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
Plasma cell myeloma 6812.63 21.46 2354 57863 44292 56187558
Death 1865.04 21.46 2044 58173 339382 55892468
White blood cell count decreased 1467.55 21.46 1154 59063 124836 56107014
Full blood count decreased 1428.28 21.46 629 59588 22720 56209130
Pneumonia 1352.56 21.46 1900 58317 405198 55826652
Neuropathy peripheral 867.13 21.46 783 59434 102110 56129740
Laboratory test abnormal 819.83 21.46 438 59779 24257 56207593
Neutropenia 767.79 21.46 894 59323 157273 56074577
Fatigue 473.60 21.46 1873 58344 786679 55445171
Thrombosis 426.31 21.46 414 59803 59013 56172837
Platelet count decreased 388.31 21.46 522 59695 105861 56125989
Rheumatoid arthritis 388.14 21.46 4 60213 382600 55849250
Neutrophil count decreased 385.60 21.46 362 59855 49460 56182390
Unevaluable event 373.88 21.46 349 59868 47338 56184512
Constipation 371.01 21.46 725 59492 201218 56030632
Plasma cell myeloma recurrent 290.47 21.46 110 60107 2664 56229186
Adverse drug reaction 282.04 21.46 348 59869 64784 56167066
Condition aggravated 272.32 21.46 27 60190 344871 55886979
COVID-19 256.60 21.46 357 59860 74701 56157149
Plasmacytoma 248.18 21.46 95 60122 2371 56229479
Influenza 237.37 21.46 391 59826 94870 56136980
Human chorionic gonadotropin increased 216.88 21.46 74 60143 1312 56230538
Muscle spasms 195.74 21.46 445 59772 136926 56094924
Drug ineffective 174.49 21.46 462 59755 918527 55313323
Product dose omission issue 157.30 21.46 529 59688 204224 56027626
Tremor 152.59 21.46 374 59843 120715 56111135
Drug interaction 147.07 21.46 24 60193 209731 56022119
Nasopharyngitis 145.78 21.46 543 59674 220416 56011434
Bronchitis 137.38 21.46 343 59874 111968 56119882
Drug hypersensitivity 133.17 21.46 64 60153 275141 55956709
Asthenia 132.00 21.46 718 59499 342255 55889595
Urinary tract infection 125.09 21.46 549 59668 239964 55991886
Infusion related reaction 123.90 21.46 35 60182 208896 56022954
Diarrhoea 122.58 21.46 1128 59089 637379 55594471
Cytopenia 116.57 21.46 91 60126 9664 56222186
Peripheral swelling 113.95 21.46 525 59692 234201 55997649
Arthralgia 112.56 21.46 230 59987 501439 55730411
Full blood count increased 111.92 21.46 41 60176 902 56230948
Injection site pain 111.21 21.46 3 60214 117115 56114735
Renal disorder 108.90 21.46 146 60071 29459 56202391
Light chain analysis increased 104.04 21.46 41 60176 1108 56230742
Product use in unapproved indication 103.53 21.46 14 60203 140808 56091042
Cardiac disorder 103.12 21.46 180 60037 45707 56186143
Treatment failure 102.02 21.46 28 60189 170364 56061486
Thrombocytopenia 96.66 21.46 343 59874 135881 56095969
Product use issue 96.66 21.46 39 60178 186002 56045848
Anaemia 96.09 21.46 550 59667 266961 55964889
Red blood cell count decreased 94.74 21.46 153 60064 36464 56195386
Glossodynia 91.36 21.46 25 60192 152433 56079417
Therapeutic product effect decreased 87.25 21.46 36 60181 169416 56062434
Back pain 86.04 21.46 489 59728 236681 55995169
Wound 82.72 21.46 23 60194 138781 56093069
Atrial fibrillation 79.65 21.46 277 59940 108620 56123230
Abdominal pain 78.39 21.46 97 60120 258708 55973142
Hepatic enzyme increased 78.14 21.46 43 60174 171341 56060509
Dizziness 77.20 21.46 675 59542 375465 55856385
Discomfort 76.47 21.46 28 60189 141733 56090117
Psoriasis 76.40 21.46 6 60211 92686 56139164
Therapeutic product effect incomplete 74.56 21.46 12 60205 106019 56125831
Overdose 74.36 21.46 12 60205 105818 56126032
Cataract 72.84 21.46 166 60051 51081 56180769
Infection 72.71 21.46 413 59804 199793 56032057
Hip fracture 71.55 21.46 114 60103 26859 56204991
Pain 71.03 21.46 418 59799 662766 55569084
Haemoglobin decreased 66.44 21.46 302 59915 133835 56098015
Sepsis 65.69 21.46 310 59907 139530 56092320
Bone pain 65.25 21.46 157 60060 50028 56181822
Helicobacter infection 62.52 21.46 4 60213 73264 56158586
Tooth disorder 62.35 21.46 104 60113 25449 56206401
Blood test abnormal 61.30 21.46 72 60145 12712 56219138
Full blood count abnormal 61.00 21.46 105 60112 26357 56205493
Pulmonary thrombosis 59.44 21.46 57 60160 7980 56223870
Immune system disorder 58.57 21.46 59 60158 8768 56223082
Impaired healing 58.48 21.46 11 60206 86830 56145020
Mobility decreased 57.86 21.46 17 60200 98974 56132876
Rash 57.59 21.46 791 59426 492256 55739594
Plasma cell leukaemia 56.90 21.46 27 60190 1156 56230694
Headache 56.30 21.46 359 59858 558685 55673165
Off label use 55.58 21.46 358 59859 555822 55676028
Fall 54.42 21.46 603 59614 356907 55874943
Illness 53.78 21.46 116 60101 34395 56197455
Respiratory syncytial virus infection 50.70 21.46 44 60173 5417 56226433
