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

Stem definitionDrug idCAS RN
tyrosine kinase inhibitors 4942 417716-92-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • E-7080
  • E 7080
  • lenvatinib
  • lenvima
  • ER-203492-00
  • E7080
  • lenvatinib mesylate
  • lenvatinib mesilate
a receptor tyrosine kinase (RTK) inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4)
  • Molecular weight: 426.86
  • Formula: C21H19ClN4O4
  • CLOGP: 3.05
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 3
  • TPSA: 115.57
  • ALOGS: -4.84
  • ROTB: 6
  • Status: ONP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
20 mg O

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 3.218 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 28.907 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 15.704 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 1.600 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 7.200 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 14.920 % High 1
herg hERG pIC50 4.662 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 1.439 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 3.327 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 2.440 % High 1
kinase-safety-class ABL1,ABL2,ACVR1B,ACVR2A,ACVR2B,ACVRL1,AKT1,ALK,AURKA,AURKB,AURKC,AXL,BLK,BMX,BRAF,BTK,CAMK2B,CAMK2D,CDK1,CDK16,CDK19,CDK7,CDK9,CSF1R,CSK,DDR1,EGFR,EIF2AK3,EPHA2,EPHB1,EPHB4,ERBB2,ERBB4,FGFR1,FGFR4,FLT1,FLT3,FLT4,FYN,GAK,GRK2,GSK3B,INSR,IRAK1,IRAK3,ITK,JAK1,JAK2,KDR,KIT,LCK,LYN,MAP2K1,MAP3K1,MAP3K10,MAP3K11,MAP3K14,MAP3K21,MAP3K7,MAP4K1,MAP4K2,MAP4K3,MAP4K5,MAPK10,MAPK12,MAPK14,MAPK7,MAPK9,MARK4,MET,MINK1,MST1R,MTOR,NTRK1,NTRK2,PAK4,PDGFRB,PDK1,PDK2,PDK4,PIK3CA,PIK3CD,PIK3CG,PRKCD,PRKDC,PTK6,RET,RIPK3,SIK2,SIK3,SRC,STK10,STK33,SYK,TEK,TGFBR1,TNIK,TTK,TYRO3,ULK1,ULK2,YES1 102
kinase-selectivity-class ABL2,ACVR1B,ACVR2B,ACVRL1,ALK,AURKA,AURKB,AURKC,AXL,BLK,BMX,BRAF,BTK,CDK9,CSF1R,CSK,DDR1,EGFR,EIF2AK3,EPHA2,EPHB4,ERBB2,ERBB4,FGFR1,FGFR4,FLT1,FLT3,FLT4,FYN,GAK,INSR,JAK1,KDR,KIT,LCK,LYN,MAP2K1,MAP3K1,MAP3K11,MAP3K21,MAP4K1,MAP4K3,MAP4K5,MAPK14,MAPK7,MARK4,MET,MINK1,MKNK2,MST1R,NTRK1,NTRK3,PDGFRB,PDK4,PIK3CD,PLK4,RET,RIPK3,SIK2,SRC,STK10,STK33,SYK,TEK,TGFBR1,TNIK,TTK,TYRO3,YES1 69
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 30.339 High 1
mh-clint Mouse hepatocyte intrinsic clearance 8.166 High 1
mppb Mouse plasma protein binding (% unbound) 2.940 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 26.546 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 8.340 % High 1
rh-clint Rat hepatocyte intrinsic clearance 5.117 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 37.870 % High 1
rppb Rat plasma protein binding (% unbound) 2.540 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 1.542 uM High 1

Approvals:

DateAgencyCompanyOrphan
March 26, 2015 PMDA Eisai Co., Ltd.
Feb. 13, 2015 FDA EISAI INC
May 28, 2015 EMA Eisai Europe Ltd

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
Malignant neoplasm progression 4518.31 25.91 1700 37306 105170 90484271
Hypertension 2885.15 25.91 2004 37002 455528 90133913
Hypothyroidism 2677.09 25.91 964 38042 52163 90537278
Proteinuria 2131.66 25.91 663 38343 22628 90566813
Palmar-plantar erythrodysaesthesia syndrome 1942.86 25.91 646 38360 27377 90562064
Platelet count decreased 1418.45 25.91 825 38181 136144 90453297
Decreased appetite 839.98 25.91 916 38090 375624 90213817
Immune-mediated hypothyroidism 744.44 25.91 165 38841 1393 90588048
Adrenal insufficiency 633.28 25.91 292 38714 29629 90559812
Malaise 531.22 25.91 922 38084 585064 90004377
Interstitial lung disease 519.04 25.91 353 38653 76052 90513389
Diarrhoea 507.17 25.91 1190 37816 938000 89651441
Hepatic function abnormal 478.17 25.91 279 38727 46009 90543432
Thyroiditis 441.88 25.91 129 38877 3508 90585933
Gastrointestinal perforation 402.73 25.91 125 38881 4207 90585234
Immune-mediated enterocolitis 391.21 25.91 125 38881 4632 90584809
Hyperthyroidism 378.92 25.91 176 38830 18134 90571307
Dysphonia 375.80 25.91 269 38737 62815 90526626
Cholecystitis 368.89 25.91 169 38837 16871 90572570
Immune-mediated adrenal insuficiency 352.94 25.91 84 38922 998 90588443
Blood thyroid stimulating hormone increased 342.72 25.91 134 38872 9021 90580420
Renal impairment 318.57 25.91 303 38703 105118 90484323
Cardiac failure 303.23 25.91 300 38706 109196 90480245
Myocarditis 295.92 25.91 136 38870 13670 90575771
Pyrexia 294.77 25.91 780 38226 659705 89929736
Blood pressure increased 256.23 25.91 367 38639 196850 90392591
Posterior reversible encephalopathy syndrome 247.49 25.91 141 38865 22198 90567243
Drug ineffective 235.97 25.91 154 38852 1384144 89205297
Immune-mediated hepatic disorder 219.61 25.91 64 38942 1728 90587713
Small intestinal perforation 219.31 25.91 65 38941 1864 90587577
Type 1 diabetes mellitus 218.13 25.91 81 38925 4731 90584710
Hepatic encephalopathy 217.37 25.91 110 38896 13662 90575779
Immune-mediated myocarditis 210.69 25.91 58 38948 1267 90588174
Intestinal perforation 207.84 25.91 107 38899 13774 90575667
Therapy partial responder 201.81 25.91 123 38883 21920 90567521
Condition aggravated 188.61 25.91 19 38987 595526 89993915
Immune-mediated encephalitis 166.40 25.91 40 38966 497 90588944
Immune-mediated lung disease 165.32 25.91 52 38954 1828 90587613
Ascites 163.01 25.91 147 38859 47593 90541848
Thyroid disorder 159.63 25.91 98 38908 17687 90571754
Stomatitis 156.49 25.91 357 38649 274341 90315100
Nephrotic syndrome 156.33 25.91 72 38934 7267 90582174
Immune-mediated dermatitis 153.82 25.91 42 38964 889 90588552
Pneumothorax 152.89 25.91 98 38908 19069 90570372
Cholecystitis acute 151.00 25.91 76 38930 9328 90580113
Swelling 147.82 25.91 8 38998 419050 90170391
Thrombocytopenia 147.33 25.91 296 38710 208429 90381012
Drug hypersensitivity 143.59 25.91 16 38990 463593 90125848
Tumour haemorrhage 139.77 25.91 47 38959 2047 90587394
Enterocolitis 137.53 25.91 74 38932 10416 90579025
