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

Stem definitionDrug idCAS RN
immunosuppressants, rapamycin derivatives 1118 159351-69-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • votubia
  • everolimus
  • afinitor
  • certican
  • RAD001
A derivative of sirolimus and an inhibitor of TOR SERINE-THREONINE KINASES. It is used to prevent GRAFT REJECTION in heart and kidney transplant patients by blocking cell proliferation signals. It is also an ANTINEOPLASTIC AGENT.
  • Molecular weight: 958.24
  • Formula: C53H83NO14
  • CLOGP: 7.10
  • LIPINSKI: 3
  • HAC: 15
  • HDO: 3
  • TPSA: 204.66
  • ALOGS: -5.77
  • ROTB: 9
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
10 mg O
1.50 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Bocci G, Oprea TI, Benet LZ
S (Water solubility) 0.01 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 0 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.15 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 4.342 High 0.89
caco2-efflux Caco-2 efflux ratio (BA/AB) 7.816 High 0.89
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 22.029 10^-6 cm/s High 0.89
dh-clint Dog hepatocyte intrinsic clearance 100.231 uL/min/10^6 cells High 0.89
dppb Dog plasma protein binding (% unbound) 0.660 % High 0.89
fcs-ppb Fetal calf serum protein binding (% unbound) 2.200 % High 0.89
herg hERG pIC50 4.622 pIC50 High 0.89
hh-clint Human hepatocyte intrinsic clearance 37.239 uL/min/10^6 cells High 0.89
hlm-clint Human liver microsomal intrinsic clearance 274.157 uL/min/mg protein High 0.89
hppb Human plasma protein binding (% unbound) 1.140 % High 0.89
kinase-safety-class ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,NTRK2,PDK1,PDK2,PDK4,PRKDC,TEK 16
kinase-selectivity-class GRK2 1
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 40.926 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 7.379 High 0.89
mh-clint Mouse hepatocyte intrinsic clearance 41.783 High 0.89
mppb Mouse plasma protein binding (% unbound) 0.500 High 0.89
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 51.880 High 0.89
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 1 High 1
pppb Pig plasma protein binding (% unbound) 1.020 % High 0.89
rat-kpuu-brain Rat brain Kpuu 0.023 % High 1
rh-clint Rat hepatocyte intrinsic clearance 79.433 uL/min/10^6 cells High 0.89
rh-fuinc Rat hepatocyte fraction unbound in incubation 3.690 % High 0.89
rppb Rat plasma protein binding (% unbound) 1.150 % High 0.89
solubility-dd Solubility at pH 7.4 in DMSO 13.459 uM High 0.89

Approvals:

DateAgencyCompanyOrphan
Aug. 22, 2019 PMDA Novartis Pharma K.K.
Sept. 2, 2011 EMA
March 30, 2009 FDA NOVARTIS

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 4174.80 13.84 1928 71102 104942 90450475
Metastases to liver 1531.86 13.84 647 72383 28160 90527257
Metastases to bone 1343.21 13.84 569 72461 24936 90530481
Stomatitis 1092.29 13.84 1221 71809 273477 90281940
Pneumonitis 1087.55 13.84 584 72446 43586 90511831
Neoplasm progression 660.36 13.84 424 72606 44062 90511355
Metastases to lung 607.76 13.84 284 72746 15707 90539710
Death 537.40 13.84 1154 71876 455397 90100020
Disease progression 515.73 13.84 633 72397 155982 90399435
Mucosal inflammation 474.45 13.84 384 72646 57241 90498176
Pleural effusion 447.44 13.84 500 72530 111491 90443926
Metastases to lymph nodes 348.89 13.84 176 72854 11513 90543904
Tumour marker increased 337.20 13.84 139 72891 5668 90549749
Hyperglycaemia 328.15 13.84 295 72735 50675 90504742
Osteonecrosis of jaw 316.35 13.84 258 72772 38845 90516572
Interstitial lung disease 299.67 13.84 338 72692 76067 90479350
Infusion related reaction 281.29 13.84 13 73017 416767 90138650
Rheumatoid arthritis 271.61 13.84 4 73026 362610 90192807
Systemic lupus erythematosus 266.86 13.84 5 73025 361891 90193526
Ascites 258.55 13.84 251 72779 47489 90507928
Synovitis 249.74 13.84 3 73027 329749 90225668
Arthropathy 248.49 13.84 11 73019 366231 90189186
Contraindicated product administered 237.75 13.84 4 73026 320135 90235282
Breast cancer metastatic 236.27 13.84 149 72881 14983 90540434
Aphthous ulcer 225.31 13.84 152 72878 17135 90538282
Metastases to skin 217.28 13.84 77 72953 2063 90553354
Transplant rejection 215.32 13.84 132 72898 12626 90542791
Condition aggravated 208.80 13.84 110 72920 595435 89959982
Metastases to pleura 197.90 13.84 71 72959 1973 90553444
Musculoskeletal stiffness 191.41 13.84 12 73018 296520 90258897
Cough 190.98 13.84 692 72338 368270 90187147
Therapeutic product effect decreased 179.85 13.84 11 73019 277560 90277857
Maternal exposure during pregnancy 173.31 13.84 39 72991 360024 90195393
Wound 171.97 13.84 21 73009 302959 90252458
Hepatic lesion 170.99 13.84 86 72944 5587 90549830
Thrombotic microangiopathy 169.19 13.84 123 72907 15620 90539797
Pericarditis 168.34 13.84 13 73017 270138 90285279
Decreased appetite 168.29 13.84 674 72356 375866 90179551
PIK3CA-activated mutation 168.06 13.84 55 72975 1149 90554268
Helicobacter infection 167.69 13.84 3 73027 226847 90328570
Joint swelling 167.61 13.84 99 72931 503201 90052216
Anaemia 166.96 13.84 643 72387 352159 90203258
BK virus infection 165.04 13.84 78 72952 4420 90550997
Lung infiltration 163.33 13.84 119 72911 15163 90540254
Metastases to spine 162.66 13.84 73 72957 3670 90551747
Oral pain 160.58 13.84 163 72867 32520 90522897
Blood creatinine increased 151.83 13.84 284 72746 101102 90454315
Drug hypersensitivity 149.04 13.84 95 72935 463514 90091903
Neoplasm malignant 148.57 13.84 159 72871 33721 90521696
Irritable bowel syndrome 148.42 13.84 4 73026 207444 90347973
Discomfort 141.84 13.84 25 73005 274310 90281107
Glossodynia 141.17 13.84 42 72988 321737 90233680
Second primary malignancy 139.43 13.84 93 72937 10285 90545132
Mouth ulceration 138.52 13.84 166 72864 39808 90515609
Mobility decreased 136.02 13.84 20 73010 250714 90304703
Diarrhoea 135.22 13.84 1249 71781 937941 89617476
Epistaxis 134.43 13.84 244 72786 84881 90470536
Folliculitis 132.64 13.84 8 73022 204345 90351072
Hypersensitivity 131.89 13.84 104 72926 454573 90100844
Metastasis 131.19 13.84 74 72956 6063 90549354
Metastases to central nervous system 129.89 13.84 110 72920 17432 90537985
Metastases to peritoneum 125.26 13.84 63 72967 4092 90551325
Exposure during pregnancy 118.39 13.84 24 73006 238386 90317031
Polyomavirus viraemia 117.25 13.84 43 72987 1274 90554143
Pancreatic neuroendocrine tumour 114.12 13.84 35 72995 587 90554830
Injury 113.62 13.84 13 73017 197336 90358081
Lower respiratory tract infection 113.09 13.84 31 72999 250628 90304789
Polyomavirus-associated nephropathy 112.80 13.84 50 72980 2440 90552977
Weight increased 112.13 13.84 103 72927 417824 90137593
Sinusitis 111.99 13.84 69 72961 343019 90212398
Blood glucose increased 111.70 13.84 241 72789 95005 90460412
Viraemia 110.82 13.84 44 72986 1625 90553792
Blood triglycerides increased 109.58 13.84 90 72940 13671 90541746
Accidental exposure to product packaging 109.01 13.84 19 73011 9 90555408
Renal impairment 104.99 13.84 250 72780 105171 90450246
Dysgeusia 104.57 13.84 167 72863 52393 90503024
Oedema peripheral 103.55 13.84 447 72583 257468 90297949
Completed suicide 102.99 13.84 3 73027 145055 90410362
Gamma-glutamyltransferase increased 102.12 13.84 139 72891 37813 90517604
Bone lesion 102.03 13.84 64 72966 6373 90549044
Immunosuppressant drug level increased 101.58 13.84 57 72973 4623 90550794
Intentional product use issue 101.31 13.84 25 73005 216867 90338550
Hepatic enzyme increased 100.24 13.84 86 72944 360650 90194767
Diabetes mellitus 99.94 13.84 184 72846 64691 90490726
Carbohydrate antigen 15-3 increased 99.69 13.84 43 72987 1964 90553453
Liver injury 98.78 13.84 11 73019 170556 90384861
Ill-defined disorder 97.41 13.84 16 73014 184875 90370542
Lymphangiosis carcinomatosa 96.99 13.84 40 72990 1632 90553785
Acne 96.50 13.84 117 72913 28390 90527027
Joint range of motion decreased 95.59 13.84 3 73027 135640 90419777
Hypertriglyceridaemia 94.83 13.84 66 72964 7823 90547594
Thrombocytopenia 93.36 13.84 374 72656 208351 90347066
Arthralgia 93.26 13.84 319 72711 778203 89777214
Pyrexia 92.04 13.84 873 72157 659612 89895805
Blood lactate dehydrogenase increased 90.34 13.84 108 72922 25824 90529593
Treatment failure 88.72 13.84 69 72961 303859 90251558
Infusion site coldness 87.58 13.84 23 73007 212 90555205
Pericardial effusion 87.36 13.84 127 72903 36706 90518711
Lymphoedema 87.28 13.84 79 72951 13674 90541743
Bone pain 87.04 13.84 169 72861 61814 90493603
Post transplant lymphoproliferative disorder 85.56 13.84 59 72971 6890 90548527
Dehydration 85.03 13.84 346 72684 194101 90361316
Swelling 84.85 13.84 129 72901 418929 90136488
Pancreatic neuroendocrine tumour metastatic 83.90 13.84 18 73012 60 90555357
Therapy cessation 82.82 13.84 123 72907 36238 90519179
Gamma-glutamyltransferase decreased 82.20 13.84 24 73006 337 90555080
Fall 81.55 13.84 166 72864 481644 90073773
Type 2 diabetes mellitus 81.30 13.84 31 72999 203213 90352204
Weight decreased 80.56 13.84 553 72477 379357 90176060
Therapeutic product effect incomplete 80.22 13.84 28 73002 193868 90361549
Nephritic syndrome 79.36 13.84 24 73006 383 90555034
Product use issue 78.58 13.84 90 72940 329829 90225588
Wheezing 77.49 13.84 48 72982 238032 90317385
Concomitant disease progression 76.69 13.84 37 72993 2195 90553222
Kidney transplant rejection 76.25 13.84 48 72982 4809 90550608
Blood chromogranin A increased 76.17 13.84 23 73007 365 90555052
Palmar-plantar erythrodysaesthesia syndrome 75.94 13.84 103 72927 27920 90527497
Neutropenia 74.84 13.84 369 72661 224535 90330882
Osteoarthritis 74.79 13.84 32 72998 195698 90359719
Dyspnoea 74.09 13.84 1056 71974 879899 89675518
Alopecia 73.64 13.84 183 72847 494888 90060529
Abdominal discomfort 72.92 13.84 174 72856 477154 90078263
Bursitis 72.54 13.84 10 73020 131644 90423773
Arthritis 71.24 13.84 23 73007 167292 90388125
Loss of personal independence in daily activities 71.19 13.84 12 73018 136093 90419324
Breast cancer recurrent 70.77 13.84 48 72982 5455 90549962
Pain 70.60 13.84 492 72538 995849 89559568
Renal tubular necrosis 70.41 13.84 72 72958 14483 90540934
Device related thrombosis 69.82 13.84 34 72996 2059 90553358
Needle issue 69.36 13.84 70 72960 13864 90541553
Blister 69.33 13.84 62 72968 254936 90300481
Hypophosphataemia 69.18 13.84 72 72958 14782 90540635
Proteinuria 68.33 13.84 89 72941 23202 90532215
Cytomegalovirus infection 67.91 13.84 95 72935 26507 90528910
Confusional state 67.08 13.84 131 72899 386074 90169343
Drug ineffective 66.69 13.84 755 72275 1383543 89171874
Liver transplant rejection 66.59 13.84 31 72999 1697 90553720
Prescribed overdose 65.91 13.84 3 73027 97622 90457795
Metastases to the mediastinum 64.28 13.84 23 73007 634 90554783
Hormone receptor positive breast cancer 64.02 13.84 24 73006 757 90554660
Body temperature decreased 62.21 13.84 86 72944 23730 90531687
Asthma 62.17 13.84 62 72968 242098 90313319
General physical health deterioration 61.63 13.84 493 72537 354622 90200795
Urticaria 61.61 13.84 98 72932 312636 90242781
Parvovirus B19 infection 61.53 13.84 25 73005 981 90554436
Abdominal lymphadenopathy 61.32 13.84 25 73005 990 90554427
Cell marker increased 60.87 13.84 18 73012 265 90555152
Obesity 60.58 13.84 7 73023 105500 90449917
Depression 59.40 13.84 94 72936 300507 90254910
Drug intolerance 59.35 13.84 175 72855 447416 90108001
Haemoglobin decreased 58.39 13.84 272 72758 161684 90393733
Metastases to abdominal cavity 58.34 13.84 21 73009 589 90554828
Psoriasis 58.31 13.84 23 73007 147731 90407686
