bortezomib ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
proteasome inhibitors 391 179324-69-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • LDP-341
  • PS-341
  • bortezomib
  • velcade
  • radiciol
A pyrazine and boronic acid derivative that functions as a reversible PROTEASOME INHIBITOR. It is used as an ANTINEOPLASTIC AGENT in the treatment of MULTIPLE MYELOMA and MANTLE CELL LYMPHOMA.
  • Molecular weight: 384.24
  • Formula: C19H25BN4O4
  • CLOGP: 0.80
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 4
  • TPSA: 124.44
  • ALOGS: -3.86
  • ROTB: 9

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 3.30 mg/mL Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.08 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 10 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 19 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.17 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 18 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Nov. 14, 2019 EMA FRESENIUS KABI DEUTSCHLAND GMBH
Aug. 22, 2019 PMDA Janssen Pharmaceutical K.K.
May 13, 2003 FDA MILLENNIUM PHARMS

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
Plasma cell myeloma 6090.51 13.42 2199 61534 44447 56183887
Neuropathy peripheral 2397.94 13.42 1474 62259 101419 56126915
Thrombocytopenia 594.84 13.42 751 62982 135473 56092861
Plasma cell myeloma recurrent 572.45 13.42 185 63548 2589 56225745
Platelet count decreased 419.46 13.42 558 63175 105825 56122509
Rheumatoid arthritis 407.32 13.42 5 63728 382599 55845735
Diarrhoea 388.15 13.42 1585 62148 636922 55591412
Disease progression 377.27 13.42 527 63206 104646 56123688
Plasmacytoma 337.96 13.42 121 63612 2345 56225989
Polyneuropathy 297.58 13.42 185 63548 12865 56215469
Constipation 265.52 13.42 656 63077 201287 56027047
Pneumonia 264.16 13.42 1033 62700 406065 55822269
Neutropenia 263.29 13.42 564 63169 157603 56070731
Plasma cell leukaemia 236.36 13.42 77 63656 1106 56227228
White blood cell count decreased 219.69 13.42 458 63275 125532 56102802
Pancytopenia 192.89 13.42 354 63379 88361 56139973
Contraindicated product administered 191.39 13.42 4 63729 186282 56042052
Maternal exposure during pregnancy 183.99 13.42 7 63726 189546 56038788
Arthralgia 173.26 13.42 188 63545 501481 55726853
Drug hypersensitivity 168.82 13.42 51 63682 275154 55953180
Full blood count decreased 158.27 13.42 162 63571 23187 56205147
Headache 153.75 13.42 248 63485 558796 55669538
Sepsis 151.57 13.42 423 63310 139417 56088917
Glossodynia 150.12 13.42 5 63728 152453 56075881
Tumour lysis syndrome 145.36 13.42 98 63635 7825 56220509
Exposure during pregnancy 139.72 13.42 3 63730 136339 56091995
Pain 138.86 13.42 345 63388 662839 55565495
Anaemia 128.56 13.42 621 63112 266890 55961444
Posterior reversible encephalopathy syndrome 125.34 13.42 120 63613 15840 56212494
Amyloidosis 123.88 13.42 47 63686 1078 56227256
Drug ineffective 123.20 13.42 580 63153 918409 55309925
Therapeutic product effect decreased 120.29 13.42 23 63710 169429 56058905
Unevaluable event 120.02 13.42 203 63530 47484 56180850
Febrile neutropenia 118.00 13.42 323 63410 105222 56123112
Laboratory test abnormal 116.82 13.42 142 63591 24553 56203781
Cardiac amyloidosis 115.88 13.42 41 63692 766 56227568
Peripheral sensory neuropathy 115.70 13.42 81 63652 6875 56221459
Swelling 113.89 13.42 65 63668 239706 55988628
Deep vein thrombosis 112.67 13.42 261 63472 76716 56151618
Alopecia 111.40 13.42 101 63632 293357 55934977
Arthropathy 110.87 13.42 44 63689 200231 56028103
Dehydration 108.99 13.42 411 63322 158414 56069920
Neutrophil count decreased 103.44 13.42 195 63538 49627 56178707
Chalazion 103.27 13.42 31 63702 334 56228000
Wound 102.50 13.42 17 63716 138787 56089547
Abdominal discomfort 102.20 13.42 98 63635 277176 55951158
Primary amyloidosis 101.24 13.42 22 63711 50 56228284
Discomfort 101.11 13.42 19 63714 141742 56086592
Pericarditis 99.29 13.42 6 63727 108917 56119417
Plasma cell myeloma refractory 98.46 13.42 21 63712 42 56228292
Condition aggravated 98.39 13.42 149 63584 344749 55883585
Off label use 97.08 13.42 1008 62725 555172 55673162
Septic shock 96.51 13.42 213 63520 60622 56167712
Musculoskeletal stiffness 93.61 13.42 30 63703 155977 56072357
Joint swelling 90.81 13.42 117 63616 289683 55938651
Treatment failure 90.16 13.42 40 63693 170352 56057982
Renal failure 89.49 13.42 302 63431 110198 56118136
Cytopenia 89.49 13.42 80 63653 9675 56218659
Product use in unapproved indication 88.91 13.42 355 63378 140467 56087867
Hordeolum 82.66 13.42 46 63687 2600 56225734
Light chain analysis increased 81.54 13.42 35 63698 1114 56227220
Herpes zoster 80.59 13.42 228 63505 75661 56152673
Therapy partial responder 71.72 13.42 64 63669 7721 56220613
Overdose 71.69 13.42 16 63717 105814 56122520
Hyperviscosity syndrome 68.56 13.42 19 63714 150 56228184
Myelodysplastic syndrome 67.50 13.42 88 63645 16318 56212016
Drug interaction 67.42 13.42 83 63650 209672 56018662
Hypersensitivity 67.21 13.42 117 63616 256291 55972043
Mobility decreased 66.98 13.42 15 63718 98976 56129358
Monoclonal immunoglobulin present 66.27 13.42 27 63706 752 56227582
Thrombosis 65.50 13.42 181 63552 59246 56169088
Orthostatic hypotension 65.28 13.42 127 63606 33072 56195262
Atrial fibrillation 65.11 13.42 270 63463 108627 56119707
Helicobacter infection 63.96 13.42 5 63728 73263 56155071
Injection site pain 62.72 13.42 27 63706 117091 56111243
Protein total increased 61.95 13.42 38 63695 2577 56225757
Hepatic enzyme increased 61.44 13.42 62 63671 171322 56057012
Haemoglobin decreased 60.43 13.42 306 63427 133831 56094503
Stem cell transplant 59.12 13.42 32 63701 1712 56226622
Blister 55.35 13.42 27 63706 108860 56119474
Autonomic neuropathy 54.60 13.42 26 63707 1059 56227275
Cytomegalovirus infection reactivation 52.86 13.42 37 63696 3139 56225195
Coombs indirect test positive 52.82 13.42 12 63721 36 56228298
Pathological fracture 52.77 13.42 55 63678 8034 56220300
Fibromyalgia 52.21 13.42 4 63729 59599 56168735
Hepatitis B reactivation 51.82 13.42 33 63700 2391 56225943
Haematotoxicity 51.14 13.42 55 63678 8328 56220006
Folliculitis 50.18 13.42 3 63730 54976 56173358
Ageusia 48.47 13.42 65 63668 12386 56215948
Hypocalcaemia 48.22 13.42 103 63630 28657 56199677
Wrong technique in product usage process 48.00 13.42 5 63728 58163 56170171
Irritable bowel syndrome 47.07 13.42 10 63723 68448 56159886
Cytomegalovirus infection 47.02 13.42 81 63652 19215 56209119
Malignant neoplasm progression 45.98 13.42 185 63548 73402 56154932
Ileus paralytic 45.78 13.42 38 63695 4157 56224177
Suicide attempt 45.17 13.42 6 63727 57830 56170504
Hypercalcaemia 44.92 13.42 93 63640 25318 56203016
Bone marrow failure 44.79 13.42 99 63634 28187 56200147
Pneumonia fungal 44.63 13.42 40 63693 4853 56223481
Peripheral sensorimotor neuropathy 44.21 13.42 24 63709 1291 56227043
Bone pain 44.03 13.42 141 63592 50044 56178290
Migraine 43.39 13.42 22 63711 86775 56141559
Pyrexia 43.02 13.42 689 63044 418084 55810250
Endocarditis bacterial 40.99 13.42 18 63715 606 56227728
Morganella infection 40.23 13.42 18 63715 634 56227700
Syncope 40.04 13.42 234 63499 107965 56120369
Mesenteric abscess 39.90 13.42 11 63722 85 56228249
Cardiac failure 39.59 13.42 191 63542 81902 56146432
Inappropriate antidiuretic hormone secretion 39.25 13.42 62 63671 13694 56214640
Electrolyte imbalance 39.18 13.42 72 63661 17961 56210373
Blood pressure increased 39.14 13.42 65 63668 145111 56083223
Oedema peripheral 38.47 13.42 328 63405 170926 56057408
Plasmablastic lymphoma 38.32 13.42 14 63719 288 56228046
Peripheral motor neuropathy 37.97 13.42 23 63710 1525 56226809
Osteolysis 37.90 13.42 28 63705 2585 56225749
Large intestinal ulcer perforation 37.51 13.42 10 63723 67 56228267
Anxiety 37.50 13.42 104 63629 193068 56035266
Therapy non-responder 37.33 13.42 153 63580 61202 56167132
Body dysmorphic disorder 37.19 13.42 14 63719 314 56228020
Blood cholesterol increased 36.87 13.42 18 63715 72561 56155773
Pleural effusion 36.38 13.42 192 63541 85288 56143046
Osteoarthritis 36.34 13.42 23 63710 80273 56148061
Disturbance in social behaviour 36.25 13.42 29 63704 3012 56225322
Colitis 36.25 13.42 117 63616 41694 56186640
Blood potassium decreased 36.08 13.42 111 63622 38561 56189773
Asthenia 35.82 13.42 566 63167 342407 55885927
Hypertension 35.54 13.42 149 63584 244129 55984205
Depression 34.94 13.42 97 63636 180020 56048314
Arthritis 34.77 13.42 37 63696 99815 56128519
Nasal abscess 34.70 13.42 11 63722 144 56228190
Osteonecrosis of jaw 34.20 13.42 99 63634 33259 56195075
Death 33.99 13.42 559 63174 340867 55887467
Impaired healing 33.95 13.42 29 63704 86812 56141522
Taste disorder 33.73 13.42 48 63685 9667 56218667
Crossmatch incompatible 33.64 13.42 8 63725 31 56228303
Drug intolerance 32.93 13.42 171 63562 264647 55963687
Hip arthroplasty 32.70 13.42 3 63730 38620 56189714
Drug abuse 32.52 13.42 18 63715 67592 56160742
Gastrointestinal fungal infection 32.44 13.42 12 63721 256 56228078
Inappropriate schedule of product administration 32.41 13.42 28 63705 83359 56144975
Fatigue 32.18 13.42 1141 62592 787411 55440923
Blood pressure fluctuation 31.97 13.42 4 63729 40356 56187978