Joint swelling 135.96 25.91 26 38980 503274 90086167
Weight increased 135.75 25.91 12 38994 417915 90171526
Alopecia 132.83 25.91 26 38980 495045 90094396
Arthropathy 132.31 25.91 6 39000 366236 90223205
Hypersensitivity 130.47 25.91 20 38986 454657 90134784
Cerebral infarction 130.47 25.91 101 38905 26495 90562946
Colitis 126.05 25.91 153 38853 69789 90519652
Pain 125.47 25.91 147 38859 996194 89593247
Adrenocorticotropic hormone deficiency 123.88 25.91 34 38972 734 90588707
Immune-mediated hepatitis 116.94 25.91 45 38961 2899 90586542
Primary adrenal insufficiency 106.87 25.91 25 38981 274 90589167
Nasopharyngitis 103.80 25.91 24 38982 407080 90182361
Silent thyroiditis 103.74 25.91 22 38984 147 90589294
Drug intolerance 103.53 25.91 32 38974 447559 90141882
Treatment failure 103.51 25.91 7 38999 303921 90285520
Sinusitis 103.31 25.91 13 38993 343075 90246366
Immune-mediated thyroiditis 103.26 25.91 27 38979 481 90588960
Wound 103.12 25.91 7 38999 302973 90286468
Immune-mediated cholangitis 102.43 25.91 24 38982 265 90589176
Protein urine present 99.27 25.91 52 38954 6932 90582509
Pericarditis 98.96 25.91 4 39002 270147 90319294
Fistula 96.87 25.91 62 38944 12027 90577414
Eastern Cooperative Oncology Group performance status worsened 96.62 25.91 35 38971 1904 90587537
Discomfort 94.36 25.91 6 39000 274329 90315112
Death 93.89 25.91 417 38589 456134 90133307
Off label use 93.35 25.91 211 38795 1102041 89487400
Rheumatoid arthritis 91.20 25.91 22 38984 362592 90226849
Immune-mediated hyperthyroidism 91.17 25.91 23 38983 353 90589088
Immune-mediated pancreatitis 91.05 25.91 23 38983 355 90589086
Mobility decreased 90.87 25.91 4 39002 250730 90338711
Infusion related reaction 89.11 25.91 34 38972 416746 90172695
Fulminant type 1 diabetes mellitus 88.65 25.91 27 38979 851 90588590
Large intestine perforation 88.38 25.91 54 38952 9658 90579783
Tracheal fistula 84.90 25.91 16 38990 52 90589389
Depression 84.42 25.91 14 38992 300587 90288854
Abdominal discomfort 83.69 25.91 51 38955 477277 90112164
Female genital tract fistula 83.61 25.91 66 38940 17802 90571639
Adrenal disorder 82.05 25.91 31 38975 1899 90587542
Cerebral haemorrhage 81.69 25.91 87 38919 34435 90555006
Encephalitis 81.61 25.91 54 38952 11080 90578361
Product dose omission issue 80.99 25.91 14 38992 291673 90297768
Urogenital fistula 80.82 25.91 22 38984 460 90588981
Musculoskeletal stiffness 80.67 25.91 15 38991 296517 90292924
Wheezing 79.56 25.91 6 39000 238074 90351367
Rectal perforation 78.83 25.91 22 38984 506 90588935
Cholangitis 78.63 25.91 45 38961 7137 90582304
Dehydration 76.56 25.91 220 38786 194227 90395214
Immune-mediated renal disorder 76.07 25.91 18 38988 208 90589233
Asthma 75.81 25.91 8 38998 242152 90347289
Myelosuppression 75.78 25.91 104 38902 53487 90535954
Toxicity to various agents 75.29 25.91 16 38990 287830 90301611
Immune-mediated myositis 75.23 25.91 31 38975 2390 90587051
Duodenal perforation 74.69 25.91 25 38981 1073 90588368
Intentional product use issue 73.82 25.91 5 39001 216887 90372554
Blood cholesterol increased 73.19 25.91 4 39002 208008 90381433
Oesophageal fistula 73.03 25.91 17 38989 182 90589259
Lower respiratory tract infection 71.89 25.91 11 38995 250648 90338793
Erythema multiforme 70.05 25.91 51 38955 12195 90577246
Mucosal inflammation 68.53 25.91 103 38903 57522 90531919
Drug eruption 67.95 25.91 80 38926 35327 90554114
Hypopituitarism 66.80 25.91 26 38980 1727 90587714
Cardiomyopathy 66.56 25.91 61 38945 20145 90569296
Glossodynia 65.89 25.91 28 38978 321751 90267690
Contusion 65.62 25.91 14 38992 251202 90338239
Hyponatraemia 65.58 25.91 164 38842 133374 90456067
Osteoarthritis 65.20 25.91 5 39001 195725 90393716
Pruritus 64.66 25.91 83 38923 541442 90047999
Tumour pseudoprogression 63.63 25.91 20 38986 701 90588740
Cytokine release syndrome 63.55 25.91 69 38937 27904 90561537
Hypertensive crisis 63.13 25.91 56 38950 17728 90571713
Type 2 diabetes mellitus 62.88 25.91 7 38999 203237 90386204
Dyspnoea 62.62 25.91 184 38822 880771 89708670
Therapeutic product effect incomplete 61.73 25.91 6 39000 193890 90395551
Protein urine 61.30 25.91 20 38986 792 90588649
Migraine 60.33 25.91 6 39000 190386 90399055
Immune-mediated adverse reaction 60.10 25.91 20 38986 843 90588598
Peripheral swelling 59.65 25.91 54 38952 413052 90176389
Injection site pain 59.11 25.91 4 39002 173695 90415746
Weight decreased 57.34 25.91 318 38688 379592 90209849
Ileus 56.55 25.91 51 38955 16495 90572946
Sleep disorder 56.07 25.91 9 38997 198021 90391420
Paraesthesia 55.87 25.91 19 38987 250307 90339134
Cardiac failure acute 55.68 25.91 44 38962 11885 90577556
Dizziness 55.43 25.91 106 38900 589178 90000263
Altered state of consciousness 55.20 25.91 68 38938 31464 90557977
Anxiety 54.38 25.91 33 38973 309739 90279702
Fatigue 54.12 25.91 744 38262 1153279 89436162
KL-6 increased 53.24 25.91 12 38994 110 90589331
Peritonitis 52.63 25.91 53 38953 19652 90569789
Blood corticotrophin increased 52.38 25.91 12 38994 119 90589322
Myasthenia gravis 52.21 25.91 34 38972 6791 90582650
Insomnia 51.29 25.91 41 38965 333433 90256008
Cardiac dysfunction 48.90 25.91 26 38980 3571 90585870
Disseminated intravascular coagulation 48.70 25.91 53 38953 21485 90567956
Gait inability 48.05 25.91 4 39002 146452 90442989
Immune-mediated arthritis 47.66 25.91 13 38993 274 90589167
Lung disorder 46.77 25.91 5 39001 149878 90439563
Fall 46.75 25.91 85 38921 481725 90107716
Urticaria 46.18 25.91 40 38966 312694 90276747
Thyrotoxic crisis 45.99 25.91 18 38988 1213 90588228
Primary hypothyroidism 44.48 25.91 11 38995 155 90589286
Pulmonary toxicity 44.33 25.91 38 38968 11493 90577948
Gastrointestinal disorder 44.13 25.91 28 38978 256659 90332782
Night sweats 43.71 25.91 3 39003 128763 90460678
Gastric perforation 43.67 25.91 20 38986 1991 90587450
Tumour lysis syndrome 43.38 25.91 37 38969 11115 90578326
Encephalitis autoimmune 43.23 25.91 20 38986 2038 90587403
