daunorubicin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
antineoplastics, daunorubicin derivatives 786 20830-81-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • daunorubicin
  • acetyladriamycin
  • cerubidin
  • daunoblastina
  • daunomycine
  • daunorubicine
  • Leukaemomycin C
  • rubidomycin
  • daunorubicin hydrochloride
  • daunorubicin citrate
  • daunorubicin HCl
A very toxic anthracycline aminoglycoside antineoplastic isolated from Streptomyces peucetius and others, used in treatment of LEUKEMIA and other NEOPLASMS.
  • Molecular weight: 527.53
  • Formula: C27H29NO10
  • CLOGP: 0.78
  • LIPINSKI: 2
  • HAC: 11
  • HDO: 5
  • TPSA: 185.84
  • ALOGS: -2.93
  • ROTB: 4
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Bocci G, Oprea TI, Benet LZ
S (Water solubility) 0.63 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 2.05 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 32.05 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 47.57 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.06 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 14.24 hours Lombardo F, Berellini G, Obach RS
BA (Bioavailability) 0 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 1.251 High 0.89
caco2-efflux Caco-2 efflux ratio (BA/AB) 15.560 High 0.89
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 6.918 10^-6 cm/s High 0.89
dh-clint Dog hepatocyte intrinsic clearance 4.365 uL/min/10^6 cells High 0.89
dppb Dog plasma protein binding (% unbound) 21.950 % High 0.89
fcs-ppb Fetal calf serum protein binding (% unbound) 18.600 % High 0.89
herg hERG pIC50 4.691 pIC50 High 0.89
hh-clint Human hepatocyte intrinsic clearance 2.432 uL/min/10^6 cells High 0.89
hlm-clint Human liver microsomal intrinsic clearance 3.412 uL/min/mg protein High 0.89
hppb Human plasma protein binding (% unbound) 13.440 % High 0.89
kinase-safety-class ACVR2B,ACVRL1,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,ERBB2,FLT3,GRK2,GSK3B,ITK,KDR,KIT,MAP2K6,MAP3K14,MAP3K7,MAP4K1,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PIM2,PRKDC,SIK2,STK33,SYK,TEK,TGFBR1,ZAP70 43
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 42.954 High 0.89
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 17.579 High 0.89
mh-clint Mouse hepatocyte intrinsic clearance 7.161 High 0.89
mppb Mouse plasma protein binding (% unbound) 15.160 High 0.89
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 25.882 High 0.89
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 0.85
pppb Pig plasma protein binding (% unbound) 20.520 % High 0.89
rat-kpuu-brain Rat brain Kpuu 0.027 % High 0.89
rh-clint Rat hepatocyte intrinsic clearance 5.598 uL/min/10^6 cells High 0.89
rh-fuinc Rat hepatocyte fraction unbound in incubation 56.020 % High 0.89
rppb Rat plasma protein binding (% unbound) 12.230 % High 0.89
solubility-dd Solubility at pH 7.4 in DMSO 49.204 uM High 0.89

Approvals:

DateAgencyCompanyOrphan
Feb. 24, 2021 PMDA Meiji Seika Pharma Co., Ltd
Dec. 19, 1979 FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Febrile neutropenia 1125.39 28.44 532 13872 157817 90456226
Hypofibrinogenaemia 369.41 28.44 76 14328 1294 90612749
Neutropenia 301.45 28.44 264 14140 224640 90389403
Sepsis 290.20 28.44 235 14169 179579 90434464
Posterior reversible encephalopathy syndrome 261.34 28.44 107 14297 22232 90591811
Myelosuppression 219.76 28.44 125 14279 53466 90560577
Hyperbilirubinaemia 216.58 28.44 82 14322 13854 90600189
Pneumatosis intestinalis 167.47 28.44 48 14356 3389 90610654
Neutropenic colitis 158.61 28.44 48 14356 4095 90609948
Thrombocytopenia 151.58 28.44 176 14228 208549 90405494
Bone marrow failure 145.21 28.44 80 14324 32141 90581902
Mucormycosis 140.85 28.44 43 14361 3778 90610265
Bacteraemia 139.54 28.44 69 14335 22231 90591812
Human bocavirus infection 132.02 28.44 27 14377 445 90613598
Second primary malignancy 125.74 28.44 51 14353 10327 90603716
Septic shock 125.02 28.44 105 14299 84055 90529988
Cardiotoxicity 121.16 28.44 51 14353 11338 90602705
Multiple organ dysfunction syndrome 119.97 28.44 94 14310 68242 90545801
Enterobacter infection 116.62 28.44 34 14370 2549 90611494
Aspergillus infection 110.26 28.44 47 14357 10776 90603267
Secondary immunodeficiency 104.96 28.44 30 14374 2096 90611947
Enterococcal infection 103.81 28.44 44 14360 9947 90604096
Colitis 103.32 28.44 87 14317 69855 90544188
Human herpesvirus 6 infection 102.97 28.44 33 14371 3399 90610644
Clostridium difficile colitis 100.63 28.44 59 14345 26647 90587396
Herpes simplex 99.72 28.44 43 14361 10138 90603905
Venoocclusive liver disease 99.40 28.44 37 14367 5956 90608087
Pseudomonas infection 98.99 28.44 48 14356 14817 90599226
Febrile bone marrow aplasia 98.24 28.44 42 14362 9696 90604347
Pancytopenia 93.24 28.44 105 14299 120158 90493885
Tumour lysis syndrome 92.77 28.44 42 14362 11110 90602933
Haemophagocytic lymphohistiocytosis 91.29 28.44 46 14358 15413 90598630
Arthralgia 86.56 28.44 11 14393 778511 89835532
Bacterial infection 86.24 28.44 51 14353 23393 90590650
Fatigue 84.77 28.44 39 14365 1153984 89460059
Gastroenteritis norovirus 84.43 28.44 26 14378 2350 90611693
Retinitis viral 83.24 28.44 17 14387 278 90613765
Respiratory failure 82.74 28.44 98 14306 118320 90495723
Bronchopulmonary aspergillosis 82.57 28.44 39 14365 11359 90602684
Haematotoxicity 82.03 28.44 40 14364 12495 90601548
Mucosal inflammation 81.65 28.44 70 14334 57555 90556488
Hypertriglyceridaemia 79.50 28.44 34 14370 7855 90606188
Central nervous system haemorrhage 79.09 28.44 16 14388 249 90613794
Pain 77.37 28.44 31 14373 996310 89617733