Deep vein thrombosis 50.47 21.46 189 60028 76788 56155062
Renal failure 50.45 21.46 243 59974 110257 56121593
Abdominal discomfort 50.21 21.46 142 60075 277132 55954718
Wrong technique in product usage process 50.16 21.46 3 60214 58165 56173685
Multiple allergies 50.14 21.46 59 60158 10437 56221413
Hypercalcaemia 49.85 21.46 94 60123 25317 56206533
Crystal nephropathy 49.11 21.46 22 60195 824 56231026
Musculoskeletal stiffness 48.75 21.46 57 60160 155950 56075900
Protein total increased 46.37 21.46 31 60186 2584 56229266
Fibromyalgia 46.06 21.46 5 60212 59598 56172252
Hyponatraemia 44.57 21.46 27 60190 102112 56129738
Hypokalaemia 44.04 21.46 23 60194 94414 56137436
Vomiting 42.75 21.46 335 59882 497893 55733957
Folliculitis 41.51 21.46 5 60212 54974 56176876
Coma 41.37 21.46 7 60210 59648 56172202
Monoclonal immunoglobulin present 41.25 21.46 19 60198 760 56231090
COVID-19 pneumonia 41.20 21.46 55 60162 11047 56220803
Malaise 40.77 21.46 585 59632 367275 55864575
Anaphylactic reaction 40.74 21.46 7 60210 58988 56172862
Aspartate aminotransferase increased 40.20 21.46 19 60198 82583 56149267
Memory impairment 39.25 21.46 190 60027 86367 56145483
Seasonal allergy 38.27 21.46 67 60150 17041 56214809
Osteoarthritis 38.27 21.46 19 60198 80277 56151573
Electrocardiogram QT prolonged 36.57 21.46 7 60210 54581 56177269
Alanine aminotransferase increased 36.54 21.46 28 60189 93634 56138216
Intentional product misuse 35.81 21.46 6 60211 51498 56180352
Injection site swelling 35.40 21.46 3 60214 43575 56188275
Dyspnoea 35.14 21.46 855 59362 591722 55640128
Tachycardia 34.91 21.46 37 60180 105839 56126011
Loss of personal independence in daily activities 34.82 21.46 22 60195 81347 56150503
Respiratory tract infection 34.80 21.46 101 60116 35970 56195880
Monoclonal immunoglobulin increased 34.72 21.46 10 60207 98 56231752
Back disorder 34.35 21.46 48 60169 10065 56221785
Tooth infection 34.34 21.46 61 60156 15691 56216159
Blood potassium decreased 34.20 21.46 105 60112 38567 56193283
Anxiety 34.15 21.46 100 60117 193072 56038778
Seizure 33.69 21.46 51 60166 125068 56106782
Liver injury 33.67 21.46 3 60214 41845 56190005
Cerebrovascular accident 33.52 21.46 201 60016 99069 56132781
Arthropathy 33.05 21.46 107 60110 200168 56031682
Blood calcium increased 32.75 21.46 42 60175 8112 56223738
Metabolic acidosis 32.28 21.46 3 60214 40451 56191399
Agitation 32.06 21.46 10 60207 56026 56175824
Pneumonia influenzal 32.02 21.46 20 60197 1484 56230366
Inflammation 31.94 21.46 17 60200 69054 56162796
Bone lesion 31.89 21.46 34 60183 5396 56226454
Hypersensitivity 31.52 21.46 154 60063 256254 55975596
Swelling face 31.36 21.46 131 60086 55938 56175912
Swelling 31.24 21.46 141 60076 239630 55992220
Dry skin 30.31 21.46 115 60102 46994 56184856
Toxicity to various agents 29.89 21.46 131 60086 224433 56007417
Cardio-respiratory arrest 29.69 21.46 11 60206 55310 56176540
Inappropriate schedule of product administration 28.79 21.46 28 60189 83359 56148491
Irritable bowel syndrome 28.62 21.46 19 60198 68439 56163411
Suicidal ideation 28.53 21.46 13 60204 57729 56174121
Pancytopenia 28.28 21.46 177 60040 88538 56143312
General physical health deterioration 27.92 21.46 91 60126 169919 56061931
Cystitis 27.76 21.46 115 60102 48923 56182927
Dysphonia 27.49 21.46 103 60114 41844 56190006
Depressed level of consciousness 27.43 21.46 13 60204 56420 56175430
Feeling abnormal 26.89 21.46 239 59978 133363 56098487
Vision blurred 26.76 21.46 166 60051 82777 56149073
Amyloidosis 26.60 21.46 16 60201 1109 56230741
SARS-CoV-2 test positive 26.47 21.46 33 60184 6196 56225654
Hypoaesthesia 25.89 21.46 248 59969 141243 56090607
Nervousness 25.86 21.46 79 60138 28936 56202914
Injury 25.86 21.46 16 60201 59835 56172015
Rash pruritic 25.69 21.46 118 60099 52476 56179374
Coronavirus infection 25.36 21.46 24 60193 3305 56228545
Spinal fracture 25.35 21.46 55 60162 16369 56215481
Medication error 25.23 21.46 7 60210 42328 56189522
Stress 25.10 21.46 16 60201 58894 56172956
Oxygen saturation decreased 24.56 21.46 29 60188 79038 56152812
Sedation 24.36 21.46 4 60213 34850 56197000
Neoplasm progression 23.95 21.46 3 60214 32013 56199837
Musculoskeletal pain 23.91 21.46 31 60186 81121 56150729
Localised infection 23.84 21.46 74 60143 27338 56204512
Upper respiratory tract infection 23.84 21.46 144 60073 71144 56160706
Migraine 23.73 21.46 35 60182 86762 56145088
Light chain analysis abnormal 23.59 21.46 8 60209 139 56231711
Pseudomonas aeruginosa meningitis 23.37 21.46 4 60213 0 56231850
