thalidomide Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
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A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects.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 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 22.13 ┬ÁM/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
July 16, 1998 FDA CELGENE

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 2847.11 37.64 782 7232 16313 2333758
Death 2737.25 37.64 1108 6906 80360 2269711
Plasma cell myeloma 2601.31 37.64 627 7387 7506 2342565
Neuropathy peripheral 1279.64 37.64 386 7628 11046 2339025
Human chorionic gonadotropin increased 831.68 37.64 151 7863 335 2349736
Pneumonia 822.46 37.64 417 7597 48879 2301192
Malignant neoplasm progression 755.38 37.64 263 7751 11865 2338206
Deep vein thrombosis 511.28 37.64 201 7813 12731 2337340
Renal failure 490.10 37.64 212 7802 17137 2332934
Sepsis 435.65 37.64 199 7815 18289 2331782
Asthenia 420.36 37.64 265 7749 46661 2303410
Fatigue 356.44 37.64 303 7711 84570 2265501
Anaemia 312.25 37.64 197 7817 34595 2315476
Pulmonary embolism 308.25 37.64 156 7858 17927 2332144
Constipation 290.24 37.64 159 7855 21470 2328601
Fall 271.59 37.64 203 7811 46896 2303175
Haemoglobin decreased 261.72 37.64 140 7874 18011 2332060
Pancytopenia 252.85 37.64 118 7896 11334 2338737
Dyspnoea 252.73 37.64 242 7772 78491 2271580
Pyrexia 245.85 37.64 202 7812 53506 2296565
Dehydration 242.71 37.64 143 7871 22152 2327919
Respiratory failure 237.09 37.64 119 7895 13409 2336662
Oedema peripheral 231.70 37.64 142 7872 23621 2326450
Myelodysplastic syndrome 224.33 37.64 72 7942 2488 2347583
Thrombocytopenia 214.19 37.64 125 7889 19006 2331065
Unevaluable event 213.03 37.64 97 7917 8794 2341277
Dizziness 204.51 37.64 189 7825 58476 2291595
Thrombosis 194.90 37.64 92 7922 9052 2341019
Platelet count decreased 192.11 37.64 109 7905 15704 2334367
Hypoaesthesia 184.79 37.64 116 7898 20099 2329972
Febrile neutropenia 182.61 37.64 93 7921 10789 2339282
Cerebrovascular accident 182.42 37.64 115 7899 20071 2330000
Toxicity to various agents 179.17 37.64 137 7877 32617 2317454
Cardiac failure congestive 174.34 37.64 103 7911 15998 2334073
Pleural effusion 168.00 37.64 90 7924 11578 2338493
Vomiting 158.98 37.64 181 7833 71421 2278650
Hypotension 152.22 37.64 124 7890 32312 2317759
Plasma cell myeloma recurrent 151.49 37.64 35 7979 330 2349741
Cardiac disorder 149.25 37.64 73 7941 7760 2342311
Adverse drug reaction 148.33 37.64 74 7940 8209 2341862
Hip fracture 147.20 37.64 62 7952 4650 2345421
Acute myeloid leukaemia 146.20 37.64 53 7961 2657 2347414
Somnolence 141.14 37.64 104 7910 23381 2326690
Hepatosplenic T-cell lymphoma 137.66 37.64 24 7990 37 2350034
Paraesthesia 135.40 37.64 99 7915 21989 2328082
Syncope 134.77 37.64 89 7925 16786 2333285
Plasma cell leukaemia 129.03 37.64 27 7987 152 2349919
Acute kidney injury 126.63 37.64 105 7909 28017 2322054
Neutropenia 126.26 37.64 94 7920 21454 2328617
Plasmacytoma 123.73 37.64 30 7984 354 2349717
Atrial fibrillation 123.18 37.64 78 7936 13690 2336381
White blood cell count decreased 121.61 37.64 86 7928 18122 2331949
Chronic kidney disease 121.37 37.64 52 7962 4066 2346005
Nausea 121.18 37.64 200 7814 111989 2238082
Mucosal inflammation 118.79 37.64 55 7959 5169 2344902
Drug intolerance 118.46 37.64 76 7938 13641 2336430
Infection 113.15 37.64 82 7932 17947 2332124