Blood culture positive 75.74 28.44 29 14375 5043 90609000
Acute myeloid leukaemia recurrent 75.18 28.44 23 14381 2034 90612009
Aplasia 74.94 28.44 27 14377 3964 90610079
Acute myeloid leukaemia 73.57 28.44 44 14360 20596 90593447
Venous thrombosis 73.27 28.44 29 14375 5508 90608535
Neurotoxicity 71.97 28.44 44 14360 21423 90592620
Rhinovirus infection 71.18 28.44 29 14375 5934 90608109
Venoocclusive disease 71.17 28.44 23 14381 2432 90611611
Protothecosis 69.92 28.44 16 14388 455 90613588
Pneumonia fungal 69.85 28.44 30 14374 7001 90607042
Candida infection 68.88 28.44 51 14353 34006 90580037
Ejection fraction decreased 68.64 28.44 46 14358 26207 90587836
Fungaemia 67.95 28.44 24 14380 3326 90610717
Left atrial hypertrophy 67.53 28.44 11 14393 44 90613999
Joint swelling 67.35 28.44 3 14401 503297 90110746
Disseminated intravascular coagulation 66.77 28.44 42 14362 21496 90592547
Pseudomonal sepsis 65.68 28.44 25 14379 4277 90609766
Streptococcal bacteraemia 65.11 28.44 21 14383 2206 90611837
Enteritis 61.78 28.44 31 14373 10290 90603753
Alpha haemolytic streptococcal infection 61.51 28.44 19 14385 1735 90612308
Cerebral venous sinus thrombosis 59.78 28.44 20 14384 2356 90611687
Malaise 58.87 28.44 11 14393 585975 90028068
Systemic candida 58.79 28.44 24 14380 4935 90609108
Neoplasm recurrence 57.28 28.44 21 14383 3238 90610805
Foetal anaemia 57.11 28.44 11 14393 131 90613912
Klebsiella infection 56.03 28.44 29 14375 10268 90603775
Neutropenic sepsis 55.31 28.44 35 14369 18095 90595948
Abdominal discomfort 54.81 28.44 6 14398 477322 90136721
Stenotrophomonas infection 54.68 28.44 19 14385 2510 90611533
Leukoerythroblastosis 54.00 28.44 12 14392 298 90613745
Nasopharyngitis 52.62 28.44 3 14401 407101 90206942
Cystitis bacterial 52.51 28.44 12 14392 339 90613704
Trichosporon infection 51.54 28.44 12 14392 369 90613674
Angiokeratoma 51.32 28.44 10 14394 127 90613916
Pulmonary haemorrhage 50.72 28.44 25 14379 7988 90606055
Hepatic failure 49.74 28.44 45 14359 39683 90574360
Acute lymphocytic leukaemia recurrent 49.56 28.44 18 14386 2703 90611340
Differentiation syndrome 49.14 28.44 15 14389 1316 90612727
Pulse waveform abnormal 49.12 28.44 9 14395 80 90613963
Ankle brachial index decreased 49.02 28.44 9 14395 81 90613962
Left ventricular dysfunction 49 28.44 30 14374 14639 90599404
Pyrexia 48.22 28.44 220 14184 660265 89953778
Drug hypersensitivity 48.07 28.44 8 14396 463601 90150442
Carotid intima-media thickness increased 47.55 28.44 9 14395 97 90613946
Device related infection 46.36 28.44 36 14368 25750 90588293
Pneumonia moraxella 46.14 28.44 8 14396 50 90613993
Pericoronitis 45.65 28.44 9 14395 122 90613921
Hyperglycaemia 45.56 28.44 48 14356 50922 90563121
Dyspnoea 45.40 28.44 44 14360 880911 89733132
Acute respiratory distress syndrome 45.07 28.44 37 14367 28649 90585394
Intermittent positive pressure breathing 44.87 28.44 8 14396 60 90613983
Minimal residual disease 44.86 28.44 11 14393 423 90613620
Cerebral venous thrombosis 44.65 28.44 16 14388 2312 90611731
Dysplasia 44.27 28.44 14 14390 1380 90612663
Swelling 43.96 28.44 7 14397 419051 90194992
Leukaemia recurrent 43.57 28.44 14 14390 1453 90612590
Neuropathy peripheral 43.42 28.44 78 14326 136892 90477151
Rhinocerebral mucormycosis 42.52 28.44 12 14392 800 90613243
Electrocardiogram PR shortened 42.46 28.44 11 14393 530 90613513
Hepatotoxicity 42.46 28.44 44 14360 45798 90568245
Alanine aminotransferase increased 42.22 28.44 71 14333 118267 90495776
Infusion related reaction 41.45 28.44 8 14396 416772 90197271
Staphylococcal sepsis 41.43 28.44 23 14381 9360 90604683
Premature delivery 41.03 28.44 40 14364 38722 90575321
Respiratory distress 40.87 28.44 40 14364 38906 90575137
Periventricular leukomalacia 40.56 28.44 9 14395 222 90613821
Osteonecrosis 39.46 28.44 33 14371 26208 90587835
Fall 38.92 28.44 14 14390 481796 90132247
Cardiac arrest 38.82 28.44 64 14340 104871 90509172
Premature baby 38.67 28.44 32 14372 25045 90588998
Overgrowth fungal 38.29 28.44 8 14396 147 90613896
Renal failure 38.24 28.44 72 14332 130935 90483108
Cardiomyopathy 38.05 28.44 29 14375 20177 90593866
Sinusitis 37.67 28.44 5 14399 343083 90270960
Bone marrow disorder 37.06 28.44 15 14389 3017 90611026
Peripheral swelling 36.95 28.44 10 14394 413096 90200947
Hyperglycaemic hyperosmolar nonketotic syndrome 36.34 28.44 12 14392 1357 90612686
Otitis externa 35.88 28.44 13 14391 1938 90612105
Pleuroparenchymal fibroelastosis 35.87 28.44 8 14396 202 90613841
Blast crisis in myelogenous leukaemia 35.67 28.44 10 14394 651 90613392
Portal vein embolism 35.63 28.44 7 14397 93 90613950
Cardiopulmonary failure 35.55 28.44 16 14388 4172 90609871
Cerebral haemorrhage 35.37 28.44 35 14369 34487 90579556
Glioma 34.77 28.44 9 14395 432 90613611
Pulmonary oedema 34.73 28.44 46 14358 62034 90552009
Acute promyelocytic leukaemia 34.46 28.44 11 14393 1118 90612925
Blood bilirubin increased 33.72 28.44 38 14366 43432 90570611
Varicella zoster virus infection 33.51 28.44 15 14389 3862 90610181
Hypoaesthesia 33.50 28.44 5 14399 314205 90299838
Musculoskeletal stiffness 33.33 28.44 4 14400 296528 90317515
Aborted pregnancy 33.20 28.44 6 14398 49 90613994
Myelodysplastic syndrome 32.91 28.44 27 14377 20876 90593167
Hepatocellular injury 32.76 28.44 31 14373 28927 90585116
White matter lesion 32.64 28.44 13 14391 2508 90611535
Ileus paralytic 32.59 28.44 16 14388 5069 90608974
Glioblastoma multiforme 32.21 28.44 10 14394 928 90613115
Pericarditis 32.01 28.44 3 14401 270148 90343895
Bacillus infection 31.99 28.44 10 14394 949 90613094
Hidradenitis 31.87 28.44 15 14389 4332 90609711