International normalised ratio increased 23.23 21.46 9 60208 44032 56187818
Liver function test abnormal 23.01 21.46 10 60207 45661 56186189
Bradycardia 22.92 21.46 23 60194 67481 56164369
Hypertension 22.91 21.46 160 60057 244118 55987732
Hospitalisation 22.78 21.46 28 60189 74972 56156878
Angioedema 22.65 21.46 8 60209 41445 56190405
Fluid retention 22.59 21.46 116 60101 53962 56177888
Blister 22.58 21.46 52 60165 108835 56123015
Drug reaction with eosinophilia and systemic symptoms 22.28 21.46 3 60214 30301 56201549
Osteolysis 22.15 21.46 20 60197 2593 56229257
Balance disorder 22.14 21.46 149 60068 76371 56155479
Peritonitis viral 21.92 21.46 6 60211 48 56231802
Wheezing 21.76 21.46 29 60188 74997 56156853
Tumour lysis syndrome 21.71 21.46 34 60183 7889 56223961

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
Plasma cell myeloma 6507.36 18.88 2810 57948 53721 31582865
Death 1910.82 18.88 2845 57913 357724 31278862
Pneumonia 1513.64 18.88 2461 58297 332851 31303735
White blood cell count decreased 1124.04 18.88 1089 59669 86309 31550277
Full blood count decreased 1039.04 18.88 545 60213 15995 31620591
Fatigue 885.31 18.88 1962 58796 333244 31303342
Laboratory test abnormal 802.78 18.88 481 60277 18333 31618253
Neuropathy peripheral 658.81 18.88 767 59991 74882 31561704
Adverse drug reaction 542.13 18.88 422 60336 24779 31611807
Neutropenia 522.65 18.88 951 59807 139413 31497173
Unevaluable event 418.22 18.88 395 60363 30180 31606406
Thrombosis 414.73 18.88 471 60287 44680 31591906
Influenza 408.17 18.88 463 60295 43862 31592724
COVID-19 347.79 18.88 475 60283 54346 31582240
Drug interaction 333.46 18.88 16 60742 208527 31428059
Plasma cell myeloma recurrent 288.77 18.88 144 60614 3780 31632806
Peripheral swelling 283.05 18.88 484 60274 67381 31569205
Constipation 239 18.88 646 60112 123345 31513241
Nasopharyngitis 207.83 18.88 407 60351 62838 31573748
Rash 204.55 18.88 845 59913 200641 31435945
Neutrophil count decreased 204.08 18.88 339 60419 46055 31590531
Platelet count decreased 203.38 18.88 566 60192 109869 31526717
Condition aggravated 192.53 18.88 40 60718 163969 31472617
Infection 179.36 18.88 448 60310 81483 31555103
Cardiac disorder 161.11 18.88 278 60480 38936 31597650
Plasmacytoma 156.06 18.88 91 60667 3286 31633300
Muscle spasms 152.04 18.88 376 60382 67942 31568644
Renal disorder 137.98 18.88 197 60561 23448 31613138
Tooth disorder 135.90 18.88 129 60629 9900 31626686
Back pain 133.64 18.88 487 60271 108926 31527660
Overdose 133.48 18.88 7 60751 84657 31551929
Illness 130.82 18.88 122 60636 9155 31627431
Asthenia 121.52 18.88 791 59967 223964 31412622
Product use in unapproved indication 112.59 18.88 26 60732 99145 31537441
Product dose omission issue 110.87 18.88 448 60310 105138 31531448
Plasma cell leukaemia 94.75 18.88 43 60715 908 31635678
Localised infection 93.21 18.88 130 60628 15135 31621451
Abdominal pain 92.63 18.88 86 60672 145866 31490720
Deep vein thrombosis 92.26 18.88 291 60467 60445 31576141
Hyponatraemia 90.72 18.88 16 60742 73783 31562803
Light chain analysis increased 90.08 18.88 45 60713 1185 31635401
Immune system disorder 89.33 18.88 72 60686 4436 31632150
Rhabdomyolysis 86.97 18.88 10 60748 63571 31573015
Toxicity to various agents 85.46 18.88 135 60623 181352 31455234
Full blood count abnormal 83.55 18.88 128 60630 16219 31620367
Aspartate aminotransferase increased 83.01 18.88 11 60747 62708 31573878
Drug intolerance 82.44 18.88 253 60505 51780 31584806
Vomiting 81.67 18.88 194 60564 223779 31412807
Acute kidney injury 80.15 18.88 272 60486 279442 31357144
Rheumatoid arthritis 78.45 18.88 3 60755 47806 31588780
Sepsis 74.88 18.88 523 60235 151406 31485180
Alanine aminotransferase increased 71.19 18.88 27 60731 74629 31561957
Monoclonal immunoglobulin present 70.85 18.88 35 60723 899 31635687
Full blood count increased 69.78 18.88 33 60725 768 31635818
Bronchitis 68.69 18.88 196 60562 38521 31598065
Hypoglycaemia 67.26 18.88 9 60749 50937 31585649
Psoriasis 64.77 18.88 7 60751 46712 31589874
Blood test abnormal 63.06 18.88 68 60690 6073 31630513
Agitation 61.85 18.88 14 60744 54155 31582431
Hyperkalaemia 61.80 18.88 23 60735 64328 31572258
Bone pain 59.22 18.88 121 60637 19230 31617356
Sinusitis 57.70 18.88 178 60580 36518 31600068
Cytopenia 57.37 18.88 87 60671 10923 31625663
Atrial fibrillation 57.37 18.88 394 60364 113389 31523197
Ascites 57.22 18.88 6 60752 41007 31595579
Red blood cell count decreased 53.80 18.88 142 60616 26665 31609921
Suicide attempt 53.14 18.88 5 60753 37243 31599343
Fluid retention 52.46 18.88 134 60624 24668 31611918
