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
Neuropathy peripheral 2319.73 13.63 1430 58003 95327 50450364
Plasma cell myeloma 1302.98 13.63 666 58767 30656 50515035
Thrombocytopenia 538.84 13.63 705 58728 126968 50418723
Plasma cell myeloma recurrent 524.95 13.63 173 59260 2485 50543206
Platelet count decreased 402.77 13.63 542 58891 100184 50445507
Diarrhoea 390.34 13.63 1539 57894 586937 49958754
Disease progression 363.79 13.63 503 58930 95363 50450328
Plasmacytoma 315.13 13.63 115 59318 2270 50543421
Constipation 262.10 13.63 634 58799 185074 50360617
Pneumonia 256.40 13.63 998 58435 377403 50168288
Polyneuropathy 243.83 13.63 161 59272 11970 50533721
Neutropenia 230.27 13.63 525 58908 147440 50398251
White blood cell count decreased 218.05 13.63 446 58987 116276 50429415
Rheumatoid arthritis 214.03 13.63 5 59428 202545 50343146
Plasma cell leukaemia 188.17 13.63 63 59370 952 50544739
Pancytopenia 176.04 13.63 337 59096 83693 50461998
Maternal exposure during pregnancy 168.54 13.63 4 59429 159774 50385917
Drug hypersensitivity 158.38 13.63 49 59384 250961 50294730
Contraindicated product administered 156.08 13.63 4 59429 148954 50396737
Full blood count decreased 152.02 13.63 158 59275 22188 50523503
Tumour lysis syndrome 143.11 13.63 96 59337 7325 50538366
Headache 142.73 13.63 235 59198 506300 50039391
Arthralgia 142.70 13.63 184 59249 438518 50107173
Sepsis 139.65 13.63 407 59026 132518 50413173
Exposure during pregnancy 127.71 13.63 3 59430 121012 50424679
Drug ineffective 125.14 13.63 518 58915 818815 49726876
Laboratory test abnormal 119.74 13.63 142 59291 23066 50522625
Unevaluable event 119.72 13.63 203 59230 45863 50499828
Anaemia 119.51 13.63 599 58834 251857 50293834
Peripheral sensory neuropathy 114.63 13.63 80 59353 6511 50539180
Glossodynia 114.37 13.63 5 59428 115564 50430127
Febrile neutropenia 113.23 13.63 310 59123 97357 50448334
Dehydration 108.36 13.63 409 59024 152040 50393651
Neutrophil count decreased 105.57 13.63 192 59241 45834 50499857
Deep vein thrombosis 104.98 13.63 252 59181 73052 50472639
Pain 104.56 13.63 341 59092 578562 49967129
Cardiac amyloidosis 99.37 13.63 36 59397 695 50544996
Product use in unapproved indication 96.15 13.63 327 59106 115492 50430199
Therapeutic product effect decreased 92.36 13.63 23 59410 136027 50409664
Septic shock 91.11 13.63 205 59228 56970 50488721
Swelling 88.67 13.63 64 59369 200808 50344883
Chalazion 86.56 13.63 27 59406 321 50545370
Amyloidosis 85.57 13.63 35 59398 948 50544743
Posterior reversible encephalopathy syndrome 84.81 13.63 96 59337 14832 50530859
Condition aggravated 83.26 13.63 138 59295 296920 50248771
Alopecia 81.33 13.63 101 59332 244946 50300745
Hordeolum 80.56 13.63 44 59389 2309 50543382
Herpes zoster 80.34 13.63 223 59210 70563 50475128
Cytopenia 80.26 13.63 73 59360 8702 50536989
Light chain analysis increased 78.55 13.63 34 59399 1064 50544627
Arthropathy 78.32 13.63 44 59389 157862 50387829
Discomfort 78.21 13.63 16 59417 108364 50437327
Renal failure 77.30 13.63 288 59145 106345 50439346
Off label use 77.04 13.63 873 58560 473553 50072138
Drug interaction 76.49 13.63 73 59360 199548 50346143
Abdominal discomfort 76.31 13.63 96 59337 231545 50314146
Musculoskeletal stiffness 75.86 13.63 28 59405 128453 50417238
Wound 73.53 13.63 17 59416 105777 50439914
Pericarditis 70.07 13.63 6 59427 78683 50467008
Overdose 69.36 13.63 16 59417 99711 50445980
Orthostatic hypotension 68.88 13.63 124 59309 29357 50516334
Hyperviscosity syndrome 67.98 13.63 19 59414 149 50545542
Joint swelling 67.73 13.63 115 59318 245171 50300520
Myelodysplastic syndrome 67.41 13.63 86 59347 15046 50530645
Treatment failure 65.91 13.63 40 59393 137597 50408094
Thrombosis 63.44 13.63 176 59257 55657 50490034
Monoclonal immunoglobulin present 63.23 13.63 26 59407 714 50544977
Protein total increased 62.30 13.63 38 59395 2458 50543233
Injection site pain 60.97 13.63 27 59406 110997 50434694
Haemoglobin decreased 60.84 13.63 303 59130 126913 50418778
Atrial fibrillation 60.24 13.63 258 59175 101487 50444204
Therapy partial responder 58.65 13.63 54 59379 6537 50539154
Stem cell transplant 56.58 13.63 31 59402 1637 50544054
Hepatic enzyme increased 54.06 13.63 49 59384 137331 50408360
Pathological fracture 53.46 13.63 55 59378 7627 50538064
Cytomegalovirus infection reactivation 53.05 13.63 35 59398 2596 50543095
Coombs indirect test positive 52.39 13.63 12 59421 36 50545655
Autonomic neuropathy 52.32 13.63 25 59408 988 50544703
Mobility decreased 51.44 13.63 15 59418 79933 50465758
Haematotoxicity 50.44 13.63 54 59379 7841 50537850
Hypocalcaemia 48.23 13.63 101 59332 26715 50518976
Hypersensitivity 48.12 13.63 114 59319 215047 50330644
Pyrexia 48.01 13.63 668 58765 379535 50166156
Wrong technique in product usage process 47.38 13.63 5 59428 55505 50490186
Cytomegalovirus infection 46.44 13.63 79 59354 17883 50527808
Ileus paralytic 45.73 13.63 38 59395 4012 50541679
Ageusia 45.67 13.63 62 59371 11521 50534170
Bone marrow failure 43.93 13.63 99 59334 27525 50518166
Bone pain 43.31 13.63 138 59295 47091 50498600
Hypercalcaemia 43.23 13.63 89 59344 23263 50522428
Peripheral sensorimotor neuropathy 41.55 13.63 23 59410 1239 50544452
Fibromyalgia 41.24 13.63 3 59430 44975 50500716
Helicobacter infection 41.11 13.63 5 59428 49697 50495994
Suicide attempt 40.89 13.63 6 59427 51726 50493965
Malignant neoplasm progression 40.49 13.63 173 59260 67951 50477740
Mesenteric abscess 39.85 13.63 11 59422 82 50545609
Fatigue 39.80 13.63 1099 58334 706502 49839189
Body dysmorphic disorder 39.60 13.63 14 59419 251 50545440
Oedema peripheral 39.58 13.63 319 59114 157642 50388049
Peripheral motor neuropathy 38.86 13.63 23 59410 1408 50544283
Syncope 38.21 13.63 229 59204 102773 50442918
Endocarditis bacterial 37.93 13.63 17 59416 579 50545112
Blister 37.93 13.63 27 59406 85391 50460300
Hepatitis B reactivation 37.86 13.63 26 59407 2061 50543630
Pneumonia fungal 37.68 13.63 35 59398 4285 50541406
Electrolyte imbalance 37.31 13.63 70 59363 17099 50528592
Large intestinal ulcer perforation 37.15 13.63 10 59423 67 50545624
Drug abuse 37.10 13.63 12 59421 59834 50485857
Inappropriate antidiuretic hormone secretion 36.91 13.63 60 59373 13083 50532608
Blood potassium decreased 36.69 13.63 111 59322 36834 50508857
Colitis 36.63 13.63 114 59319 38415 50507276
Blood pressure increased 36.16 13.63 63 59370 133069 50412622
Pleural effusion 36.11 13.63 190 59243 81264 50464427
Asthenia 36.05 13.63 550 58883 318492 50227199
Migraine 35.85 13.63 22 59411 75258 50470433
Therapy non-responder 35.44 13.63 136 59297 50886 50494805
Hypoaesthesia 35.20 13.63 263 59170 126994 50418697
Nasal abscess 34.87 13.63 11 59422 136 50545555
Crossmatch incompatible 33.35 13.63 8 59425 31 50545660
Anxiety 33.00 13.63 103 59330 177503 50368188
Irritable bowel syndrome 32.45 13.63 10 59423 51431 50494260
Gastrointestinal fungal infection 32.01 13.63 12 59421 256 50545435
Depression 31.40 13.63 95 59338 165328 50380363
Osteolysis 30.99 13.63 25 59408 2532 50543159
Taste disorder 30.48 13.63 43 59390 8281 50537410
Renal amyloidosis 30.31 13.63 10 59423 144 50545547
Disturbance in social behaviour 30.30 13.63 26 59407 2868 50542823
Cardiac failure 30.10 13.63 172 59261 75868 50469823
Rash 29.95 13.63 698 58735 436773 50108918
Blood stem cell harvest failure 29.54 13.63 8 59425 55 50545636
Primary amyloidosis 29.41 13.63 7 59426 26 50545665
Large intestine perforation 29.37 13.63 40 59393 7454 50538237
Target skin lesion 29.01 13.63 9 59424 105 50545586
