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

Stem definitionDrug idCAS RN
antineoplastics, thalidomide derivatives 2616 50-35-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • thalidomide
  • (+/-)-Thalidomide
  • thalomid
A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects. It has been reintroduced and used for a number of immunological and inflammatory disorders. Thalidomide displays immunosuppressive and anti-angiogenic activity. It inhibits release of TUMOR NECROSIS FACTOR-ALPHA from monocytes, and modulates other cytokine action.
  • Molecular weight: 258.23
  • Formula: C13H10N2O4
  • CLOGP: 0.53
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 1
  • TPSA: 83.55
  • ALOGS: -2
  • ROTB: 1
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.10 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.05 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 22.13 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.95 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 3.40 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.40 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 4.70 hours Lombardo F, Berellini G, Obach RS
BA (Bioavailability) 90 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 0.416 High 0.81
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.565 High 0.81
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 79.616 10^-6 cm/s High 0.81
dh-clint Dog hepatocyte intrinsic clearance 2.818 uL/min/10^6 cells High 0.81
dppb Dog plasma protein binding (% unbound) 77.050 % High 0.81
fcs-ppb Fetal calf serum protein binding (% unbound) 75.120 % High 0.81
herg hERG pIC50 4.116 pIC50 High 0.81
hh-clint Human hepatocyte intrinsic clearance 2.239 uL/min/10^6 cells High 0.81
hlm-clint Human liver microsomal intrinsic clearance 2.864 uL/min/mg protein High 0.81
hppb Human plasma protein binding (% unbound) 73.270 % High 0.81
kinase-safety-class ACVR2A,ACVR2B,ALK,AURKA,AXL,BRAF,CAMK2B,CAMK2D,CDK5,CDK9,CHEK1,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GSK3B,IRAK1,ITK,JAK1,JAK2,KIT,MAP3K21,MAP3K7,MAPK7,MARK4,NTRK2,PDK1,PDK4,PIK3CB,PIK3CD,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TTK,ULK1,ULK2 44
kinase-selectivity-class AURKC,AXL,BRAF,CAMK2D,CDK9,EIF2AK3,GRK2,MAP2K6,MAPK1,MAPK12,MARK4,PDK1,SIK2,STK33,TEK 15
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 1.104 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 2.193 High 0.81
mh-clint Mouse hepatocyte intrinsic clearance 2.553 High 0.81
mppb Mouse plasma protein binding (% unbound) 86.210 High 0.81
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 2.673 High 0.81
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1
pppb Pig plasma protein binding (% unbound) 78.330 % High 0.81
rat-kpuu-brain Rat brain Kpuu 0.813 % High 1
rh-clint Rat hepatocyte intrinsic clearance 3.069 uL/min/10^6 cells High 0.81
rh-fuinc Rat hepatocyte fraction unbound in incubation 94.390 % High 0.81
rppb Rat plasma protein binding (% unbound) 72.410 % High 0.81
solubility-dd Solubility at pH 7.4 in DMSO 200.909 uM High 0.81

Approvals:

DateAgencyCompanyOrphan
Feb. 24, 2021 PMDA Fujimoto Pharmaceutical Corporation
July 16, 1998 FDA CELGENE
April 16, 2008 EMA Bristol-Myers Squibb Pharma EEIG