Leukopenia 58.07 13.84 196 72834 100514 90454903
Feeding disorder 57.85 13.84 71 72959 17441 90537976
Memory impairment 57.25 13.84 45 72985 197199 90358218
Polyneuropathy 56.88 13.84 74 72956 19267 90536150
Impaired healing 56.71 13.84 63 72967 234136 90321281
Intentional product misuse 56.66 13.84 4 73026 89600 90465817
Metastases to chest wall 56.39 13.84 21 73009 650 90554767
Nasopharyngitis 55.56 13.84 157 72873 406947 90148470
Spinal pain 55.47 13.84 66 72964 15701 90539716
Sleep disorder 55.21 13.84 47 72983 197983 90357434
Pneumocystis jirovecii pneumonia 54.89 13.84 77 72953 21539 90533878
Drug abuse 54.10 13.84 3 73027 82344 90473073
Gastrointestinal disorder 53.87 13.84 77 72953 256610 90298807
Malignant pleural effusion 53.44 13.84 32 72998 2932 90552485
Epstein-Barr virus infection 53.39 13.84 53 72977 10291 90545126
Product dose omission issue 53.22 13.84 96 72934 291591 90263826
Sciatica 52.88 13.84 9 73021 101373 90454044
Gait inability 52.74 13.84 26 73004 146430 90408987
Fatigue 51.89 13.84 1255 71775 1152768 89402649
Hypophagia 51.69 13.84 99 72931 35838 90519579
Lymphadenopathy mediastinal 51.48 13.84 32 72998 3135 90552282
Nephropathy toxic 51.18 13.84 57 72973 12631 90542786
Cholangitis 51.05 13.84 44 72986 7138 90548279
Renal failure 50.93 13.84 225 72805 130782 90424635
Platelet count decreased 50.82 13.84 232 72798 136737 90418680
Neoplasm 50.42 13.84 48 72982 8855 90546562
Autoimmune disorder 49.79 13.84 3 73027 76741 90478676
Breast cancer 49.77 13.84 124 72906 53637 90501780
Peripheral venous disease 49.63 13.84 5 73025 83916 90471501
Cytomegalovirus gastritis 49.17 13.84 16 73014 328 90555089
Complications of transplanted kidney 49.12 13.84 30 73000 2848 90552569
Blood alkaline phosphatase increased 48.90 13.84 115 72915 47964 90507453
Eating disorder 48.85 13.84 84 72946 27989 90527428
Concomitant disease aggravated 48.64 13.84 53 72977 11465 90543952
Injection site reaction 48.41 13.84 8 73022 92072 90463345
Joint stiffness 47.89 13.84 4 73026 78038 90477379
Drug level decreased 46.82 13.84 48 72982 9682 90545735
Metastases to spleen 46.26 13.84 14 73016 224 90555193
Odynophagia 46.05 13.84 46 72984 8997 90546420
West Nile viral infection 46.03 13.84 17 73013 514 90554903
Suicide attempt 45.90 13.84 4 73026 75395 90480022
Injection site hypersensitivity 45.84 13.84 28 73002 2659 90552758
Hepatic neoplasm 45.62 13.84 26 73004 2172 90553245
Metastases to adrenals 45.47 13.84 20 73010 958 90554459
Flatulence 45.44 13.84 102 72928 41265 90514152
Immunosuppressant drug level decreased 45.02 13.84 21 73009 1155 90554262
Aspartate aminotransferase increased 44.82 13.84 183 72847 102754 90452663
Night sweats 44.67 13.84 24 73006 128742 90426675
Onychoclasis 44.02 13.84 41 72989 7358 90548059
Off label use 43.68 13.84 626 72404 1101626 89453791
Hypoaesthesia 42.97 13.84 121 72909 314089 90241328
Pseudocirrhosis 42.90 13.84 19 73011 925 90554492
Lip dry 42.75 13.84 14 73016 100941 90454476
Karnofsky scale worsened 42.52 13.84 8 73022 10 90555407
Blood pressure systolic increased 42.35 13.84 123 72907 58222 90497195
Injection site mass 42.31 13.84 69 72961 22021 90533396
Oncologic complication 42.28 13.84 13 73017 220 90555197
Infusion site induration 42.24 13.84 22 73008 1537 90553880
Red blood cell sedimentation rate increased 41.63 13.84 8 73022 82587 90472830
Lower limb fracture 41.26 13.84 9 73021 85004 90470413
Muscle contractions involuntary 41.17 13.84 27 73003 2901 90552516
Lung disorder 40.97 13.84 233 72797 149650 90405767
Pelvic neoplasm 40.08 13.84 14 73016 359 90555058
Product use in unapproved indication 39.72 13.84 430 72600 335806 90219611
Wound infection 39.68 13.84 18 73012 106384 90449033
Glomerular filtration rate decreased 39.59 13.84 58 72972 16874 90538543
Amnesia 39.47 13.84 19 73011 108486 90446931
Drug level increased 39.34 13.84 76 72954 27686 90527731
Ingrowing nail 39.25 13.84 26 73004 2841 90552576
Adverse event 39.12 13.84 23 73007 117395 90438022
Cardiac failure 38.79 13.84 183 72847 109313 90446104
Mean cell haemoglobin decreased 38.69 13.84 34 72996 5661 90549756
Bradycardia 38.48 13.84 10 73020 83837 90471580
Heart transplant rejection 38.40 13.84 17 73013 827 90554590
Tumour pain 38.31 13.84 22 73008 1865 90553552
Kidney fibrosis 37.40 13.84 23 73007 2211 90553206
Skin toxicity 37.35 13.84 36 72994 6743 90548674
Migraine 37.15 13.84 60 72970 190332 90365085
Cachexia 36.91 13.84 36 72994 6842 90548575
Intestinal obstruction 36.88 13.84 88 72942 37043 90518374
Overdose 36.46 13.84 44 72986 157665 90397752
Escherichia sepsis 36.10 13.84 33 72997 5783 90549634
Asthenia 35.98 13.84 617 72413 533134 90022283
Adverse drug reaction 35.95 13.84 25 73005 116676 90438741
Headache 35.89 13.84 485 72545 862261 89693156
Metastases to thorax 35.83 13.84 12 73018 270 90555147
Ovarian cyst 35.78 13.84 56 72974 17262 90538155
Hepatic mass 35.40 13.84 22 73008 2155 90553262
Post-traumatic neck syndrome 34.91 13.84 23 73007 2491 90552926
Lymphocyte count decreased 34.74 13.84 83 72947 34967 90520450
Colitis ulcerative 34.59 13.84 4 73026 60262 90495155
Somnolence 34.49 13.84 73 72957 209011 90346406
Muscle spasms 34.43 13.84 97 72933 251786 90303631
Genitourinary tract neoplasm 34.21 13.84 8 73022 43 90555374
Metastases to pelvis 34.16 13.84 14 73016 562 90554855
Foot deformity 34.14 13.84 4 73026 59647 90495770
Hepatic function abnormal 33.99 13.84 98 72932 46190 90509227
Carcinoembryonic antigen increased 33.85 13.84 22 73008 2328 90553089
Eyelid oedema 33.71 13.84 44 72986 11490 90543927
Congenital coronary artery malformation 33.70 13.84 10 73020 149 90555268
Suicidal ideation 33.53 13.84 9 73021 73846 90481571
Porocarcinoma 33.44 13.84 7 73023 20 90555397
Multiple organ dysfunction syndrome 33.40 13.84 126 72904 68210 90487207
Recurrent cancer 32.94 13.84 22 73008 2437 90552980
Metastases to muscle 32.93 13.84 10 73020 162 90555255
Delirium 32.62 13.84 22 73008 104337 90451080
Dry skin 32.52 13.84 149 72881 87924 90467493
Vasodilatation 32.05 13.84 23 73007 2861 90552556
Contusion 31.98 13.84 100 72930 251116 90304301
Gastrooesophageal reflux disease 31.91 13.84 53 72977 166284 90389133
Product quality issue 31.87 13.84 12 73018 79313 90476104
Bone erosion 31.77 13.84 3 73027 53018 90502399
Nephrotic syndrome 31.39 13.84 34 72996 7305 90548112
Metastases to meninges 30.94 13.84 25 73005 3710 90551707
Intestinal metastasis 30.37 13.84 10 73020 213 90555204
Reflux gastritis 30.20 13.84 17 73013 1387 90554030
Muscular weakness 30.19 13.84 77 72953 206589 90348828
Nasal discharge discolouration 29.99 13.84 22 73008 2831 90552586
Metastases to pancreas 29.93 13.84 11 73019 328 90555089
Exposed bone in jaw 29.49 13.84 22 73008 2904 90552513
Anaphylactic reaction 29.36 13.84 17 73013 87507 90467910
Metastases to kidney 29.13 13.84 10 73020 243 90555174
Angiosarcoma 29.06 13.84 10 73020 245 90555172
Dyspepsia 28.82 13.84 74 72956 198086 90357331
Carcinoid tumour pulmonary 28.68 13.84 12 73018 508 90554909
Stomatitis haemorrhagic 28.48 13.84 8 73022 97 90555320
Soft tissue sarcoma 28.45 13.84 9 73021 168 90555249
Hepatic angiosarcoma 28.44 13.84 6 73024 18 90555399
Pulmonary mass 28.37 13.84 68 72962 28704 90526713
Drug-induced liver injury 28.28 13.84 19 73011 90299 90465118
Neuroendocrine tumour 28.16 13.84 14 73016 887 90554530
Lymphadenopathy 28.08 13.84 91 72939 45684 90509733
Pleural disorder 28.07 13.84 13 73017 703 90554714
Generalised oedema 28.03 13.84 53 72977 19000 90536417
Drug resistance 27.93 13.84 70 72960 30379 90525038
Cytomegalovirus gastrointestinal infection 27.68 13.84 11 73019 407 90555010
Bone cancer 27.54 13.84 17 73013 1645 90553772
Carcinoid tumour 27.46 13.84 11 73019 416 90555001
Renal amyloidosis 27.37 13.84 10 73020 293 90555124
Pleural neoplasm 27.36 13.84 11 73019 420 90554997
Nausea 27.28 13.84 1123 71907 1109193 89446224
Hepatic failure 27.16 13.84 82 72948 39646 90515771
Herpes simplex hepatitis 27.06 13.84 12 73018 586 90554831
Chronic obstructive pulmonary disease 26.74 13.84 13 73017 73816 90481601
Alanine aminotransferase increased 26.65 13.84 175 72855 118163 90437254
Hyperhidrosis 26.54 13.84 43 72987 136262 90419155
Lymphocele 26.53 13.84 13 73017 798 90554619
Urine output decreased 26.38 13.84 41 72989 12562 90542855
Therapeutic product effective for unapproved indication 26.32 13.84 8 73022 130 90555287
Pulmonary fibrosis 25.92 13.84 29 73001 107474 90447943
Japanese spotted fever 25.86 13.84 6 73024 31 90555386
Metastases to bladder 25.76 13.84 9 73021 231 90555186
Visual impairment 25.55 13.84 42 72988 132323 90423094
Injection site pruritus 25.52 13.84 6 73024 53828 90501589
Chapped lips 25.44 13.84 20 73010 2853 90552564
Organising pneumonia 25.41 13.84 31 72999 7566 90547851
Pathological fracture 25.40 13.84 35 72995 9625 90545792
Jejunal ulcer perforation 25.39 13.84 6 73024 34 90555383
Nasal cavity cancer 25.22 13.84 7 73023 81 90555336
Exostosis 25.04 13.84 6 73024 53128 90502289
Dizziness 24.91 13.84 330 72700 588954 89966463
Insomnia 24.81 13.84 162 72868 333312 90222105
Therapy change 24.72 13.84 32 72998 8290 90547127
Pulmonary tumour thrombotic microangiopathy 24.61 13.84 7 73023 89 90555328
Osteoporosis 24.43 13.84 25 73005 96506 90458911
Pulmonary oedema 24.40 13.84 107 72923 61973 90493444
Oral mucosal blistering 24.38 13.84 29 73001 6895 90548522
Tonic convulsion 24.37 13.84 16 73014 1722 90553695
Pneumothorax 24.19 13.84 50 72980 19117 90536300
Blood creatinine decreased 24.13 13.84 28 73002 6487 90548930
Lymphangitis 24.09 13.84 13 73017 976 90554441
Ageusia 24.00 13.84 45 72985 16031 90539386
Cognitive disorder 23.97 13.84 13 73017 69394 90486023
Renal disorder 23.89 13.84 76 72954 37783 90517634
Metastases to soft tissue 23.71 13.84 9 73021 294 90555123
Haemolytic uraemic syndrome 23.68 13.84 19 73011 2792 90552625
Abdominal distension 23.52 13.84 183 72847 130418 90424999
Toothache 23.51 13.84 54 72976 22176 90533241
Neutrophil count decreased 23.49 13.84 117 72913 71415 90484002
Gait disturbance 23.43 13.84 119 72911 260377 90295040
Cancer pain 23.36 13.84 22 73008 4003 90551414
Injection site erythema 23.28 13.84 27 73003 98475 90456942
Lactic acidosis 23.19 13.84 6 73024 50457 90504960
Hepatitis E 23.09 13.84 16 73014 1883 90553534
Road traffic accident 22.84 13.84 32 72998 107594 90447823
Tongue ulceration 22.71 13.84 22 73008 4146 90551271
Blood pressure fluctuation 22.66 13.84 7 73023 52406 90503011
Abdominal pain 22.63 13.84 446 72584 395275 90160142
Aortitis salmonella 22.59 13.84 5 73025 20 90555397
Selenium deficiency 22.59 13.84 6 73024 58 90555359
Peripheral coldness 22.14 13.84 40 72990 13852 90541565
Eosinophil cationic protein increased 21.97 13.84 6 73024 65 90555352
Insulinoma 21.86 13.84 7 73023 136 90555281
Vomiting 21.82 13.84 808 72222 787485 89767932
Oral herpes 21.80 13.84 68 72962 33456 90521961
Tumour marker abnormal 21.64 13.84 9 73021 375 90555042
Disseminated varicella zoster vaccine virus infection 21.57 13.84 6 73024 70 90555347
Hypotension 21.32 13.84 164 72866 325233 90230184
Mass 21.29 13.84 42 72988 15535 90539882
Oedematous kidney 21.26 13.84 7 73023 149 90555268
Tumour necrosis 21.21 13.84 12 73018 989 90554428
Cheilitis 21.07 13.84 23 73007 4984 90550433
Skin sensitisation 21.05 13.84 12 73018 1003 90554414
Invasive lobular breast carcinoma 20.90 13.84 12 73018 1017 90554400
Unevaluable event 20.88 13.84 9 73021 54839 90500578
Hydrothorax 20.85 13.84 12 73018 1021 90554396
Vein disorder 20.85 13.84 24 73006 5512 90549905
Lung transplant rejection 20.77 13.84 12 73018 1029 90554388
