azacitidine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| nucleosides antiviral or antineoplastic agents, cytarabine or azacitidine derivatives | 25 | 320-67-2 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A pyrimidine analogue that inhibits DNA methyltransferase, impairing DNA methylation. It is also an antimetabolite of cytidine, incorporated primarily into RNA. Azacytidine has been used as an antineoplastic agent.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 3 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 89 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 62 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 177.10 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| Vd (Volume of distribution) | 0.47 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 35 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 0.36 hours | Lombardo F, Berellini G, Obach RS |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 21, 2011 | PMDA | Nippon Shinyaku Co., Ltd. | |
| Aug. 2, 2019 | EMA | Celgene Europe BV | |
| May 19, 2004 | FDA | CELGENE |
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 |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 1634.10 | 22.16 | 732 | 15754 | 117717 | 63354819 |
| Acute myeloid leukaemia | 687.22 | 22.16 | 231 | 16255 | 16916 | 63455620 |
| Death | 475.29 | 22.16 | 532 | 15954 | 373849 | 63098687 |
| Thrombocytopenia | 473.52 | 22.16 | 357 | 16129 | 150800 | 63321736 |
| Pancytopenia | 385.75 | 22.16 | 265 | 16221 | 96668 | 63375868 |
| Acute myeloid leukaemia recurrent | 361.41 | 22.16 | 84 | 16402 | 1539 | 63470997 |
| Neutropenia | 352.34 | 22.16 | 320 | 16166 | 174685 | 63297851 |
| Sepsis | 352.18 | 22.16 | 302 | 16184 | 152821 | 63319715 |
| Pneumonia | 348.35 | 22.16 | 504 | 15982 | 456263 | 63016273 |
| Myelosuppression | 264.02 | 22.16 | 127 | 16359 | 23576 | 63448960 |
| Septic shock | 222.81 | 22.16 | 164 | 16322 | 66465 | 63406071 |
| Platelet count decreased | 201.87 | 22.16 | 196 | 16290 | 115926 | 63356610 |
| Neutrophil count decreased | 197.99 | 22.16 | 143 | 16343 | 56263 | 63416273 |
| Blast cell count increased | 182.31 | 22.16 | 38 | 16448 | 408 | 63472128 |
| Cytopenia | 166.06 | 22.16 | 74 | 16412 | 11527 | 63461009 |
| Bronchopulmonary aspergillosis | 162.98 | 22.16 | 67 | 16419 | 8568 | 63463968 |
| Myelodysplastic syndrome transformation | 154.42 | 22.16 | 33 | 16453 | 403 | 63472133 |
| Pyrexia | 154.06 | 22.16 | 361 | 16125 | 470117 | 63002419 |
| Anaemia | 145.12 | 22.16 | 267 | 16219 | 293163 | 63179373 |
| Transformation to acute myeloid leukaemia | 122.66 | 22.16 | 25 | 16461 | 238 | 63472298 |
| Pain | 119.24 | 22.16 | 24 | 16462 | 740604 | 62731932 |
| Pneumonitis | 113.81 | 22.16 | 85 | 16401 | 35137 | 63437399 |
| Pneumonia fungal | 108.66 | 22.16 | 44 | 16442 | 5411 | 63467125 |
| White blood cell count decreased | 94.41 | 22.16 | 146 | 16340 | 138958 | 63333578 |
| Arthralgia | 84.49 | 22.16 | 22 | 16464 | 569688 | 62902848 |
| Respiratory failure | 82.18 | 22.16 | 116 | 16370 | 101742 | 63370794 |
| Multiple organ dysfunction syndrome | 80.60 | 22.16 | 86 | 16400 | 56666 | 63415870 |
| Tumour lysis syndrome | 78.88 | 22.16 | 41 | 16445 | 8949 | 63463587 |
| Differentiation syndrome | 78.18 | 22.16 | 23 | 16463 | 1080 | 63471456 |
| Neutropenic sepsis | 77.37 | 22.16 | 50 | 16436 | 16388 | 63456148 |
| Acute febrile neutrophilic dermatosis | 76.94 | 22.16 | 29 | 16457 | 2945 | 63469591 |
| Myelodysplastic syndrome | 74.07 | 22.16 | 49 | 16437 | 16705 | 63455831 |
| Aspergillus infection | 68.41 | 22.16 | 36 | 16450 | 8057 | 63464479 |
| Headache | 65.57 | 22.16 | 42 | 16444 | 633199 | 62839337 |
| Cerebral haemorrhage | 65.10 | 22.16 | 58 | 16428 | 30671 | 63441865 |
| Leukaemia | 63.94 | 22.16 | 28 | 16458 | 4180 | 63468356 |
| Bone marrow failure | 59.52 | 22.16 | 54 | 16432 | 29236 | 63443300 |
| Joint swelling | 58.35 | 22.16 | 8 | 16478 | 327658 | 63144878 |
| Disease progression | 58.31 | 22.16 | 110 | 16376 | 122648 | 63349888 |
| Acute graft versus host disease | 56.25 | 22.16 | 26 | 16460 | 4402 | 63468134 |
| Infection | 54.14 | 22.16 | 156 | 16330 | 229017 | 63243519 |
| Swelling | 53.34 | 22.16 | 5 | 16481 | 275373 | 63197163 |
| Graft versus host disease in skin | 52.97 | 22.16 | 22 | 16464 | 2883 | 63469653 |
| Abdominal discomfort | 52.29 | 22.16 | 10 | 16476 | 320875 | 63151661 |
| Allogenic stem cell transplantation | 51.67 | 22.16 | 10 | 16476 | 71 | 63472465 |
| Pneumonia adenoviral | 51.49 | 22.16 | 11 | 16475 | 134 | 63472402 |
| Cardiac failure | 51.46 | 22.16 | 87 | 16399 | 89055 | 63383481 |
| Agranulocytosis | 50.40 | 22.16 | 46 | 16440 | 25088 | 63447448 |
| Subdural haematoma | 49.46 | 22.16 | 36 | 16450 | 14292 | 63458244 |
| Myelofibrosis | 49.01 | 22.16 | 17 | 16469 | 1360 | 63471176 |
| Product dose omission issue | 48.92 | 22.16 | 3 | 16483 | 234310 | 63238226 |
| Soft tissue infection | 48.70 | 22.16 | 19 | 16467 | 2118 | 63470418 |
| Nasopharyngitis | 48.23 | 22.16 | 5 | 16481 | 254252 | 63218284 |
| Drug hypersensitivity | 47.91 | 22.16 | 11 | 16475 | 310676 | 63161860 |
| Therapy non-responder | 47.74 | 22.16 | 77 | 16409 | 75824 | 63396712 |
| Graft versus host disease in gastrointestinal tract | 47.41 | 22.16 | 21 | 16465 | 3220 | 63469316 |
| Alopecia | 46.33 | 22.16 | 15 | 16471 | 337521 | 63135015 |
| Peripheral swelling | 46.15 | 22.16 | 7 | 16479 | 265935 | 63206601 |
| Stenotrophomonas infection | 46.12 | 22.16 | 18 | 16468 | 2009 | 63470527 |
| Bacteraemia | 45.45 | 22.16 | 37 | 16449 | 17311 | 63455225 |
| Maternal exposure during pregnancy | 45.39 | 22.16 | 3 | 16483 | 220059 | 63252477 |
| Leukopenia | 45.36 | 22.16 | 76 | 16410 | 77214 | 63395322 |
| Escherichia sepsis | 44.39 | 22.16 | 23 | 16463 | 4984 | 63467552 |
| Organising pneumonia | 44.06 | 22.16 | 24 | 16462 | 5752 | 63466784 |
| Refractory anaemia with an excess of blasts | 43.78 | 22.16 | 12 | 16474 | 435 | 63472101 |
| Acute myeloid leukaemia refractory | 42.97 | 22.16 | 9 | 16477 | 99 | 63472437 |
| Enterococcal infection | 42.26 | 22.16 | 26 | 16460 | 7822 | 63464714 |