Gastrointestinal haemorrhage 112.61 37.64 71 7943 12364 2337707
Hypoxia 109.59 37.64 55 7959 6172 2343899
Metastatic malignant melanoma 107.44 37.64 26 7988 304 2349767
Therapy non-responder 106.84 37.64 59 7955 8045 2342026
Urinary tract infection 105.01 37.64 97 7917 29845 2320226
Laboratory test abnormal 102.83 37.64 50 7964 5240 2344831
Full blood count decreased 101.38 37.64 44 7970 3549 2346522
Rash 100.14 37.64 131 7883 59427 2290644
Tremor 96.82 37.64 79 7935 20582 2329489
Human chorionic gonadotropin positive 95.71 37.64 17 7997 31 2350040
Diarrhoea 95.49 37.64 153 7861 83411 2266660
Neoplasm progression 93.38 37.64 45 7969 4623 2345448
Haematocrit decreased 90.55 37.64 43 7971 4275 2345796
Bradycardia 90.37 37.64 57 7957 9924 2340147
Posterior reversible encephalopathy syndrome 88.84 37.64 36 7978 2444 2347627
Chest pain 88.79 37.64 86 7928 28051 2322020
Cardiac failure 87.43 37.64 60 7954 12034 2338037
Hypercalcaemia 83.92 37.64 35 7979 2557 2347514
Chronic obstructive pulmonary disease 83.72 37.64 48 7966 7029 2343042
Metastases to central nervous system 83.24 37.64 33 7981 2115 2347956
Diverticulitis 82.85 37.64 40 7974 4125 2345946
Pregnancy test urine positive 81.77 37.64 14 8000 18 2350053
Varicella zoster virus infection 80.62 37.64 21 7993 337 2349734
Confusional state 79.80 37.64 76 7938 24268 2325803
Blood creatinine increased 77.89 37.64 53 7961 10480 2339591
Oedema 77.02 37.64 52 7962 10151 2339920
Product dose omission 73.47 37.64 90 7924 38167 2311904
Back pain 73.32 37.64 82 7932 31577 2318494
Pain 70.18 37.64 113 7901 61744 2288327
Failure to thrive 68.40 37.64 23 7991 919 2349152
Lung infiltration 68.05 37.64 29 7985 2235 2347836
Diverticular perforation 66.01 37.64 19 7995 449 2349622
Brain neoplasm malignant 65.65 37.64 16 7998 193 2349878
Human chorionic gonadotropin abnormal 65.27 37.64 12 8002 29 2350042
Sinusitis 64.68 37.64 57 7957 16469 2333602
Pain in extremity 64.40 37.64 89 7925 42451 2307620
Acute leukaemia 64.23 37.64 17 7997 291 2349780
Hypertension 63.56 37.64 71 7943 27290 2322781
Large intestinal ulcer perforation 63.31 37.64 10 8004 4 2350067
Growth failure 61.75 37.64 12 8002 43 2350028
Bacteraemia 61.57 37.64 25 7989 1705 2348366
Seizure 61.18 37.64 66 7948 24400 2325671
Blood albumin decreased 60.67 37.64 25 7989 1770 2348301
Multiple organ dysfunction syndrome 60.20 37.64 40 7974 7601 2342470
Mesenteric abscess 59.74 37.64 10 8004 10 2350061
Refractory cytopenia with multilineage dysplasia 58.88 37.64 11 8003 30 2350041
Gastrointestinal fungal infection 58.87 37.64 12 8002 58 2350013
Transient ischaemic attack 58.79 37.64 36 7978 5942 2344129
Herpes zoster 58.16 37.64 43 7971 9682 2340389
Spinal cord compression 57.17 37.64 18 7996 582 2349489
Basal cell carcinoma 57.07 37.64 27 7987 2660 2347411
Drug ineffective 56.97 37.64 138 7876 101486 2248585
Epstein-Barr viraemia 56.50 37.64 13 8001 120 2349951
Acute lymphocytic leukaemia 56.43 37.64 17 7997 473 2349598
Atelectasis 55.21 37.64 24 7990 1941 2348130
Enterococcal sepsis 54.52 37.64 13 8001 142 2349929
Pulmonary oedema 54.30 37.64 37 7977 7326 2342745
Complications of bone marrow transplant 53.99 37.64 11 8003 53 2350018
Bronchitis 53.05 37.64 47 7967 13667 2336404
Malaise 52.98 37.64 94 7920 55491 2294580
Nasal abscess 52.33 37.64 10 8004 32 2350039
Sinus polyp 52.25 37.64 11 8003 64 2350007
Staphylococcal infection 52.19 37.64 32 7982 5294 2344777
