thalidomide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects.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

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 1509.23 14.59 851 28928 121907 63337336
Death 1396.70 14.59 1249 28530 373132 63086111
Plasma cell myeloma 823.28 14.59 380 29399 35525 63423718
Human chorionic gonadotropin increased 663.15 14.59 153 29626 1432 63457811
Neuropathy peripheral 633.44 14.59 481 29298 113186 63346057
Malignant neoplasm progression 322.92 14.59 284 29495 81837 63377406
Osteonecrosis 204.27 14.59 133 29646 24397 63434846
Deep vein thrombosis 202.22 14.59 222 29557 83578 63375665
Renal failure 182.01 14.59 249 29530 117403 63341840
Pneumonia 175.25 14.59 540 29239 456227 63003016
Plasma cell myeloma recurrent 137.24 14.59 53 29726 3160 63456083
Hepatosplenic T-cell lymphoma 133.94 14.59 35 29744 568 63458675
Sepsis 119.43 14.59 238 29541 152885 63306358
Exposure via body fluid 118.94 14.59 32 29747 584 63458659
Pancytopenia 113.45 14.59 180 29599 96753 63362490
Plasma cell leukaemia 103.88 14.59 33 29746 1097 63458146
Pregnancy test urine positive 103.67 14.59 17 29762 13 63459230
Plasmacytoma 101.18 14.59 40 29739 2539 63456704
Human chorionic gonadotropin positive 95.33 14.59 17 29762 32 63459211
Polyneuropathy 92.76 14.59 67 29712 14522 63444721
Arthralgia 92.55 14.59 79 29700 569631 62889612
Alopecia 83.85 14.59 27 29752 337509 63121734
Unevaluable event 82.75 14.59 111 29668 51275 63407968
Myelodysplastic syndrome 82.37 14.59 66 29713 16688 63442555
Pulmonary embolism 81.07 14.59 173 29606 116511 63342732
Human chorionic gonadotropin abnormal 80.11 14.59 14 29765 22 63459221
Abdominal discomfort 79.12 14.59 26 29753 320859 63138384
Varicella zoster virus infection 76.00 14.59 33 29746 2656 63456587
Complications of bone marrow transplant 74.87 14.59 21 29758 450 63458793
Headache 72.51 14.59 116 29663 633125 62826118
Acute myeloid leukaemia 70.68 14.59 61 29718 17086 63442157
Thrombocytopenia 66.47 14.59 188 29591 150969 63308274
Therapeutic product effect decreased 65.81 14.59 7 29772 193180 63266063
Infusion related reaction 65.80 14.59 17 29762 245504 63213739
Drug hypersensitivity 65.43 14.59 32 29747 310655 63148588
Glossodynia 64.90 14.59 5 29774 178871 63280372
Osteonecrosis of jaw 64.55 14.59 81 29698 35042 63424201
Bone disorder 61.15 14.59 62 29717 21264 63437979
Maternal exposure during pregnancy 59.42 14.59 15 29764 220047 63239196
Pain 59.36 14.59 166 29613 740462 62718781
Synovitis 58.29 14.59 9 29770 186909 63272334
Musculoskeletal stiffness 57.32 14.59 9 29770 184609 63274634
Haemoglobin decreased 56.36 14.59 173 29606 145312 63313931
Hip fracture 55.80 14.59 69 29710 29405 63429838
Hepatic enzyme increased 54.22 14.59 14 29765 202314 63256929
Drug interaction 53.97 14.59 20 29759 229111 63230132
Body dysmorphic disorder 53.15 14.59 15 29764 329 63458914
Respiratory failure 53.14 14.59 135 29644 101723 63357520
Constipation 52.68 14.59 227 29552 224716 63234527
Plasma cell myeloma refractory 52.52 14.59 15 29764 344 63458899
Thrombosis 50.82 14.59 101 29678 64654 63394589
Refractory cytopenia with multilineage dysplasia 49.90 14.59 12 29767 136 63459107
Arthropathy 49.69 14.59 24 29755 234768 63224475
Mesenteric abscess 49.53 14.59 11 29768 85 63459158
Acute leukaemia 49.48 14.59 19 29760 1115 63458128
Bone lesion 49.21 14.59 32 29747 5849 63453394
Gastrointestinal fungal infection 48.41 14.59 14 29765 336 63458907
Jaw operation 47.16 14.59 17 29762 835 63458408
Mucosal inflammation 46.60 14.59 81 29698 46847 63412396
Acute lymphocytic leukaemia 46.50 14.59 23 29756 2493 63456750
Pruritus 46.38 14.59 61 29718 361392 63097851
Nasal abscess 46.37 14.59 12 29767 187 63459056
Large intestinal ulcer perforation 46.27 14.59 10 29769 67 63459176
Pregnancy test false positive 45.73 14.59 12 29767 198 63459045
Cardiac disorder 45.71 14.59 84 29695 50732 63408511
Joint swelling 45.51 14.59 52 29727 327614 63131629
Platelet count decreased 44.88 14.59 138 29641 115984 63343259
Hypersensitivity 44.52 14.59 43 29736 292642 63166601
Growth failure 44.41 14.59 13 29766 326 63458917
Epstein-Barr viraemia 44.34 14.59 17 29762 993 63458250
Injection site pain 43.44 14.59 5 29774 129795 63329448
Cerebrovascular accident 42.32 14.59 129 29650 107895 63351348
Sinus polyp 42.13 14.59 13 29766 392 63458851
Drug ineffective 41.97 14.59 303 29476 1044462 62414781
Hair follicle tumour benign 41.33 14.59 13 29766 418 63458825
Rhesus antigen positive 40.76 14.59 10 29769 124 63459119
Asthenia 40.52 14.59 313 29466 383291 63075952
Discomfort 40.44 14.59 14 29765 167360 63291883
Endocarditis bacterial 40.05 14.59 14 29765 628 63458615
Morganella infection 39.45 14.59 14 29765 657 63458586
Wound 38.85 14.59 14 29765 163249 63295994
Condition aggravated 38.53 14.59 82 29697 402135 63057108
Posterior reversible encephalopathy syndrome 38.43 14.59 44 29735 17301 63441942
Cardiac failure congestive 37.73 14.59 112 29667 92321 63366922
Tooth extraction 37.29 14.59 34 29745 10230 63449013