Epstein-Barr virus infection 31.63 28.44 20 14384 10324 90603719
Depression 31.55 28.44 5 14399 300596 90313447
Tachycardia 31.27 28.44 74 14330 157599 90456444
Hypotension 31.21 28.44 118 14286 325279 90288764
Gene mutation 31.16 28.44 12 14392 2118 90611925
Soft tissue infection 30.89 28.44 13 14391 2884 90611159
Dizziness 30.81 28.44 29 14375 589255 90024788
Pathogen resistance 30.75 28.44 18 14386 8097 90605946
Weight decreased 30.74 28.44 11 14393 379899 90234144
Weight increased 30.72 28.44 14 14390 417913 90196130
Escherichia infection 30.34 28.44 23 14381 15872 90598171
Genotoxicity 30.31 28.44 5 14399 22 90614021
Skin maceration 30.20 28.44 7 14397 211 90613832
Blister 29.77 28.44 3 14401 254995 90359048
Transient acantholytic dermatosis 29.33 28.44 6 14398 99 90613944
Muscle spasms 29.31 28.44 3 14401 251880 90362163
Cardiac failure 29.28 28.44 58 14346 109438 90504605
Leukopenia 28.95 28.44 55 14349 100655 90513388
Staphylococcal infection 28.81 28.44 37 14367 48402 90565641
Intestinal haematoma 28.78 28.44 6 14398 109 90613934
Cholestasis 28.62 28.44 32 14372 36267 90577776
Cerebral fungal infection 28.48 28.44 7 14397 272 90613771

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Febrile neutropenia 735.15 21.56 603 16674 185100 42418958
Acute myeloid leukaemia recurrent 344.01 21.56 104 17173 3408 42600650
Hypofibrinogenaemia 322.25 21.56 87 17190 1880 42602178
Myelosuppression 312.56 21.56 198 17079 40263 42563795
Posterior reversible encephalopathy syndrome 265.46 21.56 121 17156 12700 42591358
Bone marrow failure 240.75 21.56 156 17121 32937 42571121
Neutropenia 214.00 21.56 328 16949 199103 42404955
Septic shock 198.73 21.56 214 17063 91458 42512600
Lymphoid tissue hypoplasia 187.83 21.56 48 17229 830 42603228
Thymus hypoplasia 183.79 21.56 47 17230 815 42603243
Aspergillus infection 181.25 21.56 100 17177 15737 42588321
Hypertriglyceridaemia 179.93 21.56 86 17191 10040 42594018
Fungal infection 155.84 21.56 98 17179 19624 42584434
Bronchopulmonary aspergillosis 152.16 21.56 96 17181 19333 42584725
Disseminated aspergillosis 147.20 21.56 46 17231 1684 42602374
Pancytopenia 140.77 21.56 204 17073 117539 42486519
Neutropenic colitis 131.20 21.56 54 17223 4416 42599642
Mucormycosis 130.96 21.56 62 17215 7081 42596977
Hyperbilirubinaemia 122.95 21.56 86 17191 20549 42583509
Pneumonia fungal 122.12 21.56 64 17213 9082 42594976
Leukaemia recurrent 115.36 21.56 39 17238 1837 42602221
Glioma 114.82 21.56 29 17248 477 42603581
Skin toxicity 114.44 21.56 55 17222 6494 42597564
Haematotoxicity 113.81 21.56 65 17212 10920 42593138
Sepsis 111.73 21.56 248 17029 199086 42404972
Hepatotoxicity 105.57 21.56 85 17192 25082 42578976
Acute lymphocytic leukaemia recurrent 102.95 21.56 43 17234 3648 42600410
Clostridium difficile colitis 96.04 21.56 75 17202 21177 42582881
Glioblastoma multiforme 94.48 21.56 28 17249 854 42603204
Multiple-drug resistance 91.42 21.56 49 17228 7273 42596785
Mucosal inflammation 89.26 21.56 105 17172 49269 42554789
Brain sarcoma 86.39 21.56 15 17262 28 42604030
Lymphopenia 84.48 21.56 70 17207 21493 42582565
Pyrexia 81.41 21.56 345 16932 393697 42210361
Leukoencephalopathy 78.74 21.56 39 17238 4915 42599143
Tumour lysis syndrome 78.54 21.56 68 17209 22163 42581895
Blood fibrinogen decreased 78.04 21.56 28 17249 1575 42602483
Fatigue 77.74 21.56 40 17237 435601 42168457
Cerebellar tumour 74.91 21.56 16 17261 119 42603939
Central nervous system fungal infection 74.01 21.56 20 17257 433 42603625
Bacteraemia 73.50 21.56 69 17208 24971 42579087
Cerebral venous thrombosis 73.42 21.56 24 17253 1017 42603041
Colitis 72.74 21.56 92 17185 46480 42557578
Device related infection 71.58 21.56 62 17215 20217 42583841
Cytomegalovirus viraemia 68.29 21.56 46 17231 10331 42593727
Venoocclusive disease 62.75 21.56 31 17246 3884 42600174
Febrile bone marrow aplasia 61.95 21.56 43 17234 10138 42593920
Multiple organ dysfunction syndrome 60.24 21.56 126 17151 96909 42507149
Bacterial infection 60.10 21.56 65 17212 27814 42576244
Systemic mycosis 57.28 21.56 25 17252 2362 42601696
Graft versus host disease 57.06 21.56 45 17232 12880 42591178
Osteonecrosis 54.96 21.56 48 17229 15817 42588241
Second primary malignancy 54.91 21.56 39 17238 9536 42594522
Candida infection 54.87 21.56 55 17222 21555 42582503
Cytomegalovirus infection reactivation 53.88 21.56 41 17236 11137 42592921
Thrombocytopenia 52.57 21.56 183 17094 190096 42413962
Arthralgia 52.17 21.56 10 17267 205228 42398830
Cerebral venous sinus thrombosis 51.70 21.56 17 17260 734 42603324
Pain 50.71 21.56 18 17259 244830 42359228
Escherichia infection 48.85 21.56 39 17238 11357 42592701
Fibrinous bronchitis 48.06 21.56 11 17266 116 42603942
Death 47.23 21.56 74 17203 471111 42132947
Differentiation syndrome 46.82 21.56 20 17257 1793 42602265
Infection 46.12 21.56 124 17153 111944 42492114
Dizziness 45.68 21.56 22 17255 249232 42354826
Meningeal neoplasm 44.55 21.56 10 17267 96 42603962
Product use in unapproved indication 43.84 21.56 169 17108 184287 42419771
Respiratory failure 43.25 21.56 132 17145 128000 42476058
Pulmonary haemorrhage 42.56 21.56 36 17241 11361 42592697
Blood bilirubin increased 41.59 21.56 67 17210 42185 42561873
Intracranial pressure increased 41.41 21.56 25 17252 4649 42599409
Dyspnoea 41.10 21.56 73 17204 442548 42161510
Lymphadenopathy 40.03 21.56 58 17219 33307 42570751
Malaise 39.98 21.56 18 17259 212138 42391920
Neoplasm recurrence 39.05 21.56 20 17257 2704 42601354
Lower respiratory tract infection fungal 38.82 21.56 13 17264 594 42603464
Enterococcus test positive 38.34 21.56 17 17260 1668 42602390
