pomalidomide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4746 | 19171-19-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
an immunomodulator with antineoplastic and angiogenesis inhibitor activity
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 3 | mg | O |
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Feb. 8, 2013 | FDA | CELGENE | |
| March 26, 2015 | PMDA | CELGENE K.K. |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Death | 1741.41 | 20.97 | 1936 | 52751 | 323443 | 50226994 |
| White blood cell count decreased | 1393.18 | 20.97 | 1089 | 53598 | 115633 | 50434804 |
| Full blood count decreased | 1383.90 | 20.97 | 609 | 54078 | 21737 | 50528700 |
| Pneumonia | 1335.45 | 20.97 | 1827 | 52860 | 376574 | 50173863 |
| Laboratory test abnormal | 824.22 | 20.97 | 432 | 54255 | 22776 | 50527661 |
| Neuropathy peripheral | 822.27 | 20.97 | 743 | 53944 | 96014 | 50454423 |
| Neutropenia | 656.59 | 20.97 | 803 | 53884 | 147162 | 50403275 |
| Fatigue | 467.52 | 20.97 | 1744 | 52943 | 705857 | 49844580 |
| Thrombosis | 408.55 | 20.97 | 395 | 54292 | 55438 | 50494999 |
| Unevaluable event | 379.30 | 20.97 | 348 | 54339 | 45718 | 50504719 |
| Platelet count decreased | 372.57 | 20.97 | 500 | 54187 | 100226 | 50450211 |
| Neutrophil count decreased | 369.84 | 20.97 | 343 | 54344 | 45683 | 50504754 |
| Constipation | 362.52 | 20.97 | 688 | 53999 | 185020 | 50365417 |
| Adverse drug reaction | 320.76 | 20.97 | 345 | 54342 | 54877 | 50495560 |
| COVID-19 | 261.28 | 20.97 | 286 | 54401 | 46376 | 50504061 |
| Plasma cell myeloma recurrent | 257.96 | 20.97 | 100 | 54587 | 2558 | 50547879 |
| Plasmacytoma | 243.13 | 20.97 | 93 | 54594 | 2292 | 50548145 |
| Influenza | 241.44 | 20.97 | 383 | 54304 | 89155 | 50461282 |
| Condition aggravated | 235.59 | 20.97 | 24 | 54663 | 297034 | 50253403 |
| Rheumatoid arthritis | 199.30 | 20.97 | 4 | 54683 | 202546 | 50347891 |
| Human chorionic gonadotropin increased | 192.01 | 20.97 | 66 | 54621 | 1185 | 50549252 |
| Muscle spasms | 188.74 | 20.97 | 418 | 54269 | 125135 | 50425302 |
| Nasopharyngitis | 175.81 | 20.97 | 532 | 54155 | 192395 | 50358042 |
| Drug ineffective | 153.44 | 20.97 | 421 | 54266 | 818912 | 49731525 |
| Drug interaction | 153.38 | 20.97 | 18 | 54669 | 199603 | 50350834 |
| Bronchitis | 144.48 | 20.97 | 336 | 54351 | 103823 | 50446614 |
| Tremor | 143.63 | 20.97 | 356 | 54331 | 114547 | 50435890 |
| Asthenia | 133.90 | 20.97 | 689 | 53998 | 318353 | 50232084 |
| Plasma cell myeloma | 128.79 | 20.97 | 164 | 54523 | 31158 | 50519279 |
| Peripheral swelling | 125.56 | 20.97 | 497 | 54190 | 205439 | 50344998 |
| Urinary tract infection | 123.45 | 20.97 | 524 | 54163 | 223496 | 50326941 |
| Product dose omission issue | 118.83 | 20.97 | 452 | 54235 | 183386 | 50367051 |
| Diarrhoea | 117.63 | 20.97 | 1057 | 53630 | 587419 | 49963018 |
| Drug hypersensitivity | 116.68 | 20.97 | 63 | 54624 | 250947 | 50299490 |
| Renal disorder | 106.79 | 20.97 | 140 | 54547 | 27365 | 50523072 |
| Full blood count increased | 106.12 | 20.97 | 39 | 54648 | 857 | 50549580 |
| Injection site pain | 106.04 | 20.97 | 3 | 54684 | 111021 | 50439416 |
| Cardiac disorder | 102.41 | 20.97 | 174 | 54513 | 42805 | 50507632 |
| Infusion related reaction | 99.16 | 20.97 | 30 | 54657 | 169527 | 50380910 |
| Light chain analysis increased | 98.41 | 20.97 | 39 | 54648 | 1059 | 50549378 |
| Red blood cell count decreased | 97.01 | 20.97 | 149 | 54538 | 33686 | 50516751 |
| Cytopenia | 95.89 | 20.97 | 78 | 54609 | 8697 | 50541740 |
| Anaemia | 93.39 | 20.97 | 527 | 54160 | 251929 | 50298508 |
| Infection | 92.43 | 20.97 | 401 | 54286 | 172553 | 50377884 |
| Arthralgia | 90.49 | 20.97 | 214 | 54473 | 438488 | 50111949 |
| Back pain | 86.48 | 20.97 | 467 | 54220 | 219563 | 50330874 |
| Thrombocytopenia | 82.47 | 20.97 | 314 | 54373 | 127359 | 50423078 |
| Dizziness | 81.52 | 20.97 | 646 | 54041 | 345723 | 50204714 |
| Product use in unapproved indication | 80.61 | 20.97 | 14 | 54673 | 115805 | 50434632 |
| Atrial fibrillation | 79.17 | 20.97 | 266 | 54421 | 101479 | 50448958 |
| Cataract | 77.26 | 20.97 | 163 | 54524 | 47137 | 50503300 |
| Treatment failure | 74.11 | 20.97 | 28 | 54659 | 137609 | 50412828 |
| Abdominal pain | 71.70 | 20.97 | 90 | 54597 | 236138 | 50314299 |
| Hip fracture | 71.26 | 20.97 | 112 | 54575 | 25819 | 50524618 |
| Product use issue | 70.14 | 20.97 | 37 | 54650 | 149438 | 50400999 |
| Overdose | 69.51 | 20.97 | 12 | 54675 | 99715 | 50450722 |
| Haemoglobin decreased | 68.71 | 20.97 | 296 | 54391 | 126920 | 50423517 |
| Therapeutic product effect incomplete | 63.81 | 20.97 | 11 | 54676 | 91504 | 50458933 |
| Therapeutic product effect decreased | 61.91 | 20.97 | 35 | 54652 | 136015 | 50414422 |
| Immune system disorder | 61.64 | 20.97 | 59 | 54628 | 8158 | 50542279 |
| Tooth disorder | 61.59 | 20.97 | 101 | 54586 | 24127 | 50526310 |
| Glossodynia | 61.40 | 20.97 | 24 | 54663 | 115545 | 50434892 |
| Sepsis | 60.42 | 20.97 | 294 | 54393 | 132631 | 50417806 |
| Multiple allergies | 60.16 | 20.97 | 59 | 54628 | 8404 | 50542033 |
| Bone pain | 59.63 | 20.97 | 147 | 54540 | 47082 | 50503355 |
| Illness | 59.30 | 20.97 | 100 | 54587 | 24440 | 50525997 |
| Rash | 59.21 | 20.97 | 727 | 53960 | 436744 | 50113693 |
| Blood test abnormal | 59.20 | 20.97 | 67 | 54620 | 11252 | 50539185 |
| Psoriasis | 58.91 | 20.97 | 4 | 54683 | 68996 | 50481441 |
| Intentional product use issue | 58.86 | 20.97 | 7 | 54680 | 76911 | 50473526 |
