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

Stem definitionDrug idCAS RN
antivirals bicyclic heterocycle compounds 1277 82410-32-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • ganciclovir
  • denosine
  • gancyclovir
  • hydroxyacyclovir
  • natclovir
  • ganciclovir sodium
An ACYCLOVIR analog that is a potent inhibitor of the Herpesvirus family including cytomegalovirus. Ganciclovir is used to treat complications from AIDS-associated cytomegalovirus infections.
  • Molecular weight: 255.23
  • Formula: C9H13N5O4
  • CLOGP: -2.15
  • LIPINSKI: 0
  • HAC: 9
  • HDO: 4
  • TPSA: 134.99
  • ALOGS: -1.35
  • ROTB: 5
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
3 g O
0.50 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 3 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 91 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 78.36 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 4 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 4.60 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.99 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 3.70 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -1.745 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 8.511 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 0.552 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 0.687 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 89.420 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 93.570 % High 1
herg hERG pIC50 3.453 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 1.002 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 3.112 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 83.900 % High 1
kinase-safety-class ACVR2B,CAMK2D,CDK5,EIF2AK3,GRK2,ITK,MAP3K21,PDK1,PDK2,PRKDC 10
kinase-selectivity-class AXL,CDK1,CDK16,CDK2,CDK3,CDK7,CDK9,DYRK1A,MAP3K21,PDK1 10
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 0.658 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 1.079 High 1
mh-clint Mouse hepatocyte intrinsic clearance 0.755 High 1
mppb Mouse plasma protein binding (% unbound) 94.930 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 1.253 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 Moderate 0.74
pppb Pig plasma protein binding (% unbound) 92.370 % High 1
rat-kpuu-brain Rat brain Kpuu 0.008 % High 1
rh-clint Rat hepatocyte intrinsic clearance 1.439 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 96.900 % High 1
rppb Rat plasma protein binding (% unbound) 88.820 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 988.553 uM High 1

Approvals:

DateAgencyCompanyOrphan
June 23, 1989 FDA ROCHE PALO

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 718.04 24.82 240 15263 26362 90586582
Drug resistance 621.52 24.82 223 15280 30226 90582718
Post transplant lymphoproliferative disorder 539.01 24.82 142 15361 6807 90606137
Smooth muscle cell neoplasm 463.78 24.82 93 15410 1280 90611664
Epstein-Barr virus infection 396.71 24.82 122 15381 10222 90602722
Off label use 395.37 24.82 685 14818 1101567 89511377
Multiple organ dysfunction syndrome 389.34 24.82 203 15300 68133 90544811
Cytomegalovirus viraemia 380.07 24.82 110 15393 7476 90605468
Pathogen resistance 346.64 24.82 104 15399 8011 90604933
Cytomegalovirus infection reactivation 261.38 24.82 83 15420 7717 90605227
Pancytopenia 218.84 24.82 174 15329 120089 90492855
Haemophagocytic lymphohistiocytosis 212.83 24.82 85 15418 15374 90597570
Graft versus host disease 209.66 24.82 71 15432 8073 90604871
Encephalitis cytomegalovirus 208.85 24.82 43 15460 679 90612265
Neutropenia 197.91 24.82 217 15286 224687 90388257
Pneumonia cytomegaloviral 186.88 24.82 52 15451 3059 90609885
Leukopenia 181.64 24.82 145 15358 100565 90512379
Nephropathy toxic 178.95 24.82 71 15432 12617 90600327
Cytomegalovirus colitis 173.56 24.82 50 15453 3336 90609608
Transplant rejection 171.63 24.82 69 15434 12689 90600255
Epstein-Barr virus associated lymphoproliferative disorder 157.55 24.82 44 15459 2623 90610321
Haemorrhage intracranial 156.85 24.82 68 15435 15094 90597850
Cystitis haemorrhagic 149.55 24.82 50 15453 5463 90607481
Fatigue 128.14 24.82 22 15481 1154001 89458943
Renal impairment 125.80 24.82 120 15383 105301 90507643
Cytomegalovirus test positive 123.55 24.82 39 15464 3552 90609392
Pain 122.24 24.82 14 15489 996327 89616617
Cytomegalovirus chorioretinitis 116.35 24.82 34 15469 2385 90610559
Pneumocystis jirovecii pneumonia 113.80 24.82 61 15442 21555 90591389
Aspergillus infection 110.17 24.82 48 15455 10775 90602169
Sepsis 109.46 24.82 144 15359 179670 90433274
Graft versus host disease in gastrointestinal tract 108.01 24.82 37 15466 4351 90608593
Respiratory failure 106.99 24.82 116 15387 118302 90494642
Viral haemorrhagic cystitis 103.80 24.82 28 15475 1465 90611479
Gastric ulcer 102.80 24.82 62 15441 27386 90585558
Acute graft versus host disease 100.05 24.82 37 15466 5431 90607513
Thrombotic microangiopathy 98.83 24.82 50 15453 15693 90597251
Product use in unapproved indication 97.54 24.82 192 15311 336044 90276900
Drug ineffective 94.32 24.82 475 15028 1383823 89229121
