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:

None

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 3103.41 15.18 5635 142660 541973 49914856
Fluid retention 2824.48 15.18 1790 146505 48859 50407970
Hospitalisation 2631.41 15.18 1916 146379 66021 50390808
Death 1740.51 15.18 3277 145018 322102 50134727
Drug ineffective 1688.37 15.18 213 148082 819120 49637709
Dyspnoea exertional 1404.50 15.18 1179 147116 50054 50406775
Pain in jaw 1305.67 15.18 1003 147292 37425 50419404
Nasal congestion 1188.35 15.18 1071 147224 50049 50406780
Transfusion 1136.30 15.18 614 147681 12291 50444538
Right ventricular failure 1061.29 15.18 631 147664 15262 50441567
Headache 1042.65 15.18 3548 144747 502987 49953842
Hypervolaemia 962.38 15.18 709 147586 24790 50432039
Pulmonary hypertension 894.67 15.18 759 147536 32658 50424171
Oxygen saturation decreased 802.26 15.18 1030 147265 72218 50384611
Off label use 690.33 15.18 265 148030 474161 49982668
Oedema 624.03 15.18 892 147403 69289 50387540
Catheter management 576.91 15.18 238 148057 2501 50454328
Pneumonia 575.47 15.18 2410 145885 375991 50080838
Catheter site erythema 538.42 15.18 253 148042 3709 50453120
Oedema peripheral 525.44 15.18 1317 146978 156644 50300185
Product dose omission issue 508.40 15.18 1431 146864 182407 50274422
Toxicity to various agents 502.92 15.18 30 148265 212469 50244360
Lung transplant 496.93 15.18 216 148079 2609 50454220
Cough 495.66 15.18 1693 146602 239571 50217258
Infusion related reaction 479.37 15.18 3 148292 169554 50287275
Catheter site pain 476.88 15.18 229 148066 3533 50453296
Pulmonary oedema 472.06 15.18 647 147648 48291 50408538
Infusion site pain 462.74 15.18 342 147953 12004 50444825
Unevaluable event 457.92 15.18 618 147677 45448 50411381
Oxygen consumption increased 456.61 15.18 218 148077 3318 50453511
Catheter site pruritus 440.11 15.18 179 148116 1808 50455021
Maternal exposure during pregnancy 416.66 15.18 11 148284 159767 50297062
Drug hypersensitivity 415.98 15.18 111 148184 250899 50205930
Contraindicated product administered 401.21 15.18 7 148288 148951 50307878
Alopecia 399.23 15.18 112 148183 244935 50211894
Hypotension 395.29 15.18 1548 146747 233921 50222908
Chest pain 391.96 15.18 1274 147021 175608 50281221
Pulmonary arterial hypertension 391.65 15.18 384 147911 19935 50436894
Treatment failure 386.17 15.18 3 148292 137634 50319195
Catheterisation cardiac 383.01 15.18 202 148093 3838 50452991
Rheumatoid arthritis 372.72 15.18 71 148224 202479 50254350
Therapeutic product effect decreased 368.03 15.18 6 148289 136044 50320785
Drug interaction 363.03 15.18 72 148223 199549 50257280
Neutropenia 355.76 15.18 19 148276 147946 50308883
Therapy change 352.71 15.18 209 148086 5016 50451813
Flushing 348.14 15.18 669 147626 66346 50390483
Pulmonary arterial pressure increased 336.25 15.18 174 148121 3174 50453655
Rash 321.88 15.18 491 147804 436980 50019849
Malaise 315.42 15.18 1866 146429 333666 50123163
Dialysis 312.89 15.18 243 148052 9195 50447634
Hypoxia 309.15 15.18 545 147750 50578 50406251
Dizziness 306.99 15.18 1897 146398 344472 50112357
Glossodynia 297.38 15.18 9 148286 115560 50341269
Vascular device infection 292.37 15.18 174 148121 4210 50452619
Arthropathy 289.03 15.18 56 148239 157850 50298979
Palpitations 280.92 15.18 756 147539 93750 50363079
Scleroderma 280.30 15.18 175 148120 4626 50452203
Peripheral swelling 273.98 15.18 1262 147033 204674 50252155
Diarrhoea 271.94 15.18 2772 145523 585704 49871125
Catheter site discharge 271.56 15.18 125 148170 1743 50455086
Catheter site infection 264.88 15.18 162 148133 4124 50452705
Febrile neutropenia 261.24 15.18 5 148290 97662 50359167
Catheter site rash 242.05 15.18 89 148206 666 50456163
Catheter placement 240.85 15.18 118 148177 1906 50454923
Stomatitis 237.47 15.18 15 148280 101329 50355500
Cardiac failure 236.79 15.18 619 147676 75421 50381408
Cardiac failure congestive 235.80 15.18 660 147635 83722 50373107
Device related infection 232.05 15.18 295 148000 20440 50436389
Syncope 228.79 15.18 743 147552 102259 50354570
Catheter site haemorrhage 228.74 15.18 127 148168 2683 50454146
Concomitant disease aggravated 227.14 15.18 189 148106 7902 50448927
Product use issue 224.15 15.18 79 148216 149396 50307433
Transplant evaluation 222.86 15.18 92 148203 968 50455861
Catheter site swelling 220.96 15.18 98 148197 1246 50455583
Joint swelling 214.11 15.18 242 148053 245044 50211785
Musculoskeletal stiffness 212.24 15.18 57 148238 128424 50328405
Therapeutic product effect incomplete 210.14 15.18 15 148280 91500 50365329
Productive cough 210.14 15.18 472 147823 52222 50404607
Condition aggravated 207.10 15.18 1534 146761 295524 50161305
Device alarm issue 202.15 15.18 93 148202 1295 50455534
Abdominal distension 201.48 15.18 568 147727 72335 50384494
Drug intolerance 194.67 15.18 213 148082 218891 50237938
Therapy non-responder 194.55 15.18 449 147846 50573 50406256
Product use in unapproved indication 193.93 15.18 50 148245 115769 50341060
Hepatic enzyme increased 193.67 15.18 80 148215 137300 50319529
Exposure during pregnancy 191.91 15.18 58 148237 120957 50335872
Hypersensitivity 188.04 15.18 212 148083 214949 50241880
Malignant neoplasm progression 184.17 15.18 3 148292 68121 50388708
Infusion site erythema 175.77 15.18 169 148126 8558 50448271
Epistaxis 175.45 15.18 497 147798 63457 50393372
Device leakage 172.71 15.18 141 148154 5737 50451092
Pericarditis 172.06 15.18 16 148279 78673 50378156
Ascites 171.59 15.18 346 147949 35515 50421314
Cardiac pacemaker insertion 171.16 15.18 116 148179 3537 50453292
Hospice care 170.74 15.18 139 148156 5633 50451196
Rehabilitation therapy 169.67 15.18 81 148214 1232 50455597
Leukopenia 164.34 15.18 8 148287 67520 50389309
Infusion site infection 162.46 15.18 83 148212 1472 50455357
Oxygen therapy 161.61 15.18 87 148208 1725 50455104
Overdose 161.40 15.18 46 148249 99681 50357148
Dyspnoea at rest 159.51 15.18 111 148184 3536 50453293
Wound 156.70 15.18 57 148238 105737 50351092
Drug abuse 156.35 15.18 4 148291 59842 50396987
Systemic lupus erythematosus 153.18 15.18 113 148182 140509 50316320
Cardiac disorder 152.72 15.18 368 147927 42611 50414218
Chest discomfort 151.38 15.18 605 147690 92117 50364712
Dermatitis contact 151.13 15.18 155 148140 8491 50448338
Cardiac operation 150.98 15.18 97 148198 2698 50454131
Impaired healing 147.86 15.18 16 148279 69770 50387059
Intentional overdose 147.15 15.18 9 148286 62495 50394334
Thrombocytopenia 146.46 15.18 97 148198 127576 50329253
Infusion site discharge 144.16 15.18 58 148237 568 50456261
Catheter site irritation 143.06 15.18 55 148240 472 50456357
Pericardial effusion 142.13 15.18 263 148032 25326 50431503
Disease progression 140.40 15.18 605 147690 95261 50361568
Infusion site swelling 138.95 15.18 136 148159 7040 50449789
Paracentesis 138.51 15.18 63 148232 853 50455976
Brain natriuretic peptide increased 138.10 15.18 111 148184 4416 50452413
Device infusion issue 137.14 15.18 71 148224 1296 50455533
Respiratory failure 137.05 15.18 580 147715 90601 50366228
Feeling abnormal 133.93 15.18 723 147572 124769 50332060
Urticaria 133.65 15.18 110 148185 129451 50327378
Discomfort 133.11 15.18 76 148219 108304 50348525
Influenza 132.60 15.18 567 147728 88971 50367858
Internal haemorrhage 129.87 15.18 106 148189 4311 50452518
Acute respiratory failure 129.78 15.18 271 148024 28511 50428318
Psoriasis 129.31 15.18 23 148272 68977 50387852
Intentional product use issue 129.12 15.18 33 148262 76885 50379944
Emergency care 128.13 15.18 58 148237 776 50456053
Blood pressure increased 124.24 15.18 124 148171 133008 50323821
Psoriatic arthropathy 123.40 15.18 3 148292 47029 50409800
Injection site pain 121.17 15.18 89 148206 110935 50345894
Confusional state 119.44 15.18 227 148068 185701 50271128
Presyncope 118.77 15.18 236 148059 23962 50432867
Nausea 118.66 15.18 2800 145495 702598 49754231
Central venous catheterisation 117.72 15.18 75 148220 2055 50454774
Electrocardiogram QT prolonged 117.68 15.18 9 148286 51877 50404952
Hypertension 115.63 15.18 282 148013 210921 50245908
Suicide attempt 114.48 15.18 10 148285 51722 50405107
Aspiration pleural cavity 113.74 15.18 52 148243 713 50456116
Neutrophil count decreased 113.46 15.18 5 148290 46021 50410808
Disease complication 113.16 15.18 81 148214 2701 50454128
Anaphylactic reaction 112.97 15.18 13 148282 54042 50402787
Injection site reaction 112.56 15.18 9 148286 50023 50406806
Osteoarthritis 112.19 15.18 31 148264 68575 50388254
Blister 112.10 15.18 55 148240 85363 50371466
Device dislocation 111.66 15.18 215 148080 21331 50435498
Acute kidney injury 109.41 15.18 325 147970 227733 50229096
White blood cell count decreased 108.58 15.18 109 148186 116613 50340216
Wrong technique in product usage process 107.35 15.18 17 148278 55493 50401336
Myalgia 107.16 15.18 677 147618 123642 50333187
Blood pressure decreased 107.08 15.18 384 147911 55525 50401304
N-terminal prohormone brain natriuretic peptide increased 106.60 15.18 65 148230 1645 50455184
Dizziness postural 105.30 15.18 109 148186 6036 50450793
Helicobacter infection 101.30 15.18 13 148282 49689 50407140
Folliculitis 101.05 15.18 3 148292 39222 50417607
Infusion site haemorrhage 100.99 15.18 78 148217 2926 50453903
Dyspepsia 98.92 15.18 455 147840 73642 50383187
Suicidal ideation 98.43 15.18 21 148274 55364 50401465
Abortion spontaneous 98.36 15.18 6 148289 41766 50415063
Rhabdomyolysis 97.00 15.18 4 148291 39023 50417806
Depression 96.85 15.18 213 148082 165210 50291619
Device occlusion 96.37 15.18 103 148192 5920 50450909
Blood cholesterol increased 95.97 15.18 22 148273 55193 50401636
Muscle injury 95.02 15.18 3 148292 37108 50419721
Injection site erythema 94.23 15.18 51 148244 74885 50381944
Catheter site inflammation 93.74 15.18 44 148251 643 50456186
Arthralgia 91.38 15.18 834 147461 437868 50018961
Lower respiratory tract infection 90.73 15.18 87 148208 95114 50361715
Catheter site related reaction 90.52 15.18 45 148250 751 50456078
Haemoglobin decreased 90.07 15.18 660 147635 126556 50330273
Pancytopenia 89.57 15.18 69 148226 83961 50372868
Liver transplant 88.85 15.18 63 148232 2069 50454760
Seizure 88.54 15.18 130 148165 117744 50339085
Walking distance test abnormal 87.71 15.18 39 148256 499 50456330
Pulmonary veno-occlusive disease 87.48 15.18 47 148248 928 50455901
Chronic obstructive pulmonary disease 87.42 15.18 349 147946 53086 50403743
Abdominal cavity drainage 86.08 15.18 35 148260 353 50456476
Depressed level of consciousness 85.83 15.18 23 148272 51930 50404899
Decreased appetite 85.68 15.18 933 147362 199990 50256839
Seasonal allergy 85.49 15.18 154 148141 14522 50442307
Terminal state 84.82 15.18 61 148234 2049 50454780
Pain in extremity 84.05 15.18 1192 147103 271673 50185156
Mineral supplementation 83.91 15.18 41 148254 658 50456171
Catheter site vesicles 83.60 15.18 32 148263 271 50456558
Anaemia 82.68 15.18 1115 147180 251341 50205488
Renal disorder 82.58 15.18 221 148074 27284 50429545
Cognitive disorder 82.03 15.18 15 148280 44108 50412721
Coma 81.93 15.18 32 148263 56847 50399982
Lung disorder 81.81 15.18 303 147992 44496 50412333
Atrial septal defect repair 81.39 15.18 29 148266 196 50456633
Endarterectomy 81.30 15.18 27 148268 143 50456686
C-reactive protein increased 81.05 15.18 47 148248 66427 50390402