Bronchitis 43.18 25.91 7 38999 152920 90436521
Immune-mediated neuropathy 42.71 25.91 10 38996 110 90589331
Oral pain 42.59 25.91 61 38945 32622 90556819
Memory impairment 42.25 25.91 16 38990 197228 90392213
Hypoaesthesia 41.94 25.91 44 38962 314166 90275275
Liver injury 41.58 25.91 11 38995 170556 90418885
Pancreatitis 41.04 25.91 92 38914 69734 90519707
Intestinal obstruction 40.81 25.91 64 38942 37067 90552374
Neutrophil count decreased 40.65 25.91 93 38913 71439 90518002
Pneumonitis 40.29 25.91 70 38936 44100 90545341
Aortic dissection 40.17 25.91 20 38986 2397 90587044
Epistaxis 40.16 25.91 103 38903 85022 90504419
Skin disorder 39.97 25.91 63 38943 36643 90552798
Pleural effusion 39.57 25.91 122 38884 111869 90477572
Arterial haemorrhage 39.36 25.91 20 38986 2503 90586938
Psoriasis 39.05 25.91 8 38998 147746 90441695
Hyperhidrosis 39.02 25.91 6 39000 136299 90453142
Thrombophlebitis migrans 38.70 25.91 11 38995 271 90589170
Upper respiratory tract infection 38.25 25.91 5 39001 128313 90461128
Gastrooesophageal reflux disease 38.20 25.91 12 38994 166325 90423116
Therapy non-responder 36.97 25.91 7 38999 136697 90452744
Pulmonary embolism 35.15 25.91 130 38876 130690 90458751
Medical device site thrombosis 35.05 25.91 8 38998 78 90589363
Amylase increased 34.99 25.91 27 38979 7045 90582396
Cytokine storm 34.62 25.91 12 38994 573 90588868
Obesity 34.28 25.91 3 39003 105504 90483937
Confusional state 34.10 25.91 72 38934 386133 90203308
Malignant gastrointestinal obstruction 33.80 25.91 7 38999 41 90589400
Muscle spasms 32.79 25.91 36 38970 251847 90337594
Blister 32.59 25.91 37 38969 254961 90334480
Hypercholesterolaemia 32.43 25.91 3 39003 100889 90488552
Cortisol increased 32.36 25.91 11 38995 495 90588946
Ill-defined disorder 32.00 25.91 20 38986 184871 90404570
Thyroiditis subacute 31.38 25.91 10 38996 367 90589074
Pyelonephritis 31.08 25.91 42 38964 21274 90568167
Osteoporosis 30.68 25.91 3 39003 96528 90492913
Cancer pain 30.66 25.91 20 38986 4005 90585436
Cholangitis acute 30.21 25.91 11 38995 607 90588834
Physical deconditioning 29.95 25.91 16 38990 2219 90587222
Dyspepsia 29.66 25.91 25 38981 198135 90391306
Adverse drug reaction 29.46 25.91 7 38999 116694 90472747
Overdose 28.79 25.91 16 38990 157693 90431748
Perforation 28.78 25.91 15 38991 1979 90587462
Meningitis 28.70 25.91 26 38980 8455 90580986
Influenza 28.67 25.91 12 38994 139252 90450189
Pain in extremity 28.47 25.91 99 38907 450430 90139011
Gingivitis 28.38 25.91 27 38979 9342 90580099
Gait disturbance 27.97 25.91 43 38963 260453 90328988
Nausea 27.90 25.91 649 38357 1109667 89479774
Gastrointestinal fistula 27.69 25.91 10 38996 539 90588902
Loss of personal independence in daily activities 27.58 25.91 12 38994 136093 90453348
Tumour cavitation 27.57 25.91 6 39000 46 90589395
Drug interaction 27.48 25.91 48 38958 276405 90313036
Biloma infected 27.01 25.91 4 39002 0 90589441
Tracheal haemorrhage 27 25.91 8 38998 229 90589212
Liver carcinoma ruptured 26.82 25.91 6 39000 53 90589388
Abdominal pain 26.73 25.91 274 38732 395447 90193994
Haemophagocytic lymphohistiocytosis 26.51 25.91 33 38973 15426 90574015
Pyoderma gangrenosum 26.46 25.91 19 38987 4445 90584996
Vomiting 26.43 25.91 481 38525 787812 89801629
Pulmonary fibrosis 26.07 25.91 7 38999 107496 90481945

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
Proteinuria 1579.41 20.88 594 28832 22389 42569520
Malignant neoplasm progression 1483.05 20.88 923 28503 107477 42484432
Hypertension 1459.54 20.88 1077 28349 166127 42425782
Palmar-plantar erythrodysaesthesia syndrome 1345.25 20.88 513 28913 20069 42571840
Decreased appetite 1146.84 20.88 993 28433 192144 42399765
Hypothyroidism 915.29 20.88 445 28981 31639 42560270
Hepatic encephalopathy 856.43 20.88 348 29078 16094 42575815
Diarrhoea 585.70 20.88 1094 28332 459755 42132154
Adrenal insufficiency 409.35 20.88 218 29208 18706 42573203
Dysphonia 339.13 20.88 223 29203 28227 42563682
Interstitial lung disease 330.89 20.88 335 29091 78127 42513782
Tumour haemorrhage 323.66 20.88 114 29312 3524 42588385
Malaise 292.83 20.88 524 28902 211632 42380277
Hepatic function abnormal 281.51 20.88 254 29172 51313 42540596
Stomatitis 241.99 20.88 231 29195 50098 42541811
Liver carcinoma ruptured 189.32 20.88 43 29383 239 42591670
Drug ineffective 184.13 20.88 104 29322 630093 41961816
Ascites 157.73 20.88 195 29231 56483 42535426
Oesophageal varices haemorrhage 146.33 20.88 64 29362 3543 42588366
Fatigue 145.27 20.88 639 28787 435002 42156907
Cholecystitis 143.07 20.88 97 29329 12891 42579018
Immune-mediated hypothyroidism 140.90 20.88 47 29379 1227 42590682
Platelet count decreased 138.08 20.88 299 29127 138282 42453627
Therapy partial responder 136.31 20.88 112 29314 19909 42572000
Blood pressure increased 135.30 20.88 248 29178 101680 42490229
Cholangitis 134.85 20.88 87 29339 10640 42581269
Immune-mediated hepatic disorder 126.57 20.88 52 29374 2462 42589447
Thyroiditis 123.47 20.88 55 29371 3181 42588728
Immune-mediated hepatitis 115.38 20.88 55 29371 3719 42588190
Hepatic failure 113.95 20.88 136 29290 37964 42553945
Condition aggravated 110.12 20.88 23 29403 260731 42331178
Immune-mediated enterocolitis 102.25 20.88 58 29368 5619 42586290
Immune-mediated adrenal insuficiency 100.54 20.88 32 29394 717 42591192
Drug interaction 100.28 20.88 30 29396 266969 42324940
Toxicity to various agents 99.26 20.88 19 29407 229117 42362792
Renal impairment 94.30 20.88 224 29202 110004 42481905
Nephrotic syndrome 91.01 20.88 63 29363 8655 42583254
Pneumothorax 87.32 20.88 94 29332 23449 42568460
Blood bilirubin increased 86.22 20.88 125 29301 42127 42549782
Off label use 85.30 20.88 198 29228 638137 41953772
Dehydration 84.60 20.88 252 29174 141515 42450394
Blood thyroid stimulating hormone increased 81.90 20.88 49 29377 5243 42586666
Ammonia increased 79.62 20.88 46 29380 4613 42587296
Liver disorder 76.15 20.88 114 29312 39530 42552379