Morganella infection 28.89 13.63 14 59419 571 50545120
Osteoarthritis 28.77 13.63 23 59410 68583 50477108
Blood pressure fluctuation 28.67 13.63 4 59429 35819 50509872
Renal impairment 28.55 13.63 169 59264 75492 50470199
Hypokalaemia 28.50 13.63 189 59244 87803 50457888
Arthritis 28.45 13.63 36 59397 86685 50459006
Clostridium bacteraemia 28.20 13.63 10 59423 181 50545510
Guillain-Barre syndrome 28.09 13.63 27 59406 3450 50542241
Suicidal ideation 28.06 13.63 15 59418 55370 50490321
Acute lymphocytic leukaemia 27.35 13.63 22 59411 2219 50543472
COVID-19 27.34 13.63 118 59315 46544 50499147
Anaphylactic reaction 26.86 13.63 15 59418 54040 50491651
Refractory cytopenia with multilineage dysplasia 26.70 13.63 9 59424 139 50545552
Blood lactate dehydrogenase increased 26.64 13.63 66 59367 19496 50526195
Inappropriate schedule of product administration 26.63 13.63 27 59406 71804 50473887
Spinal cord compression 26.62 13.63 27 59406 3682 50542009
Sinus polyp 26.59 13.63 11 59422 307 50545384
Drug intolerance 26.47 13.63 150 59283 218954 50326737
Loss of personal independence in daily activities 26.35 13.63 26 59407 70024 50475667
Bronchiolitis 26.18 13.63 22 59411 2359 50543332
Adverse drug reaction 25.99 13.63 131 59302 55091 50490600
Adenoviral haemorrhagic cystitis 25.85 13.63 9 59424 154 50545537
Hypertension 25.83 13.63 144 59289 211059 50334632
Graft versus host disease 25.83 13.63 34 59399 6132 50539559
Joint ankylosis 25.36 13.63 14 59419 750 50544941
Osteonecrosis of jaw 25.35 13.63 90 59343 32436 50513255
Joint stiffness 25.18 13.63 3 59430 30305 50515386
Death 25.03 13.63 528 58905 324851 50220840
Hypophosphataemia 24.43 13.63 39 59394 8375 50537316
Pseudomonal sepsis 24.27 13.63 20 59413 2087 50543604
Cardiac failure congestive 24.24 13.63 176 59257 84206 50461485
Blood pressure systolic increased 24.02 13.63 6 59427 35443 50510248
Bone lesion 24.00 13.63 30 59403 5140 50540551
Neuralgia 23.92 13.63 68 59365 21795 50523896
Impaired healing 23.91 13.63 28 59405 69758 50475933
Blood cholesterol increased 23.80 13.63 18 59415 55197 50490494
Palpitations 23.64 13.63 47 59386 94459 50451232
Heart rate increased 23.38 13.63 34 59399 77216 50468475
Toxic skin eruption 23.37 13.63 45 59388 11206 50534485
Pneumonia pneumococcal 23.37 13.63 18 59415 1705 50543986
Cerebellar haemangioma 23.36 13.63 7 59426 72 50545619
Intraductal proliferative breast lesion 22.90 13.63 21 59412 2529 50543162
Flushing 22.84 13.63 27 59406 66988 50478703
Compression fracture 22.64 13.63 31 59402 5806 50539885
Stress 22.59 13.63 18 59415 53775 50491916
Neurotoxicity 22.52 13.63 52 59381 14688 50531003
Salmonella sepsis 22.45 13.63 9 59424 231 50545460
Injury 22.33 13.63 15 59418 48910 50496781
Pregnancy 22.10 13.63 4 59429 29573 50516118
Failure to thrive 22.04 13.63 32 59401 6326 50539365
Hyperproteinaemia 21.73 13.63 7 59426 93 50545598
Injection site swelling 21.63 13.63 11 59422 41762 50503929
Mucosal inflammation 21.62 13.63 99 59334 40043 50505648
Nasal congestion 21.60 13.63 17 59416 51103 50494588
Seasonal allergy 21.57 13.63 51 59382 14625 50531066
Varicella zoster virus infection 21.39 13.63 20 59413 2469 50543222
Peritonitis viral 21.36 13.63 6 59427 48 50545643
Product quality issue 21.35 13.63 5 59428 30853 50514838
Acute kidney injury 21.22 13.63 381 59052 227677 50318014
Enterococcal sepsis 21.06 13.63 15 59418 1260 50544431
Hypothyroidism 20.87 13.63 7 59426 34118 50511573
Malaise 20.62 13.63 274 59159 335258 50210433
Disease recurrence 20.56 13.63 61 59372 20020 50525671
Hypotension 20.04 13.63 388 59045 235081 50310610
Hypoalbuminaemia 19.94 13.63 39 59394 9821 50535870
5q minus syndrome 19.86 13.63 8 59425 208 50545483
Cardiotoxicity 19.62 13.63 32 59401 6995 50538696
Gait disturbance 19.59 13.63 100 59333 149905 50395786
Ileus 19.47 13.63 46 59387 13183 50532508
Thrombotic microangiopathy 19.29 13.63 36 59397 8755 50536936
Serotonin syndrome 19.22 13.63 3 59430 24710 50520981
Back pain 19.21 13.63 364 59069 219666 50326025
Myalgia 19.14 13.63 78 59355 124241 50421450
Meningitis listeria 19.13 13.63 10 59423 480 50545211
Transplant 19.11 13.63 11 59422 639 50545052
Human chorionic gonadotropin increased 19.03 13.63 14 59419 1237 50544454
Contusion 18.81 13.63 68 59365 112115 50433576
Blood creatine phosphokinase increased 18.79 13.63 4 59429 26363 50519328
Toxicity to various agents 18.71 13.63 352 59081 212147 50333544
VIth nerve paresis 18.68 13.63 6 59427 79 50545612
Mucosal erosion 18.68 13.63 14 59419 1273 50544418
Ill-defined disorder 18.65 13.63 22 59411 54632 50491059
Injection site bruising 18.56 13.63 10 59423 36758 50508933
Sleep disorder 18.55 13.63 24 59409 57259 50488432
Paraesthesia 18.36 13.63 219 59214 120024 50425667
Acute myopia 18.27 13.63 6 59427 85 50545606
Plasma cells decreased 18.26 13.63 5 59428 36 50545655
Full blood count increased 18.26 13.63 12 59421 884 50544807
Pulmonary embolism 18.15 13.63 191 59242 101513 50444178
Wheezing 18.11 13.63 28 59405 62019 50483672
Meningitis cryptococcal 17.84 13.63 13 59420 1132 50544559
Light chain analysis 17.72 13.63 4 59429 11 50545680
Spinal fracture 17.59 13.63 49 59384 15524 50530167
Diarrhoea haemorrhagic 17.56 13.63 32 59401 7643 50538048
Fungal oesophagitis 17.52 13.63 10 59423 572 50545119
Sedation 17.50 13.63 7 59426 30603 50515088
Hypogammaglobulinaemia 17.36 13.63 27 59406 5672 50540019
Monoclonal immunoglobulin increased 17.32 13.63 6 59427 101 50545590
Nocardiosis 17.26 13.63 15 59418 1683 50544008
Infection reactivation 17.21 13.63 12 59421 975 50544716
Somnolence 17.17 13.63 109 59324 154876 50390815
Tooth disorder 17.16 13.63 65 59368 24163 50521528
Cardiac failure acute 17.14 13.63 33 59400 8217 50537474
Pneumonia influenzal 17.06 13.63 14 59419 1453 50544238
Hypoglossal nerve paresis 17.05 13.63 6 59427 106 50545585
Incorrect dose administered 17.05 13.63 19 59414 48395 50497296
Bacteraemia 16.88 13.63 46 59387 14387 50531304
Infection in an immunocompromised host 16.82 13.63 9 59424 453 50545238
Sensory level abnormal 16.70 13.63 6 59427 113 50545578
Acute myeloid leukaemia 16.60 13.63 47 59386 15027 50530664
Multiple allergies 16.54 13.63 33 59400 8430 50537261
Spinal compression fracture 16.50 13.63 42 59391 12614 50533077
Osteonecrosis 16.44 13.63 61 59372 22456 50523235
Myeloma cast nephropathy 16.41 13.63 6 59427 119 50545572
Pseudomyopia 16.38 13.63 5 59428 55 50545636
Pulmonary oedema 16.38 13.63 106 59327 48832 50496859
Sleep apnoea syndrome 16.25 13.63 4 59429 23864 50521827
Duodenal stenosis 16.22 13.63 9 59424 487 50545204
Oncologic complication 16.09 13.63 6 59427 126 50545565
Hyperamylasaemia 16.03 13.63 8 59425 348 50545343
Human herpesvirus 8 infection 16.03 13.63 7 59426 224 50545467
Chronic graft versus host disease in skin 16.02 13.63 10 59423 674 50545017
Skin exfoliation 16.00 13.63 80 59353 33532 50512159
Superficial spreading melanoma stage unspecified 15.96 13.63 6 59427 129 50545562
Respiratory tract infection 15.80 13.63 77 59356 31940 50513751
Blepharitis 15.79 13.63 16 59417 2179 50543512
Injection site haemorrhage 15.71 13.63 3 59430 21343 50524348
Rash pruritic 15.62 13.63 103 59330 47743 50497948
Pain in extremity 15.61 13.63 226 59207 272639 50273052
Drug withdrawal syndrome 15.59 13.63 5 59428 25076 50520615
Performance status decreased 15.57 13.63 19 59414 3176 50542515
Clostridium difficile colitis 15.49 13.63 51 59382 17691 50528000
Blood immunoglobulin A increased 15.48 13.63 8 59425 375 50545316