Sinus congestion 80.61 15.18 146 148149 13825 50443004
Intentional product misuse 80.47 15.18 19 148276 46715 50410114
Atrial flutter 80.14 15.18 113 148182 8650 50448179
Left ventricular failure 79.60 15.18 84 148211 4757 50452072
Hyponatraemia 78.26 15.18 100 148195 96039 50360790
Blood potassium decreased 77.01 15.18 261 148034 36684 50420145
Angioedema 76.43 15.18 10 148285 37666 50419163
Heart rate increased 75.64 15.18 435 147860 76815 50380014
Exercise tolerance decreased 75.61 15.18 82 148213 4792 50452037
Pruritus 74.83 15.18 505 147790 283063 50173766
Pulmonary endarterectomy 74.41 15.18 24 148271 114 50456715
Haemoptysis 73.29 15.18 202 148093 25371 50431458
Infusion site warmth 73.12 15.18 48 148247 1386 50455443
Mobility decreased 72.81 15.18 76 148219 79872 50376957
Nasopharyngitis 72.41 15.18 874 147421 192053 50264776
Stent placement 71.93 15.18 68 148227 3370 50453459
Right ventricular dilatation 71.83 15.18 41 148254 915 50455914
Rhinorrhoea 70.50 15.18 319 147976 51264 50405565
Injury 69.69 15.18 28 148267 48897 50407932
Blood iron decreased 69.09 15.18 123 148172 11492 50445337
Product supply issue 68.22 15.18 43 148252 1156 50455673
Bone marrow failure 68.09 15.18 3 148292 27621 50429208
Pleural effusion 67.93 15.18 440 147855 81014 50375815
Chemotherapy 67.80 15.18 45 148250 1324 50455505
Irritable bowel syndrome 67.66 15.18 33 148262 51408 50405421
Pulmonary arterial pressure abnormal 67.61 15.18 31 148264 428 50456401
Cardioversion 67.50 15.18 42 148253 1103 50455726
Transplant 65.90 15.18 34 148261 616 50456213
Neuropathy peripheral 65.77 15.18 114 148181 96643 50360186
Product quality issue 65.54 15.18 7 148288 30851 50425978
Paraesthesia 65.38 15.18 161 148134 120082 50336747
Deep vein thrombosis 65.28 15.18 71 148224 73233 50383596
Cardiac ablation 65.22 15.18 43 148252 1251 50455578
Right ventricular dysfunction 64.57 15.18 46 148249 1522 50455307
Infusion site induration 64.41 15.18 37 148258 836 50455993
Therapeutic response decreased 64.12 15.18 29 148266 47202 50409627
Oropharyngeal pain 64.10 15.18 419 147876 77382 50379447
Nasal dryness 64.07 15.18 65 148230 3514 50453315
Type 2 diabetes mellitus 63.23 15.18 12 148283 34363 50422466
Pulmonary arterial wedge pressure increased 62.94 15.18 26 148269 274 50456555
Ill-defined disorder 61.99 15.18 42 148253 54612 50402217
Blood pressure systolic increased 61.85 15.18 14 148281 35435 50421394
Red blood cell sedimentation rate increased 61.65 15.18 7 148288 29409 50427420
Bradycardia 61.23 15.18 59 148236 64367 50392462
Hepatocellular injury 60.27 15.18 4 148291 25943 50430886
Gout 60.09 15.18 115 148180 11355 50445474
Adverse event 59.32 15.18 270 148025 43493 50413336
Metabolic acidosis 59.03 15.18 20 148275 38805 50418024
Fibromyalgia 58.93 15.18 29 148266 44949 50411880
Pulmonary pain 58.67 15.18 51 148244 2264 50454565
Blood creatine phosphokinase increased 58.60 15.18 5 148290 26362 50430467
Infusion site irritation 58.53 15.18 31 148264 594 50456235
Hallucination 56.85 15.18 33 148262 46624 50410205
Weight increased 56.60 15.18 868 147427 201023 50255806
Plasma cell myeloma 55.39 15.18 12 148283 31310 50425519
Inappropriate schedule of product administration 55.12 15.18 78 148217 71753 50385076
Diagnostic procedure 54.89 15.18 18 148277 91 50456738
Pulmonary congestion 54.62 15.18 131 148164 15116 50441713
Hypoglycaemia 54.58 15.18 46 148249 53535 50403294
Injection site pruritus 54.57 15.18 25 148270 40386 50416443
Orthopnoea 54.47 15.18 75 148220 5614 50451215
Angioplasty 54.42 15.18 38 148257 1217 50455612
Biopsy 54.25 15.18 26 148269 399 50456430
Dysarthria 53.93 15.18 21 148274 37382 50419447
Cholestasis 53.34 15.18 6 148289 25395 50431434
Dependence on oxygen therapy 53.22 15.18 24 148271 318 50456511
Catheter site warmth 53.08 15.18 21 148274 196 50456633
Respiration abnormal 53.02 15.18 70 148225 5032 50451797
Pericardial drainage 52.80 15.18 21 148274 199 50456630
Hypocalcaemia 52.32 15.18 8 148287 26808 50430021
Sinus disorder 52.10 15.18 145 148150 18313 50438516
Generalised tonic-clonic seizure 50.99 15.18 8 148287 26302 50430527
Lymphocyte count decreased 50.98 15.18 8 148287 26299 50430530
Bronchitis 50.65 15.18 497 147798 103662 50353167
Extra dose administered 50.23 15.18 68 148227 5008 50451821
Cardiac output increased 49.86 15.18 18 148277 127 50456702
Concomitant disease progression 49.72 15.18 44 148251 2001 50454828
Toxic epidermal necrolysis 49.47 15.18 3 148292 20989 50435840
Complication associated with device 49.39 15.18 123 148172 14532 50442297
Biopsy lung 49.12 15.18 19 148276 166 50456663
Catheterisation cardiac abnormal 48.82 15.18 20 148275 206 50456623
Stevens-Johnson syndrome 48.68 15.18 4 148291 21748 50435081
Catheter site scab 48.53 15.18 19 148276 172 50456657
Medical device change 48.10 15.18 22 148273 302 50456527
Multiple sclerosis 48.08 15.18 3 148292 20490 50436339
Hypercalcaemia 47.84 15.18 6 148289 23346 50433483
Agranulocytosis 47.77 15.18 4 148291 21417 50435412
Hypoacusis 47.63 15.18 151 148144 20496 50436333
Device connection issue 47.17 15.18 26 148269 541 50456288
Mouth ulceration 47.06 15.18 12 148283 28012 50428817
Emotional distress 46.76 15.18 13 148282 28650 50428179
Delirium 46.55 15.18 27 148268 38165 50418664
Head discomfort 46.48 15.18 101 148194 10918 50445911
Medication error 46.22 15.18 24 148271 36080 50420749
Infusion site pruritus 45.60 15.18 57 148238 3880 50452949
Basal cell carcinoma 45.50 15.18 7 148288 23349 50433480
Hyperglycaemia 45.43 15.18 25 148270 36380 50420449
Hepatotoxicity 45.07 15.18 12 148283 27214 50429615
Swollen tongue 44.85 15.18 14 148281 28616 50428213
Cardiac failure acute 44.81 15.18 84 148211 8166 50448663
Oxygen saturation abnormal 44.63 15.18 47 148248 2655 50454174
Device related sepsis 44.62 15.18 53 148242 3422 50453407
Medical procedure 43.82 15.18 20 148275 273 50456556
Respiratory tract congestion 43.54 15.18 115 148180 14084 50442745
Bone disorder 43.24 15.18 3 148292 18749 50438080
Drug dependence 43.22 15.18 4 148291 19755 50437074
Hepatitis 43.18 15.18 19 148276 31434 50425395
Atrial fibrillation 43.08 15.18 472 147823 101273 50355556
Incorrect route of product administration 43.00 15.18 3 148292 18663 50438166
Lactic acidosis 42.96 15.18 22 148273 33333 50423496
Chronic respiratory failure 42.90 15.18 37 148258 1625 50455204
Injection site swelling 42.38 15.18 36 148259 41737 50415092
Multiple allergies 42.08 15.18 83 148212 8380 50448449
Catheter site discolouration 42.02 15.18 15 148280 102 50456727
Cardiac failure high output 41.99 15.18 19 148276 254 50456575
Premature delivery 41.98 15.18 9 148286 23654 50433175
Choking 41.84 15.18 83 148212 8415 50448414
Wrong dose 41.74 15.18 28 148267 839 50455990
Hyperkalaemia 41.26 15.18 48 148247 48041 50408788
Cytomegalovirus infection 41.05 15.18 3 148292 17959 50438870
Hyperhidrosis 40.98 15.18 130 148165 89296 50367533
Jugular vein distension 40.25 15.18 27 148268 809 50456020
Drug-induced liver injury 40.14 15.18 16 148279 28079 50428750
Polypectomy 39.83 15.18 24 148271 594 50456235
Drug withdrawal syndrome 39.76 15.18 12 148283 25069 50431760
Heart valve replacement 39.69 15.18 22 148273 463 50456366
Infusion site discolouration 39.69 15.18 24 148271 598 50456231
Premature baby 39.35 15.18 4 148291 18333 50438496
Foot deformity 39.20 15.18 5 148290 19205 50437624
Pregnancy 38.85 15.18 19 148276 29558 50427271
Epilepsy 38.68 15.18 8 148287 21559 50435270
Metastases to bone 38.43 15.18 4 148291 17991 50438838
Blood glucose increased 38.36 15.18 96 148199 71228 50385601
Agitation 38.02 15.18 61 148234 53323 50403506
Drug eruption 37.96 15.18 11 148284 23595 50433234
Iron deficiency anaemia 37.82 15.18 122 148173 16712 50440117
Hernia repair 37.51 15.18 31 148264 1283 50455546
Pulmonary embolism 37.34 15.18 162 148133 101542 50355287
Psychotic disorder 37.29 15.18 9 148286 21803 50435026
Osteonecrosis 37.13 15.18 10 148285 22507 50434322
Drug level increased 37.02 15.18 6 148289 19262 50437567
Catheter removal 36.98 15.18 19 148276 341 50456488
Cor pulmonale 36.98 15.18 36 148259 1851 50454978
Illness 36.74 15.18 156 148139 24384 50432445
Accidental exposure to product 36.61 15.18 11 148284 23046 50433783
Pain 36.43 15.18 1359 146936 577544 49879285
Biopsy liver 35.88 15.18 19 148276 364 50456465
Hepatic cirrhosis 35.59 15.18 123 148172 17454 50439375
Aggression 35.54 15.18 9 148286 21107 50435722
Nocturnal dyspnoea 35.51 15.18 27 148268 989 50455840
Skin lesion 35.37 15.18 17 148278 26710 50430119
General physical health deterioration 35.36 15.18 258 148037 142176 50314653
Endotracheal intubation 34.75 15.18 37 148258 2117 50454712
Hepatic steatosis 34.65 15.18 14 148281 24370 50432459
Gastrointestinal haemorrhage 34.25 15.18 347 147948 72974 50383855
Osteoporosis 34.16 15.18 49 148246 44830 50411999
Live birth 34.14 15.18 4 148291 16404 50440425
Drug ineffective for unapproved indication 34.07 15.18 10 148285 21271 50435558
Hypoaesthesia 33.81 15.18 226 148069 127031 50329798
Asthma 33.59 15.18 141 148154 89196 50367633
Diabetic ketoacidosis 33.38 15.18 6 148289 17866 50438963
Eosinophilia 33.28 15.18 7 148288 18645 50438184
Somnolence 33.28 15.18 292 148003 154693 50302136
Catheter site erosion 33.16 15.18 11 148284 58 50456771
Encephalopathy 33.05 15.18 30 148265 33681 50423148
Pulmonary artery aneurysm 32.99 15.18 10 148285 37 50456792
Joint range of motion decreased 32.92 15.18 7 148288 18505 50438324
Ischaemic stroke 32.91 15.18 4 148291 15944 50440885
Oxygen consumption 32.50 15.18 12 148283 91 50456738
Cholecystectomy 32.32 15.18 79 148216 9224 50447605
Balance disorder 32.07 15.18 103 148192 70487 50386342
Lymphopenia 32.03 15.18 4 148291 15617 50441212
Pneumocystis jirovecii pneumonia 31.99 15.18 3 148292 14660 50442169
Skin exfoliation 31.68 15.18 31 148264 33581 50423248
Tracheostomy 31.65 15.18 20 148275 540 50456289
Infection 31.59 15.18 339 147956 172615 50284214
Product prescribing error 31.51 15.18 11 148284 20950 50435879
Myoclonus 31.46 15.18 3 148292 14467 50442362
Heart and lung transplant 31.31 15.18 12 148283 102 50456727
Metastases to liver 31.19 15.18 10 148285 20094 50436735
Osteopenia 31.17 15.18 6 148289 17012 50439817
Paranasal sinus discomfort 31.08 15.18 41 148254 2945 50453884
Liver injury 31.00 15.18 17 148278 24789 50432040
Ejection fraction decreased 30.96 15.18 8 148287 18512 50438317
Treatment noncompliance 30.96 15.18 172 148123 29978 50426851
Head injury 30.93 15.18 146 148149 23874 50432955
Localised oedema 30.84 15.18 53 148242 4814 50452015
Dyskinesia 30.81 15.18 22 148273 27839 50428990
Mood swings 30.58 15.18 5 148290 15949 50440880
Withdrawal syndrome 30.58 15.18 7 148288 17583 50439246
Acute myeloid leukaemia 30.57 15.18 4 148291 15070 50441759
Upper respiratory tract congestion 30.54 15.18 32 148263 1797 50455032
Platelet transfusion 30.51 15.18 21 148274 657 50456172
Biopsy bone marrow 30.47 15.18 16 148279 301 50456528
No adverse event 30.47 15.18 32 148263 33546 50423283
Spinal osteoarthritis 30.43 15.18 3 148292 14089 50442740
Systemic scleroderma 30.40 15.18 23 148272 836 50455993
Catheter site nodule 30.26 15.18 10 148285 52 50456777
Pancreatitis acute 30.23 15.18 16 148279 23796 50433033
Hallucination, visual 30.05 15.18 6 148289 16576 50440253
