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 2595.04 14.08 1565 65225 112102 63310130
Plasma cell myeloma 1523.98 14.08 747 66043 35158 63387074
Plasma cell myeloma recurrent 719.15 14.08 224 66566 2989 63419243
Thrombocytopenia 693.96 14.08 824 65966 150333 63271899
Disease progression 494.69 14.08 627 66163 122131 63300101
Platelet count decreased 450.33 14.08 582 66208 115540 63306692
Diarrhoea 414.45 14.08 1663 65127 713703 62708529
Plasmacytoma 345.14 14.08 122 66668 2457 63419775
Neutropenia 325.70 14.08 626 66164 174379 63247853
Polyneuropathy 323.95 14.08 198 66592 14391 63407841
Pneumonia 279.52 14.08 1082 65708 455685 62966547
Constipation 271.66 14.08 676 66114 224267 63197965
Rheumatoid arthritis 242.64 14.08 5 66785 253814 63168418
White blood cell count decreased 230.24 14.08 474 66316 138630 63283602
Plasma cell myeloma refractory 224.35 14.08 56 66734 303 63421929
Pancytopenia 217.17 14.08 376 66414 96557 63325675
Contraindicated product administered 209.16 14.08 4 66786 217644 63204588
Plasma cell leukaemia 204.35 14.08 67 66723 1063 63421169
Maternal exposure during pregnancy 190.45 14.08 10 66780 220052 63202180
Arthralgia 183.25 14.08 198 66592 569512 62852720
Drug hypersensitivity 179.82 14.08 52 66738 310635 63111597
Sepsis 175.04 14.08 451 66339 152672 63269560
Headache 171.47 14.08 251 66539 632990 62789242
Glossodynia 165.29 14.08 5 66785 178871 63243361
Cytopenia 164.29 14.08 119 66671 11482 63410750
Anaemia 161.24 14.08 673 66117 292757 63129475
Full blood count decreased 158.90 14.08 165 66625 25859 63396373
Off label use 157.73 14.08 1229 65561 673233 62748999
Exposure during pregnancy 148.83 14.08 3 66787 155544 63266688
Pain 144.86 14.08 357 66433 740271 62681961
Tumour lysis syndrome 143.00 14.08 99 66691 8891 63413341
Therapy partial responder 132.28 14.08 101 66689 10557 63411675
Posterior reversible encephalopathy syndrome 131.95 14.08 124 66666 17221 63405011
Febrile neutropenia 129.27 14.08 343 66447 118106 63304126
Therapeutic product effect decreased 128.20 14.08 24 66766 193163 63229069
Arthropathy 127.40 14.08 44 66746 234748 63187484
Alopecia 123.85 14.08 104 66686 337432 63084800
Light chain analysis increased 123.01 14.08 48 66742 1285 63420947
Peripheral sensory neuropathy 120.75 14.08 83 66707 7368 63414864
Unevaluable event 119.82 14.08 203 66587 51183 63371049
Swelling 119.22 14.08 71 66719 275307 63146925
Completed suicide 118.89 14.08 9 66781 145664 63276568
Laboratory test abnormal 118.64 14.08 144 66646 26768 63395464
Renal failure 117.71 14.08 330 66460 117322 63304910
Deep vein thrombosis 116.16 14.08 266 66524 83534 63338698
Septic shock 115.97 14.08 232 66558 66397 63355835
Abdominal discomfort 115.12 14.08 101 66689 320784 63101448
Discomfort 114.96 14.08 19 66771 167355 63254877
Cardiac amyloidosis 114.25 14.08 40 66750 782 63421450
Pericarditis 113.72 14.08 6 66784 131573 63290659
Neutrophil count decreased 111.14 14.08 207 66583 56199 63366033
Dehydration 109.01 14.08 415 66375 172939 63249293
Musculoskeletal stiffness 108.39 14.08 30 66760 184588 63237644
Chalazion 106.10 14.08 32 66758 380 63421852
Amyloidosis 105.19 14.08 41 66749 1094 63421138
Wound 104.71 14.08 22 66768 163241 63258991
Joint swelling 100.59 14.08 118 66672 327548 63094684
Condition aggravated 99.51 14.08 169 66621 402048 63020184
Herpes zoster 97.35 14.08 246 66544 82216 63340016
Treatment failure 87.97 14.08 50 66740 198993 63223239
Hordeolum 84.31 14.08 49 66741 3243 63418989
Monoclonal immunoglobulin present 83.35 14.08 32 66758 819 63421413
Product use in unapproved indication 83.20 14.08 391 66399 178689 63243543
Mobility decreased 80.46 14.08 15 66775 121144 63301088
Helicobacter infection 77.82 14.08 5 66785 92780 63329452
Myelodysplastic syndrome 77.69 14.08 92 66698 16662 63405570
Atrial fibrillation 77.24 14.08 284 66506 116352 63305880
Cardiac failure 76.66 14.08 237 66553 88905 63333327
Death 74.61 14.08 659 66131 373722 63048510
Hypersensitivity 73.22 14.08 122 66668 292563 63129669
Overdose 72.77 14.08 16 66774 115062 63307170
Hepatic enzyme increased 72.11 14.08 64 66726 202264 63219968
Therapy non-responder 72.08 14.08 209 66581 75692 63346540
Thrombosis 71.08 14.08 188 66602 64567 63357665
Orthostatic hypotension 70.34 14.08 132 66658 36028 63386204
Peripheral sensorimotor neuropathy 68.85 14.08 33 66757 1470 63420762
Fibromyalgia 68.44 14.08 4 66786 80416 63341816
Hyperviscosity syndrome 67.84 14.08 19 66771 170 63422062
Drug ineffective 66.53 14.08 742 66048 1044023 62378209
Injection site pain 65.88 14.08 27 66763 129773 63292459
Drug interaction 65.56 14.08 87 66703 229044 63193188
Blister 64.28 14.08 28 66762 129786 63292446
Haemoglobin decreased 64.18 14.08 313 66477 145172 63277060
Pathological fracture 63.09 14.08 61 66729 8773 63413459
Primary amyloidosis 62.90 14.08 14 66776 41 63422191
Protein total increased 62.42 14.08 38 66752 2739 63419493
Haematotoxicity 61.86 14.08 62 66728 9314 63412918
Cytomegalovirus infection 61.53 14.08 92 66698 20860 63401372
Folliculitis 61.40 14.08 3 66787 70314 63351918
Stem cell transplant 60.01 14.08 32 66758 1790 63420442
Osteolysis 58.70 14.08 37 66753 2837 63419395
Acute lymphocytic leukaemia 55.46 14.08 34 66756 2482 63419750
Irritable bowel syndrome 55.14 14.08 10 66780 82402 63339830
Autonomic neuropathy 54.78 14.08 26 66764 1133 63421099
Hypercalcaemia 54.60 14.08 103 66687 28219 63394013
Bone marrow failure 54.59 14.08 105 66685 29185 63393047
Coombs indirect test positive 53.70 14.08 12 66778 36 63422196
Osteonecrosis of jaw 50.31 14.08 113 66677 35010 63387222
Blood cholesterol increased 50.30 14.08 18 66772 94014 63328218
Ageusia 50.28 14.08 67 66723 13661 63408571
Cytomegalovirus infection reactivation 50.15 14.08 38 66752 3925 63418307
Hypocalcaemia 49.94 14.08 106 66684 31607 63390625
Ileus paralytic 49.71 14.08 40 66750 4511 63417721
Pneumonia pneumococcal 48.99 14.08 30 66760 2185 63420047
Wrong technique in product usage process 47.74 14.08 5 66785 62335 63359897
Bone pain 47.63 14.08 146 66644 54495 63367737
Pneumonia fungal 47.35 14.08 42 66748 5413 63416819
Migraine 47.02 14.08 25 66765 103321 63318911
Malignant neoplasm progression 47.01 14.08 191 66599 81930 63340302
Hepatitis B reactivation 46.29 14.08 33 66757 3104 63419128
Pyrexia 45.19 14.08 720 66070 469758 62952474
Pleural effusion 45.07 14.08 206 66584 93004 63329228
Meningitis listeria 44.60 14.08 19 66771 640 63421592
Suicide attempt 43.90 14.08 6 66784 60912 63361320
Inappropriate schedule of product administration 43.27 14.08 28 66762 103937 63318295
Blood pressure increased 42.89 14.08 65 66725 161997 63260235
Bone lesion 42.73 14.08 41 66749 5840 63416392
Acute kidney injury 42.63 14.08 444 66346 262971 63159261
Endocarditis bacterial 41.77 14.08 18 66772 624 63421608
Syncope 41.74 14.08 238 66552 117147 63305085
Body dysmorphic disorder 41.23 14.08 15 66775 329 63421903
Morganella infection 41.00 14.08 18 66772 653 63421579
Nasal abscess 40.88 14.08 13 66777 186 63422046
Impaired healing 40.82 14.08 29 66761 102513 63319719
Mesenteric abscess 40.70 14.08 11 66779 85 63422147
Oedema peripheral 40.48 14.08 339 66451 189172 63233060
Pneumococcal sepsis 40.27 14.08 18 66772 682 63421550
B-cell type acute leukaemia 40.14 14.08 13 66777 198 63422034
Cardiac failure congestive 40.11 14.08 198 66592 92235 63329997
Infection in an immunocompromised host 39.60 14.08 18 66772 710 63421522
Osteoarthritis 39.24 14.08 26 66764 95317 63326915
Colitis 38.93 14.08 126 66664 48402 63373830
Anxiety 38.37 14.08 110 66680 217431 63204801
Large intestinal ulcer perforation 38.24 14.08 10 66780 67 63422165
Transplant 38.02 14.08 18 66772 780 63421452
Peripheral motor neuropathy 37.78 14.08 23 66767 1658 63420574
Electrolyte imbalance 37.44 14.08 72 66718 20004 63402228
Arthritis 37.41 14.08 40 66750 115881 63306351
Hypertension 37.32 14.08 159 66631 279144 63143088
Gastrointestinal fungal infection 37.30 14.08 14 66776 336 63421896
Blood potassium decreased 37.29 14.08 113 66677 41913 63380319
Inappropriate antidiuretic hormone secretion 37.24 14.08 62 66728 15400 63406832
Disturbance in social behaviour 37.18 14.08 32 66758 3961 63418271
Asthenia 37.15 14.08 588 66202 383016 63039216
Liver injury 37.08 14.08 9 66781 60511 63361721
N-terminal prohormone brain natriuretic peptide decreased 36.32 14.08 8 66782 22 63422210
Hip arthroplasty 36.03 14.08 4 66786 47642 63374590
Injury 35.93 14.08 16 66774 73231 63349001
Depression 35.66 14.08 98 66692 196394 63225838
Loss of personal independence in daily activities 35.57 14.08 30 66760 97260 63324972
B precursor type acute leukaemia 34.94 14.08 12 66778 221 63422011
Blood pressure fluctuation 34.74 14.08 4 66786 46313 63375919
Fatigue 34.44 14.08 1197 65593 886831 62535401
Wheezing 34.31 14.08 30 66760 95565 63326667
Neurotoxicity 34.26 14.08 63 66727 16927 63405305
