daratumumab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
human origin 5063 945721-28-8

Description:

MoleculeDescription

Synonyms:

  • daratumumab
  • HuMax-CD38
  • 3003-005
  • darzalex
Daratumumab is an IgG1k human monoclonal antibody (mAb) that binds to CD38 and inhibits the growth of CD38 expressing tumor cells by inducing apoptosis directly through Fc mediated cross linking as well as by immune-mediated tumor cell lysis through complement dependent cytotoxicity (CDC), antibody dependent cell mediated cytotoxicity (ADCC) and antibody dependent cellular phagocytosis (ADCP).
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
64.30 mg P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Sept. 27, 2017 PMDA Janssen Pharmaceutical KK
May 20, 2016 EMA Janssen-Cilag International N.V.
Nov. 16, 2015 FDA JANSSEN BIOTECH

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
Neutropenia 932.30 19.58 707 30898 224197 90372645
Infusion related reaction 740.91 19.58 814 30791 415966 90180876
Neuropathy peripheral 623.24 19.58 456 31149 136514 90460328
Thrombocytopenia 422.97 19.58 438 31167 208287 90388555
Off label use 412.18 19.58 1065 30540 1101187 89495655
Plasma cell myeloma 383.54 19.58 215 31390 40613 90556229
Myelosuppression 381.91 19.58 236 31369 53355 90543487
Polyneuropathy 344.26 19.58 157 31448 19184 90577658
White blood cell count decreased 286.08 19.58 321 31284 166788 90430054
Hypogammaglobulinaemia 252.89 19.58 106 31499 10568 90586274
Plasma cell myeloma recurrent 233.11 19.58 78 31527 4150 90592692
Pneumonia 222.98 19.58 603 31002 637456 89959386
COVID-19 222.55 19.58 284 31321 168559 90428283
Platelet count decreased 205.59 19.58 246 31359 136723 90460119
Cytopenia 203.15 19.58 106 31499 17343 90579499
Neutrophil count decreased 195.14 19.58 177 31428 71355 90525487
Anaemia 186.44 19.58 392 31213 352410 90244432
COVID-19 pneumonia 185.09 19.58 101 31504 18076 90578766
Plasma cell myeloma refractory 181.31 19.58 47 31558 1009 90595833
Osteolysis 170.27 19.58 59 31546 3491 90593351
Febrile neutropenia 169.87 19.58 241 31364 158108 90438734
Disease progression 164.52 19.58 236 31369 156379 90440463
Pancytopenia 159.48 19.58 203 31402 120060 90476782
Cytokine release syndrome 156.78 19.58 106 31499 27867 90568975
Cytomegalovirus infection reactivation 147.26 19.58 66 31539 7734 90589108
Plasmacytoma 144 19.58 49 31556 2744 90594098
Cytomegalovirus infection 142.43 19.58 98 31507 26504 90570338
Stem cell transplant 131.81 19.58 43 31562 2111 90594731
Leukopenia 127.22 19.58 166 31439 100544 90496298
Tumour lysis syndrome 124.83 19.58 66 31539 11086 90585756
Crossmatch incompatible 118.62 19.58 19 31586 20 90596822
Cardiac failure 117.87 19.58 167 31438 109329 90487513
Light chain analysis increased 115.44 19.58 36 31569 1526 90595316
Septic shock 109.85 19.58 141 31464 84019 90512823
Intentional product use issue 101.81 19.58 230 31375 216662 90380180
Coombs indirect test positive 99.69 19.58 17 31588 34 90596808
Glossodynia 98.54 19.58 3 31602 321776 90275066
Meningitis listeria 95.37 19.58 26 31579 681 90596161
Therapy partial responder 94.59 19.58 71 31534 21972 90574870
Atrial fibrillation 94.29 19.58 168 31437 133443 90463399
Joint swelling 92.86 19.58 30 31575 503270 90093572
Drug hypersensitivity 88.45 19.58 26 31579 463583 90133259
Respiratory tract infection 88.35 19.58 106 31499 58972 90537870
Arthropathy 87.55 19.58 12 31593 366230 90230612
Arthralgia 87.18 19.58 86 31519 778436 89818406
Swelling 86.62 19.58 20 31585 419038 90177804
Chills 85.59 19.58 160 31445 131821 90465021
Wound 85.57 19.58 5 31600 302975 90293867
Pain 84.60 19.58 136 31469 996205 89600637
Headache 83.85 19.58 107 31498 862639 89734203
Sepsis 83.59 19.58 190 31415 179624 90417218
Plasma cell leukaemia 82.70 19.58 26 31579 1132 90595710
Transplant 80.99 19.58 25 31580 1024 90595818
Bone marrow transplant 77.12 19.58 23 31582 837 90596005
Pericarditis 74.66 19.58 5 31600 270146 90326696
Constipation 74.50 19.58 241 31364 280154 90316688
Musculoskeletal stiffness 72.58 19.58 9 31596 296523 90300319
Peripheral sensory neuropathy 69.04 19.58 42 31563 9208 90587634
Abdominal discomfort 68.26 19.58 41 31564 477287 90119555
Alopecia 66.06 19.58 46 31559 495025 90101817
Impaired healing 65.70 19.58 4 31601 234195 90362647
Asphyxia 65.54 19.58 37 31568 7066 90589776
Mobility decreased 65.47 19.58 6 31599 250728 90346114
Diarrhoea 64.47 19.58 552 31053 938638 89658204
Deep vein thrombosis 64.35 19.58 115 31490 91505 90505337
Body dysmorphic disorder 64.34 19.58 17 31588 394 90596448
Haematotoxicity 64.32 19.58 45 31560 12490 90584352
Posterior reversible encephalopathy syndrome 64.27 19.58 57 31548 22282 90574560
Blister 64.24 19.58 7 31598 254991 90341851
Therapeutic product effect decreased 64.22 19.58 10 31595 277561 90319281
Bronchospasm 63.92 19.58 55 31550 20654 90576188
Hyperpyrexia 61.41 19.58 31 31574 4730 90592112
Light chain analysis abnormal 61.16 19.58 14 31591 174 90596668
Cardiac amyloidosis 60.64 19.58 20 31585 1016 90595826
Helicobacter infection 60.39 19.58 5 31600 226845 90369997
Death 60.22 19.58 316 31289 456235 90140607
Type 2 diabetes mellitus 58.46 19.58 3 31602 203241 90393601
Respiratory failure 58.22 19.58 128 31477 118290 90478552
Progressive multifocal leukoencephalopathy 57.53 19.58 46 31559 15609 90581233
Weight increased 56.85 19.58 38 31567 417889 90178953
Condition aggravated 56.58 19.58 75 31530 595470 90001372
Injury 56.49 19.58 3 31602 197346 90399496
Thrombosis 54.09 19.58 94 31511 73157 90523685
Full blood count decreased 54.06 19.58 59 31546 29630 90567212
Lymphopenia 53.48 19.58 52 31553 22829 90574013
Pulmonary embolism 52.92 19.58 131 31474 130689 90466153