Electrocardiogram QT prolonged 51.87 18.88 6 60752 37981 31598605
Wrong technique in product usage process 51.77 18.88 3 60755 33340 31603246
Back disorder 51.54 18.88 61 60697 6032 31630554
Off label use 51.36 18.88 423 60335 346851 31289735
Aggression 50.65 18.88 6 60752 37285 31599301
Cellulitis enterococcal 48.79 18.88 15 60743 98 31636488
Cataract 48.68 18.88 127 60631 23680 31612906
Anxiety 48.44 18.88 62 60696 90971 31545615
International normalised ratio increased 47.20 18.88 14 60744 45209 31591377
Adverse event 47.08 18.88 101 60657 16604 31619982
Hypotension 47.02 18.88 217 60541 204401 31432185
Hypokalaemia 46.85 18.88 22 60736 53552 31583034
Injection site pain 46.00 18.88 6 60752 34628 31601958
Interstitial lung disease 45.40 18.88 31 60727 61372 31575214
SARS-CoV-2 test positive 45.29 18.88 49 60709 4392 31632194
Arthropathy 44.84 18.88 124 60634 23927 31612659
Coma 44.32 18.88 12 60746 41138 31595448
Inappropriate schedule of product administration 44.24 18.88 21 60737 50802 31585784
Pulmonary thrombosis 44.08 18.88 60 60698 6825 31629761
Dyspnoea 43.77 18.88 911 59847 342568 31294018
Tachycardia 43.63 18.88 49 60709 76158 31560428
Rib fracture 42.81 18.88 85 60673 13231 31623355
Seizure 42.50 18.88 79 60679 99689 31536897
General physical health deterioration 42.26 18.88 97 60661 113338 31523248
White blood cell count abnormal 41.34 18.88 39 60719 2968 31633618
Pancreatitis 41.32 18.88 9 60749 35762 31600824
Haematuria 40.52 18.88 19 60739 46295 31590291
Depressed level of consciousness 40.19 18.88 12 60746 38589 31597997
Incorrect dose administered 39.31 18.88 10 60748 35742 31600844
Bradycardia 39.22 18.88 45 60713 69282 31567304
Dysarthria 39.20 18.88 7 60751 32010 31604576
Drug hypersensitivity 39.08 18.88 49 60709 72550 31564036
Blood calcium increased 38.25 18.88 39 60719 3263 31633323
Melaena 38.16 18.88 8 60750 32646 31603940
Drug reaction with eosinophilia and systemic symptoms 38.00 18.88 6 60752 30012 31606574
Upper limb fracture 37.96 18.88 44 60714 4255 31632331
Headache 37.46 18.88 203 60555 183449 31453137
COVID-19 pneumonia 37.38 18.88 78 60680 12577 31624009
Gastrointestinal haemorrhage 37.29 18.88 63 60695 82486 31554100
Cholestasis 36.76 18.88 3 60755 25072 31611514
Squamous cell carcinoma of skin 36.45 18.88 68 60690 10106 31626480
Hip fracture 36.37 18.88 71 60687 10915 31625671
Jaundice 36.27 18.88 7 60751 30280 31606306
Mucosal inflammation 35.31 18.88 11 60747 34416 31602170
Hypoaesthesia 35.02 18.88 205 60553 55817 31580769
Cardiac arrest 34.93 18.88 74 60684 88988 31547598
Oxygen saturation decreased 34.73 18.88 26 60732 49089 31587497
Balance disorder 34.69 18.88 153 60605 37269 31599317
Coronary artery disease 34.42 18.88 23 60735 46064 31590522
Respiratory tract infection 34.19 18.88 92 60666 17469 31619117
Angioedema 34.02 18.88 11 60747 33607 31602979
JC virus infection 33.60 18.88 29 60729 1965 31634621
Protein total increased 33.38 18.88 30 60728 2145 31634441
Body height decreased 32.83 18.88 37 60721 3470 31633116
Drug ineffective 32.66 18.88 548 60210 395025 31241561
Dizziness 32.46 18.88 549 60209 198598 31437988
Bone lesion 32.24 18.88 33 60725 2774 31633812
Gamma-glutamyltransferase increased 32.14 18.88 7 60751 27818 31608768
White blood cell disorder 31.93 18.88 25 60733 1476 31635110
Psychotic disorder 31.78 18.88 3 60755 22290 31614296
Hepatic function abnormal 31.57 18.88 20 60738 41202 31595384
Stress 31.53 18.88 5 60753 24936 31611650
Lower respiratory tract infection 31.32 18.88 122 60636 28115 31608471
Progressive multifocal leukoencephalopathy 31.06 18.88 60 60698 9153 31627433
Acute myocardial infarction 30.96 18.88 31 60727 50792 31585794
Metabolic acidosis 30.58 18.88 19 60739 39558 31597028
Haematemesis 30.57 18.88 6 60752 25647 31610939
Gastric disorder 30.55 18.88 68 60690 11460 31625126
Multiple allergies 30.49 18.88 30 60728 2405 31634181
Tooth infection 30.36 18.88 47 60711 6007 31630579
Feeling abnormal 30.24 18.88 200 60558 56802 31579784
Blood urea increased 30.24 18.88 9 60749 29003 31607583
Hypercalcaemia 29.97 18.88 76 60682 13924 31622662
Agranulocytosis 29.91 18.88 3 60755 21244 31615342
Cardio-respiratory arrest 29.88 18.88 33 60725 51693 31584893
Blood bilirubin increased 29.84 18.88 15 60743 35121 31601465
Pneumonia respiratory syncytial viral 29.72 18.88 19 60739 811 31635775
Lactic acidosis 29.68 18.88 12 60746 31925 31604661
Epilepsy 29.55 18.88 3 60755 21038 31615548
Malaise 29.47 18.88 470 60288 168041 31468545
Fall 29.23 18.88 510 60248 185579 31451007