Aggression 15.47 13.63 3 59430 21113 50524578
Decreased appetite 15.40 13.63 326 59107 200597 50345094
Osteoporosis 15.38 13.63 18 59415 44861 50500830
Coma 15.36 13.63 27 59406 56852 50488839
Rhabdomyolysis 15.24 13.63 14 59419 39013 50506678
Clavicle fracture 15.18 13.63 18 59415 2921 50542770
Dysarthria 15.11 13.63 13 59420 37390 50508301
JC virus CSF test positive 15.10 13.63 4 59429 25 50545666
Sinusitis 15.03 13.63 128 59305 170430 50375261
Haemorrhoidal haemorrhage 15.02 13.63 20 59413 3647 50542044
Staphylococcal bacteraemia 14.70 13.63 23 59410 4854 50540837
Atelectasis 14.62 13.63 51 59382 18219 50527472
Infusion related reaction 14.61 13.63 128 59305 169429 50376262
Underdose 14.60 13.63 3 59430 20275 50525416
Therapy interrupted 14.48 13.63 3 59430 20149 50525542
Hepatitis B 14.35 13.63 19 59414 3447 50542244
Paraproteinaemia 14.32 13.63 6 59427 173 50545518
Weight increased 14.22 13.63 160 59273 201731 50343960
Lactic acidosis 14.21 13.63 11 59422 33344 50512347
Herpes zoster reactivation 14.13 13.63 4 59429 33 50545658
Cough 14.09 13.63 199 59234 241065 50304626
Plasmablastic lymphoma 13.91 13.63 6 59427 186 50545505
Respiratory failure 13.88 13.63 166 59267 91015 50454676
Pneumonia cytomegaloviral 13.69 13.63 14 59419 1927 50543764
Cryptococcosis 13.65 13.63 10 59423 878 50544813

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
Neuropathy peripheral 2398.76 12.99 1690 68143 69337 29435357
Plasma cell myeloma 1272.29 12.99 893 68940 36222 29468472
Plasma cell myeloma recurrent 555.39 12.99 237 69596 3446 29501248
Thrombocytopenia 434.38 12.99 972 68861 133851 29370843
Polyneuropathy 433.35 12.99 300 69533 11852 29492842
Platelet count decreased 393.77 12.99 804 69029 103868 29400826
Disease progression 318.27 12.99 638 69195 81278 29423416
Pneumonia 282.93 12.99 1493 68340 318679 29186015
Plasmacytoma 275.76 12.99 140 69693 3075 29501619
Drug interaction 260.72 12.99 72 69761 197313 29307381
Unevaluable event 224.53 12.99 313 69520 29538 29475156
Completed suicide 197.62 12.99 3 69830 90243 29414451
Drug abuse 173.45 12.99 3 69830 79880 29424814
Tumour lysis syndrome 166.35 12.99 184 69649 13700 29490994
Plasma cell leukaemia 163.61 12.99 64 69769 733 29503961
Orthostatic hypotension 162.31 12.99 232 69601 22397 29482297
Herpes zoster 142.38 12.99 255 69578 29797 29474897
Constipation 139.33 12.99 586 69247 113574 29391120
White blood cell count decreased 134.69 12.99 468 69365 82894 29421800
Diarrhoea 126.35 12.99 1268 68565 331430 29173264
Peripheral sensory neuropathy 122.49 12.99 106 69727 5833 29498861
Fatigue 120.49 12.99 1208 68625 315613 29189081
Overdose 111.16 12.99 26 69807 79793 29424901
Deep vein thrombosis 106.70 12.99 338 69495 57061 29447633
Autonomic neuropathy 102.97 12.99 47 69786 808 29503886
Neutropenia 97.43 12.99 587 69246 131124 29373570
Product use issue 95.67 12.99 303 69530 51141 29453553
Hypercalcaemia 91.74 12.99 131 69702 12628 29492066
Light chain analysis increased 85.92 12.99 45 69788 1056 29503638
Product use in unapproved indication 84.29 12.99 417 69416 86458 29418236
Rhabdomyolysis 84.27 12.99 20 69813 60788 29443906
Headache 82.70 12.99 180 69653 173827 29330867
Rash 82.40 12.99 745 69088 189074 29315620
Ileus paralytic 81.95 12.99 80 69753 5143 29499551
Amyloidosis 77.39 12.99 52 69781 1952 29502742
Full blood count decreased 77.38 12.99 137 69696 15855 29488839
Thrombosis 76.80 12.99 250 69583 42795 29461899
Myelodysplastic syndrome 74.23 12.99 143 69690 17651 29487043
Pancytopenia 74.23 12.99 390 69443 82778 29421916
Osteonecrosis of jaw 72.98 12.99 136 69697 16374 29488320
Blood creatine phosphokinase increased 65.72 12.99 9 69824 40635 29464059
Off label use 62.71 12.99 1027 68806 299773 29204921
Pyrexia 62.56 12.99 989 68844 286633 29218061
Therapy partial responder 60.70 12.99 68 69765 5131 29499563
Adverse drug reaction 59.64 12.99 157 69676 23863 29480831
Inappropriate schedule of product administration 58.96 12.99 16 69817 44456 29460238
Arthralgia 57.92 12.99 155 69678 139462 29365232
Plasma cell myeloma refractory 56.45 12.99 17 69816 80 29504614
Neuralgia 56.32 12.99 96 69737 10778 29493916
Depression 55.24 12.99 72 69761 85075 29419619
Hypertension 55.03 12.99 121 69712 116493 29388201
B precursor type acute leukaemia 53.91 12.99 18 69815 125 29504569
Atrial fibrillation 53.83 12.99 430 69403 105216 29399478
Spinal compression fracture 53.58 12.99 69 69764 6025 29498669
Chalazion 53.03 12.99 17 69816 102 29504592
Infection 52.83 12.99 336 69497 76415 29428279
Hypoaesthesia 52.77 12.99 258 69575 53209 29451485
Aggression 52.69 12.99 10 69823 35531 29469163
Psoriasis 52.43 12.99 7 69826 32220 29472474
Cytopenia 49.69 12.99 86 69747 9773 29494921
Protein total increased 48.18 12.99 40 69793 2078 29502616
Sepsis 47.76 12.99 531 69302 142151 29362543
Spinal cord compression 47.32 12.99 50 69783 3532 29501162
Condition aggravated 47.00 12.99 182 69651 146113 29358581
Seizure 46.98 12.99 93 69740 93030 29411664
Drug hypersensitivity 46.28 12.99 56 69777 68350 29436344
Primary amyloidosis 45.32 12.99 15 69818 101 29504593
Laboratory test abnormal 45.28 12.99 119 69714 18066 29486628
Blood pressure increased 45.25 12.99 65 69768 73738 29430956
Suicidal ideation 45.07 12.99 13 69820 34703 29469991
Abdominal pain 45.03 12.99 166 69667 135191 29369503
Anxiety 44.14 12.99 84 69749 85281 29419413
Stem cell transplant 44.11 12.99 37 69796 1950 29502744
Cardiac amyloidosis 43.68 12.99 27 69806 876 29503818
Compression fracture 41.84 12.99 41 69792 2647 29502047
Septic shock 41.27 12.99 271 69562 62289 29442405
Wrong technique in product usage process 40.37 12.99 12 69821 31416 29473278
Paraesthesia 40.35 12.99 241 69592 53604 29451090
Neutrophil count decreased 39.99 12.99 206 69627 43361 29461333
Ageusia 39.96 12.99 74 69759 8864 29495830
Peripheral sensorimotor neuropathy 39.88 12.99 30 69803 1349 29503345
Hypoglycaemia 39.02 12.99 34 69799 48312 29456382
Metapneumovirus infection 38.79 12.99 22 69811 607 29504087
Hyperviscosity syndrome 38.33 12.99 15 69818 172 29504522
Pathological fracture 37.64 12.99 46 69787 3809 29500885
Rash pruritic 37.30 12.99 127 69706 22236 29482458
Hypogammaglobulinaemia 37.20 12.99 57 69776 5850 29498844
Cystitis haemorrhagic 36.71 12.99 51 69782 4791 29499903
Osteolysis 36.52 12.99 30 69803 1535 29503159
Haematochezia 36.43 12.99 21 69812 36962 29467732
Monoclonal immunoglobulin present 36.38 12.99 24 69809 873 29503821
Bradycardia 35.32 12.99 63 69770 65566 29439128
Oroantral fistula 33.26 12.99 14 69819 196 29504498
Hiccups 33.13 12.99 68 69765 8785 29495909
Adenocarcinoma of colon 32.94 12.99 38 69795 2960 29501734
Guillain-Barre syndrome 32.12 12.99 49 69784 5009 29499685
Hallucination 31.97 12.99 35 69798 44677 29460017
Stress 31.95 12.99 6 69827 21484 29483210
Asthenia 31.94 12.99 698 69135 214552 29290142
Bone pain 31.84 12.99 106 69727 18346 29486348
Dehydration 31.34 12.99 411 69422 114337 29390357
Squamous cell carcinoma of skin 31.05 12.99 69 69764 9417 29495277
Flushing 30.71 12.99 15 69818 28977 29475717
Pulmonary embolism 30.37 12.99 295 69538 76239 29428455
Bone disorder 29.87 12.99 51 69782 5732 29498962
Ileus 29.70 12.99 88 69745 14314 29490380
Agitation 29.68 12.99 47 69786 51257 29453437
Intentional product misuse 29.67 12.99 23 69810 34638 29470056
Hyperkalaemia 29.51 12.99 63 69770 61329 29443365
Blood stem cell harvest failure 29.17 12.99 7 69826 10 29504684
Peripheral motor neuropathy 28.96 12.99 27 69806 1638 29503056
