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

Stem definitionDrug idCAS RN
antineoplastics, thalidomide derivatives 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 2085.83 21.25 2165 59567 372216 63055074
White blood cell count decreased 1614.85 21.25 1223 60509 137881 63289409
Full blood count decreased 1485.13 21.25 649 61083 25375 63401915
Pneumonia 1452.26 21.25 1986 59746 454781 62972509
Neutropenia 953.93 21.25 1004 60728 174001 63253289
Neuropathy peripheral 927.92 21.25 815 60917 112852 63314438
Laboratory test abnormal 849.21 21.25 447 61285 26465 63400825
Fatigue 536.14 21.25 1979 59753 886049 62541241
Thrombosis 460.19 21.25 430 61302 64325 63362965
Platelet count decreased 433.71 21.25 549 61183 115573 63311717
Neutrophil count decreased 415.14 21.25 382 61350 56024 63371266
Constipation 411.48 21.25 763 60969 224180 63203110
Unevaluable event 380.07 21.25 349 61383 51037 63376253
Plasma cell myeloma recurrent 295.69 21.25 113 61619 3100 63424190
Influenza 274.27 21.25 426 61306 108296 63318994
Plasmacytoma 260.15 21.25 97 61635 2482 63424808
Adverse drug reaction 255.75 21.25 350 61382 79364 63347926
Condition aggravated 243.35 21.25 48 61684 402169 63025121
Human chorionic gonadotropin increased 241.51 21.25 81 61651 1504 63425786
COVID-19 236.28 21.25 407 61325 112696 63314594
Rheumatoid arthritis 222.77 21.25 5 61727 253814 63173476
Muscle spasms 209.22 21.25 466 61266 155684 63271606
Product dose omission issue 185.20 21.25 574 61158 233739 63193551
Plasma cell myeloma 175.56 21.25 195 61537 35710 63391580
Tremor 174.11 21.25 392 61340 131847 63295443
Cytopenia 158.76 21.25 113 61619 11488 63415802
Nasopharyngitis 156.75 21.25 573 61159 253684 63173606
Diarrhoea 155.41 21.25 1206 60526 714160 62713130
Bronchitis 155.22 21.25 362 61370 124573 63302717
Drug ineffective 153.75 21.25 514 61218 1044251 62383039
Asthenia 148.04 21.25 750 60982 382854 63044436
Drug interaction 143.42 21.25 25 61707 229106 63198184
Light chain analysis increased 141.30 21.25 52 61680 1281 63426009
Urinary tract infection 139.01 21.25 567 61165 264117 63163173
Drug hypersensitivity 131.64 21.25 69 61663 310618 63116672
Thrombocytopenia 128.38 21.25 380 61352 150777 63276513
Peripheral swelling 127.41 21.25 554 61178 265388 63161902
Infusion related reaction 125.81 21.25 41 61691 245480 63181810
Anaemia 120.37 21.25 584 61148 292846 63134444
Product use in unapproved indication 115.47 21.25 18 61714 179062 63248228
Full blood count increased 114.60 21.25 42 61690 1022 63426268
Renal disorder 113.62 21.25 150 61582 32824 63394466
Injection site pain 112.11 21.25 3 61729 129797 63297493
Treatment failure 109.71 21.25 29 61703 199014 63228276
Cardiac disorder 108.80 21.25 185 61547 50631 63376659
Product use issue 105.83 21.25 41 61691 220479 63206811
Arthralgia 102.63 21.25 254 61478 569456 62857834
Red blood cell count decreased 101.98 21.25 159 61573 40486 63386804
Glossodynia 100.61 21.25 25 61707 178851 63248439
Back pain 96.52 21.25 509 61223 263636 63163654
Atrial fibrillation 93.13 21.25 287 61445 116349 63310941
Therapeutic product effect decreased 92.55 21.25 36 61696 193151 63234139
Wound 89.55 21.25 24 61708 163239 63264051
Hepatic enzyme increased 84.07 21.25 46 61686 202282 63225008
Discomfort 83.87 21.25 29 61703 167345 63259945
Dizziness 83.23 21.25 707 61025 429218 62998072
Infection 79.86 21.25 436 61296 228737 63198553
Haemoglobin decreased 79.69 21.25 316 61416 145169 63282121
Abdominal pain 78.68 21.25 102 61630 293354 63133936
Therapeutic product effect incomplete 77.43 21.25 14 61718 125042 63302248
Cataract 77.09 21.25 171 61561 56882 63370408
Rash 74.25 21.25 852 60880 560019 62867271
Helicobacter infection 73.81 21.25 4 61728 92781 63334509
Hip fracture 73.51 21.25 115 61617 29359 63397931
Sepsis 73.20 21.25 319 61413 152804 63274486
Overdose 73.18 21.25 12 61720 115066 63312224
Bone pain 69.61 21.25 160 61572 54481 63372809
Tooth disorder 69.03 21.25 109 61623 28048 63399242
Fall 67.53 21.25 629 61103 391705 63035585
Pulmonary thrombosis 66.01 21.25 60 61672 8642 63418648
Pain 65.51 21.25 437 61295 740191 62687099
Renal failure 64.77 21.25 256 61476 117396 63309894
Impaired healing 64.52 21.25 11 61721 102531 63324759
Immune system disorder 63.48 21.25 62 61670 9772 63417518
Psoriasis 62.73 21.25 6 61726 86951 63340339
Respiratory syncytial virus infection 62.49 21.25 53 61679 6965 63420325
Mobility decreased 62.42 21.25 20 61712 121139 63306151
Full blood count abnormal 60.78 21.25 110 61622 31607 63395683
Deep vein thrombosis 60.29 21.25 199 61533 83601 63343689
Fibromyalgia 59.49 21.25 5 61727 80415 63346875
Hypercalcaemia 59.14 21.25 102 61630 28220 63399070
Illness 57.43 21.25 139 61593 48920 63378370
Musculoskeletal stiffness 57.24 21.25 57 61675 184561 63242729
Blood test abnormal 56.79 21.25 73 61659 15556 63411734
Headache 52.78 21.25 380 61352 632861 62794429
Abdominal discomfort 52.36 21.25 150 61582 320735 63106555
Plasma cell leukaemia 51.12 21.25 24 61708 1106 63426184
Folliculitis 50.33 21.25 5 61727 70312 63356978
Crystal nephropathy 48.99 21.25 22 61710 914 63426376
Wrong technique in product usage process 48.62 21.25 3 61729 62337 63364953