Anaemia 37.07 14.59 250 29529 293180 63166063
Joint ankylosis 36.80 14.59 15 29764 1031 63458212
Metastatic malignant melanoma 36.71 14.59 16 29763 1299 63457944
Graft versus host disease 36.16 14.59 28 29751 6735 63452508
Full blood count decreased 35.60 14.59 52 29727 25972 63433271
Pregnancy test positive 35.22 14.59 9 29770 133 63459110
Systemic lupus erythematosus 35.00 14.59 28 29751 208890 63250353
Oedema peripheral 33.93 14.59 177 29602 189334 63269909
Peripheral sensory neuropathy 33.77 14.59 28 29751 7423 63451820
Swelling 33.76 14.59 48 29731 275330 63183913
Pleural effusion 33.46 14.59 108 29671 93102 63366141
Actinomycosis 33.36 14.59 14 29765 1036 63458207
Laboratory test abnormal 32.86 14.59 51 29728 26861 63432382
Inappropriate schedule of product administration 32.41 14.59 5 29774 103960 63355283
Enterococcal sepsis 32.41 14.59 15 29764 1403 63457840
Pneumonia fungal 32.29 14.59 24 29755 5431 63453812
Clostridium bacteraemia 31.91 14.59 9 29770 197 63459046
Hypoglossal nerve paresis 31.78 14.59 8 29771 111 63459132
Stem cell transplant 31.73 14.59 16 29763 1806 63457437
Weight increased 31.43 14.59 46 29733 260746 63198497
Encephalitis viral 29.55 14.59 15 29764 1717 63457526
Therapy non-responder 29.12 14.59 90 29689 75811 63383432
Diverticular perforation 28.97 14.59 19 29760 3523 63455720
Neoplasm progression 28.79 14.59 57 29722 36371 63422872
Mucosal erosion 28.44 14.59 14 29765 1502 63457741
Haematocrit decreased 28.06 14.59 59 29720 39281 63419962
Migraine 27.96 14.59 7 29772 103339 63355904
Syncope 27.84 14.59 119 29660 117266 63341977
Pathological fracture 27.76 14.59 27 29752 8807 63450436
Malnutrition 27.65 14.59 35 29744 15263 63443980
Adverse drug reaction 27.38 14.59 91 29688 79623 63379620
Fungal oesophagitis 27.31 14.59 11 29768 733 63458510
Bone debridement 26.06 14.59 8 29771 237 63459006
Peripheral sensorimotor neuropathy 25.60 14.59 13 29766 1490 63457753
Graft versus host disease in gastrointestinal tract 25.57 14.59 17 29762 3224 63456019
Staphylococcal bacteraemia 25.52 14.59 21 29758 5509 63453734
Protein total increased 25.44 14.59 16 29763 2761 63456482
Hypoaesthesia 25.28 14.59 150 29629 168243 63291000
Debridement 25.11 14.59 12 29767 1206 63458037
Blister 24.91 14.59 15 29764 129799 63329444
Cytomegalovirus infection reactivation 24.73 14.59 18 29761 3945 63455298
Mobility decreased 24.69 14.59 13 29766 121146 63338097
Osteomyelitis 24.65 14.59 44 29735 25976 63433267
Blood immunoglobulin G decreased 24.64 14.59 15 29764 2443 63456800
Anxiety 24.64 14.59 40 29739 217501 63241742
Product use issue 24.56 14.59 41 29738 220479 63238764
Blood albumin increased 24.51 14.59 11 29768 958 63458285
Dehydration 24.49 14.59 152 29627 173202 63286041
Lung infiltration 24.43 14.59 32 29747 14431 63444812
Blood immunoglobulin M decreased 24.30 14.59 11 29768 977 63458266
Blood cholesterol increased 24.24 14.59 7 29772 94025 63365218
Viraemia 24.23 14.59 12 29767 1304 63457939
Splenomegaly 24.20 14.59 28 29751 11129 63448114
VIth nerve paresis 24.12 14.59 6 29773 79 63459164
Overdose 23.96 14.59 12 29767 115066 63344177
Herpes zoster 23.89 14.59 89 29690 82373 63376870
Cellulitis staphylococcal 23.85 14.59 10 29769 738 63458505
Bradycardia 23.74 14.59 82 29697 73145 63386098
Metastases to central nervous system 23.71 14.59 30 29749 13075 63446168
Squamous cell carcinoma of skin 23.63 14.59 21 29758 6111 63453132
Nasopharyngitis 23.35 14.59 53 29726 254204 63205039
Neutropenia 23.20 14.59 151 29628 174854 63284389
Treatment failure 23.11 14.59 36 29743 199007 63260236
Enterococcal infection 22.83 14.59 23 29756 7825 63451418
Endocarditis 22.77 14.59 20 29759 5730 63453513
Blood luteinising hormone increased 22.64 14.59 6 29773 103 63459140
Failure to thrive 22.62 14.59 22 29757 7176 63452067
Osteolysis 22.49 14.59 15 29764 2859 63456384
Chronic kidney disease 22.45 14.59 59 29720 45339 63413904
Graft versus host disease in skin 22.35 14.59 15 29764 2890 63456353
Actinomycotic sepsis 22.32 14.59 6 29773 109 63459134
Oral surgery 21.97 14.59 11 29768 1223 63458020
Spinal cord compression 21.80 14.59 17 29762 4131 63455112
Musculoskeletal pain 21.80 14.59 8 29771 92269 63366974
Oral fungal infection 21.50 14.59 15 29764 3076 63456167
Immunoglobulins decreased 21.49 14.59 11 29768 1281 63457962
Nausea 21.35 14.59 278 29501 854193 62605050
Cerebral toxoplasmosis 21.28 14.59 10 29769 968 63458275
Growth retardation 21.11 14.59 11 29768 1330 63457913
Fibromyalgia 20.71 14.59 6 29773 80414 63378829
Listeria sepsis 20.71 14.59 9 29770 726 63458517
Oral disorder 20.53 14.59 23 29756 8831 63450412
Decubitus ulcer 20.51 14.59 25 29754 10495 63448748
Klebsiella sepsis 20.26 14.59 11 29768 1444 63457799
Hypoperfusion 20.18 14.59 11 29768 1456 63457787
Jaw disorder 19.98 14.59 18 29761 5331 63453912
Hodgkin's disease 19.88 14.59 9 29770 800 63458443
Protein urine present 19.78 14.59 19 29760 6101 63453142
Hypercalcaemia 19.64 14.59 42 29737 28280 63430963
Leukaemia 19.46 14.59 16 29763 4192 63455051
Monoclonal immunoglobulin present 19.44 14.59 9 29770 842 63458401