Arthralgia 92.77 24.82 12 15491 778510 89834434
Renal failure 92.50 24.82 113 15390 130894 90482050
Septic shock 91.38 24.82 91 15412 84069 90528875
Cytomegalovirus gastritis 90.84 24.82 19 15484 325 90612619
Transplant dysfunction 86.67 24.82 33 15470 5249 90607695
Drug ineffective for unapproved indication 85.48 24.82 79 15424 66565 90546379
Bone marrow failure 84.11 24.82 58 15445 32163 90580781
Bronchopulmonary aspergillosis 82.84 24.82 40 15463 11358 90601586
Retinitis viral 82.00 24.82 17 15486 278 90612666
Enterococcal infection 81.61 24.82 38 15465 9953 90602991
BK virus infection 80.70 24.82 30 15473 4468 90608476
Graft versus host disease in skin 77.66 24.82 28 15475 3825 90609119
Kidney transplant rejection 74.88 24.82 29 15474 4828 90608116
Brain abscess 74.27 24.82 25 15478 2787 90610157
Intussusception 74.17 24.82 20 15483 1045 90611899
Dyspnoea 71.14 24.82 31 15472 880924 89732020
Cytomegalovirus oesophagitis 70.73 24.82 16 15487 400 90612544
Cytomegalovirus gastrointestinal infection 70.65 24.82 16 15487 402 90612542
Mucormycosis 70.44 24.82 26 15477 3795 90609149
Epstein-Barr virus infection reactivation 69.96 24.82 21 15482 1616 90611328
Adenovirus infection 69.14 24.82 27 15476 4595 90608349
Thrombocytopenia 68.86 24.82 126 15377 208599 90404345
Acute graft versus host disease in skin 68.39 24.82 27 15476 4729 90608215
Posterior reversible encephalopathy syndrome 67.39 24.82 44 15459 22295 90590649
Alopecia 65.75 24.82 5 15498 495066 90117878
Splenomegaly 63.92 24.82 35 15468 12889 90600055
Adrenal mass 63.42 24.82 18 15485 1137 90611807
Viral load increased 62.37 24.82 19 15484 1537 90611407
Agranulocytosis 62.17 24.82 50 15453 34952 90577992
Polyomavirus-associated nephropathy 61.30 24.82 21 15482 2469 90610475
Chronic graft versus host disease 61.29 24.82 24 15479 4115 90608829
Infected neoplasm 61.21 24.82 14 15489 368 90612576
Headache 61.20 24.82 36 15467 862710 89750234
Fusarium infection 60.04 24.82 17 15486 1065 90611879
Cytomegalovirus enterocolitis 58.93 24.82 16 15487 858 90612086
Nausea 56.83 24.82 64 15439 1110252 89502692
Brain oedema 56.78 24.82 36 15467 17349 90595595
Swelling 56.29 24.82 4 15499 419054 90193890
Lymphopenia 54.61 24.82 39 15464 22842 90590102
Disseminated mucormycosis 53.37 24.82 14 15489 657 90612287
Parvovirus B19 infection 52.20 24.82 15 15488 991 90611953
Gastrointestinal stromal tumour 51.78 24.82 16 15487 1357 90611587
Hypersensitivity 51.74 24.82 8 15495 454669 90158275
Intracranial infection 51.06 24.82 11 15492 218 90612726
Drug hypersensitivity 50.88 24.82 9 15494 463600 90149344
Pruritus 50.52 24.82 15 15488 541510 90071434
Fungal sepsis 49.97 24.82 16 15487 1525 90611419
Hyperammonaemia 47.89 24.82 23 15480 6452 90606492
Disseminated intravascular coagulation 47.51 24.82 35 15468 21503 90591441
Systemic lupus erythematosus 47.06 24.82 4 15499 361892 90251052
Bladder hypertrophy 46.61 24.82 12 15491 523 90612421
Venoocclusive liver disease 46.50 24.82 22 15481 5971 90606973
Hepatic function abnormal 46.47 24.82 48 15455 46240 90566704
Immune reconstitution inflammatory syndrome 46.13 24.82 23 15480 6996 90605948
Transplant failure 46.12 24.82 16 15487 1953 90610991
Weight increased 46.10 24.82 8 15495 417919 90195025
Pulmonary haemorrhage 46.09 24.82 24 15479 7989 90604955
Scedosporium infection 45.93 24.82 13 15490 813 90612131
Dizziness 45.52 24.82 22 15481 589262 90023682
Pain in extremity 44.80 24.82 11 15492 450518 90162426
Complications of transplanted kidney 43.71 24.82 17 15486 2861 90610083
Abdominal discomfort 43.11 24.82 14 15489 477314 90135630
Lung transplant rejection 42.96 24.82 13 15490 1028 90611916
Pyrexia 42.69 24.82 224 15279 660261 89952683
Staphylococcal sepsis 42.54 24.82 24 15479 9359 90603585
Oesophagitis ulcerative 41.59 24.82 12 15491 804 90612140
Bacterial sepsis 40.94 24.82 19 15484 4936 90608008
Malaise 40.71 24.82 25 15478 585961 90026983
Ureaplasma infection 40.37 24.82 12 15491 893 90612051
Nephrogenic diabetes insipidus 39.54 24.82 12 15491 958 90611986
Immune recovery uveitis 39.17 24.82 7 15496 49 90612895
Drug intolerance 38.91 24.82 14 15489 447577 90165367
Necrotising herpetic retinopathy 38.57 24.82 8 15495 131 90612813
Epstein-Barr viraemia 38.55 24.82 13 15490 1457 90611487
Cytomegalovirus myocarditis 38.24 24.82 7 15496 57 90612887
Lymphadenopathy 38.11 24.82 43 15460 45732 90567212
Systemic mycosis 38.04 24.82 13 15490 1517 90611427
Klebsiella infection 37.87 24.82 23 15480 10274 90602670
Gastrointestinal mucormycosis 37.15 24.82 9 15494 305 90612639
Aplasia pure red cell 37.05 24.82 18 15485 5176 90607768
Imprisonment 36.38 24.82 9 15494 333 90612611
Infusion related reaction 36.28 24.82 13 15490 416767 90196177
Product use issue 35.93 24.82 131 15372 329788 90283156
Immunosuppressant drug level increased 35.76 24.82 17 15486 4663 90608281
Contraindicated product administered 35.57 24.82 6 15497 320133 90292811
Multiple-drug resistance 35.55 24.82 20 15483 7756 90605188
Abdominal pain upper 35.32 24.82 7 15496 332667 90280277
Sinusitis 34.83 24.82 8 15495 343080 90269864
Acute respiratory distress syndrome 34.83 24.82 33 15470 28653 90584291
