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

Stem definitionDrug idCAS RN
antineoplastics, daunorubicin derivatives 1030 56420-45-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • epirubicin
  • epiadriamycin
  • epidoxorubicin
  • epirarubicin
  • farmarubicin
  • farmarubicine
  • pharmarubicin
  • epirubicin hydrochloride
  • epirubicin HCl
An anthracycline which is the 4'-epi-isomer of doxorubicin. The compound exerts its antitumor effects by interference with the synthesis and function of DNA.
  • Molecular weight: 543.53
  • Formula: C27H29NO11
  • CLOGP: 0.26
  • LIPINSKI: 3
  • HAC: 12
  • HDO: 6
  • TPSA: 206.07
  • ALOGS: -2.67
  • ROTB: 5
  • 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 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 9.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 5.75 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 0 %
Vd (Volume of distribution) 45 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 20 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.25 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 36 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 0.626 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 10.641 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 2.518 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 3.899 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 33.640 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 25.880 % High 1
herg hERG pIC50 4.624 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 1.923 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 3.243 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 18.530 % High 1
kinase-safety-class ACVR2B,ACVRL1,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,ERBB2,FLT3,GRK2,GSK3B,ITK,KDR,KIT,MAP2K6,MAP3K21,MAP3K7,MAP4K1,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PIM2,PRKDC,SIK2,STK33,SYK,TEK,TGFBR1,ZAP70 42
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 9.016 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 8.395 High 1
mh-clint Mouse hepatocyte intrinsic clearance 6.761 High 1
mppb Mouse plasma protein binding (% unbound) 22.790 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 13.152 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 Moderate 0.75
pppb Pig plasma protein binding (% unbound) 32.830 % High 1
rat-kpuu-brain Rat brain Kpuu 0.011 % High 1
rh-clint Rat hepatocyte intrinsic clearance 3.690 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 68.480 % High 1
rppb Rat plasma protein binding (% unbound) 18.220 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 99.770 uM High 1

Approvals:

DateAgencyCompanyOrphan
Sept. 15, 1999 FDA PFIZER INC

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
Myelosuppression 1780.68 18.02 734 41364 52857 90533492
White blood cell count decreased 1121.95 18.02 788 41310 166321 90420028
Febrile neutropenia 1105.78 18.02 765 41333 157584 90428765
Agranulocytosis 1092.85 18.02 459 41639 34543 90551806
Neutropenia 910.22 18.02 786 41312 224118 90362231
Hepatic function abnormal 657.63 18.02 353 41745 45935 90540414
Neutrophil count decreased 592.90 18.02 385 41713 71147 90515202
Disease recurrence 565.39 18.02 298 41800 37355 90548994
Malignant neoplasm progression 502.59 18.02 408 41690 106462 90479887
Bone marrow failure 497.94 18.02 260 41838 31961 90554388
Metastases to bone 482.49 18.02 236 41862 25269 90561080
Leukopenia 428.73 18.02 363 41735 100347 90486002
Ejection fraction decreased 417.53 18.02 216 41882 26037 90560312
Acute myeloid leukaemia 411.52 18.02 198 41900 20442 90565907
Cardiac failure 382.83 18.02 353 41745 109143 90477206
Cardiotoxicity 363.96 18.02 152 41946 11237 90575112
Cardiac dysfunction 344.04 18.02 108 41990 3489 90582860
Congestive cardiomyopathy 328.57 18.02 125 41973 7229 90579120
Metastases to liver 317.27 18.02 186 41912 28621 90557728
Febrile bone marrow aplasia 287.95 18.02 123 41975 9615 90576734
Metastases to lung 284.62 18.02 142 41956 15849 90570500
Second primary malignancy 267.51 18.02 119 41979 10259 90576090
Palmar-plantar erythrodysaesthesia syndrome 262.27 18.02 163 41935 27860 90558489
Neuropathy peripheral 234.21 18.02 303 41795 136667 90449682
Disease progression 233.47 18.02 324 41774 156291 90430058
Neoplasm progression 230.59 18.02 180 41918 44306 90542043
Asthenia 210.98 18.02 634 41464 533117 90053232
Nausea 204.21 18.02 1034 41064 1109282 89477067
Breast cancer recurrent 198.11 18.02 80 42018 5423 90580926
Metastases to lymph nodes 193.95 18.02 99 41999 11590 90574759
Mucosal inflammation 178.73 18.02 174 41924 57451 90528898
Breast cancer metastatic 177.98 18.02 102 41996 15030 90571319
Immune-mediated adrenal insuficiency 175.94 18.02 49 42049 1033 90585316
Ventricular dysfunction 172.37 18.02 65 42033 3666 90582683
Cardiomyopathy 170.25 18.02 110 41988 20096 90566253
Pancytopenia 167.59 18.02 241 41857 120022 90466327
Vomiting 165.97 18.02 764 41334 787529 89798820
Granulocyte count decreased 163.31 18.02 56 42042 2396 90583953
Pyrexia 156.99 18.02 664 41434 659821 89926528
Joint swelling 155.68 18.02 24 42074 503276 90083073
Death 149.77 18.02 509 41589 456042 90130307
Rheumatoid arthritis 146.17 18.02 5 42093 362609 90223740
Systemic lupus erythematosus 145.85 18.02 5 42093 361891 90224458
Anaemia 144.70 18.02 425 41673 352377 90233972