Crossmatch incompatible 34.23 14.08 8 66782 31 63422201
Ill-defined disorder 34.04 14.08 22 66768 81733 63340499
Renal impairment 33.98 14.08 183 66607 88172 63334060
Cardiotoxicity 33.73 14.08 43 66747 8395 63413837
Joint stiffness 33.00 14.08 3 66787 41866 63380366
Type 2 diabetes mellitus 32.86 14.08 13 66777 63855 63358377
COVID-19 32.45 14.08 217 66573 112886 63309346
Spinal cord compression 32.21 14.08 30 66760 4118 63418114
Hypokalaemia 32.13 14.08 203 66587 103601 63318631
Hypersensitivity myocarditis 31.91 14.08 11 66779 205 63422027
Sinus polyp 31.86 14.08 13 66777 392 63421840
Urosepsis 31.61 14.08 64 66726 18460 63403772
Cerebellar haemangioma 31.42 14.08 9 66781 88 63422144
Renal amyloidosis 31.20 14.08 10 66780 147 63422085
Blood pressure systolic increased 31.17 14.08 6 66784 47391 63374841
Mucosal inflammation 30.81 14.08 114 66676 46814 63375418
Hyperproteinaemia 30.55 14.08 9 66781 98 63422134
Precursor B-lymphoblastic lymphoma 30.18 14.08 7 66783 26 63422206
Guillain-Barre syndrome 29.93 14.08 28 66762 3865 63418367
Sinusitis 29.67 14.08 130 66660 226523 63195709
Blood stem cell harvest failure 29.36 14.08 8 66782 64 63422168
Taste disorder 29.25 14.08 52 66738 13610 63408622
Target skin lesion 29.10 14.08 9 66781 117 63422115
Thrombotic microangiopathy 29.07 14.08 45 66745 10516 63411716
Acute myeloid leukaemia 28.97 14.08 59 66731 17088 63405144
Large intestine perforation 28.94 14.08 40 66750 8442 63413790
Lymphopenia 28.55 14.08 61 66729 18266 63403966
Suicidal ideation 28.54 14.08 15 66775 62406 63359826
Clostridium bacteraemia 28.54 14.08 10 66780 196 63422036
Blood lactate dehydrogenase increased 28.34 14.08 70 66720 23046 63399186
Stress 28.07 14.08 18 66772 67149 63355083
Varicella zoster virus infection 28.03 14.08 23 66767 2666 63419566
Contusion 27.84 14.08 74 66716 149970 63272262
Heart rate increased 27.73 14.08 35 66755 94203 63328029
Pneumonia influenzal 27.72 14.08 19 66771 1678 63420554
Ileus 27.69 14.08 53 66737 14672 63407560
Refractory cytopenia with multilineage dysplasia 27.67 14.08 9 66781 139 63422093
Sleep disorder 27.61 14.08 27 66763 81539 63340693
Hypoaesthesia 27.28 14.08 284 66506 168109 63254123
Clostridium difficile colitis 27.05 14.08 64 66726 20505 63401727
Diarrhoea haemorrhagic 26.97 14.08 40 66750 9002 63413230
Drug abuse 26.95 14.08 22 66768 72496 63349736
Nasal congestion 26.89 14.08 18 66772 65642 63356590
Malaise 26.82 14.08 294 66496 415660 63006572
Adenoviral haemorrhagic cystitis 26.82 14.08 9 66781 154 63422078
Rhinovirus infection 26.36 14.08 28 66762 4501 63417731
Graft versus host disease 26.30 14.08 34 66756 6729 63415503
Light chain analysis abnormal 26.09 14.08 9 66781 168 63422064
Pseudomonal sepsis 26.01 14.08 21 66769 2380 63419852
Enterococcal sepsis 25.86 14.08 17 66773 1401 63420831
Pregnancy 25.68 14.08 4 66786 36832 63385400
Bronchiolitis 25.55 14.08 22 66768 2725 63419507
Joint ankylosis 25.29 14.08 15 66775 1031 63421201
Gait disturbance 25.24 14.08 103 66687 183075 63239157
Myelosuppression 25.17 14.08 68 66722 23635 63398597
Weight increased 25.04 14.08 166 66624 260626 63161606
Toxic skin eruption 25.00 14.08 47 66743 12838 63409394
Oncologic complication 24.80 14.08 9 66781 196 63422036
Febrile infection 24.42 14.08 17 66773 1540 63420692
Fungal oesophagitis 24.31 14.08 13 66777 731 63421501
Toxicity to various agents 23.89 14.08 379 66411 246871 63175361
Palpitations 23.78 14.08 52 66738 112718 63309514
Monoclonal immunoglobulin increased 23.78 14.08 8 66782 138 63422094
Disease recurrence 23.59 14.08 74 66716 27956 63394276
Failure to thrive 23.15 14.08 33 66757 7165 63415067
Hypothyroidism 23.07 14.08 8 66782 42624 63379608
Flushing 23.03 14.08 27 66763 75060 63347172
Compression fracture 22.89 14.08 31 66759 6417 63415815
Product quality issue 22.63 14.08 5 66785 35860 63386372
Hypoglobulinaemia 22.59 14.08 6 66784 43 63422189
Acute respiratory distress syndrome 22.51 14.08 65 66725 23469 63398763
Mucosal erosion 22.49 14.08 16 66774 1500 63420732
Injection site swelling 22.39 14.08 11 66779 47561 63374671
Myalgia 22.38 14.08 79 66711 146450 63275782
Salmonella sepsis 22.36 14.08 9 66781 262 63421970
Intraductal proliferative breast lesion 22.29 14.08 21 66769 2924 63419308
Anaphylactic reaction 22.24 14.08 22 66768 66078 63356154
Peritonitis viral 22.02 14.08 6 66784 48 63422184
Respiratory tract infection 21.79 14.08 94 66696 41389 63380843
Bacteraemia 21.76 14.08 53 66737 17295 63404937
Listeria sepsis 21.68 14.08 12 66778 723 63421509
Hypoalbuminaemia 21.60 14.08 42 66748 11763 63410469
Sedation 21.49 14.08 7 66783 38802 63383430
Pulmonary embolism 21.42 14.08 202 66588 116482 63305750
Neuralgia 21.41 14.08 68 66722 25858 63396374
Hypophosphataemia 21.33 14.08 41 66749 11385 63410847
Drug intolerance 21.16 14.08 215 66575 308446 63113786
Pain in extremity 21.07 14.08 235 66555 331251 63090981
Back pain 20.86 14.08 392 66398 263753 63158479
Nocardiosis 20.81 14.08 17 66773 1959 63420273
Hypotension 20.65 14.08 402 66388 272202 63150030
Atrial rupture 20.65 14.08 6 66784 62 63422170
5q minus syndrome 20.37 14.08 8 66782 218 63422014
Hyperintensity in brain deep nuclei 20.36 14.08 5 66785 25 63422207
Serotonin syndrome 20.25 14.08 3 66787 28679 63393553
Pulmonary oedema 19.98 14.08 112 66678 54761 63367471
Osteonecrosis 19.95 14.08 64 66726 24466 63397766
Tooth disorder 19.83 14.08 70 66720 28087 63394145
Blepharitis 19.80 14.08 19 66771 2706 63419526
Blood creatine phosphokinase increased 19.70 14.08 4 66786 30426 63391806
Pulmonary sepsis 19.70 14.08 15 66775 1561 63420671
Human chorionic gonadotropin increased 19.62 14.08 15 66775 1570 63420662
Therapy interrupted 19.54 14.08 5 66785 32450 63389782
Foot deformity 19.47 14.08 3 66787 27850 63394382
Rash 19.43 14.08 747 66043 560124 62862108
Infusion related reaction 19.41 14.08 165 66625 245356 63176876
Escherichia infection 19.35 14.08 42 66748 12712 63409520
Asthma 19.33 14.08 69 66721 127492 63294740
VIth nerve paresis 19.33 14.08 6 66784 79 63422153
Injection site bruising 19.26 14.08 10 66780 41900 63380332
Nasopharyngitis 19.16 14.08 173 66617 254084 63168148
Underdose 19.10 14.08 3 66787 27453 63394779
Somnolence 19.08 14.08 110 66680 178575 63243657
Respiratory failure 19.02 14.08 177 66613 101681 63320551
Hypogammaglobulinaemia 19.01 14.08 30 66760 7125 63415107
Incorrect dose administered 19 14.08 21 66769 59947 63362285
Meningitis pneumococcal 18.82 14.08 8 66782 268 63421964
Plasma cells decreased 18.69 14.08 5 66785 37 63422195
Infection reactivation 18.59 14.08 13 66777 1186 63421046
Toxic neuropathy 18.41 14.08 9 66781 419 63421813
Paraproteinaemia 18.27 14.08 7 66783 178 63422054
Osteoporosis 18.25 14.08 20 66770 57318 63364914
Light chain analysis 18.16 14.08 4 66786 11 63422221
Spinal fracture 18.00 14.08 51 66739 18220 63404012
Bone disorder 17.67 14.08 56 66734 21270 63400962
Cough 17.63 14.08 210 66580 292533 63129699
Acute myopia 17.60 14.08 6 66784 108 63422124
Full blood count increased 17.59 14.08 12 66778 1052 63421180
Clostridium difficile infection 17.43 14.08 70 66720 29852 63392380
Hypoglossal nerve paresis 17.34 14.08 6 66784 113 63422119
Drug reaction with eosinophilia and systemic symptoms 17.26 14.08 76 66714 33760 63388472
Meningitis cryptococcal 16.98 14.08 13 66777 1364 63420868
Pseudomyopia 16.92 14.08 5 66785 55 63422177
Myeloma cast nephropathy 16.83 14.08 6 66784 124 63422108
Bursitis 16.78 14.08 9 66781 37032 63385200
Urticaria 16.68 14.08 104 66686 165698 63256534
Sleep apnoea syndrome 16.59 14.08 5 66785 29128 63393104
Hyperhidrosis 16.56 14.08 58 66732 107778 63314454
Inflammation 16.48 14.08 39 66751 82234 63339998
Duodenal stenosis 16.40 14.08 9 66781 533 63421699
Urinary tract infection 16.37 14.08 379 66411 264305 63157927
Cardiac failure acute 16.36 14.08 33 66757 9490 63412742
Multiple organ dysfunction syndrome 16.34 14.08 109 66681 56643 63365589
Superficial spreading melanoma stage unspecified 16.31 14.08 6 66784 136 63422096
Hypoperfusion 16.25 14.08 13 66777 1454 63420778
Spinal compression fracture 16.20 14.08 42 66748 14241 63407991
Injection site haemorrhage 16.15 14.08 3 66787 24311 63397921
Chronic graft versus host disease in skin 16.15 14.08 10 66780 743 63421489
Bronchopulmonary aspergillosis 16.14 14.08 31 66759 8604 63413628
Paranoia 16.08 14.08 37 66753 11642 63410590
Human herpesvirus 8 infection 16.02 14.08 7 66783 251 63421981
Pulmonary alveolar haemorrhage 15.91 14.08 22 66768 4646 63417586
Coma 15.90 14.08 27 66763 64337 63357895
Haemorrhoidal haemorrhage 15.85 14.08 21 66769 4258 63417974
Sensory level abnormal 15.83 14.08 6 66784 148 63422084
Staphylococcal bacteraemia 15.83 14.08 24 66766 5506 63416726
Seasonal allergy 15.55 14.08 53 66737 20897 63401335
Bacterial sepsis 15.55 14.08 20 66770 3938 63418294
Erysipelas 15.54 14.08 29 66761 7876 63414356
Rhabdomyolysis 15.52 14.08 14 66776 43937 63378295