Morganella infection 52.82 19.58 17 31588 799 90596043
Ill-defined disorder 52.33 19.58 3 31602 184888 90411954
Pyrexia 52.13 19.58 401 31204 660084 89936758
Pneumococcal sepsis 50.85 19.58 17 31588 901 90595941
Hepatic enzyme increased 50.13 19.58 32 31573 360704 90236138
Aspiration bone marrow 49.67 19.58 12 31593 191 90596651
Blood cholesterol increased 49.24 19.58 7 31598 208005 90388837
Thrombotic microangiopathy 48.97 19.58 42 31563 15701 90581141
Endocarditis 47.27 19.58 30 31575 7083 90589759
Tachypnoea 47.15 19.58 47 31558 21262 90575580
Listeria sepsis 46.28 19.58 15 31590 721 90596121
Migraine 46.03 19.58 6 31599 190386 90406456
Temperature intolerance 45.60 19.58 36 31569 11994 90584848
Pneumocystis jirovecii pneumonia 44.76 19.58 46 31559 21570 90575272
Prohormone brain natriuretic peptide increased 44.51 19.58 12 31593 301 90596541
Contusion 44.48 19.58 16 31589 251200 90345642
Pseudomyopia 44.09 19.58 9 31596 62 90596780
Endocarditis bacterial 44.06 19.58 14 31591 631 90596211
Renal failure 43.61 19.58 122 31483 130885 90465957
Intervertebral discitis 42.94 19.58 24 31581 4496 90592346
Inflammation 42.29 19.58 6 31599 178586 90418256
Paraproteinaemia 42.00 19.58 11 31594 246 90596596
Measles 41.81 19.58 12 31593 381 90596461
Cerebellar haemangioma 41.29 19.58 9 31596 88 90596754
Acute myopia 41.23 19.58 10 31595 162 90596680
Natural killer cell count decreased 39.92 19.58 9 31596 104 90596738
Gait inability 39.61 19.58 3 31602 146453 90450389
Drug interaction 39.12 19.58 24 31581 276429 90320413
Pathological fracture 38.98 19.58 30 31575 9630 90587212
Hypocalcaemia 38.89 19.58 60 31545 42308 90554534
Depression 38.65 19.58 29 31576 300572 90296270
Joint ankylosis 37.91 19.58 15 31590 1288 90595554
Anxiety 37.19 19.58 32 31573 309740 90287102
Pain in extremity 36.68 19.58 63 31542 450466 90146376
Injection site pain 36.42 19.58 8 31597 173691 90423151
Leukaemic infiltration extramedullary 36.01 19.58 9 31596 166 90596676
Bone lesion 35.12 19.58 24 31581 6413 90590429
Escherichia sepsis 34.89 19.58 23 31582 5793 90591049
Stomatitis 34.68 19.58 27 31578 274671 90322171
Acute respiratory distress syndrome 34.21 19.58 46 31559 28640 90568202
Osteoarthritis 33.75 19.58 13 31592 195717 90401125
Acute kidney injury 32.52 19.58 207 31398 320180 90276662
Varicella 32.04 19.58 16 31589 2386 90594456
Overdose 31.61 19.58 8 31597 157701 90439141
Asthma 31.59 19.58 23 31582 242137 90354705
Urinary tract infection 31.35 19.58 198 31407 305434 90291408
Leukoencephalopathy 31.01 19.58 20 31585 4853 90591989
Toxicity to various agents 30.74 19.58 33 31572 287813 90309029
Pneumonia pneumococcal 30.26 19.58 16 31589 2686 90594156
Plasma cells decreased 30.11 19.58 6 31599 36 90596806
Pseudomembranous colitis 29.99 19.58 18 31587 3850 90592992
Bursitis 29.85 19.58 5 31600 131649 90465193
Discomfort 29.80 19.58 31 31574 274304 90322538
Rhinovirus infection 29.65 19.58 21 31584 5942 90590900
Primary amyloidosis 29.36 19.58 7 31598 105 90596737
Bronchopulmonary aspergillosis 28.71 19.58 27 31578 11371 90585471
Laboratory test abnormal 28.68 19.58 52 31553 41802 90555040
Bone marrow disorder 28.53 19.58 16 31589 3016 90593826
Pneumonia cytomegaloviral 28.15 19.58 16 31589 3095 90593747
Visceral leishmaniasis 28.11 19.58 10 31595 639 90596203
Treatment failure 28.07 19.58 39 31566 303889 90292953
Gait disturbance 27.66 19.58 30 31575 260466 90336376
B-cell aplasia 27.58 19.58 8 31597 264 90596578
Chest discomfort 27.32 19.58 108 31497 138257 90458585
Cerebral toxoplasmosis 26.87 19.58 12 31593 1393 90595449
Enterocolitis bacterial 26.85 19.58 8 31597 290 90596552
Hypercalcaemia 26.66 19.58 45 31560 34195 90562647
Wound infection 26.58 19.58 3 31602 106399 90490443
Acute erythroid leukaemia 26.42 19.58 7 31598 164 90596678
Urticaria 26.11 19.58 43 31562 312691 90284151
Dry mouth 26.00 19.58 16 31589 184043 90412799
Gastrointestinal infection 25.72 19.58 25 31580 10965 90585877
Pneumomediastinum 25.54 19.58 13 31592 2018 90594824
Febrile infection 25.31 19.58 13 31592 2056 90594786
Monoclonal gammopathy 25.20 19.58 10 31595 865 90595977
Acute hepatitis B 25.17 19.58 8 31597 361 90596481
Hepatitis B 25.01 19.58 17 31588 4502 90592340
Candida pneumonia 24.77 19.58 7 31598 210 90596632
Renal impairment 24.75 19.58 87 31518 105334 90491508
Blood disorder 24.67 19.58 21 31584 7769 90589073
Road traffic accident 24.60 19.58 4 31601 107622 90489220
Escherichia urinary tract infection 24.36 19.58 27 31578 13788 90583054
Pneumonia influenzal 24.34 19.58 13 31592 2227 90594615
Melanoderma 24.28 19.58 7 31598 226 90596616
Parainfluenzae virus infection 24.25 19.58 14 31591 2789 90594053
Intraductal proliferative breast lesion 24.04 19.58 15 31590 3438 90593404
Musculoskeletal pain 24.03 19.58 15 31590 171236 90425606
Neovascular age-related macular degeneration 23.91 19.58 8 31597 425 90596417
Liver injury 23.85 19.58 15 31590 170552 90426290
Meningitis cryptococcal 23.83 19.58 12 31593 1821 90595021
Free fatty acids increased 23.46 19.58 4 31601 8 90596834
Hepatitis E 23.43 19.58 12 31593 1887 90594955
Osteoporosis 23.43 19.58 3 31602 96528 90500314
Rash maculo-papular 23.30 19.58 47 31558 40886 90555956
Dyspnoea 23.07 19.58 433 31172 880522 89716320
Respiratory syncytial virus infection 22.97 19.58 23 31582 10457 90586385
Respiratory tract infection viral 22.96 19.58 14 31591 3082 90593760
H1N1 influenza 22.79 19.58 12 31593 1998 90594844
Renal amyloidosis 22.46 19.58 7 31598 296 90596546
Cholestasis 22.26 19.58 43 31562 36256 90560586
Urosepsis 22.25 19.58 32 31573 21200 90575642
Monoclonal immunoglobulin present 22.16 19.58 12 31593 2112 90594730