Interstitial lung disease 143.15 18.02 177 41921 76228 90510121
Synovitis 138.64 18.02 3 42095 329749 90256600
Therapy partial responder 133.69 18.02 98 42000 21945 90564404
Colony stimulating factor therapy 131.11 18.02 32 42066 392 90585957
Pain 127.66 18.02 166 41932 996175 89590174
Alopecia 126.31 18.02 509 41589 494562 90091787
Metastasis 125.70 18.02 60 42038 6077 90580272
Haematotoxicity 122.56 18.02 75 42023 12460 90573889
Weight increased 122.42 18.02 23 42075 417904 90168445
Swelling 118.69 18.02 25 42073 419033 90167316
Thrombocytopenia 118.59 18.02 284 41814 208441 90377908
Product dose omission issue 117.61 18.02 4 42094 291683 90294666
Diffuse large B-cell lymphoma recurrent 115.80 18.02 48 42050 3478 90582871
Radiotherapy 110.35 18.02 33 42065 902 90585447
Wound 110.01 18.02 8 42090 302972 90283377
Glossodynia 110.00 18.02 11 42087 321768 90264581
Left ventricular dysfunction 109.37 18.02 74 42024 14595 90571754
Arthropathy 107.58 18.02 20 42078 366222 90220127
Lymphangiosis carcinomatosa 106.75 18.02 37 42061 1635 90584714
Polyneuropathy 106.16 18.02 81 42017 19260 90567089
Therapeutic product effect decreased 104.71 18.02 6 42092 277565 90308784
Abdominal discomfort 103.74 18.02 46 42052 477282 90109067
Contusion 102.86 18.02 3 42095 251213 90335136
Treatment failure 102.31 18.02 11 42087 303917 90282432
Fall 102.28 18.02 48 42050 481762 90104587
Pruritus 99 18.02 65 42033 541460 90044889
Vasogenic cerebral oedema 95.90 18.02 32 42066 1258 90585091
Immune-mediated hypophysitis 95.55 18.02 26 42072 501 90585848
Device related thrombosis 95.01 18.02 36 42062 2057 90584292
Metastases to skin 94.23 18.02 36 42062 2104 90584245
Drug ineffective 94.06 18.02 330 41768 1383968 89202381
Pneumocystis jirovecii pneumonia 94.06 18.02 79 42019 21537 90564812
Administration site extravasation 93.39 18.02 31 42067 1199 90585150
Drug hypersensitivity 91.21 18.02 51 42047 463558 90122791
Neutropenic sepsis 90.97 18.02 72 42026 18058 90568291
Aortitis 90.56 18.02 31 42067 1319 90585030
Immune-mediated hypothyroidism 89.99 18.02 32 42066 1526 90584823
Mobility decreased 89.93 18.02 7 42091 250727 90335622
Platelet count decreased 88.36 18.02 196 41902 136773 90449576
Urticaria 85.80 18.02 20 42078 312714 90273635
Pneumonitis 85.40 18.02 104 41994 44066 90542283
Product use issue 84.95 18.02 24 42074 329895 90256454
Nasopharyngitis 82.67 18.02 43 42055 407061 90179288
Musculoskeletal stiffness 81.27 18.02 19 42079 296513 90289836
Sinusitis 81.16 18.02 29 42069 343059 90243290
Granulocytopenia 80.00 18.02 45 42053 6396 90579953
Hypertension 79.49 18.02 58 42040 457474 90128875
Wheezing 79.14 18.02 9 42089 238071 90348278
Neurotoxicity 78.38 18.02 71 42027 21396 90564953
Folliculitis 78.36 18.02 4 42094 204349 90382000
Metastases to central nervous system 78.16 18.02 65 42033 17477 90568872
Thyroiditis 75.83 18.02 36 42062 3601 90582748
Decreased appetite 73.74 18.02 358 41740 376182 90210167
Contraindicated product administered 72.47 18.02 29 42069 320110 90266239
Type 2 diabetes mellitus 69.29 18.02 7 42091 203237 90383112
Pericarditis 68.89 18.02 20 42078 270131 90316218
Osteoarthritis 68.70 18.02 6 42092 195724 90390625
Hormone receptor positive breast cancer 68.68 18.02 22 42076 759 90585590
Confusional state 67.01 18.02 49 42049 386156 90200193
Transaminases increased 66.17 18.02 84 42014 37108 90549241
Pleural effusion 65.28 18.02 154 41944 111837 90474512
Hypersensitivity 65.25 18.02 69 42029 454608 90131741
Arthritis 65.02 18.02 3 42095 167312 90419037
Metastases to pleura 64.35 18.02 27 42071 2017 90584332
Migraine 63.76 18.02 7 42091 190385 90395964
Impaired healing 62.22 18.02 16 42082 234183 90352166
Troponin I increased 61.70 18.02 28 42070 2527 90583822
Arthralgia 61.50 18.02 173 41925 778349 89808000
Myocarditis 61.19 18.02 51 42047 13755 90572594
Extravasation 60.76 18.02 29 42069 2935 90583414
Ovarian failure 59.53 18.02 24 42074 1619 90584730
Metastases to chest wall 59.41 18.02 19 42079 652 90585697
Hypertransaminasaemia 59.08 18.02 53 42045 15772 90570577
Initial insomnia 57.82 18.02 42 42056 9268 90577081
Skin toxicity 57.33 18.02 37 42061 6742 90579607
Infusion related reaction 56.77 18.02 66 42032 416714 90169635
Peripheral swelling 56.72 18.02 65 42033 413041 90173308
Acute leukaemia 55.84 18.02 21 42077 1175 90585174
Hyperpyrexia 55.73 18.02 32 42066 4729 90581620
Hydrothorax 55.09 18.02 20 42078 1013 90585336
Chemotherapy 53.75 18.02 23 42075 1804 90584545
Rash 53.66 18.02 190 41908 795910 89790439
Depression 53.62 18.02 37 42061 300564 90285785
Blister 53.13 18.02 26 42072 254972 90331377
Acute lymphocytic leukaemia 52.77 18.02 26 42072 2822 90583527
Gait inability 52.75 18.02 4 42094 146452 90439897
Hypothyroidism 52.48 18.02 91 42007 53036 90533313
Immune-mediated hyperthyroidism 51.97 18.02 15 42083 361 90585988
Left ventricular dilatation 51.45 18.02 17 42081 648 90585701
Hemianopia 50.86 18.02 23 42075 2059 90584290
Troponin increased 50.61 18.02 45 42053 13236 90573113
Somnolence 50.57 18.02 17 42081 209067 90377282
Lower respiratory tract infection 50.07 18.02 27 42071 250632 90335717
Neurological symptom 49.75 18.02 34 42064 6813 90579536
Metastases to the mediastinum 47.66 18.02 16 42082 641 90585708
Laryngopharyngitis 47.04 18.02 10 42088 62 90586287
Anxiety 46.70 18.02 45 42053 309727 90276622
Hypophysitis 46.67 18.02 23 42075 2497 90583852