Electrocardiogram QT prolonged 28.46 12.99 26 69807 36111 29468583
Renal failure 28.41 12.99 415 69418 118184 29386510
Asthma 28.30 12.99 23 69810 33826 29470868
Osteonecrosis 28.25 12.99 83 69750 13436 29491258
Angioedema 27.55 12.99 21 69812 31894 29472800
Bacterial infection 27.54 12.99 80 69753 12868 29491826
Bone marrow failure 27.45 12.99 133 69700 27316 29477378
Contraindicated product administered 27.37 12.99 5 69828 18261 29486433
Hordeolum 26.97 12.99 19 69814 771 29503923
Malaise 26.92 12.99 244 69589 159358 29345336
Bacteraemia 26.61 12.99 92 69741 16231 29488463
Diverticular perforation 26.56 12.99 34 69799 2950 29501744
Meningitis pneumococcal 26.53 12.99 11 69822 148 29504546
Drug-induced liver injury 26.51 12.99 9 69824 21646 29483048
Visceral leishmaniasis 26.42 12.99 16 69817 500 29504194
Respirovirus test positive 26.42 12.99 9 69824 67 29504627
Erythema 26.26 12.99 91 69742 75515 29429179
Therapy non-responder 26.20 12.99 143 69690 30768 29473926
VIth nerve paralysis 25.49 12.99 18 69815 733 29503961
Tooth deposit 25.33 12.99 9 69824 77 29504617
Myocardial infarction 25.08 12.99 155 69678 110141 29394553
Cytomegalovirus infection 25.05 12.99 115 69718 23100 29481594
Progressive multifocal leukoencephalopathy 24.78 12.99 60 69773 8659 29496035
Somnolence 24.64 12.99 126 69707 93829 29410865
Metabolic acidosis 24.25 12.99 32 69801 37630 29467064
Haemoglobin decreased 23.92 12.99 374 69459 108001 29396693
Febrile neutropenia 23.89 12.99 385 69448 111855 29392839
Hyperhidrosis 23.56 12.99 76 69757 64464 29440230
Lactic acidosis 23.53 12.99 22 69811 30225 29474469
Performance status decreased 23.52 12.99 36 69797 3691 29501003
Incorrect dose administered 23.38 12.99 26 69807 32958 29471736
H1N1 influenza 23.12 12.99 18 69815 852 29503842
Gastric ulcer 23.00 12.99 3 69830 14058 29490636
Bone lesion 22.81 12.99 30 69803 2674 29502020
Anaphylactic reaction 22.72 12.99 19 69814 27554 29477140
Drug level increased 22.67 12.99 8 69825 18779 29485915
Injection site pain 22.53 12.99 26 69807 32420 29472274
Parainfluenzae virus infection 22.22 12.99 27 69806 2222 29502472
Mobility decreased 22.20 12.99 17 69816 25763 29478931
Spinal fracture 22.16 12.99 48 69785 6438 29498256
Pallor 22.08 12.99 11 69822 21013 29483681
Respiratory tract infection 21.94 12.99 84 69749 15567 29489127
Anaemia 21.85 12.99 625 69208 200326 29304368
Gastrointestinal amyloidosis 21.79 12.99 6 69827 19 29504675
Abnormal behaviour 21.57 12.99 14 69819 23113 29481581
Dysarthria 21.22 12.99 25 69808 30886 29473808
Chronic inflammatory demyelinating polyradiculoneuropathy 21.20 12.99 15 69818 613 29504081
Brief psychotic disorder with marked stressors 21.15 12.99 10 69823 187 29504507
Rib fracture 21.00 12.99 72 69761 12646 29492048
Drug ineffective 20.98 12.99 676 69157 362494 29142200
Neurogenic bladder 20.66 12.99 22 69811 1568 29503126
Cytomegalovirus infection reactivation 20.54 12.99 32 69801 3332 29501362
Rectal adenocarcinoma 20.43 12.99 16 69817 764 29503930
Monoclonal gammopathy 20.41 12.99 11 69822 274 29504420
Emotional distress 20.40 12.99 4 69829 13891 29490803
Clostridium difficile colitis 20.27 12.99 73 69760 13139 29491555
Colitis ulcerative 20.23 12.99 3 69830 12766 29491928
Palmar-plantar erythrodysaesthesia syndrome 20.15 12.99 5 69828 14754 29489940
Myalgia 20.12 12.99 98 69735 73921 29430773
Blood pressure fluctuation 20.02 12.99 11 69822 19883 29484811
Blood immunoglobulin A increased 19.98 12.99 11 69822 286 29504408
Coronary artery disease 19.88 12.99 47 69786 44143 29460551
Acute febrile neutrophilic dermatosis 19.81 12.99 18 69815 1056 29503638
Autologous haematopoietic stem cell transplant 19.79 12.99 5 69828 10 29504684
Conjunctival irritation 19.75 12.99 8 69825 101 29504593
Wheezing 19.65 12.99 30 69803 33210 29471484
Respiratory depression 19.63 12.99 4 69829 13519 29491175
Infusion related reaction 19.32 12.99 173 69660 43713 29460981
Basal cell carcinoma 19.17 12.99 85 69748 16825 29487869
Demyelinating polyneuropathy 18.84 12.99 18 69815 1126 29503568
Blood calcium increased 18.79 12.99 30 69803 3189 29501505
Accidental overdose 18.78 12.99 9 69824 17584 29487110
Jaundice 18.75 12.99 25 69808 29271 29475423
Disturbance in attention 18.61 12.99 14 69819 21410 29483284
Blood lactate dehydrogenase increased 18.44 12.99 92 69741 19117 29485577
Musculoskeletal stiffness 18.36 12.99 38 69795 37420 29467274
Pleuritic pain 18.25 12.99 28 69805 2877 29501817
Blood immunoglobulin M increased 18.13 12.99 9 69824 188 29504506
Cerebrovascular accident 18.04 12.99 107 69726 76804 29427890
Product prescribing error 18.00 12.99 10 69823 17966 29486728
Respiratory arrest 17.62 12.99 21 69812 25812 29478882
Enterococcal infection 17.50 12.99 51 69782 8217 29496477
Acute lymphocytic leukaemia 17.44 12.99 26 69807 2605 29502089
Tachycardia 17.38 12.99 100 69733 72310 29432384
Acute myeloid leukaemia 17.22 12.99 81 69752 16432 29488262
Hallucination, visual 17.10 12.99 7 69826 15008 29489686
Blood immunoglobulin G increased 16.86 12.99 15 69818 856 29503838
Depressed level of consciousness 16.85 12.99 39 69794 36903 29467791
Haematotoxicity 16.84 12.99 44 69789 6655 29498039
Peripheral swelling 16.83 12.99 227 69606 63512 29441182
Cardiac arrest 16.61 12.99 126 69707 85465 29419229
Autonomic nervous system imbalance 16.50 12.99 24 69809 2352 29502342
Neutropenic sepsis 16.49 12.99 63 69770 11664 29493030
Adenovirus infection 16.45 12.99 34 69799 4413 29500281
Blepharitis 16.44 12.99 16 69817 1024 29503670
Sopor 16.36 12.99 3 69830 10931 29493763
Dyskinesia 16.31 12.99 14 69819 20047 29484647
Synovitis 16.27 12.99 3 69830 10887 29493807
Pleural effusion 16.17 12.99 249 69584 71659 29433035
Laryngeal cancer metastatic 16.15 12.99 6 69827 59 29504635
Renal amyloidosis 16.15 12.99 6 69827 59 29504635
Haematuria 16.09 12.99 52 69781 44087 29460607
Haemorrhagic fever 16.04 12.99 5 69828 27 29504667
Full blood count increased 16.02 12.99 14 69819 780 29503914
Type 2 diabetes mellitus 16.02 12.99 6 69827 13575 29491119
Genital erythema 15.99 12.99 8 69825 170 29504524
Accidental exposure to product 15.99 12.99 3 69830 10750 29493944
Loss of personal independence in daily activities 15.98 12.99 22 69811 25418 29479276
Taste disorder 15.92 12.99 35 69798 4741 29499953
Medication error 15.84 12.99 16 69817 21195 29483499
Nephrolithiasis 15.82 12.99 22 69811 25312 29479382
Hyperlipidaemia 15.82 12.99 5 69828 12585 29492109
COVID-19 pneumonia 15.81 12.99 54 69779 9468 29495226
Fat tissue increased 15.76 12.99 10 69823 340 29504354
Product quality issue 15.69 12.99 9 69824 15886 29488808
Ascites 15.65 12.99 40 69793 36579 29468115
Escherichia sepsis 15.57 12.99 31 69802 3918 29500776
Gastrooesophageal reflux disease 15.40 12.99 32 69801 31464 29473230
Morganella infection 15.32 12.99 11 69822 460 29504234
Depressed mood 15.28 12.99 10 69823 16438 29488256
Melaena 14.97 12.99 32 69801 31144 29473550
Light chain analysis decreased 14.94 12.99 5 69828 35 29504659
Aphasia 14.89 12.99 14 69819 19184 29485510
Heart rate increased 14.81 12.99 45 69788 38893 29465801
Body height decreased 14.72 12.99 28 69805 3422 29501272
Coma 14.71 12.99 46 69787 39404 29465290
Refractory cytopenia with multilineage dysplasia 14.70 12.99 7 69826 133 29504561
Blood culture positive 14.65 12.99 33 69800 4544 29500150
Blood pressure systolic increased 14.64 12.99 11 69822 16834 29487860
Injury 14.64 12.99 14 69819 19032 29485662
Diabetic ketoacidosis 14.62 12.99 10 69823 16063 29488631