Infection reactivation 19.35 14.59 10 29769 1189 63458054
Paraesthesia 19.34 14.59 133 29646 156833 63302410
Stress 19.26 14.59 4 29775 67163 63392080
Lymphopenia 18.67 14.59 32 29747 18295 63440948
Septic shock 18.54 14.59 71 29708 66558 63392685
Rectal adenocarcinoma 18.47 14.59 8 29771 640 63458603
BK virus infection 18.46 14.59 14 29765 3265 63455978
White blood cell count decreased 18.42 14.59 120 29659 138984 63320259
Wheezing 18.40 14.59 11 29768 95584 63363659
Light chain analysis increased 18.35 14.59 10 29769 1323 63457920
Blood albumin decreased 18.05 14.59 28 29751 14738 63444505
Frostbite 18.01 14.59 5 29774 103 63459140
Pregnancy with contraceptive device 17.94 14.59 16 29763 4678 63454565
Large intestine perforation 17.92 14.59 21 29758 8461 63450782
Anxiety disorder 17.90 14.59 15 29764 4035 63455208
Medulloblastoma 17.57 14.59 4 29775 35 63459208
Metastases to bone marrow 17.54 14.59 7 29772 455 63458788
Gastrointestinal haemorrhage 17.50 14.59 80 29699 81096 63378147
Febrile neutropenia 17.44 14.59 105 29674 118344 63340899
Enterocolitis bacterial 17.41 14.59 6 29773 258 63458985
Hyperbaric oxygen therapy 17.27 14.59 4 29775 38 63459205
Lower respiratory tract infection 17.27 14.59 22 29757 132285 63326958
Cardiopulmonary failure 17.26 14.59 14 29765 3598 63455645
Therapy partial responder 17.11 14.59 23 29756 10635 63448608
Refractory anaemia with ringed sideroblasts 17.06 14.59 3 29776 5 63459238
Amyloidosis 16.98 14.59 9 29770 1126 63458117
Flushing 16.92 14.59 7 29772 75080 63384163
Acute monocytic leukaemia 16.91 14.59 5 29774 130 63459113
Clostridial sepsis 16.73 14.59 7 29772 514 63458729
Cardiac amyloidosis 16.65 14.59 8 29771 814 63458429
Urticaria 16.51 14.59 33 29746 165769 63293474
Bone marrow failure 16.50 14.59 40 29739 29250 63429993
Incorrect dose administered 16.34 14.59 4 29775 59964 63399279
Ill-defined disorder 16.32 14.59 9 29770 81746 63377497
Cutaneous tuberculosis 16.13 14.59 5 29774 153 63459090
Focal nodular hyperplasia 16.11 14.59 7 29772 564 63458679
Endothelial dysfunction 15.92 14.59 5 29774 160 63459083
Maxillofacial operation 15.84 14.59 3 29776 9 63459234
Haemophagocytic lymphohistiocytosis 15.65 14.59 22 29757 10605 63448638
Diarrhoea 15.27 14.59 240 29539 715126 62744117
Medication error 15.23 14.59 3 29776 52281 63406962
Light chain analysis 15.17 14.59 3 29776 12 63459231
Atrial fibrillation 15.06 14.59 100 29679 116536 63342707
Brain herniation 14.99 14.59 13 29766 3664 63455579
Contusion 14.82 14.59 30 29749 150014 63309229
Myalgia 14.73 14.59 29 29750 146500 63312743
Nocardiosis 14.71 14.59 10 29769 1966 63457277
Exposure during pregnancy 14.61 14.59 32 29747 155515 63303728

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 1894.46 14.85 1243 34486 106834 34814368
Death 1621.73 14.85 1996 33733 396053 34525149
Plasma cell myeloma 731.37 14.85 483 35246 41554 34879648
Neuropathy peripheral 694.38 14.85 617 35112 82646 34838556
Malignant neoplasm progression 345.25 14.85 437 35292 87609 34833593
Osteonecrosis 333.44 14.85 201 35528 14689 34906513
Plasma cell myeloma recurrent 300.19 14.85 127 35602 4338 34916864
Deep vein thrombosis 291.44 14.85 346 35383 64902 34856300
Plasmacytoma 196.19 14.85 89 35640 3602 34917600
Acute myeloid leukaemia 173.15 14.85 146 35583 18124 34903078
Pneumonia 167.39 14.85 772 34957 361855 34559347
Bone disorder 147.13 14.85 87 35642 6128 34915074
Pulmonary embolism 121.35 14.85 277 35452 89469 34831733
Tooth extraction 116.69 14.85 68 35661 4660 34916542
Drug interaction 114.48 14.85 44 35685 225902 34695300
Polyneuropathy 96.09 14.85 96 35633 14800 34906402
Unevaluable event 93.05 14.85 139 35590 32451 34888751
Renal failure 89.46 14.85 315 35414 130242 34790960
Squamous cell carcinoma of skin 83.17 14.85 77 35652 10804 34910398
Constipation 76.03 14.85 309 35420 136673 34784529
Completed suicide 74.82 14.85 7 35722 98161 34823041
Pregnancy of partner 73.39 14.85 23 35706 323 34920879
Sepsis 67.94 14.85 343 35386 166218 34754984
Plasma cell leukaemia 67.28 14.85 28 35701 916 34920286
Basal cell carcinoma 66.62 14.85 91 35638 19567 34901635
Overdose 65.54 14.85 8 35721 91051 34830151
Spinal cord compression 64.91 14.85 44 35685 3931 34917271
Myelodysplastic syndrome 62.22 14.85 87 35642 19121 34902081
Thrombosis 58.68 14.85 147 35582 50311 34870891
BK virus infection 56.70 14.85 47 35682 5691 34915511
JC virus infection 55.13 14.85 32 35697 2176 34919026
Full blood count decreased 52.83 14.85 78 35651 18010 34903192
Leukaemia 52.49 14.85 41 35688 4562 34916640
Osteomyelitis 52.13 14.85 73 35656 16063 34905139
Inappropriate schedule of product administration 51.56 14.85 3 35726 62293 34858909
Acute lymphocytic leukaemia 50.58 14.85 34 35695 2995 34918207
Bone debridement 49.21 14.85 15 35714 191 34921011
Progressive multifocal leukoencephalopathy 48.88 14.85 55 35674 9709 34911493
Bone lesion 48.86 14.85 33 35696 2930 34918272
Debridement 48.70 14.85 22 35707 881 34920321
Osteonecrosis of jaw 47.78 14.85 74 35655 17815 34903387