| Hypertension | 40.89 | 22.16 | 11 | 16475 | 279292 | 63193244 |
| Adenoviral hepatitis | 40.37 | 22.16 | 11 | 16475 | 390 | 63472146 |
| Hypersensitivity | 40.17 | 22.16 | 13 | 16473 | 292672 | 63179864 |
| Weight increased | 38.69 | 22.16 | 10 | 16476 | 260782 | 63211754 |
| Cellulitis | 38.34 | 22.16 | 73 | 16413 | 81885 | 63390651 |
| Periorbital cellulitis | 38.25 | 22.16 | 12 | 16474 | 701 | 63471835 |
| Graft versus host disease | 37.94 | 22.16 | 23 | 16463 | 6740 | 63465796 |
| Fatigue | 35.99 | 22.16 | 115 | 16371 | 887913 | 62584623 |
| Chloroma | 35.71 | 22.16 | 9 | 16477 | 234 | 63472302 |
| Infusion related reaction | 35.32 | 22.16 | 10 | 16476 | 245511 | 63227025 |
| Toxic neuropathy | 35.11 | 22.16 | 10 | 16476 | 418 | 63472118 |
| Dizziness | 33.95 | 22.16 | 37 | 16449 | 429888 | 63042648 |
| Liver abscess | 33.90 | 22.16 | 16 | 16470 | 2838 | 63469698 |
| Condition aggravated | 33.58 | 22.16 | 33 | 16453 | 402184 | 63070352 |
| Pulmonary sepsis | 32.37 | 22.16 | 13 | 16473 | 1563 | 63470973 |
| Haematotoxicity | 31.10 | 22.16 | 23 | 16463 | 9353 | 63463183 |
| Anxiety | 31.03 | 22.16 | 9 | 16477 | 217532 | 63255004 |
| Full blood count decreased | 31.01 | 22.16 | 36 | 16450 | 25988 | 63446548 |
| Graft versus host disease in liver | 30.88 | 22.16 | 10 | 16476 | 647 | 63471889 |
| Drug intolerance | 29.81 | 22.16 | 22 | 16464 | 308639 | 63163897 |
| Exposure during pregnancy | 29.63 | 22.16 | 3 | 16483 | 155544 | 63316992 |
| Haemoglobin decreased | 29.56 | 22.16 | 94 | 16392 | 145391 | 63327145 |
| Pseudomonas infection | 29.55 | 22.16 | 24 | 16462 | 11189 | 63461347 |
| Staphylococcal sepsis | 29.37 | 22.16 | 21 | 16465 | 8107 | 63464429 |
| Off label use | 28.79 | 22.16 | 284 | 16202 | 674178 | 62798358 |
| Dyspnoea | 28.62 | 22.16 | 83 | 16403 | 661230 | 62811306 |
| Pleural effusion | 28.61 | 22.16 | 70 | 16416 | 93140 | 63379396 |
| Pericardial effusion | 28.41 | 22.16 | 37 | 16449 | 30021 | 63442515 |
| Iron overload | 27.90 | 22.16 | 10 | 16476 | 881 | 63471655 |
| Discomfort | 27.69 | 22.16 | 5 | 16481 | 167369 | 63305167 |
| Bone marrow necrosis | 27.45 | 22.16 | 6 | 16480 | 82 | 63472454 |
| Disseminated intravascular coagulation | 27.25 | 22.16 | 29 | 16457 | 19022 | 63453514 |
| Fusarium infection | 27.01 | 22.16 | 9 | 16477 | 637 | 63471899 |
| Pain in extremity | 26.73 | 22.16 | 28 | 16458 | 331458 | 63141078 |
| Pseudomonal skin infection | 26.25 | 22.16 | 4 | 16482 | 4 | 63472532 |
| Bacterial sepsis | 26.24 | 22.16 | 15 | 16471 | 3943 | 63468593 |
| Leukocytosis | 26.20 | 22.16 | 33 | 16453 | 25902 | 63446634 |
| Hypoaesthesia | 25.85 | 22.16 | 6 | 16480 | 168387 | 63304149 |
| Therapeutic product effect decreased | 25.75 | 22.16 | 9 | 16477 | 193178 | 63279358 |
| Renal tubular disorder | 25.75 | 22.16 | 13 | 16473 | 2669 | 63469867 |
| Portal vein cavernous transformation | 25.40 | 22.16 | 6 | 16480 | 118 | 63472418 |
| Rash | 25.27 | 22.16 | 69 | 16417 | 560802 | 62911734 |
| Pseudomonal bacteraemia | 25.27 | 22.16 | 11 | 16475 | 1617 | 63470919 |
| Adenovirus infection | 24.94 | 22.16 | 14 | 16472 | 3557 | 63468979 |
| Renal tubular acidosis | 24.87 | 22.16 | 11 | 16475 | 1681 | 63470855 |
| Bacillus infection | 24.57 | 22.16 | 9 | 16477 | 844 | 63471692 |
| Minimal residual disease | 24.51 | 22.16 | 6 | 16480 | 138 | 63472398 |
| Febrile bone marrow aplasia | 24.36 | 22.16 | 18 | 16468 | 7307 | 63465229 |
| Constipation | 24.21 | 22.16 | 119 | 16367 | 224824 | 63247712 |
| Insomnia | 23.99 | 22.16 | 13 | 16473 | 215239 | 63257297 |
| Leukaemia recurrent | 23.95 | 22.16 | 10 | 16476 | 1328 | 63471208 |
| Abdominal pain upper | 23.70 | 22.16 | 12 | 16474 | 206432 | 63266104 |
| Intestinal ulcer | 23.44 | 22.16 | 10 | 16476 | 1401 | 63471135 |
| Klebsiella sepsis | 23.14 | 22.16 | 10 | 16476 | 1445 | 63471091 |
| COVID-19 pneumonia | 22.79 | 22.16 | 23 | 16463 | 14186 | 63458350 |
| Acute erythroid leukaemia | 22.70 | 22.16 | 5 | 16481 | 71 | 63472465 |
| Subarachnoid haemorrhage | 22.69 | 22.16 | 23 | 16463 | 14260 | 63458276 |
| Acute graft versus host disease in skin | 22.67 | 22.16 | 13 | 16473 | 3439 | 63469097 |
| Colitis | 22.41 | 22.16 | 43 | 16443 | 48485 | 63424051 |
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 |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 1875.17 | 18.21 | 1196 | 24824 | 135653 | 34795258 |
| Acute myeloid leukaemia | 858.41 | 18.21 | 367 | 25653 | 17903 | 34913008 |
| Pneumonia | 558.18 | 18.21 | 976 | 25044 | 361651 | 34569260 |
| Sepsis | 457.03 | 18.21 | 589 | 25431 | 165972 | 34764939 |
| Neutrophil count decreased | 401.08 | 18.21 | 320 | 25700 | 50784 | 34880127 |
| Death | 390.98 | 18.21 | 889 | 25131 | 397160 | 34533751 |
| Neutropenia | 367.84 | 18.21 | 514 | 25506 | 156264 | 34774647 |
| Platelet count decreased | 333.39 | 18.21 | 427 | 25593 | 119290 | 34811621 |
| Acute myeloid leukaemia recurrent | 297.93 | 18.21 | 96 | 25924 | 2074 | 34928837 |
| Pancytopenia | 270.33 | 18.21 | 343 | 25677 | 94814 | 34836097 |
| Thrombocytopenia | 266.48 | 18.21 | 442 | 25578 | 155805 | 34775106 |
| Blast cell count increased | 261.70 | 18.21 | 74 | 25946 | 1004 | 34929907 |
| Myelosuppression | 243.11 | 18.21 | 161 | 25859 | 19104 | 34911807 |
| Cytopenia | 241.50 | 18.21 | 138 | 25882 | 12585 | 34918326 |
| Tumour lysis syndrome | 238.41 | 18.21 | 152 | 25868 | 16907 | 34914004 |
| Pneumonia fungal | 226.38 | 18.21 | 109 | 25911 | 6991 | 34923920 |
| Septic shock | 221.59 | 18.21 | 270 | 25750 | 71564 | 34859347 |
| White blood cell count decreased | 201.31 | 18.21 | 298 | 25722 | 95147 | 34835764 |
| Transformation to acute myeloid leukaemia | 200.94 | 18.21 | 56 | 25964 | 718 | 34930193 |
| Anaemia | 190.71 | 18.21 | 487 | 25533 | 232848 | 34698063 |
| Infection | 183.33 | 18.21 | 278 | 25742 | 90637 | 34840274 |
| Myelodysplastic syndrome transformation | 178.55 | 18.21 | 45 | 25975 | 379 | 34930532 |
| Myelodysplastic syndrome | 145.56 | 18.21 | 118 | 25902 | 19090 | 34911821 |
| Pyrexia | 138.81 | 18.21 | 551 | 25469 | 332462 | 34598449 |
| Bronchopulmonary aspergillosis | 132.60 | 18.21 | 100 | 25920 | 14559 | 34916352 |