Encephalopathy 28.91 18.88 13 60745 32461 31604125
Blood immunoglobulin M increased 28.66 18.88 12 60746 207 31636379
Respiration abnormal 28.54 18.88 31 60727 2791 31633795
Parainfluenzae virus infection 28.51 18.88 29 60729 2420 31634166
Drug-induced liver injury 28.40 18.88 6 60752 24357 31612229
Musculoskeletal disorder 27.98 18.88 44 60714 5700 31630886
Anaphylactic reaction 27.64 18.88 11 60747 29542 31607044
Spinal fracture 27.17 18.88 48 60710 6840 31629746
Product prescribing error 27.07 18.88 3 60755 19639 31616947
Respiratory syncytial virus infection 27.00 18.88 35 60723 3796 31632790
Toxic epidermal necrolysis 26.86 18.88 3 60755 19521 31617065
Transaminases increased 26.39 18.88 7 60751 24334 31612252
Neutropenic sepsis 26.29 18.88 67 60691 12312 31624274
Hepatotoxicity 26.16 18.88 3 60755 19123 31617463
Blood alkaline phosphatase increased 25.89 18.88 12 60746 29441 31607145
Blood lactate dehydrogenase increased 25.89 18.88 4 60754 20335 31616251
Respiratory arrest 25.85 18.88 9 60749 26248 31610338
Clostridium difficile infection 25.48 18.88 82 60676 17197 31619389
White blood cell count increased 24.67 18.88 23 60735 38977 31597609
Blood creatinine increased 24.47 18.88 88 60670 88990 31547596
Blood immunoglobulin A increased 24.37 18.88 12 60746 306 31636280
Therapeutic product effect incomplete 24.02 18.88 29 60729 43667 31592919
C-reactive protein increased 23.98 18.88 35 60723 48615 31587971
Lower limb fracture 23.91 18.88 33 60725 3802 31632784
Medication error 23.85 18.88 7 60751 22765 31613821
Protein total abnormal 23.74 18.88 12 60746 324 31636262
Blood pressure abnormal 23.64 18.88 47 60711 7322 31629264
Ventricular tachycardia 23.55 18.88 8 60750 23693 31612893
Upper respiratory tract infection 23.37 18.88 115 60643 29307 31607279
Cardiogenic shock 23.26 18.88 7 60751 22401 31614185
Vertebral lesion 23.19 18.88 10 60748 186 31636400
Generalised tonic-clonic seizure 23.05 18.88 5 60753 19926 31616660
Leukocytosis 22.79 18.88 7 60751 22107 31614479
Pneumonia influenzal 22.75 18.88 20 60738 1389 31635197
Circulatory collapse 22.73 18.88 5 60753 19739 31616847
Cerebral toxoplasmosis 22.73 18.88 21 60737 1556 31635030
Pyrexia 22.58 18.88 751 60007 303089 31333497
Sinus disorder 22.46 18.88 42 60716 6253 31630333
Product use issue 22.38 18.88 47 60711 56712 31579874
Thrombocytopenia 22.31 18.88 391 60367 142356 31494230
Blood pressure systolic increased 22.28 18.88 5 60753 19465 31617121
Seasonal allergy 22.12 18.88 39 60719 5549 31631037
Abnormal behaviour 22.07 18.88 9 60749 23819 31612767
Arthralgia 22.02 18.88 185 60573 151239 31485347
Pleural effusion 21.94 18.88 72 60686 74848 31561738
Shock 21.89 18.88 8 60750 22637 31613949
Tremor 21.69 18.88 233 60525 76187 31560399
Haemoptysis 21.54 18.88 18 60740 32171 31604415
Drug resistance 21.49 18.88 9 60749 23444 31613142
Nausea 21.48 18.88 439 60319 307508 31329078
Sedation 21.44 18.88 5 60753 18960 31617626
Eosinophilia 21.18 18.88 9 60749 23244 31613342
Product quality issue 20.89 18.88 3 60755 16108 31620478
Dyskinesia 20.88 18.88 7 60751 20903 31615683
Hospitalisation 20.70 18.88 40 60718 49767 31586819
Hepatic enzyme increased 20.64 18.88 23 60735 35885 31600701
Hallucination, visual 20.35 18.88 3 60755 15791 31620795
Viral infection 20.33 18.88 71 60687 15522 31621064
Hypertension 20.24 18.88 153 60605 127947 31508639
Dysphagia 20.13 18.88 51 60707 57625 31578961
Clonal haematopoiesis 19.90 18.88 7 60751 73 31636513
Respiratory distress 19.83 18.88 21 60737 33532 31603054
Restlessness 19.80 18.88 10 60748 23351 31613235
Myocardial ischaemia 19.64 18.88 4 60754 16663 31619923
Upper gastrointestinal haemorrhage 19.53 18.88 10 60748 23173 31613413
Swelling face 19.47 18.88 87 60671 21303 31615283
Hiccups 19.45 18.88 50 60708 9237 31627349
Monoclonal immunoglobulin increased 19.33 18.88 7 60751 80 31636506
Hypoacusis 19.30 18.88 68 60690 14931 31621655
Ageusia 19.30 18.88 50 60708 9281 31627305
Wound infection 19.23 18.88 40 60718 6435 31630151
Malignant neoplasm progression 19.17 18.88 82 60676 78916 31557670
Unresponsive to stimuli 19.10 18.88 13 60745 25787 31610799
Haematochezia 19.08 18.88 30 60728 40434 31596152
Spinal disorder 19.05 18.88 30 60728 3890 31632696
Coronavirus infection 19.04 18.88 29 60729 3654 31632932
Rectal haemorrhage 19.01 18.88 25 60733 36279 31600307

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
Plasma cell myeloma 10336.74 18.45 3566 69685 69635 70785558
Death 3138.76 18.45 3194 70057 506867 70348326
Pneumonia 2388.11 18.45 2989 70262 593243 70261950
White blood cell count decreased 1451.89 18.45 1283 71968 168858 70686335