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
Disease progression 1587.05 16.51 873 31694 155742 90440138
Death 1533.11 16.51 1280 31287 455271 90140609
Plasma cell myeloma 892.99 16.51 386 32181 40442 90555438
Neuropathy peripheral 779.99 16.51 529 32038 136441 90459439
Human chorionic gonadotropin increased 683.24 16.51 155 32412 1791 90594089
Malignant neoplasm progression 339.75 16.51 292 32275 106578 90489302
Deep vein thrombosis 264.37 16.51 237 32330 91383 90504497
Osteonecrosis 228.65 16.51 133 32434 26108 90569772
Renal failure 223.56 16.51 255 32312 130752 90465128
Pneumonia 171.05 16.51 560 32007 637499 89958381
Plasma cell myeloma recurrent 169.53 16.51 62 32505 4166 90591714
Sepsis 153.40 16.51 250 32317 179564 90416316
Exposure via body fluid 142.01 16.51 35 32532 589 90595291
Hepatosplenic T-cell lymphoma 138.82 16.51 35 32532 649 90595231
Pancytopenia 133.42 16.51 189 32378 120074 90475806
Polyneuropathy 132.37 16.51 84 32483 19257 90576623
Plasma cell leukaemia 129.48 16.51 37 32530 1121 90594759
Plasmacytoma 127.17 16.51 45 32522 2748 90593132
Human chorionic gonadotropin positive 106.40 16.51 18 32549 32 90595848
Pulmonary embolism 103.61 16.51 176 32391 130644 90465236
Unevaluable event 102.43 16.51 112 32455 54736 90541144
Plasma cell myeloma refractory 101.50 16.51 30 32537 1026 90594854
Pregnancy test urine positive 101.40 16.51 16 32551 13 90595867
Varicella zoster virus infection 99.08 16.51 41 32526 3836 90592044
Alopecia 98.48 16.51 28 32539 495043 90100837
Abdominal discomfort 96.80 16.51 26 32541 477302 90118578
Glossodynia 95.11 16.51 5 32562 321774 90274106
Synovitis 86.48 16.51 9 32558 329743 90266137
Myelodysplastic syndrome 85.00 16.51 66 32501 20837 90575043
Pericarditis 83.78 16.51 3 32564 270148 90325732
Arthralgia 83.77 16.51 94 32473 778428 89817452
Human chorionic gonadotropin abnormal 83.45 16.51 14 32553 23 90595857
Thrombocytopenia 82.53 16.51 211 32356 208514 90387366
Hepatic enzyme increased 82.48 16.51 15 32552 360721 90235159
Infusion related reaction 82.07 16.51 24 32543 416756 90179124
Complications of bone marrow transplant 80.42 16.51 21 32546 450 90595430
Haemoglobin decreased 79.41 16.51 178 32389 161778 90434102
Osteonecrosis of jaw 78.54 16.51 83 32484 39020 90556860
Maternal exposure during pregnancy 78.08 16.51 17 32550 360046 90235834
Acute myeloid leukaemia 77.11 16.51 62 32505 20578 90575302
Bone disorder 75.02 16.51 64 32503 23056 90572824
Therapeutic product effect decreased 74.28 16.51 7 32560 277564 90318316
Musculoskeletal stiffness 73.04 16.51 10 32557 296522 90299358
Respiratory failure 70.62 16.51 141 32426 118277 90477603
Constipation 70.23 16.51 241 32326 280154 90315726
Headache 70.20 16.51 127 32440 862619 89733261
Drug hypersensitivity 66.96 16.51 42 32525 463567 90132313
Thrombosis 66.69 16.51 105 32462 73146 90522734
Wound 66.30 16.51 14 32553 302966 90292914
Hip fracture 66.06 16.51 70 32497 33007 90562873
Arthropathy 65.26 16.51 25 32542 366217 90229663
Pain 62.71 16.51 169 32398 996172 89599708
Cardiac failure congestive 61.85 16.51 120 32447 98574 90497306
Posterior reversible encephalopathy syndrome 60.84 16.51 56 32511 22283 90573597
Neutropenia 59.55 16.51 197 32370 224707 90371173
Acute lymphocytic leukaemia 59.14 16.51 26 32541 2822 90593058
Joint swelling 58.28 16.51 57 32510 503243 90092637
Platelet count decreased 57.81 16.51 142 32425 136827 90459053
Systemic lupus erythematosus 57.69 16.51 29 32538 361867 90234013
Graft versus host disease 57.29 16.51 36 32531 8108 90587772
Cerebrovascular accident 56.36 16.51 132 32435 123401 90472479
Discomfort 55.45 16.51 15 32552 274320 90321560
Pruritus 55.35 16.51 68 32499 541457 90054423
Cardiac disorder 55.23 16.51 84 32483 56788 90539092
Body dysmorphic disorder 54.46 16.51 15 32552 396 90595484
Bone lesion 54.40 16.51 32 32535 6405 90589475
Anaemia 53.80 16.51 260 32307 352542 90243338
Acute leukaemia 53.43 16.51 19 32548 1177 90594703
Hypersensitivity 53.20 16.51 51 32516 454626 90141254
Fibromyalgia 53.11 16.51 6 32561 206263 90389617
Mesenteric abscess 52.34 16.51 11 32556 86 90595794
Enterococcal sepsis 51.37 16.51 20 32547 1596 90594284
Blood cholesterol increased 51.24 16.51 7 32560 208005 90387875
Mucosal inflammation 50.24 16.51 81 32486 57544 90538336
Mobility decreased 50.12 16.51 14 32553 250720 90345160
Wheezing 50.07 16.51 12 32555 238068 90357812
Type 2 diabetes mellitus 49.69 16.51 7 32560 203237 90392643
Blister 49.58 16.51 15 32552 254983 90340897
Large intestinal ulcer perforation 48.80 16.51 10 32557 68 90595812
Lymphopenia 48.51 16.51 50 32517 22831 90573049
Refractory cytopenia with multilineage dysplasia 48.31 16.51 11 32556 129 90595751
Jaw operation 47.26 16.51 16 32551 855 90595025
Weight increased 46.46 16.51 49 32518 417878 90178002
Actinomycotic sepsis 46.36 16.51 12 32555 248 90595632
Growth failure 46.07 16.51 13 32554 376 90595504
Full blood count decreased 45.90 16.51 55 32512 29634 90566246
Swelling 45.62 16.51 50 32517 419008 90176872
Pregnancy test false positive 45.56 16.51 12 32555 266 90595614
Migraine 45.52 16.51 7 32560 190385 90405495
Hair follicle tumour benign 45.14 16.51 13 32554 405 90595475
Nasal abscess 44.92 16.51 11 32556 180 90595700
Injection site pain 44.85 16.51 5 32562 173694 90422186
Gastrointestinal fungal infection 44.43 16.51 13 32554 429 90595451
Off label use 44.24 16.51 596 31971 1101656 89494224
Endocarditis bacterial 43.65 16.51 14 32553 631 90595249
Rhesus antigen positive 43.41 16.51 10 32557 124 90595756
Drug interaction 42.78 16.51 23 32544 276430 90319450
Growth retardation 42.69 16.51 18 32549 1765 90594115
Epstein-Barr viraemia 42.55 16.51 17 32550 1453 90594427
Cellulitis staphylococcal 42.20 16.51 15 32552 928 90594952
Septic shock 41.78 16.51 93 32474 84067 90511813
Tooth extraction 41.77 16.51 34 32533 11479 90584401
Psoriasis 41.51 16.51 3 32564 147751 90448129
Sinus polyp 40.58 16.51 12 32555 411 90595469
Squamous cell carcinoma of skin 40.42 16.51 28 32539 7421 90588459
Morganella infection 40.42 16.51 14 32553 802 90595078
Syncope 40.40 16.51 122 32445 132541 90463339
Graft versus host disease in gastrointestinal tract 40.23 16.51 23 32544 4365 90591515
Pleural effusion 39.92 16.51 109 32458 111882 90483998
Asthenia 39.54 16.51 327 32240 533424 90062456
Injury 39.47 16.51 11 32556 197338 90398542
Cytomegalovirus infection reactivation 39.26 16.51 28 32539 7772 90588108
Liver injury 39.15 16.51 7 32560 170560 90425320
Condition aggravated 38.89 16.51 99 32468 595446 90000434
Nasopharyngitis 38.61 16.51 54 32513 407050 90188830
Progressive multifocal leukoencephalopathy 38.33 16.51 37 32530 15618 90580262
Haematocrit decreased 38.11 16.51 60 32507 41772 90554108
Metastatic malignant melanoma 37.57 16.51 16 32551 1608 90594272
Herpes zoster infection neurological 37.54 16.51 12 32555 535 90595345
Joint ankylosis 37.47 16.51 15 32552 1288 90594592
Cytomegalovirus infection 37.43 16.51 47 32520 26555 90569325
Focal nodular hyperplasia 37.29 16.51 13 32554 759 90595121
Musculoskeletal pain 37.26 16.51 8 32559 171243 90424637
Peripheral sensory neuropathy 37.15 16.51 29 32538 9221 90586659
Inappropriate schedule of product administration 37.03 16.51 5 32562 149928 90445952
Dehydration 36.89 16.51 153 32414 194294 90401586
Stomatitis 36.79 16.51 27 32540 274671 90321209
Herpes zoster 36.65 16.51 95 32472 94549 90501331
Actinomycosis 35.90 16.51 14 32553 1122 90594758