Catheter site dermatitis 29.95 15.18 10 148285 54 50456775
Cardiac flutter 29.94 15.18 43 148252 3347 50453482
Diet noncompliance 29.72 15.18 15 148280 259 50456570
Body temperature decreased 29.57 15.18 6 148289 16389 50440440
Hypokalaemia 29.43 15.18 145 148150 87847 50368982
Liver function test abnormal 29.43 15.18 53 148242 44286 50412543
Impaired work ability 29.21 15.18 3 148292 13637 50443192
Injection site discharge 29.06 15.18 17 148278 398 50456431
Carbon dioxide increased 28.87 15.18 25 148270 1104 50455725
Erythema 28.78 15.18 282 148013 146132 50310697
Asthenia 28.67 15.18 1175 147120 317867 50138962
Tubulointerstitial nephritis 28.64 15.18 5 148290 15206 50441623
Dizziness exertional 28.56 15.18 16 148279 344 50456485
Abnormal behaviour 28.40 15.18 11 148284 19647 50437182
Chest tube insertion 28.21 15.18 9 148286 41 50456788
Dialysis related complication 28.14 15.18 10 148285 67 50456762
Pyelonephritis 28.06 15.18 5 148290 14984 50441845
Sinus bradycardia 27.97 15.18 3 148292 13180 50443649
Infusion site abscess 27.94 15.18 13 148282 186 50456643
Visual acuity reduced 27.91 15.18 12 148283 20127 50436702
Device physical property issue 27.90 15.18 29 148266 1613 50455216
Full blood count abnormal 27.84 15.18 139 148156 23249 50433580
Oral herpes 27.70 15.18 13 148282 20712 50436117
Pulmonary vascular resistance abnormality 27.69 15.18 9 148286 44 50456785
Critical illness 27.67 15.18 12 148283 144 50456685
Thrombectomy 27.67 15.18 12 148283 144 50456685
Pulmonary artery dilatation 27.52 15.18 14 148281 246 50456583
Diplopia 27.46 15.18 11 148284 19249 50437580
Biopsy lymph gland 27.42 15.18 8 148287 25 50456804
Gastrointestinal tube insertion 27.14 15.18 23 148272 986 50455843
CREST syndrome 27.03 15.18 17 148278 455 50456374
Injection site rash 27.02 15.18 7 148288 16170 50440659
Catheter site extravasation 26.73 15.18 14 148281 262 50456567
Cerebral infarction 26.72 15.18 15 148280 21589 50435240
Rash erythematous 26.58 15.18 38 148257 34814 50422015
Arteriovenous malformation 26.54 15.18 25 148270 1233 50455596
Acute myocardial infarction 26.45 15.18 28 148267 29245 50427584
Myelosuppression 26.44 15.18 4 148291 13513 50443316
Therapeutic response unexpected 26.37 15.18 7 148288 15908 50440921
Ventilation perfusion mismatch 26.26 15.18 13 148282 215 50456614
Weight decreased 26.01 15.18 840 147455 220405 50236424
Tenderness 25.83 15.18 11 148284 18554 50438275
Disturbance in attention 25.82 15.18 32 148263 31154 50425675
Right ventricular systolic pressure increased 25.77 15.18 17 148278 495 50456334
Secretion discharge 25.77 15.18 75 148220 9716 50447113
Heart valve operation 25.51 15.18 11 148284 130 50456699
Hypertensive crisis 25.49 15.18 4 148291 13150 50443679
Unevaluable investigation 25.33 15.18 8 148287 35 50456794
Tremor 25.32 15.18 215 148080 114688 50342141
Right-to-left cardiac shunt 25.17 15.18 12 148283 182 50456647
Acne 25.12 15.18 13 148282 19582 50437247
Body temperature increased 25.08 15.18 33 148262 31308 50425521
Colitis ulcerative 25.07 15.18 9 148286 16845 50439984
Blood lactate dehydrogenase increased 25.04 15.18 13 148282 19549 50437280
Pericardial excision 24.72 15.18 7 148288 19 50456810
Tendonitis 24.72 15.18 9 148286 16696 50440133
Femur fracture 24.67 15.18 45 148250 37419 50419410
Echocardiogram abnormal 24.63 15.18 23 148272 1122 50455707
Abdominal pain upper 24.57 15.18 626 147669 158683 50298146
Cancer surgery 24.56 15.18 16 148279 456 50456373
Thrombosis in device 24.55 15.18 35 148260 2706 50454123
Infusion site vesicles 24.48 15.18 15 148280 383 50456446
Proteinuria 24.46 15.18 9 148286 16588 50440241
Cardiomegaly 24.37 15.18 102 148193 15843 50440986
Retching 24.32 15.18 88 148207 12774 50444055
Pneumonia bacterial 24.27 15.18 61 148234 7248 50449581
Blood bilirubin increased 24.25 15.18 169 148126 31869 50424960
Medical device implantation 24.24 15.18 18 148277 636 50456193
Contusion 24.23 15.18 211 148084 111972 50344857
Coronary artery disease 24.09 15.18 31 148264 29695 50427134
Congestive hepatopathy 24.06 15.18 33 148262 2461 50454368
Mechanical ventilation 23.94 15.18 23 148272 1163 50455666
Blood pressure abnormal 23.92 15.18 87 148208 12660 50444169
Application site pruritus 23.90 15.18 41 148254 3718 50453111
Hip surgery 23.90 15.18 34 148261 2624 50454205
Brain natriuretic peptide abnormal 23.81 15.18 14 148281 331 50456498
Acute right ventricular failure 23.79 15.18 11 148284 155 50456674
Cardiomyopathy 23.74 15.18 8 148287 15578 50441251
Paranasal sinus hypersecretion 23.67 15.18 37 148258 3105 50453724
Heart transplant 23.64 15.18 15 148280 408 50456421
Poisoning 23.59 15.18 4 148291 12425 50444404
Peritonitis 23.50 15.18 8 148287 15478 50441351
Dry eye 23.49 15.18 36 148259 32059 50424770
Pulmonary arterial pressure decreased 23.43 15.18 9 148286 77 50456752
Palliative care 23.40 15.18 14 148281 342 50456487
Hyperlipidaemia 23.33 15.18 11 148284 17479 50439350
Altered state of consciousness 23.32 15.18 18 148277 21892 50434937
Sickle cell anaemia 23.31 15.18 16 148279 498 50456331
Joint stiffness 23.15 15.18 33 148262 30275 50426554
Device breakage 23.11 15.18 71 148224 9476 50447353
Loss of personal independence in daily activities 23.10 15.18 116 148179 69934 50386895
Dysphagia 23.00 15.18 133 148162 77385 50379444
Oxygen saturation increased 22.98 15.18 10 148285 121 50456708
Catheter culture positive 22.98 15.18 10 148285 121 50456708
Cardio-respiratory arrest 22.87 15.18 81 148214 53811 50403018
Metastases to central nervous system 22.87 15.18 3 148292 11279 50445550
Urinary retention 22.61 15.18 26 148269 26164 50430665
Catheter site induration 22.59 15.18 8 148287 53 50456776
Obstructive airways disorder 22.22 15.18 9 148286 15643 50441186
Choking sensation 21.98 15.18 36 148259 3144 50453685
Lip swelling 21.97 15.18 24 148271 24712 50432117
Carpal tunnel syndrome 21.96 15.18 11 148284 16882 50439947
Medical device site haemorrhage 21.92 15.18 7 148288 32 50456797
Gastroenteritis viral 21.90 15.18 111 148184 18675 50438154
Cor pulmonale chronic 21.79 15.18 11 148284 190 50456639
Oesophageal motility disorder 21.78 15.18 13 148282 316 50456513
Skin necrosis 21.76 15.18 3 148292 10864 50445965
Muscle twitching 21.70 15.18 9 148286 15422 50441407
Pancreatitis 21.65 15.18 59 148236 42555 50414274
Ear congestion 21.62 15.18 28 148267 1975 50454854
Sluggishness 21.60 15.18 43 148252 4370 50452459
Gastrointestinal surgery 21.58 15.18 11 148284 194 50456635
Exostosis 21.57 15.18 4 148291 11649 50445180
Viral infection 21.43 15.18 156 148139 29830 50426999
Hallucination, auditory 21.39 15.18 3 148292 10725 50446104
Bursitis 21.34 15.18 20 148275 22115 50434714
Muscular weakness 21.28 15.18 177 148118 94836 50361993
Cardiac monitoring 21.27 15.18 6 148289 16 50456813
Drug therapy 21.27 15.18 6 148289 16 50456813
Joint dislocation 21.25 15.18 5 148290 12328 50444501
Platelet count increased 21.23 15.18 8 148287 14532 50442297
Colonoscopy 21.21 15.18 23 148272 1344 50455485
Sleep disorder 21.17 15.18 91 148204 57192 50399637
Mydriasis 21.13 15.18 3 148292 10624 50446205
Mixed connective tissue disease 21.12 15.18 14 148281 411 50456418
Arthritis 21.07 15.18 158 148137 86563 50370266
Ear discomfort 21.06 15.18 55 148240 6689 50450140
Disseminated intravascular coagulation 21.04 15.18 12 148283 17123 50439706
Myelodysplastic syndrome 21.00 15.18 9 148286 15123 50441706
Drug titration error 20.86 15.18 16 148279 594 50456235
Labelled drug-drug interaction medication error 20.73 15.18 3 148292 10474 50446355
Blood triglycerides increased 20.69 15.18 4 148291 11308 50445521
Night sweats 20.65 15.18 42 148253 33532 50423297
Transaminases increased 20.57 15.18 31 148264 27793 50429036
Respiratory depression 20.44 15.18 5 148290 12005 50444824
Neutrophil count increased 20.41 15.18 8 148287 14187 50442642
Paranoia 20.39 15.18 3 148292 10345 50446484
Right ventricular enlargement 20.36 15.18 12 148283 285 50456544
Cardiac septal defect 20.32 15.18 12 148283 286 50456543
Throat irritation 20.30 15.18 155 148140 30084 50426745
Dialysis device insertion 20.27 15.18 6 148289 20 50456809
Suture related complication 20.27 15.18 10 148285 164 50456665
Life support 20.08 15.18 11 148284 226 50456603
Vasculitis 19.93 15.18 8 148287 13983 50442846
Living in residential institution 19.92 15.18 14 148281 453 50456376
Aphasia 19.87 15.18 33 148262 28461 50428368
Prescribed overdose 19.76 15.18 9 148286 14591 50442238
Clostridium difficile infection 19.73 15.18 135 148160 25304 50431525
Hypercholesterolaemia 19.67 15.18 5 148290 11698 50445131
Infusion site discomfort 19.59 15.18 18 148277 860 50455969
Bronchoscopy 19.56 15.18 7 148288 48 50456781
Spinal operation 19.50 15.18 51 148244 6209 50450620
Liver ablation 19.34 15.18 4 148291 0 50456829
Immune tolerance induction 19.34 15.18 4 148291 0 50456829
Cyanosis 19.33 15.18 92 148203 15092 50441737
Catheter site bruise 19.32 15.18 12 148283 314 50456515
Faeces discoloured 19.31 15.18 96 148199 16028 50440801
Coordination abnormal 19.25 15.18 5 148290 11529 50445300
Upper-airway cough syndrome 19.24 15.18 62 148233 8488 50448341
Eczema 19.11 15.18 23 148272 22679 50434150
Premature labour 19.10 15.18 5 148290 11471 50445358
Infusion site inflammation 19.01 15.18 11 148284 252 50456577
Portal hypertension 19.00 15.18 35 148260 3357 50453472
Vitamin D deficiency 18.92 15.18 5 148290 11397 50445432
Respiratory arrest 18.92 15.18 37 148258 29972 50426857
Walking disability 18.71 15.18 21 148274 1275 50455554
Intervertebral disc degeneration 18.69 15.18 8 148287 13453 50443376
Hip fracture 18.58 15.18 135 148160 25796 50431033
Haematuria 18.49 15.18 29 148266 25584 50431245
Drain placement 18.42 15.18 7 148288 58 50456771
Drug titration 18.39 15.18 5 148290 11 50456818
Catheter site dryness 18.35 15.18 6 148289 30 50456799
Inflammation 18.33 15.18 95 148200 56817 50400012
Anhedonia 18.22 15.18 3 148292 9521 50447308
Infusion site rash 18.11 15.18 21 148274 1321 50455508
Device issue 17.95 15.18 110 148185 19862 50436967
Blood pressure fluctuation 17.90 15.18 50 148245 35773 50421056
Adverse drug reaction 17.89 15.18 92 148203 55130 50401699
Rales 17.80 15.18 67 148228 9911 50446918
Renal tubular necrosis 17.77 15.18 4 148291 10164 50446665
Mania 17.71 15.18 5 148290 10911 50445918
Cataract operation 17.70 15.18 38 148257 4073 50452756
Portopulmonary hypertension 17.61 15.18 8 148287 108 50456721
Sinus tachycardia 17.58 15.18 22 148273 21332 50435497
Obesity 17.58 15.18 14 148281 16761 50440068
Injection site haemorrhage 17.57 15.18 22 148273 21324 50435505
Musculoskeletal disorder 17.54 15.18 15 148280 17334 50439495
Conjunctivitis 17.52 15.18 13 148282 16132 50440697
Oral pain 17.45 15.18 29 148266 25004 50431825
Injection site infection 17.42 15.18 23 148272 1653 50455176
Respiratory syncytial virus infection 17.38 15.18 43 148252 5059 50451770
Spinal stenosis 17.35 15.18 9 148286 13541 50443288
Generalised oedema 17.34 15.18 83 148212 13648 50443181
Pulmonary thrombosis 17.25 15.18 55 148240 7486 50449343
Cardiorenal syndrome 17.24 15.18 14 148281 565 50456264
Myopathy 17.22 15.18 3 148292 9136 50447693
Orthostatic hypotension 17.19 15.18 38 148257 29443 50427386
Gastrointestinal endoscopic therapy 17.17 15.18 6 148289 38 50456791