Mantle cell lymphoma 31.73 13.42 15 63718 601 56227733
Hypoaesthesia 31.24 13.42 270 63463 141221 56087113
Hypokalaemia 30.99 13.42 198 63535 94239 56134095
Loss of personal independence in daily activities 30.81 13.42 28 63705 81341 56146993
Cerebellar haemangioma 30.77 13.42 9 63724 88 56228246
Renal amyloidosis 30.67 13.42 10 63723 144 56228190
Acute lymphocytic leukaemia 30.24 13.42 25 63708 2719 56225615
Hypersensitivity myocarditis 30.22 13.42 8 63725 52 56228282
Cardiac failure congestive 30.08 13.42 186 63547 87534 56140800
Joint stiffness 29.34 13.42 3 63730 35422 56192912
Target skin lesion 29.33 13.42 9 63724 105 56228229
Acute kidney injury 29.28 13.42 408 63325 240355 55987979
Blood stem cell harvest failure 29.23 13.42 8 63725 60 56228274
Large intestine perforation 29.06 13.42 40 63693 7811 56220523
Acute myeloid leukaemia 28.69 13.42 61 63672 16911 56211423
Injury 28.69 13.42 16 63717 59835 56168499
Clostridium bacteraemia 28.45 13.42 10 63723 183 56228151
Suicidal ideation 28.31 13.42 15 63718 57727 56170607
Neurotoxicity 28.14 13.42 58 63675 15737 56212597
Guillain-Barre syndrome 28.00 13.42 27 63706 3593 56224741
Blood pressure systolic increased 28.00 13.42 6 63727 40830 56187504
Ill-defined disorder 27.90 13.42 22 63711 68521 56159813
Renal impairment 27.58 13.42 171 63562 80542 56147792
Refractory cytopenia with multilineage dysplasia 27.02 13.42 9 63724 139 56228195
Spinal cord compression 26.99 13.42 27 63706 3757 56224577
Bone lesion 26.94 13.42 32 63701 5398 56222936
Blood lactate dehydrogenase increased 26.88 13.42 67 63666 20608 56207726
Meningitis listeria 26.75 13.42 13 63720 554 56227780
Sinus polyp 26.45 13.42 11 63722 323 56228011
Pseudomonal sepsis 26.38 13.42 21 63712 2165 56226169
Adenoviral haemorrhagic cystitis 26.12 13.42 9 63724 155 56228179
Bronchiolitis 26.09 13.42 22 63711 2460 56225874
Hyperproteinaemia 26.02 13.42 8 63725 94 56228240
Wheezing 25.90 13.42 28 63705 74998 56153336
Toxic skin eruption 25.66 13.42 47 63686 11692 56216642
Heart rate increased 25.63 13.42 34 63699 83239 56145095
Anaphylactic reaction 25.21 13.42 18 63715 58977 56169357
Liver injury 25.16 13.42 8 63725 41840 56186494
Stress 25.14 13.42 18 63715 58892 56169442
Ileus 24.76 13.42 51 63682 13831 56214503
Oncologic complication 24.68 13.42 9 63724 184 56228150
Pregnancy 24.47 13.42 4 63729 33029 56195305
Nasal congestion 24.35 13.42 17 63716 56353 56171981
Graft versus host disease 24.28 13.42 34 63699 6747 56221587
Transplant 24.27 13.42 13 63720 681 56227653
Hypophosphataemia 23.99 13.42 41 63692 9661 56218673
Malaise 23.89 13.42 284 63449 367576 55860758
COVID-19 23.78 13.42 156 63577 74902 56153432
Sinusitis 23.76 13.42 129 63604 197452 56030882
Joint ankylosis 23.43 13.42 14 63719 905 56227429
Flushing 23.28 13.42 27 63706 70073 56158261
Compression fracture 22.90 13.42 31 63702 5958 56222376
Contusion 22.84 13.42 72 63661 128358 56099976
Sleep disorder 22.53 13.42 26 63707 67637 56160697
Pneumonia pneumococcal 22.38 13.42 18 63715 1884 56226450
Salmonella sepsis 22.31 13.42 9 63724 244 56228090
Intraductal proliferative breast lesion 22.31 13.42 21 63712 2712 56225622
Gait disturbance 22.28 13.42 102 63631 163219 56065115
N-terminal prohormone brain natriuretic peptide decreased 22.27 13.42 5 63728 14 56228320
Thrombotic microangiopathy 22.27 13.42 39 63694 9372 56218962
Palpitations 22.18 13.42 50 63683 99622 56128712
Failure to thrive 22.13 13.42 32 63701 6538 56221796
Neuralgia 22.09 13.42 68 63665 23627 56204707
Injection site swelling 21.84 13.42 11 63722 43567 56184767
Type 2 diabetes mellitus 21.79 13.42 13 63720 46849 56181485
Hypothyroidism 21.76 13.42 8 63725 38188 56190146
Bacteraemia 21.75 13.42 52 63681 15579 56212755
Peritonitis viral 21.58 13.42 6 63727 48 56228286
Varicella zoster virus infection 21.37 13.42 20 63713 2564 56225770
Product quality issue 21.08 13.42 5 63728 31731 56196603
Weight increased 20.99 13.42 163 63570 229540 55998794
Enterococcal sepsis 20.99 13.42 15 63718 1315 56227019
Mucosal inflammation 20.92 13.42 100 63633 42710 56185624
Blepharitis 20.81 13.42 19 63714 2361 56225973
Myalgia 20.78 13.42 78 63655 131947 56096387
Infusion related reaction 20.65 13.42 145 63588 208786 56019548
Rash 20.65 13.42 716 63017 492331 55736003
Urosepsis 20.51 13.42 53 63680 16663 56211671
Acute respiratory distress syndrome 20.51 13.42 63 63670 21863 56206471
Human chorionic gonadotropin increased 20.43 13.42 15 63718 1371 56226963
Sedation 20.36 13.42 7 63726 34847 56193487
Hypotension 20.23 13.42 397 63336 250111 55978223
Hypoalbuminaemia 20.17 13.42 40 63693 10559 56217775
Serotonin syndrome 20.09 13.42 3 63730 26487 56201847
Toxicity to various agents 19.89 13.42 361 63372 224203 56004131
Cardiotoxicity 19.81 13.42 33 63700 7617 56220717
Osteoporosis 19.60 13.42 18 63715 52034 56176300
Pulmonary embolism 19.40 13.42 196 63537 106928 56121406
Blood creatine phosphokinase increased 19.38 13.42 4 63729 27948 56200386
5q minus syndrome 19.30 13.42 8 63725 233 56228101
Rhinovirus infection 19.27 13.42 23 63710 3899 56224435
Adverse drug reaction 19.21 13.42 133 63600 64999 56163335
Spinal fracture 19.06 13.42 51 63682 16373 56211961
Tooth disorder 19.06 13.42 68 63665 25485 56202849
Mucosal erosion 18.90 13.42 14 63719 1297 56227037
Injection site bruising 18.89 13.42 10 63723 38511 56189823
VIth nerve paresis 18.89 13.42 6 63727 79 56228255
Seasonal allergy 18.73 13.42 52 63681 17056 56211278
Back pain 18.53 13.42 374 63359 236796 55991538
Pulmonary oedema 18.51 13.42 110 63623 51033 56177301
Acute myopia 18.49 13.42 6 63727 85 56228249
Plasma cells decreased 18.44 13.42 5 63728 36 56228298
Pain in extremity 18.39 13.42 232 63501 297199 55931135
Somnolence 18.39 13.42 109 63624 163304 56065030
Disease recurrence 18.23 13.42 64 63669 23796 56204538
Asthma 18.16 13.42 66 63667 112704 56115630
Full blood count increased 18.10 13.42 12 63721 931 56227403
Light chain analysis 17.87 13.42 4 63729 11 56228323
Clostridium difficile colitis 17.68 13.42 54 63679 18684 56209650
Fungal oesophagitis 17.60 13.42 10 63723 588 56227746
Sleep apnoea syndrome 17.52 13.42 4 63729 26057 56202277
Cough 17.51 13.42 199 63534 259762 55968572
Monoclonal immunoglobulin increased 17.48 13.42 6 63727 102 56228232
Paraesthesia 17.42 13.42 225 63508 130289 56098045
Lymphopenia 17.40 13.42 50 63683 16724 56211610
Foot deformity 17.39 13.42 3 63730 23822 56204512
Diarrhoea haemorrhagic 17.33 13.42 32 63701 8011 56220323
Underdose 17.32 13.42 3 63730 23754 56204580
Meningitis cryptococcal 17.27 13.42 13 63720 1234 56227100
Respiratory failure 17.25 13.42 174 63559 94888 56133446
Drug reaction with eosinophilia and systemic symptoms 17.20 13.42 74 63659 30230 56198104
Pneumonia influenzal 17.20 13.42 14 63719 1490 56226844
Hyperintensity in brain deep nuclei 17.14 13.42 4 63729 14 56228320
Therapy interrupted 17.09 13.42 4 63729 25621 56202713
Hypogammaglobulinaemia 17.01 13.42 28 63705 6398 56221936
Nocardiosis 16.92 13.42 15 63718 1793 56226541
Hypoglossal nerve paresis 16.91 13.42 6 63727 113 56228221
Inflammation 16.75 13.42 33 63700 69038 56159296
Infection reactivation 16.70 13.42 12 63721 1061 56227273
Clostridium difficile infection 16.68 13.42 68 63665 27130 56201204
Osteonecrosis 16.65 13.42 61 63672 23154 56205180
Incorrect dose administered 16.64 13.42 21 63712 52526 56175808
Myeloma cast nephropathy 16.62 13.42 6 63727 119 56228215
Pseudomyopia 16.56 13.42 5 63728 55 56228279
Spinal compression fracture 16.49 13.42 42 63691 13092 56215242
Duodenal stenosis 16.35 13.42 9 63724 498 56227836
Cardiac failure acute 16.30 13.42 33 63700 8840 56219494
Superficial spreading melanoma stage unspecified 16.17 13.42 6 63727 129 56228205
Human herpesvirus 8 infection 16.16 13.42 7 63726 228 56228106
Lower respiratory tract infection 16.07 13.42 71 63662 114723 56113611
Autoimmune retinopathy 15.83 13.42 4 63729 21 56228313
Coma 15.80 13.42 27 63706 59628 56168706
Injection site haemorrhage 15.76 13.42 3 63730 22198 56206136
Chronic graft versus host disease in skin 15.76 13.42 10 63723 720 56227614
Sensory level abnormal 15.76 13.42 6 63727 139 56228195
Hyperamylasaemia 15.72 13.42 8 63725 377 56227957
Dysarthria 15.71 13.42 13 63720 39537 56188797
Infection in an immunocompromised host 15.66 13.42 9 63724 541 56227793
Staphylococcal bacteraemia 15.59 13.42 24 63709 5185 56223149
Aggression 15.57 13.42 3 63730 22003 56206331
Performance status decreased 15.53 13.42 19 63714 3304 56225030
Drug withdrawal syndrome 15.44 13.42 5 63728 25852 56202482
Rhabdomyolysis 15.38 13.42 14 63719 40644 56187690
Myelosuppression 15.26 13.42 49 63684 17406 56210928
Joint injury 15.25 13.42 5 63728 25649 56202685
Clavicle fracture 15.20 13.42 18 63715 3027 56225307
Blood immunoglobulin A increased 15.02 13.42 8 63725 414 56227920
Pulmonary alveolar haemorrhage 14.70 13.42 21 63712 4243 56224091
Cryptococcosis 14.70 13.42 11 63722 1035 56227299
Rash pruritic 14.69 13.42 106 63627 52488 56175846
Respiratory tract infection 14.64 13.42 80 63653 35991 56192343
JC virus CSF test positive 14.61 13.42 4 63729 30 56228304
Paraproteinaemia 14.53 13.42 6 63727 173 56228161
Urticaria 14.48 13.42 100 63633 144576 56083758