Aplasia 38.06 21.56 24 17253 4819 42599239
Haemophagocytic lymphohistiocytosis 36.69 21.56 41 17236 18181 42585877
Insomnia 36.68 21.56 3 17274 118250 42485808
Myocardial infarction 36.21 21.56 4 17273 124005 42480053
Candida endophthalmitis 36.10 21.56 9 17268 140 42603918
Inappropriate antidiuretic hormone secretion 34.65 21.56 38 17239 16503 42587555
Hepatic steatosis 34.47 21.56 43 17234 21405 42582653
Asthenia 34.30 21.56 38 17239 280755 42323303
Personality change due to a general medical condition 34.08 21.56 7 17270 42 42604016
Disseminated intravascular coagulation 34.06 21.56 46 17231 24748 42579310
Congenital pneumonia 33.93 21.56 8 17269 97 42603961
Nervous system disorder 33.44 21.56 38 17239 17157 42586901
Stomatitis 33.13 21.56 67 17210 50262 42553796
Pruritus 32.57 21.56 18 17259 188753 42415305
Oesophageal stenosis 32.19 21.56 16 17261 2030 42602028
Enamel anomaly 31.81 21.56 9 17268 232 42603826
Overdose 31.75 21.56 3 17274 105261 42498797
Intracranial tumour haemorrhage 31.29 21.56 10 17267 394 42603664
Acute monocytic leukaemia 31.26 21.56 10 17267 395 42603663
Enterococcal infection 31.21 21.56 31 17246 12008 42592050
Tooth hypoplasia 31.13 21.56 9 17268 251 42603807
Gallbladder empyema 31.11 21.56 7 17270 68 42603990
Hydrocephalus 30.85 21.56 23 17254 6055 42598003
Viral haemorrhagic cystitis 30.66 21.56 15 17262 1839 42602219
Scedosporium infection 30.02 21.56 14 17263 1544 42602514
Rash 29.12 21.56 42 17235 276912 42327146
Large intestine infection 28.75 21.56 15 17262 2106 42601952
Intussusception 28.65 21.56 11 17266 748 42603310
Acute myeloid leukaemia 28.62 21.56 40 17237 22216 42581842
Stenotrophomonas infection 28.22 21.56 18 17259 3686 42600372
Neurotoxicity 28.20 21.56 41 17236 23610 42580448
Astrocytoma 28.06 21.56 8 17269 212 42603846
Fall 27.26 21.56 33 17244 234487 42369571
Minimal residual disease 27.07 21.56 10 17267 611 42603447
Pseudomonal bacteraemia 27.04 21.56 15 17262 2381 42601677
Acute graft versus host disease in skin 26.80 21.56 23 17254 7401 42596657
Systemic candida 26.71 21.56 20 17257 5299 42598759
Hypertransaminasaemia 26.25 21.56 25 17252 9202 42594856
Cellulitis 26.17 21.56 69 17208 61516 42542542
Peripheral swelling 26.12 21.56 3 17274 90267 42513791
Neoplasm progression 25.86 21.56 44 17233 28956 42575102
Graft versus host disease in skin 24.85 21.56 19 17258 5193 42598865
Pseudomonas test positive 24.69 21.56 12 17265 1451 42602607
Superior sagittal sinus thrombosis 24.56 21.56 8 17269 335 42603723
Muscle spasms 24.55 21.56 3 17274 86041 42518017
Neurological examination abnormal 24.54 21.56 8 17269 336 42603722
Prothrombin level abnormal 24.46 21.56 6 17271 87 42603971
Adenovirus infection 24.38 21.56 21 17256 6788 42597270
Coagulopathy 24.38 21.56 37 17240 22125 42581933
Leukopenia 24.25 21.56 76 17201 74670 42529388
Venoocclusive liver disease 23.93 21.56 25 17252 10277 42593781
Fusarium infection 23.55 21.56 12 17265 1604 42602454
Drug resistance 23.02 21.56 46 17231 34202 42569856
Hip deformity 22.84 21.56 6 17271 116 42603942
Central nervous system haemorrhage 22.70 21.56 6 17271 119 42603939
Myocardial oedema 22.48 21.56 7 17270 253 42603805
Non-alcoholic steatohepatitis 22.47 21.56 10 17267 989 42603069
Nausea 22.45 21.56 84 17193 396715 42207343
Acute graft versus host disease in intestine 22.43 21.56 16 17261 3935 42600123
Weight decreased 22.37 21.56 31 17246 207917 42396141
Ileus paralytic 22.30 21.56 21 17256 7620 42596438
Somnolence 22.17 21.56 15 17262 141090 42462968
Steroid diabetes 22.08 21.56 14 17263 2838 42601220
Klebsiella infection 21.96 21.56 25 17252 11307 42592751
Pulmonary mucormycosis 21.78 21.56 11 17266 1444 42602614

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Febrile neutropenia 1748.24 22.13 1099 30606 315668 110241926
Posterior reversible encephalopathy syndrome 505.29 22.13 229 31476 33632 110523962
Secondary immunodeficiency 457.14 22.13 128 31577 4548 110553046
Bone marrow failure 426.75 22.13 243 31462 57605 110499989
Aspergillus infection 426.22 22.13 187 31518 25429 110532165
Neutropenia 424.68 22.13 529 31176 374091 110183503
Acute myeloid leukaemia recurrent 422.94 22.13 123 31582 5016 110552578
Bacterial infection 404.42 22.13 217 31488 45819 110511775
Thymus hypoplasia 401.97 22.13 94 31611 1593 110556001
Lymphoid tissue hypoplasia 392.65 22.13 92 31613 1573 110556021
Hypofibrinogenaemia 384.56 22.13 98 31607 2409 110555185
Myelosuppression 374.61 22.13 268 31437 94072 110463522
Bronchopulmonary aspergillosis 368.12 22.13 177 31528 29686 110527908
Sepsis 356.02 22.13 453 31252 326893 110230701
Clostridium difficile colitis 333.89 22.13 188 31517 43590 110514004
Septic shock 321.88 22.13 304 31401 157224 110400370
Neutropenic colitis 275.40 22.13 99 31606 7966 110549628
Human bocavirus infection 269.52 22.13 63 31642 1065 110556529
Hypertriglyceridaemia 265.67 22.13 117 31588 16037 110541557
Hyperbilirubinaemia 253.77 22.13 139 31566 30532 110527062
Human herpesvirus 6 infection 240.66 22.13 85 31620 6496 110551098
Pseudomonal sepsis 228.39 22.13 89 31616 8957 110548637
Pancytopenia 224.23 22.13 288 31417 209325 110348269
Pneumatosis intestinalis 222.74 22.13 86 31619 8443 110549151
Mycobacterium chelonae infection 220.10 22.13 66 31639 2994 110554600
Mucormycosis 217.88 22.13 90 31615 10538 110547056
Fungal infection 207.67 22.13 147 31558 50659 110506935
Cystitis bacterial 207.10 22.13 52 31653 1201 110556393
Pneumonia fungal 201.86 22.13 94 31611 14660 110542934
Haematotoxicity 195.27 22.13 103 31602 20979 110536615
