pomalidomide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
4746 19171-19-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • pomalyst
  • actimid
  • pomalidomide
an immunomodulator with antineoplastic and angiogenesis inhibitor activity
  • Molecular weight: 273.25
  • Formula: C13H11N3O4
  • CLOGP: -0.19
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 2
  • TPSA: 109.57
  • ALOGS: -2.03
  • ROTB: 1

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
3 mg O

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Feb. 8, 2013 FDA CELGENE
March 26, 2015 PMDA CELGENE K.K.

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
Death 1741.41 20.97 1936 52751 323443 50226994
White blood cell count decreased 1393.18 20.97 1089 53598 115633 50434804
Full blood count decreased 1383.90 20.97 609 54078 21737 50528700
Pneumonia 1335.45 20.97 1827 52860 376574 50173863
Laboratory test abnormal 824.22 20.97 432 54255 22776 50527661
Neuropathy peripheral 822.27 20.97 743 53944 96014 50454423
Neutropenia 656.59 20.97 803 53884 147162 50403275
Fatigue 467.52 20.97 1744 52943 705857 49844580
Thrombosis 408.55 20.97 395 54292 55438 50494999
Unevaluable event 379.30 20.97 348 54339 45718 50504719
Platelet count decreased 372.57 20.97 500 54187 100226 50450211
Neutrophil count decreased 369.84 20.97 343 54344 45683 50504754
Constipation 362.52 20.97 688 53999 185020 50365417
Adverse drug reaction 320.76 20.97 345 54342 54877 50495560
COVID-19 261.28 20.97 286 54401 46376 50504061
Plasma cell myeloma recurrent 257.96 20.97 100 54587 2558 50547879
Plasmacytoma 243.13 20.97 93 54594 2292 50548145
Influenza 241.44 20.97 383 54304 89155 50461282
Condition aggravated 235.59 20.97 24 54663 297034 50253403
Rheumatoid arthritis 199.30 20.97 4 54683 202546 50347891
Human chorionic gonadotropin increased 192.01 20.97 66 54621 1185 50549252
Muscle spasms 188.74 20.97 418 54269 125135 50425302
Nasopharyngitis 175.81 20.97 532 54155 192395 50358042
Drug ineffective 153.44 20.97 421 54266 818912 49731525
Drug interaction 153.38 20.97 18 54669 199603 50350834
Bronchitis 144.48 20.97 336 54351 103823 50446614
Tremor 143.63 20.97 356 54331 114547 50435890
Asthenia 133.90 20.97 689 53998 318353 50232084
Plasma cell myeloma 128.79 20.97 164 54523 31158 50519279
Peripheral swelling 125.56 20.97 497 54190 205439 50344998
Urinary tract infection 123.45 20.97 524 54163 223496 50326941
Product dose omission issue 118.83 20.97 452 54235 183386 50367051
Diarrhoea 117.63 20.97 1057 53630 587419 49963018
Drug hypersensitivity 116.68 20.97 63 54624 250947 50299490
Renal disorder 106.79 20.97 140 54547 27365 50523072
Full blood count increased 106.12 20.97 39 54648 857 50549580
Injection site pain 106.04 20.97 3 54684 111021 50439416
Cardiac disorder 102.41 20.97 174 54513 42805 50507632
Infusion related reaction 99.16 20.97 30 54657 169527 50380910
Light chain analysis increased 98.41 20.97 39 54648 1059 50549378
Red blood cell count decreased 97.01 20.97 149 54538 33686 50516751
Cytopenia 95.89 20.97 78 54609 8697 50541740
Anaemia 93.39 20.97 527 54160 251929 50298508
Infection 92.43 20.97 401 54286 172553 50377884
Arthralgia 90.49 20.97 214 54473 438488 50111949
Back pain 86.48 20.97 467 54220 219563 50330874
Thrombocytopenia 82.47 20.97 314 54373 127359 50423078
Dizziness 81.52 20.97 646 54041 345723 50204714
Product use in unapproved indication 80.61 20.97 14 54673 115805 50434632
Atrial fibrillation 79.17 20.97 266 54421 101479 50448958
Cataract 77.26 20.97 163 54524 47137 50503300
Treatment failure 74.11 20.97 28 54659 137609 50412828
Abdominal pain 71.70 20.97 90 54597 236138 50314299
Hip fracture 71.26 20.97 112 54575 25819 50524618
Product use issue 70.14 20.97 37 54650 149438 50400999
Overdose 69.51 20.97 12 54675 99715 50450722
Haemoglobin decreased 68.71 20.97 296 54391 126920 50423517
Therapeutic product effect incomplete 63.81 20.97 11 54676 91504 50458933
Therapeutic product effect decreased 61.91 20.97 35 54652 136015 50414422
Immune system disorder 61.64 20.97 59 54628 8158 50542279
Tooth disorder 61.59 20.97 101 54586 24127 50526310
Glossodynia 61.40 20.97 24 54663 115545 50434892
Sepsis 60.42 20.97 294 54393 132631 50417806
Multiple allergies 60.16 20.97 59 54628 8404 50542033
Bone pain 59.63 20.97 147 54540 47082 50503355
Illness 59.30 20.97 100 54587 24440 50525997
Rash 59.21 20.97 727 53960 436744 50113693
Blood test abnormal 59.20 20.97 67 54620 11252 50539185
Psoriasis 58.91 20.97 4 54683 68996 50481441
Intentional product use issue 58.86 20.97 7 54680 76911 50473526
Off label use 57.34 20.97 291 54396 474135 50076302
Fall 56.83 20.97 582 54105 334350 50216087
Full blood count abnormal 56.11 20.97 95 54592 23293 50527144
Hepatic enzyme increased 54.81 20.97 41 54646 137339 50413098
Wound 54.52 20.97 23 54664 105771 50444666
Pulmonary thrombosis 54.40 20.97 53 54634 7488 50542949
Discomfort 53.59 20.97 25 54662 108355 50442082
Respiratory syncytial virus infection 52.91 20.97 44 54643 5058 50545379
Pain 51.34 20.97 391 54296 578512 49971925
Deep vein thrombosis 51.23 20.97 185 54502 73119 50477318
Plasma cell leukaemia 51.16 20.97 24 54663 991 50549446
Hypercalcaemia 49.71 20.97 90 54597 23262 50527175
Crystal nephropathy 49.68 20.97 22 54665 793 50549644
Malaise 49.47 20.97 567 54120 334965 50215472
Renal failure 49.27 20.97 237 54450 106396 50444041
Wrong technique in product usage process 48.03 20.97 3 54684 55507 50494930
Protein total increased 47.40 20.97 31 54656 2465 50547972