Capnocytophaga infection 15.50 14.08 3 66787 3 63422229
Aggression 15.40 14.08 3 66787 23495 63398737
Cardiomyopathy 15.33 14.08 47 66743 17537 63404695
Venoocclusive liver disease 15.31 14.08 22 66768 4813 63417419
Metapneumovirus infection 15.29 14.08 11 66779 1049 63421183
Joint injury 15.24 14.08 6 66784 29566 63392666
Performance status decreased 15.11 14.08 19 66771 3659 63418573
Rash pruritic 14.96 14.08 111 66679 59688 63362544
Drug withdrawal syndrome 14.89 14.08 5 66785 27189 63395043
Atelectasis 14.78 14.08 53 66737 21430 63400802
Hyponatraemia 14.62 14.08 181 66609 111719 63310513
Hyperamylasaemia 14.61 14.08 8 66782 472 63421760
Hepatitis B 14.57 14.08 19 66771 3793 63418439
Clavicle fracture 14.43 14.08 18 66772 3437 63418795
Cryptococcosis 14.43 14.08 11 66779 1146 63421086
Therapy cessation 14.40 14.08 7 66783 30450 63391782
Oral fungal infection 14.37 14.08 17 66773 3074 63419158
Lower respiratory tract infection 14.36 14.08 81 66709 132226 63290006
JC virus CSF test positive 14.36 14.08 4 66786 35 63422197
Klebsiella sepsis 14.24 14.08 12 66778 1443 63420789

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 2654.45 12.95 1873 76342 81390 34797326
Plasma cell myeloma 1487.00 12.95 1010 77205 41027 34837689
Plasma cell myeloma recurrent 793.02 12.95 318 77897 4147 34874569
Polyneuropathy 566.76 12.95 375 77840 14521 34864195
Thrombocytopenia 493.48 12.95 1082 77133 155165 34723551
Platelet count decreased 407.42 12.95 855 77360 118862 34759854
Disease progression 378.32 12.95 781 77434 107296 34771420
Pneumonia 327.80 12.95 1637 76578 360990 34517726
Plasmacytoma 313.77 12.95 157 78058 3534 34875182
Plasma cell myeloma refractory 308.73 12.95 95 78120 520 34878196
Drug interaction 277.38 12.95 81 78134 225865 34652851
Unevaluable event 225.10 12.95 319 77896 32271 34846445
Drug abuse 206.12 12.95 3 78212 99093 34779623
Completed suicide 204.07 12.95 3 78212 98165 34780551
Tumour lysis syndrome 184.72 12.95 209 78006 16850 34861866
Plasma cell leukaemia 166.76 12.95 67 78148 877 34877839
Orthostatic hypotension 160.51 12.95 241 77974 25678 34853038
Herpes zoster 152.40 12.95 275 77940 34124 34844592
Therapy partial responder 143.81 12.95 140 78075 9476 34869240
Diarrhoea 131.60 12.95 1390 76825 388522 34490194
White blood cell count decreased 131.00 12.95 490 77725 94955 34783761
Overdose 124.42 12.95 26 78189 91033 34787683
Peripheral sensory neuropathy 123.44 12.95 110 78105 6650 34872066
Constipation 122.52 12.95 618 77597 136364 34742352
Neutropenia 120.92 12.95 679 77536 156099 34722617
Deep vein thrombosis 120.40 12.95 370 77845 64878 34813838
Autonomic neuropathy 112.70 12.95 51 78164 909 34877807
Off label use 110.94 12.95 1427 76788 418097 34460619
Product use issue 109.74 12.95 351 77864 62865 34815851
Fatigue 104.41 12.95 1276 76939 369377 34509339
Pancytopenia 100.79 12.95 451 77764 94706 34784010
Cytopenia 92.95 12.95 128 78087 12595 34866121
Rash 92.43 12.95 830 77385 221922 34656794
Rhabdomyolysis 92.00 12.95 20 78195 68143 34810573
Light chain analysis increased 91.62 12.95 50 78165 1351 34877365
Therapy non-responder 90.67 12.95 241 77974 38905 34839811
B precursor type acute leukaemia 86.28 12.95 28 78187 187 34878529
Hypercalcaemia 86.17 12.95 137 78078 15331 34863385
Inappropriate schedule of product administration 82.62 12.95 19 78196 62277 34816439
Headache 82.05 12.95 207 78008 200428 34678288
Amyloidosis 82.03 12.95 54 78161 2069 34876647
Myelodysplastic syndrome 81.80 12.95 151 78064 19057 34859659
Osteonecrosis of jaw 80.46 12.95 144 78071 17745 34860971
Ileus paralytic 79.88 12.95 82 78133 5915 34872801
Cystitis haemorrhagic 78.09 12.95 79 78136 5600 34873116
Full blood count decreased 76.78 12.95 142 78073 17946 34860770
Thrombosis 75.87 12.95 267 77948 50191 34828525
Arthralgia 74.61 12.95 169 78046 169872 34708844
Rheumatoid arthritis 72.55 12.95 3 78212 38235 34840481
Product use in unapproved indication 66.81 12.95 471 77744 117028 34761688
Blood creatine phosphokinase increased 65.10 12.95 11 78204 44846 34833870
Infection 64.89 12.95 386 77829 90529 34788187
Primary amyloidosis 63.73 12.95 20 78195 118 34878598
Depression 63.69 12.95 74 78141 97024 34781692
Psoriasis 62.25 12.95 7 78208 38805 34839911
Acute lymphocytic leukaemia 60.75 12.95 52 78163 2977 34875739
Abdominal pain 60.69 12.95 177 78038 163441 34715275
Condition aggravated 59.56 12.95 225 77990 191971 34686745
Sepsis 58.74 12.95 600 77615 165961 34712755
Spinal compression fracture 57.18 12.95 75 78140 7041 34871675
Hypertension 57.10 12.95 139 78076 136304 34742412
Blood pressure increased 56.86 12.95 68 78147 88034 34790682
Drug hypersensitivity 56.53 12.95 58 78157 80471 34798245
Septic shock 55.82 12.95 312 77903 71522 34807194
Anxiety 55.81 12.95 85 78130 99343 34779373
Pyrexia 53.47 12.95 1043 77172 331970 34546746
Hypoaesthesia 53.26 12.95 275 77940 61169 34817547
Guillain-Barre syndrome 51.80 12.95 66 78149 6021 34872695
Chalazion 51.71 12.95 18 78197 153 34878563
Protein total increased 51.54 12.95 42 78173 2245 34876471
Aggression 51.42 12.95 12 78203 38952 34839764
Suicidal ideation 50.30 12.95 14 78201 40374 34838342
Atrial fibrillation 49.56 12.95 454 77761 121939 34756777
Peripheral sensorimotor neuropathy 48.74 12.95 35 78180 1547 34877169
Spinal cord compression 48.73 12.95 52 78163 3923 34874793
Adverse drug reaction 48.24 12.95 160 78055 29182 34849534
Stem cell transplant 47.61 12.95 39 78176 2100 34876616
Seizure 46.11 12.95 104 78111 104753 34773963
Wrong technique in product usage process 45.71 12.95 12 78203 35974 34842742
BK virus infection 45.37 12.95 60 78155 5678 34873038
Haematochezia 44.94 12.95 24 78191 46510 34832206
Compression fracture 44.81 12.95 44 78171 3008 34875708
Monoclonal immunoglobulin present 44.33 12.95 28 78187 998 34877718
Paraesthesia 44.19 12.95 270 77945 63902 34814814
Hypoglycaemia 43.53 12.95 35 78180 54605 34824111
Hordeolum 43.45 12.95 28 78187 1034 34877682
Neuralgia 43.36 12.95 101 78114 15012 34863704
Laboratory test abnormal 42.68 12.95 121 78094 20270 34858446
Intentional product misuse 41.93 12.95 25 78190 45586 34833130
Cardiac amyloidosis 41.61 12.95 29 78186 1222 34877494
Bradycardia 40.86 12.95 66 78149 75352 34803364
Haematotoxicity 40.80 12.95 69 78146 8125 34870591
Hyperviscosity syndrome 40.20 12.95 16 78199 204 34878512
Asthma 39.75 12.95 23 78192 42633 34836083
Chronic inflammatory demyelinating polyradiculoneuropathy 39.03 12.95 23 78192 722 34877994
Ageusia 38.91 12.95 77 78138 10231 34868485
Stress 38.77 12.95 10 78205 30337 34848379
Rash pruritic 37.45 12.95 139 78076 26802 34851914
Bone pain 36.90 12.95 116 78099 20570 34858146
Dehydration 36.56 12.95 448 77767 129521 34749195
Osteolysis 36.52 12.95 40 78175 3108 34875608
Pathological fracture 36.40 12.95 47 78168 4344 34874372
Renal failure 36.29 12.95 449 77766 130108 34748608
Neutrophil count decreased 35.80 12.95 216 77999 50888 34827828
Ileus 35.60 12.95 99 78116 16400 34862316
Hallucination 35.11 12.95 38 78177 51460 34827256
Metapneumovirus infection 34.76 12.95 22 78193 787 34877929
Parainfluenzae virus infection 34.65 12.95 37 78178 2793 34875923
Progressive multifocal leukoencephalopathy 34.55 12.95 71 78144 9693 34869023
Agitation 34.23 12.95 47 78168 57352 34821364
Keratopathy 34.02 12.95 20 78195 625 34878091
Oroantral fistula 33.99 12.95 14 78201 196 34878520
Asthenia 33.02 12.95 749 77466 244502 34634214
Squamous cell carcinoma of skin 32.63 12.95 74 78141 10807 34867909
Somnolence 32.50 12.95 133 78082 110983 34767733
Malaise 32.47 12.95 263 77952 185562 34693154
Flushing 32.38 12.95 16 78199 32404 34846312
Angioedema 32.27 12.95 22 78193 37352 34841364
Incorrect dose administered 32.21 12.95 26 78189 40489 34838227
Bone disorder 31.83 12.95 53 78162 6162 34872554
H1N1 influenza 31.29 12.95 22 78193 940 34877776
Adenocarcinoma of colon 30.82 12.95 38 78177 3353 34875363
Pseudomyopia 30.78 12.95 9 78206 40 34878676
Erythema 30.76 12.95 99 78116 88681 34790035
Drug-induced liver injury 30.70 12.95 13 78202 28819 34849897
Hypogammaglobulinaemia 30.65 12.95 59 78156 7681 34871035
Hyperhidrosis 30.17 12.95 79 78136 75613 34803103
Bone lesion 29.87 12.95 35 78180 2928 34875788
Injection site pain 29.81 12.95 26 78189 38979 34839737
Visceral leishmaniasis 29.74 12.95 18 78197 594 34878122
Bone marrow failure 29.68 12.95 137 78078 29116 34849600
Hiccups 29.60 12.95 68 78147 10014 34868702
Infusion related reaction 28.55 12.95 210 78005 52847 34825869
Febrile neutropenia 28.44 12.95 447 77768 136402 34742314
Pulmonary embolism 28.17 12.95 316 77899 89430 34789286
Peripheral motor neuropathy 28.08 12.95 27 78188 1799 34876917
Osteonecrosis 27.95 12.95 85 78130 14805 34863911
Contraindicated product administered 27.59 12.95 7 78208 21474 34857242
Blood pressure fluctuation 27.51 12.95 11 78204 25238 34853478