Immune-mediated hepatitis 46.14 18.02 24 42074 2920 90583429
Loss of personal independence in daily activities 45.58 18.02 5 42093 136100 90450249
Ill-defined disorder 44.77 18.02 15 42083 184876 90401473
Influenza 44.46 18.02 6 42092 139258 90447091
Pericardial effusion 44.36 18.02 69 42029 36764 90549585
Septic shock 43.99 18.02 111 41987 84049 90502300
Neutropenic colitis 43.62 18.02 26 42072 4117 90582232
Psoriasis 43.48 18.02 8 42090 147746 90438603
Invasive ductal breast carcinoma 43.47 18.02 33 42065 7785 90578564
Systemic scleroderma 43.46 18.02 19 42079 1570 90584779
Overdose 43.39 18.02 10 42088 157699 90428650
Systolic dysfunction 43.26 18.02 20 42078 1884 90584465
N-terminal prohormone brain natriuretic peptide increased 43.16 18.02 23 42075 2939 90583410
Hepatic failure 43.15 18.02 71 42027 39657 90546692
Xerophthalmia 43.14 18.02 15 42083 669 90585680
Hepatic enzyme increased 43.07 18.02 63 42035 360673 90225676
White blood cell count abnormal 42.44 18.02 32 42066 7472 90578877
Blood creatine increased 42.29 18.02 31 42067 6936 90579413
PIK3CA-activated mutation 41.61 18.02 17 42081 1187 90585162
Subclavian vein thrombosis 41.25 18.02 20 42078 2096 90584253
Drug-induced liver injury 40.98 18.02 113 41985 90205 90496144
Menopausal disorder 40.79 18.02 9 42089 68 90586281
Acute interstitial pneumonitis 40.50 18.02 15 42083 804 90585545
Night sweats 40.05 18.02 6 42092 128760 90457589
Miller Fisher syndrome 39.94 18.02 10 42088 137 90586212
Adverse drug reaction 39.81 18.02 4 42094 116697 90469652
C-reactive protein abnormal 39.49 18.02 6 42092 127423 90458926
Leukaemia cutis 39.47 18.02 10 42088 144 90586205
Drug intolerance 39.45 18.02 94 42004 447497 90138852
Acute promyelocytic leukaemia 39.22 18.02 16 42082 1113 90585236
Pain in extremity 38.62 18.02 96 42002 450433 90135916
Metastases to meninges 38.18 18.02 23 42075 3712 90582637
Malignant pleural effusion 37.60 18.02 21 42077 2943 90583406
Hospitalisation 37.56 18.02 7 42091 128093 90458256
Therapeutic product effect incomplete 37.11 18.02 22 42076 193874 90392475
Diarrhoea 37.11 18.02 627 41471 938563 89647786
Osteonecrosis of jaw 36.06 18.02 65 42033 39038 90547311
Gastrointestinal necrosis 35.95 18.02 21 42077 3204 90583145
Urinary tract infection 35.86 18.02 54 42044 305578 90280771
Tumour marker increased 35.62 18.02 26 42072 5781 90580568
Recurrent cancer 35.56 18.02 19 42079 2440 90583909
Human herpesvirus 6 infection 34.74 18.02 21 42077 3411 90582938
Left ventricular failure 34.45 18.02 27 42071 6673 90579676
Female sexual dysfunction 34.35 18.02 8 42090 79 90586270
Activated PI3 kinase delta syndrome 34.26 18.02 8 42090 80 90586269
Adrenocorticotropic hormone deficiency 34.10 18.02 13 42085 755 90585594
Mitral valve incompetence 34.09 18.02 47 42051 22477 90563872
Acute pulmonary oedema 33.63 18.02 31 42067 9549 90576800
Cytopenia 33.58 18.02 41 42057 17408 90568941
Lymphopenia 33.52 18.02 47 42051 22834 90563515
Weight decreased 33.29 18.02 80 42018 379830 90206519
Cardiac failure acute 33.23 18.02 34 42064 11895 90574454
Immune-mediated enterocolitis 33.10 18.02 23 42075 4734 90581615
Hyponatraemia 32.86 18.02 136 41962 133402 90452947
Metastases to soft tissue 32.78 18.02 10 42088 293 90586056
Gait disturbance 32.56 18.02 44 42054 260452 90325897
Hypopituitarism 32.47 18.02 16 42082 1737 90584612
Intentional product use issue 32.11 18.02 32 42066 216860 90369489
Gastrointestinal toxicity 32.01 18.02 30 42068 9437 90576912
Merycism 31.91 18.02 10 42088 321 90586028
Hepatocellular injury 31.78 18.02 52 42046 28906 90557443
Immune-mediated dermatitis 31.68 18.02 13 42085 918 90585431
Retinopathy 31.65 18.02 20 42078 3514 90582835
Lymphoma 31.27 18.02 35 42063 13556 90572793
Feeling abnormal 30.58 18.02 20 42078 167215 90419134
Blood pressure increased 30.47 18.02 28 42070 197189 90389160
Condition aggravated 30.31 18.02 158 41940 595387 89990962
Muscle spasms 30.03 18.02 44 42054 251839 90334510
Necrotising fasciitis 29.94 18.02 20 42078 3860 90582489
Ultrasound foetal abnormal 29.86 18.02 8 42090 145 90586204
Hot flush 29.57 18.02 77 42021 59411 90526938
Metastases to thorax 29.20 18.02 9 42089 273 90586076
Osteoporosis 28.89 18.02 5 42093 96526 90489823
Anal erythema 28.62 18.02 9 42089 292 90586057
Neutrophil toxic granulation present 28.62 18.02 8 42090 171 90586178
Polyneuropathy in malignant disease 28.37 18.02 7 42091 90 90586259
Metastatic neoplasm 28.27 18.02 21 42077 4794 90581555
Intentional product misuse 28.27 18.02 4 42094 89600 90496749
Asthma 28.19 18.02 43 42055 242117 90344232
Acute respiratory distress syndrome 28.15 18.02 49 42049 28637 90557712
Menopause 27.77 18.02 18 42080 3303 90583046
Tympanic membrane disorder 27.66 18.02 8 42090 194 90586155
Dyspepsia 27.35 18.02 31 42067 198129 90388220
Immune-mediated myocarditis 27.27 18.02 13 42085 1312 90585037
Injection site reaction 27.06 18.02 5 42093 92075 90494274
Wound infection 26.88 18.02 8 42090 106394 90479955
Musculoskeletal pain 26.83 18.02 24 42074 171227 90415122
Headache 26.79 18.02 264 41834 862482 89723867
Axillary lymphadenectomy 26.72 18.02 7 42091 116 90586233
Injection site phlebitis 26.49 18.02 7 42091 120 90586229
Injection site pain 26.43 18.02 25 42073 173674 90412675
Immune-mediated hepatic disorder 26.35 18.02 14 42084 1778 90584571
Catheter site bruise 26.34 18.02 10 42088 574 90585775
