valganciclovir ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antivirals bicyclic heterocycle compounds 2801 175865-59-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • valganciclovir
  • valganciclovir hydrochloride
  • valganciclovir HCl
Valganciclovir is an L-valyl ester (prodrug) of ganciclovir that exists as a mixture of two diastereomers. After oral administration, both diastereomers are rapidly converted to ganciclovir by intestinal and hepatic esterases. Ganciclovir is a synthetic analogue of 2'-deoxyguanosine, which inhibits replication of human CMV in cell culture and in vivo.
  • Molecular weight: 354.37
  • Formula: C14H22N6O5
  • CLOGP: -1.60
  • LIPINSKI: 1
  • HAC: 11
  • HDO: 4
  • TPSA: 167.08
  • ALOGS: -1.89
  • ROTB: 9

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.90 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 70 mg/mL Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 84.66 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 61 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
March 29, 2001 FDA HOFFMANN LA ROCHE
Nov. 5, 2004 PMDA Tanabe Seiyaku Co., Ltd.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Cytomegalovirus infection 829.37 18.72 276 14297 17686 50572865
Leukopenia 435.63 18.72 260 14313 67268 50523283
Cytomegalovirus viraemia 428.79 18.72 122 14451 4587 50585964
Transplant rejection 366.09 18.72 128 14445 9481 50581070
Pathogen resistance 342.19 18.72 107 14466 5582 50584969
Drug resistance 316.82 18.72 139 14434 18850 50571701
Neutropenia 259.97 18.72 263 14310 147702 50442849
BK virus infection 206.42 18.72 62 14511 2819 50587732
Kidney transplant rejection 194.61 18.72 64 14509 3923 50586628
Polyomavirus-associated nephropathy 172.33 18.72 47 14526 1505 50589046
Pancytopenia 144.74 18.72 148 14425 83882 50506669
Immunosuppressant drug level increased 144.51 18.72 48 14525 3034 50587517
Off label use 142.24 18.72 375 14198 474051 50116500
Agranulocytosis 123.71 18.72 77 14496 21344 50569207
Epstein-Barr virus infection 122.40 18.72 53 14520 6944 50583607
Smooth muscle cell neoplasm 122.36 18.72 31 14542 740 50589811
Transplant dysfunction 121.31 18.72 47 14526 4637 50585914
Encephalitis cytomegalovirus 117.49 18.72 28 14545 514 50590037
Cytomegalovirus gastrointestinal infection 117.30 18.72 25 14548 269 50590282
Post transplant lymphoproliferative disorder 111.78 18.72 43 14530 4161 50586390
Delayed graft function 107.15 18.72 29 14544 901 50589650
Cytomegalovirus colitis 102.41 18.72 33 14540 1894 50588657
Lung transplant rejection 98.15 18.72 26 14547 743 50589808
Posterior reversible encephalopathy syndrome 94.72 18.72 57 14516 14871 50575680
Nocardiosis 94.02 18.72 30 14543 1668 50588883
Lymphocele 92.67 18.72 25 14548 767 50589784
Cytomegalovirus infection reactivation 92.34 18.72 33 14540 2598 50587953
Complications of transplanted kidney 90.64 18.72 31 14542 2142 50588409
Bronchopulmonary aspergillosis 84.37 18.72 42 14531 7550 50583001
Renal transplant failure 84.35 18.72 22 14551 591 50589960
Thrombotic microangiopathy 84.23 18.72 44 14529 8747 50581804
Intentional product use issue 83.92 18.72 107 14466 76811 50513740
Graft versus host disease 83.31 18.72 39 14534 6127 50584424
Ureaplasma infection 83.06 18.72 21 14552 497 50590054
Cytomegalovirus chorioretinitis 80.87 18.72 26 14547 1481 50589070
Acute kidney injury 80.20 18.72 192 14381 227866 50362685
Blood creatinine increased 80.03 18.72 104 14469 76056 50514495
Renal tubular necrosis 78.22 18.72 44 14529 10124 50580427
Strongyloidiasis 77.00 18.72 22 14551 837 50589714
Fatigue 76.20 18.72 56 14517 707545 49883006
Hyperammonaemia 73.62 18.72 33 14540 4691 50585860
Nephropathy toxic 73.55 18.72 39 14534 7990 50582561
Arthralgia 71.74 18.72 19 14554 438683 50151868
Human ehrlichiosis 71.11 18.72 15 14558 153 50590398
Pneumonia cytomegaloviral 70.59 18.72 25 14548 1916 50588635
Renal impairment 62.48 18.72 92 14481 75569 50514982
Scedosporium infection 61.84 18.72 16 14557 416 50590135
Enterococcal infection 58.96 18.72 32 14541 6866 50583685
Transplant failure 58.04 18.72 20 14553 1413 50589138
Thrombocytopenia 57.77 18.72 119 14454 127554 50462997
Myelosuppression 57.13 18.72 40 14533 13477 50577074
Aspergillus infection 56.52 18.72 31 14542 6790 50583761
Pneumocystis jirovecii pneumonia 56.47 18.72 41 14532 14622 50575929
Neutrophil Pelger-Huet anomaly present 55.35 18.72 11 14562 81 50590470
Escherichia infection 54.88 18.72 36 14537 10905 50579646
Adenoviral hepatitis 54.73 18.72 13 14560 235 50590316
Adenovirus infection 52.16 18.72 23 14550 3145 50587406
Viraemia 51.42 18.72 17 14556 1058 50589493
Fall 50.16 18.72 17 14556 334915 50255636
Pain 50.04 18.72 56 14517 578847 50011704
Epstein-Barr virus infection reactivation 49.37 18.72 14 14559 518 50590033
Renal transplant 49.32 18.72 17 14556 1202 50589349
Liver transplant rejection 48.12 18.72 17 14556 1293 50589258
Pseudomonas infection 47.23 18.72 31 14542 9399 50581152
Graft loss 45.23 18.72 12 14561 345 50590206
Systemic candida 45.11 18.72 20 14553 2770 50587781
Peripheral swelling 44.62 18.72 4 14569 205932 50384619
Mucormycosis 44.04 18.72 19 14554 2464 50588087
Adrenal mass 43.87 18.72 14 14559 778 50589773
Toxoplasmosis 43.12 18.72 16 14557 1401 50589150
Hepatocellular injury 41.53 18.72 44 14529 25903 50564648
Pericarditis constrictive 40.54 18.72 11 14562 345 50590206
Cytomegalovirus test positive 40.05 18.72 18 14555 2574 50587977
Product use in unapproved indication 40.05 18.72 97 14476 115722 50474829
Joint swelling 39.30 18.72 11 14562 245275 50345276
Cholestasis 38.76 18.72 42 14531 25359 50565192
Pyrexia 38.61 18.72 213 14360 379990 50210561
Pyelonephritis 38.47 18.72 33 14540 14956 50575595
Swelling 38.34 18.72 6 14567 200866 50389685
Hypersensitivity 37.69 18.72 8 14565 215153 50375398
Bone marrow failure 37.56 18.72 43 14530 27581 50562970
Cytopenia 37.15 18.72 26 14547 8749 50581802
Klebsiella infection 36.88 18.72 24 14549 7170 50583381
Alopecia 35.69 18.72 13 14560 245034 50345517
Urosepsis 35.59 18.72 32 14541 15433 50575118
Pleural mesothelioma malignant 35.53 18.72 7 14566 49 50590502
Anaemia 35.28 18.72 155 14418 252301 50338250
Dizziness 35.09 18.72 29 14544 346340 50244211
Drug level increased 35.04 18.72 35 14538 19233 50571318
Infusion related reaction 34.89 18.72 4 14569 169553 50420998
Abdominal discomfort 34.23 18.72 12 14561 231629 50358922
Renal artery stenosis 33.67 18.72 14 14559 1658 50588893
Sepsis 33.48 18.72 99 14474 132826 50457725
Escherichia urinary tract infection 33.22 18.72 26 14547 10369 50580182
Parvovirus B19 infection 32.81 18.72 10 14563 477 50590074