Coombs direct test positive 22.01 19.58 6 31599 157 90596685
Metapneumovirus pneumonia 21.93 19.58 5 31600 61 90596781
Partial seizures 21.83 19.58 19 31586 7241 90589601
Factor VII deficiency 21.71 19.58 5 31600 64 90596778
Listeriosis 21.46 19.58 11 31594 1732 90595110
Toxic skin eruption 21.46 19.58 27 31578 15747 90581095
Light chain analysis 21.41 19.58 4 31601 16 90596826
Renal vein thrombosis 21.24 19.58 8 31597 601 90596241
Hepatocellular injury 21.16 19.58 37 31568 28921 90567921
Autologous haematopoietic stem cell transplant 20.86 19.58 4 31601 19 90596823
Hypersensitivity 20.65 19.58 85 31520 454592 90142250
Nasopharyngitis 20.49 19.58 73 31532 407031 90189811
Syncope 20.38 19.58 96 31509 132567 90464275
Monoclonal immunoglobulin increased 20.20 19.58 7 31598 414 90596428
Respiratory distress 20.15 19.58 43 31562 38903 90557939
Acetabulum fracture 20.13 19.58 7 31598 418 90596424
Creatinine renal clearance 19.93 19.58 4 31601 25 90596817
Lower limb fracture 19.79 19.58 3 31602 85010 90511832
Muscular weakness 19.60 19.58 26 31579 206640 90390202

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
Infusion related reaction 1565.52 16.03 852 36779 59954 42523750
Neutropenia 389.94 16.03 659 36972 198772 42384932
Off label use 371.27 16.03 1316 36315 637019 41946685
Neuropathy peripheral 351.78 16.03 441 37190 101412 42482292
Plasma cell myeloma recurrent 309.75 16.03 134 37497 5623 42578081
Plasma cell myeloma refractory 305.21 16.03 92 37539 1318 42582386
Plasmacytoma 300.11 16.03 121 37510 4243 42579461
Polyneuropathy 298.82 16.03 193 37438 18468 42565236
Pneumonia 283.44 16.03 915 36716 421234 42162470
Plasma cell myeloma 263.92 16.03 264 37367 47314 42536390
COVID-19 213.93 16.03 374 37257 115574 42468130
White blood cell count decreased 207.44 16.03 359 37272 110037 42473667
COVID-19 pneumonia 199.57 16.03 160 37471 21453 42562251
Myelosuppression 198.10 16.03 210 37421 40251 42543453
Hypogammaglobulinaemia 187.90 16.03 122 37509 11769 42571935
Thrombocytopenia 183.78 16.03 471 37160 189808 42393896
Drug interaction 180.07 16.03 15 37616 266984 42316720
Intentional product use issue 139.25 16.03 237 37394 71596 42512108
Cytopenia 119.53 16.03 109 37522 17388 42566316
Febrile neutropenia 118.76 16.03 397 37234 185306 42398398
Chills 116.77 16.03 257 37374 93809 42489895
Platelet count decreased 116.38 16.03 326 37305 138255 42445449
Therapy partial responder 101.65 16.03 106 37525 19915 42563789
Neutrophil count decreased 100.84 16.03 192 37439 63223 42520481
Respiratory tract infection 87.48 16.03 112 37519 26210 42557494
Blood immunoglobulin A decreased 87.14 16.03 30 37601 669 42583035
Stem cell transplant 87.12 16.03 44 37587 2628 42581076
Blood immunoglobulin G decreased 87.04 16.03 42 37589 2272 42581432
Cytomegalovirus infection reactivation 81.00 16.03 72 37559 11106 42572598
Light chain analysis increased 80.80 16.03 37 37594 1777 42581927
Sepsis 76.99 16.03 364 37267 198970 42384734
Cardiac failure 76.85 16.03 238 37393 106618 42477086
Toxicity to various agents 75.96 16.03 55 37576 229081 42354623
Pancytopenia 71.86 16.03 248 37383 117495 42466209
Infection 70.98 16.03 239 37392 111829 42471875
Overdose 70.60 16.03 6 37625 105258 42478446
BK virus infection 70.55 16.03 60 37571 8724 42574980
Pseudomyopia 67.94 16.03 16 37615 80 42583624
Blood immunoglobulin M decreased 66.46 16.03 26 37605 840 42582864
Parainfluenzae virus infection 61.55 16.03 39 37592 3604 42580100
Influenza 60.92 16.03 155 37476 62020 42521684
Cytokine release syndrome 57.85 16.03 124 37507 44403 42539301
Coombs indirect test positive 57.35 16.03 11 37620 14 42583690
Pyrexia 57.02 16.03 564 37067 393478 42190226
Septic shock 56.70 16.03 194 37437 91478 42492226
Temperature intolerance 56.40 16.03 41 37590 4747 42578957
Hypercalcaemia 55.58 16.03 74 37557 17984 42565720
Disease progression 55.15 16.03 262 37369 143394 42440310
Monoclonal immunoglobulin increased 54.97 16.03 19 37612 429 42583275
Crossmatch incompatible 54.30 16.03 9 37622 0 42583704
Arthralgia 53.99 16.03 61 37570 205177 42378527
Atrial fibrillation 53.15 16.03 254 37377 139339 42444365
Cytomegalovirus infection 52.78 16.03 99 37532 32207 42551497
Osteolysis 52.33 16.03 35 37596 3545 42580159
Progressive multifocal leukoencephalopathy 51.37 16.03 57 37574 11479 42572225
Hyperpyrexia 50.29 16.03 34 37597 3506 42580198
Headache 50.06 16.03 84 37547 239285 42344419
Visceral leishmaniasis 49.71 16.03 23 37608 1131 42582573
Spinal column injury 48.16 16.03 19 37612 628 42583076
Tumour lysis syndrome 47.92 16.03 77 37554 22154 42561550
Condition aggravated 47.90 16.03 99 37532 260655 42323049
Transplant 47.39 16.03 21 37610 933 42582771
Product use issue 47.08 16.03 162 37469 76589 42507115
Monoclonal immunoglobulin present 45.87 16.03 22 37609 1174 42582530
Autologous haematopoietic stem cell transplant 45.58 16.03 12 37619 101 42583603
Tachypnoea 45.29 16.03 74 37557 21588 42562116
Myelodysplastic syndrome 45.27 16.03 76 37555 22669 42561035
Atypical haemolytic uraemic syndrome 43.67 16.03 17 37614 542 42583162
Depression 41.99 16.03 23 37608 111340 42472364
Rhabdomyolysis 41.62 16.03 9 37622 78010 42505694
Bone lesion 41.55 16.03 30 37601 3436 42580268
Cystitis haemorrhagic 41.18 16.03 41 37590 7288 42576416
Cytomegalovirus viraemia 40.68 16.03 48 37583 10329 42573375
H1N1 influenza 40.40 16.03 20 37611 1144 42582560
Drug reaction with eosinophilia and systemic symptoms 40.27 16.03 104 37527 41971 42541733
Intentional product misuse 40.23 16.03 4 37627 61896 42521808
Increased viscosity of upper respiratory secretion 39.43 16.03 14 37617 343 42583361
Bile acid malabsorption 39.39 16.03 11 37620 118 42583586