Delirium 26.08 18.02 8 42090 104351 90481998
SAPHO syndrome 25.77 18.02 7 42091 134 90586215
Hepatic cytolysis 25.51 18.02 49 42049 30867 90555482
Infusion site vesicles 25.46 18.02 10 42088 630 90585719
Tricuspid valve incompetence 25.45 18.02 35 42063 16696 90569653
Malaise 25.25 18.02 164 41934 585822 90000527
Myeloproliferative neoplasm 25.13 18.02 10 42088 652 90585697
Breast cancer 25.11 18.02 68 42030 53693 90532656
Joint range of motion decreased 25.10 18.02 16 42082 135627 90450722
Paraneoplastic syndrome 25.10 18.02 10 42088 654 90585695
Blepharitis 24.83 18.02 18 42080 3958 90582391
Suicide attempt 24.66 18.02 3 42095 75396 90510953
Precursor T-lymphoblastic lymphoma/leukaemia 24.47 18.02 6 42092 75 90586274
Portal hypertension 24.29 18.02 19 42079 4682 90581667
Deafness 24.13 18.02 40 42058 22474 90563875
Dysgeusia 24.07 18.02 66 42032 52494 90533855
Pneumonia 23.87 18.02 186 41912 637873 89948476
Administration site oedema 23.66 18.02 5 42093 30 90586319
Insomnia 23.46 18.02 78 42020 333396 90252953
Dysentery 23.45 18.02 11 42087 1071 90585278
Bronchitis 23.28 18.02 22 42076 152905 90433444
Wrong technique in product usage process 23.04 18.02 3 42095 71568 90514781
Hypokalaemia 23.01 18.02 121 41977 130995 90455354
Gait apraxia 22.87 18.02 5 42093 36 90586313
Hand dermatitis 22.67 18.02 9 42089 583 90585766
Dandy-Walker syndrome 22.43 18.02 6 42092 108 90586241
Post embolisation syndrome 22.31 18.02 4 42094 8 90586341
Oxygen saturation decreased 22.31 18.02 11 42087 107472 90478877
B-cell type acute leukaemia 22.28 18.02 9 42089 610 90585739
Triple negative breast cancer 22.21 18.02 8 42090 396 90585953
Brachydactyly 22.21 18.02 7 42091 229 90586120
Medication error 22.06 18.02 6 42092 84646 90501703
Unwanted pregnancy 21.93 18.02 6 42092 118 90586231
Vision blurred 21.83 18.02 12 42086 110281 90476068
Organising pneumonia 21.79 18.02 22 42076 7575 90578774
Live birth 21.79 18.02 5 42093 79102 90507247
Myocardial fibrosis 21.76 18.02 10 42088 929 90585420
Neurodevelopmental disorder 21.73 18.02 7 42091 246 90586103
Incorrect dose administered 21.71 18.02 5 42093 78925 90507424
Mastectomy 21.65 18.02 13 42085 2086 90584263
Adrenocortical insufficiency acute 21.51 18.02 14 42084 2587 90583762
Hypercholesterolaemia 21.44 18.02 10 42088 100882 90485467
Endocardial fibrosis 21.42 18.02 4 42094 11 90586338
Product use in unapproved indication 21.42 18.02 82 42016 336154 90250195
Nail disorder 21.17 18.02 68 42030 58999 90527350
Epistaxis 21.17 18.02 87 42011 85038 90501311
Pulmonary imaging procedure abnormal 21.16 18.02 4 42094 12 90586337
Acute kidney injury 21.15 18.02 77 42021 320310 90266039
Rash pruritic 21.10 18.02 6 42092 82208 90504141
Neutrophilia 20.87 18.02 19 42079 5759 90580590
Paraesthesia 20.64 18.02 192 41906 250134 90336215
Inflammation 20.51 18.02 32 42066 178560 90407789
Acute monocytic leukaemia 20.28 18.02 6 42092 158 90586191
Arachnoid cyst 20.27 18.02 7 42091 306 90586043
Hyperthyroidism 20.26 18.02 33 42065 18277 90568072
Exposure during pregnancy 20.24 18.02 51 42047 238359 90347990
Cardiac failure congestive 20.09 18.02 95 42003 98599 90487750
Peripheral venous disease 19.97 18.02 7 42091 83914 90502435
Heart rate increased 19.97 18.02 14 42084 112888 90473461
Respiratory failure 19.91 18.02 108 41990 118310 90468039
Foetal growth restriction 19.63 18.02 23 42075 9357 90576992
Myelodysplastic syndrome 19.60 18.02 35 42063 20868 90565481
Breast conserving surgery 19.55 18.02 10 42088 1175 90585174
Lymphatic obstruction 19.54 18.02 4 42094 20 90586329
Colitis 19.42 18.02 74 42024 69868 90516481
Lichenoid keratosis 19.40 18.02 13 42085 2521 90583828
Vena cava thrombosis 19.32 18.02 13 42085 2539 90583810
Alanine aminotransferase increased 19.27 18.02 107 41991 118231 90468118
Lymphocyte count decreased 19.12 18.02 47 42051 35003 90551346
Neck pain 19.04 18.02 15 42083 113948 90472401
Mucosal dryness 19.02 18.02 14 42084 3153 90583196
Chronic myeloid leukaemia 18.81 18.02 13 42085 2651 90583698
CSF volume increased 18.79 18.02 4 42094 25 90586324
Discomfort 18.72 18.02 65 42033 274270 90312079
Pseudocirrhosis 18.63 18.02 9 42089 935 90585414
Chest discomfort 18.61 18.02 119 41979 138246 90448103
Hepatitis B 18.60 18.02 16 42082 4503 90581846
Maternal exposure during pregnancy 18.58 18.02 95 42003 359968 90226381
Leukocytosis 18.46 18.02 43 42055 30947 90555402
Acute myelomonocytic leukaemia 18.43 18.02 6 42092 218 90586131
Cardiac perfusion defect 18.40 18.02 4 42094 28 90586321
Amnestic disorder 18.32 18.02 7 42091 409 90585940
Fluid retention 18.30 18.02 9 42089 88082 90498267
Hypocalcaemia 18.22 18.02 52 42046 42316 90544033
Respiratory disorder 18.04 18.02 4 42094 64812 90521537

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
Myelosuppression 709.11 27.12 258 6426 40203 42574448
Bone marrow failure 247.40 27.12 115 6569 32978 42581673
Hepatic artery stenosis 130.98 27.12 23 6661 159 42614492
Anastomotic leak 113.71 27.12 26 6658 748 42613903
Disease progression 94.00 27.12 114 6570 143542 42471109
Neutropenia 82.94 27.12 127 6557 199304 42415347
White blood cell count decreased 71.14 27.12 87 6597 110309 42504342
Off label use 70.57 27.12 239 6445 638096 41976555
Neutrophil count decreased 65.32 27.12 64 6620 63351 42551300
Hepatic function abnormal 64.55 27.12 58 6626 51509 42563142
Delayed puberty 63.53 27.12 13 6671 218 42614433
