256438 90198570
Catheter site erythema 630.36 15.17 265 173174 4629 90450379
Oxygen consumption increased 606.20 15.17 253 173186 4336 90450672
Unevaluable event 604.78 15.17 630 172809 54218 90400790
Infusion site pain 567.97 15.17 394 173045 19344 90435664
Alopecia 567.17 15.17 127 173312 494944 89960064
Glossodynia 561.58 15.17 11 173428 321768 90133240
Flushing 558.93 15.17 765 172674 87726 90367282
Maternal exposure during pregnancy 551.00 15.17 35 173404 360028 90094980
Catheterisation cardiac 532.18 15.17 236 173203 4720 90450288
Catheter site pain 527.21 15.17 243 173196 5336 90449672
Cardiac failure 525.90 15.17 832 172607 108664 90346344
Therapy change 524.54 15.17 275 173164 8047 90446961
Hypoxia 520.58 15.17 667 172772 71732 90383276
Catheter site pruritus 510.94 15.17 185 173254 2117 90452891
Treatment failure 505.51 15.17 17 173422 303911 90151097
Drug hypersensitivity 499.68 15.17 135 173304 463474 89991534
Diarrhoea 488.27 15.17 3266 170173 935924 89519084
Arthropathy 487.29 15.17 63 173376 366179 90088829
Therapeutic product effect decreased 486.28 15.17 9 173430 277562 90177446
Contraindicated product administered 484.23 15.17 33 173406 320106 90134902
Cardiac failure congestive 452.08 15.17 734 172705 97960 90357048
Rheumatoid arthritis 450.97 15.17 76 173363 362538 90092470
Stomatitis 444.36 15.17 19 173420 274679 90180329
Chest pain 429.15 15.17 1466 171973 318179 90136829
Pulmonary arterial pressure increased 428.61 15.17 189 173250 3727 90451281
Pericarditis 426.25 15.17 22 173417 270129 90184879
Toxicity to various agents 425.74 15.17 33 173406 287813 90167195
Syncope 424.77 15.17 844 172595 131819 90323189
Psoriatic arthropathy 419.57 15.17 3 173436 228332 90226676
Dizziness 416.86 15.17 2223 171216 587061 89867947
Product use in unapproved indication 412.53 15.17 73 173366 336163 90118845
Palpitations 404.70 15.17 842 172597 135886 90319122
Dialysis 400.31 15.17 257 173182 11072 90443936
Hepatic enzyme increased 400.10 15.17 99 173340 360637 90094371
Vascular device infection 390.17 15.17 258 173181 11694 90443314
Rash 388.89 15.17 577 172862 795523 89659485
Folliculitis 373.90 15.17 3 173436 204350 90250658
Wound 373.35 15.17 65 173374 302915 90152093
Scleroderma 369.45 15.17 198 173241 6063 90448945
Epistaxis 366.82 15.17 616 172823 84509 90370499
Helicobacter infection 365.82 15.17 16 173423 226834 90228174
Musculoskeletal stiffness 364.55 15.17 64 173375 296468 90158540
Impaired healing 360.41 15.17 22 173417 234177 90220831
Device related infection 354.27 15.17 334 173105 25452 90429556
Oedema 349.11 15.17 1006 172433 199289 90255719
Systemic lupus erythematosus 328.03 15.17 141 173298 361755 90093253
Catheter site discharge 325.56 15.17 135 173304 2274 90452734
Neutropenia 323.65 15.17 29 173410 224875 90230133
Muscle injury 321.22 15.17 3 173436 176651 90278357
Pericardial effusion 320.89 15.17 374 173065 36459 90418549
Type 2 diabetes mellitus 316.04 15.17 18 173421 203226 90251782
Catheter site infection 311.90 15.17 171 173268 5483 90449525
Blood cholesterol increased 304.29 15.17 25 173414 207987 90247021
Malaise 300.30 15.17 2033 171406 583953 89871055
Respiratory failure 297.72 15.17 683 172756 117735 90337273
Joint swelling 296.21 15.17 316 173123 502984 89952024
Cardiac disorder 292.23 15.17 446 172993 56426 90398582
Blister 288.47 15.17 67 173372 254931 90200077
Hypersensitivity 286.39 15.17 269 173170 454408 90000600
Discomfort 285.80 15.17 85 173354 274250 90180758
Intentional product use issue 284.25 15.17 39 173400 216853 90238155
Catheter placement 283.30 15.17 124 173315 2400 90452608
Catheter site haemorrhage 283.09 15.17 139 173300 3529 90451479
Fibromyalgia 282.72 15.17 32 173407 206237 90248771
Irritable bowel syndrome 279.82 15.17 34 173405 207414 90247594
Ascites 277.87 15.17 397 173042 47343 90407665
Febrile neutropenia 277.77 15.17 5 173434 158344 90296664
Urticaria 276.81 15.17 126 173313 312608 90142400
Device alarm issue 276.42 15.17 112 173327 1773 90453235
Catheter site rash 276.02 15.17 90 173349 730 90454278
Productive cough 275.62 15.17 514 172925 76549 90378459
Product use issue 273.74 15.17 145 173294 329774 90125234
Injury 267.03 15.17 32 173407 197317 90257691
Feeling abnormal 265.68 15.17 813 172626 166422 90288586
Osteoarthritis 264.19 15.17 32 173407 195698 90259310
Concomitant disease aggravated 261 15.17 199 173240 11319 90443689
Nausea 258.79 15.17 3248 170191 1107068 89347940
Drug interaction 256.40 15.17 104 173335 276349 90178659
Mobility decreased 251.66 15.17 83 173356 250651 90204357
Therapeutic product effect incomplete 251.41 15.17 36 173403 193860 90261148
Acute respiratory failure 251.40 15.17 358 173081 42560 90412448
Drug intolerance 249.10 15.17 294 173145 447297 90007711
Catheter site swelling 249.08 15.17 103 173336 1722 90453286
Transplant evaluation 246.73 15.17 94 173345 1252 90453756
Chest discomfort 239.04 15.17 693 172746 137672 90317336
Liver injury 237.45 15.17 25 173414 170542 90284466
Peripheral swelling 237.45 15.17 1476 171963 411630 90043378
Lower respiratory tract infection 236.20 15.17 92 173347 250567 90204441
Infusion site erythema 233.06 15.17 200 173239 13470 90441538
Blood pressure decreased 231.80 15.17 470 172969 74425 90380583
Infusion site infection 230.09 15.17 109 173330 2551 90452457
Joint range of motion decreased 227.48 15.17 7 173432 135636 90319372
Device leakage 227.23 15.17 173 173266 9818 90445190
Anaemia 226.69 15.17 1298 172141 351504 90103504
Hypertension 225.42 15.17 329 173110 457203 89997805
Ill-defined disorder 216.31 15.17 45 173394 184846 90270162
Oxygen therapy 211.28 15.17 108 173331 2994 90452014
Cardiac operation 211.13 15.17 117 173322 3832 90451176
Dermatitis contact 209.90 15.17 188 173251 13407 90441601
Confusional state 208.13 15.17 260 173179 385945 90069063
Cardiac pacemaker insertion 207.10 15.17 120 173319 4287 90450721
Brain natriuretic peptide increased 206.67 15.17 134 173305 5871 90449137
Exposure during pregnancy 203.32 15.17 101 173338 238309 90216699
Device occlusion 202.94 15.17 157 173282 9125 90445883
Abdominal distension 201.87 15.17 629 172810 129972 90325036
Haemoglobin decreased 198.99 15.17 722 172717 161234 90293774
Hospice care 198.91 15.17 158 173281 9546 90445462
C-reactive protein increased 198.57 15.17 51 173388 181338 90273670
Rehabilitation therapy 196.00 15.17 89 173350 1885 90453123
Dyspnoea at rest 195.24 15.17 119 173320 4672 90450336
Psoriasis 194.90 15.17 26 173413 147728 90307280
Myalgia 184.95 15.17 744 172695 174381 90280627
Bursitis 178.93 15.17 21 173418 131633 90323375
Internal haemorrhage 178.53 15.17 124 173315 6096 90448912
Catheter site irritation 178.07 15.17 61 173378 585 90454423
Pulmonary veno-occlusive disease 177.31 15.17 77 173362 1461 90453547
Influenza 177.16 15.17 628 172811 138636 90316372
Malignant neoplasm progression 174.01 15.17 7 173432 106863 90348145
Paracentesis 169.93 15.17 66 173373 929 90454079
Presyncope 168.42 15.17 253 173186 31552 90423456
Device infusion issue 167.84 15.17 88 173351 2574 90452434
Hypercholesterolaemia 166.35 15.17 6 173433 100886 90354122
Disease progression 165.87 15.17 666 172773 155949 90299059
Device dislocation 163.26 15.17 248 173191 31234 90423774
Pleural effusion 159.96 15.17 525 172914 111466 90343542
Disease complication 159.66 15.17 96 173343 3676 90451332
Haemoptysis 159.55 15.17 253 173186 33067 90421941
Central venous catheterisation 158.49 15.17 86 173353 2700 90452308
Infusion site swelling 155.62 15.17 149 173290 11571 90443437
Lip dry 150.77 15.17 11 173428 100944 90354064
Prescribed overdose 150.62 15.17 9 173430 97616 90357392
Heart rate increased 147.78 15.17 514 172925 112388 90342620
Leukopenia 147.51 15.17 12 173427 100698 90354310
Emergency care 146.35 15.17 68 173371 1521 90453487
N-terminal prohormone brain natriuretic peptide increased 145.45 15.17 83 173356 2879 90452129
Obesity 145.45 15.17 16 173423 105491 90349517
Chronic obstructive pulmonary disease 145.42 15.17 388 173051 73441 90381567
Sleep disorder 144.64 15.17 101 173338 197929 90257079
Intentional overdose 143.72 15.17 9 173430 93825 90361183
Gastrointestinal haemorrhage 142.52 15.17 438 173001 89810 90365198
Blood potassium decreased 141.15 15.17 294 173145 47433 90407575
Therapy interrupted 139.32 15.17 301 173138 49807 90405201
Liver transplant 135.93 15.17 73 173366 2244 90452764
Dizziness postural 133.48 15.17 122 173317 8931 90446077
Asthma 132.48 15.17 161 173278 241999 90213009
Renal disorder 132.18 15.17 250 173189 37609 90417399
Drug abuse 132.05 15.17 6 173433 82341 90372667
General physical health deterioration 131.45 15.17 304 173135 354811 90100197
Hypoaesthesia 130.51 15.17 252 173187 313958 90141050
Atrial flutter 130.19 15.17 130 173309 10628 90444380
Aspiration pleural cavity 129.44 15.17 53 173386 863 90454145
Red blood cell sedimentation rate increased 129.31 15.17 7 173432 82588 90372420
Left ventricular failure 128.64 15.17 105 173334 6595 90448413
Complication associated with device 128.54 15.17 172 173267 19277 90435731
Overdose 128.22 15.17 71 173368 157638 90297370
Pruritus 126.82 15.17 569 172870 540956 89914052
Epilepsy 125.55 15.17 8 173431 82198 90372810
Infusion site discharge 124.34 15.17 70 173369 2365 90452643
Atrial fibrillation 122.63 15.17 544 172895 133067 90321941
Depression 122.32 15.17 244 173195 300357 90154651
Seasonal allergy 121.94 15.17 183 173256 22800 90432208
Thrombocytopenia 121.49 15.17 132 173307 208593 90246415
Night sweats 118.39 15.17 49 173390 128717 90326291
Wound infection 118.19 15.17 29 173410 106373 90348635
Walking distance test abnormal 118.08 15.17 44 173395 549 90454459
Live birth 117.05 15.17 9 173430 79098 90375910
Delirium 116.79 15.17 28 173411 104331 90350677
Pulmonary congestion 116.59 15.17 164 173275 19269 90435739
Anaphylactic reaction 116.37 15.17 15 173424 87509 90367499
Pain in extremity 115.50 15.17 1344 172095 449185 90005823
Paraesthesia 114.52 15.17 189 173250 250137 90204871
Injection site reaction 112.77 15.17 20 173419 92060 90362948
Arthralgia 112.34 15.17 952 172487 777570 89677438
Product quality issue 111.99 15.17 11 173428 79314 90375694
Drug-induced liver injury 111.96 15.17 19 173420 90299 90364709
Catheter site related reaction 111.33 15.17 50 173389 1031 90453977
Therapy cessation 111.06 15.17 227 173212 36134 90418874
Infusion site haemorrhage 110.68 15.17 88 173351 5323 90449685
Intentional product misuse 108.57 15.17 20 173419 89584 90365424
Condition aggravated 108.16 15.17 1669 171770 593876 89861132
Oropharyngeal pain 107.98 15.17 472 172967 114715 90340293
Mineral supplementation 107.48 15.17 44 173395 716 90454292
Neutrophil count decreased 106.22 15.17 8 173431 71524 90383484
Inflammation 106.10 15.17 111 173328 178481 90276527
Endarterectomy 105.74 15.17 32 173407 197 90454811
Suicide attempt 102.50 15.17 12 173427 75387 90379621
Electrocardiogram QT prolonged 102.42 15.17 10 173429 72446 90382562
Blood iron decreased 99.59 15.17 146 173293 17813 90437195
Catheter site vesicles 98.71 15.17 35 173404 375 90454633
Atrial septal defect repair 98.31 15.17 31 173408 223 90454785
Catheter site inflammation 97.72 15.17 44 173395 913 90454095
Terminal state 97.26 15.17 63 173376 2755 90452253
Right ventricular dysfunction 97.05 15.17 59 173380 2305 90452703
Respiration abnormal 95.94 15.17 96 173343 7867 90447141
Peripheral venous disease 94.93 15.17 22 173417 83899 90371109
Abdominal cavity drainage 94.78 15.17 35 173404 425 90454583
Pulmonary endarterectomy 94.76 15.17 27 173412 130 90454878
Blood pressure increased 93.87 15.17 145 173294 197072 90257936
Transplant 93.85 15.17 44 173395 1005 90454003
Foot deformity 93.55 15.17 5 173434 59646 90395362
Right ventricular dilatation 92.65 15.17 51 173388 1648 90453360
Stent placement 91.68 15.17 71 173368 4132 90450876
Exercise tolerance decreased 89.08 15.17 90 173349 7461 90447547
Hypoacusis 88.79 15.17 177 173262 27673 90427335
Pulmonary arterial pressure abnormal 88.61 15.17 36 173403 574 90454434
Medication error 88.49 15.17 26 173413 84626 90370382
Gait inability 88.15 15.17 90 173349 146366 90308642
Cardiac failure high output 87.20 15.17 33 173406 431 90454577
Therapy non-responder 84.35 15.17 498 172941 136206 90318802
Cardioversion 82.72 15.17 44 173395 1326 90453682
Myelosuppression 82.48 15.17 5 173434 53586 90401422
Exostosis 81.65 15.17 5 173434 53129 90401879
Device related sepsis 81.44 15.17 70 173369 4723 90450285
Therapeutic response decreased 81.10 15.17 35 173404 89694 90365314
Infusion site warmth 80.90 15.17 51 173388 2127 90452881
Rhinorrhoea 80.57 15.17 359 173080 87957 90367051
Pulmonary arterial wedge pressure increased 80.10 15.17 30 173409 380 90454628
Cardiac ablation 79.01 15.17 46 173393 1658 90453350
Sedation 78.93 15.17 3 173436 48168 90406840
Sinus congestion 77.67 15.17 166 173273 27258 90427750
Bronchitis 77.57 15.17 530 172909 152397 90302611
White blood cell count decreased 77.49 15.17 125 173314 166984 90288024
Injection site bruising 77.24 15.17 6 173433 52301 90402707
Systemic scleroderma 76.62 15.17 44 173395 1545 90453463
Orthopnoea 76.16 15.17 79 173360 6756 90448252
Injection site pain 75.88 15.17 135 173304 173564 90281444
Angioedema 75.41 15.17 16 173423 64860 90390148
Rhabdomyolysis 75.35 15.17 6 173433 51250 90403758
Gout 75.23 15.17 124 173315 16735 90438273
Fall 75.03 15.17 1317 172122 480493 89974515
Cognitive disorder 75.00 15.17 20 173419 69387 90385621
Onychomadesis 74.91 15.17 3 173436 45995 90409013
Infusion site induration 74.72 15.17 43 173396 1516 90453492