Gastrointestinal perforation 73.25 20.88 43 29383 4443 42587466
Tumour rupture 71.91 20.88 21 29405 348 42591561
Taste disorder 65.10 20.88 55 29371 10152 42581757
Tracheal fistula 63.24 20.88 16 29410 149 42591760
Protein urine present 60.73 20.88 42 29384 5759 42586150
Neutropenia 60.66 20.88 31 29395 199400 42392509
Immune-mediated encephalitis 60.31 20.88 21 29405 626 42591283
Cardiac failure 59.07 20.88 185 29241 106671 42485238
Immune-mediated myocarditis 58.90 20.88 29 29397 2105 42589804
Immune-mediated lung disease 55.94 20.88 33 29393 3440 42588469
Cholecystitis acute 54.81 20.88 44 29382 7562 42584347
Immune-mediated renal disorder 54.50 20.88 18 29408 455 42591454
Completed suicide 54.37 20.88 3 29423 96462 42495447
Weight decreased 54.33 20.88 285 29141 207663 42384246
Pneumonitis 53.36 20.88 100 29326 41618 42550291
Product dose omission issue 53.24 20.88 20 29406 154345 42437564
Immune-mediated dermatitis 53.18 20.88 23 29403 1238 42590671
Tumour lysis syndrome 53.15 20.88 71 29355 22160 42569749
Immune-mediated pancreatitis 52.26 20.88 16 29410 314 42591595
Oral pain 51.52 20.88 53 29373 12543 42579366
Pyrexia 51.12 20.88 454 28972 393588 42198321
Cerebral infarction 47.95 20.88 81 29345 31088 42560821
Nephrectomy 46.47 20.88 19 29407 888 42591021
Hyperthyroidism 45.85 20.88 53 29373 14288 42577621
Hyperhidrosis 44.92 20.88 5 29421 90507 42501402
Primary adrenal insufficiency 44.48 20.88 14 29412 302 42591607
Cerebral haemorrhage 44.45 20.88 89 29337 38877 42553032
Intestinal perforation 43.12 20.88 45 29381 10829 42581080
Haemobilia 43.12 20.88 15 29411 446 42591463
Overdose 42.91 20.88 10 29416 105254 42486655
Fall 41.54 20.88 61 29365 234459 42357450
Gastric perforation 41.13 20.88 26 29400 3067 42588842
Epistaxis 40.94 20.88 120 29306 66706 42525203
Tracheo-oesophageal fistula 40.37 20.88 15 29411 541 42591368
Impaired healing 40.05 20.88 54 29372 16999 42574910
Drug hypersensitivity 39.42 20.88 10 29416 99379 42492530
Portal vein thrombosis 38.62 20.88 29 29397 4520 42587389
Intentional product use issue 38.22 20.88 3 29423 71830 42520079
Type 1 diabetes mellitus 37.97 20.88 31 29395 5456 42586453
Hyperammonaemia 37.54 20.88 36 29390 7830 42584079
Somnolence 37.16 20.88 26 29400 141079 42450830
Rash 36.28 20.88 320 29106 276634 42315275
Colitis 35.88 20.88 91 29335 46481 42545428
Protein induced by vitamin K absence or antagonist II increased 34.99 20.88 8 29418 46 42591863
Arterial haemorrhage 34.81 20.88 17 29409 1212 42590697
Upper gastrointestinal haemorrhage 34.31 20.88 69 29357 30230 42561679
Depression 34.29 20.88 17 29409 111346 42480563
Liver abscess 34.22 20.88 28 29398 4942 42586967
Pancreatitis 33.81 20.88 85 29341 43183 42548726
Tumour embolism 33.50 20.88 9 29417 108 42591801
Hypersensitivity 33.49 20.88 5 29421 72365 42519544
Duodenal perforation 32.87 20.88 18 29408 1628 42590281
Alpha 1 foetoprotein increased 32.83 20.88 14 29412 728 42591181
Chronic obstructive pulmonary disease 32.58 20.88 3 29423 63111 42528798
Myelosuppression 31.11 20.88 79 29347 40382 42551527
Agitation 30.80 20.88 4 29422 64310 42527599
Polycythaemia 30.46 20.88 21 29405 2865 42589044
Hepatic lesion 30.28 20.88 25 29401 4469 42587440
Paraesthesia 29.89 20.88 7 29419 73452 42518457
Vomiting 29.69 20.88 318 29108 289405 42302504
Aortic dissection 29.27 20.88 21 29405 3051 42588858
Hepatic haemorrhage 27.62 20.88 12 29414 653 42591256
Tachycardia 27.44 20.88 18 29408 101069 42490840
Anxiety 27.26 20.88 25 29401 118535 42473374
Hyponatraemia 27.07 20.88 140 29286 101322 42490587
Injection site pain 26.73 20.88 4 29422 57794 42534115
Tremor 26.67 20.88 17 29409 96912 42494997
Urticaria 26.51 20.88 9 29417 74027 42517882
Therapeutic product effect incomplete 26.51 20.88 8 29418 70931 42520978
Immune-mediated nephritis 26.47 20.88 12 29414 723 42591186
Immune-mediated adverse reaction 26.00 20.88 13 29413 975 42590934
Hypotension 25.34 20.88 92 29334 257539 42334370
Cardiac arrest 25.19 20.88 23 29403 109297 42482612
Aspartate aminotransferase increased 24.56 20.88 112 29314 77051 42514858
Hallucination 24.36 20.88 5 29421 57502 42534407
Coma 24.10 20.88 4 29422 53550 42538359
Multiple organ dysfunction syndrome 24.09 20.88 19 29407 97016 42494893
Immune-mediated thyroiditis 24.03 20.88 10 29416 489 42591420
Chest pain 23.99 20.88 37 29389 139493 42452416
Biliary obstruction 23.95 20.88 19 29407 3210 42588699
Cholangitis acute 23.86 20.88 13 29413 1164 42590745
Rhythm idioventricular 23.73 20.88 9 29417 344 42591565
Seizure 23.71 20.88 29 29397 120532 42471377
Leukopenia 23.63 20.88 11 29415 74735 42517174
Febrile neutropenia 23.50 20.88 59 29367 185644 42406265
Nausea 23.38 20.88 394 29032 396405 42195504
Thrombophlebitis migrans 23.31 20.88 9 29417 361 42591548
KL-6 increased 23.03 20.88 7 29419 134 42591775
Dyspnoea 22.75 20.88 196 29230 442425 42149484
Myocarditis 22.49 20.88 44 29382 18894 42573015
Thyroglobulin increased 22.45 20.88 5 29421 25 42591884
Tumour necrosis 22.31 20.88 14 29412 1630 42590279
Osteonecrosis of jaw 22.30 20.88 44 29382 19005 42572904
Weight increased 22.28 20.88 25 29401 107958 42483951
Bradycardia 22.17 20.88 16 29410 85468 42506441
Gastric varices haemorrhage 21.92 20.88 8 29418 274 42591635
Cardio-respiratory arrest 21.22 20.88 7 29419 58629 42533280
Inappropriate schedule of product administration 21.13 20.88 21 29405 95881 42496028

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
Malignant neoplasm progression 4523.23 21.82 2023 51456 172544 110363276
Hypertension 3500.40 21.82 2464 51015 507620 110028200
Proteinuria 2981.29 21.82 1002 52477 39016 110496804
Hypothyroidism 2782.52 21.82 1115 52364 71784 110464036
Palmar-plantar erythrodysaesthesia syndrome 2568.06 21.82 902 52577 40123 110495697
Decreased appetite 1478.23 21.82 1458 52021 474388 110061432
Platelet count decreased 1114.19 21.82 908 52571 229535 110306285
Diarrhoea 771.89 21.82 1694 51785 1137811 109398009