Protein total increased 47.37 21.25 31 61701 2746 63424544
Liver injury 46.94 21.25 3 61729 60517 63366773
Malaise 45.47 21.25 610 61122 415344 63011946
Injection site reaction 45.10 21.25 3 61729 58521 63368769
COVID-19 pneumonia 44.92 21.25 62 61670 14147 63413143
Osteoarthritis 43.63 21.25 19 61713 95324 63331966
Dyspnoea 43.14 21.25 891 60841 660422 62766868
Multiple allergies 41.80 21.25 59 61673 13743 63413547
Anaphylactic reaction 41.78 21.25 7 61725 66093 63361197
Monoclonal immunoglobulin increased 41.39 21.25 12 61720 134 63427156
Monoclonal immunoglobulin present 41.37 21.25 19 61713 832 63426458
Respiratory tract infection 40.73 21.25 110 61622 41373 63385917
Coma 40.27 21.25 7 61725 64357 63362933
Loss of personal independence in daily activities 39.11 21.25 23 61709 97267 63330023
Hyponatraemia 38.93 21.25 31 61701 111869 63315421
Aspartate aminotransferase increased 38.23 21.25 20 61712 90257 63337033
Cerebrovascular accident 37.88 21.25 206 61526 107818 63319472
Blood potassium decreased 37.87 21.25 108 61624 41918 63385372
Vomiting 37.81 21.25 355 61377 559262 62868028
Back disorder 37.76 21.25 50 61682 10967 63416323
Osteolysis 37.04 21.25 27 61705 2847 63424443
Arthropathy 36.65 21.25 112 61620 234680 63192610
Electrocardiogram QT prolonged 36.12 21.25 7 61725 59523 63367767
Blood calcium increased 36.07 21.25 45 61687 9305 63417985
Pneumonia pneumococcal 36.02 21.25 24 61708 2191 63425099
Inappropriate schedule of product administration 35.92 21.25 29 61703 103936 63323354
Coronavirus infection 35.43 21.25 31 61701 4247 63423043
Tooth infection 35.41 21.25 63 61669 17857 63409433
Memory impairment 35.33 21.25 197 61535 104061 63323229
Inflammation 35.18 21.25 18 61714 82255 63345035
Injection site swelling 35.06 21.25 3 61729 47569 63379721
Pancytopenia 34.76 21.25 186 61546 96747 63330543
Alanine aminotransferase increased 34.55 21.25 30 61702 103740 63323550
Seasonal allergy 34.36 21.25 68 61664 20882 63406408
Bone lesion 34.13 21.25 35 61697 5846 63421444
Tachycardia 33.80 21.25 39 61693 118117 63309173
Hypokalaemia 33.38 21.25 31 61701 103773 63323517
Swelling face 33.21 21.25 136 61596 63339 63363951
Metabolic acidosis 32.79 21.25 3 61729 45066 63382224
Leukopenia 32.41 21.25 155 61577 77135 63350155
Irritable bowel syndrome 32.40 21.25 20 61712 82392 63344898
Swelling 32.13 21.25 148 61584 275230 63152060
Vision blurred 32.02 21.25 175 61557 91749 63335541
Anxiety 31.69 21.25 107 61625 217434 63209856
Pneumonia influenzal 31.55 21.25 20 61712 1677 63425613
Intentional product misuse 31.46 21.25 10 61722 60907 63366383
Injury 31.35 21.25 16 61716 73231 63354059
Nervousness 31.27 21.25 83 61649 30896 63396394
Spinal fracture 30.81 21.25 60 61672 18211 63409079
Feeling abnormal 30.70 21.25 248 61484 148144 63279146
Agitation 30.53 21.25 10 61722 59747 63367543
Febrile neutropenia 30.19 21.25 208 61524 118241 63309049
Medication error 29.97 21.25 7 61725 52277 63375013
Peripheral sensory neuropathy 28.97 21.25 36 61696 7415 63419875
Cystitis 28.91 21.25 118 61614 54873 63372417
Hypersensitivity 28.15 21.25 168 61564 292517 63134773
Suicidal ideation 27.68 21.25 13 61719 62408 63364882
Dry skin 27.51 21.25 119 61613 56768 63370522
Dysphonia 27.31 21.25 105 61627 47509 63379781
Plasma cell myeloma refractory 27.30 21.25 11 61721 348 63426942
Wheezing 26.86 21.25 32 61700 95563 63331727
Stress 26.82 21.25 16 61716 67151 63360139
Light chain analysis abnormal 26.79 21.25 9 61723 168 63427122
Rash pruritic 26.59 21.25 122 61610 59677 63367613
Migraine 26.55 21.25 37 61695 103309 63323981
Toxicity to various agents 26.45 21.25 137 61595 247113 63180177
Seizure 26.29 21.25 56 61676 132578 63294712
Depressed level of consciousness 25.92 21.25 14 61718 62064 63365226
Diverticulitis 25.85 21.25 91 61641 39466 63387824
Musculoskeletal pain 25.81 21.25 31 61701 92246 63335044
Oxygen saturation decreased 25.59 21.25 29 61703 88556 63338734
Blister 25.57 21.25 55 61677 129759 63297531
Fluid retention 25.24 21.25 120 61612 59566 63367724
SARS-CoV-2 test positive 25.23 21.25 35 61697 8021 63419269
Upper respiratory tract infection 25.16 21.25 151 61581 81896 63345394
Sedation 24.77 21.25 4 61728 38805 63388485
Localised infection 24.69 21.25 75 61657 30135 63397155
Angioedema 24.55 21.25 8 61724 47957 63379333
Hypoaesthesia 24.04 21.25 260 61472 168133 63259157
White blood cell count abnormal 24.01 21.25 30 61702 6212 63421078
Dehydration 23.99 21.25 266 61466 173088 63254202
Blood cholesterol increased 23.82 21.25 34 61698 93998 63333292
Balance disorder 23.78 21.25 152 61580 84270 63343020
Pseudomonas aeruginosa meningitis 23.75 21.25 4 61728 0 63427290
Viral infection 23.27 21.25 82 61650 35581 63391709
Febrile infection 23.24 21.25 16 61716 1541 63425749
Drug reaction with eosinophilia and systemic symptoms 22.72 21.25 3 61729 33833 63393457
Hyperproteinaemia 22.57 21.25 7 61725 100 63427190
Peritonitis viral 22.48 21.25 6 61726 48 63427242
General physical health deterioration 22.45 21.25 110 61622 201292 63225998
Blood pressure systolic increased 22.40 21.25 9 61723 47388 63379902