Pruritus 47.57 14.85 45 35684 141936 34779266
Pancytopenia 44.53 14.85 204 35525 94953 34826249
Oedema peripheral 44.14 14.85 240 35489 119572 34801630
Hypoaesthesia 41.77 14.85 148 35581 61296 34859906
Type 2 lepra reaction 41.51 14.85 13 35716 182 34921020
Cystitis haemorrhagic 41.11 14.85 39 35690 5640 34915562
Metastases to central nervous system 40.70 14.85 46 35683 8159 34913043
Stem cell transplant 40.57 14.85 26 35703 2113 34919089
Acute leukaemia 40.40 14.85 21 35708 1148 34920054
Sequestrectomy 39.13 14.85 13 35716 222 34920980
Hospitalisation 38.57 14.85 6 35723 56896 34864306
Neoplasm progression 38.40 14.85 78 35651 23222 34897980
Pseudomyopia 37.77 14.85 9 35720 40 34921162
Spinal column injury 36.20 14.85 16 35713 608 34920594
Asthenia 35.59 14.85 395 35334 244856 34676346
Pathological fracture 35.36 14.85 32 35697 4359 34916843
Respiratory failure 34.42 14.85 209 35520 108363 34812839
Metastatic malignant melanoma 34.15 14.85 23 35706 2032 34919170
Bone sequestrum 34.01 14.85 15 35714 567 34920635
Therapy non-responder 33.52 14.85 102 35627 39044 34882158
Jaw disorder 32.97 14.85 23 35706 2152 34919050
Adverse drug reaction 32.55 14.85 84 35645 29258 34891944
Blood pressure increased 31.81 14.85 26 35703 88076 34833126
Rhabdomyolysis 31.68 14.85 15 35714 68148 34853054
Headache 31.29 14.85 103 35626 200532 34720670
Amyloidosis 31.14 14.85 22 35707 2101 34919101
Metastasis 31.03 14.85 29 35700 4115 34917087
Infusion related reaction 30.95 14.85 8 35721 53049 34868153
Oral surgery 30.66 14.85 14 35715 575 34920627
Cardiac failure congestive 28.77 14.85 164 35565 83106 34838096
Intentional product misuse 28.34 14.85 6 35723 45605 34875597
Pain in jaw 28.14 14.85 49 35680 12991 34908211
Acute kidney injury 27.87 14.85 190 35539 304798 34616404
Blood creatine phosphokinase increased 27.67 14.85 6 35723 44851 34876351
Off label use 27.67 14.85 285 35444 419239 34501963
Laboratory test abnormal 27.56 14.85 63 35666 20328 34900874
Urticaria 27.08 14.85 15 35714 62362 34858840
Hypoglycaemia 27.00 14.85 11 35718 54629 34866573
Hypercalcaemia 26.94 14.85 53 35676 15415 34905787
Diarrhoea 26.90 14.85 262 35467 389650 34531552
Arthralgia 26.70 14.85 87 35642 169954 34751248
Paraesthesia 26.68 14.85 133 35596 64039 34857163
Alanine aminotransferase increased 26.59 14.85 26 35703 80789 34840413
Failure to thrive 26.43 14.85 38 35691 8563 34912639
Conjunctival irritation 26.30 14.85 8 35721 101 34921101
Hip fracture 25.98 14.85 45 35684 11880 34909322
Malignant neoplasm of unknown primary site 25.44 14.85 11 35718 396 34920806
Infection 25.09 14.85 169 35560 90746 34830456
Meibomian gland dysfunction 24.41 14.85 7 35722 71 34921131
Insomnia 24.38 14.85 43 35686 103864 34817338
Peripheral sensory neuropathy 23.97 14.85 32 35697 6728 34914474
Tear break up time decreased 23.95 14.85 5 35724 10 34921192
Acute generalised exanthematous pustulosis 23.91 14.85 32 35697 6744 34914458
Diverticular perforation 23.75 14.85 23 35706 3411 34917791
Cerebral toxoplasmosis 23.33 14.85 17 35712 1704 34919498
Enterococcal infection 22.78 14.85 37 35692 9269 34911933
Hyponatraemia 22.47 14.85 31 35698 82660 34838542
Compression fracture 22.17 14.85 21 35708 3031 34918171
Cardiac disorder 22.07 14.85 95 35634 43031 34878171
Haemoglobin decreased 22.01 14.85 204 35525 120568 34800634
Follicular mucinosis 21.61 14.85 5 35724 19 34921183
Abdominal pain 21.55 14.85 90 35639 163528 34757674
Impaired healing 21.41 14.85 48 35681 15286 34905916
Jaw operation 21.31 14.85 8 35721 198 34921004
Staphylococcal bacteraemia 21.23 14.85 34 35695 8418 34912784
Plasma cell myeloma refractory 21.11 14.85 11 35718 604 34920598
Laryngeal cancer metastatic 21.09 14.85 6 35723 59 34921143
Hyperviscosity syndrome 20.80 14.85 8 35721 212 34920990
Hepatitis B 20.72 14.85 28 35701 5955 34915247
Electrocardiogram QT prolonged 20.63 14.85 8 35721 40944 34880258
VIth nerve paralysis 20.59 14.85 12 35717 822 34920380
Varicella zoster virus infection 20.40 14.85 16 35713 1790 34919412
Incorrect dose administered 20.27 14.85 8 35721 40507 34880695
Weight decreased 20.24 14.85 102 35627 176199 34745003
Platelet count decreased 20.22 14.85 199 35530 119518 34801684
Suicidal ideation 20.17 14.85 8 35721 40380 34880822
Malaise 19.94 14.85 110 35619 185715 34735487
Wrong technique in product usage process 19.92 14.85 6 35723 35980 34885222
Lung infiltration 19.85 14.85 42 35687 12863 34908339
Drug-induced liver injury 19.62 14.85 3 35726 28829 34892373
Renal cell carcinoma 19.62 14.85 25 35704 5023 34916179
Blood bilirubin decreased 19.52 14.85 9 35720 378 34920824
Light chain analysis increased 19.36 14.85 14 35715 1387 34919815
Therapy partial responder 19.29 14.85 35 35694 9581 34911621
Genital erythema 19.27 14.85 8 35721 260 34920942
Viral haemorrhagic cystitis 19.12 14.85 13 35716 1167 34920035
Aggression 19.00 14.85 8 35721 38956 34882246
Drug ineffective 18.95 14.85 341 35388 456410 34464792
Genotoxicity 18.95 14.85 5 35724 36 34921166
Hypercapnic coma 18.77 14.85 7 35722 170 34921032