Immune-mediated hypothyroidism 760.84 21.82 193 53286 2682 110533138
Hepatic encephalopathy 710.00 21.82 322 53157 27934 110507886
Adrenal insufficiency 647.65 21.82 344 53135 42046 110493774
Malaise 594.50 21.82 1118 52361 670701 109865119
Hepatic function abnormal 575.39 21.82 418 53061 88877 110446943
Dysphonia 522.55 21.82 370 53109 75559 110460261
Interstitial lung disease 475.17 21.82 451 53028 138883 110396937
Thyroiditis 427.66 21.82 149 53330 6424 110529396
Immune-mediated enterocolitis 412.56 21.82 163 53316 10022 110525798
Tumour haemorrhage 412.23 21.82 137 53342 5108 110530712
Cholecystitis 383.84 21.82 206 53273 25676 110510144
Therapy partial responder 370.21 21.82 228 53251 36833 110498987
Immune-mediated adrenal insuficiency 338.74 21.82 92 53387 1688 110534132
Blood thyroid stimulating hormone increased 317.82 21.82 143 53336 12158 110523662
Renal impairment 300.19 21.82 411 53068 188034 110347786
Immune-mediated hepatic disorder 293.82 21.82 102 53377 4348 110531472
Drug ineffective 284.24 21.82 195 53284 1520345 109015475
Hyperthyroidism 277.01 21.82 174 53305 29087 110506733
Ascites 243.81 21.82 261 53218 92547 110443273
Condition aggravated 231.12 21.82 39 53440 734797 109801023
Cardiac failure 228.95 21.82 361 53118 187265 110348555
Pyrexia 227.14 21.82 946 52533 897319 109638501
Immune-mediated myocarditis 226.41 21.82 79 53400 3419 110532401
Pneumothorax 213.14 21.82 159 53320 35126 110500694
Gastrointestinal perforation 212.94 21.82 93 53386 7363 110528457
Blood pressure increased 207.70 21.82 414 53065 257959 110277861
Nephrotic syndrome 202.00 21.82 109 53370 13722 110522098
Immune-mediated hepatitis 195.87 21.82 85 53394 6626 110529194
Stomatitis 193.66 21.82 413 53066 269829 110265991
Myocarditis 191.80 21.82 140 53339 29915 110505905
Cholecystitis acute 188.56 21.82 109 53370 15673 110520147
Immune-mediated dermatitis 176.69 21.82 59 53420 2231 110533589
Posterior reversible encephalopathy syndrome 174.80 21.82 139 53340 33722 110502098
Immune-mediated encephalitis 169.37 21.82 49 53430 1141 110534679
Small intestinal perforation 163.20 21.82 66 53413 4310 110531510
Drug hypersensitivity 154.47 21.82 19 53460 454071 110081749
Immune-mediated lung disease 150.97 21.82 66 53413 5237 110530583
Liver carcinoma ruptured 148.46 21.82 34 53445 296 110535524
Toxicity to various agents 145.53 21.82 28 53451 480527 110055293
Cholangitis 144.29 21.82 93 53386 16242 110519578
Intestinal perforation 141.49 21.82 101 53378 20843 110514977
Primary adrenal insufficiency 141.25 21.82 37 53442 587 110535233
Dehydration 135.25 21.82 367 53112 279144 110256676
Hypersensitivity 134.74 21.82 18 53461 403980 110131840
Immune-mediated renal disorder 130.04 21.82 36 53443 711 110535109
Cerebral infarction 129.46 21.82 142 53337 51696 110484124
Type 1 diabetes mellitus 125.73 21.82 69 53410 8978 110526842
Joint swelling 125.51 21.82 30 53449 442815 110093005
Oesophageal varices haemorrhage 123.02 21.82 56 53423 4889 110530931
Pain 122.71 21.82 170 53309 954785 109581035
Myelosuppression 122.62 21.82 187 53292 94153 110441667
Weight increased 121.76 21.82 27 53452 419617 110116203
Swelling 121.05 21.82 14 53465 351027 110184793
Arthropathy 121.02 21.82 4 53475 287518 110248302
Synovitis 118.34 21.82 3 53476 274089 110261731
Off label use 116.61 21.82 357 53122 1499828 109035992
Product dose omission issue 115.66 21.82 11 53468 321771 110214049
Tracheal fistula 115.59 21.82 26 53453 207 110535613
Colitis 115.30 21.82 190 53289 102133 110433687
Immune-mediated pancreatitis 112.85 21.82 32 53447 692 110535128
Nasopharyngitis 111.18 21.82 27 53452 394334 110141486
Blood bilirubin increased 110.83 21.82 159 53320 75813 110460007
Protein urine present 110.45 21.82 69 53410 11415 110524405
Sinusitis 107.00 21.82 10 53469 296678 110239142
Alopecia 106.75 21.82 23 53456 364730 110171090
Drug intolerance 106.75 21.82 32 53447 406480 110129340
Cerebral haemorrhage 103.73 21.82 142 53337 64826 110470994
Wheezing 102.53 21.82 5 53474 255225 110280595
Infusion related reaction 100.08 21.82 30 53449 381132 110154688
Adrenocorticotropic hormone deficiency 99.26 21.82 38 53441 2144 110533676
Intentional product use issue 96.04 21.82 6 53473 247900 110287920
Rheumatoid arthritis 96.03 21.82 15 53464 299598 110236222
Treatment failure 93.24 21.82 12 53467 277222 110258598
Drug interaction 93.09 21.82 64 53415 500119 110035701
Pericarditis 92.37 21.82 3 53476 219111 110316709
Large intestine perforation 91.72 21.82 71 53408 16558 110519262
Immune-mediated thyroiditis 91.62 21.82 30 53449 1066 110534754
Asthma 91.42 21.82 8 53471 250283 110285537
Eastern Cooperative Oncology Group performance status worsened 91.22 21.82 39 53440 2930 110532890
Depression 90.86 21.82 21 53458 317314 110218506
Immune-mediated hyperthyroidism 90.01 21.82 26 53453 602 110535218
Wound 89.84 21.82 6 53473 234431 110301389
Hyponatraemia 87.98 21.82 268 53211 217385 110318435
Silent thyroiditis 87.56 21.82 22 53457 293 110535527
Pemphigus 86.83 21.82 4 53475 214566 110321254
Hepatic failure 86.14 21.82 134 53345 68605 110467215
Fistula 85.87 21.82 66 53413 15233 110520587
Immune-mediated cholangitis 85.37 21.82 27 53452 857 110534963
Musculoskeletal stiffness 85.29 21.82 16 53463 279806 110256014
Fatigue 83.61 21.82 926 52553 1215032 109320788
Mobility decreased 83.00 21.82 9 53470 237413 110298407
Drug eruption 82.24 21.82 115 53364 53544 110482276
Paraesthesia 79.75 21.82 18 53461 276503 110259317
Therapeutic product effect incomplete 79.48 21.82 8 53471 223797 110312023
Psoriatic arthropathy 78.55 21.82 4 53475 196757 110339063
Discomfort 78.04 21.82 7 53472 214700 110321120
Thyroid disorder 77.76 21.82 65 53414 16904 110518916
Oesophageal fistula 77.35 21.82 22 53457 481 110535339
Tumour lysis syndrome 76.24 21.82 84 53395 30717 110505103
Gastric perforation 75.21 21.82 40 53439 4889 110530931
Duodenal perforation 74.09 21.82 33 53446 2737 110533083
Tracheo-oesophageal fistula 74.08 21.82 23 53456 686 110535134