Neutropenic sepsis 21.89 21.25 49 61683 16389 63410901
Compression fracture 21.69 21.25 29 61703 6419 63420871
International normalised ratio increased 21.64 21.25 9 61723 46416 63380874
Incorrect dose administered 21.63 21.25 16 61716 59952 63367338
Cardio-respiratory arrest 21.63 21.25 16 61716 59943 63367347
Pulmonary fibrosis 21.53 21.25 6 61726 39803 63387487
Liver function test abnormal 21.42 21.25 10 61722 48171 63379119
Pathological fracture 21.37 21.25 34 61698 8800 63418490

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 2151.51 18.78 3038 58832 395011 34500050
Pneumonia 1649.61 18.78 2557 59313 360070 34534991
White blood cell count decreased 1207.46 18.78 1137 60733 94308 34800753
Full blood count decreased 1108.55 18.78 571 61299 17517 34877544
Fatigue 971.79 18.78 2062 59808 368591 34526470
Laboratory test abnormal 838.98 18.78 495 61375 19896 34875165
Neuropathy peripheral 738.48 18.78 820 61050 82443 34812618
Neutropenia 618.97 18.78 1042 60828 155736 34739325
Adverse drug reaction 517.26 18.78 423 61447 28919 34866142
Unevaluable event 427.43 18.78 397 61473 32193 34862868
Thrombosis 426.24 18.78 485 61385 49973 34845088
Influenza 422.27 18.78 479 61391 49187 34845874
Drug interaction 324.19 18.78 19 61851 225927 34669134
COVID-19 320.49 18.78 527 61343 77023 34818038
Peripheral swelling 297.39 18.78 506 61364 76035 34819026
Plasma cell myeloma recurrent 293.71 18.78 148 61722 4317 34890744
Constipation 270.51 18.78 685 61185 136297 34758764
Rash 249.29 18.78 912 60958 221840 34673221
Nasopharyngitis 234.89 18.78 434 61436 69534 34825527
Neutrophil count decreased 231.09 18.78 362 61508 50742 34844319
Platelet count decreased 229.32 18.78 592 61278 119125 34775936
Infection 207.45 18.78 481 61389 90434 34804627
Condition aggravated 185.61 18.78 55 61815 192141 34702920
Plasmacytoma 179.44 18.78 100 61770 3591 34891470
Muscle spasms 170.13 18.78 396 61474 74605 34820456
Cardiac disorder 168.48 18.78 286 61584 42840 34852221
Renal disorder 146.19 18.78 202 61668 25278 34869783
Tooth disorder 143.36 18.78 133 61737 10749 34884312
Back pain 142.88 18.78 507 61363 121282 34773779
Asthenia 138.18 18.78 822 61048 244429 34650632
Illness 133.05 18.78 141 61729 13388 34881673
Overdose 132.40 18.78 7 61863 91052 34804009
Product dose omission issue 130.80 18.78 487 61383 119224 34775837
Product use in unapproved indication 116.32 18.78 32 61838 117467 34777594
Deep vein thrombosis 108.94 18.78 307 61563 64941 34830120
Plasma cell myeloma 98.58 18.78 225 61645 41812 34853249
Hyponatraemia 95.08 18.78 16 61854 82675 34812386
Light chain analysis increased 93.77 18.78 47 61823 1354 34893707
Abdominal pain 92.41 18.78 92 61778 163526 34731535
Localised infection 91.36 18.78 133 61737 17454 34877607
Plasma cell leukaemia 88.71 18.78 40 61830 904 34894157
Drug intolerance 87.67 18.78 268 61602 59302 34835759
Full blood count abnormal 86.74 18.78 134 61736 18534 34876527
Immune system disorder 86.38 18.78 72 61798 5043 34890018
Rhabdomyolysis 85.84 18.78 10 61860 68153 34826908
Sepsis 83.36 18.78 542 61328 166019 34729042
Monoclonal immunoglobulin present 79.38 18.78 38 61832 988 34894073
Cytopenia 79.24 18.78 105 61765 12618 34882443
Toxicity to various agents 78.52 18.78 147 61723 200215 34694846
Aspartate aminotransferase increased 78.17 18.78 13 61857 67770 34827291
Bronchitis 77.55 18.78 205 61665 41758 34853303
Adverse event 77.41 18.78 128 61742 18749 34876312
Acute kidney injury 75.24 18.78 282 61588 304706 34590355
Vomiting 73.45 18.78 211 61659 247410 34647651
Alanine aminotransferase increased 69.48 18.78 28 61842 80787 34814274
Full blood count increased 69.26 18.78 33 61837 849 34894212
Bone pain 66.40 18.78 126 61744 20560 34874501
Hypoglycaemia 66.40 18.78 9 61861 54631 34840430
Blood test abnormal 65.62 18.78 71 61799 6900 34888161
Atrial fibrillation 65.33 18.78 405 61465 121988 34773073
Agitation 59.91 18.78 14 61856 57385 34837676
Sinusitis 59.71 18.78 185 61685 41217 34853844
Back disorder 59.58 18.78 66 61804 6585 34888476
Suicidal ideation 59.01 18.78 3 61867 40385 34854676
Red blood cell count decreased 58.78 18.78 147 61723 28943 34866118
Fluid retention 58.73 18.78 140 61730 26747 34868314
Hyperkalaemia 58.09 18.78 25 61845 69364 34825697
Dyspnoea 56.24 18.78 957 60913 375825 34519236
Ascites 55.81 18.78 8 61862 46563 34848498
Cataract 55.74 18.78 135 61735 26051 34869010
Rheumatoid arthritis 55.36 18.78 3 61867 38235 34856826
Plasma cell myeloma refractory 54.45 18.78 25 61845 590 34894471
Electrocardiogram QT prolonged 51.57 18.78 6 61864 40946 34854115
Suicide attempt 51.12 18.78 5 61865 39111 34855950
Cellulitis enterococcal 49.96 18.78 15 61855 98 34894963
Wrong technique in product usage process 48.65 18.78 4 61866 35982 34859079
Injection site pain 48.41 18.78 6 61864 38999 34856062
Aggression 48.34 18.78 6 61864 38958 34856103
Inappropriate schedule of product administration 48.22 18.78 25 61845 62271 34832790
Pulmonary thrombosis 47.46 18.78 62 61808 7345 34887716
Anxiety 46.34 18.78 65 61805 99363 34795698
Coma 45.99 18.78 12 61858 45666 34849395
Psoriasis 45.74 18.78 7 61863 38805 34856256
Hypokalaemia 45.60 18.78 23 61847 58191 34836870