| Acute febrile neutrophilic dermatosis | 117.27 | 18.21 | 42 | 25978 | 1261 | 34929650 |
| Chronic myelomonocytic leukaemia | 94.14 | 18.21 | 30 | 25990 | 624 | 34930287 |
| Bacteraemia | 93.51 | 18.21 | 93 | 25927 | 19624 | 34911287 |
| Drug interaction | 85.12 | 18.21 | 31 | 25989 | 225915 | 34704996 |
| Neutropenic sepsis | 74.82 | 18.21 | 70 | 25950 | 13697 | 34917214 |
| Headache | 69.87 | 18.21 | 31 | 25989 | 200604 | 34730307 |
| Product dose omission issue | 64.43 | 18.21 | 7 | 26013 | 119704 | 34811207 |
| Blood product transfusion dependent | 64.30 | 18.21 | 20 | 26000 | 383 | 34930528 |
| Organising pneumonia | 63.60 | 18.21 | 45 | 25975 | 5934 | 34924977 |
| Toxicity to various agents | 59.42 | 18.21 | 38 | 25982 | 200324 | 34730587 |
| Febrile bone marrow aplasia | 59.16 | 18.21 | 49 | 25971 | 8160 | 34922751 |
| Completed suicide | 57.54 | 18.21 | 4 | 26016 | 98164 | 34832747 |
| Graft versus host disease in gastrointestinal tract | 56.90 | 18.21 | 35 | 25985 | 3648 | 34927263 |
| Disseminated intravascular coagulation | 54.54 | 18.21 | 74 | 25946 | 21742 | 34909169 |
| Cerebral haemorrhage | 49.07 | 18.21 | 91 | 25929 | 34846 | 34896065 |
| Pyoderma gangrenosum | 48.74 | 18.21 | 23 | 25997 | 1408 | 34929503 |
| Anxiety | 48.30 | 18.21 | 8 | 26012 | 99420 | 34831491 |
| Blood pressure increased | 47.78 | 18.21 | 5 | 26015 | 88097 | 34842814 |
| Arthralgia | 46.74 | 18.21 | 35 | 25985 | 170006 | 34760905 |
| Acute leukaemia | 43.57 | 18.21 | 20 | 26000 | 1149 | 34929762 |
| Therapy non-responder | 42.99 | 18.21 | 92 | 25928 | 39054 | 34891857 |
| Minimal residual disease | 42.80 | 18.21 | 15 | 26005 | 422 | 34930489 |
| Allogenic stem cell transplantation | 42.21 | 18.21 | 10 | 26010 | 63 | 34930848 |
| Soft tissue infection | 41.68 | 18.21 | 24 | 25996 | 2216 | 34928695 |
| Tremor | 41.57 | 18.21 | 6 | 26014 | 82581 | 34848330 |
| Neutropenic colitis | 41.38 | 18.21 | 27 | 25993 | 3117 | 34927794 |
| Overdose | 40.67 | 18.21 | 9 | 26011 | 91050 | 34839861 |
| Somnolence | 40.51 | 18.21 | 16 | 26004 | 111100 | 34819811 |
| Graft versus host disease in skin | 40.50 | 18.21 | 29 | 25991 | 3896 | 34927015 |
| Myelofibrosis | 40.33 | 18.21 | 21 | 25999 | 1590 | 34929321 |
| Drug hypersensitivity | 40.19 | 18.21 | 6 | 26014 | 80523 | 34850388 |
| Cardiac failure | 40.13 | 18.21 | 154 | 25866 | 91094 | 34839817 |
| Injection site reaction | 40.09 | 18.21 | 49 | 25971 | 12984 | 34917927 |
| Pneumonitis | 39.97 | 18.21 | 82 | 25938 | 33796 | 34897115 |
| Bone marrow failure | 39.59 | 18.21 | 75 | 25945 | 29178 | 34901733 |
| Pain in extremity | 38.85 | 18.21 | 23 | 25997 | 126490 | 34804421 |
| Escherichia sepsis | 37.96 | 18.21 | 30 | 25990 | 4674 | 34926237 |
| Graft versus host disease | 37.93 | 18.21 | 43 | 25977 | 10526 | 34920385 |
| Necrotising fasciitis | 37.26 | 18.21 | 27 | 25993 | 3695 | 34927216 |
| Pain | 36.60 | 18.21 | 60 | 25960 | 204615 | 34726296 |
| Weight increased | 36.28 | 18.21 | 12 | 26008 | 93021 | 34837890 |
| Haemoglobin abnormal | 36.25 | 18.21 | 27 | 25993 | 3853 | 34927058 |
| Dyspnoea | 35.67 | 18.21 | 152 | 25868 | 376630 | 34554281 |
| Anal abscess | 35.33 | 18.21 | 33 | 25987 | 6440 | 34924471 |
| Myositis | 34.91 | 18.21 | 44 | 25976 | 12026 | 34918885 |
| Leukaemia recurrent | 34.66 | 18.21 | 19 | 26001 | 1596 | 34929315 |
| Muscle spasms | 34.34 | 18.21 | 7 | 26013 | 74994 | 34855917 |
| Cellulitis | 33.53 | 18.21 | 101 | 25919 | 52850 | 34878061 |
| Peripheral swelling | 33.31 | 18.21 | 8 | 26012 | 76533 | 34854378 |
| Off label use | 32.87 | 18.21 | 465 | 25555 | 419059 | 34511852 |
| Enteritis infectious | 32.28 | 18.21 | 17 | 26003 | 1317 | 34929594 |
| General physical health deterioration | 31.03 | 18.21 | 182 | 25838 | 128087 | 34802824 |
| Disease progression | 30.58 | 18.21 | 160 | 25860 | 107917 | 34822994 |
| Leukocytosis | 30.48 | 18.21 | 60 | 25960 | 24005 | 34906906 |
| Hypoaesthesia | 29.70 | 18.21 | 5 | 26015 | 61439 | 34869472 |
| Acute myeloid leukaemia refractory | 29.70 | 18.21 | 7 | 26013 | 43 | 34930868 |
| Acute graft versus host disease | 29.58 | 18.21 | 30 | 25990 | 6473 | 34924438 |
| Paraesthesia | 29.35 | 18.21 | 6 | 26014 | 64166 | 34866745 |
| Depression | 29.31 | 18.21 | 18 | 26002 | 97080 | 34833831 |
| Hyperhidrosis | 29.09 | 18.21 | 10 | 26010 | 75682 | 34855229 |
| Dizziness | 28.97 | 18.21 | 76 | 25944 | 218445 | 34712466 |
| Escherichia bacteraemia | 28.82 | 18.21 | 22 | 25998 | 3258 | 34927653 |
| Aeromonas infection | 28.78 | 18.21 | 10 | 26010 | 274 | 34930637 |
| Aspergillus infection | 28.27 | 18.21 | 40 | 25980 | 12214 | 34918697 |
| Septal panniculitis | 27.98 | 18.21 | 7 | 26013 | 57 | 34930854 |
| Insomnia | 27.74 | 18.21 | 22 | 25998 | 103885 | 34827026 |
| Condition aggravated | 27.70 | 18.21 | 64 | 25956 | 192132 | 34738779 |
| Myalgia | 27.68 | 18.21 | 14 | 26006 | 84096 | 34846815 |
| Meningeal neoplasm | 27.46 | 18.21 | 7 | 26013 | 62 | 34930849 |
| Pseudomembranous colitis | 27.38 | 18.21 | 20 | 26000 | 2771 | 34928140 |
| Gait disturbance | 26.80 | 18.21 | 15 | 26005 | 85125 | 34845786 |
| Pulmonary sepsis | 26.32 | 18.21 | 18 | 26002 | 2247 | 34928664 |
| Weight decreased | 25.98 | 18.21 | 58 | 25962 | 176243 | 34754668 |
| Enterococcal infection | 25.46 | 18.21 | 33 | 25987 | 9273 | 34921638 |
| International normalised ratio increased | 24.86 | 18.21 | 3 | 26017 | 47324 | 34883587 |
| Pneumonia bacterial | 24.84 | 18.21 | 37 | 25983 | 11835 | 34919076 |
| Seizure | 24.64 | 18.21 | 25 | 25995 | 104832 | 34826079 |
| Graft versus host disease in liver | 24.54 | 18.21 | 14 | 26006 | 1270 | 34929641 |
| Urticaria | 24.39 | 18.21 | 8 | 26012 | 62369 | 34868542 |
| Febrile infection | 24.35 | 18.21 | 17 | 26003 | 2194 | 34928717 |
| Leukaemia | 24.23 | 18.21 | 23 | 25997 | 4580 | 34926331 |
| Pruritus | 24.09 | 18.21 | 43 | 25977 | 141938 | 34788973 |
| Iron overload | 24.05 | 18.21 | 14 | 26006 | 1319 | 34929592 |
| Epstein-Barr virus infection reactivation | 23.72 | 18.21 | 13 | 26007 | 1091 | 34929820 |
| Intentional product misuse | 23.69 | 18.21 | 3 | 26017 | 45608 | 34885303 |
| Malaise | 23.59 | 18.21 | 66 | 25954 | 185759 | 34745152 |