Weight increased 32.43 18.72 9 14564 201882 50388669
Acinetobacter infection 32.32 18.72 13 14560 1414 50589137
Drug hypersensitivity 32.27 18.72 16 14557 250994 50339557
Superinfection bacterial 32.26 18.72 10 14563 505 50590046
Parainfluenzae virus infection 32.12 18.72 14 14559 1861 50588690
Aplasia pure red cell 31.76 18.72 18 14555 4197 50586354
Septic shock 31.56 18.72 58 14515 57117 50533434
Cystitis haemorrhagic 31.15 18.72 17 14556 3685 50586866
Cytomegalovirus oesophagitis 31.11 18.72 8 14565 203 50590348
Venous haemorrhage 30.96 18.72 8 14565 207 50590344
Cryptococcosis 30.64 18.72 11 14562 877 50589674
Tonic clonic movements 30.57 18.72 12 14561 1225 50589326
Dyspnoea 30.30 18.72 71 14502 547537 50043014
Epstein-Barr virus associated lymphoproliferative disorder 30.21 18.72 13 14560 1676 50588875
Product dose omission issue 29.89 18.72 8 14565 183830 50406721
Urate nephropathy 29.82 18.72 7 14566 120 50590431
Mesothelioma malignant 29.75 18.72 6 14567 48 50590503
Lymphopenia 29.56 18.72 29 14544 15592 50574959
JC virus infection 29.31 18.72 13 14560 1802 50588749
Oesophageal candidiasis 28.93 18.72 18 14555 4976 50585575
Eye infection toxoplasmal 28.86 18.72 8 14565 272 50590279
Pneumonia fungal 28.71 18.72 17 14556 4303 50586248
Herpes simplex viraemia 28.57 18.72 7 14566 145 50590406
Septal panniculitis 28.55 18.72 6 14567 60 50590491
Reticulocytopenia 28.46 18.72 6 14567 61 50590490
Complications of transplant surgery 27.96 18.72 7 14566 159 50590392
Urinary tract infection 27.90 18.72 133 14440 223887 50366664
Oral candidiasis 27.63 18.72 29 14544 16886 50573665
Hyperuricaemia 27.45 18.72 17 14556 4663 50585888
Pain in extremity 27.43 18.72 23 14550 272842 50317709
Superinfection viral 27.34 18.72 5 14568 22 50590529
Pancreatic pseudoaneurysm 27.11 18.72 6 14567 78 50590473
Cytomegalovirus gastritis 27.09 18.72 7 14566 181 50590370
Epstein-Barr viraemia 27.05 18.72 10 14563 866 50589685
Urinary tract infection bacterial 26.68 18.72 16 14557 4143 50586408
Venoocclusive liver disease 26.32 18.72 16 14557 4245 50586306
Brain abscess 26.28 18.72 12 14561 1779 50588772
Central nervous system fungal infection 26.19 18.72 6 14567 92 50590459
Cervicitis 26.18 18.72 8 14565 385 50590166
Escherichia sepsis 26.11 18.72 16 14557 4308 50586243
Infection reactivation 25.89 18.72 10 14563 977 50589574
Ascites 25.89 18.72 41 14532 35820 50554731
Pulmonary mucormycosis 25.81 18.72 7 14566 219 50590332
Febrile neutropenia 25.78 18.72 74 14499 97593 50492958
Feeling abnormal 25.71 18.72 3 14570 125489 50465062
Hepatic necrosis 25.66 18.72 17 14556 5231 50585320
Microsporidia infection 25.28 18.72 7 14566 237 50590314
Multiple organ dysfunction syndrome 25.22 18.72 49 14524 50288 50540263
Heart transplant rejection 25.05 18.72 8 14565 446 50590105
Diabetes mellitus 24.89 18.72 48 14525 48985 50541566
Polyomavirus viraemia 24.84 18.72 8 14565 458 50590093
Human herpesvirus 6 infection reactivation 24.64 18.72 6 14567 121 50590430
Herpes simplex oesophagitis 24.50 18.72 6 14567 124 50590427
Drug interaction 24.47 18.72 118 14455 199503 50391048
Graft versus host disease in gastrointestinal tract 24.04 18.72 13 14560 2768 50587783
Proteus infection 23.72 18.72 9 14564 838 50589713
Coronavirus infection 23.41 18.72 13 14560 2916 50587635
Muscle spasms 23.39 18.72 4 14569 125549 50465002
Bacterial infection 23.24 18.72 26 14547 16255 50574296
Respiratory tract infection viral 23.08 18.72 11 14562 1798 50588753
Insomnia 22.68 18.72 11 14562 174854 50415697
Renal lymphocele 22.59 18.72 5 14568 65 50590486
Rash 22.38 18.72 59 14514 437412 50153139
Acute graft versus host disease 22.26 18.72 14 14559 3944 50586607
Anorexia nervosa 22.18 18.72 6 14567 186 50590365
Pneumonia influenzal 22.07 18.72 10 14563 1457 50589094
Disseminated cryptococcosis 22.04 18.72 7 14566 383 50590168
Back pain 21.55 18.72 19 14554 220011 50370540
Haematotoxicity 21.52 18.72 18 14555 7877 50582674
Glomerulonephritis 21.49 18.72 10 14563 1549 50589002
Hypertensive emergency 21.46 18.72 10 14563 1553 50588998
Liver transplant 21.36 18.72 11 14562 2121 50588430
Genital lesion 21.34 18.72 6 14567 215 50590336
Systemic lupus erythematosus 21.25 18.72 7 14566 140615 50449936
Complications of transplanted lung 21.24 18.72 6 14567 219 50590332
Cytomegalovirus enteritis 21.16 18.72 6 14567 222 50590329
Respiratory failure 21.14 18.72 66 14507 91115 50499436
Rhinovirus infection 21.14 18.72 13 14560 3521 50587030
Human herpesvirus 8 infection 21.08 18.72 6 14567 225 50590326
Viral mutation identified 21.07 18.72 10 14563 1619 50588932
Delayed engraftment 20.77 18.72 5 14568 96 50590455
Asterixis 20.75 18.72 9 14564 1182 50589369
Malaise 20.58 18.72 41 14532 335491 50255060
Hepatic cyst infection 20.48 18.72 5 14568 102 50590449
Urticaria 20.38 18.72 6 14567 129555 50460996
Escherichia bacteraemia 20.02 18.72 12 14561 3104 50587447
Mycobacterium abscessus infection 19.92 18.72 7 14566 524 50590027
Nephrogenic diabetes insipidus 19.86 18.72 8 14565 873 50589678
Obliterative bronchiolitis 19.84 18.72 10 14563 1843 50588708
Periostitis 19.75 18.72 6 14567 283 50590268
No adverse event 19.71 18.72 35 14538 33543 50557008
Serum sickness 19.58 18.72 11 14562 2521 50588030
Pulmonary alveolar haemorrhage 19.58 18.72 13 14560 4014 50586537
Donor specific antibody present 19.40 18.72 5 14568 128 50590423
Haemothorax 19.28 18.72 10 14563 1956 50588595
Cytomegalovirus hepatitis 19.21 18.72 6 14567 311 50590240
Drug ineffective 19.19 18.72 148 14425 819185 49771366
Oropharyngeal candidiasis 19.14 18.72 8 14565 960 50589591
Drug intolerance 19.05 18.72 21 14552 219083 50371468

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
Cytomegalovirus infection 745.89 15.66 356 21341 22859 29529971
Cytomegalovirus viraemia 619.39 15.66 216 21481 6104 29546726
Leukopenia 434.58 15.66 344 21353 54859 29497971
Transplant rejection 428.14 15.66 183 21514 9029 29543801
Drug resistance 339.59 15.66 206 21491 21334 29531496
Pathogen resistance 237.67 15.66 117 21580 7999 29544831
Polyomavirus-associated nephropathy 224.77 15.66 87 21610 3309 29549521
Neutropenia 192.13 15.66 345 21352 131366 29421464
Kidney transplant rejection 190.37 15.66 96 21601 6909 29545921
Cytomegalovirus colitis 180.44 15.66 68 21629 2401 29550429
BK virus infection 156.36 15.66 74 21623 4633 29548197
Cytomegalovirus chorioretinitis 155.88 15.66 66 21631 3172 29549658
Pneumonia cytomegaloviral 140.29 15.66 58 21639 2624 29550206
Delayed graft function 136.93 15.66 52 21645 1875 29550955
Transplant dysfunction 135.59 15.66 54 21643 2216 29550614