Abdominal pain 52.12 37.64 72 7942 34302 2315769
Osteonecrosis of jaw 51.55 37.64 37 7977 7959 2342112
Pneumonia fungal 51.39 37.64 15 7999 373 2349698
Peripheral sensory neuropathy 51.29 37.64 19 7995 1011 2349060
Pathological fracture 51.01 37.64 20 7994 1244 2348827
Bone lesion 50.97 37.64 17 7997 662 2349409
Pulmonary mycosis 50.41 37.64 12 8002 130 2349941
Peripheral swelling 50.29 37.64 51 7963 17546 2332525
Myelofibrosis 48.92 37.64 14 8000 324 2349747
Gait inability 48.91 37.64 32 7982 5923 2344148
Mucosal erosion 48.77 37.64 13 8001 229 2349842
Staphylococcal bacteraemia 48.73 37.64 16 7998 593 2349478
Weight decreased 48.46 37.64 63 7951 28308 2321763
Polyneuropathy 47.80 37.64 21 7993 1742 2348329
Stem cell transplant 47.22 37.64 14 8000 368 2349703
Amyloidosis 46.98 37.64 13 8001 265 2349806
Pregnancy test false positive 46.23 37.64 11 8003 119 2349952
Clostridium bacteraemia 46.15 37.64 9 8005 33 2350038
Decreased appetite 46.03 37.64 62 7952 28829 2321242
Protein total increased 45.85 37.64 14 8000 408 2349663
Loss of consciousness 45.80 37.64 50 7964 18717 2331354
Hypoglossal nerve paresis 45.25 37.64 8 8006 14 2350057
Colitis 45.17 37.64 29 7985 5197 2344874
Osteonecrosis 45.11 37.64 33 7981 7309 2342762
Balance disorder 45.04 37.64 37 7977 9710 2340361
Haemorrhage 45.03 37.64 39 7975 11000 2339071
Squamous cell carcinoma of skin 45.03 37.64 16 7998 755 2349316
Septic shock 44.00 37.64 32 7982 7022 2343049
Splenomegaly 43.76 37.64 19 7995 1532 2348539
Candida infection 43.65 37.64 23 7991 2850 2347221
Orthostatic hypotension 43.61 37.64 23 7991 2856 2347215
Myocardial infarction 43.54 37.64 49 7965 18964 2331107
Mental status changes 43.43 37.64 29 7985 5553 2344518
Muscle spasms 43.40 37.64 52 7962 21514 2328557
Respiratory distress 43.19 37.64 28 7986 5101 2344970
Prothrombin time prolonged 42.33 37.64 19 7995 1658 2348413
Hair follicle tumour benign 42.25 37.64 8 8006 24 2350047
Oral fungal infection 41.59 37.64 13 8001 410 2349661
Gait disturbance 41.55 37.64 52 7962 22493 2327578
Blood glucose increased 41.43 37.64 39 7975 12251 2337820
Pulmonary hypertension 40.81 37.64 27 7987 5091 2344980
Hepatic failure 40.55 37.64 28 7986 5661 2344410
Encephalitis viral 40.38 37.64 11 8003 211 2349860
Pneumothorax 39.42 37.64 20 7994 2292 2347779
Cytomegalovirus infection 39.19 37.64 21 7993 2692 2347379
Neutrophil count decreased 39.17 37.64 29 7985 6538 2343533
Renal disorder 39.02 37.64 25 7989 4463 2345608
Compression fracture 38.91 37.64 15 7999 891 2349180
Electrolyte imbalance 38.80 37.64 19 7995 2018 2348053
Cardiac arrest 38.57 37.64 41 7973 14889 2335182
Bone marrow failure 38.23 37.64 27 7987 5659 2344412
Cough 38.15 37.64 61 7953 33056 2317015
Malnutrition 37.92 37.64 18 7996 1785 2348286

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 3885.99 39.76 1172 8920 16091 1720598
Death 3829.91 39.76 1769 8323 85674 1651015
Plasma cell myeloma 3051.09 39.76 863 9229 9151 1727538
Neuropathy peripheral 1152.35 39.76 405 9687 8848 1727841
Pneumonia 1134.87 39.76 645 9447 45537 1691152
Malignant neoplasm progression 971.04 39.76 401 9691 13757 1722932
Deep vein thrombosis 799.90 39.76 316 9776 9604 1727085
Pulmonary embolism 542.96 39.76 261 9831 12798 1723891
Renal failure 515.59 39.76 290 9802 19727 1716962
Sepsis 466.51 39.76 269 9823 19169 1717520
Constipation 454.15 39.76 242 9850 14758 1721931
Asthenia 407.69 39.76 307 9785 34363 1702326