| Off label use | 57.34 | 20.97 | 291 | 54396 | 474135 | 50076302 |
| Fall | 56.83 | 20.97 | 582 | 54105 | 334350 | 50216087 |
| Full blood count abnormal | 56.11 | 20.97 | 95 | 54592 | 23293 | 50527144 |
| Hepatic enzyme increased | 54.81 | 20.97 | 41 | 54646 | 137339 | 50413098 |
| Wound | 54.52 | 20.97 | 23 | 54664 | 105771 | 50444666 |
| Pulmonary thrombosis | 54.40 | 20.97 | 53 | 54634 | 7488 | 50542949 |
| Discomfort | 53.59 | 20.97 | 25 | 54662 | 108355 | 50442082 |
| Respiratory syncytial virus infection | 52.91 | 20.97 | 44 | 54643 | 5058 | 50545379 |
| Pain | 51.34 | 20.97 | 391 | 54296 | 578512 | 49971925 |
| Deep vein thrombosis | 51.23 | 20.97 | 185 | 54502 | 73119 | 50477318 |
| Plasma cell leukaemia | 51.16 | 20.97 | 24 | 54663 | 991 | 50549446 |
| Hypercalcaemia | 49.71 | 20.97 | 90 | 54597 | 23262 | 50527175 |
| Crystal nephropathy | 49.68 | 20.97 | 22 | 54665 | 793 | 50549644 |
| Malaise | 49.47 | 20.97 | 567 | 54120 | 334965 | 50215472 |
| Renal failure | 49.27 | 20.97 | 237 | 54450 | 106396 | 50444041 |
| Wrong technique in product usage process | 48.03 | 20.97 | 3 | 54684 | 55507 | 50494930 |
| Protein total increased | 47.40 | 20.97 | 31 | 54656 | 2465 | 50547972 |
| Hyponatraemia | 46.27 | 20.97 | 23 | 54664 | 96116 | 50454321 |
| Headache | 45.87 | 20.97 | 340 | 54347 | 506195 | 50044242 |
| Hypokalaemia | 43.96 | 20.97 | 20 | 54667 | 87972 | 50462465 |
| Hospitalisation | 43.52 | 20.97 | 10 | 54677 | 67927 | 50482510 |
| Impaired healing | 43.28 | 20.97 | 11 | 54676 | 69775 | 50480662 |
| Monoclonal immunoglobulin present | 41.99 | 20.97 | 19 | 54668 | 721 | 50549716 |
| Mobility decreased | 41.80 | 20.97 | 17 | 54670 | 79931 | 50470506 |
| Seasonal allergy | 41.17 | 20.97 | 64 | 54623 | 14612 | 50535825 |
| Memory impairment | 40.04 | 20.97 | 181 | 54506 | 79179 | 50471258 |
| Respiratory tract infection | 39.71 | 20.97 | 99 | 54588 | 31918 | 50518519 |
| Helicobacter infection | 39.34 | 20.97 | 4 | 54683 | 49698 | 50500739 |
| Coma | 39.29 | 20.97 | 7 | 54680 | 56872 | 50493565 |
| Vomiting | 38.54 | 20.97 | 316 | 54371 | 460442 | 50089995 |
| COVID-19 pneumonia | 37.76 | 20.97 | 46 | 54641 | 8349 | 50542088 |
| Dyspnoea | 37.44 | 20.97 | 813 | 53874 | 546795 | 50003642 |
| Aspartate aminotransferase increased | 37.02 | 20.97 | 19 | 54668 | 77979 | 50472458 |
| Anaphylactic reaction | 36.59 | 20.97 | 7 | 54680 | 54048 | 50496389 |
| Tooth infection | 34.75 | 20.97 | 58 | 54629 | 14054 | 50536383 |
| Monoclonal immunoglobulin increased | 34.72 | 20.97 | 10 | 54677 | 97 | 50550340 |
| Electrocardiogram QT prolonged | 34.53 | 20.97 | 7 | 54680 | 51879 | 50498558 |
| Alanine aminotransferase increased | 34.42 | 20.97 | 27 | 54660 | 88332 | 50462105 |
| Blood calcium increased | 34.24 | 20.97 | 42 | 54645 | 7677 | 50542760 |
| Injection site swelling | 34.03 | 20.97 | 3 | 54684 | 41770 | 50508667 |
| Back disorder | 34.01 | 20.97 | 46 | 54641 | 9259 | 50541178 |
| Anxiety | 33.11 | 20.97 | 91 | 54596 | 177515 | 50372922 |
| Seizure | 32.59 | 20.97 | 48 | 54639 | 117826 | 50432611 |
| Tachycardia | 32.37 | 20.97 | 36 | 54651 | 99727 | 50450710 |
| Pneumonia influenzal | 32.29 | 20.97 | 20 | 54667 | 1447 | 50548990 |
| Fibromyalgia | 32.25 | 20.97 | 5 | 54682 | 44973 | 50505464 |
| Musculoskeletal stiffness | 32.06 | 20.97 | 56 | 54631 | 128425 | 50422012 |
| Agitation | 31.99 | 20.97 | 9 | 54678 | 53375 | 50497062 |
| Swelling face | 31.99 | 20.97 | 127 | 54560 | 52468 | 50497969 |
| Cerebrovascular accident | 31.87 | 20.97 | 193 | 54494 | 94487 | 50455950 |
| Blood potassium decreased | 31.78 | 20.97 | 100 | 54587 | 36845 | 50513592 |
| Abdominal discomfort | 31.47 | 20.97 | 136 | 54551 | 231505 | 50318932 |
| Bone lesion | 31.20 | 20.97 | 33 | 54654 | 5137 | 50545300 |
| Metabolic acidosis | 31.06 | 20.97 | 3 | 54684 | 38822 | 50511615 |
| Cystitis | 30.72 | 20.97 | 112 | 54575 | 44452 | 50505985 |
| SARS-CoV-2 test positive | 30.39 | 20.97 | 31 | 54656 | 4628 | 50545809 |
| Rash pruritic | 30.29 | 20.97 | 117 | 54570 | 47729 | 50502708 |
| Dry skin | 29.31 | 20.97 | 108 | 54579 | 43083 | 50507354 |
| Osteoarthritis | 29.30 | 20.97 | 19 | 54668 | 68587 | 50481850 |
| Cardio-respiratory arrest | 28.93 | 20.97 | 11 | 54676 | 53881 | 50496556 |
| Dysphonia | 28.74 | 20.97 | 100 | 54587 | 38792 | 50511645 |
| Pancytopenia | 28.73 | 20.97 | 172 | 54515 | 83858 | 50466579 |
| Toxicity to various agents | 28.72 | 20.97 | 125 | 54562 | 212374 | 50338063 |
| Suicidal ideation | 28.59 | 20.97 | 12 | 54675 | 55373 | 50495064 |
| Hypoaesthesia | 28.52 | 20.97 | 235 | 54452 | 127022 | 50423415 |
| Folliculitis | 26.71 | 20.97 | 5 | 54682 | 39220 | 50511217 |
| Inappropriate schedule of product administration | 26.68 | 20.97 | 23 | 54664 | 71808 | 50478629 |
| Feeling abnormal | 26.67 | 20.97 | 229 | 54458 | 125263 | 50425174 |
| Loss of personal independence in daily activities | 26.54 | 20.97 | 22 | 54665 | 70028 | 50480409 |
| Spinal fracture | 25.80 | 20.97 | 54 | 54633 | 15519 | 50534918 |
| Nervousness | 25.79 | 20.97 | 77 | 54610 | 27574 | 50522863 |
| Coronavirus infection | 25.78 | 20.97 | 23 | 54664 | 2906 | 50547531 |
| Localised infection | 25.72 | 20.97 | 73 | 54614 | 25412 | 50525025 |
| Depressed level of consciousness | 25.65 | 20.97 | 12 | 54675 | 51941 | 50498496 |
| Upper respiratory tract infection | 25.22 | 20.97 | 139 | 54548 | 65759 | 50484678 |
| Malignant neoplasm progression | 25.07 | 20.97 | 22 | 54665 | 68102 | 50482335 |