Biopsy kidney 17.10 15.18 8 148287 116 50456713
Tooth extraction 17.08 15.18 62 148233 9013 50447816
Device difficult to use 17.05 15.18 4 148291 9882 50446947
Hypomagnesaemia 16.92 15.18 26 148269 23130 50433699
Decreased activity 16.92 15.18 43 148252 5144 50451685
Hypothermia 16.91 15.18 7 148288 12009 50444820
Immune thrombocytopenia 16.90 15.18 3 148292 9014 50447815
Delusion 16.86 15.18 5 148290 10564 50446265
Speech disorder 16.76 15.18 51 148244 35497 50421332
Fear 16.74 15.18 11 148284 14538 50442291
Acute left ventricular failure 16.72 15.18 16 148279 805 50456024
Hysterectomy 16.66 15.18 56 148239 7834 50448995
Body height decreased 16.62 15.18 3 148292 8905 50447924
Cardiac septal defect repair 16.58 15.18 4 148291 4 50456825
Flatulence 16.54 15.18 145 148150 29313 50427516
Pharyngeal oedema 16.48 15.18 9 148286 13156 50443673
Female sterilisation 16.48 15.18 13 148282 503 50456326
Sensory disturbance 16.47 15.18 7 148288 11822 50445007
Eosinophil count increased 16.41 15.18 3 148292 8827 50448002
Pulmonary artery occlusion 16.39 15.18 5 148290 19 50456810
Cardiac pacemaker replacement 16.38 15.18 11 148284 330 50456499
Purulent discharge 16.36 15.18 38 148257 4294 50452535
Irritability 16.28 15.18 37 148258 28389 50428440
Diabetes mellitus 16.27 15.18 81 148214 48952 50407877
Cytopenia 16.27 15.18 3 148292 8772 50448057
Colon operation 16.27 15.18 11 148284 334 50456495
Vomiting 16.25 15.18 1564 146731 459194 49997635
Metastases to lung 16.20 15.18 6 148289 11014 50445815
Blood culture negative 16.17 15.18 8 148287 132 50456697
Large intestinal polypectomy 16.13 15.18 9 148286 192 50456637
Bronchospasm 16.07 15.18 12 148283 14842 50441987
Tooth disorder 16.04 15.18 29 148266 24199 50432630
Coeliac disease 16.04 15.18 3 148292 8682 50448147
Skin fissures 15.99 15.18 3 148292 8665 50448164
Endoscopy 15.98 15.18 11 148284 344 50456485
Application site hypersensitivity 15.84 15.18 9 148286 199 50456630
Lymphadenopathy 15.83 15.18 48 148247 33451 50423378
Infusion site nodule 15.83 15.18 18 148277 1109 50455720
Bronchial artery embolisation 15.70 15.18 4 148291 6 50456823
Haematoma 15.68 15.18 42 148253 30468 50426361
Nodule 15.66 15.18 16 148279 16987 50439842
Dysentery 15.65 15.18 15 148280 756 50456073
Right ventricular hypertrophy 15.61 15.18 14 148281 648 50456181
Bacterial infection 15.48 15.18 91 148204 16190 50440639
Full blood count decreased 15.47 15.18 26 148269 22320 50434509
Feeding tube user 15.46 15.18 5 148290 24 50456805
Memory impairment 15.37 15.18 322 147973 79038 50377791
Gastric haemorrhage 15.34 15.18 44 148251 5652 50451177
Infusion site dryness 15.32 15.18 4 148291 7 50456822
Nervous system disorder 15.24 15.18 15 148280 16208 50440621
Drug tolerance decreased 15.23 15.18 4 148291 9156 50447673
Anxiety 15.21 15.18 400 147895 177206 50279623

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 1261.76 20.53 637 42480 22923 29508487
Dyspnoea 1048.11 20.53 1769 41348 324963 29206447
Hospitalisation 899.83 20.53 651 42466 45337 29486073
Death 875.59 20.53 1680 41437 340404 29191006
Right ventricular failure 632.56 20.53 282 42835 7608 29523802
Pain in jaw 562.36 20.53 294 42823 11347 29520063
Pulmonary hypertension 448.95 20.53 300 42817 18308 29513102
Transfusion 427.43 20.53 210 42907 7088 29524322
Dyspnoea exertional 425.52 20.53 382 42735 36108 29495302
Headache 417.41 20.53 835 42282 173172 29358238
Oxygen saturation decreased 345.88 20.53 375 42742 44562 29486848
Hypervolaemia 334.71 20.53 245 42872 17300 29514110
Oedema 322.35 20.53 344 42773 40139 29491271
Nasal congestion 307.79 20.53 240 42877 18639 29512771
Drug ineffective 282.24 20.53 90 43027 363080 29168330
Peripheral swelling 244.83 20.53 377 42740 63362 29468048
Lung transplant 240.17 20.53 92 43025 1664 29529746
Drug interaction 238.53 20.53 12 43105 197373 29334037
Toxicity to various agents 218.25 20.53 8 43109 173653 29357757
Catheter management 206.11 20.53 68 43049 776 29530634
Oxygen consumption increased 203.55 20.53 75 43042 1212 29530198
Pulmonary arterial hypertension 196.32 20.53 127 42990 7322 29524088
Oedema peripheral 177.24 20.53 435 42682 103122 29428288
Neutropenia 176.96 20.53 3 43114 131708 29399702
Condition aggravated 174.29 20.53 538 42579 145757 29385653
Catheterisation cardiac 169.40 20.53 76 43041 2077 29529333
Product dose omission issue 151.42 20.53 392 42725 95991 29435419
Catheter site erythema 146.34 20.53 58 43059 1153 29530257
Febrile neutropenia 145.09 20.53 4 43113 112236 29419174
Flushing 135.09 20.53 188 42929 28804 29502606
Therapy non-responder 133.05 20.53 193 42924 30718 29500692
Concomitant disease aggravated 131.48 20.53 85 43032 4893 29526517
Infusion site pain 127.40 20.53 69 43048 2856 29528554
Dialysis 127.03 20.53 111 43006 10097 29521313
Transplant evaluation 126.19 20.53 41 43076 444 29530966
Off label use 123.28 20.53 155 42962 300645 29230765
Unevaluable event 117.87 20.53 179 42938 29672 29501738
Catheter site pain 110.82 20.53 47 43070 1117 29530293
Pulmonary arterial pressure increased 103.89 20.53 44 43073 1042 29530368
Hypoxia 103.04 20.53 219 42898 47160 29484250
Weight increased 100.55 20.53 292 42825 76375 29455035
Thrombocytopenia 98.06 20.53 37 43080 134786 29396624
Acute kidney injury 97.24 20.53 148 42969 265119 29266291
Oxygen therapy 95.97 20.53 37 43080 681 29530729
Therapy change 93.31 20.53 54 43063 2544 29528866
Drug abuse 92.81 20.53 6 43111 79877 29451533
Pain in extremity 92.78 20.53 362 42755 110071 29421339
Pneumonia 92.62 20.53 788 42329 319384 29212026
Malaise 92.36 20.53 468 42649 159134 29372276
Catheter site pruritus 92.05 20.53 29 43088 282 29531128
Swelling 88.44 20.53 173 42944 35110 29496300
Brain natriuretic peptide increased 87.30 20.53 62 43055 4168 29527242
Cough 83.63 20.53 386 42731 126341 29405069
Catheter site rash 83.12 20.53 24 43093 168 29531242
Dizziness 82.44 20.53 515 42602 189169 29342241
Catheter site discharge 78.84 20.53 30 43087 532 29530878
Hypotension 76.68 20.53 515 42602 193839 29337571
Pulmonary oedema 75.57 20.53 182 42935 42553 29488857
Liver transplant 72.36 20.53 44 43073 2272 29529138
Catheter site irritation 70.09 20.53 19 43098 102 29531308
Aspiration pleural cavity 69.70 20.53 30 43087 740 29530670
Catheter placement 69.49 20.53 29 43088 661 29530749
Abdominal distension 69.16 20.53 184 42933 45727 29485683
Pancytopenia 67.16 20.53 19 43098 83149 29448261
Overdose 66.78 20.53 17 43100 79802 29451608
Syncope 66.06 20.53 264 42853 81107 29450303
Product use in unapproved indication 64.54 20.53 23 43094 86852 29444558
Vascular device infection 61.82 20.53 41 43076 2464 29528946
Diarrhoea 61.42 20.53 747 42370 331951 29199459
Disease complication 61.18 20.53 40 43077 2346 29529064
Adverse event 60.76 20.53 92 43025 15199 29516211
Productive cough 60.57 20.53 138 42979 31121 29500289
Device dislocation 59.91 20.53 51 43066 4476 29526934
Leukopenia 58.97 20.53 6 43111 55197 29476213
Cardiac failure 58.65 20.53 250 42867 79037 29452373
Paracentesis 54.54 20.53 21 43096 385 29531025
Rash 54.28 20.53 123 42994 189696 29341714
Endarterectomy 53.01 20.53 16 43101 133 29531277
Abdominal discomfort 52.09 20.53 171 42946 47732 29483678
Catheter site haemorrhage 51.70 20.53 34 43083 2014 29529396
Cardiac operation 50.65 20.53 37 43080 2599 29528811
Infusion site infection 50.43 20.53 20 43097 398 29531012
Cardiac pacemaker insertion 50.38 20.53 36 43081 2443 29528967
Intentional product use issue 49.92 20.53 3 43114 42495 29488915
Lung operation 49.40 20.53 13 43104 61 29531349
Drug hypersensitivity 49.30 20.53 19 43098 68387 29463023
Pulmonary veno-occlusive disease 49.01 20.53 20 43097 430 29530980
Chronic obstructive pulmonary disease 48.90 20.53 151 42966 40804 29490606
Feeling abnormal 48.52 20.53 182 42935 54263 29477147
Cardiac failure congestive 48.04 20.53 230 42887 76351 29455059
Cardiac disorder 47.89 20.53 141 42976 37122 29494288
Chest pain 47.87 20.53 303 42814 111670 29419740
Sinus congestion 47.29 20.53 45 43072 4567 29526843
Confusional state 47.05 20.53 71 43046 127806 29403604
Hospice care 45.53 20.53 46 43071 5022 29526388
Nasopharyngitis 44.77 20.53 189 42928 59476 29471934
Hyperkalaemia 44.33 20.53 17 43100 61375 29470035
Pulmonary endarterectomy 43.57 20.53 12 43105 69 29531341
Disease progression 42.97 20.53 234 42883 81682 29449728
Infusion site erythema 42.92 20.53 28 43089 1636 29529774
Rehabilitation therapy 42.24 20.53 20 43097 620 29530790
Emergency care 40.55 20.53 15 43102 245 29531165
Neuropathy peripheral 40.33 20.53 27 43090 71000 29460410
Catheter site infection 40.13 20.53 29 43088 2003 29529407
Seizure 40.07 20.53 46 43071 93077 29438333
Hypertension 39.82 20.53 68 43049 116546 29414864
Deep vein thrombosis 39.64 20.53 17 43100 57382 29474028
White blood cell count decreased 39.44 20.53 38 43079 83324 29448086
Acute myocardial infarction 39.21 20.53 11 43106 48427 29482983
Epistaxis 38.95 20.53 164 42953 51540 29479870
Walking distance test abnormal 38.51 20.53 13 43104 160 29531250
Hallucination 38.40 20.53 9 43108 44703 29486707
Metabolic acidosis 37.96 20.53 5 43112 37657 29493753
Acute respiratory failure 37.91 20.53 104 43013 26298 29505112
Device alarm issue 37.84 20.53 18 43099 564 29530846
Palpitations 37.80 20.53 119 42998 32485 29498925
Respiratory failure 37.34 20.53 256 42861 96875 29434535
Exercise tolerance decreased 37.27 20.53 38 43079 4193 29527217
Bradycardia 37.19 20.53 25 43092 65604 29465806
Cardiac ablation 37.15 20.53 19 43098 698 29530712
Ascites 36.51 20.53 127 42990 36492 29494918
Abdominal cavity drainage 36.43 20.53 15 43102 330 29531080
Blood iron decreased 35.69 20.53 38 43079 4410 29527000
Atrial septal defect repair 35.38 20.53 11 43106 102 29531308
Stomatitis 34.94 20.53 6 43111 37107 29494303
Complication associated with device 34.18 20.53 40 43077 5151 29526259
Dizziness exertional 33.86 20.53 11 43106 119 29531291
Delirium 33.70 20.53 8 43109 39389 29492021
Stent placement 33.16 20.53 36 43081 4270 29527140
Haemoptysis 33.14 20.53 109 43008 30441 29500969
Aggression 32.90 20.53 6 43111 35535 29495875
Heart rate increased 32.90 20.53 128 42989 38810 29492600
Internal haemorrhage 32.34 20.53 36 43081 4391 29527019
Hyperhidrosis 32.21 20.53 28 43089 64512 29466898
Suture insertion 31.84 20.53 8 43109 30 29531380
Intentional product misuse 31.77 20.53 6 43111 34655 29496755
Catheter site swelling 31.41 20.53 13 43104 290 29531120
Hyperglycaemia 31.29 20.53 6 43111 34281 29497129
Lung disorder 30.87 20.53 106 43011 30256 29501154
Plasma cell myeloma 30.84 20.53 8 43109 37107 29494303
Device leakage 30.20 20.53 35 43082 4460 29526950
Blood pressure increased 30.10 20.53 38 43079 73765 29457645
Terminal state 30.09 20.53 31 43086 3463 29527947
Dizziness postural 29.89 20.53 38 43079 5329 29526081
Hernia repair 29.63 20.53 19 43098 1078 29530332
Myalgia 29.58 20.53 197 42920 73822 29457588
Pyrexia 29.41 20.53 273 42844 287349 29244061
Infusion site haemorrhage 28.64 20.53 16 43101 704 29530706
Catheter site warmth 28.48 20.53 8 43109 50 29531360
Device infusion issue 28.23 20.53 15 43102 597 29530813
Rhinorrhoea 28.19 20.53 82 43035 21437 29509973
Therapeutic product effect incomplete 28.17 20.53 11 43106 39294 29492116
Wrong technique in product usage process 27.64 20.53 6 43111 31422 29499988