Incorrect route of product administration 74.22 15.17 6 173433 50620 90404388
Contusion 74.19 15.17 240 173199 250976 90204032
Angioplasty 74.17 15.17 42 173397 1435 90453573
Chemotherapy 73.47 15.17 45 173394 1782 90453226
Hepatitis 73.44 15.17 22 173417 70717 90384291
Suicidal ideation 73.07 15.17 25 173414 73830 90381178
Infection 72.85 15.17 401 173038 361693 90093315
Nasal dryness 72.27 15.17 70 173369 5513 90449495
Neoplasm progression 72.12 15.17 3 173436 44483 90410525
Wheezing 72.02 15.17 225 173214 237855 90217153
Decreased appetite 71.98 15.17 1065 172374 375475 90079533
Inappropriate schedule of product administration 70.60 15.17 111 173328 149822 90305186
Infusion site irritation 69.37 15.17 39 173400 1314 90453694
Foetal exposure during pregnancy 69.33 15.17 3 173436 42972 90412036
Coeliac disease 69.15 15.17 4 173435 44606 90410402
Drug reaction with eosinophilia and systemic symptoms 68.93 15.17 3 173436 42755 90412253
Sciatica 68.49 15.17 56 173383 101326 90353682
Autoimmune disorder 67.69 15.17 31 173408 76713 90378295
Head discomfort 67.39 15.17 116 173323 16217 90438791
Cardiac failure acute 66.17 15.17 97 173342 11832 90443176
Device connection issue 65.87 15.17 34 173405 962 90454046
Chronic respiratory failure 65.74 15.17 49 173390 2692 90452316
Biopsy 65.26 15.17 27 173412 452 90454556
Catheter site warmth 64.88 15.17 22 173417 204 90454804
Haemorrhage 64.80 15.17 284 173155 69085 90385923
Colitis ulcerative 63.93 15.17 18 173421 60248 90394760
Oxygen saturation abnormal 63.64 15.17 58 173381 4230 90450778
Drug ineffective for unapproved indication 63.48 15.17 24 173415 66620 90388388
Pericardial drainage 63.22 15.17 23 173416 267 90454741
Pregnancy 63.15 15.17 20 173419 62027 90392981
Concomitant disease progression 62.89 15.17 44 173395 2188 90452820
Extra dose administered 62.35 15.17 82 173357 9036 90445972
Osteoporosis 61.94 15.17 56 173383 96475 90358533
Medical procedure 61.85 15.17 27 173412 519 90454489
Cellulitis 61.75 15.17 341 173098 90996 90364012
Depressed level of consciousness 61.74 15.17 31 173408 72753 90382255
Head injury 61.48 15.17 164 173275 31024 90423984
Abortion spontaneous 61.47 15.17 14 173425 54042 90400966
Iron deficiency anaemia 61.09 15.17 138 173301 23524 90431484
Biopsy lung 60.97 15.17 21 173418 205 90454803
Joint stiffness 60.76 15.17 37 173402 78005 90377003
Muscular weakness 60.62 15.17 198 173241 206468 90248540
Wrong technique in product usage process 59.94 15.17 31 173408 71540 90383468
Gastrointestinal disorder 59.78 15.17 270 173169 256417 90198591
Dependence on oxygen therapy 59.75 15.17 27 173412 565 90454443
Disease recurrence 59.54 15.17 3 173436 37650 90417358
Catheterisation cardiac abnormal 58.36 15.17 22 173417 284 90454724
Catheter site scab 57.78 15.17 21 173418 243 90454765
Cardiomegaly 57.61 15.17 118 173321 18807 90436201
Blood pressure systolic increased 57.29 15.17 20 173419 58325 90396683
Diagnostic procedure 57.02 15.17 18 173421 130 90454878
Medical device change 56.62 15.17 22 173417 310 90454698
Cardiac output increased 55.82 15.17 25 173414 512 90454496
Hip fracture 55.45 15.17 164 173275 32913 90422095
Acute kidney injury 54.92 15.17 373 173066 320014 90134994
Joint dislocation 53.90 15.17 10 173429 44572 90410436
Pulmonary pain 53.23 15.17 57 173382 5057 90449951
Treatment noncompliance 53.13 15.17 218 173221 51509 90403499
Cyanosis 53.08 15.17 116 173323 19339 90435669
Sepsis 52.63 15.17 551 172888 179263 90275745
Localised oedema 52.44 15.17 62 173377 6132 90448876
Thrombosis in device 52.43 15.17 45 173394 3030 90451978
Hypocalcaemia 52.31 15.17 9 173430 42359 90412649
Dry mouth 52.16 15.17 179 173260 183880 90271128
Pancytopenia 52.03 15.17 94 173345 120169 90334839
No adverse event 51.86 15.17 33 173406 67949 90387059
Coma 51.75 15.17 38 173401 72594 90382414
Agranulocytosis 51.72 15.17 4 173435 34998 90420010
Choking 51.68 15.17 87 173352 11946 90443062
Infusion site pruritus 51.23 15.17 64 173375 6701 90448307
Renal failure 50.64 15.17 426 173013 130581 90324427
Hyponatraemia 50.40 15.17 113 173326 133425 90321583
Toxic epidermal necrolysis 50.16 15.17 3 173436 32525 90422483
Metabolic acidosis 49.86 15.17 22 173417 55654 90399354
Bone marrow failure 49.60 15.17 3 173436 32218 90422790
Product supply issue 49.43 15.17 43 173396 2949 90452059
Multiple allergies 49.17 15.17 97 173342 15049 90439959
Skin exfoliation 49.08 15.17 35 173404 67878 90387130
Swollen tongue 48.24 15.17 14 173425 45942 90409066
Faeces discoloured 48.13 15.17 118 173321 21202 90433806
Hepatotoxicity 48.05 15.17 14 173425 45828 90409180
Cholecystectomy 47.86 15.17 83 173356 11672 90443336
Catheter site discolouration 47.68 15.17 15 173424 107 90454901
Cor pulmonale 47.57 15.17 36 173403 2024 90452984
Right ventricular enlargement 47.43 15.17 22 173417 490 90454518
Device maintenance issue 47.38 15.17 17 173422 189 90454819
Nocturnal dyspnoea 46.79 15.17 31 173408 1409 90453599
Jugular vein distension 46.73 15.17 28 173411 1065 90453943
Dysarthria 46.52 15.17 23 173416 54459 90400549
Injection site erythema 46.29 15.17 73 173366 98429 90356579
Sinus disorder 46.06 15.17 158 173281 34289 90420719
Amnesia 45.88 15.17 86 173353 108419 90346589
Injection site infection 45.73 15.17 37 173402 2295 90452713
Vascular device occlusion 44.86 15.17 20 173419 405 90454603
Pulmonary fibrosis 44.76 15.17 86 173353 107417 90347591
Pulmonary artery aneurysm 44.74 15.17 13 173426 68 90454940
Cholestasis 44.19 15.17 8 173431 36291 90418717
Hernia repair 43.91 15.17 33 173406 1836 90453172
Musculoskeletal pain 43.63 15.17 174 173265 171077 90283931
Cardiac flutter 43.60 15.17 49 173390 4589 90450419
Heart valve replacement 43.47 15.17 24 173415 780 90454228
Weight decreased 43.18 15.17 991 172448 378919 90076089
Catheter removal 43.06 15.17 19 173420 375 90454633
Loss of consciousness 42.58 15.17 433 173006 139805 90315203
Blood creatine phosphokinase increased 42.51 15.17 7 173432 34016 90420992
Immunodeficiency 42.14 15.17 15 173424 43219 90411789
Onychomycosis 41.86 15.17 10 173429 37366 90417642
Haemoglobin increased 41.74 15.17 61 173378 7420 90447588
Infusion site discolouration 41.70 15.17 26 173413 1063 90453945
Biopsy liver 41.68 15.17 19 173420 406 90454602
Multiple sclerosis 41.66 15.17 3 173436 27837 90427171
Echocardiogram abnormal 41.55 15.17 30 173409 1569 90453439
Ventilation perfusion mismatch 41.45 15.17 21 173418 571 90454437
Hallucination 41.44 15.17 39 173400 65920 90389088
Catheter site extravasation 41.39 15.17 19 173420 413 90454595
Acute right ventricular failure 40.89 15.17 16 173423 230 90454778
Seizure 40.86 15.17 152 173287 152477 90302531
Neuropathy peripheral 40.31 15.17 131 173308 136839 90318169
Polypectomy 40.04 15.17 25 173414 1025 90453983
Lymphocyte count decreased 40.01 15.17 9 173430 35041 90419967
Sickle cell disease 39.81 15.17 13 173426 106 90454902
Generalised tonic-clonic seizure 39.77 15.17 9 173430 34894 90420114
Heart and lung transplant 39.59 15.17 13 173426 108 90454900
Endotracheal intubation 39.51 15.17 40 173399 3324 90451684
Carbon dioxide increased 39.44 15.17 31 173408 1844 90453164
Basal cell carcinoma 39.28 15.17 8 173431 33381 90421627
Asthenia 39.14 15.17 1316 172123 532435 89922573
Accidental exposure to product 39.13 15.17 16 173423 42350 90412658
Surgery 39.08 15.17 180 173259 44707 90410301
Drug titration 39.05 15.17 10 173429 29 90454979
Clostridium difficile infection 39.02 15.17 155 173284 36090 90418918
Viral infection 39.01 15.17 170 173269 41244 90413764
Catheter site dermatitis 38.71 15.17 12 173427 81 90454927
Hypercalcaemia 38.67 15.17 9 173430 34231 90420777
Pulmonary thrombosis 38.44 15.17 68 173371 9714 90445294
Blood pressure abnormal 38.42 15.17 103 173336 19542 90435466
Plasma cell myeloma 38.39 15.17 15 173424 40813 90414195
Blood bilirubin increased 38.35 15.17 175 173264 43295 90411713
Arthritis 38.33 15.17 177 173262 167138 90287870
Road traffic accident 38.27 15.17 94 173345 107532 90347476
Device physical property issue 38.20 15.17 36 173403 2740 90452268
Retching 38.02 15.17 101 173338 19058 90435950
Catheter site erosion 37.78 15.17 11 173428 58 90454950
Chest tube insertion 37.20 15.17 10 173429 37 90454971
Device malfunction 37.08 15.17 106 173333 20871 90434137
Mouth ulceration 37.07 15.17 15 173424 39959 90415049
Oxygen consumption 36.95 15.17 12 173427 96 90454912
Pulmonary vascular resistance abnormality 36.73 15.17 12 173427 98 90454910
Drug dependence 36.72 15.17 6 173433 29321 90425687
Deep vein thrombosis 36.67 15.17 75 173364 91545 90363463
Biopsy bone marrow 36.47 15.17 17 173422 383 90454625
Generalised oedema 36.36 15.17 99 173340 18954 90436054
Drug titration error 36.30 15.17 25 173414 1212 90453796
Lower limb fracture 36.28 15.17 67 173372 84946 90370062
Hepatocellular injury 36.09 15.17 6 173433 28952 90426056
Respiratory tract congestion 36.01 15.17 125 173314 27285 90427723
Eczema 35.96 15.17 29 173410 52841 90402167
Hyperglycaemia 35.88 15.17 27 173412 50943 90404065
Device issue 35.65 15.17 131 173308 29406 90425602
Device breakage 35.24 15.17 81 173358 13963 90441045
Lactic acidosis 35.18 15.17 27 173412 50436 90404572
Upper respiratory tract congestion 35.15 15.17 32 173407 2330 90452678
Application site pruritus 35.11 15.17 42 173397 4205 90450803
Heart transplant 35.09 15.17 19 173420 594 90454414
Metastases to bone 34.81 15.17 4 173435 25501 90429507
Pain 34.80 15.17 1556 171883 994785 89460223
Dizziness exertional 34.72 15.17 18 173421 514 90454494
Tracheostomy 34.70 15.17 20 173419 707 90454301
Stevens-Johnson syndrome 34.64 15.17 7 173432 29369 90425639
Tooth extraction 34.12 15.17 71 173368 11442 90443566
Localised infection 34.12 15.17 141 173298 33421 90421587
Drug level increased 34.05 15.17 6 173433 27756 90427252
Catheter site nodule 33.99 15.17 10 173429 55 90454953
Wrong dose 33.76 15.17 29 173410 1955 90453053
Psychotic disorder 33.74 15.17 9 173430 31221 90423787
Throat irritation 33.71 15.17 183 173256 48512 90406496
Congestive hepatopathy 33.69 15.17 35 173404 2998 90452010
Pulmonary hypertensive crisis 33.63 15.17 17 173422 460 90454548
Loss of personal independence in daily activities 33.59 15.17 140 173299 135965 90319043
Sinusitis 33.37 15.17 459 172980 342629 90112379
Arteriovenous malformation 33.33 15.17 26 173413 1529 90453479
Eosinophilia 33.23 15.17 7 173432 28526 90426482
Vomiting 32.93 15.17 1833 171606 786460 89668548
Medical device implantation 32.91 15.17 19 173420 674 90454334
Right ventricular systolic pressure increased 32.83 15.17 18 173421 577 90454431
Ear discomfort 32.72 15.17 65 173374 10135 90444873
Suture related complication 32.68 15.17 15 173424 326 90454682
Choking sensation 32.62 15.17 39 173400 3903 90451105
Hepatic steatosis 32.46 15.17 15 173424 36930 90418078
Dialysis related complication 32.25 15.17 11 173428 104 90454904
Gastrointestinal tube insertion 32.24 15.17 24 173415 1316 90453692
CREST syndrome 32.22 15.17 18 173421 599 90454409
Acute hepatic failure 32.18 15.17 3 173436 22558 90432450
Disability 32.16 15.17 19 173420 40726 90414282
Diet noncompliance 31.96 15.17 16 173423 424 90454584
Abdominal discomfort 31.75 15.17 684 172755 476644 89978364
Right-to-left cardiac shunt 31.65 15.17 14 173425 278 90454730
Respiratory distress 31.59 15.17 153 173286 38793 90416215
Pericardial excision 31.55 15.17 8 173431 22 90454986
Purulent discharge 31.51 15.17 45 173394 5360 90449648
Taste disorder 31.47 15.17 43 173396 61503 90393505
Pulmonary artery dilatation 31.39 15.17 15 173424 358 90454650
Gastric haemorrhage 31.36 15.17 52 173387 7051 90447957
Paranasal sinus hypersecretion 31.23 15.17 41 173398 4510 90450498
Illness 30.85 15.17 265 173174 81704 90373304
Paraesthesia oral 30.83 15.17 11 173428 31648 90423360
Pulmonary arterial pressure decreased 30.79 15.17 10 173429 80 90454928
Bone disorder 30.64 15.17 4 173435 23116 90431892
Flatulence 30.37 15.17 158 173281 41209 90413799
Lymphopenia 30.22 15.17 4 173435 22877 90432131
Dry eye 30.10 15.17 40 173399 57891 90397117
Mechanical ventilation 30.09 15.17 24 173415 1458 90453550
Cytomegalovirus infection 30.03 15.17 7 173432 26595 90428413
Biopsy lymph gland 29.89 15.17 8 173431 29 90454979
Rash erythematous 29.88 15.17 49 173390 65055 90389953
Full blood count abnormal 29.85 15.17 144 173295 36453 90418555
Hypoglycaemia 29.85 15.17 55 173384 69793 90385215
Secretion discharge 29.74 15.17 82 173357 15814 90439194
Chronic sinusitis 29.51 15.17 5 173434 23797 90431211
Brain natriuretic peptide abnormal 29.43 15.17 15 173424 413 90454595
Injection site swelling 29.41 15.17 43 173396 59796 90395212
Premature delivery 29.31 15.17 19 173420 38743 90416265
Injection site pruritus 29.19 15.17 36 173403 53798 90401210
Multiple epiphyseal dysplasia 29.09 15.17 10 173429 97 90454911
Emotional distress 29.07 15.17 17 173422 36645 90418363
Platelet transfusion 29.07 15.17 21 173418 1099 90453909
Influenza like illness 28.98 15.17 258 173181 80353 90374655
Ischaemic stroke 28.98 15.17 4 173435 22162 90432846
Gastroenteritis viral 28.89 15.17 125 173314 30230 90424778
Injection site mass 28.85 15.17 4 173435 22086 90432922
Cancer surgery 28.82 15.17 17 173422 628 90454380
Colonoscopy 28.73 15.17 25 173414 1715 90453293
Decreased activity 28.47 15.17 54 173385 8138 90446870
Diabetic ketoacidosis 28.40 15.17 6 173433 24401 90430607
Infusion site abscess 28.31 15.17 14 173425 361 90454647
Dehydration 28.23 15.17 526 172913 193921 90261087
Skeletal dysplasia 28.22 15.17 10 173429 107 90454901