| Inflammation | 23.98 | 20.97 | 16 | 54671 | 56896 | 50493541 |
| Ear infection | 23.92 | 20.97 | 72 | 54615 | 25898 | 50524539 |
| Liver function test abnormal | 23.88 | 20.97 | 9 | 54678 | 44330 | 50506107 |
| Pseudomonas aeruginosa meningitis | 23.33 | 20.97 | 4 | 54683 | 0 | 50550437 |
| Oxygen saturation decreased | 23.14 | 20.97 | 27 | 54660 | 73221 | 50477216 |
| International normalised ratio increased | 22.84 | 20.97 | 9 | 54678 | 43143 | 50507294 |
| Stress | 22.83 | 20.97 | 15 | 54672 | 53778 | 50496659 |
| Vision blurred | 22.57 | 20.97 | 154 | 54533 | 78493 | 50471944 |
| Balance disorder | 22.56 | 20.97 | 142 | 54545 | 70448 | 50479989 |
| Musculoskeletal pain | 22.38 | 20.97 | 27 | 54660 | 72150 | 50478287 |
| Bradycardia | 22.30 | 20.97 | 22 | 54665 | 64404 | 50486033 |
| Kidney infection | 22.24 | 20.97 | 57 | 54630 | 18689 | 50531748 |
| Viral infection | 22.07 | 20.97 | 77 | 54610 | 29909 | 50520528 |
| Peritonitis viral | 21.86 | 20.97 | 6 | 54681 | 48 | 50550389 |
| Taste disorder | 21.55 | 20.97 | 35 | 54652 | 8289 | 50542148 |
| Neoplasm progression | 21.46 | 20.97 | 3 | 54684 | 29154 | 50521283 |
| Hypoglycaemia | 21.34 | 20.97 | 16 | 54671 | 53565 | 50496872 |
| Feeling jittery | 21.24 | 20.97 | 41 | 54646 | 11119 | 50539318 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Death | 1864.59 | 18.64 | 2677 | 51808 | 339407 | 29180635 |
| Pneumonia | 1577.16 | 18.64 | 2392 | 52093 | 317780 | 29202262 |
| White blood cell count decreased | 1085.13 | 18.64 | 1027 | 53458 | 82335 | 29437707 |
| Full blood count decreased | 1015.99 | 18.64 | 524 | 53961 | 15468 | 29504574 |
| Fatigue | 866.39 | 18.64 | 1836 | 52649 | 314985 | 29205057 |
| Laboratory test abnormal | 811.89 | 18.64 | 472 | 54013 | 17713 | 29502329 |
| Neuropathy peripheral | 669.42 | 18.64 | 736 | 53749 | 70291 | 29449751 |
| Adverse drug reaction | 570.70 | 18.64 | 420 | 54065 | 23600 | 29496442 |
| Neutropenia | 467.98 | 18.64 | 855 | 53630 | 130856 | 29389186 |
| Unevaluable event | 430.01 | 18.64 | 390 | 54095 | 29461 | 29490581 |
| Influenza | 423.74 | 18.64 | 451 | 54034 | 41430 | 29478612 |
| Thrombosis | 411.76 | 18.64 | 450 | 54035 | 42595 | 29477447 |
| COVID-19 | 385.99 | 18.64 | 400 | 54085 | 35614 | 29484428 |
| Drug interaction | 301.94 | 18.64 | 15 | 54470 | 197370 | 29322672 |
| Peripheral swelling | 277.05 | 18.64 | 453 | 54032 | 63286 | 29456756 |
| Plasma cell myeloma recurrent | 263.75 | 18.64 | 131 | 54354 | 3552 | 29516490 |
| Constipation | 242.82 | 18.64 | 602 | 53883 | 113558 | 29406484 |
| Nasopharyngitis | 222.21 | 18.64 | 396 | 54089 | 59269 | 29460773 |
| Platelet count decreased | 210.00 | 18.64 | 540 | 53945 | 104132 | 29415910 |
| Neutrophil count decreased | 207.53 | 18.64 | 323 | 54162 | 43244 | 29476798 |
| Rash | 188.31 | 18.64 | 769 | 53716 | 189050 | 29330992 |
| Infection | 185.96 | 18.64 | 426 | 54059 | 76325 | 29443717 |
| Condition aggravated | 169.85 | 18.64 | 32 | 54453 | 146263 | 29373779 |
| Cardiac disorder | 168.76 | 18.64 | 270 | 54215 | 36993 | 29483049 |
| Plasmacytoma | 155.45 | 18.64 | 88 | 54397 | 3127 | 29516915 |
| Muscle spasms | 148.57 | 18.64 | 353 | 54132 | 64729 | 29455313 |
| Back pain | 140.55 | 18.64 | 461 | 54024 | 101823 | 29418219 |
| Renal disorder | 140.30 | 18.64 | 190 | 54295 | 22405 | 29497637 |
| Tooth disorder | 140 | 18.64 | 126 | 54359 | 9403 | 29510639 |
| Illness | 132.57 | 18.64 | 105 | 54380 | 6569 | 29513473 |
| Overdose | 118.92 | 18.64 | 7 | 54478 | 79812 | 29440230 |
| Asthenia | 118.66 | 18.64 | 739 | 53746 | 214511 | 29305531 |
| Deep vein thrombosis | 101.62 | 18.64 | 283 | 54202 | 57116 | 29462926 |
| Localised infection | 101.08 | 18.64 | 126 | 54359 | 13690 | 29506352 |
| Drug intolerance | 94.13 | 18.64 | 247 | 54238 | 48132 | 29471910 |
| Product dose omission issue | 90.92 | 18.64 | 385 | 54100 | 95998 | 29424044 |
| Immune system disorder | 90.23 | 18.64 | 70 | 54415 | 4247 | 29515795 |
| Product use in unapproved indication | 88.80 | 18.64 | 25 | 54460 | 86850 | 29433192 |
| Full blood count abnormal | 88.29 | 18.64 | 123 | 54362 | 14890 | 29505152 |
| Sepsis | 86.17 | 18.64 | 502 | 53983 | 142180 | 29377862 |
| Plasma cell leukaemia | 80.66 | 18.64 | 36 | 54449 | 761 | 29519281 |
| Aspartate aminotransferase increased | 78.59 | 18.64 | 9 | 54476 | 59716 | 29460326 |
| Rhabdomyolysis | 77.96 | 18.64 | 10 | 54475 | 60798 | 29459244 |
| Hyponatraemia | 77.95 | 18.64 | 15 | 54470 | 67618 | 29452424 |
| Abdominal pain | 77.55 | 18.64 | 81 | 54404 | 135276 | 29384766 |
| Light chain analysis increased | 75.39 | 18.64 | 38 | 54447 | 1063 | 29518979 |
| Plasma cell myeloma | 74.75 | 18.64 | 192 | 54293 | 36923 | 29483119 |
| Acute kidney injury | 71.66 | 18.64 | 250 | 54235 | 265017 | 29255025 |
| Full blood count increased | 71.31 | 18.64 | 33 | 54452 | 761 | 29519281 |
| Atrial fibrillation | 70.54 | 18.64 | 382 | 54103 | 105264 | 29414778 |
| Toxicity to various agents | 70.51 | 18.64 | 133 | 54352 | 173528 | 29346514 |
| Vomiting | 70.25 | 18.64 | 182 | 54303 | 212078 | 29307964 |
| Bronchitis | 68.42 | 18.64 | 185 | 54300 | 36683 | 29483359 |
| Alanine aminotransferase increased | 66.13 | 18.64 | 24 | 54461 | 70920 | 29449122 |
| Malignant neoplasm progression | 62.35 | 18.64 | 29 | 54456 | 73830 | 29446212 |
| Blood test abnormal | 61.74 | 18.64 | 64 | 54421 | 5685 | 29514357 |
| Monoclonal immunoglobulin present | 61.54 | 18.64 | 31 | 54454 | 866 | 29519176 |
| Agitation | 59.92 | 18.64 | 11 | 54474 | 51293 | 29468749 |