Blepharitis 27.35 12.95 24 78191 1421 34877295
Spinal column injury 26.89 12.95 17 78198 607 34878109
Drug level increased 26.88 12.95 8 78207 22088 34856628
Bacteraemia 26.80 12.95 101 78114 19616 34859100
Wheezing 26.65 12.95 32 78183 41370 34837346
Respirovirus test positive 26.55 12.95 9 78206 70 34878646
Hyperkalaemia 26.46 12.95 74 78141 69315 34809401
Performance status decreased 26.35 12.95 39 78176 4098 34874618
Gastrointestinal amyloidosis 26.33 12.95 7 78208 20 34878696
Phrenic nerve paralysis 26.13 12.95 10 78205 114 34878602
Musculoskeletal stiffness 26.08 12.95 40 78175 46640 34832076
Metabolic acidosis 25.80 12.95 36 78179 43644 34835072
Renal amyloidosis 25.70 12.95 9 78206 78 34878638
Lactic acidosis 25.59 12.95 24 78191 34748 34843968
Blood stem cell harvest failure 25.15 12.95 7 78208 25 34878691
Product prescribing error 24.96 12.95 10 78205 22917 34855799
Cytomegalovirus infection 24.77 12.95 120 78095 26015 34852701
Myocardial infarction 24.67 12.95 164 78051 120921 34757795
VIth nerve paralysis 24.67 12.95 18 78197 816 34877900
Monoclonal gammopathy 24.60 12.95 14 78201 411 34878305
Therapeutic response decreased 24.55 12.95 130 78085 29183 34849533
Mobility decreased 24.37 12.95 19 78196 30109 34848607
Tooth deposit 24.30 12.95 9 78206 93 34878623
Diverticular perforation 24.26 12.95 34 78181 3400 34875316
Disturbance in attention 24.15 12.95 14 78201 25931 34852785
Demyelinating polyneuropathy 24.12 12.95 21 78194 1230 34877486
Colitis ulcerative 24.08 12.95 4 78211 16516 34862200
Tachycardia 23.83 12.95 103 78112 84669 34794047
Hepatitis B reactivation 23.81 12.95 36 78179 3855 34874861
JC virus infection 23.80 12.95 27 78188 2181 34876535
Spinal fracture 23.61 12.95 52 78163 7446 34871270
Blood pressure systolic increased 23.42 12.95 11 78204 22941 34855775
Pallor 23.36 12.95 14 78201 25466 34853250
Meningitis pneumococcal 23.29 12.95 11 78204 217 34878499
Ascites 23.17 12.95 43 78172 46528 34832188
Myalgia 23.16 12.95 103 78112 84007 34794709
Loss of personal independence in daily activities 23.15 12.95 24 78191 33155 34845561
Anaphylactic reaction 22.95 12.95 23 78192 32278 34846438
Anaphylactic shock 22.92 12.95 4 78211 15937 34862779
Meibomian gland dysfunction 22.78 12.95 8 78207 70 34878646
Abnormal behaviour 22.50 12.95 14 78201 24955 34853761
Palmar-plantar erythrodysaesthesia syndrome 22.50 12.95 5 78210 16790 34861926
B-cell type acute leukaemia 22.34 12.95 12 78203 314 34878402
Haemoglobin decreased 22.31 12.95 387 77828 120385 34758331
Dysarthria 22.26 12.95 27 78188 34755 34843961
Enterococcal infection 22.25 12.95 58 78157 9248 34869468
Basal cell carcinoma 22.16 12.95 95 78120 19563 34859153
Obstructive airways disorder 22.04 12.95 4 78211 15490 34863226
Electrocardiogram QT prolonged 22.02 12.95 36 78179 40916 34837800
Acute myeloid leukaemia 21.92 12.95 90 78125 18180 34860536
Depressed level of consciousness 21.80 12.95 39 78176 42802 34835914
Clostridium difficile colitis 21.73 12.95 81 78134 15649 34863067
Anaemia 21.68 12.95 679 77536 232656 34646060
Accidental overdose 21.57 12.95 9 78206 20131 34858585
Mantle cell lymphoma recurrent 21.51 12.95 16 78199 747 34877969
Respiratory depression 21.44 12.95 5 78210 16240 34862476
Synovitis 21.43 12.95 3 78212 14063 34864653
Bacterial infection 21.23 12.95 85 78130 16978 34861738
Heart rate increased 21.15 12.95 45 78170 46298 34832418
Neurogenic bladder 20.97 12.95 23 78192 1790 34876926
Medication error 20.83 12.95 16 78199 25549 34853167
Hallucination, visual 20.65 12.95 7 78208 17784 34860932
Hepatitis B 20.57 12.95 43 78172 5940 34872776
Blood immunoglobulin G increased 20.50 12.95 17 78198 931 34877785
Rectal adenocarcinoma 20.35 12.95 16 78199 812 34877904
Conjunctival irritation 20.17 12.95 8 78207 101 34878615
Brief psychotic disorder with marked stressors 20.14 12.95 10 78205 221 34878495
Tear break up time decreased 20.05 12.95 5 78210 10 34878706
Pityriasis rubra pilaris 20.03 12.95 8 78207 103 34878613
Rib fracture 19.76 12.95 74 78141 14326 34864390
Blood immunoglobulin A increased 19.55 12.95 11 78204 316 34878400
Acute febrile neutrophilic dermatosis 19.53 12.95 19 78196 1284 34877432
Neurotoxicity 19.51 12.95 86 78129 17924 34860792
Coma 19.50 12.95 46 78169 45632 34833084
Ventricular fibrillation 19.17 12.95 14 78201 22940 34855776
Emotional distress 19.10 12.95 5 78210 15021 34863695
Light chain analysis decreased 19.03 12.95 6 78209 36 34878680
Bacterial parotitis 19.03 12.95 6 78209 36 34878680
Accidental exposure to product 18.88 12.95 3 78212 12799 34865917
Coronary artery disease 18.80 12.95 51 78164 48254 34830462
Cerebrovascular accident 18.75 12.95 112 78103 84699 34794017
Blood immunoglobulin M increased 18.74 12.95 10 78205 258 34878458
Dry mouth 18.69 12.95 24 78191 30141 34848575
Polyomavirus-associated nephropathy 18.65 12.95 32 78183 3812 34874904
Neuromyotonia 18.63 12.95 6 78209 39 34878677
Depressed mood 18.59 12.95 10 78205 19307 34859409
Gastric ulcer 18.44 12.95 6 78209 15644 34863072
Dyskinesia 18.29 12.95 14 78201 22399 34856317
HCoV-OC43 infection 18.25 12.95 6 78209 42 34878674
Cardiac failure 18.16 12.95 296 77919 90952 34787764
Hyperlipidaemia 18.15 12.95 5 78210 14524 34864192
Vomiting 18.10 12.95 419 77796 247202 34631514
End stage renal disease 17.97 12.95 52 78163 8809 34869907
Periodontitis 17.94 12.95 22 78193 1930 34876786
Haematuria 17.92 12.95 55 78160 50011 34828705
Nephrolithiasis 17.91 12.95 25 78190 30308 34848408
Pneumonia pneumococcal 17.83 12.95 23 78192 2123 34876593
Sopor 17.55 12.95 3 78212 12133 34866583
Blood calcium increased 17.54 12.95 30 78185 3564 34875152
Malignant fibrous histiocytoma 17.46 12.95 9 78206 216 34878500
Autologous haematopoietic stem cell transplant 17.44 12.95 6 78209 49 34878667
Type 2 diabetes mellitus 17.44 12.95 7 78208 16025 34862691
Chest discomfort 17.39 12.95 63 78152 54467 34824249
Melaena 17.30 12.95 33 78182 35347 34843369
Bacterial sepsis 17.20 12.95 37 78178 5213 34873503
Gastrooesophageal reflux disease 17.16 12.95 37 78178 37887 34840829
Hepatic steatosis 16.96 12.95 10 78205 18352 34860364
Extrapyramidal disorder 16.92 12.95 4 78211 12876 34865840
Pain 16.78 12.95 340 77875 204335 34674381
Monoclonal immunoglobulin increased 16.70 12.95 8 78207 163 34878553
Cytomegalovirus infection reactivation 16.69 12.95 36 78179 5082 34873634
Respiratory arrest 16.67 12.95 23 78192 28020 34850696
Laryngeal cancer metastatic 16.46 12.95 6 78209 59 34878657
Diabetic ketoacidosis 16.40 12.95 10 78205 18022 34860694
Escherichia sepsis 16.40 12.95 34 78181 4670 34874046
Muscle spasms 16.33 12.95 247 77968 74754 34803962
Haemorrhagic fever 16.30 12.95 5 78210 27 34878689
Jaundice 16.24 12.95 29 78186 31853 34846863
Respiratory tract infection 16.22 12.95 87 78128 19625 34859091
Autonomic nervous system imbalance 16.18 12.95 24 78191 2527 34876189
Product quality issue 16.13 12.95 9 78206 17026 34861690
Cholestasis 16.12 12.95 22 78193 26926 34851790
Troponin T increased 16.04 12.95 23 78192 2348 34876368
Glycosylated haemoglobin increased 16.01 12.95 3 78212 11357 34867359
Sleep disorder 15.99 12.95 29 78186 31659 34847057
Neutropenic sepsis 15.88 12.95 67 78148 13700 34865016
Alanine aminotransferase increased 15.69 12.95 111 78104 80704 34798012
Aphasia 15.56 12.95 15 78200 21439 34857277
Injury 15.55 12.95 14 78201 20673 34858043
Full blood count increased 15.40 12.95 14 78201 868 34877848
Oesophageal adenocarcinoma 15.36 12.95 14 78201 871 34877845
Neuromuscular toxicity 15.33 12.95 6 78209 73 34878643
Pleural effusion 15.30 12.95 262 77953 81284 34797432
Pleuritic pain 15.27 12.95 28 78187 3513 34875203
Cutaneous T-cell lymphoma 15.22 12.95 18 78197 1520 34877196
Eosinophilic pneumonia chronic 15.17 12.95 9 78206 286 34878430
Upper respiratory tract infection 15.10 12.95 126 78089 32933 34845783
Hypocalcaemic seizure 15.08 12.95 5 78210 36 34878680
Refractory cytopenia with multilineage dysplasia 15.06 12.95 7 78208 133 34878583
Cardiac arrest 15.03 12.95 140 78075 96019 34782697
Dystonia 15.00 12.95 3 78212 10842 34867874
Blood culture positive 14.87 12.95 33 78182 4750 34873966
Body height decreased 14.86 12.95 29 78186 3814 34874902
Morganella infection 14.84 12.95 11 78204 511 34878205
Hepatitis 14.83 12.95 19 78196 23885 34854831
Blood glucose increased 14.80 12.95 88 78127 66630 34812086
Refractory anaemia with an excess of blasts 14.65 12.95 10 78205 407 34878309
Prescribed overdose 14.61 12.95 3 78212 10644 34868072
Fat tissue increased 14.48 12.95 10 78205 415 34878301
Malignant neoplasm progression 14.45 12.95 277 77938 87769 34790947
Chest pain 14.16 12.95 199 78016 126563 34752153
Blood triglycerides increased 14.12 12.95 7 78208 14152 34864564
Restlessness 14.07 12.95 22 78193 25460 34853256
Cellulitis orbital 14.05 12.95 9 78206 329 34878387
VIth nerve paresis 14.01 12.95 5 78210 46 34878670