| Hypertension | 23.44 | 18.21 | 41 | 25979 | 136402 | 34794509 |
| Fatigue | 23.31 | 18.21 | 171 | 25849 | 370482 | 34560429 |
| Agitation | 23.09 | 18.21 | 7 | 26013 | 57392 | 34873519 |
| Rhabdomyolysis | 22.95 | 18.21 | 11 | 26009 | 68152 | 34862759 |
| Haemoglobin decreased | 22.82 | 18.21 | 161 | 25859 | 120611 | 34810300 |
| Chloroma | 22.80 | 18.21 | 10 | 26010 | 516 | 34930395 |
| Neutrophilic panniculitis | 22.25 | 18.21 | 5 | 26015 | 24 | 34930887 |
| Infusion related reaction | 22.21 | 18.21 | 6 | 26014 | 53051 | 34877860 |
| Epistaxis | 22.14 | 18.21 | 94 | 25926 | 58157 | 34872754 |
| Musculoskeletal stiffness | 22.12 | 18.21 | 4 | 26016 | 46676 | 34884235 |
| Clostridium difficile colitis | 22.11 | 18.21 | 41 | 25979 | 15689 | 34915222 |
| Colitis | 22.03 | 18.21 | 70 | 25950 | 37680 | 34893231 |
| Vision blurred | 21.65 | 18.21 | 4 | 26016 | 45959 | 34884952 |
| Pericardial effusion | 21.58 | 18.21 | 53 | 25967 | 24609 | 34906302 |
| Multiple organ dysfunction syndrome | 21.40 | 18.21 | 113 | 25907 | 76453 | 34854458 |
| Transplant | 21.34 | 18.21 | 11 | 26009 | 815 | 34930096 |
| Chest discomfort | 21.31 | 18.21 | 7 | 26013 | 54523 | 34876388 |
| Central nervous system leukaemia | 21.23 | 18.21 | 8 | 26012 | 278 | 34930633 |
| Joint swelling | 21.20 | 18.21 | 9 | 26011 | 59881 | 34871030 |
| Staphylococcal sepsis | 21.05 | 18.21 | 31 | 25989 | 9813 | 34921098 |
| Klebsiella sepsis | 20.90 | 18.21 | 15 | 26005 | 2022 | 34928889 |
| Wheezing | 20.84 | 18.21 | 3 | 26017 | 41399 | 34889512 |
| Platelet disorder | 20.76 | 18.21 | 14 | 26006 | 1707 | 34929204 |
| Blood glucose increased | 20.65 | 18.21 | 12 | 26008 | 66706 | 34864205 |
| Aplasia | 20.56 | 18.21 | 21 | 25999 | 4567 | 34926344 |
| Constipation | 20.52 | 18.21 | 173 | 25847 | 136809 | 34794102 |
| Full blood count decreased | 20.41 | 18.21 | 43 | 25977 | 18045 | 34912866 |
| Lower motor neurone lesion | 20.29 | 18.21 | 5 | 26015 | 38 | 34930873 |
| Acute graft versus host disease in skin | 20.10 | 18.21 | 22 | 25998 | 5179 | 34925732 |
| Bradycardia | 20.09 | 18.21 | 16 | 26004 | 75402 | 34855509 |
| Angiodysplasia | 20.01 | 18.21 | 10 | 26010 | 694 | 34930217 |
| Muscular weakness | 20.00 | 18.21 | 15 | 26005 | 72882 | 34858029 |
| Memory impairment | 19.91 | 18.21 | 4 | 26016 | 43314 | 34887597 |
| Catheter site infection | 19.75 | 18.21 | 16 | 26004 | 2581 | 34928330 |
| Abdominal discomfort | 19.62 | 18.21 | 10 | 26010 | 59825 | 34871086 |
| Asthma | 19.48 | 18.21 | 4 | 26016 | 42652 | 34888259 |
| Pseudomonal sepsis | 19.20 | 18.21 | 18 | 26002 | 3529 | 34927382 |
| Product reconstitution quality issue | 19.19 | 18.21 | 6 | 26014 | 117 | 34930794 |
| Emphysematous cholecystitis | 19.16 | 18.21 | 5 | 26015 | 49 | 34930862 |
| Subdural haematoma | 19.06 | 18.21 | 45 | 25975 | 20376 | 34910535 |
| Neutrophilic dermatosis | 18.92 | 18.21 | 7 | 26013 | 231 | 34930680 |
| Anorectal infection | 18.86 | 18.21 | 7 | 26013 | 233 | 34930678 |
| Rheumatoid arthritis | 18.73 | 18.21 | 3 | 26017 | 38235 | 34892676 |
| Feeling abnormal | 18.69 | 18.21 | 12 | 26008 | 63223 | 34867688 |
| Injection site vasculitis | 18.61 | 18.21 | 3 | 26017 | 0 | 34930911 |
| Second primary malignancy | 18.57 | 18.21 | 26 | 25994 | 7860 | 34923051 |
| Nasopharyngitis | 18.44 | 18.21 | 15 | 26005 | 69953 | 34860958 |
| Aspiration bone marrow abnormal | 18.42 | 18.21 | 6 | 26014 | 134 | 34930777 |
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 |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 3256.93 | 18.57 | 1750 | 35801 | 229249 | 79477588 |
| Acute myeloid leukaemia | 1094.34 | 18.57 | 445 | 37106 | 30440 | 79676397 |
| Pneumonia | 868.00 | 18.57 | 1289 | 36262 | 658957 | 79047880 |
| Death | 791.34 | 18.57 | 1139 | 36412 | 565375 | 79141462 |
| Sepsis | 772.85 | 18.57 | 782 | 36769 | 268646 | 79438191 |
| Neutropenia | 648.23 | 18.57 | 735 | 36816 | 286975 | 79419862 |
| Thrombocytopenia | 635.80 | 18.57 | 700 | 36851 | 264559 | 79442278 |
| Acute myeloid leukaemia recurrent | 621.23 | 18.57 | 169 | 37382 | 3214 | 79703623 |
| Neutrophil count decreased | 580.41 | 18.57 | 424 | 37127 | 93535 | 79613302 |
| Pancytopenia | 514.69 | 18.57 | 503 | 37048 | 165242 | 79541595 |
| Myelosuppression | 512.53 | 18.57 | 287 | 37264 | 40009 | 79666828 |
| Platelet count decreased | 508.44 | 18.57 | 538 | 37013 | 194126 | 79512711 |
| Septic shock | 423.32 | 18.57 | 395 | 37156 | 122406 | 79584431 |
| Blast cell count increased | 377.31 | 18.57 | 95 | 37456 | 1315 | 79705522 |
| Cytopenia | 372.38 | 18.57 | 185 | 37366 | 20198 | 79686639 |
| Anaemia | 350.98 | 18.57 | 695 | 36856 | 444320 | 79262517 |
| Pneumonia fungal | 321.16 | 18.57 | 139 | 37412 | 11071 | 79695766 |
| Tumour lysis syndrome | 313.81 | 18.57 | 174 | 37377 | 23765 | 79683072 |
| Bronchopulmonary aspergillosis | 286.63 | 18.57 | 160 | 37391 | 22134 | 79684703 |
| Transformation to acute myeloid leukaemia | 280.86 | 18.57 | 70 | 37481 | 927 | 79705910 |
| White blood cell count decreased | 279.08 | 18.57 | 391 | 37160 | 187897 | 79518940 |
| Pyrexia | 260.48 | 18.57 | 804 | 36747 | 677905 | 79028932 |
| Myelodysplastic syndrome transformation | 197.21 | 18.57 | 49 | 37502 | 640 | 79706197 |
| Infection | 168.01 | 18.57 | 359 | 37192 | 241353 | 79465484 |
| Acute febrile neutrophilic dermatosis | 165.60 | 18.57 | 64 | 37487 | 3808 | 79703029 |
| Pain | 153.49 | 18.57 | 70 | 37481 | 703732 | 79003105 |
| Headache | 150.56 | 18.57 | 60 | 37491 | 653712 | 79053125 |
| Arthralgia | 148.06 | 18.57 | 43 | 37508 | 571760 | 79135077 |
| Myelodysplastic syndrome | 141.49 | 18.57 | 116 | 37435 | 30185 | 79676652 |
| Pneumonitis | 140.61 | 18.57 | 158 | 37393 | 60702 | 79646135 |
| Bacteraemia | 133.40 | 18.57 | 116 | 37435 | 32708 | 79674129 |
| Blood product transfusion dependent | 125.11 | 18.57 | 31 | 37520 | 400 | 79706437 |
| Therapy non-responder | 119.49 | 18.57 | 180 | 37371 | 92125 | 79614712 |
| Neutropenic sepsis | 110.69 | 18.57 | 96 | 37455 | 26968 | 79679869 |
| Completed suicide | 101.94 | 18.57 | 3 | 37548 | 245764 | 79461073 |
| Organising pneumonia | 99.94 | 18.57 | 63 | 37488 | 10876 | 79695961 |