Neutropenia 1336.49 18.45 1479 71772 255677 70599516
Full blood count decreased 1296.41 18.45 586 72665 23332 70831861
Neuropathy peripheral 775.89 18.45 797 72454 126099 70729094
Fatigue 565.25 18.45 1996 71255 822323 70032870
Neutrophil count decreased 562.05 18.45 553 72698 83003 70772190
Thrombosis 540.85 18.45 517 72734 74888 70780305
Platelet count decreased 512.65 18.45 766 72485 177456 70677737
Laboratory test abnormal 472.77 18.45 308 72943 25515 70829678
COVID-19 360.25 18.45 493 72758 105264 70749929
Plasma cell myeloma recurrent 353.14 18.45 142 73109 4204 70850989
Unevaluable event 339.53 18.45 339 72912 51724 70803469
Plasmacytoma 324.37 18.45 131 73120 3923 70851270
Influenza 314.17 18.45 480 72771 113220 70741973
Drug interaction 303.71 18.45 24 73227 381417 70473776
Rheumatoid arthritis 280.68 18.45 4 73247 291801 70563392
Condition aggravated 264.88 18.45 59 73192 427576 70427617
Constipation 230.95 18.45 677 72574 251761 70603432
Sepsis 221.93 18.45 654 72597 243891 70611302
Thrombocytopenia 221.33 18.45 644 72607 238466 70616727
Deep vein thrombosis 200.11 18.45 388 72863 110654 70744539
Plasma cell leukaemia 169.00 18.45 66 73185 1805 70853388
Human chorionic gonadotropin increased 167.69 18.45 56 73195 962 70854231
Anaemia 166.16 18.45 839 72412 402584 70452609
Rash 164.98 18.45 994 72257 509568 70345625
Muscle spasms 150.22 18.45 423 72828 153623 70701570
Cytopenia 149.79 18.45 132 73119 17191 70838002
Atrial fibrillation 145.65 18.45 470 72781 183878 70671315
Drug hypersensitivity 143.81 18.45 46 73205 262413 70592780
Light chain analysis increased 140.08 18.45 54 73197 1425 70853768
Product dose omission issue 136.73 18.45 514 72737 216954 70638239
Overdose 126.10 18.45 14 73237 169731 70685462
Infection 125.76 18.45 490 72761 210295 70644898
Drug ineffective 123.08 18.45 527 72724 939225 69915968
Adverse drug reaction 120.94 18.45 206 73045 53138 70802055
Arthralgia 115.68 18.45 215 73036 503175 70352018
Abdominal pain 113.05 18.45 112 73139 342015 70513178
Asthenia 112.01 18.45 832 72419 456834 70398359
Product use in unapproved indication 109.04 18.45 39 73212 207439 70647754
Bronchitis 106.56 18.45 314 72937 116929 70738264
Cardiac disorder 100.18 18.45 202 73049 59213 70795980
Headache 99.51 18.45 290 72961 580115 70275078
Peripheral swelling 93.66 18.45 487 72764 236076 70619117
Red blood cell count decreased 92.34 18.45 181 73070 51980 70803213
Hypercalcaemia 91.79 18.45 143 73108 34242 70820951
Injection site pain 89.14 18.45 9 73242 117610 70737583
Renal disorder 89.09 18.45 149 73102 37860 70817333
Bone pain 84.74 18.45 172 73079 50650 70804543
Febrile neutropenia 83.90 18.45 425 72826 203893 70651300
Pulmonary thrombosis 78.63 18.45 76 73175 11132 70844061
Urinary tract infection 77.91 18.45 481 72770 248288 70606905
COVID-19 pneumonia 77.08 18.45 104 73147 21865 70833328
Psoriasis 75.99 18.45 7 73244 98426 70756767
Neutropenic sepsis 75.87 18.45 110 73141 24720 70830473
Therapeutic product effect decreased 74.92 18.45 27 73224 142991 70712202
Hip fracture 74.68 18.45 117 73134 28146 70827047
Pericarditis 71.19 18.45 4 73247 84701 70770492
Vomiting 71.14 18.45 343 72908 592768 70262425
Treatment failure 69.32 18.45 31 73220 144111 70711082
Pancytopenia 68.94 18.45 324 72927 150783 70704410
Respiratory tract infection 68.92 18.45 142 73109 42256 70812937
Hyponatraemia 68.67 18.45 40 73211 160047 70695146
Pyrexia 68.40 18.45 940 72311 606012 70249181
Rhabdomyolysis 68.38 18.45 9 73242 95751 70759442
Fall 66.57 18.45 726 72525 443370 70411823
Squamous cell carcinoma of skin 65.40 18.45 73 73178 12639 70842554
Anxiety 64.07 18.45 80 73171 220250 70634943
Musculoskeletal stiffness 63.27 18.45 37 73214 147723 70707470
Injection site erythema 62.68 18.45 3 73248 72921 70782272
Hepatic enzyme increased 62.16 18.45 43 73208 156947 70698246
Haemoglobin decreased 61.90 18.45 393 72858 204766 70650427
Nasopharyngitis 61.18 18.45 416 72835 221790 70633403
Suicide attempt 60.46 18.45 6 73245 79504 70775689
Monoclonal immunoglobulin present 57.89 18.45 25 73226 888 70854305
Stress 57.77 18.45 3 73248 67963 70787230
Agitation 57.43 18.45 13 73238 93362 70761831
Aspartate aminotransferase increased 56.96 18.45 30 73221 126948 70728245
Discomfort 56.77 18.45 19 73232 105417 70749776
Intentional product misuse 55.60 18.45 8 73243 79587 70775606
Back pain 55.23 18.45 473 72778 270679 70584514
Tremor 55.18 18.45 311 72940 155313 70699880
Coma 54.11 18.45 14 73237 91830 70763363
Infusion related reaction 54.07 18.45 75 73176 197459 70657734