Pneumonitis 72.95 21.82 132 53347 76399 110459421
Peripheral swelling 72.13 21.82 54 53425 403980 110131840
Blood cholesterol increased 70.01 21.82 5 53474 184780 110351040
Arterial haemorrhage 69.82 21.82 35 53444 3784 110532036
Lower respiratory tract infection 69.75 21.82 16 53463 243090 110292730
Urticaria 68.93 21.82 34 53445 318823 110216997
Weight decreased 68.85 21.82 424 53055 467633 110068187
Sleep disorder 68.25 21.82 8 53471 198636 110337184
Duodenal ulcer perforation 66.77 21.82 5 53474 177695 110358125
Contusion 65.68 21.82 16 53463 233345 110302475
Fall 65.47 21.82 120 53359 603362 109932458
Primary hypothyroidism 65.11 21.82 17 53462 266 110535554
Folliculitis 65.09 21.82 4 53475 167649 110368171
Insomnia 64.60 21.82 48 53431 360542 110175278
Injection site pain 64.12 21.82 6 53473 177916 110357904
Enterocolitis 63.82 21.82 61 53418 18888 110516932
Abdominal discomfort 63.66 21.82 58 53421 393800 110142020
Hypertensive crisis 62.99 21.82 68 53411 24304 110511516
Anxiety 61.74 21.82 46 53433 345032 110190788
Immune-mediated adverse reaction 61.20 21.82 25 53454 1675 110534145
Glossodynia 60.98 21.82 16 53463 221988 110313832
Hyperhidrosis 60.86 21.82 9 53470 187289 110348531
Overdose 60.26 21.82 19 53460 233775 110302045
Dyspnoea 59.79 21.82 304 53175 1106568 109429252
Hypopituitarism 59.67 21.82 33 53446 4357 110531463
Tumour rupture 58.97 21.82 19 53460 641 110535179
Osteoarthritis 58.82 21.82 9 53470 182614 110353206
Migraine 58.75 21.82 7 53472 171645 110364175
KL-6 increased 58.52 21.82 16 53463 301 110535519
Dizziness 58.44 21.82 160 53319 698033 109837787
Erythema multiforme 58.31 21.82 61 53418 21036 110514784
Lung disorder 57.70 21.82 9 53470 180038 110355782
Thrombocytopenia 57.02 21.82 325 53154 348560 110187260
Cardiac dysfunction 56.36 21.82 36 53443 6187 110529633
Thrombophlebitis migrans 55.99 21.82 19 53460 755 110535065
Pruritus 55.92 21.82 124 53355 581436 109954384
Ileus 54.93 21.82 71 53408 30658 110505162
Immune-mediated myositis 54.09 21.82 35 53444 6151 110529669
Female genital tract fistula 53.42 21.82 52 53427 16467 110519353
Amylase increased 53.35 21.82 46 53433 12473 110523347
Urogenital fistula 53.16 21.82 16 53463 429 110535391
Night sweats 52.61 21.82 3 53476 133980 110401840
Pancreatitis 52.55 21.82 130 53349 93403 110442417
Upper gastrointestinal haemorrhage 52.38 21.82 90 53389 50006 110485814
Intentional product misuse 52.11 21.82 3 53476 132901 110402919
Pain in extremity 51.79 21.82 98 53381 487020 110048800
Nephrectomy 50.65 21.82 25 53454 2615 110533205
Rectal perforation 50.56 21.82 19 53460 1018 110534802
Gastrointestinal disorder 50.49 21.82 27 53452 241925 110293895
Fulminant type 1 diabetes mellitus 50.22 21.82 24 53455 2339 110533481
Type 2 diabetes mellitus 50.17 21.82 12 53467 177220 110358600
Adrenal disorder 49.56 21.82 24 53455 2408 110533412
Aspartate aminotransferase increased 49.49 21.82 180 53299 159756 110376064
Epistaxis 47.56 21.82 155 53324 130217 110405603
Gastrooesophageal reflux disease 47.50 21.82 14 53465 179962 110355858
Peritonitis 47.18 21.82 68 53411 32539 110503281
Protein urine 46.36 21.82 20 53459 1536 110534284
Intentional overdose 46.36 21.82 5 53474 132496 110403324
Memory impairment 45.67 21.82 19 53460 196925 110338895
Gait inability 45.60 21.82 6 53473 136370 110399450
Malignant pleural effusion 45.54 21.82 27 53452 4066 110531754
Ammonia increased 45.01 21.82 35 53444 8215 110527605
Muscle spasms 44.88 21.82 41 53438 278116 110257704
Hypoaesthesia 44.29 21.82 52 53427 314171 110221649
Joint range of motion decreased 44.19 21.82 4 53475 121828 110413992
Ill-defined disorder 43.65 21.82 11 53468 156842 110378978
Cardiac failure acute 43.62 21.82 56 53423 24022 110511798
Chest pain 43.35 21.82 72 53407 376303 110159517
Obesity 43.12 21.82 3 53476 113348 110422472
Cholangitis acute 42.40 21.82 20 53459 1893 110533927
Blister 42.37 21.82 29 53450 227347 110308473
Cancer pain 41.96 21.82 31 53448 6741 110529079
Confusional state 41.77 21.82 104 53375 468576 110067244
Influenza 41.38 21.82 15 53464 169086 110366734
Haemoptysis 40.95 21.82 100 53379 71254 110464566
Portal vein thrombosis 40.82 21.82 31 53448 7027 110528793
Vomiting 40.38 21.82 641 52838 910034 109625786
Hyperammonaemia 40.29 21.82 41 53438 13691 110522129
Immune-mediated neuropathy 40.08 21.82 11 53468 210 110535610
Oxygen saturation decreased 40.01 21.82 13 53466 156969 110378851
Pulmonary embolism 39.87 21.82 207 53272 214267 110321553
Pulmonary toxicity 39.83 21.82 46 53433 17700 110518120
Medication error 39.48 21.82 3 53476 105363 110430457
Acute myocardial infarction 39.44 21.82 109 53370 83668 110452152
Hepatic rupture 39.27 21.82 10 53469 141 110535679
Upper respiratory tract infection 38.96 21.82 8 53471 131320 110404500
Death 38.51 21.82 511 52968 698358 109837462
Physical deconditioning 38.49 21.82 23 53456 3514 110532306
Therapy non-responder 38.41 21.82 14 53465 157293 110378527
Bronchitis 38.30 21.82 14 53465 157018 110378802
Bladder tamponade 37.77 21.82 14 53465 722 110535098
Alanine aminotransferase increased 37.42 21.82 182 53297 183591 110352229
Altered state of consciousness 36.58 21.82 84 53395 57542 110478278
Cough 36.22 21.82 109 53370 461532 110074288
Tumour pseudoprogression 36.14 21.82 17 53462 1599 110534221
Aortic dissection 36.13 21.82 25 53454 4908 110530912
Skin disorder 35.88 21.82 70 53409 42843 110492977
Mucosal inflammation 35.69 21.82 115 53364 96026 110439794
Cholangitis sclerosing 35.65 21.82 22 53457 3560 110532260
Alpha 1 foetoprotein increased 35.58 21.82 14 53465 850 110534970
Agitation 35.43 21.82 6 53473 113045 110422775
Immune-mediated arthritis 35.26 21.82 13 53466 660 110535160
Liver disorder 35.02 21.82 149 53330 142094 110393726
Embolism 34.52 21.82 41 53438 16248 110519572
Perforation 34.31 21.82 17 53462 1793 110534027
Pleural effusion 34.05 21.82 173 53306 177536 110358284