Device related infection 26.98 20.53 66 43051 15570 29515840
Psoriasis 26.68 20.53 7 43110 32220 29499190
Hyponatraemia 26.38 20.53 36 43081 67597 29463813
Catheter removal 26.04 20.53 10 43107 182 29531228
Platelet count decreased 25.85 20.53 73 43044 104599 29426811
Heart and lung transplant 25.85 20.53 8 43109 73 29531337
Urticaria 25.74 20.53 25 43092 54635 29476775
Dyspepsia 25.42 20.53 99 43018 30026 29501384
Hypoglycaemia 25.32 20.53 20 43097 48326 29483084
Coronary artery disease 24.80 20.53 17 43100 44173 29487237
Suicidal ideation 24.42 20.53 10 43107 34706 29496704
Influenza 24.25 20.53 123 42994 41758 29489652
Biopsy liver 24.12 20.53 10 43107 224 29531186
Scleroderma 23.95 20.53 18 43099 1320 29530090
Chemotherapy 23.93 20.53 13 43104 541 29530869
Cholestasis 23.92 20.53 3 43114 23459 29507951
Gout 23.66 20.53 66 43051 16845 29514565
Myocardial infarction 23.65 20.53 82 43035 110214 29421196
Blood bilirubin increased 23.59 20.53 105 43012 33788 29497622
Cardiac index increased 23.57 20.53 6 43111 24 29531386
Agitation 23.55 20.53 24 43093 51280 29480130
Oxygen saturation abnormal 23.51 20.53 17 43100 1175 29530235
Abnormal behaviour 23.47 20.53 3 43114 23124 29508286
Pneumonitis 23.39 20.53 6 43111 28038 29503372
Diuretic therapy 23.19 20.53 6 43111 26 29531384
Presyncope 22.72 20.53 63 43054 16026 29515384
Device occlusion 22.64 20.53 34 43083 5574 29525836
Ventilation perfusion mismatch 22.51 20.53 7 43110 65 29531345
Depressed level of consciousness 22.40 20.53 13 43104 36929 29494481
Right ventricular dysfunction 22.08 20.53 15 43102 938 29530472
Oesophageal variceal ligation 21.53 20.53 7 43110 76 29531334
Rheumatoid arthritis 21.44 20.53 10 43107 32142 29499268
Cardioversion 21.35 20.53 14 43103 825 29530585
Multiple organ dysfunction syndrome 21.34 20.53 37 43080 63079 29468331
Disturbance in attention 21.22 20.53 3 43114 21421 29509989
Spontaneous intrahepatic portosystemic venous shunt 20.75 20.53 5 43112 15 29531395
Abdominal pain upper 20.66 20.53 156 42961 60837 29470573

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 3585.14 14.94 6624 164956 712050 63615102
Fluid retention 3580.91 14.94 2133 169447 57473 64269679
Death 2538.41 14.94 4563 167017 478142 63849010
Hospitalisation 2172.18 14.94 1713 169867 73494 64253658
Pain in jaw 1602.04 14.94 1118 170462 39637 64287515
Dyspnoea exertional 1487.26 14.94 1367 170213 72363 64254789
Right ventricular failure 1469.00 14.94 837 170743 20634 64306518
Transfusion 1429.55 14.94 774 170806 17220 64309932
Drug ineffective 1416.57 14.94 265 171315 839982 63487170
Headache 1410.93 14.94 3814 167766 525653 63801499
Nasal congestion 1281.19 14.94 1146 170434 58512 64268640
Pulmonary hypertension 1172.63 14.94 949 170631 42190 64284962
Hypervolaemia 1164.75 14.94 900 170680 37385 64289767
Oxygen saturation decreased 934.76 14.94 1283 170297 105893 64221259
Oedema 834.05 14.94 1122 170458 90813 64236339
Toxicity to various agents 815.09 14.94 36 171544 363477 63963675
Off label use 798.41 14.94 344 171236 632462 63694690
Drug interaction 709.41 14.94 71 171509 362012 63965140
Oedema peripheral 671.53 14.94 1626 169954 208691 64118461
Product dose omission issue 649.02 14.94 1531 170049 193216 64133936
Catheter management 646.09 14.94 266 171314 3089 64324063
Catheter site erythema 585.62 14.94 277 171303 4572 64322580
Lung transplant 584.67 14.94 263 171317 3845 64323307
Completed suicide 579.14 14.94 3 171577 224411 64102741
Oxygen consumption increased 575.77 14.94 269 171311 4312 64322840
Neutropenia 556.36 14.94 18 171562 239606 64087546
Unevaluable event 513.18 14.94 652 170928 49837 64277315
Catheter site pain 511.74 14.94 246 171334 4216 64322936
Catheterisation cardiac 508.89 14.94 252 171328 4621 64322531
Cough 508.46 14.94 1861 169719 300287 64026865
Pneumonia 504.34 14.94 2864 168716 556712 63770440
Peripheral swelling 501.47 14.94 1454 170126 207699 64119453
Pulmonary arterial hypertension 466.05 14.94 447 171133 24920 64302232
Infusion site pain 459.81 14.94 307 171273 10090 64317062
Febrile neutropenia 458.84 14.94 8 171572 187649 64139503
Catheter site pruritus 446.81 14.94 180 171400 1968 64325184
Pulmonary oedema 428.98 14.94 759 170821 77915 64249237
Infusion related reaction 420.12 14.94 3 171577 164464 64162688
Flushing 407.39 14.94 742 170838 77906 64249246
Chest pain 382.74 14.94 1437 170143 234543 64092609
Pulmonary arterial pressure increased 368.97 14.94 192 171388 3924 64323228
Dizziness 358.95 14.94 2159 169421 428004 63899148
Malaise 343.48 14.94 2009 169571 394238 63932914
Drug hypersensitivity 331.00 14.94 110 171470 237705 64089447
Hypoxia 326.27 14.94 723 170857 87426 64239726
Condition aggravated 323.19 14.94 1889 169691 370537 63956615
Concomitant disease aggravated 322.02 14.94 258 171322 11284 64315868
Dialysis 321.89 14.94 304 171276 16616 64310536
Therapy change 313.81 14.94 202 171378 6232 64320920
Catheter site discharge 311.06 14.94 141 171439 2100 64325052
Drug abuse 310.49 14.94 9 171571 132365 64194787
Acute kidney injury 297.48 14.94 460 171120 448780 63878372
Catheter placement 297.47 14.94 143 171437 2450 64324702
Diarrhoea 294.71 14.94 3073 168507 719631 63607521
Treatment failure 294.11 14.94 3 171577 116813 64210339
Hypotension 293.58 14.94 1874 169706 379100 63948052
Palpitations 293.23 14.94 770 170810 103718 64223434
Transplant evaluation 291.51 14.94 121 171459 1436 64325716
Malignant neoplasm progression 279.24 14.94 4 171576 112867 64214285
Therapeutic product effect decreased 277.51 14.94 6 171574 115345 64211807
Product use in unapproved indication 276.75 14.94 65 171515 176553 64150599
Catheter site infection 273.38 14.94 177 171403 5516 64321636
Thrombocytopenia 269.71 14.94 129 171451 223672 64103480
Vascular device infection 269.70 14.94 181 171399 5999 64321153
Catheter site rash 265.58 14.94 99 171481 862 64326290
Scleroderma 264.39 14.94 163 171417 4655 64322497
Contraindicated product administered 261.83 14.94 5 171575 107824 64219328
Overdose 247.48 14.94 60 171520 159506 64167646
Rheumatoid arthritis 246.69 14.94 66 171514 164228 64162924
Therapy non-responder 242.09 14.94 539 171041 65360 64261792
Abdominal distension 239.92 14.94 678 170902 95316 64231836
Rash 237.88 14.94 544 171036 458005 63869147
Cardiac failure congestive 235.79 14.94 824 170756 129756 64197396
Syncope 226.07 14.94 924 170656 156711 64170441
Leukopenia 223.34 14.94 11 171569 101231 64225921
Catheter site haemorrhage 221.09 14.94 143 171437 4448 64322704
Productive cough 220.33 14.94 554 171026 72649 64254503
Maternal exposure during pregnancy 219.55 14.94 8 171572 95876 64231276
Cardiac failure 218.32 14.94 811 170769 131562 64195590
Catheter site swelling 218.18 14.94 100 171480 1530 64325622
Device related infection 216.08 14.94 332 171248 30294 64296858
Rhabdomyolysis 215.94 14.94 6 171574 91720 64235432
Stomatitis 215.54 14.94 21 171559 109584 64217568
Brain natriuretic peptide increased 207.37 14.94 168 171412 7465 64319687
Intentional overdose 200.90 14.94 9 171571 89935 64237217
Cardiac pacemaker insertion 197.61 14.94 138 171442 4885 64322267
Oxygen therapy 197.09 14.94 104 171476 2189 64324963
Therapeutic product effect incomplete 195.38 14.94 23 171557 103459 64223693
Device alarm issue 195.15 14.94 97 171483 1793 64325359
Infusion site erythema 192.50 14.94 154 171426 6719 64320433
Cardiac disorder 192.18 14.94 445 171135 55371 64271781
Device leakage 183.57 14.94 162 171418 8104 64319048
Alopecia 178.41 14.94 110 171470 165580 64161572
Feeling abnormal 176.59 14.94 764 170816 132838 64194314
Neutrophil count decreased 174.82 14.94 7 171573 77189 64249963
Aspiration pleural cavity 173.34 14.94 82 171498 1353 64325799
Epistaxis 171.70 14.94 613 170967 97518 64229634
Arthropathy 171.62 14.94 54 171526 120913 64206239
Intentional product use issue 168.61 14.94 26 171554 95338 64231814
Electrocardiogram QT prolonged 167.95 14.94 11 171569 79437 64247715
Paracentesis 167.77 14.94 77 171503 1182 64325970
Catheter site irritation 167.16 14.94 61 171519 497 64326655
Pancytopenia 164.47 14.94 88 171492 143221 64183931
Confusional state 164.44 14.94 276 171304 260868 64066284
Cardiac operation 163.98 14.94 115 171465 4099 64323053
Musculoskeletal stiffness 162.72 14.94 62 171518 123144 64204008
Weight increased 159.91 14.94 1043 170537 212305 64114847
Infusion site infection 156.98 14.94 79 171501 1501 64325651
Nausea 156.97 14.94 2945 168635 782855 63544297
Hospice care 156.61 14.94 143 171437 7482 64319670
Blood pressure increased 154.27 14.94 139 171441 172413 64154739
Chest discomfort 154.21 14.94 665 170915 115441 64211711
Product use issue 153.48 14.94 108 171472 151607 64175545
Emergency care 153.42 14.94 66 171514 861 64326291
Disease progression 153.17 14.94 764 170816 140916 64186236
Ascites 152.98 14.94 436 171144 61565 64265587
Pain in extremity 151.43 14.94 1347 170233 301738 64025414
Rehabilitation therapy 149.12 14.94 75 171505 1423 64325729
Suicide attempt 146.71 14.94 11 171569 70996 64256156
Hypertension 142.07 14.94 298 171282 258963 64068189
Anaphylactic reaction 140.84 14.94 11 171569 68653 64258499
Device dislocation 140.22 14.94 223 171357 20955 64306197
Chronic obstructive pulmonary disease 138.37 14.94 460 171120 70588 64256564
Hepatic enzyme increased 137.47 14.94 88 171492 129855 64197297
Infusion site swelling 137.41 14.94 115 171465 5350 64321802
Glossodynia 136.62 14.94 9 171571 64687 64262465
Acute respiratory failure 135.92 14.94 364 171216 49570 64277582
Influenza 131.49 14.94 597 170983 105934 64221218
Blood creatine phosphokinase increased 130.30 14.94 6 171574 58552 64268600
Urticaria 130.09 14.94 120 171460 147197 64179955
Pericardial effusion 127.53 14.94 306 171274 38948 64288204
Disease complication 127.04 14.94 99 171481 4156 64322996
Angioedema 126.53 14.94 10 171570 61811 64265341
Bradycardia 126.51 14.94 79 171501 118140 64209012
Nasopharyngitis 124.14 14.94 920 170660 195153 64131999
Device infusion issue 124.10 14.94 70 171510 1688 64325464
Intentional product misuse 122.71 14.94 22 171558 72273 64254879
White blood cell count decreased 122.00 14.94 144 171436 157693 64169459
Drug intolerance 121.72 14.94 195 171385 187797 64139355
Seizure 120.91 14.94 160 171420 166732 64160420
Liver transplant 119.56 14.94 94 171486 3998 64323154
Respiratory failure 118.87 14.94 785 170795 160398 64166754
Internal haemorrhage 118.44 14.94 123 171457 7544 64319608
Pericarditis 117.73 14.94 14 171566 62502 64264650
Coma 117.50 14.94 43 171537 87572 64239580
Metabolic acidosis 117.43 14.94 23 171557 70935 64256217
Hyponatraemia 117.17 14.94 133 171447 148206 64178946
Depressed level of consciousness 116.12 14.94 36 171544 81400 64245752
Myalgia 116.06 14.94 771 170809 157846 64169306
Dyspepsia 115.18 14.94 471 171109 79841 64247311
Hyperkalaemia 114.69 14.94 63 171517 101066 64226086
Infusion site haemorrhage 113.68 14.94 73 171507 2242 64324910
Joint swelling 113.45 14.94 253 171327 215129 64112023
Sinus congestion 112.60 14.94 170 171410 15269 64311883
Wrong technique in product usage process 111.96 14.94 19 171561 64955 64262197
Blood potassium decreased 111.47 14.94 296 171284 40103 64287049
Dizziness postural 110.36 14.94 133 171447 9619 64317533
Atrial septal defect repair 110.18 14.94 41 171539 355 64326797