Dyspnoea 369.15 39.76 344 9748 51715 1684974
Oedema peripheral 324.88 39.76 197 9895 15353 1721336
Pyrexia 310.13 39.76 297 9795 46103 1690586
Respiratory failure 308.74 39.76 186 9906 14319 1722370
Acute myeloid leukaemia 298.22 39.76 112 9980 2929 1733760
Unevaluable event 284.53 39.76 132 9960 5934 1730755
Anaemia 270.75 39.76 226 9866 29231 1707458
Fatigue 269.51 39.76 287 9805 50494 1686195
Thrombosis 254.66 39.76 131 9961 7390 1729299
Plasma cell myeloma recurrent 245.69 39.76 63 10029 423 1736266
Pancytopenia 245.03 39.76 147 9945 11210 1725479
Cardiac failure congestive 231.01 39.76 158 9934 15112 1721577
Myelodysplastic syndrome 223.71 39.76 93 9999 3196 1733493
Plasmacytoma 218.76 39.76 58 10034 451 1736238
Haemoglobin decreased 205.78 39.76 154 9938 16960 1719729
Dehydration 201.48 39.76 154 9938 17504 1719185
Fall 186.46 39.76 177 9915 27037 1709652
Dizziness 181.39 39.76 194 9898 34167 1702522
Basal cell carcinoma 178.28 39.76 73 10019 2410 1734279
Hypoaesthesia 175.79 39.76 113 9979 9722 1726967
Thrombocytopenia 168.41 39.76 150 9942 21099 1715590
Atrial fibrillation 168.38 39.76 130 9962 14981 1721708
Neutropenia 167.18 39.76 140 9952 18120 1718569
Squamous cell carcinoma of skin 163.87 39.76 57 10035 1185 1735504
Febrile neutropenia 153.99 39.76 109 9983 10991 1725698
Platelet count decreased 145.68 39.76 124 9968 16399 1720290
Hypotension 141.70 39.76 159 9933 29495 1707194
Neoplasm progression 137.39 39.76 66 10026 3201 1733488
Full blood count decreased 135.87 39.76 61 10031 2531 1734158
Syncope 134.52 39.76 111 9981 14058 1722631
Adverse drug reaction 133.30 39.76 73 10019 4665 1732024
Prostate cancer 129.38 39.76 71 10021 4555 1732134
Nausea 125.74 39.76 198 9894 50998 1685691
Paraesthesia 125.34 39.76 94 9998 10357 1726332
Myelofibrosis 121.96 39.76 35 10057 375 1736314
Chronic kidney disease 120.01 39.76 66 10026 4251 1732438
Cardiac disorder 119.47 39.76 81 10011 7610 1729079
Haematocrit decreased 117.89 39.76 65 10027 4208 1732481
Infection 117.65 39.76 97 9995 12263 1724426
Septic shock 115.59 39.76 81 10011 8028 1728661
White blood cell count decreased 114.45 39.76 98 9994 13051 1723638
Bradycardia 113.71 39.76 89 10003 10445 1726244
Metastases to central nervous system 112.84 39.76 46 10046 1499 1735190
Pleural effusion 111.64 39.76 90 10002 11020 1725669
Somnolence 110.87 39.76 107 9985 16632 1720057
Metastatic malignant melanoma 110.70 39.76 33 10059 408 1736281
Toxicity to various agents 110.63 39.76 139 9953 29002 1707687
Decreased appetite 108.84 39.76 125 9967 23746 1712943
Acute kidney injury 108.49 39.76 151 9941 34793 1701896
Confusional state 108.27 39.76 118 9974 21160 1715529
Myocardial infarction 106.95 39.76 132 9960 27042 1709647
Drug intolerance 106.62 39.76 69 10023 5993 1730696
Diarrhoea 103.84 39.76 187 9905 53665 1683024
Hypoxia 102.73 39.76 67 10025 5896 1730793
Spinal cord compression 100.61 39.76 34 10058 645 1736044
Type 2 lepra reaction 92.84 39.76 20 10072 53 1736636
Hip fracture 91.56 39.76 41 10051 1689 1735000
Chest pain 90.26 39.76 104 9988 19810 1716879
Rash 89.81 39.76 146 9946 38547 1698142
Malignant melanoma 87.84 39.76 39 10053 1574 1735115
Amyloidosis 86.58 39.76 26 10066 330 1736359
Therapy non-responder 85.59 39.76 61 10031 6205 1730484
Vomiting 85.44 39.76 142 9950 38173 1698516
Chronic obstructive pulmonary disease 83.73 39.76 59 10033 5894 1730795
Plasma cell leukaemia 83.29 39.76 22 10070 168 1736521