Bone pain 18.74 14.85 55 35674 20631 34900571
Flushing 18.69 14.85 5 35724 32415 34888787
Anaphylactic reaction 18.59 14.85 5 35724 32296 34888906
Lymphocytic leukaemia 18.43 14.85 7 35722 179 34921023
HCoV-OC43 infection 18.17 14.85 5 35724 43 34921159
VIth nerve paresis 17.87 14.85 5 35724 46 34921156
Musculoskeletal stiffness 17.83 14.85 13 35716 46667 34874535
Hallucination 17.60 14.85 16 35713 51482 34869720
Thrombophlebitis 17.60 14.85 19 35710 3203 34917999
B precursor type acute leukaemia 17.45 14.85 7 35722 208 34920994
Tachycardia 17.36 14.85 38 35691 84734 34836468
Squamous cell carcinoma 17.25 14.85 37 35692 11438 34909764
Weight increased 17.22 14.85 44 35685 92989 34828213
Varicella 17.12 14.85 14 35715 1663 34919539
Arachnoiditis 16.71 14.85 8 35721 366 34920836
H1N1 influenza 16.55 14.85 11 35718 951 34920251
Haematocrit decreased 16.50 14.85 71 35658 32145 34889057
Vomiting 16.35 14.85 168 35561 247453 34673749
Osteolysis 16.21 14.85 18 35711 3130 34918072
Myalgia 16.17 14.85 39 35690 84071 34837131
Agitation 16.11 14.85 21 35708 57378 34863824
Thalamic infarction 16.08 14.85 10 35719 771 34920431
Refractory cancer 15.89 14.85 6 35723 151 34921051
Refractory anaemia with an excess of blasts 15.89 14.85 8 35721 409 34920793
Cachexia 15.50 14.85 27 35702 7159 34914043
Metastatic neoplasm 15.19 14.85 17 35712 2983 34918219
Hyperbaric oxygen therapy 15.14 14.85 4 35725 29 34921173
Post procedural fistula 15.02 14.85 5 35724 86 34921116
Prothrombin time prolonged 14.92 14.85 31 35698 9375 34911827

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 3684.95 13.82 1968 50088 182394 79509938
Death 3215.58 13.82 2761 49295 563753 79128579
Plasma cell myeloma 1345.00 13.82 668 51388 52591 79639741
Neuropathy peripheral 916.06 13.82 749 51307 140556 79551776
Malignant neoplasm progression 815.13 13.82 689 51367 135301 79557031
Plasma cell myeloma recurrent 521.36 13.82 174 51882 4827 79687505
Human chorionic gonadotropin increased 461.19 13.82 115 51941 1069 79691263
Deep vein thrombosis 452.53 13.82 472 51584 120447 79571885
Osteonecrosis 434.14 13.82 264 51792 30831 79661501
Pneumonia 315.19 13.82 1045 51011 659201 79033131
Plasmacytoma 272.19 13.82 104 51952 4299 79688033
Renal failure 260.78 13.82 469 51587 200499 79491833
Acute myeloid leukaemia 232.27 13.82 179 51877 30706 79661626
Pulmonary embolism 205.45 13.82 387 51669 171267 79521065
Polyneuropathy 179.47 13.82 139 51917 24012 79668320
Sepsis 178.69 13.82 480 51576 268948 79423384
Unevaluable event 169.44 13.82 195 51861 55390 79636942
Plasma cell leukaemia 146.68 13.82 52 52004 1734 79690598
Myelodysplastic syndrome 142.27 13.82 134 51922 30167 79662165
Tooth extraction 132.33 13.82 85 51971 10910 79681422
Completed suicide 125.73 13.82 9 52047 245758 79446574
Drug interaction 125.60 13.82 57 51999 415126 79277206
Rheumatoid arthritis 121.81 13.82 3 52053 208467 79483865
Bone disorder 120.68 13.82 100 51956 19013 79673319
Arthralgia 118.85 13.82 119 51937 571684 79120648
Squamous cell carcinoma of skin 118.06 13.82 87 51969 13946 79678386
Pancytopenia 115.53 13.82 301 51755 165444 79526888
Headache 109.51 13.82 161 51895 653611 79038721
Drug hypersensitivity 107.36 13.82 31 52025 298885 79393447
Pruritus 102.09 13.82 66 51990 394582 79297750
Pregnancy test urine positive 101.15 13.82 17 52039 8 79692324
Acute lymphocytic leukaemia 90.03 13.82 50 52006 4919 79687413
Acute leukaemia 89.85 13.82 36 52020 1690 79690642
Infusion related reaction 88.13 13.82 21 52035 230216 79462116
Constipation 86.52 13.82 390 51666 282660 79409672
Arthropathy 86.36 13.82 8 52048 177103 79515229
Basal cell carcinoma 86.23 13.82 114 51942 37261 79655071
Leukaemia 84.43 13.82 51 52005 5874 79686458
Human chorionic gonadotropin positive 79.96 13.82 15 52041 26 79692306
Alopecia 79.43 13.82 26 52030 231329 79461003
Cardiac failure congestive 78.91 13.82 238 51818 142164 79550168
Varicella zoster virus infection 78.59 13.82 44 52012 4397 79687935
Metastases to central nervous system 77.98 13.82 73 51983 16302 79676030
Hepatosplenic T-cell lymphoma 77.60 13.82 27 52029 851 79691481
Metastatic malignant melanoma 75.35 13.82 37 52019 2826 79689506
Osteonecrosis of jaw 74.86 13.82 115 51941 43111 79649221
Overdose 74.13 13.82 15 52041 184191 79508141
Respiratory failure 74.09 13.82 273 51783 180638 79511694
Haemoglobin decreased 73.90 13.82 314 51742 221805 79470527
Therapeutic product effect decreased 71.04 13.82 11 52045 163852 79528480
Inappropriate schedule of product administration 70.97 13.82 4 52052 133624 79558708
Musculoskeletal stiffness 70.95 13.82 14 52042 174994 79517338
Complications of bone marrow transplant 69.40 13.82 23 52033 623 79691709
Thrombosis 69.40 13.82 163 51893 83937 79608395
Stem cell transplant 69.11 13.82 38 52018 3666 79688666
Injection site pain 68.61 13.82 4 52052 129834 79562498
Joint swelling 68.38 13.82 53 52003 288593 79403739
Synovitis 67.95 13.82 9 52047 150725 79541607
Pain 66.70 13.82 236 51820 703566 78988766
Abdominal discomfort 66.06 13.82 41 52015 250686 79441646