Pseudomonas infection 34.70 24.82 25 15478 14840 90598104
Urticaria 34.44 24.82 6 15497 312728 90300216
Hydrocephalus 34.33 24.82 18 15485 6076 90606868
Myocardial calcification 34.22 24.82 8 15495 232 90612712
Anxiety 33.99 24.82 6 15497 309766 90303178
Adenovirus reactivation 33.80 24.82 8 15495 245 90612699
Haemorrhage urinary tract 33.78 24.82 11 15492 1106 90611838
Strongyloidiasis 33.63 24.82 12 15491 1590 90611354
Product dose omission issue 33.46 24.82 5 15498 291682 90321262
Insomnia 33.41 24.82 8 15495 333466 90279478
Rash 33.39 24.82 53 15450 796047 89816897
Cytopenia 33.28 24.82 26 15477 17423 90595521
Liver transplant rejection 32.74 24.82 12 15491 1716 90611228
Myelosuppression 32.66 24.82 43 15460 53548 90559396
Hypoaesthesia 32.55 24.82 7 15496 314203 90298741
Pleural effusion 32.42 24.82 64 15439 111927 90501017
Hypomagnesaemia 32.33 24.82 35 15468 35553 90577391
Muscle spasms 32.15 24.82 3 15500 251880 90361064
Musculoskeletal stiffness 31.98 24.82 6 15497 296526 90316418
Confabulation 31.93 24.82 8 15495 312 90612632
BK polyomavirus test positive 31.67 24.82 7 15496 157 90612787
Hyperlactacidaemia 31.53 24.82 15 15488 4121 90608823
Fall 31.48 24.82 22 15481 481788 90131156
Cytomegalovirus gastroenteritis 31.11 24.82 8 15495 347 90612597
Hyphaema 30.87 24.82 8 15495 358 90612586
Acute graft versus host disease in intestine 30.56 24.82 12 15491 2071 90610873
Acute respiratory failure 30.21 24.82 37 15466 42881 90570063
Wheezing 29.95 24.82 3 15500 238077 90374867
Oesophageal candidiasis 29.70 24.82 17 15486 6812 90606132
Contusion 29.53 24.82 4 15499 251212 90361732
Varicella zoster virus infection 29.37 24.82 14 15489 3863 90609081
Impaired healing 29.33 24.82 3 15500 234196 90378748
Idiopathic pneumonia syndrome 29.21 24.82 8 15495 443 90612501
Leukoencephalopathy 29.19 24.82 15 15488 4858 90608086
Back pain 29.15 24.82 9 15494 317166 90295778
Gait disturbance 28.67 24.82 5 15498 260491 90352453
Cholestasis 28.36 24.82 33 15470 36266 90576678
Infection reactivation 27.85 24.82 11 15492 1929 90611015
Chest pain 27.75 24.82 10 15493 319635 90293309
Hypogammaglobulinaemia 27.34 24.82 19 15484 10655 90602289
Rhegmatogenous retinal detachment 27.25 24.82 6 15497 132 90612812
Paraesthesia 27.13 24.82 5 15498 250321 90362623
Depression 26.79 24.82 9 15494 300592 90312352
Encephalitis Japanese B 26.77 24.82 5 15498 46 90612898
Respiratory distress 26.49 24.82 33 15470 38913 90574031
Pneumonia bacterial 26.45 24.82 20 15483 12770 90600174
Organ failure 25.95 24.82 12 15491 3093 90609851
Central nervous system necrosis 25.94 24.82 6 15497 166 90612778
Bacteraemia 25.83 24.82 25 15478 22275 90590669
Blister 25.76 24.82 6 15497 254992 90357952
Renal transplant failure 25.75 24.82 9 15494 1123 90611821
Pneumonia pseudomonal 25.59 24.82 12 15491 3191 90609753
Red blood cells urine positive 25.51 24.82 12 15491 3213 90609731
Herpes simplex test positive 25.29 24.82 7 15496 403 90612541
Bronchiolitis obliterans syndrome 25.28 24.82 7 15496 404 90612540

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 836.42 19.01 383 21658 31923 42567371
Drug resistance 726.56 19.01 354 21687 33894 42565400
Cytomegalovirus viraemia 447.83 19.01 177 21864 10200 42589094
Cytomegalovirus infection reactivation 414.61 19.01 171 21870 11007 42588287
Pathogen resistance 367.33 19.01 158 21883 11292 42588002
Pancytopenia 288.56 19.01 329 21712 117414 42481880
Cystitis haemorrhagic 271.30 19.01 112 21929 7217 42592077
Off label use 266.47 19.01 825 21216 637510 41961784
Pneumonia cytomegaloviral 260.37 19.01 93 21948 4033 42595261
Drug ineffective 234.98 19.01 784 21257 629413 41969881
Epstein-Barr viraemia 229.19 19.01 73 21968 2216 42597078
BK virus infection 223.25 19.01 103 21938 8681 42590613
Thrombotic microangiopathy 218.36 19.01 120 21921 14662 42584632
Nephropathy toxic 214.37 19.01 124 21917 16714 42582580
Myelosuppression 197.13 19.01 165 21876 40296 42558998
Cytomegalovirus colitis 189.67 19.01 73 21968 3908 42595386
Transplant rejection 186.19 19.01 105 21936 13483 42585811
Graft versus host disease 185.60 19.01 103 21938 12822 42586472
Leukopenia 171.29 19.01 202 21839 74544 42524750
Multiple organ dysfunction syndrome 168.03 19.01 228 21813 96807 42502487
Aspergillus infection 151.14 19.01 97 21944 15740 42583554
Cytomegalovirus test positive 133.20 19.01 58 21983 4261 42595033
Pneumocystis jirovecii pneumonia 131.59 19.01 107 21934 25074 42574220
Fatigue 122.26 19.01 37 22004 435604 42163690
Encephalitis cytomegalovirus 121.91 19.01 39 22002 1200 42598094
End stage renal disease 121.10 19.01 86 21955 16472 42582822
Respiratory failure 114.45 19.01 223 21818 127909 42471385
Cytomegalovirus chorioretinitis 113.81 19.01 53 21988 4558 42594736
Drug ineffective for unapproved indication 111.07 19.01 128 21913 46035 42553259
Neutropenia 110.64 19.01 287 21754 199144 42400150
Acute graft versus host disease 108.52 19.01 62 21979 8153 42591141
Product use in unapproved indication 108.06 19.01 271 21770 184185 42415109
Bone marrow failure 100.96 19.01 104 21937 32989 42566305
