macitentan 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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: ONP
    • 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

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 3511.40 15.39 6036 152126 655277 62675583
Fluid retention 3147.89 15.39 1919 156243 57767 63273093
Hospitalisation 3015.63 15.39 2133 156029 82948 63247912
Death 2071.74 15.39 3492 154670 370889 62959971
Drug ineffective 1715.68 15.39 280 157882 1044485 62286375
Dyspnoea exertional 1489.13 15.39 1220 156942 59082 63271778
Pain in jaw 1461.81 15.39 1057 157105 42439 63288421
Right ventricular failure 1216.77 15.39 670 157492 16518 63314342
Nasal congestion 1193.46 15.39 1116 157046 64544 63266316
Transfusion 1171.23 15.39 627 157535 14590 63316270
Headache 1143.98 15.39 3811 154351 629430 62701430
Hypervolaemia 1085.51 15.39 747 157415 27666 63303194
Pulmonary hypertension 1033.16 15.39 806 157356 36317 63294543
Oxygen saturation decreased 929.07 15.39 1124 157038 87461 63243399
Off label use 807.53 15.39 337 157825 674125 62656735
Pneumonia 666.66 15.39 2568 155594 454199 62876661
Catheter management 608.24 15.39 242 157920 2745 63328115
Infusion related reaction 588.69 15.39 4 158158 245517 63085343
Lung transplant 580.29 15.39 237 157925 2891 63327969
Oedema 574.28 15.39 939 157223 96683 63234177
Oedema peripheral 573.89 15.39 1379 156783 188132 63142728
Pulmonary oedema 569.60 15.39 693 157469 54180 63276680
Catheter site erythema 568.77 15.39 256 157906 4020 63326840
Cough 525.03 15.39 1762 156400 290981 63039879
Product dose omission issue 520.26 15.39 1519 156643 232794 63098066
Hypotension 509.48 15.39 1664 156498 270940 63059920
Oxygen consumption increased 502.24 15.39 228 157934 3656 63327204
Unevaluable event 494.81 15.39 625 157537 50761 63280099
Toxicity to various agents 493.36 15.39 31 158131 247219 63083641
Alopecia 481.14 15.39 124 158038 337412 62993448
Pulmonary arterial hypertension 477.08 15.39 418 157744 22159 63308701
Maternal exposure during pregnancy 473.06 15.39 17 158145 220045 63110815
Catheter site pain 471.08 15.39 232 157930 4503 63326357
Infusion site pain 466.36 15.39 365 157797 16504 63314356
Catheter site pruritus 460.56 15.39 180 157982 1940 63328920
Treatment failure 451.52 15.39 9 158153 199034 63131826
Catheterisation cardiac 450.41 15.39 223 157939 4380 63326480
Therapeutic product effect decreased 449.67 15.39 6 158156 193181 63137679
Contraindicated product administered 444.23 15.39 24 158138 217624 63113236
Drug hypersensitivity 437.29 15.39 117 158045 310570 63020290
Chest pain 423.82 15.39 1341 156821 214618 63116242
Flushing 419.63 15.39 706 157456 74381 63256479
Therapy change 413.66 15.39 231 157931 5850 63325010
Rheumatoid arthritis 404.87 15.39 72 158090 253747 63077113
Glossodynia 402.09 15.39 9 158153 178867 63151993
Arthropathy 384.63 15.39 62 158100 234730 63096130
Hypoxia 370.32 15.39 589 157573 59203 63271657
Pulmonary arterial pressure increased 366.17 15.39 179 157983 3416 63327444
Rash 360.75 15.39 525 157637 560346 62770514
Neutropenia 357.99 15.39 19 158143 174986 63155874
Dialysis 344.48 15.39 251 157911 10176 63320684
Dizziness 327.27 15.39 2007 156155 427918 62902942
Drug interaction 324.68 15.39 85 158077 229046 63101814
Diarrhoea 322.80 15.39 2949 155213 712417 62618443
Cardiac failure 318.44 15.39 693 157469 88449 63242411
Malaise 314.79 15.39 1939 156223 414015 62916845
Vascular device infection 314.43 15.39 207 157955 7105 63323755
Scleroderma 311.51 15.39 185 157977 5277 63325583
Palpitations 307.52 15.39 789 157373 111981 63218879
Cardiac failure congestive 298.18 15.39 690 157472 91743 63239117
Catheter site discharge 285.27 15.39 126 158036 1887 63328973
Musculoskeletal stiffness 284.41 15.39 57 158105 184561 63146299
Stomatitis 280.77 15.39 16 158146 138709 63192151
Product use issue 279.64 15.39 100 158062 220420 63110440
Catheter site infection 276.50 15.39 165 157997 4749 63326111
Syncope 275.48 15.39 777 157385 116608 63214252
Hepatic enzyme increased 270.08 15.39 84 158078 202244 63128616
Febrile neutropenia 269.95 15.39 5 158157 118444 63212416
Device related infection 263.28 15.39 308 157854 23084 63307776
Peripheral swelling 262.91 15.39 1333 156829 264609 63066251
Pericarditis 260.79 15.39 17 158145 131562 63199298
Product use in unapproved indication 260.26 15.39 63 158099 179017 63151843
Catheter site rash 257.96 15.39 90 158072 683 63330177
Joint swelling 257.51 15.39 262 157900 327404 63003456
Concomitant disease aggravated 253.65 15.39 198 157964 8914 63321946
Catheter placement 245.51 15.39 118 158044 2166 63328694
Drug intolerance 242.30 15.39 247 157915 308414 63022446
Catheter site haemorrhage 241.89 15.39 130 158032 3045 63327815
Therapeutic product effect incomplete 239.66 15.39 19 158143 125037 63205823
Wound 230.36 15.39 61 158101 163202 63167658
Catheter site swelling 230.14 15.39 99 158063 1386 63329474
Transplant evaluation 226.50 15.39 92 158070 1105 63329755
Systemic lupus erythematosus 221.97 15.39 122 158040 208796 63122064
Device alarm issue 220.80 15.39 97 158065 1433 63329427
Hypersensitivity 219.87 15.39 243 157919 292442 63038418
Abdominal distension 218.69 15.39 589 157573 86026 63244834
Productive cough 217.28 15.39 484 157678 62724 63268136
Epistaxis 216.19 15.39 526 157636 72199 63258661
Psoriatic arthropathy 212.16 15.39 3 158159 91517 63239343
Ascites 209.11 15.39 369 157793 40359 63290501
Discomfort 205.24 15.39 80 158082 167294 63163566
Intentional product use issue 202.19 15.39 37 158125 127855 63203005
Oxygen therapy 193.95 15.39 99 158063 2079 63328781
Respiratory failure 191.67 15.39 624 157538 101234 63229626
Cardiac disorder 190.50 15.39 403 157759 50413 63280447
Device leakage 188.49 15.39 150 158012 6946 63323914
Impaired healing 187.25 15.39 19 158143 102523 63228337
Malignant neoplasm progression 184.97 15.39 4 158158 82117 63248743
Exposure during pregnancy 183.17 15.39 79 158083 155468 63175392
Cardiac pacemaker insertion 182.75 15.39 119 158043 4007 63326853
Pericardial effusion 180.40 15.39 292 157870 29766 63301094
Infusion site erythema 179.03 15.39 181 157981 11498 63319362
Chest discomfort 178.28 15.39 641 157521 109328 63221532
Rehabilitation therapy 173.58 15.39 84 158078 1566 63329294
Cardiac operation 173.33 15.39 106 158056 3192 63327668
Helicobacter infection 172.56 15.39 16 158146 92769 63238091
Brain natriuretic peptide increased 171.08 15.39 125 158037 5088 63325772
Infusion site infection 169.85 15.39 85 158077 1709 63329151
Dyspnoea at rest 169.39 15.39 113 158049 3966 63326894
Blister 167.67 15.39 57 158105 129757 63201103
Hospice care 165.80 15.39 146 158016 7786 63323074
Acute respiratory failure 163.72 15.39 302 157860 34183 63296677
Dermatitis contact 162.19 15.39 167 157995 10841 63320019
Folliculitis 160.06 15.39 3 158159 70314 63260546
Drug abuse 157.82 15.39 5 158157 72513 63258347
Leukopenia 156.08 15.39 9 158153 77281 63253579
Blood cholesterol increased 155.71 15.39 24 158138 94008 63236852
Infusion site discharge 154.72 15.39 60 158102 632 63330228
Paracentesis 154.72 15.39 66 158096 904 63329956
Feeling abnormal 153.58 15.39 754 157408 147638 63183222
Catheter site irritation 153.16 15.39 56 158106 494 63330366
Urticaria 150.01 15.39 116 158046 165686 63165174
Nausea 148.81 15.39 2966 155196 851505 62479355
Intentional overdose 148.63 15.39 9 158153 74143 63256717
Muscle injury 147.89 15.39 3 158159 65342 63265518
Condition aggravated 147.73 15.39 1591 156571 400626 62930234
Therapy non-responder 147.29 15.39 470 157692 75431 63255429
Internal haemorrhage 145.42 15.39 113 158049 5052 63325808
Blood pressure decreased 144.27 15.39 422 157740 64600 63266260
Emergency care 141.87 15.39 64 158098 1010 63329850
Osteoarthritis 141.51 15.39 32 158130 95311 63235549
Hypertension 141.39 15.39 303 157859 279000 63051860
Influenza 140.53 15.39 590 157572 108132 63222728
Psoriasis 139.94 15.39 24 158138 86933 63243927
Overdose 137.77 15.39 57 158105 115021 63215839
Thrombocytopenia 137.70 15.39 105 158057 151052 63179808
Device infusion issue 137.46 15.39 77 158085 1961 63328899
Disease progression 135.12 15.39 635 157527 122123 63208737
Infusion site swelling 134.60 15.39 143 158019 9627 63321233
Confusional state 133.84 15.39 240 157922 236140 63094720
Presyncope 126.48 15.39 239 157923 27546 63303314
Myalgia 126.43 15.39 708 157454 145821 63185039
Disease complication 126.32 15.39 86 158076 3123 63327737
Anaemia 125.51 15.39 1198 156964 292232 63038628
Lower respiratory tract infection 124.26 15.39 89 158073 132218 63198642
Pulmonary veno-occlusive disease 123.79 15.39 59 158103 1062 63329798
Central venous catheterisation 122.62 15.39 78 158084 2521 63328339
Blood pressure increased 122.17 15.39 134 158028 161928 63168932
Device dislocation 119.36 15.39 223 157939 25482 63305378
Aspiration pleural cavity 118.78 15.39 53 158109 814 63330046
Mobility decreased 118.44 15.39 78 158084 121081 63209779
Anaphylactic reaction 116.23 15.39 14 158148 66086 63264774
Dizziness postural 116.15 15.39 116 158046 7260 63323600
Haemoglobin decreased 115.75 15.39 688 157474 144797 63186063
Arthralgia 115.28 15.39 889 157273 568821 62762039
Neutrophil count decreased 112.58 15.39 7 158155 56399 63274461
Fibromyalgia 111.58 15.39 31 158131 80389 63250471
Electrocardiogram QT prolonged 111.39 15.39 10 158152 59520 63271340
Irritable bowel syndrome 110.26 15.39 34 158128 82378 63248482
N-terminal prohormone brain natriuretic peptide increased 109.86 15.39 68 158094 2093 63328767
Suicide attempt 109.37 15.39 12 158150 60906 63269954
Type 2 diabetes mellitus 108.75 15.39 15 158147 63853 63267007
Device occlusion 108.71 15.39 112 158050 7275 63323585
C-reactive protein increased 108.47 15.39 50 158112 94657 63236203
Chronic obstructive pulmonary disease 105.47 15.39 370 157792 62316 63268544
Liver transplant 103.74 15.39 67 158095 2224 63328636
Injection site reaction 101.43 15.39 13 158149 58511 63272349
Walking distance test abnormal 101.40 15.39 42 158120 532 63330328
Blood potassium decreased 101.23 15.39 281 157881 41745 63289115
Haemoptysis 100.96 15.39 222 157940 28504 63302356
White blood cell count decreased 100.50 15.39 119 158043 138985 63191875
Injury 98.38 15.39 30 158132 73217 63257643
Atrial flutter 97.40 15.39 121 158041 9651 63321209
Injection site pain 97.07 15.39 108 158054 129692 63201168
Mineral supplementation 96.93 15.39 44 158118 705 63330155
Pleural effusion 96.63 15.39 474 157688 92736 63238124
Pain in extremity 95.82 15.39 1253 156909 330233 63000627
Ill-defined disorder 95.44 15.39 42 158120 81713 63249147
Liver injury 94.57 15.39 18 158144 60502 63270358
Left ventricular failure 94.31 15.39 92 158070 5595 63325265
Intentional product misuse 93.33 15.39 19 158143 60898 63269962
Renal disorder 93.18 15.39 234 157928 32740 63298120
Catheter site related reaction 92.63 15.39 46 158116 909 63329951
Terminal state 91.83 15.39 62 158100 2220 63328640
Endarterectomy 91.44 15.39 30 158132 184 63330676
Catheter site inflammation 90.69 15.39 44 158118 825 63330035
Atrial septal defect repair 90.64 15.39 31 158131 220 63330640
Abdominal cavity drainage 89.15 15.39 35 158127 382 63330478
Acute kidney injury 89.06 15.39 346 157816 263069 63067791
Depression 89.05 15.39 226 157936 196266 63134594
Decreased appetite 88.70 15.39 986 157176 250066 63080794
Suicidal ideation 88.60 15.39 23 158139 62398 63268462
Cognitive disorder 88.50 15.39 16 158146 55799 63275061
Pruritus 88.38 15.39 533 157629 360920 62969940
Catheter site vesicles 87.25 15.39 32 158130 285 63330575
Heart rate increased 87.06 15.39 464 157698 93774 63237086
Rhabdomyolysis 86.10 15.39 6 158156 43945 63286915
Pulmonary endarterectomy 85.91 15.39 26 158136 117 63330743
Exercise tolerance decreased 85.73 15.39 86 158076 5411 63325449