Hyponatraemia 46.27 20.97 23 54664 96116 50454321
Headache 45.87 20.97 340 54347 506195 50044242
Hypokalaemia 43.96 20.97 20 54667 87972 50462465
Hospitalisation 43.52 20.97 10 54677 67927 50482510
Impaired healing 43.28 20.97 11 54676 69775 50480662
Monoclonal immunoglobulin present 41.99 20.97 19 54668 721 50549716
Mobility decreased 41.80 20.97 17 54670 79931 50470506
Seasonal allergy 41.17 20.97 64 54623 14612 50535825
Memory impairment 40.04 20.97 181 54506 79179 50471258
Respiratory tract infection 39.71 20.97 99 54588 31918 50518519
Helicobacter infection 39.34 20.97 4 54683 49698 50500739
Coma 39.29 20.97 7 54680 56872 50493565
Vomiting 38.54 20.97 316 54371 460442 50089995
COVID-19 pneumonia 37.76 20.97 46 54641 8349 50542088
Dyspnoea 37.44 20.97 813 53874 546795 50003642
Aspartate aminotransferase increased 37.02 20.97 19 54668 77979 50472458
Anaphylactic reaction 36.59 20.97 7 54680 54048 50496389
Tooth infection 34.75 20.97 58 54629 14054 50536383
Monoclonal immunoglobulin increased 34.72 20.97 10 54677 97 50550340
Electrocardiogram QT prolonged 34.53 20.97 7 54680 51879 50498558
Alanine aminotransferase increased 34.42 20.97 27 54660 88332 50462105
Blood calcium increased 34.24 20.97 42 54645 7677 50542760
Injection site swelling 34.03 20.97 3 54684 41770 50508667
Back disorder 34.01 20.97 46 54641 9259 50541178
Anxiety 33.11 20.97 91 54596 177515 50372922
Seizure 32.59 20.97 48 54639 117826 50432611
Tachycardia 32.37 20.97 36 54651 99727 50450710
Pneumonia influenzal 32.29 20.97 20 54667 1447 50548990
Fibromyalgia 32.25 20.97 5 54682 44973 50505464
Musculoskeletal stiffness 32.06 20.97 56 54631 128425 50422012
Agitation 31.99 20.97 9 54678 53375 50497062
Swelling face 31.99 20.97 127 54560 52468 50497969
Cerebrovascular accident 31.87 20.97 193 54494 94487 50455950
Blood potassium decreased 31.78 20.97 100 54587 36845 50513592
Abdominal discomfort 31.47 20.97 136 54551 231505 50318932
Bone lesion 31.20 20.97 33 54654 5137 50545300
Metabolic acidosis 31.06 20.97 3 54684 38822 50511615
Cystitis 30.72 20.97 112 54575 44452 50505985
SARS-CoV-2 test positive 30.39 20.97 31 54656 4628 50545809
Rash pruritic 30.29 20.97 117 54570 47729 50502708
Dry skin 29.31 20.97 108 54579 43083 50507354
Osteoarthritis 29.30 20.97 19 54668 68587 50481850
Cardio-respiratory arrest 28.93 20.97 11 54676 53881 50496556
Dysphonia 28.74 20.97 100 54587 38792 50511645
Pancytopenia 28.73 20.97 172 54515 83858 50466579
Toxicity to various agents 28.72 20.97 125 54562 212374 50338063
Suicidal ideation 28.59 20.97 12 54675 55373 50495064
Hypoaesthesia 28.52 20.97 235 54452 127022 50423415
Folliculitis 26.71 20.97 5 54682 39220 50511217
Inappropriate schedule of product administration 26.68 20.97 23 54664 71808 50478629
Feeling abnormal 26.67 20.97 229 54458 125263 50425174
Loss of personal independence in daily activities 26.54 20.97 22 54665 70028 50480409
Spinal fracture 25.80 20.97 54 54633 15519 50534918
Nervousness 25.79 20.97 77 54610 27574 50522863
Coronavirus infection 25.78 20.97 23 54664 2906 50547531
Localised infection 25.72 20.97 73 54614 25412 50525025
Depressed level of consciousness 25.65 20.97 12 54675 51941 50498496
Upper respiratory tract infection 25.22 20.97 139 54548 65759 50484678
Malignant neoplasm progression 25.07 20.97 22 54665 68102 50482335
Inflammation 23.98 20.97 16 54671 56896 50493541
Ear infection 23.92 20.97 72 54615 25898 50524539
Liver function test abnormal 23.88 20.97 9 54678 44330 50506107
Pseudomonas aeruginosa meningitis 23.33 20.97 4 54683 0 50550437
Oxygen saturation decreased 23.14 20.97 27 54660 73221 50477216
International normalised ratio increased 22.84 20.97 9 54678 43143 50507294
Stress 22.83 20.97 15 54672 53778 50496659
Vision blurred 22.57 20.97 154 54533 78493 50471944
Balance disorder 22.56 20.97 142 54545 70448 50479989
Musculoskeletal pain 22.38 20.97 27 54660 72150 50478287
Bradycardia 22.30 20.97 22 54665 64404 50486033
Kidney infection 22.24 20.97 57 54630 18689 50531748
Viral infection 22.07 20.97 77 54610 29909 50520528
Peritonitis viral 21.86 20.97 6 54681 48 50550389
Taste disorder 21.55 20.97 35 54652 8289 50542148
Neoplasm progression 21.46 20.97 3 54684 29154 50521283
Hypoglycaemia 21.34 20.97 16 54671 53565 50496872
Feeling jittery 21.24 20.97 41 54646 11119 50539318

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
Death 1864.59 18.64 2677 51808 339407 29180635
Pneumonia 1577.16 18.64 2392 52093 317780 29202262
White blood cell count decreased 1085.13 18.64 1027 53458 82335 29437707
Full blood count decreased 1015.99 18.64 524 53961 15468 29504574
Fatigue 866.39 18.64 1836 52649 314985 29205057
Laboratory test abnormal 811.89 18.64 472 54013 17713 29502329
Neuropathy peripheral 669.42 18.64 736 53749 70291 29449751
Adverse drug reaction 570.70 18.64 420 54065 23600 29496442
Neutropenia 467.98 18.64 855 53630 130856 29389186
Unevaluable event 430.01 18.64 390 54095 29461 29490581
Influenza 423.74 18.64 451 54034 41430 29478612
Thrombosis 411.76 18.64 450 54035 42595 29477447
COVID-19 385.99 18.64 400 54085 35614 29484428
Drug interaction 301.94 18.64 15 54470 197370 29322672
Peripheral swelling 277.05 18.64 453 54032 63286 29456756
Plasma cell myeloma recurrent 263.75 18.64 131 54354 3552 29516490
Constipation 242.82 18.64 602 53883 113558 29406484
Nasopharyngitis 222.21 18.64 396 54089 59269 29460773
Platelet count decreased 210.00 18.64 540 53945 104132 29415910
Neutrophil count decreased 207.53 18.64 323 54162 43244 29476798