Thrombocytopenia 65.58 13.82 344 51712 264915 79427417
Bone debridement 64.50 13.82 20 52036 435 79691897
BK virus infection 63.93 13.82 50 52006 8754 79683578
Weight increased 63.12 13.82 53 52003 277333 79414999
Hypersensitivity 62.30 13.82 48 52008 262191 79430141
Bone lesion 62.09 13.82 42 52014 5877 79686455
Nasopharyngitis 60.91 13.82 46 52010 253835 79438497
Plasma cell myeloma refractory 60.68 13.82 21 52035 651 79691681
Exposure via body fluid 60.63 13.82 18 52038 336 79691996
Full blood count decreased 60.63 13.82 81 51975 26738 79665594
Malaise 60.39 13.82 145 51911 489724 79202608
Amyloidosis 59.59 13.82 31 52025 2675 79689657
Oral surgery 57.04 13.82 23 52033 1098 79691234
Hepatic enzyme increased 56.83 13.82 24 52032 182586 79509746
Oedema peripheral 56.82 13.82 319 51737 251969 79440363
Jaw operation 56.38 13.82 21 52035 808 79691524
Osteomyelitis 56.30 13.82 87 51969 32778 79659554
Haematocrit decreased 55.18 13.82 123 51933 61189 79631143
Maternal exposure during pregnancy 53.13 13.82 12 52044 136526 79555806
Therapy non-responder 52.74 13.82 156 51900 92149 79600183
Spinal cord compression 52.43 13.82 39 52017 6338 79685994
Glossodynia 52.20 13.82 4 52052 103333 79588999
Asthenia 51.43 13.82 535 51521 511154 79181178
Platelet count decreased 51.24 13.82 257 51799 194407 79497925
Diverticular perforation 50.61 13.82 37 52019 5856 79686476
Debridement 50.29 13.82 24 52032 1721 79690611
Human chorionic gonadotropin abnormal 48.98 13.82 9 52047 13 79692319
Progressive multifocal leukoencephalopathy 46.23 13.82 62 51994 20538 79671794
Staphylococcal bacteraemia 46.14 13.82 48 52008 12170 79680162
Neoplasm progression 45.74 13.82 103 51953 51579 79640753
Wound 45.62 13.82 10 52046 116169 79576163
Peripheral sensory neuropathy 45.32 13.82 49 52007 12984 79679348
Urticaria 43.84 13.82 34 52022 185167 79507165
Refractory cytopenia with multilineage dysplasia 43.04 13.82 13 52043 258 79692074
Large intestinal ulcer perforation 42.98 13.82 10 52046 67 79692265
Nasal abscess 42.81 13.82 12 52044 181 79692151
Renal cell carcinoma 42.74 13.82 35 52021 6543 79685789
Pleural effusion 42.70 13.82 198 51858 145064 79547268
Anxiety 42.65 13.82 60 51996 248452 79443880
Cystitis haemorrhagic 41.97 13.82 40 52016 9132 79683200
Mucosal inflammation 41.53 13.82 126 51930 75454 79616878
Blood pressure increased 41.53 13.82 46 52010 211314 79481018
VIth nerve paresis 41.41 13.82 11 52045 134 79692198
Pericarditis 40.87 13.82 9 52047 104227 79588105
Type 2 lepra reaction 40.83 13.82 12 52044 216 79692116
Mesenteric abscess 40.82 13.82 11 52045 142 79692190
Body dysmorphic disorder 40.71 13.82 13 52043 312 79692020
Stress 40.44 13.82 3 52053 79609 79612723
Hypercalcaemia 40.24 13.82 82 51974 38348 79653984
Hip fracture 40.05 13.82 72 51984 30689 79661643
Therapy partial responder 40.02 13.82 53 52003 17344 79674988
JC virus infection 39.43 13.82 27 52029 3854 79688478
Pregnancy of partner 39.05 13.82 12 52044 253 79692079
Bone sequestrum 38.80 13.82 18 52038 1211 79691121
Gastrointestinal fungal infection 38.36 13.82 14 52042 508 79691824
Drug ineffective 38.12 13.82 488 51568 1080425 78611907
Enterococcal infection 38.03 13.82 49 52007 15611 79676721
Migraine 37.62 13.82 6 52050 87487 79604845
Rhesus antigen positive 37.48 13.82 10 52046 124 79692208
Metastasis 37.31 13.82 33 52023 6847 79685485
Actinomycosis 37.24 13.82 17 52039 1102 79691230
Lung infiltration 36.95 13.82 59 51997 22853 79669479
Injection site erythema 36.88 13.82 4 52052 78193 79614139
Condition aggravated 36.87 13.82 185 51871 500939 79191393
Anaemia 36.37 13.82 447 51609 444568 79247764
Hair follicle tumour benign 36.01 13.82 13 52043 457 79691875
Nausea 35.66 13.82 427 51629 956769 78735563
Failure to thrive 35.14 13.82 41 52015 11803 79680529
Pseudomyopia 34.55 13.82 9 52047 101 79692231
Sinus polyp 34.30 13.82 13 52043 525 79691807
Insomnia 33.92 13.82 68 51988 245102 79447230
Diarrhoea 33.85 13.82 390 51666 880099 78812233
Pathological fracture 33.84 13.82 38 52018 10499 79681833
Prothrombin time prolonged 33.63 13.82 48 52008 16851 79675481
Blood cholesterol increased 33.29 13.82 7 52049 83713 79608619
Pregnancy test false positive 32.47 13.82 9 52047 130 79692202
Duodenal ulcer perforation 32.23 13.82 3 52053 66208 79626124
Endocarditis bacterial 32.20 13.82 17 52039 1512 79690820
Blister 32.19 13.82 19 52037 119457 79572875
Mobility decreased 32.12 13.82 20 52036 122155 79570177
Exposure during pregnancy 31.92 13.82 13 52043 101119 79591213
Tear break up time decreased 31.43 13.82 6 52050 12 79692320
Acute generalised exanthematous pustulosis 31.42 13.82 47 52009 17207 79675125
Angioedema 30.98 13.82 6 52050 76029 79616303
Laboratory test abnormal 30.74 13.82 61 51995 27987 79664345
Myalgia 30.68 13.82 46 52010 185595 79506737
Chronic kidney disease 30.63 13.82 104 51952 66050 79626282
Intentional product misuse 30.42 13.82 12 52044 95153 79597179
Alanine aminotransferase increased 30.18 13.82 37 52019 162533 79529799
Flushing 30.13 13.82 10 52046 88258 79604074