Refractory anaemia with an excess of blasts 14.61 12.99 10 69823 387 29504307
Obstructive airways disorder 14.53 12.99 4 69829 11012 29493682
Cellulitis orbital 14.45 12.99 9 69824 296 29504398
JC virus infection 14.41 12.99 20 69813 1877 29502817
Oesophageal adenocarcinoma 14.18 12.99 13 69820 772 29503922
Colitis 14.18 12.99 124 69709 31124 29473570
Extrapyramidal disorder 14.16 12.99 4 69829 10827 29493867
Muscle spasms 14.12 12.99 224 69609 64858 29439836
Hepatitis 14.06 12.99 17 69816 20766 29483928
Pregnancy of partner 14.05 12.99 9 69824 311 29504383
VIth nerve paresis 14.05 12.99 5 69828 43 29504651
Cholestasis 14.04 12.99 21 69812 23441 29481253
Alanine aminotransferase increased 13.97 12.99 104 69729 70840 29433854
Vomiting 13.96 12.99 388 69445 211872 29292822
Dystonia 13.91 12.99 3 69830 9746 29494948
Hypersensitivity 13.83 12.99 71 69762 52832 29451862
Serratia sepsis 13.80 12.99 4 69829 16 29504678
COVID-19 13.39 12.99 137 69696 35877 29468817
Spinal pain 13.32 12.99 33 69800 4831 29499863
Pneumonia mycoplasmal 13.31 12.99 11 69822 568 29504126
Hypercapnic coma 13.30 12.99 7 69826 166 29504528
Hyposmia 13.26 12.99 7 69826 167 29504527
Glomerular filtration rate decreased 13.25 12.99 5 69828 11261 29493433
Glycosylated haemoglobin increased 13.25 12.99 3 69830 9423 29495271
Meningioma 13.10 12.99 16 69817 1324 29503370
Hypothyroidism 13.06 12.99 11 69822 15895 29488799
Blood triglycerides increased 13.05 12.99 7 69826 12827 29491867

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
Neuropathy peripheral 3188.08 11.93 2104 100824 115421 64280383
Plasma cell myeloma 2047.47 11.93 1134 101794 44941 64350863
Plasma cell myeloma recurrent 1088.95 11.93 359 102569 3706 64392098
Thrombocytopenia 998.85 11.93 1488 101440 222313 64173491
Platelet count decreased 724.38 11.93 1099 101829 166612 64229192
Disease progression 652.51 11.93 957 101971 140723 64255081
Polyneuropathy 623.14 11.93 391 102537 19503 64376301
Pneumonia 617.75 11.93 2125 100803 557451 63838353
Plasmacytoma 551.09 11.93 214 102714 3656 64392148
Completed suicide 332.37 11.93 5 102923 224409 64171395
Unevaluable event 325.21 11.93 402 102526 50087 64345717
Plasma cell leukaemia 313.55 11.93 111 102817 1442 64394362
Neutropenia 307.68 11.93 960 101968 238664 64157140
Tumour lysis syndrome 288.42 11.93 243 102685 19197 64376607
Diarrhoea 266.88 11.93 2016 100912 720688 63675116
Drug interaction 247.49 11.93 135 102793 361948 64033856
Product use in unapproved indication 246.59 11.93 729 102199 175889 64219915
Rheumatoid arthritis 246.10 11.93 3 102925 164291 64231513
White blood cell count decreased 245.13 11.93 677 102251 157160 64238644
Peripheral sensory neuropathy 244.32 11.93 177 102751 11201 64384603
Headache 243.11 11.93 293 102635 529174 63866630
Arthralgia 226.98 11.93 223 102705 442037 63953767
Pancytopenia 222.80 11.93 615 102313 142694 64253110
Orthostatic hypotension 219.46 11.93 319 102609 46419 64349385
Drug hypersensitivity 214.95 11.93 57 102871 237758 64158046
Constipation 204.46 11.93 815 102113 228522 64167282
Sepsis 203.30 11.93 816 102112 229525 64166279
Off label use 196.55 11.93 1698 101230 631108 63764696
Amyloidosis 188.47 11.93 88 102840 2406 64393398
Deep vein thrombosis 185.34 11.93 473 102455 104709 64291095
Herpes zoster 179.62 11.93 393 102535 78794 64317010
Septic shock 160.35 11.93 449 102479 104988 64290816
Drug abuse 159.44 11.93 14 102914 132360 64263444
Myelodysplastic syndrome 157.63 11.93 207 102721 27372 64368432
Febrile neutropenia 154.58 11.93 651 102277 187006 64208798
Autonomic neuropathy 149.20 11.93 66 102862 1586 64394218
Overdose 146.50 11.93 37 102891 159529 64236275
Synovitis 143.35 11.93 3 102925 99087 64296717
Maternal exposure during pregnancy 138.33 11.93 3 102925 95881 64299923
Light chain analysis increased 136.93 11.93 58 102870 1250 64394554
Neutrophil count decreased 136.82 11.93 348 102580 76848 64318956
Contraindicated product administered 136.65 11.93 9 102919 107820 64287984
Cardiac amyloidosis 135.79 11.93 59 102869 1356 64394448
Ileus paralytic 134.81 11.93 110 102818 8305 64387499
Anaemia 129.30 11.93 1039 101889 377641 64018163
Atrial fibrillation 128.98 11.93 578 102350 170511 64225293
Pyrexia 128.30 11.93 1408 101520 557236 63838568
Dehydration 125.39 11.93 679 102249 216084 64179720
Cytopenia 124.24 11.93 138 102790 15333 64380471
Chalazion 118.73 11.93 39 102889 397 64395407
Pain 118.23 11.93 469 102459 553042 63842762
Therapy partial responder 114.16 11.93 109 102819 10139 64385665
Full blood count decreased 110.17 11.93 157 102771 22425 64373379
Systemic lupus erythematosus 109.76 11.93 3 102925 77609 64318195
Product use issue 109.45 11.93 506 102422 151209 64244595
Alopecia 107.00 11.93 66 102862 165624 64230180
Hypercalcaemia 106.77 11.93 185 102743 31231 64364573
Exposure during pregnancy 106.29 11.93 4 102924 77671 64318133
Arthropathy 105.47 11.93 31 102897 120936 64274868
Condition aggravated 102.56 11.93 282 102646 372144 64023660
Joint swelling 101.96 11.93 116 102812 215266 64180538
Anxiety 97.17 11.93 108 102820 202541 64193263
Psoriasis 97.07 11.93 4 102924 71699 64324105
Musculoskeletal stiffness 94.65 11.93 39 102889 123167 64272637
Blood pressure increased 93.00 11.93 83 102845 172469 64223335
Suicide attempt 92.77 11.93 5 102923 71002 64324802
Renal failure 92.40 11.93 550 102378 181138 64214666
Hypersensitivity 90.61 11.93 108 102820 196344 64199460
Malignant neoplasm progression 88.54 11.93 386 102542 112485 64283319
Therapeutic product effect decreased 87.82 11.93 37 102891 115314 64280490
Glossodynia 86.29 11.93 4 102924 64692 64331112
Peripheral sensorimotor neuropathy 83.91 11.93 52 102876 2533 64393271
Stem cell transplant 83.62 11.93 58 102870 3423 64392381
Cytomegalovirus infection 83.59 11.93 184 102744 37015 64358789
Injection site pain 82.81 11.93 37 102891 111371 64284433
Swelling 81.72 11.93 81 102847 160137 64235667
Thrombosis 80.43 11.93 272 102656 70370 64325434
Pathological fracture 78.71 11.93 84 102844 8921 64386883
Primary amyloidosis 77.84 11.93 21 102907 99 64395705
Hyperviscosity syndrome 77.31 11.93 27 102901 336 64395468
Rhabdomyolysis 75.52 11.93 26 102902 91700 64304104
Cytomegalovirus infection reactivation 73.36 11.93 66 102862 5690 64390114
Abdominal discomfort 73.15 11.93 111 102817 182211 64213593
Depression 73.14 11.93 112 102816 183179 64212625
Pleural effusion 72.78 11.93 396 102532 126163 64269641
Peripheral motor neuropathy 72.55 11.93 50 102878 2920 64392884
Bone marrow failure 71.65 11.93 203 102725 47749 64348055
Spinal cord compression 69.95 11.93 64 102864 5639 64390165
Mobility decreased 69.52 11.93 25 102903 85815 64309989
Haemoglobin decreased 69.01 11.93 540 102388 194523 64201281
Wrong technique in product usage process 68.05 11.93 11 102917 64963 64330841
Wound 67.76 11.93 19 102909 76458 64319346
Blood stem cell harvest failure 67.58 11.93 18 102910 80 64395724
Monoclonal immunoglobulin present 67.54 11.93 31 102897 814 64394990
Discomfort 66.45 11.93 23 102905 80855 64314949
Posterior reversible encephalopathy syndrome 66.36 11.93 126 102802 22820 64372984
Malaise 66.01 11.93 367 102561 395880 63999924
Plasma cell myeloma refractory 65.52 11.93 18 102910 92 64395712
Osteonecrosis of jaw 64.86 11.93 174 102754 39651 64356153
B precursor type acute leukaemia 62.76 11.93 22 102906 277 64395527
Pulmonary embolism 62.57 11.93 424 102504 145932 64249872
Colitis 62.50 11.93 221 102707 58453 64337351