Rib fracture 45.33 18.78 87 61783 14313 34880748
Arthropathy 45.25 18.78 127 61743 26780 34868281
International normalised ratio increased 44.76 18.78 14 61856 47313 34847748
Dizziness 44.58 18.78 586 61284 217935 34677126
Tachycardia 43.01 18.78 52 61818 84720 34810341
Hypotension 43.00 18.78 224 61646 221425 34673636
General physical health deterioration 42.74 18.78 103 61767 128166 34766895
Interstitial lung disease 42.51 18.78 32 61838 65250 34829811
Incorrect dose administered 42.04 18.78 10 61860 40505 34854556
Pancreatitis 41.55 18.78 9 61861 38882 34856179
White blood cell count abnormal 41.38 18.78 39 61831 3214 34891847
Hypoaesthesia 41.07 18.78 216 61654 61228 34833833
Drug hypersensitivity 40.22 18.78 50 61820 80479 34814582
Monoclonal immunoglobulin increased 39.98 18.78 14 61856 157 34894904
COVID-19 pneumonia 39.95 18.78 91 61779 16876 34878185
Depressed level of consciousness 39.93 18.78 13 61857 42828 34852233
Blood calcium increased 39.92 18.78 40 61830 3554 34891507
Dysarthria 39.37 18.78 7 61863 34775 34860286
Haematuria 38.88 18.78 20 61850 50046 34845015
Bone lesion 38.60 18.78 36 61834 2927 34892134
Melaena 38.18 18.78 8 61862 35372 34859689
Mucosal inflammation 37.29 18.78 11 61859 38611 34856450
Upper limb fracture 37.12 18.78 44 61826 4722 34890339
Respiratory tract infection 37.11 18.78 97 61773 19615 34875446
Squamous cell carcinoma of skin 37.06 18.78 68 61802 10813 34884248
SARS-CoV-2 test positive 36.99 18.78 49 61821 5884 34889177
Stress 36.86 18.78 5 61865 30342 34864719
Balance disorder 36.73 18.78 156 61714 40498 34854563
Seizure 36.70 18.78 82 61788 104775 34790286
Cholestasis 36.41 18.78 3 61867 26945 34868116
Hip fracture 36.26 18.78 71 61799 11854 34883207
Thrombocytopenia 35.66 18.78 428 61442 155819 34739242
Angioedema 35.44 18.78 11 61859 37363 34857698
Bradycardia 35.43 18.78 49 61821 75369 34819692
JC virus infection 35.06 18.78 30 61840 2178 34892883
Jaundice 34.84 18.78 7 61863 31875 34863186
Drug reaction with eosinophilia and systemic symptoms 34.54 18.78 8 61862 33004 34862057
Gastrointestinal haemorrhage 34.51 18.78 65 61805 88412 34806649
Progressive multifocal leukoencephalopathy 34.50 18.78 62 61808 9702 34885359
Fall 34.49 18.78 527 61343 202358 34692703
Pneumonia respiratory syncytial viral 34.27 18.78 21 61849 902 34894159
Protein total increased 34.14 18.78 30 61840 2257 34892804
Headache 33.40 18.78 213 61657 200422 34694639
Oxygen saturation decreased 33.01 18.78 28 61842 53790 34841271
Cardiac arrest 32.99 18.78 76 61794 96083 34798978
Respiratory syncytial virus infection 32.66 18.78 41 61829 4668 34890393
Body height decreased 32.48 18.78 37 61833 3806 34891255
Coronary artery disease 32.33 18.78 23 61847 48282 34846779
Psychotic disorder 32.28 18.78 3 61867 24449 34870612
Drug-induced liver injury 32.20 18.78 6 61864 28826 34866235
Hypercalcaemia 32.12 18.78 79 61791 15389 34879672
White blood cell disorder 31.56 18.78 25 61845 1628 34893433
Lower respiratory tract infection 31.42 18.78 125 61745 31512 34863549
Malaise 31.31 18.78 482 61388 185343 34709718
Hepatic function abnormal 31.19 18.78 20 61850 44343 34850718
Feeling abnormal 31.06 18.78 205 61665 63030 34832031
Pyrexia 30.85 18.78 789 61081 332224 34562837
Gamma-glutamyltransferase increased 30.75 18.78 7 61863 29224 34865837
Gastric disorder 30.71 18.78 68 61802 12373 34882688
Blood bilirubin increased 30.18 18.78 15 61855 38281 34856780
Lactic acidosis 29.95 18.78 12 61858 34760 34860301
Musculoskeletal disorder 29.46 18.78 45 61825 6159 34888902
Tremor 29.36 18.78 248 61622 82339 34812722
Tooth infection 29.22 18.78 47 61823 6724 34888337
Parainfluenzae virus infection 28.71 18.78 30 61840 2800 34892261
Blood urea increased 28.68 18.78 9 61861 30355 34864706
Upper respiratory tract infection 28.43 18.78 125 61745 32934 34862127
Spinal fracture 28.29 18.78 49 61821 7449 34887612
Neutropenic sepsis 28.25 18.78 70 61800 13697 34881364
Anaphylactic reaction 28.06 18.78 11 61859 32290 34862771
Metabolic acidosis 27.69 18.78 22 61848 43658 34851403
Toxic epidermal necrolysis 27.68 18.78 3 61867 21643 34873418
Encephalopathy 27.58 18.78 14 61856 35305 34859756
Respiration abnormal 27.56 18.78 31 61839 3145 34891916
Epilepsy 27.43 18.78 3 61867 21492 34873569
Blood lactate dehydrogenase increased 27.42 18.78 4 61866 22986 34872075
Blood immunoglobulin M increased 27.24 18.78 12 61858 256 34894805
Multiple allergies 27.24 18.78 30 61840 2973 34892088
Agranulocytosis 26.51 18.78 5 61865 23816 34871245
Osteolysis 26.08 18.78 30 61840 3118 34891943
Pancytopenia 25.94 18.78 270 61600 94887 34800174
Therapeutic product effect incomplete 25.63 18.78 31 61839 50510 34844551
Respiratory arrest 25.28 18.78 9 61861 28034 34867027
Medication error 25.20 18.78 7 61863 25558 34869503
Blood pressure systolic increased 25.16 18.78 5 61865 22947 34872114
Product prescribing error 25.12 18.78 5 61865 22922 34872139
Clostridium difficile infection 25 18.78 82 61788 18816 34876245
Blood immunoglobulin A increased 24.96 18.78 12 61858 315 34894746
Blood alkaline phosphatase increased 24.88 18.78 12 61858 31163 34863898
Haematemesis 24.80 18.78 9 61861 27702 34867359