Rash 188.31 18.64 769 53716 189050 29330992
Infection 185.96 18.64 426 54059 76325 29443717
Condition aggravated 169.85 18.64 32 54453 146263 29373779
Cardiac disorder 168.76 18.64 270 54215 36993 29483049
Plasmacytoma 155.45 18.64 88 54397 3127 29516915
Muscle spasms 148.57 18.64 353 54132 64729 29455313
Back pain 140.55 18.64 461 54024 101823 29418219
Renal disorder 140.30 18.64 190 54295 22405 29497637
Tooth disorder 140 18.64 126 54359 9403 29510639
Illness 132.57 18.64 105 54380 6569 29513473
Overdose 118.92 18.64 7 54478 79812 29440230
Asthenia 118.66 18.64 739 53746 214511 29305531
Deep vein thrombosis 101.62 18.64 283 54202 57116 29462926
Localised infection 101.08 18.64 126 54359 13690 29506352
Drug intolerance 94.13 18.64 247 54238 48132 29471910
Product dose omission issue 90.92 18.64 385 54100 95998 29424044
Immune system disorder 90.23 18.64 70 54415 4247 29515795
Product use in unapproved indication 88.80 18.64 25 54460 86850 29433192
Full blood count abnormal 88.29 18.64 123 54362 14890 29505152
Sepsis 86.17 18.64 502 53983 142180 29377862
Plasma cell leukaemia 80.66 18.64 36 54449 761 29519281
Aspartate aminotransferase increased 78.59 18.64 9 54476 59716 29460326
Rhabdomyolysis 77.96 18.64 10 54475 60798 29459244
Hyponatraemia 77.95 18.64 15 54470 67618 29452424
Abdominal pain 77.55 18.64 81 54404 135276 29384766
Light chain analysis increased 75.39 18.64 38 54447 1063 29518979
Plasma cell myeloma 74.75 18.64 192 54293 36923 29483119
Acute kidney injury 71.66 18.64 250 54235 265017 29255025
Full blood count increased 71.31 18.64 33 54452 761 29519281
Atrial fibrillation 70.54 18.64 382 54103 105264 29414778
Toxicity to various agents 70.51 18.64 133 54352 173528 29346514
Vomiting 70.25 18.64 182 54303 212078 29307964
Bronchitis 68.42 18.64 185 54300 36683 29483359
Alanine aminotransferase increased 66.13 18.64 24 54461 70920 29449122
Malignant neoplasm progression 62.35 18.64 29 54456 73830 29446212
Blood test abnormal 61.74 18.64 64 54421 5685 29514357
Monoclonal immunoglobulin present 61.54 18.64 31 54454 866 29519176
Agitation 59.92 18.64 11 54474 51293 29468749
Intentional product use issue 59.59 18.64 5 54480 42493 29477549
Hypoglycaemia 59.50 18.64 9 54476 48337 29471705
Hyperkalaemia 55.16 18.64 22 54463 61370 29458672
Fluid retention 54.99 18.64 129 54356 23431 29496611
Sinusitis 54.59 18.64 163 54322 34187 29485855
Dyspnoea 54.56 18.64 874 53611 325858 29194184
Bone pain 54.40 18.64 111 54374 18341 29501701
Red blood cell count decreased 54.20 18.64 135 54350 25467 29494575
Off label use 54.09 18.64 329 54156 300471 29219571
Cytopenia 53.87 18.64 78 54407 9781 29510261
Cataract 53.84 18.64 124 54361 22254 29497788
Back disorder 52.79 18.64 60 54425 5913 29514129
Arthropathy 50.28 18.64 118 54367 21436 29498606
Rheumatoid arthritis 47.31 18.64 3 54482 32149 29487893
SARS-CoV-2 test positive 47.22 18.64 43 54442 3256 29516786
Ascites 46.98 18.64 6 54479 36613 29483429
Electrocardiogram QT prolonged 46.17 18.64 6 54479 36131 29483911
Wrong technique in product usage process 46.05 18.64 3 54482 31425 29488617
Suicide attempt 45.22 18.64 5 54480 34105 29485937
Aggression 45.17 18.64 6 54479 35535 29484507
Hypokalaemia 45.08 18.64 18 54467 50185 29469857
Rib fracture 44.18 18.64 82 54403 12636 29507406
International normalised ratio increased 43.09 18.64 14 54471 44358 29475684
Pulmonary thrombosis 41.94 18.64 56 54429 6509 29513533
Upper limb fracture 41.54 18.64 44 54441 4007 29516035
White blood cell count abnormal 40.67 18.64 37 54448 2798 29517244
Squamous cell carcinoma of skin 40.54 18.64 67 54418 9419 29510623
Hospitalisation 40.46 18.64 17 54468 45971 29474071
Injection site pain 40.01 18.64 6 54479 32440 29487602
Inappropriate schedule of product administration 39.84 18.64 16 54469 44456 29475586
Interstitial lung disease 39.71 18.64 29 54456 57689 29462353
Anxiety 39.54 18.64 60 54425 85305 29434737
Coma 39.10 18.64 12 54473 39438 29480604
General physical health deterioration 38.91 18.64 82 54403 102775 29417267
Blood calcium increased 38.53 18.64 38 54447 3181 29516861
Balance disorder 37.60 18.64 149 54336 36021 29484021
Dysarthria 37.47 18.64 6 54479 30905 29489137
Psoriasis 37.43 18.64 7 54478 32220 29487822
Depressed level of consciousness 37.04 18.64 11 54474 36931 29483111
Pancreatitis 37.02 18.64 9 54476 34505 29485537
Hypoaesthesia 36.76 18.64 195 54290 53272 29466770
Hypotension 36.75 18.64 209 54276 194145 29325897
Tachycardia 36.40 18.64 48 54437 72362 29447680
Seizure 36.27 18.64 73 54412 93050 29426992
Respiratory tract infection 35.76 18.64 85 54400 15566 29504476
Hip fracture 35.64 18.64 67 54418 10425 29509617
Dizziness 35.60 18.64 518 53967 189166 29330876
Protein total increased 35.10 18.64 30 54455 2088 29517954
Drug reaction with eosinophilia and systemic symptoms 34.92 18.64 5 54480 27987 29492055
Gastrointestinal haemorrhage 34.84 18.64 58 54427 79475 29440567
Haematuria 34.73 18.64 19 54466 44120 29475922
Malaise 34.48 18.64 447 54038 159155 29360887
Melaena 33.69 18.64 8 54477 31168 29488874
Cellulitis enterococcal 33.50 18.64 10 54475 61 29519981
Tooth infection 33.48 18.64 46 54439 5493 29514549
Gastric disorder 33.47 18.64 66 54419 10638 29509404
Fall 33.30 18.64 484 54001 176694 29343348
Multiple allergies 33.27 18.64 29 54456 2073 29517969
Feeling abnormal 33.05 18.64 192 54293 54253 29465789
Body height decreased 32.79 18.64 36 54449 3414 29516628
Incorrect dose administered 32.75 18.64 10 54475 32974 29487068