Pancytopenia 134.22 15.66 228 21469 82940 29469890
Post transplant lymphoproliferative disorder 128.28 15.66 68 21629 5425 29547405
Complications of transplanted kidney 127.78 15.66 61 21636 3893 29548937
Off label use 117.63 15.66 483 21214 300317 29252513
Immunosuppressant drug level increased 114.14 15.66 60 21637 4705 29548125
Cytomegalovirus syndrome 111.30 15.66 24 21673 93 29552737
Cytomegalovirus infection reactivation 109.01 15.66 52 21645 3312 29549518
Epstein-Barr virus infection 108.47 15.66 65 21632 6564 29546266
Nocardiosis 107.50 15.66 51 21646 3209 29549621
Aspergillus infection 102.98 15.66 75 21622 10506 29542324
Immune reconstitution inflammatory syndrome 96.31 15.66 64 21633 7738 29545092
Mucormycosis 96.05 15.66 55 21642 5103 29547727
Agranulocytosis 95.92 15.66 95 21602 20245 29532585
Intentional product use issue 87.02 15.66 130 21567 42368 29510462
Renal impairment 84.37 15.66 185 21512 81148 29471682
Cytomegalovirus test positive 81.69 15.66 43 21654 3380 29549450
Cytomegalovirus enteritis 79.96 15.66 24 21673 412 29552418
Cytomegalovirus gastrointestinal infection 79.16 15.66 20 21677 173 29552657
Pneumocystis jirovecii pneumonia 76.58 15.66 77 21620 16702 29536128
Encephalitis cytomegalovirus 72.84 15.66 23 21674 471 29552359
Cryptococcosis 71.99 15.66 33 21664 1919 29550911
Liver transplant rejection 71.64 15.66 33 21664 1941 29550889
Bone marrow failure 71.09 15.66 94 21603 27355 29525475
Cytomegalovirus oesophagitis 68.17 15.66 21 21676 395 29552435
Lung transplant rejection 68.00 15.66 24 21673 700 29552130
Nephropathy toxic 67.65 15.66 59 21638 10697 29542133
Pseudomonas infection 67.19 15.66 59 21638 10793 29542037
Fall 60.80 15.66 27 21670 177151 29375679
Glomerulosclerosis 56.88 15.66 21 21676 699 29552131
Septic shock 56.73 15.66 135 21562 62425 29490405
Focal segmental glomerulosclerosis 55.72 15.66 27 21670 1780 29551050
Fatigue 54.70 15.66 93 21604 316728 29236102
Lymphopenia 54.36 15.66 58 21639 13475 29539355
Toxoplasmosis 53.56 15.66 23 21674 1144 29551686
Polyomavirus viraemia 51.53 15.66 19 21678 630 29552200
Large intestinal ulcer 51.08 15.66 25 21672 1684 29551146
Mycobacterium avium complex infection 49.91 15.66 27 21670 2242 29550588
Trichophytosis 49.89 15.66 15 21682 259 29552571
Enterococcal infection 49.29 15.66 44 21653 8224 29544606
Subcapsular renal haematoma 48.51 15.66 16 21681 378 29552452
Kidney fibrosis 46.82 15.66 25 21672 2022 29550808
Myocardial infarction 46.13 15.66 12 21685 110284 29442546
Dizziness 45.87 15.66 43 21654 189641 29363189
Fungal skin infection 45.80 15.66 26 21671 2372 29550458
Infection reactivation 45.25 15.66 20 21677 1067 29551763
Renal artery stenosis 45.00 15.66 24 21673 1937 29550893
Cytopenia 44.53 15.66 45 21652 9814 29543016
Transplant failure 44.13 15.66 27 21670 2829 29550001
Viral load increased 44.01 15.66 24 21673 2025 29550805
Somnolence 43.79 15.66 8 21689 93947 29458883
Granulomatous dermatitis 43.54 15.66 13 21684 219 29552611
Myelosuppression 43.21 15.66 49 21648 12178 29540652
Product use in unapproved indication 43.16 15.66 151 21546 86724 29466106
Escherichia urinary tract infection 42.58 15.66 27 21670 3012 29549818
Pyrexia 41.70 15.66 356 21341 287266 29265564
Lymphocele 41.36 15.66 20 21677 1312 29551518
Pneumocystis jirovecii infection 39.78 15.66 20 21677 1428 29551402
Pericarditis fungal 39.06 15.66 11 21686 149 29552681
Renal tubular necrosis 38.56 15.66 50 21647 14265 29538565
Clostridium difficile colitis 38.52 15.66 48 21649 13164 29539666
Pain 37.87 15.66 42 21655 171390 29381440
Candida infection 37.66 15.66 51 21646 15174 29537656
Pain in extremity 37.57 15.66 17 21680 110416 29442414
Tubulointerstitial nephritis 37.56 15.66 55 21642 17588 29535242
Human ehrlichiosis 36.48 15.66 11 21686 192 29552638
Hypogammaglobulinaemia 36.33 15.66 32 21665 5875 29546955
Bronchopulmonary aspergillosis 36.23 15.66 45 21652 12299 29540531
Disseminated cytomegaloviral infection 36.16 15.66 11 21686 198 29552632
Vena cava injury 35.70 15.66 11 21686 207 29552623
Dermatophytosis 35.46 15.66 11 21686 212 29552618
Intraductal papillary mucinous neoplasm 34.73 15.66 12 21685 328 29552502
JC virus infection 34.70 15.66 20 21677 1877 29550953
Hepatic artery thrombosis 34.57 15.66 11 21686 231 29552599
Product dose omission issue 34.11 15.66 14 21683 96369 29456461
Botulism 33.97 15.66 10 21687 160 29552670
Syncope 33.73 15.66 9 21688 81362 29471468
Gene mutation 33.44 15.66 16 21681 1025 29551805
Rectal prolapse 33.35 15.66 11 21686 260 29552570
Viraemia 32.97 15.66 16 21681 1058 29551772
Renal cyst haemorrhage 32.68 15.66 12 21685 393 29552437
Renal tubular injury 32.68 15.66 14 21683 692 29552138
Escherichia infection 32.62 15.66 32 21665 6732 29546098
Thrombocytopenia 32.48 15.66 189 21508 134634 29418196
Klebsiella infection 32.20 15.66 33 21664 7316 29545514
Pulmonary nocardiosis 32.17 15.66 13 21684 554 29552276
Cytomegalovirus hepatitis 31.97 15.66 11 21686 297 29552533
Cytomegalovirus gastritis 31.52 15.66 10 21687 208 29552622
Renal transplant failure 31.25 15.66 15 21682 968 29551862
Liver transplant 31.02 15.66 20 21677 2296 29550534
SARS-CoV-2 antibody test positive 30.86 15.66 10 21687 223 29552607
Cell-mediated cytotoxicity 30.38 15.66 7 21690 39 29552791
Gastritis fungal 30.27 15.66 8 21689 84 29552746
Blood creatinine increased 30.13 15.66 133 21564 84969 29467861
Disseminated trichosporonosis 29.80 15.66 7 21690 43 29552787
Cystitis haemorrhagic 29.32 15.66 26 21671 4816 29548014
Parvovirus B19 infection 29.10 15.66 13 21684 711 29552119
Pulmonary mucormycosis 29.03 15.66 12 21685 542 29552288
Retinal scar 28.92 15.66 10 21687 274 29552556
Chronic papillomatous dermatitis 28.89 15.66 7 21690 50 29552780
Fungal endocarditis 28.75 15.66 10 21687 279 29552551
Glomerulonephropathy 28.24 15.66 9 21688 190 29552640
Headache 28.20 15.66 53 21644 173954 29378876
Fungal infection 28.17 15.66 42 21655 13643 29539187
Cytomegalovirus nephritis 27.97 15.66 8 21689 115 29552715
Progressive multifocal leukoencephalopathy 27.56 15.66 33 21664 8686 29544144
Isosporiasis 26.89 15.66 7 21690 69 29552761
Graft versus host disease 26.51 15.66 34 21663 9594 29543236
Asthenia 26.49 15.66 76 21621 215174 29337656
Granulomatous rosacea 26.46 15.66 8 21689 141 29552689
Hyperparathyroidism 26.32 15.66 14 21683 1123 29551707
Actinic keratosis 26.31 15.66 22 21675 3764 29549066
Anxiety 26.24 15.66 15 21682 85350 29467480
End stage renal disease 25.87 15.66 30 21667 7634 29545196
Cardiac failure congestive 25.70 15.66 12 21685 76569 29476261
Protothecosis 25.66 15.66 6 21691 36 29552794