Pregnancy test positive 35.69 16.51 9 32558 167 90595713
Bacterial sepsis 35.10 16.51 22 32545 4933 90590947
Hypoglossal nerve paresis 33.90 16.51 8 32559 111 90595769
Stem cell transplant 33.24 16.51 16 32551 2138 90593742
Oedema peripheral 32.95 16.51 181 32386 257734 90338146
Neoplasm progression 32.76 16.51 58 32509 44428 90551452
Diverticular perforation 32.53 16.51 19 32548 3753 90592127
Clostridium bacteraemia 32.41 16.51 9 32558 245 90595635
Bradycardia 32.30 16.51 84 32483 83763 90512117
Encephalitis viral 32.11 16.51 15 32552 1874 90594006
Product use issue 32.03 16.51 43 32524 329876 90266004
Pathological fracture 31.87 16.51 27 32540 9633 90586247
Lower respiratory tract infection 31.83 16.51 26 32541 250633 90345247
Osteomyelitis 31.19 16.51 44 32523 27802 90568078
Ill-defined disorder 30.68 16.51 14 32553 184877 90411003
Pneumonia fungal 30.33 16.51 23 32544 7008 90588872
Spinal cord compression 30.32 16.51 20 32547 4891 90590989
Urticaria 30.12 16.51 41 32526 312693 90283187
Obliterative bronchiolitis 29.93 16.51 16 32551 2665 90593215
Lung infiltration 29.90 16.51 32 32535 15250 90580630
Malnutrition 29.71 16.51 35 32532 18523 90577357
Therapy partial responder 29.52 16.51 38 32529 22005 90573875
Therapy non-responder 29.49 16.51 112 32455 136592 90459288
Chronic kidney disease 28.99 16.51 59 32508 50132 90545748
Splenomegaly 28.77 16.51 29 32538 12895 90582985
Acute respiratory distress syndrome 28.74 16.51 43 32524 28643 90567237
Infection reactivation 28.70 16.51 14 32553 1926 90593954
Bone debridement 28.63 16.51 8 32559 223 90595657
Acute graft versus host disease in skin 28.48 16.51 19 32548 4737 90591143
Debridement 27.88 16.51 12 32555 1237 90594643
Haemophagocytic lymphohistiocytosis 27.86 16.51 31 32536 15428 90580452
Osteoarthritis 27.85 16.51 18 32549 195712 90400168
Rhabdoid tumour 27.70 16.51 6 32561 55 90595825
Laboratory test abnormal 27.57 16.51 52 32515 41802 90554078
Graft versus host disease in skin 27.02 16.51 17 32550 3836 90592044
Staphylococcal bacteraemia 26.97 16.51 22 32545 7447 90588433
White blood cell count decreased 26.76 16.51 125 32442 166984 90428896
Gastrointestinal haemorrhage 26.53 16.51 82 32485 90166 90505714
Mucosal erosion 26.35 16.51 13 32554 1832 90594048
Night sweats 26.08 16.51 7 32560 128759 90467121
Protein total increased 25.92 16.51 16 32551 3493 90592387
Fungal oesophagitis 25.92 16.51 10 32557 779 90595101
VIth nerve paresis 25.71 16.51 6 32561 79 90595801
Decubitus ulcer 25.37 16.51 26 32541 11787 90584093
Blood albumin increased 25.20 16.51 11 32556 1174 90594706
Peripheral sensorimotor neuropathy 25.09 16.51 13 32554 2032 90593848
Bone marrow transplant 25.08 16.51 10 32557 850 90595030
Pregnancy with contraceptive device 25.07 16.51 18 32549 5048 90590832
Obesity 24.94 16.51 4 32563 105503 90490377
Anxiety 24.73 16.51 46 32521 309726 90286154
Failure to thrive 24.70 16.51 22 32545 8389 90587491
Metastases to central nervous system 24.69 16.51 31 32536 17511 90578369
Adverse drug reaction 24.66 16.51 95 32472 116606 90479274
Viraemia 24.56 16.51 12 32555 1657 90594223
B-cell type acute leukaemia 24.53 16.51 9 32558 610 90595270
Atrial fibrillation 24.45 16.51 104 32463 133507 90462373
Frostbite 24.22 16.51 7 32560 221 90595659
Hypoperfusion 23.80 16.51 12 32555 1772 90594108
Bone marrow failure 23.71 16.51 42 32525 32179 90563701
Endocarditis 23.71 16.51 20 32547 7093 90588787
Blood immunoglobulin M decreased 23.61 16.51 11 32556 1366 90594514
Jaw disorder 23.57 16.51 18 32549 5541 90590339
Cerebral toxoplasmosis 23.40 16.51 11 32556 1394 90594486
Enterococcal infection 23.31 16.51 23 32544 9968 90585912
Blood immunoglobulin G decreased 23.29 16.51 15 32552 3523 90592357
Osteolysis 23.25 16.51 15 32552 3535 90592345
Blood luteinising hormone increased 23.13 16.51 6 32561 125 90595755
Overdose 23.13 16.51 14 32553 157695 90438185
Contusion 23.12 16.51 34 32533 251182 90344698
Asthma 23.05 16.51 32 32535 242128 90353752
Listeria sepsis 23.01 16.51 9 32558 727 90595153
Hodgkin's disease 22.77 16.51 9 32558 748 90595132
Gastrooesophageal reflux disease 22.72 16.51 16 32551 166321 90429559
Clostridium difficile colitis 22.54 16.51 37 32530 26669 90569211
Toxicity to various agents 22.15 16.51 178 32389 287668 90308212
Oral surgery 22.07 16.51 11 32556 1585 90594295
Large intestine perforation 22.00 16.51 22 32545 9690 90586190
Protein urine present 21.98 16.51 19 32548 6965 90588915
Abdominal pain upper 21.91 16.51 55 32512 332619 90263261
Vitiligo 21.90 16.51 12 32555 2098 90593782
Hypercalcaemia 21.88 16.51 42 32525 34198 90561682
Immunoglobulins decreased 21.87 16.51 11 32556 1615 90594265
Type 2 lepra reaction 21.70 16.51 5 32562 62 90595818
Oral fungal infection 21.63 16.51 14 32553 3318 90592562
Factor VII deficiency 21.56 16.51 5 32562 64 90595816
Impaired healing 21.26 16.51 32 32535 234167 90361713
Neurotoxicity 21.25 16.51 32 32535 21435 90574445
Exposure during pregnancy 21.23 16.51 33 32534 238377 90357503
Medulloblastoma 21.14 16.51 5 32562 70 90595810
Wound infection 21.14 16.51 6 32561 106396 90489484
Blood albumin decreased 21.00 16.51 28 32539 16775 90579105
Klebsiella sepsis 20.93 16.51 11 32556 1770 90594110
General physical health deterioration 20.92 16.51 62 32505 355053 90240827
Oral disorder 20.84 16.51 22 32545 10323 90585557
Leukaemia 20.81 16.51 16 32551 4976 90590904
Lepromatous leprosy 20.74 16.51 4 32563 19 90595861
Gastrointestinal disorder 20.59 16.51 38 32529 256649 90339231
Medication error 20.48 16.51 3 32564 84649 90511231
Mycobacterium haemophilum infection 20.22 16.51 6 32561 208 90595672
Febrile neutropenia 20.12 16.51 111 32456 158238 90437642
Multiple organ dysfunction syndrome 20 16.51 62 32505 68274 90527606
Rectal adenocarcinoma 19.70 16.51 8 32559 713 90595167
Atelectasis 19.51 16.51 33 32534 24376 90571504
Light chain analysis increased 19.36 16.51 10 32557 1552 90594328
Anxiety disorder 18.84 16.51 15 32552 4907 90590973
Cardiopulmonary failure 18.73 16.51 14 32553 4174 90591706
Haemorrhage intracranial 18.54 16.51 25 32542 15137 90580743
Amyloidosis 18.39 16.51 9 32558 1247 90594633
Hyperbaric oxygen therapy 18.34 16.51 4 32563 38 90595842
Cardiac failure 18.33 16.51 83 32484 109413 90486467
Enterocolitis bacterial 18.26 16.51 6 32561 292 90595588
Secondary adrenocortical insufficiency 18.22 16.51 11 32556 2307 90593573
Somnolence 18.14 16.51 133 32434 208951 90386929
Sciatica 17.90 16.51 7 32560 101375 90494505
Clostridial sepsis 17.89 16.51 7 32560 566 90595314
Refractory anaemia with ringed sideroblasts 17.85 16.51 3 32564 5 90595875
BK virus infection 17.84 16.51 14 32553 4484 90591396
Chillblains 17.84 16.51 6 32561 314 90595566
Rash pustular 17.81 16.51 18 32549 8031 90587849
Intervertebral discitis 17.78 16.51 14 32553 4506 90591374
Arachnoiditis 17.74 16.51 7 32560 579 90595301
Haemorrhage 17.65 16.51 60 32507 69309 90526571
Stress 17.30 16.51 4 32563 81391 90514489
Nausea 17.30 16.51 288 32279 1110028 89485852
Acute monocytic leukaemia 17.26 16.51 5 32562 159 90595721
Cardiac amyloidosis 16.91 16.51 8 32559 1028 90594852
Jaw fracture 16.76 16.51 11 32556 2667 90593213
Basal cell carcinoma 16.68 16.51 37 32530 33352 90562528
Maxillofacial operation 16.64 16.51 3 32564 9 90595871
Prothrombin time prolonged 16.60 16.51 19 32548 9753 90586127
Incorrect dose administered 16.54 16.51 4 32563 78926 90516954
Blood potassium increased 16.51 16.51 28 32539 20721 90575159