Haemorrhoidal haemorrhage 14.33 13.42 20 63713 3956 56224378
Hepatitis B 14.23 13.42 19 63714 3605 56224729
Nasopharyngitis 14.16 13.42 171 63562 220788 56007546
Atelectasis 14.07 13.42 51 63682 19257 56209077
Blood magnesium decreased 13.91 13.42 37 63696 11837 56216497
Skin exfoliation 13.76 13.42 80 63653 36820 56191514
Decreased appetite 13.72 13.42 335 63398 218896 56009438
Pneumonia cytomegaloviral 13.69 13.42 14 63719 2000 56226334
Therapy cessation 13.49 13.42 7 63726 27257 56201077
Precursor B-lymphoblastic lymphoma 13.47 13.42 3 63730 8 56228326

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
Plasma cell myeloma 6273.25 13.01 2924 72306 53607 31568507
Neuropathy peripheral 2435.35 13.01 1752 73478 73897 31548217
Plasma cell myeloma recurrent 582.21 13.01 250 74980 3674 31618440
Polyneuropathy 518.91 13.01 345 74885 12677 31609437
Thrombocytopenia 447.22 13.01 1021 74209 141726 31480388
Platelet count decreased 390.99 13.01 830 74400 109605 31512509
Plasmacytoma 330.19 13.01 161 75069 3216 31618898
Disease progression 306.27 13.01 668 74562 89796 31532318
Drug interaction 275.85 13.01 77 75153 208466 31413648
Pneumonia 272.86 13.01 1535 73695 333777 31288337
Unevaluable event 223.35 13.01 317 74913 30258 31591856
Completed suicide 201.66 13.01 3 75227 91511 31530603
Drug abuse 192.84 13.01 3 75227 87755 31534359
Plasma cell leukaemia 179.60 13.01 72 75158 879 31621235
Tumour lysis syndrome 165.02 13.01 193 75037 15192 31606922
Orthostatic hypotension 161.46 13.01 240 74990 23879 31598235
Herpes zoster 138.65 13.01 262 74968 31731 31590383
Plasma cell myeloma refractory 133.79 13.01 36 75194 101 31622013
White blood cell count decreased 128.96 13.01 478 74752 86920 31535194
Amyloidosis 123.70 13.01 73 75157 2163 31619951
Diarrhoea 123.05 13.01 1326 73904 351083 31271031
Overdose 121.98 13.01 26 75204 84638 31537476
Constipation 120.92 13.01 598 74632 123393 31498721
Peripheral sensory neuropathy 118.36 13.01 107 75123 6208 31615906
Autonomic neuropathy 111.26 13.01 50 75180 823 31621291
Fatigue 109.48 13.01 1245 73985 333961 31288153
Product use issue 104.25 13.01 334 74896 56425 31565689
Deep vein thrombosis 104.02 13.01 349 74881 60387 31561727
Primary amyloidosis 96.06 13.01 29 75201 137 31621977
Neutropenia 93.25 13.01 611 74619 139753 31482361
Headache 91.89 13.01 186 75044 183466 31438648
Hypercalcaemia 91.80 13.01 138 75092 13862 31608252
Rhabdomyolysis 90.60 13.01 20 75210 63561 31558553
Light chain analysis increased 86.54 13.01 47 75183 1183 31620931
Pancytopenia 84.94 13.01 421 74809 86895 31535219
Psoriasis 84.62 13.01 7 75223 46712 31575402
Rash 83.42 13.01 786 74444 200700 31421414
Ileus paralytic 82.94 13.01 82 75148 5326 31616788
Osteonecrosis of jaw 79.20 13.01 144 75086 16927 31605187
Full blood count decreased 78.62 13.01 141 75089 16399 31605715
Thrombosis 74.25 13.01 256 74974 44895 31577219
Therapy partial responder 73.16 13.01 84 75146 6478 31615636
Product use in unapproved indication 72.82 13.01 443 74787 98728 31523386
Myelodysplastic syndrome 71.71 13.01 148 75082 19103 31603011
Off label use 70.69 13.01 1186 74044 346088 31276026
Cystitis haemorrhagic 69.86 13.01 74 75156 5215 31616899
Blood creatine phosphokinase increased 69.04 13.01 9 75221 41965 31580149
Arthralgia 67.77 13.01 163 75067 151261 31470853
Cytopenia 67.21 13.01 105 75125 10905 31611209
Inappropriate schedule of product administration 66.58 13.01 19 75211 50804 31571310
Hypertension 62.94 13.01 131 75099 127969 31494145
Depression 62.56 13.01 74 75156 90741 31531373
B precursor type acute leukaemia 61.01 13.01 23 75207 235 31621879
Condition aggravated 59.03 13.01 196 75034 163813 31458301
Abdominal pain 56.32 13.01 169 75061 145783 31476331
Chalazion 55.64 13.01 18 75212 111 31622003
Adverse drug reaction 54.39 13.01 157 75073 25044 31597070
Spinal compression fracture 52.65 13.01 71 75159 6451 31615663
Blood pressure increased 52.62 13.01 67 75163 79566 31542548
Aggression 52.57 13.01 12 75218 37279 31584835
Seizure 52.46 13.01 98 75132 99670 31522444
Neuralgia 52.40 13.01 98 75132 11768 31610346
Anxiety 51.88 13.01 85 75145 90948 31531166
Drug hypersensitivity 51.24 13.01 58 75172 72541 31549573
Infection 50.92 13.01 351 74879 81580 31540534
Hypoaesthesia 50.84 13.01 265 74965 55757 31566357
Cardiac amyloidosis 50.61 13.01 31 75199 984 31621130
Pyrexia 50.59 13.01 1006 74224 302834 31319280
Protein total increased 49.13 13.01 41 75189 2134 31619980
Suicidal ideation 48.82 13.01 13 75217 36393 31585721
Atrial fibrillation 47.52 13.01 445 74785 113338 31508776
Sepsis 45.18 13.01 555 74675 151374 31470740
Spinal cord compression 44.91 13.01 50 75180 3727 31618387
Wrong technique in product usage process 44.53 13.01 12 75218 33331 31588783
Laboratory test abnormal 44.31 13.01 121 75109 18693 31603421
Asthma 44.11 13.01 23 75207 42588 31579526
Hypoglycaemia 43.83 13.01 34 75196 50912 31571202
Compression fracture 43.22 13.01 43 75187 2814 31619300
Stem cell transplant 42.97 13.01 37 75193 2011 31620103
Therapy non-responder 40.97 13.01 174 75056 33637 31588477
BK virus infection 40.42 13.01 55 75175 5040 31617074
Peripheral sensorimotor neuropathy 40.25 13.01 31 75199 1437 31620677
Haematochezia 40.20 13.01 23 75207 40441 31581673
Bradycardia 40.17 13.01 64 75166 69263 31552851
Ageusia 39.88 13.01 76 75154 9255 31612859
Paraesthesia 39.54 13.01 248 74982 55823 31566291
Stress 39.48 13.01 6 75224 24935 31597179
Hyperviscosity syndrome 39.21 13.01 16 75214 205 31621909
Septic shock 38.50 13.01 279 74951 65879 31556235
Metapneumovirus infection 38.30 13.01 22 75208 619 31621495
Guillain-Barre syndrome 36.80 13.01 54 75176 5306 31616808
Rash pruritic 36.13 13.01 132 75098 23806 31598308
Monoclonal immunoglobulin present 35.39 13.01 24 75206 910 31621204
Pathological fracture 35.35 13.01 46 75184 4036 31618078
Neutrophil count decreased 35.11 13.01 209 75021 46185 31575929
Hypogammaglobulinaemia 34.74 13.01 59 75171 6568 31615546
Agitation 34.31 13.01 47 75183 54122 31567992
Oroantral fistula 33.20 13.01 14 75216 196 31621918
Intentional product misuse 33.06 13.01 25 75205 37926 31584188
Hallucination 32.82 13.01 37 75193 46373 31575741
Bone pain 32.03 13.01 110 75120 19241 31602873
Flushing 31.57 13.01 16 75214 30112 31592002
Bone disorder 31.56 13.01 53 75177 5846 31616268
Asthenia 31.45 13.01 726 74504 224029 31398085
Hyperkalaemia 31.41 13.01 66 75164 64285 31557829
Malaise 31.23 13.01 253 74977 168258 31453856
Progressive multifocal leukoencephalopathy 31.03 13.01 68 75162 9145 31612969
Squamous cell carcinoma of skin 30.82 13.01 72 75158 10102 31612012
Angioedema 30.78 13.01 21 75209 33597 31588517
Contraindicated product administered 30.74 13.01 5 75225 19767 31602347
Hiccups 30.66 13.01 68 75162 9219 31612895
H1N1 influenza 30.65 13.01 22 75208 915 31621199
Electrocardiogram QT prolonged 30.63 13.01 27 75203 37960 31584154
Colitis ulcerative 30.40 13.01 4 75226 18525 31603589
Erythema 30.33 13.01 94 75136 80311 31541803
Dehydration 30.30 13.01 423 74807 118688 31503426
Adenocarcinoma of colon 30.04 13.01 38 75192 3242 31618872
Hordeolum 29.45 13.01 21 75209 864 31621250
Renal failure 29.39 13.01 433 74797 122897 31499217
Drug-induced liver injury 28.58 13.01 11 75219 24352 31597762
Osteonecrosis 28.52 13.01 85 75145 13799 31608315
Ileus 28.48 13.01 90 75140 15079 31607035
Parainfluenzae virus infection 28.40 13.01 32 75198 2417 31619697
Pulmonary embolism 28.13 13.01 307 74923 81339 31540775
Incorrect dose administered 28.12 13.01 26 75204 35726 31586388
Somnolence 27.97 13.01 131 75099 99314 31522800
Myocardial infarction 27.66 13.01 157 75073 113297 31508817
Peripheral motor neuropathy 27.65 13.01 27 75203 1727 31620387
Bacterial infection 27.17 13.01 83 75147 13656 31608458
Bone marrow failure 27.15 13.01 135 75095 27873 31594241
Hyperhidrosis 26.70 13.01 77 75153 67316 31554798
Lactic acidosis 26.60 13.01 22 75208 31915 31590199
Metabolic acidosis 26.44 13.01 33 75197 39544 31582570
Osteolysis 26.42 13.01 30 75200 2285 31619829
Injection site pain 26.29 13.01 26 75204 34608 31587506
Blood stem cell harvest failure 26.18 13.01 7 75223 19 31622095
Respirovirus test positive 26.03 13.01 9 75221 70 31622044
Gastrointestinal amyloidosis 25.92 13.01 7 75223 20 31622094
Renal amyloidosis 25.92 13.01 9 75221 71 31622043
Visceral leishmaniasis 25.65 13.01 16 75214 525 31621589
Drug level increased 25.60 13.01 8 75222 20178 31601936
Bacteraemia 25.57 13.01 96 75134 17538 31604576
Blood pressure fluctuation 25.48 13.01 11 75219 22725 31599389
Mobility decreased 25.36 13.01 17 75213 27452 31594662
Tooth deposit 25.28 13.01 9 75221 77 31622037
Anaphylactic reaction 25.06 13.01 20 75210 29533 31592581
VIth nerve paralysis 25.00 13.01 18 75212 752 31621362
Diverticular perforation 24.82 13.01 34 75196 3135 31618979
Meningitis pneumococcal 24.10 13.01 11 75219 188 31621926
Performance status decreased 23.69 13.01 37 75193 3841 31618273
Acute lymphocytic leukaemia 23.61 13.01 35 75195 3471 31618643
Pallor 23.36 13.01 12 75218 22412 31599702
Bone lesion 23.33 13.01 31 75199 2776 31619338
Musculoskeletal stiffness 23.14 13.01 39 75191 41286 31580828
Abnormal behaviour 23.02 13.01 14 75216 23814 31598300