Malaise 25.51 15.66 49 21648 159553 29393277
Hyperhidrosis 25.16 15.66 8 21689 64532 29488298
Constipation 25.15 15.66 28 21669 114132 29438698
Rash 24.86 15.66 65 21632 189754 29363076
Depression 24.72 15.66 16 21681 85131 29467699
Immune recovery uveitis 24.70 15.66 5 21692 13 29552817
Feeling abnormal 24.58 15.66 5 21692 54440 29498390
Thrombotic microangiopathy 24.44 15.66 31 21666 8650 29544180
Gastrointestinal haemorrhage 24.41 15.66 14 21683 79519 29473311
Odynophagia 24.23 15.66 23 21674 4647 29548183
Multiple organ dysfunction syndrome 24.14 15.66 101 21596 63015 29489815
Graft loss 24.14 15.66 12 21685 836 29551994
Eye infection toxoplasmal 24.06 15.66 8 21689 194 29552636
Enterovirus infection 23.57 15.66 11 21686 666 29552164
Steroid diabetes 23.55 15.66 15 21682 1686 29551144
Cerebral toxoplasmosis 23.46 15.66 14 21683 1402 29551428
Myocarditis toxoplasmal 23.44 15.66 6 21691 55 29552775
Human polyomavirus infection 23.36 15.66 11 21686 680 29552150
Oesophagopleural fistula 23.15 15.66 6 21691 58 29552772
Dyspnoea 23.05 15.66 143 21554 326589 29226241
Type 3 diabetes mellitus 22.68 15.66 5 21692 22 29552808
Toxic optic neuropathy 22.63 15.66 11 21686 730 29552100
Acute kidney injury 22.56 15.66 295 21402 264972 29287858
Optic discs blurred 22.29 15.66 6 21691 68 29552762
Squamous cell carcinoma of skin 22.28 15.66 31 21666 9455 29543375
Muscle spasms 22.15 15.66 10 21687 65072 29487758
Biloma 22.05 15.66 6 21691 71 29552759
Bacterial toxaemia 22.04 15.66 7 21690 146 29552684
Dehiscence 21.97 15.66 6 21691 72 29552758
Nausea 21.77 15.66 124 21573 289131 29263699
Bacteraemia 21.46 15.66 41 21656 16282 29536548
Anastomotic stenosis 21.34 15.66 8 21689 278 29552552
Arthralgia 21.33 15.66 44 21653 139573 29413257
Klebsiella sepsis 21.23 15.66 14 21683 1670 29551160
Hydronephrosis 21.21 15.66 29 21668 8701 29544129
Staphylococcal infection 21.17 15.66 58 21639 29182 29523648
Urticaria 20.91 15.66 7 21690 54653 29498177
Encephalitis viral 20.88 15.66 12 21685 1120 29551710
Granuloma 20.70 15.66 16 21681 2448 29550382
Heart transplant rejection 20.70 15.66 12 21685 1139 29551691
Lung transplant 20.69 15.66 14 21683 1742 29551088
Serum sickness 20.63 15.66 14 21683 1751 29551079
Immunosuppressant drug level decreased 20.63 15.66 12 21685 1146 29551684
Genitourinary tract infection 20.27 15.66 6 21691 98 29552732
Sepsis 20.25 15.66 176 21521 142506 29410324
IVth nerve paralysis 19.99 15.66 6 21691 103 29552727
Epstein-Barr viraemia 19.75 15.66 11 21686 967 29551863
Colitis 19.73 15.66 59 21638 31189 29521641
Cutaneous mucormycosis 19.57 15.66 6 21691 111 29552719
Neutrophilic dermatosis 19.34 15.66 7 21690 220 29552610
Necrotising retinitis 19.33 15.66 10 21687 758 29552072
Renal tubular atrophy 19.11 15.66 11 21686 1030 29551800
Bronchial anastomosis complication 19.10 15.66 4 21693 13 29552817
Thrombotic thrombocytopenic purpura 18.98 15.66 17 21680 3189 29549641
Trichophytic granuloma 18.88 15.66 5 21692 53 29552777
Drug intolerance 18.85 15.66 6 21691 48373 29504457
Graft infection 18.84 15.66 8 21689 387 29552443
Abscess 18.73 15.66 29 21668 9733 29543097
Malignant neoplasm progression 18.70 15.66 16 21681 73843 29478987
Urogenital infection bacterial 18.63 15.66 5 21692 56 29552774
Drug level increased 18.60 15.66 42 21655 18745 29534085
American trypanosomiasis 18.57 15.66 7 21690 247 29552583
Abdominal wall haemorrhage 18.52 15.66 7 21690 249 29552581
Meningitis cryptococcal 18.44 15.66 14 21683 2086 29550744
Gait disturbance 18.44 15.66 16 21681 73333 29479497
Viral mutation identified 18.42 15.66 15 21682 2473 29550357
Rhabdomyolysis 18.24 15.66 11 21686 60797 29492033
Carotid arteriosclerosis 18.23 15.66 12 21685 1426 29551404
Encephalopathy 18.09 15.66 57 21640 30986 29521844
Renal tubular disorder 18.09 15.66 19 21678 4333 29548497
Joint swelling 17.89 15.66 7 21690 49623 29503207
Post procedural bile leak 17.86 15.66 7 21690 275 29552555
Blood creatine phosphokinase increased 17.80 15.66 4 21693 40640 29512190
Lymphorrhoea 17.74 15.66 5 21692 68 29552762
Nasopharyngitis 17.61 15.66 11 21686 59654 29493176
Gastric fistula 17.54 15.66 5 21692 71 29552759
Disseminated varicella zoster virus infection 17.51 15.66 6 21691 160 29552670
Epistaxis 17.50 15.66 8 21689 51696 29501134
Paraspinal abscess 17.41 15.66 5 21692 73 29552757
Agitation 17.27 15.66 8 21689 51296 29501534
Blastomycosis 17.17 15.66 7 21690 305 29552525
Peripheral swelling 17.15 15.66 13 21684 63726 29489104
Hyperparathyroidism secondary 17.05 15.66 11 21686 1264 29551566
Mycobacterium fortuitum infection 17.00 15.66 6 21691 175 29552655
Electrocardiogram QT prolonged 16.99 15.66 3 21694 36134 29516696
Therapeutic product effect incomplete 16.95 15.66 4 21693 39301 29513529
Retinal artery occlusion 16.92 15.66 12 21685 1611 29551219
Fusarium infection 16.89 15.66 10 21687 987 29551843
Pruritus 16.86 15.66 38 21659 116811 29436019
Pneumonia fungal 16.85 15.66 21 21676 5756 29547074
Hirsutism 16.81 15.66 6 21691 181 29552649
Cerebrovascular accident 16.78 15.66 19 21678 76892 29475938
Hepatitis viral 16.74 15.66 8 21689 511 29552319
Neutropenic colitis 16.74 15.66 14 21683 2397 29550433
Hypersensitivity 16.68 15.66 9 21688 52894 29499936
Urinoma 16.53 15.66 6 21691 190 29552640
Hyperplasia 16.48 15.66 8 21689 529 29552301
Renal and pancreas transplant rejection 16.45 15.66 4 21693 29 29552801
Graft complication 16.36 15.66 7 21690 345 29552485
Graft versus host disease in skin 16.32 15.66 16 21681 3363 29549467
Cytomegalovirus gastroenteritis 16.18 15.66 6 21691 202 29552628
Donor specific antibody present 16.18 15.66 5 21692 95 29552735
Meningitis fungal 16.09 15.66 5 21692 97 29552733
Adenovirus infection 16.01 15.66 18 21679 4429 29548401
Polycystic liver disease 15.89 15.66 4 21693 34 29552796
Back pain 15.81 15.66 32 21665 102252 29450578
Scopulariopsis infection 15.76 15.66 5 21692 104 29552726

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
Cytomegalovirus infection 1288.60 15.04 539 32319 36660 64429214
Cytomegalovirus viraemia 998.66 15.04 323 32535 10505 64455369
Leukopenia 814.31 15.04 553 32305 100689 64365185
Transplant rejection 679.49 15.04 275 32583 17126 64448748
Drug resistance 671.96 15.04 337 32521 34765 64431109
Pathogen resistance 558.57 15.04 218 32640 12325 64453549
Neutropenia 384.71 15.04 538 32320 239086 64226788
Polyomavirus-associated nephropathy 375.07 15.04 127 32731 4761 64461113
Kidney transplant rejection 359.78 15.04 147 32711 9364 64456510
BK virus infection 327.00 15.04 128 32730 7284 64458590
Cytomegalovirus colitis 285.49 15.04 98 32760 3830 64462044