Central venous catheterisation 109.45 14.94 76 171504 2665 64324487
Presyncope 109.15 14.94 269 171311 34820 64292332
Psoriasis 109.10 14.94 28 171552 71675 64255477
Hypersensitivity 109.10 14.94 224 171356 196228 64130924
Walking distance test abnormal 108.67 14.94 48 171532 670 64326482
Dyspnoea at rest 107.73 14.94 107 171473 6222 64320930
Suicidal ideation 107.15 14.94 23 171557 66519 64260633
N-terminal prohormone brain natriuretic peptide increased 106.67 14.94 83 171497 3476 64323676
Bone marrow failure 106.41 14.94 5 171575 47947 64279205
Catheter site inflammation 105.03 14.94 51 171529 894 64326258
Abdominal cavity drainage 104.65 14.94 47 171533 684 64326468
Renal disorder 104.64 14.94 266 171314 35099 64292053
Pulmonary veno-occlusive disease 101.18 14.94 57 171523 1371 64325781
Blood iron decreased 100.60 14.94 142 171438 12000 64315152
Stent placement 100.08 14.94 97 171483 5474 64321678
Infusion site discharge 99.59 14.94 42 171538 520 64326632
Hepatocellular injury 99.47 14.94 5 171575 45230 64281922
Device occlusion 99.04 14.94 127 171453 9786 64317366
Dermatitis contact 99.01 14.94 121 171459 8879 64318273
Deep vein thrombosis 98.51 14.94 81 171499 105101 64222051
Impaired healing 97.17 14.94 21 171559 60452 64266700
Delirium 96.15 14.94 32 171548 69162 64257990
Injection site pain 95.70 14.94 93 171487 111315 64215837
Lactic acidosis 95.33 14.94 23 171557 61387 64265765
Hypoglycaemia 94.89 14.94 61 171519 89831 64237321
Exposure during pregnancy 94.65 14.94 44 171536 77631 64249521
Hallucination 93.82 14.94 38 171542 72750 64254402
Mineral supplementation 92.09 14.94 44 171536 743 64326409
Injection site reaction 91.56 14.94 9 171571 46655 64280497
Seasonal allergy 91.09 14.94 133 171447 11593 64315559
C-reactive protein increased 90.24 14.94 72 171508 94837 64232315
Cholestasis 89.78 14.94 8 171572 44864 64282288
Pulmonary endarterectomy 89.51 14.94 30 171550 184 64326968
Exercise tolerance decreased 88.64 14.94 106 171474 7604 64319548
Lung disorder 88.62 14.94 358 171222 60342 64266810
Rhinorrhoea 88.60 14.94 355 171225 59614 64267538
Endarterectomy 87.86 14.94 33 171547 294 64326858
Cardiac ablation 87.31 14.94 56 171524 1716 64325436
Acute myocardial infarction 85.71 14.94 39 171541 69679 64257473
Complication associated with device 85.36 14.94 148 171432 14932 64312220
Hyperglycaemia 85.06 14.94 28 171552 60940 64266212
Cognitive disorder 84.79 14.94 21 171559 55066 64272086
Agranulocytosis 84.78 14.94 4 171576 38225 64288927
Heart rate increased 83.56 14.94 498 171082 98177 64228975
Haemoglobin decreased 82.37 14.94 837 170743 194226 64132926
Blood pressure systolic increased 81.89 14.94 16 171564 49437 64277715
Osteoarthritis 81.74 14.94 33 171547 63303 64263849
Blood cholesterol increased 81.23 14.94 17 171563 50049 64277103
Catheter site vesicles 80.83 14.94 31 171549 294 64326858
Multiple allergies 80.48 14.94 88 171492 5726 64321426
Blood pressure decreased 79.48 14.94 445 171135 85754 64241398
Cardioversion 79.36 14.94 54 171526 1831 64325321
Product supply issue 79.10 14.94 48 171532 1331 64325821
Cytomegalovirus infection 79.06 14.94 5 171575 37194 64289958
Dysarthria 78.23 14.94 30 171550 59376 64267776
Aggression 76.46 14.94 15 171565 46217 64280935
Nasal dryness 76.09 14.94 68 171512 3458 64323694
Eosinophilia 75.61 14.94 7 171573 38069 64289083
Adverse event 75.37 14.94 254 171326 39235 64287917
Chemotherapy 75.18 14.94 48 171532 1459 64325693
Bronchitis 74.97 14.94 521 171059 108222 64218930
Hypocalcaemia 74.67 14.94 11 171569 41742 64285410
Neuropathy peripheral 74.07 14.94 124 171456 117401 64209751
Oropharyngeal pain 73.64 14.94 446 171134 88421 64238731
Infusion site irritation 73.54 14.94 32 171548 430 64326722
Depression 72.78 14.94 247 171333 183044 64144108
Generalised tonic-clonic seizure 72.44 14.94 10 171570 39847 64287305
Drug dependence 72.25 14.94 4 171576 33308 64293844
Drug-induced liver injury 71.72 14.94 19 171561 47624 64279528
Catheter site related reaction 71.50 14.94 40 171540 949 64326203
Inappropriate schedule of product administration 71.49 14.94 84 171496 92202 64234950
Blister 71.39 14.94 66 171514 80901 64246251
Pulmonary arterial pressure abnormal 70.95 14.94 35 171545 636 64326516
Lymphocyte count decreased 69.90 14.94 12 171568 40687 64286465
Sinus disorder 69.74 14.94 145 171435 16763 64310389
Right ventricular dysfunction 69.58 14.94 53 171527 2150 64325002
Tubulointerstitial nephritis 69.31 14.94 3 171577 30906 64296246
Agitation 68.92 14.94 80 171500 88287 64238865
Drug level increased 68.68 14.94 6 171574 34190 64292962
Infusion site warmth 68.49 14.94 40 171540 1032 64326120
Hernia repair 68.28 14.94 48 171532 1717 64325435
Haemoptysis 68.21 14.94 285 171295 48763 64278389
Plasma cell myeloma 68.18 14.94 19 171561 46056 64281096
Hepatotoxicity 68.16 14.94 12 171568 39950 64287202
Catheter site warmth 68.13 14.94 26 171554 243 64326909
Left ventricular failure 67.61 14.94 97 171483 8320 64318832
Folliculitis 67.18 14.94 3 171577 30074 64297078
Lower respiratory tract infection 67.18 14.94 92 171488 94522 64232630
Pulmonary arterial wedge pressure increased 66.96 14.94 30 171550 434 64326718
Injection site erythema 66.93 14.94 54 171526 70746 64256406
Helicobacter infection 66.57 14.94 11 171569 38351 64288801
Hyperhidrosis 65.51 14.94 147 171433 124773 64202379
Transplant 64.81 14.94 36 171544 842 64326310
Right ventricular dilatation 64.68 14.94 43 171537 1402 64325750
Terminal state 64.56 14.94 69 171511 4375 64322777
Gout 64.32 14.94 162 171418 21251 64305901
Angioplasty 63.28 14.94 45 171535 1640 64325512
Concomitant disease progression 62.67 14.94 59 171521 3210 64323942
Disease recurrence 62.02 14.94 6 171574 31504 64295648
Injury 61.86 14.94 36 171544 55956 64271196
Hypercalcaemia 61.79 14.94 6 171574 31410 64295742
Hepatitis 61.74 14.94 22 171558 45560 64281592
Biopsy lung 61.32 14.94 23 171557 204 64326948
Encephalopathy 60.60 14.94 41 171539 58778 64268374
Pulmonary pain 60.10 14.94 52 171528 2532 64324620
Psychotic disorder 59.81 14.94 10 171570 34568 64292584
Pancreatitis acute 59.22 14.94 20 171560 42835 64284317
Red blood cell sedimentation rate increased 58.79 14.94 7 171573 31228 64295924
Atrial flutter 58.61 14.94 147 171433 19233 64307919
Pruritus 58.49 14.94 540 171040 311860 64015292
Hallucination, visual 58.39 14.94 4 171576 27830 64299322
Oxygen saturation abnormal 58.26 14.94 59 171521 3512 64323640
Pulmonary embolism 58.24 14.94 197 171383 146159 64180993
Pneumocystis jirovecii pneumonia 57.88 14.94 4 171576 27630 64299522
Orthopnoea 57.48 14.94 94 171486 9040 64318112
Mobility decreased 57.46 14.94 87 171493 85753 64241399
Acute hepatic failure 57.05 14.94 3 171577 26109 64301043
Emotional distress 56.91 14.94 13 171567 36025 64291127
Medication error 56.82 14.94 31 171549 49935 64277217
Medical device change 56.35 14.94 27 171553 459 64326693
Pleural effusion 56.26 14.94 549 171031 126010 64201142
Coronary artery disease 56.00 14.94 47 171533 60386 64266766
Catheter site scab 55.92 14.94 21 171559 187 64326965
Product prescribing error 55.15 14.94 13 171567 35256 64291896
Pulmonary congestion 55.10 14.94 164 171416 23716 64303436
Extra dose administered 54.53 14.94 78 171502 6672 64320480
Therapeutic response decreased 54.27 14.94 36 171544 52152 64275000
Head discomfort 54.19 14.94 106 171474 11728 64315424
Cor pulmonale 53.80 14.94 44 171536 1981 64325171
General physical health deterioration 53.74 14.94 321 171259 204104 64123048
Diagnostic procedure 53.72 14.94 19 171561 140 64327012
Wound 53.65 14.94 75 171505 76402 64250750
Cerebral infarction 53.59 14.94 21 171559 41023 64286129
Cardiac output increased 53.56 14.94 20 171560 175 64326977
Ischaemic stroke 53.45 14.94 7 171573 29028 64298124
Epilepsy 53.15 14.94 12 171568 33519 64293633
Diabetic ketoacidosis 53.05 14.94 8 171572 29837 64297315
Product quality issue 52.94 14.94 8 171572 29791 64297361
Myocardial infarction 52.75 14.94 244 171336 165577 64161575
Catheterisation cardiac abnormal 52.63 14.94 22 171558 266 64326886
Swollen tongue 52.50 14.94 14 171566 34940 64292212
Haematuria 52.47 14.94 50 171530 60421 64266731
Fatigue 52.24 14.94 2462 169118 746268 63580884
Skin lesion 52.23 14.94 16 171564 36466 64290686
Paraesthesia 52.22 14.94 183 171397 134339 64192813
Discomfort 52.20 14.94 84 171496 80794 64246358
Muscle injury 52.12 14.94 5 171575 26432 64300720
Acute myeloid leukaemia 52.07 14.94 6 171574 27457 64299695
Abdominal pain upper 52.00 14.94 702 170878 174328 64152824
Pericardial drainage 51.95 14.94 23 171557 323 64326829
Accidental exposure to product 51.94 14.94 5 171575 26359 64300793
Myoclonus 51.57 14.94 4 171576 25114 64302038
Device connection issue 51.46 14.94 31 171549 848 64326304
Drug eruption 51.46 14.94 16 171564 36120 64291032
Dependence on oxygen therapy 51.17 14.94 24 171556 388 64326764
Cholecystectomy 51.01 14.94 83 171497 7949 64319203
Basal cell carcinoma 51.01 14.94 10 171570 30828 64296324
Dizziness exertional 50.84 14.94 25 171555 451 64326701
Respiratory tract congestion 50.34 14.94 124 171456 16041 64311111
Choking 50.22 14.94 96 171484 10442 64316710
Lymphopenia 50.20 14.94 5 171575 25652 64301500
Heart and lung transplant 49.94 14.94 19 171561 176 64326976
Biopsy liver 49.75 14.94 26 171554 536 64326616
Abnormal behaviour 49.50 14.94 14 171566 33608 64293544
Biopsy 49.02 14.94 25 171555 489 64326663
Abortion spontaneous 48.93 14.94 5 171575 25138 64302014
Sinus bradycardia 48.88 14.94 3 171577 22890 64304262
Device related sepsis 48.31 14.94 64 171516 5091 64322061
Blood lactate dehydrogenase increased 48.28 14.94 14 171566 33064 64294088
Drug withdrawal syndrome 48.01 14.94 12 171568 31279 64295873
Incorrect route of product administration 47.03 14.94 4 171576 23294 64303858
Blood glucose increased 46.98 14.94 121 171459 97952 64229200
Mouth ulceration 46.86 14.94 14 171566 32430 64294722
Ataxia 46.83 14.94 3 171577 22081 64305071
Somnolence 46.81 14.94 333 171247 203312 64123840
Catheter removal 46.75 14.94 25 171555 541 64326611
Disseminated intravascular coagulation 46.65 14.94 14 171566 32334 64294818
Status epilepticus 45.77 14.94 3 171577 21660 64305492
Myelosuppression 45.70 14.94 5 171575 23825 64303327
Swelling 45.31 14.94 637 170943 159581 64167571
Pyrexia 45.02 14.94 1137 170443 557507 63769645
Cardio-respiratory arrest 44.42 14.94 125 171455 98268 64228884
Ejection fraction decreased 44.07 14.94 11 171569 28696 64298456
Skin exfoliation 43.99 14.94 33 171547 44852 64282300
Cardiac flutter 43.96 14.94 55 171525 4134 64323018
Labelled drug-drug interaction medication error 43.95 14.94 4 171576 22058 64305094
Drug ineffective for unapproved indication 43.95 14.94 14 171566 31119 64296033
Proteinuria 43.78 14.94 10 171570 27713 64299439
Body temperature decreased 43.75 14.94 8 171572 25920 64301232
Injection site pruritus 43.70 14.94 23 171557 37803 64289349
Myelodysplastic syndrome 43.45 14.94 10 171570 27569 64299583
Type 2 diabetes mellitus 43.45 14.94 18 171562 34002 64293150
Medical procedure 43.16 14.94 19 171561 263 64326889
Infusion site induration 42.72 14.94 27 171553 806 64326346
Biopsy bone marrow 42.66 14.94 20 171560 323 64326829
Respiration abnormal 42.49 14.94 67 171513 6248 64320904