Cerebral toxoplasmosis 24.55 18.78 22 61848 1699 34893362
Rhinovirus infection 24.51 18.78 34 61836 4265 34890796
Acute myocardial infarction 24.14 18.78 36 61834 53683 34841378
Protein total abnormal 24.09 18.78 12 61858 341 34894720
Lower limb fracture 24.05 18.78 33 61837 4098 34890963
Cardio-respiratory arrest 23.92 18.78 38 61832 55235 34839826
Cardiogenic shock 23.23 18.78 9 61861 26609 34868452
Ventricular tachycardia 23.17 18.78 9 61861 26570 34868491
Blood pressure abnormal 23.13 18.78 47 61823 8059 34887002
Diarrhoea 23.09 18.78 875 60995 389037 34506024
Vertebral lesion 23.07 18.78 10 61860 205 34894856
Coronavirus infection 22.99 18.78 33 61837 4274 34890787
Pneumonia influenzal 22.72 18.78 20 61850 1508 34893553
Hypoacusis 22.71 18.78 72 61798 16229 34878832
Listeriosis 22.66 18.78 17 61853 1021 34894040
Eosinophilia 22.66 18.78 9 61861 26213 34868848
Generalised tonic-clonic seizure 22.41 18.78 5 61865 21169 34873892
Sedation 22.16 18.78 5 61865 21001 34874060
Haematochezia 22.09 18.78 30 61840 46504 34848557
Blood creatinine increased 21.92 18.78 90 61780 94886 34800175
Drug ineffective 21.58 18.78 630 61240 456121 34438940
Hallucination, visual 21.44 18.78 3 61867 17788 34877273
Shock 21.39 18.78 8 61862 24171 34870890
Sinus disorder 21.32 18.78 42 61828 7043 34888018
Treatment failure 21.27 18.78 31 61839 46666 34848395
Viral infection 21.14 18.78 74 61796 17549 34877512
White blood cell count increased 21.12 18.78 25 61845 41126 34853935
C-reactive protein increased 20.86 18.78 40 61830 54058 34841003
Loss of personal independence in daily activities 20.66 18.78 17 61853 33162 34861899
Seasonal allergy 20.60 18.78 40 61830 6635 34888426
Dyskinesia 20.54 18.78 7 61863 22406 34872655
Haemoptysis 20.51 18.78 19 61851 34987 34860074
Pleural effusion 20.27 18.78 75 61795 81471 34813590
Product quality issue 20.23 18.78 3 61867 17032 34878029
Wound infection 20.14 18.78 41 61829 7038 34888023
Clonal haematopoiesis 20.11 18.78 7 61863 77 34894984
Rectal haemorrhage 20.08 18.78 25 61845 40224 34854837
Keratopathy 19.77 18.78 13 61857 632 34894429
Arthralgia 19.72 18.78 199 61671 169842 34725219
Ageusia 19.68 18.78 51 61819 10257 34884804
Leukocytosis 19.61 18.78 9 61861 24056 34871005
Swelling face 19.59 18.78 87 61783 23018 34872043
Hiccups 19.37 18.78 50 61820 10032 34885029
Abnormal behaviour 19.34 18.78 10 61860 24959 34870102
Cerebrovascular accident 19.17 18.78 232 61638 84579 34810482
Haemoglobin decreased 19.07 18.78 310 61560 120462 34774599
Spinal disorder 19.02 18.78 30 61840 4222 34890839

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 3614.99 19.02 3507 73473 563007 79104401
Pneumonia 2581.92 19.02 3162 73818 657084 79010324
White blood cell count decreased 1647.57 19.02 1399 75581 186889 79480519
Neutropenia 1618.09 19.02 1671 75309 286039 79381369
Full blood count decreased 1415.56 19.02 632 76348 26187 79641221
Neuropathy peripheral 894.97 19.02 877 76103 140428 79526980
Fatigue 674.85 19.02 2193 74787 927534 78739874
Neutrophil count decreased 618.43 19.02 596 76384 93363 79574045
Thrombosis 581.04 19.02 548 76432 83552 79583856
Platelet count decreased 574.20 19.02 817 76163 193847 79473561
Laboratory test abnormal 525.33 19.02 331 76649 27717 79639691
Plasma cell myeloma recurrent 387.68 19.02 155 76825 4846 79662562
COVID-19 361.47 19.02 589 76391 157085 79510323
Plasmacytoma 353.62 19.02 140 76840 4263 79663145
Influenza 352.66 19.02 524 76456 129082 79538326
Unevaluable event 343.79 19.02 341 76639 55244 79612164
Plasma cell myeloma 337.32 19.02 331 76649 52928 79614480
Drug interaction 301.87 19.02 27 76953 415156 79252252
Constipation 279.99 19.02 748 76232 282302 79385106
Thrombocytopenia 278.71 19.02 717 76263 264542 79402866
Condition aggravated 245.10 19.02 89 76891 501035 79166373
Sepsis 235.74 19.02 681 76299 268747 79398661
Deep vein thrombosis 224.90 19.02 412 76568 120507 79546901
Cytopenia 218.57 19.02 171 76809 20212 79647196
Rash 215.89 19.02 1114 75866 577244 79090164
Anaemia 191.46 19.02 893 76087 444122 79223286
Human chorionic gonadotropin increased 190.77 19.02 63 76917 1121 79666287
Product dose omission issue 184.85 19.02 592 76388 246945 79420463
Rheumatoid arthritis 178.02 19.02 5 76975 208465 79458943
Light chain analysis increased 175.14 19.02 65 76915 1653 79665755
Muscle spasms 170.73 19.02 460 76520 174270 79493138
Atrial fibrillation 164.13 19.02 491 76489 197395 79470013
Plasma cell leukaemia 161.86 19.02 62 76918 1724 79665684
Infection 150.45 19.02 544 76436 241168 79426240
Drug hypersensitivity 149.54 19.02 51 76929 298865 79368543
Asthenia 130.19 19.02 892 76088 510797 79156611
Overdose 128.41 19.02 14 76966 184192 79483216
Bronchitis 125.60 19.02 342 76638 130302 79537106
Product use in unapproved indication 117.97 19.02 47 76933 250312 79417096
Abdominal pain 117.15 19.02 122 76858 389447 79277961
Cardiac disorder 112.14 19.02 216 76764 65541 79601867
Peripheral swelling 110.53 19.02 534 76446 269083 79398325
Arthralgia 102.98 19.02 252 76728 571551 79095857
Hypercalcaemia 102.39 19.02 154 76826 38276 79629132
Adverse drug reaction 102.27 19.02 209 76771 66183 79601225