Pregnancy test positive 30.07 13.82 8 52048 98 79692234
Malignant neoplasm of unknown primary site 29.95 13.82 13 52043 747 79691585
Rectal adenocarcinoma 29.95 13.82 16 52040 1457 79690875
Discomfort 29.80 13.82 23 52033 125594 79566738
Wrong technique in product usage process 29.74 13.82 6 52050 73869 79618463
B precursor type acute leukaemia 29.68 13.82 11 52045 417 79691915
Drug-induced liver injury 29.66 13.82 4 52052 66113 79626219
Incorrect dose administered 29.28 13.82 7 52049 76623 79615709
Hyperbaric oxygen therapy 29.11 13.82 7 52049 55 79692277
Systemic lupus erythematosus 28.97 13.82 22 52034 121127 79571205
Hypoglossal nerve paresis 28.77 13.82 8 52048 117 79692215
Abdominal pain 28.53 13.82 144 51912 389425 79302907
Peripheral sensorimotor neuropathy 28.37 13.82 20 52036 2990 79689342
Rhabdomyolysis 28.36 13.82 16 52040 103115 79589217
Wheezing 28.13 13.82 21 52035 116643 79575689
Conjunctival irritation 28.10 13.82 8 52048 128 79692204
Syncope 28.07 13.82 207 51849 179242 79513090
Morganella infection 27.98 13.82 14 52042 1113 79691219
Neutropenia 27.50 13.82 298 51758 287412 79404920
Contusion 27.47 13.82 34 52022 148742 79543590
Suicide attempt 27.27 13.82 10 52046 82922 79609410
Jaw disorder 27.13 13.82 24 52032 4982 79687350
Abdominal pain upper 26.93 13.82 67 51989 223752 79468580
Oxygen saturation decreased 26.55 13.82 27 52029 129020 79563312
Nocardiosis 26.43 13.82 25 52031 5654 79686678
Blood immunoglobulin M decreased 26.00 13.82 14 52042 1295 79691037
Oropharyngeal pain 25.96 13.82 20 52036 109333 79582999
Folliculitis 25.70 13.82 3 52053 55377 79636955
Sequestrectomy 25.28 13.82 12 52044 850 79691482
Osteolysis 25.25 13.82 22 52034 4476 79687856
Light chain analysis increased 25.02 13.82 15 52041 1703 79690629
Arthritis 24.84 13.82 23 52033 114857 79577475
Dehydration 24.61 13.82 259 51797 247928 79444404
Cellulitis staphylococcal 24.58 13.82 13 52043 1160 79691172
Blood albumin decreased 24.52 13.82 51 52005 24192 79668140
Cardiopulmonary failure 24.40 13.82 26 52030 6775 79685557
Meibomian gland dysfunction 24.27 13.82 8 52048 213 79692119
Spinal column injury 24.02 13.82 16 52040 2182 79690150
Blood pressure fluctuation 24.00 13.82 7 52049 67138 79625194
Blood immunoglobulin G decreased 23.97 13.82 19 52037 3390 79688942
Feeling hot 23.74 13.82 5 52051 59729 79632603
Gastrooesophageal reflux disease 23.58 13.82 20 52036 104226 79588106
Weight decreased 23.40 13.82 136 51920 355062 79337270
Hepatitis B 23.33 13.82 28 52028 8304 79684028
Follicular mucinosis 23.26 13.82 5 52051 22 79692310
Mucosal erosion 23.25 13.82 16 52040 2302 79690030
Clostridium bacteraemia 23.17 13.82 9 52047 389 79691943
Metastatic neoplasm 23.09 13.82 22 52034 5020 79687312
Cerebral toxoplasmosis 22.98 13.82 16 52040 2346 79689986
Clostridium colitis 22.53 13.82 17 52039 2822 79689510
Hyperviscosity syndrome 22.43 13.82 9 52047 424 79691908
Hypoglycaemia 22.37 13.82 20 52036 101574 79590758
Nasal congestion 22.34 13.82 11 52045 76541 79615791
Bacteraemia 22.20 13.82 59 51997 32765 79659567
Electrocardiogram QT prolonged 22.14 13.82 16 52040 90370 79601962
Osteoarthritis 21.99 13.82 15 52041 87294 79605038
Peripheral swelling 21.87 13.82 96 51960 269521 79422811
Asthma 21.81 13.82 34 52022 135061 79557271
Posterior reversible encephalopathy syndrome 21.73 13.82 51 52005 26230 79666102
Blood creatine phosphokinase increased 21.67 13.82 8 52048 66082 79626250
Erythema 21.65 13.82 74 51982 223216 79469116
Loss of personal independence in daily activities 21.63 13.82 21 52035 102559 79589773
Cardiac amyloidosis 21.58 13.82 14 52042 1826 79690506
Musculoskeletal pain 21.53 13.82 21 52035 102333 79589999
Cerebrovascular accident 21.43 13.82 174 51882 155118 79537214
Hospitalisation 21.41 13.82 18 52038 94218 79598114
Staphylococcal infection 21.39 13.82 85 51971 58210 79634122
Medication error 21.37 13.82 9 52047 68633 79623699
Cachexia 21.35 13.82 31 52025 11052 79681280
Genital erythema 21.28 13.82 8 52048 316 79692016
Enterococcal sepsis 20.92 13.82 16 52040 2710 79689622
Swelling 20.88 13.82 72 51984 216639 79475693
Fungal oesophagitis 20.85 13.82 11 52045 977 79691355
Actinomycotic sepsis 20.79 13.82 6 52050 101 79692231
Lymphopenia 20.74 13.82 55 52001 30502 79661830
Thrombophlebitis 20.61 13.82 23 52033 6312 79686020
Septic shock 20.55 13.82 144 51912 122657 79569675
Blood pressure systolic increased 20.51 13.82 9 52047 66977 79625355
Chest discomfort 20.21 13.82 37 52019 138007 79554325
Febrile neutropenia 20.13 13.82 235 51821 230764 79461568
Large intestine perforation 20.12 13.82 35 52021 14532 79677800
Monoclonal immunoglobulin present 19.88 13.82 11 52045 1074 79691258
Refractory cancer 19.87 13.82 7 52049 229 79692103
Infection 19.79 13.82 243 51813 241469 79450863
Laryngeal cancer metastatic 19.72 13.82 5 52051 50 79692282
Drug intolerance 19.68 13.82 97 51959 264022 79428310
Pneumonia fungal 19.65 13.82 30 52026 11180 79681152
Blood immunoglobulin G increased 19.62 13.82 16 52040 2973 79689359