Cellulitis 81.58 39.76 60 10032 6408 1730281
Staphylococcal infection 81.34 39.76 53 10039 4654 1732035
Gastrointestinal haemorrhage 81.15 39.76 84 10008 14183 1722506
Failure to thrive 81.03 39.76 33 10059 1072 1735617
Metastasis 78.94 39.76 30 10062 808 1735881
Cardiac failure 78.61 39.76 78 10014 12524 1724165
Diverticulitis 74.27 39.76 39 10053 2286 1734403
Mental status changes 73.57 39.76 55 10037 6020 1730669
Cough 71.84 39.76 91 10001 19106 1717583
Pneumonitis 67.44 39.76 44 10048 3871 1732818
Diverticular perforation 67.06 39.76 23 10069 457 1736232
Hypercalcaemia 67.05 39.76 34 10058 1852 1734837
Oedema 67.04 39.76 55 10037 6893 1729796
Pathological fracture 66.29 39.76 24 10068 562 1736127
Leukaemia 66.03 39.76 26 10066 772 1735917
Prostate cancer metastatic 65.52 39.76 27 10065 904 1735785
Laboratory test abnormal 65.49 39.76 45 10047 4314 1732375
General physical health deterioration 63.61 39.76 71 10021 13047 1723642
Pregnancy of partner 63.47 39.76 18 10074 184 1736505
Lung infiltration 62.72 39.76 34 10058 2125 1734564
Cerebrovascular accident 62.61 39.76 82 10010 17784 1718905
Back pain 62.53 39.76 79 10013 16534 1720155
Acute leukaemia 60.57 39.76 20 10072 352 1736337
Cardiac arrest 60.35 39.76 76 10016 15854 1720835
Orthostatic hypotension 60.17 39.76 39 10053 3392 1733297
Pain 59.61 39.76 99 9993 26558 1710131
Bacteraemia 58.52 39.76 31 10061 1849 1734840
Colitis 57.77 39.76 41 10051 4139 1732550
Atelectasis 57.70 39.76 31 10061 1903 1734786
Multiple organ dysfunction syndrome 57.23 39.76 57 10035 9185 1727504
Renal disorder 56.29 39.76 40 10052 4046 1732643
Neutropenic sepsis 56.28 39.76 28 10064 1464 1735225
Enterococcal infection 56.27 39.76 24 10068 877 1735812
Staphylococcal bacteraemia 55.90 39.76 23 10069 767 1735922
Hepatic failure 55.42 39.76 46 10046 5857 1730832
Blood sodium decreased 55.27 39.76 32 10060 2272 1734417
Pulmonary oedema 55.03 39.76 48 10044 6538 1730151
Pain in extremity 54.48 39.76 78 10014 18394 1718295
Pneumonia aspiration 53.56 39.76 43 10049 5223 1731466
Lung neoplasm malignant 52.97 39.76 35 10057 3144 1733545
Brain neoplasm malignant 51.90 39.76 15 10077 165 1736524
Chills 51.15 39.76 60 10032 11627 1725062
Urinary tract infection 51.02 39.76 56 10036 10097 1726592
Drug ineffective 50.94 39.76 157 9935 63644 1673045
Sinusitis 49.65 39.76 41 10051 5182 1731507
Condition aggravated 49.21 39.76 80 10012 21070 1715619
Bone pain 48.83 39.76 34 10058 3328 1733361
Stem cell transplant 48.65 39.76 18 10074 449 1736240
Peripheral sensory neuropathy 47.46 39.76 21 10071 840 1735849
Renal cell carcinoma 47.32 39.76 25 10067 1483 1735206
Tremor 47.12 39.76 61 10031 13070 1723619
Dialysis 46.31 39.76 29 10063 2375 1734314
Hyperglycaemia 45.90 39.76 39 10053 5126 1731563
Muscular weakness 45.48 39.76 53 10039 10196 1726493
Fluid retention 45.02 39.76 34 10058 3775 1732914
Cardio-respiratory arrest 44.52 39.76 50 10042 9243 1727446
Osteonecrosis 43.83 39.76 34 10058 3928 1732761
Bone marrow failure 43.64 39.76 38 10054 5162 1731527
Prothrombin time prolonged 42.88 39.76 24 10068 1597 1735092
Blood albumin decreased 42.51 39.76 24 10068 1624 1735065
Skin ulcer 42.39 39.76 29 10063 2759 1733930
Mucosal inflammation 42.30 39.76 34 10058 4135 1732554
Squamous cell carcinoma 42.28 39.76 25 10067 1846 1734843
Lethargy 42.07 39.76 43 10049 7141 1729548
Acute lymphocytic leukaemia 42.00 39.76 17 10075 543 1736146