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
Disease progression 1754.23 14.72 1267 37656 142389 42440023
Death 1628.00 14.72 2058 36865 469127 42113285
Neuropathy peripheral 758.22 14.72 674 38249 101179 42481233
Plasma cell myeloma 738.33 14.72 488 38435 47090 42535322
Plasma cell myeloma recurrent 364.90 14.72 152 38771 5605 42576807
Osteonecrosis 337.30 14.72 199 38724 15666 42566746
Malignant neoplasm progression 328.93 14.72 448 38475 107952 42474460
Deep vein thrombosis 297.83 14.72 359 38564 76598 42505814
Plasmacytoma 249.17 14.72 107 38816 4257 42578155
Acute myeloid leukaemia 194.86 14.72 162 38761 22094 42560318
Pneumonia 189.15 14.72 823 38100 421326 42161086
Bone disorder 151.21 14.72 87 38836 6526 42575886
Renal failure 124.17 14.72 349 38574 143377 42439035
Drug interaction 121.62 14.72 46 38877 266953 42315459
Polyneuropathy 116.04 14.72 112 38811 18549 42563863
Tooth extraction 109.29 14.72 66 38857 5414 42576998
Unevaluable event 99.63 14.72 139 38784 34149 42548263
Pulmonary embolism 98.91 14.72 286 38637 119326 42463086
Sepsis 95.97 14.72 398 38525 198936 42383476
Spinal cord compression 92.39 14.72 54 38869 4170 42578242
Squamous cell carcinoma of skin 84.09 14.72 79 38844 12647 42569765
Plasma cell myeloma refractory 81.89 14.72 35 38888 1375 42581037
IVth nerve paralysis 79.19 14.72 27 38896 564 42581848
Plasma cell leukaemia 76.07 14.72 32 38891 1208 42581204
Constipation 75.67 14.72 321 38602 161970 42420442
Pseudomyopia 72.64 14.72 17 38906 79 42582333
Pregnancy of partner 70.75 14.72 23 38900 412 42582000
Inappropriate schedule of product administration 68.35 14.72 5 38918 95897 42486515
Basal cell carcinoma 65.79 14.72 92 38831 22641 42559771
Myelodysplastic syndrome 65.75 14.72 92 38831 22653 42559759
Acute lymphocytic leukaemia 65.02 14.72 40 38883 3391 42579021
Completed suicide 63.45 14.72 7 38916 96458 42485954
Pruritus 60.70 14.72 50 38873 188721 42393691
Overdose 59.25 14.72 12 38911 105252 42477160
B-cell type acute leukaemia 56.85 14.72 23 38900 785 42581627
Full blood count decreased 54.78 14.72 80 38843 20480 42561932
Bone lesion 54.71 14.72 36 38887 3430 42578982
JC virus infection 54.34 14.72 34 38889 2970 42579442
Bone debridement 53.55 14.72 15 38908 157 42582255
BK virus infection 53.24 14.72 52 38871 8732 42573680
Osteonecrosis of jaw 52.03 14.72 75 38848 18974 42563438
Type 2 lepra reaction 50.64 14.72 17 38906 338 42582074
Osteomyelitis 50.14 14.72 72 38851 18151 42564261
Progressive multifocal leukoencephalopathy 49.80 14.72 57 38866 11479 42570933
Leukaemia 48.39 14.72 41 38882 5731 42576681
Pancytopenia 47.36 14.72 223 38700 117520 42464892
Debridement 46.29 14.72 21 38902 953 42581459
Pathological fracture 45.20 14.72 38 38885 5255 42577157
Oedema peripheral 45.09 14.72 244 38679 135832 42446580
Thrombosis 44.71 14.72 151 38772 68360 42514052
Hypoaesthesia 43.58 14.72 154 38769 71309 42511103
Cystitis haemorrhagic 41.85 14.72 42 38881 7287 42575125
Acute leukaemia 41.57 14.72 21 38902 1212 42581200
Spinal column injury 40.70 14.72 17 38906 630 42581782
Therapy non-responder 39.69 14.72 123 38800 53236 42529176
IgA nephropathy 38.30 14.72 25 38898 2349 42580063
Stem cell transplant 37.96 14.72 26 38897 2646 42579766
Asthenia 37.28 14.72 406 38517 280387 42302025
Sequestrectomy 37.12 14.72 12 38911 211 42582201
Intentional product misuse 37.10 14.72 6 38917 61894 42520518
Bone sequestrum 37.08 14.72 15 38908 512 42581900
Cardiac failure congestive 36.53 14.72 165 38758 85437 42496975
Metastases to central nervous system 36.24 14.72 46 38877 10309 42572103
Headache 36.04 14.72 106 38817 239263 42343149
Jaw disorder 35.74 14.72 23 38900 2110 42580302
Amyloidosis 35.47 14.72 24 38899 2395 42580017
Respiratory failure 33.55 14.72 216 38707 127916 42454496
Metastatic malignant melanoma 33.50 14.72 23 38900 2350 42580062
Device related sepsis 33.39 14.72 28 38895 3859 42578553
Rhabdomyolysis 32.92 14.72 15 38908 78004 42504408
Neoplasm progression 32.77 14.72 78 38845 28922 42553490
Blood pressure increased 32.72 14.72 27 38896 101901 42480511
Oral surgery 31.61 14.72 14 38909 600 42581812
Metastasis 30.68 14.72 29 38894 4676 42577736
Paraesthesia 30.15 14.72 140 38783 73319 42509093
Urticaria 30.06 14.72 15 38908 74021 42508391
Laboratory test abnormal 29.50 14.72 65 38858 22913 42559499
Tear break up time decreased 29.42 14.72 6 38917 12 42582400
Peripheral sensory neuropathy 29.22 14.72 38 38885 8724 42573688
Diarrhoea 28.69 14.72 276 38647 460573 42121839
Pain in jaw 28.37 14.72 49 38874 14453 42567959
Infection 28.15 14.72 187 38736 111881 42470531
Arthralgia 27.99 14.72 95 38828 205143 42377269
Acute kidney injury 27.78 14.72 209 38714 367128 42215284
Hyponatraemia 27.76 14.72 31 38892 101431 42480981
Hypercalcaemia 27.76 14.72 55 38868 18003 42564409
Conjunctival irritation 27.56 14.72 8 38915 96 42582316
Varicella zoster virus infection 27.15 14.72 21 38902 2580 42579832
Failure to thrive 27.06 14.72 38 38885 9384 42573028
Meibomian gland dysfunction 26.63 14.72 8 38915 109 42582303
Malignant neoplasm of unknown primary site 26.25 14.72 11 38912 411 42582001
Blood creatine phosphokinase increased 26.19 14.72 6 38917 48332 42534080
Incorrect dose administered 26.00 14.72 8 38915 52966 42529446
Streptococcal infection 25.96 14.72 30 38893 6102 42576310
Adverse drug reaction 25.73 14.72 84 38839 37350 42545062
Hip fracture 25.67 14.72 45 38878 13427 42568985
Insomnia 25.45 14.72 43 38880 118210 42464202
Alanine aminotransferase increased 25.31 14.72 26 38897 88380 42494032
Condition aggravated 24.97 14.72 138 38785 260616 42321796
Haemoglobin decreased 24.72 14.72 206 38717 132265 42450147
Hypoglycaemia 24.49 14.72 12 38911 59842 42522570
Hypogammaglobulinaemia 24.34 14.72 41 38882 11850 42570562
Therapy partial responder 23.87 14.72 55 38868 19966 42562446
Anaphylactic reaction 23.77 14.72 5 38918 42738 42539674
Cardiac disorder 23.68 14.72 98 38825 48834 42533578
Genotoxicity 23.44 14.72 6 38917 43 42582369
Malaise 22.72 14.72 108 38815 212048 42370364
Cardiac amyloidosis 22.72 14.72 17 38906 1988 42580424
Diverticular perforation 22.52 14.72 22 38901 3694 42578718
Compression fracture 22.39 14.72 22 38901 3720 42578692
Suicidal ideation 22.36 14.72 8 38915 48153 42534259
Drug-induced liver injury 22.29 14.72 4 38919 38269 42544143
Infusion related reaction 22.26 14.72 14 38909 60792 42521620
Hepatitis B 22.21 14.72 29 38894 6682 42575730
Electrocardiogram QT prolonged 22.20 14.72 8 38915 47937 42534475
Weight decreased 22.19 14.72 106 38817 207842 42374570
Follicular mucinosis 22.17 14.72 5 38918 19 42582393
Jaw operation 22.08 14.72 8 38915 201 42582211
Cerebral toxoplasmosis 22.03 14.72 17 38906 2081 42580331
Loss of personal independence in daily activities 21.93 14.72 9 38914 49807 42532605
Laryngeal cancer metastatic 21.76 14.72 6 38917 59 42582353
Renal cell carcinoma 21.71 14.72 26 38897 5491 42576921
Impaired healing 21.62 14.72 48 38875 17005 42565407
Musculoskeletal stiffness 21.56 14.72 13 38910 57752 42524660
Abdominal pain 20.96 14.72 96 38827 190375 42392037
Acute generalised exanthematous pustulosis 20.83 14.72 32 38891 8563 42573849
Lung infiltration 20.77 14.72 42 38881 13947 42568465
Intervertebral disc disorder 20.74 14.72 16 38907 1958 42580454
Asthma 20.63 14.72 16 38907 62298 42520114
VIth nerve paralysis 20.57 14.72 12 38911 923 42581489
Lepromatous leprosy 20.52 14.72 6 38917 74 42582338
Platelet count decreased 20.51 14.72 205 38718 138376 42444036
Wrong technique in product usage process 19.94 14.72 7 38916 42628 42539784
Bone pain 19.72 14.72 57 38866 23735 42558677
Wheezing 19.53 14.72 13 38910 54768 42527644
Aggression 19.40 14.72 8 38915 44155 42538257
Hyperviscosity syndrome 19.29 14.72 8 38915 291 42582121
Flushing 19.27 14.72 5 38918 37023 42545389
Hypercapnic coma 19.20 14.72 7 38916 179 42582233
Genital erythema 19.14 14.72 8 38915 297 42582115
Enterococcal infection 18.90 14.72 37 38886 12002 42570410
Hallucination 18.74 14.72 15 38908 57492 42524920
Staphylococcal bacteraemia 18.47 14.72 35 38888 11086 42571326
Weight increased 18.35 14.72 45 38878 107938 42474474
HCoV-OC43 infection 18.15 14.72 5 38918 49 42582363
Neutropenia 18.14 14.72 269 38654 199162 42383250
Psoriasis 18.06 14.72 11 38912 48593 42533819
Refractory anaemia with an excess of blasts 18.04 14.72 8 38915 344 42582068
Thrombophlebitis 17.97 14.72 20 38903 3906 42578506
Vomiting 17.77 14.72 174 38749 289549 42292863
Haematocrit decreased 17.75 14.72 71 38852 34837 42547575
Osteolysis 17.71 14.72 19 38904 3561 42578851
VIth nerve paresis 17.71 14.72 5 38918 54 42582358
Lymphocytic leukaemia 17.67 14.72 7 38916 226 42582186
Light chain analysis increased 17.54 14.72 14 38909 1800 42580612
Post procedural fistula 17.48 14.72 6 38917 128 42582284
Oxygen saturation decreased 17.43 14.72 20 38903 64667 42517745
Productive cough 17.37 14.72 13 38910 51554 42530858
Lymphopenia 17.24 14.72 51 38872 21512 42560900
Prothrombin time prolonged 17.23 14.72 31 38892 9438 42572974
B precursor type acute leukaemia 17.19 14.72 7 38916 243 42582169
Arachnoiditis 17.17 14.72 8 38915 386 42582026
Restlessness 17.16 14.72 3 38920 29246 42553166
Eczema 16.99 14.72 5 38918 34081 42548331
Squamous cell carcinoma 16.97 14.72 37 38886 12945 42569467
Spinal compression fracture 16.94 14.72 27 38896 7456 42574956
Haematochezia 16.94 14.72 17 38906 58419 42523993
Pallor 16.87 14.72 3 38920 28883 42553529
Liposarcoma 16.86 14.72 6 38917 143 42582269
Anxiety 16.74 14.72 54 38869 118506 42463906
Blood bilirubin decreased 16.52 14.72 9 38914 607 42581805
Accidental overdose 16.42 14.72 3 38920 28327 42554085
Hepatic enzyme increased 16.14 14.72 11 38912 45773 42536639
Autologous bone marrow transplantation therapy 16.10 14.72 4 38919 25 42582387
Cholestasis 16.07 14.72 5 38918 32874 42549538
Plasmacytosis 16.02 14.72 5 38918 78 42582334
Neutropenic sepsis 16.01 14.72 41 38882 15905 42566507
Varicella 15.95 14.72 14 38909 2051 42580361
Hyperhidrosis 15.95 14.72 37 38886 90475 42491937
Thrombocytopenia 15.89 14.72 253 38670 190026 42392386
Lactic acidosis 15.78 14.72 11 38912 45250 42537162
H1N1 influenza 15.77 14.72 11 38912 1153 42581259
Myalgia 15.58 14.72 41 38882 96039 42486373
Tooth disorder 15.50 14.72 34 38889 11945 42570467
Refractory cancer 15.43 14.72 6 38917 184 42582228
Cachexia 15.35 14.72 27 38896 8077 42574335
Agitation 15.15 14.72 22 38901 64292 42518120
Myelodysplastic syndrome transformation 15.10 14.72 8 38915 510 42581902
Drug dependence 15.00 14.72 4 38919 29090 42553322
Neurogenic bladder 14.87 14.72 14 38909 2246 42580166
Factor VII deficiency 14.82 14.72 4 38919 36 42582376
Metastatic neoplasm 14.76 14.72 17 38906 3444 42578968