Granulocyte count decreased 59.53 27.12 18 6666 1552 42613099
Body height below normal 57.13 27.12 12 6672 230 42614421
Carbohydrate antigen 15-3 increased 50.43 27.12 9 6675 69 42614582
Neutropenic sepsis 49.60 27.12 31 6653 15915 42598736
Intestinal atresia 49.14 27.12 9 6675 81 42614570
Ameloblastoma 47.10 27.12 9 6675 104 42614547
Hepatic artery occlusion 41.51 27.12 8 6676 97 42614554
Oligohydramnios 40.66 27.12 10 6674 395 42614256
Mucosal inflammation 40.29 27.12 44 6640 49330 42565321
Liver abscess 39.31 27.12 18 6666 4952 42609699
Vascular pseudoaneurysm 38.89 27.12 15 6669 2697 42611954
Chemical cystitis 38.81 27.12 5 6679 0 42614651
Idiosyncratic drug reaction 38.07 27.12 10 6674 516 42614135
Malignant neoplasm progression 38.01 27.12 64 6620 108336 42506315
Focal nodular hyperplasia 37.57 27.12 8 6676 164 42614487
Extravasation 37.07 27.12 14 6670 2376 42612275
Foetal growth abnormality 36.34 27.12 6 6678 27 42614624
Thrombocytopenia 36.18 27.12 87 6597 190192 42424459
Hyperammonaemic encephalopathy 35.13 27.12 14 6670 2744 42611907
Basal cell naevus syndrome 34.90 27.12 6 6678 36 42614615
Interstitial lung disease 33.93 27.12 51 6633 78411 42536240
Bladder perforation 32.43 27.12 8 6676 320 42614331
Polyneuropathy 31.59 27.12 25 6659 18636 42596015
Hypersensitivity 31.23 27.12 47 6637 72323 42542328
Post embolisation syndrome 30.96 27.12 6 6678 75 42614576
Pyrexia 30.35 27.12 132 6552 393910 42220741
Infection 30.16 27.12 59 6625 112009 42502642
Renal hypoplasia 29.08 27.12 6 6678 105 42614546
Liver injury 28.92 27.12 24 6660 19124 42595527
Leukopenia 28.70 27.12 46 6638 74700 42539951

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
Myelosuppression 2239.06 17.14 968 42399 93372 110452560
White blood cell count decreased 1153.45 17.14 849 42518 228541 110317391
Agranulocytosis 983.22 17.14 481 42886 61279 110484653
Neutropenia 707.72 17.14 800 42567 373820 110172112
Bone marrow failure 642.61 17.14 354 43013 57494 110488438
Febrile neutropenia 617.59 17.14 688 42679 316079 110229853
Hepatic function abnormal 576.85 17.14 386 42981 88909 110457023
Neutrophil count decreased 540.71 17.14 418 42949 120523 110425409
Leukopenia 380.33 17.14 374 42993 148417 110397515
Metastases to bone 350.99 17.14 193 43174 31179 110514753
Malignant neoplasm progression 325.51 17.14 371 42996 174196 110371736
Acute myeloid leukaemia 310.96 17.14 191 43176 37919 110508013
Cardiac dysfunction 277.58 17.14 101 43266 6122 110539810
Congestive cardiomyopathy 275.71 17.14 127 43240 14092 110531840
Nausea 274.30 17.14 1080 42287 1234610 109311322
Ejection fraction decreased 271.66 17.14 180 43187 40700 110505232
Febrile bone marrow aplasia 239.24 17.14 123 43244 17342 110528590
Metastases to lung 231.07 17.14 132 43235 22931 110523001
Neoplasm progression 230.70 17.14 196 43171 64399 110481533
Metastases to liver 216.40 17.14 148 43219 35238 110510694
Cardiac failure 215.88 17.14 314 43053 187312 110358620
Second primary malignancy 215.51 17.14 116 43251 17952 110527980
Cardiotoxicity 211.53 17.14 112 43255 16769 110529163
Granulocyte count decreased 209.43 17.14 73 43294 3901 110542031
Vomiting 207.10 17.14 803 42564 909872 109636060
Asthenia 200.52 17.14 659 42708 688340 109857592
Palmar-plantar erythrodysaesthesia syndrome 190.09 17.14 145 43222 40880 110505052
Pyrexia 177.83 17.14 759 42608 897506 109648426
Disease progression 174.84 17.14 330 43037 243704 110302228
Mucosal inflammation 168.40 17.14 198 43169 95943 110449989
Metastases to lymph nodes 164.03 17.14 91 43276 14941 110530991
Breast cancer recurrent 147.95 17.14 56 43311 3790 110542142
Neuropathy peripheral 146.85 17.14 257 43110 179020 110366912
Immune-mediated adrenal insuficiency 139.04 17.14 44 43323 1736 110544196
Ventricular dysfunction 136.02 17.14 64 43303 7447 110538485
Neutropenic sepsis 125.82 17.14 101 43266 30645 110515287
Therapy partial responder 125.26 17.14 109 43258 36952 110508980
Interstitial lung disease 123.63 17.14 207 43160 139127 110406805
Haematotoxicity 121.42 17.14 85 43282 20997 110524935
Hepatic artery stenosis 120.81 17.14 27 43340 263 110545669
Cardiomyopathy 118.17 17.14 101 43266 33424 110512508
Colony stimulating factor therapy 113.68 17.14 30 43337 612 110545320
Fall 112.49 17.14 48 43319 603434 109942498
Breast cancer metastatic 109.32 17.14 63 43304 11118 110534814
Thrombocytopenia 108.64 17.14 342 43025 348543 110197389
Product dose omission issue 108.55 17.14 4 43363 321778 110224154
Pancytopenia 108.38 17.14 248 43119 209365 110336567
Anaemia 105.33 17.14 459 42908 546627 109999305
Radiotherapy 104.81 17.14 34 43333 1454 110544478
Joint swelling 104.43 17.14 23 43344 442822 110103110
Rheumatoid arthritis 96.85 17.14 5 43362 299608 110246324
Administration site extravasation 95.90 17.14 33 43334 1696 110544236
Lymphangiosis carcinomatosa 94.97 17.14 36 43331 2446 110543486
Platelet count decreased 94.04 17.14 249 43118 230194 110315738
Synovitis 93.87 17.14 3 43364 274089 110271843
Diffuse large B-cell lymphoma recurrent 91.01 17.14 46 43321 6253 110539679
Weight increased 90.81 17.14 26 43341 419618 110126314
Metastases to skin 90.34 17.14 34 43333 2265 110543667
Extravasation 86.86 17.14 41 43326 4804 110541128
Polyneuropathy 86.39 17.14 83 43284 31929 110514003
Pruritus 85.62 17.14 62 43305 581498 109964434
Vasogenic cerebral oedema 83.69 17.14 32 43335 2226 110543706