Macular degeneration 28.19 15.17 19 173420 37951 90417057
Food allergy 28.18 15.17 7 173432 25471 90429537
Pneumonia bacterial 28.04 15.17 70 173369 12720 90442288
Pneumocystis jirovecii pneumonia 28.03 15.17 4 173435 21612 90433396
Vasodilatation 28.02 15.17 31 173408 2853 90452155
Thrombectomy 28.01 15.17 12 173427 220 90454788
Product label confusion 27.89 15.17 5 173434 22845 90432163
Bradycardia 27.69 15.17 76 173363 83771 90371237
Mixed connective tissue disease 27.42 15.17 16 173423 579 90454429
Walking aid user 27.40 15.17 17 173422 35489 90419519
Oral herpes 27.36 15.17 15 173424 33509 90421499
Gastrointestinal surgery 27.15 15.17 12 173427 238 90454770
Life support 27.10 15.17 12 173427 239 90454769
Hyperkalaemia 27.01 15.17 52 173387 64912 90390096
Heart valve operation 26.93 15.17 11 173428 178 90454830
Haematocrit decreased 26.82 15.17 154 173285 41678 90413330
Sluggishness 26.82 15.17 44 173395 5915 90449093
Back injury 26.53 15.17 30 173409 46592 90408416
Foetal death 26.49 15.17 4 173435 20719 90434289
Mood swings 26.45 15.17 4 173435 20698 90434310
Infusion site vesicles 26.34 15.17 16 173423 624 90454384
Acute myeloid leukaemia 26.34 15.17 4 173435 20636 90434372
Sickle cell anaemia 26.30 15.17 16 173423 626 90454382
Chills 26.22 15.17 376 173063 131605 90323403
Hallucination, visual 26.22 15.17 6 173433 23086 90431922
Myoclonus 26.18 15.17 3 173436 19165 90435843
Spinal osteoarthritis 26.14 15.17 3 173436 19145 90435863
Tubulointerstitial nephritis 26.09 15.17 8 173431 25335 90429673
Hip surgery 26.05 15.17 36 173403 4159 90450849
Hysterectomy 26.03 15.17 64 173375 11520 90443488
Product administration interrupted 25.96 15.17 67 173372 12425 90442583
Catheter site induration 25.94 15.17 8 173431 53 90454955
Infusion site discomfort 25.85 15.17 24 173415 1792 90453216
Ejection fraction decreased 25.77 15.17 9 173430 26244 90428764
Walking disability 25.74 15.17 22 173417 1473 90453535
Unevaluable investigation 25.68 15.17 8 173431 55 90454953
Body temperature decreased 25.47 15.17 7 173432 23809 90431199
Coordination abnormal 25.37 15.17 5 173434 21351 90433657
Therapeutic procedure 25.15 15.17 18 173421 928 90454080
Right ventricular hypertrophy 25.13 15.17 17 173422 800 90454208
Critical illness 25.09 15.17 12 173427 287 90454721
Blood pressure systolic decreased 24.98 15.17 55 173384 9215 90445793
Metastases to liver 24.84 15.17 12 173427 28795 90426213
Aggression 24.74 15.17 10 173429 26658 90428350
Polyarthritis 24.74 15.17 3 173436 18347 90436661
Dyspepsia 24.73 15.17 524 172915 197636 90257372
Dry skin 24.70 15.17 86 173353 87987 90367021
Cardiac procedure complication 24.64 15.17 10 173429 159 90454849
Drug eruption 24.61 15.17 19 173420 35388 90419620
Medical device site haemorrhage 24.41 15.17 8 173431 66 90454942
Upper-airway cough syndrome 24.38 15.17 74 173365 15061 90439947
Impaired quality of life 24.38 15.17 7 173432 23137 90431871
Procedural pain 24.35 15.17 17 173422 33343 90421665
Portal hypertension 24.32 15.17 37 173402 4664 90450344
Middle ear effusion 24.31 15.17 28 173411 2693 90452315
Injection site discharge 24.27 15.17 21 173418 1430 90453578
Sensory loss 24.26 15.17 3 173436 18072 90436936
Back pain 24.22 15.17 786 172653 316389 90138619
Paranasal sinus discomfort 24.18 15.17 43 173396 6167 90448841
Osteopenia 24.15 15.17 7 173432 22995 90432013
Product substitution issue 24.14 15.17 3 173436 18005 90437003
Nasopharyngitis 24.04 15.17 980 172459 406124 90048884
Cardiac discomfort 23.98 15.17 19 173420 1143 90453865
Catheter culture positive 23.92 15.17 10 173429 172 90454836
Product prescribing error 23.87 15.17 14 173425 30131 90424877
Palliative care 23.85 15.17 17 173422 871 90454137
Cardiac monitoring 23.80 15.17 6 173433 16 90454992
Hyperhidrosis 23.67 15.17 158 173281 136147 90318861
Portopulmonary hypertension 23.61 15.17 9 173430 120 90454888
Skin lesion 23.58 15.17 22 173417 37343 90417665
Withdrawal syndrome 23.39 15.17 7 173432 22517 90432491
Metastases to central nervous system 23.33 15.17 3 173436 17539 90437469
Food poisoning 23.32 15.17 38 173401 5080 90449928
Drug withdrawal syndrome 23.23 15.17 13 173426 28710 90426298
Knee operation 23.22 15.17 45 173394 6891 90448117
Polyuria 23.12 15.17 56 173383 9984 90445024
Drug delivery system malfunction 23.12 15.17 20 173419 1361 90453647
Telangiectasia 23.10 15.17 20 173419 1363 90453645
Acne 22.92 15.17 13 173426 28494 90426514
Aphthous ulcer 22.88 15.17 3 173436 17284 90437724
Cor pulmonale chronic 22.85 15.17 11 173428 267 90454741
Dialysis device insertion 22.80 15.17 6 173433 20 90454988
Radiculopathy 22.69 15.17 4 173435 18501 90436507
Ammonia increased 22.69 15.17 37 173402 4949 90450059
Pulmonary alveolar haemorrhage 22.68 15.17 41 173398 5957 90449051
Respiratory syncytial virus infection 22.60 15.17 57 173382 10423 90444585
Cardiorenal syndrome 22.56 15.17 18 173421 1094 90453914
Skin fissures 22.47 15.17 6 173433 20803 90434205
Myositis 22.46 15.17 9 173430 24119 90430889
Sinus bradycardia 22.30 15.17 3 173436 16949 90438059
Skin necrosis 22.28 15.17 3 173436 16938 90438070
Adrenal insufficiency 22.17 15.17 15 173424 29906 90425102
Ear congestion 22.07 15.17 30 173409 3412 90451596
Impaired work ability 21.98 15.17 5 173434 19321 90435687
Bacterial infection 21.90 15.17 96 173343 23348 90431660
Cardiac failure chronic 21.87 15.17 39 173400 5607 90449401
Coronary arterial stent insertion 21.72 15.17 27 173412 2813 90452195
Drug tolerance 21.70 15.17 4 173435 17912 90437096
Intra-abdominal fluid collection 21.69 15.17 27 173412 2817 90452191
Pulmonary vasculitis 21.67 15.17 10 173429 220 90454788
Gastric disorder 21.47 15.17 123 173316 33261 90421747
Pyelonephritis 21.46 15.17 7 173432 21309 90433699
Brachydactyly 21.43 15.17 10 173429 226 90454782
Blood sodium decreased 21.34 15.17 107 173332 27506 90427502
Encephalopathy 21.27 15.17 35 173404 46409 90408599
Primary biliary cholangitis 21.21 15.17 19 173420 1355 90453653
Fatigue 21.15 15.17 2519 170920 1151504 89303504
Osteonecrosis 21.05 15.17 12 173427 26229 90428779
Liver ablation 21.04 15.17 4 173435 0 90455008
Immune tolerance induction 21.04 15.17 4 173435 0 90455008
Vascular resistance pulmonary increased 21.03 15.17 7 173432 61 90454947
Cardiac septal defect 21.02 15.17 15 173424 770 90454238
Muscle twitching 20.99 15.17 10 173429 24192 90430816
Brain operation 20.96 15.17 14 173425 645 90454363
Feeling cold 20.93 15.17 106 173333 27359 90427649
Infusion site inflammation 20.91 15.17 13 173426 529 90454479
Catheter site dryness 20.87 15.17 6 173433 30 90454978
Hypercapnia 20.76 15.17 42 173397 6635 90448373
Cataract operation 20.65 15.17 40 173399 6123 90448885
Oral surgery 20.64 15.17 20 173419 1576 90453432
Living in residential institution 20.60 15.17 14 173425 664 90454344
Tenderness 20.55 15.17 13 173426 26855 90428153
Female sterilisation 20.51 15.17 14 173425 669 90454339
Diplopia 20.48 15.17 15 173424 28699 90426309
Renal impairment 20.41 15.17 299 173140 105122 90349886
Vaginal discharge 20.30 15.17 6 173433 19458 90435550
Oxygen saturation increased 20.22 15.17 11 173428 347 90454661
Gastrointestinal arteriovenous malformation 20.20 15.17 13 173426 562 90454446
Drug tolerance decreased 20.18 15.17 19 173420 32111 90422897
Pancreatitis acute 20.16 15.17 19 173420 32096 90422912
Catheter site bruise 20.02 15.17 13 173426 571 90454437
Laryngitis 19.93 15.17 42 173397 50711 90404297
Pulmonary artery occlusion 19.82 15.17 6 173433 37 90454971
Bronchoscopy 19.74 15.17 7 173432 75 90454933
Lip swelling 19.71 15.17 27 173412 38583 90416425
Gastrointestinal endoscopic therapy 19.68 15.17 6 173433 38 90454970
Pulmonary vascular disorder 19.66 15.17 11 173428 367 90454641
Proteinuria 19.63 15.17 10 173429 23281 90431727
Cardiac output decreased 19.61 15.17 16 173423 1004 90454004
Blood culture positive 19.60 15.17 35 173404 5037 90449971
Spinal operation 19.48 15.17 53 173386 10143 90444865
Hypertensive crisis 19.45 15.17 5 173434 17779 90437229
Altered state of consciousness 19.39 15.17 19 173420 31513 90423495
Disturbance in attention 19.33 15.17 38 173401 47071 90407937
Right atrial dilatation 19.17 15.17 14 173425 745 90454263
Pulmonary arterial pressure 19.17 15.17 6 173433 42 90454966
Vitamin D deficiency 19.08 15.17 5 173434 17551 90437457
Kidney infection 19.03 15.17 99 173340 25817 90429191
Cardiac pacemaker replacement 18.98 15.17 11 173428 393 90454615
Rales 18.93 15.17 70 173369 15757 90439251
Schizophrenia 18.79 15.17 3 173436 14911 90440097
Vasculitis 18.75 15.17 10 173429 22683 90432325
Ocular icterus 18.74 15.17 30 173409 3950 90451058
Endoscopy 18.66 15.17 11 173428 406 90454602
Left ventricular end-diastolic pressure increased 18.56 15.17 11 173428 410 90454598
Agitation 18.49 15.17 66 173373 67032 90387976
Pulmonary capillary haemangiomatosis 18.47 15.17 6 173433 48 90454960
Oesophageal motility disorder 18.47 15.17 13 173426 653 90454355
Knee arthroplasty 18.45 15.17 89 173350 83093 90371915
Hallucination, auditory 18.44 15.17 4 173435 15971 90439037
Weight increased 18.41 15.17 977 172462 416950 90038058
Drain placement 18.39 15.17 7 173432 93 90454915
Intracardiac pressure increased 18.36 15.17 6 173433 49 90454959
General symptom 18.36 15.17 3 173436 14665 90440343
Gastrointestinal polyp haemorrhage 18.30 15.17 11 173428 421 90454587
Rash vesicular 18.28 15.17 6 173433 18191 90436817
Hepatopulmonary syndrome 18.25 15.17 7 173432 95 90454913
Labelled drug-drug interaction medication error 18.22 15.17 3 173436 14579 90440429
Dyskinesia 18.20 15.17 26 173413 36508 90418500
Sinus headache 18.11 15.17 39 173400 6437 90448571
Toe amputation 18.00 15.17 21 173418 2048 90452960
Blood lactate dehydrogenase increased 17.91 15.17 14 173425 25918 90429090
Infusion 17.90 15.17 8 173431 163 90454845
End stage renal disease 17.84 15.17 46 173393 8525 90446483
Obstructive airways disorder 17.83 15.17 14 173425 25855 90429153
Cardiac septal defect repair 17.81 15.17 4 173435 5 90455003
Hypersomnia 17.76 15.17 85 173354 21446 90433562
Carpal tunnel syndrome 17.73 15.17 12 173427 23916 90431092
Conjunctivitis 17.72 15.17 15 173424 26691 90428317
Arteriovenous fistula operation 17.72 15.17 9 173430 246 90454762
Myelodysplastic syndrome 17.58 15.17 9 173430 20894 90434114
Infusion site nodule 17.57 15.17 19 173420 1704 90453304
Blood potassium abnormal 17.56 15.17 25 173414 2969 90452039
Pyrexia 17.55 15.17 1060 172379 659425 89795583
Gallbladder operation 17.54 15.17 24 173415 2747 90452261
Vascular cauterisation 17.47 15.17 6 173433 58 90454950
Erythema 17.47 15.17 321 173118 228925 90226083
Galectin-3 increased 17.39 15.17 5 173434 25 90454983
Fluid intake restriction 17.39 15.17 5 173434 25 90454983
Bronchial artery embolisation 17.39 15.17 4 173435 6 90455002
Bedridden 17.37 15.17 57 173382 12091 90442917
Peritonitis 17.31 15.17 8 173431 19697 90435311
Blood glucose increased 17.25 15.17 109 173330 95137 90359871
Limb operation 17.19 15.17 31 173408 4496 90450512
Varices oesophageal 17.14 15.17 28 173411 3751 90451257
Procedural complication 17.13 15.17 36 173403 5842 90449166
Balance disorder 17.12 15.17 112 173327 96968 90358040
Cytopenia 17.10 15.17 6 173433 17443 90437565
Frequent bowel movements 17.06 15.17 54 173385 56881 90398127
Liver function test increased 17.01 15.17 94 173345 84761 90370247
Rectal prolapse repair 17.01 15.17 4 173435 7 90455001
Visual acuity reduced 17.00 15.17 12 173427 23398 90431610
Colon operation 16.96 15.17 11 173428 482 90454526
Normal newborn 16.93 15.17 12 173427 23350 90431658
Mydriasis 16.84 15.17 4 173435 15008 90440000
Application site hypersensitivity 16.84 15.17 9 173430 274 90454734
Neutrophil count increased 16.84 15.17 8 173431 19382 90435626
Tendonitis 16.82 15.17 10 173429 21362 90433646
Biopsy kidney 16.82 15.17 8 173431 189 90454819
Hemiplegia 16.82 15.17 5 173434 16155 90438853
Dysentery 16.77 15.17 15 173424 1067 90453941
Anxiety 16.70 15.17 458 172981 309314 90145694
Lung neoplasm malignant 16.65 15.17 91 173348 24182 90430826
Breast cancer female 16.64 15.17 4 173435 14882 90440126
Blood culture negative 16.63 15.17 8 173431 194 90454814
Cardiac index decreased 16.62 15.17 6 173433 68 90454940
Biopsy breast 16.60 15.17 9 173430 282 90454726
Swelling 16.55 15.17 645 172794 418413 90036595
Arrhythmia 16.53 15.17 138 173301 42194 90412814
Wound treatment 16.51 15.17 8 173431 197 90454811
Infusion site rash 16.47 15.17 22 173417 2461 90452547
Eye operation 16.45 15.17 23 173416 2686 90452322
Aortic valve replacement 16.41 15.17 14 173425 935 90454073
Myopathy 16.41 15.17 3 173436 13515 90441493
Aphasia 16.33 15.17 36 173403 42776 90412232
Acute left ventricular failure 16.31 15.17 16 173423 1280 90453728
Device related thrombosis 16.17 15.17 20 173419 2073 90452935
Urine output decreased 16.15 15.17 57 173382 12546 90442462
Renal tubular necrosis 16.09 15.17 4 173435 14551 90440457
Mental status changes 16.06 15.17 143 173296 44536 90410472
Colitis 16.00 15.17 74 173365 69868 90385140
Vascular operation 15.97 15.17 7 173432 136 90454872
Body temperature increased 15.93 15.17 39 173400 44671 90410337
Diuretic therapy 15.92 15.17 7 173432 137 90454871
Pancreatitis 15.91 15.17 74 173365 69752 90385256
Thrombosis 15.89 15.17 212 173227 73039 90381969
Respiratory depression 15.88 15.17 5 173434 15570 90439438
Haemodynamic test abnormal 15.85 15.17 5 173434 36 90454972
Balloon atrial septostomy 15.81 15.17 6 173433 79 90454929
Cranial operation 15.78 15.17 3 173436 0 90455008
Cardiac index abnormal 15.78 15.17 3 173436 0 90455008