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
Disease progression 3695.67 14.14 2012 55816 242022 110289449
Death 3427.94 14.14 2852 54976 696017 109835454
Plasma cell myeloma 1418.85 14.14 681 57147 62255 110469216
Neuropathy peripheral 1122.68 14.14 850 56978 178427 110353044
Malignant neoplasm progression 836.92 14.14 708 57120 173859 110357612
Plasma cell myeloma recurrent 655.36 14.14 213 57615 6829 110524642
Deep vein thrombosis 533.86 14.14 499 57329 139388 110392083
Human chorionic gonadotropin increased 467.04 14.14 117 57711 1415 110530056
Osteonecrosis 463.03 14.14 262 57566 33479 110497992
Plasmacytoma 374.09 14.14 130 57698 5132 110526339
Renal failure 354.25 14.14 510 57318 226064 110305407
Pneumonia 335.50 14.14 1112 56716 875602 109655869
Acute myeloid leukaemia 274.54 14.14 197 57631 37913 110493558
Sepsis 263.23 14.14 549 57279 326797 110204674
Polyneuropathy 257.40 14.14 177 57651 31835 110499636
Pulmonary embolism 218.97 14.14 398 57430 214076 110317395
Unevaluable event 196.84 14.14 196 57632 59031 110472440
Plasma cell leukaemia 181.51 14.14 60 57768 2028 110529443
Myelodysplastic syndrome 166.91 14.14 146 57682 37338 110494133
Plasma cell myeloma refractory 144.40 14.14 50 57778 1951 110529520
Rheumatoid arthritis 142.01 14.14 3 57825 299610 110231861
Pancytopenia 141.54 14.14 328 57500 209285 110322186
Squamous cell carcinoma of skin 140.35 14.14 96 57732 17107 110514364
Bone disorder 135.56 14.14 102 57726 21090 110510381
Tooth extraction 131.59 14.14 83 57745 12908 110518563
Pruritus 123.17 14.14 76 57752 581484 109949987
Acute lymphocytic leukaemia 119.51 14.14 59 57769 5706 110525765
Drug hypersensitivity 117.92 14.14 45 57783 454045 110077426
Arthralgia 116.53 14.14 142 57686 779490 109751981
Headache 115.52 14.14 177 57651 882200 109649271
Cardiac failure congestive 113.90 14.14 247 57581 150753 110380718
Arthropathy 113.41 14.14 10 57818 287512 110243959
Alopecia 111.18 14.14 27 57801 364726 110166745
Drug interaction 110.65 14.14 62 57766 500121 110031350
Synovitis 109.57 14.14 9 57819 274083 110257388
Constipation 103.97 14.14 416 57412 357370 110174101
Infusion related reaction 103.66 14.14 35 57793 381127 110150344
Varicella zoster virus infection 99.80 14.14 54 57774 6314 110525157
Haemoglobin decreased 99.38 14.14 321 57507 248406 110283065
Glossodynia 98.72 14.14 4 57824 222000 110309471
Pregnancy test urine positive 98.43 14.14 16 57812 8 110531463
Abdominal discomfort 97.41 14.14 42 57786 393816 110137655
Musculoskeletal stiffness 97.30 14.14 15 57813 279807 110251664
Thrombocytopenia 96.09 14.14 399 57429 348486 110182985
Hepatic enzyme increased 95.38 14.14 25 57803 320867 110210604
Respiratory failure 95.34 14.14 288 57540 215044 110316427
Acute leukaemia 95.20 14.14 36 57792 1813 110529658
Completed suicide 94.06 14.14 9 57819 242372 110289099
Joint swelling 93.53 14.14 58 57770 442787 110088684
Basal cell carcinoma 92.10 14.14 116 57712 45154 110486317
IVth nerve paralysis 91.10 14.14 27 57801 632 110530839
Therapeutic product effect decreased 89.90 14.14 11 57817 244305 110287166
Osteonecrosis of jaw 89.79 14.14 118 57710 47899 110483572
Maternal exposure during pregnancy 87.86 14.14 14 57814 254869 110276602
Wound 87.64 14.14 10 57818 234427 110297044
Nasopharyngitis 87.01 14.14 49 57779 394312 110137159
Spinal cord compression 86.01 14.14 52 57776 7500 110523971
Weight increased 85.83 14.14 57 57771 419587 110111884
B-cell type acute leukaemia 84.51 14.14 31 57797 1433 110530038
Human chorionic gonadotropin positive 84.03 14.14 15 57813 24 110531447
Bone lesion 83.83 14.14 50 57778 7037 110524434
Leukaemia 83.66 14.14 51 57777 7467 110524004
Inappropriate schedule of product administration 83.31 14.14 6 57822 203631 110327840
Hypersensitivity 82.45 14.14 55 57773 403943 110127528
Pericarditis 80.29 14.14 10 57818 219104 110312367
Hepatosplenic T-cell lymphoma 79.84 14.14 27 57801 980 110530491
Duodenal ulcer perforation 79.69 14.14 3 57825 177697 110353774
Neutropenia 79.67 14.14 397 57431 374223 110157248
Metastatic malignant melanoma 77.01 14.14 37 57791 3372 110528099
Injection site pain 76.52 14.14 4 57824 177918 110353553
Malaise 75.72 14.14 148 57680 671671 109859800
Folliculitis 74.60 14.14 3 57825 167650 110363821
Progressive multifocal leukoencephalopathy 74.55 14.14 78 57750 24878 110506593
Thrombosis 74.34 14.14 171 57657 108491 110422980
Exposure via body fluid 74.12 14.14 20 57808 329 110531142
Complications of bone marrow transplant 74.00 14.14 23 57805 635 110530836
Off label use 73.60 14.14 1145 56683 1499040 109032431
Pain 73.50 14.14 255 57573 954700 109576771
Metastases to central nervous system 73.01 14.14 74 57754 22743 110508728
Wheezing 71.91 14.14 22 57806 255208 110276263
Pseudomyopia 71.53 14.14 17 57811 162 110531309
Full blood count decreased 71.34 14.14 86 57742 32013 110499458
Blood cholesterol increased 71.32 14.14 7 57821 184778 110346693
Stem cell transplant 70.66 14.14 38 57790 4389 110527082
Bone debridement 70.36 14.14 20 57808 402 110531069
Amyloidosis 70.27 14.14 34 57794 3147 110528324
Systemic lupus erythematosus 69.74 14.14 23 57805 254315 110277156
Haematocrit decreased 69.02 14.14 124 57704 65993 110465478
Migraine 67.59 14.14 6 57822 171646 110359825
Urticaria 66.96 14.14 42 57786 318815 110212656
BK virus infection 66.42 14.14 55 57773 13051 110518420
Platelet count decreased 66.11 14.14 267 57561 230176 110301295
Overdose 64.35 14.14 21 57807 233773 110297698
Blister 63.33 14.14 20 57808 227356 110304115
Osteomyelitis 62.41 14.14 86 57742 36514 110494957
Type 2 lepra reaction 61.75 14.14 18 57810 397 110531074
Therapy partial responder 60.08 14.14 85 57743 36976 110494495
Mobility decreased 59.17 14.14 25 57803 237397 110294074
Lymphopenia 59.11 14.14 88 57740 40082 110491389
Therapy non-responder 58.30 14.14 198 57630 157109 110374362
Type 2 diabetes mellitus 58.29 14.14 11 57817 177221 110354250
Peripheral sensory neuropathy 56.87 14.14 56 57772 16624 110514847
Oedema peripheral 56.72 14.14 329 57499 328331 110203140
Jaw operation 56.72 14.14 20 57808 824 110530647
Oral surgery 55.85 14.14 23 57805 1453 110530018
Anaemia 54.82 14.14 480 57348 546606 109984865
Liver injury 54.76 14.14 7 57821 150406 110381065
Diverticular perforation 53.07 14.14 36 57792 6326 110525145
Bursitis 52.64 14.14 4 57824 129914 110401557
Human chorionic gonadotropin abnormal 50.57 14.14 9 57819 14 110531457
Debridement 50.46 14.14 23 57805 1860 110529611
IgA nephropathy 49.98 14.14 27 57801 3146 110528325
Osteoarthritis 49.21 14.14 17 57811 182606 110348865
Septic shock 48.78 14.14 187 57641 157341 110374130
Insomnia 48.33 14.14 71 57757 360519 110170952
Anxiety 48.18 14.14 66 57762 345012 110186459
Exposure during pregnancy 47.93 14.14 14 57814 167410 110364061
Pathological fracture 47.88 14.14 44 57784 11988 110519483
Asthenia 47.62 14.14 560 57268 688439 109843032
Stomatitis 47.24 14.14 43 57785 270199 110261272
Asthma 47.21 14.14 37 57791 250254 110281217
Condition aggravated 47.03 14.14 211 57617 734625 109796846
Discomfort 46.86 14.14 27 57801 214680 110316791