Pathological fracture 36.19 16.03 33 37598 5260 42578444
Anxiety 36.03 16.03 31 37600 118529 42465175
Bacterial sepsis 35.94 16.03 36 37595 6446 42577258
Peripheral sensory neuropathy 35.13 16.03 41 37590 8721 42574983
Respirovirus test positive 35.04 16.03 9 37622 68 42583636
Anaemia 34.68 16.03 389 37242 279889 42303815
Injection site pain 34.44 16.03 5 37626 57793 42525911
Spinal cord compression 34.22 16.03 29 37602 4195 42579509
Somnolence 33.84 16.03 45 37586 141060 42442644
Ischaemic stroke 33.69 16.03 66 37565 22167 42561537
Respiratory syncytial virus infection 32.99 16.03 36 37595 7116 42576588
Electrocardiogram QT prolonged 31.41 16.03 3 37628 47942 42535762
Dizziness 31.24 16.03 114 37517 249140 42334564
Nasal obstruction 31.23 16.03 16 37615 985 42582719
Meningitis listeria 30.85 16.03 14 37617 658 42583046
Bronchopulmonary aspergillosis 29.83 16.03 58 37573 19371 42564333
Varicella 29.73 16.03 20 37611 2045 42581659
Metapneumovirus pneumonia 29.34 16.03 8 37623 78 42583626
Ureteric haemorrhage 29.09 16.03 10 37621 222 42583482
Drug hypersensitivity 28.98 16.03 27 37604 99362 42484342
Disseminated varicella zoster virus infection 28.84 16.03 14 37617 767 42582937
Troponin T increased 28.71 16.03 22 37609 2758 42580946
Pneumonia respiratory syncytial viral 28.42 16.03 17 37614 1417 42582287
Bronchospasm 28.27 16.03 45 37586 12840 42570864
Plasma cell leukaemia 28.01 16.03 16 37615 1224 42582480
HCoV-OC43 infection 27.97 16.03 7 37624 47 42583657
Pneumonia pneumococcal 27.92 16.03 21 37610 2560 42581144
Cardiac amyloidosis 27.87 16.03 19 37612 1986 42581718
Metastatic squamous cell carcinoma 27.82 16.03 13 37618 654 42583050
Acute myeloid leukaemia 27.77 16.03 61 37570 22195 42561509
Pneumocystis jirovecii pneumonia 26.99 16.03 65 37566 25116 42558588
Spinal compression fracture 26.69 16.03 33 37598 7450 42576254
Pneumonia influenzal 26.15 16.03 18 37613 1911 42581793
Device related sepsis 26.12 16.03 24 37607 3863 42579841
Weight increased 25.32 16.03 35 37596 107948 42475756
JC virus infection 25.11 16.03 21 37610 2983 42580721
Chest discomfort 25.08 16.03 117 37514 63499 42520205
Agitation 24.64 16.03 13 37618 64301 42519403
Hypoglycaemia 24.61 16.03 11 37620 59843 42523861
Lymphodepletion 24.56 16.03 6 37625 36 42583668
Hallucination 24.55 16.03 10 37621 57497 42526207
Hyperkalaemia 24.48 16.03 21 37610 80437 42503267
Cytomegalovirus chorioretinitis 24.45 16.03 25 37606 4586 42579118
Keratopathy 24.25 16.03 12 37619 686 42583018
Loss of personal independence in daily activities 24.14 16.03 7 37624 49809 42533895
Stress 23.78 16.03 5 37626 44207 42539497
Gastroenteritis salmonella 23.75 16.03 12 37619 717 42582987
Haematochezia 23.62 16.03 11 37620 58425 42525279
Rectal abscess 23.24 16.03 16 37615 1699 42582005
Laboratory test abnormal 23.23 16.03 58 37573 22920 42560784
Diverticular perforation 23.15 16.03 22 37609 3694 42580010
Musculoskeletal stiffness 23.15 16.03 11 37620 57754 42525950
Blood immunoglobulin A increased 23.05 16.03 10 37621 422 42583282
Full blood count decreased 23.04 16.03 54 37577 20506 42563198
Sleep disorder 22.86 16.03 7 37624 48088 42535616
Leukopenia 22.84 16.03 128 37503 74618 42509086
Neoplasm 22.80 16.03 28 37603 6277 42577427
Cerebral toxoplasmosis 22.54 16.03 17 37614 2081 42581623
Renal oncocytoma 22.19 16.03 8 37623 205 42583499
Metabolic acidosis 22.16 16.03 9 37622 51849 42531855
Granulocyte count decreased 22.11 16.03 15 37616 1555 42582149
Epstein-Barr virus associated lymphoma 22.08 16.03 13 37618 1053 42582651
Squamous cell carcinoma of skin 22.04 16.03 40 37591 12686 42571018
Coma 21.77 16.03 10 37621 53544 42530160
Blood creatine phosphokinase increased 21.30 16.03 8 37623 48330 42535374
Herpes zoster 21.20 16.03 79 37552 38798 42544906
Acute lymphocytic leukaemia 20.78 16.03 20 37611 3411 42580293
Masked fever 20.76 16.03 5 37626 28 42583676
Abdominal pain 20.75 16.03 92 37539 190379 42393325
White blood cell count increased 20.66 16.03 7 37624 45080 42538624
Gastrooesophageal reflux disease 20.61 16.03 7 37624 45016 42538688
Angioedema 20.52 16.03 6 37625 42471 42541233
Deep vein thrombosis 20.43 16.03 127 37504 76830 42506874
Joint swelling 20.39 16.03 18 37613 68004 42515700
Neuromyotonia 20.06 16.03 5 37626 33 42583671
Spinal fracture 20.03 16.03 32 37599 9158 42574546
Oxygen saturation decreased 19.91 16.03 111 37520 64576 42519128
Neurotrophic keratopathy 19.75 16.03 4 37627 8 42583696
Bacterial parotitis 19.68 16.03 5 37626 36 42583668
Administration related reaction 19.62 16.03 7 37624 174 42583530
Minimal residual disease 19.59 16.03 10 37621 611 42583093
Pneumonia bacterial 19.57 16.03 43 37588 15649 42568055
Seizure 19.47 16.03 49 37582 120512 42463192
Pulmonary sepsis 19.43 16.03 19 37612 3305 42580399
Light chain analysis decreased 19.11 16.03 5 37626 41 42583663
Cutaneous T-cell lymphoma 18.87 16.03 15 37616 1983 42581721
Campylobacter colitis 18.69 16.03 5 37626 45 42583659
Dry mouth 18.60 16.03 6 37625 39873 42543831
Malignant melanoma 18.16 16.03 31 37600 9369 42574335
Abdominal pain upper 18.16 16.03 28 37603 82581 42501123
Bone marrow transplant 18.11 16.03 12 37619 1197 42582507
Fall 18.07 16.03 127 37504 234393 42349311
Choroidal detachment 17.92 16.03 9 37622 531 42583173
Cardiac pacemaker evaluation 17.76 16.03 6 37625 126 42583578
Rectal haemorrhage 17.61 16.03 11 37620 49595 42534109
Pituitary tumour benign 17.61 16.03 11 37620 991 42582713
Immunoglobulins decreased 17.44 16.03 11 37620 1008 42582696
B precursor type acute leukaemia 17.42 16.03 7 37624 243 42583461
Polyomavirus-associated nephropathy 17.26 16.03 23 37608 5592 42578112
Bacterial tracheitis 17.25 16.03 5 37626 62 42583642