| Cerebral haemorrhage | 99.30 | 18.57 | 129 | 37422 | 57544 | 79649293 |
| Drug hypersensitivity | 94.66 | 18.57 | 14 | 37537 | 298902 | 79407935 |
| Joint swelling | 90.30 | 18.57 | 14 | 37537 | 288632 | 79418205 |
| Escherichia sepsis | 87.91 | 18.57 | 53 | 37498 | 8455 | 79698382 |
| Product dose omission issue | 87.29 | 18.57 | 8 | 37543 | 247529 | 79459308 |
| Multiple organ dysfunction syndrome | 86.17 | 18.57 | 181 | 37370 | 120065 | 79586772 |
| Allogenic stem cell transplantation | 82.50 | 18.57 | 17 | 37534 | 87 | 79706750 |
| Aspergillus infection | 82.48 | 18.57 | 70 | 37481 | 19091 | 79687746 |
| Peripheral swelling | 82.26 | 18.57 | 14 | 37537 | 269603 | 79437234 |
| Respiratory failure | 81.92 | 18.57 | 228 | 37323 | 180683 | 79526154 |
| Rheumatoid arthritis | 81.48 | 18.57 | 4 | 37547 | 208466 | 79498371 |
| Differentiation syndrome | 81.23 | 18.57 | 34 | 37517 | 2490 | 79704347 |
| Cardiac failure | 80.06 | 18.57 | 205 | 37346 | 154637 | 79552200 |
| Graft versus host disease | 79.69 | 18.57 | 62 | 37489 | 14964 | 79691873 |
| Weight increased | 79.13 | 18.57 | 17 | 37534 | 277369 | 79429468 |
| Soft tissue infection | 78.87 | 18.57 | 38 | 37513 | 3874 | 79702963 |
| Febrile bone marrow aplasia | 78.50 | 18.57 | 58 | 37493 | 12962 | 79693875 |
| Drug interaction | 77.61 | 18.57 | 50 | 37501 | 415133 | 79291704 |
| Toxicity to various agents | 75.80 | 18.57 | 53 | 37498 | 421487 | 79285350 |
| Anxiety | 75.60 | 18.57 | 13 | 37538 | 248499 | 79458338 |
| Abdominal discomfort | 74.36 | 18.57 | 14 | 37537 | 250713 | 79456124 |
| Bone marrow failure | 73.84 | 18.57 | 105 | 37446 | 51002 | 79655835 |
| Disseminated intravascular coagulation | 72.62 | 18.57 | 87 | 37464 | 35755 | 79671082 |
| Pain in extremity | 72.18 | 18.57 | 41 | 37510 | 364497 | 79342340 |
| Cellulitis | 71.07 | 18.57 | 158 | 37393 | 108902 | 79597935 |
| Dyspnoea | 71.05 | 18.57 | 190 | 37361 | 856835 | 78850002 |
| Acute leukaemia | 68.41 | 18.57 | 27 | 37524 | 1699 | 79705138 |
| Cardiovascular disorder | 67.83 | 18.57 | 61 | 37490 | 17964 | 79688873 |
| Disease progression | 66.10 | 18.57 | 214 | 37337 | 184148 | 79522689 |
| Nasopharyngitis | 65.74 | 18.57 | 19 | 37532 | 253862 | 79452975 |
| Hypersensitivity | 65.42 | 18.57 | 21 | 37530 | 262218 | 79444619 |
| Leukaemia | 64.05 | 18.57 | 38 | 37513 | 5887 | 79700950 |
| Infusion related reaction | 63.86 | 18.57 | 15 | 37536 | 230222 | 79476615 |
| Dizziness | 63.06 | 18.57 | 94 | 37457 | 526347 | 79180490 |
| Enterococcal infection | 62.92 | 18.57 | 55 | 37496 | 15605 | 79691232 |
| Acute graft versus host disease | 62.89 | 18.57 | 46 | 37505 | 10121 | 79696716 |
| Swelling | 62.37 | 18.57 | 13 | 37538 | 216698 | 79490139 |
| Fatigue | 62.30 | 18.57 | 227 | 37324 | 929500 | 78777337 |
| Blood pressure increased | 62.24 | 18.57 | 12 | 37539 | 211348 | 79495489 |
| Myelofibrosis | 61.92 | 18.57 | 28 | 37523 | 2472 | 79704365 |
| Subdural haematoma | 61.56 | 18.57 | 75 | 37476 | 31359 | 79675478 |
| Graft versus host disease in liver | 61.09 | 18.57 | 25 | 37526 | 1729 | 79705108 |
| Neutropenic colitis | 60.12 | 18.57 | 36 | 37515 | 5671 | 79701166 |
| Stenotrophomonas infection | 59.43 | 18.57 | 31 | 37520 | 3742 | 79703095 |
| Pericardial effusion | 58.14 | 18.57 | 89 | 37462 | 46148 | 79660689 |
| Chloroma | 56.59 | 18.57 | 19 | 37532 | 751 | 79706086 |
| Graft versus host disease in gastrointestinal tract | 56.55 | 18.57 | 36 | 37515 | 6320 | 79700517 |
| Paraesthesia | 56.39 | 18.57 | 8 | 37543 | 176315 | 79530522 |
| Malaise | 56.23 | 18.57 | 90 | 37461 | 489779 | 79217058 |
| Tremor | 56.10 | 18.57 | 7 | 37544 | 170076 | 79536761 |
| Hypoaesthesia | 55.38 | 18.57 | 9 | 37542 | 179343 | 79527494 |
| Drug intolerance | 54.75 | 18.57 | 28 | 37523 | 264091 | 79442746 |
| Acute myeloid leukaemia refractory | 54.28 | 18.57 | 13 | 37538 | 144 | 79706693 |
| Pulmonary sepsis | 54.22 | 18.57 | 29 | 37522 | 3683 | 79703154 |
| Condition aggravated | 53.00 | 18.57 | 97 | 37454 | 501027 | 79205810 |
| Pruritus | 52.75 | 18.57 | 65 | 37486 | 394583 | 79312254 |
| Maternal exposure during pregnancy | 52.15 | 18.57 | 3 | 37548 | 136535 | 79570302 |
| Somnolence | 51.55 | 18.57 | 24 | 37527 | 238957 | 79467880 |
| Hypertension | 51.48 | 18.57 | 48 | 37503 | 330944 | 79375893 |
| Overdose | 51.08 | 18.57 | 12 | 37539 | 184194 | 79522643 |
| Gait disturbance | 51.07 | 18.57 | 17 | 37534 | 207489 | 79499348 |
| Necrotising fasciitis | 50.70 | 18.57 | 33 | 37518 | 6017 | 79700820 |
| Graft versus host disease in skin | 50.58 | 18.57 | 33 | 37518 | 6040 | 79700797 |
| Leukaemia recurrent | 50.11 | 18.57 | 25 | 37526 | 2749 | 79704088 |
| Constipation | 48.58 | 18.57 | 262 | 37289 | 282788 | 79424049 |
| Escherichia bacteraemia | 48.26 | 18.57 | 33 | 37518 | 6529 | 79700308 |
| Staphylococcal sepsis | 47.99 | 18.57 | 46 | 37505 | 14680 | 79692157 |
| Insomnia | 47.89 | 18.57 | 28 | 37523 | 245142 | 79461695 |
| Full blood count decreased | 47.73 | 18.57 | 61 | 37490 | 26758 | 79680079 |
| Minimal residual disease | 47.35 | 18.57 | 15 | 37536 | 492 | 79706345 |
| Iron overload | 46.56 | 18.57 | 21 | 37530 | 1843 | 79704994 |
| Asthma | 45.94 | 18.57 | 5 | 37546 | 135090 | 79571747 |
| Muscle spasms | 45.36 | 18.57 | 13 | 37538 | 174717 | 79532120 |
| Alopecia | 44.37 | 18.57 | 27 | 37524 | 231328 | 79475509 |
| Anal abscess | 44.05 | 18.57 | 36 | 37515 | 9319 | 79697518 |
| Klebsiella sepsis | 43.58 | 18.57 | 24 | 37527 | 3228 | 79703609 |
| Pyoderma gangrenosum | 43.21 | 18.57 | 26 | 37525 | 4132 | 79702705 |
| Epistaxis | 42.27 | 18.57 | 132 | 37419 | 111383 | 79595454 |
| Acute graft versus host disease in skin | 41.48 | 18.57 | 32 | 37519 | 7626 | 79699211 |
| General physical health deterioration | 41.43 | 18.57 | 246 | 37305 | 274992 | 79431845 |
| Agranulocytosis | 40.99 | 18.57 | 75 | 37476 | 44955 | 79661882 |
| Mobility decreased | 40.35 | 18.57 | 5 | 37546 | 122170 | 79584667 |
| Leukocytosis | 40.35 | 18.57 | 73 | 37478 | 43382 | 79663455 |
| Pneumonia bacterial | 39.28 | 18.57 | 47 | 37504 | 19284 | 79687553 |
| Haemoglobin decreased | 39.04 | 18.57 | 207 | 37344 | 221912 | 79484925 |