Infusion site haemorrhage 85.69 15.39 83 158079 5003 63325857
Red blood cell sedimentation rate increased 83.35 15.39 7 158155 43975 63286885
Sedation 83.29 15.39 3 158159 38806 63292054
Depressed level of consciousness 82.34 15.39 26 158136 62052 63268808
Stent placement 82.27 15.39 71 158091 3684 63327176
Dyspepsia 81.70 15.39 484 157678 101712 63229148
Sinus congestion 81.38 15.39 155 158007 17968 63312892
Wrong technique in product usage process 81.12 15.39 27 158135 62313 63268547
Paraesthesia 79.58 15.39 170 157992 156796 63174064
Transplant 79.07 15.39 39 158123 759 63330101
Seasonal allergy 78.31 15.39 166 157996 20784 63310076
Abortion spontaneous 78.22 15.39 12 158150 47183 63283677
Pancytopenia 77.70 15.39 76 158086 96857 63234003
Angioedema 77.69 15.39 13 158149 47952 63282908
Right ventricular dilatation 76.88 15.39 46 158116 1330 63329530
Seizure 75.60 15.39 134 158028 132500 63198360
Injection site erythema 75.42 15.39 58 158104 83116 63247744
Cardioversion 75.32 15.39 44 158118 1216 63329644
Coma 75.23 15.39 33 158129 64331 63266529
Blood iron decreased 75.05 15.39 133 158029 14588 63316272
Infusion site warmth 74.61 15.39 50 158112 1768 63329092
Pulmonary congestion 74.57 15.39 146 158016 17272 63313588
Hyponatraemia 73.31 15.39 103 158059 111797 63219063
Respiration abnormal 73.03 15.39 85 158077 6332 63324528
Inappropriate schedule of product administration 72.90 15.39 91 158071 103874 63226986
Rhinorrhoea 72.67 15.39 340 157822 65237 63265623
Blood pressure systolic increased 72.16 15.39 15 158147 47382 63283478
Pulmonary arterial pressure abnormal 71.74 15.39 32 158130 491 63330369
Drug reaction with eosinophilia and systemic symptoms 71.31 15.39 3 158159 33833 63297027
Therapeutic response decreased 71.19 15.39 32 158130 61493 63269367
Lung disorder 69.87 15.39 324 157838 61937 63268923
Right ventricular dysfunction 69.83 15.39 48 158114 1771 63329089
Oropharyngeal pain 68.89 15.39 437 157725 94050 63236810
Cardiac ablation 68.65 15.39 44 158118 1441 63329419
Chemotherapy 68.61 15.39 45 158117 1534 63329326
Pulmonary arterial wedge pressure increased 67.87 15.39 27 158135 306 63330554
Nasal dryness 66.58 15.39 69 158093 4512 63326348
Gout 66.50 15.39 119 158043 13152 63317708
Infusion site induration 66.07 15.39 40 158122 1182 63329678
Atrial fibrillation 65.96 15.39 507 157655 116129 63214731
General physical health deterioration 64.60 15.39 270 157892 201132 63129728
Medication error 64.02 15.39 25 158137 52259 63278601
Complication associated with device 62.85 15.39 134 158028 16844 63314016
Cardiac output increased 62.50 15.39 23 158139 207 63330653
Nasopharyngitis 60.49 15.39 929 157233 253328 63077532
Bone marrow failure 60.41 15.39 3 158159 29287 63301573
Neuropathy peripheral 60.22 15.39 120 158042 113547 63217313
Deep vein thrombosis 60.17 15.39 72 158090 83728 63247132
Orthopnoea 59.97 15.39 76 158086 6185 63324675
Product quality issue 59.71 15.39 9 158153 35856 63295004
Product supply issue 59.67 15.39 43 158119 1712 63329148
Infusion site irritation 59.65 15.39 34 158128 896 63329964
Gastrointestinal haemorrhage 59.52 15.39 376 157786 80800 63250060
Hypoacusis 58.66 15.39 162 158000 23989 63306871
Device related sepsis 58.31 15.39 61 158101 4033 63326827
Device connection issue 58.13 15.39 30 158132 645 63330215
Biopsy lung 57.26 15.39 21 158141 187 63330673
Bronchitis 57.25 15.39 518 157644 124417 63206443
Asthma 56.78 15.39 148 158014 127413 63203447
Joint range of motion decreased 56.68 15.39 7 158155 32421 63298439
Angioplasty 56.45 15.39 38 158124 1354 63329506
Metabolic acidosis 56.10 15.39 21 158141 45048 63285812
Catheter site warmth 56.02 15.39 21 158141 200 63330660
Extra dose administered 56.00 15.39 74 158088 6276 63324584
Biopsy 55.95 15.39 27 158135 500 63330360
Medical procedure 55.91 15.39 24 158138 334 63330526
Prescribed overdose 55.88 15.39 9 158153 34144 63296716
Delirium 55.84 15.39 28 158134 50513 63280347
Hepatotoxicity 55.82 15.39 12 158150 37029 63293831
Catheterisation cardiac abnormal 55.12 15.39 21 158141 210 63330650
Bradycardia 54.65 15.39 61 158101 73166 63257694
Blood creatine phosphokinase increased 54.60 15.39 6 158156 30424 63300436
Concomitant disease progression 54.31 15.39 44 158118 2090 63328770
Pericardial drainage 54.25 15.39 22 158140 263 63330597
Diagnostic procedure 53.85 15.39 18 158144 118 63330742
Dependence on oxygen therapy 53.63 15.39 25 158137 427 63330433
Drug-induced liver injury 53.07 15.39 17 158145 40205 63290655
Incorrect route of product administration 53.05 15.39 4 158158 27448 63303412
Hepatocellular injury 52.88 15.39 4 158158 27377 63303483
Catheter site scab 52.76 15.39 20 158142 197 63330663
Hypocalcaemia 52.70 15.39 8 158154 31705 63299155
Hallucination 52.59 15.39 36 158126 54781 63276079
Sinus disorder 52.19 15.39 157 158005 24396 63306464
Pulmonary pain 51.51 15.39 53 158109 3437 63327423
Plasma cell myeloma 51.39 15.39 13 158149 35892 63294968
Foot deformity 51.25 15.39 5 158157 27848 63303012
Cardiac failure acute 51.09 15.39 88 158074 9435 63321425
Medical device change 51.07 15.39 22 158140 309 63330551
Toxic epidermal necrolysis 50.98 15.39 3 158159 25331 63305529
Cholestasis 49.90 15.39 7 158155 29427 63301433
Head discomfort 49.79 15.39 106 158056 13309 63317551
Hypercalcaemia 49.78 15.39 6 158156 28316 63302544
Cardiac failure high output 49.47 15.39 21 158141 284 63330576
Hypoaesthesia 49.01 15.39 234 157928 168159 63162701
Live birth 48.78 15.39 4 158158 25626 63305234
Multiple sclerosis 48.70 15.39 3 158159 24369 63306491
Dysarthria 48.19 15.39 23 158139 42688 63288172
Pain 48.15 15.39 1442 156720 739186 62591674
Agranulocytosis 47.62 15.39 4 158158 25130 63305730
Oxygen saturation abnormal 47.46 15.39 51 158111 3478 63327382
Infection 47.39 15.39 355 157807 228818 63102042
Lymphocyte count decreased 47.26 15.39 9 158153 30248 63300612
Stevens-Johnson syndrome 47.19 15.39 4 158158 24946 63305914
Swollen tongue 47.18 15.39 14 158148 34786 63296074
Hepatitis 47.13 15.39 20 158142 39768 63291092
Injection site pruritus 46.91 15.39 27 158135 45089 63285771
Generalised tonic-clonic seizure 46.69 15.39 8 158154 29008 63301852
Basal cell carcinoma 46.65 15.39 7 158155 27984 63302876
Choking 46.22 15.39 86 158076 9793 63321067
Hypoglycaemia 45.96 15.39 49 158113 60016 63270844
Weight increased 45.86 15.39 908 157254 259884 63070976
Iron deficiency anaemia 45.61 15.39 131 158031 19838 63311022
Mouth ulceration 45.21 15.39 13 158149 32971 63297889
Systemic scleroderma 45.18 15.39 29 158133 952 63329908
Chronic respiratory failure 45.08 15.39 38 158124 1909 63328951
Heart valve replacement 44.39 15.39 24 158138 569 63330291
Emotional distress 44.30 15.39 13 158149 32536 63298324
Catheter site discolouration 44.03 15.39 15 158147 105 63330755
Hyperglycaemia 43.61 15.39 25 158137 41842 63289018
Premature delivery 43.27 15.39 11 158151 30270 63300590
Respiratory tract congestion 42.70 15.39 119 158043 17713 63313147
Jugular vein distension 42.60 15.39 28 158134 958 63329902
Epilepsy 42.38 15.39 8 158154 27057 63303803
Device maintenance issue 42.30 15.39 11 158151 24 63330836
Drug ineffective for unapproved indication 42.18 15.39 16 158146 34047 63296813
Myelosuppression 41.71 15.39 5 158157 23698 63307162
Bone disorder 41.51 15.39 3 158159 21323 63309537
Pregnancy 41.31 15.39 20 158142 36816 63294044
Drug dependence 41.09 15.39 6 158156 24477 63306383
Head injury 40.42 15.39 155 158007 27241 63303619
Bursitis 40.21 15.39 21 158141 37020 63293840
Cor pulmonale 39.36 15.39 36 158126 2018 63328842
Hernia repair 38.77 15.39 32 158130 1561 63329299
Infusion site discolouration 38.65 15.39 25 158137 832 63330028
Pulmonary artery aneurysm 38.20 15.39 11 158151 40 63330820
Metastases to bone 38.08 15.39 4 158158 21015 63309845
Treatment noncompliance 38.08 15.39 189 157973 37136 63293724
Biopsy liver 37.96 15.39 19 158143 382 63330478
Catheter removal 37.57 15.39 19 158143 391 63330469
Polypectomy 37.50 15.39 24 158138 784 63330076
Hyperhidrosis 37.45 15.39 140 158022 107696 63223164
Psychotic disorder 37.40 15.39 9 158153 25703 63305157
Osteoporosis 37.32 15.39 53 158109 57285 63273575
Injection site swelling 37.31 15.39 38 158124 47534 63283326
Therapy interrupted 37.22 15.39 170 157992 32285 63298575
Drug level increased 37.18 15.39 6 158156 22730 63308130
Nocturnal dyspnoea 37.14 15.39 28 158134 1196 63329664
Therapy cessation 36.78 15.39 162 158000 30295 63300565
Wrong dose 36.75 15.39 28 158134 1215 63329645
Skin exfoliation 36.65 15.39 32 158130 43070 63287790
Drug eruption 36.33 15.39 13 158149 28681 63302179
Sleep disorder 36.00 15.39 95 158067 81471 63249389
Loss of personal independence in daily activities 35.99 15.39 123 158039 97167 63233693
Cardiomegaly 35.91 15.39 111 158051 17503 63313357
Contusion 35.68 15.39 223 157939 149821 63181039
Lactic acidosis 35.60 15.39 26 158136 38261 63292599
Obesity 35.56 15.39 15 158147 29937 63300923
Cytomegalovirus infection 35.47 15.39 5 158157 20947 63309913
Accidental exposure to product 35.42 15.39 12 158150 27393 63303467
Infusion site pruritus 35.35 15.39 58 158104 5977 63324883
Eosinophilia 35.06 15.39 7 158155 22749 63308111
Premature baby 34.99 15.39 5 158157 20730 63310130
Multiple allergies 34.93 15.39 94 158068 13708 63317152
Catheter site erosion 34.92 15.39 11 158151 58 63330802
Asthenia 34.81 15.39 1224 156938 382380 62948480
Carbon dioxide increased 34.71 15.39 28 158134 1322 63329538
Cholecystectomy 34.70 15.39 80 158082 10597 63320263
Localised oedema 34.67 15.39 54 158108 5324 63325536
Colitis ulcerative 34.47 15.39 11 158151 26080 63304780
Blood glucose increased 34.41 15.39 101 158061 83655 63247205
Oxygen consumption 34.40 15.39 12 158150 91 63330769
Hyperkalaemia 34.39 15.39 51 158111 54152 63276708
Endotracheal intubation 34.10 15.39 37 158125 2551 63328309
Hypercholesterolaemia 34.07 15.39 6 158156 21328 63309532
Night sweats 33.92 15.39 43 158119 48771 63282089
Chest tube insertion 33.79 15.39 10 158152 41 63330819
No adverse event 33.71 15.39 32 158130 41373 63289487
Drug withdrawal syndrome 33.29 15.39 13 158149 27181 63303679
Hepatic steatosis 33.22 15.39 15 158147 28754 63302106
Heart and lung transplant 33.21 15.39 12 158150 102 63330758
Tubulointerstitial nephritis 33.12 15.39 5 158157 19898 63310962
Aggression 32.69 15.39 9 158153 23489 63307371
Injection site mass 32.67 15.39 4 158158 18652 63312208
Catheter site dermatitis 32.67 15.39 11 158151 74 63330786
Dizziness exertional 32.63 15.39 17 158145 373 63330487
Agitation 32.58 15.39 62 158100 59695 63271165
Impaired work ability 32.51 15.39 3 158159 17472 63313388
Skin lesion 32.49 15.39 18 158144 30703 63300157
Adverse event 32.42 15.39 283 157879 67276 63263584
Diabetic ketoacidosis 32.24 15.39 6 158156 20499 63310361
Joint stiffness 32.21 15.39 34 158128 41835 63289025
Lymphopenia 31.92 15.39 4 158158 18323 63312537
Catheter site nodule 31.86 15.39 10 158152 52 63330808
Body temperature decreased 31.83 15.39 6 158156 20313 63310547
Biopsy bone marrow 31.65 15.39 16 158146 329 63330531
Product prescribing error 31.48 15.39 13 158149 26276 63304584
Pulmonary artery dilatation 31.27 15.39 15 158147 274 63330586
Pneumocystis jirovecii pneumonia 31.21 15.39 3 158159 16911 63313949
Upper respiratory tract congestion 31.16 15.39 32 158130 2070 63328790
Ischaemic stroke 31.08 15.39 4 158158 17953 63312907
Acute right ventricular failure 31.08 15.39 13 158149 169 63330691
Balance disorder 31.04 15.39 107 158055 84315 63246545
Sickle cell disease 30.95 15.39 10 158152 58 63330802
Fall 30.82 15.39 1232 156930 391102 62939758
Tracheostomy 30.80 15.39 20 158142 670 63330190
Catheter site extravasation 30.79 15.39 16 158146 349 63330511
Ventilation perfusion mismatch 30.73 15.39 18 158144 500 63330360