Post transplant lymphoproliferative disorder 94.85 19.01 59 21982 9061 42590233
Respiratory distress 89.10 19.01 109 21932 41711 42557583
Dizziness 88.72 19.01 12 22029 249242 42350052
Fall 84.15 19.01 11 22030 234509 42364785
Epstein-Barr virus infection 84.09 19.01 56 21985 9662 42589632
Haemophagocytic lymphohistiocytosis 79.88 19.01 70 21971 18152 42581142
Product use issue 77.66 19.01 141 21900 76610 42522684
Klebsiella infection 76.32 19.01 56 21985 11276 42588018
Generalised oedema 75.56 19.01 63 21978 15273 42584021
Death 72.96 19.01 82 21959 471103 42128191
Acute graft versus host disease in skin 72.12 19.01 46 21995 7378 42591916
Septic shock 71.59 19.01 151 21890 91521 42507773
Immune reconstitution inflammatory syndrome 70.29 19.01 51 21990 10092 42589202
Human herpesvirus 8 infection 69.69 19.01 27 22014 1470 42597824
Acute graft versus host disease in intestine 69.35 19.01 36 22005 3915 42595379
Product dose omission issue 67.12 19.01 3 22038 154362 42444932
Incision site pain 66.75 19.01 28 22013 1875 42597419
Renal impairment 65.52 19.01 163 21878 110065 42489229
Pain 64.63 19.01 23 22018 244825 42354469
Glomerulosclerosis 63.94 19.01 22 22019 852 42598442
Asthenia 63.60 19.01 33 22008 280760 42318534
Kidney transplant rejection 63.24 19.01 45 21996 8638 42590656
Adenovirus infection 63.20 19.01 41 22000 6768 42592526
Chronic graft versus host disease 62.70 19.01 39 22002 5986 42593308
Enterococcal infection 60.44 19.01 50 21991 11989 42587305
Arthralgia 60.05 19.01 16 22025 205222 42394072
Candida infection 58.93 19.01 64 21977 21546 42577748
Parvovirus B19 infection 55.80 19.01 24 22017 1710 42597584
Lymphopenia 55.58 19.01 62 21979 21501 42577793
Bronchopulmonary aspergillosis 55.55 19.01 59 21982 19370 42579924
Dyspnoea 55.33 19.01 90 21951 442531 42156763
Immune recovery uveitis 54.81 19.01 12 22029 77 42599217
Thrombocytopenia 54.14 19.01 218 21823 190061 42409233
Pruritus 52.84 19.01 16 22025 188755 42410539
Graft versus host disease in skin 52.38 19.01 33 22008 5179 42594115
Encephalitis 52.26 19.01 41 22000 9117 42590177
Neutrophil Pelger-Huet anomaly present 50.76 19.01 14 22027 254 42599040
Cytomegalovirus syndrome 50.47 19.01 12 22029 116 42599178
Pneumocystis jirovecii infection 47.18 19.01 25 22016 2835 42596459
Stenotrophomonas infection 46.37 19.01 27 22014 3677 42595617
Epstein-Barr virus infection reactivation 46.29 19.01 24 22017 2603 42596691
Necrotising retinitis 45.90 19.01 18 22023 1012 42598282
Retinal detachment 45.65 19.01 33 22008 6492 42592802
Graft versus host disease in gastrointestinal tract 45.37 19.01 30 22011 5113 42594181
Pseudomonas infection 44.89 19.01 48 21993 15875 42583419
Nausea 43.87 19.01 87 21954 396712 42202582
Anxiety 43.85 19.01 5 22036 118555 42480739
Viral load increased 43.32 19.01 24 22017 2973 42596321
Cytomegalovirus gastrointestinal infection 42.57 19.01 13 22028 342 42598952
Aplastic anaemia 41.55 19.01 41 22000 12343 42586951
Acanthamoeba infection 41.53 19.01 14 22027 509 42598785
Headache 39.91 19.01 39 22002 239330 42359964
Brain herniation 39.82 19.01 27 22014 4796 42594498
Back pain 39.68 19.01 12 22029 141764 42457530
Myocardial infarction 39.55 19.01 8 22033 124001 42475293
Botulism 39.30 19.01 11 22030 211 42599083
Retinal toxicity 37.52 19.01 13 22028 514 42598780
Retinal scar 37.51 19.01 12 22029 369 42598925
Pneumonia bacterial 36.85 19.01 43 21998 15649 42583645
Aplasia pure red cell 36.46 19.01 30 22011 7136 42592158
Cytomegalovirus oesophagitis 36.19 19.01 13 22028 572 42598722
Cytomegalovirus gastritis 35.89 19.01 11 22030 293 42599001
Scedosporium infection 35.65 19.01 17 22024 1541 42597753
Sepsis 34.53 19.01 198 21843 199136 42400158
Blood pressure increased 33.72 19.01 6 22035 101922 42497372
Urinary tract inflammation 33.69 19.01 10 22031 238 42599056
Infection reactivation 32.90 19.01 18 22023 2176 42597118
Lung disorder 32.89 19.01 75 21966 47848 42551446
Mesangioproliferative glomerulonephritis 32.59 19.01 9 22032 164 42599130
Renal tubular disorder 32.46 19.01 24 22017 4885 42594409
Red blood cells urine positive 32.37 19.01 17 22024 1893 42597401
Rash 32.06 19.01 59 21982 276895 42322399
Depression 31.94 19.01 9 22032 111354 42487940
Acute respiratory distress syndrome 31.29 19.01 56 21985 30052 42569242
Somnolence 31.28 19.01 17 22024 141088 42458206
Constipation 31.24 19.01 23 22018 162268 42437026
Epstein-Barr virus associated lymphoproliferative disorder 31.09 19.01 18 22023 2425 42596869
Retinitis 30.67 19.01 11 22030 482 42598812
Focal segmental glomerulosclerosis 30.39 19.01 18 22023 2530 42596764
Viral haemorrhagic cystitis 30.00 19.01 16 22025 1838 42597456
Pain in extremity 29.43 19.01 21 22020 150583 42448711
Lymphocyte count decreased 29.25 19.01 52 21989 27757 42571537
Acute graft versus host disease in liver 29.18 19.01 16 22025 1942 42597352
Inappropriate schedule of product administration 28.93 19.01 7 22034 95895 42503399
Malignant neoplasm progression 28.87 19.01 10 22031 108390 42490904
Weight increased 28.69 19.01 10 22031 107973 42491321
Treatment failure 28.51 19.01 84 21957 62540 42536754