Iron deficiency anaemia 13.99 12.95 3 78212 10326 34868390
General physical condition abnormal 13.88 12.95 28 78187 3771 34874945
Adenovirus infection 13.86 12.95 34 78181 5223 34873493
Pregnancy of partner 13.85 12.95 9 78206 337 34878379
Colitis 13.74 12.95 137 78078 37613 34841103
Agranulocytosis 13.70 12.95 20 78195 23801 34854915
Peripheral swelling 13.67 12.95 244 77971 76297 34802419
Psychotic disorder 13.61 12.95 21 78194 24431 34854285
Myositis 13.58 12.95 5 78210 12065 34866651
Paranoia 13.57 12.95 5 78210 12063 34866653
Thoracic vertebral fracture 13.54 12.95 18 78197 1712 34877004
Product substitution issue 13.53 12.95 3 78212 10092 34868624
Blood lactate dehydrogenase increased 13.53 12.95 93 78122 22897 34855819
Heart rate decreased 13.52 12.95 32 78183 31713 34847003
Hypercapnic coma 13.50 12.95 7 78208 170 34878546
Speech disorder 13.42 12.95 23 78192 25663 34853053
Intentional product use issue 13.41 12.95 198 78017 59618 34819098
Encephalitis viral 13.37 12.95 15 78200 1197 34877519
Protein total decreased 13.33 12.95 33 78182 5097 34873619
Genital erythema 13.33 12.95 8 78207 260 34878456
Therapy interrupted 13.31 12.95 7 78208 13690 34865026
Chromaturia 13.28 12.95 8 78207 14512 34864204
Frequent bowel movements 13.24 12.95 6 78209 12781 34865935
Lip swelling 13.18 12.95 10 78205 16070 34862646
Lymphocytic leukaemia 13.17 12.95 7 78208 179 34878537
Dermatitis exfoliative generalised 13.16 12.95 27 78188 3680 34875036
Coombs indirect test positive 13.14 12.95 4 78211 21 34878695
Nightmare 13.06 12.95 8 78207 14383 34864333
Influenza 13.00 12.95 169 78046 49497 34829219

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 3691.30 12.17 2395 114705 138910 79488378
Plasma cell myeloma 2292.95 12.17 1248 115852 52011 79575277
Plasma cell myeloma recurrent 1501.27 12.17 472 116628 4529 79622759
Thrombocytopenia 1210.73 12.17 1706 115394 263553 79363735
Disease progression 855.22 12.17 1196 115904 183166 79444122
Polyneuropathy 840.93 12.17 493 116607 23658 79603630
Platelet count decreased 795.14 12.17 1189 115911 193475 79433813
Pneumonia 683.40 12.17 2322 114778 657924 78969364
Plasmacytoma 612.47 12.17 234 116866 4169 79623119
Plasma cell myeloma refractory 457.14 12.17 120 116980 552 79626736
Neutropenia 406.35 12.17 1130 115970 286580 79340708
Off label use 351.67 12.17 2403 114697 904812 78722476
Unevaluable event 330.61 12.17 408 116692 55177 79572111
Plasma cell leukaemia 322.46 12.17 115 116985 1671 79625617
Completed suicide 308.57 12.17 12 117088 245755 79381533
Tumour lysis syndrome 305.68 12.17 265 116835 23674 79603614
Arthralgia 288.27 12.17 250 116850 571553 79055735
Diarrhoea 286.71 12.17 2238 114862 878251 78749037
Rheumatoid arthritis 285.17 12.17 4 117096 208466 79418822
Headache 277.20 12.17 332 116768 653440 78973848
Pancytopenia 271.16 12.17 688 116412 165057 79462231
Cytopenia 256.95 12.17 224 116876 20159 79607129
Drug hypersensitivity 256.20 12.17 62 117038 298854 79328434
Sepsis 253.18 12.17 920 116180 268508 79358780
Peripheral sensory neuropathy 251.69 12.17 184 116916 12849 79614439
White blood cell count decreased 249.32 12.17 723 116377 187565 79439723
Drug interaction 240.55 12.17 157 116943 415026 79212262
Product use in unapproved indication 221.03 12.17 838 116262 249521 79377767
Orthostatic hypotension 214.50 12.17 333 116767 55831 79571457
Therapy partial responder 210.90 12.17 187 116913 17210 79610078
Deep vein thrombosis 209.31 12.17 513 116587 120406 79506882
Septic shock 206.25 12.17 515 116585 122286 79505002
Synovitis 205.65 12.17 3 117097 150731 79476557
Constipation 202.72 12.17 888 116212 282162 79345126
Herpes zoster 202.18 12.17 432 116668 92651 79534637
Amyloidosis 201.08 12.17 92 117008 2614 79624674
Contraindicated product administered 187.04 12.17 11 117089 157527 79469761
Light chain analysis increased 178.57 12.17 74 117026 1644 79625644
Myelodysplastic syndrome 177.84 12.17 221 116879 30080 79597208
Febrile neutropenia 170.90 12.17 732 116368 230267 79397021
Pain 165.89 12.17 508 116592 703294 78923994
Maternal exposure during pregnancy 163.72 12.17 9 117091 136529 79490759
Systemic lupus erythematosus 162.78 12.17 3 117097 121146 79506142
Arthropathy 161.25 12.17 32 117068 177079 79450209
Alopecia 161.06 12.17 69 117031 231286 79396002
Overdose 160.12 12.17 37 117063 184169 79443119
Drug abuse 159.95 12.17 24 117076 162667 79464621
Autonomic neuropathy 158.56 12.17 70 117030 1825 79625463
Anaemia 153.96 12.17 1149 115951 443866 79183422
Joint swelling 145.39 12.17 126 116974 288520 79338768
Atrial fibrillation 144.73 12.17 625 116475 197261 79430027
Chalazion 138.45 12.17 45 117055 484 79626804
Ileus paralytic 138.22 12.17 114 116986 9506 79617782
Cardiac amyloidosis 138.12 12.17 63 117037 1777 79625511
Musculoskeletal stiffness 137.31 12.17 43 117057 174965 79452323
Neutrophil count decreased 136.17 12.17 373 116727 93586 79533702
Dehydration 135.90 12.17 721 116379 247466 79379822
Glossodynia 133.29 12.17 4 117096 103333 79523955
Renal failure 132.87 12.17 616 116484 200352 79426936
Therapeutic product effect decreased 132.66 12.17 38 117062 163825 79463463
Exposure during pregnancy 130.14 12.17 4 117096 101128 79526160
B precursor type acute leukaemia 122.63 12.17 39 117061 389 79626899
Condition aggravated 121.99 12.17 356 116744 500768 79126520
Acute lymphocytic leukaemia 121.29 12.17 81 117019 4888 79622400
Hypersensitivity 119.73 12.17 125 116975 262114 79365174
Abdominal discomfort 117.32 12.17 117 116983 250610 79376678
Primary amyloidosis 116.67 12.17 30 117070 125 79627163
Full blood count decreased 116.62 12.17 169 116931 26650 79600638
Hypercalcaemia 115.97 12.17 205 116895 38225 79589063
Anxiety 115.10 12.17 117 116983 248395 79378893
Swelling 114.78 12.17 90 117010 216621 79410667
Pyrexia 114.72 12.17 1509 115591 677200 78950088
Blood pressure increased 114.21 12.17 86 117014 211274 79416014
Psoriasis 113.65 12.17 4 117096 89583 79537705
Peripheral sensorimotor neuropathy 111.49 12.17 64 117036 2946 79624342
Discomfort 109.61 12.17 25 117075 125592 79501696
Cardiac failure 107.05 12.17 481 116619 154361 79472927
Posterior reversible encephalopathy syndrome 101.95 12.17 157 116943 26124 79601164
Mobility decreased 101.37 12.17 27 117073 122148 79505140
Malignant neoplasm progression 99.73 12.17 430 116670 135560 79491728
Wound 99.62 12.17 24 117076 116155 79511133
Suicide attempt 97.78 12.17 6 117094 82926 79544362
Cytomegalovirus infection 97.28 12.17 202 116898 42442 79584846
Haematotoxicity 97.23 12.17 117 116983 15402 79611886
Monoclonal immunoglobulin present 97.02 12.17 42 117058 1043 79626245
Weight increased 93.47 12.17 165 116935 277221 79350067
Injection site pain 93.10 12.17 37 117063 129801 79497487
Osteonecrosis of jaw 91.94 12.17 199 116901 43027 79584261
Product use issue 90.29 12.17 572 116528 209250 79418038
Thrombosis 89.90 12.17 300 116800 83800 79543488
Inappropriate schedule of product administration 89.58 12.17 42 117058 133586 79493702
Stem cell transplant 89.50 12.17 60 117040 3644 79623644
Therapy non-responder 88.86 12.17 318 116782 91987 79535301
Pathological fracture 85.73 12.17 91 117009 10446 79616842
Depression 85.41 12.17 116 116984 216674 79410614
Bone marrow failure 84.32 12.17 213 116887 50894 79576394
Malaise 83.86 12.17 402 116698 489467 79137821
Osteolysis 83.46 12.17 62 117038 4436 79622852
Blood cholesterol increased 83.07 12.17 12 117088 83708 79543580
Death 82.41 12.17 1227 115873 565287 79062001
Helicobacter infection 82.30 12.17 5 117095 69699 79557589
Cystitis haemorrhagic 81.42 12.17 83 117017 9089 79618199
Fibromyalgia 81.17 12.17 3 117097 64337 79562951
Duodenal ulcer perforation 80.50 12.17 4 117096 66207 79561081
Pleural effusion 80.10 12.17 423 116677 144839 79482449
Rhabdomyolysis 79.69 12.17 26 117074 103105 79524183
Guillain-Barre syndrome 79.36 12.17 81 117019 8884 79618404
Hepatitis B reactivation 78.73 12.17 68 117032 6040 79621248
Hyperviscosity syndrome 78.62 12.17 28 117072 405 79626883
Spinal cord compression 78.19 12.17 69 117031 6308 79620980
Blood pressure fluctuation 75.84 12.17 6 117094 67139 79560149
Hordeolum 74.84 12.17 51 117049 3182 79624106
Hypertension 73.46 12.17 245 116855 330747 79296541
Wrong technique in product usage process 72.35 12.17 11 117089 73864 79553424
Stress 71.15 12.17 15 117085 79597 79547691
Blister 70.66 12.17 44 117056 119432 79507856
Peripheral motor neuropathy 70.64 12.17 50 117050 3317 79623971
Ileus 70.44 12.17 133 116967 26078 79601210
Nasopharyngitis 70.28 12.17 169 116931 253712 79373576
Haemoglobin decreased 69.10 12.17 560 116540 221559 79405729
Arthritis 68.37 12.17 42 117058 114838 79512450
Migraine 67.70 12.17 22 117078 87471 79539817
Cytomegalovirus infection reactivation 66.92 12.17 73 117027 8643 79618645
Hepatic enzyme increased 66.72 12.17 103 116997 182507 79444781
Pulmonary embolism 66.56 12.17 456 116644 171198 79456090