Protein total increased 62.32 11.93 48 102880 3333 64392471
Weight increased 62.10 11.93 157 102771 213191 64182613
Osteolysis 61.07 11.93 44 102884 2759 64393045
Blood pressure fluctuation 61.06 11.93 6 102922 51865 64343939
Therapy non-responder 60.82 11.93 237 102691 65662 64330142
Hordeolum 60.31 11.93 40 102888 2192 64393612
Stress 59.61 11.93 12 102916 60522 64335282
Hypertension 59.51 11.93 213 102715 259048 64136756
Blood lactate dehydrogenase increased 59.49 11.93 150 102778 32928 64362876
Blood creatine phosphokinase increased 58.95 11.93 11 102917 58547 64337257
Coombs indirect test positive 58.61 11.93 15 102913 55 64395749
Inappropriate schedule of product administration 57.85 11.93 38 102890 92248 64303556
Haematotoxicity 57.58 11.93 86 102842 12810 64382994
Flushing 55.55 11.93 28 102900 78620 64317184
Hypogammaglobulinaemia 55.31 11.93 75 102853 10224 64385580
Cardiac failure 54.50 11.93 380 102548 131993 64263811
Guillain-Barre syndrome 54.36 11.93 64 102864 7571 64388233
Ileus 53.19 11.93 115 102813 22851 64372953
Arthritis 50.55 11.93 36 102892 83778 64312026
Metapneumovirus infection 48.98 11.93 30 102898 1431 64394373
Hepatitis B reactivation 48.85 11.93 49 102879 4840 64390964
Hepatic enzyme increased 48.44 11.93 83 102845 129860 64265944
Infection 47.84 11.93 478 102450 184402 64211402
Renal amyloidosis 47.31 11.93 15 102913 135 64395669
Nasopharyngitis 47.06 11.93 158 102770 195915 64199889
Suicidal ideation 46.53 11.93 24 102904 66518 64329286
Bacteraemia 46.28 11.93 120 102808 26791 64369013
Bone pain 46.28 11.93 174 102754 47398 64348406
Migraine 46.27 11.93 21 102907 62656 64333148
Anaphylactic reaction 46.21 11.93 26 102902 68638 64327166
Treatment failure 45.99 11.93 72 102856 116744 64279060
Compression fracture 45.65 11.93 51 102877 5701 64390103
Neuralgia 45.28 11.93 117 102811 26067 64369737
Morganella infection 45.25 11.93 25 102903 981 64394823
Blood cholesterol increased 45.17 11.93 12 102916 50054 64345750
Drug ineffective 44.35 11.93 1013 101915 839234 63556570
Acute lymphocytic leukaemia 44.02 11.93 44 102884 4327 64391477
Aggression 43.81 11.93 10 102918 46222 64349582
Helicobacter infection 43.71 11.93 5 102923 38357 64357447
Gastrooesophageal reflux disease 43.57 11.93 41 102887 83102 64312702
Squamous cell carcinoma of skin 43.07 11.93 72 102856 11804 64384000
Injury 42.54 11.93 18 102910 55974 64339830
Hypocalcaemia 42.53 11.93 155 102773 41598 64354206
Asthenia 42.24 11.93 936 101992 427108 63968696
Myalgia 42.17 11.93 122 102806 158495 64237309
Somnolence 41.77 11.93 175 102753 203470 64192334
Acute myeloid leukaemia 41.74 11.93 117 102811 27346 64368458
Respiratory tract infection 41.65 11.93 143 102785 37264 64358540
Sedation 41.28 11.93 8 102920 41454 64354350
Pruritus 40.48 11.93 312 102616 312088 64083716
Erythema 40.09 11.93 158 102770 186912 64208892
Blister 40.05 11.93 42 102886 80925 64314879
Large intestine perforation 39.95 11.93 72 102856 12532 64383272
Irritable bowel syndrome 39.87 11.93 6 102922 37363 64358441
Crossmatch incompatible 39.66 11.93 10 102918 34 64395770
Wheezing 39.63 11.93 42 102886 80537 64315267
Rash 39.51 11.93 984 101944 457565 63938239
Spinal compression fracture 38.91 11.93 78 102850 14697 64381107
Refractory cytopenia with multilineage dysplasia 38.63 11.93 15 102913 256 64395548
Red blood cell sedimentation rate increased 38.43 11.93 3 102925 31232 64364572
Performance status decreased 38.25 11.93 45 102883 5319 64390485
Syncope 38.12 11.93 402 102526 157233 64238571
Pneumonia fungal 37.93 11.93 58 102870 8819 64386985
Blood pressure systolic increased 37.40 11.93 16 102912 49437 64346367
Osteoarthritis 37.16 11.93 28 102900 63308 64332496
Thrombotic microangiopathy 36.98 11.93 82 102846 16573 64379231
Nasal congestion 36.80 11.93 25 102903 59633 64336171
Heart rate increased 36.80 11.93 63 102865 98612 64297192
Loss of personal independence in daily activities 36.50 11.93 37 102891 72417 64323387
Sopor 36.07 11.93 3 102925 29658 64366146
Diverticular perforation 35.96 11.93 43 102885 5170 64390634
Hyperhidrosis 35.50 11.93 93 102835 124827 64270977
Cystitis haemorrhagic 35.44 11.93 53 102875 7903 64387901
Palpitations 35.17 11.93 71 102857 104417 64291387
Hypophosphataemia 34.42 11.93 74 102854 14646 64381158
Toxicity to various agents 34.29 11.93 790 102138 362723 64033081
Sleep disorder 34.26 11.93 27 102901 59682 64336122
Large intestinal ulcer perforation 34.12 11.93 10 102918 67 64395737
Inappropriate antidiuretic hormone secretion 33.91 11.93 95 102833 22194 64373610
Ill-defined disorder 33.72 11.93 14 102914 44038 64351766
Lactic acidosis 33.71 11.93 29 102899 61381 64334423
Drug withdrawal syndrome 33.44 11.93 5 102923 31286 64364518
Contusion 33.03 11.93 84 102844 113881 64281923
Mesenteric abscess 32.97 11.93 11 102917 118 64395686
Nocardiosis 32.36 11.93 39 102889 4728 64391076
VIth nerve paresis 31.93 11.93 11 102917 131 64395673
Oedema peripheral 31.93 11.93 492 102436 209825 64185979
Drug intolerance 31.84 11.93 173 102755 187819 64207985
Pneumonia pneumococcal 31.55 11.93 32 102896 3202 64392602
Abdominal pain upper 31.37 11.93 158 102770 174872 64220932
Blood immunoglobulin A increased 31.36 11.93 16 102912 533 64395271
Urticaria 31.19 11.93 125 102803 147192 64248612
COVID-19 pneumonia 30.89 11.93 76 102852 16428 64379376
Nasal abscess 30.79 11.93 11 102917 147 64395657
Hypothyroidism 30.74 11.93 13 102915 40444 64355360
Respiratory failure 30.47 11.93 392 102536 160791 64235013
Clostridium difficile colitis 30.25 11.93 104 102824 27119 64368685
Visceral leishmaniasis 30.25 11.93 19 102909 948 64394856
Inflammation 29.97 11.93 36 102892 65264 64330540
Neurotoxicity 29.85 11.93 104 102824 27300 64368504
Hypoalbuminaemia 29.56 11.93 78 102850 17596 64378208
Folliculitis 29.53 11.93 6 102922 30071 64365733
Rib fracture 29.53 11.93 95 102833 23943 64371861
Demyelinating polyneuropathy 29.51 11.93 22 102906 1454 64394350
Product quality issue 29.14 11.93 6 102922 29793 64366011
Endocarditis bacterial 29.07 11.93 21 102907 1322 64394482
Body dysmorphic disorder 28.84 11.93 12 102916 247 64395557
Injection site swelling 28.78 11.93 15 102913 41338 64354466
Asthma 28.52 11.93 69 102859 95156 64300648
Osteoporosis 28.22 11.93 16 102912 42064 64353740
Hepatitis B 28.14 11.93 47 102881 7698 64388106
Osteonecrosis 28.08 11.93 104 102824 28125 64367679
Dysarthria 28.07 11.93 32 102896 59374 64336430
Seizure 28.03 11.93 154 102774 166738 64229066
Underdose 27.90 11.93 4 102924 25825 64369979
Hypoglycaemia 27.83 11.93 64 102864 89828 64305976
Failure to thrive 27.49 11.93 55 102873 10349 64385455
Meningitis pneumococcal 27.36 11.93 13 102915 370 64395434
Cough 27.15 11.93 330 102598 301818 64093986
Mucosal inflammation 27.13 11.93 182 102746 62402 64333402
Oroantral fistula 27.10 11.93 13 102915 378 64395426
Rectal adenocarcinoma 26.81 11.93 20 102908 1323 64394481
Bacterial sepsis 26.76 11.93 45 102883 7412 64388392
Hiccups 26.74 11.93 48 102880 8328 64387476
Abdominal pain 26.63 11.93 345 102583 312030 64083774
Taste disorder 26.29 11.93 51 102877 9382 64386422
Ageusia 26.27 11.93 64 102864 13749 64382055
Pericarditis 26.08 11.93 37 102891 62479 64333325
Progressive multifocal leukoencephalopathy 26.08 11.93 76 102852 18156 64377648
Fatigue 25.81 11.93 1450 101478 747280 63648524
Chronic inflammatory demyelinating polyradiculoneuropathy 25.79 11.93 17 102911 922 64394882
Fungal oesophagitis 25.75 11.93 16 102912 783 64395021
Hypoaesthesia 25.74 11.93 337 102591 138771 64257033