Jaundice 32.69 18.64 7 54478 29289 29490753
Bradycardia 32.49 18.64 44 54441 65585 29454457
Musculoskeletal disorder 32.41 18.64 44 54441 5196 29514846
Cholestasis 32.24 18.64 3 54482 23459 29496583
Coronary artery disease 31.99 18.64 21 54464 44169 29475873
White blood cell disorder 31.77 18.64 24 54461 1399 29518643
Drug hypersensitivity 31.75 18.64 48 54437 68358 29451684
Lower respiratory tract infection 31.53 18.64 114 54371 26388 29493654
Headache 31.34 18.64 190 54295 173817 29346225
Blood urea increased 30.80 18.64 7 54478 28105 29491937
Spinal fracture 30.71 18.64 48 54437 6438 29513604
Blood bilirubin increased 30.67 18.64 12 54473 33881 29486161
Bone lesion 30.66 18.64 31 54454 2673 29517369
Gamma-glutamyltransferase increased 30.64 18.64 6 54479 26731 29493311
Pneumonia respiratory syncytial viral 30.53 18.64 19 54466 805 29519237
Pyrexia 30.35 18.64 718 53767 286904 29233138
COVID-19 pneumonia 30.12 18.64 59 54426 9463 29510579
Cardiac arrest 30.10 18.64 71 54414 85520 29434522
Hypercalcaemia 29.91 18.64 70 54415 12689 29507353
Angioedema 29.38 18.64 11 54474 31904 29488138
Cardio-respiratory arrest 29.25 18.64 30 54455 50571 29469471
Oxygen saturation decreased 29.10 18.64 24 54461 44913 29475129
Respiration abnormal 29.07 18.64 30 54455 2650 29517392
Mucosal inflammation 28.90 18.64 11 54474 31584 29488458
Hepatic function abnormal 27.95 18.64 19 54466 39240 29480802
Parainfluenzae virus infection 27.76 18.64 27 54458 2222 29517820
Haematemesis 27.24 18.64 6 54479 24620 29495422
Psychotic disorder 26.93 18.64 3 54482 20351 29499691
Agranulocytosis 26.91 18.64 3 54482 20337 29499705
Blood immunoglobulin M increased 26.89 18.64 11 54474 186 29519856
Acute myocardial infarction 26.57 18.64 30 54455 48408 29471634
Encephalopathy 26.47 18.64 12 54473 31031 29489011
Upper respiratory tract infection 26.30 18.64 110 54375 27239 29492803
Respiratory syncytial virus infection 26.16 18.64 33 54452 3626 29516416
Neutropenic sepsis 26.05 18.64 63 54422 11664 29508378
Metabolic acidosis 25.80 18.64 19 54466 37643 29482399
Cerebral toxoplasmosis 25.41 18.64 21 54464 1395 29518647
Lactic acidosis 25.32 18.64 12 54473 30235 29489807
Blood pressure abnormal 25.13 18.64 45 54440 6745 29513297
Clostridium difficile infection 25.07 18.64 76 54409 16065 29503977
Blood lactate dehydrogenase increased 25.00 18.64 3 54482 19206 29500836
Drug-induced liver injury 24.52 18.64 5 54480 21650 29498392
Seasonal allergy 24.49 18.64 38 54447 5064 29514978
White blood cell count increased 24.34 18.64 20 54465 37496 29482546
Stress 24.26 18.64 5 54480 21485 29498557
Transaminases increased 24.12 18.64 6 54479 22656 29497386
Shock 24.12 18.64 5 54480 21399 29498643
Sinus disorder 24.03 18.64 41 54444 5914 29514128
Ventricular tachycardia 23.98 18.64 6 54479 22568 29497474
Epilepsy 23.69 18.64 3 54482 18429 29501613
Tremor 23.68 18.64 223 54262 73315 29446727
Respiratory arrest 23.62 18.64 9 54476 25824 29494218
Lower limb fracture 23.09 18.64 31 54454 3621 29516421
Blood creatinine increased 23.01 18.64 80 54405 85022 29435020
Anaphylactic reaction 22.98 18.64 11 54474 27562 29492480
Product prescribing error 22.92 18.64 3 54482 17973 29502069
Thrombocytopenia 22.86 18.64 362 54123 134461 29385581
Progressive multifocal leukoencephalopathy 22.85 18.64 50 54435 8669 29511373
Hepatotoxicity 22.74 18.64 3 54482 17864 29502178
Blood alkaline phosphatase increased 22.68 18.64 12 54473 28394 29491648
Blood immunoglobulin A increased 22.56 18.64 11 54474 286 29519756
Drug ineffective 22.53 18.64 504 53981 362666 29157376
Hypoacusis 22.49 18.64 68 54417 14355 29505687
Viral infection 22.32 18.64 69 54416 14741 29505301
Swelling face 22.09 18.64 85 54400 20265 29499777
JC virus infection 21.97 18.64 22 54463 1875 29518167
Circulatory collapse 21.80 18.64 4 54481 18669 29501373
Neoplasm progression 21.70 18.64 4 54481 18608 29501434
Spinal disorder 21.31 18.64 30 54455 3665 29516377
Vertebral lesion 20.95 18.64 9 54476 173 29519869
Coronavirus infection 20.93 18.64 28 54457 3260 29516782
Ear infection 20.72 18.64 46 54439 8054 29511988
Generalised tonic-clonic seizure 20.50 18.64 5 54480 19134 29500908
Diverticulitis 20.08 18.64 75 54410 17629 29502413
Medication error 20.05 18.64 7 54478 21204 29498838
Leukocytosis 19.95 18.64 7 54478 21135 29498907
Respiratory distress 19.75 18.64 18 54467 32088 29487954
Sedation 19.75 18.64 4 54481 17401 29502641
Light chain analysis abnormal 19.68 18.64 7 54478 79 29519963
Abnormal behaviour 19.62 18.64 9 54476 23118 29496924
Hepatic enzyme increased 19.57 18.64 20 54465 33779 29486263
Product quality issue 19.45 18.64 3 54482 15892 29504150
Taste disorder 19.43 18.64 33 54452 4743 29515299
Gastrointestinal infection 18.93 18.64 29 54456 3822 29516220
Drug resistance 18.88 18.64 8 54477 21532 29498510
Pancytopenia 18.79 18.64 235 54250 82933 29437109
Therapeutic product effect incomplete 18.79 18.64 27 54458 39278 29480764
Ageusia 18.77 18.64 47 54438 8891 29511151
Protein total abnormal 18.73 18.64 10 54475 316 29519726
C-reactive protein increased 18.71 18.64 33 54452 44230 29475812

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
Death 2941.73 18.54 2938 60471 479767 63955556
Pneumonia 2435.83 18.54 2853 60556 556723 63878600
White blood cell count decreased 1330.63 18.54 1157 62252 156680 64278643
Full blood count decreased 1223.73 18.54 545 62864 22037 64413286
Neutropenia 1178.93 18.54 1308 62101 238316 64197007