Malaise 28.47 19.01 41 22000 212115 42387179
Peripheral swelling 28.41 19.01 6 22035 90264 42509030
Cardiac failure congestive 28.40 19.01 5 22036 85597 42513697
Cytomegalovirus enterocolitis 28.36 19.01 14 22027 1369 42597925
Meningitis viral 28.19 19.01 13 22028 1092 42598202
Disseminated cytomegaloviral infection 28.16 19.01 9 22032 276 42599018
Insomnia 28.08 19.01 13 22028 118240 42481054
Cytomegalovirus enteritis 27.53 19.01 11 22030 650 42598644
Enterocolitis viral 27.27 19.01 10 22031 467 42598827
Kidney fibrosis 26.77 19.01 17 22024 2705 42596589
Syncope 26.76 19.01 9 22032 99397 42499897
Toxoplasmosis 26.37 19.01 14 22027 1593 42597701
Malnutrition 26.36 19.01 35 22006 14507 42584787
Cytomegalovirus hepatitis 26.19 19.01 10 22031 523 42598771
Pneumonia pseudomonal 25.92 19.01 21 22020 4888 42594406
Large intestinal ulcer 25.77 19.01 16 22025 2447 42596847
Adenoviral hepatitis 25.73 19.01 10 22031 549 42598745
Glomerulonephropathy 25.49 19.01 8 22033 231 42599063
Macular fibrosis 25.48 19.01 9 22032 377 42598917
Hospitalisation 25.42 19.01 4 22037 74326 42524968
Human herpesvirus 6 infection 25.40 19.01 16 22025 2509 42596785
Oesophagopleural fistula 25.23 19.01 6 22035 58 42599236
Fungal sepsis 25.22 19.01 12 22029 1082 42598212
Fungal infection 24.88 19.01 40 22001 19682 42579612
Fungaemia 24.57 19.01 17 22024 3119 42596175
Oliguria 24.37 19.01 27 22014 9286 42590008
Iris neovascularisation 23.89 19.01 5 22036 25 42599269
Urinary bladder toxicity 23.89 19.01 5 22036 25 42599269
Viral mutation identified 23.65 19.01 17 22024 3314 42595980
Pharyngeal abscess 23.51 19.01 9 22032 474 42598820
Pyrexia 23.26 19.01 308 21733 393734 42205560
Conductive deafness 22.92 19.01 9 22032 508 42598786
Chest pain 22.91 19.01 23 22018 139507 42459787
Gait disturbance 22.91 19.01 11 22030 97989 42501305
Meningoencephalitis herpetic 22.80 19.01 11 22030 1023 42598271
Cytopenia 22.78 19.01 36 22005 17461 42581833
Red blood cell schistocytes present 22.49 19.01 8 22033 342 42598952
Septic embolus 22.38 19.01 12 22029 1393 42597901
Flavobacterium infection 22.34 19.01 6 22035 98 42599196
Complications of transplanted kidney 22.34 19.01 20 22021 5330 42593964
Brain compression 22.14 19.01 7 22034 207 42599087
Hypogammaglobulinaemia 22.14 19.01 29 22012 11862 42587432
Toxic epidermal necrolysis 21.94 19.01 45 21996 26705 42572589
Pulmonary embolism 21.68 19.01 18 22023 119594 42479700
Hepatitis cholestatic 21.54 19.01 26 22015 9798 42589496
Clostridium difficile colitis 21.40 19.01 39 22002 21213 42578081
Tubulointerstitial nephritis 21.23 19.01 49 21992 31499 42567795
Bone marrow disorder 21.03 19.01 13 22028 1973 42597321
Chimerism 20.86 19.01 7 22034 251 42599043
Transplant failure 20.72 19.01 17 22024 4027 42595267
Decreased appetite 20.71 19.01 43 21998 193094 42406200
Deep vein thrombosis 20.66 19.01 7 22034 76950 42522344
Blood culture negative 20.61 19.01 5 22036 53 42599241
Liver transplant rejection 20.58 19.01 14 22027 2499 42596795
Joint swelling 20.44 19.01 5 22036 68017 42531277
Cerebral toxoplasmosis 20.37 19.01 13 22028 2085 42597209
Bacterial toxaemia 20.29 19.01 6 22035 141 42599153
Acute myocardial infarction 20.18 19.01 3 22038 58162 42541132
Hyperplasia 20.15 19.01 9 22032 702 42598592
Myocarditis toxoplasmal 20.12 19.01 5 22036 59 42599235
ADAMTS13 activity decreased 20.09 19.01 6 22035 146 42599148
Pulmonary haemorrhage 20.00 19.01 27 22014 11370 42587924
Abdominal discomfort 19.93 19.01 7 22034 75248 42524046
Eye infection fungal 19.92 19.01 8 22033 479 42598815
Asthma 19.90 19.01 4 22037 62310 42536984
Cerebral aspergillosis 19.76 19.01 12 22029 1765 42597529
Retinal ischaemia 19.73 19.01 8 22033 491 42598803
Abdominal pain upper 19.73 19.01 9 22032 82600 42516694
Scopulariopsis infection 19.71 19.01 6 22035 156 42599138
Intentional product misuse 19.71 19.01 4 22037 61896 42537398
CD4 lymphocytes increased 19.68 19.01 6 22035 157 42599137
Infection in an immunocompromised host 19.62 19.01 10 22031 1047 42598247
Polyomavirus-associated nephropathy 19.60 19.01 19 22022 5596 42593698
Immunosuppressant drug level increased 19.52 19.01 22 22019 7709 42591585
Complications of transplanted liver 19.47 19.01 7 22034 309 42598985
Lymphoproliferative disorder 19.29 19.01 15 22026 3292 42596002
Burkholderia cepacia complex infection 19.19 19.01 7 22034 322 42598972
Procedural pain 19.14 19.01 19 22022 5760 42593534
Bacterial sepsis 19.08 19.01 20 22021 6462 42592832
Protein urine present 19.08 19.01 19 22022 5782 42593512

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 1521.58 20.52 594 34970 53850 110499885
Drug resistance 1438.68 20.52 576 34988 55798 110497937
Cytomegalovirus viraemia 777.75 20.52 270 35294 17494 110536241
Pathogen resistance 717.71 20.52 254 35310 17418 110536317
Cytomegalovirus infection reactivation 659.93 20.52 241 35323 18092 110535643
Off label use 598.12 20.52 1411 34153 1498774 109054961
Pancytopenia 541.96 20.52 485 35079 209128 110344607
Multiple organ dysfunction syndrome 506.98 20.52 407 35157 151303 110402432
Post transplant lymphoproliferative disorder 469.73 20.52 180 35384 15433 110538302