Wheezing 23.01 13.01 31 75199 35955 31586159
Phrenic nerve paralysis 22.89 13.01 9 75221 104 31622010
Autologous haematopoietic stem cell transplant 22.79 13.01 6 75224 15 31622099
Spinal fracture 22.25 13.01 50 75180 6838 31615276
Dysarthria 22.12 13.01 26 75204 31991 31590123
Hepatitis B reactivation 22.10 13.01 34 75196 3484 31618630
Demyelinating polyneuropathy 21.99 13.01 20 75210 1169 31620945
Cytomegalovirus infection 21.80 13.01 116 75114 24591 31597523
Palmar-plantar erythrodysaesthesia syndrome 21.78 13.01 5 75225 15478 31606636
Tachycardia 21.65 13.01 100 75130 76107 31546007
Chronic inflammatory demyelinating polyradiculoneuropathy 21.62 13.01 16 75214 698 31621416
JC virus infection 21.35 13.01 25 75205 1969 31620145
Product prescribing error 21.23 13.01 10 75220 19632 31602482
Anaphylactic shock 21.07 13.01 4 75226 14141 31607973
Coronary artery disease 21.06 13.01 49 75181 46038 31576076
Myalgia 21.00 13.01 103 75127 77155 31544959
Haemoglobin decreased 20.67 13.01 379 74851 112296 31509818
Disturbance in attention 20.58 13.01 14 75216 22436 31599678
Brief psychotic disorder with marked stressors 20.40 13.01 10 75220 202 31621912
Accidental overdose 20.37 13.01 9 75221 18341 31603773
Blood immunoglobulin M increased 20.09 13.01 10 75220 209 31621905
Ascites 20.06 13.01 42 75188 40971 31581143
Gastric ulcer 20.05 13.01 5 75225 14629 31607485
Cerebrovascular accident 19.90 13.01 109 75121 79375 31542739
Respiratory depression 19.80 13.01 5 75225 14505 31607609
Neurogenic bladder 19.79 13.01 22 75208 1637 31620477
Conjunctival irritation 19.71 13.01 8 75222 101 31622013
Acute febrile neutrophilic dermatosis 19.54 13.01 19 75211 1209 31620905
Acute myeloid leukaemia 19.53 13.01 92 75138 18580 31603534
Loss of personal independence in daily activities 19.51 13.01 23 75207 28265 31593849
Emotional distress 19.48 13.01 5 75225 14351 31607763
Rectal adenocarcinoma 19.47 13.01 16 75214 815 31621299
Blood pressure systolic increased 19.43 13.01 11 75219 19459 31602655
Febrile neutropenia 19.35 13.01 401 74829 121448 31500666
Synovitis 19.34 13.01 3 75227 12280 31609834
Basal cell carcinoma 19.33 13.01 90 75140 18089 31604025
Depressed level of consciousness 19.33 13.01 39 75191 38562 31583552
Monoclonal gammopathy 19.33 13.01 11 75219 304 31621810
Blood immunoglobulin A increased 19.23 13.01 11 75219 307 31621807
Infusion related reaction 19.06 13.01 186 75044 47869 31574245
Polyomavirus-associated nephropathy 19.01 13.01 32 75198 3536 31618578
End stage renal disease 18.94 13.01 52 75178 8057 31614057
Rib fracture 18.90 13.01 72 75158 13244 31608870
Hallucination, visual 18.75 13.01 7 75223 15787 31606327
Cardiac arrest 18.72 13.01 129 75101 88933 31533181
Respiratory arrest 18.49 13.01 21 75209 26236 31595878
Jaundice 18.46 13.01 27 75203 30260 31591854
Enterococcal infection 18.45 13.01 54 75176 8677 31613437
Blood immunoglobulin G increased 18.40 13.01 16 75214 881 31621233
Clostridium difficile colitis 18.33 13.01 74 75156 13982 31608132
Haematuria 18.28 13.01 53 75177 46261 31575853
Neuromyotonia 18.28 13.01 6 75224 39 31622075
Anaemia 18.20 13.01 648 74582 212874 31409240
Blood calcium increased 18.11 13.01 30 75200 3272 31618842
Obstructive airways disorder 17.99 13.01 4 75226 12660 31609454
Dyskinesia 17.92 13.01 14 75216 20896 31601218
Sopor 17.78 13.01 3 75227 11549 31610565
Heart rate increased 17.76 13.01 45 75185 41065 31581049
Accidental exposure to product 17.66 13.01 3 75227 11492 31610622
Depressed mood 17.44 13.01 10 75220 17565 31604549
Medication error 17.39 13.01 17 75213 22755 31599359
Vomiting 17.37 13.01 402 74828 223571 31398543
Alanine aminotransferase increased 17.28 13.01 105 75125 74551 31547563
Respiratory tract infection 17.27 13.01 85 75145 17476 31604638
Melaena 17.21 13.01 32 75198 32622 31589492
Gastrooesophageal reflux disease 17.15 13.01 34 75196 33837 31588277
Hyperlipidaemia 17.08 13.01 5 75225 13155 31608959
Coma 17.05 13.01 46 75184 41104 31581010
Nephrolithiasis 17.03 13.01 24 75206 27315 31594799
Blepharitis 16.86 13.01 17 75213 1130 31620984
Type 2 diabetes mellitus 16.81 13.01 7 75223 14777 31607337
Cytomegalovirus infection reactivation 16.79 13.01 32 75198 3897 31618217
Pleuritic pain 16.65 13.01 28 75202 3092 31619022
Aphasia 16.27 13.01 14 75216 19917 31602197
Diabetic ketoacidosis 16.24 13.01 10 75220 16895 31605219
Product quality issue 16.22 13.01 9 75221 16102 31606012
Extrapyramidal disorder 16.18 13.01 4 75226 11774 31610340
Laryngeal cancer metastatic 16.12 13.01 6 75224 59 31622055
Haemorrhagic fever 16.01 13.01 5 75225 27 31622087
Pain 15.97 13.01 330 74900 186429 31435685
Hypersensitivity 15.92 13.01 73 75157 55670 31566444
Injury 15.90 13.01 14 75216 19695 31602419
Full blood count increased 15.86 13.01 14 75216 787 31621327
Autonomic nervous system imbalance 15.72 13.01 24 75206 2443 31619671
Fat tissue increased 15.71 13.01 10 75220 340 31621774
Spinal column injury 15.64 13.01 12 75218 553 31621561
Cholestasis 15.63 13.01 22 75208 25053 31597061
Blood lactate dehydrogenase increased 15.62 13.01 92 75138 20247 31601867
Hypocalcaemic seizure 15.57 13.01 5 75225 30 31622084
Genital erythema 15.50 13.01 8 75222 181 31621933
Escherichia sepsis 15.47 13.01 32 75198 4135 31617979
Glycosylated haemoglobin increased 15.36 13.01 3 75227 10397 31611717
Eosinophilic pneumonia chronic 15.33 13.01 9 75221 264 31621850
Bacterial parotitis 15.30 13.01 5 75225 32 31622082
Neutropenic sepsis 15.22 13.01 64 75166 12315 31609799
Oesophageal adenocarcinoma 15.21 13.01 14 75216 831 31621283
Chest discomfort 15.10 13.01 63 75167 49306 31572808
Hepatic steatosis 15.06 13.01 10 75220 16229 31605885
Dystonia 15.00 13.01 3 75227 10222 31611892
Haematotoxicity 14.95 13.01 44 75186 7093 31615021
Light chain analysis decreased 14.92 13.01 5 75225 35 31622079
Inflammation 14.90 13.01 23 75207 25218 31596896
HCoV-OC43 infection 14.79 13.01 5 75225 36 31622078
Adenovirus infection 14.79 13.01 34 75196 4720 31617394
Morganella infection 14.68 13.01 11 75219 489 31621625
Refractory cytopenia with multilineage dysplasia 14.62 13.01 7 75223 134 31621980
Plasmablastic lymphoma 14.54 13.01 9 75221 291 31621823
Peripheral swelling 14.50 13.01 234 74996 67631 31554483
Ventricular fibrillation 14.48 13.01 14 75216 18834 31603280
Bacterial sepsis 14.44 13.01 34 75196 4794 31617320
Blood culture positive 14.43 13.01 33 75197 4565 31617549
Body height decreased 14.29 13.01 28 75202 3479 31618635
Drug ineffective 14.25 13.01 781 74449 394792 31227322
Blood triglycerides increased 14.21 13.01 7 75223 13390 31608724
Hepatitis 14.11 13.01 19 75211 22047 31600067
Cellulitis orbital 14.06 13.01 9 75221 309 31621805
Bladder sphincter atony 13.99 13.01 4 75226 15 31622099
Refractory anaemia with an excess of blasts 13.95 13.01 10 75220 415 31621699
Agranulocytosis 13.89 13.01 18 75212 21229 31600885
Pregnancy of partner 13.88 13.01 9 75221 316 31621798
Mantle cell lymphoma 13.86 13.01 19 75211 1753 31620361
Colitis 13.84 13.01 132 75098 33755 31588359
VIth nerve paresis 13.82 13.01 5 75225 45 31622069
Therapy interrupted 13.80 13.01 4 75226 10592 31611522
Hepatotoxicity 13.79 13.01 15 75215 19111 31603003
Serratia sepsis 13.78 13.01 4 75226 16 31622098
Chest pain 13.77 13.01 195 75035 116762 31505352
International normalised ratio increased 13.65 13.01 58 75172 45165 31576949
Blood glucose increased 13.57 13.01 87 75143 60996 31561118
Hepatitis B 13.43 13.01 37 75193 5744 31616370
Speech disorder 13.40 13.01 23 75207 24178 31597936
Pleural effusion 13.37 13.01 251 74979 74669 31547445
Muscle spasms 13.29 13.01 232 74998 68086 31554028
Iron deficiency anaemia 13.21 13.01 3 75227 9356 31612758
Dyspnoea 13.14 13.01 674 74556 342805 31279309
Blastic plasmacytoid dendritic cell neoplasia 13.12 13.01 6 75224 103 31622011
Restlessness 13.12 13.01 22 75208 23339 31598775
Hypercapnic coma 13.11 13.01 7 75223 170 31621944
Acute myocardial infarction 13.10 13.01 69 75161 50754 31571360
Myositis 13.03 13.01 5 75225 11089 31611025

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
Plasma cell myeloma 11018.79 11.89 4178 107343 69023 70747900
Neuropathy peripheral 3283.77 11.89 2194 109327 124702 70692221
Plasma cell myeloma recurrent 1162.49 11.89 382 111139 3964 70812959
Thrombocytopenia 1070.93 11.89 1580 109941 237530 70579393
Polyneuropathy 761.53 11.89 454 111067 20961 70795962
Platelet count decreased 746.04 11.89 1142 110379 177080 70639843
Disease progression 658.42 11.89 1006 110515 155666 70661257
Plasmacytoma 615.73 11.89 234 111287 3820 70813103
Pneumonia 615.34 11.89 2193 109328 594039 70222884
Rheumatoid arthritis 441.65 11.89 3 111518 291802 70525121
Plasma cell leukaemia 388.40 11.89 136 111385 1735 70815188
Completed suicide 331.34 11.89 5 111516 227130 70589793
Neutropenia 327.09 11.89 1017 110504 256139 70560784
Unevaluable event 326.48 11.89 406 111115 51657 70765266
Tumour lysis syndrome 293.71 11.89 254 111267 21106 70795817
Arthralgia 272.51 11.89 235 111286 503155 70313768
Headache 269.51 11.89 310 111211 580095 70236828
Diarrhoea 263.23 11.89 2114 109407 781227 70035696
Amyloidosis 262.24 11.89 114 111407 2665 70814258