Polyneuropathy 41.10 39.76 24 10068 1731 1734958
Spinal compression fracture 40.80 39.76 19 10073 857 1735832
Abdominal pain 40.43 39.76 74 10018 21416 1715273
Balance disorder 40.01 39.76 38 10054 5774 1730915
Blood creatinine increased 39.80 39.76 58 10034 13888 1722801

Pharmacologic Action:

SourceCodeDescription
ATC L04AX02 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Other immunosuppressants
FDA PE N0000008663 Decreased Immunologically Active Molecule Activity
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:35816 leprostatic drug
CHEBI has role CHEBI:48422 angiogenesis inhibitor
CHEBI has role CHEBI:35623 anticonvulsant
CHEBI has role CHEBI:50919 antiemetic
CHEBI has role CHEBI:35717 sedative
CHEBI has role CHEBI:35472 anti-inflammatory drug
CHEBI has role CHEBI:35610 antineoplastic agent
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

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Multiple myeloma indication 109989006 DOID:9538
Erythema nodosum leprosum indication 240411003
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
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

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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
100MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 6315720 Oct. 23, 2020 METHOD FOR DELIVERING A DRUG TO A PATIENT IN NEED OF THE DRUG, WHILE AVOIDING THE OCCURRENCE OF AN ADVERSE SIDE EFFECT KNOWN OR SUSPECTED OF BEING CAUSED BY SAID DRUG
100MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 6315720 Oct. 23, 2020 USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
100MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 6561977 Oct. 23, 2020 APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED 'SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY' (S.T.E.P.S.)
100MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 6561977 Oct. 23, 2020 USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
100MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 6755784 Oct. 23, 2020 APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED 'SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY' (S.T.E.P.S.)
100MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 6755784 Oct. 23, 2020 USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
100MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 6869399 Oct. 23, 2020 ACUTE TREATMENT OF THE CUTANEOUS MANIFESTATIONS OF MODERATE TO SEVERE ERYTHEMA NODOSUM LEPROSUM (ENL)
100MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 6869399 Oct. 23, 2020 APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED 'SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY' (S.T.E.P.S.)
100MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 6869399 Oct. 23, 2020 MAINTENANCE THERAPY FOR PREVENTION AND SUPPRESSION OF THE CUTANEOUS MANIFESTATIONS OF ENL RECURRENCE
100MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 6869399 Oct. 23, 2020 USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
100MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 7141018 Oct. 23, 2020 ACUTE TREATMENT OF THE CUTANEOUS MANIFESTATIONS OF MODERATE TO SEVERE ERYTHEMA NODOSUM LEPROSUM (ENL)
100MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 7141018 Oct. 23, 2020 APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED 'SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY' (S.T.E.P.S.)
100MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 7141018 Oct. 23, 2020 MAINTENANCE THERAPY FOR PREVENTION AND SUPPRESSION OF THE CUTANEOUS MANIFESTATIONS OF ENL RECURRENCE
100MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 7141018 Oct. 23, 2020 USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
100MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 7959566 Oct. 23, 2020 USE OF THALIDOMIDE IN TREATMENT OF CUTANEOUS MANIFESTATIONS OF ERYTHEMA NODOSUM LEPROSUM (ENL)
100MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 8315886 Oct. 23, 2020 TREATMENT OF MALE PATIENT HAVING A DISEASE OR CONDITION RESPONSIVE TO A TERATOGENIC DRUG
100MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 8626531 Oct. 23, 2020 USE OF THALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO THALIDOMIDE
150MG THALOMID CELGENE N020785 Jan. 10, 2007 RX CAPSULE ORAL 6315720 Oct. 23, 2020 USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
150MG THALOMID CELGENE N020785 Jan. 10, 2007 RX CAPSULE ORAL 6561977 Oct. 23, 2020 USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
150MG THALOMID CELGENE N020785 Jan. 10, 2007 RX CAPSULE ORAL 6755784 Oct. 23, 2020 USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
150MG THALOMID CELGENE N020785 Jan. 10, 2007 RX CAPSULE ORAL 6869399 Oct. 23, 2020 USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
150MG THALOMID CELGENE N020785 Jan. 10, 2007 RX CAPSULE ORAL 7141018 Oct. 23, 2020 USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
150MG THALOMID CELGENE N020785 Jan. 10, 2007 RX CAPSULE ORAL 7959566 Oct. 23, 2020 USE OF THALIDOMIDE IN TREATMENT OF CUTANEOUS MANIFESTATIONS OF ERYTHEMA NODOSUM LEPROSUM (ENL)
150MG THALOMID CELGENE N020785 Jan. 10, 2007 RX CAPSULE ORAL 8315886 Oct. 23, 2020 TREATMENT OF MALE PATIENT HAVING A DISEASE OR CONDITION RESPONSIVE TO A TERATOGENIC DRUG
150MG THALOMID CELGENE N020785 Jan. 10, 2007 RX CAPSULE ORAL 8626531 Oct. 23, 2020 USE OF THALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO THALIDOMIDE
200MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 6315720 Oct. 23, 2020 METHOD FOR DELIVERING A DRUG TO A PATIENT IN NEED OF THE DRUG, WHILE AVOIDING THE OCCURRENCE OF AN ADVERSE SIDE EFFECT KNOWN OR SUSPECTED OF BEING CAUSED BY SAID DRUG
200MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 6315720 Oct. 23, 2020 USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
200MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 6561977 Oct. 23, 2020 APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED 'SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY' (S.T.E.P.S.)
200MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 6561977 Oct. 23, 2020 USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
200MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 6755784 Oct. 23, 2020 APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED 'SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY' (S.T.E.P.S.)
200MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 6755784 Oct. 23, 2020 USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
200MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 6869399 Oct. 23, 2020 ACUTE TREATMENT OF THE CUTANEOUS MANIFESTATIONS OF MODERATE TO SEVERE ERYTHEMA NODOSUM LEPROSUM (ENL)
200MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 6869399 Oct. 23, 2020 APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED 'SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY' (S.T.E.P.S.)
200MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 6869399 Oct. 23, 2020 MAINTENANCE THERAPY FOR PREVENTION AND SUPPRESSION OF THE CUTANEOUS MANIFESTATIONS OF ENL RECURRENCE
200MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 6869399 Oct. 23, 2020 USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
200MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 7141018 Oct. 23, 2020 ACUTE TREATMENT OF THE CUTANEOUS MANIFESTATIONS OF MODERATE TO SEVERE ERYTHEMA NODOSUM LEPROSUM (ENL)
200MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 7141018 Oct. 23, 2020 APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED 'SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY' (S.T.E.P.S.)
200MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 7141018 Oct. 23, 2020 MAINTENANCE THERAPY FOR PREVENTION AND SUPPRESSION OF THE CUTANEOUS MANIFESTATIONS OF ENL RECURRENCE
200MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 7141018 Oct. 23, 2020 USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
200MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 7959566 Oct. 23, 2020 USE OF THALIDOMIDE IN TREATMENT OF CUTANEOUS MANIFESTATIONS OF ERYTHEMA NODOSUM LEPROSUM (ENL)
200MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 8315886 Oct. 23, 2020 TREATMENT OF MALE PATIENT HAVING A DISEASE OR CONDITION RESPONSIVE TO A TERATOGENIC DRUG
200MG THALOMID CELGENE N020785 Jan. 17, 2003 RX CAPSULE ORAL 8626531 Oct. 23, 2020 USE OF THALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO THALIDOMIDE
50MG THALOMID CELGENE N020785 July 16, 1998 RX CAPSULE ORAL 6315720 Oct. 23, 2020 METHOD FOR DELIVERING A DRUG TO A PATIENT IN NEED OF THE DRUG, WHILE AVOIDING THE OCCURRENCE OF AN ADVERSE SIDE EFFECT KNOWN OR SUSPECTED OF BEING CAUSED BY SAID DRUG
50MG THALOMID CELGENE N020785 July 16, 1998 RX CAPSULE ORAL 6315720 Oct. 23, 2020 USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
50MG THALOMID CELGENE N020785 July 16, 1998 RX CAPSULE ORAL 6561977 Oct. 23, 2020 APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED 'SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY' (S.T.E.P.S.)