Irritable bowel syndrome 66.44 12.17 7 117093 62234 79565054
Protein total increased 65.48 12.17 50 117050 3729 79623559
Blood stem cell harvest failure 65.31 12.17 18 117082 103 79627185
Colitis 65.04 12.17 246 116854 73061 79554227
Wheezing 64.90 12.17 46 117054 116618 79510670
Coombs indirect test positive 64.42 12.17 16 117084 56 79627232
Pericarditis 63.58 12.17 37 117063 104199 79523089
Injury 60.83 12.17 19 117081 77477 79549811
Acute myeloid leukaemia 59.84 12.17 137 116963 30748 79596540
Hypogammaglobulinaemia 58.33 12.17 83 117017 12868 79614420
Blood creatine phosphokinase increased 57.95 12.17 13 117087 66077 79561211
Flushing 57.24 12.17 29 117071 88239 79539049
Blood lactate dehydrogenase increased 56.21 12.17 155 116945 39015 79588273
Intentional product use issue 55.98 12.17 399 116701 151713 79475575
Ill-defined disorder 55.70 12.17 14 117086 65861 79561427
Morganella infection 55.70 12.17 29 117071 1098 79626190
Red blood cell sedimentation rate increased 55.14 12.17 3 117097 45939 79581349
B-cell type acute leukaemia 55.12 12.17 23 117077 520 79626768
Folliculitis 54.79 12.17 8 117092 55372 79571916
Loss of personal independence in daily activities 53.78 12.17 43 117057 102537 79524751
Asthma 53.47 12.17 72 117028 135023 79492265
Blood pressure systolic increased 53.34 12.17 16 117084 66970 79560318
Neurotoxicity 53.09 12.17 135 116965 32383 79594905
Treatment failure 52.48 12.17 107 116993 170379 79456909
Bacteraemia 52.27 12.17 135 116965 32689 79594599
Osteoarthritis 51.83 12.17 32 117068 87277 79540011
Sleep disorder 51.43 12.17 31 117069 85646 79541642
Metapneumovirus infection 50.71 12.17 32 117068 1752 79625536
Bone pain 50.23 12.17 188 116912 55554 79571734
Sedation 50.19 12.17 8 117092 51887 79575401
Hypocalcaemia 49.75 12.17 174 116926 49750 79577538
BK virus infection 49.71 12.17 63 117037 8741 79618547
Suicidal ideation 49.62 12.17 25 117075 76315 79550973
Somnolence 48.90 12.17 183 116917 238798 79388490
Pseudomyopia 48.63 12.17 14 117086 96 79627192
Heart rate increased 48.13 12.17 64 117036 120660 79506628
Myalgia 47.93 12.17 128 116972 185513 79441775
Contusion 47.84 12.17 91 117009 148685 79478603
Pneumonia fungal 47.80 12.17 70 117030 11140 79616148
Compression fracture 47.68 12.17 53 117047 6407 79620881
Renal amyloidosis 47.68 12.17 15 117085 144 79627144
Progressive multifocal leukoencephalopathy 47.47 12.17 98 117002 20502 79606786
Nasal congestion 46.93 12.17 27 117073 76525 79550763
Squamous cell carcinoma of skin 46.45 12.17 78 117022 13955 79613333
Respiratory failure 46.29 12.17 437 116663 180474 79446814
Chronic inflammatory demyelinating polyradiculoneuropathy 46.05 12.17 26 117074 1159 79626129
Syncope 45.68 12.17 433 116667 179016 79448272
Infection 45.55 12.17 549 116551 241163 79386125
Pruritus 45.51 12.17 366 116734 394282 79233006
Hyperhidrosis 45.01 12.17 97 117003 151395 79475893
Type 2 diabetes mellitus 44.84 12.17 14 117086 57108 79570180
Blepharitis 44.83 12.17 37 117063 3087 79624201
Thrombotic microangiopathy 44.20 12.17 94 117006 20075 79607213
Anaphylactic reaction 44.02 12.17 35 117065 83708 79543580
Lymphopenia 43.93 12.17 121 116979 30436 79596852
Prescribed overdose 43.88 12.17 3 117097 37880 79589408
Light chain analysis abnormal 43.23 12.17 15 117085 200 79627088
Keratopathy 43.19 12.17 25 117075 1169 79626119
Sinusitis 43.13 12.17 145 116955 195356 79431932
Meningitis listeria 43.02 12.17 24 117076 1045 79626243
Urticaria 42.49 12.17 135 116965 185066 79442222
Erythema 42.48 12.17 176 116924 223114 79404174
Pneumonia pneumococcal 42.30 12.17 40 117060 3997 79623291
Gastrooesophageal reflux disease 41.82 12.17 55 117045 104191 79523097
Clostridium difficile colitis 41.70 12.17 123 116977 32160 79595128
Performance status decreased 41.46 12.17 48 117052 6065 79621223
Anaphylactic shock 41.26 12.17 3 117097 35993 79591295
Asthenia 41.02 12.17 1012 116088 510677 79116611
Aggression 40.88 12.17 12 117088 50946 79576342
Impaired healing 40.84 12.17 41 117059 87614 79539674
Spinal compression fracture 40.64 12.17 82 117018 16876 79610412
Bacterial sepsis 40.60 12.17 55 117045 8143 79619145
Crossmatch incompatible 40.49 12.17 10 117090 34 79627254
Respiratory tract infection 40.41 12.17 160 116940 48529 79578759
Palpitations 40.22 12.17 78 117022 126532 79500756
Obesity 40.06 12.17 3 117097 35122 79592166
Hepatitis B 39.91 12.17 55 117045 8277 79619011
Refractory cytopenia with multilineage dysplasia 39.84 12.17 15 117085 256 79627032
JC virus infection 39.80 12.17 38 117062 3843 79623445
Abdominal pain upper 39.78 12.17 181 116919 223638 79403650
Visceral leishmaniasis 39.26 12.17 23 117077 1100 79626188
Large intestine perforation 39.24 12.17 74 117026 14493 79612795
Toxic skin eruption 38.97 12.17 95 117005 22198 79605090
Dry mouth 38.96 12.17 43 117057 87976 79539312
Neuralgia 38.28 12.17 122 116978 33262 79594026
Hypophosphataemia 38.21 12.17 88 117012 19825 79607463
Mucosal inflammation 38.20 12.17 215 116885 75365 79551923
Myelosuppression 38.06 12.17 138 116962 40158 79587130
Abdominal pain 38.01 12.17 377 116723 389192 79238096
Diverticular perforation 37.85 12.17 45 117055 5848 79621440
Infection in an immunocompromised host 37.54 12.17 24 117076 1344 79625944
Cough 37.46 12.17 351 116749 366438 79260850
Sopor 37.14 12.17 3 117097 33007 79594281
Inflammation 37.06 12.17 50 117050 93703 79533585
Nasal abscess 37.02 12.17 13 117087 180 79627108
COVID-19 pneumonia 36.40 12.17 109 116991 28740 79598548
Osteoporosis 36.26 12.17 17 117083 54095 79573193
Hip arthroplasty 35.76 12.17 5 117095 35751 79591537
Rash 35.41 12.17 1105 115995 577253 79050035
Pain in extremity 35.05 12.17 354 116746 364184 79263104
Large intestinal ulcer perforation 34.94 12.17 10 117090 67 79627221
Joint injury 34.83 12.17 3 117097 31332 79595956
Demyelinating polyneuropathy 34.76 12.17 25 117075 1701 79625587
Toxicity to various agents 34.74 12.17 837 116263 420703 79206585
Underdose 34.69 12.17 4 117096 33147 79594141
Bone lesion 34.45 12.17 43 117057 5876 79621412
Colitis ulcerative 34.41 12.17 5 117095 34737 79592551
Drug withdrawal syndrome 34.38 12.17 5 117095 34713 79592575
Enterococcal infection 34.33 12.17 73 117027 15587 79611701
Fungal oesophagitis 33.92 12.17 20 117080 968 79626320
Heart rate decreased 33.79 12.17 32 117068 70284 79557004
Incorrect dose administered 33.30 12.17 38 117062 76592 79550696
Erysipelas 32.88 12.17 58 117042 10792 79616496
Inappropriate antidiuretic hormone secretion 32.80 12.17 99 117001 26214 79601074
Cardiotoxicity 32.76 12.17 62 117038 12177 79615111
COVID-19 32.75 12.17 365 116735 157309 79469979
VIth nerve paresis 32.61 12.17 11 117089 134 79627154
Joint range of motion decreased 32.48 12.17 5 117095 33277 79594011
Mesenteric abscess 32.03 12.17 11 117089 142 79627146
Injection site swelling 31.29 12.17 15 117085 47117 79580171
Product quality issue 31.15 12.17 6 117094 33934 79593354
Nocardiosis 31.06 12.17 40 117060 5639 79621649
Parainfluenzae virus infection 31.04 12.17 40 117060 5642 79621646
Transplant 30.98 12.17 19 117081 989 79626299
Pneumonia influenzal 30.86 12.17 29 117071 2875 79624413
Drug reaction with eosinophilia and systemic symptoms 30.66 12.17 180 116920 64064 79563224
Osteonecrosis 30.65 12.17 108 116992 30987 79596301
Endocarditis bacterial 30.46 12.17 22 117078 1507 79625781
Lactic acidosis 30.45 12.17 35 117065 70324 79556964
Body dysmorphic disorder 30.44 12.17 13 117087 312 79626976
Lip swelling 30.41 12.17 11 117089 40900 79586388
End stage renal disease 30.38 12.17 60 117040 12160 79615128
Hyperproteinaemia 30.16 12.17 11 117089 171 79627117
Drug intolerance 29.93 12.17 246 116854 263873 79363415
Drug-induced liver injury 29.59 12.17 32 117068 66085 79561203
Bursitis 29.57 12.17 8 117092 35836 79591452
Dyspepsia 29.53 12.17 73 117027 108614 79518674
General physical condition abnormal 29.47 12.17 42 117058 6521 79620767
Hypoglycaemia 29.39 12.17 66 117034 101528 79525760
Hypoalbuminaemia 29.30 12.17 83 117017 21214 79606074
Rib fracture 29.23 12.17 99 117001 27848 79599440
Ageusia 29.20 12.17 71 117029 16561 79610727
Gait disturbance 28.98 12.17 182 116918 207324 79419964
Angioedema 28.61 12.17 42 117058 75993 79551295
Oedema peripheral 28.60 12.17 525 116575 251763 79375525
Oropharyngeal pain 28.51 12.17 75 117025 109278 79518010
Cerebellar haemangioma 28.46 12.17 9 117091 88 79627200
H1N1 influenza 28.40 12.17 26 117074 2493 79624795
Musculoskeletal pain 28.40 12.17 68 117032 102286 79525002
Liver injury 28.11 12.17 25 117075 56589 79570699
Memory impairment 28.11 12.17 78 117022 111656 79515632
Oroantral fistula 27.82 12.17 13 117087 388 79626900
Febrile bone marrow aplasia 27.75 12.17 60 117040 12960 79614328
Pulmonary oedema 27.67 12.17 223 116877 88031 79539257
Swollen tongue 27.57 12.17 14 117086 42556 79584732
Gastrointestinal fungal infection 27.44 12.17 14 117086 508 79626780