Pancytopenia 250.99 15.04 336 32522 142973 64322901
Immunosuppressant drug level increased 240.20 15.04 102 32756 7157 64458717
Delayed graft function 237.32 15.04 80 32778 2956 64462918
Cytomegalovirus chorioretinitis 235.05 15.04 90 32768 4822 64461052
Transplant dysfunction 234.45 15.04 98 32760 6610 64459264
Post transplant lymphoproliferative disorder 231.90 15.04 108 32750 9436 64456438
Cytomegalovirus syndrome 222.74 15.04 47 32811 251 64465623
Epstein-Barr virus infection 215.77 15.04 112 32746 12376 64453498
Complications of transplanted kidney 205.51 15.04 84 32774 5351 64460523
Agranulocytosis 198.86 15.04 161 32697 38068 64427806
Pneumonia cytomegaloviral 198.69 15.04 77 32781 4262 64461612
Mucormycosis 193.78 15.04 88 32770 7253 64458621
Nocardiosis 188.21 15.04 76 32782 4691 64461183
Cytomegalovirus infection reactivation 187.52 15.04 80 32778 5676 64460198
Cytomegalovirus gastrointestinal infection 176.55 15.04 42 32816 414 64465460
Encephalitis cytomegalovirus 175.05 15.04 49 32809 956 64464918
Aspergillus infection 164.34 15.04 103 32755 16276 64449598
Nephropathy toxic 150.71 15.04 100 32758 17414 64448460
Renal impairment 144.51 15.04 252 32606 134765 64331109
Lung transplant rejection 136.11 15.04 43 32815 1289 64464585
Pneumocystis jirovecii pneumonia 128.31 15.04 109 32749 27525 64438349
Fatigue 122.55 15.04 121 32737 748609 63717265
Cryptococcosis 115.96 15.04 46 32812 2709 64463165
Smooth muscle cell neoplasm 114.18 15.04 34 32824 832 64465042
Pseudomonas infection 114.02 15.04 85 32773 17798 64448076
Enterococcal infection 106.96 15.04 74 32784 13792 64452082
Bronchopulmonary aspergillosis 106.94 15.04 84 32774 19001 64446873
Pain 104.38 15.04 78 32780 553433 63912441
Fall 104.37 15.04 41 32817 416785 64049089
Renal tubular necrosis 104.26 15.04 88 32770 22022 64443852
Human ehrlichiosis 101.27 15.04 26 32832 359 64465515
Completed suicide 100.59 15.04 3 32855 224411 64241463
Bone marrow failure 100.40 15.04 123 32735 47829 64418045
Arthralgia 99.00 15.04 51 32807 442209 64023665
Cytomegalovirus test positive 97.15 15.04 49 32809 5095 64460779
Toxoplasmosis 96.60 15.04 39 32819 2405 64463469
Renal transplant failure 96.58 15.04 35 32823 1605 64464269
Graft versus host disease 93.34 15.04 68 32790 13745 64452129
Lymphocele 92.84 15.04 34 32824 1607 64464267
Immune reconstitution inflammatory syndrome 92.56 15.04 65 32793 12405 64453469
Off label use 90.69 15.04 591 32267 632215 63833659
Thrombotic microangiopathy 90.51 15.04 72 32786 16583 64449291
Blood creatinine increased 87.17 15.04 205 32653 135577 64330297
Cytomegalovirus enteritis 86.33 15.04 26 32832 662 64465212
Dizziness 85.78 15.04 57 32801 430106 64035768
Liver transplant rejection 85.67 15.04 38 32820 2961 64462913
Escherichia infection 85.50 15.04 67 32791 15101 64450773
Acute kidney injury 85.24 15.04 452 32406 448788 64017086
Polyomavirus viraemia 84.46 15.04 29 32829 1133 64464741
Septic shock 84.45 15.04 174 32684 105263 64360611
Product use in unapproved indication 83.82 15.04 238 32620 176380 64289494
Myelosuppression 83.05 15.04 80 32778 23750 64442124
Renal artery stenosis 82.83 15.04 37 32821 2932 64462942
Cytomegalovirus oesophagitis 80.64 15.04 24 32834 586 64465288
Ureaplasma infection 80.31 15.04 25 32833 713 64465161
Posterior reversible encephalopathy syndrome 79.91 15.04 77 32781 22869 64443005
Cytopenia 77.97 15.04 64 32794 15407 64450467
Transplant failure 77.14 15.04 38 32820 3756 64462118
Thrombocytopenia 75.43 15.04 268 32590 223533 64242341
Lymphopenia 74.47 15.04 78 32780 25579 64440295
Pyrexia 73.47 15.04 511 32347 558133 63907741
Strongyloidiasis 69.00 15.04 33 32825 3057 64462817
Infection reactivation 68.72 15.04 29 32829 2001 64463873
Mycobacterium avium complex infection 67.08 15.04 35 32823 3905 64461969
Klebsiella infection 67.05 15.04 55 32803 13226 64452648
Pain in extremity 66.20 15.04 36 32822 303049 64162825
Viraemia 64.65 15.04 29 32829 2320 64463554
Focal segmental glomerulosclerosis 64.40 15.04 31 32827 2913 64462961
Joint swelling 63.05 15.04 16 32842 215366 64250508
Malaise 62.36 15.04 66 32792 396181 64069693
Cytomegalovirus gastritis 61.96 15.04 18 32840 403 64465471
Hypersensitivity 60.66 15.04 13 32845 196439 64269435
JC virus infection 60.56 15.04 31 32827 3324 64462550
Headache 60.56 15.04 111 32747 529356 63936518
Parvovirus B19 infection 60.34 15.04 23 32835 1216 64464658
Pyelonephritis 60.23 15.04 58 32800 17208 64448666
Product dose omission issue 59.91 15.04 13 32845 194734 64271140
Dyspnoea 59.57 15.04 179 32679 718495 63747379
Escherichia urinary tract infection 59.00 15.04 49 32809 11988 64453886
Fungal skin infection 58.48 15.04 35 32823 5090 64460784
Peripheral swelling 58.47 15.04 17 32841 209136 64256738
Cystitis haemorrhagic 57.95 15.04 41 32817 7915 64457959
Viral load increased 56.88 15.04 27 32831 2460 64463414
Trichophytosis 56.64 15.04 16 32842 323 64465551
Adenovirus infection 56.61 15.04 39 32819 7216 64458658
Drug level increased 54.91 15.04 77 32781 34119 64431755
Glomerulosclerosis 54.61 15.04 20 32838 945 64464929
Pulmonary mucormycosis 54.14 15.04 19 32839 793 64465081
Anxiety 53.91 15.04 18 32840 202631 64263243
Graft loss 53.78 15.04 20 32838 987 64464887
Subcapsular renal haematoma 53.08 15.04 18 32840 677 64465197
Nasopharyngitis 52.89 15.04 17 32841 196056 64269818
Feeling abnormal 52.79 15.04 4 32854 133598 64332276
Pericarditis fungal 51.72 15.04 13 32845 164 64465710
Kidney fibrosis 51.23 15.04 27 32831 3074 64462800
Somnolence 50.93 15.04 20 32838 203625 64262249
Eye infection toxoplasmal 50.92 15.04 16 32842 471 64465403
Rash 49.89 15.04 99 32759 458450 64007424
Death 49.33 15.04 108 32750 482597 63983277
Disseminated cytomegaloviral infection 48.79 15.04 15 32843 410 64465464
Sepsis 47.87 15.04 238 32620 230103 64235771
Cytomegalovirus hepatitis 47.45 15.04 16 32842 591 64465283
Tubulointerstitial nephritis 47.27 15.04 68 32790 30841 64435033
Renal transplant 47.15 15.04 23 32835 2225 64463649
Abdominal discomfort 47.10 15.04 17 32841 182305 64283569
Drug hypersensitivity 46.67 15.04 32 32826 237783 64228091
Infusion related reaction 46.64 15.04 13 32845 164454 64301420
Multiple organ dysfunction syndrome 46.44 15.04 135 32723 101278 64364596
Myocardial infarction 45.39 15.04 14 32844 165807 64300067
Alopecia 45.33 15.04 14 32844 165676 64300198
Pneumonia fungal 45.31 15.04 37 32821 8840 64457034
Granulomatous rosacea 44.81 15.04 12 32846 197 64465677
Hypogammaglobulinaemia 44.50 15.04 39 32819 10260 64455614
Therapeutic product effect decreased 44.06 15.04 4 32854 115347 64350527
Epstein-Barr virus infection reactivation 44.00 15.04 18 32840 1148 64464726