Pneumonia cytomegaloviral 425.15 20.52 136 35428 6818 110546917
Epstein-Barr virus infection 420.95 20.52 175 35389 18563 110535172
Drug ineffective 420.51 20.52 1250 34314 1519290 109034445
Cystitis haemorrhagic 418.99 20.52 155 35409 12054 110541681
Nephropathy toxic 414.58 20.52 194 35370 27284 110526451
Graft versus host disease 383.63 20.52 164 35400 18642 110535093
Cytomegalovirus colitis 354.59 20.52 119 35445 6942 110546793
BK virus infection 351.40 20.52 139 35425 12967 110540768
Leukopenia 340.80 20.52 322 35242 148469 110405266
Transplant rejection 335.59 20.52 162 35402 24405 110529330
Encephalitis cytomegalovirus 315.13 20.52 81 35483 1829 110551906
Smooth muscle cell neoplasm 308.29 20.52 75 35489 1342 110552393
Epstein-Barr viraemia 281.93 20.52 85 35479 3494 110550241
Thrombotic microangiopathy 281.13 20.52 152 35412 28997 110524738
Aspergillus infection 273.63 20.52 143 35421 25473 110528262
Neutropenia 263.70 20.52 449 35115 374171 110179564
Haemophagocytic lymphohistiocytosis 251.01 20.52 145 35419 31414 110522321
Cytomegalovirus test positive 240.18 20.52 89 35475 6947 110546788
Fatigue 231.74 20.52 54 35510 1215904 109337831
Pneumocystis jirovecii pneumonia 208.28 20.52 144 35420 42591 110511144
Myelosuppression 206.04 20.52 199 35365 94141 110459594
Cytomegalovirus chorioretinitis 203.03 20.52 79 35485 7049 110546686
Pain 201.55 20.52 33 35531 954922 109598813
Renal impairment 200.66 20.52 274 35290 188171 110365564
Drug ineffective for unapproved indication 200.65 20.52 204 35360 102634 110451101
Product use in unapproved indication 199.23 20.52 442 35122 446935 110106800
Respiratory failure 196.71 20.52 291 35273 215041 110338694
Acute graft versus host disease 188.24 20.52 89 35475 12792 110540943
Bone marrow failure 181.94 20.52 150 35414 57698 110496037
Arthralgia 173.51 20.52 23 35541 779609 109774126
Septic shock 170.62 20.52 231 35333 157297 110396438
Cytomegalovirus syndrome 168.82 20.52 35 35529 288 110553447
Graft versus host disease in gastrointestinal tract 153.02 20.52 69 35495 8899 110544836
Epstein-Barr virus associated lymphoproliferative disorder 150.27 20.52 57 35507 4745 110548990
Enterococcal infection 144.67 20.52 87 35477 20279 110533456
Dizziness 138.78 20.52 28 35536 698165 109855570
End stage renal disease 135.37 20.52 85 35479 21388 110532347
Graft versus host disease in skin 132.92 20.52 61 35503 8193 110545542
Viral haemorrhagic cystitis 130.90 20.52 47 35517 3352 110550383
Sepsis 129.59 20.52 309 35255 327037 110226698
Adenovirus infection 127.84 20.52 65 35499 10929 110542806
Cytomegalovirus gastritis 127.41 20.52 32 35532 656 110553079
Respiratory distress 125.94 20.52 132 35432 68742 110484993
Dyspnoea 123.66 20.52 105 35459 1106767 109446968
Klebsiella infection 123.12 20.52 78 35486 19931 110533804
Kidney transplant rejection 122.54 20.52 65 35499 11922 110541813
Joint swelling 120.93 20.52 5 35559 442840 110110895
Acute graft versus host disease in skin 120.54 20.52 62 35502 10678 110543057
Nausea 118.70 20.52 134 35430 1235556 109318179
Immune reconstitution inflammatory syndrome 117.02 20.52 70 35494 16156 110537579
Lymphopenia 115.64 20.52 99 35465 40071 110513664
Headache 115.03 20.52 71 35493 882306 109671429
Pruritus 112.08 20.52 25 35539 581535 109972200
Epstein-Barr virus infection reactivation 111.85 20.52 44 35520 4040 110549695
Fall 110.33 20.52 29 35535 603453 109950282
Bronchopulmonary aspergillosis 110.03 20.52 85 35479 29778 110523957
Peripheral swelling 108.86 20.52 5 35559 404029 110149706
Parvovirus B19 infection 107.80 20.52 39 35525 2842 110550893
Chronic graft versus host disease 107.31 20.52 55 35509 9402 110544333
Thrombocytopenia 103.83 20.52 296 35268 348589 110205146
Cytomegalovirus oesophagitis 97.79 20.52 28 35536 958 110552777
Incision site pain 97.33 20.52 37 35527 3098 110550637
Immune recovery uveitis 94.60 20.52 19 35545 131 110553604
Viral load increased 94.52 20.52 37 35527 3353 110550382
Alopecia 93.64 20.52 6 35558 364747 110188988
Cytomegalovirus gastrointestinal infection 92.15 20.52 25 35539 699 110553036
Renal failure 88.63 20.52 213 35351 226361 110327374
Pseudomonas infection 87.08 20.52 72 35492 27781 110525954
Nasopharyngitis 86.71 20.52 12 35552 394349 110159386
Product dose omission issue 86.61 20.52 4 35560 321778 110231957
Swelling 86.58 20.52 7 35557 351034 110202701
Aplasia pure red cell 84.19 20.52 47 35517 9531 110544204
Human herpesvirus 8 infection 84.00 20.52 29 35535 1842 110551893
Weight increased 82.93 20.52 17 35547 419627 110134108
Product use issue 82.74 20.52 254 35310 311441 110242294
Haemorrhage intracranial 82.57 20.52 71 35493 28898 110524837
Anxiety 82.08 20.52 8 35556 345070 110208665
Pain in extremity 80.67 20.52 28 35536 487090 110066645
Malaise 79.52 20.52 60 35504 671759 109881976
Acute graft versus host disease in intestine 79.44 20.52 38 35526 5601 110548134
Drug hypersensitivity 78.90 20.52 24 35540 454066 110099669
Gastric ulcer 77.60 20.52 79 35485 39748 110513987
Candida infection 77.21 20.52 86 35478 47923 110505812
Urticaria 76.88 20.52 7 35557 318850 110234885