Pain 53.59 18.45 405 72846 628411 70226782
Glossodynia 53.27 18.45 12 73239 86475 70768718
Hypertension 52.74 18.45 145 73106 295888 70559305
Pulmonary embolism 52.32 18.45 307 72944 155560 70699633
Blood calcium increased 52.13 18.45 55 73196 8938 70846255
Respiratory syncytial virus infection 52.00 18.45 51 73200 7604 70847589
Diarrhoea 51.38 18.45 1112 72139 782229 70072964
Leukopenia 51.18 18.45 232 73019 106328 70748865
Electrocardiogram QT prolonged 50.62 18.45 12 73239 83505 70771688
Therapeutic product effect incomplete 49.94 18.45 31 73220 119851 70735342
Hypokalaemia 49.24 18.45 38 73213 131150 70724043
Renal failure 48.52 18.45 348 72903 188722 70666471
Toxicity to various agents 46.90 18.45 219 73032 381953 70473240
Cerebrovascular accident 46.49 18.45 280 72971 143190 70712003
Wound 46.27 18.45 22 73229 98710 70756483
Progressive multifocal leukoencephalopathy 45.92 18.45 76 73175 19138 70836055
Adverse event 45.40 18.45 133 73118 49328 70805865
Rib fracture 44.88 18.45 88 73163 25268 70829925
Product use issue 44.71 18.45 73 73178 179864 70675329
Tooth disorder 43.49 18.45 84 73167 23854 70831339
Immune system disorder 43.23 18.45 52 73199 9749 70845444
Hypoglycaemia 42.75 18.45 22 73229 94342 70760851
Mobility decreased 42.40 18.45 27 73224 102972 70752221
Alanine aminotransferase increased 41.35 18.45 55 73196 147425 70707768
Dyspnoea 41.21 18.45 1063 72188 768997 70086196
Crystal nephropathy 41.03 18.45 22 73229 1268 70853925
Impaired healing 40.74 18.45 13 73238 74361 70780832
Inflammation 39.27 18.45 16 73235 78649 70776544
Osteoarthritis 38.81 18.45 14 73237 74133 70781060
Aggression 38.61 18.45 3 73248 48443 70806750
Pneumonia influenzal 37.92 18.45 27 73224 2583 70852610
Oxygen saturation decreased 37.38 18.45 39 73212 116390 70738803
Cellulitis enterococcal 36.98 18.45 9 73242 44 70855149
Full blood count abnormal 36.93 18.45 97 73154 33781 70821412
Dizziness 36.70 18.45 678 72573 463463 70391730
Suicidal ideation 36.67 18.45 13 73238 69583 70785610
Blood test abnormal 36.62 18.45 59 73192 14531 70840662
SARS-CoV-2 test positive 36.49 18.45 45 73206 8656 70846537
Anaphylactic reaction 36.23 18.45 16 73235 74958 70780235
Lymphocyte count decreased 36.13 18.45 113 73138 43426 70811767
Peripheral sensory neuropathy 36.05 18.45 53 73198 12057 70843136
Full blood count increased 36.05 18.45 15 73236 485 70854708
Hypotension 35.54 18.45 258 72993 404123 70451070
White blood cell count abnormal 35.25 18.45 35 73216 5295 70849898
Weight decreased 35.14 18.45 183 73068 310305 70544888
Pneumonia pneumococcal 34.91 18.45 29 73222 3485 70851708
International normalised ratio increased 34.85 18.45 20 73231 80706 70774487
JC virus infection 34.64 18.45 29 73222 3522 70851671
Depressed level of consciousness 34.52 18.45 24 73227 87407 70767786
Lactic acidosis 34.51 18.45 12 73239 65012 70790181
Type 2 diabetes mellitus 34.38 18.45 3 73248 44077 70811116
Amyloidosis 34.17 18.45 26 73225 2753 70852440
Angioedema 34.15 18.45 13 73238 66597 70788596
Drug-induced liver injury 34.13 18.45 8 73243 56105 70799088
Back disorder 34.03 18.45 48 73203 10516 70844677
Upper respiratory tract infection 33.97 18.45 167 73084 79107 70776086
Drug reaction with eosinophilia and systemic symptoms 33.87 18.45 9 73242 58004 70797189
Haematemesis 33.86 18.45 5 73246 48792 70806401
Depression 33.54 18.45 100 73151 198874 70656319
Inappropriate schedule of product administration 33.44 18.45 37 73214 107518 70747675
Medication error 32.90 18.45 9 73242 56903 70798290
Incorrect dose administered 32.61 18.45 14 73237 66705 70788488
Melaena 32.42 18.45 9 73242 56346 70798847
Sedation 31.94 18.45 5 73246 46726 70808467
Pathological fracture 31.55 18.45 44 73207 9539 70845654
Dyskinesia 31.48 18.45 3 73248 41071 70814122
Blood pressure systolic increased 31.38 18.45 10 73241 57249 70797944
Loss of personal independence in daily activities 31.34 18.45 25 73226 84885 70770308
Blood pressure fluctuation 31.13 18.45 11 73240 59001 70796192
Parainfluenzae virus infection 31.11 18.45 32 73219 5048 70850145
Bone lesion 31.10 18.45 33 73218 5397 70849796
Tumour lysis syndrome 30.63 18.45 68 73183 21292 70833901
Cataract 30.42 18.45 126 73125 55519 70799674
Pneumonia respiratory syncytial viral 30.40 18.45 19 73232 1462 70853731
Rash pruritic 30.12 18.45 137 73114 62854 70792339
Toxic epidermal necrolysis 30.03 18.45 3 73248 39554 70815639
Tachycardia 29.46 18.45 76 73175 158470 70696723
Weight increased 29.03 18.45 140 73111 242191 70613002
Ascites 28.78 18.45 17 73234 67530 70787663