Vascular device infection 17.22 16.03 24 37607 6086 42577618
Product use in unapproved indication 17.19 16.03 243 37388 184213 42399491
Swelling 17.09 16.03 14 37617 54871 42528833
Bone marrow failure 17.02 16.03 66 37565 33027 42550677
N-terminal prohormone brain natriuretic peptide increased 17.01 16.03 18 37613 3435 42580269
Blood stem cell harvest 16.82 16.03 4 37627 21 42583683
Rash 16.72 16.03 340 37291 276614 42307090
Blood immunoglobulin M increased 16.70 16.03 7 37624 271 42583433
Alanine aminotransferase increased 16.67 16.03 33 37598 88373 42495331
Diarrhoea 16.66 16.03 528 37103 460321 42123383
Dysphagia 16.61 16.03 24 37607 72695 42511009
Acute myopia 16.23 16.03 4 37627 25 42583679
Autologous bone marrow transplantation therapy 16.23 16.03 4 37627 25 42583679
Plasmacytosis 16.19 16.03 5 37626 78 42583626
Pneumonia parainfluenzae viral 16.16 16.03 7 37624 294 42583410
Pityriasis rubra pilaris 16.14 16.03 7 37624 295 42583409

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
Infusion related reaction 1465.60 17.32 1386 58799 379776 110149338
Neutropenia 1206.05 17.32 1237 58948 373383 110155731
Neuropathy peripheral 754.36 17.32 687 59498 178590 110350524
Off label use 746.55 17.32 2133 58052 1498052 109031062
Polyneuropathy 594.82 17.32 308 59877 31704 110497410
Thrombocytopenia 586.13 17.32 829 59356 348056 110181058
Plasma cell myeloma 584.22 17.32 386 59799 62550 110466564
Myelosuppression 568.64 17.32 445 59740 93895 110435219
Pneumonia 565.32 17.32 1376 58809 875338 109653776
Plasma cell myeloma recurrent 467.40 17.32 167 60018 6875 110522239
COVID-19 437.48 17.32 600 59585 244460 110284654
Hypogammaglobulinaemia 416.10 17.32 208 59977 19868 110509246
Plasmacytoma 411.45 17.32 141 60044 5121 110523993
COVID-19 pneumonia 391.89 17.32 247 59938 36896 110492218
Plasma cell myeloma refractory 375.89 17.32 105 60080 1896 110527218
White blood cell count decreased 365.42 17.32 532 59653 228858 110300256
Cytopenia 355.12 17.32 215 59970 29901 110499213
Febrile neutropenia 350.21 17.32 622 59563 316145 110212969
Platelet count decreased 307.04 17.32 492 59693 229951 110299163
Neutrophil count decreased 281.45 17.32 338 59847 120603 110408511
Intentional product use issue 263.82 17.32 479 59706 247427 110281687
Cytomegalovirus infection reactivation 226.78 17.32 135 60050 18198 110510916
Pancytopenia 222.93 17.32 405 59780 209208 110319906
Cytokine release syndrome 210.40 17.32 224 59961 70082 110459032
Anaemia 207.95 17.32 712 59473 546374 109982740
Chills 207.44 17.32 372 59813 190208 110338906
Osteolysis 198.81 17.32 84 60101 5439 110523675
Cytomegalovirus infection 198.52 17.32 193 59992 54251 110474863
Sepsis 193.97 17.32 499 59686 326847 110202267
Cardiac failure 192.50 17.32 357 59828 187269 110341845
Stem cell transplant 185.32 17.32 75 60110 4352 110524762
Septic shock 177.20 17.32 312 59873 157216 110371898
Arthralgia 172.12 17.32 106 60079 779526 109749588
Headache 171.11 17.32 138 60047 882239 109646875
Drug interaction 165.89 17.32 35 60150 500148 110028966
Atrial fibrillation 164.76 17.32 377 59808 229265 110299849
Respiratory tract infection 163.00 17.32 198 59987 71419 110457695
Tumour lysis syndrome 157.28 17.32 132 60053 30669 110498445
Joint swelling 150.97 17.32 29 60156 442816 110086298
Disease progression 150.69 17.32 378 59807 243656 110285458
Leukopenia 149.93 17.32 281 59904 148510 110380604
Coombs indirect test positive 148.40 17.32 27 60158 48 110529066
Drug hypersensitivity 144.09 17.32 35 60150 454055 110075059
Therapy partial responder 136.25 17.32 132 60053 36929 110492185
Light chain analysis increased 130.84 17.32 49 60136 2306 110526808
Pyrexia 127.45 17.32 880 59305 897385 109631729
Meningitis listeria 122.21 17.32 40 60145 1257 110527857
Swelling 121.73 17.32 22 60163 351019 110178095
Arthropathy 116.45 17.32 11 60174 287511 110241603
Myelodysplastic syndrome 114.90 17.32 121 60064 37363 110491751
Hyperpyrexia 114.58 17.32 65 60120 8004 110521110
Alopecia 113.96 17.32 29 60156 364724 110164390
Weight increased 113.86 17.32 43 60142 419601 110109513
Peripheral sensory neuropathy 112.03 17.32 84 60101 16596 110512518
Plasma cell leukaemia 110.76 17.32 42 60143 2046 110527068
Temperature intolerance 109.02 17.32 77 60108 13873 110515241
Pseudomyopia 108.27 17.32 24 60161 155 110528959
Tachypnoea 108.19 17.32 120 60065 39275 110489839
Pain 107.92 17.32 224 59961 954731 109574383
Crossmatch incompatible 107.88 17.32 19 60166 25 110529089
Glossodynia 106.85 17.32 3 60182 222001 110307113
Musculoskeletal stiffness 98.16 17.32 17 60168 279805 110249309
Progressive multifocal leukoencephalopathy 97.64 17.32 92 60093 24864 110504250
Therapeutic product effect decreased 97.21 17.32 10 60175 244306 110284808
Condition aggravated 96.61 17.32 157 60028 734679 109794435
Deep vein thrombosis 94.06 17.32 224 59961 139663 110389451
Wound 89.74 17.32 11 60174 234426 110294688
Toxicity to various agents 89.44 17.32 78 60107 480477 110048637
Hypercalcaemia 88.74 17.32 118 60067 46539 110482575
Blood cholesterol increased 87.11 17.32 3 60182 184782 110344332
Overdose 87.01 17.32 12 60173 233782 110295332
Pneumocystis jirovecii pneumonia 85.81 17.32 111 60074 42624 110486490
Helicobacter infection 85.57 17.32 3 60182 181874 110347240
Contraindicated product administered 85.09 17.32 16 60169 248251 110280863
Visceral leishmaniasis 84.85 17.32 33 60152 1723 110527391
Blister 83.85 17.32 12 60173 227364 110301750
Pericarditis 82.13 17.32 11 60174 219103 110310011
Abdominal discomfort 80.74 17.32 58 60127 393800 110135314
Depression 80.41 17.32 36 60149 317299 110211815
Injury 79.81 17.32 4 60181 177261 110351853
Cardiac amyloidosis 78.92 17.32 36 60149 2801 110526313