Osteopenia 30.66 15.39 6 158156 19779 63311081
Joint dislocation 30.65 15.39 5 158157 18795 63312065
Hip fracture 30.60 15.39 150 158012 29324 63301536
Cardiac flutter 30.51 15.39 44 158118 4052 63326808
Inflammation 30.43 15.39 104 158058 82169 63248691
Gastrointestinal tube insertion 30.31 15.39 24 158138 1103 63329757
Platelet transfusion 30.31 15.39 21 158141 785 63330075
Ejection fraction decreased 30.25 15.39 9 158153 22323 63308537
Encephalopathy 30.11 15.39 31 158131 38589 63292271
Drug titration error 29.91 15.39 21 158141 802 63330058
CREST syndrome 29.85 15.39 18 158144 528 63330332
Right ventricular systolic pressure increased 29.82 15.39 18 158144 529 63330331
Thrombosis in device 29.76 15.39 37 158125 2953 63327907
Diet noncompliance 29.68 15.39 16 158146 377 63330483
Hallucination, visual 29.59 15.39 6 158156 19292 63311568
Osteonecrosis 29.58 15.39 12 158150 24518 63306342
Spinal osteoarthritis 29.53 15.39 3 158159 16183 63314677
Drug titration 29.46 15.39 8 158154 22 63330838
Hepatic cirrhosis 29.44 15.39 131 158031 24603 63306257
Metastases to liver 29.44 15.39 11 158151 23628 63307232
Mood swings 29.43 15.39 5 158157 18243 63312617
Dialysis related complication 29.36 15.39 10 158152 70 63330790
Arthritis 29.28 15.39 169 157993 115752 63215108
Acute myeloid leukaemia 29.25 15.39 4 158158 17143 63313717
Faeces discoloured 29.20 15.39 107 158055 18402 63312458
Pulmonary vascular resistance abnormality 29.13 15.39 9 158153 44 63330816
Withdrawal syndrome 29.09 15.39 7 158155 19990 63310870
Myoclonus 28.80 15.39 3 158159 15865 63314995
Device physical property issue 28.69 15.39 30 158132 1982 63328878
Retching 28.67 15.39 91 158071 14554 63316306
Congestive hepatopathy 28.63 15.39 36 158126 2906 63327954
Thrombectomy 28.62 15.39 12 158150 157 63330703
Exostosis 28.57 15.39 5 158157 17857 63313003
Infusion site abscess 28.54 15.39 13 158149 210 63330650
Pulmonary embolism 28.47 15.39 172 157990 116512 63214348
Arteriovenous malformation 28.36 15.39 25 158137 1335 63329525
Oral herpes 27.98 15.39 15 158147 26059 63304801
Biopsy lymph gland 27.80 15.39 8 158154 29 63330831
Injection site infection 27.76 15.39 29 158133 1914 63328946
Echocardiogram abnormal 27.76 15.39 25 158137 1373 63329487
Cardiac septal defect 27.64 15.39 14 158148 289 63330571
Tenderness 27.30 15.39 11 158151 22567 63308293
Pancreatitis acute 27.20 15.39 17 158145 27149 63303711
Blood bilirubin increased 27.19 15.39 172 157990 36968 63293892
Brain natriuretic peptide abnormal 27.10 15.39 15 158147 373 63330487
Application site pruritus 27.09 15.39 41 158121 3943 63326917
Tooth extraction 27.09 15.39 71 158091 10193 63320667
Mechanical ventilation 27.03 15.39 24 158138 1294 63329566
Dyskinesia 26.92 15.39 24 158138 31978 63298882
Paranasal sinus discomfort 26.91 15.39 43 158119 4333 63326527
Critical illness 26.79 15.39 12 158150 186 63330674
Weight decreased 26.79 15.39 890 157272 275908 63054952
Right-to-left cardiac shunt 26.78 15.39 13 158149 244 63330616
Blood pressure abnormal 26.67 15.39 91 158071 15107 63315753
Device breakage 26.63 15.39 76 158086 11466 63319394
Pyelonephritis 26.30 15.39 6 158156 17772 63313088
Generalised oedema 26.27 15.39 93 158069 15725 63315135
Choking sensation 26.21 15.39 38 158124 3516 63327344
Dry eye 26.21 15.39 38 158124 40723 63290137
Somnolence 26.04 15.39 302 157860 178383 63152477
Erythema 26.02 15.39 296 157866 175455 63155405
Muscular weakness 26 15.39 188 157974 122165 63208695
Pulmonary hypertensive crisis 25.97 15.39 14 158148 330 63330530
Cyanosis 25.96 15.39 97 158065 16838 63314022
Pulmonary thrombosis 25.89 15.39 63 158099 8639 63322221
Pericardial excision 25.85 15.39 7 158155 19 63330841
Secretion discharge 25.80 15.39 78 158084 12153 63318707
Sinus bradycardia 25.78 15.39 3 158159 14548 63316312
Drug tolerance decreased 25.64 15.39 6 158156 17467 63313393
Acne 25.59 15.39 13 158149 23280 63307580
Pneumonia bacterial 25.52 15.39 66 158096 9399 63321461
Cancer surgery 25.46 15.39 16 158146 506 63330354
Ear discomfort 25.43 15.39 59 158103 7847 63323013
Medical device implantation 25.21 15.39 19 158143 811 63330049
Obstructive airways disorder 25.17 15.39 10 158152 20689 63310171
Disturbance in attention 25.15 15.39 35 158127 38154 63292706
Eczema 25.09 15.39 26 158136 32265 63298595
Hypertensive crisis 25.07 15.39 4 158158 15282 63315578
Abnormal behaviour 25.01 15.39 11 158151 21415 63309445
Diplopia 24.95 15.39 14 158148 23714 63307146
Heart valve operation 24.83 15.39 11 158151 166 63330694
Clostridium difficile infection 24.72 15.39 143 158019 29779 63301081
Sickle cell anaemia 24.61 15.39 16 158146 537 63330323
Pulmonary arterial pressure decreased 24.55 15.39 9 158153 80 63330780
Palliative care 24.51 15.39 16 158146 541 63330319
Gastrointestinal surgery 24.50 15.39 12 158150 230 63330630
Skin necrosis 24.41 15.39 3 158159 13947 63316913
Aphthous ulcer 24.38 15.39 3 158159 13935 63316925
Paranasal sinus hypersecretion 24.32 15.39 38 158124 3757 63327103
Hypokalaemia 24.29 15.39 155 158007 103649 63227211
Vomiting 24.29 15.39 1661 156501 557956 62772904
Visual acuity reduced 24.25 15.39 12 158150 21814 63309046
Device issue 23.96 15.39 120 158042 23661 63307199
Life support 23.90 15.39 12 158150 243 63330617
Catheter site induration 23.86 15.39 8 158154 53 63330807
Carpal tunnel syndrome 23.81 15.39 11 158151 20806 63310054
Blood lactate dehydrogenase increased 23.79 15.39 14 158148 23102 63307758
Right ventricular enlargement 23.75 15.39 13 158149 316 63330544
Throat irritation 23.74 15.39 168 157994 37479 63293381
Vascular device occlusion 23.70 15.39 10 158152 133 63330727
Proteinuria 23.69 15.39 9 158153 19136 63311724
Hip surgery 23.68 15.39 35 158127 3296 63327564
Unevaluable investigation 23.61 15.39 8 158154 55 63330805
Rash erythematous 23.27 15.39 44 158118 42466 63288394
Colonoscopy 23.25 15.39 24 158138 1562 63329298
Mixed connective tissue disease 23.19 15.39 15 158147 499 63330361
Labelled drug-drug interaction medication error 23.15 15.39 3 158159 13396 63317464
Muscle twitching 23.11 15.39 10 158152 19658 63311202
Injection site rash 23.01 15.39 9 158153 18800 63312060
Tendonitis 23.00 15.39 10 158152 19605 63311255
Viral infection 22.99 15.39 160 158002 35503 63295357
Liver function test abnormal 22.91 15.39 54 158108 48127 63282733
Oxygen saturation increased 22.73 15.39 11 158151 205 63330655
Body temperature increased 22.63 15.39 36 158126 37156 63293704
Haemorrhage 22.56 15.39 242 157920 60780 63270080
Heart transplant 22.52 15.39 15 158147 525 63330335
Cerebral infarction 22.51 15.39 16 158146 23877 63306983
Infusion site vesicles 22.49 15.39 15 158147 526 63330334
Metastases to central nervous system 22.49 15.39 3 158159 13102 63317758
Platelet count increased 22.47 15.39 8 158154 17703 63313157
Cardiac monitoring 22.23 15.39 6 158156 16 63330844
Cor pulmonale chronic 22.21 15.39 11 158151 216 63330644
Injection site discharge 22.20 15.39 18 158144 856 63330004
Gastroenteritis viral 22.07 15.39 117 158045 23583 63307277
Medical device site haemorrhage 22.05 15.39 7 158155 38 63330822
Lip swelling 21.96 15.39 27 158135 31036 63299824
Catheter culture positive 21.93 15.39 10 158152 162 63330698
Surgery 21.92 15.39 159 158003 35753 63295107
Hallucination, auditory 21.85 15.39 3 158159 12821 63318039
Vasculitis 21.81 15.39 9 158153 18200 63312660
Coeliac disease 21.79 15.39 3 158159 12794 63318066
Oesophageal motility disorder 21.78 15.39 13 158149 374 63330486
Cellulitis 21.62 15.39 305 157857 81653 63249207
Acute myocardial infarction 21.60 15.39 29 158133 32095 63298765
Poisoning 21.56 15.39 4 158158 13696 63317164
Portal hypertension 21.42 15.39 36 158126 3783 63327077
Hyperlipidaemia 21.38 15.39 11 158151 19560 63311300
Peritonitis 21.33 15.39 8 158154 17146 63313714
Therapeutic response unexpected 21.32 15.39 10 158152 18749 63312111
Breast cancer female 21.25 15.39 4 158158 13555 63317305
Dialysis device insertion 21.24 15.39 6 158156 20 63330840
Sluggishness 21.15 15.39 43 158119 5226 63325634
Altered state of consciousness 21.13 15.39 19 158143 25211 63305649
Procedural pain 20.91 15.39 14 158148 21555 63309305
Macular degeneration 20.84 15.39 18 158144 24358 63306502
Purulent discharge 20.82 15.39 40 158122 4666 63326194
Paraesthesia oral 20.78 15.39 11 158151 19245 63311615
Cardiomyopathy 20.57 15.39 9 158153 17575 63313285
Suture related complication 20.49 15.39 10 158152 190 63330670
Portopulmonary hypertension 20.36 15.39 9 158153 135 63330725
Living in residential institution 20.14 15.39 14 158148 526 63330334
Neutrophil count increased 20.07 15.39 8 158154 16519 63314341
Coronary artery disease 20.02 15.39 31 158131 32346 63298514
Liver ablation 19.99 15.39 4 158158 0 63330860
Immune tolerance induction 19.99 15.39 4 158158 0 63330860
Vitamin D deficiency 19.94 15.39 5 158157 13887 63316973
Walking disability 19.86 15.39 21 158141 1406 63329454
Vasodilatation 19.73 15.39 27 158135 2368 63328492
Full blood count abnormal 19.69 15.39 141 158021 31576 63299284
Coordination abnormal 19.68 15.39 5 158157 13768 63317092
Ear congestion 19.63 15.39 29 158133 2730 63328130
Device difficult to use 19.58 15.39 4 158158 12792 63318068
Respiratory depression 19.56 15.39 5 158157 13710 63317150
Drain placement 19.53 15.39 7 158155 58 63330802
Conjunctivitis 19.49 15.39 14 158148 20782 63310078
Drug therapy 19.48 15.39 6 158156 29 63330831
Infusion site inflammation 19.34 15.39 12 158150 371 63330489
Loss of consciousness 19.31 15.39 407 157755 117714 63213146
Catheter site dryness 19.31 15.39 6 158156 30 63330830
Paranoia 19.28 15.39 3 158159 11676 63319184
Hypomagnesaemia 19.26 15.39 26 158136 28711 63302149
Primary biliary cholangitis 19.14 15.39 19 158143 1180 63329680
Flatulence 19.12 15.39 150 158012 34552 63296308
Decreased activity 19.07 15.39 46 158116 6274 63324586
Gastrointestinal disorder 19.04 15.39 222 157940 131017 63199843
Myelodysplastic syndrome 18.93 15.39 9 158153 16745 63314115
Blood pressure fluctuation 18.91 15.39 56 158106 46261 63284599
Femur fracture 18.91 15.39 48 158114 41708 63289152
Blood triglycerides increased 18.91 15.39 4 158158 12484 63318376
Upper-airway cough syndrome 18.85 15.39 67 158095 11351 63319509
Cardiac discomfort 18.80 15.39 17 158145 939 63329921
Gastric haemorrhage 18.70 15.39 46 158116 6352 63324508
Oral surgery 18.68 15.39 19 158143 1215 63329645
Skin fissures 18.63 15.39 3 158159 11385 63319475
Hysterectomy 18.57 15.39 59 158103 9440 63321420
Bronchoscopy 18.55 15.39 7 158155 68 63330792
Immunodeficiency 18.51 15.39 14 158148 20240 63310620
Transaminases increased 18.49 15.39 31 158131 31336 63299524
Intervertebral disc degeneration 18.48 15.39 8 158154 15724 63315136
Orthostatic hypotension 18.44 15.39 39 158123 36121 63294739
Illness 18.34 15.39 195 157967 48864 63281996
Food poisoning 18.26 15.39 36 158126 4280 63326580
Myopathy 18.19 15.39 3 158159 11188 63319672
Gastrointestinal endoscopic therapy 18.13 15.39 6 158156 38 63330822
Hepatopulmonary syndrome 18.09 15.39 5 158157 15 63330845
Localised infection 18.00 15.39 133 158029 30077 63300783
Infusion site discomfort 17.89 15.39 20 158142 1426 63329434
Abdominal pain upper 17.76 15.39 655 157507 205789 63125071
Mydriasis 17.76 15.39 4 158158 11952 63318908
Chronic sinusitis 17.72 15.39 5 158157 12838 63318022
Anhedonia 17.71 15.39 3 158159 10971 63319889
Disseminated intravascular coagulation 17.63 15.39 13 158149 19038 63311822
Pulmonary arterial pressure 17.61 15.39 6 158156 42 63330818
Eosinophil count increased 17.61 15.39 3 158159 10925 63319935
Renal tubular necrosis 17.59 15.39 4 158158 11874 63318986
Tremor 17.55 15.39 228 157934 132011 63198849
Abdominal discomfort 17.37 15.39 639 157523 320246 63010614
Blood pressure systolic decreased 17.35 15.39 49 158113 7348 63323512