Red blood cell count decreased 101.87 19.02 192 76788 57321 79610087
Febrile neutropenia 98.63 19.02 463 76517 230536 79436872
Renal disorder 97.25 19.02 158 76822 41947 79625461
Headache 93.73 19.02 321 76659 653451 79013957
Injection site pain 92.72 19.02 9 76971 129829 79537579
Bone pain 91.26 19.02 180 76800 55562 79611846
Urinary tract infection 90.60 19.02 512 76468 274000 79393408
COVID-19 pneumonia 90.60 19.02 125 76855 28724 79638684
Drug ineffective 88.74 19.02 646 76334 1080267 78587141
Pulmonary thrombosis 87.17 19.02 81 76899 12090 79655318
Neutropenic sepsis 84.59 19.02 117 76863 26947 79640461
Pancytopenia 84.20 19.02 350 76630 165395 79502013
Therapeutic product effect decreased 83.56 19.02 27 76953 163836 79503572
Nasopharyngitis 83.42 19.02 473 76507 253408 79414000
Adverse event 81.68 19.02 180 76800 60034 79607374
Pericarditis 80.67 19.02 5 76975 104231 79563177
Treatment failure 80.29 19.02 32 76948 170454 79496954
Diarrhoea 79.66 19.02 1241 75739 879248 78788160
Respiratory tract infection 79.43 19.02 157 76823 48532 79618876
Fall 79.25 19.02 768 76212 486861 79180547
Pyrexia 79.23 19.02 1001 75979 677708 78989700
Hip fracture 74.55 19.02 118 76862 30643 79636765
Musculoskeletal stiffness 74.36 19.02 38 76942 174970 79492438
Respiratory syncytial virus infection 74.04 19.02 66 76914 9336 79658072
Haemoglobin decreased 73.06 19.02 414 76566 221705 79445703
Tremor 71.89 19.02 340 76640 169743 79497665
Leukopenia 70.49 19.02 260 76720 116253 79551155
Rhabdomyolysis 68.98 19.02 9 76971 103122 79564286
Hyponatraemia 67.89 19.02 44 76936 177804 79489604
Back pain 67.17 19.02 513 76467 303667 79363741
Plasma cell myeloma refractory 66.94 19.02 25 76955 647 79666761
Vomiting 66.16 19.02 375 76605 665453 79001955
Squamous cell carcinoma of skin 65.22 19.02 74 76906 13959 79653449
Monoclonal immunoglobulin present 65.06 19.02 28 76952 1057 79666351
Hepatic enzyme increased 64.65 19.02 49 76931 182561 79484847
Progressive multifocal leukoencephalopathy 64.30 19.02 89 76891 20511 79646897
Stress 64.16 19.02 3 76977 79609 79587799
Renal failure 63.74 19.02 371 76609 200597 79466811
Discomfort 63.51 19.02 21 76959 125596 79541812
Injection site erythema 62.84 19.02 3 76977 78194 79589214
Glossodynia 62.39 19.02 12 76968 103325 79564083
Psoriasis 61.92 19.02 7 76973 89580 79577828
Anxiety 61.81 19.02 90 76890 248422 79418986
Cerebrovascular accident 60.28 19.02 303 76677 154989 79512419
Wrong technique in product usage process 58.84 19.02 3 76977 73872 79593536
Suicide attempt 58.55 19.02 6 76974 82926 79584482
Pulmonary embolism 57.78 19.02 322 76658 171332 79496076
Agitation 57.28 19.02 13 76967 99702 79567706
Coma 56.08 19.02 14 76966 100635 79566773
Blood calcium increased 55.55 19.02 59 76921 10341 79657067
Intentional product misuse 55.48 19.02 12 76968 95153 79572255
Infusion related reaction 54.72 19.02 86 76894 230151 79437257
Aspartate aminotransferase increased 54.70 19.02 33 76947 138608 79528800
Therapeutic product effect incomplete 54.11 19.02 35 76945 141610 79525798
Dyspnoea 53.76 19.02 1141 75839 855884 78811524
Tooth disorder 53.33 19.02 93 76887 26140 79641268
Electrocardiogram QT prolonged 51.48 19.02 12 76968 90374 79577034
Product use issue 51.18 19.02 77 76903 209745 79457663
Wound 49.68 19.02 25 76955 116154 79551254
Peripheral sensory neuropathy 49.48 19.02 62 76918 12971 79654437
Dizziness 49.31 19.02 747 76233 525694 79141714
Rib fracture 47.87 19.02 92 76888 27855 79639553
Osteolysis 46.62 19.02 37 76943 4461 79662947
Immune system disorder 45.97 19.02 55 76925 10974 79656434
Mobility decreased 45.57 19.02 31 76949 122144 79545264
Impaired healing 45.46 19.02 14 76966 87641 79579767
Osteoarthritis 45.18 19.02 14 76966 87295 79580113
Hypertension 44.97 19.02 166 76814 330826 79336582
Pain 43.95 19.02 451 76529 703351 78964057
Back disorder 43.83 19.02 55 76925 11523 79655885
Pneumonia pneumococcal 43.55 19.02 34 76946 4003 79663405
Inflammation 43.47 19.02 18 76962 93735 79573673
Type 2 diabetes mellitus 43.43 19.02 3 76977 57119 79610289
Toxicity to various agents 42.00 19.02 237 76743 421303 79246105
Hypoglycaemia 41.75 19.02 23 76957 101571 79565837
Pathological fracture 41.41 19.02 51 76929 10486 79656922
Alanine aminotransferase increased 41.27 19.02 58 76922 162512 79504896
Hypokalaemia 41.12 19.02 47 76933 143993 79523415
JC virus infection 40.39 19.02 32 76948 3849 79663559
Crystal nephropathy 39.94 19.02 22 76958 1433 79665975
Inappropriate schedule of product administration 39.92 19.02 42 76938 133586 79533822
Full blood count abnormal 39.90 19.02 107 76873 40367 79627041
Upper respiratory tract infection 39.77 19.02 184 76796 90984 79576424
Medication error 39.32 19.02 9 76971 68633 79598775
Drug-induced liver injury 39.23 19.02 8 76972 66109 79601299
Weight decreased 39.11 19.02 193 76787 355005 79312403
Anaphylactic reaction 38.95 19.02 16 76964 83727 79583681
White blood cell count abnormal 38.77 19.02 37 76943 5708 79661700
Full blood count increased 38.61 19.02 16 76964 549 79666859
Oxygen saturation decreased 38.06 19.02 41 76939 129006 79538402
Angioedema 37.92 19.02 13 76967 76022 79591386