| Refractory anaemia with an excess of blasts | 38.83 | 18.57 | 15 | 37536 | 891 | 79705946 |
| Chest discomfort | 38.25 | 18.57 | 9 | 37542 | 138035 | 79568802 |
| Leukopenia | 37.95 | 18.57 | 131 | 37420 | 116382 | 79590455 |
| Therapeutic product effect decreased | 37.65 | 18.57 | 15 | 37536 | 163848 | 79542989 |
| Enteritis infectious | 37.63 | 18.57 | 22 | 37529 | 3316 | 79703521 |
| Transplant | 37.28 | 18.57 | 15 | 37536 | 993 | 79705844 |
| Haematotoxicity | 37.03 | 18.57 | 41 | 37510 | 15478 | 79691359 |
| Colitis | 36.76 | 18.57 | 96 | 37455 | 73211 | 79633626 |
| Off label use | 36.40 | 18.57 | 614 | 36937 | 906601 | 78800236 |
| Exposure during pregnancy | 36.36 | 18.57 | 3 | 37548 | 101129 | 79605708 |
| Myositis | 36.34 | 18.57 | 45 | 37506 | 19123 | 79687714 |
| Wheezing | 35.68 | 18.57 | 6 | 37545 | 116658 | 79590179 |
| Discomfort | 35.18 | 18.57 | 8 | 37543 | 125609 | 79581228 |
| Febrile infection | 34.97 | 18.57 | 21 | 37530 | 3325 | 79703512 |
| Periorbital cellulitis | 34.87 | 18.57 | 14 | 37537 | 921 | 79705916 |
| Blister | 34.70 | 18.57 | 7 | 37544 | 119469 | 79587368 |
| Fusarium infection | 34.54 | 18.57 | 17 | 37534 | 1815 | 79705022 |
| Aplasia | 34.54 | 18.57 | 29 | 37522 | 7791 | 79699046 |
| Feeling abnormal | 34.30 | 18.57 | 16 | 37535 | 159183 | 79547654 |
| Rash | 34.29 | 18.57 | 148 | 37403 | 578210 | 79128627 |
| Abdominal pain upper | 34.15 | 18.57 | 33 | 37518 | 223786 | 79483051 |
| Myalgia | 33.76 | 18.57 | 23 | 37528 | 185618 | 79521219 |
| Haemorrhage intracranial | 33.75 | 18.57 | 51 | 37500 | 26142 | 79680695 |
| Memory impairment | 33.62 | 18.57 | 6 | 37545 | 111728 | 79595109 |
| Hyperhidrosis | 32.99 | 18.57 | 15 | 37536 | 151477 | 79555360 |
| Haemoglobin abnormal | 32.90 | 18.57 | 27 | 37524 | 7027 | 79699810 |
| Chronic myelomonocytic leukaemia | 32.42 | 18.57 | 13 | 37538 | 853 | 79705984 |
| Clostridium difficile colitis | 32.24 | 18.57 | 56 | 37495 | 32227 | 79674610 |
| Weight decreased | 32.22 | 18.57 | 75 | 37476 | 355123 | 79351714 |
| Platelet disorder | 32.22 | 18.57 | 19 | 37532 | 2910 | 79703927 |
| Liver abscess | 32.14 | 18.57 | 25 | 37526 | 6029 | 79700808 |
| Loss of personal independence in daily activities | 31.99 | 18.57 | 5 | 37546 | 102575 | 79604262 |
| Depression | 31.88 | 18.57 | 33 | 37518 | 216757 | 79490080 |
| Palpitations | 31.80 | 18.57 | 10 | 37541 | 126600 | 79580237 |
| Pseudomonal sepsis | 31.71 | 18.57 | 25 | 37526 | 6149 | 79700688 |
| Pleural effusion | 31.67 | 18.57 | 144 | 37407 | 145118 | 79561719 |
| Pneumonia klebsiella | 31.56 | 18.57 | 23 | 37528 | 5031 | 79701806 |
| Pseudomonal bacteraemia | 31.32 | 18.57 | 19 | 37532 | 3063 | 79703774 |
| Pneumonia adenoviral | 31.27 | 18.57 | 11 | 37540 | 501 | 79706336 |
| Vision blurred | 31.19 | 18.57 | 6 | 37545 | 105892 | 79600945 |
| Intentional product misuse | 31.17 | 18.57 | 4 | 37547 | 95161 | 79611676 |
| Epstein-Barr virus infection reactivation | 31.10 | 18.57 | 16 | 37535 | 1876 | 79704961 |
| Sinusitis | 30.79 | 18.57 | 28 | 37523 | 195473 | 79511364 |
| Aeromonas infection | 30.52 | 18.57 | 10 | 37541 | 366 | 79706471 |
| Systemic candida | 29.89 | 18.57 | 25 | 37526 | 6681 | 79700156 |
| Anorectal infection | 29.16 | 18.57 | 10 | 37541 | 422 | 79706415 |
| Muscular weakness | 29.11 | 18.57 | 20 | 37531 | 160709 | 79546128 |
| Neutrophilic panniculitis | 28.79 | 18.57 | 7 | 37544 | 83 | 79706754 |
| Renal tubular disorder | 28.54 | 18.57 | 24 | 37527 | 6462 | 79700375 |
| Gastrooesophageal reflux disease | 28.48 | 18.57 | 7 | 37544 | 104239 | 79602598 |
| Cough | 28.27 | 18.57 | 84 | 37467 | 366705 | 79340132 |
| Dry mouth | 28.11 | 18.57 | 4 | 37547 | 88015 | 79618822 |
| Impaired healing | 27.96 | 18.57 | 4 | 37547 | 87651 | 79619186 |
| Migraine | 27.89 | 18.57 | 4 | 37547 | 87489 | 79619348 |
| Chest pain | 27.74 | 18.57 | 57 | 37494 | 282247 | 79424590 |
| Geotrichum infection | 27.55 | 18.57 | 12 | 37539 | 969 | 79705868 |
| Pseudomonas infection | 27.36 | 18.57 | 41 | 37510 | 20862 | 79685975 |
| Agitation | 26.65 | 18.57 | 7 | 37544 | 99708 | 79607129 |
| Balance disorder | 26.31 | 18.57 | 7 | 37544 | 98850 | 79607987 |
| Neutrophilic dermatosis | 26.11 | 18.57 | 10 | 37541 | 580 | 79706257 |
| Flushing | 25.99 | 18.57 | 5 | 37546 | 88263 | 79618574 |
| Septal panniculitis | 25.82 | 18.57 | 7 | 37544 | 131 | 79706706 |
| Bacterial sepsis | 25.57 | 18.57 | 25 | 37526 | 8173 | 79698664 |
| Cystitis haemorrhagic | 25.00 | 18.57 | 26 | 37525 | 9146 | 79697691 |
| Acute erythroid leukaemia | 24.95 | 18.57 | 8 | 37543 | 273 | 79706564 |
| COVID-19 pneumonia | 24.94 | 18.57 | 47 | 37504 | 28802 | 79678035 |
| Adenoviral hepatitis | 24.93 | 18.57 | 11 | 37540 | 916 | 79705921 |
| Mucormycosis | 24.88 | 18.57 | 25 | 37526 | 8444 | 79698393 |
| Blast cells present | 24.82 | 18.57 | 11 | 37540 | 926 | 79705911 |
| Toxic neuropathy | 24.35 | 18.57 | 11 | 37540 | 969 | 79705868 |
| Gingival bleeding | 24.33 | 18.57 | 34 | 37517 | 16242 | 79690595 |
| Cytomegalovirus infection reactivation | 24.28 | 18.57 | 25 | 37526 | 8691 | 79698146 |
| Interstitial lung disease | 24.08 | 18.57 | 111 | 37440 | 112489 | 79594348 |
| Diverticulitis | 23.89 | 18.57 | 61 | 37490 | 45875 | 79660962 |
| Pseudomembranous colitis | 23.88 | 18.57 | 20 | 37531 | 5354 | 79701483 |
| Klebsiella infection | 23.74 | 18.57 | 33 | 37518 | 15687 | 79691150 |
| Visual impairment | 23.63 | 18.57 | 7 | 37544 | 92124 | 79614713 |
| Leukaemic infiltration extramedullary | 23.43 | 18.57 | 7 | 37544 | 188 | 79706649 |
| Transfusion reaction | 23.30 | 18.57 | 13 | 37538 | 1793 | 79705044 |
| Fungal sepsis | 23.14 | 18.57 | 13 | 37538 | 1817 | 79705020 |
| Angiodysplasia | 23.11 | 18.57 | 11 | 37540 | 1091 | 79705746 |
| Lower motor neurone lesion | 23.05 | 18.57 | 5 | 37546 | 34 | 79706803 |
| Second primary malignancy | 22.99 | 18.57 | 31 | 37520 | 14319 | 79692518 |
| Cytogenetic abnormality | 22.90 | 18.57 | 11 | 37540 | 1114 | 79705723 |
| Injection site reaction | 22.77 | 18.57 | 67 | 37484 | 54718 | 79652119 |
| Helicobacter infection | 22.66 | 18.57 | 3 | 37548 | 69701 | 79637136 |