Device related thrombosis 83.37 17.14 36 43331 3426 110542506
Swelling 83.21 17.14 18 43349 351023 110194909
Systemic lupus erythematosus 82.98 17.14 4 43363 254334 110291598
Aortitis 79.90 17.14 30 43337 1985 110543947
Arthropathy 78.65 17.14 10 43357 287512 110258420
Contusion 78.35 17.14 3 43364 233358 110312574
Immune-mediated hypothyroidism 76.20 17.14 32 43335 2843 110543089
Anastomotic leak 75.75 17.14 26 43341 1326 110544606
Immune-mediated hypophysitis 75.59 17.14 24 43343 957 110544975
Decreased appetite 75.16 17.14 377 42990 475469 110070463
Ovarian failure 71.60 17.14 23 43344 953 110544979
Metastases to chest wall 71.09 17.14 21 43346 655 110545277
Wheezing 69.50 17.14 9 43358 255221 110290711
Urticaria 68.51 17.14 20 43347 318837 110227095
Pneumocystis jirovecii pneumonia 68.21 17.14 84 43283 42651 110503281
Mobility decreased 68.08 17.14 7 43360 237415 110308517
Therapeutic product effect decreased 68.03 17.14 8 43359 244308 110301624
Somnolence 67.02 17.14 17 43350 297432 110248500
Wound 64.48 17.14 8 43359 234429 110311503
Metastases to central nervous system 63.16 17.14 60 43307 22757 110523175
Musculoskeletal stiffness 63.03 17.14 16 43351 279806 110266126
Pain 62.32 17.14 181 43186 954774 109591158
Hypertension 62.17 17.14 65 43302 510019 110035913
Thyroiditis 61.51 17.14 36 43331 6537 110539395
Granulocytopenia 61.22 17.14 46 43321 12669 110533263
Nasopharyngitis 60.71 17.14 40 43327 394321 110151611
Drug hypersensitivity 59.82 17.14 54 43313 454036 110091896
Confusional state 59.08 17.14 58 43309 468622 110077310
Overdose 57.43 17.14 11 43356 233783 110312149
Hyperpyrexia 57.16 17.14 37 43330 8032 110537900
Treatment failure 56.67 17.14 19 43348 277215 110268717
Hydrothorax 56.13 17.14 22 43345 1636 110544296
Glossodynia 55.49 17.14 10 43357 221994 110323938
Initial insomnia 55.46 17.14 40 43327 10349 110535583
Left ventricular dysfunction 54.31 17.14 56 43311 23437 110522495
Osteoarthritis 53.36 17.14 5 43362 182618 110363314
Drug interaction 53.18 17.14 71 43296 500112 110045820
Abdominal discomfort 52.87 17.14 46 43321 393812 110152120
White blood cell count abnormal 52.21 17.14 33 43334 6876 110539056
Metastasis 51.53 17.14 35 43332 8232 110537700
Sinusitis 51.48 17.14 26 43341 296662 110249270
Metastases to the mediastinum 51.34 17.14 17 43350 776 110545156
Chemotherapy 50.65 17.14 22 43345 2124 110543808
Acute kidney injury 50.28 17.14 109 43258 635321 109910611
Acute promyelocytic leukaemia 49.91 17.14 21 43346 1875 110544057
Arthralgia 48.49 17.14 151 43216 779481 109766451
Drug ineffective 47.93 17.14 375 42992 1520165 109025767
Neutropenic colitis 47.56 17.14 33 43334 8032 110537900
Immune-mediated hyperthyroidism 46.89 17.14 15 43352 613 110545319
Menopausal disorder 46.55 17.14 9 43358 39 110545893
Depression 46.42 17.14 34 43333 317301 110228631
Drug-induced liver injury 45.18 17.14 126 43241 119941 110425991
Diarrhoea 44.79 17.14 660 42707 1138845 109407087
Hemianopia 44.55 17.14 22 43345 2846 110543086
Migraine 44.51 17.14 7 43360 171645 110374287
Transaminases increased 44.41 17.14 85 43282 63305 110482627
Anxiety 44.28 17.14 42 43325 345036 110200896
Influenza 43.61 17.14 7 43360 169094 110376838
Laryngopharyngitis 43.47 17.14 10 43357 112 110545820
Carbohydrate antigen 15-3 increased 43.19 17.14 18 43349 1569 110544363
Systemic scleroderma 42.61 17.14 19 43348 1953 110543979
Type 2 diabetes mellitus 42.15 17.14 9 43358 177223 110368709
Hypothyroidism 41.85 17.14 90 43277 72809 110473123
Infusion related reaction 41.63 17.14 53 43314 381109 110164823
Loss of personal independence in daily activities 41.54 17.14 5 43362 150015 110395917
Troponin I increased 41.10 17.14 26 43341 5426 110540506
Xerophthalmia 40.79 17.14 15 43352 936 110544996
Pericarditis 39.84 17.14 18 43349 219096 110326836
Ameloblastoma 38.87 17.14 9 43358 104 110545828
Hospitalisation 38.84 17.14 5 43362 142488 110403444
Rash 38.70 17.14 178 43189 820786 109725146
Blood pressure increased 38.68 17.14 27 43340 258346 110287586
Myocarditis 38.49 17.14 53 43314 30002 110515930
Liver injury 38.36 17.14 138 43229 150275 110395657
Recurrent cancer 38.10 17.14 21 43346 3402 110542530
Intentional product misuse 37.88 17.14 4 43363 132900 110413032
Intestinal atresia 37.20 17.14 8 43359 64 110545868
Folliculitis 36.95 17.14 10 43357 167643 110378289
Bursitis 36.79 17.14 4 43363 129914 110416018
Gait inability 36.66 17.14 5 43362 136371 110409561
Leukaemia cutis 36.55 17.14 10 43357 235 110545697
Hepatic failure 36.22 17.14 82 43285 68657 110477275
Impaired healing 36.02 17.14 16 43351 196701 110349231
Mitral valve incompetence 35.70 17.14 54 43313 33275 110512657
Peripheral swelling 35.63 17.14 65 43302 403969 110141963
Neurotoxicity 35.14 17.14 61 43306 42146 110503786
Brachydactyly 34.90 17.14 7 43360 38 110545894
Ultrasound foetal abnormal 34.83 17.14 8 43359 89 110545843
Acute interstitial pneumonitis 34.70 17.14 15 43352 1431 110544501
Post embolisation syndrome 34.27 17.14 8 43359 96 110545836
Gastrointestinal toxicity 34.10 17.14 31 43336 11117 110534815
Hypophysitis 33.93 17.14 23 43344 5392 110540540
Hepatic artery occlusion 33.47 17.14 8 43359 107 110545825
Product use issue 33.35 17.14 44 43323 311651 110234281
Delayed puberty 33.25 17.14 9 43358 203 110545729
Blood creatine increased 33.23 17.14 31 43336 11490 110534442
Merycism 32.88 17.14 10 43357 345 110545587