Parainfluenzae virus infection 77.61 17.32 48 60137 6926 110522188
Pathological fracture 77.28 17.32 59 60126 11973 110517141
Anxiety 77.26 17.32 46 60139 345032 110184082
Transplant 76.26 17.32 28 60157 1246 110527868
BK virus infection 74.94 17.32 60 60125 13046 110516068
Bronchospasm 74.37 17.32 87 60098 30152 110498962
Blood immunoglobulin A decreased 73.68 17.32 32 60153 2216 110526898
Respiratory failure 73.58 17.32 271 59914 215061 110314053
Hepatic enzyme increased 72.93 17.32 42 60143 320850 110208264
Asphyxia 72.72 17.32 61 60124 14154 110514960
Bone marrow transplant 72.51 17.32 29 60156 1631 110527483
Lymphopenia 72.44 17.32 99 60086 40071 110489043
Ill-defined disorder 72.37 17.32 3 60182 156850 110372264
Type 2 diabetes mellitus 71.16 17.32 7 60178 177225 110351889
Mobility decreased 70.15 17.32 21 60164 237401 110291713
Blood immunoglobulin G decreased 70.01 17.32 41 60144 5359 110523755
Monoclonal immunoglobulin present 69.93 17.32 32 60153 2508 110526606
Migraine 68.34 17.32 7 60178 171645 110357469
Haematotoxicity 68.10 17.32 70 60115 21012 110508102
Pulmonary embolism 67.55 17.32 263 59922 214211 110314903
Bronchopulmonary aspergillosis 67.01 17.32 82 60103 29781 110499333
Injection site pain 66.51 17.32 9 60176 177913 110351201
Varicella 66.48 17.32 35 60150 3720 110525394
Dry mouth 66.18 17.32 14 60171 199934 110329180
Drug reaction with eosinophilia and systemic symptoms 63.52 17.32 139 60046 81956 110447158
Contusion 63.10 17.32 24 60161 233337 110295777
Inflammation 63.00 17.32 14 60171 193224 110335890
Irritable bowel syndrome 62.12 17.32 8 60177 164207 110364907
Nasopharyngitis 61.99 17.32 74 60111 394287 110134827
Death 61.34 17.32 615 59570 698254 109830860
Bone lesion 59.78 17.32 41 60144 7046 110522068
H1N1 influenza 58.80 17.32 30 60155 2988 110526126
Osteoarthritis 58.01 17.32 14 60171 182609 110346505
Acute myeloid leukaemia 57.09 17.32 86 60099 38024 110491090
Influenza 56.23 17.32 211 59974 168890 110360224
Stomatitis 55.09 17.32 40 60145 270202 110258912
Chest discomfort 54.58 17.32 213 59972 173635 110355479
Escherichia sepsis 54.46 17.32 45 60140 10227 110518887
Respiratory syncytial virus infection 54.00 17.32 52 60133 14432 110514682
Memory impairment 53.67 17.32 20 60165 196924 110332190
Pneumonia influenzal 52.28 17.32 30 60155 3775 110525339
Blood immunoglobulin M decreased 50.87 17.32 24 60161 2017 110527097
Aspiration bone marrow 50.50 17.32 13 60172 169 110528945
Nasal obstruction 50.32 17.32 28 60157 3322 110525792
Cytomegalovirus viraemia 50.31 17.32 55 60130 17709 110511405
Pain in extremity 50.16 17.32 120 60065 486998 110042116
Obesity 49.65 17.32 3 60182 113348 110415766
Ischaemic stroke 49.31 17.32 84 60101 41179 110487935
Musculoskeletal pain 49.18 17.32 19 60166 183004 110346110
Urticaria 48.86 17.32 61 60124 318796 110210318
Gait inability 48.44 17.32 8 60177 136368 110392746
Spinal cord compression 48.43 17.32 37 60148 7515 110521599
Peripheral swelling 47.86 17.32 92 60093 403942 110125172
Bursitis 47.55 17.32 7 60178 129911 110399203
Atypical haemolytic uraemic syndrome 47.49 17.32 21 60164 1519 110527595
Pneumonia pneumococcal 47.35 17.32 31 60154 4934 110524180
Intentional product misuse 46.75 17.32 8 60177 132896 110396218
Pneumonia cytomegaloviral 46.65 17.32 35 60150 6919 110522195
Cytomegalovirus chorioretinitis 45.88 17.32 35 60150 7093 110522021
Bacterial sepsis 45.77 17.32 41 60144 10385 110518729
Somnolence 45.47 17.32 57 60128 297392 110231722
Thrombotic microangiopathy 45.41 17.32 67 60118 29082 110500032
Posterior reversible encephalopathy syndrome 44.57 17.32 72 60113 33789 110495325
Metapneumovirus pneumonia 43.63 17.32 12 60173 204 110528910
Natural killer cell count decreased 43.54 17.32 11 60174 132 110528982
Body dysmorphic disorder 43.36 17.32 14 60171 421 110528693
Renal failure 43.25 17.32 240 59945 226334 110302780
Light chain analysis abnormal 42.58 17.32 12 60173 224 110528890
Leukoencephalopathy 42.04 17.32 37 60148 9158 110519956
Suicide attempt 41.72 17.32 4 60181 103390 110425724
Squamous cell carcinoma of skin 41.48 17.32 49 60136 17154 110511960
Pneumonia respiratory syncytial viral 41.35 17.32 23 60162 2726 110526388
Malaise 41.07 17.32 207 59978 671612 109857502
Cystitis haemorrhagic 40.27 17.32 41 60144 12168 110516946
Herpes zoster 40.05 17.32 140 60045 108239 110420875
Intervertebral discitis 39.96 17.32 32 60153 6958 110522156
Acute myopia 39.35 17.32 11 60174 199 110528915
Abdominal pain upper 39.19 17.32 82 60103 349029 110180085
Increased viscosity of upper respiratory secretion 38.23 17.32 14 60171 618 110528496
Oxygen saturation decreased 38.17 17.32 178 60007 156804 110372310
Listeria sepsis 38.07 17.32 15 60170 811 110528303
Ureteric haemorrhage 37.97 17.32 10 60175 143 110528971
Infection 37.83 17.32 331 59854 361869 110167245
Diarrhoea 37.63 17.32 847 59338 1138658 109390456
Weight decreased 37.41 17.32 130 60055 467927 110061187
Cerebellar haemangioma 37.30 17.32 9 60176 88 110529026
Bone marrow failure 37.10 17.32 91 60094 57757 110471357
Morganella infection 36.80 17.32 17 60168 1362 110527752
Asthma 36.17 17.32 50 60135 250241 110278873
Prohormone brain natriuretic peptide increased 36.01 17.32 12 60173 399 110528715
Gait disturbance 35.94 17.32 60 60125 278148 110250966
Granulocyte count decreased 35.93 17.32 24 60161 3950 110525164
Atrial flutter 35.28 17.32 54 60131 24208 110504906
Plasmacytosis 34.88 17.32 10 60175 199 110528915
Acute respiratory failure 34.84 17.32 105 60080 75155 110453959
Monoclonal immunoglobulin increased 34.79 17.32 13 60172 608 110528506
Dizziness 34.70 17.32 230 59955 697963 109831151
Pneumococcal sepsis 34.63 17.32 19 60166 2193 110526921