Macular degeneration 20.64 13.84 3 73027 37967 90517450
Hepatic atrophy 20.55 13.84 8 73022 280 90555137
Portal hypertension 20.49 13.84 22 73008 4679 90550738
Hallucination 20.48 13.84 14 73016 65945 90489472
Metastases to spinal cord 20.47 13.84 8 73022 283 90555134
Onychomalacia 20.46 13.84 4 73026 7 90555410
Enterocolitis 20.40 13.84 33 72997 10457 90544960
Jaundice 20.27 13.84 65 72965 32452 90522965
Crepitations 20.23 13.84 30 73000 8822 90546595
Therapeutic product ineffective for unapproved indication 20.21 13.84 8 73022 293 90555124
Onychomycosis 20.20 13.84 3 73027 37373 90518044
Upper respiratory tract infection 20.17 13.84 46 72984 128272 90427145
Kidney congestion 20.13 13.84 5 73025 36 90555381
Metastatic neoplasm 20.06 13.84 22 73008 4793 90550624
Hepatitis viral 20.02 13.84 10 73020 640 90554777
Cerebral ventricle collapse 20.01 13.84 5 73025 37 90555380
Dyslipidaemia 19.94 13.84 32 72998 10075 90545342
Renal transplant failure 19.84 13.84 12 73018 1120 90554297
Sedation 19.83 13.84 7 73023 48164 90507253
Respiratory failure 19.73 13.84 163 72867 118255 90437162
Transplantation associated food allergy 19.67 13.84 5 73025 40 90555377
Bile duct stenosis 19.60 13.84 14 73016 1728 90553689
5-hydroxyindolacetic acid increased 19.50 13.84 4 73026 10 90555407
Pruritus 19.47 13.84 313 72717 541212 90014205
Neck pain 19.45 13.84 39 72991 113924 90441493
Anxiety 19.42 13.84 158 72872 309614 90245803
Subileus 19.42 13.84 19 73011 3625 90551792
Mouth injury 19.34 13.84 12 73018 1172 90554245
Dermatitis 19.26 13.84 50 72980 22170 90533247
Skin lesion 19.18 13.84 70 72960 37295 90518122
Infection 19.08 13.84 193 72837 361901 90193516
Hormone refractory breast cancer 18.96 13.84 4 73026 12 90555405
5-hydroxyindolacetic acid 18.96 13.84 4 73026 12 90555405
Hydronephrosis 18.87 13.84 35 72995 12367 90543050
Walking aid user 18.85 13.84 3 73027 35503 90519914
Serum serotonin increased 18.85 13.84 7 73023 215 90555202
Agitation 18.60 13.84 16 73014 67082 90488335
5-hydroxyindolacetic acid in urine 18.49 13.84 4 73026 14 90555403
Plasma cell myeloma 18.49 13.84 5 73025 40823 90514594
Complications of transplanted heart 18.48 13.84 6 73024 122 90555295
Steatorrhoea 18.27 13.84 9 73021 559 90554858
Plasmodium falciparum infection 18.16 13.84 5 73025 56 90555361
Neutrophilic panniculitis 18.08 13.84 5 73025 57 90555360
Epstein-Barr virus infection reactivation 18.06 13.84 13 73017 1624 90553793
Oral disorder 18.06 13.84 31 72999 10314 90545103
Biliary dilatation 18.05 13.84 16 73014 2695 90552722
Metastases to breast 18.04 13.84 8 73022 391 90555026
Metastases to stomach 18.01 13.84 7 73023 244 90555173
Splenic lesion 17.98 13.84 7 73023 245 90555172
Infusion site haemorrhage 17.97 13.84 22 73008 5389 90550028
Acute kidney injury 17.94 13.84 360 72670 320027 90235390
Breast pain 17.90 13.84 31 72999 10387 90545030
Oesophagitis ulcerative 17.88 13.84 10 73020 806 90554611
Cytomegalovirus oesophagitis 17.72 13.84 8 73022 408 90555009
Injection site pain 17.59 13.84 76 72954 173623 90381794
Skin plaque 17.55 13.84 30 73000 9945 90545472
Terminal state 17.51 13.84 16 73014 2802 90552615
Joint dislocation 17.48 13.84 7 73023 44575 90510842
Renal lymphocele 17.48 13.84 5 73025 65 90555352
Delayed graft function 17.31 13.84 12 73018 1413 90554004
Lymphangioleiomyomatosis 17.17 13.84 7 73023 277 90555140
Vision blurred 16.96 13.84 40 72990 110253 90445164
Retinal detachment 16.87 13.84 24 73006 6798 90548619
Anorexia nervosa 16.83 13.84 7 73023 292 90555125
Varicella zoster virus infection 16.65 13.84 18 73012 3859 90551558
Bacterial infection 16.60 13.84 49 72981 23395 90532022
Radiation pneumonitis 16.60 13.84 13 73017 1845 90553572
Trichodysplasia spinulosa 16.45 13.84 9 73021 695 90554722
Mediastinal disorder 16.36 13.84 8 73022 489 90554928
Mucinous breast carcinoma 16.33 13.84 4 73026 27 90555390
Vasoactive intestinal polypeptide increased 16.30 13.84 3 73027 3 90555414
Primary pulmonary melanoma 16.30 13.84 3 73027 3 90555414
Bowel movement irregularity 16.23 13.84 23 73007 6491 90548926
Eastern Cooperative Oncology Group performance status worsened 16.11 13.84 13 73017 1926 90553491
Polyomavirus test positive 16.03 13.84 5 73025 89 90555328
Hepatic pain 15.98 13.84 17 73013 3578 90551839
Device dislocation 15.97 13.84 3 73027 31479 90523938
Ejection fraction decreased 15.93 13.84 52 72978 26201 90529216
Dysphagia 15.83 13.84 149 72881 112129 90443288
No adverse event 15.67 13.84 19 73011 67963 90487454
Emotional distress 15.67 13.84 5 73025 36657 90518760
Atypical pneumonia 15.56 13.84 20 73010 5144 90550273
Congestive cardiomyopathy 15.50 13.84 24 73006 7330 90548087
Post transplant distal limb syndrome 15.45 13.84 7 73023 360 90555057
Cardiac arrest 15.39 13.84 39 72991 104896 90450521
Febrile infection 15.37 13.84 13 73017 2056 90553361
Amenorrhoea 15.29 13.84 31 72999 11691 90543726
Cardio-respiratory arrest 15.25 13.84 17 73013 63123 90492294
Anal ulcer 15.18 13.84 9 73021 810 90554607
Ascariasis 15.08 13.84 3 73027 6 90555411
Oral administration complication 15.08 13.84 5 73025 109 90555308
Water intoxication 15.05 13.84 8 73022 583 90554834
Cardiomyopathy 15.05 13.84 43 72987 20163 90535254
Loss of consciousness 15.04 13.84 60 72970 140178 90415239
Transient ischaemic attack 15.04 13.84 8 73022 43168 90512249
Haematotoxicity 15.00 13.84 32 72998 12503 90542914
Acute respiratory distress syndrome 14.94 13.84 54 72976 28632 90526785
Amniotic fluid index decreased 14.94 13.84 4 73026 40 90555377
Burning sensation mucosal 14.94 13.84 4 73026 40 90555377
Impaired insulin secretion 14.94 13.84 4 73026 40 90555377
Noninfective gingivitis 14.92 13.84 13 73017 2140 90553277
Foetal exposure during pregnancy 14.91 13.84 8 73022 42967 90512450
Vena cava thrombosis 14.91 13.84 14 73016 2538 90552879
Carcinoid heart disease 14.85 13.84 4 73026 41 90555376
Sinus arrhythmia 14.84 13.84 11 73019 1438 90553979
Underdose 14.82 13.84 13 73017 54004 90501413
Mucosal haemorrhage 14.81 13.84 11 73019 1442 90553975
Dysuria 14.79 13.84 67 72963 39334 90516083
Blood urea increased 14.79 13.84 56 72974 30357 90525060
Treatment noncompliance 14.75 13.84 12 73018 51715 90503702
Alveolitis 14.71 13.84 15 73015 3006 90552411
Salpingectomy 14.69 13.84 7 73023 404 90555013
Fibrin D dimer increased 14.69 13.84 20 73010 5440 90549977
Hot flush 14.64 13.84 90 72940 59398 90496019
Septic shock 14.64 13.84 117 72913 84043 90471374
Uterine mass 14.62 13.84 7 73023 408 90555009
Throat tightness 14.55 13.84 3 73027 29481 90525936
Focal segmental glomerulosclerosis 14.51 13.84 12 73018 1839 90553578
Aortic intramural haematoma 14.47 13.84 5 73025 124 90555293
Rectal haemorrhage 14.39 13.84 28 73002 82716 90472701
Peritoneal disorder 14.39 13.84 8 73022 637 90554780
Pneumonia 14.39 13.84 640 72390 637419 89917998
Cornea verticillata 14.38 13.84 6 73024 252 90555165
Organ failure 14.37 13.84 15 73015 3090 90552327
Blood potassium increased 14.34 13.84 43 72987 20706 90534711
Pancreatitis viral 14.22 13.84 3 73027 9 90555408
Pleural mass 14.22 13.84 3 73027 9 90555408
Ovarian cyst torsion 14.22 13.84 3 73027 9 90555408
Bone disorder 14.21 13.84 46 72984 23074 90532343
Presyncope 14.20 13.84 4 73026 31801 90523616
Injection site induration 14.03 13.84 28 73002 10440 90544977
Escherichia infection 14.02 13.84 36 72994 15859 90539558
Renal salt-wasting syndrome 13.95 13.84 7 73023 452 90554965
Hypoxia 13.90 13.84 103 72927 72296 90483121
Arterial thrombosis 13.87 13.84 11 73019 1589 90553828

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
Malignant neoplasm progression 1096.73 13.11 965 50733 107435 42462202
Stomatitis 661.33 13.11 522 51176 49807 42519830
Polyomavirus-associated nephropathy 358.44 13.11 162 51536 5453 42564184
Polyomavirus viraemia 325.17 13.11 115 51583 1997 42567640
Neoplasm malignant 307.22 13.11 240 51458 22503 42547134
BK virus infection 260.19 13.11 151 51547 8633 42561004
Neoplasm progression 252.61 13.11 238 51460 28762 42540875
Metastases to liver 237.34 13.11 180 51518 16146 42553491
Post transplant lymphoproliferative disorder 224.02 13.11 139 51559 8981 42560656
Metastases to lung 211.83 13.11 146 51552 11278 42558359
Pneumonitis 210.03 13.11 256 51442 41462 42528175
Transplant rejection 191.31 13.11 147 51551 13441 42556196
Kidney transplant rejection 187.50 13.11 122 51576 8561 42561076
Viraemia 183.10 13.11 72 51626 1698 42567939
Interstitial lung disease 161.28 13.11 318 51380 78144 42491493
Diarrhoea 157.59 13.11 1025 50673 459824 42109813
Mouth ulceration 142.26 13.11 129 51569 14834 42554803
Proteinuria 140.67 13.11 156 51542 22827 42546810
Immunosuppressant drug level decreased 133.69 13.11 58 51640 1766 42567871
Renal impairment 130.78 13.11 360 51338 109868 42459769
Liver transplant rejection 124.86 13.11 61 51637 2452 42567185
Thrombotic microangiopathy 109.37 13.11 111 51587 14671 42554966
Drug abuse 106.05 13.11 5 51693 104766 42464871
Cytomegalovirus infection 105.84 13.11 161 51537 32145 42537492
Oral pain 105.11 13.11 101 51597 12495 42557142
Heart transplant rejection 103.43 13.11 46 51652 1488 42568149
Metastases to bone 101.98 13.11 107 51591 14702 42554935
Epstein-Barr virus infection 100.75 13.11 88 51610 9630 42560007
Death 100.57 13.11 940 50758 470245 42099392
Decreased appetite 92.06 13.11 470 51228 192667 42376970
Cough 86.67 13.11 436 51262 177667 42391970
Hepatitis E 85.24 13.11 51 51647 3083 42566554
Acne 79.01 13.11 90 51608 13554 42556083
Immunosuppressant drug level increased 78.12 13.11 69 51629 7662 42561975
Fall 75.13 13.11 105 51593 234415 42335222
Aphthous ulcer 74.75 13.11 60 51638 5841 42563796
Complications of transplanted kidney 69.06 13.11 55 51643 5295 42564342
Hyperglycaemia 67.98 13.11 163 51535 45696 42523941
Concomitant disease progression 66.18 13.11 40 51658 2463 42567174
Mucosal inflammation 64.26 13.11 167 51531 49207 42520430
Lymphocele 63.50 13.11 33 51665 1514 42568123
Blood creatinine increased 63.43 13.11 283 51415 109720 42459917
Pleural effusion 62.19 13.11 258 51440 96908 42472729
Metastases to lymph nodes 61.54 13.11 54 51644 5944 42563693
Infusion related reaction 61.20 13.11 3 51695 60803 42508834
C-reactive protein increased 60.41 13.11 192 51506 63368 42506269
Blood chromogranin A increased 58.75 13.11 20 51678 308 42569329
Gamma-glutamyltransferase increased 56.46 13.11 123 51575 32374 42537263
Hypotension 55.66 13.11 146 51552 257485 42312152
Stenotrophomonas infection 54.16 13.11 41 51657 3663 42565974
Atrial fibrillation 53.74 13.11 54 51644 139539 42430098
Lung infiltration 53.46 13.11 75 51623 13914 42555723
Renal transplant failure 53.03 13.11 29 51669 1476 42568161
Cholangitis 52.59 13.11 65 51633 10662 42558975
Condition aggravated 50.99 13.11 155 51543 260599 42309038
Fatigue 50.82 13.11 775 50923 434866 42134771
Human herpesvirus 8 infection 50.42 13.11 28 51670 1469 42568168
Oedema peripheral 50.02 13.11 309 51389 135767 42433870
Product dose omission issue 49.49 13.11 69 51629 154296 42415341
Somnolence 49.44 13.11 59 51639 141046 42428591
Hepatic lesion 49.22 13.11 42 51656 4452 42565185
Bradycardia 49.22 13.11 21 51677 85463 42484174
Product use in unapproved indication 49.05 13.11 387 51311 184069 42385568
Drug hypersensitivity 48.91 13.11 30 51668 99359 42470278
Osteonecrosis of jaw 48.86 13.11 85 51613 18964 42550673
Squamous cell carcinoma of skin 48.29 13.11 68 51630 12658 42556979
Metastasis 47.55 13.11 42 51656 4663 42564974
Asthma 47.48 13.11 9 51689 62305 42507332
Metastases to peritoneum 47.04 13.11 32 51666 2417 42567220