Viral mutation identified 43.85 15.04 25 32833 3321 64462553
Hyperammonaemia 43.79 15.04 38 32820 9866 64456008
Adenoviral hepatitis 43.26 15.04 14 32844 454 64465420
Clostridium difficile colitis 43.26 15.04 61 32797 27162 64438712
Granulomatous dermatitis 43.09 15.04 13 32845 333 64465541
Urticaria 42.99 15.04 11 32847 147306 64318568
Drug intolerance 42.99 15.04 21 32837 187971 64277903
Hydronephrosis 42.89 15.04 44 32814 14081 64451793
Gene mutation 42.77 15.04 21 32837 2061 64463813
Epstein-Barr viraemia 42.60 15.04 20 32838 1777 64464097
Acinetobacter infection 42.56 15.04 22 32836 2407 64463467
Serum sickness 42.26 15.04 24 32834 3165 64462709
Liver transplant 41.71 15.04 26 32832 4066 64461808
Nausea 41.64 15.04 233 32625 785567 63680307
Oesophageal atresia 41.48 15.04 9 32849 56 64465818
Brain abscess 41.19 15.04 26 32832 4155 64461719
Depression 41.12 15.04 21 32837 183270 64282604
Muscle spasms 40.26 15.04 11 32847 141012 64324862
Systemic candida 40.06 15.04 28 32830 5301 64460573
Back pain 40.06 15.04 41 32817 250130 64215744
Candida infection 39.36 15.04 63 32795 31356 64434518
Fungal infection 39.29 15.04 66 32792 34185 64431689
Vena cava injury 39.08 15.04 11 32847 219 64465655
Teratogenicity 38.97 15.04 9 32849 77 64465797
Neutrophil Pelger-Huet anomaly present 38.59 15.04 12 32846 341 64465533
Actinic keratosis 38.51 15.04 27 32831 5138 64460736
Squamous cell carcinoma of skin 37.89 15.04 38 32820 11838 64454036
Steroid diabetes 37.87 15.04 21 32837 2645 64463229
Pneumocystis jirovecii infection 37.43 15.04 20 32838 2341 64463533
Aplasia pure red cell 37.42 15.04 30 32828 6984 64458890
Injection site pain 37.31 15.04 6 32852 111402 64354472
Asthma 37.19 15.04 3 32855 95222 64370652
Toxic optic neuropathy 37.04 15.04 15 32843 932 64464942
Oral candidiasis 36.86 15.04 52 32806 23160 64442714
Pericarditis constrictive 36.76 15.04 13 32845 555 64465319
Pulmonary nocardiosis 36.64 15.04 14 32844 745 64465129
Central nervous system fungal infection 36.48 15.04 12 32846 410 64465464
Contusion 36.29 15.04 7 32851 113958 64351916
Scedosporium infection 36.17 15.04 16 32842 1238 64464636
Hepatic artery thrombosis 36.09 15.04 11 32847 292 64465582
Heart transplant rejection 35.78 15.04 16 32842 1271 64464603
Renal cyst haemorrhage 35.42 15.04 12 32846 450 64465424
Graft versus host disease in skin 35.39 15.04 26 32832 5321 64460553
Cerebrovascular accident 35.24 15.04 13 32845 137570 64328304
Pruritus 35.19 15.04 66 32792 312334 64153540
Hyperuricaemia 35.10 15.04 34 32824 10157 64455717
Swelling 34.99 15.04 19 32839 160199 64305675
Colitis 34.82 15.04 86 32772 58588 64407286
Hyperkalaemia 34.77 15.04 122 32736 101007 64364867
Encephalitis viral 34.50 15.04 19 32839 2361 64463513
Fungal endocarditis 34.39 15.04 12 32846 492 64465382
Oesophageal candidiasis 33.92 15.04 30 32828 7987 64457887
Large intestinal ulcer 33.80 15.04 23 32835 4170 64461704
SARS-CoV-2 antibody test positive 33.80 15.04 10 32848 239 64465635
Cytomegalovirus nephritis 33.76 15.04 9 32849 145 64465729
Cerebral toxoplasmosis 33.33 15.04 17 32841 1809 64464065
Haemolytic anaemia 33.29 15.04 41 32817 16012 64449862
Renal tubular atrophy 33.14 15.04 16 32842 1513 64464361
Anaemia 33.09 15.04 316 32542 378364 64087510
Weight increased 32.99 15.04 36 32822 213312 64252562
Constipation 32.99 15.04 41 32817 229296 64236578
Adrenal mass 32.94 15.04 14 32844 983 64464891
Dermatophytosis 32.92 15.04 11 32847 395 64465479
Musculoskeletal stiffness 32.65 15.04 11 32847 123195 64342679
Intraductal papillary mucinous neoplasm 32.41 15.04 12 32846 585 64465289
Cell-mediated cytotoxicity 32.34 15.04 7 32851 43 64465831
Cytomegalovirus gastroenteritis 32.33 15.04 11 32847 418 64465456
Febrile neutropenia 32.20 15.04 184 32674 187473 64278401
Blood pressure increased 31.53 15.04 25 32833 172527 64293347
Syncope 31.19 15.04 21 32837 157614 64308260
Diabetes mellitus 30.91 15.04 89 32769 66385 64399489
Renal tubular injury 30.89 15.04 14 32844 1147 64464727
Progressive multifocal leukoencephalopathy 30.68 15.04 42 32816 18190 64447684
Granuloma 30.41 15.04 26 32832 6615 64459259
Respiratory failure 30.29 15.04 162 32696 161021 64304853
Gait disturbance 30.15 15.04 26 32832 172129 64293745
Botulism 30.15 15.04 10 32848 351 64465523
Hyperhidrosis 30.03 15.04 13 32845 124907 64340967
Donor specific antibody present 30 15.04 9 32849 226 64465648
Bacteraemia 29.73 15.04 51 32807 26860 64439014
Arthritis 29.25 15.04 4 32854 83810 64382064
Retinal scar 29.24 15.04 10 32848 386 64465488
Microsporidia infection 29.22 15.04 12 32846 773 64465101
Guillain-Barre syndrome 29.21 15.04 27 32831 7608 64458266
Chronic papillomatous dermatitis 29.15 15.04 7 32851 72 64465802
Hepatocellular injury 28.66 15.04 68 32790 45167 64420707
Glomerulonephritis 28.33 15.04 18 32840 2910 64462964
Disseminated trichosporonosis 28.17 15.04 7 32851 84 64465790
Chest discomfort 28.04 15.04 12 32846 116094 64349780
Protothecosis 27.98 15.04 6 32852 35 64465839
Glomerulonephropathy 27.84 15.04 9 32849 291 64465583
Cardiac failure congestive 27.76 15.04 16 32842 130564 64335310
Superinfection bacterial 27.46 15.04 13 32845 1177 64464697
Odynophagia 27.42 15.04 29 32829 9612 64456262
Gastritis fungal 27.29 15.04 8 32850 185 64465689
Urosepsis 27.26 15.04 44 32814 22050 64443824
End stage renal disease 27.15 15.04 30 32828 10445 64455429
Cervicitis 27.09 15.04 8 32850 190 64465684
Blastomycosis 27.08 15.04 10 32848 484 64465390
Escherichia sepsis 26.76 15.04 25 32833 7140 64458734
Mycobacterium fortuitum infection 26.55 15.04 8 32850 204 64465670
Immune recovery uveitis 26.52 15.04 5 32853 13 64465861
Loss of personal independence in daily activities 26.40 15.04 3 32855 72451 64393423
Isosporiasis 26.30 15.04 7 32851 112 64465762
Hyperparathyroidism 26.27 15.04 17 32841 2835 64463039
Suicide attempt 25.72 15.04 3 32855 71004 64394870
Trichophytic granuloma 25.42 15.04 6 32852 57 64465817
Acute graft versus host disease 25.26 15.04 27 32831 9057 64456817
Myocarditis toxoplasmal 25.14 15.04 6 32852 60 64465814
Complications of transplanted lung 25.04 15.04 9 32849 403 64465471
Electrocardiogram QT prolonged 25.04 15.04 5 32853 79443 64386431
Prostatitis 24.92 15.04 18 32840 3588 64462286
Epstein-Barr virus associated lymphoproliferative disorder 24.89 15.04 17 32841 3102 64462772
Obliterative bronchiolitis 24.83 15.04 16 32842 2649 64463225
Venous haemorrhage 24.76 15.04 8 32850 258 64465616
Graft infection 24.70 15.04 10 32848 621 64465253
Staphylococcal infection 24.68 15.04 69 32789 50609 64415265