| Intentional product use issue | 59.59 | 18.64 | 5 | 54480 | 42493 | 29477549 |
| Hypoglycaemia | 59.50 | 18.64 | 9 | 54476 | 48337 | 29471705 |
| Hyperkalaemia | 55.16 | 18.64 | 22 | 54463 | 61370 | 29458672 |
| Fluid retention | 54.99 | 18.64 | 129 | 54356 | 23431 | 29496611 |
| Sinusitis | 54.59 | 18.64 | 163 | 54322 | 34187 | 29485855 |
| Dyspnoea | 54.56 | 18.64 | 874 | 53611 | 325858 | 29194184 |
| Bone pain | 54.40 | 18.64 | 111 | 54374 | 18341 | 29501701 |
| Red blood cell count decreased | 54.20 | 18.64 | 135 | 54350 | 25467 | 29494575 |
| Off label use | 54.09 | 18.64 | 329 | 54156 | 300471 | 29219571 |
| Cytopenia | 53.87 | 18.64 | 78 | 54407 | 9781 | 29510261 |
| Cataract | 53.84 | 18.64 | 124 | 54361 | 22254 | 29497788 |
| Back disorder | 52.79 | 18.64 | 60 | 54425 | 5913 | 29514129 |
| Arthropathy | 50.28 | 18.64 | 118 | 54367 | 21436 | 29498606 |
| Rheumatoid arthritis | 47.31 | 18.64 | 3 | 54482 | 32149 | 29487893 |
| SARS-CoV-2 test positive | 47.22 | 18.64 | 43 | 54442 | 3256 | 29516786 |
| Ascites | 46.98 | 18.64 | 6 | 54479 | 36613 | 29483429 |
| Electrocardiogram QT prolonged | 46.17 | 18.64 | 6 | 54479 | 36131 | 29483911 |
| Wrong technique in product usage process | 46.05 | 18.64 | 3 | 54482 | 31425 | 29488617 |
| Suicide attempt | 45.22 | 18.64 | 5 | 54480 | 34105 | 29485937 |
| Aggression | 45.17 | 18.64 | 6 | 54479 | 35535 | 29484507 |
| Hypokalaemia | 45.08 | 18.64 | 18 | 54467 | 50185 | 29469857 |
| Rib fracture | 44.18 | 18.64 | 82 | 54403 | 12636 | 29507406 |
| International normalised ratio increased | 43.09 | 18.64 | 14 | 54471 | 44358 | 29475684 |
| Pulmonary thrombosis | 41.94 | 18.64 | 56 | 54429 | 6509 | 29513533 |
| Upper limb fracture | 41.54 | 18.64 | 44 | 54441 | 4007 | 29516035 |
| White blood cell count abnormal | 40.67 | 18.64 | 37 | 54448 | 2798 | 29517244 |
| Squamous cell carcinoma of skin | 40.54 | 18.64 | 67 | 54418 | 9419 | 29510623 |
| Hospitalisation | 40.46 | 18.64 | 17 | 54468 | 45971 | 29474071 |
| Injection site pain | 40.01 | 18.64 | 6 | 54479 | 32440 | 29487602 |
| Inappropriate schedule of product administration | 39.84 | 18.64 | 16 | 54469 | 44456 | 29475586 |
| Interstitial lung disease | 39.71 | 18.64 | 29 | 54456 | 57689 | 29462353 |
| Anxiety | 39.54 | 18.64 | 60 | 54425 | 85305 | 29434737 |
| Coma | 39.10 | 18.64 | 12 | 54473 | 39438 | 29480604 |
| General physical health deterioration | 38.91 | 18.64 | 82 | 54403 | 102775 | 29417267 |
| Blood calcium increased | 38.53 | 18.64 | 38 | 54447 | 3181 | 29516861 |
| Balance disorder | 37.60 | 18.64 | 149 | 54336 | 36021 | 29484021 |
| Dysarthria | 37.47 | 18.64 | 6 | 54479 | 30905 | 29489137 |
| Psoriasis | 37.43 | 18.64 | 7 | 54478 | 32220 | 29487822 |
| Depressed level of consciousness | 37.04 | 18.64 | 11 | 54474 | 36931 | 29483111 |
| Pancreatitis | 37.02 | 18.64 | 9 | 54476 | 34505 | 29485537 |
| Hypoaesthesia | 36.76 | 18.64 | 195 | 54290 | 53272 | 29466770 |
| Hypotension | 36.75 | 18.64 | 209 | 54276 | 194145 | 29325897 |
| Tachycardia | 36.40 | 18.64 | 48 | 54437 | 72362 | 29447680 |
| Seizure | 36.27 | 18.64 | 73 | 54412 | 93050 | 29426992 |
| Respiratory tract infection | 35.76 | 18.64 | 85 | 54400 | 15566 | 29504476 |
| Hip fracture | 35.64 | 18.64 | 67 | 54418 | 10425 | 29509617 |
| Dizziness | 35.60 | 18.64 | 518 | 53967 | 189166 | 29330876 |
| Protein total increased | 35.10 | 18.64 | 30 | 54455 | 2088 | 29517954 |
| Drug reaction with eosinophilia and systemic symptoms | 34.92 | 18.64 | 5 | 54480 | 27987 | 29492055 |
| Gastrointestinal haemorrhage | 34.84 | 18.64 | 58 | 54427 | 79475 | 29440567 |
| Haematuria | 34.73 | 18.64 | 19 | 54466 | 44120 | 29475922 |
| Malaise | 34.48 | 18.64 | 447 | 54038 | 159155 | 29360887 |
| Melaena | 33.69 | 18.64 | 8 | 54477 | 31168 | 29488874 |
| Cellulitis enterococcal | 33.50 | 18.64 | 10 | 54475 | 61 | 29519981 |
| Tooth infection | 33.48 | 18.64 | 46 | 54439 | 5493 | 29514549 |
| Gastric disorder | 33.47 | 18.64 | 66 | 54419 | 10638 | 29509404 |
| Fall | 33.30 | 18.64 | 484 | 54001 | 176694 | 29343348 |
| Multiple allergies | 33.27 | 18.64 | 29 | 54456 | 2073 | 29517969 |
| Feeling abnormal | 33.05 | 18.64 | 192 | 54293 | 54253 | 29465789 |
| Body height decreased | 32.79 | 18.64 | 36 | 54449 | 3414 | 29516628 |
| Incorrect dose administered | 32.75 | 18.64 | 10 | 54475 | 32974 | 29487068 |
| Jaundice | 32.69 | 18.64 | 7 | 54478 | 29289 | 29490753 |
| Bradycardia | 32.49 | 18.64 | 44 | 54441 | 65585 | 29454457 |
| Musculoskeletal disorder | 32.41 | 18.64 | 44 | 54441 | 5196 | 29514846 |
| Cholestasis | 32.24 | 18.64 | 3 | 54482 | 23459 | 29496583 |
| Coronary artery disease | 31.99 | 18.64 | 21 | 54464 | 44169 | 29475873 |
| White blood cell disorder | 31.77 | 18.64 | 24 | 54461 | 1399 | 29518643 |
| Drug hypersensitivity | 31.75 | 18.64 | 48 | 54437 | 68358 | 29451684 |
| Lower respiratory tract infection | 31.53 | 18.64 | 114 | 54371 | 26388 | 29493654 |
| Headache | 31.34 | 18.64 | 190 | 54295 | 173817 | 29346225 |
| Blood urea increased | 30.80 | 18.64 | 7 | 54478 | 28105 | 29491937 |
| Spinal fracture | 30.71 | 18.64 | 48 | 54437 | 6438 | 29513604 |
| Blood bilirubin increased | 30.67 | 18.64 | 12 | 54473 | 33881 | 29486161 |
| Bone lesion | 30.66 | 18.64 | 31 | 54454 | 2673 | 29517369 |
| Gamma-glutamyltransferase increased | 30.64 | 18.64 | 6 | 54479 | 26731 | 29493311 |
| Pneumonia respiratory syncytial viral | 30.53 | 18.64 | 19 | 54466 | 805 | 29519237 |
| Pyrexia | 30.35 | 18.64 | 718 | 53767 | 286904 | 29233138 |