Miller Fisher syndrome 32.83 17.14 10 43357 347 110545585
Dysphagia 32.65 17.14 133 43234 153467 110392465
Feeling abnormal 32.61 17.14 15 43352 180696 110365236
Contraindicated product administered 32.09 17.14 30 43337 248237 110297695
C-reactive protein abnormal 32.06 17.14 6 43361 129689 110416243
Hormone receptor positive breast cancer 31.95 17.14 11 43356 566 110545366
Immune-mediated hepatitis 31.69 17.14 24 43343 6687 110539245
Bladder irritation 31.59 17.14 10 43357 395 110545537
Psoriasis 31.52 17.14 8 43359 139985 110405947
Night sweats 31.46 17.14 7 43360 133976 110411956
Chemical cystitis 31.28 17.14 5 43362 4 110545928
Pneumonia 30.99 17.14 209 43158 876505 109669427
Retinopathy 30.61 17.14 20 43347 4409 110541523
Acute lymphocytic leukaemia 30.32 17.14 22 43345 5743 110540189
Oligohydramnios 29.99 17.14 19 43348 3975 110541957
Hepatitis B 29.94 17.14 27 43340 9585 110536347
Breast cancer 29.89 17.14 54 43313 38488 110507444
Suicide attempt 29.75 17.14 3 43364 103391 110442541
Paraesthesia 29.75 17.14 198 43169 276323 110269609
Acute pulmonary oedema 29.72 17.14 35 43332 16961 110528971
Bradycardia 29.50 17.14 12 43355 155505 110390427
Basal cell naevus syndrome 29.41 17.14 6 43361 36 110545896
Axillary lymphadenectomy 29.40 17.14 7 43360 92 110545840
Joint range of motion decreased 29.35 17.14 6 43361 121826 110424106
Pain in extremity 29.07 17.14 96 43271 487022 110058910
Muscle spasms 29.01 17.14 40 43327 278117 110267815
Tympanic membrane disorder 28.96 17.14 8 43359 195 110545737
Adrenocorticotropic hormone deficiency 28.82 17.14 15 43352 2167 110543765
Unwanted pregnancy 28.73 17.14 6 43361 41 110545891
Left ventricular dilatation 28.50 17.14 13 43354 1409 110544523
Osteonecrosis of jaw 28.38 17.14 60 43307 47957 110497975
Ill-defined disorder 28.33 17.14 13 43354 156840 110389092
Lymphopenia 28.30 17.14 54 43313 40116 110505816
Adverse drug reaction 28.06 17.14 4 43363 105555 110440377
Metastases to meninges 27.96 17.14 20 43347 5108 110540824
Catheter site bruise 27.88 17.14 10 43357 581 110545351
Toxicity to various agents 27.80 17.14 96 43271 480459 110065473
Organising pneumonia 27.72 17.14 31 43336 14212 110531720
Musculoskeletal pain 27.55 17.14 19 43348 183004 110362928
Pneumonitis 27.50 17.14 79 43288 76452 110469480
Pleural effusion 27.41 17.14 140 43227 177569 110368363
Troponin increased 27.41 17.14 45 43322 29721 110516211
Neutrophil toxic granulation present 27.38 17.14 8 43359 240 110545692
Infusion site vesicles 27.18 17.14 10 43357 625 110545307
Metastases to heart 26.92 17.14 9 43358 423 110545509
Pseudocirrhosis 26.92 17.14 11 43356 912 110545020
Metastases to pleura 26.73 17.14 14 43353 2049 110543883
Liver abscess 26.62 17.14 23 43344 7716 110538216
Blister 26.53 17.14 30 43337 227346 110318586
Gastrointestinal disorder 26.47 17.14 174 43193 241778 110304154
Lymphoma 26.47 17.14 36 43331 20135 110525797
Delirium 26.30 17.14 10 43357 135015 110410917
Injection site phlebitis 26.07 17.14 7 43360 153 110545779
Metastases to soft tissue 25.97 17.14 10 43357 709 110545223
Cytopenia 25.69 17.14 44 43323 30072 110515860
Breast mass 25.62 17.14 23 43344 8118 110537814
Gastrointestinal necrosis 25.45 17.14 21 43346 6619 110539313
Neurological symptom 25.42 17.14 31 43336 15577 110530355
Blepharitis 25.39 17.14 18 43349 4534 110541398
Septic shock 24.92 17.14 125 43242 157403 110388529
N-terminal prohormone brain natriuretic peptide increased 24.81 17.14 20 43347 6101 110539831
Weight decreased 24.77 17.14 97 43270 467960 110077972
Therapeutic product effect incomplete 24.54 17.14 31 43336 223774 110322158
Hypertransaminasaemia 24.15 17.14 38 43329 24217 110521715
Administration site oedema 24.09 17.14 5 43362 33 110545899
Hepatocellular injury 24.04 17.14 58 43309 50584 110495348
Bladder perforation 23.73 17.14 8 43359 386 110545546
Breast conserving surgery 23.72 17.14 10 43357 897 110545035
Insomnia 23.68 17.14 68 43299 360522 110185410
Hypokalaemia 23.60 17.14 137 43230 182311 110363621
Cardiac perfusion defect 23.60 17.14 5 43362 37 110545895
Lymphocyte count decreased 23.46 17.14 62 43305 57181 110488751
Lower respiratory tract infection 23.35 17.14 37 43330 243069 110302863
Gait apraxia 23.25 17.14 5 43362 40 110545892
Alopecia 22.85 17.14 231 43136 364522 110181410
Acute myelomonocytic leukaemia 22.81 17.14 8 43359 435 110545497
Myocardial infarction 22.78 17.14 25 43342 192058 110353874
Dysentery 22.74 17.14 11 43356 1360 110544572
Left ventricular failure 22.53 17.14 25 43342 11364 110534568
Malignant pleural effusion 22.40 17.14 16 43351 4077 110541855
Dandy-Walker syndrome 22.07 17.14 5 43362 52 110545880
Hand dermatitis 22.07 17.14 9 43358 742 110545190
Precursor T-lymphoblastic lymphoma/leukaemia 22.05 17.14 6 43361 138 110545794
Medication error 21.90 17.14 7 43360 105359 110440573
Skin toxicity 21.83 17.14 25 43342 11758 110534174
Urinary tract infection 21.82 17.14 61 43306 326221 110219711
Gait disturbance 21.73 17.14 48 43319 278160 110267772
Intentional product use issue 21.73 17.14 40 43327 247866 110298066
Mastectomy 21.73 17.14 11 43356 1500 110544432
Wrong technique in product usage process 21.67 17.14 4 43363 87344 110458588
Heart rate increased 21.56 17.14 15 43352 143819 110402113
Angioedema 21.47 17.14 6 43361 98494 110447438
Rash pruritic 21.32 17.14 6 43361 98063 110447869
Aspartate aminotransferase increased 21.27 17.14 121 43246 159815 110386117