Suicidal ideation 34.52 17.32 5 60180 93932 110435182
Respirovirus test positive 34.41 17.32 9 60176 125 110528989
Bile acid malabsorption 34.34 17.32 12 60173 462 110528652
Night sweats 34.23 17.32 15 60170 133968 110395146
Blood pressure systolic increased 34.05 17.32 3 60182 82988 110446126
Sinusitis 33.87 17.32 69 60116 296619 110232495
Treatment failure 33.80 17.32 62 60123 277172 110251942
Urosepsis 33.47 17.32 60 60125 30615 110498499
Cerebral toxoplasmosis 33.38 17.32 21 60164 3121 110525993
Immunoglobulins decreased 33.19 17.32 19 60166 2380 110526734
Rhabdomyolysis 33.18 17.32 12 60173 120389 110408725
Blood stem cell harvest 33.09 17.32 7 60178 35 110529079
Rash maculo-papular 32.91 17.32 102 60083 74120 110454994
Enterocolitis bacterial 32.73 17.32 13 60172 718 110528396
Arthritis 32.61 17.32 26 60159 167560 110361554
Metastatic squamous cell carcinoma 32.39 17.32 13 60172 738 110528376
Product use in unapproved indication 32.35 17.32 379 59806 446998 110082116
Neutropenic sepsis 32.10 17.32 59 60126 30687 110498427
Pneumonia bacterial 32.09 17.32 54 60131 26207 110502907
Abdominal pain 31.93 17.32 157 60028 512832 110016282
Discomfort 31.92 17.32 42 60143 214665 110314449
Bacteraemia 31.91 17.32 71 60114 42319 110486795
Blood immunoglobulin A increased 31.75 17.32 16 60169 1552 110527562
Disseminated varicella zoster virus infection 31.73 17.32 15 60170 1266 110527848
Toxic skin eruption 31.54 17.32 55 60130 27460 110501654
Febrile bone marrow aplasia 31.42 17.32 43 60142 17422 110511692
Rectal haemorrhage 31.27 17.32 13 60172 119820 110409294
Spinal column injury 31.02 17.32 18 60167 2313 110526801
Psoriasis 30.83 17.32 19 60166 139974 110389140
Loss of personal independence in daily activities 30.82 17.32 22 60163 149998 110379116
Rhinovirus infection 30.80 17.32 35 60150 11754 110517360
Gastrointestinal infection 30.68 17.32 38 60147 13967 110515147
Measles 30.27 17.32 12 60173 659 110528455
Hypocalcaemia 30.07 17.32 91 60094 65275 110463839
Stress 29.89 17.32 10 60175 105338 110423776
Pulmonary sepsis 29.83 17.32 24 60161 5254 110523860
Pulmonary oedema 29.70 17.32 121 60064 100538 110428576
Hypoglycaemia 29.65 17.32 13 60172 116091 110413023
Device related sepsis 29.54 17.32 28 60157 7619 110521495
Wound infection 29.46 17.32 8 60177 96457 110432657
Hypersensitivity 29.15 17.32 117 60068 403881 110125233
Full blood count decreased 29.08 17.32 58 60127 32041 110497073
Confusional state 28.84 17.32 144 60041 468536 110060578
Pneumonia haemophilus 28.48 17.32 18 60167 2697 110526417
Sleep disorder 28.38 17.32 40 60145 198604 110330510
Acute respiratory distress syndrome 28.28 17.32 78 60107 53120 110475994
Injection site reaction 27.94 17.32 7 60178 89063 110440051
Diverticular perforation 27.89 17.32 25 60160 6337 110522777
Keratopathy 27.78 17.32 14 60171 1359 110527755
Gastroenteritis salmonella 27.76 17.32 14 60171 1361 110527753
Road traffic accident 27.47 17.32 12 60173 107386 110421728
Troponin T increased 27.40 17.32 21 60164 4285 110524829
Endocarditis 27.26 17.32 35 60150 13336 110515778
Endocarditis bacterial 26.87 17.32 15 60170 1790 110527324
Medication error 26.59 17.32 12 60173 105354 110423760
Product quality issue 26.43 17.32 5 60180 77294 110451820
Haematochezia 26.39 17.32 15 60170 115509 110413605
Minimal residual disease 26.22 17.32 12 60173 941 110528173
Acute lymphocytic leukaemia 25.96 17.32 23 60162 5742 110523372
Coma 25.95 17.32 16 60169 117853 110411261
Autologous haematopoietic stem cell transplant 25.85 17.32 7 60178 112 110529002
Leukaemic infiltration extramedullary 25.84 17.32 9 60176 343 110528771
Lymphodepletion 25.73 17.32 6 60179 50 110529064
Paraproteinaemia 25.55 17.32 10 60175 531 110528583
Lower limb fracture 25.50 17.32 5 60180 75343 110453771
Listeriosis 25.45 17.32 17 60168 2797 110526317
Neck pain 25.37 17.32 18 60167 123112 110406002
Vomiting 25.10 17.32 347 59838 910328 109618786
Amnesia 25.08 17.32 13 60172 105395 110423719
Acute erythroid leukaemia 25.01 17.32 9 60176 378 110528736
Dysphagia 24.99 17.32 28 60157 153572 110375542
Gastrooesophageal reflux disease 24.96 17.32 37 60148 179939 110349175
Interstitial lung disease 24.87 17.32 145 60040 139189 110389925
Plasmablastic lymphoma 24.83 17.32 11 60174 799 110528315
Pruritus 24.81 17.32 200 59985 581360 109947754
Renal oncocytoma 24.79 17.32 8 60177 240 110528874
Hepatic cytolysis 24.72 17.32 76 60109 54977 110474137
Nausea 24.55 17.32 500 59685 1235190 109293924
Constipation 24.48 17.32 300 59885 357486 110171628
Pneumonia legionella 24.02 17.32 18 60167 3551 110525563
Epstein-Barr virus infection reactivation 23.99 17.32 19 60166 4065 110525049
Plasma cells decreased 23.91 17.32 6 60179 70 110529044
Joint stiffness 23.75 17.32 4 60181 67239 110461875
Malignant melanoma 23.72 17.32 37 60148 16854 110512260
Rectal abscess 23.70 17.32 16 60169 2680 110526434
Sudden hearing loss 23.69 17.32 15 60170 2254 110526860
JC virus infection 23.61 17.32 21 60164 5269 110523845
Autonomic neuropathy 23.51 17.32 15 60170 2285 110526829
Osteoporosis 23.48 17.32 9 60176 87143 110441971
Monoclonal gammopathy 23.47 17.32 12 60173 1200 110527914
Muscular weakness 23.39 17.32 64 60121 248404 110280710
Injection site erythema 23.34 17.32 11 60174 94165 110434949
Bone pain 23.08 17.32 83 60102 65050 110464064
Liver injury 22.79 17.32 29 60156 150384 110378730
Hepatitis B reactivation 22.65 17.32 24 60161 7460 110521654
Hepatitis E 22.53 17.32 19 60166 4440 110524674
Masked fever 22.33 17.32 5 60180 34 110529080
Acute pulmonary oedema 22.18 17.32 36 60149 16960 110512154
Urinary tract infection 22.07 17.32 273 59912 326009 110203105
Colorectal cancer recurrent 21.98 17.32 6 60179 99 110529015