Maternal exposure during pregnancy 24.65 15.04 9 32849 95875 64369999
Septal panniculitis 24.54 15.04 6 32852 67 64465807
Optic discs blurred 24.46 15.04 6 32852 68 64465806
Urate nephropathy 24.43 15.04 7 32851 149 64465725
Left ventricular hypertrophy 24.25 15.04 27 32831 9479 64456395
Bacterial toxaemia 24.12 15.04 7 32851 156 64465718
Pleural mesothelioma malignant 23.87 15.04 7 32851 162 64465712
Intentional product use issue 23.79 15.04 104 32754 95260 64370614
Graft versus host disease in gastrointestinal tract 23.74 15.04 21 32837 5591 64460283
Pancreatic pseudoaneurysm 23.70 15.04 6 32852 78 64465796
Complications of transplant surgery 23.17 15.04 10 32848 729 64465145
Meningitis cryptococcal 23.06 15.04 16 32842 2993 64462881
Haemophagocytic lymphohistiocytosis 23.01 15.04 36 32822 17573 64448301
Reticulocytopenia 22.99 15.04 7 32851 185 64465689
Type 3 diabetes mellitus 22.79 15.04 5 32853 33 64465841
Urogenital infection bacterial 22.72 15.04 6 32852 93 64465781
Flushing 22.69 15.04 6 32852 78642 64387232
Necrotising retinitis 22.67 15.04 11 32847 1052 64464822
Renal tubular disorder 22.57 15.04 21 32837 5966 64459908
Bacterial pyelonephritis 22.52 15.04 9 32849 540 64465334
Blood pressure decreased 22.31 15.04 8 32850 86191 64379683
Immunosuppressant drug level decreased 22.29 15.04 13 32845 1802 64464072
Systemic lupus erythematosus 22.24 15.04 6 32852 77606 64388268
Bacterial sepsis 22.22 15.04 23 32835 7434 64458440
Mobility decreased 22.16 15.04 8 32850 85832 64380042
Osteoarthritis 22.15 15.04 3 32855 63333 64402541
Enterovirus infection 22.14 15.04 12 32846 1445 64464429
Insomnia 22.07 15.04 42 32816 197794 64268080
Rhinovirus infection 22.07 15.04 21 32837 6135 64459739
Pneumonia pseudomonal 22.05 15.04 19 32839 4884 64460990
Herpes simplex 21.99 15.04 27 32831 10509 64455365
Superinfection viral 21.95 15.04 5 32853 40 64465834
Palpitations 21.93 15.04 13 32845 104475 64361399
Migraine 21.85 15.04 3 32855 62674 64403200
Dehiscence 21.83 15.04 6 32852 109 64465765
Discomfort 21.81 15.04 7 32851 80871 64385003
Chronic graft versus host disease 21.73 15.04 21 32837 6255 64459619
Oropharyngeal candidiasis 21.70 15.04 12 32846 1503 64464371
Therapeutic product effect incomplete 21.54 15.04 13 32845 103469 64362405
Renal lymphocele 21.53 15.04 6 32852 115 64465759
Angioedema 21.45 15.04 3 32855 61818 64404056
Clostridium difficile infection 21.45 15.04 53 32805 36110 64429764
Muscular weakness 21.37 15.04 20 32838 127318 64338556
Urinary tract infection bacterial 21.34 15.04 19 32839 5102 64460772
Rhabdomyolysis 21.33 15.04 10 32848 91716 64374158
Tonic clonic movements 21.19 15.04 13 32845 1976 64463898
Delayed engraftment 21.12 15.04 7 32851 245 64465629
Cutaneous mucormycosis 21.11 15.04 6 32852 124 64465750
Herpes simplex viraemia 20.99 15.04 7 32851 250 64465624
Drug level fluctuating 20.81 15.04 9 32849 660 64465214
Lung transplant 20.71 15.04 17 32841 4091 64461783
Oesophagopleural fistula 20.69 15.04 5 32853 53 64465821
Ascites 20.61 15.04 74 32784 61927 64403947
Memory impairment 20.46 15.04 9 32849 85673 64380201
Disseminated tuberculosis 20.32 15.04 16 32842 3629 64462245
Epstein-Barr virus test positive 20.30 15.04 10 32848 988 64464886
Anaphylactic reaction 20.27 15.04 5 32853 68659 64397215
Post procedural urine leak 20.22 15.04 6 32852 145 64465729
Cytomegalovirus myocarditis 20.11 15.04 4 32854 15 64465859
Human polyomavirus infection 20.10 15.04 10 32848 1009 64464865
Inappropriate schedule of product administration 20.06 15.04 11 32847 92275 64373599
Biloma 19.99 15.04 6 32852 151 64465723
Asthenia 19.91 15.04 132 32726 427912 64037962
Venoocclusive liver disease 19.84 15.04 25 32833 9990 64455884
Malignant neoplasm progression 19.81 15.04 17 32841 112854 64353020
Balance disorder 19.75 15.04 9 32849 83917 64381957
Cytomegalovirus test negative 19.75 15.04 3 32855 0 64465874
IVth nerve paralysis 19.52 15.04 6 32852 164 64465710
Perinephric collection 19.42 15.04 7 32851 316 64465558
Periostitis 19.28 15.04 8 32850 529 64465345
Retinal detachment 19.23 15.04 22 32836 7954 64457920
American trypanosomiasis 19.19 15.04 7 32851 327 64465547
Neutropenic colitis 19.10 15.04 17 32841 4564 64461310
Neuropathy peripheral 19.09 15.04 19 32839 117506 64348368
Anorexia nervosa 19.08 15.04 6 32852 177 64465697
Oxygen saturation decreased 18.98 15.04 16 32842 107160 64358714
Chronic allograft nephropathy 18.96 15.04 11 32847 1510 64464364
Bronchial anastomosis complication 18.86 15.04 4 32854 22 64465852
Loss of consciousness 18.84 15.04 29 32829 148336 64317538
Polycystic liver disease 18.56 15.04 5 32853 84 64465790
Thyroid tuberculosis 18.56 15.04 4 32854 24 64465850
Escherichia bacteraemia 18.56 15.04 18 32840 5385 64460489
Parvovirus infection 18.50 15.04 8 32850 586 64465288
Post procedural bile leak 18.42 15.04 7 32851 367 64465507
Heart rate increased 18.39 15.04 14 32844 98661 64367213
Pneumonia influenzal 18.37 15.04 13 32845 2509 64463365
Sleep disorder 18.31 15.04 4 32854 59705 64406169
Oesophageal ulcer 18.23 15.04 19 32839 6191 64459683
Hepatitis viral 18.21 15.04 9 32849 896 64464978
Coronavirus infection 18.20 15.04 18 32840 5512 64460362
Epistaxis 18.19 15.04 14 32844 98117 64367757
Carotid arteriosclerosis 18.19 15.04 12 32846 2067 64463807
Proteus infection 18.17 15.04 11 32847 1632 64464242
Viral uveitis 18.03 15.04 5 32853 94 64465780
Abscess 18.02 15.04 34 32824 19270 64446604
Enterobacter infection 18.01 15.04 15 32843 3681 64462193
Mesothelioma malignant 17.92 15.04 6 32852 217 64465657
Chest pain 17.89 15.04 61 32797 235919 64229955
Klebsiella sepsis 17.87 15.04 13 32845 2619 64463255
Rectal prolapse 17.67 15.04 11 32847 1715 64464159
Pneumonia pneumococcal 17.61 15.04 14 32844 3220 64462654
Meningitis viral 17.60 15.04 11 32847 1727 64464147
Corynebacterium infection 17.59 15.04 9 32849 964 64464910
Abdominal wall haemorrhage 17.55 15.04 7 32851 418 64465456
Stomatitis 17.48 15.04 18 32840 109587 64356287
Neck pain 17.18 15.04 5 32853 61528 64404346
Agitation 17.17 15.04 12 32846 88355 64377519
Pyelonephritis fungal 17.17 15.04 5 32853 113 64465761
Scopulariopsis infection 17.12 15.04 5 32853 114 64465760
Pulmonary interstitial emphysema syndrome 16.97 15.04 7 32851 456 64465418
Herpes simplex oesophagitis 16.97 15.04 6 32852 256 64465618
Hyperparathyroidism secondary 16.95 15.04 12 32846 2318 64463556
Haemolytic uraemic syndrome 16.92 15.04 15 32843 4006 64461868
Pneumonia klebsiella 16.86 15.04 15 32843 4022 64461852
Pericarditis infective 16.84 15.04 5 32853 121 64465753
Dyspepsia 16.84 15.04 10 32848 80302 64385572
Dry mouth 16.70 15.04 5 32853 60413 64405461