Feeling abnormal 25.44 11.93 118 102810 133484 64262320
Oral surgery 25.37 11.93 17 102911 948 64394856
Incorrect dose administered 25.32 11.93 36 102892 60729 64335075
VIth nerve paralysis 25.26 11.93 20 102908 1446 64394358
Adenocarcinoma of colon 25.23 11.93 35 102893 4873 64390931
Blood immunoglobulin G increased 25.23 11.93 22 102906 1819 64393985
Autonomic nervous system imbalance 25.14 11.93 32 102896 4100 64391704
Target skin lesion 25.14 11.93 9 102919 121 64395683
Lymphopenia 25.08 11.93 94 102834 25563 64370241
Respirovirus test positive 24.94 11.93 9 102919 124 64395680
Refractory anaemia with an excess of blasts 24.91 11.93 16 102912 830 64394974
Gait disturbance 24.65 11.93 167 102761 171988 64223816
Pain in extremity 24.65 11.93 338 102590 302747 64093057
Iron deficiency anaemia 24.57 11.93 3 102925 21886 64373918
Respiratory depression 24.47 11.93 4 102924 23439 64372365
Blepharitis 24.42 11.93 25 102903 2530 64393274
Clostridium bacteraemia 24.32 11.93 11 102917 279 64395525
Chest discomfort 24.27 11.93 99 102829 116007 64279797
Gastrointestinal fungal infection 24.19 11.93 12 102916 376 64395428
Escherichia sepsis 24.08 11.93 42 102886 7123 64388681
Enterococcal infection 24.02 11.93 62 102866 13804 64382000
Colitis ulcerative 23.88 11.93 4 102924 23024 64372780
Hip arthroplasty 23.79 11.93 3 102925 21348 64374456
Diabetic ketoacidosis 23.64 11.93 9 102919 29836 64365968
Dyskinesia 23.64 11.93 17 102911 39371 64356433
Meningitis listeria 23.62 11.93 15 102913 763 64395041
Accidental overdose 23.61 11.93 12 102916 33545 64362259
Heart rate decreased 23.57 11.93 32 102896 55035 64340769
Angioedema 23.48 11.93 39 102889 61782 64334022
COVID-19 23.36 11.93 181 102747 64959 64330845
Drug-induced liver injury 23.24 11.93 25 102903 47618 64348186
Lip swelling 23.07 11.93 11 102917 31896 64363908
Hyperproteinaemia 23.05 11.93 9 102919 156 64395648
Blood potassium decreased 22.92 11.93 126 102802 40273 64355531
Meningitis cryptococcal 22.72 11.93 26 102902 2983 64392821
Type 2 diabetes mellitus 22.72 11.93 13 102915 34007 64361797
Electrolyte imbalance 22.64 11.93 90 102838 25153 64370651
Obesity 22.64 11.93 3 102925 20559 64375245
Laboratory test abnormal 22.56 11.93 87 102841 23976 64371828
Swollen tongue 22.44 11.93 14 102914 34940 64360864
Pneumonia cytomegaloviral 22.40 11.93 31 102897 4308 64391496
Pseudomonal sepsis 22.39 11.93 34 102894 5138 64390666
Nephrolithiasis 22.35 11.93 22 102906 43661 64352143
Prescribed overdose 22.31 11.93 3 102925 20328 64375476
Basal cell carcinoma 22.30 11.93 103 102825 30735 64365069
Acute febrile neutrophilic dermatosis 22.21 11.93 27 102901 3302 64392502
Impaired healing 22.19 11.93 39 102889 60434 64335370
Neurogenic bladder 21.98 11.93 28 102900 3591 64392213
Crying 21.96 11.93 3 102925 20087 64375717
Depressed mood 21.75 11.93 20 102908 40992 64354812
Hot flush 21.74 11.93 25 102903 46210 64349594
Parainfluenzae virus infection 21.71 11.93 32 102896 4711 64391093
Sinusitis 21.68 11.93 140 102788 145788 64250016
Pallor 21.67 11.93 18 102910 38763 64357041
Lung infiltration 21.65 11.93 78 102850 20811 64374993
Bacterial infection 21.62 11.93 88 102840 24862 64370942
Bradycardia 21.58 11.93 106 102822 118113 64277691
Surgery 21.54 11.93 9 102919 28204 64367600
End stage renal disease 21.50 11.93 50 102878 10425 64385379
Medication error 21.42 11.93 29 102899 49937 64345867
Depressed level of consciousness 21.36 11.93 63 102865 81373 64314431
Superficial spreading melanoma stage unspecified 21.36 11.93 10 102918 275 64395529
H1N1 influenza 21.34 11.93 22 102906 2244 64393560
Blood culture positive 21.27 11.93 42 102886 7826 64387978
Cerebellar haemangioma 21.24 11.93 7 102921 72 64395732
Electrocardiogram QT prolonged 21.18 11.93 61 102867 79387 64316417
Graft versus host disease 21.14 11.93 59 102869 13754 64382050
Throat irritation 21.14 11.93 13 102915 32698 64363106
Pulmonary oedema 21.09 11.93 205 102723 78469 64317335
Conjunctival irritation 21.08 11.93 8 102920 128 64395676
Neutropenic sepsis 20.90 11.93 83 102845 23189 64372615
Toxic skin eruption 20.84 11.93 73 102855 19211 64376593
Accidental exposure to product 20.80 11.93 8 102920 26356 64369448
Amnesia 20.71 11.93 28 102900 48241 64347563
JC virus infection 20.44 11.93 26 102902 3329 64392475
Visual impairment 20.39 11.93 56 102872 74021 64321783
Hypokalaemia 20.37 11.93 290 102638 121613 64274191
Oropharyngeal pain 20.36 11.93 73 102855 88794 64307010
Bronchiolitis 20.29 11.93 27 102901 3614 64392190
Coma 20.06 11.93 72 102856 87543 64308261
Leukaemia 20.01 11.93 32 102896 5056 64390748
Tooth deposit 19.98 11.93 9 102919 226 64395578
Refractory cancer 19.94 11.93 9 102919 227 64395577
Musculoskeletal pain 19.83 11.93 65 102863 81229 64314575
Intentional product misuse 19.64 11.93 55 102873 72240 64323564
Sinus polyp 19.60 11.93 11 102917 445 64395359
General physical condition abnormal 19.56 11.93 33 102895 5449 64390355
Hallucination, visual 19.51 11.93 10 102918 27824 64367980
Pneumonia influenzal 19.40 11.93 22 102906 2500 64393304
Irritability 19.39 11.93 18 102910 36728 64359076
Chromaturia 19.32 11.93 6 102922 22605 64373199
Device dislocation 19.25 11.93 5 102923 21173 64374631
Lung disorder 19.24 11.93 164 102764 60536 64335268
Paraesthesia 19.00 11.93 311 102617 134211 64261593
Extrapyramidal disorder 18.99 11.93 4 102924 19548 64376256
Injection site bruising 18.98 11.93 18 102910 36355 64359449
Atrial flutter 18.94 11.93 71 102857 19309 64376495
Mantle cell lymphoma recurrent 18.87 11.93 11 102917 479 64395325
Death 18.82 11.93 946 101982 481759 63914045
Brief psychotic disorder with marked stressors 18.75 11.93 9 102919 262 64395542
Adenovirus infection 18.74 11.93 38 102890 7217 64388587
Dry mouth 18.71 11.93 43 102885 60375 64335429
Therapeutic response decreased 18.70 11.93 145 102783 52043 64343761
Intraductal proliferative breast lesion 18.68 11.93 20 102908 2131 64393673
Peritonitis viral 18.64 11.93 6 102922 57 64395747
Memory impairment 18.58 11.93 72 102856 85610 64310194
Faeces discoloured 18.40 11.93 9 102919 25720 64370084
Dyspepsia 18.38 11.93 66 102862 80246 64315558
Acne 18.21 11.93 7 102921 23074 64372730
Multiple sclerosis 18.14 11.93 4 102924 18937 64376867
Pseudomyopia 18.10 11.93 6 102922 63 64395741
Torsade de pointes 18.04 11.93 3 102925 17360 64378444
Bursitis 17.83 11.93 6 102922 21479 64374325
Malignant melanoma in situ 17.74 11.93 18 102910 1802 64394002
Plasma cells present 17.73 11.93 4 102924 7 64395797
Therapy interrupted 17.70 11.93 5 102923 20031 64375773
Rash pruritic 17.62 11.93 154 102774 57250 64338554
Light chain analysis abnormal 17.58 11.93 7 102921 128 64395676
Disturbance in social behaviour 17.47 11.93 26 102902 3861 64391943
Drug reaction with eosinophilia and systemic symptoms 17.46 11.93 147 102781 54070 64341734
Injection site exfoliation 17.29 11.93 7 102921 134 64395670
Frequent bowel movements 17.26 11.93 4 102924 18301 64377503
Genital erythema 17.19 11.93 8 102920 217 64395587
Bone lesion 17.12 11.93 30 102898 5107 64390697
Hyperthyroidism 17.09 11.93 4 102924 18175 64377629
Blood immunoglobulin M increased 17.01 11.93 10 102918 442 64395362
Cerebral aspergillosis 16.97 11.93 17 102911 1676 64394128
Gastric ulcer 16.93 11.93 14 102914 30220 64365584
Multiple organ dysfunction syndrome 16.84 11.93 241 102687 101172 64294632
Myelosuppression 16.80 11.93 79 102849 23751 64372053
Light chain analysis 16.77 11.93 4 102924 10 64395794