Immune-mediated nephritis 33.99 21.82 15 53464 1217 110534603
Feeling hot 33.01 21.82 3 53476 91103 110444717
Abdominal pain 32.47 21.82 385 53094 512604 110023216
Adverse drug reaction 32.22 21.82 6 53473 105553 110430267
Blood corticotrophin increased 32.12 21.82 10 53469 301 110535519
Liver abscess 32.10 21.82 28 53451 7711 110528109
Chronic obstructive pulmonary disease 31.66 21.82 7 53472 109151 110426669
Psoriasis 31.66 21.82 14 53465 139979 110395841
Suicide attempt 31.30 21.82 6 53473 103388 110432432
Nasal congestion 31.29 21.82 5 53474 98277 110437543
Medical device site thrombosis 30.96 21.82 8 53471 120 110535700
Lipase increased 30.08 21.82 41 53438 18631 110517189
Flushing 29.81 21.82 7 53472 104729 110431091
Polycythaemia 29.80 21.82 19 53460 3256 110532564
Angioedema 29.22 21.82 6 53473 98494 110437326
Road traffic accident 28.99 21.82 8 53471 107390 110428430
Drug reaction with eosinophilia and systemic symptoms 28.96 21.82 3 53476 82092 110453728
Rhinorrhoea 28.95 21.82 7 53472 102659 110433161
Hypotension 28.67 21.82 143 53336 523706 110012114
Encephalitis autoimmune 28.50 21.82 19 53460 3509 110532311
Nausea 28.46 21.82 790 52689 1234900 109300920
Tumour associated fever 28.41 21.82 13 53466 1148 110534672
Disseminated intravascular coagulation 28.24 21.82 62 53417 41224 110494596
Hypercholesterolaemia 28.08 21.82 5 53474 90832 110444988
Somnolence 28.07 21.82 64 53415 297385 110238435
Hepatic lesion 27.96 21.82 27 53452 8466 110527354
Hypophysitis 27.45 21.82 22 53457 5393 110530427
Immune-mediated hypophysitis 27.24 21.82 12 53467 969 110534851
Cardiomyopathy 27.20 21.82 54 53425 33471 110502349
Inflammation 27.19 21.82 32 53447 193206 110342614
Oesophageal perforation 26.84 21.82 14 53465 1645 110534175
Adrenocortical insufficiency acute 26.78 21.82 20 53459 4420 110531400
Swelling face 26.62 21.82 6 53473 92315 110443505
Tachycardia 26.41 21.82 43 53436 226602 110309218
Therapeutic response decreased 26.40 21.82 7 53472 96492 110439328
Coma 26.32 21.82 12 53467 117857 110417963
Musculoskeletal pain 26.08 21.82 30 53449 182993 110352827
Protein induced by vitamin K absence or antagonist II increased 25.73 21.82 6 53473 57 110535763
Encephalitis 25.39 21.82 38 53441 18801 110517019
No adverse event 25.29 21.82 3 53476 73836 110461984
Postrenal failure 25.25 21.82 11 53468 865 110534955
Gastrointestinal haemorrhage 24.93 21.82 151 53328 165367 110370453
Haemobilia 24.87 21.82 10 53469 643 110535177
Stress 24.68 21.82 10 53469 105338 110430482
Lung abscess 24.64 21.82 20 53459 4992 110530828
Thyroiditis subacute 24.51 21.82 9 53470 452 110535368
Respiratory tract infection 24.30 21.82 3 53476 71614 110464206
Feeling abnormal 24.29 21.82 31 53448 180680 110355140
Neutropenia 24.27 21.82 96 53383 374524 110161296
Respiratory disorder 24.20 21.82 3 53476 71379 110464441
Pneumonia aspiration 23.92 21.82 90 53389 81143 110454677
Visual impairment 23.91 21.82 18 53461 134410 110401410
Vascular access complication 23.83 21.82 15 53464 2513 110533307
Wound dehiscence 23.77 21.82 24 53455 7938 110527882
Anaphylactic reaction 23.48 21.82 13 53466 114287 110421533
Acute kidney injury 23.28 21.82 434 53045 634996 109900824
Hallucination 23.16 21.82 10 53469 101422 110434398
Malignant ascites 23.10 21.82 12 53467 1398 110534422
Gait disturbance 23.03 21.82 64 53415 278144 110257676
Tracheal haemorrhage 22.74 21.82 10 53469 804 110535016
Leukopenia 22.74 21.82 23 53456 148768 110387052
Myositis 22.74 21.82 48 53431 31068 110504752
Bradycardia 22.70 21.82 25 53454 155492 110380328
Anal abscess 22.56 21.82 28 53451 11610 110524210
Gingivitis 21.89 21.82 26 53453 10305 110525515
Headache 21.88 21.82 298 53181 882079 109653741
Tumour necrosis 21.83 21.82 14 53465 2422 110533398

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01EX08 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
PROTEIN KINASE INHIBITORS
Other protein kinase inhibitors
FDA MoA N0000020000 Receptor Tyrosine Kinase Inhibitors
MeSH PA D000970 Antineoplastic Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D047428 Protein Kinase Inhibitors
FDA EPC N0000175605 Kinase Inhibitor
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:62434 EC 2.7.10.1 (receptor protein-tyrosine kinase) inhibitor
CHEBI has role CHEBI:63457 fibroblast growth factor receptor antagonist
CHEBI has role CHEBI:65207 vascular endothelial growth factor receptor antagonist
CHEBI has role CHEBI:71031 orphan drug
CHEBI has role CHEBI:231911 renoprotective agent

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

DiseaseRelationSNOMED_IDDOID
Liver cell carcinoma indication 109841003 DOID:684
Endometrial carcinoma progressing after chemotherapy indication 254878006 DOID:2871
Follicular thyroid carcinoma indication 255028004 DOID:3962
Papillary thyroid carcinoma indication 255029007 DOID:3969
Hurthle cell carcinoma of thyroid indication 423158009 DOID:8161
Renal cell carcinoma indication 702391001 DOID:4450
Thymic carcinoma indication 722670005
Breastfeeding (mother) contraindication 413712001




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.09 acidic
pKa2 12.74 acidic
pKa3 13.02 acidic
pKa4 4.67 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 10MG BASE LENVIMA EISAI INC N206947 Feb. 13, 2015 RX CAPSULE ORAL 9006256 July 27, 2027 METHOD FOR TREATING THYROID CARCINOMA INCLUDING DIFFERENTIATED THYROID CANCER
EQ 4MG BASE LENVIMA EISAI INC N206947 Feb. 13, 2015 RX CAPSULE ORAL 9006256 July 27, 2027 METHOD FOR TREATING THYROID CARCINOMA INCLUDING DIFFERENTIATED THYROID CANCER
EQ 10MG BASE LENVIMA EISAI INC N206947 Feb. 13, 2015 RX CAPSULE ORAL 11090386 Feb. 23, 2036 TREATMENT WITH LENVIMA BY ADMINISTERING LENVIMA AS A SUSPENSION
EQ 4MG BASE LENVIMA EISAI INC N206947 Feb. 13, 2015 RX CAPSULE ORAL 11090386 Feb. 23, 2036 TREATMENT WITH LENVIMA BY ADMINISTERING LENVIMA AS A SUSPENSION