Chronic allograft nephropathy 46.06 13.11 27 51671 1571 42568066
Renal tubular atrophy 45.71 13.11 26 51672 1429 42568208
Second primary malignancy 45.31 13.11 57 51641 9518 42560119
Suicide attempt 44.17 13.11 3 51695 46097 42523540
Bile duct stenosis 44.14 13.11 25 51673 1363 42568274
Acanthoma 44.11 13.11 10 51688 27 42569610
Intentional product misuse 42.99 13.11 11 51687 61889 42507748
Palmar-plantar erythrodysaesthesia syndrome 42.92 13.11 84 51614 20498 42549139
Biphasic mesothelioma 41.84 13.11 11 51687 64 42569573
Blood pressure increased 41.64 13.11 238 51460 101690 42467947
Lung disorder 41.25 13.11 140 51558 47783 42521854
Febrile neutropenia 41.02 13.11 104 51594 185599 42384038
Superinfection viral 39 13.11 9 51689 27 42569610
Suicidal ideation 38.79 13.11 6 51692 48155 42521482
Mycobacterium haemophilum infection 38.53 13.11 16 51682 436 42569201
Loss of personal independence in daily activities 38.36 13.11 7 51691 49809 42519828
Foetal exposure during pregnancy 37.86 13.11 6 51692 47305 42522332
Pyrexia 37.40 13.11 678 51020 393364 42176273
Dizziness 36.99 13.11 166 51532 249088 42320549
Drug reaction with eosinophilia and systemic symptoms 36.87 13.11 4 51694 42071 42527566
Tachycardia 36.77 13.11 41 51657 101046 42468591
Insulinoma 36.02 13.11 8 51690 19 42569618
Epistaxis 35.57 13.11 168 51530 66658 42502979
Chronic obstructive pulmonary disease 35.54 13.11 16 51682 63098 42506539
Myocardial infarction 35.35 13.11 60 51638 123949 42445688
Needle issue 35.16 13.11 48 51650 8679 42560958
Psoriasis 35.00 13.11 8 51690 48596 42521041
Paraesthesia 35.00 13.11 23 51675 73436 42496201
Metastases to central nervous system 34.45 13.11 52 51646 10303 42559334
Enterocolitis viral 34.41 13.11 15 51683 462 42569175
Loss of consciousness 34.09 13.11 37 51661 92317 42477320
Lymphangiosis carcinomatosa 33.85 13.11 19 51679 1018 42568619
Disease progression 33.13 13.11 292 51406 143364 42426273
Metastases to pancreas 33.13 13.11 14 51684 399 42569238
Kidney fibrosis 33.05 13.11 27 51671 2695 42566942
Nephropathy toxic 33.04 13.11 67 51631 16771 42552866
Pancreatic neuroendocrine tumour 33.04 13.11 13 51685 307 42569330
Intentional product use issue 32.23 13.11 24 51674 71809 42497828
Musculoskeletal stiffness 31.98 13.11 15 51683 57750 42511887
Drug ineffective 31.84 13.11 556 51142 629641 41939996
Parvovirus B19 infection 31.75 13.11 22 51676 1712 42567925
Depression 31.63 13.11 54 51644 111309 42458328
Odynophagia 31.55 13.11 40 51658 6730 42562907
Carcinoid crisis 31.29 13.11 12 51686 264 42569373
Vascular hyalinosis 31.29 13.11 10 51688 125 42569512
Cardiac arrest 31.06 13.11 53 51645 109267 42460370
Gastric ulcer haemorrhage, obstructive 30.85 13.11 7 51691 19 42569618
Pancreatic neuroendocrine tumour metastatic 30.79 13.11 10 51688 132 42569505
JC virus infection 30.73 13.11 27 51671 2977 42566660
Anxiety 30.56 13.11 61 51637 118499 42451138
Metastases to gastrointestinal tract 30.25 13.11 9 51689 87 42569550
Metastases to adrenals 30.14 13.11 18 51680 1084 42568553
Weight decreased 29.79 13.11 384 51314 207564 42362073
Coma 29.50 13.11 14 51684 53540 42516097
Parasitic gastroenteritis 29.43 13.11 10 51688 153 42569484
Haemoglobin decreased 29.38 13.11 267 51431 132204 42437433
Elephantiasis nostras verrucosa 28.58 13.11 5 51693 0 42569637
Metastases to eye 28.57 13.11 9 51689 107 42569530
Anaemia 28.21 13.11 487 51211 279791 42289846
Isosporiasis 27.91 13.11 9 51689 116 42569521
Polyomavirus test positive 27.68 13.11 10 51688 185 42569452
Metastases to pleura 27.46 13.11 14 51684 617 42569020
International normalised ratio increased 27.45 13.11 12 51686 48156 42521481
Transitional cell carcinoma 27.41 13.11 24 51674 2634 42567003
Cardio-respiratory arrest 27.07 13.11 19 51679 58617 42511020
Blood alkaline phosphatase increased 27.04 13.11 96 51602 33501 42536136
Hypertriglyceridaemia 27.04 13.11 46 51652 10080 42559557
Dyslipidaemia 26.77 13.11 44 51654 9374 42560263
Overdose 26.41 13.11 55 51643 105209 42464428
Ascites 26.26 13.11 137 51561 56541 42513096
Hypercholesterolaemia 26.25 13.11 52 51646 12797 42556840
Lactic acidosis 26.24 13.11 11 51687 45250 42524387
Cytomegalovirus colitis 26.05 13.11 28 51670 3953 42565684
Hypoaesthesia 25.96 13.11 29 51669 71434 42498203
Pneumocystis jirovecii infection 25.89 13.11 24 51674 2836 42566801
Complications of transplanted heart 25.79 13.11 11 51687 321 42569316
Agitation 25.75 13.11 24 51674 64290 42505347
Electrocardiogram QT prolonged 25.70 13.11 13 51685 47932 42521705
Granulomatous rosacea 25.46 13.11 9 51689 156 42569481
Anogenital warts 25.45 13.11 14 51684 721 42568916
Biliary obstruction 25.26 13.11 25 51673 3204 42566433
Pneumonia cytomegaloviral 25.22 13.11 28 51670 4098 42565539
Pseudohypoaldosteronism 25.12 13.11 5 51693 5 42569632
Drug level decreased 24.91 13.11 44 51654 9933 42559704
Hallucination 24.79 13.11 20 51678 57487 42512150
Haemolytic uraemic syndrome 24.79 13.11 22 51676 2457 42567180
Hyperhidrosis 24.69 13.11 45 51653 90467 42479170
Pyelonephritis acute 24.63 13.11 22 51676 2478 42567159
Gastrointestinal ulcer perforation 24.48 13.11 7 51691 58 42569579
Mononeuropathy 24.06 13.11 10 51688 273 42569364
Cytokine release syndrome 23.98 13.11 12 51686 44515 42525122
Treatment noncompliance 23.77 13.11 8 51690 37664 42531973
Blood pressure systolic increased 23.44 13.11 81 51617 27887 42541750
Erythrophagocytosis 23.26 13.11 6 51692 32 42569605
Neoplasm 22.90 13.11 33 51665 6272 42563365
Accidental exposure to product packaging 22.86 13.11 4 51694 0 42569637
General physical health deterioration 22.79 13.11 282 51416 150964 42418673
Transplant dysfunction 22.73 13.11 24 51674 3319 42566318
Human polyomavirus infection 22.62 13.11 16 51682 1287 42568350
Drug dependence 22.59 13.11 4 51694 29090 42540547
Metastases to spine 22.56 13.11 23 51675 3054 42566583
Blood gastrin increased 22.39 13.11 6 51692 38 42569599
Toxic epidermal necrolysis 22.31 13.11 3 51695 26747 42542890
Cell marker increased 22.31 13.11 11 51687 451 42569186
Neuroendocrine tumour 22.31 13.11 14 51684 922 42568715
Anaphylactic reaction 22.30 13.11 12 51686 42731 42526906
Norovirus infection 22.22 13.11 13 51685 754 42568883
Abdominal pain 22.13 13.11 339 51359 190132 42379505
Drug level increased 22.06 13.11 76 51622 26124 42543513
Haematochezia 22.02 13.11 23 51675 58413 42511224
Cerebrovascular accident 21.75 13.11 54 51644 97106 42472531
Syncope 21.67 13.11 56 51642 99350 42470287
Therapeutic product effect incomplete 21.45 13.11 33 51665 70906 42498731
Biliary anastomosis complication 21.24 13.11 7 51691 97 42569540
Arthropathy 21.05 13.11 5 51693 29592 42540045
Hepatic artery stenosis 20.94 13.11 8 51690 174 42569463
Muscle spasms 20.71 13.11 46 51652 85998 42483639
Contraindicated product administered 20.69 13.11 3 51695 25269 42544368
Tumour compression 20.61 13.11 8 51690 182 42569455
Dysgeusia 20.46 13.11 89 51609 34100 42535537
Renal failure 20.38 13.11 265 51433 143461 42426176
COVID-19 pneumonia 20.25 13.11 65 51633 21548 42548089
Renal cancer metastatic 20.18 13.11 11 51687 556 42569081
Metastases to skin 20.17 13.11 11 51687 557 42569080
Cardiogenic shock 20.12 13.11 9 51689 35631 42534006
Lung consolidation 20.07 13.11 32 51666 6645 42562992
Anorectal varices 19.98 13.11 6 51692 60 42569577
Muscular weakness 19.81 13.11 45 51653 83453 42486184
Ileal ulcer 19.73 13.11 13 51685 931 42568706
Ventricular fibrillation 19.71 13.11 6 51692 30117 42539520
Blood lactate dehydrogenase increased 19.69 13.11 73 51625 26008 42543629
Neuropathy peripheral 19.53 13.11 61 51637 101792 42467845
Stress 19.53 13.11 15 51683 44197 42525440
Liver abscess 19.52 13.11 27 51671 4943 42564694
Hyponatraemia 19.29 13.11 61 51637 101401 42468236
Concomitant disease aggravated 19.03 13.11 31 51667 6555 42563082
Crepitations 18.95 13.11 22 51676 3379 42566258
Blood triglycerides increased 18.88 13.11 52 51646 15844 42553793
Carcinoid tumour pulmonary 18.83 13.11 4 51694 7 42569630
Hepatic vein stenosis 18.83 13.11 4 51694 7 42569630
Metastases to the mediastinum 18.79 13.11 9 51689 346 42569291
Renal cell carcinoma 18.77 13.11 28 51670 5489 42564148
Metastases to kidney 18.69 13.11 9 51689 350 42569287
Actinic keratosis 18.67 13.11 27 51671 5149 42564488
Oedema 18.39 13.11 117 51581 51884 42517753
Metastases to thorax 18.35 13.11 6 51692 81 42569556
Bone pain 18.31 13.11 67 51631 23725 42545912
Dehydration 18.30 13.11 257 51441 141510 42428127
Lymphoedema 18.12 13.11 26 51672 4922 42564715
Feeding disorder 18.12 13.11 35 51663 8456 42561181
Cardiac failure congestive 18.06 13.11 49 51649 85553 42484084
Palpitations 18.03 13.11 21 51677 50776 42518861
Transitional cell cancer of renal pelvis and ureter metastatic 17.87 13.11 4 51694 10 42569627
Arthralgia 17.85 13.11 161 51537 205077 42364560
Oxygen saturation decreased 17.78 13.11 32 51666 64655 42504982
Hepatic artery thrombosis 17.78 13.11 8 51690 266 42569371
Cytomegalovirus test positive 17.77 13.11 24 51674 4295 42565342
Acute respiratory distress syndrome 17.73 13.11 78 51620 30030 42539607
Inferior vena cava stenosis 17.71 13.11 6 51692 91 42569546
Donor specific antibody present 17.65 13.11 7 51691 169 42569468
Malacoplakia 17.57 13.11 12 51686 912 42568725
Biliary ischaemia 17.47 13.11 6 51692 95 42569542
Pyelonephritis 17.35 13.11 33 51665 7881 42561756
Lung squamous cell carcinoma stage II 17.33 13.11 4 51694 12 42569625
Tumour necrosis 17.26 13.11 15 51683 1629 42568008
Rhabdomyoma 17.15 13.11 3 51695 0 42569637
Confusional state 17.08 13.11 126 51572 167471 42402166
Incisional hernia 17.04 13.11 14 51684 1408 42568229
Transitional cell carcinoma metastatic 17.02 13.11 6 51692 103 42569534
Bacteriuria 17.01 13.11 8 51690 295 42569342
Gonococcal infection 16.93 13.11 5 51693 47 42569590
Cryptosporidiosis infection 16.84 13.11 11 51687 776 42568861
Mucosal toxicity 16.84 13.11 8 51690 302 42569335
Orthostatic hypotension 16.82 13.11 8 51690 30562 42539075
Anaphylactic shock 16.67 13.11 4 51694 23513 42546124
Necrosis of artery 16.65 13.11 4 51694 15 42569622
Carcinoid syndrome 16.51 13.11 6 51692 113 42569524
Brain neoplasm 16.50 13.11 21 51677 3547 42566090
Obstructive nephropathy 16.39 13.11 5 51693 53 42569584
Prostate cancer 16.34 13.11 18 51680 44625 42525012
Amnesia 16.34 13.11 7 51691 28430 42541207
Subdural haematoma 16.28 13.11 4 51694 23134 42546503
Coronary artery aneurysm 16.27 13.11 6 51692 118 42569519
Complex regional pain syndrome 16.26 13.11 10 51688 635 42569002
Cell death 16.26 13.11 19 51679 2940 42566697
Coronary artery disease 16.23 13.11 25 51673 53695 42515942
Lung transplant rejection 16.22 13.11 12 51686 1035 42568602
Encephalitis viral 16.16 13.11 14 51684 1514 42568123
Adverse drug reaction 16.16 13.11 13 51685 37421 42532216
Disturbance in attention 16.15 13.11 8 51690 29858 42539779
Therapy cessation 16.08 13.11 58 51640 20392 42549245
IgA nephropathy 16.07 13.11 17 51681 2357 42567280
Blood bilirubin abnormal 16.03 13.11 11 51687 843 42568794
Body temperature decreased 15.99 13.11 46 51652 14367 42555270
Diabetes mellitus 15.89 13.11 126 51572 59961 42509676
Cytomegalovirus gastrointestinal infection 15.81 13.11 8 51690 347 42569290
Procedural hypertension 15.75 13.11 5 51693 61 42569576
Alveolitis necrotising 15.72 13.11 4 51694 20 42569617
Impaired healing 15.72 13.11 51 51647 17002 42552635
Hypersensitivity 15.59 13.11 41 51657 72329 42497308
Eating disorder 15.58 13.11 36 51662 9849 42559788
Restlessness 15.57 13.11 8 51690 29241 42540396