Rhinovirus infection 27.38 12.17 45 117055 7908 79619380
Accidental overdose 27.20 12.17 12 117088 39569 79587719
Iron deficiency anaemia 27.11 12.17 3 117097 25669 79601619
Cardiac failure congestive 27.04 12.17 324 116776 142078 79485210
Depressed level of consciousness 26.98 12.17 64 117036 96588 79530700
Failure to thrive 26.88 12.17 56 117044 11788 79615500
Dysarthria 26.79 12.17 36 117064 67586 79559702
Polyomavirus-associated nephropathy 26.74 12.17 37 117063 5590 79621698
N-terminal prohormone brain natriuretic peptide decreased 26.70 12.17 7 117093 32 79627256
Seizure 26.69 12.17 165 116935 188669 79438619
Rectal adenocarcinoma 26.65 12.17 20 117080 1453 79625835
Tear break up time decreased 26.58 12.17 6 117094 12 79627276
Pallor 26.21 12.17 21 117079 50041 79577247
Hypersensitivity myocarditis 26.03 12.17 11 117089 257 79627031
Autonomic nervous system imbalance 25.93 12.17 33 117067 4597 79622691
Depressed mood 25.81 12.17 20 117080 48460 79578828
Dyskinesia 25.76 12.17 17 117083 44756 79582532
Throat irritation 25.73 12.17 14 117086 40932 79586356
Adenocarcinoma of colon 25.68 12.17 36 117064 5505 79621783
Diabetic ketoacidosis 25.66 12.17 9 117091 34113 79593175
Pneumonia cytomegaloviral 25.62 12.17 34 117066 4935 79622353
Amnesia 25.56 12.17 33 117067 63024 79564264
Frequent bowel movements 25.51 12.17 6 117094 29533 79597755
Chest discomfort 25.50 12.17 110 116990 137934 79489354
Meningitis pneumococcal 25.39 12.17 13 117087 475 79626813
Multiple organ dysfunction syndrome 25.25 12.17 279 116821 119967 79507321
Escherichia sepsis 25.16 12.17 45 117055 8463 79618825
Bronchopulmonary aspergillosis 25.13 12.17 81 117019 22213 79605075
Refractory anaemia with an excess of blasts 25.13 12.17 16 117084 890 79626398
Respirovirus test positive 25.03 12.17 9 117091 134 79627154
VIth nerve paralysis 24.92 12.17 20 117080 1604 79625684
Venoocclusive liver disease 24.81 12.17 54 117046 11717 79615571
Medication error 24.78 12.17 39 117061 68603 79558685
Nephrolithiasis 24.74 12.17 25 117075 53266 79574022
Feeling abnormal 24.69 12.17 135 116965 159064 79468224
Hiccups 24.63 12.17 49 117051 9982 79617306
Target skin lesion 24.61 12.17 9 117091 141 79627147
Staphylococcal bacteraemia 24.56 12.17 55 117045 12163 79615125
Oral surgery 24.34 12.17 17 117083 1104 79626184
Basal cell carcinoma 24.23 12.17 114 116986 37261 79590027
Sinus polyp 24.20 12.17 13 117087 525 79626763
Neutropenic sepsis 24.14 12.17 91 117009 26973 79600315
Renal impairment 24.10 12.17 345 116755 157438 79469850
Coma 24.04 12.17 72 117028 100577 79526711
Acute respiratory distress syndrome 24.04 12.17 128 116972 43939 79583349
Therapy interrupted 24.03 12.17 8 117092 31333 79595955
Accidental exposure to product 24.01 12.17 8 117092 31314 79595974
Blood immunoglobulin A increased 23.93 12.17 16 117084 967 79626321
Hypothyroidism 23.84 12.17 25 117075 52367 79574921
Pulmonary sepsis 23.27 12.17 28 117072 3684 79623604
Respiratory depression 23.11 12.17 6 117094 27624 79599664
Engraftment syndrome 23.01 12.17 18 117082 1391 79625897
Device dislocation 22.98 12.17 5 117095 25965 79601323
Pityriasis rubra pilaris 22.70 12.17 8 117092 112 79627176
Blood potassium decreased 22.64 12.17 131 116969 46381 79580907
Disturbance in social behaviour 22.60 12.17 32 117068 4938 79622350
Pneumonia bacterial 22.49 12.17 71 117029 19260 79608028
Hallucination, visual 22.37 12.17 10 117090 32719 79594569
Fatigue 22.35 12.17 1618 115482 928109 78699179
Acute febrile neutrophilic dermatosis 22.33 12.17 28 117072 3844 79623444
Bronchiolitis 22.13 12.17 29 117071 4159 79623129
Taste disorder 22.09 12.17 62 117038 15761 79611527
Neurogenic bladder 22.00 12.17 29 117071 4183 79623105
Hot flush 21.96 12.17 29 117071 54848 79572440
Clostridium bacteraemia 21.87 12.17 11 117089 387 79626901
Superficial spreading melanoma stage unspecified 21.73 12.17 10 117090 288 79627000
Conjunctival irritation 21.72 12.17 8 117092 128 79627160
Blood culture positive 21.70 12.17 42 117058 8387 79618901
Adenovirus infection 21.63 12.17 42 117058 8405 79618883
Laboratory test abnormal 21.55 12.17 90 117010 27958 79599330
Feeling hot 21.51 12.17 34 117066 59700 79567588
Bacterial infection 21.45 12.17 97 117003 31183 79596105
Procedural pain 21.35 12.17 4 117096 23080 79604208
Pseudomonal sepsis 21.35 12.17 35 117065 6139 79621149
Crying 21.30 12.17 4 117096 23039 79604249
Meningitis cryptococcal 21.26 12.17 26 117074 3480 79623808
Lung infiltration 21.24 12.17 78 117022 22834 79604454
Meibomian gland dysfunction 21.23 12.17 9 117091 212 79627076
Blood immunoglobulin G increased 21.17 12.17 24 117076 2965 79624323
Graft versus host disease 21.10 12.17 59 117041 14967 79612321
Leukaemia 21.05 12.17 34 117066 5891 79621397
Neck pain 21.00 12.17 50 117050 75367 79551921
Bradycardia 20.99 12.17 115 116985 135442 79491846
Surgery 20.89 12.17 11 117089 32755 79594533
Bacterial parotitis 20.86 12.17 6 117094 41 79627247
Stomatitis 20.86 12.17 128 116972 146629 79480659
Extrapyramidal disorder 20.83 12.17 4 117096 22675 79604613
Product prescribing error 20.83 12.17 21 117079 44792 79582496
Chromaturia 20.77 12.17 6 117094 25740 79601548
Acne 20.74 12.17 7 117093 27183 79600105
Refractory cancer 20.66 12.17 9 117091 227 79627061
Irritability 20.63 12.17 18 117082 41126 79586162
Foot deformity 20.58 12.17 5 117095 24069 79603219
Periodontitis 20.52 12.17 29 117071 4467 79622821
Injection site bruising 20.48 12.17 18 117082 40984 79586304
Phrenic nerve paralysis 20.44 12.17 10 117090 331 79626957
Tachycardia 20.39 12.17 165 116935 177603 79449685
Atrial flutter 20.37 12.17 74 117026 21551 79605737
Leukopenia 20.35 12.17 261 116839 116252 79511036
Multiple sclerosis 20.32 12.17 4 117096 22278 79605010
Lymphocytic leukaemia 20.23 12.17 9 117091 239 79627049
Hyperthyroidism 20.22 12.17 4 117096 22205 79605083
Monoclonal gammopathy 20.20 12.17 14 117086 898 79626390
Disturbance in attention 20.17 12.17 27 117073 50774 79576514
Electrolyte imbalance 19.88 12.17 94 117006 30787 79596501
Visual impairment 19.85 12.17 69 117031 92062 79535226
Varicella 19.85 12.17 23 117077 2909 79624379
Small intestinal obstruction 19.79 12.17 86 117014 27186 79600102
Troponin T increased 19.57 12.17 25 117075 3497 79623791
Enterococcal sepsis 19.49 12.17 22 117078 2704 79624584
Therapeutic response decreased 19.39 12.17 166 116934 66687 79560601
Hypercholesterolaemia 19.35 12.17 5 117095 23090 79604198
N-terminal prohormone brain natriuretic peptide increased 19.28 12.17 29 117071 4726 79622562
Nodule 19.22 12.17 5 117095 22989 79604299
Peritonitis viral 19.13 12.17 6 117094 57 79627231
Body temperature decreased 18.77 12.17 12 117088 32133 79595155
Tooth deposit 18.77 12.17 9 117091 285 79627003
Intentional product misuse 18.72 12.17 74 117026 95091 79532197
Haematochezia 18.64 12.17 66 117034 87579 79539709
Torsade de pointes 18.62 12.17 3 117097 19309 79607979
Sciatica 18.60 12.17 13 117087 33209 79594079
Glycosylated haemoglobin increased 18.55 12.17 3 117097 19257 79608031
Malignant fibrous histiocytoma 18.47 12.17 8 117092 199 79627089
Poisoning 18.44 12.17 7 117093 25265 79602023
Brief psychotic disorder with marked stressors 18.34 12.17 9 117091 300 79626988
Rash pruritic 18.29 12.17 173 116927 71456 79555832
Paraproteinaemia 18.26 12.17 10 117090 420 79626868
Sleep apnoea syndrome 18.24 12.17 16 117084 36462 79590826
Pneumonia parainfluenzae viral 18.20 12.17 9 117091 305 79626983
Gastrointestinal toxicity 18.01 12.17 38 117062 8071 79619217
Dyspnoea 17.96 12.17 1053 116047 855972 78771316
Hypocalcaemic seizure 17.94 12.17 6 117094 71 79627217
Clostridial infection 17.91 12.17 31 117069 5683 79621605
Grip strength decreased 17.82 12.17 5 117095 21864 79605424
Product substitution issue 17.72 12.17 4 117096 20252 79607036
Plasma cells present 17.72 12.17 4 117096 8 79627280
Intraductal proliferative breast lesion 17.64 12.17 20 117080 2471 79624817
Gastrointestinal amyloidosis 17.57 12.17 6 117094 76 79627212
Mantle cell lymphoma recurrent 17.57 12.17 11 117089 594 79626694
Hypoaesthesia 17.53 12.17 365 116735 178987 79448301
Nightmare 17.52 12.17 8 117092 25853 79601435
Oncologic complication 17.50 12.17 9 117091 332 79626956
Listeria sepsis 17.45 12.17 12 117088 760 79626528
Cerebral aspergillosis 17.32 12.17 17 117083 1779 79625509
Empyema 17.22 12.17 26 117074 4250 79623038
Illness 17.20 12.17 26 117074 46485 79580803
Enteric neuropathy 17.10 12.17 4 117096 10 79627278
Light chain analysis 17.10 12.17 4 117096 10 79627278
Hypokalaemia 17.10 12.17 302 116798 143738 79483550
Plasma cells decreased 17.04 12.17 5 117095 37 79627251
Squamous cell carcinoma 16.92 12.17 56 117044 15566 79611722
Tendonitis 16.73 12.17 7 117093 23823 79603465
Bone erosion 16.71 12.17 3 117097 17844 79609444
Thrombotic thrombocytopenic purpura 16.69 12.17 32 117068 6344 79620944