Altered state of consciousness 42.40 14.94 24 171556 37878 64289274
Pneumonitis 42.14 14.94 43 171537 50322 64276830
Catheter site discolouration 42.12 14.94 15 171565 113 64327039
Hepatic steatosis 41.93 14.94 15 171565 30992 64296160
Decreased appetite 41.11 14.94 1009 170571 280280 64046872
Osteonecrosis 41.10 14.94 12 171568 28217 64298935
Jaundice 41.06 14.94 41 171539 48471 64278681
Cardiac failure high output 40.90 14.94 18 171562 249 64326903
Heart valve replacement 40.89 14.94 25 171555 703 64326449
Hepatic cirrhosis 40.70 14.94 158 171422 26140 64301012
Pulmonary vascular resistance abnormality 40.60 14.94 15 171565 127 64327025
Blood pressure fluctuation 40.39 14.94 47 171533 51824 64275328
Jugular vein distension 39.99 14.94 31 171549 1291 64325861
Device physical property issue 39.94 14.94 38 171542 2095 64325057
Metastases to bone 39.93 14.94 4 171576 20431 64306721
Irritable bowel syndrome 39.92 14.94 25 171555 37344 64289808
Fibromyalgia 39.43 14.94 23 171557 35708 64291444
Multiple organ dysfunction syndrome 39.32 14.94 138 171442 101275 64225877
Heart valve operation 39.30 14.94 16 171564 180 64326972
Bronchopulmonary aspergillosis 39.29 14.94 3 171577 19082 64308070
Renal tubular necrosis 39.13 14.94 6 171574 22104 64305048
Rash erythematous 39.03 14.94 43 171537 48590 64278562
Urinary retention 38.94 14.94 44 171536 49157 64277995
Anaemia 38.89 14.94 1299 170281 377381 63949771
Chronic respiratory failure 38.81 14.94 41 171539 2565 64324587
Infusion site pruritus 38.81 14.94 41 171539 2565 64324587
Visual acuity reduced 38.68 14.94 12 171568 27129 64300023
Poisoning 38.58 14.94 6 171574 21873 64305279
Dyskinesia 38.54 14.94 29 171551 39359 64287793
Iron deficiency anaemia 38.46 14.94 137 171443 21752 64305400
Cardiac failure acute 38.42 14.94 113 171467 16231 64310921
Carbon dioxide increased 38.32 14.94 36 171544 1953 64325199
Catheter site erosion 38.01 14.94 12 171568 59 64327093
Application site pruritus 37.99 14.94 47 171533 3492 64323660
Disturbance in attention 37.99 14.94 32 171548 41042 64286110
Neutrophil count increased 37.96 14.94 10 171570 25164 64301988
Tracheostomy 37.71 14.94 28 171552 1092 64326060
Peritonitis 37.62 14.94 10 171570 25013 64302139
Pancreatitis 37.44 14.94 63 171517 59544 64267608
Wrong dose 37.32 14.94 29 171551 1212 64325940
Paranasal sinus discomfort 37.30 14.94 44 171536 3111 64324041
Prescribed underdose 36.62 14.94 3 171577 18012 64309140
Secretion discharge 36.44 14.94 91 171489 11873 64315279
Choking sensation 36.43 14.94 46 171534 3489 64323663
Transaminases increased 36.26 14.94 39 171541 44555 64282597
Withdrawal syndrome 36.06 14.94 9 171571 23483 64303669
Erythema 35.56 14.94 322 171258 186748 64140404
Nocturnal dyspnoea 35.32 14.94 29 171551 1313 64325839
Ill-defined disorder 35.30 14.94 39 171541 44013 64283139
Respiratory arrest 35.16 14.94 54 171526 52931 64274221
Transplant rejection 35.09 14.94 3 171577 17398 64309754
Torsade de pointes 34.99 14.94 3 171577 17360 64309792
Gastrointestinal tube insertion 34.97 14.94 30 171550 1444 64325708
Hypokalaemia 34.95 14.94 186 171394 121717 64205435
Localised oedema 34.87 14.94 66 171514 7125 64320027
Device breakage 34.84 14.94 74 171506 8681 64318471
Infusion site abscess 34.71 14.94 15 171565 198 64326954
Paranasal sinus hypersecretion 34.66 14.94 42 171538 3054 64324098
Hypertensive crisis 34.57 14.94 4 171576 18244 64308908
Polypectomy 34.45 14.94 25 171555 941 64326211
Diplopia 34.44 14.94 14 171566 26751 64300401
Blood pressure abnormal 34.12 14.94 100 171480 14335 64312817
Illness 34.11 14.94 132 171448 21806 64305346
Blood bilirubin increased 34.08 14.94 266 171314 57287 64269865
Treatment noncompliance 33.98 14.94 215 171365 43267 64283885
Liver function test abnormal 33.56 14.94 67 171513 59334 64267818
Hip surgery 33.48 14.94 37 171543 2436 64324716
Gastroenteritis viral 33.41 14.94 122 171458 19607 64307545
Myopathy 33.18 14.94 4 171576 17676 64309476
Cardiomyopathy 33.06 14.94 13 171567 25343 64301809
Acute respiratory distress syndrome 32.85 14.94 33 171547 38902 64288250
Joint range of motion decreased 32.57 14.94 6 171574 19337 64307815
Aspergillus infection 32.55 14.94 3 171577 16376 64310776
Sinus tachycardia 32.41 14.94 23 171557 32165 64294987
Injection site discharge 32.40 14.94 18 171562 421 64326731
Systemic scleroderma 32.26 14.94 24 171556 939 64326213
Liver injury 32.00 14.94 20 171560 29912 64297240
Right ventricular systolic pressure increased 31.94 14.94 23 171557 855 64326297
Hypoacusis 31.91 14.94 145 171435 25722 64301430
Systemic lupus erythematosus 31.87 14.94 103 171477 77509 64249643
Lip swelling 31.86 14.94 23 171557 31884 64295268
Cardiac pacemaker replacement 31.78 14.94 17 171563 368 64326784
Catheter site nodule 31.70 14.94 10 171570 49 64327103
Diuretic therapy 31.64 14.94 13 171567 150 64327002
Injection site swelling 31.63 14.94 38 171542 41315 64285837
Colonoscopy 31.52 14.94 30 171550 1655 64325497
Endotracheal intubation 31.45 14.94 45 171535 3850 64323302
Colitis ulcerative 31.38 14.94 11 171569 23017 64304135
Thrombectomy 31.36 14.94 15 171565 254 64326898
Catheter site dermatitis 31.34 14.94 11 171569 79 64327073
Bone disorder 30.94 14.94 4 171576 16755 64310397
Aphasia 30.85 14.94 38 171542 40868 64286284
Congestive hepatopathy 30.77 14.94 45 171535 3928 64323224
Oxygen consumption 30.76 14.94 11 171569 84 64327068
Nephropathy toxic 30.44 14.94 5 171575 17509 64309643
Diabetes mellitus 30.33 14.94 84 171496 66390 64260762
Foot deformity 30.33 14.94 4 171576 16500 64310652
Arthralgia 30.20 14.94 921 170659 441339 63885813
Gastrointestinal surgery 30.09 14.94 14 171566 222 64326930
Hypercholesterolaemia 30.06 14.94 3 171577 15370 64311782
Hypomagnesaemia 30.04 14.94 33 171547 37343 64289809
Obstructive airways disorder 30.04 14.94 12 171568 23173 64303979
Paranoia 29.96 14.94 4 171576 16348 64310804
Disorientation 29.83 14.94 65 171515 55763 64271389
Mania 29.80 14.94 4 171576 16282 64310870
Hypothermia 29.73 14.94 8 171572 19848 64307304
Pulmonary artery dilatation 29.48 14.94 16 171564 357 64326795
Delusion 29.46 14.94 6 171574 18008 64309144
Catheter site extravasation 29.44 14.94 16 171564 358 64326794
Blood triglycerides increased 29.40 14.94 7 171573 18859 64308293
Diabetes mellitus inadequate control 29.37 14.94 10 171570 21311 64305841
Arteriovenous malformation 29.36 14.94 28 171552 1548 64325604
Ventilation perfusion mismatch 29.34 14.94 15 171565 295 64326857
Haemolytic anaemia 29.24 14.94 4 171576 16049 64311103
Upper respiratory tract congestion 29.23 14.94 33 171547 2225 64324927
Tooth extraction 29.21 14.94 73 171507 9528 64317624
Colitis 29.18 14.94 71 171509 58603 64268549
Suture insertion 29.09 14.94 12 171568 140 64327012
Respiratory depression 28.99 14.94 13 171567 23430 64303722
Prescribed overdose 28.95 14.94 9 171571 20322 64306830
Tendonitis 28.84 14.94 9 171571 20273 64306879
Abdominal discomfort 28.73 14.94 661 170919 181661 64145491
Head injury 28.58 14.94 167 171413 32675 64294477
Acute coronary syndrome 28.50 14.94 8 171572 19302 64307850
Dysphagia 28.43 14.94 167 171413 106645 64220507
Cardiac septal defect 28.40 14.94 14 171566 254 64326898
Erythema multiforme 28.39 14.94 4 171576 15697 64311455
Pericardial excision 28.38 14.94 9 171571 45 64327107
Atrial septal defect 28.23 14.94 28 171552 1625 64325527
Cancer surgery 28.17 14.94 20 171560 727 64326425
Pulmonary arterial pressure decreased 28.17 14.94 11 171569 110 64327042
Limb operation 28.03 14.94 36 171544 2778 64324374
Hyperlipidaemia 28.01 14.94 13 171567 22963 64304189
Cataract operation 27.88 14.94 42 171538 3764 64323388
Prostate cancer 27.77 14.94 9 171571 19786 64307366
Pyelonephritis 27.72 14.94 6 171574 17260 64309892
Brain oedema 27.68 14.94 12 171568 22063 64305089
Oesophageal variceal ligation 27.65 14.94 11 171569 116 64327036
Hysterectomy 27.60 14.94 49 171531 5036 64322116
Cardiac index increased 27.50 14.94 8 171572 28 64327124
Skin necrosis 27.50 14.94 3 171577 14326 64312826
Mydriasis 27.45 14.94 4 171576 15308 64311844
Abdominal pain 27.22 14.94 628 170952 311747 64015405
Right-to-left cardiac shunt 27.20 14.94 12 171568 167 64326985
Ear congestion 27.12 14.94 31 171549 2119 64325033
Orthostatic hypotension 27.02 14.94 52 171528 46686 64280466
Septic shock 26.93 14.94 167 171413 105270 64221882
Chest tube insertion 26.92 14.94 11 171569 125 64327027
Haemorrhage intracranial 26.89 14.94 15 171565 23869 64303283
Premature delivery 26.88 14.94 8 171572 18581 64308571
Bronchospasm 26.85 14.94 12 171568 21670 64305482
Nervous system disorder 26.70 14.94 14 171566 23064 64304088
Aplastic anaemia 26.49 14.94 3 171577 13917 64313235
Cerebrovascular accident 26.49 14.94 236 171344 137347 64189805
Metastases to central nervous system 26.48 14.94 3 171577 13909 64313243
Eczema 26.46 14.94 24 171556 29696 64297456
Asthma 26.35 14.94 147 171433 95078 64232074
Mood swings 26.22 14.94 7 171573 17461 64309691
Sluggishness 26.22 14.94 51 171529 5619 64321533
Speech disorder 26.21 14.94 56 171524 48385 64278767
Blood culture negative 26.16 14.94 12 171568 184 64326968
Knee operation 26.15 14.94 45 171535 4512 64322640
Influenza like illness 26.11 14.94 265 171315 61437 64265715
Muscular weakness 26.05 14.94 215 171365 127123 64200029
Portopulmonary hypertension 25.95 14.94 11 171569 138 64327014
Osteoporosis 25.95 14.94 45 171535 42035 64285117
Fall 25.88 14.94 1356 170224 415470 63911682
Vasculitis 25.78 14.94 8 171572 18087 64309065
Spinal operation 25.76 14.94 53 171527 6080 64321072
Cyanosis 25.71 14.94 122 171458 22033 64305119
Gallbladder operation 25.70 14.94 27 171553 1678 64325474
Lung operation 25.70 14.94 12 171568 192 64326960
Hip fracture 25.69 14.94 141 171439 26958 64300194
Conjunctivitis 25.62 14.94 11 171569 20343 64306809
Walking disability 25.59 14.94 28 171552 1823 64325329
Leukocytosis 25.49 14.94 38 171542 37702 64289450
Platelet count increased 25.36 14.94 9 171571 18687 64308465
Mixed connective tissue disease 25.27 14.94 13 171567 259 64326893
Myocarditis 25.27 14.94 7 171573 17036 64310116
Petechiae 25.20 14.94 9 171571 18617 64308535
Thrombosis in device 25.16 14.94 47 171533 5024 64322128
Intracardiac pressure increased 25.13 14.94 7 171573 20 64327132
Medical device implantation 25.04 14.94 16 171564 487 64326665
Pulmonary thrombosis 24.99 14.94 73 171507 10445 64316707
Ear discomfort 24.99 14.94 58 171522 7222 64319930
Cardiac monitoring 24.88 14.94 7 171573 21 64327131
Tremor 24.85 14.94 263 171317 147967 64179185
Dialysis related complication 24.78 14.94 12 171568 209 64326943
Hypophagia 24.71 14.94 42 171538 39545 64287607
Retching 24.71 14.94 93 171487 15163 64311989
Haematoma 24.58 14.94 54 171526 46196 64280956
Decreased activity 24.43 14.94 57 171523 7123 64320029
Lymphadenopathy 24.41 14.94 55 171525 46631 64280521
Ammonia increased 24.41 14.94 56 171524 6921 64320231
Thrombotic microangiopathy 24.39 14.94 7 171573 16648 64310504
Infusion site discolouration 23.68 14.94 16 171564 536 64326616
Acute right ventricular failure 23.68 14.94 13 171567 297 64326855
Anhedonia 23.62 14.94 4 171576 13702 64313450
Pneumonia aspiration 23.41 14.94 80 171500 59191 64267961
Oral herpes 23.41 14.94 15 171565 22137 64305015
Hemiparesis 23.25 14.94 27 171553 29800 64297352