Aphasia 17.33 15.39 35 158127 32965 63297895
Knee operation 17.33 15.39 43 158119 5970 63324890
Biopsy kidney 17.25 15.39 8 158154 135 63330725
Device malfunction 17.21 15.39 89 158073 17768 63313092
Colon operation 17.14 15.39 11 158151 361 63330499
Cytopenia 16.99 15.39 4 158158 11597 63319263
Urinary retention 16.90 15.39 31 158131 30270 63300590
Right ventricular hypertrophy 16.85 15.39 14 158148 689 63330171
Pancreatitis 16.82 15.39 64 158098 48991 63281869
Sepsis 16.81 15.39 500 157662 152623 63178237
Cardiac septal defect repair 16.76 15.39 4 158158 5 63330855
Spinal operation 16.75 15.39 52 158110 8219 63322641
Mania 16.72 15.39 5 158157 12362 63318498
Catheter site bruise 16.63 15.39 12 158150 479 63330381
Synovial cyst 16.52 15.39 3 158159 10430 63320430
Cardiac pacemaker replacement 16.49 15.39 11 158151 386 63330474
Endoscopy 16.46 15.39 11 158151 387 63330473
Rales 16.45 15.39 69 158093 12628 63318232
Brain operation 16.44 15.39 13 158149 596 63330264
Bronchial artery embolisation 16.34 15.39 4 158158 6 63330854
Female sterilisation 16.33 15.39 13 158149 602 63330258
Bone density decreased 16.28 15.39 8 158154 14604 63316256
Nodule 16.25 15.39 17 158145 21009 63309851
Intracardiac pressure increased 16.21 15.39 6 158156 55 63330805
Impaired quality of life 16.21 15.39 7 158155 13776 63317084
Blood culture negative 16.21 15.39 8 158154 156 63330704
Cardiorenal syndrome 16.11 15.39 15 158147 860 63330000
Sensory loss 16.09 15.39 3 158159 10235 63320625
Large intestinal polypectomy 16.07 15.39 9 158153 229 63330631
Middle ear effusion 16.04 15.39 25 158137 2466 63328394
Infusion 16.02 15.39 8 158154 160 63330700
Delusion 15.99 15.39 5 158157 12012 63318848
Respiratory syncytial virus infection 15.99 15.39 46 158116 6972 63323888
Bacterial infection 15.98 15.39 93 158069 19406 63311454
Infusion site dryness 15.96 15.39 4 158158 7 63330853
Application site hypersensitivity 15.90 15.39 9 158153 234 63330626
Polyarthritis 15.88 15.39 3 158159 10143 63320717
Hypothermia 15.81 15.39 7 158155 13574 63317286
Metastases to lung 15.77 15.39 6 158156 12744 63318116
Body height decreased 15.73 15.39 3 158159 10075 63320785
Foetal death 15.67 15.39 4 158158 10976 63319884
Fluid intake restriction 15.62 15.39 5 158157 28 63330832
Musculoskeletal disorder 15.61 15.39 17 158145 20627 63310233
Blood pressure diastolic increased 15.59 15.39 3 158159 10007 63320853
Colitis 15.57 15.39 65 158097 48463 63282397
Aortic valve replacement 15.51 15.39 14 158148 771 63330089
Vascular resistance pulmonary increased 15.49 15.39 6 158156 63 63330797
Vascular cauterisation 15.49 15.39 6 158156 63 63330797
Pulmonary capillary haemangiomatosis 15.48 15.39 5 158157 29 63330831
Product storage error 15.48 15.39 9 158153 14947 63315913
Spinal stenosis 15.42 15.39 9 158153 14916 63315944
Cataract operation 15.40 15.39 39 158123 5483 63325377

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 1403.93 19.55 694 45846 26193 34884198
Dyspnoea 1171.16 19.55 1913 44627 374869 34535522
Hospitalisation 1038.56 19.55 745 45795 56157 34854234
Death 933.66 19.55 1788 44752 396261 34514130
Right ventricular failure 718.66 19.55 310 46230 8474 34901917
Pain in jaw 601.81 19.55 310 46230 12730 34897661
Pulmonary hypertension 512.12 19.55 329 46211 20595 34889796
Headache 479.53 19.55 912 45628 199723 34710668
Dyspnoea exertional 433.92 19.55 400 46140 42879 34867512
Transfusion 418.98 19.55 212 46328 8373 34902018
Oxygen saturation decreased 385.10 19.55 414 46126 53404 34856987
Hypervolaemia 383.96 19.55 269 46271 19440 34890951
Oedema 341.55 19.55 360 46180 45381 34865010
Nasal congestion 303.44 19.55 249 46291 22808 34887583
Drug ineffective 284.71 19.55 127 46413 456624 34453767
Lung transplant 271.44 19.55 102 46438 1922 34908469
Peripheral swelling 253.97 19.55 403 46137 76138 34834253
Drug interaction 238.75 19.55 16 46524 225930 34684461
Toxicity to various agents 231.42 19.55 8 46532 200354 34710037
Pulmonary arterial hypertension 230.10 19.55 144 46396 8595 34901796
Oxygen consumption increased 217.05 19.55 78 46462 1288 34909103
Catheter management 207.20 19.55 69 46471 896 34909495
Neutropenia 193.46 19.55 3 46537 156775 34753616
Oedema peripheral 185.55 19.55 458 46082 119354 34791037
Catheterisation cardiac 185.07 19.55 84 46456 2593 34907798
Off label use 164.05 19.55 191 46349 419333 34491058
Febrile neutropenia 163.26 19.55 4 46536 136845 34773546
Flushing 150.10 19.55 200 46340 32220 34878171
Product dose omission issue 148.06 19.55 421 46119 119290 34791101
Catheter site erythema 143.17 19.55 58 46482 1345 34909046
Dialysis 141.04 19.55 118 46422 11090 34899301
Condition aggravated 135.49 19.55 560 45980 191636 34718755
Concomitant disease aggravated 135.30 19.55 88 46452 5613 34904778
Infusion site pain 131.40 19.55 75 46465 3776 34906615
Transplant evaluation 128.14 19.55 41 46499 465 34909926
Therapy non-responder 125.38 19.55 203 46337 38943 34871448
Unevaluable event 119.69 19.55 180 46360 32410 34877981
Hypoxia 119.33 19.55 241 46299 54854 34855537
Catheter site pain 111.91 19.55 48 46492 1290 34909101
Pneumonia 109.39 19.55 840 45700 361787 34548604
Therapy change 107.88 19.55 61 46479 3016 34907375
Weight increased 107.06 19.55 319 46221 92714 34817677
Pulmonary arterial pressure increased 104.55 19.55 45 46495 1220 34909171
Drug abuse 104.55 19.55 7 46533 99089 34811302
Swelling 101.02 19.55 193 46347 42173 34868218
Pain in extremity 99.74 19.55 382 46158 126131 34784260
Catheter site pruritus 96.45 19.55 30 46510 308 34910083
Thrombocytopenia 95.96 19.55 44 46496 156203 34754188
Oxygen therapy 94.73 19.55 38 46502 858 34909533
Malaise 94.29 19.55 492 46048 185333 34725058
Pulmonary oedema 92.48 19.55 199 46341 47330 34863061
Hypotension 91.41 19.55 555 45985 221094 34689297
Acute kidney injury 91.29 19.55 167 46373 304821 34605570
Brain natriuretic peptide increased 89.18 19.55 68 46472 5591 34904800
Dizziness 88.73 19.55 545 45995 217976 34692415
Cough 85.63 19.55 411 46129 149729 34760662
Catheter site rash 81.94 19.55 24 46516 197 34910194
Catheter site discharge 81.14 19.55 31 46509 612 34909779
Product use in unapproved indication 78.73 19.55 29 46511 117470 34792921
Catheter placement 78.04 19.55 32 46508 766 34909625
Liver transplant 77.58 19.55 46 46494 2488 34907903
Diarrhoea 73.61 19.55 817 45723 389095 34521296
Syncope 73.54 19.55 278 46262 91173 34819218
Catheter site irritation 71.49 19.55 19 46521 104 34910287
Cardiac failure 71.41 19.55 275 46265 90973 34819418
Overdose 70.95 19.55 17 46523 91042 34819349
Aspiration pleural cavity 69.67 19.55 30 46510 814 34909577
Pancytopenia 68.07 19.55 21 46519 95136 34815255
Adverse event 67.49 19.55 103 46437 18774 34891617
Cardiac failure congestive 64.37 19.55 250 46290 83020 34827371
Disease complication 64.35 19.55 42 46498 2694 34907697
Intentional product use issue 63.73 19.55 4 46536 59812 34850579
Productive cough 62.04 19.55 148 46392 37665 34872726
Leukopenia 61.94 19.55 6 46534 62850 34847541
Endarterectomy 61.53 19.55 18 46522 147 34910244
Pulmonary veno-occlusive disease 61.13 19.55 24 46516 511 34909880
Abdominal distension 61.10 19.55 194 46346 58298 34852093
Vascular device infection 60.96 19.55 48 46492 4137 34906254
Lung operation 57.41 19.55 15 46525 76 34910315
Infusion site infection 56.54 19.55 22 46518 457 34909934
Rash 56.40 19.55 134 46406 222618 34687773
Device dislocation 55.34 19.55 54 46486 6195 34904196
Paracentesis 54.76 19.55 21 46519 419 34909972
Catheter site haemorrhage 54.42 19.55 35 46505 2189 34908202
Epistaxis 54.39 19.55 186 46354 58065 34852326
Drug hypersensitivity 53.71 19.55 20 46520 80509 34829882
Chronic obstructive pulmonary disease 53.62 19.55 165 46375 48753 34861638
Cardiac disorder 53.49 19.55 152 46388 42974 34867417
Chest pain 53.11 19.55 319 46221 126443 34783948
Nasopharyngitis 50.78 19.55 206 46334 69762 34840629
Feeling abnormal 50.61 19.55 192 46348 63043 34847348
Cardiac pacemaker insertion 50.52 19.55 37 46503 2861 34907530
Cardiac operation 50.42 19.55 38 46502 3069 34907322
Treatment failure 50.11 19.55 3 46537 46694 34863697
Confusional state 49.49 19.55 72 46468 144088 34766303
Abdominal discomfort 48.98 19.55 183 46357 59652 34850739
Acute respiratory failure 47.47 19.55 118 46422 30810 34879581
Sinus congestion 45.14 19.55 46 46494 5559 34904832
Pulmonary endarterectomy 44.36 19.55 12 46528 71 34910320
Infusion site erythema 44.16 19.55 31 46509 2242 34908149
Respiratory failure 43.42 19.55 270 46270 108302 34802089
Hyperkalaemia 43.39 19.55 19 46521 69370 34841021
Catheter site infection 42.67 19.55 32 46508 2565 34907826
Exercise tolerance decreased 42.48 19.55 43 46497 5155 34905236
Hospice care 42.00 19.55 49 46491 6891 34903500
Internal haemorrhage 41.75 19.55 42 46498 4999 34905392
Intentional product misuse 40.87 19.55 6 46534 45605 34864786
Rehabilitation therapy 40.74 19.55 21 46519 861 34909530
Neuropathy peripheral 40.42 19.55 31 46509 83232 34827159
Acute myocardial infarction 39.97 19.55 11 46529 53708 34856683
Hallucination 39.35 19.55 10 46530 51488 34858903
Bradycardia 39.34 19.55 26 46514 75392 34834999
Haemoptysis 39.21 19.55 119 46421 34887 34875504
Walking distance test abnormal 38.95 19.55 13 46527 170 34910221
Dizziness postural 38.11 19.55 44 46496 6120 34904271
Hypertension 37.83 19.55 78 46462 136365 34774026
Emergency care 37.75 19.55 15 46525 330 34910061
Device alarm issue 37.66 19.55 18 46522 626 34909765
Palpitations 37.59 19.55 128 46412 39858 34870533
White blood cell count decreased 37.56 19.55 43 46497 95402 34814989
Complication associated with device 37.35 19.55 43 46497 5963 34904428
Stomatitis 37.16 19.55 6 46534 42508 34867883
Lung disorder 37.05 19.55 116 46424 34580 34875811
Blood iron decreased 36.39 19.55 40 46500 5273 34905118
Atrial septal defect repair 36.36 19.55 11 46529 102 34910289
Seizure 36.33 19.55 52 46488 104805 34805586
Deep vein thrombosis 36.10 19.55 21 46519 65227 34845164
Hyperhidrosis 35.71 19.55 29 46511 75663 34834728
Blood pressure increased 35.42 19.55 39 46501 88063 34822328
Lactic acidosis 35.11 19.55 3 46537 34769 34875622
Abdominal cavity drainage 35.08 19.55 15 46525 400 34909991
Delirium 34.67 19.55 8 46532 43983 34866408
Therapeutic product effect incomplete 34.63 19.55 12 46528 50529 34859862
Metabolic acidosis 34.31 19.55 8 46532 43672 34866719
Pyrexia 34.04 19.55 282 46258 332731 34577660
Cardiac ablation 33.96 19.55 20 46520 1068 34909323
Hyperglycaemia 33.56 19.55 6 46534 39474 34870917
Aggression 32.96 19.55 6 46534 38958 34871433
Ascites 32.89 19.55 136 46404 46435 34863956
Hyponatraemia 32.80 19.55 37 46503 82654 34827737
Catheter site swelling 32.78 19.55 14 46526 372 34910019
Stent placement 32.66 19.55 37 46503 5041 34905350
Plasma cell myeloma 32.43 19.55 8 46532 42029 34868362
Myalgia 32.26 19.55 207 46333 83903 34826488
Device related infection 32.16 19.55 71 46469 17166 34893225
Pericardial effusion 31.62 19.55 88 46452 24574 34885817
Terminal state 31.16 19.55 32 46508 3902 34906489
Hernia repair 31.08 19.55 20 46520 1252 34909139
Heart rate increased 30.91 19.55 133 46407 46210 34864181
Psoriasis 30.70 19.55 7 46533 38805 34871586
Suture insertion 30.38 19.55 8 46532 42 34910349
Infusion site haemorrhage 30.14 19.55 18 46522 986 34909405
Ventilation perfusion mismatch 29.70 19.55 9 46531 84 34910307
Device infusion issue 29.56 19.55 17 46523 868 34909523
Catheter removal 29.33 19.55 11 46529 206 34910185
Catheter site warmth 29.20 19.55 8 46532 50 34910341
Dizziness exertional 29.03 19.55 11 46529 212 34910179
Disease progression 28.86 19.55 244 46296 107833 34802558
Surgery 28.34 19.55 60 46480 14097 34896294
Device occlusion 28.17 19.55 39 46501 6506 34903885
Transplant 27.94 19.55 16 46524 810 34909581