Pancytopenia 246.59 11.89 654 110867 150453 70666470
Drug interaction 244.17 11.89 149 111372 381292 70435631
Plasma cell myeloma refractory 241.85 11.89 58 111463 153 70816770
Peripheral sensory neuropathy 241.26 11.89 179 111342 11931 70804992
White blood cell count decreased 238.80 11.89 697 110824 169444 70647479
Drug hypersensitivity 235.60 11.89 61 111460 262398 70554525
Off label use 228.39 11.89 1966 109555 741094 70075829
Product use in unapproved indication 226.22 11.89 779 110742 206699 70610224
Sepsis 215.39 11.89 857 110664 243688 70573235
Orthostatic hypotension 213.72 11.89 330 111191 51413 70765510
Primary amyloidosis 205.66 11.89 51 111470 162 70816761
Constipation 194.37 11.89 849 110672 251589 70565334
Deep vein thrombosis 191.73 11.89 491 111030 110551 70706372
Synovitis 187.72 11.89 3 111518 129225 70687698
Herpes zoster 176.14 11.89 404 111117 84831 70732092
Contraindicated product administered 174.42 11.89 9 111512 134603 70682320
Pain 163.01 11.89 480 111041 628336 70188587
Drug abuse 162.75 11.89 20 111501 147236 70669687
Septic shock 160.38 11.89 463 111058 111795 70705128
Myelodysplastic syndrome 158.11 11.89 214 111307 29571 70787352
Overdose 157.02 11.89 37 111484 169708 70647215
Autonomic neuropathy 156.66 11.89 69 111452 1666 70815257
Cytopenia 155.96 11.89 163 111358 17160 70799763
Maternal exposure during pregnancy 155.04 11.89 6 111515 115339 70701584
Febrile neutropenia 149.49 11.89 677 110844 203641 70613282
Cardiac amyloidosis 146.24 11.89 64 111457 1521 70815402
Systemic lupus erythematosus 145.40 11.89 3 111518 101899 70715024
Alopecia 142.27 11.89 67 111454 198423 70618500
Arthropathy 140.19 11.89 32 111489 150025 70666898
Light chain analysis increased 137.37 11.89 60 111461 1419 70815504
Chalazion 136.93 11.89 44 111477 422 70816501
Ileus paralytic 136.53 11.89 112 111409 8649 70808274
Psoriasis 136.25 11.89 4 111517 98429 70718494
Joint swelling 134.56 11.89 120 111401 253091 70563832
Atrial fibrillation 129.76 11.89 604 110917 183744 70633179
Neutrophil count decreased 128.50 11.89 354 111167 83202 70733721
Therapy partial responder 128.04 11.89 126 111395 12348 70804575
Anaemia 127.83 11.89 1076 110445 402347 70414576
Condition aggravated 126.09 11.89 306 111215 427329 70389594
Dehydration 125.53 11.89 693 110828 225449 70591474
Therapeutic product effect decreased 121.26 11.89 37 111484 142981 70673942
Exposure during pregnancy 119.84 11.89 4 111517 87713 70729210
Musculoskeletal stiffness 118.65 11.89 42 111479 147718 70669205
Hypersensitivity 118.43 11.89 112 111409 229700 70587223
Glossodynia 117.96 11.89 4 111517 86483 70730440
Full blood count decreased 116.68 11.89 165 111356 23753 70793170
Pyrexia 111.16 11.89 1448 110073 605504 70211419
Hypercalcaemia 110.59 11.89 196 111325 34189 70782734
Anxiety 110.49 11.89 110 111411 220220 70596703
Swelling 109.27 11.89 82 111439 188457 70628466
Blood pressure increased 105.44 11.89 85 111436 188432 70628491
Renal failure 101.30 11.89 574 110947 188496 70628427
Abdominal discomfort 101.09 11.89 113 111408 214545 70602378
Suicide attempt 100.86 11.89 6 111515 79504 70737419
Product use issue 99.53 11.89 551 110970 179386 70637537
Posterior reversible encephalopathy syndrome 97.06 11.89 153 111368 24249 70792674
Wound 96.41 11.89 19 111502 98713 70718210
Malignant neoplasm progression 93.94 11.89 410 111111 121329 70695594
Discomfort 93.57 11.89 25 111496 105411 70711512
Mobility decreased 90.32 11.89 25 111496 102974 70713949
Injection site pain 88.50 11.89 37 111484 117582 70699341
Stem cell transplant 85.20 11.89 59 111462 3526 70813397
Peripheral sensorimotor neuropathy 84.66 11.89 53 111468 2669 70814254
Depression 82.93 11.89 115 111406 198859 70618064
Weight increased 82.41 11.89 160 111361 242171 70574752
Cytomegalovirus infection 80.49 11.89 187 111334 39571 70777352
Thrombosis 80.16 11.89 281 111240 75124 70741799
Hyperviscosity syndrome 79.06 11.89 28 111493 370 70816553
Rhabdomyolysis 78.97 11.89 26 111495 95734 70721189
Malaise 78.42 11.89 382 111139 432550 70384373
Hepatitis B reactivation 78.33 11.89 66 111455 5289 70811634
Hypertension 75.71 11.89 227 111294 295806 70521117
Pathological fracture 75.43 11.89 84 111437 9499 70807424
Osteonecrosis of jaw 74.56 11.89 185 111336 40817 70776106
Bone marrow failure 72.71 11.89 205 111316 48805 70768118
Wrong technique in product usage process 71.93 11.89 11 111510 68687 70748236
Monoclonal immunoglobulin present 71.90 11.89 33 111488 880 70816043
Peripheral motor neuropathy 70.82 11.89 50 111471 3082 70813841
Blood pressure fluctuation 70.39 11.89 6 111515 59006 70757917
Cystitis haemorrhagic 68.80 11.89 76 111445 8517 70808406
Inappropriate schedule of product administration 68.68 11.89 42 111479 107513 70709410
Cytomegalovirus infection reactivation 68.67 11.89 68 111453 6713 70810210
Stress 68.66 11.89 12 111509 67954 70748969
Spinal cord compression 68.64 11.89 64 111457 5864 70811059
Pleural effusion 68.26 11.89 399 111122 132465 70684458
Helicobacter infection 68.23 11.89 5 111516 55651 70761272
B precursor type acute leukaemia 66.84 11.89 26 111495 453 70816470
Blood stem cell harvest failure 65.63 11.89 18 111503 93 70816830
Haemoglobin decreased 64.68 11.89 547 110974 204612 70612311
Treatment failure 64.48 11.89 79 111442 144063 70672860
Duodenal ulcer perforation 64.39 11.89 4 111517 51108 70765815
Blood cholesterol increased 63.98 11.89 12 111509 64592 70752331
Cardiac failure 63.03 11.89 414 111107 143127 70673796
Protein total increased 62.95 11.89 49 111472 3508 70813415
Arthritis 62.93 11.89 38 111483 97942 70718981
Colitis 62.88 11.89 232 111289 63582 70753341
Pulmonary embolism 62.74 11.89 440 111081 155427 70661496
Fibromyalgia 62.63 11.89 3 111518 47871 70769052
Nasopharyngitis 61.50 11.89 164 111357 222042 70594881
Blood creatine phosphokinase increased 61.49 11.89 11 111510 61252 70755671
Guillain-Barre syndrome 60.76 11.89 69 111452 7971 70808952
Hordeolum 60.16 11.89 42 111479 2543 70814380
Therapy non-responder 59.27 11.89 259 111262 76656 70740267
Blister 59.14 11.89 43 111478 100483 70716440
Osteolysis 59.09 11.89 47 111474 3472 70813451
Coombs indirect test positive 58.83 11.89 15 111506 55 70816868
Ileus 58.10 11.89 122 111399 24115 70792808
Hepatic enzyme increased 57.49 11.89 99 111422 156891 70660032
Migraine 57.17 11.89 21 111500 72217 70744706
Flushing 56.92 11.89 29 111492 82143 70734780
Hypogammaglobulinaemia 56.87 11.89 80 111441 11458 70805465
Blood lactate dehydrogenase increased 56.14 11.89 151 111370 34976 70781947
Haematotoxicity 56.13 11.89 87 111434 13587 70803336
Irritable bowel syndrome 55.93 11.89 7 111514 50843 70766080
Acute myeloid leukaemia 55.62 11.89 139 111382 30801 70786122
Morganella infection 54.45 11.89 29 111492 1073 70815850
Wheezing 51.95 11.89 43 111478 94127 70722796
Injury 51.58 11.89 19 111502 65226 70751697
Plasmablastic lymphoma 51.48 11.89 23 111498 575 70816348
Acute lymphocytic leukaemia 51.38 11.89 53 111468 5492 70811431
Asthma 51.13 11.89 69 111452 120724 70696199
Bacteraemia 49.90 11.89 129 111392 29180 70787743
Suicidal ideation 49.05 11.89 24 111497 69572 70747351
Pericarditis 48.83 11.89 37 111484 84668 70732255
Red blood cell sedimentation rate increased 48.75 11.89 3 111518 38639 70778284
Metapneumovirus infection 48.29 11.89 30 111491 1490 70815433
Gastrooesophageal reflux disease 48.25 11.89 43 111478 90796 70726127
Anaphylactic reaction 48.25 11.89 29 111492 74945 70741978
Sedation 47.75 11.89 8 111513 46723 70770200
Compression fracture 47.70 11.89 53 111468 5978 70810945
Renal amyloidosis 47.43 11.89 15 111506 136 70816787
Osteoarthritis 47.27 11.89 29 111492 74118 70742805
Pruritus 47.01 11.89 334 111187 345226 70471697
Bone pain 46.94 11.89 181 111340 50641 70766282
Ill-defined disorder 46.67 11.89 14 111507 54727 70762196
Hypocalcaemia 46.66 11.89 166 111355 44693 70772230
Blood pressure systolic increased 46.41 11.89 16 111505 57243 70759680
Squamous cell carcinoma of skin 45.51 11.89 76 111445 12636 70804287
Loss of personal independence in daily activities 45.33 11.89 40 111481 84870 70732053
Somnolence 45.17 11.89 180 111341 215426 70601497
Myalgia 44.14 11.89 127 111394 167765 70649158
Erythema 43.47 11.89 164 111357 199399 70617524
Pneumonia fungal 43.22 11.89 65 111456 9888 70807035
Heart rate increased 42.57 11.89 63 111458 106085 70710838
Sleep disorder 42.26 11.89 29 111492 69843 70747080
Syncope 42.16 11.89 422 111099 165287 70651636
Aggression 42.01 11.89 12 111509 48434 70768489
Folliculitis 41.96 11.89 8 111513 42562 70774361
Neuralgia 41.79 11.89 119 111402 28484 70788439
Drug intolerance 41.44 11.89 198 111323 225489 70591434
Nasal congestion 41.43 11.89 26 111495 65646 70751277
Asthenia 41.35 11.89 976 110545 456690 70360233
Inflammation 40.87 11.89 38 111483 78627 70738296
Contusion 40.55 11.89 88 111433 127948 70688975
BK virus infection 40.28 11.89 56 111465 7933 70808990
Crossmatch incompatible 39.81 11.89 10 111511 34 70816889
Large intestine perforation 39.60 11.89 73 111448 13122 70803801
Spinal compression fracture 39.29 11.89 80 111441 15473 70801450
Performance status decreased 38.86 11.89 46 111475 5555 70811368