Pneumonia respiratory syncytial viral 16.59 12.17 17 117083 1873 79625415
Varicella zoster virus infection 16.48 12.17 26 117074 4415 79622873
Adenoviral haemorrhagic cystitis 16.40 12.17 10 117090 515 79626773
Klebsiella sepsis 16.38 12.17 22 117078 3230 79624058
Clostridium difficile infection 16.29 12.17 113 116987 42572 79584716
Malignant melanoma in situ 16.21 12.17 19 117081 2433 79624855
Fear 16.19 12.17 6 117094 21980 79605308
Spinal column injury 16.16 12.17 18 117082 2180 79625108
Movement disorder 16.16 12.17 10 117090 27249 79600039
Pulmonary alveolar haemorrhage 16.10 12.17 45 117055 11412 79615876
Neuromyotonia 15.80 12.17 6 117094 105 79627183
Disability 15.76 12.17 3 117097 17117 79610171
Eosinophil count increased 15.75 12.17 3 117097 17102 79610186
Laryngeal cancer metastatic 15.71 12.17 5 117095 50 79627238
Panic attack 15.63 12.17 8 117092 24208 79603080
Myocardial infarction 15.59 12.17 184 116916 183945 79443343
Escherichia infection 15.59 12.17 60 117040 17957 79609331
Obstructive airways disorder 15.49 12.17 14 117086 31445 79595843
Organising pneumonia 15.41 12.17 43 117057 10896 79616392
Venous thrombosis 15.40 12.17 33 117067 7083 79620205
Respiratory arrest 15.36 12.17 39 117061 57511 79569777
Respiratory syncytial virus infection 15.31 12.17 39 117061 9363 79617925
Blood creatinine increased 15.29 12.17 316 116784 154741 79472547
Ulcer 15.16 12.17 13 117087 29959 79597329
Impaired work ability 15.13 12.17 5 117095 19676 79607612
Hypoglossal nerve paresis 15.11 12.17 6 117094 119 79627169
Parkinsonism 15.07 12.17 3 117097 16581 79610707
Genital erythema 15.05 12.17 8 117092 316 79626972
Infection reactivation 14.98 12.17 19 117081 2638 79624650
Klebsiella infection 14.98 12.17 54 117046 15666 79611622
Atrial rupture 14.97 12.17 5 117095 59 79627229
Precursor B-lymphoblastic lymphoma 14.96 12.17 4 117096 20 79627268
Toxic neuropathy 14.89 12.17 12 117088 968 79626320
Hyperlipidaemia 14.89 12.17 10 117090 26083 79601205
Immunosuppression 14.87 12.17 47 117053 12756 79614532
Prescribed underdose 14.69 12.17 13 117087 29501 79597787
Pneumococcal sepsis 14.68 12.17 15 117085 1647 79625641
Capillary leak syndrome 14.60 12.17 23 117077 3902 79623386
Cholelithiasis 14.59 12.17 35 117065 52629 79574659
Cardiac pacemaker evaluation 14.57 12.17 6 117094 131 79627157
Faeces discoloured 14.29 12.17 13 117087 29114 79598174
Prinzmetal angina 14.25 12.17 15 117085 1705 79625583
Blood pressure diastolic decreased 14.23 12.17 14 117086 30202 79597086
Gastrointestinal disorder 14.21 12.17 113 116987 122092 79505196
Minimal residual disease 14.18 12.17 9 117091 498 79626790
Pseudomembranous colitis 14.11 12.17 27 117073 5347 79621941
Protein total decreased 14.07 12.17 37 117063 9055 79618233
Transitional cell carcinoma 14.06 12.17 18 117082 2523 79624765
Cardiomegaly 14.00 12.17 76 117024 26276 79601012
Eosinophilic pneumonia chronic 14.00 12.17 9 117091 509 79626779
Oesophageal adenocarcinoma 13.98 12.17 11 117089 857 79626431
Poor quality sleep 13.94 12.17 8 117092 22714 79604574
Hepatitis 13.94 12.17 39 117061 55688 79571600
Therapy cessation 13.88 12.17 21 117079 37541 79589747
Atelectasis 13.88 12.17 88 117012 32169 79595119
Drug level increased 13.87 12.17 23 117077 39628 79587660
Plasmablastic lymphoma 13.86 12.17 9 117091 518 79626770
Encephalitis viral 13.85 12.17 18 117082 2561 79624727
Aphasia 13.81 12.17 30 117070 46702 79580586
Road traffic accident 13.77 12.17 27 117073 43637 79583651
Squamous cell carcinoma of lung 13.77 12.17 17 117083 2297 79624991
Mucosal erosion 13.75 12.17 17 117083 2301 79624987
Drug ineffective for unapproved indication 13.70 12.17 125 116975 51113 79576175
Mouth ulceration 13.68 12.17 22 117078 38372 79588916
Psychotic disorder 13.59 12.17 25 117075 41377 79585911
Lip dry 13.58 12.17 3 117097 15415 79611873
Osteopenia 13.54 12.17 5 117095 18359 79608929
Hypoperfusion 13.52 12.17 18 117082 2621 79624667
Scrotal pain 13.51 12.17 9 117091 541 79626747
Blood triglycerides increased 13.51 12.17 7 117093 21033 79606255
Cerebral toxoplasmosis 13.49 12.17 17 117083 2345 79624943
Fall 13.49 12.17 582 116518 487047 79140241
Gastric ulcer 13.48 12.17 18 117082 33887 79593401
Haemorrhagic fever 13.47 12.17 4 117096 31 79627257
Paranoid personality disorder 13.47 12.17 4 117096 31 79627257
Exostosis 13.47 12.17 4 117096 16854 79610434
Muscle twitching 13.46 12.17 10 117090 24754 79602534
Oxygen saturation decreased 13.36 12.17 123 116977 128924 79498364
Heart rate irregular 13.35 12.17 17 117083 32662 79594626
Bence Jones proteinuria 13.29 12.17 3 117097 6 79627282
Hyperamylasaemia 13.25 12.17 12 117088 1135 79626153
Gastrointestinal infection 13.24 12.17 42 117058 11419 79615869
Decreased appetite 13.19 12.17 622 116478 341796 79285492
Procalcitonin increased 13.15 12.17 19 117081 2987 79624301
Eczema 13.08 12.17 25 117075 40793 79586495
Liver function test increased 13.07 12.17 24 117076 39749 79587539
Malignant neoplasm of unknown primary site 13.05 12.17 10 117090 750 79626538
Febrile infection 12.99 12.17 20 117080 3326 79623962
Delayed engraftment 12.98 12.17 7 117093 285 79627003
Follicle centre lymphoma, follicular grade I, II, III recurrent 12.97 12.17 3 117097 7 79627281
Cytomegalovirus enterocolitis 12.95 12.17 14 117086 1641 79625647
Injection site exfoliation 12.91 12.17 7 117093 288 79627000
Ejection fraction decreased 12.88 12.17 91 117009 34486 79592802
Sputum discoloured 12.86 12.17 8 117092 21735 79605553
Delusion 12.81 12.17 7 117093 20416 79606872
Restlessness 12.80 12.17 31 117069 46461 79580827
Hypotension 12.79 12.17 779 116321 439538 79187750
Vertigo 12.78 12.17 55 117045 69027 79558261
Cytomegalovirus hepatitis 12.77 12.17 10 117090 774 79626514
Malnutrition 12.71 12.17 66 117034 22436 79604852
Cholangiocarcinoma 12.70 12.17 17 117083 2489 79624799
Paraesthesia 12.69 12.17 344 116756 175979 79451309
Ventricular fibrillation 12.64 12.17 17 117083 31909 79595379
Congestive cardiomyopathy 12.56 12.17 42 117058 11738 79615550
Amyotrophy 12.53 12.17 9 117091 611 79626677
Clostridium colitis 12.50 12.17 18 117082 2821 79624467
Meningoencephalitis herpetic 12.47 12.17 15 117085 1974 79625314
Acute kidney injury 12.43 12.17 904 116196 518500 79108788
Electrodesiccation 12.43 12.17 3 117097 9 79627279
Spinal fracture 12.39 12.17 56 117044 17998 79609290
Pneumocystis jirovecii pneumonia 12.37 12.17 86 117014 32422 79594866
Cellulitis 12.36 12.17 227 116873 108833 79518455
Red blood cell count decreased 12.32 12.17 134 116966 57379 79569909
Enterocolitis 12.29 12.17 48 117052 14464 79612824
Impaired quality of life 12.27 12.17 3 117097 14383 79612905
Electrocardiogram QT prolonged 12.24 12.17 80 117020 90306 79536982
Lung disorder 12.24 12.17 176 116924 80381 79546907
Pneumocystis jirovecii infection 12.23 12.17 18 117082 2876 79624412
Adenocarcinoma pancreas 12.20 12.17 15 117085 2018 79625270

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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
3.5MG/1.4ML (2.5MG/ML) BORTEZOMIB MAIA PHARMS INC N215331 July 27, 2022 RX SOLUTION INTRAVENOUS 11679119 Sept. 23, 2042 TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA
3.5MG/1.4ML (2.5MG/ML) BORTEZOMIB MAIA PHARMS INC N215331 July 27, 2022 RX SOLUTION INTRAVENOUS 11679119 Sept. 23, 2042 TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA
3.5MG/3.5ML (1MG/ML) BORTEZOMIB MAIA PHARMS INC N215331 July 27, 2022 DISCN SOLUTION INTRAVENOUS 11679119 Sept. 23, 2042 TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA
3.5MG/3.5ML (1MG/ML) BORTEZOMIB MAIA PHARMS INC N215331 July 27, 2022 DISCN SOLUTION INTRAVENOUS 11679119 Sept. 23, 2042 TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
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
Proteasome subunit beta type-5 Enzyme INHIBITOR Ki 9.26 CHEMBL CHEMBL
Proteasome subunit beta type-8 Enzyme INHIBITOR IC50 8.09 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
Lon protease homolog, mitochondrial Enzyme IC50 6.74 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
NACHT, LRR and PYD domains-containing protein 3 Unclassified IC50 7.39 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
398907002 SNOMEDCT_US
407097007 SNOMEDCT_US
4021393 VANDF
009985 NDDF

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 34 sections
BORTEZOMIB HUMAN PRESCRIPTION DRUG LABEL 1 0409-1703 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 2.50 mg INTRAVENOUS NDA 34 sections
BORTEZOMIB HUMAN PRESCRIPTION DRUG LABEL 1 0409-1704 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1 mg INTRAVENOUS NDA 34 sections
BORTEZOMIB HUMAN PRESCRIPTION DRUG LABEL 1 0409-1704 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1 mg INTRAVENOUS NDA 34 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 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 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