Vascular device user 15.78 15.17 3 173436 0 90455008
Vena cava filter removal 15.78 15.17 3 173436 0 90455008
Carbon dioxide abnormal 15.77 15.17 8 173431 218 90454790
Liver disorder 15.77 15.17 152 173287 121117 90333891
Right atrial enlargement 15.74 15.17 8 173431 219 90454789
Infusion site pustule 15.62 15.17 5 173434 38 90454970
Heart rate abnormal 15.61 15.17 35 173404 5936 90449072
Application site irritation 15.57 15.17 19 173420 1942 90453066
Injection site rash 15.53 15.17 14 173425 24159 90430849
Bronchiectasis 15.50 15.17 12 173427 22318 90432690
Skin haemorrhage 15.47 15.17 11 173428 21369 90433639
Gait disturbance 15.40 15.17 380 173059 260116 90194892
Paranoia 15.38 15.17 3 173436 12905 90442103
Blood pressure diastolic increased 15.38 15.17 3 173436 12903 90442105
Colon cancer 15.34 15.17 51 173388 10893 90444115
Poisoning 15.31 15.17 5 173434 15212 90439796
Cerebral infarction 15.26 15.17 17 173422 26579 90428429
Limb injury 15.25 15.17 108 173331 31400 90423608
Diastolic hypotension 15.22 15.17 6 173433 88 90454920
Craniotomy 15.22 15.17 9 173430 334 90454674
Upper respiratory tract inflammation 15.22 15.17 22 173417 2650 90452358
Renal stone removal 15.21 15.17 7 173432 153 90454855
Product storage error 15.20 15.17 10 173429 20231 90434777
Catheter site cellulitis 15.17 15.17 9 173430 336 90454672

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
Fluid retention 1539.23 19.08 752 50230 30867 42539486
Dyspnoea 1280.58 19.08 2052 48930 440569 42129784
Hospitalisation 1131.89 19.08 836 50146 73494 42496859
Death 1040.56 19.08 1940 49042 469245 42101108
Right ventricular failure 775.38 19.08 325 50657 9230 42561123
Pain in jaw 681.12 19.08 337 50645 14165 42556188
Pulmonary hypertension 617.06 19.08 372 50610 23197 42547156
Headache 568.79 19.08 1021 49961 238348 42332005
Dyspnoea exertional 482.26 19.08 432 50550 49716 42520637
Oxygen saturation decreased 426.31 19.08 453 50529 64234 42506119
Hypervolaemia 419.79 19.08 290 50692 22835 42547518
Transfusion 411.17 19.08 216 50766 10298 42560055
Oedema 391.05 19.08 391 50591 51610 42518743
Lung transplant 358.03 19.08 127 50855 2259 42568094
Drug ineffective 338.54 19.08 167 50815 630030 41940323
Nasal congestion 309.15 19.08 267 50715 29234 42541119
Peripheral swelling 285.79 19.08 439 50543 89831 42480522
Pulmonary arterial hypertension 272.15 19.08 163 50819 10024 42560329
Off label use 248.51 19.08 240 50742 638095 41932258
Drug interaction 247.65 19.08 19 50963 266980 42303373
Toxicity to various agents 238.51 19.08 8 50974 229128 42341225
Catheterisation cardiac 229.77 19.08 96 50886 2698 42567655
Neutropenia 222.97 19.08 3 50979 199428 42370925
Catheter management 217.98 19.08 71 50911 961 42569392
Oxygen consumption increased 217.78 19.08 80 50902 1579 42568774
Oedema peripheral 208.32 19.08 485 50497 135591 42434762
Febrile neutropenia 198.63 19.08 5 50977 185698 42384655
Flushing 174.02 19.08 218 50764 36810 42533543
Product dose omission issue 156.45 19.08 472 50510 153893 42416460
Infusion site pain 153.69 19.08 90 50892 5305 42565048
Dialysis 151.53 19.08 121 50861 11865 42558488
Hypoxia 140.30 19.08 278 50704 69508 42500845
Concomitant disease aggravated 139.60 19.08 91 50891 6495 42563858
Pneumonia 138.58 19.08 920 50062 421229 42149124
Catheter site erythema 136.05 19.08 58 50924 1715 42568638
Transplant evaluation 131.13 19.08 41 50941 482 42569871
Pulmonary oedema 127.93 19.08 229 50753 53043 42517310
Unevaluable event 127.43 19.08 180 50802 34108 42536245
Pulmonary arterial pressure increased 123.63 19.08 52 50930 1486 42568867
Therapy change 121.11 19.08 70 50912 4025 42566328
Weight increased 119.65 19.08 341 50641 107642 42462711
Dizziness 117.25 19.08 598 50384 248656 42321697
Product use in unapproved indication 116.13 19.08 38 50944 184418 42385935
Malignant neoplasm progression 115.52 19.08 3 50979 108397 42461956
Liver transplant 112.95 19.08 58 50924 2633 42567720
Hypotension 110.80 19.08 603 50379 257028 42313325
Malaise 106.79 19.08 519 50463 211637 42358716
Therapy non-responder 106.53 19.08 212 50770 53147 42517206
Acute kidney injury 105.84 19.08 173 50809 367164 42203189
Catheter site pain 105.62 19.08 48 50934 1659 42568694
Cardiac failure 103.70 19.08 322 50660 106534 42463819
Pain in extremity 100.50 19.08 401 50581 150203 42420150
Oxygen therapy 99.51 19.08 43 50939 1315 42569038
Catheter site pruritus 99.44 19.08 30 50952 310 42570043
Swelling 98.87 19.08 209 50773 54676 42515677
Syncope 97.80 19.08 301 50681 99105 42471248
Cough 97.10 19.08 446 50536 177657 42392696
Condition aggravated 96.83 19.08 587 50395 260167 42310186
Drug abuse 95.45 19.08 8 50974 104763 42465590
Thrombocytopenia 94.78 19.08 55 50927 190224 42380129
Brain natriuretic peptide increased 93.46 19.08 72 50910 6698 42563655
Diarrhoea 92.65 19.08 898 50084 459951 42110402
Cardiac failure congestive 87.74 19.08 263 50719 85339 42485014
Catheter site rash 83.02 19.08 24 50958 211 42570142
Catheter placement 82.87 19.08 34 50948 911 42569442
Pulmonary veno-occlusive disease 77.62 19.08 29 50953 601 42569752
Catheter site discharge 76.86 19.08 31 50951 794 42569559
Disease complication 76.51 19.08 47 50935 3023 42567330
Pancytopenia 76.30 19.08 23 50959 117720 42452633
Infusion site infection 75.32 19.08 28 50954 572 42569781
Epistaxis 74.89 19.08 212 50770 66614 42503739
Aspiration pleural cavity 74.29 19.08 31 50951 868 42569485
Catheter site irritation 73.51 19.08 19 50963 104 42570249
Adverse event 73.28 19.08 114 50868 23526 42546827
Overdose 73.01 19.08 18 50964 105246 42465107
Intentional product use issue 72.93 19.08 3 50979 71830 42498523
Chest pain 70.56 19.08 342 50640 139188 42431165
Device occlusion 69.86 19.08 67 50915 8383 42561970
Paracentesis 69.72 19.08 25 50957 459 42569894
Device dislocation 68.38 19.08 64 50918 7767 42562586
Rash 66.82 19.08 145 50837 276809 42293544
Endarterectomy 63.12 19.08 18 50964 150 42570203
Cardiac disorder 62.58 19.08 163 50819 48769 42521584
Feeling abnormal 61.01 19.08 203 50779 69583 42500770
Lung operation 60.38 19.08 16 50966 98 42570255
Leukopenia 59.81 19.08 9 50973 74737 42495616
Vascular device infection 59.34 19.08 53 50929 6057 42564296
Device alarm issue 57.81 19.08 25 50957 766 42569587
Abdominal distension 56.89 19.08 202 50780 71533 42498820
Treatment failure 56.42 19.08 5 50977 62619 42507734
Catheter site haemorrhage 55.95 19.08 36 50946 2512 42567841
Cardiac pacemaker insertion 54.85 19.08 39 50943 3209 42567144
Complication associated with device 53.40 19.08 52 50930 6629 42563724
Drug hypersensitivity 51.95 19.08 27 50955 99362 42470991
Respiratory failure 51.63 19.08 295 50687 127837 42442516
Intentional product misuse 50.58 19.08 7 50975 61893 42508460
Cardiac operation 50.35 19.08 39 50943 3656 42566697
Chronic obstructive pulmonary disease 50.27 19.08 178 50804 62936 42507417
Acute respiratory failure 50.25 19.08 130 50852 38728 42531625
Abdominal discomfort 49.00 19.08 199 50783 75056 42495297
Pulmonary endarterectomy 48.33 19.08 13 50969 85 42570268
Nasopharyngitis 47.65 19.08 213 50769 83783 42486570
Confusional state 47.12 19.08 80 50902 167517 42402836
Infusion site erythema 46.70 19.08 37 50945 3585 42566768
Rehabilitation therapy 46.40 19.08 24 50958 1106 42569247
Neuropathy peripheral 45.81 19.08 33 50949 101820 42468533
Productive cough 45.05 19.08 150 50832 51417 42518936
Internal haemorrhage 44.85 19.08 43 50939 5378 42564975
Foetal exposure during pregnancy 44.81 19.08 3 50979 47308 42523045
Transplant 44.24 19.08 22 50960 932 42569421
Inappropriate schedule of product administration 43.22 19.08 31 50951 95871 42474482
Hospice care 42.99 19.08 52 50930 8461 42561892
Therapy interrupted 42.70 19.08 87 50895 22163 42548190
Abdominal cavity drainage 41.98 19.08 17 50965 440 42569913
Hyperkalaemia 41.83 19.08 22 50960 80436 42489917
Ventilation perfusion mismatch 41.26 19.08 13 50969 157 42570196
Sinus congestion 40.86 19.08 46 50936 6934 42563419
Catheter site infection 40.84 19.08 32 50950 3051 42567302
Pulmonary congestion 40.81 19.08 70 50912 15660 42554693
Exercise tolerance decreased 40.78 19.08 43 50939 6023 42564330
Hypertension 40.71 19.08 87 50895 167117 42403236
Suicide attempt 40.67 19.08 4 50978 46096 42524257
Stomatitis 40.40 19.08 6 50976 50323 42520030
Haemoptysis 40.07 19.08 134 50848 46033 42524320
Walking distance test abnormal 40.04 19.08 13 50969 174 42570179
Pericardial effusion 39.99 19.08 100 50882 29175 42541178
Blood iron decreased 39.33 19.08 43 50939 6275 42564078
Therapeutic product effect incomplete 38.99 19.08 18 50964 70921 42499432
White blood cell count decreased 38.68 19.08 45 50937 110351 42460002
Device related infection 38.57 19.08 79 50903 20200 42550153
Pyrexia 38.41 19.08 295 50687 393747 42176606
Delirium 38.36 19.08 8 50974 52511 42517842
Dizziness postural 38.36 19.08 47 50935 7748 42562605
Terminal state 38.33 19.08 36 50946 4387 42565966
Seizure 38.24 19.08 53 50929 120508 42449845
Cardiac ablation 38.01 19.08 22 50960 1268 42569085
Ascites 37.78 19.08 151 50831 56527 42513826
Metabolic acidosis 37.67 19.08 8 50974 51850 42518503
Hallucination 37.66 19.08 11 50971 57496 42512857
Hyperhidrosis 37.32 19.08 32 50950 90480 42479873
Lactic acidosis 37.25 19.08 5 50977 45256 42525097
Deep vein thrombosis 37.20 19.08 23 50959 76934 42493419
Psoriasis 36.35 19.08 7 50975 48597 42521756
Stent placement 36.04 19.08 38 50944 5322 42565031
Atrial septal defect repair 35.68 19.08 11 50971 123 42570230
Palpitations 35.20 19.08 137 50845 50660 42519693
Hyponatraemia 34.86 19.08 42 50940 101420 42468933
Acute myocardial infarction 34.80 19.08 13 50969 58152 42512201
Blood pressure increased 34.17 19.08 43 50939 101885 42468468
Myalgia 34.06 19.08 214 50768 95866 42474487
Heart rate increased 34.00 19.08 140 50842 53115 42517238
Emergency care 33.99 19.08 15 50967 483 42569870
Hernia repair 33.75 19.08 21 50961 1382 42568971
Hyperglycaemia 33.47 19.08 7 50975 45852 42524501
Plasma cell myeloma 33.24 19.08 8 50974 47570 42522783
Infusion site haemorrhage 32.97 19.08 20 50962 1257 42569096
Device infusion issue 32.92 19.08 19 50963 1089 42569264
Haemoglobin decreased 32.47 19.08 270 50712 132201 42438152
Therapy cessation 32.40 19.08 74 50908 20376 42549977
Drug-induced liver injury 32.05 19.08 4 50978 38269 42532084
Drug ineffective for unapproved indication 31.79 19.08 8 50974 46155 42524198
Aggression 31.70 19.08 7 50975 44156 42526197
Suture insertion 31.07 19.08 8 50974 43 42570310
Rhinorrhoea 30.96 19.08 96 50886 31698 42538655
Bradycardia 30.86 19.08 34 50948 85450 42484903
Catheter removal 30.67 19.08 11 50971 202 42570151
Drug resistance 30.14 19.08 3 50979 34245 42536108
Multiple organ dysfunction syndrome 29.44 19.08 44 50938 96991 42473362
Surgery 29.31 19.08 65 50917 17551 42552802
Influenza 28.96 19.08 149 50833 62026 42508327
Pruritus 28.80 19.08 122 50860 188649 42381704
Cholestasis 28.62 19.08 3 50979 32876 42537477
Pulmonary embolism 28.46 19.08 63 50919 119549 42450804
Suicidal ideation 28.42 19.08 11 50971 48150 42522203
Catheter site swelling 28.29 19.08 14 50968 587 42569766
Musculoskeletal stiffness 28.28 19.08 17 50965 57748 42512605
Lung disorder 28.27 19.08 123 50859 47800 42522553
Dizziness exertional 28.06 19.08 11 50971 261 42570092
Heart and lung transplant 27.51 19.08 8 50974 72 42570281
Eczema 27.50 19.08 4 50978 34082 42536271
Dyspepsia 27.42 19.08 110 50872 41242 42529111
Blood pressure decreased 27.32 19.08 140 50842 58192 42512161
Skin exfoliation 27.11 19.08 8 50974 41545 42528808
Scleroderma 26.95 19.08 20 50962 1758 42568595
Agranulocytosis 26.12 19.08 3 50979 30609 42539744
Respiration abnormal 26.02 19.08 28 50954 4014 42566339
Cardiac output increased 25.74 19.08 7 50975 48 42570305
Hypocalcaemia 25.64 19.08 3 50979 30170 42540183
Catheter site warmth 25.51 19.08 8 50974 95 42570258
Pneumonitis 25.50 19.08 9 50973 41709 42528644
Oesophageal variceal ligation 25.07 19.08 8 50974 101 42570252
Agitation 25.00 19.08 24 50958 64290 42506063
Fall 24.78 19.08 406 50576 234114 42336239
Cardiac index increased 24.75 19.08 6 50976 24 42570329
Blood bilirubin increased 24.58 19.08 108 50874 42144 42528209
Rheumatoid arthritis 24.54 19.08 10 50972 42430 42527923
Asthma 24.52 19.08 23 50959 62291 42508062
Ammonia increased 24.41 19.08 29 50953 4630 42565723
Chemotherapy 24.41 19.08 14 50968 793 42569560
Biopsy liver 24.30 19.08 10 50972 270 42570083
N-terminal prohormone brain natriuretic peptide increased 24.15 19.08 25 50957 3428 42566925
Cardioversion 24.12 19.08 15 50967 986 42569367
Urticaria 24.02 19.08 32 50950 74004 42496349
Dermatitis contact 23.55 19.08 28 50954 4475 42565878
Diuretic therapy 23.34 19.08 6 50976 32 42570321
Renal disorder 23.29 19.08 82 50900 28898 42541455
Right atrial pressure increased 23.27 19.08 8 50974 129 42570224
Coma 23.23 19.08 18 50964 53536 42516817
Biopsy lung 23.16 19.08 8 50974 131 42570222
Oxygen saturation abnormal 23.01 19.08 19 50963 1952 42568401
Disturbance in attention 22.98 19.08 4 50978 29862 42540491
Dependence on oxygen therapy 22.52 19.08 9 50973 225 42570128
Hypoglycaemia 22.50 19.08 23 50959 59831 42510522
Depressed level of consciousness 22.27 19.08 15 50967 47955 42522398
Fatigue 21.80 19.08 678 50304 434963 42135390
Spontaneous intrahepatic portosystemic venous shunt 21.74 19.08 5 50977 15 42570338
Right ventricular dysfunction 21.70 19.08 16 50966 1393 42568960
Cardiac flutter 21.65 19.08 19 50963 2121 42568232
Abdominal pain upper 21.65 19.08 171 50811 82438 42487915
Abnormal behaviour 21.58 19.08 3 50979 26448 42543905