Neuropathy peripheral 724.99 18.54 725 62684 116800 64318523
Neutrophil count decreased 554.34 18.54 518 62891 76678 64358645
Thrombosis 518.72 18.54 480 62929 70162 64365161
Fatigue 510.77 18.54 1751 61658 746979 63688344
Platelet count decreased 508.64 18.54 720 62689 166991 64268332
Laboratory test abnormal 471.10 18.54 294 63115 23769 64411554
Unevaluable event 351.11 18.54 333 63076 50156 64385167
Influenza 329.43 18.54 462 62947 106069 64329254
COVID-19 315.97 18.54 354 63055 64786 64370537
Plasmacytoma 315.43 18.54 125 63284 3745 64431578
Plasma cell myeloma recurrent 312.93 18.54 126 63283 3939 64431384
Drug interaction 285.15 18.54 18 63391 362065 64073258
Plasma cell myeloma 263.08 18.54 273 63136 45802 64389521
Sepsis 230.12 18.54 618 62791 229723 64205600
Condition aggravated 221.41 18.54 48 63361 372378 64062945
Thrombocytopenia 216.07 18.54 593 62816 223208 64212115
Deep vein thrombosis 213.39 18.54 376 63033 104806 64330517
Constipation 212.86 18.54 599 62810 228738 64206585
Anaemia 182.63 18.54 796 62613 377884 64057439
Atrial fibrillation 159.70 18.54 448 62961 170641 64264682
Plasma cell leukaemia 154.52 18.54 58 63351 1495 64433828
Infection 152.32 18.54 463 62946 184417 64250906
Adverse drug reaction 146.08 18.54 201 63208 45263 64390060
Rash 145.66 18.54 857 62552 457692 63977631
Human chorionic gonadotropin increased 145.33 18.54 48 63361 838 64434485
Rheumatoid arthritis 142.92 18.54 4 63405 164290 64271033
Muscle spasms 139.23 18.54 377 63032 140646 64294677
Cytopenia 130.91 18.54 114 63295 15357 64419966
Light chain analysis increased 119.85 18.54 46 63363 1262 64434061
Drug hypersensitivity 116.59 18.54 44 63365 237771 64197552
Bronchitis 112.64 18.54 296 63113 108447 64326876
Overdose 109.20 18.54 14 63395 159552 64275771
Asthenia 108.61 18.54 756 62653 427288 64008035
Drug ineffective 104.46 18.54 449 62960 839798 63595525
Cardiac disorder 99.76 18.54 189 63220 55627 64379696
Febrile neutropenia 97.54 18.54 404 63005 187253 64248070
Peripheral swelling 96.99 18.54 435 62974 208718 64226605
Arthralgia 95.68 18.54 181 63228 442079 63993244
Abdominal pain 95.24 18.54 100 63309 312275 64123048
Red blood cell count decreased 94.20 18.54 170 63239 48216 64387107
Hypercalcaemia 93.62 18.54 134 63275 31282 64404041
Pyrexia 88.80 18.54 888 62521 557756 63877567
Renal disorder 84.35 18.54 136 63273 35229 64400094
Urinary tract infection 83.29 18.54 448 62961 231148 64204175
Headache 81.28 18.54 259 63150 529208 63906115
Nasopharyngitis 80.75 18.54 394 63015 195679 64239644
Neutropenic sepsis 79.46 18.54 106 63303 23166 64412157
Injection site pain 78.12 18.54 9 63400 111399 64323924
Product use in unapproved indication 78.04 18.54 38 63371 176580 64258743
Respiratory tract infection 76.12 18.54 134 63275 37273 64398050
Fall 75.27 18.54 681 62728 416145 64019178
Bone pain 75.20 18.54 153 63256 47419 64387904
Pancytopenia 74.79 18.54 309 63100 143000 64292323
Hip fracture 74.10 18.54 111 63298 26988 64408335
Squamous cell carcinoma of skin 70.69 18.54 72 63337 11804 64423519
Haemoglobin decreased 70.56 18.54 378 63031 194685 64240638
Pulmonary thrombosis 70.44 18.54 68 63341 10450 64424873
Product dose omission issue 68.15 18.54 374 63035 194373 64240950
Intentional product use issue 61.43 18.54 10 63399 95354 64339969
Hyponatraemia 60.98 18.54 35 63374 148304 64287019
Rhabdomyolysis 60.49 18.54 9 63400 91717 64343606
COVID-19 pneumonia 59.16 18.54 77 63332 16427 64418896
Intentional product misuse 58.62 18.54 3 63406 72292 64363031
Agitation 57.52 18.54 9 63400 88358 64346965
Vomiting 57.48 18.54 313 63096 550804 63884519
Renal failure 55.12 18.54 336 63073 181352 64253971
Anxiety 55.10 18.54 71 63338 202578 64232745
Blood calcium increased 54.91 18.54 54 63355 8488 64426835
Back pain 53.67 18.54 425 62984 249746 64185577
Tremor 52.72 18.54 286 63123 147944 64287379
Respiratory syncytial virus infection 52.50 18.54 49 63360 7219 64428104
Psoriasis 52.30 18.54 5 63404 71698 64363625
Dyspnoea 51.14 18.54 990 62419 717684 63717639
Pulmonary embolism 49.78 18.54 279 63130 146077 64289246
Aspartate aminotransferase increased 49.61 18.54 28 63381 119760 64315563
Diarrhoea 49.55 18.54 990 62419 721714 63713609
Therapeutic product effect decreased 49.17 18.54 26 63383 115325 64319998
Suicide attempt 49.12 18.54 6 63403 71001 64364322
Cerebrovascular accident 48.62 18.54 265 63144 137318 64298005
Monoclonal immunoglobulin present 47.66 18.54 21 63388 824 64434499
Hypokalaemia 46.99 18.54 31 63378 121872 64313451
Coma 46.74 18.54 14 63395 87601 64347722
Pericarditis 46.56 18.54 4 63405 62512 64372811
Leukopenia 44.93 18.54 208 63201 101034 64334289
Rib fracture 44.93 18.54 83 63326 23955 64411368
Immune system disorder 44.81 18.54 50 63359 9091 64426232
Electrocardiogram QT prolonged 43.66 18.54 12 63397 79436 64355887
Treatment failure 43.30 18.54 31 63378 116785 64318538
Tooth disorder 42.69 18.54 78 63331 22324 64412999
Hepatic enzyme increased 42.54 18.54 39 63370 129904 64305419
Crystal nephropathy 42.45 18.54 22 63387 1243 64434080
Lymphocyte count decreased 42.31 18.54 111 63298 40588 64394735
Dizziness 41.58 18.54 623 62786 429540 64005783
Musculoskeletal stiffness 41.50 18.54 36 63373 123170 64312153
Discomfort 41.23 18.54 14 63395 80864 64354459
Hypoglycaemia 38.69 18.54 20 63389 89872 64345451
Pain 38.68 18.54 353 63056 553158 63882165
Infusion related reaction 38.45 18.54 64 63345 164403 64270920
Upper respiratory tract infection 37.98 18.54 157 63252 72628 64362695