Balance disorder 15.55 13.11 21 51677 47624 42522013
Psychotic disorder 15.53 13.11 8 51690 29200 42540437
Transient ischaemic attack 15.48 13.11 11 51687 33728 42535909
Sebaceous hyperplasia 15.48 13.11 6 51692 136 42569501
Hepatic neoplasm 15.38 13.11 16 51682 2175 42567462
Tumour invasion 15.33 13.11 8 51690 370 42569267
Injection site erythema 15.20 13.11 3 51695 20192 42549445
Pericardial effusion 15.13 13.11 73 51625 29202 42540435
Chimerism 15.07 13.11 7 51691 251 42569386
Hernial eventration 15.06 13.11 5 51693 71 42569566
Blood glucose increased 15.05 13.11 146 51552 73553 42496084
Trichodysplasia spinulosa 15.04 13.11 8 51690 385 42569252
Migraine 15.01 13.11 6 51692 25408 42544229
Eccrine carcinoma 14.97 13.11 4 51694 25 42569612
Depressed level of consciousness 14.80 13.11 22 51676 47948 42521689
Respiratory arrest 14.80 13.11 8 51690 28416 42541221
Renal mass 14.74 13.11 15 51683 1987 42567650
Unresponsive to stimuli 14.72 13.11 10 51688 31393 42538244
Performance status decreased 14.71 13.11 23 51675 4697 42564940
Drug withdrawal syndrome 14.63 13.11 4 51694 21545 42548092
Oral discomfort 14.53 13.11 18 51680 2959 42566678
Intestinal tuberculosis 14.50 13.11 6 51692 162 42569475
Urticaria 14.43 13.11 44 51654 73992 42495645
Delirium 14.42 13.11 26 51672 52493 42517144
Gastric antral vascular ectasia 14.38 13.11 8 51690 421 42569216
Neutrophil count decreased 14.38 13.11 35 51663 63380 42506257
Intra-abdominal fluid collection 14.36 13.11 13 51685 1490 42568147
Bile output abnormal 14.34 13.11 4 51694 30 42569607
Oesophageal obstruction 14.34 13.11 9 51689 593 42569044
Splenic artery aneurysm 14.23 13.11 4 51694 31 42569606
Contusion 14.22 13.11 18 51680 41967 42527670
Hepatocellular carcinoma 14.21 13.11 31 51667 8163 42561474
Asthenia 14.15 13.11 443 51255 280350 42289287
Bacterial infection 14.04 13.11 69 51629 27810 42541827
Metastases to salivary gland 14.02 13.11 5 51693 89 42569548
Incorrect route of product administration 13.93 13.11 6 51692 24299 42545338
Angiomyolipoma 13.92 13.11 5 51693 91 42569546
Tumour pain 13.88 13.11 12 51686 1295 42568342
Myocarditis 13.87 13.11 3 51695 18935 42550702
Renal hamartoma 13.86 13.11 3 51695 6 42569631
Infected seroma 13.86 13.11 3 51695 6 42569631
Lymphatic fistula 13.86 13.11 3 51695 6 42569631
Gastroduodenal haemorrhage 13.85 13.11 6 51692 182 42569455
Large intestinal ulcer 13.84 13.11 16 51682 2447 42567190
Human herpesvirus 6 infection reactivation 13.75 13.11 8 51690 459 42569178
Antiacetylcholine receptor antibody positive 13.62 13.11 5 51693 97 42569540
Thoracic cavity drainage 13.58 13.11 6 51692 191 42569446
Insomnia 13.48 13.11 86 51612 118167 42451470
Astrocytoma, low grade 13.34 13.11 5 51693 103 42569534
Drug resistance 13.33 13.11 79 51619 34169 42535468
Dysphonia 13.33 13.11 69 51629 28381 42541256
Cachexia 13.31 13.11 30 51668 8074 42561563
Vasculitis 13.30 13.11 3 51695 18391 42551246
Urinary tract infection staphylococcal 13.22 13.11 9 51689 681 42568956
Pneumocystis jirovecii pneumonia 13.17 13.11 63 51635 25118 42544519

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 3279.87 13.10 1967 92183 172600 110322549
Metastases to liver 1253.83 13.10 609 93541 34777 110460372
Metastases to bone 1031.03 13.10 513 93637 30859 110464290
Stomatitis 1010.49 13.10 1196 92954 269046 110226103
Polyomavirus-associated nephropathy 687.84 13.10 260 93890 7941 110487208
Pneumonitis 645.15 13.10 529 93621 76002 110419147
Metastases to lung 612.88 13.10 327 93823 22736 110472413
BK virus infection 579.58 13.10 263 93887 12843 110482306
Neoplasm progression 487.55 13.10 419 93731 64176 110430973
Polyomavirus viraemia 485.61 13.10 161 93989 3313 110491836
Transplant rejection 475.49 13.10 283 93867 24284 110470865
Post transplant lymphoproliferative disorder 419.39 13.10 223 93927 15390 110479759
Disease progression 395.32 13.10 729 93421 243305 110251844
Mucosal inflammation 384.25 13.10 441 93709 95700 110399449
Interstitial lung disease 373.93 13.10 524 93626 138810 110356339
Metastases to lymph nodes 332.85 13.10 189 93961 14843 110480306
Thrombotic microangiopathy 320.61 13.10 236 93914 28913 110466236
Viraemia 297.42 13.10 117 94033 3985 110491164
Kidney transplant rejection 282.46 13.10 157 93993 11830 110483319
Pleural effusion 277.74 13.10 523 93627 177186 110317963
Infusion related reaction 263.90 13.10 15 94135 381147 110114002
Hyperglycaemia 255.43 13.10 338 93812 84752 110410397
Osteonecrosis of jaw 252.94 13.10 255 93895 47762 110447387
Renal impairment 252.62 13.10 520 93630 187925 110307224
Death 246.64 13.10 1211 92939 697658 109797491
Aphthous ulcer 227.65 13.10 169 93981 20967 110474182
Mouth ulceration 223.63 13.10 239 93911 47899 110447250
Tumour marker increased 203.23 13.10 95 94055 4965 110490184
Arthropathy 203.10 13.10 10 94140 287512 110207637
Cytomegalovirus infection 199.56 13.10 239 93911 54205 110440944
Synovitis 198.63 13.10 8 94142 274084 110221065
Proteinuria 197.12 13.10 205 93945 39813 110455336
Immunosuppressant drug level decreased 193.78 13.10 77 94073 2694 110492455
Metastases to skin 193.17 13.10 73 94077 2226 110492923
Contraindicated product administered 191.72 13.10 4 94146 248263 110246886
Systemic lupus erythematosus 189.25 13.10 6 94144 254332 110240817
Cough 179.29 13.10 823 93327 460818 110034331
Immunosuppressant drug level increased 178.58 13.10 116 94034 11608 110483541
Therapeutic product effect decreased 167.86 13.10 10 94140 244306 110250843
Musculoskeletal stiffness 166.47 13.10 21 94129 279801 110215348
Hepatic lesion 164.73 13.10 98 94052 8395 110486754
Epstein-Barr virus infection 162.96 13.10 132 94018 18606 110476543
Condition aggravated 159.36 13.10 237 93913 734599 109760550
Liver transplant rejection 155.63 13.10 73 94077 3845 110491304
Diarrhoea 147.77 13.10 1549 92601 1137956 109357193
Pancreatic neuroendocrine tumour 142.00 13.10 46 94104 877 110494272
Joint swelling 138.19 13.10 105 94045 442740 110052409
Drug hypersensitivity 135 13.10 113 94037 453977 110041172
Decreased appetite 132.28 13.10 773 93377 475073 110020076
Pericarditis 131.40 13.10 16 94134 219098 110276051
Needle issue 131.03 13.10 114 94036 17726 110477423
Breast cancer metastatic 130.82 13.10 94 94056 11087 110484062
Lung infiltration 130.06 13.10 131 94019 24497 110470652
Drug abuse 125.80 13.10 6 94144 177405 110317744
Irritable bowel syndrome 125.38 13.10 3 94147 164212 110330937
Ascites 125.31 13.10 257 93893 92551 110402598
Complications of transplanted kidney 124.18 13.10 78 94072 7364 110487785
Metastasis 123.96 13.10 81 94069 8186 110486963
Maternal exposure during pregnancy 123.92 13.10 32 94118 254851 110240298
Fall 123.72 13.10 202 93948 603280 109891869
Hypersensitivity 120.73 13.10 100 94050 403898 110091251
Oral pain 120.51 13.10 154 93996 37290 110457859
Wound 118.74 13.10 27 94123 234410 110260739
Second primary malignancy 117.91 13.10 108 94042 17960 110477189
Blood creatinine increased 117.71 13.10 383 93767 182506 110312643
Neoplasm malignant 115.22 13.10 150 94000 36993 110458156
Oedema peripheral 115.12 13.10 569 93581 328091 110167058
Mobility decreased 115.06 13.10 30 94120 237392 110257757
Heart transplant rejection 113.50 13.10 48 94102 1973 110493176
Renal transplant failure 112.87 13.10 52 94098 2628 110492521
Helicobacter infection 112.26 13.10 12 94138 181865 110313284
Acne 109.68 13.10 139 94011 33381 110461768
Metastases to pleura 109.25 13.10 47 94103 2016 110493133
Metastases to peritoneum 106.89 13.10 64 94086 5546 110489603
Intentional product use issue 103.03 13.10 41 94109 247865 110247284
Anaemia 101.30 13.10 804 93346 546282 109948867
Accidental exposure to product packaging 100.07 13.10 18 94132 12 110495137
Metastases to spine 99.34 13.10 60 94090 5283 110489866
Intentional overdose 98.99 13.10 3 94147 132498 110362651
Lymphocele 97.03 13.10 42 94108 1829 110493320
Metastases to central nervous system 96.75 13.10 108 94042 22709 110472440
Pancreatic neuroendocrine tumour metastatic 96.54 13.10 25 94125 204 110494945
Lymphangiosis carcinomatosa 94.76 13.10 45 94105 2437 110492712
Pyrexia 92.28 13.10 1168 92982 897097 109598052
Product use in unapproved indication 92.03 13.10 674 93476 446703 110048446
Exposure during pregnancy 91.63 13.10 16 94134 167408 110327741
Parvovirus B19 infection 91.31 13.10 46 94104 2835 110492314
Diabetes mellitus 90.82 13.10 236 93914 99145 110396004
Bone pain 88.66 13.10 181 93969 64952 110430197
Arthralgia 87.73 13.10 354 93796 779278 109715871
Injury 86.64 13.10 22 94128 177243 110317906
Body temperature decreased 86.01 13.10 130 94020 36805 110458344
Ill-defined disorder 85.82 13.10 15 94135 156838 110338311
Folliculitis 85.50 13.10 19 94131 167634 110327515
Glossodynia 85.46 13.10 41 94109 221963 110273186
Discomfort 85.21 13.10 38 94112 214669 110280480
Loss of personal independence in daily activities 85.09 13.10 13 94137 150007 110345142
Epistaxis 84.74 13.10 274 93876 130098 110365051
Hepatic enzyme increased 84.56 13.10 89 94061 320803 110174346
Infusion site coldness 82.42 13.10 23 94127 256 110494893
Nephropathy toxic 82.17 13.10 109 94041 27369 110467780
Lower respiratory tract infection 81.89 13.10 53 94097 243053 110252096
Gamma-glutamyltransferase increased 81.83 13.10 169 93981 61140 110434009
Bone lesion 81.58 13.10 59 94091 7028 110488121
Therapy cessation 81.42 13.10 141 94009 44716 110450433
Blood triglycerides increased 81.11 13.10 101 94049 23825 110471324
Confusional state 80.87 13.10 174 93976 468506 110026643
Kidney fibrosis 80.83 13.10 49 94101 4343 110490806
Joint range of motion decreased 80.67 13.10 6 94144 121826 110373323
Hypertriglyceridaemia 79.98 13.10 83 94067 16071 110479078
Weight increased 79.96 13.10 147 94003 419497 110075652
Drug level increased 78.90 13.10 144 94006 47575 110447574
Gamma-glutamyltransferase decreased 78.41 13.10 24 94126 377 110494772
PIK3CA-activated mutation 77.60 13.10 27 94123 646 110494503
Cell marker increased 77.29 13.10 27 94123 654 110494495
Palmar-plantar erythrodysaesthesia syndrome 77.15 13.10 131 94019 40894 110454255
Liver injury 76.79 13.10 17 94133 150396 110344753
Sleep disorder due to general medical condition, insomnia type 76.78 13.10 3 94147 105640 110389509
Osteoarthritis 76.20 13.10 30 94120 182593 110312556
Blood glucose increased 75.98 13.10 267 93883 132229 110362920
Arthritis 75.97 13.10 24 94126 167562 110327587
Somnolence 75.59 13.10 85 94065 297364 110197785
Blood chromogranin A increased 75.35 13.10 27 94123 706 110494443
Sinusitis 75.16 13.10 85 94065 296603 110198546
Odynophagia 74.44 13.10 75 94075 14026 110481123
Asthma 73.44 13.10 63 94087 250228 110244921
Drug level decreased 72.21 13.10 84 94066 18464 110476685
Intentional product misuse 72.07 13.10 13 94137 132891 110362258
Obesity 71.18 13.10 7 94143 113344 110381805
Dysgeusia 71.06 13.10 173 93977 69812 110425337
Weight decreased 70.36 13.10 657 93493 467400 110027749
Product dose omission issue 70.35 13.10 103 94047 321679 110173470
Bursitis 69.82 13.10 13 94137 129905 110365244
Urticaria 69.77 13.10 102 94048 318755 110176394
Depression 68.96 13.10 102 94048 317233 110177916
Nephritic syndrome 68.83 13.10 23 94127 485 110494664
Suicide attempt 68.72 13.10 5 94145 103389 110391760
Therapeutic product effect incomplete 68.55 13.10 54 94096 223751 110271398
Hepatitis E 67.61 13.10 44 94106 4415 110490734
Bradycardia 67.48 13.10 24 94126 155493 110339656
Blood lactate dehydrogenase increased 67.33 13.10 129 94021 44205 110450944
Blood pressure systolic increased 66.71 13.10 188 93962 82803 110412346