Pneumonitis 27.02 19.55 6 46534 33872 34876519
Gout 26.99 19.55 71 46469 19182 34891209
Suicidal ideation 26.97 19.55 10 46530 40378 34870013
Hypoglycaemia 26.95 19.55 20 46520 54620 34855771
Heart and lung transplant 26.56 19.55 8 46532 73 34910318
Device leakage 26.55 19.55 38 46502 6537 34903854
Chemotherapy 26.27 19.55 14 46526 615 34909776
Rhinorrhoea 25.75 19.55 84 46456 25584 34884807
Inappropriate schedule of product administration 25.67 19.55 27 46513 62269 34848122
Cholestasis 25.44 19.55 3 46537 26945 34883446
Influenza 25.42 19.55 132 46408 49534 34860857
Drug-induced liver injury 25.35 19.55 4 46536 28828 34881563
Scleroderma 25.01 19.55 19 46521 1553 34908838
Dyspepsia 24.94 19.55 106 46434 36626 34873765
Depressed level of consciousness 24.83 19.55 13 46527 42828 34867563
Coronary artery disease 24.72 19.55 17 46523 48288 34862103
Rheumatoid arthritis 24.65 19.55 10 46530 38228 34872163
Agitation 24.65 19.55 24 46516 57375 34853016
Urticaria 24.64 19.55 28 46512 62349 34848042
Disturbance in attention 24.22 19.55 3 46537 25942 34884449
Cardiac index increased 24.11 19.55 6 46534 24 34910367
Wrong technique in product usage process 23.88 19.55 9 46531 35977 34874414
Respiration abnormal 23.66 19.55 25 46515 3151 34907240
Multiple organ dysfunction syndrome 23.63 19.55 41 46499 76525 34833866
Platelet count decreased 23.63 19.55 81 46459 119636 34790755
Renal disorder 23.45 19.55 81 46459 25399 34884992
Ammonia increased 23.41 19.55 29 46511 4340 34906051
Oxygen saturation abnormal 23.26 19.55 18 46522 1512 34908879
Biopsy liver 23.17 19.55 10 46530 273 34910118
Musculoskeletal stiffness 23.13 19.55 17 46523 46663 34863728
Abnormal behaviour 23.04 19.55 3 46537 24966 34885425
Haemoglobin decreased 23.02 19.55 254 46286 120518 34789873
Diuretic therapy 22.71 19.55 6 46534 32 34910359
Hypocalcaemia 22.21 19.55 3 46537 24286 34886105
Coma 22.17 19.55 17 46523 45661 34864730
Blood bilirubin increased 21.87 19.55 105 46435 38191 34872200
Biopsy lung 21.83 19.55 8 46532 140 34910251
Oesophageal variceal ligation 21.83 19.55 7 46533 80 34910311
Pulmonary thrombosis 21.79 19.55 37 46503 7370 34903021
Agranulocytosis 21.65 19.55 3 46537 23818 34886573
Pulmonary congestion 21.62 19.55 53 46487 13712 34896679
Idiopathic pulmonary fibrosis 21.47 19.55 25 46515 3509 34906882
Spontaneous intrahepatic portosystemic venous shunt 21.20 19.55 5 46535 15 34910376
Cardioversion 21.13 19.55 14 46526 921 34909470
Abdominal pain 20.81 19.55 130 46410 163488 34746903
Presyncope 20.60 19.55 64 46476 18995 34891396
Right ventricular dysfunction 20.46 19.55 15 46525 1161 34909230
Fall 20.30 19.55 381 46159 202504 34707887
Cardiac flutter 20.24 19.55 18 46522 1835 34908556
Angioplasty 20.15 19.55 14 46526 996 34909395
Device physical property issue 19.88 19.55 13 46527 836 34909555
Intracardiac pressure increased 19.72 19.55 4 46536 4 34910387

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 3933.83 15.22 6938 172874 850087 78714489
Fluid retention 3842.95 15.22 2227 177585 67582 79496994
Death 2825 15.22 4769 175043 561745 79002831
Hospitalisation 2403.95 15.22 1864 177948 92372 79472204
Pain in jaw 1746.55 15.22 1161 178651 44990 79519586
Right ventricular failure 1698.50 15.22 898 178914 22599 79541977
Dyspnoea exertional 1554.48 15.22 1402 178410 85671 79478905
Drug ineffective 1490.44 15.22 315 179497 1080598 78483978
Headache 1487.99 15.22 4003 175809 649769 78914807
Transfusion 1459.51 15.22 786 179026 20544 79544032
Pulmonary hypertension 1350.28 15.22 1008 178804 47072 79517504
Hypervolaemia 1286.66 15.22 934 178878 41756 79522820
Nasal congestion 1269.44 15.22 1183 178629 75369 79489207
Oxygen saturation decreased 1037.46 15.22 1364 178448 127683 79436893
Off label use 946.04 15.22 434 179378 906781 78657795
Toxicity to various agents 795.74 15.22 37 179775 421503 79143073
Oedema 792.72 15.22 1152 178660 118428 79446148
Oedema peripheral 703.97 15.22 1673 178139 250615 79313961
Catheter management 679.96 15.22 270 179542 3393 79561183
Drug interaction 661.44 15.22 80 179732 415103 79149473
Lung transplant 649.05 15.22 278 179534 4283 79560293
Product dose omission issue 635.62 15.22 1590 178222 245947 79318629
Catheter site erythema 615.16 15.22 279 179533 4961 79559615
Oxygen consumption increased 612.80 15.22 274 179538 4705 79559871
Pneumonia 590.82 15.22 2991 176821 657255 78907321
Catheterisation cardiac 573.03 15.22 273 179539 5455 79559121
Pulmonary arterial hypertension 570.13 15.22 489 179323 27877 79536699
Neutropenia 567.33 15.22 18 179794 287692 79276884
Unevaluable event 554.25 15.22 655 179157 54930 79509646
Completed suicide 536.36 15.22 3 179809 245764 79318812
Cough 527.44 15.22 1920 177892 364869 79199707
Pulmonary oedema 514.45 15.22 801 179011 87453 79477123
Catheter site pain 508.95 15.22 247 179565 5149 79559427
Infusion related reaction 491.67 15.22 5 179807 230232 79334344
Febrile neutropenia 480.19 15.22 8 179804 230991 79333585
Peripheral swelling 474.90 15.22 1511 178301 268106 79296470
Flushing 470.34 15.22 769 179043 87499 79477077
Catheter site pruritus 464.41 15.22 180 179632 2111 79562465
Infusion site pain 451.68 15.22 321 179491 13855 79550721
Chest pain 415.78 15.22 1490 178322 280814 79283762
Pulmonary arterial pressure increased 398.24 15.22 198 179614 4357 79560219
Hypoxia 388.30 15.22 773 179039 102470 79462106
Hypotension 377.46 15.22 1973 177839 438344 79126232
Dizziness 372.57 15.22 2240 177572 524201 79040375
Dialysis 368.38 15.22 317 179495 18145 79546431
Drug hypersensitivity 358.30 15.22 114 179698 298802 79265774
Concomitant disease aggravated 355.91 15.22 270 179542 12897 79551679
Therapy change 351.38 15.22 215 179597 7184 79557392
Treatment failure 345.84 15.22 8 179804 170478 79394098
Therapeutic product effect decreased 339.13 15.22 6 179806 163857 79400719
Malaise 335.42 15.22 2067 177745 487802 79076774
Diarrhoea 331.70 15.22 3230 176582 877259 78687317
Product use in unapproved indication 330.82 15.22 79 179733 250280 79314296
Catheter site discharge 323.48 15.22 141 179671 2271 79562305
Drug abuse 321.18 15.22 10 179802 162681 79401895
Catheter placement 310.53 15.22 146 179666 2828 79561748
Cardiac failure congestive 307.20 15.22 858 178954 141544 79423032
Palpitations 302.33 15.22 792 179020 125818 79438758
Transplant evaluation 300.78 15.22 121 179691 1576 79563000
Cardiac failure 291.82 15.22 889 178923 153953 79410623
Scleroderma 284.62 15.22 169 179643 5341 79559235
Catheter site infection 281.33 15.22 181 179631 6614 79557962
Malignant neoplasm progression 281.31 15.22 5 179807 135985 79428591
Contraindicated product administered 278.00 15.22 20 179792 157518 79407058
Catheter site rash 277.22 15.22 99 179713 906 79563670
Syncope 275.76 15.22 961 178851 178488 79386088
Rheumatoid arthritis 274.95 15.22 66 179746 208404 79356172
Vascular device infection 269.56 15.22 207 179605 10069 79554507
Rash 263.03 15.22 571 179241 577787 78986789
Stomatitis 252.28 15.22 21 179791 146736 79417840
Acute kidney injury 252.03 15.22 494 179318 518910 79045666
Device related infection 251.47 15.22 347 179465 33947 79530629
Maternal exposure during pregnancy 250.85 15.22 14 179798 136524 79428052
Brain natriuretic peptide increased 250.52 15.22 187 179625 8713 79555863
Thrombocytopenia 248.22 15.22 145 179667 265114 79299462
Intentional product use issue 240.17 15.22 30 179782 152082 79412494
Alopecia 237.82 15.22 112 179700 231243 79333333
Abdominal distension 237.71 15.22 700 179112 118950 79445626
Condition aggravated 234.95 15.22 1930 177882 499194 79065382
Catheter site haemorrhage 233.59 15.22 145 179667 4972 79559604
Arthropathy 229.78 15.22 58 179754 177053 79387523
Therapeutic product effect incomplete 228.41 15.22 26 179786 141619 79422957
Overdose 224.64 15.22 68 179744 184138 79380438
Catheter site swelling 224.55 15.22 101 179711 1759 79562817
Productive cough 222.60 15.22 564 179248 87767 79476809
Epistaxis 219.22 15.22 650 179162 110865 79453711
Musculoskeletal stiffness 218.18 15.22 62 179750 174946 79389630
Cardiac disorder 215.04 15.22 465 179347 65292 79499284
Oxygen therapy 213.94 15.22 111 179701 2679 79561897
Leukopenia 213.86 15.22 12 179800 116501 79448075
Cardiac pacemaker insertion 209.29 15.22 142 179670 5680 79558896
Device alarm issue 207.23 15.22 99 179713 1990 79562586
Intentional overdose 200.56 15.22 9 179803 105951 79458625
Rhabdomyolysis 197.73 15.22 8 179804 103123 79461453
Glossodynia 194.87 15.22 9 179803 103328 79461248
Therapy non-responder 193.89 15.22 551 179261 91754 79472822
Infusion site erythema 185.81 15.22 161 179651 9299 79555277
Feeling abnormal 185.57 15.22 781 179031 158418 79406158
Hepatic enzyme increased 185.19 15.22 90 179722 182520 79382056
Product use issue 183.41 15.22 124 179688 209698 79354878
Device leakage 182.06 15.22 169 179643 10687 79553889
Aspiration pleural cavity 180.05 15.22 83 179729 1534 79563042
Pericarditis 178.90 15.22 15 179797 104221 79460355
Catheter site irritation 177.22 15.22 62 179750 531 79564045
Acute respiratory failure 175.53 15.22 404 179408 59137 79505439
Paracentesis 175.09 15.22 77 179735 1268 79563308
Neutrophil count decreased 174.55 15.22 9 179803 93950 79470626
Nausea 173.80 15.22 3074 176738 954122 78610454
Chest discomfort 173.33 15.22 693 179119 137351 79427225
Confusional state 172.40 15.22 282 179530 317715 79246861
Infusion site infection 169.38 15.22 82 179730 1699 79562877
Drug intolerance 169.16 15.22 208 179604 263911 79300665
Pain in extremity 168.43 15.22 1400 178412 363138 79201438
Respiratory failure 168.00 15.22 830 178982 180081 79384495
Cardiac operation 167.79 15.22 117 179695 4895 79559681
Ascites 167.48 15.22 460 179352 75102 79489474
Pericardial effusion 165.14 15.22 339 179473 45898 79518678
Emergency care 160.61 15.22 68 179744 1016 79563560
Electrocardiogram QT prolonged 157.92 15.22 12 179800 90374 79474202
Blood pressure increased 156.99 15.22 147 179665 211213 79353363
Hypertension 156.70 15.22 319 179493 330673 79233903
Chronic obstructive pulmonary disease 148.41 15.22 477 179335 84942 79479634
Rehabilitation therapy 147.73 15.22 76 179736 1801 79562775
Anaphylactic reaction 146.64 15.22 11 179801 83732 79480844
Pancytopenia 146.11 15.22 97 179715 165648 79398928
Device dislocation 146.04 15.22 232 179580 25738 79538838
Suicide attempt 144.92 15.22 11 179801 82921 79481655
Hospice care 143.55 15.22 145 179667 10179 79554397
Joint swelling 142.82 15.22 271 179541 288375 79276201
Intentional product misuse 142.58 15.22 22 179790 95143 79469433
Pulmonary veno-occlusive disease 142.18 15.22 71 179741 1577 79562999
Urticaria 142.06 15.22 125 179687 185076 79379500
Weight increased 138.72 15.22 1085 178727 276301 79288275
Liver transplant 138.22 15.22 99 179713 4324 79560252
Disease complication 137.32 15.22 103 179709 4834 79559742
Disease progression 136.55 15.22 795 179017 183567 79381009
Myalgia 135.87 15.22 798 179014 184843 79379733
Influenza 134.37 15.22 614 179198 128992 79435584
Internal haemorrhage 133.83 15.22 130 179682 8703 79555873
Hypersensitivity 133.45 15.22 242 179570 261997 79302579
Blood potassium decreased 130.97 15.22 310 179502 46202 79518374
Blood cholesterol increased 130.93 15.22 17 179795 83703 79480873
Angioedema 130.31 15.22 11 179801 76024 79488552
Infusion site swelling 129.63 15.22 121 179691 7705 79556871
Dizziness postural 128.34 15.22 144 179668 11405 79553171
Impaired healing 127.44 15.22 22 179790 87633 79476943
Device infusion issue 127.12 15.22 74 179738 2252 79562324
Blood creatine phosphokinase increased 120.67 15.22 7 179805 66083 79498493
Walking distance test abnormal 118.42 15.22 49 179763 689 79563887
Atrial septal defect repair 118.20 15.22 43 179769 417 79564159
Hyponatraemia 118.15 15.22 136 179676 177712 79386864
Renal disorder 117.87 15.22 280 179532 41825 79522751