Embolism 21.94 17.32 35 60150 16254 110512860
Guillain-Barre syndrome 21.71 17.32 28 60157 10716 110518398
Free fatty acids increased 21.68 17.32 4 60181 8 110529106
Bacterial parotitis 21.40 17.32 5 60180 42 110529072
Bone marrow disorder 21.35 17.32 18 60167 4205 110524909
Metabolic acidosis 21.32 17.32 14 60171 99730 110429384
Amyloidosis 21.31 17.32 16 60169 3165 110525949
Dermatitis exfoliative generalised 21.24 17.32 28 60157 10944 110518170
B-cell aplasia 21.17 17.32 8 60177 386 110528728
Sciatica 21.10 17.32 12 60173 92387 110436727
N-terminal prohormone brain natriuretic peptide increased 21.00 17.32 21 60164 6100 110523014
Adenocarcinoma of colon 20.86 17.32 21 60164 6147 110522967
Polyomavirus-associated nephropathy 20.84 17.32 24 60161 8177 110520937
Angioedema 20.82 17.32 14 60171 98486 110430628
Abdominal sepsis 20.76 17.32 14 60171 2341 110526773
American trypanosomiasis 20.70 17.32 9 60176 625 110528489
Blood disorder 20.50 17.32 26 60159 9784 110519330
Lichenoid keratosis 20.49 17.32 21 60164 6281 110522833
Dyspepsia 20.46 17.32 46 60139 190919 110338195
Thrombophlebitis 20.41 17.32 23 60162 7656 110521458
Intraductal proliferative breast lesion 20.33 17.32 15 60170 2890 110526224
Peripheral sensorimotor neuropathy 20.33 17.32 17 60168 3926 110525188
Pseudomembranous colitis 20.24 17.32 21 60164 6370 110522744
Cardiac pacemaker evaluation 20.19 17.32 6 60179 136 110528978
Pneumonia parainfluenzae viral 20.08 17.32 9 60176 672 110528442
Syncope 20.04 17.32 183 60002 202353 110326761
Pityriasis rubra pilaris 20.02 17.32 7 60178 270 110528844
Aplasia 19.94 17.32 23 60162 7850 110521264
Infection reactivation 19.82 17.32 17 60168 4064 110525050
Blood pressure fluctuation 19.71 17.32 8 60177 74816 110454298
Acinetobacter infection 19.67 17.32 16 60169 3557 110525557
Sudden death 19.65 17.32 42 60143 24353 110504761
Light chain analysis 19.64 17.32 4 60181 16 110529098
Cytomegalovirus gastroenteritis 19.53 17.32 9 60176 717 110528397
Escherichia urinary tract infection 19.44 17.32 33 60152 16129 110512985
Pachymeningitis 19.27 17.32 8 60177 495 110528619
Candida pneumonia 19.26 17.32 10 60175 1033 110528081
Clostridium difficile colitis 19.25 17.32 60 60125 43718 110485396
Ear pain 19.17 17.32 3 60182 53223 110475891
Administration related reaction 19.14 17.32 7 60178 308 110528806
Autoimmune disorder 18.96 17.32 6 60179 65477 110463637
Hypothyroidism 18.87 17.32 8 60177 72891 110456223
Spinal compression fracture 18.83 17.32 35 60150 18357 110510757
Prescribed underdose 18.82 17.32 6 60179 65168 110463946
Cytomegalovirus enterocolitis 18.78 17.32 13 60172 2268 110526846
Hepatitis 18.77 17.32 13 60172 90041 110439073
Pneumonitis 18.75 17.32 87 60098 76444 110452670
Neurotrophic keratopathy 18.75 17.32 4 60181 21 110529093
Haemophilus infection 18.58 17.32 14 60171 2786 110526328
Colorectal adenocarcinoma 18.57 17.32 8 60177 543 110528571
Lactic acidosis 18.56 17.32 14 60171 92797 110436317
Venous thrombosis 18.51 17.32 23 60162 8482 110520632
Acute hepatitis B 18.35 17.32 8 60177 559 110528555
Acute kidney injury 18.34 17.32 464 59721 634966 109894148
Cutaneous T-cell lymphoma 18.30 17.32 15 60170 3369 110525745
Multiple organ dysfunction syndrome 18.14 17.32 143 60042 151567 110377547
Neovascular age-related macular degeneration 18.09 17.32 8 60177 579 110528535
Thrombosis 18.05 17.32 111 60074 108551 110420563
Respiratory tract infection viral 18.05 17.32 19 60166 5859 110523255
Renal impairment 18.01 17.32 169 60016 188276 110340838
Seizure 17.94 17.32 61 60124 221124 110307990
Oropharyngeal discomfort 17.94 17.32 25 60160 10302 110518812
Choroidal effusion 17.78 17.32 9 60176 881 110528233
Intraocular pressure test 17.76 17.32 5 60180 93 110529021
Drug ineffective for unapproved indication 17.69 17.32 106 60079 102732 110426382
Myalgia 17.58 17.32 62 60123 222319 110306795
Pneumonia staphylococcal 17.49 17.32 19 60166 6072 110523042
Laryngitis bacterial 17.41 17.32 4 60181 31 110529083
Blood creatine phosphokinase increased 17.41 17.32 9 60176 73068 110456046
Epstein-Barr virus associated lymphoma 17.34 17.32 11 60174 1659 110527455
Nail disorder 17.33 17.32 5 60180 57930 110471184

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01FC01 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
CD38 (Clusters of Differentiation 38) inhibitors
FDA CS M0001357 Antibodies, Monoclonal
MeSH PA D000970 Antineoplastic Agents
FDA MoA N0000192335 CD38-directed Antibody Interactions
FDA EPC N0000192336 CD38-directed Cytolytic Antibody
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:75835 anti-anaemic agent

Related Drugs by ATC class:

L01FC CD38 (Clusters of Differentiation 38) inhibitors 1 drug
isatuximab

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




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Lymphocyte differentiation antigen CD38 Tumour-associated antigen ANTIBODY BINDING Kd 8.22 IUPHAR DRUG LABEL

External reference:

IDSource
D10777 KEGG_DRUG
4035125 VANDF
CHEBI:750086 CHEBI
CHEMBL1743007 ChEMBL_ID
C556306 MESH_SUPPLEMENTAL_RECORD_UI
7395 IUPHAR_LIGAND_ID
DB09331 DRUGBANK_ID
1721947 RXNORM
237137 MMSL
31294 MMSL
d08399 MMSL
016591 NDDF
716016006 SNOMEDCT_US
781328004 SNOMEDCT_US
C2346801 UMLSCUI
9128 INN_ID
4Z63YK6E0E UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
DARZALEX HUMAN PRESCRIPTION DRUG LABEL 1 57894-502 INJECTION, SOLUTION, CONCENTRATE 100 mg INTRAVENOUS BLA 32 sections
Darzalex Faspro HUMAN PRESCRIPTION DRUG LABEL 2 57894-503 INJECTION 1800 mg SUBCUTANEOUS BLA 32 sections
Darzalex IV HUMAN PRESCRIPTION DRUG LABEL 1 57894-505 INJECTION, SOLUTION, CONCENTRATE 100 mg INTRAVENOUS BLA 32 sections