Hypoaesthesia 66.35 13.10 103 94047 314120 110181029
Metastases to the mediastinum 65.97 13.10 25 94125 768 110494381
Wheezing 65.87 13.10 72 94078 255158 110239991
Hypotension 65.26 13.10 228 93922 523621 109971528
Memory impairment 63.56 13.10 45 94105 196899 110298250
Pneumocystis jirovecii pneumonia 63.25 13.10 123 94027 42612 110452537
Thrombocytopenia 62.43 13.10 509 93641 348376 110146773
Alopecia 62.41 13.10 136 94014 364617 110130532
Blister 62.23 13.10 61 94089 227315 110267834
Dyslipidaemia 61.65 13.10 72 94078 15893 110479256
Carbohydrate antigen 15-3 increased 61.28 13.10 29 94121 1558 110493591
Dizziness 60.96 13.10 347 93803 697846 109797303
Lymphoedema 60.46 13.10 69 94081 14860 110480289
Human herpesvirus 8 infection 59.67 13.10 30 94120 1841 110493308
Swelling 57.52 13.10 134 94016 350907 110144242
Cholangitis 57.05 13.10 70 94080 16265 110478884
Pericardial effusion 56.56 13.10 140 94010 57077 110438072
Prescribed overdose 56.08 13.10 5 94145 87576 110407573
Chronic allograft nephropathy 56.05 13.10 30 94120 2096 110493053
Hepatic neoplasm 55.82 13.10 37 94113 3830 110491319
Concomitant disease progression 55.67 13.10 36 94114 3574 110491575
Renal tubular necrosis 55.58 13.10 96 94054 30379 110464770
Stenotrophomonas infection 54.63 13.10 43 94107 5815 110489334
Device related thrombosis 54.56 13.10 35 94115 3427 110491722
Gait inability 54.31 13.10 24 94126 136352 110358797
Renal tubular atrophy 54.13 13.10 30 94120 2246 110492903
Haemolytic uraemic syndrome 53.99 13.10 40 94110 4945 110490204
Renal failure 53.36 13.10 353 93797 226221 110268928
Metastases to abdominal cavity 53.16 13.10 22 94128 856 110494293
Type 2 diabetes mellitus 52.72 13.10 44 94106 177188 110317961
Muscular weakness 51.91 13.10 82 94068 248386 110246763
Epstein-Barr viraemia 51.07 13.10 34 94116 3545 110491604
Injection site reaction 49.86 13.10 8 94142 89062 110406087
Lip dry 49.71 13.10 12 94138 100071 110395078
Metastases to pancreas 49.66 13.10 20 94130 725 110494424
Gastrointestinal disorder 49.47 13.10 81 94069 241871 110253278
Psoriasis 49.24 13.10 29 94121 139964 110355185
Suicidal ideation 49.21 13.10 10 94140 93927 110401222
Eating disorder 48.35 13.10 91 94059 30767 110464382
Polyomavirus test positive 47.32 13.10 15 94135 266 110494883
Hormone receptor positive breast cancer 47.32 13.10 18 94132 559 110494590
Chronic obstructive pulmonary disease 47.09 13.10 17 94133 109141 110386008
Feeding disorder 46.66 13.10 73 94077 21289 110473860
Abdominal discomfort 46.65 13.10 175 93975 393683 110101466
Drug resistance 46.58 13.10 129 94021 56245 110438904
Neuroendocrine tumour 46.41 13.10 24 94126 1563 110493586
Human polyomavirus infection 46.31 13.10 25 94125 1777 110493372
Haemoglobin decreased 46.16 13.10 366 93784 248361 110246788
Peripheral venous disease 46.10 13.10 8 94142 84109 110411040
Muscle spasms 45.70 13.10 106 94044 278051 110217098
Anal ulcer 45.37 13.10 25 94125 1851 110493298
Blood alkaline phosphatase increased 45.10 13.10 148 94002 70787 110424362
Atrial fibrillation 44.99 13.10 79 94071 229563 110265586
Lung transplant rejection 44.69 13.10 25 94125 1906 110493243
Metastases to chest wall 44.55 13.10 18 94132 658 110494491
Concomitant disease aggravated 44.51 13.10 62 94088 16302 110478847
Amnesia 44.48 13.10 17 94133 105391 110389758
Tumour pain 44.31 13.10 29 94121 2938 110492211
Autoimmune disorder 44.00 13.10 3 94147 65480 110429669
Metastases to pelvis 43.77 13.10 19 94131 833 110494316
Infusion site induration 43.70 13.10 22 94128 1354 110493795
Headache 43.62 13.10 511 93639 881866 109613283
Squamous cell carcinoma of skin 43.57 13.10 63 94087 17140 110478009
Mycobacterium haemophilum infection 43.48 13.10 18 94132 701 110494448
Complications of transplanted heart 43.35 13.10 16 94134 456 110494693
Insulinoma 43.28 13.10 13 94137 191 110494958
Acanthoma 43.16 13.10 10 94140 48 110495101
Sleep disorder 42.99 13.10 64 94086 198580 110296569
Metastases to thorax 42.78 13.10 14 94136 276 110494873
Migraine 42.56 13.10 50 94100 171602 110323547
Bile duct stenosis 42.04 13.10 27 94123 2649 110492500
Granulomatous rosacea 41.96 13.10 13 94137 213 110494936
Red blood cell sedimentation rate increased 41.72 13.10 8 94142 78294 110416855
Injection site mass 41.61 13.10 75 94075 24538 110470611
West Nile viral infection 41.52 13.10 21 94129 1305 110493844
Injection site hypersensitivity 41.48 13.10 26 94124 2445 110492704
Chronic kidney disease 41.38 13.10 151 93999 76140 110419009
Biphasic mesothelioma 41.29 13.10 10 94140 60 110495089
Vascular hyalinosis 40.95 13.10 12 94138 161 110494988
Bacterial infection 40.69 13.10 108 94042 45928 110449221
Joint stiffness 40.07 13.10 5 94145 67238 110427911
Treatment failure 39.87 13.10 113 94037 277121 110218028
Anaphylactic reaction 39.74 13.10 24 94126 114276 110380873
Breast cancer recurrent 39.73 13.10 30 94120 3816 110491333
Insomnia 39.65 13.10 165 93985 360425 110134724
Metastases to breast 39.25 13.10 14 94136 361 110494788
Pseudocirrhosis 39.15 13.10 18 94132 905 110494244
Serotonin syndrome 38.91 13.10 3 94147 59150 110435999
Nasopharyngitis 38.26 13.10 189 93961 394172 110100977
Pelvic neoplasm 38.22 13.10 13 94137 290 110494859
Cardio-respiratory arrest 37.98 13.10 26 94124 115810 110379339
Neoplasm 37.90 13.10 47 94103 11040 110484109
COVID-19 pneumonia 37.89 13.10 92 94058 37051 110458098
Overdose 37.67 13.10 90 94060 233704 110261445
Acute kidney injury 37.56 13.10 754 93396 634676 109860473
Cytomegalovirus gastritis 37.51 13.10 16 94134 672 110494477
Acute respiratory distress syndrome 37.48 13.10 115 94035 53083 110442066
Contusion 37.47 13.10 90 94060 233271 110261878
Pyelonephritis acute 37.41 13.10 38 94112 7175 110487974
Cardiac arrest 37.36 13.10 69 94081 196684 110298465
Ingrowing nail 37.19 13.10 27 94123 3235 110491914
Hydrothorax 37.11 13.10 21 94129 1637 110493512
Product quality issue 36.98 13.10 10 94140 77289 110417860
Toxic epidermal necrolysis 36.97 13.10 3 94147 56724 110438425
Enterocolitis viral 36.81 13.10 17 94133 864 110494285
Drug intolerance 36.53 13.10 200 93950 406312 110088837
Dehydration 36.40 13.10 381 93769 279130 110216019
Platelet count decreased 36.34 13.10 327 93823 230116 110265033
Cytomegalovirus colitis 36.26 13.10 37 94113 7024 110488125
Lactic acidosis 35.92 13.10 17 94133 92794 110402355
Superinfection viral 35.84 13.10 9 94141 64 110495085
Septic shock 35.61 13.10 243 93907 157285 110337864
Lower limb fracture 35.58 13.10 10 94140 75338 110419811
Congenital coronary artery malformation 35.38 13.10 10 94140 117 110495032
Hepatic mass 35.37 13.10 25 94125 2873 110492276
Pyelonephritis 35.34 13.10 71 94079 25179 110469970
Abdominal lymphadenopathy 35.21 13.10 21 94129 1807 110493342
Gastrooesophageal reflux disease 35.17 13.10 62 94088 179914 110315235
Pain 34.76 13.10 588 93562 954367 109540782
Hypophosphataemia 34.72 13.10 83 94067 33099 110462050
Spinal pain 34.65 13.10 59 94091 18456 110476693
Tachycardia 34.37 13.10 90 94060 226555 110268594
Tumour compression 34.04 13.10 11 94139 208 110494941
Prescribed underdose 34.01 13.10 7 94143 65167 110429982
Crepitations 33.97 13.10 44 94106 10791 110484358
Trichodysplasia spinulosa 33.97 13.10 17 94133 1033 110494116
Vasodilatation 33.88 13.10 27 94123 3717 110491432
Ovarian cyst 33.81 13.10 50 94100 13880 110481269
Hyperhidrosis 33.55 13.10 68 94082 187230 110307919
Cachexia 33.49 13.10 48 94102 12957 110482192
International normalised ratio increased 33.42 13.10 16 94134 86756 110408393
Gastric ulcer haemorrhage, obstructive 33.32 13.10 7 94143 19 110495130
Transitional cell carcinoma 33.32 13.10 25 94125 3150 110491999
Post-traumatic neck syndrome 33.10 13.10 23 94127 2572 110492577
Lung disorder 32.88 13.10 264 93886 179783 110315366
Anaphylactic shock 32.84 13.10 3 94147 51543 110443606
Cell death 32.79 13.10 32 94118 5759 110489390
Hypophagia 32.73 13.10 109 94041 52517 110442632
Mean cell haemoglobin decreased 32.22 13.10 35 94115 7139 110488010
Night sweats 32.18 13.10 40 94110 133943 110361206
Loss of consciousness 32.08 13.10 75 94075 196231 110298918
Tumour necrosis 32.03 13.10 22 94128 2414 110492735
Biliary anastomosis complication 31.83 13.10 10 94140 172 110494977
Drug reaction with eosinophilia and systemic symptoms 31.82 13.10 15 94135 82080 110413069
Delirium 31.71 13.10 41 94109 134984 110360165
Hepatic angiosarcoma 31.71 13.10 9 94141 107 110495042
Adverse drug reaction 31.64 13.10 26 94124 105533 110389616
Organising pneumonia 31.56 13.10 49 94101 14194 110480955
Metastases to muscle 31.53 13.10 12 94138 373 110494776
Gastrointestinal ulcer perforation 31.49 13.10 8 94142 60 110495089
Neck pain 31.46 13.10 35 94115 123095 110372054
Pulmonary mass 31.45 13.10 86 94064 37215 110457934
Fatigue 31.45 13.10 1299 92851 1214659 109280490
Pneumonia cytomegaloviral 31.36 13.10 34 94116 6920 110488229
Sciatica 31.29 13.10 20 94130 92379 110402770
Genitourinary tract neoplasm 31.03 13.10 8 94142 64 110495085
Renal cell carcinoma 30.82 13.10 35 94115 7495 110487654
Renal lymphocele 30.43 13.10 9 94141 125 110495024
Foot deformity 30.42 13.10 3 94147 48477 110446672
Elephantiasis nostras verrucosa 30.35 13.10 5 94145 0 110495149
Intestinal obstruction 30.27 13.10 107 94043 53120 110442029
Pneumocystis jirovecii infection 30.08 13.10 27 94123 4373 110490776
Liver abscess 30.04 13.10 35 94115 7704 110487445
Anogenital warts 29.86 13.10 16 94134 1120 110494029
Muscle contractions involuntary 29.85 13.10 27 94123 4417 110490732
Epstein-Barr virus infection reactivation 29.79 13.10 26 94124 4058 110491091
Transplant dysfunction 29.59 13.10 36 94114 8292 110486857
Metastases to kidney 29.53 13.10 13 94137 590 110494559
Recurrent cancer 29.52 13.10 24 94126 3399 110491750
Actinic keratosis 29.39 13.10 33 94117 6980 110488169
Exposed bone in jaw 29.30 13.10 25 94125 3786 110491363
Drug ineffective 29.23 13.10 1031 93119 1519509 108975640
Oxygen saturation decreased 28.97 13.10 56 94094 156926 110338223
Adverse event 28.83 13.10 30 94120 108779 110386370
Parasitic gastroenteritis 28.83 13.10 10 94140 237 110494912
Bone erosion 28.75 13.10 3 94147 46368 110448781
Leukopenia 28.72 13.10 221 93929 148570 110346579
Colitis ulcerative 28.68 13.10 15 94135 77348 110417801
Drug-induced liver injury 28.67 13.10 36 94114 120031 110375118
Depressed level of consciousness 28.59 13.10 32 94118 112246 110382903
Reflux gastritis 28.33 13.10 17 94133 1479 110493670
Lymphocyte count decreased 28.31 13.10 110 94040 57133 110438016
Anxiety 28.20 13.10 175 93975 344903 110150246
Syncope 28.06 13.10 84 94066 202452 110292697
Escherichia sepsis 28.06 13.10 39 94111 10233 110484916
Hallucination 27.98 13.10 27 94123 101405 110393744
Dry skin 27.96 13.10 172 93978 107481 110387668
Asthenia 27.93 13.10 776 93374 688223 109806926
Alveolar proteinosis 27.91 13.10 17 94133 1519 110493630
Injection site pruritus 27.81 13.10 5 94145 51253 110443896
Eyelid oedema 27.73 13.10 48 94102 15214 110479935
JC virus infection 27.67 13.10 28 94122 5262 110489887
Focal segmental glomerulosclerosis 27.48 13.10 25 94125 4120 110491029
Visual impairment 27.47 13.10 45 94105 134383 110360766
Dyspepsia 27.33 13.10 78 94072 190887 110304262
Carcinoid crisis 27.29 13.10 12 94138 543 110494606
Febrile neutropenia 27.27 13.10 158 93992 316609 110178540
Flatulence 27.26 13.10 102 94048 52047 110443102
Cytomegalovirus gastrointestinal infection 27.25 13.10 13 94137 711 110494438
Isosporiasis 27.15 13.10 9 94141 185 110494964
Agitation 26.89 13.10 34 94116 113017 110382132
Renal disorder 26.89 13.10 98 94052 49381 110445768