EQ 10MG BASE LENVIMA EISAI INC N206947 Feb. 13, 2015 RX CAPSULE ORAL 12083112 March 3, 2036 FIRST-LINE TREATMENT OF ADULTS PATIENTS WITH ADVANCED RENAL CELL CARCINOMA BY ADMINISTERING LENVIMA IN COMBINATION WITH PEMBROLIZUMAB
EQ 10MG BASE LENVIMA EISAI INC N206947 Feb. 13, 2015 RX CAPSULE ORAL 12083112 March 3, 2036 TREATMENT OF PATIENTS WITH PMMR/NOT MSI-H ADVANCED ENDOMETRIAL CARCINOMA, HAVE DISEASE PROGRESSION FOLLOWING PRIOR SYSTEMIC THERAPY, AND ARE NOT CANDIDATES FOR CURATIVE SURGERY OR RADIATION, BY ADMINISTERING LENVIMA IN COMBINATION WITH PEMBROLIZUMAB
EQ 4MG BASE LENVIMA EISAI INC N206947 Feb. 13, 2015 RX CAPSULE ORAL 12083112 March 3, 2036 FIRST-LINE TREATMENT OF ADULTS PATIENTS WITH ADVANCED RENAL CELL CARCINOMA BY ADMINISTERING LENVIMA IN COMBINATION WITH PEMBROLIZUMAB
EQ 4MG BASE LENVIMA EISAI INC N206947 Feb. 13, 2015 RX CAPSULE ORAL 12083112 March 3, 2036 TREATMENT OF PATIENTS WITH PMMR/NOT MSI-H ADVANCED ENDOMETRIAL CARCINOMA, HAVE DISEASE PROGRESSION FOLLOWING PRIOR SYSTEMIC THERAPY, AND ARE NOT CANDIDATES FOR CURATIVE SURGERY OR RADIATION, BY ADMINISTERING LENVIMA IN COMBINATION WITH PEMBROLIZUMAB
EQ 10MG BASE LENVIMA EISAI INC N206947 Feb. 13, 2015 RX CAPSULE ORAL 12226409 May 15, 2038 FIRST-LINE TREATMENT OF PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC) USING DOSAGE MODIFICATIONS FOR ADVERSE REACTIONS
EQ 4MG BASE LENVIMA EISAI INC N206947 Feb. 13, 2015 RX CAPSULE ORAL 12226409 May 15, 2038 FIRST-LINE TREATMENT OF PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC) USING DOSAGE MODIFICATIONS FOR ADVERSE REACTIONS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 10MG BASE LENVIMA EISAI INC N206947 Feb. 13, 2015 RX CAPSULE ORAL Aug. 15, 2025 INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC)
EQ 4MG BASE LENVIMA EISAI INC N206947 Feb. 13, 2015 RX CAPSULE ORAL Aug. 15, 2025 INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC)
EQ 10MG BASE LENVIMA EISAI INC N206947 Feb. 13, 2015 RX CAPSULE ORAL Feb. 15, 2026 PEDIATRIC EXCLUSIVITY
EQ 4MG BASE LENVIMA EISAI INC N206947 Feb. 13, 2015 RX CAPSULE ORAL Feb. 15, 2026 PEDIATRIC EXCLUSIVITY
EQ 10MG BASE LENVIMA EISAI INC N206947 Feb. 13, 2015 RX CAPSULE ORAL April 3, 2027 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
EQ 4MG BASE LENVIMA EISAI INC N206947 Feb. 13, 2015 RX CAPSULE ORAL April 3, 2027 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
EQ 10MG BASE LENVIMA EISAI INC N206947 Feb. 13, 2015 RX CAPSULE ORAL Oct. 3, 2027 PEDIATRIC EXCLUSIVITY
EQ 4MG BASE LENVIMA EISAI INC N206947 Feb. 13, 2015 RX CAPSULE ORAL Oct. 3, 2027 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Proto-oncogene tyrosine-protein kinase receptor Ret Kinase INHIBITOR Ki 8.82 CHEMBL DRUG LABEL
Mast/stem cell growth factor receptor Kit Kinase INHIBITOR IC50 7 SCIENTIFIC LITERATURE DRUG LABEL
Vascular endothelial growth factor receptor 1 Kinase INHIBITOR IC50 7.66 SCIENTIFIC LITERATURE DRUG LABEL
Vascular endothelial growth factor receptor 2 Kinase INHIBITOR IC50 8.40 SCIENTIFIC LITERATURE DRUG LABEL
Vascular endothelial growth factor receptor 3 Kinase INHIBITOR IC50 8.28 SCIENTIFIC LITERATURE DRUG LABEL
Platelet-derived growth factor receptor alpha Kinase INHIBITOR IC50 7.29 SCIENTIFIC LITERATURE DRUG LABEL
Fibroblast growth factor receptor 1 Kinase INHIBITOR IC50 7.34 SCIENTIFIC LITERATURE DRUG LABEL
TRAF2 and NCK-interacting protein kinase Kinase Kd 6.25 CHEMBL
Mitogen-activated protein kinase 14 Kinase Kd 6.66 CHEMBL
Mitogen-activated protein kinase kinase kinase kinase 5 Kinase Kd 5.51 CHEMBL
Receptor-interacting serine/threonine-protein kinase 2 Kinase Kd 7.96 CHEMBL
STE20-like serine/threonine-protein kinase Kinase Kd 5.41 CHEMBL
Epithelial discoidin domain-containing receptor 1 Kinase Kd 7.34 CHEMBL
Protein-tyrosine kinase 6 Kinase Kd 6.76 CHEMBL
MAP kinase-activated protein kinase 2 Kinase Kd 7.20 CHEMBL
Discoidin domain-containing receptor 2 Kinase Kd 6.66 CHEMBL
Ribosyldihydronicotinamide dehydrogenase [quinone] Enzyme Kd 5.82 CHEMBL
Fibroblast growth factor receptor 4 Kinase IC50 8.72 CHEMBL
Mitogen-activated protein kinase kinase kinase kinase 2 Kinase Kd 6.24 CHEMBL
Serine/threonine-protein kinase/endoribonuclease IRE1 Kinase Kd 5.65 CHEMBL
Dual specificity mitogen-activated protein kinase kinase 5 Kinase Kd 5.54 CHEMBL
Ferrochelatase, mitochondrial Enzyme Kd 5.55 CHEMBL
Receptor-interacting serine/threonine-protein kinase 3 Kinase Kd 6.50 CHEMBL
Mitogen-activated protein kinase kinase kinase 6 Kinase Kd 5.80 CHEMBL
Platelet-derived growth factor receptor beta Kinase INHIBITOR IC50 7.41 SCIENTIFIC LITERATURE
Epidermal growth factor receptor Kinase INHIBITOR IC50 5.19 SCIENTIFIC LITERATURE
Aurora kinase B Kinase Kd 5.75 CHEMBL
Tyrosine-protein kinase ABL1 Kinase Kd 5.42 CHEMBL
Carbonic anhydrase 5A, mitochondrial Enzyme Ki 6.88 CHEMBL
Breakpoint cluster region protein Kinase Kd 5.39 CHEMBL
Fibroblast growth factor receptor 3 Kinase IC50 7.57 CHEMBL
Serine/threonine-protein kinase 10 Kinase Kd 6.10 CHEMBL
Fibroblast growth factor receptor 2 Kinase IC50 7.96 CHEMBL

External reference:

IDSource
EE083865G2 UNII
D09919 KEGG_DRUG
4034239 VUID
N0000191429 NUI
857890-39-2 SECONDARY_CAS_RN
4034239 VANDF
C2986924 UMLSCUI
CHEBI:85994 CHEBI
LEV PDB_CHEM_ID
CHEMBL1289601 ChEMBL_ID
9823820 PUBCHEM_CID
DB09078 DRUGBANK_ID
CHEMBL2105704 ChEMBL_ID
9361 INN_ID
C531958 MESH_SUPPLEMENTAL_RECORD_UI
7426 IUPHAR_LIGAND_ID
1603296 RXNORM
232716 MMSL
294829 MMSL
294831 MMSL
30895 MMSL
d08346 MMSL
015899 NDDF
015900 NDDF
714108002 SNOMEDCT_US
714109005 SNOMEDCT_US
735068004 SNOMEDCT_US
EE083865G2 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Lenvima HUMAN PRESCRIPTION DRUG LABEL 1 62856-704 CAPSULE 4 mg ORAL NDA 32 sections
Lenvima HUMAN PRESCRIPTION DRUG LABEL 1 62856-708 CAPSULE 4 mg ORAL NDA 32 sections
Lenvima HUMAN PRESCRIPTION DRUG LABEL 1 62856-710 CAPSULE 10 mg ORAL NDA 32 sections
Lenvima HUMAN PRESCRIPTION DRUG LABEL 1 62856-712 CAPSULE 4 mg ORAL NDA 32 sections
Lenvima HUMAN PRESCRIPTION DRUG LABEL 1 62856-720 CAPSULE 10 mg ORAL NDA 32 sections