Transplant dysfunction 76.31 20.52 42 35522 8286 110545449
Scedosporium infection 76.27 20.52 29 35535 2429 110551306
Abdominal discomfort 75.69 20.52 17 35547 393841 110159894
Generalised oedema 75.07 20.52 69 35495 30635 110523100
Muscle spasms 73.13 20.52 4 35560 278153 110275582
Drug intolerance 71.50 20.52 21 35543 406491 110147244
Asthenia 71.24 20.52 70 35494 688929 109864806
Cytomegalovirus enterocolitis 71.10 20.52 27 35537 2254 110551481
Hypersensitivity 70.82 20.52 21 35543 403977 110149758
Rash 69.28 20.52 98 35466 820866 109732869
Necrotising retinitis 68.80 20.52 24 35540 1572 110552163
Polyomavirus-associated nephropathy 68.71 20.52 39 35525 8162 110545573
Infusion related reaction 68.31 20.52 19 35545 381143 110172592
Back pain 67.41 20.52 18 35546 370978 110182757
Abdominal pain upper 67.21 20.52 15 35549 349096 110204639
Wheezing 66.08 20.52 4 35560 255226 110298509
Encephalitis 65.88 20.52 52 35512 18787 110534948
Systemic lupus erythematosus 65.81 20.52 4 35560 254334 110299401
Lower respiratory tract infection 65.48 20.52 3 35561 243103 110310632
Musculoskeletal stiffness 65.21 20.52 7 35557 279815 110273920
Insomnia 64.56 20.52 18 35546 360572 110193163
Mucormycosis 64.31 20.52 41 35523 10587 110543148
Retinitis viral 63.84 20.52 17 35547 442 110553293
Vomiting 63.57 20.52 123 35441 910552 109643183
Contusion 62.46 20.52 3 35561 233358 110320377
Pyrexia 62.16 20.52 497 35067 897768 109655967
Acute respiratory distress syndrome 62.11 20.52 81 35483 53117 110500618
Asthma 61.68 20.52 5 35559 250286 110303449
Contraindicated product administered 61.07 20.52 5 35559 248262 110305473
Hypogammaglobulinaemia 60.89 20.52 51 35513 20025 110533710
Immunosuppressant drug level increased 60.63 20.52 41 35523 11683 110542052
Therapeutic product effect decreased 59.87 20.52 5 35559 244311 110309424
Infection reactivation 59.01 20.52 28 35536 4053 110549682
Blood pressure increased 58.85 20.52 7 35557 258366 110295369
Complications of transplanted kidney 58.63 20.52 34 35530 7408 110546327
Glomerulosclerosis 58.13 20.52 20 35544 1257 110552478
Liver transplant rejection 57.02 20.52 27 35537 3891 110549844
Pulmonary haemorrhage 56.64 20.52 45 35519 16411 110537324
Sinusitis 56.59 20.52 13 35551 296675 110257060
Cytomegalovirus hepatitis 56.52 20.52 18 35546 888 110552847
Depression 56.51 20.52 16 35548 317319 110236416
Fusarium infection 55.94 20.52 24 35540 2747 110550988
Brain herniation 55.64 20.52 35 35529 8828 110544907
Red blood cells urine positive 55.50 20.52 29 35535 5156 110548579
Retinal detachment 55.46 20.52 38 35526 11062 110542673
Mobility decreased 55.16 20.52 6 35558 237416 110316319
Hypoaesthesia 53.85 20.52 17 35547 314206 110239529
Aplastic anaemia 52.49 20.52 51 35513 24257 110529478
Stenotrophomonas infection 52.18 20.52 29 35535 5829 110547906
Neutrophil Pelger-Huet anomaly present 51.89 20.52 14 35550 383 110553352
Pneumocystis jirovecii infection 51.11 20.52 26 35538 4374 110549361
Pneumonia bacterial 50.99 20.52 52 35512 26209 110527526
Fungal sepsis 50.58 20.52 21 35543 2216 110551519
Pneumonia pseudomonal 50.41 20.52 31 35533 7515 110546220
Cytopenia 50.24 20.52 55 35509 30061 110523674
Acanthamoeba infection 49.94 20.52 15 35549 608 110553127
Cytomegalovirus enteritis 49.53 20.52 17 35547 1061 110552674
Lymphocyte count decreased 48.80 20.52 75 35489 57168 110496567
Disseminated intravascular coagulation 48.41 20.52 63 35501 41223 110512512
Brain abscess 48.26 20.52 29 35535 6745 110546990
Fungal infection 48.23 20.52 70 35494 50736 110502999
Bacterial sepsis 48.13 20.52 34 35530 10392 110543343
Strongyloidiasis 48.05 20.52 26 35538 4960 110548775
Chest pain 47.93 20.52 31 35533 376344 110177391
Paraesthesia 47.31 20.52 15 35549 276506 110277229
Helicobacter infection 46.62 20.52 3 35561 181874 110371861
Adrenal mass 46.48 20.52 18 35546 1584 110552151
Hepatic function abnormal 46.25 20.52 94 35470 89201 110464534
Gait disturbance 46.00 20.52 16 35548 278192 110275543
Hyperhidrosis 45.43 20.52 4 35560 187294 110366441
Injection site pain 45.41 20.52 3 35561 177919 110375816
Transplant failure 45.07 20.52 26 35538 5609 110548126
Human herpesvirus 6 infection 43.87 20.52 27 35537 6554 110547181
Cerebral toxoplasmosis 43.73 20.52 21 35543 3121 110550614
Migraine 43.50 20.52 3 35561 171649 110382086
Impaired healing 43.18 20.52 6 35558 196711 110357024
Venoocclusive liver disease 42.78 20.52 37 35527 15170 110538565
Mesangioproliferative glomerulonephritis 42.76 20.52 11 35553 249 110553486
Meningitis viral 42.65 20.52 19 35545 2380 110551355
Viral mutation identified 42.46 20.52 23 35541 4396 110549339
Infected neoplasm 42.04 20.52 13 35551 582 110553153
Posterior reversible encephalopathy syndrome 41.79 20.52 53 35511 33808 110519927
Somnolence 41.40 20.52 22 35542 297427 110256308
Disseminated cytomegaloviral infection 41.35 20.52 13 35551 615 110553120
Blister 41.34 20.52 11 35553 227365 110326370
Focal segmental glomerulosclerosis 41.02 20.52 22 35542 4123 110549612
Renal tubular disorder 40.87 20.52 27 35537 7402 110546333
Acute kidney injury 40.84 20.52 346 35218 635084 109918651