Refractory cytopenia with multilineage dysplasia 38.79 11.89 15 111506 257 70816666
Drug ineffective 38.57 11.89 1155 110366 938597 69878326
Thrombotic microangiopathy 38.39 11.89 86 111435 17762 70799161
Hyperhidrosis 38.01 11.89 95 111426 131491 70685432
Respiratory failure 37.89 11.89 419 111102 168316 70648607
Sopor 37.78 11.89 3 111518 31264 70785659
Mantle cell lymphoma 37.62 11.89 27 111494 1708 70815215
Urticaria 37.48 11.89 131 111390 162918 70654005
Colitis ulcerative 36.51 11.89 5 111516 33918 70783005
Progressive multifocal leukoencephalopathy 36.31 11.89 88 111433 19126 70797797
Diverticular perforation 36.21 11.89 44 111477 5460 70811463
Abdominal pain upper 36.04 11.89 169 111352 193433 70623490
Palpitations 36.01 11.89 75 111446 110678 70706245
Osteoporosis 35.80 11.89 16 111505 48891 70768032
Inappropriate antidiuretic hormone secretion 35.14 11.89 98 111423 23178 70793745
Cough 34.89 11.89 335 111186 325042 70491881
JC virus infection 34.83 11.89 35 111486 3516 70813407
Drug withdrawal syndrome 34.79 11.89 5 111516 32710 70784213
Respiratory tract infection 34.37 11.89 145 111376 42253 70774670
Sinusitis 34.33 11.89 143 111378 169052 70647871
Infection 34.32 11.89 493 111028 210292 70606631
Large intestinal ulcer perforation 34.26 11.89 10 111511 67 70816856
Neurotoxicity 34.18 11.89 114 111407 29712 70787211
Impaired healing 34.05 11.89 40 111481 74334 70742589
Abdominal pain 33.49 11.89 360 111161 341767 70475156
Bacterial sepsis 33.29 11.89 50 111471 7597 70809326
Hypophosphataemia 33.27 11.89 77 111444 16249 70800674
Lactic acidosis 33.09 11.89 32 111489 64992 70751931
Type 2 diabetes mellitus 32.93 11.89 14 111507 44066 70772857
Demyelinating polyneuropathy 32.69 11.89 24 111497 1573 70815350
End stage renal disease 32.67 11.89 61 111460 11072 70805851
Lymphopenia 32.63 11.89 106 111415 27253 70789670
Underdose 32.42 11.89 4 111517 29379 70787544
Rash 32.29 11.89 1040 110481 509522 70307401
Mesenteric abscess 32.02 11.89 11 111510 132 70816791
VIth nerve paresis 31.94 11.89 11 111510 133 70816790
Prescribed overdose 31.78 11.89 3 111518 27178 70789745
Pneumonia pneumococcal 31.51 11.89 33 111488 3481 70813442
Obesity 31.18 11.89 3 111518 26768 70790155
Seizure 31.01 11.89 159 111362 177803 70639120
Nasal abscess 30.95 11.89 11 111510 147 70816776
Pain in extremity 30.60 11.89 349 111172 327733 70489190
Hypoglycaemia 30.59 11.89 64 111457 94300 70722623
Nocardiosis 30.54 11.89 39 111482 5090 70811833
Hip arthroplasty 30.50 11.89 4 111517 28036 70788887
Injection site swelling 30.23 11.89 15 111506 43142 70773781
Blepharitis 30.14 11.89 29 111492 2764 70814159
Endocarditis bacterial 30.10 11.89 22 111499 1432 70815491
Toxicity to various agents 30.03 11.89 800 110721 381372 70435551
Clostridium difficile colitis 29.89 11.89 107 111414 28889 70788034
Blood immunoglobulin A increased 29.89 11.89 16 111505 598 70816325
Heart rate decreased 29.87 11.89 32 111489 61983 70754940
Hepatitis B 29.70 11.89 49 111472 8065 70808858
Product quality issue 29.58 11.89 6 111515 30555 70786368
Visceral leishmaniasis 29.32 11.89 19 111502 1016 70815907
Ageusia 29.09 11.89 69 111452 14793 70802130
Dysarthria 29.08 11.89 33 111488 62280 70754643
Hypothyroidism 29.02 11.89 18 111503 45737 70771186
Meningitis listeria 28.83 11.89 18 111503 902 70816021
Hypoalbuminaemia 28.37 11.89 80 111441 19042 70797881
Chronic inflammatory demyelinating polyradiculoneuropathy 28.35 11.89 19 111502 1076 70815847
Incorrect dose administered 28.34 11.89 38 111483 66681 70750242
Rib fracture 28.25 11.89 96 111425 25260 70791663
Mucosal inflammation 28.13 11.89 193 111328 67657 70749266
Drug-induced liver injury 28.11 11.89 28 111493 56085 70760838
H1N1 influenza 28.05 11.89 26 111495 2364 70814559
Oedema peripheral 27.96 11.89 509 111012 227582 70589341
Osteonecrosis 27.87 11.89 105 111416 29055 70787868
Cerebellar haemangioma 27.85 11.89 9 111512 88 70816835
Liver injury 27.65 11.89 15 111506 41020 70775903
Oroantral fistula 27.25 11.89 13 111508 379 70816544
Feeling abnormal 27.21 11.89 123 111398 142196 70674727
Dry mouth 27.11 11.89 43 111478 70414 70746509
Taste disorder 26.93 11.89 57 111464 11328 70805595
Enterococcal infection 26.72 11.89 66 111455 14516 70802407
Body dysmorphic disorder 26.71 11.89 12 111509 304 70816619
Multiple sclerosis 26.58 11.89 4 111517 25281 70791642
Failure to thrive 26.52 11.89 55 111466 10774 70806149
Hyperproteinaemia 26.43 11.89 10 111511 161 70816762
Pneumonia cytomegaloviral 26.09 11.89 34 111487 4527 70812396
Rectal adenocarcinoma 26.09 11.89 20 111501 1400 70815523
Blood immunoglobulin G increased 26.01 11.89 23 111498 1967 70814956
Autonomic nervous system imbalance 25.84 11.89 33 111488 4306 70812617
Hiccups 25.82 11.89 49 111472 9003 70807920
Iron deficiency anaemia 25.80 11.89 3 111518 23069 70793854
Meningitis pneumococcal 25.66 11.89 13 111508 433 70816490
Musculoskeletal pain 25.47 11.89 66 111455 90261 70726662
Joint range of motion decreased 25.42 11.89 5 111516 26021 70790902
Depressed level of consciousness 25.34 11.89 63 111458 87368 70729555
Angioedema 25.30 11.89 41 111480 66569 70750354
Drug reaction with eosinophilia and systemic symptoms 25.24 11.89 167 111354 57846 70759077
Diabetic ketoacidosis 25.20 11.89 9 111512 31503 70785420
Oropharyngeal pain 25.19 11.89 73 111448 96237 70720686
Fungal oesophagitis 25.15 11.89 16 111505 829 70816094
Lip swelling 25.14 11.89 11 111510 34043 70782880
Myelosuppression 25.14 11.89 104 111417 30041 70786882
Gait disturbance 25.09 11.89 179 111342 184927 70631996
Target skin lesion 25.07 11.89 9 111512 124 70816799
Respirovirus test positive 25.00 11.89 9 111512 125 70816798
Oral surgery 25.00 11.89 17 111504 986 70815937
Accidental overdose 24.91 11.89 12 111509 35109 70781814
Dyskinesia 24.90 11.89 17 111504 41057 70775866
VIth nerve paralysis 24.79 11.89 20 111501 1508 70815415
Chest discomfort 24.68 11.89 106 111415 124275 70692648
Adenocarcinoma of colon 24.54 11.89 36 111485 5356 70811567
Blastic plasmacytoid dendritic cell neoplasia 24.43 11.89 9 111512 134 70816789
Gastrointestinal fungal infection 24.36 11.89 12 111509 376 70816547
COVID-19 pneumonia 24.32 11.89 83 111438 21886 70795037
Swollen tongue 24.30 11.89 14 111507 37032 70779891
Refractory anaemia with an excess of blasts 24.26 11.89 16 111505 882 70816041
Depressed mood 24.17 11.89 20 111501 43800 70773123
Clostridium bacteraemia 23.80 11.89 11 111510 298 70816625
Respiratory depression 23.77 11.89 5 111516 24826 70792097
Dyspepsia 23.68 11.89 67 111454 89010 70727913
Throat irritation 23.65 11.89 13 111508 35291 70781632
Bradycardia 23.64 11.89 108 111413 124507 70692416
Death 23.50 11.89 1003 110518 509058 70307865
Bacterial infection 23.36 11.89 93 111428 26399 70790524
Nephrolithiasis 23.26 11.89 24 111497 47299 70769624
Parainfluenzae virus infection 23.24 11.89 34 111487 5046 70811877
Escherichia sepsis 22.97 11.89 42 111479 7501 70809422
Acute febrile neutrophilic dermatosis 22.94 11.89 28 111493 3491 70813432
Electrocardiogram QT prolonged 22.81 11.89 62 111459 83455 70733468
Hypersensitivity myocarditis 22.71 11.89 8 111513 104 70816819
Electrolyte imbalance 22.66 11.89 93 111428 26768 70790155
Basal cell carcinoma 22.63 11.89 109 111412 33589 70783334
Medication error 22.60 11.89 34 111487 56878 70760045
Pneumonia influenzal 22.49 11.89 24 111497 2586 70814337
Pseudomonal sepsis 22.41 11.89 35 111486 5502 70811421
Hot flush 22.34 11.89 27 111494 49557 70767366
Coma 22.32 11.89 72 111449 91772 70725151
Pallor 22.23 11.89 19 111502 40955 70775968
Blood potassium decreased 22.15 11.89 128 111393 42293 70774630
Pseudomyopia 21.99 11.89 7 111514 65 70816858
Therapy interrupted 21.77 11.89 6 111515 24796 70792127
Neutropenic sepsis 21.77 11.89 87 111434 24743 70792180
Hypoaesthesia 21.70 11.89 351 111170 153388 70663535
Superficial spreading melanoma stage unspecified 21.50 11.89 10 111511 275 70816648
Blood culture positive 21.50 11.89 42 111479 7884 70809039
Toxic skin eruption 21.30 11.89 75 111446 20087 70796836
Disturbance in social behaviour 21.24 11.89 29 111492 4038 70812885
Acute respiratory distress syndrome 21.23 11.89 124 111397 41130 70775793
Conjunctival irritation 21.19 11.89 8 111513 128 70816795
Neurogenic bladder 21.15 11.89 28 111493 3785 70813138
Pulmonary oedema 21.13 11.89 210 111311 82068 70734855
Meningitis cryptococcal 20.92 11.89 26 111495 3302 70813621
Memory impairment 20.90 11.89 75 111446 92566 70724357
Crying 20.85 11.89 4 111517 21195 70795728
Hallucination, visual 20.84 11.89 10 111511 29327 70787596
Accidental exposure to product 20.81 11.89 9 111512 28042 70788881
Mantle cell lymphoma recurrent 20.80 11.89 12 111509 520 70816403
Frequent bowel movements 20.79 11.89 4 111517 21149 70795774
Lung infiltration 20.78 11.89 78 111443 21546 70795377
Pulmonary arterial hypertension 20.73 11.89 13 111508 32842 70784081
Bursitis 20.69 11.89 8 111513 26665 70790258
Laboratory test abnormal 20.68 11.89 88 111433 25735 70791188
N-terminal prohormone brain natriuretic peptide decreased 20.63 11.89 5 111516 14 70816909
Device dislocation 20.61 11.89 5 111516 22502 70794421
Leukaemia 20.41 11.89 33 111488 5342 70811581
Irritability 20.41 11.89 18 111503 38207 70778716