Enterobacter infection 193.41 22.13 70 31635 5741 110551853
Bacteraemia 192.85 22.13 131 31574 42259 110515335
Norovirus test positive 189.30 22.13 46 31659 924 110556670
Disseminated aspergillosis 189.28 22.13 56 31649 2424 110555170
Thrombocytopenia 178.18 22.13 341 31364 348544 110209050
Cytomegalovirus viraemia 176.57 22.13 91 31614 17673 110539921
Mucosal inflammation 170.83 22.13 172 31533 95969 110461625
Pain 163.62 22.13 37 31668 954918 109602676
Parainfluenzae virus infection 163.36 22.13 65 31640 6909 110550685
Fatigue 162.68 22.13 73 31632 1215885 109341709
Leukaemia recurrent 160.02 22.13 52 31653 3079 110554515
Colitis 156.58 22.13 169 31536 102154 110455440
Tumour lysis syndrome 156.54 22.13 102 31603 30699 110526895
Second primary malignancy 155.30 22.13 84 31621 17984 110539610
Multiple organ dysfunction syndrome 153.64 22.13 203 31502 151507 110406087
Acute lymphocytic leukaemia recurrent 153.42 22.13 59 31646 5728 110551866
Glioma 152.49 22.13 38 31667 850 110556744
Arthralgia 151.15 22.13 22 31683 779610 109777984
Enteritis 147.98 22.13 83 31622 19073 110538521
Rhinovirus infection 142.57 22.13 69 31636 11720 110545874
Viraemia 138.71 22.13 50 31655 4052 110553542
Viral infection 134.88 22.13 116 31589 53023 110504571
Hepatotoxicity 130.53 22.13 123 31582 63277 110494317
Glioblastoma multiforme 128.52 22.13 37 31668 1453 110556141
Febrile bone marrow aplasia 127.69 22.13 73 31632 17392 110540202
Pyrexia 122.41 22.13 545 31160 897720 109659874
Respiratory failure 116.64 22.13 216 31489 215116 110342478
Malaise 114.98 22.13 26 31679 671793 109885801
Device related infection 114.22 22.13 93 31612 39426 110518168
Venoocclusive disease 114.20 22.13 49 31656 6301 110551293
Joint swelling 112.97 22.13 3 31702 442842 110114752
Pseudomonas infection 112.42 22.13 80 31625 27773 110529821
Candida infection 112.19 22.13 100 31605 47909 110509685
Lymphopenia 110.80 22.13 92 31613 40078 110517516
Cardiotoxicity 108.74 22.13 65 31640 16816 110540778
Skin toxicity 107.49 22.13 57 31648 11726 110545868
Enterococcal infection 104.84 22.13 68 31637 20298 110537296
Haemophagocytic lymphohistiocytosis 103.49 22.13 80 31625 31479 110526115
Disseminated intravascular coagulation 102.48 22.13 89 31616 41197 110516397
Neurotoxicity 100.78 22.13 89 31616 42118 110515476
Pulmonary haemorrhage 99.90 22.13 61 31644 16395 110541199
Neoplasm recurrence 99.48 22.13 42 31663 5190 110552404
Nasopharyngitis 99.36 22.13 3 31702 394358 110163236
Multiple-drug resistance 98.58 22.13 56 31649 13179 110544415
Aplasia 97.98 22.13 47 31658 7826 110549768
Brain sarcoma 97.63 22.13 16 31689 30 110557564
Cerebral venous sinus thrombosis 96.81 22.13 35 31670 2860 110554734
Differentiation syndrome 91.42 22.13 34 31671 3010 110554584
Leukoencephalopathy 91.07 22.13 47 31658 9148 110548446
Central nervous system haemorrhage 90.66 22.13 22 31683 439 110557155
Abscess bacterial 88.61 22.13 25 31680 912 110556682
Dyspnoea 88.32 22.13 113 31592 1106759 109450835
Dizziness 85.44 22.13 47 31658 698146 109859448
Diffuse alveolar damage 85.41 22.13 35 31670 4012 110553582
Acute myeloid leukaemia 84.35 22.13 77 31628 38033 110519561
Abdominal discomfort 83.91 22.13 8 31697 393850 110163744
Venoocclusive liver disease 83.79 22.13 53 31652 15154 110542440
Venous thrombosis 82.87 22.13 43 31662 8462 110549132
Drug hypersensitivity 80.85 22.13 16 31689 454074 110103520
Blood fibrinogen decreased 80.78 22.13 30 31675 2645 110554949
Cerebellar tumour 80.43 22.13 17 31688 176 110557418
Stenotrophomonas infection 79.12 22.13 37 31668 5821 110551773
Peripheral swelling 76.80 22.13 12 31693 404022 110153572
Pruritus 75.82 22.13 36 31669 581524 109976070
Cerebral venous thrombosis 75.00 22.13 30 31675 3232 110554362
Cytomegalovirus infection reactivation 74.77 22.13 53 31652 18280 110539314
Escherichia infection 72.96 22.13 58 31647 23758 110533836
Fall 71.83 22.13 42 31663 603440 109954154
Systemic candida 71.06 22.13 41 31664 9933 110547661
Infusion related reaction 70.92 22.13 12 31693 381150 110176444
Oesophageal candidiasis 70.64 22.13 43 31662 11491 110546103
Minimal residual disease 70.46 22.13 21 31684 932 110556662
Urticaria 69.19 22.13 6 31699 318851 110238743
Alopecia 68.94 22.13 11 31694 364742 110192852
Ejection fraction decreased 68.67 22.13 71 31634 40809 110516785
Swelling 67.68 22.13 10 31695 351031 110206563
Systemic mycosis 67.06 22.13 29 31676 3800 110553794
Blood culture positive 66.90 22.13 38 31667 8938 110548656
Retinitis viral 65.78 22.13 17 31688 442 110557152
Graft versus host disease 64.56 22.13 49 31656 18757 110538837
Insomnia 63.55 22.13 13 31692 360577 110197017
Acute respiratory distress syndrome 62.99 22.13 77 31628 53121 110504473
Nausea 61.47 22.13 168 31537 1235522 109322072
Musculoskeletal stiffness 61.44 22.13 5 31700 279817 110277777
Cytomegalovirus chorioretinitis 60.86 22.13 33 31672 7095 110550499
Central nervous system fungal infection 60.69 22.13 17 31688 604 110556990
Ileus paralytic 59.94 22.13 39 31666 11698 110545896
Klebsiella infection 59.73 22.13 48 31657 19961 110537633
Blood bilirubin increased 59.55 22.13 90 31615 75882 110481712
Left atrial hypertrophy 58.55 22.13 11 31694 58 110557536
Protothecosis 57.88 22.13 16 31689 541 110557053
Wheezing 57.62 22.13 4 31701 255226 110302368
Inappropriate antidiuretic hormone secretion 57.23 22.13 59 31646 33792 110523802
Coronavirus infection 56.96 22.13 35 31670 9510 110548084
Intracranial pressure increased 56.25 22.13 36 31669 10499 110547095
Weight increased 56.17 22.13 25 31680 419619 110137975
Muscle spasms 55.80 22.13 7 31698 278150 110279444