Lymphocyte count decreased 37.86 19.02 116 76864 47173 79620235
Aggression 37.81 19.02 3 76977 50955 79616453
Cellulitis enterococcal 37.58 19.02 9 76971 44 79667364
Coronavirus infection 37.35 19.02 41 76939 7456 79659952
Blood cholesterol increased 37.34 19.02 17 76963 83703 79583705
Cataract 37.03 19.02 138 76842 61982 79605426
Loss of personal independence in daily activities 36.97 19.02 27 76953 102553 79564855
Pneumonia influenzal 36.96 19.02 27 76953 2877 79664531
Folliculitis 36.63 19.02 5 76975 55375 79612033
Suicidal ideation 36.47 19.02 14 76966 76326 79591082
Blood test abnormal 36.28 19.02 63 76917 17647 79649761
Illness 36.23 19.02 113 76867 46398 79621010
Blood pressure systolic increased 36.02 19.02 10 76970 66976 79600432
Bone lesion 35.98 19.02 36 76944 5883 79661525
Liver injury 35.41 19.02 6 76974 56608 79610800
Keratopathy 35.40 19.02 19 76961 1175 79666233
Lactic acidosis 35.14 19.02 12 76968 70347 79597061
Incorrect dose administered 35.06 19.02 15 76965 76615 79590793
Pneumonia respiratory syncytial viral 34.60 19.02 22 76958 1868 79665540
Blood pressure fluctuation 34.33 19.02 11 76969 67134 79600274
Injury 34.15 19.02 16 76964 77480 79589928
Depressed level of consciousness 34.11 19.02 26 76954 96626 79570782
International normalised ratio increased 33.64 19.02 20 76960 84701 79582707
Sedation 33.59 19.02 5 76975 51890 79615518
Parainfluenzae virus infection 33.52 19.02 34 76946 5648 79661760
Muscle injury 33.05 19.02 4 76976 48557 79618851
Tumour lysis syndrome 32.95 19.02 72 76908 23867 79643541
Melaena 32.91 19.02 9 76971 60881 79606527
Hypotension 32.23 19.02 271 76709 440046 79227362
Tachycardia 32.16 19.02 78 76902 177690 79489718
Weight increased 32.11 19.02 148 76832 277238 79390170
Toxic epidermal necrolysis 32.06 19.02 3 76977 44578 79622830
Drug reaction with eosinophilia and systemic symptoms 32.01 19.02 11 76969 64233 79603175
SARS-CoV-2 test positive 31.27 19.02 47 76933 11669 79655739
Wheezing 31.25 19.02 40 76940 116624 79550784
Rash pruritic 30.82 19.02 144 76836 71485 79595923
Irritable bowel syndrome 30.42 19.02 11 76969 62230 79605178
Ill-defined disorder 29.97 19.02 13 76967 65862 79601546
Dyskinesia 29.71 19.02 4 76976 44769 79622639
Chest discomfort 28.75 19.02 56 76924 137988 79529420
Ascites 28.40 19.02 19 76961 75543 79591865
Pneumocystis jirovecii pneumonia 28.16 19.02 82 76898 32426 79634982
Blood pressure increased 28.03 19.02 107 76873 211253 79456155
Haematemesis 27.73 19.02 8 76972 52256 79615152
Abdominal discomfort 27.71 19.02 136 76844 250591 79416817
Drug level increased 27.65 19.02 3 76977 39648 79627760
Pancreatitis 27.49 19.02 16 76964 68559 79598849
Osteoporosis 27.42 19.02 9 76971 54103 79613305
Blister 27.08 19.02 46 76934 119430 79547978
Feeling hot 26.84 19.02 12 76968 59722 79607686
Spinal fracture 26.81 19.02 56 76924 17998 79649410
Localised infection 26.28 19.02 88 76892 37487 79629921
Prescribed overdose 26.08 19.02 3 76977 37880 79629528
Hyperkalaemia 25.97 19.02 44 76936 114354 79553054
Dehydration 25.86 19.02 359 76621 247828 79419580
Mucosal inflammation 25.82 19.02 21 76959 75559 79591849
Migraine 25.57 19.02 28 76952 87465 79579943
Depression 25.48 19.02 115 76865 216675 79450733
Clavicle fracture 25.45 19.02 26 76954 4355 79663053
Product prescribing error 25.42 19.02 6 76974 44807 79622601
Metabolic acidosis 24.57 19.02 26 76954 82503 79584905
Listeriosis 24.38 19.02 19 76961 2231 79665177
Atrial flutter 24.23 19.02 60 76920 21565 79645843
Hip arthroplasty 24.19 19.02 3 76977 35753 79631655
Dysarthria 24.10 19.02 18 76962 67604 79599804
Hepatitis 23.80 19.02 12 76968 55715 79611693
Musculoskeletal pain 23.58 19.02 39 76941 102315 79565093
Viral infection 23.53 19.02 93 76887 42923 79624485
Septic shock 23.19 19.02 200 76780 122601 79544807
Depressed mood 22.97 19.02 9 76971 48471 79618937
Pulmonary fibrosis 22.95 19.02 7 76973 44105 79623303
Arthropathy 22.63 19.02 91 76889 177020 79490388
Product quality issue 22.60 19.02 3 76977 33937 79633471
Leukocytosis 22.42 19.02 7 76973 43448 79623960
Clostridium difficile infection 22.32 19.02 91 76889 42594 79624814
Respiratory arrest 22.27 19.02 14 76966 57536 79609872
Epilepsy 22.15 19.02 6 76974 40854 79626554
Injection site swelling 21.92 19.02 9 76971 47123 79620285
Blood bilirubin increased 21.89 19.02 19 76961 66213 79601195
Compression fracture 21.81 19.02 29 76951 6431 79660977
Peritonitis viral 21.61 19.02 6 76974 57 79667351
Restlessness 21.43 19.02 9 76971 46483 79620925
Coronary artery disease 21.38 19.02 19 76961 65455 79601953
Upper limb fracture 21.36 19.02 51 76929 17916 79649492
Gastrointestinal infection 21.21 19.02 39 76941 11422 79655986
Bradycardia 21.11 19.02 64 76916 135493 79531915
Accidental overdose 21.11 19.02 6 76974 39575 79627833
Generalised tonic-clonic seizure 21.06 19.02 8 76972 43902 79623506
Colitis ulcerative 21.04 19.02 4 76976 34738 79632670
Swelling face 20.96 19.02 129 76851 71083 79596325
Neutrophil count abnormal 20.62 19.02 21 76959 3505 79663903
Spinal cord compression 20.57 19.02 28 76952 6349 79661059
Haematochezia 20.55 19.02 33 76947 87612 79579796
Eosinophilia 20.55 19.02 9 76971 45336 79622072