Device occlusion 116.82 15.22 139 179673 11727 79552849
Psoriasis 116.80 15.22 29 179783 89558 79475018
Bradycardia 115.91 15.22 82 179730 135475 79429101
Helicobacter infection 114.36 15.22 12 179800 69692 79494884
Central venous catheterisation 112.97 15.22 78 179734 3211 79561365
Presyncope 112.75 15.22 271 179541 40783 79523793
Sinus congestion 112.23 15.22 178 179634 19718 79544858
Depressed level of consciousness 111.92 15.22 39 179773 96613 79467963
Dyspnoea at rest 111.63 15.22 108 179704 7194 79557382
Metabolic acidosis 110.98 15.22 25 179787 82504 79482072
Coma 110.86 15.22 44 179768 100605 79463971
Folliculitis 110.73 15.22 3 179809 55377 79509199
White blood cell count decreased 110.58 15.22 158 179654 188130 79376446
Infusion site discharge 109.17 15.22 44 179768 576 79564000
Haemoglobin decreased 108.88 15.22 865 178947 221254 79343322
N-terminal prohormone brain natriuretic peptide increased 107.98 15.22 88 179724 4667 79559909
Blister 107.90 15.22 68 179744 119408 79445168
C-reactive protein increased 107.78 15.22 80 179732 128947 79435629
Blood pressure decreased 107.41 15.22 477 179335 98989 79465587
Abdominal cavity drainage 106.38 15.22 47 179765 783 79563793
Nasopharyngitis 105.07 15.22 952 178860 252929 79311647
Infusion site haemorrhage 104.33 15.22 78 179734 3642 79560934
Exercise tolerance decreased 104.06 15.22 115 179697 8956 79555620
Catheter site inflammation 103.91 15.22 51 179761 1090 79563486
Dermatitis contact 103.32 15.22 126 179686 10907 79553669
Osteoarthritis 103.23 15.22 34 179778 87275 79477301
Suicidal ideation 102.90 15.22 23 179789 76317 79488259
Seizure 102.67 15.22 167 179645 188667 79375909
Mineral supplementation 102.64 15.22 46 179766 794 79563782
Stent placement 102.63 15.22 98 179714 6422 79558154
Blood iron decreased 102.53 15.22 149 179663 15285 79549291
Pulmonary endarterectomy 101.27 15.22 32 179780 192 79564384
Delirium 99.98 15.22 33 179779 84594 79479982
Hyperkalaemia 99.39 15.22 68 179744 114330 79450246
Dyspepsia 95.43 15.22 491 179321 108196 79456380
Complication associated with device 95.22 15.22 154 179658 17342 79547234
Haemoptysis 94.79 15.22 310 179502 55689 79508887
Bone marrow failure 94.59 15.22 5 179807 51102 79513474
Cognitive disorder 94.39 15.22 21 179791 69905 79494671
Discomfort 93.66 15.22 87 179725 125530 79439046
Inappropriate schedule of product administration 93.36 15.22 98 179714 133530 79431046
Endarterectomy 91.75 15.22 34 179778 349 79564227
Wrong technique in product usage process 90.50 15.22 27 179785 73848 79490728
Hallucination 90.39 15.22 40 179772 85705 79478871
Wound 89.56 15.22 78 179734 116101 79448475
Muscle injury 89.10 15.22 5 179807 48556 79516020
Drug-induced liver injury 88.96 15.22 20 179792 66097 79498479
Lower respiratory tract infection 88.89 15.22 96 179716 129124 79435452
Deep vein thrombosis 88.68 15.22 85 179727 120834 79443742
Blood pressure systolic increased 88.66 15.22 21 179791 66965 79497611
Heart rate increased 87.66 15.22 518 179294 120206 79444370
Mobility decreased 87.16 15.22 88 179724 122087 79442489
Cardioversion 87.13 15.22 56 179756 2042 79562534
Hepatocellular injury 87.01 15.22 5 179807 47588 79516988
Seasonal allergy 86.03 15.22 142 179670 16264 79548312
Injection site reaction 85.96 15.22 11 179801 54774 79509802
Cardiac ablation 85.90 15.22 57 179755 2196 79562380
Left ventricular failure 85.82 15.22 107 179705 9474 79555102
Cholestasis 85.41 15.22 9 179803 52100 79512476
Exposure during pregnancy 85.37 15.22 62 179750 101070 79463506
Hypoglycaemia 84.83 15.22 63 179749 101531 79463045
Catheter site vesicles 84.55 15.22 31 179781 308 79564268
Rhinorrhoea 84.53 15.22 368 179444 75706 79488870
Injection site pain 84.38 15.22 101 179711 129737 79434839
Lung disorder 83.72 15.22 382 179430 80175 79484401
Lactic acidosis 82.13 15.22 28 179784 70331 79494245
Hyperglycaemia 82.09 15.22 28 179784 70307 79494269
Injury 81.92 15.22 36 179776 77460 79487116
Bronchitis 81.39 15.22 539 179273 130105 79434471
Pleural effusion 79.14 15.22 580 179232 144682 79419894
Nasal dryness 78.38 15.22 72 179740 4491 79560085
Chemotherapy 78.21 15.22 49 179763 1708 79562868
Fibromyalgia 77.94 15.22 24 179788 64316 79500260
Red blood cell sedimentation rate increased 77.76 15.22 7 179805 45935 79518641
Atrial flutter 77.73 15.22 159 179653 21466 79543110
Pulmonary congestion 76.69 15.22 181 179631 26919 79537657
Hepatotoxicity 76.62 15.22 12 179800 51340 79513236
Eosinophilia 76.50 15.22 7 179805 45338 79519238
General physical health deterioration 76.24 15.22 340 179472 274898 79289678
Pulmonary arterial pressure abnormal 76.16 15.22 36 179776 706 79563870
Hypocalcaemia 76.02 15.22 11 179801 49913 79514663
Agranulocytosis 75.84 15.22 7 179805 45023 79519553
Acute myocardial infarction 75.02 15.22 40 179772 76996 79487580
Neuropathy peripheral 74.91 15.22 127 179685 141178 79423398
Gout 74.10 15.22 169 179643 24580 79539996
Disease recurrence 73.91 15.22 7 179805 44102 79520474
Type 2 diabetes mellitus 73.47 15.22 19 179793 57103 79507473
Tubulointerstitial nephritis 73.16 15.22 3 179809 38232 79526344
Catheter site related reaction 72.46 15.22 41 179771 1181 79563395
Medication error 72.38 15.22 32 179780 68610 79495966
Catheter site warmth 72.32 15.22 26 179786 243 79564333
Irritable bowel syndrome 72.25 15.22 25 179787 62216 79502360
Right ventricular dilatation 71.68 15.22 48 179764 1878 79562698
Pulmonary arterial wedge pressure increased 71.41 15.22 31 179781 494 79564082
Transplant 71.31 15.22 38 179774 970 79563606
Right ventricular dysfunction 71.13 15.22 54 179758 2581 79561995
Cytomegalovirus infection 70.84 15.22 7 179805 42637 79521939
Hernia repair 70.71 15.22 49 179763 2029 79562547
Dysarthria 70.56 15.22 32 179780 67590 79496986
Oropharyngeal pain 70.44 15.22 455 179357 108898 79455678
Terminal state 70.42 15.22 70 179742 4819 79559757
Concomitant disease progression 70.01 15.22 60 179752 3413 79561163
Drug dependence 69.57 15.22 6 179806 40763 79523813
Aggression 69.39 15.22 15 179797 50943 79513633
Product supply issue 69.00 15.22 48 179764 2000 79562576
Liver injury 68.79 15.22 21 179791 56593 79507983
Infusion site irritation 68.75 15.22 34 179778 739 79563837
Myelosuppression 68.58 15.22 6 179806 40290 79524286
Depression 68.04 15.22 255 179557 216535 79348041
Drug level increased 67.22 15.22 6 179806 39645 79524931
Sinus disorder 66.81 15.22 153 179659 22311 79542265
Pruritus 66.71 15.22 569 179243 394079 79170497
Lymphocyte count decreased 66.30 15.22 13 179799 47276 79517300
Generalised tonic-clonic seizure 66.11 15.22 10 179802 43900 79520676
Plasma cell myeloma 66.09 15.22 19 179793 53240 79511336
Angioplasty 65.92 15.22 45 179767 1818 79562758
Infusion site warmth 65.83 15.22 41 179771 1414 79563162
Hepatitis 65.35 15.22 22 179790 55705 79508871
Biopsy lung 65.23 15.22 24 179788 241 79564335
Paraesthesia 65.22 15.22 193 179619 176130 79388446
Hypercalcaemia 64.65 15.22 6 179806 38424 79526152
Cardiac output increased 64.28 15.22 24 179788 252 79564324
Hyperhidrosis 64.21 15.22 155 179657 151337 79413239
Anaemia 63.57 15.22 1380 178432 443635 79120941
Incorrect route of product administration 62.86 15.22 4 179808 34925 79529651
Multiple allergies 62.36 15.22 96 179716 10364 79554212
Orthopnoea 62.24 15.22 94 179718 9979 79554597
Agitation 62.23 15.22 80 179732 99635 79464941
Extra dose administered 61.45 15.22 85 179727 8330 79556246
Oxygen saturation abnormal 61.24 15.22 63 179749 4519 79560057
Psychotic disorder 61.04 15.22 10 179802 41392 79523184
Catheter site scab 60.51 15.22 22 179790 213 79564363
Drug ineffective for unapproved indication 60.48 15.22 20 179792 51218 79513358
Systemic lupus erythematosus 59.62 15.22 114 179698 121035 79443541
Product prescribing error 59.40 15.22 14 179798 44799 79519777
Medical device change 59.27 15.22 27 179785 485 79564091
Therapeutic response decreased 59.05 15.22 39 179773 66814 79497762
Hallucination, visual 58.15 15.22 4 179808 32725 79531851
Pneumocystis jirovecii pneumonia 57.68 15.22 4 179808 32504 79532072
Ill-defined disorder 57.42 15.22 39 179773 65836 79498740
Device connection issue 56.37 15.22 33 179779 1015 79563561
Prescribed overdose 56.18 15.22 9 179803 37874 79526702
Head discomfort 56.16 15.22 110 179702 14392 79550184
Choking 55.89 15.22 99 179713 12002 79552574
Cor pulmonale 55.82 15.22 44 179768 2224 79562352
Epilepsy 55.69 15.22 12 179800 40848 79523728
Acute hepatic failure 55.55 15.22 3 179809 30110 79534466
Catheterisation cardiac abnormal 55.21 15.22 22 179790 279 79564297
Swollen tongue 55.06 15.22 14 179798 42556 79522020
Encephalopathy 54.72 15.22 43 179769 67354 79497222
Prescribed underdose 54.26 15.22 3 179809 29511 79535065
Diagnostic procedure 53.97 15.22 19 179793 166 79564410
Drug eruption 53.92 15.22 16 179796 43919 79520657
Joint range of motion decreased 53.90 15.22 6 179806 33276 79531300
Dependence on oxygen therapy 53.82 15.22 26 179786 536 79564040
Basal cell carcinoma 52.98 15.22 10 179802 37365 79527211
Respiration abnormal 52.92 15.22 76 179736 7712 79556864
Pericardial drainage 52.79 15.22 24 179788 429 79564147
Heart and lung transplant 52.71 15.22 19 179793 179 79564397
Iron deficiency anaemia 52.65 15.22 152 179660 25520 79539056
Accidental exposure to product 52.40 15.22 5 179807 31317 79533259
Emotional distress 51.97 15.22 13 179799 39956 79524620
Injection site erythema 51.68 15.22 60 179752 78137 79486439
Cholecystectomy 51.30 15.22 83 179729 9349 79555227
Ischaemic stroke 51.15 15.22 7 179805 33124 79531452
Biopsy liver 51.08 15.22 26 179786 602 79563974
Pancreatitis acute 50.93 15.22 24 179788 49580 79514996
Diabetic ketoacidosis 50.85 15.22 8 179804 34114 79530462
Respiratory tract congestion 50.84 15.22 128 179684 19826 79544750
Lymphopenia 50.80 15.22 5 179807 30552 79534024
Dizziness exertional 50.32 15.22 25 179787 549 79564027
Device related sepsis 50.09 15.22 66 179746 6174 79558402
Adverse event 50.06 15.22 268 179544 59946 79504630
Skin lesion 49.98 15.22 16 179796 41828 79522748
Systemic scleroderma 49.83 15.22 32 179780 1165 79563411
Catheter removal 49.83 15.22 26 179786 635 79563941
Acute myeloid leukaemia 48.94 15.22 6 179806 30879 79533697
Skin exfoliation 47.52 15.22 33 179779 55067 79509509
Myoclonus 47.39 15.22 4 179808 27656 79536920
Labelled drug-drug interaction medication error 47.37 15.22 4 179808 27646 79536930
Mouth ulceration 47.08 15.22 14 179798 38380 79526196
Prostate cancer 46.94 15.22 9 179803 33259 79531317
Pulmonary embolism 46.92 15.22 213 179599 171441 79393135
Coronary artery disease 46.87 15.22 47 179765 65427 79499149
Body temperature decreased 46.86 15.22 8 179804 32137 79532439
Blood lactate dehydrogenase increased 46.74 15.22 15 179797 39155 79525421
Pulmonary pain 46.70 15.22 54 179758 4419 79560157
Cardiac failure high output 46.57 15.22 20 179792 310 79564266
Medical procedure 46.40 15.22 20 179792 313 79564263
Haematuria 46.38 15.22 52 179760 68784 79495792
Decreased appetite 46.36 15.22 1054 178758 341364 79223212
Asthma 46.32 15.22 153 179659 134942 79429634
Product quality issue 46.19 15.22 10 179802 33930 79530646
Blood pressure fluctuation 46.04 15.22 50 179762 67095 79497481
Cardiac failure acute 45.71 15.22 119 179693 18810 79545766
Cardiac flutter 45.45 15.22 56 179756 4898 79559678
Ejection fraction decreased 45.44 15.22 11 179801 34566 79530010
Sinus bradycardia 45.11 15.22 3 179809 25244 79539332
Status epilepticus 44.67 15.22 3 179809 25038 79539538
Ataxia 44.66 15.22 3 179809 25036 79539540
Catheter site discolouration 44.55 15.22 15 179797 113 79564463
Fatigue 44.29 15.22 2539 177273 927188 78637388
Cerebral infarction 44.05 15.22 24 179788 45652 79518924
Infusion site induration 43.96 15.22 29 179783 1106 79563470