Hodgkin's disease 19.36 13.82 10 52046 850 79691482
Graft versus host disease 19.34 13.82 35 52021 14991 79677341
Stomatitis 19.20 13.82 42 52014 146715 79545617
Refractory anaemia with an excess of blasts 18.87 13.82 10 52046 896 79691436
Dialysis 18.86 13.82 39 52017 18423 79673909
Pain in extremity 18.82 13.82 150 51906 364388 79327944
Dental care 18.75 13.82 10 52046 908 79691424
Lower respiratory tract infection 18.59 13.82 35 52021 129185 79563147
Knee arthroplasty 18.51 13.82 3 52053 43245 79649087
Hypoxia 18.42 13.82 123 51933 103120 79589212
Liver injury 18.32 13.82 7 52049 56607 79635725
Protein total increased 18.28 13.82 17 52039 3762 79688570
General physical condition abnormal 18.28 13.82 22 52034 6541 79685791
VIth nerve paralysis 18.18 13.82 12 52044 1612 79690720
Thalamic infarction 17.98 13.82 11 52045 1296 79691036
White blood cell count decreased 17.96 13.82 195 51861 188093 79504239
Viral haemorrhagic cystitis 17.83 13.82 13 52043 2048 79690284
Encephalopathy 17.76 13.82 11 52045 67386 79624946
Cytomegalovirus infection reactivation 17.70 13.82 25 52031 8691 79683641
Prostate cancer metastatic 17.44 13.82 17 52039 3990 79688342
Vomiting 17.41 13.82 318 51738 665510 79026822
Cardiac disorder 17.41 13.82 87 51969 65670 79626662
Bone trimming 17.30 13.82 4 52052 26 79692306
Injection site bruising 17.21 13.82 3 52053 40999 79651333
Joint ankylosis 17.18 13.82 13 52043 2167 79690165
Squamous cell carcinoma 17.15 13.82 34 52022 15588 79676744
Aggression 17.00 13.82 6 52050 50952 79641380
Atelectasis 16.99 13.82 53 52003 32204 79660128
Compression fracture 16.93 13.82 21 52035 6439 79685893
Bence Jones protein urine present 16.93 13.82 3 52053 3 79692329
Intestinal perforation 16.86 13.82 36 52020 17390 79674942
Blood culture positive 16.86 13.82 24 52032 8405 79683927
Blood luteinising hormone increased 16.78 13.82 6 52050 205 79692127
Colitis 16.67 13.82 93 51963 73214 79619118
Atrial fibrillation 16.65 13.82 200 51856 197686 79494646
Blood albumin increased 16.62 13.82 11 52045 1484 79690848
Hepatic function abnormal 16.57 13.82 14 52042 73093 79619239
Lactic acidosis 16.53 13.82 13 52043 70346 79621986
Accidental overdose 16.38 13.82 3 52053 39578 79652754
Oral disorder 16.28 13.82 26 52030 10069 79682263
Heart rate increased 16.24 13.82 34 52022 120690 79571642
Immunoglobulins decreased 16.20 13.82 11 52045 1549 79690783
Endothelial dysfunction 16.05 13.82 6 52050 233 79692099
Hypercapnic coma 15.89 13.82 7 52049 417 79691915
Lymphocytic leukaemia 15.84 13.82 6 52050 242 79692090
Hot flush 15.84 13.82 8 52048 54869 79637463
Bence Jones proteinuria 15.71 13.82 3 52053 6 79692326
Type 2 diabetes mellitus 15.50 13.82 9 52047 57113 79635219
Hypoaesthesia 15.41 13.82 182 51874 179170 79513162
Hypertension 15.37 13.82 140 51916 330852 79361480
Diverticulitis 15.29 13.82 65 51991 45871 79646461
Gastrointestinal disorder 15.15 13.82 36 52020 122169 79570163
Dyspepsia 15.14 13.82 30 52026 108657 79583675
Infection reactivation 14.92 13.82 13 52043 2644 79689688
Bladder transitional cell carcinoma stage III 14.82 13.82 4 52052 52 79692280
Hyperhidrosis 14.82 13.82 50 52006 151442 79540890
Aspartate aminotransferase increased 14.79 13.82 44 52012 138597 79553735
Chloroma 14.64 13.82 8 52048 762 79691570
Illness 14.64 13.82 6 52050 46505 79645827
Listeria sepsis 14.62 13.82 8 52048 764 79691568
Feeling abnormal 14.60 13.82 54 52002 159145 79533187
Brain herniation 14.56 13.82 21 52035 7442 79684890
Renal amyloidosis 14.48 13.82 5 52051 154 79692178
Pneumonia parainfluenzae viral 14.47 13.82 6 52050 308 79692024
C-reactive protein increased 14.46 13.82 40 52016 128987 79563345
Hydrocephalus 14.46 13.82 23 52033 8877 79683455
Light chain analysis 14.39 13.82 3 52053 11 79692321
Therapeutic product effect incomplete 14.37 13.82 46 52010 141599 79550733
Agitation 14.35 13.82 27 52029 99688 79592644
Paraesthesia 14.31 13.82 177 51879 176146 79516186
Acute monocytic leukaemia 14.29 13.82 7 52049 532 79691800
Strongyloidiasis 14.16 13.82 15 52041 3883 79688449
Parainfluenzae virus infection 14.14 13.82 18 52038 5664 79686668
Paraneoplastic thrombosis 13.99 13.82 3 52053 13 79692319
Product use issue 13.98 13.82 80 51976 209742 79482590

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 D020533 Angiogenesis Inhibitors
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective 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 D009676 Noxae
MeSH PA D013723 Teratogens
CHEBI has role CHEBI:35472 anti-inflammatory drugs
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:35623 anticonvulsants
CHEBI has role CHEBI:35705 immunosuppressive agents
CHEBI has role CHEBI:35717 hypnotics
CHEBI has role CHEBI:35816 leprostatic drugs
CHEBI has role CHEBI:48422 angiogenesis antagonist
CHEBI has role CHEBI:50905 teratogeno
CHEBI has role CHEBI:50919 antiemetico

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 Unclassified 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

Pharmaceutical products:

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