Restlessness 23.23 14.94 44 171536 39741 64287411
Infusion site rash 23.22 14.94 21 171559 1085 64326067
Infusion site nodule 23.02 14.94 12 171568 246 64326906
Epstein-Barr virus infection 23.01 14.94 3 171577 12485 64314667
Spinal osteoarthritis 22.99 14.94 5 171575 14336 64312816
Myocardial ischaemia 22.90 14.94 17 171563 23234 64303918
Heart transplant 22.88 14.94 22 171558 1229 64325923
Hepatitis acute 22.87 14.94 4 171576 13385 64313767
Palliative care 22.76 14.94 17 171563 669 64326483
Cor pulmonale chronic 22.76 14.94 12 171568 252 64326900
Catheter culture positive 22.70 14.94 11 171569 192 64326960
Throat irritation 22.68 14.94 157 171423 32554 64294598
Brain natriuretic peptide abnormal 22.68 14.94 17 171563 673 64326479
Arteriosclerosis 22.66 14.94 7 171573 15870 64311282
Unevaluable investigation 22.61 14.94 8 171572 59 64327093
Viral infection 22.49 14.94 169 171411 35971 64291181
Sickle cell anaemia 22.43 14.94 16 171564 586 64326566
Endoscopy 22.36 14.94 14 171566 411 64326741
Critical illness 22.34 14.94 12 171568 262 64326890
Device issue 22.26 14.94 119 171461 22529 64304623
Biopsy kidney 22.24 14.94 10 171570 146 64327006
Pulmonary artery aneurysm 22.24 14.94 10 171570 146 64327006
Injection site infection 22.03 14.94 26 171554 1839 64325313
Irritability 22.02 14.94 40 171540 36706 64290446
Myositis 22.01 14.94 8 171572 16369 64310783
Dermatitis bullous 21.96 14.94 3 171577 12051 64315101
Full blood count abnormal 21.94 14.94 145 171435 29612 64297540
Osteopenia 21.91 14.94 7 171573 15533 64311619
Arteriosclerosis coronary artery 21.89 14.94 7 171573 15522 64311630
CREST syndrome 21.86 14.94 14 171566 428 64326724
Phlebotomy 21.84 14.94 6 171574 16 64327136
Asthenia 21.83 14.94 1368 170212 426676 63900476
Aphthous ulcer 21.74 14.94 4 171576 12902 64314250
Surgery 21.73 14.94 139 171441 28074 64299078
Metastases to liver 21.71 14.94 19 171561 23922 64303230
Therapeutic response unexpected 21.70 14.94 9 171571 16992 64310160
Therapeutic procedure 21.68 14.94 17 171563 720 64326432
Localised infection 21.65 14.94 146 171434 30015 64297137
Catheter site bruise 21.55 14.94 12 171568 282 64326870
Chronic hepatic failure 21.44 14.94 18 171562 841 64326311
Nightmare 21.13 14.94 15 171565 20978 64306174
Infusion site discomfort 21.10 14.94 17 171563 749 64326403
Platelet transfusion 20.98 14.94 25 171555 1786 64325366
Cardiovascular disorder 20.94 14.94 8 171572 15873 64311279
Immune thrombocytopenia 20.87 14.94 7 171573 15059 64312093
Fear 20.85 14.94 14 171566 20157 64306995
Memory impairment 20.83 14.94 332 171248 85350 64241802
Thoracic cavity drainage 20.82 14.94 11 171569 232 64326920
Infusion site vesicles 20.81 14.94 13 171567 380 64326772
Product administration interrupted 20.79 14.94 20 171560 1118 64326034
Oesophagogastroduodenoscopy 20.76 14.94 10 171570 172 64326980
Liver ablation 20.73 14.94 5 171575 6 64327146
Purpura 20.65 14.94 10 171570 17236 64309916
Injection site rash 20.64 14.94 8 171572 15734 64311418
Drug level decreased 20.64 14.94 3 171577 11500 64315652
Faeces discoloured 20.58 14.94 128 171452 25601 64301551
Hydronephrosis 20.57 14.94 6 171574 14119 64313033
Klebsiella infection 20.56 14.94 5 171575 13276 64313876
Eosinophil count increased 20.54 14.94 6 171574 14106 64313046
Exostosis 20.48 14.94 3 171577 11435 64315717
Ventricular fibrillation 20.38 14.94 20 171560 23840 64303312
Sickle cell disease 20.29 14.94 9 171571 127 64327025
Body temperature increased 20.16 14.94 42 171538 36624 64290528
Hypophosphataemia 20.11 14.94 7 171573 14713 64312439
Catheter site induration 20.10 14.94 7 171573 49 64327103
Drug titration error 20.03 14.94 18 171562 922 64326230
Upper-airway cough syndrome 20.01 14.94 60 171520 8710 64318442
Mechanical ventilation 19.98 14.94 28 171552 2350 64324802
Circulatory collapse 19.96 14.94 37 171543 33695 64293457
Candida infection 19.92 14.94 33 171547 31386 64295766
Diet noncompliance 19.88 14.94 13 171567 412 64326740
Vena cava filter removal 19.73 14.94 4 171576 0 64327152
Immune tolerance induction 19.73 14.94 4 171576 0 64327152
Echocardiogram abnormal 19.59 14.94 24 171556 1765 64325387
Cardiac septal defect repair 19.54 14.94 5 171575 9 64327143
Activated partial thromboplastin time prolonged 19.53 14.94 5 171575 12826 64314326
Psychomotor hyperactivity 19.52 14.94 7 171573 14444 64312708
Right atrial pressure increased 19.51 14.94 11 171569 265 64326887
Haemodynamic test abnormal 19.40 14.94 7 171573 55 64327097
Biopsy lymph gland 19.34 14.94 8 171572 94 64327058
Squamous cell carcinoma of skin 19.33 14.94 4 171576 11872 64315280
Hereditary haemorrhagic telangiectasia 19.26 14.94 6 171574 28 64327124
Life support 19.23 14.94 13 171567 436 64326716
Erectile dysfunction 19.07 14.94 5 171575 12622 64314530
Adrenal insufficiency 19.03 14.94 19 171561 22468 64304684
Atrial tachycardia 18.94 14.94 34 171546 3525 64323627
Coagulopathy 18.90 14.94 35 171545 31885 64295267
Sickle cell anaemia with crisis 18.88 14.94 43 171537 5289 64321863
Cellulitis 18.83 14.94 352 171228 93305 64233847
Generalised oedema 18.77 14.94 107 171473 20746 64306406
Infusion site inflammation 18.67 14.94 10 171570 217 64326935
Gastrooesophageal reflux disease 18.67 14.94 318 171262 82825 64244327
Application site irritation 18.66 14.94 22 171558 1554 64325598
Pharyngeal oedema 18.60 14.94 9 171571 15522 64311630
Ecchymosis 18.59 14.94 7 171573 14015 64313137
Sensory disturbance 18.53 14.94 6 171574 13202 64313950
Gastrointestinal endoscopic therapy 18.48 14.94 7 171573 64 64327088
Drug therapy 18.45 14.94 6 171574 33 64327119
Vascular operation 18.42 14.94 8 171572 107 64327045
Pregnancy 18.39 14.94 17 171563 20848 64306304
Bursitis 18.36 14.94 18 171562 21467 64305685
Immunodeficiency 18.34 14.94 10 171570 16114 64311038
Device malfunction 18.26 14.94 94 171486 17539 64309613
Cerebral haemorrhage 18.18 14.94 72 171508 51018 64276134
Malignant melanoma 18.00 14.94 6 171574 12958 64314194
Balloon atrial septostomy 17.96 14.94 8 171572 114 64327038
Balance disorder 17.94 14.94 140 171440 83786 64243366
Diffuse large B-cell lymphoma 17.91 14.94 3 171577 10358 64316794
Congestive cardiomyopathy 17.87 14.94 3 171577 10341 64316811
Bronchoscopy 17.84 14.94 7 171573 71 64327081
Obesity 17.84 14.94 17 171563 20545 64306607
Cardiomegaly 17.82 14.94 116 171464 23568 64303584
Skin fissures 17.78 14.94 3 171577 10303 64316849
Cardiac discomfort 17.78 14.94 18 171562 1071 64326081
Live birth 17.77 14.94 4 171576 11200 64315952
Spontaneous intrahepatic portosystemic venous shunt 17.77 14.94 5 171575 15 64327137
Catheter site dryness 17.61 14.94 6 171574 39 64327113
Platelet count decreased 17.59 14.94 327 171253 167384 64159768
Subcutaneous drug absorption impaired 17.53 14.94 5 171575 16 64327136
Oesophagitis 17.49 14.94 19 171561 21611 64305541
Sensory loss 17.46 14.94 3 171577 10166 64316986
Cardiorenal syndrome 17.44 14.94 19 171561 1231 64325921
Coordination abnormal 17.43 14.94 9 171571 14955 64312197
Inflammation 17.42 14.94 102 171478 65198 64261954
Hepatic function abnormal 17.40 14.94 100 171480 64213 64262939
Muscle twitching 17.32 14.94 15 171565 18983 64308169
Bronchial artery embolisation 17.30 14.94 5 171575 17 64327135
Craniotomy 17.30 14.94 11 171569 332 64326820
Hypoaesthesia 17.28 14.94 263 171317 138845 64188307
Tenderness 17.25 14.94 16 171564 19586 64307566
Large intestine perforation 17.21 14.94 6 171574 12598 64314554
Protein-losing gastroenteropathy 17.05 14.94 13 171567 528 64326624
Atrial fibrillation 17.03 14.94 585 170995 170504 64156648
Dry eye 17.02 14.94 32 171548 28987 64298165
Photosensitivity reaction 17.00 14.94 14 171566 18159 64308993
Drug titration 16.97 14.94 4 171576 4 64327148
Culture negative 16.97 14.94 4 171576 4 64327148
Food poisoning 16.96 14.94 32 171548 3446 64323706
Haemorrhagic stroke 16.94 14.94 3 171577 9948 64317204
Dysentery 16.91 14.94 16 171564 876 64326276
Night sweats 16.85 14.94 45 171535 36001 64291151
Infusion site cellulitis 16.85 14.94 10 171570 266 64326886
Transcatheter aortic valve implantation 16.76 14.94 6 171574 46 64327106
Aortic valve replacement 16.72 14.94 18 171562 1151 64326001
Suture related complication 16.68 14.94 10 171570 271 64326881
White blood cell count increased 16.62 14.94 105 171475 65909 64261243
Metastases to lung 16.60 14.94 10 171570 15254 64311898
Device difficult to use 16.58 14.94 3 171577 9795 64317357
Red cell distribution width increased 16.57 14.94 6 171574 12303 64314849
Infection 16.56 14.94 370 171210 184510 64142642
Biopsy breast 16.54 14.94 8 171572 139 64327013
Tachycardia 16.52 14.94 289 171291 149290 64177862
Application site hypersensitivity 16.46 14.94 10 171570 278 64326874
Polyarthritis 16.39 14.94 3 171577 9712 64317440
Oesophageal motility disorder 16.37 14.94 12 171568 459 64326693
Hypernatraemia 16.30 14.94 6 171574 12183 64314969
Device programming error 16.29 14.94 7 171573 91 64327061
Argon plasma coagulation 16.29 14.94 5 171575 22 64327130
Odynophagia 16.21 14.94 3 171577 9638 64317514
Haematotoxicity 16.18 14.94 7 171573 12889 64314263
Mitral valve repair 16.14 14.94 9 171571 212 64326940
Brain operation 16.04 14.94 13 171567 578 64326574
Hemiplegia 15.91 14.94 7 171573 12761 64314391
Injection site haemorrhage 15.86 14.94 25 171555 24253 64302899
Anxiety 15.83 14.94 414 171166 202235 64124917
Limb injury 15.82 14.94 112 171468 23393 64303759
Nocturia 15.79 14.94 5 171575 11160 64315992
Cardiac dysfunction 15.68 14.94 29 171551 3077 64324075
Oxygen saturation increased 15.66 14.94 12 171568 491 64326661
Dialysis device insertion 15.64 14.94 6 171574 57 64327095
Abnormal weight gain 15.62 14.94 24 171556 2189 64324963
Psychiatric evaluation 15.61 14.94 5 171575 26 64327126
Portal hypertension 15.59 14.94 44 171536 6175 64320977
International normalised ratio increased 15.58 14.94 135 171445 79032 64248120
Oral pain 15.53 14.94 31 171549 27462 64299690
Product storage error 15.53 14.94 8 171572 13310 64313842
Haemolysis 15.52 14.94 5 171575 11034 64316118
Right ventricular enlargement 15.49 14.94 12 171568 499 64326653
Weight decreased 15.44 14.94 918 170662 284821 64042331
Cardiac procedure complication 15.35 14.94 10 171570 315 64326837
Nasal operation 15.30 14.94 8 171572 165 64326987
Musculoskeletal disorder 15.30 14.94 15 171565 17891 64309261
Anticoagulant therapy 15.30 14.94 5 171575 28 64327124
Intervertebral disc degeneration 15.12 14.94 8 171572 13112 64314040
Ventricular tachycardia 15.11 14.94 44 171536 34221 64292931
Bundle branch block left 15.10 14.94 4 171576 10030 64317122
Primary biliary cholangitis 15.09 14.94 16 171564 1005 64326147
Wound treatment 15.05 14.94 8 171572 171 64326981
Device maintenance issue 15.04 14.94 4 171576 9 64327143
Eye operation 15.02 14.94 21 171559 1759 64325393
Vasodilatation 15.01 14.94 28 171552 2990 64324162
Flatulence 15.00 14.94 153 171427 35513 64291639
Respiratory syncytial virus infection 14.98 14.94 48 171532 7220 64319932
Sinus headache 14.97 14.94 34 171546 4173 64322979
Duodenal ulcer 14.95 14.94 10 171570 14425 64312727

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C02KX04 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, WHERIN 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, WHERIN 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