Pulmonary thrombosis 21.46 19.08 37 50945 8311 42562042
Product administration interrupted 21.36 19.08 28 50954 4938 42565415
No adverse event 21.28 19.08 10 50972 39011 42531342
Angioplasty 21.09 19.08 14 50968 1030 42569323
Colitis 21.04 19.08 15 50967 46557 42523796
Infusion site irritation 20.97 19.08 10 50972 386 42569967
Sickle cell disease 20.97 19.08 8 50974 176 42570177
Coronary artery disease 20.93 19.08 20 50962 53700 42516653
Carbon dioxide increased 20.85 19.08 15 50967 1257 42569096
Lymphocyte count decreased 20.80 19.08 4 50978 27805 42542548
Disease recurrence 20.71 19.08 5 50977 29673 42540680
Nausea 20.49 19.08 620 50362 396179 42174174
Encephalopathy 20.46 19.08 12 50970 41321 42529032
Thoracic cavity drainage 20.44 19.08 8 50974 189 42570164
Presyncope 20.33 19.08 66 50916 22321 42548032
Intracardiac pressure increased 20.15 19.08 4 50978 4 42570349
Pulmonary arterial wedge pressure increased 20.02 19.08 7 50975 119 42570234
Left ventricular failure 19.97 19.08 30 50952 6001 42564352
Haematuria 19.76 19.08 24 50958 57775 42512578
Pulmonary vascular resistance abnormality 19.72 19.08 6 50976 64 42570289
Blood cholesterol increased 19.68 19.08 4 50978 26737 42543616
Right ventricular dilatation 19.40 19.08 12 50970 781 42569572
Heart valve operation 19.31 19.08 6 50976 69 42570284
Unevaluable investigation 19.25 19.08 5 50977 28 42570325
Colitis ulcerative 19.09 19.08 4 50978 26171 42544182

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 4496.98 16.10 7358 185468 1099514 109296959
Fluid retention 4063.71 16.10 2345 190481 91962 110304511
Death 3356.56 16.10 5029 187797 693840 109702633
Hospitalisation 2554.32 16.10 2060 190766 140433 110256040
Pain in jaw 2107.97 16.10 1237 191589 49940 110346533
Right ventricular failure 2068.97 16.10 976 191850 24978 110371495
Dyspnoea exertional 1837.46 16.10 1492 191334 102568 110293905
Pulmonary hypertension 1705.16 16.10 1111 191715 54109 110342364
Headache 1669.71 16.10 4292 188534 878085 109518388
Transfusion 1538.52 16.10 793 192033 24679 110371794
Hypervolaemia 1495.00 16.10 982 191844 48478 110347995
Drug ineffective 1437.43 16.10 438 192388 1520102 108876371
Nasal congestion 1366.59 16.10 1229 191597 97053 110299420
Oxygen saturation decreased 1290.22 16.10 1477 191349 155505 110240968
Off label use 1137.05 16.10 604 192222 1499581 108896892
Product dose omission issue 797.44 16.10 1743 191083 320039 110076434
Oedema peripheral 796.11 16.10 1764 191062 326896 110069577
Lung transplant 754.26 16.10 300 192526 4986 110391487
Catheter management 746.09 16.10 271 192555 3464 110393009
Pulmonary arterial hypertension 744.92 16.10 545 192281 32023 110364450
Pulmonary oedema 710.71 16.10 877 191949 99782 110296691
Oxygen consumption increased 695.81 16.10 289 192537 5396 110391077
Pneumonia 685.13 16.10 3180 189646 873534 109522939
Toxicity to various agents 684.02 16.10 38 192788 480517 109915956
Catheter site erythema 672.85 16.10 287 192539 5741 110390732
Catheterisation cardiac 665.47 16.10 287 192539 5904 110390569
Unevaluable event 662.74 16.10 657 192169 58570 110337903
Cough 651.09 16.10 2024 190802 459617 109936856
Infusion related reaction 613.75 16.10 10 192816 381152 110015321
Oedema 603.23 16.10 1209 191617 208767 110187706
Hypotension 590.75 16.10 2130 190696 521719 109874754
Flushing 587.72 16.10 815 192011 103921 110292552
Drug interaction 563.66 16.10 97 192729 500086 109896387
Catheter site pain 558.72 16.10 257 192569 6189 110390284
Neutropenia 538.02 16.10 28 192798 374592 110021881
Catheter site pruritus 523.62 16.10 184 192642 2122 110394351
Hypoxia 519.52 16.10 862 191964 128653 110267820
Infusion site pain 516.70 16.10 342 192484 17077 110379396
Febrile neutropenia 507.04 16.10 9 192817 316758 110079715
Cardiac failure 494.78 16.10 1043 191783 186583 110209890
Product use in unapproved indication 488.37 16.10 94 192732 447283 109949190
Cardiac failure congestive 471.81 16.10 901 191925 150099 110246374
Chest pain 465.83 16.10 1579 191247 374796 110021677
Diarrhoea 463.74 16.10 3481 189345 1136024 109260449
Pulmonary arterial pressure increased 461.94 16.10 210 192616 4917 110391556
Dizziness 454.19 16.10 2406 190420 695787 109700686
Dialysis 432.13 16.10 321 192505 19298 110377175
Peripheral swelling 431.49 16.10 1615 191211 402419 109994054
Therapy change 428.05 16.10 248 192578 9749 110386724
Drug hypersensitivity 426.22 16.10 131 192695 453959 109942514
Syncope 418.32 16.10 1022 191804 201514 110194959
Treatment failure 413.43 16.10 16 192810 277218 110119255
Completed suicide 405.24 16.10 3 192823 242378 110154095
Therapeutic product effect decreased 382.73 16.10 9 192817 244307 110152166
Stomatitis 382.31 16.10 22 192804 270220 110126253
Concomitant disease aggravated 374.50 16.10 274 192552 16090 110380383
Palpitations 362.94 16.10 835 191991 158377 110238096
Catheter placement 357.12 16.10 154 192672 3166 110393307
Catheter site discharge 353.00 16.10 148 192678 2831 110393642
Epistaxis 344.99 16.10 726 192100 129646 110266827
Glossodynia 340.90 16.10 10 192816 221994 110174479
Maternal exposure during pregnancy 339.46 16.10 28 192798 254855 110141618
Contraindicated product administered 334.19 16.10 26 192800 248241 110148232
Scleroderma 330.53 16.10 179 192647 6162 110390311
Device related infection 329.47 16.10 375 192451 39144 110357329
Malaise 328.31 16.10 2148 190678 669671 109726802
Alopecia 326.74 16.10 114 192712 364639 110031834
Intentional product use issue 325.33 16.10 29 192797 247877 110148596
Transplant evaluation 321.80 16.10 121 192705 1714 110394759
Arthropathy 316.59 16.10 59 192767 287463 110109010
Rheumatoid arthritis 312.25 16.10 70 192756 299543 110096930
Catheter site infection 307.24 16.10 185 192641 7815 110388658
Pericarditis 303.40 16.10 20 192806 219094 110177379
Catheter site rash 302.84 16.10 100 192726 940 110395533
Vascular device infection 297.85 16.10 240 192586 16272 110380201
Rash 297.78 16.10 616 192210 820348 109576125
Cardiac disorder 288.86 16.10 495 192331 75785 110320688
Feeling abnormal 287.75 16.10 828 191998 179883 110216590
Musculoskeletal stiffness 286.36 16.10 68 192758 279754 110116719
Hepatic enzyme increased 282.75 16.10 103 192723 320789 110075684
Pericardial effusion 280.88 16.10 418 192408 56799 110339674
Brain natriuretic peptide increased 275.49 16.10 196 192630 11013 110385460
Folliculitis 271.37 16.10 4 192822 167649 110228824
Nausea 264.91 16.10 3300 189526 1232390 109164083
Malignant neoplasm progression 263.92 16.10 9 192817 174558 110221915
Drug abuse 261.87 16.10 11 192815 177400 110219073
Device alarm issue 261.59 16.10 113 192713 2333 110394140
Helicobacter infection 259.68 16.10 14 192812 181863 110214610
Impaired healing 255.43 16.10 24 192802 196693 110199780
Therapeutic product effect incomplete 254.93 16.10 42 192784 223763 110172710
Catheter site haemorrhage 254.75 16.10 147 192679 5733 110390740
Blood cholesterol increased 252.51 16.10 18 192808 184767 110211706
Respiratory failure 246.54 16.10 881 191945 214451 110182022
Productive cough 242.45 16.10 583 192243 113722 110282751
Cardiac pacemaker insertion 237.57 16.10 144 192682 6157 110390316
Device occlusion 235.02 16.10 202 192624 14983 110381490
Catheter site swelling 234.33 16.10 103 192723 2221 110394252
Acute respiratory failure 232.35 16.10 447 192379 74813 110321660
Type 2 diabetes mellitus 231.77 16.10 21 192805 177211 110219262
Urticaria 230.34 16.10 135 192691 318722 110077751
Oxygen therapy 227.01 16.10 121 192705 4032 110392441
Thrombocytopenia 223.37 16.10 169 192657 348716 110047757
Chest discomfort 222.29 16.10 738 192088 173110 110223363
Muscle injury 221.20 16.10 5 192821 140802 110255671
Hypertension 220.36 16.10 343 192483 509741 109886732
Ascites 218.32 16.10 493 192333 92315 110304158
Abdominal distension 217.40 16.10 736 192090 174367 110222106
Confusional state 216.26 16.10 301 192525 468379 109928094
Infusion site erythema 216.07 16.10 174 192652 11785 110384688
Pulmonary veno-occlusive disease 212.71 16.10 94 192732 2054 110394419
Product use issue 212.66 16.10 141 192685 311554 110084919
Fibromyalgia 211.24 16.10 25 192801 170884 110225589
Infusion site infection 210.82 16.10 95 192731 2177 110394296
Drug intolerance 210.56 16.10 239 192587 406273 109990200
Osteoarthritis 206.35 16.10 35 192791 182588 110213885
Catheter site irritation 203.40 16.10 66 192760 584 110395889
Irritable bowel syndrome 200.55 16.10 25 192801 164190 110232283
Blister 200.21 16.10 73 192753 227303 110169170
Overdose 199.29 16.10 79 192747 233715 110162758
Aspiration pleural cavity 198.15 16.10 84 192742 1653 110394820
Acute kidney injury 196.26 16.10 519 192307 634911 109761562
Leukopenia 196.26 16.10 17 192809 148774 110247699
Cardiac operation 195.67 16.10 125 192701 5870 110390603
Paracentesis 194.67 16.10 78 192748 1322 110395151
Wound 193.72 16.10 83 192743 234354 110162119
Intentional overdose 192.95 16.10 9 192817 132492 110263981
Injury 189.54 16.10 39 192787 177226 110219247
Device leakage 188.71 16.10 183 192643 15865 110380608
Myalgia 187.66 16.10 827 191999 221554 110174919
Haemoglobin decreased 186.94 16.10 894 191932 247833 110148640
Pain in extremity 185.62 16.10 1468 191358 485650 109910823
Joint range of motion decreased 185.14 16.10 6 192820 121826 110274647
Hypersensitivity 184.80 16.10 261 192565 403737 109992736
Device dislocation 184.15 16.10 251 192575 31453 110365020
Liver transplant 183.71 16.10 109 192717 4480 110391993
Joint swelling 183.49 16.10 306 192520 442539 109953934
Mobility decreased 182.37 16.10 93 192733 237329 110159144
Lower respiratory tract infection 181.18 16.10 99 192727 243007 110153466
Rehabilitation therapy 177.45 16.10 83 192743 2078 110394395
Blood pressure decreased 177.01 16.10 521 192305 114570 110281903
Rhabdomyolysis 175.90 16.10 8 192818 120393 110276080
C-reactive protein increased 174.00 16.10 81 192745 217838 110178635
Neutrophil count decreased 173.60 16.10 9 192817 120932 110275541
Hospice care 173.17 16.10 156 192670 12317 110384156
Liver injury 171.77 16.10 28 192798 150385 110246088
Condition aggravated 170.97 16.10 1995 190831 732841 109663632
Disease complication 169.40 16.10 113 192713 5714 110390759
Chronic obstructive pulmonary disease 167.73 16.10 494 192332 108664 110287809
Blood potassium decreased 165.29 16.10 320 192506 53794 110342679
Internal haemorrhage 164.10 16.10 138 192688 9933 110386540
Emergency care 161.56 16.10 69 192757 1384 110395089
Bursitis 160.55 16.10 19 192807 129899 110266574
Influenza 159.01 16.10 650 192176 168451 110228022
Anaphylactic reaction 156.52 16.10 11 192815 114289 110282184
Systemic lupus erythematosus 155.44 16.10 129 192697 254209 110142264
Discomfort 153.46 16.10 92 192734 214615 110181858
Intentional product misuse 153.43 16.10 24 192802 132880 110263593
Ill-defined disorder 152.94 16.10 42 192784 156811 110239662
N-terminal prohormone brain natriuretic peptide increased 152.66 16.10 108 192718 6013 110390460
Psoriasis 149.24 16.10 31 192795 139962 110256511
Dizziness postural 146.82 16.10 153 192673 14456 110382017
Disease progression 146.50 16.10 824 192002 243210 110153263
Renal disorder 145.55 16.10 288 192538 49191 110347282
Electrocardiogram QT prolonged 144.92 16.10 12 192814 108948 110287525
Presyncope 144.34 16.10 285 192541 48602 110347871
Pulmonary congestion 141.71 16.10 219 192607 30747 110365726
Complication associated with device 141.70 16.10 175 192651 19898 110376575
Hypercholesterolaemia 139.73 16.10 4 192822 90833 110305640
Drug-induced liver injury 137.88 16.10 22 192804 120045 110276428
Delirium 137.70 16.10 33 192793 134992 110261481
Walking distance test abnormal 137.42 16.10 51 192775 695 110395778
Heart rate increased 136.10 16.10 554 192272 143280 110253193
Infusion site swelling 136.07 16.10 123 192703 9754 110386719
Myelosuppression 135.46 16.10 7 192819 94333 110302140
Dyspnoea at rest 135.24 16.10 114 192712 8232 110388241
Device infusion issue 134.25 16.10 77 192749 2968 110393505
Suicide attempt 133.17 16.10 13 192813 103381 110293092
Pleural effusion 132.92 16.10 638 192188 177071 110219402
Blood pressure increased 132.51 16.10 153 192673 258220 110138253
Obesity 131.91 16.10 20 192806 113331 110283142
Dermatitis contact 131.12 16.10 141 192685 13812 110382661
Lip dry 130.45 16.10 12 192814 100071 110296402
Central venous catheterisation 130.10 16.10 82 192744 3760 110392713
Left ventricular failure 128.55 16.10 127 192699 11262 110385211
Epilepsy 128.02 16.10 13 192813 100196 110296277
Angioedema 125.26 16.10 13 192813 98487 110297986
Therapy non-responder 125.14 16.10 575 192251 156732 110239741
Atrial septal defect repair 124.10 16.10 43 192783 474 110395999
Blood iron decreased 123.72 16.10 160 192666 19054 110377419
Seasonal allergy 123.51 16.10 162 192664 19560 110376913
Grip strength decreased 121.63 16.10 4 192822 80170 110316303
Infusion site haemorrhage 121.37 16.10 84 192742 4514 110391959
Abdominal cavity drainage 120.62 16.10 49 192777 862 110395611
Haemoptysis 120.36 16.10 334 192492 71020 110325453
Prescribed overdose 118.28 16.10 9 192817 87572 110308901
Stent placement 117.61 16.10 99 192727 7135 110389338
Catheter site inflammation 115.54 16.10 52 192774 1188 110395285
Pancytopenia 115.38 16.10 117 192709 209496 110186977
Anaemia 115.13 16.10 1458 191368 545628 109850845
General physical health deterioration 114.67 16.10 370 192456 424925 109971548
Pulmonary endarterectomy 113.12 16.10 34 192792 227 110396246
Inappropriate schedule of product administration 112.84 16.10 113 192713 203524 110192949