Pneumonia influenzal 37.59 18.54 26 63383 2496 64432827
SARS-CoV-2 test positive 37.21 18.54 38 63371 6248 64429075
Hospitalisation 36.67 18.54 14 63395 75193 64360130
Therapeutic product effect incomplete 36.38 18.54 29 63380 103453 64331870
Rash pruritic 35.80 18.54 131 63278 57273 64378050
Alanine aminotransferase increased 35.46 18.54 51 63358 138980 64296343
Toxicity to various agents 34.84 18.54 212 63197 363301 64072022
Cataract 34.54 18.54 120 63289 51142 64384181
Hypertension 33.57 18.54 136 63273 259125 64176198
Back disorder 33.33 18.54 45 63364 9945 64425378
Glossodynia 33.32 18.54 11 63398 64685 64370638
Suicidal ideation 33.09 18.54 12 63397 66530 64368793
Blood test abnormal 32.54 18.54 51 63358 12892 64422431
Tumour lysis syndrome 32.48 18.54 64 63345 19376 64415947
Pneumonia respiratory syncytial viral 31.87 18.54 19 63390 1412 64433911
Oxygen saturation decreased 31.83 18.54 35 63374 107141 64328182
Pneumonia pneumococcal 31.82 18.54 26 63383 3208 64432115
Full blood count abnormal 31.79 18.54 82 63327 29675 64405648
White blood cell count abnormal 31.79 18.54 31 63378 4823 64430500
Progressive multifocal leukoencephalopathy 31.65 18.54 61 63348 18171 64417152
Pneumocystis jirovecii pneumonia 31.45 18.54 78 63331 27556 64407767
Inappropriate schedule of product administration 31.03 18.54 27 63382 92259 64343064
Full blood count increased 31.01 18.54 13 63396 451 64434872
Pathological fracture 30.71 18.54 41 63368 8964 64426359
International normalised ratio increased 30.68 18.54 20 63389 79147 64356176
Osteoarthritis 30.53 18.54 12 63397 63324 64371999
Drug reaction with eosinophilia and systemic symptoms 30.15 18.54 8 63401 54209 64381114
Haematemesis 30.10 18.54 5 63404 46994 64388329
Depressed level of consciousness 29.67 18.54 22 63387 81414 64353909
Melaena 29.59 18.54 8 63401 53540 64381783
Cellulitis enterococcal 29.49 18.54 7 63402 32 64435291
Lactic acidosis 29.00 18.54 12 63397 61398 64373925
Inflammation 28.90 18.54 14 63395 65286 64370037
Peripheral sensory neuropathy 28.84 18.54 45 63364 11333 64423990
Bone lesion 28.51 18.54 30 63379 5107 64430216
Anaphylactic reaction 28.49 18.54 16 63393 68648 64366675
Localised infection 28.09 18.54 79 63330 30082 64405241
Dyskinesia 28.06 18.54 3 63406 39385 64395938
Blood immunoglobulin M increased 28.00 18.54 12 63397 440 64434883
Mobility decreased 27.81 18.54 26 63383 85814 64349509
Product use issue 27.79 18.54 68 63341 151647 64283676
Angioedema 27.75 18.54 13 63396 61808 64373515
Off label use 27.60 18.54 447 62962 632359 63802964
Sedation 27.49 18.54 4 63405 41458 64393865
Wound 27.42 18.54 21 63388 76456 64358867
Depression 27.09 18.54 91 63318 183200 64252123
Incorrect dose administered 26.93 18.54 13 63396 60752 64374571
Impaired healing 26.71 18.54 13 63396 60460 64374863
Drug-induced liver injury 26.55 18.54 7 63402 47636 64387687
Blood pressure systolic increased 26.19 18.54 8 63401 49445 64385878
Upper limb fracture 26.12 18.54 50 63359 14816 64420507
Lower respiratory tract infection 25.58 18.54 170 63239 94444 64340879
Parainfluenzae virus infection 25.08 18.54 27 63382 4716 64430607
Medication error 24.86 18.54 9 63400 49957 64385366
Hypotension 24.84 18.54 247 63162 380727 64054596
Blood pressure fluctuation 24.72 18.54 10 63399 51861 64383462
Clostridium difficile infection 24.66 18.54 85 63324 36078 64399245
Cardio-respiratory arrest 24.20 18.54 37 63372 98356 64336967
Spinal fracture 24.20 18.54 49 63360 15125 64420198
Chest discomfort 23.74 18.54 49 63360 116057 64319266
Swelling face 23.67 18.54 118 63291 59048 64376275
Malignant neoplasm progression 23.62 18.54 47 63362 112824 64322499
Dehydration 23.29 18.54 320 63089 216443 64218880
Type 2 diabetes mellitus 23.22 18.54 3 63406 34017 64401306
Hepatitis 23.04 18.54 8 63401 45574 64389749
Viral infection 22.97 18.54 83 63326 36057 64399266
Neoplasm progression 22.86 18.54 6 63403 40958 64394365
Clavicle fracture 22.80 18.54 23 63386 3726 64431597
Weight decreased 22.71 18.54 176 63233 285563 64149760
Osteolysis 22.40 18.54 20 63389 2783 64432540
Tachycardia 22.28 18.54 74 63335 149505 64285818
Ascites 22.26 18.54 17 63392 61984 64373339
Hyperkalaemia 22.13 18.54 41 63368 101088 64334235
Pancreatitis 21.84 18.54 16 63393 59591 64375732
Coronavirus infection 21.71 18.54 27 63382 5503 64429820
Dysarthria 21.70 18.54 16 63393 59390 64375933
Peritonitis viral 21.50 18.54 6 63403 57 64435266
Feeling hot 21.44 18.54 9 63400 45654 64389669
Metabolic acidosis 21.26 18.54 23 63386 70935 64364388
Coronary artery disease 21.15 18.54 17 63392 60416 64374907
Depressed mood 21.07 18.54 7 63402 41005 64394318
Protein total increased 21.04 18.54 21 63388 3360 64431963
Septic shock 20.87 18.54 176 63233 105261 64330062
Accidental overdose 20.56 18.54 4 63405 33553 64401770
Injury 20.56 18.54 15 63394 55977 64379346
Epilepsy 20.54 18.54 4 63405 33527 64401796
Blood bilirubin increased 20.38 18.54 16 63393 57537 64377786
Atrial flutter 20.29 18.54 53 63356 19327 64415996
Dysphagia 20.25 18.54 47 63362 106765 64328558
Osteoporosis 20.23 18.54 8 63401 42072 64393251
Mucosal inflammation 20.22 18.54 19 63390 62565 64372758
Weight increased 20.10 18.54 125 63284 213223 64222100
Seizure 20.07 18.54 90 63319 166802 64268521
Loss of personal independence in daily activities 20.07 18.54 25 63384 72429 64362894
Anaphylactic shock 19.93 18.54 3 63406 30325 64404998
Flushing 19.90 18.54 29 63380 78619 64356704
Body dysmorphic disorder 19.83 18.54 8 63401 251 64435072