JC virus infection 46.69 14.14 31 57797 5259 110526212
Hip fracture 46.09 14.14 73 57755 35078 110496393
Staphylococcal bacteraemia 46.03 14.14 50 57778 16638 110514833
Mucosal inflammation 45.76 14.14 132 57696 96009 110435462
Neoplasm progression 45.66 14.14 103 57725 64492 110466979
Pleural effusion 45.56 14.14 199 57629 177510 110353961
Renal cell carcinoma 45.41 14.14 35 57793 7495 110523976
Cystitis haemorrhagic 45.41 14.14 43 57785 12166 110519305
Syncope 45.40 14.14 218 57610 202318 110329153
Drug-induced liver injury 45.16 14.14 5 57823 120062 110411409
Large intestinal ulcer perforation 44.69 14.14 10 57818 71 110531400
Hypercalcaemia 44.28 14.14 84 57744 46573 110484898
Lung infiltration 43.70 14.14 59 57769 24569 110506902
Joint range of motion decreased 43.56 14.14 6 57822 121826 110409645
Stress 43.38 14.14 3 57825 105345 110426126
VIth nerve paresis 43.31 14.14 11 57817 141 110531330
Lower respiratory tract infection 43.30 14.14 38 57790 243068 110288403
Bacterial sepsis 43.20 14.14 39 57789 10387 110521084
Mesenteric abscess 43.10 14.14 11 57817 144 110531327
Musculoskeletal pain 42.90 14.14 21 57807 183002 110348469
Bone sequestrum 42.57 14.14 18 57810 1215 110530256
Swelling 42.44 14.14 74 57754 350967 110180504
Refractory cytopenia with multilineage dysplasia 41.77 14.14 12 57816 251 110531220
Gastrooesophageal reflux disease 41.66 14.14 21 57807 179955 110351516
Prothrombin time prolonged 41.25 14.14 48 57780 17213 110514258
Lepromatous leprosy 40.53 14.14 10 57818 113 110531358
Metastasis 40.45 14.14 34 57794 8233 110523238
Nasal abscess 40.26 14.14 11 57817 190 110531281
Pregnancy of partner 39.74 14.14 12 57816 300 110531171
Rhesus antigen positive 39.68 14.14 10 57818 124 110531347
Psoriasis 39.54 14.14 12 57816 139981 110391490
Hair follicle tumour benign 39.22 14.14 13 57815 443 110531028
Cardiac amyloidosis 38.81 14.14 22 57806 2815 110528656
Contusion 38.60 14.14 39 57789 233322 110298149
Blood pressure increased 38.55 14.14 47 57781 258326 110273145
Ill-defined disorder 38.30 14.14 17 57811 156836 110374635
Tear break up time decreased 38.21 14.14 7 57821 14 110531457
Failure to thrive 38.01 14.14 41 57787 13533 110517938
Actinomycosis 37.91 14.14 17 57811 1323 110530148
Hypogammaglobulinaemia 37.00 14.14 49 57779 20027 110511444
Factor VII deficiency 36.70 14.14 9 57819 99 110531372
Sleep disorder 36.66 14.14 30 57798 198614 110332857
Abdominal pain upper 36.64 14.14 80 57748 349031 110182440
Enterococcal infection 36.45 14.14 49 57779 20317 110511154
Intentional product misuse 36.45 14.14 12 57816 132892 110398579
Staphylococcal infection 36.19 14.14 99 57729 69845 110461626
Body dysmorphic disorder 35.82 14.14 12 57816 423 110531048
Chronic kidney disease 35.58 14.14 104 57724 76187 110455284
Acute generalised exanthematous pustulosis 35.58 14.14 50 57778 21614 110509857
Dehydration 35.45 14.14 259 57569 279252 110252219
Actinomycotic sepsis 35.23 14.14 10 57818 200 110531271
Injection site erythema 35.22 14.14 4 57824 94172 110437299
Graft versus host disease 34.82 14.14 46 57782 18760 110512711
Posterior reversible encephalopathy syndrome 34.69 14.14 63 57765 33798 110497673
Sciatica 34.37 14.14 4 57824 92395 110439076
Cellulitis staphylococcal 34.05 14.14 16 57812 1387 110530084
Nausea 33.68 14.14 450 57378 1235240 109296231
Peripheral swelling 33.66 14.14 104 57724 403930 110127541
Enterococcal sepsis 33.14 14.14 21 57807 3291 110528180
Endocarditis bacterial 33.09 14.14 17 57811 1788 110529683
Incorrect dose administered 32.89 14.14 7 57821 103634 110427837
Angioedema 32.63 14.14 6 57822 98494 110432977
Device related sepsis 32.46 14.14 29 57799 7618 110523853
Gastrointestinal fungal infection 32.43 14.14 13 57815 766 110530705
Malignant neoplasm of unknown primary site 32.40 14.14 13 57815 768 110530703
Inflammation 32.29 14.14 32 57796 193206 110338265
Pregnancy test false positive 32.04 14.14 9 57819 173 110531298
Night sweats 31.97 14.14 15 57813 133968 110397503
Feeling hot 31.39 14.14 5 57823 91101 110440370
Hypercholesterolaemia 31.26 14.14 5 57823 90832 110440639
Rectal adenocarcinoma 31.23 14.14 16 57812 1673 110529798
Jaw disorder 30.94 14.14 24 57804 5188 110526283
Sinus polyp 30.74 14.14 12 57816 659 110530812
Hypoglossal nerve paresis 30.72 14.14 8 57820 114 110531357
Abdominal pain 30.60 14.14 151 57677 512838 110018633
Pregnancy test positive 30.59 14.14 8 57820 116 110531355
B precursor type acute leukaemia 30.37 14.14 11 57817 490 110530981
Blood immunoglobulin G decreased 30.19 14.14 24 57804 5376 110526095
Arthritis 30.07 14.14 26 57802 167560 110363911
Diarrhoea 29.94 14.14 418 57410 1139087 109392384
Medication error 29.81 14.14 9 57819 105357 110426114
Peripheral sensorimotor neuropathy 29.80 14.14 21 57807 3922 110527549
Conjunctival irritation 29.40 14.14 8 57820 136 110531335
Spinal column injury 29.02 14.14 17 57811 2314 110529157
Loss of personal independence in daily activities 28.50 14.14 22 57806 149998 110381473
Cerebrovascular accident 28.38 14.14 177 57651 181107 110350364
Gastrointestinal disorder 28.33 14.14 52 57776 241900 110289571
Morganella infection 28.25 14.14 14 57814 1365 110530106
Peripheral venous disease 28.13 14.14 5 57823 84112 110447359
Haematotoxicity 27.94 14.14 44 57784 21038 110510433
Blood albumin decreased 27.76 14.14 51 57777 27601 110503870
Osteolysis 27.62 14.14 23 57805 5500 110525971
C-reactive protein increased 27.18 14.14 45 57783 217874 110313597
Dyspepsia 27.16 14.14 36 57792 190929 110340542
Bone marrow failure 27.11 14.14 79 57749 57769 110473702
Meibomian gland dysfunction 27.09 14.14 9 57819 309 110531162
Hepatitis B 26.86 14.14 29 57799 9583 110521888
Cytomegalovirus infection reactivation 26.74 14.14 40 57788 18293 110513178
Obesity 26.57 14.14 13 57815 113338 110418133
Drug intolerance 26.39 14.14 116 57712 406396 110125075
Herpes zoster infection neurological 26.25 14.14 10 57818 514 110530957
Dry mouth 26.16 14.14 40 57788 199908 110331563
Cardiopulmonary failure 25.96 14.14 26 57802 7877 110523594
Injury 25.64 14.14 33 57795 177232 110354239
Arachnoiditis 25.63 14.14 12 57816 1032 110530439
Wrong technique in product usage process 25.56 14.14 7 57821 87341 110444130
White blood cell count decreased 25.42 14.14 206 57622 229184 110302287
Vomiting 25.36 14.14 330 57498 910345 109621126
Nocardiosis 25.27 14.14 25 57803 7461 110524010
Hyperbaric oxygen therapy 25.26 14.14 6 57822 57 110531414
Rhabdomyolysis 25.06 14.14 16 57812 120385 110411086
Sequestrectomy 24.92 14.14 11 57817 825 110530646
Atrial fibrillation 24.79 14.14 205 57623 229437 110302034
Flushing 24.57 14.14 12 57816 104724 110426747
Laboratory test abnormal 24.42 14.14 64 57764 44015 110487456
Metastatic neoplasm 24.39 14.14 22 57806 5851 110525620
Cerebral toxoplasmosis 24.37 14.14 17 57811 3125 110528346
Follicular mucinosis 24.36 14.14 5 57823 22 110531449
Protein total increased 24.30 14.14 20 57808 4704 110526767
Haemophagocytic lymphohistiocytosis 24.20 14.14 52 57776 31507 110499964
Road traffic accident 24.15 14.14 13 57815 107385 110424086
Myalgia 24.12 14.14 50 57778 222331 110309140