Immune-mediated hepatic disorder 21.20 17.14 16 43351 4434 110541498
Hypoproteinaemia 21.13 17.14 18 43349 5927 110540005
Cerebrovascular accident 21.05 17.14 24 43343 181260 110364672
Nail disorder 21.00 17.14 60 43307 57875 110488057
Hyponatraemia 20.55 17.14 151 43216 217502 110328430
Focal nodular hyperplasia 20.38 17.14 9 43358 904 110545028
Dyspepsia 20.37 17.14 27 43340 190938 110354994
Malassezia infection 20.27 17.14 5 43362 77 110545855
Heart rate decreased 20.09 17.14 4 43363 82752 110463180
Metastases to muscle 20.01 17.14 7 43360 378 110545554
Immune-mediated myocarditis 19.90 17.14 14 43353 3484 110542448
Vascular pseudoaneurysm 19.82 17.14 15 43352 4175 110541757
Asthma 19.70 17.14 43 43324 250248 110295684
Incorrect dose administered 19.65 17.14 8 43359 103633 110442299
Acute leukaemia 19.64 17.14 11 43356 1838 110544094
Osteoporosis 19.58 17.14 5 43362 87147 110458785
Tumour marker increased 19.38 17.14 16 43351 5044 110540888
Tricuspid valve incompetence 19.22 17.14 34 43333 23839 110522093
Necrotising fasciitis 19.20 17.14 19 43348 7572 110538360
Hypopituitarism 19.20 17.14 15 43352 4375 110541557
Hepatic lesion 19.19 17.14 20 43347 8473 110537459
B-cell type acute leukaemia 19.15 17.14 10 43357 1454 110544478
Arterial thrombosis 18.95 17.14 13 43354 3106 110542826
Arachnoid cyst 18.94 17.14 7 43360 443 110545489
Oesophageal candidiasis 18.93 17.14 23 43344 11511 110534421
Hot flush 18.92 17.14 63 43304 65973 110479959
Idiosyncratic drug reaction 18.70 17.14 10 43357 1526 110544406
Vision blurred 18.62 17.14 14 43353 129008 110416924
Peripheral venous disease 18.56 17.14 5 43362 84112 110461820
Disease recurrence 18.32 17.14 59 43308 60725 110485207
Polyneuropathy in malignant disease 18.21 17.14 7 43360 494 110545438
Blood pressure systolic increased 18.19 17.14 5 43362 82986 110462946
Glucocorticoid deficiency 18.16 17.14 9 43358 1173 110544759
Soft tissue necrosis 18.05 17.14 9 43358 1189 110544743
Cardiac arrest 17.91 17.14 31 43336 196722 110349210
Mental status changes 17.82 17.14 4 43363 76118 110469814
Amenorrhoea 17.81 17.14 20 43347 9211 110536721
Chest discomfort 17.79 17.14 123 43244 173725 110372207
Malaise 17.79 17.14 173 43194 671646 109874286
Cardiac failure acute 17.74 17.14 33 43334 24045 110521887
Dysgeusia 17.65 17.14 64 43303 69921 110476011
Live birth 17.64 17.14 3 43364 69481 110476451
Ovarian necrosis 17.62 17.14 4 43363 42 110545890
Vena cava thrombosis 17.62 17.14 13 43354 3481 110542451
Carcinoma in situ 17.61 17.14 5 43362 135 110545797
Neutrophilia 17.61 17.14 21 43346 10308 110535624
Rhabdomyolysis 17.46 17.14 13 43354 120388 110425544
Adenocarcinoma 17.38 17.14 14 43353 4266 110541666
Portal hypertension 17.16 17.14 19 43348 8618 110537314

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01DB03 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
CYTOTOXIC ANTIBIOTICS AND RELATED SUBSTANCES
Anthracyclines and related substances
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

Related Drugs by ATC class:

L01DB Anthracyclines and related substances 10 drugs
aclarubicinamrubicindaunorubicindoxorubicinidarubicinmitoxantronepirarubicinpixantronevalrubicinzorubicin

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

DiseaseRelationSNOMED_IDDOID
Carcinoma of breast indication 254838004 DOID:3459
Diffuse non-Hodgkin's lymphoma, large cell off-label use 109969005
Hodgkin's disease off-label use 118599009
Osteosarcoma of bone off-label use 307576001 DOID:3376
Malignant tumor of stomach off-label use 363349007 DOID:10534
Metastatic Breast Carcinoma off-label use
Myocardial infarction contraindication 22298006 DOID:5844
Conduction disorder of the heart contraindication 44808001
Chronic heart failure contraindication 48447003
Hepatic failure contraindication 59927004
Stomatitis contraindication 61170000 DOID:9637
Acute infectious disease contraindication 63171007
Cardiomyopathy contraindication 85898001 DOID:0050700
Kidney disease contraindication 90708001 DOID:557
Disease of liver contraindication 235856003 DOID:409
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Breastfeeding (mother) contraindication 413712001
Life-Threatening Cardiac Arrhythmias contraindication
Severe Bone Marrow Depression 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 9.21 acidic
pKa3 9.92 acidic
pKa4 11.11 acidic
pKa5 8.6 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
DNA topoisomerase 2-alpha Enzyme IC50 8.52 CHEMBL
Tyrosine-protein kinase Fyn Kinase IC50 5.29 DRUG MATRIX
5-hydroxytryptamine receptor 4 GPCR Ki 5.88 DRUG MATRIX
NS3 Enzyme IC50 6.12 CHEMBL
Genome polyprotein Polyprotein IC50 6.12 CHEMBL

External reference:

IDSource
4021192 VUID
N0000148638 NUI
D02214 KEGG_DRUG
56390-09-1 SECONDARY_CAS_RN
4021192 VANDF
4021193 VANDF
C0014582 UMLSCUI
CHEBI:47898 CHEBI
DM6 PDB_CHEM_ID
CHEMBL417 ChEMBL_ID
CHEMBL1200981 ChEMBL_ID
D015251 MESH_DESCRIPTOR_UI
DB00445 DRUGBANK_ID
5171 INN_ID
3Z8479ZZ5X UNII
41867 PUBCHEM_CID
203213 RXNORM
8302 MMSL
90558 MMSL
d04454 MMSL
003716 NDDF
003717 NDDF
116108007 SNOMEDCT_US
349848009 SNOMEDCT_US
417916005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ellence HUMAN PRESCRIPTION DRUG LABEL 1 0009-5091 INJECTION, SOLUTION 2 mg INTRAVENOUS NDA 32 sections
Ellence HUMAN PRESCRIPTION DRUG LABEL 1 0009-5093 INJECTION, SOLUTION 2 mg INTRAVENOUS NDA 32 sections