Drug dependence 26.88 13.10 5 94145 50015 110445134
Cheilitis 26.76 13.10 30 94120 6335 110488814
Cerebrovascular accident 26.72 13.10 73 94077 181211 110313938
Nasal discharge discolouration 26.67 13.10 22 94128 3179 110491970
Impaired insulin secretion 26.52 13.10 7 94143 62 110495087
Myocardial infarction 26.37 13.10 80 94070 192003 110303146
Gastric antral vascular ectasia 26.36 13.10 15 94135 1182 110493967
Oral herpes 26.36 13.10 79 94071 36001 110459148
Hepatocellular carcinoma 26.23 13.10 37 94113 9843 110485306
Oncologic complication 26.08 13.10 11 94139 449 110494700
Exostosis 26.01 13.10 4 94146 45952 110449197
Renal amyloidosis 25.92 13.10 10 94140 323 110494826
Therapy change 25.89 13.10 37 94113 9960 110485189
Metastases to eye 25.77 13.10 10 94140 328 110494821
Cognitive disorder 25.68 13.10 22 94128 87489 110407660
Glomerular filtration rate decreased 25.66 13.10 68 94082 28888 110466261
Japanese spotted fever 25.53 13.10 6 94144 31 110495118
Porocarcinoma 25.37 13.10 6 94144 32 110495117
Hydronephrosis 25.29 13.10 55 94095 20610 110474539
Steatorrhoea 25.28 13.10 14 94136 1047 110494102
Sedation 25.12 13.10 14 94136 69669 110425480
Erythrophagocytosis 25.06 13.10 6 94144 34 110495115
Lymphadenopathy mediastinal 25.06 13.10 27 94123 5457 110489692
Carcinoid heart disease 24.92 13.10 7 94143 80 110495069
Pruritus 24.88 13.10 347 93803 581213 109913936
Mononeuropathy 24.82 13.10 10 94140 363 110494786
Hepatic function abnormal 24.68 13.10 145 94005 89150 110405999
Skin sensitisation 24.58 13.10 14 94136 1105 110494044
Therapeutic product effective for unapproved indication 24.57 13.10 8 94142 155 110494994
Mucosal toxicity 24.53 13.10 12 94138 694 110494455
Nephrotic syndrome 24.48 13.10 43 94107 13788 110481361
Urine output decreased 24.44 13.10 53 94097 19823 110475326
Orthostatic hypotension 24.33 13.10 13 94137 66236 110428913
Impaired healing 24.19 13.10 86 94064 196631 110298518
Sleep apnoea syndrome 24.12 13.10 3 94147 40444 110454705
Cytokine release syndrome 24.11 13.10 15 94135 70291 110424858
Paraesthesia 23.76 13.10 138 94012 276383 110218766
Encephalitis viral 23.68 13.10 20 94130 2987 110492162
Toothache 23.63 13.10 58 94092 23517 110471632
Metastases to gastrointestinal tract 23.62 13.10 8 94142 176 110494973
Carcinoid tumour pulmonary 23.58 13.10 10 94140 414 110494735
Norovirus infection 23.49 13.10 18 94132 2341 110492808
Hallucination, visual 23.46 13.10 3 94147 39602 110455547
Carcinoid tumour 23.37 13.10 11 94139 584 110494565
Tumour marker abnormal 23.29 13.10 9 94141 292 110494857
Herpes simplex hepatitis 23.27 13.10 12 94138 777 110494372
Soft tissue sarcoma 23.26 13.10 9 94141 293 110494856
Renal cancer metastatic 23.20 13.10 12 94138 782 110494367
Malacoplakia 23.12 13.10 14 94136 1238 110493911
Biliary ischaemia 23.05 13.10 7 94143 107 110495042
Balance disorder 22.91 13.10 40 94110 116520 110378629
Respiratory failure 22.82 13.10 282 93868 215050 110280099
Unresponsive to stimuli 22.73 13.10 13 94137 63777 110431372
Dysplasia 22.69 13.10 16 94134 1832 110493317
Skin toxicity 22.65 13.10 38 94112 11745 110483404
Haematotoxicity 22.34 13.10 53 94097 21029 110474120
Metastases to adrenals 22.32 13.10 15 94135 1588 110493561
Renal mass 22.31 13.10 21 94129 3614 110491535
Escherichia infection 22.20 13.10 57 94093 23759 110471390
Cholestasis 22.04 13.10 111 94039 64407 110430742
Pulmonary fibrosis 21.95 13.10 33 94117 102009 110393140
Treatment noncompliance 21.85 13.10 18 94132 72972 110422177
Lung consolidation 21.77 13.10 35 94115 10441 110484708
Blood pressure fluctuation 21.73 13.10 19 94131 74805 110420344
Complications of transplanted lung 21.71 13.10 11 94139 686 110494463
Injection site erythema 21.70 13.10 29 94121 94147 110401002
Anorectal varices 21.65 13.10 6 94144 65 110495084
Eosinophil cationic protein increased 21.65 13.10 6 94144 65 110495084
Vasoactive intestinal polypeptide increased 21.51 13.10 4 94146 4 110495145
Transient ischaemic attack 21.46 13.10 14 94136 63968 110431181
Multiple organ dysfunction syndrome 21.27 13.10 210 93940 151500 110343649
Aortitis salmonella 21.25 13.10 5 94145 26 110495123
Metastases to spinal cord 21.07 13.10 8 94142 247 110494902
General physical health deterioration 21.03 13.10 492 93658 424803 110070346
Selenium deficiency 21.01 13.10 6 94144 73 110495076
Chapped lips 21.00 13.10 19 94131 3109 110492040
Stomatitis haemorrhagic 20.86 13.10 8 94142 254 110494895
IgA nephropathy 20.77 13.10 19 94131 3154 110491995
Angiosarcoma 20.76 13.10 10 94140 559 110494590
Donor specific antibody present 20.68 13.10 9 94141 397 110494752
Skin lesion 20.66 13.10 93 94057 51538 110443611
Nightmare 20.64 13.10 4 94146 38859 110456290
Pulmonary tumour thrombotic microangiopathy 20.63 13.10 7 94143 155 110494994
Muscle spasticity 20.62 13.10 3 94147 35912 110459237
Respiratory arrest 20.60 13.10 12 94138 58287 110436862
Pleural neoplasm 20.51 13.10 9 94141 405 110494744
Eccrine carcinoma 20.50 13.10 5 94145 31 110495118
Disseminated varicella zoster vaccine virus infection 20.46 13.10 7 94143 159 110494990
Cancer pain 20.46 13.10 27 94123 6745 110488404
Ventricular fibrillation 20.42 13.10 5 94145 41308 110453841
Onychomycosis 20.39 13.10 4 94146 38527 110456622
Pulmonary toxicity 20.33 13.10 46 94104 17700 110477449
Sebaceous hyperplasia 20.11 13.10 6 94144 86 110495063
Drug withdrawal syndrome 20.03 13.10 4 94146 38050 110457099
No adverse event 19.97 13.10 20 94130 73819 110421330
Infusion site haemorrhage 19.90 13.10 22 94128 4576 110490573
Graft loss 19.88 13.10 13 94137 1315 110493834
Metastases to spleen 19.73 13.10 11 94139 833 110494316
Abdominal distension 19.72 13.10 232 93918 174871 110320278
Biliary obstruction 19.70 13.10 24 94126 5534 110489615
Delayed graft function 19.52 13.10 21 94129 4236 110490913
Pathological fracture 19.50 13.10 36 94114 11996 110483153
Therapeutic product ineffective for unapproved indication 19.46 13.10 8 94142 306 110494843
Hepatic atrophy 19.36 13.10 9 94141 464 110494685
Laryngitis 19.34 13.10 6 94144 42405 110452744
Emotional distress 19.31 13.10 7 94143 44840 110450309
Drug interaction 19.31 13.10 560 93590 499623 109995526
Post transplant distal limb syndrome 19.26 13.10 11 94139 873 110494276
Road traffic accident 19.22 13.10 39 94111 107359 110387790
Cytomegalovirus viraemia 19.20 13.10 45 94105 17719 110477430
Tongue oedema 19.13 13.10 29 94121 8227 110486922
Blood urea increased 19.09 13.10 95 94055 54862 110440287
Onychoclasis 19.06 13.10 27 94123 7210 110487939
Wound infection 19.05 13.10 33 94117 96432 110398717
Transitional cell cancer of renal pelvis and ureter metastatic 19.00 13.10 4 94146 11 110495138
Pain in extremity 18.97 13.10 296 93854 486822 110008327
5-hydroxyindolacetic acid 18.74 13.10 4 94146 12 110495137
Carcinoembryonic antigen increased 18.66 13.10 17 94133 2807 110492342
Palpitations 18.66 13.10 71 94079 159141 110336008
Biliary dilatation 18.62 13.10 19 94131 3606 110491543
Rectal haemorrhage 18.61 13.10 47 94103 119786 110375363
Metastases to soft tissue 18.55 13.10 10 94140 709 110494440
Lymphadenopathy 18.51 13.10 105 94045 63730 110431419
Necrosis of artery 18.50 13.10 4 94146 13 110495136
Papilloma viral infection 18.46 13.10 15 94135 2123 110493026
Inferior vena cava stenosis 18.44 13.10 6 94144 116 110495033
Malignant pleural effusion 18.43 13.10 20 94130 4073 110491076
Dysarthria 18.29 13.10 27 94123 84094 110411055
Blood creatinine decreased 18.28 13.10 30 94120 9107 110486042
5-hydroxyindolacetic acid in urine 18.27 13.10 4 94146 14 110495135
Jejunal ulcer perforation 18.25 13.10 6 94144 120 110495029
Breast cancer 18.20 13.10 73 94077 38469 110456680
Haematochezia 18.18 13.10 45 94105 115479 110379670
Cytomegalovirus oesophagitis 18.14 13.10 11 94139 975 110494174
Abdominal pain 18.10 13.10 568 93582 512421 109982728
Abnormal faeces 18.04 13.10 30 94120 9206 110485943
Retinitis 17.88 13.10 3 94147 32324 110462825
Pneumonia bacterial 17.78 13.10 56 94094 26205 110468944
Cholangitis acute 17.75 13.10 14 94136 1899 110493250
Angioedema 17.74 13.10 144 94006 98356 110396793
Blood glucose abnormal 17.70 13.10 36 94114 12880 110482269
Metastatic carcinoid tumour 17.57 13.10 5 94145 60 110495089
Stevens-Johnson syndrome 17.53 13.10 9 94141 46892 110448257
Burning sensation mucosal 17.50 13.10 5 94145 61 110495088
Hyponatraemia 17.45 13.10 111 94039 217542 110277607
Tonic convulsion 17.43 13.10 17 94133 3057 110492092
Oral administration complication 17.43 13.10 6 94144 139 110495010
Pleural disorder 17.42 13.10 11 94139 1048 110494101
Vein disorder 17.42 13.10 24 94126 6246 110488903
Transitional cell carcinoma metastatic 17.15 13.10 6 94144 146 110495003
Oedematous kidney 17.14 13.10 7 94143 263 110494886
Gonococcal infection 17.14 13.10 5 94145 66 110495083
Alveolitis necrotising 17.13 13.10 4 94146 20 110495129
Incisional hernia 17.11 13.10 16 94134 2731 110492418
Osteoporosis 17.04 13.10 30 94120 87122 110408027
Skin plaque 17.03 13.10 35 94115 12610 110482539
Metastases to heart 17.01 13.10 8 94142 424 110494725
Febrile convulsion 16.95 13.10 11 94139 1099 110494050
Complex regional pain syndrome 16.92 13.10 15 94135 2390 110492759
Hernial eventration 16.87 13.10 5 94145 70 110495079
Liver function test increased 16.85 13.10 31 94119 88517 110406632
Malignant ascites 16.83 13.10 12 94138 1398 110493751
Lung squamous cell carcinoma stage II 16.81 13.10 4 94146 22 110495127
Pseudohypoaldosteronism 16.80 13.10 5 94145 71 110495078
Mental disorder 16.80 13.10 6 94144 38785 110456364
Pneumothorax 16.79 13.10 67 94083 35218 110459931
Smooth muscle cell neoplasm 16.78 13.10 12 94138 1405 110493744
Eye pain 16.75 13.10 11 94139 50088 110445061
Cytomegalovirus test positive 16.71 13.10 25 94125 7011 110488138
Restlessness 16.68 13.10 14 94136 56245 110438904
Cryptosporidiosis infection 16.65 13.10 11 94139 1132 110494017
Cardiac failure congestive 16.64 13.10 69 94081 150931 110344218
Eye irritation 16.63 13.10 4 94146 33448 110461701
Infection 16.60 13.10 213 93937 361987 110133162
Gait disturbance 16.59 13.10 154 93996 278054 110217095
Incorrect route of product administration 16.59 13.10 18 94132 64043 110431106
Bone cancer 16.58 13.10 15 94135 2455 110492694
Coronary artery aneurysm 16.39 13.10 6 94144 167 110494982
Metastases to meninges 16.35 13.10 21 94129 5107 110490042
Dyspnoea 16.31 13.10 1122 93028 1105750 109389399
Nasal cavity cancer 16.25 13.10 7 94143 301 110494848
Coma 16.24 13.10 49 94101 117820 110377329
Ileal ulcer 16.22 13.10 13 94137 1804 110493345
Hepatic pain 16.22 13.10 20 94130 4670 110490479
Gastroduodenal haemorrhage 16.21 13.10 7 94143 303 110494846
Anorexia nervosa 16.19 13.10 7 94143 304 110494845
Primary pulmonary melanoma 16.13 13.10 3 94147 3 110495146
Obstructive nephropathy 16.08 13.10 5 94145 83 110495066
Unevaluable event 16.06 13.10 16 94134 59211 110435938
Chimerism 15.98 13.10 7 94143 314 110494835
Bone neoplasm 15.91 13.10 10 94140 945 110494204
Intentional self-injury 15.85 13.10 6 94144 37423 110457726
Pseudomonas infection 15.84 13.10 56 94094 27797 110467352
Tongue ulceration 15.78 13.10 20 94130 4802 110490347
Metastases to salivary gland 15.75 13.10 5 94145 89 110495060
Mucinous breast carcinoma 15.74 13.10 4 94146 30 110495119
Cytomegalovirus gastroenteritis 15.72 13.10 9 94141 717 110494432
Varicella zoster virus infection 15.66 13.10 23 94127 6345 110488804
Neutrophilic panniculitis 15.65 13.10 5 94145 91 110495058
Salpingectomy 15.61 13.10 7 94143 332 110494817