Alpha haemolytic streptococcal infection 55.77 22.13 25 31680 3568 110554026
Fusarium infection 55.21 22.13 23 31682 2748 110554846
Wound 54.95 22.13 3 31702 234434 110323160
Staphylococcal sepsis 54.52 22.13 43 31662 17411 110540183
Fungaemia 54.27 22.13 29 31676 6057 110551537
Hypersensitivity 54.18 22.13 24 31681 403974 110153620
Enterococcus test positive 54.17 22.13 23 31682 2881 110554713
Blister 53.01 22.13 3 31702 227373 110330221
Pancreatitis acute 52.43 22.13 75 31630 60199 110497395
Oral herpes 52.38 22.13 58 31647 36022 110521572
Cellulitis 52.08 22.13 113 31592 125903 110431691
Osteonecrosis 52.04 22.13 56 31649 33685 110523909
Herpes simplex 51.76 22.13 40 31665 15724 110541870
Intracardiac thrombus 51.66 22.13 25 31680 4243 110553351
Leukopenia 51.08 22.13 124 31581 148667 110408927
Lower respiratory tract infection fungal 51.07 22.13 16 31689 841 110556753
Contraindicated product administered 50.40 22.13 6 31699 248261 110309333
Respiratory distress 50.34 22.13 79 31626 68795 110488799
Rash 50.06 22.13 100 31605 820864 109736730
Fibrinous bronchitis 49.60 22.13 11 31694 145 110557449
Streptococcal bacteraemia 49.53 22.13 25 31680 4644 110552950
Gastroenteritis norovirus 49.36 22.13 23 31682 3588 110554006
Weight decreased 48.39 22.13 38 31667 468019 110089575
Depression 47.26 22.13 16 31689 317319 110240275
Carotid intima-media thickness increased 47.10 22.13 10 31695 106 110557488
Pulmonary mucormycosis 46.82 22.13 19 31686 2124 110555470
Inappropriate schedule of product administration 46.52 22.13 3 31702 203634 110353960
Hypoaesthesia 46.52 22.13 16 31689 314207 110243387
Contusion 46.49 22.13 6 31699 233355 110324239
Coagulopathy 46.47 22.13 58 31647 40853 110516741
Dry mouth 45.52 22.13 3 31702 199945 110357649
Product use in unapproved indication 45.35 22.13 250 31455 447127 110110467
Pseudomonas test positive 45.10 22.13 19 31686 2335 110555259
Overdose 44.27 22.13 7 31698 233787 110323807
Hyperglycaemic hyperosmolar nonketotic syndrome 43.74 22.13 20 31685 2989 110554605
Pulse waveform abnormal 43.52 22.13 9 31696 83 110557511
Ankle brachial index decreased 43.52 22.13 9 31696 83 110557511
Alanine aminotransferase increased 42.95 22.13 133 31572 183640 110373954
Platelet count decreased 42.52 22.13 154 31551 230289 110327305
Confusional state 42.51 22.13 43 31662 468637 110088957
Sleep disorder 42.37 22.13 4 31701 198640 110358954
Lower respiratory tract infection 42.33 22.13 9 31696 243097 110314497
Bacterial sepsis 42.19 22.13 30 31675 10396 110547198
Impaired healing 41.86 22.13 4 31701 196713 110360881
Renal replacement therapy 41.77 22.13 10 31695 188 110557406
Neoplasm progression 41.64 22.13 70 31635 64525 110493069
Gastrointestinal protozoal infection 41.60 22.13 9 31696 105 110557489
Angiokeratoma 40.86 22.13 10 31695 207 110557387
Osteoarthritis 40.82 22.13 3 31702 182620 110374974
Gastrooesophageal reflux disease 40.10 22.13 3 31702 179973 110377621
Electrocardiogram PR shortened 39.59 22.13 11 31694 379 110557215
Memory impairment 39.38 22.13 5 31700 196939 110360655
Seizure 39.28 22.13 146 31559 221039 110336555
Neutropenic sepsis 38.84 22.13 46 31659 30700 110526894
Blood cholesterol increased 38.68 22.13 4 31701 184781 110372813
Hepatic steatosis 38.47 22.13 58 31647 48773 110508821
Pericarditis 38.38 22.13 8 31697 219106 110338488
Geotrichum infection 38.10 22.13 14 31691 1198 110556396
Pericoronitis 38.07 22.13 9 31696 160 110557434
Left ventricular dysfunction 38.01 22.13 40 31665 23453 110534141
Migraine 37.85 22.13 3 31702 171649 110385945
Hydrocephalus 37.77 22.13 28 31677 10347 110547247
Asthenia 37.76 22.13 89 31616 688910 109868684
Ileus 37.22 22.13 45 31660 30684 110526910
Blast crisis in myelogenous leukaemia 36.77 22.13 13 31692 995 110556599
Gait disturbance 36.54 22.13 17 31688 278191 110279403
Antithrombin III decreased 36.46 22.13 11 31694 509 110557085
Candida endophthalmitis 35.96 22.13 9 31696 205 110557389
Encephalitis 35.82 22.13 35 31670 18804 110538790
Pain in extremity 35.42 22.13 53 31652 487065 110070529
Pancreatitis 35.41 22.13 81 31624 93452 110464142
Infection reactivation 35.14 22.13 19 31686 4062 110553532
Superior sagittal sinus thrombosis 35.07 22.13 13 31692 1140 110556454
Bilirubin conjugated increased 35.05 22.13 22 31683 6202 110551392
Rhinocerebral mucormycosis 35.04 22.13 14 31691 1503 110556091
Klebsiella sepsis 34.83 22.13 19 31686 4134 110553460
Acute monocytic leukaemia 34.66 22.13 11 31694 603 110556991
Arthritis 34.13 22.13 4 31701 167582 110390012
Bone marrow necrosis 34.06 22.13 10 31695 421 110557173
Graft versus host disease in skin 33.98 22.13 24 31681 8230 110549364
Inflammation 33.96 22.13 7 31698 193231 110364363
Staphylococcal infection 33.91 22.13 67 31638 69877 110487717
Escherichia bacteraemia 33.83 22.13 26 31679 10138 110547456
Cardiac ventricular thrombosis 33.82 22.13 17 31688 3130 110554464
Pneumonia moraxella 33.69 22.13 8 31697 145 110557449
Myocardial infarction 33.67 22.13 7 31698 192076 110365518
Blood pressure increased 33.61 22.13 16 31689 258357 110299237
Escherichia sepsis 33.58 22.13 26 31679 10246 110547348
Sinusitis 33.37 22.13 22 31683 296666 110260928
Hypoxia 33.33 22.13 97 31608 129418 110428176
Overgrowth fungal 33.29 22.13 8 31697 153 110557441
Toxic optic neuropathy 33.28 22.13 13 31692 1315 110556279
Hepatic enzyme increased 33.21 22.13 26 31679 320866 110236728
Condition aggravated 32.73 22.13 105 31600 734731 109822863
Acute graft versus host disease in skin 32.56 22.13 26 31679 10714 110546880
Cerebral haemorrhage 32.43 22.13 63 31642 64905 110492689