Mineral supplementation 112.73 16.10 46 192780 819 110395654
Asthma 112.10 16.10 164 192662 250127 110146346
Exposure during pregnancy 109.79 16.10 79 192747 167345 110229128
Red blood cell sedimentation rate increased 108.78 16.10 7 192819 78295 110318178
Bronchitis 108.33 16.10 551 192275 156481 110239992
Exercise tolerance decreased 108.26 16.10 119 192707 11948 110384525
Injection site reaction 107.67 16.10 14 192812 89056 110307417
Sedation 107.43 16.10 3 192823 69680 110326793
Atrial flutter 106.03 16.10 168 192658 24094 110372379
Night sweats 105.09 16.10 51 192775 133932 110262541
Endarterectomy 102.66 16.10 35 192791 366 110396107
Oropharyngeal pain 101.38 16.10 486 192340 134790 110261683
Sleep disorder 100.36 16.10 119 192707 198525 110197948
Prescribed underdose 99.77 16.10 3 192823 65171 110331302
Sinus congestion 99.04 16.10 185 192641 30274 110366199
Neoplasm progression 98.78 16.10 3 192823 64592 110331881
Paraesthesia 98.64 16.10 209 192617 276312 110120161
Metabolic acidosis 98.56 16.10 26 192800 99718 110296755
Cardioversion 97.78 16.10 57 192769 2266 110394207
Weight increased 97.63 16.10 1140 191686 418504 109977969
Blood creatine phosphokinase increased 97.31 16.10 8 192818 73069 110323404
Product quality issue 96.26 16.10 11 192815 77288 110319185
Pruritus 95.97 16.10 607 192219 580953 109815520
Drug ineffective for unapproved indication 95.73 16.10 30 192796 102808 110293665
Right ventricular dysfunction 95.53 16.10 64 192762 3259 110393214
Pulmonary arterial pressure abnormal 95.32 16.10 42 192784 911 110395562
Inflammation 95.25 16.10 118 192708 193120 110203353
Cardiac ablation 95.25 16.10 59 192767 2623 110393850
Medication error 94.12 16.10 33 192793 105333 110291140
Catheter site vesicles 93.32 16.10 33 192793 388 110396085
Hyponatraemia 92.28 16.10 148 192678 217505 110178968
Suicidal ideation 91.85 16.10 25 192801 93912 110302561
Live birth 91.45 16.10 8 192818 69476 110326997
Depression 91.24 16.10 268 192558 317067 110079406
Right ventricular dilatation 91.14 16.10 55 192771 2332 110394141
Coma 90.73 16.10 46 192780 117823 110278650
White blood cell count decreased 89.91 16.10 164 192662 229226 110167247
Pulmonary arterial wedge pressure increased 89.85 16.10 36 192790 610 110395863
Rhinorrhoea 88.95 16.10 385 192441 102281 110294192
Hepatitis 87.99 16.10 24 192802 90030 110306443
Cardiac failure high output 87.15 16.10 33 192793 477 110395996
Incorrect route of product administration 85.34 16.10 7 192819 64054 110332419
Wound infection 84.82 16.10 31 192795 96434 110300039
Depressed level of consciousness 84.67 16.10 45 192781 112233 110284240
Cognitive disorder 84.24 16.10 24 192802 87487 110308986
Catheter site related reaction 84.11 16.10 44 192782 1410 110395063
Transplant 83.69 16.10 42 192784 1232 110395241
Terminal state 82.88 16.10 73 192753 5594 110390879
Nasal dryness 82.45 16.10 73 192753 5633 110390840
Concomitant disease progression 81.58 16.10 60 192766 3550 110392923
Agranulocytosis 81.58 16.10 7 192819 61753 110334720
Chemotherapy 80.79 16.10 49 192777 2097 110394376
Hyperkalaemia 80.33 16.10 71 192755 135725 110260748
Lactic acidosis 79.64 16.10 31 192795 92780 110303693
Angioplasty 79.38 16.10 47 192779 1924 110394549
Infusion site discharge 79.33 16.10 47 192779 1926 110394547
Orthopnoea 79.27 16.10 97 192729 10924 110385549
Drug resistance 78.43 16.10 5 192821 56369 110340104
Cholestasis 78.32 16.10 10 192816 64508 110331965
Bone marrow failure 77.96 16.10 6 192820 57842 110338631
Fall 77.92 16.10 1481 191345 602001 109794472
Bradycardia 77.66 16.10 94 192732 155423 110241050
Blood pressure systolic increased 77.62 16.10 24 192802 82967 110313506
Peripheral venous disease 77.47 16.10 25 192801 84092 110312381
Disease recurrence 77.34 16.10 8 192818 60776 110335697
Injection site pain 77.30 16.10 119 192707 177803 110218670
Catheter site warmth 77.25 16.10 27 192799 306 110396167
Fatigue 76.51 16.10 2711 190115 1213247 109183226
Hallucination 75.97 16.10 41 192785 101391 110295082
Hernia repair 75.70 16.10 50 192776 2486 110393987
Multiple allergies 75.66 16.10 100 192726 12163 110384310
Eosinophilia 75.36 16.10 7 192819 57929 110338544
Hypocalcaemia 74.99 16.10 12 192814 65354 110331119
Colitis ulcerative 74.87 16.10 21 192805 77342 110319131
Systemic scleroderma 74.17 16.10 45 192781 1927 110394546
Hypoaesthesia 73.57 16.10 290 192536 313933 110082540
Injection site bruising 72.98 16.10 4 192822 51259 110345214
Tubulointerstitial nephritis 72.12 16.10 6 192820 54278 110342195
Infusion site irritation 72.12 16.10 37 192789 1138 110395335
Seizure 70.93 16.10 177 192649 221008 110175465
Hyperglycaemia 70.45 16.10 30 192796 85060 110311413
Wrong technique in product usage process 70.42 16.10 32 192794 87316 110309157
Biopsy lung 70.06 16.10 24 192802 255 110396218
Foot deformity 68.34 16.10 4 192822 48476 110347997
Infusion site warmth 68.08 16.10 41 192785 1732 110394741
Medical device change 67.91 16.10 27 192799 448 110396025
Device related sepsis 67.88 16.10 75 192751 7572 110388901
Oxygen saturation abnormal 67.88 16.10 65 192761 5546 110390927
Catheter site scab 67.85 16.10 23 192803 236 110396237
Hepatotoxicity 67.64 16.10 14 192812 63386 110333087
Exostosis 67.29 16.10 3 192823 45953 110350520
Cytomegalovirus infection 67.16 16.10 8 192818 54436 110342037
Dependence on oxygen therapy 66.35 16.10 30 192796 693 110395780
Head discomfort 66.32 16.10 119 192707 18881 110377592
Skin exfoliation 66.28 16.10 35 192791 87616 110308857
Atrial fibrillation 65.97 16.10 651 192175 228991 110167482
Cor pulmonale 65.51 16.10 44 192782 2250 110394223
Respiration abnormal 65.22 16.10 83 192743 9726 110386747
Drug dependence 65.17 16.10 6 192820 50014 110346459
Cardiac output increased 64.60 16.10 28 192798 583 110395890
Dysarthria 64.48 16.10 33 192793 84088 110312385
Neuropathy peripheral 64.32 16.10 135 192691 179142 110217331
Extra dose administered 64.25 16.10 92 192734 12067 110384406
Deep vein thrombosis 64.24 16.10 90 192736 139797 110256676
Therapeutic response decreased 63.95 16.10 45 192781 96454 110300019
Device connection issue 63.73 16.10 35 192791 1239 110395234
Iron deficiency anaemia 63.71 16.10 158 192668 31401 110365072
Onychomadesis 63.67 16.10 4 192822 45659 110350814
Hepatocellular injury 63.57 16.10 7 192819 50635 110345838
Cholecystectomy 63.41 16.10 86 192740 10723 110385750
Swollen tongue 63.03 16.10 14 192812 60348 110336125
Catheterisation cardiac abnormal 62.75 16.10 23 192803 302 110396171
Gout 62.48 16.10 172 192654 36394 110360079
Drug level increased 61.44 16.10 6 192820 47713 110348760
Heart and lung transplant 61.24 16.10 20 192806 181 110396292
Choking 61.08 16.10 101 192725 15009 110381464
Pericardial drainage 60.86 16.10 25 192801 453 110396020
Generalised tonic-clonic seizure 60.60 16.10 11 192815 54669 110341804
Ventilation perfusion mismatch 60.50 16.10 29 192797 768 110395705
Lymphocyte count decreased 60.33 16.10 13 192813 57230 110339243
Nasopharyngitis 59.05 16.10 991 191835 393370 110003103
Chronic respiratory failure 58.53 16.10 51 192775 3852 110392621
Diagnostic procedure 58.37 16.10 19 192807 170 110396303
Hypoglycaemia 58.15 16.10 70 192756 116034 110280439
Blood bilirubin increased 57.66 16.10 274 192552 75698 110320775
Eczema 57.47 16.10 27 192799 72266 110324207
Plasma cell myeloma 57.44 16.10 19 192807 62917 110333556
Cardiac flutter 57.32 16.10 60 192766 5697 110390776
Gastrointestinal haemorrhage 57.04 16.10 488 192338 165030 110231443
Psychotic disorder 56.99 16.10 10 192816 50927 110345546
Sinus disorder 56.97 16.10 155 192671 32573 110363900
Coeliac disease 56.75 16.10 5 192821 43182 110353291
Cardiac failure acute 56.69 16.10 128 192698 23950 110372523
Catheter removal 56.51 16.10 26 192800 626 110395847
Biopsy liver 56.48 16.10 26 192800 627 110395846
Pneumocystis jirovecii pneumonia 56.02 16.10 5 192821 42730 110353743
Muscular weakness 55.82 16.10 233 192593 248235 110148238
Aggression 55.59 16.10 17 192809 59193 110337280
Accidental exposure to product 55.56 16.10 10 192816 49998 110346475
Hip fracture 54.84 16.10 160 192666 34991 110361482
Hypercalcaemia 54.81 16.10 8 192818 46649 110349824
Surgery 54.26 16.10 177 192649 41106 110355367
Product supply issue 53.83 16.10 48 192778 3738 110392735
Hypoacusis 53.78 16.10 159 192667 35032 110361441
Hallucination, visual 53.67 16.10 4 192822 39601 110356872
Product administration interrupted 53.26 16.10 81 192745 11211 110385262
Pulmonary vascular resistance abnormality 52.15 16.10 18 192808 196 110396277
Wheezing 52.12 16.10 248 192578 254982 110141491
Thrombosis in device 52.12 16.10 55 192771 5272 110391201
Localised oedema 52.02 16.10 72 192754 9151 110387322
Cellulitis 51.86 16.10 387 192439 125629 110270844
Lymphopenia 51.85 16.10 5 192821 40165 110356308
Treatment noncompliance 51.63 16.10 258 192568 72732 110323741
Sciatica 51.48 16.10 51 192775 92348 110304125
Biopsy 50.33 16.10 25 192801 717 110395756
Vascular device occlusion 49.58 16.10 24 192802 650 110395823
Pulmonary pain 49.55 16.10 58 192768 6235 110390238
Acute myocardial infarction 49.31 16.10 44 192782 83733 110312740
Dizziness exertional 49.30 16.10 25 192801 750 110395723
Choking sensation 49.20 16.10 49 192777 4387 110392086
Head injury 49.15 16.10 176 192650 42841 110353632
Loss of consciousness 49.05 16.10 541 192285 195765 110200708
Decreased appetite 49.00 16.10 1130 191696 474716 109921757
Cardiomegaly 48.76 16.10 136 192690 28994 110367479
Medical procedure 48.74 16.10 22 192804 506 110395967
Jugular vein distension 48.57 16.10 32 192794 1584 110394889
Carbon dioxide increased 48.47 16.10 40 192786 2804 110393669
Basal cell carcinoma 48.29 16.10 10 192816 45260 110351213
Application site pruritus 48.09 16.10 47 192779 4113 110392360
Biopsy bone marrow 47.94 16.10 21 192805 449 110396024
Gait inability 47.83 16.10 104 192722 136272 110260201
Product prescribing error 47.72 16.10 15 192811 51316 110345157
Autoimmune disorder 46.84 16.10 28 192798 65455 110331018
Dyspepsia 46.67 16.10 524 192302 190441 110206032
Nocturnal dyspnoea 46.57 16.10 33 192793 1842 110394631
Ischaemic stroke 46.39 16.10 8 192818 41255 110355218
Hyperhidrosis 46.31 16.10 169 192657 187129 110209344
Acute myeloid leukaemia 46.03 16.10 6 192820 38104 110358369
Catheter site discolouration 45.90 16.10 15 192811 136 110396337
Infusion site induration 45.67 16.10 29 192797 1347 110395126
Right ventricular enlargement 45.50 16.10 26 192800 995 110395478
Diabetic ketoacidosis 45.46 16.10 9 192817 42049 110354424
Osteoporosis 45.31 16.10 51 192775 87101 110309372
Arthralgia 45.28 16.10 1025 191801 778607 109617866
Encephalopathy 44.85 16.10 45 192781 81010 110315463
No adverse event 44.40 16.10 38 192788 73801 110322672
Pancreatitis acute 44.21 16.10 25 192801 60249 110336224
Cyanosis 44.14 16.10 133 192693 29608 110366865
Faeces discoloured 44.12 16.10 145 192681 33803 110362670
Device physical property issue 44.11 16.10 43 192783 3751 110392722
Pulmonary artery dilatation 44.07 16.10 22 192804 638 110395835
Influenza like illness 43.73 16.10 284 192542 88128 110308345
Heart valve operation 43.73 16.10 16 192810 209 110396264
Pulmonary arterial pressure decreased 43.54 16.10 14 192812 120 110396353
Acute hepatic failure 43.43 16.10 6 192820 36462 110360011
Dry mouth 43.37 16.10 190 192636 199758 110196715
Skin lesion 43.06 16.10 18 192808 51613 110344860
Respiratory tract congestion 43.01 16.10 135 192691 30722 110365751
Tracheostomy 42.92 16.10 29 192797 1498 110394975
Myoclonus 42.88 16.10 4 192822 32994 110363479
Device breakage 42.74 16.10 82 192744 13687 110382786
Drug eruption 42.72 16.10 20 192806 53639 110342834
Catheter site erosion 42.52 16.10 12 192814 62 110396411
Hepatic steatosis 42.41 16.10 16 192810 48815 110347658
Agitation 42.36 16.10 83 192743 112968 110283505
Pregnancy 42.28 16.10 18 192808 51049 110345424
Paranasal sinus hypersecretion 42.09 16.10 46 192780 4588 110391885
Blood pressure abnormal 41.86 16.10 109 192717 22315 110374158
Haemorrhage 41.85 16.10 324 192502 106368 110290105
Right ventricular systolic pressure increased 41.77 16.10 25 192801 1044 110395429
Heart valve replacement 41.69 16.10 26 192800 1170 110395303
Device maintenance issue 41.66 16.10 13 192813 100 110396373
Mouth ulceration 41.43 16.10 16 192810 48122 110348351
Right-to-left cardiac shunt 41.39 16.10 17 192809 308 110396165
Congestive hepatopathy 40.92 16.10 48 192778 5172 110391301
Ataxia 40.92 16.10 3 192823 30105 110366368
Infection 40.75 16.10 419 192407 361781 110034692
Altered state of consciousness 40.72 16.10 25 192801 57601 110338872
Status epilepticus 40.57 16.10 4 192822 31567 110364906
Bronchopulmonary aspergillosis 40.51 16.10 3 192823 29860 110366613
Obstructive airways disorder 40.28 16.10 15 192811 46134 110350339
Gastroenteritis viral 40.25 16.10 133 192693 31093 110365380
Polypectomy 40.18 16.10 28 192798 1521 110394952
Ammonia increased 40.08 16.10 60 192766 8190 110388283
Pulmonary thrombosis 39.93 16.10 80 192746 13783 110382690
Drug delivery system malfunction 39.91 16.10 24 192802 1011 110395462
Sinus bradycardia 39.89 16.10 3 192823 29480 110366993
Tooth extraction 39.88 16.10 77 192749 12914 110383559
Atrial septal defect 39.66 16.10 32 192794 2173 110394300
Pyrexia 39.53 16.10 1229 191597 897036 109499437
Acute right ventricular failure 39.37 16.10 18 192808 427 110396046
Injection site infection 39.12 16.10 34 192792 2559 110393914
Injection site erythema 39.00 16.10 65 192761 94111 110302362