Seizure 20.53 19.02 103 76877 188731 79478677
Product distribution issue 20.27 19.02 14 76966 1366 79666042
Dysphagia 20.24 19.02 56 76924 122080 79545328
Anaphylactic shock 20.06 19.02 5 76975 35991 79631417
Hypothyroidism 19.92 19.02 13 76967 52379 79615029
General physical health deterioration 19.84 19.02 170 76810 275068 79392340
Unresponsive to stimuli 19.69 19.02 15 76965 55773 79611635
Bacteraemia 19.62 19.02 73 76907 32751 79634657
Diverticulitis 19.50 19.02 92 76888 45844 79621564
Protein total increased 19.41 19.02 21 76959 3758 79663650
Hallucination, visual 19.33 19.02 4 76976 32725 79634683
Shock 19.17 19.02 9 76971 43539 79623869
Light chain analysis decreased 19.07 19.02 4 76976 9 79667399

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 BRISTOL N204026 Feb. 8, 2013 RX CAPSULE ORAL 8673939 May 15, 2023 USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
1MG POMALYST BRISTOL 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 BRISTOL N204026 Feb. 8, 2013 RX CAPSULE ORAL 8735428 May 15, 2023 USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
1MG POMALYST BRISTOL 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 BRISTOL N204026 Feb. 8, 2013 RX CAPSULE ORAL 8673939 May 15, 2023 USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
2MG POMALYST BRISTOL 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 BRISTOL N204026 Feb. 8, 2013 RX CAPSULE ORAL 8735428 May 15, 2023 USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
2MG POMALYST BRISTOL 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 BRISTOL N204026 Feb. 8, 2013 RX CAPSULE ORAL 8673939 May 15, 2023 USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
3MG POMALYST BRISTOL 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 BRISTOL N204026 Feb. 8, 2013 RX CAPSULE ORAL 8735428 May 15, 2023 USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
3MG POMALYST BRISTOL 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 BRISTOL N204026 Feb. 8, 2013 RX CAPSULE ORAL 8673939 May 15, 2023 USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
4MG POMALYST BRISTOL 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 BRISTOL N204026 Feb. 8, 2013 RX CAPSULE ORAL 8735428 May 15, 2023 USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
4MG POMALYST BRISTOL 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 BRISTOL N204026 Feb. 8, 2013 RX CAPSULE ORAL 8198262 June 17, 2025 USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
1MG POMALYST BRISTOL 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 BRISTOL N204026 Feb. 8, 2013 RX CAPSULE ORAL 8198262 June 17, 2025 USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
2MG POMALYST BRISTOL 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 BRISTOL N204026 Feb. 8, 2013 RX CAPSULE ORAL 8198262 June 17, 2025 USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
3MG POMALYST BRISTOL 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 BRISTOL N204026 Feb. 8, 2013 RX CAPSULE ORAL 8198262 June 17, 2025 USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
4MG POMALYST BRISTOL 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 BRISTOL N204026 Feb. 8, 2013 RX CAPSULE ORAL Nov. 20, 2023 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
2MG POMALYST BRISTOL N204026 Feb. 8, 2013 RX CAPSULE ORAL Nov. 20, 2023 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
3MG POMALYST BRISTOL N204026 Feb. 8, 2013 RX CAPSULE ORAL Nov. 20, 2023 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
4MG POMALYST BRISTOL N204026 Feb. 8, 2013 RX CAPSULE ORAL Nov. 20, 2023 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
1MG POMALYST BRISTOL N204026 Feb. 8, 2013 RX CAPSULE ORAL May 20, 2024 PEDIATRIC EXCLUSIVITY
2MG POMALYST BRISTOL N204026 Feb. 8, 2013 RX CAPSULE ORAL May 20, 2024 PEDIATRIC EXCLUSIVITY
3MG POMALYST BRISTOL N204026 Feb. 8, 2013 RX CAPSULE ORAL May 20, 2024 PEDIATRIC EXCLUSIVITY
4MG POMALYST BRISTOL N204026 Feb. 8, 2013 RX CAPSULE ORAL May 20, 2024 PEDIATRIC EXCLUSIVITY
1MG POMALYST BRISTOL 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 BRISTOL 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 BRISTOL 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 BRISTOL 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 BRISTOL 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 BRISTOL 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 BRISTOL 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 BRISTOL 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 BRISTOL N204026 Feb. 8, 2013 RX CAPSULE ORAL Nov. 14, 2027 PEDIATRIC EXCLUSIVITY
2MG POMALYST BRISTOL N204026 Feb. 8, 2013 RX CAPSULE ORAL Nov. 14, 2027 PEDIATRIC EXCLUSIVITY
3MG POMALYST BRISTOL N204026 Feb. 8, 2013 RX CAPSULE ORAL Nov. 14, 2027 PEDIATRIC EXCLUSIVITY
4MG POMALYST BRISTOL 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 59572-501 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 59572-502 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 59572-503 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
Pomalyst HUMAN PRESCRIPTION DRUG LABEL 1 59572-504 CAPSULE 4 mg ORAL NDA 32 sections