Suicide attempt 24.02 14.14 12 57816 103382 110428089
Focal nodular hyperplasia 23.99 14.14 11 57817 902 110530569
Taste disorder 23.90 14.14 3 57825 65384 110466087
Large intestine perforation 23.85 14.14 36 57792 16593 110514878
Prescribed underdose 23.80 14.14 3 57825 65171 110466300
Light chain analysis increased 23.73 14.14 15 57813 2340 110529131
Knee arthroplasty 23.69 14.14 3 57825 64945 110466526
Erythema 23.57 14.14 76 57752 291371 110240100
Clostridium colitis 23.55 14.14 17 57811 3298 110528173
Dialysis 23.35 14.14 39 57789 19580 110511891
General physical condition abnormal 23.16 14.14 24 57804 7566 110523905
Clostridium bacteraemia 23.15 14.14 9 57819 489 110530982
Blood immunoglobulin M decreased 23.10 14.14 14 57814 2027 110529444
Oropharyngeal pain 23.06 14.14 22 57806 135254 110396217
Oxygen saturation decreased 22.94 14.14 29 57799 156953 110374518
Thrombophlebitis 22.93 14.14 24 57804 7655 110523816
Alanine aminotransferase increased 22.87 14.14 38 57790 183735 110347736
Cachexia 22.83 14.14 31 57797 12974 110518497
Infection reactivation 22.52 14.14 18 57810 4063 110527408
Memory impairment 22.46 14.14 43 57785 196901 110334570
Genital erythema 22.40 14.14 8 57820 342 110531129
Visceral leishmaniasis 22.37 14.14 13 57815 1743 110529728
Cardiac disorder 22.34 14.14 89 57739 76191 110455280
Pulmonary oedema 22.29 14.14 108 57720 100551 110430920
Atelectasis 22.10 14.14 55 57773 36657 110494814
Hyperviscosity syndrome 22.05 14.14 9 57819 556 110530915
Nasal congestion 21.95 14.14 12 57816 98270 110433201
Autologous bone marrow transplantation therapy 21.93 14.14 5 57823 39 110531432
Bacteraemia 21.93 14.14 60 57768 42330 110489141
Hodgkin's disease 21.92 14.14 10 57818 810 110530661
Weight decreased 21.88 14.14 149 57679 467908 110063563
Herpes zoster 21.68 14.14 113 57715 108266 110423205
Refractory anaemia with an excess of blasts 21.61 14.14 10 57818 837 110530634
Mucosal erosion 21.25 14.14 15 57813 2809 110528662
Liver disorder 21.07 14.14 26 57802 142217 110389254
Myocardial infarction 21.01 14.14 172 57656 191911 110339560
Laryngeal cancer metastatic 20.82 14.14 5 57823 50 110531421
Eczema 20.77 14.14 6 57822 72287 110459184
Electrocardiogram QT prolonged 20.67 14.14 16 57812 108944 110422527
Bone marrow transplant 20.39 14.14 12 57816 1648 110529823
Febrile neutropenia 20.30 14.14 254 57574 316513 110214958
Refractory cancer 20.29 14.14 7 57821 270 110531201
Blood pressure systolic increased 20.25 14.14 9 57819 82982 110448489
Hypoxia 19.98 14.14 126 57702 129389 110402082
Blood culture positive 19.86 14.14 24 57804 8952 110522519
Wound infection 19.83 14.14 13 57815 96452 110435019
Squamous cell carcinoma 19.74 14.14 35 57793 18428 110513043
VIth nerve paralysis 19.69 14.14 12 57816 1755 110529716
Obliterative bronchiolitis 19.65 14.14 16 57812 3707 110527764
Autoimmune disorder 19.63 14.14 5 57823 65478 110465993
Live birth 19.54 14.14 6 57822 69478 110461993
Splenomegaly 19.51 14.14 41 57787 24457 110507014
Blood immunoglobulin G increased 19.33 14.14 16 57812 3792 110527679
Congestive cardiomyopathy 19.29 14.14 30 57798 14189 110517282
Dental care 19.23 14.14 10 57818 1079 110530392
Streptococcal infection 19.18 14.14 26 57802 10864 110520607
Neurotoxicity 19.16 14.14 57 57771 42150 110489321
Depression 19.14 14.14 93 57735 317242 110214229
Intestinal perforation 19.00 14.14 37 57791 20907 110510564
Product use issue 19.00 14.14 91 57737 311604 110219867
Acute respiratory distress syndrome 18.85 14.14 66 57762 53132 110478339
Fungal oesophagitis 18.79 14.14 10 57818 1131 110530340
Diverticulitis 18.62 14.14 66 57762 53456 110478015
Pain in extremity 18.58 14.14 164 57664 486954 110044517
Bradycardia 18.51 14.14 142 57686 155375 110376096
Pneumonia fungal 18.46 14.14 30 57798 14724 110516747
Blood pressure fluctuation 18.44 14.14 8 57820 74816 110456655
Bone trimming 18.18 14.14 4 57824 26 110531445
Infection 18.16 14.14 278 57550 361922 110169549
Blood creatine phosphokinase increased 17.71 14.14 8 57820 73069 110458402
Blood luteinising hormone increased 17.71 14.14 6 57822 219 110531252
Intervertebral discitis 17.65 14.14 20 57808 6970 110524501
Prostate cancer metastatic 17.61 14.14 17 57811 4926 110526545
Bence Jones protein urine present 17.59 14.14 3 57825 3 110531468
Accidental overdose 17.51 14.14 3 57825 51831 110479640
Hypoglycaemia 17.43 14.14 21 57807 116083 110415388
Sudden death 17.35 14.14 39 57789 24356 110507115
Chest discomfort 17.28 14.14 41 57787 173807 110357664
Pyrexia 17.24 14.14 602 57226 897663 109633808
Injection site bruising 17.24 14.14 3 57825 51260 110480211
Lactic acidosis 17.14 14.14 14 57814 92797 110438674
Joint stiffness 16.87 14.14 7 57821 67236 110464235
Autonomic neuropathy 16.81 14.14 12 57816 2288 110529183
Multiple sclerosis relapse 16.77 14.14 3 57825 50237 110481234
Multiple organ dysfunction syndrome 16.67 14.14 136 57692 151574 110379897
Ear infection 16.62 14.14 6 57822 62726 110468745
Bence Jones proteinuria 16.38 14.14 3 57825 6 110531465
Frostbite 16.30 14.14 6 57822 280 110531191
Blood albumin increased 16.28 14.14 11 57817 1920 110529551
Hypercapnic coma 16.08 14.14 7 57821 508 110530963
Compression fracture 16.07 14.14 22 57806 9277 110522194
Joint ankylosis 15.93 14.14 12 57816 2485 110528986
Listeria sepsis 15.78 14.14 8 57820 818 110530653
Lymphocytic leukaemia 15.77 14.14 6 57822 307 110531164
Neck pain 15.75 14.14 25 57803 123105 110408366
Pneumonia pneumococcal 15.69 14.14 16 57812 4949 110526522
Mental status changes 15.66 14.14 80 57748 76042 110455429
Chloroma 15.59 14.14 8 57820 840 110530631
Growth retardation 15.57 14.14 12 57816 2570 110528901
Malignant melanoma 15.52 14.14 30 57798 16861 110514610
Bladder transitional cell carcinoma stage III 15.49 14.14 4 57824 55 110531416
Performance status decreased 15.38 14.14 19 57809 7247 110524224
Brain herniation 15.37 14.14 21 57807 8842 110522629
Encephalopathy 15.25 14.14 12 57816 81043 110450428
Hypertension 15.23 14.14 182 57646 509902 110021569
Aggression 15.12 14.14 6 57822 59204 110472267
Pregnancy 15.11 14.14 4 57824 51063 110480408
Decubitus ulcer 15.09 14.14 31 57797 18205 110513266
Endothelial dysfunction 15.07 14.14 6 57822 347 110531124
Acute monocytic leukaemia 14.90 14.14 7 57821 607 110530864
Obstructive airways disorder 14.88 14.14 3 57825 46146 110485325
Hot flush 14.84 14.14 8 57820 66028 110465443
Paraneoplastic thrombosis 14.66 14.14 3 57825 13 110531458
Thalamic infarction 14.60 14.14 9 57819 1343 110530128
General physical health deterioration 14.58 14.14 147 57681 425148 110106323
Adenocarcinoma of colon 14.48 14.14 17 57811 6151 110525320
Oral disorder 14.47 14.14 24 57804 11979 110519492
Illness 14.43 14.14 13 57815 82158 110449313
Neutropenic sepsis 14.41 14.14 42 57786 30704 110500767
Medulloblastoma recurrent 14.39 14.14 5 57823 197 110531274
Parainfluenzae virus infection 14.39 14.14 18 57810 6956 110524515
Hydrocephalus 14.23 14.14 22 57806 10353 110521118
Plasmacytosis 14.23 14.14 5 57823 204 110531267
Pneumonia parainfluenzae viral 14.21 14.14 7 57821 674 110530797