50MG THALOMID CELGENE N020785 July 16, 1998 RX CAPSULE ORAL 6561977 Oct. 23, 2020 USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
50MG THALOMID CELGENE N020785 July 16, 1998 RX CAPSULE ORAL 6755784 Oct. 23, 2020 APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED 'SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY' (S.T.E.P.S.)
50MG THALOMID CELGENE N020785 July 16, 1998 RX CAPSULE ORAL 6755784 Oct. 23, 2020 USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
50MG THALOMID CELGENE N020785 July 16, 1998 RX CAPSULE ORAL 6869399 Oct. 23, 2020 ACUTE TREATMENT OF THE CUTANEOUS MANIFESTATIONS OF MODERATE TO SEVERE ERYTHEMA NODOSUM LEPROSUM (ENL)
50MG THALOMID CELGENE N020785 July 16, 1998 RX CAPSULE ORAL 6869399 Oct. 23, 2020 APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED 'SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY' (S.T.E.P.S.)
50MG THALOMID CELGENE N020785 July 16, 1998 RX CAPSULE ORAL 6869399 Oct. 23, 2020 MAINTENANCE THERAPY FOR PREVENTION AND SUPPRESSION OF THE CUTANEOUS MANIFESTATIONS OF ENL RECURRENCE
50MG THALOMID CELGENE N020785 July 16, 1998 RX CAPSULE ORAL 6869399 Oct. 23, 2020 USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
50MG THALOMID CELGENE N020785 July 16, 1998 RX CAPSULE ORAL 7141018 Oct. 23, 2020 ACUTE TREATMENT OF THE CUTANEOUS MANIFESTATIONS OF MODERATE TO SEVERE ERYTHEMA NODOSUM LEPROSUM (ENL)
50MG THALOMID CELGENE N020785 July 16, 1998 RX CAPSULE ORAL 7141018 Oct. 23, 2020 APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED 'SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY' (S.T.E.P.S.)
50MG THALOMID CELGENE N020785 July 16, 1998 RX CAPSULE ORAL 7141018 Oct. 23, 2020 MAINTENANCE THERAPY FOR PREVENTION AND SUPPRESSION OF THE CUTANEOUS MANIFESTATIONS OF ENL RECURRENCE
50MG THALOMID CELGENE N020785 July 16, 1998 RX CAPSULE ORAL 7141018 Oct. 23, 2020 USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
50MG THALOMID CELGENE N020785 July 16, 1998 RX CAPSULE ORAL 7959566 Oct. 23, 2020 USE OF THALIDOMIDE IN TREATMENT OF CUTANEOUS MANIFESTATIONS OF ERYTHEMA NODOSUM LEPROSUM (ENL)
50MG THALOMID CELGENE N020785 July 16, 1998 RX CAPSULE ORAL 8315886 Oct. 23, 2020 TREATMENT OF MALE PATIENT HAVING A DISEASE OR CONDITION RESPONSIVE TO A TERATOGENIC DRUG
50MG THALOMID CELGENE N020785 July 16, 1998 RX CAPSULE ORAL 8626531 Oct. 23, 2020 USE OF THALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO THALIDOMIDE

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
Tumor necrosis factor Cytokine IC50 8 WOMBAT-PK
Prostaglandin G/H synthase 1 Enzyme IC50 6.43 WOMBAT-PK
Prostaglandin G/H synthase 2 Enzyme IC50 6.30 WOMBAT-PK
Prostaglandin G/H synthase 2 Enzyme IC50 6.30 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 6.43 CHEMBL

External reference:

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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Thalomid HUMAN PRESCRIPTION DRUG LABEL 1 59572-205 CAPSULE 50 mg ORAL NDA 22 sections
Thalomid HUMAN PRESCRIPTION DRUG LABEL 1 59572-210 CAPSULE 100 mg ORAL NDA 22 sections
Thalomid HUMAN PRESCRIPTION DRUG LABEL 1 59572-215 CAPSULE 150 mg ORAL NDA 22 sections
Thalomid HUMAN PRESCRIPTION DRUG LABEL 1 59572-220 CAPSULE 200 mg ORAL NDA 22 sections