Neurological examination abnormal 32.16 22.13 11 31694 763 110556831
Transient acantholytic dermatosis 32.12 22.13 9 31696 320 110557274
Anxiety 32.03 22.13 31 31674 345047 110212547
Lymphadenopathy 31.98 22.13 62 31643 63773 110493821
Scedosporium infection 31.58 22.13 15 31690 2443 110555151
T-cell type acute leukaemia 31.57 22.13 9 31696 341 110557253
Tooth hypoplasia 31.39 22.13 9 31696 348 110557246
Nervous system disorder 31.37 22.13 42 31663 31679 110525915
Pleuroparenchymal fibroelastosis 31.25 22.13 9 31696 354 110557240
Pseudomonal bacteraemia 31.22 22.13 18 31687 4353 110553241
Hypoalbuminaemia 31.20 22.13 40 31665 28934 110528660
Polyneuropathy 31.07 22.13 42 31663 31970 110525624
Portal vein embolism 30.98 22.13 7 31698 101 110557493
Oesophageal stenosis 30.97 22.13 19 31686 5146 110552448
Large intestine infection 30.77 22.13 18 31687 4474 110553120
Hyperglycaemia 30.36 22.13 72 31633 85018 110472576
Chest pain 30.32 22.13 38 31667 376337 110181257
Enamel anomaly 29.99 22.13 8 31697 236 110557358
Aborted pregnancy 29.67 22.13 6 31699 49 110557545
Myelopathy 29.63 22.13 19 31686 5557 110552037
Cardiomyopathy 29.57 22.13 42 31663 33483 110524111
Dyspepsia 29.53 22.13 9 31696 190956 110366638
Astrocytoma 29.48 22.13 8 31697 252 110557342
Gallbladder empyema 29.27 22.13 7 31698 131 110557463
Mobility decreased 28.94 22.13 16 31689 237406 110320188
Acute myeloid leukaemia refractory 28.56 22.13 8 31697 284 110557310
Hidradenitis 28.40 22.13 18 31687 5162 110552432
Staphylococcal bacteraemia 28.05 22.13 29 31676 16659 110540935
Shock 28.02 22.13 53 31652 53535 110504059
Adenovirus infection 27.88 22.13 24 31681 10970 110546624
Cardiac dysfunction 27.73 22.13 19 31686 6204 110551390
Respiratory syncytial virus infection 27.71 22.13 27 31678 14457 110543137
Musculoskeletal pain 27.63 22.13 9 31696 183014 110374580
Neuropathy peripheral 27.48 22.13 113 31592 179164 110378430
Pulmonary oedema 27.46 22.13 77 31628 100582 110457012
Leukoerythroblastosis 27.24 22.13 8 31697 337 110557257
Sinusitis fungal 27.21 22.13 14 31691 2706 110554888
Viral haemorrhagic cystitis 26.99 22.13 15 31690 3384 110554210
Bronchitis 26.95 22.13 6 31699 157026 110400568
Psoriasis 26.93 22.13 4 31701 139989 110417605
Ill-defined disorder 26.91 22.13 6 31699 156847 110400747
Diarrhoea 26.87 22.13 204 31501 1139301 109418293
Paraesthesia 26.65 22.13 24 31681 276497 110281097
Pneumonia klebsiella 26.64 22.13 19 31686 6613 110550981
Acute lymphocytic leukaemia 26.64 22.13 18 31687 5747 110551847
Trichosporon infection 26.61 22.13 11 31694 1289 110556305
Bone marrow disorder 26.52 22.13 16 31689 4207 110553387
Abdominal pain upper 26.33 22.13 37 31668 349074 110208520
Chronic myeloid leukaemia recurrent 26.14 22.13 8 31697 389 110557205
Delivery 25.80 22.13 10 31695 991 110556603
Back pain 25.40 22.13 42 31663 370954 110186640
Tachycardia 25.20 22.13 130 31575 226515 110331079
Bacillus bacteraemia 24.74 22.13 7 31698 258 110557336
Chronic graft versus host disease 24.71 22.13 21 31684 9436 110548158
Genotoxicity 24.70 22.13 5 31700 41 110557553
Myelodysplastic syndrome 24.66 22.13 41 31664 37443 110520151
Acute graft versus host disease in intestine 24.62 22.13 17 31688 5622 110551972
Gastrointestinal necrosis 24.35 22.13 18 31687 6622 110550972
Myalgia 24.32 22.13 17 31688 222364 110335230
Intussusception 24.27 22.13 11 31694 1610 110555984
Acute febrile neutrophilic dermatosis 24.23 22.13 16 31689 4920 110552674
Pleural effusion 24.14 22.13 108 31597 177601 110379993
Epstein-Barr virus infection 23.61 22.13 28 31677 18710 110538884
Personality change due to a general medical condition 23.54 22.13 7 31698 308 110557286
Central nervous system leukaemia 23.01 22.13 8 31697 583 110557011
Dysplasia 22.90 22.13 11 31694 1837 110555757
Radiation myelopathy 22.85 22.13 4 31701 13 110557581
Dehydration 22.74 22.13 28 31677 279483 110278111
Acute promyelocytic leukaemia 22.63 22.13 11 31694 1885 110555709
Non-alcoholic steatohepatitis 22.41 22.13 12 31693 2515 110555079

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01DB02 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
CYTOTOXIC ANTIBIOTICS AND RELATED SUBSTANCES
Anthracyclines and related substances
ATC L01XY01 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
OTHER ANTINEOPLASTIC AGENTS
Combinations of antineoplastic agents
FDA CS M0028312 Anthracyclines
FDA MoA N0000000176 Topoisomerase Inhibitors
FDA EPC N0000175414 Anthracycline Topoisomerase Inhibitor
MeSH PA D000903 Antibiotics, Antineoplastic
MeSH PA D000970 Antineoplastic Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D059005 Topoisomerase II Inhibitors
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:75835 anti-anaemic agent
CHEBI has role CHEBI:64951 anti-HBV agent
CHEBI has role CHEBI:76969 bacterial metabolite
CHEBI has role CHEBI:233423 antifibrotic agent

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L01XY Combinations of antineoplastic agents 1 drug
cytarabine

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

DiseaseRelationSNOMED_IDDOID
Acute lymphoid leukemia indication 91857003 DOID:9952
Acute myeloid leukemia, disease indication 91861009
Erythroleukemia, FAB M6 indication 93451002
Kaposi's sarcoma indication 109385007
Acute promyelocytic leukemia, FAB M3 indication 110004001
Acute monocytic/monoblastic leukemia indication 413442004
Blast crisis of chronic myeloidleukemia indication 413656006
Nephroblastoma off-label use 302849000 DOID:2154
Neuroblastoma off-label use 432328008 DOID:769
Mycosis contraindication 3218000 DOID:1564
Pericarditis contraindication 3238004 DOID:1787