Hepatitis 28.71 18.45 8 73243 49972 70805221
Injury 28.40 18.45 16 73235 65229 70789964
Folliculitis 28.11 18.45 5 73246 42565 70812628
Blood immunoglobulin M increased 28.02 18.45 13 73238 548 70854645
Blood cholesterol increased 27.89 18.45 16 73235 64588 70790605
Chest discomfort 27.70 18.45 54 73197 124327 70730866
Hyperkalaemia 27.64 18.45 42 73209 106549 70748644
Drug level increased 27.08 18.45 3 73248 36466 70818727
Blood pressure increased 26.81 18.45 102 73149 188415 70666778
Muscle injury 26.58 18.45 4 73247 38490 70816703
Pancreatitis 26.38 18.45 16 73235 62652 70792541
Mucosal inflammation 26.29 18.45 19 73232 67831 70787362
Metabolic acidosis 26.08 18.45 23 73228 74323 70780870
Osteoporosis 26.00 18.45 9 73242 48898 70806295
Irritable bowel syndrome 25.94 18.45 10 73241 50840 70804353
Pneumocystis jirovecii pneumonia 25.81 18.45 79 73172 30003 70825190
Cardio-respiratory arrest 25.79 18.45 40 73211 100637 70754556
Abdominal discomfort 25.71 18.45 124 73127 214534 70640659
Localised infection 25.64 18.45 84 73167 33074 70822119
Wheezing 25.50 18.45 36 73215 94134 70761059
Depressed mood 25.20 18.45 7 73244 43813 70811380
Dysarthria 24.74 18.45 17 73234 62296 70792897
Liver injury 24.66 18.45 6 73245 41029 70814164
Epilepsy 24.66 18.45 5 73246 38779 70816414
Ill-defined disorder 24.44 18.45 13 73238 54728 70800465
Seizure 24.22 18.45 98 73153 177864 70677329
Blister 23.84 18.45 42 73209 100484 70754709
Bradycardia 23.71 18.45 59 73192 124556 70730637
Dysphagia 23.42 18.45 51 73200 112783 70742410
Migraine 23.40 18.45 24 73227 72214 70782979
General physical health deterioration 22.99 18.45 146 73105 235885 70619308
Neoplasm progression 22.90 18.45 9 73242 45219 70809974
Clavicle fracture 22.85 18.45 24 73227 3880 70851313
Injection site swelling 22.84 18.45 8 73243 43149 70812044
Upper limb fracture 22.76 18.45 51 73200 16068 70839125
Feeling hot 22.56 18.45 11 73240 48659 70806534
Coronary artery disease 22.50 18.45 19 73232 62717 70792476
Respiratory arrest 22.38 18.45 14 73237 53919 70801274
Colitis ulcerative 22.36 18.45 4 73247 33919 70821274
Restlessness 21.97 18.45 8 73243 42120 70813073
Leukocytosis 21.61 18.45 7 73244 39661 70815532
Generalised tonic-clonic seizure 21.58 18.45 8 73243 41653 70813540
Spinal fracture 21.55 18.45 50 73201 16117 70839076
Product quality issue 21.51 18.45 3 73248 30558 70824635
Pulmonary arterial hypertension 21.39 18.45 4 73247 32851 70822342
Accidental overdose 21.37 18.45 5 73246 35116 70820077
Clostridium difficile infection 21.30 18.45 88 73163 38728 70816465
Peritonitis viral 21.21 18.45 6 73245 57 70855136
Coronavirus infection 21.02 18.45 29 73222 6223 70848970
Hypersensitivity 20.95 18.45 145 73106 229667 70625526
Swelling face 20.90 18.45 124 73127 63040 70792153
Septic shock 20.83 18.45 192 73059 112066 70743127
Listeriosis 20.66 18.45 17 73234 2015 70853178
Dehydration 20.57 18.45 338 72913 225804 70629389
Blood bilirubin increased 20.45 18.45 19 73232 59882 70795311
Musculoskeletal pain 20.29 18.45 39 73212 90288 70764905
Nausea 20.26 18.45 699 72552 851389 70003804
Viral infection 20.25 18.45 86 73165 38305 70816888
Hemiparesis 20.13 18.45 4 73247 31465 70823728
Atelectasis 20.02 18.45 3 73248 28959 70826234
Atrial flutter 19.95 18.45 56 73195 20271 70834922
Off label use 19.94 18.45 600 72651 742460 70112733
Light chain analysis decreased 19.85 18.45 4 73247 6 70855187
Transaminases increased 19.79 18.45 12 73239 47006 70808187
Flushing 19.78 18.45 34 73217 82138 70773055
Gastrointestinal haemorrhage 19.76 18.45 74 73177 137334 70717859
Arthropathy 19.56 18.45 84 73167 149973 70705220
Unresponsive to stimuli 19.53 18.45 15 73236 51916 70803277
Neutrophil count abnormal 19.52 18.45 20 73231 3141 70852052
Osteolysis 19.47 18.45 21 73230 3498 70851695
Meningitis listeria 19.38 18.45 12 73239 908 70854285
Protein total increased 19.29 18.45 21 73230 3536 70851657
Hip arthroplasty 19.16 18.45 3 73248 28037 70827156
Anaphylactic shock 19.04 18.45 5 73246 32485 70822708
Avulsion fracture 18.96 18.45 8 73243 268 70854925
Shock 18.95 18.45 9 73242 40416 70814777
Eosinophilia 18.86 18.45 9 73242 40310 70814883
Compression fracture 18.83 18.45 27 73224 6004 70849189
Pulmonary fibrosis 18.78 18.45 6 73245 34304 70820889
Gastrointestinal disorder 18.47 18.45 52 73199 105375 70749818

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
1369713 RXNORM
199372 MMSL
29234 MMSL
d08041 MMSL
014897 NDDF
703789000 SNOMEDCT_US
703790009 SNOMEDCT_US
C2347624 UMLSCUI
134780 PUBCHEM_CID

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