Bronchopulmonary aspergillosis 20.38 11.89 76 111445 20926 70795997
Extrapyramidal disorder 20.23 11.89 4 111517 20746 70796177
Acne 20.22 11.89 7 111514 24982 70791941
Injection site bruising 20.20 11.89 18 111503 38014 70778909
Bone lesion 20.16 11.89 33 111488 5397 70811526
Surgery 20.15 11.89 11 111510 29978 70786945
Dyspnoea 20.10 11.89 998 110523 769062 70047861
Chromaturia 20.08 11.89 6 111515 23522 70793401
Amnesia 19.90 11.89 32 111489 52123 70764800
Light chain analysis abnormal 19.88 11.89 8 111513 153 70816770
Refractory cancer 19.78 11.89 9 111512 235 70816688
Bronchiolitis 19.62 11.89 27 111494 3787 70813136
Visual impairment 19.44 11.89 63 111458 80187 70736736
Fatigue 19.36 11.89 1525 109996 822794 69994129
Sinus polyp 19.36 11.89 11 111510 463 70816460
Hyperthyroidism 19.33 11.89 4 111517 20087 70796836
General physical condition abnormal 19.29 11.89 34 111487 5902 70811021
Transplant 18.93 11.89 14 111507 928 70815995
Torsade de pointes 18.74 11.89 3 111518 18113 70798810
Peritonitis viral 18.72 11.89 6 111515 57 70816866
Rhinovirus infection 18.65 11.89 36 111485 6697 70810226
Graft versus host disease 18.64 11.89 59 111462 14964 70801959
Polyomavirus-associated nephropathy 18.57 11.89 31 111490 5152 70811771
Tooth deposit 18.57 11.89 9 111512 272 70816651
Adenovirus infection 18.50 11.89 39 111482 7729 70809194
Brief psychotic disorder with marked stressors 18.36 11.89 9 111512 279 70816644
COVID-19 18.26 11.89 250 111271 105507 70711416
Intentional product misuse 18.25 11.89 64 111457 79531 70737392
Varicella 18.14 11.89 22 111499 2725 70814198
Foot deformity 18.12 11.89 5 111516 20650 70796273
Malignant melanoma in situ 18.09 11.89 19 111502 2010 70814913
Sleep apnoea syndrome 17.96 11.89 15 111506 32698 70784225
Cardiac failure congestive 17.91 11.89 306 111215 135151 70681772
Oncologic complication 17.90 11.89 9 111512 295 70816628
Intraductal proliferative breast lesion 17.89 11.89 20 111501 2271 70814652
Neck pain 17.82 11.89 50 111471 66607 70750316
Product prescribing error 17.77 11.89 21 111500 38931 70777992
Faeces discoloured 17.77 11.89 10 111511 26799 70790124
Glycosylated haemoglobin increased 17.72 11.89 3 111518 17388 70799535
Poor quality sleep 17.72 11.89 5 111516 20344 70796579
Blood immunoglobulin M increased 17.64 11.89 11 111510 550 70816373
Atrial flutter 17.64 11.89 71 111450 20256 70796667
Tachycardia 17.50 11.89 162 111359 158384 70658539
Plasma cells present 17.45 11.89 4 111517 8 70816915
Phrenic nerve paralysis 17.33 11.89 9 111512 316 70816607
Haematochezia 17.27 11.89 58 111463 73023 70743900
Hypokalaemia 17.22 11.89 296 111225 130892 70686031
Nodule 17.21 11.89 5 111516 19964 70796959
Body temperature decreased 17.20 11.89 12 111509 28660 70788263
Paraesthesia 17.20 11.89 323 111198 145214 70671709
Gastrointestinal amyloidosis 17.03 11.89 6 111515 78 70816845
Gastric ulcer 16.93 11.89 15 111506 31775 70785148
Therapeutic response decreased 16.90 11.89 153 111368 58300 70758623
Genital erythema 16.84 11.89 8 111513 231 70816692
Enteric neuropathy 16.83 11.89 4 111517 10 70816913
Light chain analysis 16.83 11.89 4 111517 10 70816913
Plasma cells decreased 16.82 11.89 5 111516 36 70816887
Rash pruritic 16.77 11.89 162 111359 62829 70754094
Small intestinal obstruction 16.73 11.89 80 111441 24575 70792348
Disturbance in attention 16.67 11.89 26 111495 42868 70774055
Cerebral aspergillosis 16.66 11.89 17 111504 1739 70815184
Myocardial infarction 16.61 11.89 181 111340 171464 70645459
Stomatitis 16.58 11.89 126 111395 128385 70688538
Tendonitis 16.56 11.89 7 111514 22115 70794808
Fear 16.55 11.89 6 111515 20805 70796118
Renal impairment 16.51 11.89 318 111203 143619 70673304
Procedural pain 16.49 11.89 4 111517 18005 70798918
Injection site exfoliation 16.41 11.89 7 111514 156 70816767
Respiratory arrest 16.31 11.89 38 111483 53895 70763028
Blood immunoglobulin A decreased 16.25 11.89 11 111510 633 70816290
Enterococcal sepsis 16.11 11.89 20 111501 2537 70814386
Staphylococcal bacteraemia 16.08 11.89 46 111475 11036 70805887
Aphasia 16.07 11.89 27 111494 43222 70773701
Pulmonary alveolar haemorrhage 15.99 11.89 44 111477 10325 70806598
Thrombotic thrombocytopenic purpura 15.87 11.89 32 111489 6145 70810778
Clostridium difficile infection 15.84 11.89 110 111411 38706 70778217
Adenoviral haemorrhagic cystitis 15.82 11.89 10 111511 512 70816411
Multiple organ dysfunction syndrome 15.77 11.89 249 111272 108266 70708657
Febrile bone marrow aplasia 15.71 11.89 48 111473 11943 70804980
Liver function test increased 15.71 11.89 18 111503 33829 70783094
Hyperlipidaemia 15.68 11.89 9 111512 23854 70793069
Paraproteinaemia 15.64 11.89 9 111512 388 70816535
Pneumonia parainfluenzae viral 15.48 11.89 8 111513 278 70816645
Hyperkalaemia 15.47 11.89 101 111420 106490 70710433
Neuromyotonia 15.40 11.89 6 111515 105 70816818
Venous thrombosis 15.39 11.89 33 111488 6616 70810307
Laryngeal cancer metastatic 15.37 11.89 5 111516 50 70816873
Engraftment syndrome 15.32 11.89 14 111507 1250 70815673
Pneumonia respiratory syncytial viral 15.27 11.89 15 111506 1466 70815457
Blood creatinine increased 15.09 11.89 312 111209 142689 70674234
Nightmare 15.07 11.89 8 111513 22148 70794775
Immunosuppression 15.06 11.89 46 111475 11446 70805477
Panic attack 15.03 11.89 8 111513 22111 70794812
Feeling hot 14.95 11.89 34 111487 48636 70768287
Empyema 14.94 11.89 24 111497 3863 70813060
Escherichia infection 14.94 11.89 58 111463 16273 70800650
Ejection fraction decreased 14.89 11.89 91 111430 30671 70786252
Organising pneumonia 14.86 11.89 42 111479 10008 70806915
Parkinsonism 14.85 11.89 3 111518 15322 70801601
Hypercholesterolaemia 14.79 11.89 5 111516 18112 70798811
Hypocalcaemic seizure 14.79 11.89 5 111516 57 70816866
Hypoglossal nerve paresis 14.71 11.89 6 111515 119 70816804
Eosinophil count increased 14.71 11.89 3 111518 15219 70801704
Infection in an immunocompromised host 14.70 11.89 13 111508 1112 70815811
Bone erosion 14.64 11.89 3 111518 15170 70801753
Movement disorder 14.61 11.89 10 111511 24119 70792804
Leukopenia 14.55 11.89 242 111279 106318 70710605
Lung disorder 14.43 11.89 170 111351 69314 70747609
Disability 14.38 11.89 3 111518 14980 70801943
Pneumonia bacterial 14.34 11.89 58 111463 16583 70800340
Light chain disease 14.34 11.89 7 111514 215 70816708
Periodontitis 14.34 11.89 25 111496 4303 70812620
Serratia sepsis 14.31 11.89 6 111515 128 70816795
Drug level increased 14.27 11.89 22 111499 36447 70780476
Erysipelas 14.22 11.89 41 111480 9883 70807040
Capillary leak syndrome 14.17 11.89 22 111499 3440 70813483
Mouth ulceration 14.15 11.89 20 111501 34329 70782594
Monoclonal gammopathy 14.14 11.89 11 111510 787 70816136
Infection reactivation 14.06 11.89 18 111503 2355 70814568
Transitional cell carcinoma 14.03 11.89 18 111503 2359 70814564
Eosinophilic pneumonia chronic 13.96 11.89 9 111512 477 70816446
Oesophageal adenocarcinoma 13.84 11.89 11 111510 812 70816111
Hyperamylasaemia 13.71 11.89 12 111509 1012 70815911
Blood triglycerides increased 13.52 11.89 7 111514 19657 70797266
Scrotal pain 13.44 11.89 9 111512 509 70816414
Cardiomegaly 13.43 11.89 75 111446 24470 70792453
Cytomegalovirus enterocolitis 13.43 11.89 14 111507 1469 70815454
Delayed engraftment 13.39 11.89 7 111514 249 70816674
Venoocclusive liver disease 13.30 11.89 42 111479 10636 70806287
Gastrointestinal disorder 13.30 11.89 104 111417 105323 70711600
Cardiotoxicity 13.30 11.89 43 111478 11027 70805896
Haemorrhagic fever 13.20 11.89 4 111517 31 70816892
Squamous cell carcinoma of lung 13.15 11.89 17 111504 2245 70814678
Bence Jones proteinuria 13.08 11.89 3 111518 6 70816917
Decreased appetite 13.04 11.89 595 110926 304185 70512738
Cholelithiasis 13.03 11.89 35 111486 47305 70769618
Atelectasis 12.98 11.89 84 111437 28878 70788045
Osteopenia 12.96 11.89 5 111516 16692 70800231
Clostridium colitis 12.95 11.89 18 111503 2548 70814375
Delusion 12.92 11.89 7 111514 19158 70797765
Malignant neoplasm of unknown primary site 12.84 11.89 10 111511 716 70816207
Pneumocystis jirovecii infection 12.80 11.89 18 111503 2576 70814347
Follicle centre lymphoma, follicular grade I, II, III recurrent 12.77 11.89 3 111518 7 70816916
Protein total decreased 12.75 11.89 35 111486 8201 70808722
Ulcer 12.73 11.89 13 111508 25741 70791182
Cytomegalovirus hepatitis 12.70 11.89 10 111511 728 70816195
Psychotic disorder 12.70 11.89 25 111496 37676 70779247
Paranoid personality disorder 12.67 11.89 4 111517 36 70816887
Bacterial parotitis 12.67 11.89 4 111517 36 70816887
Sciatica 12.67 11.89 12 111509 24615 70792308
Squamous cell carcinoma 12.66 11.89 51 111470 14553 70802370
Minimal residual disease 12.62 11.89 8 111513 412 70816511
Insomnia 12.59 11.89 254 111267 217552 70599371
Heart rate irregular 12.57 11.89 17 111504 29726 70787197
Therapy cessation 12.53 11.89 21 111500 33655 70783268
Impaired work ability 12.51 11.89 5 111516 16335 70800588
Prinzmetal angina 12.46 11.89 14 111507 1598 70815325
Hepatitis 12.27 11.89 39 111482 49941 70766982
Anger 12.25 11.89 5 111516 16127 70800796
Electrodesiccation 12.23 11.89 3 111518 9 70816914
Pulmonary sepsis 12.14 11.89 20 111501 3287 70813636