Parainfluenzae virus infection 16.67 15.04 16 32842 4727 64461147
Disseminated varicella zoster virus infection 16.62 15.04 6 32852 272 64465602
Lymphadenitis viral 16.58 15.04 4 32854 42 64465832
Oesophagogastroscopy normal 16.46 15.04 3 32855 6 64465868
Abdominal pain upper 16.35 15.04 41 32817 174989 64290885
Adenoviral haemorrhagic cystitis 16.30 15.04 7 32851 504 64465370
Urinary tract infection 16.27 15.04 185 32673 231411 64234463
Subcutaneous abscess 16.24 15.04 19 32839 7034 64458840
Human herpesvirus 6 infection reactivation 16.23 15.04 6 32852 291 64465583
Renal and pancreas transplant rejection 16.17 15.04 4 32854 47 64465827
Cholestasis 16.16 15.04 55 32803 44817 64421057
Antiviral drug level above therapeutic 16.10 15.04 4 32854 48 64465826
Fusarium infection 16.07 15.04 10 32848 1559 64464315
Brain oedema 15.99 15.04 35 32823 22040 64443834
Suicidal ideation 15.87 15.04 7 32851 66535 64399339
Neutrophilic dermatosis 15.75 15.04 7 32851 548 64465326
Blister 15.72 15.04 11 32847 80956 64384918
Gastric fistula 15.70 15.04 5 32853 154 64465720
Confusional state 15.68 15.04 74 32784 261070 64204804
Hypervolaemia 15.66 15.04 49 32809 38236 64427638
Wheezing 15.58 15.04 11 32847 80568 64385306
Drug interaction 15.57 15.04 265 32593 361818 64104056
Hepatic cyst infection 15.54 15.04 5 32853 159 64465715
Speech disorder 15.36 15.04 3 32855 48438 64417436
Bacterial infection 15.25 15.04 37 32821 24913 64440961
Paraspinal abscess 15.17 15.04 5 32853 172 64465702
Hypoaesthesia 15.10 15.04 30 32828 139078 64326796
Hypophosphataemia 15.09 15.04 27 32831 14693 64451181

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J05AB14 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Nucleosides and nucleotides excl. reverse transcriptase inhibitors
FDA MoA N0000020060 DNA Polymerase Inhibitors
FDA EXT N0000175459 Nucleoside Analog
FDA EPC N0000175461 Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000998 Antiviral Agents
CHEBI has role CHEBI:36044 antiviral drugs
CHEBI has role CHEBI:50266 Prodrugs

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

DiseaseRelationSNOMED_IDDOID
Prevention of CMV Disease After Kidney Transplantation indication
CMV Retinitis in AIDS Patients indication
Prevention of CMV Disease After Cardiac Transplantation indication
Prevention of CMV Disease After Kidney-Pancreas Transplantation indication
Prevention of Cytomegalovirus Disease off-label use
Dehydration contraindication 34095006
Acute nephropathy contraindication 58574008
Kidney disease contraindication 90708001 DOID:557
Anemia contraindication 271737000 DOID:2355
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Aplastic anemia contraindication 306058006 DOID:12449
Breastfeeding (mother) contraindication 413712001
Granulocytopenic disorder contraindication 417672002
Severe Bone Marrow Depression contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.97 acidic
pKa2 11.83 acidic
pKa3 7.81 Basic
pKa4 3.68 Basic
pKa5 2.12 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
DNA polymerase catalytic subunit Enzyme INHIBITOR DRUGBANK CHEMBL

External reference:

IDSource
4021263 VUID
N0000148704 NUI
D02495 KEGG_DRUG
4021263 VANDF
4021264 VANDF
4030204 VANDF
C0909381 UMLSCUI
CHEBI:63635 CHEBI
CHEMBL1201314 ChEMBL_ID
CHEMBL252321 ChEMBL_ID
CHEMBL400177 ChEMBL_ID
DB01610 DRUGBANK_ID
CHEMBL1200454 ChEMBL_ID
D000077562 MESH_DESCRIPTOR_UI
135413535 PUBCHEM_CID
4716 IUPHAR_LIGAND_ID
7650 INN_ID
GCU97FKN3R UNII
275891 RXNORM
15960 MMSL
231338 MMSL
d04755 MMSL
009135 NDDF
009136 NDDF
129476000 SNOMEDCT_US
395266000 SNOMEDCT_US
412326001 SNOMEDCT_US
175865-60-8 SECONDARY_CAS_RN

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Valcyte HUMAN PRESCRIPTION DRUG LABEL 1 0004-0038 TABLET, FILM COATED 450 mg ORAL NDA 31 sections
Valcyte HUMAN PRESCRIPTION DRUG LABEL 1 0004-0039 POWDER, FOR SOLUTION 50 mg ORAL NDA 31 sections
Valganciclovir hydrochloride for Oral HUMAN PRESCRIPTION DRUG LABEL 1 0591-2579 POWDER, FOR SOLUTION 50 mg ORAL ANDA 29 sections
Valganciclovir hydrochloride for Oral HUMAN PRESCRIPTION DRUG LABEL 1 0591-2579 POWDER, FOR SOLUTION 50 mg ORAL ANDA 29 sections
Valganciclovir HUMAN PRESCRIPTION DRUG LABEL 1 0603-6330 TABLET, FILM COATED 450 mg ORAL ANDA 32 sections
Valganciclovir HUMAN PRESCRIPTION DRUG LABEL 1 0904-6796 TABLET, FILM COATED 450 mg ORAL ANDA 26 sections
Valganciclovir HUMAN PRESCRIPTION DRUG LABEL 1 16714-765 TABLET, FILM COATED 450 mg ORAL ANDA 26 sections
Valganciclovir Human Prescription Drug Label 1 27241-158 TABLET 450 mg ORAL ANDA 28 sections
Valganciclovir hydrochloride Human Prescription Drug Label 1 27241-159 POWDER, FOR SOLUTION 50 mg ORAL ANDA 28 sections
Valganciclovir Human Prescription Drug Label 1 31722-832 TABLET, FILM COATED 450 mg ORAL ANDA 26 sections
Valganciclovir HUMAN PRESCRIPTION DRUG LABEL 1 42291-875 TABLET, FILM COATED 450 mg ORAL ANDA 29 sections
valganciclovir hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43598-356 TABLET 450 mg ORAL ANDA 28 sections
Valganciclovir HUMAN PRESCRIPTION DRUG LABEL 1 48433-124 TABLET, FILM COATED 450 mg ORAL ANDA 26 sections
Valganciclovir HUMAN PRESCRIPTION DRUG LABEL 1 50268-787 TABLET, FILM COATED 450 mg ORAL ANDA 26 sections
Valganciclovir HUMAN PRESCRIPTION DRUG LABEL 1 55111-762 TABLET, FILM COATED 450 mg ORAL ANDA 26 sections
Valganciclovir HUMAN PRESCRIPTION DRUG LABEL 1 60429-846 TABLET, FILM COATED 450 mg ORAL ANDA 26 sections
Valganciclovir HUMAN PRESCRIPTION DRUG LABEL 1 60429-846 TABLET, FILM COATED 450 mg ORAL ANDA 26 sections
Valganciclovir HUMAN PRESCRIPTION DRUG LABEL 1 63629-2288 TABLET, FILM COATED 450 mg ORAL ANDA 31 sections
Valganciclovir HUMAN PRESCRIPTION DRUG LABEL 1 63629-2288 TABLET, FILM COATED 450 mg ORAL ANDA 31 sections
Valganciclovir HUMAN PRESCRIPTION DRUG LABEL 1 63739-076 TABLET, FILM COATED 450 mg ORAL ANDA 26 sections
VALGANCICLOVIR HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 63739-357 TABLET 450 mg ORAL ANDA 29 sections
VALGANCICLOVIR HYDROCHLORIDE Human Prescription Drug Label 1 65862-753 TABLET 450 mg ORAL ANDA 28 sections
Valganciclovir HUMAN PRESCRIPTION DRUG LABEL 1 68084-965 TABLET, FILM COATED 450 mg ORAL ANDA 29 sections
Valganciclovir HUMAN PRESCRIPTION DRUG LABEL 1 69097-277 TABLET 450 mg ORAL ANDA 27 sections
VALGANCICLOVIR HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 70010-051 FOR SOLUTION 50 mg ORAL ANDA 28 sections
VALGANCICLOVIR HYDROCHLORIDE Human Prescription Drug Label 1 70069-810 FOR SOLUTION 50 mg ORAL ANDA 28 sections
VALGANCICLOVIR HUMAN PRESCRIPTION DRUG LABEL 1 71151-003 FOR SOLUTION 50 mg ORAL ANDA 30 sections