Ventricular tachycardia contraindication 25569003
Viral disease contraindication 34014006 DOID:934
Hyperuricemia contraindication 35885006 DOID:1920
Conduction disorder of the heart contraindication 44808001
Chronic heart failure contraindication 48447003
Myocarditis contraindication 50920009 DOID:820
Epilepsy contraindication 84757009 DOID:1826
Cardiomyopathy contraindication 85898001 DOID:0050700
Bacterial infectious disease contraindication 87628006
Kidney disease contraindication 90708001 DOID:557
Disease of liver contraindication 235856003 DOID:409
Pregnancy, function contraindication 289908002
Neutropenic disorder contraindication 303011007 DOID:1227
Bone marrow depression contraindication 307762000
Breastfeeding (mother) contraindication 413712001
Granulocytopenic disorder contraindication 417672002
Protozoal Infection contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.85 acidic
pKa2 9.79 acidic
pKa3 11.6 acidic
pKa4 8.6 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
100MG;44MG VYXEOS JAZZ PHARMS THERAP N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 7850990 Jan. 23, 2027 FOR THE TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN ADULTS AND PEDIATRIC PATIENTS 1 YEAR AND OLDER
100MG;44MG VYXEOS JAZZ PHARMS THERAP N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 8022279 Sept. 14, 2027 FOR THE TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN ADULTS AND PEDIATRIC PATIENTS 1 YEAR AND OLDER
100MG;44MG VYXEOS JAZZ PHARMS THERAP N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 8092828 April 1, 2029 FOR THE TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN ADULTS AND PEDIATRIC PATIENTS 1 YEAR AND OLDER
100MG;44MG VYXEOS JAZZ PHARMS THERAP N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 10028912 Oct. 15, 2032 METHOD OF ADMINISTERING A RECONSTITUTED LIPOSOMAL COMPOSITION CONTAINING CYTARABINE AND DAUNORUBICIN TO TREAT NEWLY-DIAGNOSED THERAPY-RELATED AML (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PATIENTS 1 YEAR AND OLDER
100MG;44MG VYXEOS JAZZ PHARMS THERAP N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 10028912 Oct. 15, 2032 METHOD OF RECONSTITUTING A LYOPHILIZED LIPOSOMAL COMPOSITION FOR ADMINISTERING CYTARABINE AND DAUNORUBICIN TO TREAT NEWLY-DIAGNOSED THERAPY-RELATED AML (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PATIENTS 1 YEAR AND OLDER
100MG;44MG VYXEOS JAZZ PHARMS THERAP N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 10166184 Oct. 15, 2032 METHOD OF RECONSTITUTING A LYOPHILIZED LIPOSOMAL COMPOSITION FOR ADMINISTERING CYTARABINE AND DAUNORUBICIN TO TREAT NEWLY-DIAGNOSED THERAPY-RELATED AML (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PATIENTS 1 YEAR AND OLDER
100MG;44MG VYXEOS JAZZ PHARMS THERAP N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 10835492 Oct. 15, 2032 METHOD OF ADMINISTERING A RECONSTITUTED LIPOSOMAL COMPOSITION CONTAINING CYTARABINE AND DAUNORUBICIN TO TREAT NEWLY-DIAGNOSED THERAPY-RELATED AML (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PATIENTS 1 YEAR AND OLDER

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
100MG;44MG VYXEOS JAZZ PHARMS THERAP N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS March 30, 2028 TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PEDIATRIC PATIENTS AGES 1 YEAR AND OLDER
100MG;44MG VYXEOS JAZZ PHARMS THERAP N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS Sept. 30, 2028 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
DNA topoisomerase 2-alpha Enzyme INHIBITOR IC50 8 CHEMBL CHEMBL
Multidrug resistance-associated protein 1 Transporter WOMBAT-PK
ATP-binding cassette sub-family G member 2 Transporter WOMBAT-PK
Multidrug resistance-associated protein 6 Transporter WOMBAT-PK
72 kDa type IV collagenase Enzyme IC50 5.72 CHEMBL
Histone deacetylase 1 Enzyme IC50 7.33 CHEMBL
Histone deacetylase 6 Enzyme IC50 7.70 CHEMBL
Histone deacetylase 8 Enzyme IC50 6.66 CHEMBL
Multidrug resistance protein 1 Transporter WOMBAT-PK
ORF 73 Nuclear other AC50 5.63 CHEMBL

External reference:

IDSource
4019704 VUID
N0000147796 NUI
D01264 KEGG_DRUG
23541-50-6 SECONDARY_CAS_RN
1364321 RXNORM
C0011015 UMLSCUI
CHEBI:41977 CHEBI
DM1 PDB_CHEM_ID
CHEMBL178 ChEMBL_ID
CHEMBL1563 ChEMBL_ID
CHEMBL1200475 ChEMBL_ID
D003630 MESH_DESCRIPTOR_UI
DB00694 DRUGBANK_ID
7063 IUPHAR_LIGAND_ID
2257 INN_ID
371770-68-2 SECONDARY_CAS_RN
ZS7284E0ZP UNII
30323 PUBCHEM_CID
11753 MMSL
4538 MMSL
d00205 MMSL
002662 NDDF
004821 NDDF
108790000 SNOMEDCT_US
35300007 SNOMEDCT_US
372715008 SNOMEDCT_US
65972004 SNOMEDCT_US
4018061 VANDF
4019704 VANDF
ZS7284E0ZP INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Daunorubicin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9550 INJECTION 5 mg INTRAVENOUS NDA 21 sections
Daunorubicin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9551 INJECTION 5 mg INTRAVENOUS NDA 21 sections
Daunorubicin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42658-019 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 22 sections
Daunorubicin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42658-021 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 22 sections
Daunorubicin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42658-021 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 22 sections
VYXEOS HUMAN PRESCRIPTION DRUG LABEL 2 68727-745 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION 44 mg INTRAVENOUS NDA 27 sections
daunorubicin hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 71288-182 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 26 sections