| Blood lactate dehydrogenase increased | 22.47 | 18.57 | 54 | 37497 | 39116 | 79667721 |
| Atypical pneumonia | 22.14 | 18.57 | 21 | 37530 | 6615 | 79700222 |
| Acute graft versus host disease in intestine | 22.13 | 18.57 | 17 | 37534 | 4024 | 79702813 |
| Tumour associated fever | 22.07 | 18.57 | 10 | 37541 | 887 | 79705950 |
| Central nervous system leukaemia | 21.69 | 18.57 | 8 | 37543 | 418 | 79706419 |
| Portal vein cavernous transformation | 21.57 | 18.57 | 6 | 37545 | 124 | 79706713 |
| Injury | 21.57 | 18.57 | 5 | 37546 | 77491 | 79629346 |
| Blood pressure systolic increased | 21.50 | 18.57 | 3 | 37548 | 66983 | 79639854 |
| Adverse drug reaction | 21.24 | 18.57 | 3 | 37548 | 66389 | 79640448 |
| Nasal congestion | 21.18 | 18.57 | 5 | 37546 | 76547 | 79630290 |
| Sleep disorder | 21.10 | 18.57 | 7 | 37544 | 85670 | 79621167 |
| Musculoskeletal pain | 20.97 | 18.57 | 11 | 37540 | 102343 | 79604494 |
| Pseudomonal skin infection | 20.86 | 18.57 | 4 | 37547 | 13 | 79706824 |
| Refractoriness to platelet transfusion | 20.72 | 18.57 | 6 | 37545 | 144 | 79706693 |
| Acinetobacter bacteraemia | 20.72 | 18.57 | 7 | 37544 | 282 | 79706555 |
| Haemophagocytic lymphohistiocytosis | 20.67 | 18.57 | 37 | 37514 | 21800 | 79685037 |
| Heart rate decreased | 20.67 | 18.57 | 4 | 37547 | 70312 | 79636525 |
| Phlebitis | 20.50 | 18.57 | 23 | 37528 | 8807 | 79698030 |
| Staphylococcal bacteraemia | 20.50 | 18.57 | 27 | 37524 | 12191 | 79694646 |
| Emphysematous cholecystitis | 20.44 | 18.57 | 5 | 37546 | 61 | 79706776 |
| Urticaria | 20.29 | 18.57 | 35 | 37516 | 185166 | 79521671 |
| Fungal infection | 20.24 | 18.57 | 54 | 37497 | 41694 | 79665143 |
| Wrong technique in product usage process | 20.10 | 18.57 | 5 | 37546 | 73870 | 79632967 |
| Osteoarthritis | 20.03 | 18.57 | 8 | 37543 | 87301 | 79619536 |
| Injection site vasculitis | 20.02 | 18.57 | 4 | 37547 | 17 | 79706820 |
| Isocitrate dehydrogenase gene mutation | 19.98 | 18.57 | 3 | 37548 | 0 | 79706837 |
| Medication error | 19.98 | 18.57 | 4 | 37547 | 68638 | 79638199 |
| Aspiration bone marrow abnormal | 19.88 | 18.57 | 6 | 37545 | 167 | 79706670 |
| Rhabdomyolysis | 19.81 | 18.57 | 12 | 37539 | 103119 | 79603718 |
| Neutropenic infection | 19.75 | 18.57 | 13 | 37538 | 2414 | 79704423 |
| Dry skin | 19.71 | 18.57 | 4 | 37547 | 67991 | 79638846 |
| Blast cell count decreased | 19.66 | 18.57 | 4 | 37547 | 19 | 79706818 |
| Hepatic enzyme increased | 19.56 | 18.57 | 35 | 37516 | 182575 | 79524262 |
| Bradycardia | 19.51 | 18.57 | 21 | 37530 | 135536 | 79571301 |
| Anal fissure | 19.51 | 18.57 | 21 | 37530 | 7682 | 79699155 |
| Thrombocytosis | 19.44 | 18.57 | 22 | 37529 | 8504 | 79698333 |
| Anal infection | 19.42 | 18.57 | 6 | 37545 | 181 | 79706656 |
| Rhinorrhoea | 19.11 | 18.57 | 6 | 37545 | 76068 | 79630769 |
| Swelling face | 19.03 | 18.57 | 5 | 37546 | 71207 | 79635630 |
| Graft versus host disease in lung | 18.81 | 18.57 | 9 | 37542 | 903 | 79705934 |
| Seizure | 18.65 | 18.57 | 38 | 37513 | 188796 | 79518041 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01BC07 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS ANTIMETABOLITES Pyrimidine analogues |
| FDA MoA | N0000000233 | Nucleic Acid Synthesis Inhibitors |
| FDA EPC | N0000175595 | Nucleoside Metabolic Inhibitor |
| CHEBI has role | CHEBI:35610 | antineoplastic agents |
| MeSH PA | D000963 | Antimetabolites |
| MeSH PA | D000964 | Antimetabolites, Antineoplastic |
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D009676 | Noxae |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Acute myeloid leukemia, disease | indication | 91861009 | |
| Myelodysplastic syndrome | indication | 109995007 | |
| Chronic myelomonocytic leukemia | indication | 127225006 | |
| Hepatic failure | contraindication | 59927004 | |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Pregnancy, function | contraindication | 289908002 | |
| Thrombocytopenic disorder | contraindication | 302215000 | DOID:1588 |
| Neutropenic disorder | contraindication | 303011007 | DOID:1227 |
| Breastfeeding (mother) | contraindication | 413712001 | |
| Advanced Malignant Neoplasm of Liver | contraindication |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 12.32 | acidic |
| pKa2 | 12.92 | acidic |
| pKa3 | 13.79 | acidic |
| pKa4 | 4.43 | Basic |
| pKa5 | 2.98 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 200MG | ONUREG | BRISTOL | N214120 | Sept. 1, 2020 | RX | TABLET | ORAL | 8846628 | June 3, 2030 | CONTINUED TREATMENT OF ADULTS WITH ACUTE MYELOID LEUKEMIA WHO ACHIEVED FIRST COMPLETE REMISSION (CR) OR CR WITH INCOMPLETE BLOOD COUNT RECOVERY FOLLOWING INTENSIVE INDUCTION CHEMOTHERAPY AND ARE NOT ABLE TO COMPLETE INTENSIVE CURATIVE THERAPY |
| 300MG | ONUREG | BRISTOL | N214120 | Sept. 1, 2020 | RX | TABLET | ORAL | 8846628 | June 3, 2030 | CONTINUED TREATMENT OF ADULTS WITH ACUTE MYELOID LEUKEMIA WHO ACHIEVED FIRST COMPLETE REMISSION (CR) OR CR WITH INCOMPLETE BLOOD COUNT RECOVERY FOLLOWING INTENSIVE INDUCTION CHEMOTHERAPY AND ARE NOT ABLE TO COMPLETE INTENSIVE CURATIVE THERAPY |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 200MG | ONUREG | BRISTOL | N214120 | Sept. 1, 2020 | RX | TABLET | ORAL | Sept. 1, 2023 | NEW PRODUCT |
| 300MG | ONUREG | BRISTOL | N214120 | Sept. 1, 2020 | RX | TABLET | ORAL | Sept. 1, 2023 | NEW PRODUCT |
| 100MG/VIAL | VIDAZA | BRISTOL-MYERS | N050794 | May 19, 2004 | RX | POWDER | INTRAVENOUS, SUBCUTANEOUS | May 20, 2025 | TREATMENT OF PEDIATRIC PATIENTS AGED ONE MONTH AND OLDER WITH NEWLY DIAGNOSED JUVENILE MYELOMONOCYTIC LEUKEMIA (JMML) |
| 200MG | ONUREG | BRISTOL | N214120 | Sept. 1, 2020 | RX | TABLET | ORAL | Sept. 1, 2027 | INDICATED FOR CONTINUED TREATMENT OF ADULT PATIENTS WITH ACUTE MYELOID LEUKEMIA WHO ACHIEVED FIRST COMPLETE REMISSION (CR) OR COMPLETE REMISSION WITH INCOMPLETE BLOOD COUNT RECOVERY (CRI) FOLLOWING INTENSIVE INDUCTION CHEMOTHERAPY AND ARE NOT ABLE TO COMPLETE INTENSIVE CURATIVE THERAPY |
| 300MG | ONUREG | BRISTOL | N214120 | Sept. 1, 2020 | RX | TABLET | ORAL | Sept. 1, 2027 | INDICATED FOR CONTINUED TREATMENT OF ADULT PATIENTS WITH ACUTE MYELOID LEUKEMIA WHO ACHIEVED FIRST COMPLETE REMISSION (CR) OR COMPLETE REMISSION WITH INCOMPLETE BLOOD COUNT RECOVERY (CRI) FOLLOWING INTENSIVE INDUCTION CHEMOTHERAPY AND ARE NOT ABLE TO COMPLETE INTENSIVE CURATIVE THERAPY |