Encephalitis viral 12.13 11.89 17 111504 2425 70814498
Spinal fracture 12.11 11.89 54 111467 16113 70800810
Vertigo 12.05 11.89 54 111467 62589 70754334
Glomerular filtration rate decreased 12.04 11.89 9 111512 20747 70796176
Obstructive airways disorder 12.00 11.89 14 111507 26099 70790824
Oxygen saturation decreased 11.98 11.89 121 111400 116308 70700615
Cardio-respiratory arrest 11.93 11.89 101 111420 100576 70716347

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01XG01 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
OTHER ANTINEOPLASTIC AGENTS
Proteasome inhibitors
FDA MoA N0000175075 Proteasome Inhibitors
MeSH PA D000970 Antineoplastic Agents
FDA EPC N0000175604 Proteasome Inhibitor
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:35820 antiprotozoal drugs
CHEBI has role CHEBI:37670 protease inhibitors
CHEBI has role CHEBI:52726 proteasome inhibitors

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

DiseaseRelationSNOMED_IDDOID
Systemic AL amyloidosis indication 23132008
Multiple myeloma indication 109989006 DOID:9538
Mantle cell lymphoma indication 443487006
Orthostatic hypotension contraindication 28651003
Dehydration contraindication 34095006
Low blood pressure contraindication 45007003
Chronic heart failure contraindication 48447003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Interstitial pneumonia contraindication 64667001
Adult respiratory distress syndrome contraindication 67782005 DOID:11394
Pulmonary hypertension contraindication 70995007 DOID:6432
Diabetes mellitus contraindication 73211009 DOID:9351
Intestinal obstruction contraindication 81060008 DOID:8437
Prolonged QT interval contraindication 111975006
Pneumonia contraindication 233604007 DOID:552
Disease of liver contraindication 235856003 DOID:409
Syncope contraindication 271594007
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Peripheral nerve disease contraindication 302226006
Neutropenic disorder contraindication 303011007 DOID:1227
Breastfeeding (mother) contraindication 413712001
Posterior reversible encephalopathy syndrome contraindication 450886002
Chemotherapy-Induced Hyperuricemia contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.39 acidic
pKa2 12.09 acidic
pKa3 13.65 acidic
pKa4 2.9 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
3.5MG/VIAL VELCADE TAKEDA PHARMS USA N021602 May 13, 2003 RX INJECTABLE INTRAVENOUS, SUBCUTANEOUS April 8, 2022 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Proteasome subunit beta type-5 Enzyme INHIBITOR Ki 9.26 CHEMBL CHEMBL
Proteasome subunit beta type-8 Enzyme INHIBITOR IC50 8.09 CHEMBL CHEMBL
Proteasome subunit alpha type-1 Enzyme INHIBITOR Ki 9.21 WOMBAT-PK CHEMBL
Proteasome subunit beta type-1 Enzyme INHIBITOR IC50 7.28 CHEMBL CHEMBL
Proteasome subunit beta type-2 Enzyme INHIBITOR IC50 6.23 CHEMBL CHEMBL
Prothrombin Enzyme Ki 4.89 CHEMBL
Carbonic anhydrase 5A, mitochondrial Enzyme Ki 5.16 CHEMBL
Carbonic anhydrase 5B, mitochondrial Enzyme Ki 5.17 CHEMBL
Carbonic anhydrase 7 Enzyme Ki 5.16 CHEMBL
Cytochrome P450 2C19 Enzyme Ki 4.75 WOMBAT-PK
26S proteasome non-ATPase regulatory subunit 1 Cytosolic other Ki 7.75 WOMBAT-PK
Histone deacetylase 2 Enzyme IC50 6.10 CHEMBL
Histone deacetylase 1 Enzyme IC50 6.21 CHEMBL
Histone deacetylase 3 Enzyme IC50 5.93 CHEMBL
Histone deacetylase 6 Enzyme IC50 4.16 CHEMBL
Neutrophil elastase Enzyme Ki 5.64 CHEMBL
Carbonic anhydrase 3 Enzyme Ki 5.34 CHEMBL
Carbonic anhydrase 6 Enzyme Ki 5.36 CHEMBL
Histone deacetylase 8 Enzyme IC50 7.14 CHEMBL
Cathepsin G Enzyme Ki 6.20 CHEMBL
Carbonic anhydrase 14 Enzyme Ki 5.48 CHEMBL
Chymase Enzyme IC50 5.92 CHEMBL
Chymotrypsinogen B Enzyme Ki 6.49 CHEMBL
Lysosomal protective protein Enzyme IC50 5.04 CHEMBL
Carbonic anhydrase 13 Enzyme Ki 5.07 CHEMBL
PH and SEC7 domain-containing protein 1 Unclassified Ki 7.75 WOMBAT-PK
Nuclear factor NF-kappa-B complex Transcription factor IC50 8.01 CHEMBL
Proteasome subunit beta type-9 Enzyme IC50 8.52 CHEMBL
Proteasome subunit beta type-10 Enzyme IC50 6.03 CHEMBL
Carbonic anhydrase 2 Enzyme Ki 5.94 CHEMBL
Carbonic anhydrase 1 Enzyme Ki 5.89 CHEMBL
Carbonic anhydrase 4 Enzyme Ki 5.19 CHEMBL
Carbonic anhydrase 9 Enzyme Ki 5.47 CHEMBL
Carbonic anhydrase 12 Enzyme Ki 5.23 CHEMBL
Carbonic anhydrase 15 Enzyme Ki 5.57 CHEMBL
Beta-carbonic anhydrase 1 Enzyme Ki 5.14 CHEMBL
Alpha-chymotrypsin Enzyme Ki 5.62 CHEMBL
Proteasome subunit beta Enzyme IC50 7.51 IUPHAR
Proteasome subunit beta type-8 Enzyme IC50 7.78 CHEMBL
ATP-dependent Clp protease proteolytic subunit Enzyme IC50 5.28 CHEMBL

External reference:

IDSource
4021393 VUID
N0000148811 NUI
D03150 KEGG_DRUG
356733 RXNORM
4021393 VANDF
C1176309 UMLSCUI
CHEBI:52717 CHEBI
BO2 PDB_CHEM_ID
CHEMBL325041 ChEMBL_ID
DB00188 DRUGBANK_ID
D000069286 MESH_DESCRIPTOR_UI
387447 PUBCHEM_CID
6391 IUPHAR_LIGAND_ID
8331 INN_ID
69G8BD63PP UNII
17263 MMSL
233935 MMSL
46756 MMSL
d04871 MMSL
009985 NDDF
398907002 SNOMEDCT_US
407097007 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
bortezomib HUMAN PRESCRIPTION DRUG LABEL 1 0143-9098 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 3.50 mg INTRAVENOUS ANDA 31 sections
Bortezomib HUMAN PRESCRIPTION DRUG LABEL 1 0409-1700 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 3.50 mg INTRAVENOUS ANDA 33 sections
BORTEZOMIB HUMAN PRESCRIPTION DRUG LABEL 1 0409-1703 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 2.50 mg INTRAVENOUS NDA 33 sections
BORTEZOMIB HUMAN PRESCRIPTION DRUG LABEL 1 0409-1704 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1 mg INTRAVENOUS NDA 33 sections
bortezomib HUMAN PRESCRIPTION DRUG LABEL 1 0781-3258 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 3.50 mg INTRAVENOUS ANDA 27 sections
BORTEZOMIB HUMAN PRESCRIPTION DRUG LABEL 1 10019-991 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 3.50 mg INTRAVENOUS ANDA 28 sections
BORTEZOMIB HUMAN PRESCRIPTION DRUG LABEL 1 25021-244 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 3.50 mg INTRAVENOUS ANDA 31 sections
Bortezomib HUMAN PRESCRIPTION DRUG LABEL 1 43598-426 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 3.50 mg INTRAVENOUS ANDA 30 sections
Bortezomib HUMAN PRESCRIPTION DRUG LABEL 1 43598-865 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 3.50 mg INTRAVENOUS NDA 26 sections
Bortezomib HUMAN PRESCRIPTION DRUG LABEL 1 50742-484 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 3.50 mg INTRAVENOUS ANDA 31 sections
Bortezomib HUMAN PRESCRIPTION DRUG LABEL 1 51817-586 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 3.50 mg INTRAVENOUS ANDA 32 sections
BORTEZOMIB Human Prescription Drug Label 1 55150-337 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 3.50 mg INTRAVENOUS ANDA 28 sections
BORTEZOMIB HUMAN PRESCRIPTION DRUG LABEL 1 60505-6050 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 3.50 mg INTRAVENOUS ANDA 28 sections
VELCADE HUMAN PRESCRIPTION DRUG LABEL 1 63020-049 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 3.50 mg INTRAVENOUS NDA 31 sections
VELCADE HUMAN PRESCRIPTION DRUG LABEL 1 63020-049 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 3.50 mg INTRAVENOUS NDA 31 sections
VELCADE HUMAN PRESCRIPTION DRUG LABEL 1 63020-049 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 3.50 mg INTRAVENOUS NDA 31 sections
Bortezomib HUMAN PRESCRIPTION DRUG LABEL 1 63323-721 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1 mg INTRAVENOUS NDA 31 sections
Bortezomib HUMAN PRESCRIPTION DRUG LABEL 1 63323-721 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1 mg INTRAVENOUS NDA 31 sections
Bortezomib HUMAN PRESCRIPTION DRUG LABEL 1 63323-821 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 3.50 mg INTRAVENOUS ANDA 30 sections
Bortezomib HUMAN PRESCRIPTION DRUG LABEL 1 67184-0530 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 3.50 mg INTRAVENOUS ANDA 31 sections
Bortezomib HUMAN PRESCRIPTION DRUG LABEL 1 68001-534 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 3.50 mg INTRAVENOUS ANDA 31 sections
Bortezomib HUMAN PRESCRIPTION DRUG LABEL 1 68001-540 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 3.50 mg INTRAVENOUS ANDA 31 sections
Bortezomib HUMAN PRESCRIPTION DRUG LABEL 1 68001-541 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 3.50 mg INTRAVENOUS ANDA 26 sections
Bortezomib HUMAN PRESCRIPTION DRUG LABEL 1 70511-161 INJECTION 1 mg INTRAVENOUS NDA 31 sections
Bortezomib HUMAN PRESCRIPTION DRUG LABEL 1 70511-162 INJECTION 2.50 mg INTRAVENOUS NDA 31 sections
BORTEZOMIB HUMAN PRESCRIPTION DRUG LABEL 1 70710-1411 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1 mg INTRAVENOUS ANDA 26 sections
BORTEZOMIB HUMAN PRESCRIPTION DRUG LABEL 1 70771-1708 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1 mg INTRAVENOUS ANDA 2 sections
Bortezomib HUMAN PRESCRIPTION DRUG LABEL 1 70860-225 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 3.50 mg INTRAVENOUS ANDA 31 sections
Bortezomib HUMAN PRESCRIPTION DRUG LABEL 1 71288-118 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 3.50 mg INTRAVENOUS ANDA 28 sections
Bortezomib Human Prescription Drug Label 1 72205-183 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 3.50 mg INTRAVENOUS ANDA 26 sections