Metastases to bladder 15.53 13.10 7 94143 336 110494813
Illness 15.43 13.10 29 94121 82142 110413007
Bile output abnormal 15.41 13.10 4 94146 33 110495116
Blood pressure diastolic decreased 15.40 13.10 66 94084 35819 110459330
Panic attack 15.32 13.10 3 94147 28937 110466212
Intestinal metastasis 15.19 13.10 8 94142 541 110494608
Withdrawal syndrome 15.12 13.10 4 94146 31376 110463773
Epstein-Barr virus associated lymphoma 15.02 13.10 12 94138 1658 110493491
Urinary fistula 14.98 13.10 5 94145 105 110495044
Cardiogenic shock 14.97 13.10 16 94134 57322 110437827
Paraesthesia oral 14.94 13.10 5 94145 33666 110461483
Myositis 14.93 13.10 4 94146 31112 110464037
Ascariasis 14.92 13.10 3 94147 6 110495143
Blood glucose decreased 14.85 13.10 57 94093 29431 110465718
Throat tightness 14.81 13.10 5 94145 33484 110461665
Tumour invasion 14.76 13.10 8 94142 573 110494576
Performance status decreased 14.73 13.10 24 94126 7242 110487907
Neutropenic sepsis 14.66 13.10 4 94146 30742 110464407
Fluid retention 14.63 13.10 37 94113 94270 110400879
Oophorectomy 14.62 13.10 7 94143 386 110494763
Tinnitus 14.61 13.10 18 94132 60522 110434627
Dry mouth 14.52 13.10 105 94045 199843 110295306
Renal vein thrombosis 14.42 13.10 10 94140 1115 110494034
Renal hamartoma 14.36 13.10 5 94145 120 110495029
Obstructive airways disorder 14.29 13.10 11 94139 46138 110449011
Sinus disorder 14.28 13.10 5 94145 32723 110462426
Vision blurred 14.19 13.10 59 94091 128963 110366186
Ventricular tachycardia 14.16 13.10 13 94137 49996 110445153
Pancytopenia 14.15 13.10 254 93896 209359 110285790
Nasopharyngeal cancer metastatic 14.06 13.10 3 94147 9 110495140
Shock haemorrhagic 13.99 13.10 53 94097 27194 110467955
Blood bilirubin abnormal 13.94 13.10 12 94138 1838 110493311
5-hydroxyindolacetic acid increased 13.94 13.10 5 94145 131 110495018
Angiofibroma 13.91 13.10 5 94145 132 110495017
Klebsiella infection 13.85 13.10 43 94107 19966 110475183
Depressed mood 13.73 13.10 19 94131 60790 110434359
Lymphopenia 13.64 13.10 69 94081 40101 110455048
Joint dislocation 13.64 13.10 6 94144 34184 110460965
Transplantation associated food allergy 13.63 13.10 5 94145 140 110495009
Injection site induration 13.59 13.10 30 94120 11353 110483796
Rash erythematous 13.57 13.10 31 94119 81801 110413348
Serositis 13.53 13.10 11 94139 1558 110493591
Oral cavity fistula 13.51 13.10 8 94142 679 110494470
Pneumonitis chemical 13.50 13.10 8 94142 680 110494469
Poisoning 13.49 13.10 4 94146 29101 110466048
Aplasia pure red cell 13.48 13.10 27 94123 9551 110485598
Impaired work ability 13.45 13.10 3 94147 26416 110468733
Intestinal tuberculosis 13.43 13.10 6 94144 282 110494867
Skin laceration 13.34 13.10 6 94144 33747 110461402
Pneumonia 13.30 13.10 891 93259 875823 109619326
Carcinoid syndrome 13.25 13.10 6 94144 291 110494858
Vascular stent thrombosis 13.21 13.10 17 94133 4144 110491005
Hyperlipidaemia 13.19 13.10 63 94087 35785 110459364
Hepatic vein stenosis 13.18 13.10 4 94146 61 110495088
Acute pulmonary oedema 13.16 13.10 38 94112 16958 110478191
Blood gastrin increased 13.12 13.10 4 94146 62 110495087

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01EG02 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
PROTEIN KINASE INHIBITORS
Mammalian target of rapamycin (mTOR) kinase inhibitors
ATC L04AH02 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Mammalian target of rapamycin (mTOR) kinase inhibitors
FDA MoA N0000175076 Protein Kinase Inhibitors
FDA PE N0000175550 Decreased Immunologic Activity
MeSH PA D000091203 MTOR Inhibitors
MeSH PA D000970 Antineoplastic Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
MeSH PA D047428 Protein Kinase Inhibitors
FDA EPC N0000175605 Kinase Inhibitor
FDA MoA N0000175624 mTOR Inhibitors
FDA EPC N0000175625 mTOR Inhibitor Immunosuppressant
FDA MoA N0000182137 Cytochrome P450 2D6 Inhibitors
FDA MoA N0000182141 Cytochrome P450 3A4 Inhibitors
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:68481 mTOR inhibitor
CHEBI has role CHEBI:149553 anticoronaviral agent
CHEBI has role CHEBI:176497 geroprotector

Related Drugs by ATC class:

L01EG Mammalian target of rapamycin (mTOR) kinase inhibitors 3 drugs
ridaforolimussirolimustemsirolimus
L04AH Mammalian target of rapamycin (mTOR) kinase inhibitors 1 drug
sirolimus

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

DiseaseRelationSNOMED_IDDOID
Tuberous sclerosis syndrome indication 7199000 DOID:13515
Carcinoma of breast indication 254838004 DOID:3459
Angiomyolipoma of kidney indication 254921004 DOID:8411
Hormone receptor positive malignant neoplasm of breast indication 417181009
Renal cell carcinoma indication 702391001 DOID:4450
Pancreatic Neuroendocrine Tumor indication 717919005
Prevention of Kidney Transplant Rejection indication
Subependymal Giant Cell Astrocytoma associated with Tuberous Sclerosis indication
Hypercholesterolemia contraindication 13644009
Proteinuria contraindication 29738008 DOID:576
Hyperlipidemia contraindication 55822004 DOID:1168
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Stomatitis contraindication 61170000 DOID:9637
Acute infectious disease contraindication 63171007
Interstitial pneumonia contraindication 64667001
Diabetes mellitus contraindication 73211009 DOID:9351
Thrombotic thrombocytopenic purpura contraindication 78129009 DOID:10772
Hyperglycemia contraindication 80394007 DOID:4195
Leukopenia contraindication 84828003 DOID:615
Kidney disease contraindication 90708001 DOID:557
Thrombosis of renal artery contraindication 95579008
Hemolytic uremic syndrome contraindication 111407006 DOID:12554
Malignant lymphoma contraindication 118600007 DOID:0060058
Disease of liver contraindication 235856003 DOID:409
Edema contraindication 267038008
Impaired wound healing contraindication 271618001
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Hypertriglyceridemia contraindication 302870006
Neutropenic disorder contraindication 303011007 DOID:1227
Primary malignant neoplasm contraindication 372087000
Pericardial effusion contraindication 373945007 DOID:118
Ascites contraindication 389026000
Breastfeeding (mother) contraindication 413712001
BK Polyomavirus Reactivation Nephropathy contraindication
Pleural Effusions contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 10.5 acidic
pKa2 13.7 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG AFINITOR NOVARTIS N022334 March 30, 2009 RX TABLET ORAL 8410131 Nov. 1, 2025 TREATMENT OF SOLID EXCRETORY SYSTEM TUMORS; ADVANCED RENAL CELL CARCINOMA (RCC), AFTER FAILURE OF TREATMENT WITH SUNITINIB OR SORAFENIB
2.5MG AFINITOR NOVARTIS N022334 July 9, 2010 RX TABLET ORAL 8410131 Nov. 1, 2025 TREATMENT OF SOLID EXCRETORY SYSTEM TUMORS; ADVANCED RENAL CELL CARCINOMA (RCC), AFTER FAILURE OF TREATMENT WITH SUNITINIB OR SORAFENIB
5MG AFINITOR NOVARTIS N022334 March 30, 2009 RX TABLET ORAL 8410131 Nov. 1, 2025 TREATMENT OF SOLID EXCRETORY SYSTEM TUMORS; ADVANCED RENAL CELL CARCINOMA (RCC), AFTER FAILURE OF TREATMENT WITH SUNITINIB OR SORAFENIB
7.5MG AFINITOR NOVARTIS N022334 March 30, 2012 RX TABLET ORAL 8410131 Nov. 1, 2025 TREATMENT OF SOLID EXCRETORY SYSTEM TUMORS; ADVANCED RENAL CELL CARCINOMA (RCC), AFTER FAILURE OF TREATMENT WITH SUNITINIB OR SORAFENIB
10MG AFINITOR NOVARTIS N022334 March 30, 2009 RX TABLET ORAL 9006224 July 1, 2028 TREATMENT OF PATIENTS WITH PROGRESSIVE NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET) THAT ARE UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC
2.5MG AFINITOR NOVARTIS N022334 July 9, 2010 RX TABLET ORAL 9006224 July 1, 2028 TREATMENT OF PATIENTS WITH PROGRESSIVE NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET) THAT ARE UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC
5MG AFINITOR NOVARTIS N022334 March 30, 2009 RX TABLET ORAL 9006224 July 1, 2028 TREATMENT OF PATIENTS WITH PROGRESSIVE NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET) THAT ARE UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC
7.5MG AFINITOR NOVARTIS N022334 March 30, 2012 RX TABLET ORAL 9006224 July 1, 2028 TREATMENT OF PATIENTS WITH PROGRESSIVE NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET) THAT ARE UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Peptidyl-prolyl cis-trans isomerase FKBP1A Enzyme INHIBITOR IC50 8.26 WOMBAT-PK CHEMBL
Multidrug resistance protein 1 Transporter WOMBAT-PK
Serine/threonine-protein kinase mTOR Kinase INHIBITOR IC50 8.70 IUPHAR

External reference:

IDSource
4028636 VUID
N0000178379 NUI
D02714 KEGG_DRUG
4028636 VANDF
C0541315 UMLSCUI
CHEBI:68478 CHEBI
E53 PDB_CHEM_ID
CHEMBL1908360 ChEMBL_ID
D000068338 MESH_DESCRIPTOR_UI
DB01590 DRUGBANK_ID
5889 IUPHAR_LIGAND_ID
7863 INN_ID
9HW64Q8G6G UNII
6442177 PUBCHEM_CID
141704 RXNORM
162489 MMSL
20447 MMSL
269938 MMSL
d05626 MMSL
010829 NDDF
428127005 SNOMEDCT_US
428698007 SNOMEDCT_US
9HW64Q8G6G INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Everolimus HUMAN PRESCRIPTION DRUG LABEL 1 0054-0470 TABLET 0.25 mg ORAL ANDA 27 sections
Everolimus HUMAN PRESCRIPTION DRUG LABEL 1 0054-0471 TABLET 0.50 mg ORAL ANDA 27 sections
Everolimus HUMAN PRESCRIPTION DRUG LABEL 1 0054-0472 TABLET 0.75 mg ORAL ANDA 27 sections
Everolimus HUMAN PRESCRIPTION DRUG LABEL 1 0054-0480 TABLET 2.50 mg ORAL ANDA 26 sections
Everolimus HUMAN PRESCRIPTION DRUG LABEL 1 0054-0481 TABLET 5 mg ORAL ANDA 26 sections
Everolimus HUMAN PRESCRIPTION DRUG LABEL 1 0054-0482 TABLET 10 mg ORAL ANDA 26 sections
Everolimus HUMAN PRESCRIPTION DRUG LABEL 1 0054-0497 TABLET 7.50 mg ORAL ANDA 26 sections
Everolimus HUMAN PRESCRIPTION DRUG LABEL 1 0054-0604 TABLET 1 mg ORAL ANDA 27 sections
Zortress HUMAN PRESCRIPTION DRUG LABEL 1 0078-0414 TABLET 0.50 mg ORAL NDA 32 sections
Zortress HUMAN PRESCRIPTION DRUG LABEL 1 0078-0415 TABLET 0.75 mg ORAL NDA 32 sections
Zortress HUMAN PRESCRIPTION DRUG LABEL 1 0078-0417 TABLET 0.25 mg ORAL NDA 32 sections
Zortress HUMAN PRESCRIPTION DRUG LABEL 1 0078-0422 TABLET 1 mg ORAL NDA 32 sections
Afinitor HUMAN PRESCRIPTION DRUG LABEL 1 0078-0566 TABLET 5 mg ORAL NDA 33 sections
Afinitor HUMAN PRESCRIPTION DRUG LABEL 1 0078-0567 TABLET 10 mg ORAL NDA 33 sections
Afinitor HUMAN PRESCRIPTION DRUG LABEL 1 0078-0594 TABLET 2.50 mg ORAL NDA 33 sections
Afinitor HUMAN PRESCRIPTION DRUG LABEL 1 0078-0620 TABLET 7.50 mg ORAL NDA 33 sections
AfinitorDisperz HUMAN PRESCRIPTION DRUG LABEL 1 0078-0626 TABLET, FOR SUSPENSION 2 mg ORAL NDA 33 sections
AfinitorDisperz HUMAN PRESCRIPTION DRUG LABEL 1 0078-0627 TABLET, FOR SUSPENSION 3 mg ORAL NDA 33 sections
AfinitorDisperz HUMAN PRESCRIPTION DRUG LABEL 1 0078-0628 TABLET, FOR SUSPENSION 5 mg ORAL NDA 33 sections
Everolimus HUMAN PRESCRIPTION DRUG LABEL 1 0093-7766 TABLET 2.50 mg ORAL ANDA 30 sections
Everolimus HUMAN PRESCRIPTION DRUG LABEL 1 0093-7767 TABLET 5 mg ORAL ANDA 30 sections
Everolimus HUMAN PRESCRIPTION DRUG LABEL 1 0093-7768 TABLET 7.50 mg ORAL ANDA 30 sections
Everolimus HUMAN PRESCRIPTION DRUG LABEL 1 0093-7769 TABLET 10 mg ORAL ANDA 30 sections
TORPENZ HUMAN PRESCRIPTION DRUG LABEL 1 0245-0822 TABLET 2.50 mg ORAL ANDA 32 sections
TORPENZ HUMAN PRESCRIPTION DRUG LABEL 1 0245-0822 TABLET 2.50 mg ORAL ANDA 32 sections
TORPENZ HUMAN PRESCRIPTION DRUG LABEL 1 0245-0823 TABLET 5 mg ORAL ANDA 32 sections
TORPENZ HUMAN PRESCRIPTION DRUG LABEL 1 0245-0823 TABLET 5 mg ORAL ANDA 32 sections
TORPENZ HUMAN PRESCRIPTION DRUG LABEL 1 0245-0824 TABLET 7.50 mg ORAL ANDA 32 sections
TORPENZ HUMAN PRESCRIPTION DRUG LABEL 1 0245-0824 TABLET 7.50 mg ORAL ANDA 32 sections
TORPENZ HUMAN PRESCRIPTION DRUG LABEL 1 0245-0825 TABLET 10 mg ORAL ANDA 32 sections