| COVID-19 pneumonia | 30.12 | 18.64 | 59 | 54426 | 9463 | 29510579 |
| Cardiac arrest | 30.10 | 18.64 | 71 | 54414 | 85520 | 29434522 |
| Hypercalcaemia | 29.91 | 18.64 | 70 | 54415 | 12689 | 29507353 |
| Angioedema | 29.38 | 18.64 | 11 | 54474 | 31904 | 29488138 |
| Cardio-respiratory arrest | 29.25 | 18.64 | 30 | 54455 | 50571 | 29469471 |
| Oxygen saturation decreased | 29.10 | 18.64 | 24 | 54461 | 44913 | 29475129 |
| Respiration abnormal | 29.07 | 18.64 | 30 | 54455 | 2650 | 29517392 |
| Mucosal inflammation | 28.90 | 18.64 | 11 | 54474 | 31584 | 29488458 |
| Hepatic function abnormal | 27.95 | 18.64 | 19 | 54466 | 39240 | 29480802 |
| Parainfluenzae virus infection | 27.76 | 18.64 | 27 | 54458 | 2222 | 29517820 |
| Haematemesis | 27.24 | 18.64 | 6 | 54479 | 24620 | 29495422 |
| Psychotic disorder | 26.93 | 18.64 | 3 | 54482 | 20351 | 29499691 |
| Agranulocytosis | 26.91 | 18.64 | 3 | 54482 | 20337 | 29499705 |
| Blood immunoglobulin M increased | 26.89 | 18.64 | 11 | 54474 | 186 | 29519856 |
| Acute myocardial infarction | 26.57 | 18.64 | 30 | 54455 | 48408 | 29471634 |
| Encephalopathy | 26.47 | 18.64 | 12 | 54473 | 31031 | 29489011 |
| Upper respiratory tract infection | 26.30 | 18.64 | 110 | 54375 | 27239 | 29492803 |
| Respiratory syncytial virus infection | 26.16 | 18.64 | 33 | 54452 | 3626 | 29516416 |
| Neutropenic sepsis | 26.05 | 18.64 | 63 | 54422 | 11664 | 29508378 |
| Metabolic acidosis | 25.80 | 18.64 | 19 | 54466 | 37643 | 29482399 |
| Cerebral toxoplasmosis | 25.41 | 18.64 | 21 | 54464 | 1395 | 29518647 |
| Lactic acidosis | 25.32 | 18.64 | 12 | 54473 | 30235 | 29489807 |
| Blood pressure abnormal | 25.13 | 18.64 | 45 | 54440 | 6745 | 29513297 |
| Clostridium difficile infection | 25.07 | 18.64 | 76 | 54409 | 16065 | 29503977 |
| Blood lactate dehydrogenase increased | 25.00 | 18.64 | 3 | 54482 | 19206 | 29500836 |
| Drug-induced liver injury | 24.52 | 18.64 | 5 | 54480 | 21650 | 29498392 |
| Seasonal allergy | 24.49 | 18.64 | 38 | 54447 | 5064 | 29514978 |
| White blood cell count increased | 24.34 | 18.64 | 20 | 54465 | 37496 | 29482546 |
| Stress | 24.26 | 18.64 | 5 | 54480 | 21485 | 29498557 |
| Transaminases increased | 24.12 | 18.64 | 6 | 54479 | 22656 | 29497386 |
| Shock | 24.12 | 18.64 | 5 | 54480 | 21399 | 29498643 |
| Sinus disorder | 24.03 | 18.64 | 41 | 54444 | 5914 | 29514128 |
| Ventricular tachycardia | 23.98 | 18.64 | 6 | 54479 | 22568 | 29497474 |
| Epilepsy | 23.69 | 18.64 | 3 | 54482 | 18429 | 29501613 |
| Tremor | 23.68 | 18.64 | 223 | 54262 | 73315 | 29446727 |
| Respiratory arrest | 23.62 | 18.64 | 9 | 54476 | 25824 | 29494218 |
| Lower limb fracture | 23.09 | 18.64 | 31 | 54454 | 3621 | 29516421 |
| Blood creatinine increased | 23.01 | 18.64 | 80 | 54405 | 85022 | 29435020 |
| Anaphylactic reaction | 22.98 | 18.64 | 11 | 54474 | 27562 | 29492480 |
| Product prescribing error | 22.92 | 18.64 | 3 | 54482 | 17973 | 29502069 |
| Thrombocytopenia | 22.86 | 18.64 | 362 | 54123 | 134461 | 29385581 |
| Progressive multifocal leukoencephalopathy | 22.85 | 18.64 | 50 | 54435 | 8669 | 29511373 |
| Hepatotoxicity | 22.74 | 18.64 | 3 | 54482 | 17864 | 29502178 |
| Blood alkaline phosphatase increased | 22.68 | 18.64 | 12 | 54473 | 28394 | 29491648 |
| Blood immunoglobulin A increased | 22.56 | 18.64 | 11 | 54474 | 286 | 29519756 |
| Drug ineffective | 22.53 | 18.64 | 504 | 53981 | 362666 | 29157376 |
| Hypoacusis | 22.49 | 18.64 | 68 | 54417 | 14355 | 29505687 |
| Viral infection | 22.32 | 18.64 | 69 | 54416 | 14741 | 29505301 |
| Swelling face | 22.09 | 18.64 | 85 | 54400 | 20265 | 29499777 |
| JC virus infection | 21.97 | 18.64 | 22 | 54463 | 1875 | 29518167 |
| Circulatory collapse | 21.80 | 18.64 | 4 | 54481 | 18669 | 29501373 |
| Neoplasm progression | 21.70 | 18.64 | 4 | 54481 | 18608 | 29501434 |
| Spinal disorder | 21.31 | 18.64 | 30 | 54455 | 3665 | 29516377 |
| Vertebral lesion | 20.95 | 18.64 | 9 | 54476 | 173 | 29519869 |
| Coronavirus infection | 20.93 | 18.64 | 28 | 54457 | 3260 | 29516782 |
| Ear infection | 20.72 | 18.64 | 46 | 54439 | 8054 | 29511988 |
| Generalised tonic-clonic seizure | 20.50 | 18.64 | 5 | 54480 | 19134 | 29500908 |
| Diverticulitis | 20.08 | 18.64 | 75 | 54410 | 17629 | 29502413 |
| Medication error | 20.05 | 18.64 | 7 | 54478 | 21204 | 29498838 |
| Leukocytosis | 19.95 | 18.64 | 7 | 54478 | 21135 | 29498907 |
| Respiratory distress | 19.75 | 18.64 | 18 | 54467 | 32088 | 29487954 |
| Sedation | 19.75 | 18.64 | 4 | 54481 | 17401 | 29502641 |
| Light chain analysis abnormal | 19.68 | 18.64 | 7 | 54478 | 79 | 29519963 |
| Abnormal behaviour | 19.62 | 18.64 | 9 | 54476 | 23118 | 29496924 |
| Hepatic enzyme increased | 19.57 | 18.64 | 20 | 54465 | 33779 | 29486263 |
| Product quality issue | 19.45 | 18.64 | 3 | 54482 | 15892 | 29504150 |
| Taste disorder | 19.43 | 18.64 | 33 | 54452 | 4743 | 29515299 |
| Gastrointestinal infection | 18.93 | 18.64 | 29 | 54456 | 3822 | 29516220 |
| Drug resistance | 18.88 | 18.64 | 8 | 54477 | 21532 | 29498510 |
| Pancytopenia | 18.79 | 18.64 | 235 | 54250 | 82933 | 29437109 |
| Therapeutic product effect incomplete | 18.79 | 18.64 | 27 | 54458 | 39278 | 29480764 |
| Ageusia | 18.77 | 18.64 | 47 | 54438 | 8891 | 29511151 |
| Protein total abnormal | 18.73 | 18.64 | 10 | 54475 | 316 | 29519726 |
| C-reactive protein increased | 18.71 | 18.64 | 33 | 54452 | 44230 | 29475812 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Death | 2941.73 | 18.54 | 2938 | 60471 | 479767 | 63955556 |