Gastrointestinal tube insertion 38.87 16.10 31 192795 2070 110394403
Proteinuria 38.46 16.10 11 192815 40007 110356466
Infusion site abscess 38.28 16.10 17 192809 376 110396097
Onychomycosis 38.14 16.10 10 192816 38521 110357952
Ejection fraction decreased 37.91 16.10 12 192814 40868 110355605
Catheter site dermatitis 37.83 16.10 12 192814 98 110396375
Body temperature decreased 37.70 16.10 9 192817 36926 110359547
Joint dislocation 37.63 16.10 7 192819 34183 110362290
Infusion site pruritus 37.52 16.10 45 192781 4963 110391510
Hip surgery 37.52 16.10 41 192785 4089 110392384
Colonoscopy 37.37 16.10 31 192795 2189 110394284
Localised infection 36.94 16.10 161 192665 42887 110353586
Labelled drug-drug interaction medication error 36.91 16.10 4 192822 29298 110367175
Emotional distress 36.82 16.10 16 192810 44831 110351642
Myelodysplastic syndrome 36.59 16.10 10 192816 37474 110358999
Arteriovenous malformation 36.55 16.10 29 192797 1922 110394551
Pericardial excision 36.39 16.10 10 192816 46 110396427
Endotracheal intubation 36.22 16.10 49 192777 6095 110390378
Blood lactate dehydrogenase increased 36.11 16.10 16 192810 44318 110352155
Hypophosphataemia 36.08 16.10 7 192819 33175 110363298
Oxygen consumption 35.79 16.10 11 192815 80 110396393
Cytopenia 35.76 16.10 5 192821 30111 110366362
Catheter site nodule 35.38 16.10 10 192816 52 110396421
Pneumonitis 35.37 16.10 49 192777 76482 110319991
Rash erythematous 35.27 16.10 55 192771 81777 110314696
Retching 35.15 16.10 103 192723 22579 110373894
Catheter site extravasation 35.07 16.10 18 192808 554 110395919
Prostate cancer 34.99 16.10 11 192815 37630 110358843
Impaired work ability 34.88 16.10 3 192823 26416 110370057
Hallucination, auditory 34.84 16.10 3 192823 26394 110370079
Gastrointestinal surgery 34.75 16.10 15 192811 309 110396164
Pulmonary artery aneurysm 34.52 16.10 13 192813 185 110396288
Secretion discharge 34.36 16.10 95 192731 20149 110376324
Cardiac pacemaker replacement 34.34 16.10 17 192809 484 110395989
Vasculitis 34.22 16.10 10 192816 35863 110360610
Pulmonary embolism 34.20 16.10 226 192600 214248 110182225
Chest tube insertion 34.18 16.10 12 192814 138 110396335
Renal tubular necrosis 34.06 16.10 6 192820 30469 110366004
Device malfunction 33.97 16.10 110 192716 25448 110371025
Asthenia 33.94 16.10 1497 191329 687502 109708971
Diuretic therapy 33.83 16.10 13 192813 196 110396277
Haematuria 33.71 16.10 58 192768 82947 110313526
Generalised oedema 33.70 16.10 124 192702 30580 110365893
Aspergillus infection 33.57 16.10 3 192823 25613 110370860
Portopulmonary hypertension 33.57 16.10 12 192814 146 110396327
Colitis 33.48 16.10 81 192745 102242 110294231
Immunodeficiency 33.27 16.10 13 192813 38825 110357648
Right atrial pressure increased 33.23 16.10 15 192811 345 110396128
Lip swelling 33.08 16.10 24 192802 50643 110345830
Viral infection 32.88 16.10 181 192645 52958 110343515
Upper respiratory tract congestion 32.86 16.10 33 192793 2984 110393489
Gastrointestinal disorder 32.80 16.10 267 192559 241685 110154788
Contusion 32.80 16.10 255 192571 233106 110163367
Lung operation 32.73 16.10 15 192811 358 110396115
Thrombectomy 32.53 16.10 15 192811 363 110396110
Sluggishness 32.52 16.10 52 192774 7515 110388958
COVID-19 32.50 16.10 272 192554 244788 110151685
Ear discomfort 32.50 16.10 65 192761 11184 110385289
Hysterectomy 32.48 16.10 54 192772 8060 110388413
Neutrophil count increased 32.44 16.10 10 192816 34642 110361831
Therapeutic procedure 32.25 16.10 21 192805 1019 110395454
Pancreatitis 32.24 16.10 72 192754 93461 110303012
Oesophageal variceal ligation 32.24 16.10 12 192814 165 110396308
Disseminated intravascular coagulation 31.93 16.10 16 192810 41270 110355203
Transplant rejection 31.86 16.10 3 192823 24564 110371909
Hypomagnesaemia 31.74 16.10 35 192791 60335 110336138
Paranasal sinus discomfort 31.72 16.10 47 192779 6358 110390115
Nephropathy toxic 31.62 16.10 5 192821 27473 110369000
Disturbance in attention 31.44 16.10 37 192789 61958 110334515
Metastases to bone 31.33 16.10 8 192818 31364 110365109
Diplopia 31.27 16.10 17 192809 41877 110354596
Impaired quality of life 31.26 16.10 7 192819 30010 110366463
Decreased activity 31.21 16.10 63 192763 10911 110385562
Joint stiffness 31.13 16.10 43 192783 67200 110329273
Medical device implantation 30.95 16.10 17 192809 602 110395871
Transaminases increased 30.92 16.10 39 192787 63351 110333122
Mixed connective tissue disease 30.86 16.10 15 192811 410 110396063
Cardiac index increased 30.85 16.10 8 192818 28 110396445
Sickle cell disease 30.81 16.10 12 192814 188 110396285
Cancer surgery 30.78 16.10 20 192806 967 110395506
Drug withdrawal syndrome 30.58 16.10 14 192812 38040 110358433
Echocardiogram abnormal 30.51 16.10 30 192796 2644 110393829
Vasodilatation 30.30 16.10 35 192791 3709 110392764
Device issue 30.28 16.10 130 192696 34405 110362068
Nightmare 30.15 16.10 15 192811 38848 110357625
Heart transplant 30.07 16.10 24 192802 1604 110394869
Walking disability 30.04 16.10 29 192797 2499 110393974
Intracardiac pressure increased 30.01 16.10 8 192818 32 110396441
Myopathy 29.98 16.10 4 192822 24956 110371517
Limb operation 29.89 16.10 36 192790 3988 110392485
Poisoning 29.89 16.10 7 192819 29098 110367375
Cerebral infarction 29.58 16.10 28 192798 51810 110344663
Peritonitis 29.48 16.10 10 192816 32597 110363876
Withdrawal syndrome 29.48 16.10 9 192817 31371 110365102
Ear congestion 29.23 16.10 34 192792 3631 110392842
Myositis 29.09 16.10 9 192817 31107 110365366
CREST syndrome 29.07 16.10 15 192811 467 110396006
Hypertensive crisis 29.05 16.10 4 192822 24368 110372105
Aplastic anaemia 28.95 16.10 4 192822 24304 110372169
Suture related complication 28.92 16.10 14 192812 379 110396094
Abnormal behaviour 28.91 16.10 16 192810 39023 110357450
Wrong dose 28.90 16.10 29 192797 2620 110393853
Injection site pruritus 28.89 16.10 28 192798 51230 110345243
Cataract operation 28.89 16.10 43 192783 5840 110390633
Weight decreased 28.85 16.10 1042 191784 467015 109929458
Dry skin 28.72 16.10 94 192732 107559 110288914
Torsade de pointes 28.68 16.10 3 192823 22597 110373876
Therapy cessation 28.57 16.10 154 192672 44703 110351770
Back pain 28.56 16.10 848 191978 370148 110026325
Abortion spontaneous 28.51 16.10 12 192814 34270 110362203
Coronary artery disease 28.29 16.10 51 192775 71639 110324834
Dialysis related complication 28.11 16.10 13 192813 317 110396156
Gastric disorder 28.05 16.10 124 192702 33233 110363240
Chronic sinusitis 27.90 16.10 5 192821 25079 110371394
Sinus tachycardia 27.86 16.10 22 192804 44471 110352002
Adrenal insufficiency 27.78 16.10 20 192806 42370 110354103
Therapy partial responder 27.72 16.10 15 192811 37046 110359427
Throat irritation 27.70 16.10 174 192652 53378 110343095
Gallbladder operation 27.59 16.10 27 192799 2366 110394107
Infusion site discolouration 27.54 16.10 18 192808 879 110395594
Brain natriuretic peptide abnormal 27.34 16.10 18 192808 890 110395583
Knee operation 27.13 16.10 46 192780 6976 110389497
Cardiac monitoring 27.10 16.10 7 192819 24 110396449
Bronchiectasis 26.96 16.10 15 192811 36478 110359995
Right ventricular hypertrophy 26.87 16.10 23 192803 1696 110394777
Blood culture negative 26.79 16.10 12 192814 271 110396202
Cardiac procedure complication 26.79 16.10 13 192813 354 110396119
Sickle cell anaemia 26.77 16.10 17 192809 790 110395683
Cardiorenal syndrome 26.65 16.10 24 192802 1894 110394579
Pulmonary capillary haemangiomatosis 26.41 16.10 9 192817 94 110396379
Conjunctivitis 26.28 16.10 13 192813 33779 110362694
Chronic hepatic failure 26.22 16.10 20 192806 1251 110395222
Amnesia 26.12 16.10 95 192731 105313 110291160
Paraesthesia oral 26.12 16.10 13 192813 33658 110362815
Hyperlipidaemia 26.10 16.10 15 192811 35833 110360640
Drug titration 26.06 16.10 7 192819 29 110396444
Cardiomyopathy 25.92 16.10 13 192813 33512 110362961
Paranoia 25.91 16.10 4 192822 22370 110374103
Injection site discharge 25.86 16.10 21 192805 1439 110395034
Drug tolerance decreased 25.69 16.10 8 192818 27532 110368941
Endoscopy 25.64 16.10 14 192812 490 110395983
Visual acuity reduced 25.60 16.10 12 192814 32161 110364312
Mydriasis 25.57 16.10 4 192822 22153 110374320
Dry eye 25.50 16.10 36 192790 55757 110340716
Diabetes mellitus inadequate control 25.45 16.10 10 192816 29765 110366708
Injection site swelling 25.25 16.10 43 192783 61747 110334726
Erythema 25.18 16.10 357 192469 291090 110105383
Somnolence 25.12 16.10 366 192460 297083 110099390
Catheter culture positive 25.12 16.10 11 192815 235 110396238
Blood glucose decreased 25.08 16.10 110 192716 29378 110367095
Portal hypertension 25.06 16.10 50 192776 8587 110387886
Schizophrenia 25.05 16.10 4 192822 21822 110374651
Skin fissures 24.88 16.10 6 192820 24452 110372021
Biopsy kidney 24.78 16.10 11 192815 243 110396230
Dyskinesia 24.73 16.10 32 192794 51414 110345059
Acute respiratory distress syndrome 24.64 16.10 34 192792 53164 110343309
Infusion site nodule 24.64 16.10 13 192813 424 110396049
Blood glucose increased 24.61 16.10 133 192693 132363 110264110
Skin necrosis 24.56 16.10 4 192822 21508 110374965
Application site irritation 24.50 16.10 23 192803 1914 110394559
Taste disorder 24.50 16.10 48 192778 65339 110331134
Sensory loss 24.47 16.10 4 192822 21453 110375020
Metastases to central nervous system 24.42 16.10 5 192821 22812 110373661
Life support 24.31 16.10 13 192813 436 110396037
Myocarditis 24.24 16.10 11 192815 30044 110366429
Aphasia 24.16 16.10 41 192785 58956 110337517
Cardiac discomfort 24.16 16.10 20 192806 1408 110395065
Brain oedema 24.13 16.10 12 192814 31086 110365387
Wound treatment 24.11 16.10 10 192816 186 110396287
Cardiothoracic ratio increased 24.06 16.10 8 192818 77 110396396
Suture insertion 23.97 16.10 12 192814 350 110396123
Arteriosclerosis coronary artery 23.96 16.10 7 192819 25111 110371362
Loss of personal independence in daily activities 23.95 16.10 158 192668 149862 110246611
Hypothermia 23.90 16.10 8 192818 26294 110370179
Renal failure 23.88 16.10 540 192286 226034 110170439
Blood pressure fluctuation 23.87 16.10 60 192766 74764 110321709
Respiratory depression 23.86 16.10 13 192813 31988 110364485
Haematocrit decreased 23.86 16.10 197 192629 65920 110330553
Unevaluable investigation 23.79 16.10 8 192818 80 110396393
Blood pressure systolic decreased 23.74 16.10 64 192762 13377 110383096
Urinary retention 23.72 16.10 54 192772 69629 110326844
Oral herpes 23.67 16.10 17 192809 36063 110360410
Mechanical ventilation 23.61 16.10 29 192797 3278 110393195
Infusion site discomfort 23.60 16.10 22 192804 1815 110394658
Arteriosclerosis 23.45 16.10 7 192819 24760 110371713
Mania 23.45 16.10 4 192822 20792 110375681
Eye operation 23.40 16.10 26 192800 2641 110393832
Osteonecrosis 23.34 16.10 15 192811 33726 110362747
Feeling cold 23.23 16.10 119 192707 33868 110362605
Diet noncompliance 23.23 16.10 14 192812 592 110395881
Arthritis 23.13 16.10 184 192642 167402 110229071
Middle ear effusion 23.13 16.10 26 192800 2675 110393798
Flatulence 23.08 16.10 163 192663 51986 110344487
Diabetes mellitus 23.05 16.10 92 192734 99289 110297184
Motor dysfunction 22.92 16.10 7 192819 24399 110372074
Chills 22.92 16.10 463 192363 190117 110206356
Polyarthritis 22.87 16.10 3 192823 18960 110377513
Haemodynamic test abnormal 22.76 16.10 7 192819 51 110396422
Sinus headache 22.63 16.10 39 192787 5993 110390480
Infusion site vesicles 22.63 16.10 14 192812 621 110395852
Urine output decreased 22.43 16.10 81 192745 19795 110376678
Pyelonephritis 22.39 16.10 8 192818 25242 110371231
Blood triglycerides increased 22.23 16.10 7 192819 23919 110372554
Drug level decreased 22.21 16.10 3 192823 18545 110377928
Vomiting 22.12 16.10 1859 190967 908816 109487657
Bone disorder 21.95 16.10 5 192821 21187 110375286
Aortic valve replacement 21.91 16.10 20 192806 1606 110394867
Biopsy lymph gland 21.90 16.10 8 192818 104 110396369
Aphthous ulcer 21.87 16.10 5 192821 21131 110375342
Erythema multiforme 21.81 16.10 5 192821 21092 110375381
Bedridden 21.80 16.10 62 192764 13363 110383110
Activated partial thromboplastin time prolonged 21.77 16.10 6 192820 22362 110374111
Dialysis device insertion 21.77 16.10 7 192819 60 110396413
Upper-airway cough syndrome 21.76 16.10 69 192757 15788 110380685
Cardiac index decreased 21.71 16.10 9 192817 167 110396306
Benign prostatic hyperplasia 21.71 16.10 3 192823 18231 110378242
Drug titration error 21.69 16.10 20 192806 1627 110394846
Catheter site induration 21.67 16.10 7 192819 61 110396412
Adverse event 21.54 16.10 287 192539 108522 110287951
Cor pulmonale chronic 21.54 16.10 12 192814 437 110396036
Disability 21.51 16.10 13 192813 30210 110366263
Cardiac septal defect 21.48 16.10 16 192810 965 110395508
Vascular resistance pulmonary increased 21.43 16.10 8 192818 111 110396362
Immune tolerance induction 21.41 16.10 4 192822 0 110396473
Cranial operation 21.41 16.10 4 192822 0 110396473
Vena cava filter removal 21.41 16.10 4 192822 0 110396473
Infusion site cellulitis 21.37 16.10 12 192814 444 110396029
Pulmonary hypertensive crisis 21.34 16.10 12 192814 445 110396028
Thoracic cavity drainage 21.33 16.10 11 192815 342 110396131
Oesophagogastroduodenoscopy 21.32 16.10 10 192816 252 110396221
Balloon atrial septostomy 21.30 16.10 8 192818 113 110396360
Vascular operation 21.23 16.10 9 192817 177 110396296
Multiple organ dysfunction syndrome 21.20 16.10 166 192660 151544 110244929
Transcatheter aortic valve implantation 21.18 16.10 7 192819 66 110396407
Spinal operation 21.17 16.10 54 192772 10918 110385555