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AX02 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Other immunosuppressants
FDA PE N0000008663 Decreased Immunologically Active Molecule Activity
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000970 Antineoplastic Agents
MeSH PA D006131 Growth Inhibitors
MeSH PA D006133 Growth Substances
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
MeSH PA D007917 Leprostatic Agents
MeSH PA D013723 Teratogens
MeSH PA D020533 Angiogenesis Inhibitors
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35472 anti-inflammatory drug
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35623 anticonvulsant
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:35717 sedative
CHEBI has role CHEBI:35816 leprostatic drug
CHEBI has role CHEBI:48422 angiogenesis inhibitor
CHEBI has role CHEBI:50748 antipsoriatic
CHEBI has role CHEBI:50905 teratogenic agent
CHEBI has role CHEBI:50919 antiemetic
CHEBI has role CHEBI:51177 antitussive
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:233423 antifibrotic agent

Related Drugs by ATC class:

L04AX Other immunosuppressants 8 drugs
azathioprinedimethyl fumaratediroximel fumaratelenalidomidemethotrexatepirfenidonepomalidomidetegomil fumarate

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

DiseaseRelationSNOMED_IDDOID
Crow-Fukase (POEMS) syndrome indication 79268002 DOID:14039
Multiple myeloma indication 109989006 DOID:9538
Erythema nodosum leprosum indication 240411003
Refractory upper gastrointestinal bleeding due to angiodysplasia off-label use 37372002
Pyoderma gangrenosum off-label use 74578003 DOID:8553
Discoid lupus erythematosus off-label use 200938002
Actinic prurigo off-label use 201015007
Graft-versus-host disease off-label use 234646005
Erosive oral lichen planus off-label use 238662007
Subacute cutaneous lupus erythematosus off-label use 239891002
Recurrent aphthous ulcer off-label use 398870000
Refractory upper gastrointestinal bleeding due to angiodysplasia off-label use 29731000119103
Refractory upper gastrointestinal bleeding due to angiodysplasia off-label use 1082711000119110
Prevention of Recurrent Aphthous Stomatitis off-label use
Orthostatic hypotension contraindication 28651003
Bradycardia contraindication 48867003
Epilepsy contraindication 84757009 DOID:1826
Deep venous thrombosis contraindication 128053003
Pulmonary thromboembolism contraindication 233935004
Pregnancy, function contraindication 289908002
Peripheral nerve disease contraindication 302226006
Neutropenic disorder contraindication 303011007 DOID:1227
Thromboembolic disorder contraindication 371039008
Breastfeeding (mother) contraindication 413712001




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.84 acidic

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
Protein cereblon Cytosolic other MODULATOR EC50 6.39 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
Prostaglandin G/H synthase 1 Enzyme IC50 6.43 WOMBAT-PK
Tumor necrosis factor Cytokine IC50 8 WOMBAT-PK
Prostaglandin G/H synthase 2 Enzyme IC50 6.30 WOMBAT-PK
Prostaglandin G/H synthase 2 Enzyme IC50 6.30 CHEMBL
Cereblon isoform 4 Cytosolic other Ki 5.36 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 6.43 CHEMBL

External reference:

IDSource
4021134 VUID
N0000148588 NUI
D00754 KEGG_DRUG
4021134 VANDF
C0039736 UMLSCUI
CHEBI:9513 CHEBI
CHEMBL468 ChEMBL_ID
DB01041 DRUGBANK_ID
D013792 MESH_DESCRIPTOR_UI
5426 PUBCHEM_CID
7327 IUPHAR_LIGAND_ID
762 INN_ID
4Z8R6ORS6L UNII
10432 RXNORM
11845 MMSL
7488 MMSL
d04331 MMSL
005933 NDDF
404878004 SNOMEDCT_US
78702007 SNOMEDCT_US
4Z8R6ORS6L INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Thalomid HUMAN PRESCRIPTION DRUG LABEL 1 59572-205 CAPSULE 50 mg ORAL NDA 30 sections
Thalomid HUMAN PRESCRIPTION DRUG LABEL 1 59572-210 CAPSULE 100 mg ORAL NDA 30 sections
Thalomid HUMAN PRESCRIPTION DRUG LABEL 1 59572-215 CAPSULE 150 mg ORAL NDA 30 sections
Thalomid HUMAN PRESCRIPTION DRUG LABEL 1 59572-220 CAPSULE 200 mg ORAL NDA 30 sections