Respiratory arrest 19.71 18.54 14 63395 52971 64382352
Injection site swelling 19.66 18.54 8 63401 41345 64393978
Blood pressure increased 19.60 18.54 95 63314 172457 64262866
Avulsion fracture 19.43 18.54 8 63401 265 64435058
Unresponsive to stimuli 19.16 18.54 13 63396 50380 64384943
Diverticulitis 19.12 18.54 82 63327 38536 64396787
Shock 18.84 18.54 7 63402 38233 64397090
Gastrointestinal haemorrhage 18.66 18.54 67 63342 132245 64303078
Bradycardia 18.64 18.54 57 63352 118162 64317161
Palmar-plantar erythrodysaesthesia syndrome 18.60 18.54 3 63406 28816 64406507

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AX06 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Other immunosuppressants
MeSH PA D020533 Angiogenesis Inhibitors
MeSH PA D000970 Antineoplastic Agents
MeSH PA D006131 Growth Inhibitors
MeSH PA D006133 Growth Substances
MeSH PA D007155 Immunologic Factors
FDA EPC N0000184014 Thalidomide Analog
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:48422 angiogenesis antagonist
CHEBI has role CHEBI:50846 Immunologic factor

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

DiseaseRelationSNOMED_IDDOID
Multiple myeloma indication 109989006 DOID:9538




🐶 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
pKa2 1.86 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
1MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL 8673939 May 15, 2023 USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
1MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL 8673939 May 15, 2023 USE OF POMALIDOMIDE WITH DEXAMETHASONE FOR PATIENTS WITH MULTIPLE MYELOMA AFTER AT LEAST TWO PRIOR THERAPIES INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR AND DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETING THE LAST THERAPY
1MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL 8735428 May 15, 2023 USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
1MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL 8735428 May 15, 2023 USE OF POMALIDOMIDE WITH DEXAMETHASONE FOR PATIENTS WITH MULTIPLE MYELOMA AFTER AT LEAST TWO PRIOR THERAPIES INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR AND DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETING THE LAST THERAPY
2MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL 8673939 May 15, 2023 USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
2MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL 8673939 May 15, 2023 USE OF POMALIDOMIDE WITH DEXAMETHASONE FOR PATIENTS WITH MULTIPLE MYELOMA AFTER AT LEAST TWO PRIOR THERAPIES INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR AND DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETING THE LAST THERAPY
2MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL 8735428 May 15, 2023 USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
2MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL 8735428 May 15, 2023 USE OF POMALIDOMIDE WITH DEXAMETHASONE FOR PATIENTS WITH MULTIPLE MYELOMA AFTER AT LEAST TWO PRIOR THERAPIES INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR AND DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETING THE LAST THERAPY
3MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL 8673939 May 15, 2023 USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
3MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL 8673939 May 15, 2023 USE OF POMALIDOMIDE WITH DEXAMETHASONE FOR PATIENTS WITH MULTIPLE MYELOMA AFTER AT LEAST TWO PRIOR THERAPIES INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR AND DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETING THE LAST THERAPY
3MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL 8735428 May 15, 2023 USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
3MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL 8735428 May 15, 2023 USE OF POMALIDOMIDE WITH DEXAMETHASONE FOR PATIENTS WITH MULTIPLE MYELOMA AFTER AT LEAST TWO PRIOR THERAPIES INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR AND DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETING THE LAST THERAPY
4MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL 8673939 May 15, 2023 USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
4MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL 8673939 May 15, 2023 USE OF POMALIDOMIDE WITH DEXAMETHASONE FOR PATIENTS WITH MULTIPLE MYELOMA AFTER AT LEAST TWO PRIOR THERAPIES INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR AND DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETING THE LAST THERAPY
4MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL 8735428 May 15, 2023 USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
4MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL 8735428 May 15, 2023 USE OF POMALIDOMIDE WITH DEXAMETHASONE FOR PATIENTS WITH MULTIPLE MYELOMA AFTER AT LEAST TWO PRIOR THERAPIES INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR AND DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETING THE LAST THERAPY
1MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL 8198262 June 17, 2025 USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
1MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL 8198262 June 17, 2025 USE OF POMALIDOMIDE WITH DEXAMETHASONE FOR PATIENTS WITH MULTIPLE MYELOMA AFTER AT LEAST TWO PRIOR THERAPIES INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR AND DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETING THE LAST THERAPY
2MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL 8198262 June 17, 2025 USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
2MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL 8198262 June 17, 2025 USE OF POMALIDOMIDE WITH DEXAMETHASONE FOR PATIENTS WITH MULTIPLE MYELOMA AFTER AT LEAST TWO PRIOR THERAPIES INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR AND DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETING THE LAST THERAPY
3MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL 8198262 June 17, 2025 USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
3MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL 8198262 June 17, 2025 USE OF POMALIDOMIDE WITH DEXAMETHASONE FOR PATIENTS WITH MULTIPLE MYELOMA AFTER AT LEAST TWO PRIOR THERAPIES INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR AND DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETING THE LAST THERAPY
4MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL 8198262 June 17, 2025 USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
4MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL 8198262 June 17, 2025 USE OF POMALIDOMIDE WITH DEXAMETHASONE FOR PATIENTS WITH MULTIPLE MYELOMA AFTER AT LEAST TWO PRIOR THERAPIES INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR AND DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETING THE LAST THERAPY

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
1MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL Nov. 20, 2023 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
2MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL Nov. 20, 2023 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
3MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL Nov. 20, 2023 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
4MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL Nov. 20, 2023 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
1MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL May 20, 2024 PEDIATRIC EXCLUSIVITY
2MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL May 20, 2024 PEDIATRIC EXCLUSIVITY
3MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL May 20, 2024 PEDIATRIC EXCLUSIVITY
4MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL May 20, 2024 PEDIATRIC EXCLUSIVITY
1MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL May 14, 2027 FOR THE TREATMENT OF KAPOSI SARCOMA (KS) IN ADULT PATIENTS WHO ARE HIV-NEGATIVE
1MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL May 14, 2027 INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH AIDS-RELATED KAPOSI SARCOMA (KS) AFTER FAILURE OF HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART)
2MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL May 14, 2027 FOR THE TREATMENT OF KAPOSI SARCOMA (KS) IN ADULT PATIENTS WHO ARE HIV-NEGATIVE
2MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL May 14, 2027 INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH AIDS-RELATED KAPOSI SARCOMA (KS) AFTER FAILURE OF HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART)
3MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL May 14, 2027 FOR THE TREATMENT OF KAPOSI SARCOMA (KS) IN ADULT PATIENTS WHO ARE HIV-NEGATIVE
3MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL May 14, 2027 INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH AIDS-RELATED KAPOSI SARCOMA (KS) AFTER FAILURE OF HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART)
4MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL May 14, 2027 FOR THE TREATMENT OF KAPOSI SARCOMA (KS) IN ADULT PATIENTS WHO ARE HIV-NEGATIVE
4MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL May 14, 2027 INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH AIDS-RELATED KAPOSI SARCOMA (KS) AFTER FAILURE OF HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART)
1MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL Nov. 14, 2027 PEDIATRIC EXCLUSIVITY
2MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL Nov. 14, 2027 PEDIATRIC EXCLUSIVITY
3MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL Nov. 14, 2027 PEDIATRIC EXCLUSIVITY
4MG POMALYST CELGENE N204026 Feb. 8, 2013 RX CAPSULE ORAL Nov. 14, 2027 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Protein cereblon Cytosolic other MODULATOR EC50 6.58 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
Cereblon isoform 4 Unclassified Ki 6.10 CHEMBL

External reference:

IDSource
D08976 KEGG_DRUG
4032092 VANDF
CHEBI:72690 CHEBI
CHEMBL43452 ChEMBL_ID
C467566 MESH_SUPPLEMENTAL_RECORD_UI
7348 IUPHAR_LIGAND_ID
8873 INN_ID
DB08910 DRUGBANK_ID
D2UX06XLB5 UNII
134780 PUBCHEM_CID
1369713 RXNORM
199372 MMSL
29234 MMSL
d08041 MMSL
014897 NDDF
703789000 SNOMEDCT_US
703790009 SNOMEDCT_US
C2347624 UMLSCUI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Pomalyst HUMAN PRESCRIPTION DRUG LABEL 1 59572-501 CAPSULE 1 mg ORAL NDA 32 sections
Pomalyst HUMAN PRESCRIPTION DRUG LABEL 1 59572-501 CAPSULE 1 mg ORAL NDA 32 sections
Pomalyst HUMAN PRESCRIPTION DRUG LABEL 1 59572-502 CAPSULE 2 mg ORAL NDA 32 sections
Pomalyst HUMAN PRESCRIPTION DRUG LABEL 1 59572-502 CAPSULE 2 mg ORAL NDA 32 sections
Pomalyst HUMAN PRESCRIPTION DRUG LABEL 1 59572-503 CAPSULE 3 mg ORAL NDA 32 sections
Pomalyst HUMAN PRESCRIPTION DRUG LABEL 1 59572-503 CAPSULE 3 mg ORAL NDA 32 sections
Pomalyst HUMAN PRESCRIPTION DRUG LABEL 1 59572-504 CAPSULE 4 mg ORAL NDA 32 sections
Pomalyst HUMAN PRESCRIPTION DRUG LABEL 1 59572-504 CAPSULE 4 mg ORAL NDA 32 sections