| Pneumonia | 2435.83 | 18.54 | 2853 | 60556 | 556723 | 63878600 |
| White blood cell count decreased | 1330.63 | 18.54 | 1157 | 62252 | 156680 | 64278643 |
| Full blood count decreased | 1223.73 | 18.54 | 545 | 62864 | 22037 | 64413286 |
| Neutropenia | 1178.93 | 18.54 | 1308 | 62101 | 238316 | 64197007 |
| Neuropathy peripheral | 724.99 | 18.54 | 725 | 62684 | 116800 | 64318523 |
| Neutrophil count decreased | 554.34 | 18.54 | 518 | 62891 | 76678 | 64358645 |
| Thrombosis | 518.72 | 18.54 | 480 | 62929 | 70162 | 64365161 |
| Fatigue | 510.77 | 18.54 | 1751 | 61658 | 746979 | 63688344 |
| Platelet count decreased | 508.64 | 18.54 | 720 | 62689 | 166991 | 64268332 |
| Laboratory test abnormal | 471.10 | 18.54 | 294 | 63115 | 23769 | 64411554 |
| Unevaluable event | 351.11 | 18.54 | 333 | 63076 | 50156 | 64385167 |
| Influenza | 329.43 | 18.54 | 462 | 62947 | 106069 | 64329254 |
| COVID-19 | 315.97 | 18.54 | 354 | 63055 | 64786 | 64370537 |
| Plasmacytoma | 315.43 | 18.54 | 125 | 63284 | 3745 | 64431578 |
| Plasma cell myeloma recurrent | 312.93 | 18.54 | 126 | 63283 | 3939 | 64431384 |
| Drug interaction | 285.15 | 18.54 | 18 | 63391 | 362065 | 64073258 |
| Plasma cell myeloma | 263.08 | 18.54 | 273 | 63136 | 45802 | 64389521 |
| Sepsis | 230.12 | 18.54 | 618 | 62791 | 229723 | 64205600 |
| Condition aggravated | 221.41 | 18.54 | 48 | 63361 | 372378 | 64062945 |
| Thrombocytopenia | 216.07 | 18.54 | 593 | 62816 | 223208 | 64212115 |
| Deep vein thrombosis | 213.39 | 18.54 | 376 | 63033 | 104806 | 64330517 |
| Constipation | 212.86 | 18.54 | 599 | 62810 | 228738 | 64206585 |
| Anaemia | 182.63 | 18.54 | 796 | 62613 | 377884 | 64057439 |
| Atrial fibrillation | 159.70 | 18.54 | 448 | 62961 | 170641 | 64264682 |
| Plasma cell leukaemia | 154.52 | 18.54 | 58 | 63351 | 1495 | 64433828 |
| Infection | 152.32 | 18.54 | 463 | 62946 | 184417 | 64250906 |
| Adverse drug reaction | 146.08 | 18.54 | 201 | 63208 | 45263 | 64390060 |
| Rash | 145.66 | 18.54 | 857 | 62552 | 457692 | 63977631 |
| Human chorionic gonadotropin increased | 145.33 | 18.54 | 48 | 63361 | 838 | 64434485 |
| Rheumatoid arthritis | 142.92 | 18.54 | 4 | 63405 | 164290 | 64271033 |
| Muscle spasms | 139.23 | 18.54 | 377 | 63032 | 140646 | 64294677 |
| Cytopenia | 130.91 | 18.54 | 114 | 63295 | 15357 | 64419966 |
| Light chain analysis increased | 119.85 | 18.54 | 46 | 63363 | 1262 | 64434061 |
| Drug hypersensitivity | 116.59 | 18.54 | 44 | 63365 | 237771 | 64197552 |
| Bronchitis | 112.64 | 18.54 | 296 | 63113 | 108447 | 64326876 |
| Overdose | 109.20 | 18.54 | 14 | 63395 | 159552 | 64275771 |
| Asthenia | 108.61 | 18.54 | 756 | 62653 | 427288 | 64008035 |
| Drug ineffective | 104.46 | 18.54 | 449 | 62960 | 839798 | 63595525 |
| Cardiac disorder | 99.76 | 18.54 | 189 | 63220 | 55627 | 64379696 |
| Febrile neutropenia | 97.54 | 18.54 | 404 | 63005 | 187253 | 64248070 |
| Peripheral swelling | 96.99 | 18.54 | 435 | 62974 | 208718 | 64226605 |
| Arthralgia | 95.68 | 18.54 | 181 | 63228 | 442079 | 63993244 |
| Abdominal pain | 95.24 | 18.54 | 100 | 63309 | 312275 | 64123048 |
| Red blood cell count decreased | 94.20 | 18.54 | 170 | 63239 | 48216 | 64387107 |
| Hypercalcaemia | 93.62 | 18.54 | 134 | 63275 | 31282 | 64404041 |
| Pyrexia | 88.80 | 18.54 | 888 | 62521 | 557756 | 63877567 |
| Renal disorder | 84.35 | 18.54 | 136 | 63273 | 35229 | 64400094 |
| Urinary tract infection | 83.29 | 18.54 | 448 | 62961 | 231148 | 64204175 |
| Headache | 81.28 | 18.54 | 259 | 63150 | 529208 | 63906115 |
| Nasopharyngitis | 80.75 | 18.54 | 394 | 63015 | 195679 | 64239644 |
| Neutropenic sepsis | 79.46 | 18.54 | 106 | 63303 | 23166 | 64412157 |
| Injection site pain | 78.12 | 18.54 | 9 | 63400 | 111399 | 64323924 |
| Product use in unapproved indication | 78.04 | 18.54 | 38 | 63371 | 176580 | 64258743 |
| Respiratory tract infection | 76.12 | 18.54 | 134 | 63275 | 37273 | 64398050 |
| Fall | 75.27 | 18.54 | 681 | 62728 | 416145 | 64019178 |
| Bone pain | 75.20 | 18.54 | 153 | 63256 | 47419 | 64387904 |
| Pancytopenia | 74.79 | 18.54 | 309 | 63100 | 143000 | 64292323 |
| Hip fracture | 74.10 | 18.54 | 111 | 63298 | 26988 | 64408335 |
| Squamous cell carcinoma of skin | 70.69 | 18.54 | 72 | 63337 | 11804 | 64423519 |
| Haemoglobin decreased | 70.56 | 18.54 | 378 | 63031 | 194685 | 64240638 |
| Pulmonary thrombosis | 70.44 | 18.54 | 68 | 63341 | 10450 | 64424873 |
| Product dose omission issue | 68.15 | 18.54 | 374 | 63035 | 194373 | 64240950 |
| Intentional product use issue | 61.43 | 18.54 | 10 | 63399 | 95354 | 64339969 |
| Hyponatraemia | 60.98 | 18.54 | 35 | 63374 | 148304 | 64287019 |
| Rhabdomyolysis | 60.49 | 18.54 | 9 | 63400 | 91717 | 64343606 |
| COVID-19 pneumonia | 59.16 | 18.54 | 77 | 63332 | 16427 | 64418896 |
| Intentional product misuse | 58.62 | 18.54 | 3 | 63406 | 72292 | 64363031 |
| Agitation | 57.52 | 18.54 | 9 | 63400 | 88358 | 64346965 |
| Vomiting | 57.48 | 18.54 | 313 | 63096 | 550804 | 63884519 |
| Renal failure | 55.12 | 18.54 | 336 | 63073 | 181352 | 64253971 |
| Anxiety | 55.10 | 18.54 | 71 | 63338 | 202578 | 64232745 |
| Blood calcium increased | 54.91 | 18.54 | 54 | 63355 | 8488 | 64426835 |
| Back pain | 53.67 | 18.54 | 425 | 62984 | 249746 | 64185577 |
| Tremor | 52.72 | 18.54 | 286 | 63123 | 147944 | 64287379 |
| Respiratory syncytial virus infection | 52.50 | 18.54 | 49 | 63360 | 7219 | 64428104 |
| Psoriasis | 52.30 | 18.54 | 5 | 63404 | 71698 | 64363625 |
| Dyspnoea | 51.14 | 18.54 | 990 | 62419 | 717684 | 63717639 |