| 100MG/VIAL | VIDAZA | BRISTOL-MYERS | N050794 | May 19, 2004 | RX | POWDER | INTRAVENOUS, SUBCUTANEOUS | May 20, 2029 | TREATMENT OF PEDIATRIC PATIENTS AGED ONE MONTH AND OLDER WITH NEWLY DIAGNOSED JUVENILE MYELOMONOCYTIC LEUKEMIA (JMML) |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| DNA (cytosine-5)-methyltransferase 1 | Enzyme | INHIBITOR | IC50 | 6.52 | CHEMBL | CHEMBL | |||
| DNA (cytosine-5)-methyltransferase 3A | Enzyme | INHIBITOR | CHEMBL | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4021468 | VUID |
| N0000148852 | NUI |
| D03021 | KEGG_DRUG |
| 1251 | RXNORM |
| C0004475 | UMLSCUI |
| CHEBI:2038 | CHEBI |
| 5AE | PDB_CHEM_ID |
| CHEMBL1489 | ChEMBL_ID |
| D001374 | MESH_DESCRIPTOR_UI |
| DB00928 | DRUGBANK_ID |
| 6796 | IUPHAR_LIGAND_ID |
| 4520 | INN_ID |
| M801H13NRU | UNII |
| 9444 | PUBCHEM_CID |
| 412328000 | SNOMEDCT_US |
| 412329008 | SNOMEDCT_US |
| 88551000 | SNOMEDCT_US |
| 4021468 | VANDF |
| 18639 | MMSL |
| 205981 | MMSL |
| 53994 | MMSL |
| d05293 | MMSL |
| 008661 | NDDF |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Azacitidine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9606 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | INTRAVENOUS | ANDA | 24 sections |
| Azacitidine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9606 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | INTRAVENOUS | ANDA | 24 sections |
| Azacitidine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-3253 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | SUBCUTANEOUS | NDA AUTHORIZED GENERIC | 28 sections |
| Azacitidine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-3253 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | SUBCUTANEOUS | NDA AUTHORIZED GENERIC | 28 sections |
| Azacitidine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-3253 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | SUBCUTANEOUS | NDA AUTHORIZED GENERIC | 28 sections |
| Azacitidine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-9253 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | SUBCUTANEOUS | NDA AUTHORIZED GENERIC | 28 sections |
| Azacitidine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-9253 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | SUBCUTANEOUS | NDA AUTHORIZED GENERIC | 28 sections |
| Azacitidine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-9253 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | SUBCUTANEOUS | NDA AUTHORIZED GENERIC | 28 sections |
| Azacitidine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-578 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | INTRAVENOUS | ANDA | 25 sections |
| Azacitidine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-578 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | INTRAVENOUS | ANDA | 25 sections |
| Azacitidine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-927 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | SUBCUTANEOUS | ANDA | 24 sections |
| Azacitidine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-306 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | INTRAVENOUS | ANDA | 26 sections |
| Azacitidine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-306 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | INTRAVENOUS | ANDA | 26 sections |
| Azacitidine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-306 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | INTRAVENOUS | ANDA | 26 sections |
| Azacitidine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-143 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | SUBCUTANEOUS | ANDA | 25 sections |
| Azacitidine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-143 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | SUBCUTANEOUS | ANDA | 25 sections |
| Azacitidine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-305 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | SUBCUTANEOUS | ANDA | 25 sections |
| Azacitidine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-305 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | SUBCUTANEOUS | ANDA | 25 sections |
| Azacitidine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-465 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | SUBCUTANEOUS | ANDA | 25 sections |
| Azacitidine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-465 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | SUBCUTANEOUS | ANDA | 25 sections |
| AZACITIDINE AZACITIDINE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-678 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | INTRAVENOUS | ANDA | 24 sections |
| Azacitidine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43817-906 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | SUBCUTANEOUS | ANDA | 28 sections |
| Azacitidine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51991-797 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | SUBCUTANEOUS | ANDA | 30 sections |
| Azacitidine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51991-797 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | SUBCUTANEOUS | ANDA | 30 sections |
| AZACITIDINE | Human Prescription Drug Label | 1 | 55150-393 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | INTRAVENOUS | ANDA | 27 sections |
| VIDAZA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 59572-102 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | INTRAVENOUS | NDA | 27 sections |
| VIDAZA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 59572-102 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | INTRAVENOUS | NDA | 27 sections |
| VIDAZA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 59572-102 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | INTRAVENOUS | NDA | 27 sections |
| ONUREG | HUMAN PRESCRIPTION DRUG LABEL | 1 | 59572-730 | TABLET, FILM COATED | 200 mg | ORAL | NDA | 31 sections |
| ONUREG | HUMAN PRESCRIPTION DRUG LABEL | 1 | 59572-730 | TABLET, FILM COATED | 200 mg | ORAL | NDA | 31 sections |