Biopsy bone marrow 43.91 15.22 20 179792 359 79564217
Biopsy 43.91 15.22 25 179787 729 79563847
Jugular vein distension 43.87 15.22 32 179780 1438 79563138
Carbon dioxide increased 43.74 15.22 38 179774 2202 79562374
Pyrexia 43.66 15.22 1181 178631 677528 78887048
Proteinuria 43.38 15.22 10 179802 32492 79532084
Abnormal behaviour 43.37 15.22 14 179798 36407 79528169
Arthralgia 43.00 15.22 972 178840 570831 78993745
Blood glucose increased 42.39 15.22 126 179686 114849 79449727
Hepatic steatosis 42.37 15.22 16 179796 37722 79526854
Device physical property issue 42.29 15.22 40 179772 2590 79561986
Choking sensation 42.20 15.22 48 179764 3858 79560718
Pneumonitis 42.08 15.22 45 179767 60815 79503761
Drug withdrawal syndrome 41.96 15.22 13 179799 34705 79529871
Pulmonary vascular resistance abnormality 41.74 15.22 15 179797 140 79564436
Fall 41.74 15.22 1415 178397 486214 79078362
Abdominal pain upper 41.72 15.22 723 179089 223096 79341480
Heart valve replacement 41.71 15.22 26 179786 898 79563678
Treatment noncompliance 41.67 15.22 230 179582 52038 79512538
Application site pruritus 41.47 15.22 47 179765 3763 79560813
Chronic respiratory failure 41.20 15.22 42 179770 2980 79561596
Metastases to bone 40.60 15.22 4 179808 24423 79540153
Disseminated intravascular coagulation 40.57 15.22 15 179797 35827 79528749
Colitis ulcerative 40.24 15.22 14 179798 34728 79529848
Device breakage 40.16 15.22 80 179732 10595 79553981
Heart valve operation 40.15 15.22 16 179796 203 79564373
Somnolence 40.13 15.22 345 179467 238636 79325940
Catheter site erosion 39.96 15.22 12 179800 59 79564517
Foot deformity 39.86 15.22 4 179808 24070 79540506
Altered state of consciousness 39.47 15.22 25 179787 43797 79520779
Ventilation perfusion mismatch 39.38 15.22 22 179790 618 79563958
Disturbance in attention 39.27 15.22 34 179778 50767 79513809
Myelodysplastic syndrome 39.12 15.22 10 179802 30291 79534285
Bronchopulmonary aspergillosis 38.82 15.22 3 179809 22291 79542285
Gastrointestinal tube insertion 38.78 15.22 31 179781 1599 79562977
Blood bilirubin increased 38.68 15.22 269 179543 65963 79498613
Tracheostomy 38.67 15.22 28 179784 1244 79563332
Right ventricular systolic pressure increased 38.28 15.22 25 179787 937 79563639
Localised oedema 37.95 15.22 66 179746 7886 79556690
Grip strength decreased 37.92 15.22 3 179809 21866 79542710
Hypercholesterolaemia 37.82 15.22 4 179808 23091 79541485
Blood pressure abnormal 37.50 15.22 104 179708 17065 79547511
Poisoning 37.49 15.22 6 179806 25266 79539310
Neutrophil count increased 37.38 15.22 10 179802 29386 79535190
Device maintenance issue 37.08 15.22 9 179803 15 79564561
Renal tubular necrosis 37.02 15.22 6 179806 25033 79539543
Pulmonary artery dilatation 36.94 15.22 19 179793 450 79564126
Myocardial infarction 36.94 15.22 253 179559 183876 79380700
Injection site pruritus 36.89 15.22 25 179787 42258 79522318
Hypoacusis 36.71 15.22 150 179662 30000 79534576
Hip fracture 36.63 15.22 152 179660 30609 79533967
Infusion site abscess 36.37 15.22 15 179797 209 79564367
Congestive hepatopathy 36.35 15.22 48 179764 4499 79560077
Lip swelling 35.95 15.22 24 179788 40887 79523689
Obstructive airways disorder 35.89 15.22 13 179799 31446 79533130
Abortion spontaneous 35.75 15.22 11 179801 29496 79535080
Hepatic cirrhosis 35.12 15.22 164 179648 34742 79529834
Tooth extraction 35.06 15.22 77 179735 10918 79553658
Head injury 35.02 15.22 172 179640 37197 79527379
Transaminases increased 34.95 15.22 39 179773 51704 79512872
Catheter site dermatitis 34.80 15.22 12 179800 98 79564478
Peritonitis 34.79 15.22 10 179802 28026 79536550
Cytopenia 34.78 15.22 3 179809 20380 79544196
Diplopia 34.65 15.22 16 179796 33450 79531126
Nocturnal dyspnoea 34.64 15.22 29 179783 1597 79562979
Obesity 34.54 15.22 18 179794 35107 79529469
Paranasal sinus hypersecretion 34.52 15.22 43 179769 3803 79560773
Eczema 34.47 15.22 25 179787 40793 79523783
Withdrawal syndrome 34.40 15.22 9 179803 26845 79537731
Rash erythematous 34.36 15.22 48 179764 57721 79506855
Hypomagnesaemia 34.35 15.22 33 179779 46878 79517698
Atrial septal defect 34.33 15.22 31 179781 1891 79562685
Bursitis 34.33 15.22 19 179793 35825 79528751
Jaundice 34.12 15.22 42 179770 53307 79511269
Paranasal sinus discomfort 34.03 15.22 46 179766 4410 79560166
COVID-19 33.98 15.22 212 179600 157462 79407114
Visual acuity reduced 33.92 15.22 12 179800 29457 79535119
Secretion discharge 33.81 15.22 92 179720 14930 79549646
Surgery 33.75 15.22 155 179657 32611 79531965
Wrong dose 33.61 15.22 29 179783 1665 79562911
Osteonecrosis 33.57 15.22 14 179798 31081 79533495
Hip surgery 33.48 15.22 39 179773 3216 79561360
Dyskinesia 33.37 15.22 31 179781 44742 79519834
Catheter site nodule 33.33 15.22 10 179802 49 79564527
Cardiac septal defect 33.29 15.22 16 179796 326 79564250
Polypectomy 33.22 15.22 25 179787 1179 79563397
Gastroenteritis viral 33.02 15.22 127 179685 24704 79539872
Hypertensive crisis 33.00 15.22 4 179808 20766 79543810
Transplant rejection 32.79 15.22 3 179809 19434 79545142
Urinary retention 32.75 15.22 48 179764 56582 79507994
Colitis 32.66 15.22 73 179739 73234 79491342
Myopathy 32.57 15.22 4 179808 20559 79544017
Oxygen consumption 32.54 15.22 11 179801 84 79564492
Torsade de pointes 32.53 15.22 3 179809 19309 79545267
Erythema 32.49 15.22 334 179478 222956 79341620
Acute right ventricular failure 32.47 15.22 16 179796 345 79564231
Aspergillus infection 32.21 15.22 3 179809 19158 79545418
Gastrointestinal surgery 32.11 15.22 15 179797 286 79564290
Colonoscopy 32.05 15.22 30 179782 1917 79562659
Multiple organ dysfunction syndrome 31.79 15.22 151 179661 120095 79444481
Muscular weakness 31.67 15.22 222 179590 160507 79404069
Catheter site extravasation 31.62 15.22 17 179795 442 79564134
Thrombectomy 31.60 15.22 15 179797 297 79564279
Cyanosis 31.23 15.22 126 179686 25056 79539520
Thrombosis in device 31.12 15.22 49 179763 5393 79559183
Vasculitis 31.06 15.22 9 179803 25093 79539483
Abdominal pain 31.03 15.22 656 179156 388913 79175663
Chest tube insertion 31.01 15.22 12 179800 140 79564436
Cardiomyopathy 30.99 15.22 13 179799 28761 79535815
Pancreatitis 30.79 15.22 68 179744 68507 79496069
Endotracheal intubation 30.69 15.22 45 179767 4652 79559924
Arteriovenous malformation 30.66 15.22 28 179784 1733 79562843
Diuretic therapy 30.60 15.22 13 179799 196 79564380
Cardiac pacemaker replacement 30.48 15.22 17 179795 476 79564100
Paranoia 30.25 15.22 4 179808 19428 79545148
Inflammation 30.23 15.22 109 179703 93644 79470932
Influenza like illness 30.16 15.22 270 179542 71437 79493139
Cardio-respiratory arrest 30.03 15.22 134 179678 108376 79456200
Nephropathy toxic 29.95 15.22 5 179807 20414 79544162
Hysterectomy 29.85 15.22 52 179760 6220 79558356
Upper respiratory tract congestion 29.85 15.22 33 179779 2570 79562006
Pericardial excision 29.85 15.22 9 179803 45 79564531
Ammonia increased 29.67 15.22 58 179754 7577 79556999
Bone disorder 29.59 15.22 4 179808 19109 79545467
Pulmonary arterial pressure decreased 29.59 15.22 11 179801 114 79564462
Aplastic anaemia 29.58 15.22 3 179809 17902 79546674
Atrial fibrillation 29.58 15.22 618 179194 197268 79367308
Portopulmonary hypertension 29.51 15.22 12 179800 161 79564415
Injection site discharge 29.43 15.22 20 179792 802 79563774
Sinus tachycardia 29.39 15.22 24 179788 36884 79527692
Osteoporosis 29.25 15.22 48 179764 54064 79510512
Infusion site pruritus 29.18 15.22 41 179771 4077 79560499
Respiratory depression 28.94 15.22 13 179799 27617 79536959
Acute respiratory distress syndrome 28.91 15.22 34 179778 44033 79520543
Generalised oedema 28.90 15.22 118 179694 23591 79540985
Pulmonary thrombosis 28.86 15.22 76 179736 12095 79552481
Cancer surgery 28.84 15.22 20 179792 829 79563747
Live birth 28.84 15.22 4 179808 18740 79545836
Cardiac index increased 28.81 15.22 8 179804 28 79564548
Intracardiac pressure increased 28.59 15.22 8 179804 29 79564547
Hypothermia 28.43 15.22 8 179804 22738 79541838
Oesophageal variceal ligation 28.38 15.22 11 179801 129 79564447
Night sweats 28.36 15.22 46 179766 52049 79512527
Right-to-left cardiac shunt 28.26 15.22 13 179799 239 79564337
Retching 28.04 15.22 95 179717 17372 79547204
Faeces discoloured 27.96 15.22 135 179677 28992 79535584
Asthenia 27.96 15.22 1416 178396 510273 79054303
Sickle cell disease 27.86 15.22 11 179801 136 79564440
Mania 27.85 15.22 4 179808 18256 79546320
Delusion 27.83 15.22 6 179806 20417 79544159
Lung operation 27.83 15.22 13 179799 248 79564328
Diabetes mellitus inadequate control 27.72 15.22 10 179802 24254 79540322
Mixed connective tissue disease 27.55 15.22 14 179798 323 79564253
Skin necrosis 27.50 15.22 4 179808 18083 79546493
Orthostatic hypotension 27.49 15.22 53 179759 56111 79508465
Diabetes mellitus 27.41 15.22 88 179724 78302 79486274
Exostosis 27.40 15.22 3 179809 16855 79547721
Dialysis related complication 27.31 15.22 13 179799 259 79564317
Ear discomfort 27.25 15.22 60 179752 8523 79556053
Injection site swelling 27.20 15.22 40 179772 47092 79517484
Limb operation 27.13 15.22 36 179776 3390 79561186
Swelling 27.12 15.22 660 179152 216051 79348525
Conjunctivitis 27.09 15.22 12 179800 25703 79538873
Blood triglycerides increased 27.05 15.22 7 179805 21033 79543543
Tendonitis 26.92 15.22 10 179802 23820 79540756
Hypokalaemia 26.90 15.22 202 179610 143838 79420738
Pulmonary artery aneurysm 26.89 15.22 11 179801 150 79564426
Sluggishness 26.86 15.22 51 179761 6521 79558055
Ear congestion 26.79 15.22 33 179779 2886 79561690
Blood culture negative 26.78 15.22 12 179800 207 79564369
Decreased activity 26.73 15.22 60 179752 8634 79555942
Respiratory arrest 26.72 15.22 56 179756 57494 79507082
Cardiomegaly 26.65 15.22 124 179688 26228 79538348
Aphasia 26.64 15.22 40 179772 46692 79517884
Erythema multiforme 26.61 15.22 4 179808 17647 79546929
Mydriasis 26.60 15.22 4 179808 17639 79546937
Myocarditis 26.51 15.22 8 179804 21725 79542851
Metastases to central nervous system 26.40 15.22 3 179809 16372 79548204
Brain oedema 26.28 15.22 12 179800 25251 79539325
Infection 26.28 15.22 385 179427 241327 79323249
Premature delivery 26.26 15.22 10 179802 23457 79541119
Hyperlipidaemia 26.21 15.22 13 179799 26080 79538496
Nervous system disorder 26.06 15.22 14 179798 26842 79537734
Walking disability 26.03 15.22 28 179784 2115 79562461
Platelet count increased 26 15.22 9 179803 22397 79542179
Pyelonephritis 25.80 15.22 7 179805 20381 79544195
Gallbladder operation 25.77 15.22 27 179785 1978 79562598
Liver function test abnormal 25.73 15.22 68 179744 64407 79500169
CREST syndrome 25.55 15.22 15 179797 464 79564112
Acute coronary syndrome 25.38 15.22 8 179804 21125 79543451
Cardiac monitoring 25.32 15.22 7 179805 24 79564552
Injection site infection 25.30 15.22 28 179784 2184 79562392
Brain natriuretic peptide abnormal 25.27 15.22 18 179794 779 79563797
Hypophosphataemia 24.90 15.22 7 179805 19906 79544670
Device issue 24.85 15.22 124 179688 26984 79537592
Medical device implantation 24.81 15.22 17 179795 691 79563885
Haemolytic anaemia 24.77 15.22 5 179807 17815 79546761
Cataract operation 24.70 15.22 43 179769 5142 79559434
Hypoaesthesia 24.58 15.22 272 179540 179080 79385496
Knee operation 24.56 15.22 46 179766 5820 79558756
Therapeutic procedure 24.54 15.22 18 179794 816 79563760
Cellulitis 24.31 15.22 363 179449 108697 79455879
Bronchospasm 24.06 15.22 13 179799 24846 79539730
Ventricular fibrillation 23.92 15.22 22 179790 31904 79532672
Disorientation 23.71 15.22 68 179744 62708 79501868
Thrombotic microangiopathy 23.58 15.22 8 179804 20161 79544415
Viral infection 23.54 15.22 172 179640 42844 79521732
Sickle cell anaemia 23.40 15.22 16 179796 648 79563928
Immunodeficiency 23.18 15.22 10 179802 21758 79542818
Mood swings 23.04 15.22 8 179804 19872 79544704
Spinal osteoarthritis 23.01 15.22 5 179807 16922 79547654