| Pulmonary embolism | 49.78 | 18.54 | 279 | 63130 | 146077 | 64289246 |
| Aspartate aminotransferase increased | 49.61 | 18.54 | 28 | 63381 | 119760 | 64315563 |
| Diarrhoea | 49.55 | 18.54 | 990 | 62419 | 721714 | 63713609 |
| Therapeutic product effect decreased | 49.17 | 18.54 | 26 | 63383 | 115325 | 64319998 |
| Suicide attempt | 49.12 | 18.54 | 6 | 63403 | 71001 | 64364322 |
| Cerebrovascular accident | 48.62 | 18.54 | 265 | 63144 | 137318 | 64298005 |
| Monoclonal immunoglobulin present | 47.66 | 18.54 | 21 | 63388 | 824 | 64434499 |
| Hypokalaemia | 46.99 | 18.54 | 31 | 63378 | 121872 | 64313451 |
| Coma | 46.74 | 18.54 | 14 | 63395 | 87601 | 64347722 |
| Pericarditis | 46.56 | 18.54 | 4 | 63405 | 62512 | 64372811 |
| Leukopenia | 44.93 | 18.54 | 208 | 63201 | 101034 | 64334289 |
| Rib fracture | 44.93 | 18.54 | 83 | 63326 | 23955 | 64411368 |
| Immune system disorder | 44.81 | 18.54 | 50 | 63359 | 9091 | 64426232 |
| Electrocardiogram QT prolonged | 43.66 | 18.54 | 12 | 63397 | 79436 | 64355887 |
| Treatment failure | 43.30 | 18.54 | 31 | 63378 | 116785 | 64318538 |
| Tooth disorder | 42.69 | 18.54 | 78 | 63331 | 22324 | 64412999 |
| Hepatic enzyme increased | 42.54 | 18.54 | 39 | 63370 | 129904 | 64305419 |
| Crystal nephropathy | 42.45 | 18.54 | 22 | 63387 | 1243 | 64434080 |
| Lymphocyte count decreased | 42.31 | 18.54 | 111 | 63298 | 40588 | 64394735 |
| Dizziness | 41.58 | 18.54 | 623 | 62786 | 429540 | 64005783 |
| Musculoskeletal stiffness | 41.50 | 18.54 | 36 | 63373 | 123170 | 64312153 |
| Discomfort | 41.23 | 18.54 | 14 | 63395 | 80864 | 64354459 |
| Hypoglycaemia | 38.69 | 18.54 | 20 | 63389 | 89872 | 64345451 |
| Pain | 38.68 | 18.54 | 353 | 63056 | 553158 | 63882165 |
| Infusion related reaction | 38.45 | 18.54 | 64 | 63345 | 164403 | 64270920 |
| Upper respiratory tract infection | 37.98 | 18.54 | 157 | 63252 | 72628 | 64362695 |
| Pneumonia influenzal | 37.59 | 18.54 | 26 | 63383 | 2496 | 64432827 |
| SARS-CoV-2 test positive | 37.21 | 18.54 | 38 | 63371 | 6248 | 64429075 |
| Hospitalisation | 36.67 | 18.54 | 14 | 63395 | 75193 | 64360130 |
| Therapeutic product effect incomplete | 36.38 | 18.54 | 29 | 63380 | 103453 | 64331870 |
| Rash pruritic | 35.80 | 18.54 | 131 | 63278 | 57273 | 64378050 |
| Alanine aminotransferase increased | 35.46 | 18.54 | 51 | 63358 | 138980 | 64296343 |
| Toxicity to various agents | 34.84 | 18.54 | 212 | 63197 | 363301 | 64072022 |
| Cataract | 34.54 | 18.54 | 120 | 63289 | 51142 | 64384181 |
| Hypertension | 33.57 | 18.54 | 136 | 63273 | 259125 | 64176198 |
| Back disorder | 33.33 | 18.54 | 45 | 63364 | 9945 | 64425378 |
| Glossodynia | 33.32 | 18.54 | 11 | 63398 | 64685 | 64370638 |
| Suicidal ideation | 33.09 | 18.54 | 12 | 63397 | 66530 | 64368793 |
| Blood test abnormal | 32.54 | 18.54 | 51 | 63358 | 12892 | 64422431 |
| Tumour lysis syndrome | 32.48 | 18.54 | 64 | 63345 | 19376 | 64415947 |
| Pneumonia respiratory syncytial viral | 31.87 | 18.54 | 19 | 63390 | 1412 | 64433911 |
| Oxygen saturation decreased | 31.83 | 18.54 | 35 | 63374 | 107141 | 64328182 |
| Pneumonia pneumococcal | 31.82 | 18.54 | 26 | 63383 | 3208 | 64432115 |
| Full blood count abnormal | 31.79 | 18.54 | 82 | 63327 | 29675 | 64405648 |
| White blood cell count abnormal | 31.79 | 18.54 | 31 | 63378 | 4823 | 64430500 |
| Progressive multifocal leukoencephalopathy | 31.65 | 18.54 | 61 | 63348 | 18171 | 64417152 |
| Pneumocystis jirovecii pneumonia | 31.45 | 18.54 | 78 | 63331 | 27556 | 64407767 |
| Inappropriate schedule of product administration | 31.03 | 18.54 | 27 | 63382 | 92259 | 64343064 |
| Full blood count increased | 31.01 | 18.54 | 13 | 63396 | 451 | 64434872 |
| Pathological fracture | 30.71 | 18.54 | 41 | 63368 | 8964 | 64426359 |
| International normalised ratio increased | 30.68 | 18.54 | 20 | 63389 | 79147 | 64356176 |
| Osteoarthritis | 30.53 | 18.54 | 12 | 63397 | 63324 | 64371999 |
| Drug reaction with eosinophilia and systemic symptoms | 30.15 | 18.54 | 8 | 63401 | 54209 | 64381114 |
| Haematemesis | 30.10 | 18.54 | 5 | 63404 | 46994 | 64388329 |
| Depressed level of consciousness | 29.67 | 18.54 | 22 | 63387 | 81414 | 64353909 |
| Melaena | 29.59 | 18.54 | 8 | 63401 | 53540 | 64381783 |
| Cellulitis enterococcal | 29.49 | 18.54 | 7 | 63402 | 32 | 64435291 |
| Lactic acidosis | 29.00 | 18.54 | 12 | 63397 | 61398 | 64373925 |
| Inflammation | 28.90 | 18.54 | 14 | 63395 | 65286 | 64370037 |
| Peripheral sensory neuropathy | 28.84 | 18.54 | 45 | 63364 | 11333 | 64423990 |
| Bone lesion | 28.51 | 18.54 | 30 | 63379 | 5107 | 64430216 |
| Anaphylactic reaction | 28.49 | 18.54 | 16 | 63393 | 68648 | 64366675 |
| Localised infection | 28.09 | 18.54 | 79 | 63330 | 30082 | 64405241 |
| Dyskinesia | 28.06 | 18.54 | 3 | 63406 | 39385 | 64395938 |
| Blood immunoglobulin M increased | 28.00 | 18.54 | 12 | 63397 | 440 | 64434883 |
| Mobility decreased | 27.81 | 18.54 | 26 | 63383 | 85814 | 64349509 |
| Product use issue | 27.79 | 18.54 | 68 | 63341 | 151647 | 64283676 |
| Angioedema | 27.75 | 18.54 | 13 | 63396 | 61808 | 64373515 |
| Off label use | 27.60 | 18.54 | 447 | 62962 | 632359 | 63802964 |
| Sedation | 27.49 | 18.54 | 4 | 63405 | 41458 | 64393865 |
| Wound | 27.42 | 18.54 | 21 | 63388 | 76456 | 64358867 |
| Depression | 27.09 | 18.54 | 91 | 63318 | 183200 | 64252123 |
| Incorrect dose administered | 26.93 | 18.54 | 13 | 63396 | 60752 | 64374571 |
| Impaired healing | 26.71 | 18.54 | 13 | 63396 | 60460 | 64374863 |