Normal newborn 21.08 16.10 6 192820 21890 110374583
Jaundice 20.91 16.10 45 192781 59191 110337282
Gastrointestinal endoscopic therapy 20.81 16.10 7 192819 70 110396403
Lung neoplasm malignant 20.75 16.10 115 192711 33727 110362746
Nervous system disorder 20.74 16.10 15 192811 31706 110364767
Coordination abnormal 20.71 16.10 9 192817 25219 110371254
Frequent bowel movements 20.70 16.10 60 192766 71330 110325143
Dermatitis bullous 20.60 16.10 3 192823 17526 110378947
Ventricular fibrillation 20.58 16.10 25 192801 41288 110355185
Hemiplegia 20.57 16.10 7 192819 22775 110373698
Spinal osteoarthritis 20.44 16.10 5 192821 20178 110376295
Hemiparesis 20.40 16.10 28 192798 43875 110352598
Platelet transfusion 20.39 16.10 25 192801 2821 110393652
Tendonitis 20.34 16.10 10 192816 26073 110370400
Hepatitis acute 20.32 16.10 4 192822 18762 110377711
Epstein-Barr virus infection 20.27 16.10 4 192822 18734 110377739
Delusion 20.27 16.10 8 192818 23747 110372726
Pulmonary arterial pressure 20.23 16.10 6 192820 38 110396435
Klebsiella infection 20.18 16.10 5 192821 20004 110376469
Bronchospasm 20.17 16.10 14 192812 30225 110366248
Hepatopulmonary syndrome 20.10 16.10 9 192817 203 110396270
Catheter site dryness 20.10 16.10 6 192820 39 110396434
Musculoskeletal pain 20.04 16.10 213 192613 182810 110213663
Lower limb fracture 19.95 16.10 66 192760 75282 110321191
Biopsy breast 19.94 16.10 8 192818 136 110396337
Abdominal pain 19.88 16.10 713 192113 512276 109884197
Spontaneous intrahepatic portosystemic venous shunt 19.86 16.10 5 192821 15 110396458
Haemolytic anaemia 19.65 16.10 6 192820 20914 110375559
Idiopathic pulmonary fibrosis 19.63 16.10 33 192793 4971 110391502
Anxiety 19.60 16.10 455 192371 344623 110051850
Phlebotomy 19.59 16.10 7 192819 85 110396388
Oral surgery 19.59 16.10 18 192808 1458 110395015
Hypercapnia 19.57 16.10 53 192773 11106 110385367
Telangiectasia 19.48 16.10 20 192806 1857 110394616
Palliative care 19.45 16.10 19 192807 1661 110394812
Bronchial artery embolisation 19.39 16.10 5 192821 17 110396456
Upper limb fracture 19.38 16.10 80 192746 20808 110375665
Hydronephrosis 19.28 16.10 6 192820 20659 110375814
Critical illness 19.22 16.10 12 192814 541 110395932
Infusion site rash 19.13 16.10 22 192804 2321 110394152
Cardiac septal defect repair 18.96 16.10 5 192821 19 110396454
Mood swings 18.95 16.10 8 192818 22804 110373669
Respiratory syncytial virus infection 18.94 16.10 62 192764 14422 110382051
Myasthenia gravis 18.76 16.10 7 192819 21504 110374969
Left ventricular end-diastolic pressure increased 18.68 16.10 13 192813 705 110395768
Application site hypersensitivity 18.63 16.10 10 192816 338 110396135
Food poisoning 18.63 16.10 37 192789 6335 110390138
Muscle twitching 18.50 16.10 15 192811 29920 110366553
Catheter site bruise 18.49 16.10 12 192814 579 110395894
Back injury 18.45 16.10 34 192792 47365 110349108
Creatinine renal clearance abnormal 18.42 16.10 13 192813 721 110395752
Brain natriuretic peptide 18.40 16.10 6 192820 54 110396419
Blood pressure diastolic increased 18.39 16.10 5 192821 18802 110377671
Argon plasma coagulation 18.37 16.10 5 192821 22 110396451
Orthostatic hypotension 18.26 16.10 57 192769 66192 110330281
Food allergy 18.24 16.10 6 192820 19942 110376531
Injection site rash 18.23 16.10 9 192817 23410 110373063
Mitral valve repair 18.21 16.10 10 192816 354 110396119
Abdominal pain upper 18.14 16.10 763 192063 348348 110048125
Eosinophil count increased 18.12 16.10 7 192819 21051 110375422
Osteopenia 18.11 16.10 8 192818 22201 110374272
Craniotomy 18.07 16.10 12 192814 602 110395871
Infusion site inflammation 18.07 16.10 11 192815 474 110395999
Limb injury 18.06 16.10 120 192706 37516 110358957
Purpura 18.05 16.10 10 192816 24378 110372095
Primary biliary cholangitis 18.04 16.10 17 192809 1422 110395051
Erectile dysfunction 18.02 16.10 5 192821 18551 110377922
Squamous cell carcinoma of skin 17.94 16.10 4 192822 17199 110379274
Brain operation 17.94 16.10 14 192812 906 110395567
Oxygen saturation increased 17.89 16.10 13 192813 755 110395718
Cardiac output decreased 17.86 16.10 20 192806 2049 110394424
Liver ablation 17.85 16.10 5 192821 25 110396448
Galectin-3 increased 17.85 16.10 5 192821 25 110396448
Acute coronary syndrome 17.81 16.10 9 192817 23103 110373370
Kidney infection 17.76 16.10 90 192736 25509 110370964
Blood sodium decreased 17.68 16.10 121 192705 38198 110358275
Thoracotomy 17.61 16.10 8 192818 187 110396286
Pregnancy test positive 17.56 16.10 7 192819 117 110396356
Oesophageal motility disorder 17.52 16.10 13 192813 780 110395693
Intra-abdominal fluid collection 17.48 16.10 27 192799 3787 110392686
Radiculopathy 17.36 16.10 6 192820 19330 110377143
Gastrointestinal arteriovenous malformation 17.35 16.10 14 192812 951 110395522
Heart disease congenital 17.25 16.10 12 192814 650 110395823
Psychiatric evaluation 17.23 16.10 5 192821 29 110396444
Bronchoscopy 17.14 16.10 7 192819 125 110396348
Vaginal discharge 17.07 16.10 5 192821 17903 110378570
Heavy menstrual bleeding 17.05 16.10 65 192761 16300 110380173
Culture negative 17.03 16.10 4 192822 8 110396465
Psychomotor hyperactivity 17.02 16.10 7 192819 20270 110376203
Drug tolerance 17.01 16.10 4 192822 16581 110379892
Ventricular septal defect repair 16.95 16.10 5 192821 31 110396442
Product dose omission in error 16.89 16.10 10 192816 23502 110372971
Procedural complication 16.88 16.10 42 192784 8363 110388110
Dysentery 16.81 16.10 16 192810 1355 110395118
Nervousness 16.79 16.10 116 192710 36735 110359738
Metastases to lymph nodes 16.71 16.10 3 192823 15029 110381444
Hyperphosphataemia 16.70 16.10 4 192822 16377 110380096
Oral candidiasis 16.64 16.10 33 192793 44727 110351746
Petechiae 16.63 16.10 10 192816 23307 110373166
Hypothyroidism 16.58 16.10 68 192758 72831 110323642
Respiratory symptom 16.58 16.10 3 192823 14942 110381531
Haematotoxicity 16.56 16.10 8 192818 21074 110375399
Clostridium difficile infection 16.55 16.10 151 192675 51978 110344495
Bladder neoplasm surgery 16.43 16.10 5 192821 35 110396438
Dehydration 16.41 16.10 619 192207 278892 110117581
Renal transplant 16.38 16.10 24 192802 3214 110393259
Respiratory distress 16.36 16.10 188 192638 68686 110327787
Thrombotic microangiopathy 16.34 16.10 16 192810 29133 110367340
Toe amputation 16.21 16.10 28 192798 4310 110392163
Foetal death 16.20 16.10 4 192822 16041 110380432

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C02KX04 CARDIOVASCULAR SYSTEM
ANTIHYPERTENSIVES
OTHER ANTIHYPERTENSIVES
Antihypertensives for pulmonary arterial hypertension
ATC C02KX54 CARDIOVASCULAR SYSTEM
ANTIHYPERTENSIVES
OTHER ANTIHYPERTENSIVES
Antihypertensives for pulmonary arterial hypertension
FDA MoA N0000175364 Endothelin Receptor Antagonists
FDA EPC N0000175581 Endothelin Receptor Antagonist
MeSH PA D065128 Endothelin Receptor Antagonists
MeSH PA D065130 Endothelin A Receptor Antagonists
MeSH PA D065131 Endothelin B Receptor Antagonists
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:49201 anti-ulcer drug
CHEBI has role CHEBI:51451 endothelin receptor antagonist
CHEBI has role CHEBI:71031 orphan drug
CHEBI has role CHEBI:233423 antifibrotic agent

Related Drugs by ATC class:

C02KX Antihypertensives for pulmonary arterial hypertension 6 drugs
ambrisentanbosentanriociguatsitaxentansotatercept-csrktadalafil

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

DiseaseRelationSNOMED_IDDOID
Pulmonary arterial hypertension indication 11399002
Pregnancy, function contraindication 289908002




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 5.83 acidic
pKa2 10.58 acidic
pKa3 2.37 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG OPSUMIT ACTELION N204410 Oct. 18, 2013 RX TABLET ORAL 10946015 Sept. 11, 2026 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING MACITENTAN AND A POLYSORBATE, WHEREIN THE POLYSORBATE REPRESENTS 0.1 TO 1% OF THE WEIGHT OF SAID PHARMACEUTICAL COMPOSITION
10MG;20MG OPSYNVI ACTELION N218490 March 22, 2024 RX TABLET ORAL 10946015 Sept. 11, 2026 USE OF THE COMBINATION OF MACITENTAN AND TADALAFIL FOR THE CHRONIC TREATMENT OF ADULTS WITH PULMONARY ARTERIAL HYPERTENSION
10MG;40MG OPSYNVI ACTELION N218490 March 22, 2024 RX TABLET ORAL 10946015 Sept. 11, 2026 USE OF THE COMBINATION OF MACITENTAN AND TADALAFIL FOR THE CHRONIC TREATMENT OF ADULTS WITH PULMONARY ARTERIAL HYPERTENSION
10MG OPSUMIT ACTELION N204410 Oct. 18, 2013 RX TABLET ORAL 9265762 May 29, 2027 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING MACITENTAN AND A POLYSORBATE, WHEREIN THE POLYSORBATE REPRESENTS 0.1 TO 3% OF THE WEIGHT OF SAID PHARMACEUTICAL COMPOSITION
10MG OPSUMIT ACTELION N204410 Oct. 18, 2013 RX TABLET ORAL 8367685 Oct. 4, 2028 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING MACITENTAN AND A POLYSORBATE, WHEREIN THE POLYSORBATE REPRESENTS 0.1 TO 1% OF THE WEIGHT OF SAID PHARMACEUTICAL COMPOSITION
10MG OPSUMIT ACTELION N204410 Oct. 18, 2013 RX TABLET ORAL 8268847 April 18, 2029 METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING ADMINISTERING MACITENTAN IN COMBINATION WITH A COMPOUND HAVING PHOSPHODIESTERASE-5 INHIBITORY PROPERTIES
10MG;20MG OPSYNVI ACTELION N218490 March 22, 2024 RX TABLET ORAL 8268847 April 18, 2029 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A COMBINATION OF MACITENTAN AND TADALAFIL
10MG;40MG OPSYNVI ACTELION N218490 March 22, 2024 RX TABLET ORAL 8268847 April 18, 2029 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A COMBINATION OF MACITENTAN AND TADALAFIL

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
10MG MACITENTAN SEASONS BIOTECH A211026 Dec. 3, 2025 RX TABLET ORAL Dec. 3, 2026 PATENT CHALLENGE
10MG MACITENTAN LAURUS A211120 Nov. 5, 2025 RX TABLET ORAL Dec. 3, 2026 PATENT CHALLENGE
10MG MACITENTAN TEVA PHARMS USA INC A211187 June 8, 2026 RX TABLET ORAL Dec. 3, 2026 PATENT CHALLENGE
10MG MACITENTAN ZYDUS LIFESCIENCES A211224 April 6, 2021 RX TABLET ORAL Dec. 3, 2026 PATENT CHALLENGE
10MG;20MG OPSYNVI ACTELION N218490 March 22, 2024 RX TABLET ORAL March 22, 2027 NEW PRODUCT
10MG;40MG OPSYNVI ACTELION N218490 March 22, 2024 RX TABLET ORAL March 22, 2027 NEW PRODUCT
10MG;20MG OPSYNVI ACTELION N218490 March 22, 2024 RX TABLET ORAL Sept. 22, 2027 PEDIATRIC EXCLUSIVITY
10MG;40MG OPSYNVI ACTELION N218490 March 22, 2024 RX TABLET ORAL Sept. 22, 2027 PEDIATRIC EXCLUSIVITY
10MG OPSUMIT ACTELION N204410 Oct. 18, 2013 RX TABLET ORAL Feb. 28, 2028 ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
10MG OPSUMIT ACTELION N204410 Oct. 18, 2013 RX TABLET ORAL Aug. 28, 2028 PEDIATRIC EXCLUSIVITY
10MG;20MG OPSYNVI ACTELION N218490 March 22, 2024 RX TABLET ORAL March 22, 2031 CHRONIC TREATMENT OF ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH, WHO GROUP I AND WHO FUNCTIONAL CLASS (FC) II-III)
10MG;40MG OPSYNVI ACTELION N218490 March 22, 2024 RX TABLET ORAL March 22, 2031 CHRONIC TREATMENT OF ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH, WHO GROUP I AND WHO FUNCTIONAL CLASS (FC) II-III)
10MG;20MG OPSYNVI ACTELION N218490 March 22, 2024 RX TABLET ORAL Sept. 22, 2031 PEDIATRIC EXCLUSIVITY
10MG;40MG OPSYNVI ACTELION N218490 March 22, 2024 RX TABLET ORAL Sept. 22, 2031 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Endothelin-1 receptor GPCR ANTAGONIST IC50 9.30 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
Endothelin B receptor GPCR ANTAGONIST IC50 6.41 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
Translocator protein Transporter Ki 5.67 CHEMBL
Sodium-dependent noradrenaline transporter Transporter Ki 5.32 CHEMBL
D(3) dopamine receptor GPCR Ki 6 CHEMBL

External reference:

IDSource
Z9K9Y9WMVL UNII
D10135 KEGG_DRUG
4032833 VANDF
C2606556 UMLSCUI
CHEBI:76607 CHEBI
A1D5I PDB_CHEM_ID
CHEMBL2103873 ChEMBL_ID
16004692 PUBCHEM_CID
DB08932 DRUGBANK_ID
9018 INN_ID
C533860 MESH_SUPPLEMENTAL_RECORD_UI
7352 IUPHAR_LIGAND_ID
1442132 RXNORM
206622 MMSL
29714 MMSL
d08126 MMSL
015242 NDDF
710283008 SNOMEDCT_US
715555005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Macitentan HUMAN PRESCRIPTION DRUG LABEL 1 0378-0606 TABLET, FILM COATED 10 mg ORAL ANDA 30 sections
macitentan HUMAN PRESCRIPTION DRUG LABEL 1 0480-0915 TABLET, FILM COATED 10 mg ORAL ANDA 30 sections
macitentan Human Prescription Drug Label 1 0781-8135 TABLET, FILM COATED 10 mg ORAL ANDA 28 sections
Macitentan HUMAN PRESCRIPTION DRUG LABEL 1 13668-542 TABLET 10 mg ORAL ANDA 21 sections
Macitentan Human Prescription Drug Label 1 42385-907 TABLET, FILM COATED 10 mg ORAL ANDA 30 sections
Macitentan Human Prescription Drug Label 1 46708-373 TABLET, FILM COATED 10 mg ORAL ANDA 30 sections
Macitentan HUMAN PRESCRIPTION DRUG LABEL 1 47335-070 TABLET, FILM COATED 10 mg ORAL ANDA 29 sections
Macitentan Human Prescription Drug Label 1 59651-147 TABLET, FILM COATED 10 mg ORAL ANDA 30 sections
macitentan HUMAN PRESCRIPTION DRUG LABEL 1 60505-4644 TABLET, FILM COATED 10 mg ORAL ANDA 30 sections
Macitentan Human Prescription Drug Label 1 62332-373 TABLET, FILM COATED 10 mg ORAL ANDA 30 sections
OPSUMIT HUMAN PRESCRIPTION DRUG LABEL 1 66215-501 TABLET, FILM COATED 10 mg ORAL NDA 33 sections
OPSYNVI HUMAN PRESCRIPTION DRUG LABEL 2 66215-812 TABLET, FILM COATED 10 mg ORAL NDA 35 sections
OPSYNVI HUMAN PRESCRIPTION DRUG LABEL 2 66215-814 TABLET, FILM COATED 10 mg ORAL NDA 35 sections
Macitentan HUMAN PRESCRIPTION DRUG LABEL 1 69238-1327 TABLET, FILM COATED 10 mg ORAL ANDA 29 sections
MACITENTAN HUMAN PRESCRIPTION DRUG LABEL 1 70710-1166 TABLET, FILM COATED 10 mg ORAL ANDA 27 sections
Macitentan HUMAN PRESCRIPTION DRUG LABEL 1 82293-041 TABLET, FILM COATED 10 mg ORAL ANDA 30 sections