Enteric neuropathy 16.77 11.93 4 102924 10 64395794
Joint range of motion decreased 16.77 11.93 5 102923 19338 64376466
Plasma cells decreased 16.75 11.93 5 102923 36 64395768
Adverse drug reaction 16.67 11.93 127 102801 45337 64350467
Drug level increased 16.61 11.93 18 102910 34178 64361626
Ejection fraction decreased 16.60 11.93 90 102838 28617 64367187
Liver injury 16.59 11.93 14 102914 29918 64365886
Joint ankylosis 16.59 11.93 12 102916 757 64395047
Decreased appetite 16.58 11.93 576 102352 280713 64115091
Liver function test increased 16.54 11.93 15 102913 30955 64364849
Sleep apnoea syndrome 16.48 11.93 14 102914 29818 64365986
Cardio-respiratory arrest 16.40 11.93 91 102837 98302 64297502
Aphasia 16.29 11.93 25 102903 40881 64354923
Enterococcal sepsis 16.27 11.93 20 102908 2474 64393330
Thrombotic thrombocytopenic purpura 16.25 11.93 32 102896 5952 64389852
Poor quality sleep 16.25 11.93 5 102923 18946 64376858
Organising pneumonia 16.21 11.93 41 102887 9014 64386790
Respiratory arrest 16.17 11.93 38 102890 52947 64342857
Renal impairment 16.15 11.93 304 102624 134713 64261091
Glycosylated haemoglobin increased 16.14 11.93 3 102925 16016 64379788
Fear 16.11 11.93 6 102922 20165 64375639
Infection reactivation 16.11 11.93 18 102910 2012 64393792
Myocardial infarction 16.08 11.93 178 102750 165643 64230161
Venous thrombosis 15.99 11.93 33 102895 6348 64389456
Adenoviral haemorrhagic cystitis 15.88 11.93 10 102918 501 64395303
Empyema 15.73 11.93 24 102904 3641 64392163
Paraproteinaemia 15.71 11.93 9 102919 379 64395425
Blood creatinine increased 15.65 11.93 304 102624 135478 64260326
Staphylococcal bacteraemia 15.62 11.93 44 102884 10311 64385493
Pneumonia parainfluenzae viral 15.58 11.93 8 102920 270 64395534
Disturbance in attention 15.51 11.93 26 102902 41048 64354756
Infection in an immunocompromised host 15.45 11.93 13 102915 1024 64394780
Dyspnoea 15.41 11.93 965 101963 717709 63678095
Laryngeal cancer metastatic 15.30 11.93 5 102923 50 64395754
Cardiac failure congestive 15.27 11.93 293 102635 130287 64265517
Plasmablastic lymphoma 15.27 11.93 9 102919 400 64395404
Neck pain 15.15 11.93 49 102879 61484 64334320
Hypoglossal nerve paresis 15.11 11.93 6 102922 109 64395695
Hyperlipidaemia 15.03 11.93 9 102919 22967 64372837
Hyperamylasaemia 15.02 11.93 12 102916 879 64394925
Nodule 14.92 11.93 5 102923 17942 64377862
Periodontitis 14.79 11.93 25 102903 4134 64391670
Atelectasis 14.77 11.93 84 102844 27182 64368622
Capillary leak syndrome 14.74 11.93 22 102906 3275 64392529
Engraftment syndrome 14.65 11.93 13 102915 1100 64394704
Tendonitis 14.65 11.93 7 102921 20275 64375529
Monoclonal gammopathy 14.64 11.93 11 102917 736 64395068
Myositis 14.63 11.93 4 102924 16373 64379431
Immunosuppression 14.61 11.93 44 102884 10702 64385102
Product prescribing error 14.59 11.93 21 102907 35248 64360556
Serratia sepsis 14.53 11.93 6 102922 121 64395683
Scrotal pain 14.53 11.93 9 102919 438 64395366
Body temperature decreased 14.53 11.93 12 102916 25916 64369888
Hyperkalaemia 14.52 11.93 98 102830 101031 64294773
Squamous cell carcinoma of lung 14.51 11.93 17 102911 2001 64393803
Acute respiratory distress syndrome 14.41 11.93 109 102819 38826 64356978
Clostridium difficile infection 14.39 11.93 103 102825 36060 64359744
Escherichia infection 14.35 11.93 55 102873 15113 64380691
Tachycardia 14.33 11.93 161 102767 149418 64246386
Cytomegalovirus enterocolitis 14.31 11.93 14 102914 1341 64394463
Febrile bone marrow aplasia 14.30 11.93 45 102883 11210 64384594
Cardiomegaly 14.20 11.93 75 102853 23609 64372195
Nightmare 14.05 11.93 8 102920 20985 64374819
Panic attack 14.00 11.93 8 102920 20945 64374859
Bronchopulmonary aspergillosis 13.99 11.93 64 102864 19021 64376783
Varicella 13.94 11.93 19 102909 2602 64393202
Pneumocystis jirovecii infection 13.92 11.93 18 102910 2343 64393461
Cardiotoxicity 13.91 11.93 42 102886 10232 64385572
Pulmonary arterial hypertension 13.89 11.93 12 102916 25355 64370449
Parkinsonism 13.84 11.93 3 102925 14370 64381434
Pneumonia bacterial 13.80 11.93 54 102874 14981 64380823
Small intestinal obstruction 13.69 11.93 74 102854 23499 64372305
Pneumonia respiratory syncytial viral 13.67 11.93 14 102914 1417 64394387
Haematochezia 13.61 11.93 57 102871 66316 64329488
Cholelithiasis 13.60 11.93 33 102895 45473 64350331
Eosinophil count increased 13.48 11.93 3 102925 14109 64381695
Gastrointestinal amyloidosis 13.47 11.93 5 102923 75 64395729
Procedural pain 13.46 11.93 4 102924 15504 64380300
Delayed engraftment 13.40 11.93 7 102921 245 64395559
Pulmonary alveolar haemorrhage 13.36 11.93 40 102888 9698 64386106
Blood immunoglobulin A decreased 13.33 11.93 9 102919 508 64395296
Rhinovirus infection 13.32 11.93 30 102898 6126 64389678
Malignant neoplasm of unknown primary site 13.23 11.93 10 102918 675 64395129
Haemorrhagic fever 13.14 11.93 4 102924 31 64395773
Paranoid personality disorder 13.14 11.93 4 102924 31 64395773
Prinzmetal angina 13.10 11.93 14 102914 1489 64394315
Impaired work ability 13.07 11.93 4 102924 15215 64380589
Transplant 13.07 11.93 11 102917 867 64394937
Bence Jones proteinuria 13.04 11.93 3 102925 6 64395798
Foot deformity 13.03 11.93 5 102923 16499 64379305
Transitional cell carcinoma 13.03 11.93 17 102911 2232 64393572
Clostridium colitis 12.97 11.93 18 102910 2507 64393297
Feeling hot 12.96 11.93 34 102894 45629 64350175
Blood triglycerides increased 12.90 11.93 7 102921 18859 64376945
Therapy cessation 12.80 11.93 20 102908 32469 64363335
Mental disorder 12.76 11.93 14 102914 26431 64369373
Mouth ulceration 12.76 11.93 20 102908 32424 64363380
Follicle centre lymphoma, follicular grade I, II, III recurrent 12.73 11.93 3 102925 7 64395797
Minimal residual disease 12.56 11.93 8 102920 409 64395395
Movement disorder 12.55 11.93 10 102918 21990 64373814
Testicular swelling 12.54 11.93 11 102917 917 64394887
Haemorrhoidal haemorrhage 12.52 11.93 28 102900 5691 64390113
Hypotension 12.51 11.93 735 102193 380239 64015565
Malnutrition 12.47 11.93 62 102866 19063 64376741
Product storage error 12.38 11.93 3 102925 13315 64382489
Pneumocystis jirovecii pneumonia 12.36 11.93 81 102847 27553 64368251
Glomerular filtration rate decreased 12.34 11.93 8 102920 19564 64376240
Encephalitis viral 12.28 11.93 17 102911 2363 64393441
Endothelial dysfunction 12.27 11.93 6 102922 182 64395622
Oesophageal adenocarcinoma 12.21 11.93 10 102918 759 64395045
Chronic graft versus host disease in skin 12.20 11.93 13 102915 1378 64394426
Adenocarcinoma pancreas 12.19 11.93 15 102913 1858 64393946
Electrodesiccation 12.18 11.93 3 102925 9 64395795
Cerebrovascular accident 12.06 11.93 151 102777 137432 64258372
Varicella zoster virus infection 12.05 11.93 22 102906 3866 64391938
Anger 12.05 11.93 5 102923 15736 64380068

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
FDA EPC N0000175604 Proteasome Inhibitor
MeSH PA D000970 Antineoplastic Agents
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 (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
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
4021393 VANDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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 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 43598-865 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
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 68001-540 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 3.50 mg INTRAVENOUS ANDA 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