Right ventricular enlargement 22.99 15.22 16 179796 667 79563909
Nightmare 22.95 15.22 15 179797 25846 79538730
Vasodilatation 22.95 15.22 32 179780 3159 79561417
Oral herpes 22.94 15.22 17 179795 27437 79537139
Aphthous ulcer 22.93 15.22 5 179807 16884 79547692
Heart transplant 22.82 15.22 22 179790 1459 79563117
Endoscopy 22.82 15.22 14 179798 470 79564106
Biopsy kidney 22.72 15.22 10 179802 165 79564411
Catheter culture positive 22.72 15.22 11 179801 228 79564348
Spinal operation 22.53 15.22 53 179759 7864 79556712
Cor pulmonale chronic 22.49 15.22 12 179800 307 79564269
Infusion site discolouration 22.45 15.22 16 179796 693 79563883
Hepatitis acute 22.37 15.22 4 179808 15538 79549038
Drug level decreased 22.33 15.22 3 179809 14399 79550177
Haemorrhage intracranial 22.17 15.22 16 179796 26177 79538399
Product administration interrupted 22.15 15.22 35 179777 3864 79560712
Adrenal insufficiency 22.10 15.22 19 179793 28468 79536108
Hydronephrosis 22.07 15.22 6 179806 17448 79547128
Unevaluable investigation 22.04 15.22 8 179804 77 79564499
Dermatitis bullous 22.01 15.22 3 179809 14242 79550334
Osteopenia 21.97 15.22 7 179805 18357 79546219
Mechanical ventilation 21.82 15.22 29 179783 2735 79561841
Restlessness 21.79 15.22 45 179767 46447 79518129
Device malfunction 21.75 15.22 101 179711 21347 79543229
Myositis 21.73 15.22 8 179804 19160 79545416
Arteriosclerosis 21.71 15.22 7 179805 18220 79546356
Infusion site nodule 21.71 15.22 12 179800 330 79564246
Suture insertion 21.68 15.22 12 179800 331 79564245
Septic shock 21.63 15.22 175 179637 122626 79441950
Liver ablation 21.56 15.22 5 179807 6 79564570
Critical illness 21.55 15.22 12 179800 335 79564241
Cardiac discomfort 21.50 15.22 20 179792 1268 79563308
Loss of consciousness 21.47 15.22 513 179299 167430 79397146
Eosinophil count increased 21.41 15.22 6 179806 17099 79547477
Lymphadenopathy 21.37 15.22 56 179756 53191 79511385
Chronic hepatic failure 21.35 15.22 18 179794 1001 79563575
Drug titration error 21.26 15.22 19 179793 1143 79563433
Catheter site induration 21.23 15.22 7 179805 49 79564527
Muscle twitching 21.13 15.22 15 179797 24749 79539827
Joint dislocation 21.09 15.22 6 179806 16933 79547643
Anhedonia 21.08 15.22 4 179808 14894 79549682
Dysphagia 21.08 15.22 175 179637 121961 79442615
Petechiae 21.03 15.22 10 179802 20555 79544021
Arteriosclerosis coronary artery 20.95 15.22 7 179805 17809 79546767
Life support 20.88 15.22 13 179799 448 79564128
Throat irritation 20.87 15.22 161 179651 40785 79523791
Transcatheter aortic valve implantation 20.76 15.22 7 179805 53 79564523
Pregnancy 20.72 15.22 18 179794 26833 79537743
Klebsiella infection 20.66 15.22 5 179807 15715 79548861
Metastases to liver 20.64 15.22 20 179792 28294 79536282
Right atrial pressure increased 20.63 15.22 11 179801 281 79564295
Thoracic cavity drainage 20.60 15.22 11 179801 282 79564294
Diet noncompliance 20.56 15.22 14 179798 563 79564013
Haemodynamic test abnormal 20.53 15.22 7 179805 55 79564521
Localised infection 20.42 15.22 150 179662 37425 79527151
Immune tolerance induction 20.39 15.22 4 179808 0 79564576
Vena cava filter removal 20.39 15.22 4 179808 0 79564576
Cranial operation 20.39 15.22 4 179808 0 79564576
Device difficult to use 20.26 15.22 3 179809 13382 79551194
Infusion site discomfort 20.24 15.22 20 179792 1367 79563209
Infusion site cellulitis 20.18 15.22 11 179801 294 79564282
Epstein-Barr virus infection 20.13 15.22 4 179808 14412 79550164
Hemiparesis 20.09 15.22 28 179784 33705 79530871
Drug titration 20.01 15.22 5 179807 10 79564566
Dialysis device insertion 20.00 15.22 7 179805 60 79564516
Body temperature increased 19.98 15.22 44 179768 44376 79520200
Palliative care 19.97 15.22 17 179795 958 79563618
Speech disorder 19.82 15.22 60 179752 54385 79510191
Application site irritation 19.81 15.22 22 179790 1722 79562854
Dry eye 19.74 15.22 33 179779 36898 79527678
Cardiorenal syndrome 19.72 15.22 21 179791 1568 79563008
Skin fissures 19.63 15.22 3 179809 13070 79551506
Gastrointestinal endoscopic therapy 19.61 15.22 7 179805 64 79564512
Portal hypertension 19.60 15.22 47 179765 7061 79557515
Injection site rash 19.52 15.22 8 179804 17946 79546630
Oesophagogastroduodenoscopy 19.44 15.22 10 179802 237 79564339
Infusion site vesicles 19.40 15.22 13 179799 509 79564067
Haematoma 19.38 15.22 57 179755 52138 79512438
Squamous cell carcinoma of skin 19.37 15.22 4 179808 14029 79550547
Cardiothoracic ratio increased 19.32 15.22 7 179805 67 79564509
Biopsy lymph gland 19.30 15.22 8 179804 113 79564463
Aortic valve replacement 19.26 15.22 19 179793 1296 79563280
Balloon atrial septostomy 19.24 15.22 8 179804 114 79564462
Purpura 19.21 15.22 10 179802 19517 79545059
Psychomotor hyperactivity 19.15 15.22 7 179805 16842 79547734
Platelet transfusion 19.15 15.22 25 179787 2317 79562259
Hereditary haemorrhagic telangiectasia 19.13 15.22 6 179806 35 79564541
Loss of personal independence in daily activities 19.08 15.22 144 179668 102436 79462140
Infusion site inflammation 18.86 15.22 11 179801 336 79564240
Candida infection 18.75 15.22 36 179776 38178 79526398
Hypophagia 18.75 15.22 47 179765 45320 79519256
Pulmonary arterial pressure 18.71 15.22 6 179806 38 79564538
Wound treatment 18.70 15.22 9 179803 184 79564392
Eye operation 18.69 15.22 24 179788 2189 79562387
Erectile dysfunction 18.62 15.22 5 179807 14659 79549917
Spontaneous intrahepatic portosystemic venous shunt 18.59 15.22 5 179807 15 79564561
Catheter site dryness 18.58 15.22 6 179806 39 79564537
Echocardiogram abnormal 18.56 15.22 24 179788 2204 79562372
Sleep disorder 18.55 15.22 115 179697 85562 79479014
Infusion site rash 18.53 15.22 21 179791 1681 79562895
Bronchiectasis 18.53 15.22 14 179798 22372 79542204
Catheter site bruise 18.47 15.22 12 179800 446 79564130
Oxygen saturation increased 18.43 15.22 13 179799 554 79564022
Cerebrovascular accident 18.42 15.22 243 179569 155049 79409527
Oesophageal motility disorder 18.41 15.22 13 179799 555 79564021
Blood pressure diastolic increased 18.39 15.22 5 179807 14537 79550039
Subcutaneous drug absorption impaired 18.35 15.22 5 179807 16 79564560
Irritability 18.30 15.22 41 179771 41103 79523473
Food poisoning 18.25 15.22 36 179776 4733 79559843
Upper-airway cough syndrome 18.25 15.22 63 179749 11630 79552946
Bronchial artery embolisation 18.12 15.22 5 179807 17 79564559
Cardiovascular disorder 18.08 15.22 9 179803 18016 79546560
Tenderness 18.06 15.22 16 179796 23626 79540950
Oral surgery 17.93 15.22 17 179795 1104 79563472
Joint stiffness 17.91 15.22 41 179771 40789 79523787
Red cell distribution width increased 17.90 15.22 6 179806 15236 79549340
Polyarthritis 17.87 15.22 3 179809 12199 79552377
Mitral valve repair 17.83 15.22 10 179802 283 79564293
Cardiac procedure complication 17.78 15.22 11 179801 375 79564201
Diffuse large B-cell lymphoma 17.76 15.22 3 179809 12146 79552430
Biopsy breast 17.75 15.22 8 179804 140 79564436
Immune thrombocytopenia 17.69 15.22 9 179803 17796 79546780
Cardiac septal defect repair 17.68 15.22 5 179807 19 79564557
Culture negative 17.62 15.22 4 179808 4 79564572
Hepatopulmonary syndrome 17.62 15.22 6 179806 47 79564529
Sensory disturbance 17.59 15.22 6 179806 15071 79549505
Idiopathic pulmonary fibrosis 17.51 15.22 33 179779 4195 79560381
Primary biliary cholangitis 17.50 15.22 17 179795 1138 79563438
Myocardial ischaemia 17.49 15.22 19 179793 25500 79539076
Right ventricular hypertrophy 17.49 15.22 20 179792 1617 79562959
Sensory loss 17.33 15.22 4 179808 12987 79551589
Gastrointestinal haemorrhage 17.32 15.22 446 179366 147273 79417303
Drug tolerance decreased 17.31 15.22 4 179808 12974 79551602
Vascular operation 17.30 15.22 8 179804 149 79564427
Suture related complication 17.28 15.22 10 179802 301 79564275
Protein-losing gastroenteropathy 17.20 15.22 13 179799 617 79563959
Therapeutic response unexpected 17.12 15.22 12 179800 19934 79544642
Argon plasma coagulation 17.10 15.22 5 179807 22 79564554
Anxiety 17.08 15.22 428 179384 248084 79316492
Tremor 17.08 15.22 275 179537 169808 79394768
Congestive cardiomyopathy 17.02 15.22 3 179809 11777 79552799
Malignant melanoma 16.97 15.22 6 179806 14735 79549841
Motor dysfunction 16.95 15.22 6 179806 14727 79549849
Pregnancy test positive 16.88 15.22 7 179805 99 79564477
Bronchoscopy 16.88 15.22 7 179805 99 79564477
Metastases to lung 16.86 15.22 10 179802 18153 79546423
Coordination abnormal 16.83 15.22 9 179803 17303 79547273
Coagulopathy 16.74 15.22 35 179777 35971 79528605
Creatinine renal clearance abnormal 16.73 15.22 12 179800 525 79564051
Haematotoxicity 16.73 15.22 7 179805 15512 79549064
Blood pressure systolic decreased 16.70 15.22 59 179753 11017 79553559
Paraesthesia oral 16.69 15.22 13 179799 20458 79544118
Large intestine perforation 16.65 15.22 6 179806 14561 79550015
Fear 16.65 15.22 15 179797 21971 79542605
Application site hypersensitivity 16.61 15.22 10 179802 324 79564252
Brain operation 16.58 15.22 13 179799 652 79563924
Photosensitivity reaction 16.50 15.22 14 179798 21113 79543463
Product storage error 16.43 15.22 8 179804 16218 79548358
Breast cancer female 16.38 15.22 3 179809 11458 79553118
Psychiatric evaluation 16.26 15.22 5 179807 27 79564549
Pulmonary capillary haemangiomatosis 16.24 15.22 6 179806 61 79564515
Vascular device occlusion 16.13 15.22 10 179802 342 79564234
Haemorrhage 16.12 15.22 292 179520 90826 79473750
Odynophagia 16.12 15.22 3 179809 11324 79553252
Activated partial thromboplastin time prolonged 16.03 15.22 6 179806 14222 79550354
Balance disorder 16.01 15.22 144 179668 98713 79465863
Dry skin 15.93 15.22 89 179723 67906 79496670
Pulmonary hypertensive crisis 15.92 15.22 10 179802 350 79564226
Anticoagulant therapy 15.82 15.22 5 179807 30 79564546
Craniotomy 15.80 15.22 11 179801 459 79564117
Stress cardiomyopathy 15.80 15.22 3 179809 11163 79553413
No adverse event 15.79 15.22 38 179774 37154 79527422
Hemiplegia 15.69 15.22 7 179805 14932 79549644
Intervertebral disc degeneration 15.65 15.22 8 179804 15777 79548799
Cardiac dysfunction 15.63 15.22 31 179781 4093 79560483
Hypercapnia 15.60 15.22 50 179762 8885 79555691
Hernia hiatus repair 15.58 15.22 6 179806 69 79564507
Middle ear effusion 15.58 15.22 23 179789 2392 79562184
Hypoalbuminaemia 15.57 15.22 15 179797 21282 79543294
Sinus headache 15.55 15.22 35 179777 5045 79559531
Chronic sinusitis 15.52 15.22 5 179807 13021 79551555
Contusion 15.46 15.22 239 179573 148537 79416039
Arthritis 15.43 15.22 175 179637 114705 79449871
Infusion site dermatitis 15.40 15.22 4 179808 10 79564566
Abnormal weight gain 15.39 15.22 24 179788 2620 79561956
Respiratory tract procedural complication 15.29 15.22 3 179809 0 79564576
Volvulus repair 15.29 15.22 3 179809 0 79564576
Ventricular septal defect repair 15.29 15.22 5 179807 34 79564542

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 D065130 Endothelin A Receptor Antagonists
MeSH PA D065131 Endothelin B Receptor Antagonists
MeSH PA D065128 Endothelin Receptor Antagonists
CHEBI has role CHEBI:35674 antihypertensive drugs
CHEBI has role CHEBI:51451 ERA
CHEBI has role CHEBI:71031 orphan drugs

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 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

Orange Book exclusivity data (new drug applications)

None

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

External reference:

IDSource
Z9K9Y9WMVL UNII
D10135 KEGG_DRUG
4032833 VANDF
C2606556 UMLSCUI
CHEBI:76607 CHEBI
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
OPSUMIT HUMAN PRESCRIPTION DRUG LABEL 1 66215-501 TABLET, FILM COATED 10 mg ORAL NDA 33 sections
OPSUMIT HUMAN PRESCRIPTION DRUG LABEL 1 66215-501 TABLET, FILM COATED 10 mg ORAL NDA 33 sections
OPSUMIT HUMAN PRESCRIPTION DRUG LABEL 1 66215-501 TABLET, FILM COATED 10 mg ORAL NDA 33 sections