| Drug-induced liver injury | 26.55 | 18.54 | 7 | 63402 | 47636 | 64387687 |
| Blood pressure systolic increased | 26.19 | 18.54 | 8 | 63401 | 49445 | 64385878 |
| Upper limb fracture | 26.12 | 18.54 | 50 | 63359 | 14816 | 64420507 |
| Lower respiratory tract infection | 25.58 | 18.54 | 170 | 63239 | 94444 | 64340879 |
| Parainfluenzae virus infection | 25.08 | 18.54 | 27 | 63382 | 4716 | 64430607 |
| Medication error | 24.86 | 18.54 | 9 | 63400 | 49957 | 64385366 |
| Hypotension | 24.84 | 18.54 | 247 | 63162 | 380727 | 64054596 |
| Blood pressure fluctuation | 24.72 | 18.54 | 10 | 63399 | 51861 | 64383462 |
| Clostridium difficile infection | 24.66 | 18.54 | 85 | 63324 | 36078 | 64399245 |
| Cardio-respiratory arrest | 24.20 | 18.54 | 37 | 63372 | 98356 | 64336967 |
| Spinal fracture | 24.20 | 18.54 | 49 | 63360 | 15125 | 64420198 |
| Chest discomfort | 23.74 | 18.54 | 49 | 63360 | 116057 | 64319266 |
| Swelling face | 23.67 | 18.54 | 118 | 63291 | 59048 | 64376275 |
| Malignant neoplasm progression | 23.62 | 18.54 | 47 | 63362 | 112824 | 64322499 |
| Dehydration | 23.29 | 18.54 | 320 | 63089 | 216443 | 64218880 |
| Type 2 diabetes mellitus | 23.22 | 18.54 | 3 | 63406 | 34017 | 64401306 |
| Hepatitis | 23.04 | 18.54 | 8 | 63401 | 45574 | 64389749 |
| Viral infection | 22.97 | 18.54 | 83 | 63326 | 36057 | 64399266 |
| Neoplasm progression | 22.86 | 18.54 | 6 | 63403 | 40958 | 64394365 |
| Clavicle fracture | 22.80 | 18.54 | 23 | 63386 | 3726 | 64431597 |
| Weight decreased | 22.71 | 18.54 | 176 | 63233 | 285563 | 64149760 |
| Osteolysis | 22.40 | 18.54 | 20 | 63389 | 2783 | 64432540 |
| Tachycardia | 22.28 | 18.54 | 74 | 63335 | 149505 | 64285818 |
| Ascites | 22.26 | 18.54 | 17 | 63392 | 61984 | 64373339 |
| Hyperkalaemia | 22.13 | 18.54 | 41 | 63368 | 101088 | 64334235 |
| Pancreatitis | 21.84 | 18.54 | 16 | 63393 | 59591 | 64375732 |
| Coronavirus infection | 21.71 | 18.54 | 27 | 63382 | 5503 | 64429820 |
| Dysarthria | 21.70 | 18.54 | 16 | 63393 | 59390 | 64375933 |
| Peritonitis viral | 21.50 | 18.54 | 6 | 63403 | 57 | 64435266 |
| Feeling hot | 21.44 | 18.54 | 9 | 63400 | 45654 | 64389669 |
| Metabolic acidosis | 21.26 | 18.54 | 23 | 63386 | 70935 | 64364388 |
| Coronary artery disease | 21.15 | 18.54 | 17 | 63392 | 60416 | 64374907 |
| Depressed mood | 21.07 | 18.54 | 7 | 63402 | 41005 | 64394318 |
| Protein total increased | 21.04 | 18.54 | 21 | 63388 | 3360 | 64431963 |
| Septic shock | 20.87 | 18.54 | 176 | 63233 | 105261 | 64330062 |
| Accidental overdose | 20.56 | 18.54 | 4 | 63405 | 33553 | 64401770 |
| Injury | 20.56 | 18.54 | 15 | 63394 | 55977 | 64379346 |
| Epilepsy | 20.54 | 18.54 | 4 | 63405 | 33527 | 64401796 |
| Blood bilirubin increased | 20.38 | 18.54 | 16 | 63393 | 57537 | 64377786 |
| Atrial flutter | 20.29 | 18.54 | 53 | 63356 | 19327 | 64415996 |
| Dysphagia | 20.25 | 18.54 | 47 | 63362 | 106765 | 64328558 |
| Osteoporosis | 20.23 | 18.54 | 8 | 63401 | 42072 | 64393251 |
| Mucosal inflammation | 20.22 | 18.54 | 19 | 63390 | 62565 | 64372758 |
| Weight increased | 20.10 | 18.54 | 125 | 63284 | 213223 | 64222100 |
| Seizure | 20.07 | 18.54 | 90 | 63319 | 166802 | 64268521 |
| Loss of personal independence in daily activities | 20.07 | 18.54 | 25 | 63384 | 72429 | 64362894 |
| Anaphylactic shock | 19.93 | 18.54 | 3 | 63406 | 30325 | 64404998 |
| Flushing | 19.90 | 18.54 | 29 | 63380 | 78619 | 64356704 |
| Body dysmorphic disorder | 19.83 | 18.54 | 8 | 63401 | 251 | 64435072 |
| Respiratory arrest | 19.71 | 18.54 | 14 | 63395 | 52971 | 64382352 |
| Injection site swelling | 19.66 | 18.54 | 8 | 63401 | 41345 | 64393978 |
| Blood pressure increased | 19.60 | 18.54 | 95 | 63314 | 172457 | 64262866 |
| Avulsion fracture | 19.43 | 18.54 | 8 | 63401 | 265 | 64435058 |
| Unresponsive to stimuli | 19.16 | 18.54 | 13 | 63396 | 50380 | 64384943 |
| Diverticulitis | 19.12 | 18.54 | 82 | 63327 | 38536 | 64396787 |
| Shock | 18.84 | 18.54 | 7 | 63402 | 38233 | 64397090 |
| Gastrointestinal haemorrhage | 18.66 | 18.54 | 67 | 63342 | 132245 | 64303078 |
| Bradycardia | 18.64 | 18.54 | 57 | 63352 | 118162 | 64317161 |
| Palmar-plantar erythrodysaesthesia syndrome | 18.60 | 18.54 | 3 | 63406 | 28816 | 64406507 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| 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|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Multiple myeloma | indication | 109989006 | DOID:9538 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 7.84 | acidic |
| pKa2 | 1.86 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent 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 strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 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:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Protein cereblon | Cytosolic other | MODULATOR | EC50 | 6.58 | SCIENTIFIC LITERATURE | SCIENTIFIC LITERATURE | |||
| Cereblon isoform 4 | Unclassified | Ki | 6.10 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| D08976 | KEGG_DRUG |
| 4032092 | VANDF |
| CHEBI:72690 | CHEBI |
| CHEMBL43452 | ChEMBL_ID |
| C467566 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7348 | IUPHAR_LIGAND_ID |
| 8873 | INN_ID |
| DB08910 | DRUGBANK_ID |
| D2UX06XLB5 | UNII |
| 134780 | PUBCHEM_CID |
| 1369713 | RXNORM |
| 199372 | MMSL |
| 29234 | MMSL |
| d08041 | MMSL |
| 014897 | NDDF |
| 703789000 | SNOMEDCT_US |
| 703790009 | SNOMEDCT_US |
| C2347624 | UMLSCUI |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 |