Neurological decompensation 40.27 20.52 26 35538 6857 110546878
Ureaplasma infection 40.04 20.52 16 35548 1530 110552205
Acute graft versus host disease in liver 39.76 20.52 18 35546 2341 110551394
Toxic epidermal necrolysis 39.75 20.52 68 35496 56659 110497076
Constipation 39.70 20.52 34 35530 357752 110195983
Intracranial infection 39.58 20.52 11 35553 337 110553398
Agranulocytosis 38.08 20.52 70 35494 61690 110492045
Injury 37.53 20.52 6 35558 177259 110376476
Pericarditis 37.27 20.52 12 35552 219102 110334633
Toxoplasmosis 37.22 20.52 19 35545 3220 110550515
Dyspepsia 37.15 20.52 8 35556 190957 110362778
Kidney fibrosis 37.10 20.52 21 35543 4371 110549364
Lung transplant rejection 36.61 20.52 16 35548 1915 110551820
Gastrooesophageal reflux disease 36.13 20.52 7 35557 179969 110373766
Retinal scar 36.11 20.52 11 35553 468 110553267
Necrotising herpetic retinopathy 35.76 20.52 9 35555 186 110553549
Myocardial infarction 35.48 20.52 9 35555 192074 110361661
Maternal exposure during pregnancy 35.25 20.52 19 35545 254864 110298871
Death 34.92 20.52 112 35452 698757 109854978
Pleural effusion 34.90 20.52 131 35433 177578 110376157
Botulism 34.87 20.52 11 35553 526 110553209
Staphylococcal sepsis 34.69 20.52 35 35529 17419 110536316
Syncope 34.61 20.52 11 35553 202525 110351210
Bladder hypertrophy 33.94 20.52 13 35551 1111 110552624
Ill-defined disorder 33.91 20.52 5 35559 156848 110396887
Urinary tract inflammation 33.71 20.52 10 35554 388 110553347
Enterocolitis viral 33.24 20.52 12 35552 869 110552866
Polyomavirus viraemia 33.15 20.52 18 35546 3456 110550279
Macular oedema 32.81 20.52 23 35541 6943 110546792
Rhegmatogenous retinal detachment 32.73 20.52 9 35555 265 110553470
Malnutrition 32.56 20.52 42 35522 27237 110526498
Protein urine present 32.42 20.52 28 35536 11456 110542279
Cardiac failure congestive 32.22 20.52 5 35559 150995 110402740
Disseminated mucormycosis 32.17 20.52 15 35549 2087 110551648
Hospitalisation 32.09 20.52 4 35560 142489 110411246
Lymphoproliferative disorder 32.08 20.52 23 35541 7195 110546540
Cerebral haemorrhage 32.00 20.52 67 35497 64901 110488834
Gastrointestinal stromal tumour 31.98 20.52 15 35549 2116 110551619
Sleep disorder 31.85 20.52 12 35552 198632 110355103
Conductive deafness 31.68 20.52 9 35555 299 110553436
Hepatic failure 31.68 20.52 69 35495 68670 110485065
Tubulointerstitial nephritis 31.56 20.52 60 35504 54224 110499511
Systemic mycosis 31.52 20.52 18 35546 3811 110549924
Inappropriate schedule of product administration 31.51 20.52 13 35551 203624 110350111
Complications of transplanted liver 31.23 20.52 10 35554 502 110553233
Cytomegalovirus myocarditis 31.22 20.52 7 35557 86 110553649
Brain oedema 31.21 20.52 44 35520 31054 110522681
Confabulation 31.06 20.52 10 35554 511 110553224
Hepatitis cholestatic 30.91 20.52 33 35531 17533 110536202
Meningoencephalitis herpetic 30.27 20.52 15 35549 2387 110551348
Persistent corneal epithelial defect 29.99 20.52 7 35557 104 110553631
Oliguria 29.27 20.52 33 35531 18624 110535111
Multiple-drug resistance 29.01 20.52 28 35536 13207 110540528
Inflammation 28.84 20.52 13 35551 193225 110360510
Retinal haemorrhage 28.53 20.52 24 35540 9477 110544258
Joint range of motion decreased 28.49 20.52 3 35561 121829 110431906
Fungaemia 28.45 20.52 20 35544 6066 110547669
Myocardial calcification 28.39 20.52 8 35556 258 110553477
Oesophageal candidiasis 28.35 20.52 26 35538 11508 110542227
Blood cholesterol increased 28.26 20.52 12 35552 184773 110368962
Memory impairment 28.24 20.52 14 35550 196930 110356805
Complications of transplanted lung 28.21 20.52 10 35554 687 110553048
Oedema peripheral 27.87 20.52 39 35525 328621 110225114
Cytomegalovirus gastroenteritis 27.81 20.52 10 35554 716 110553019
Musculoskeletal pain 27.81 20.52 12 35552 183011 110370724
Septic embolus 27.76 20.52 14 35550 2312 110551423
Varicella zoster virus infection 27.63 20.52 20 35544 6348 110547387
Gastrointestinal mucormycosis 27.61 20.52 10 35554 731 110553004
Neutrophil count increased 27.59 20.52 44 35520 34608 110519127
Blood urea increased 27.44 20.52 57 35507 54900 110498835
Hypertension 27.42 20.52 79 35485 510005 110043730
Opportunistic infection 27.42 20.52 16 35548 3527 110550208
Acinetobacter infection 27.29 20.52 16 35548 3557 110550178
Lung abscess 27.05 20.52 18 35546 4994 110548741
Escherichia sepsis 26.90 20.52 24 35540 10248 110543487
Palpitations 26.58 20.52 9 35555 159203 110394532
Hepatic enzyme increased 26.30 20.52 39 35525 320853 110232882
Oesophagitis ulcerative 26.27 20.52 12 35552 1593 110552142
Urinary bladder toxicity 26.26 20.52 5 35559 25 110553710
Clostridium difficile colitis 26.21 20.52 49 35515 43729 110510006
Chronic graft versus host disease in skin 26.20 20.52 14 35550 2605 110551130
Intussusception 26.16 20.52 12 35552 1609 110552126
Decreased appetite 26.09 20.52 73 35491 475773 110077962
Immune thrombocytopenia 25.86 20.52 34 35530 22460 110531275
Idiopathic pneumonia syndrome 25.86 20.52 10 35554 877 110552858
Glomerulonephropathy 25.85 20.52 8 35556 359 110553376
Myocardiac abscess 25.78 20.52 6 35558 88 110553647
Viral uveitis 25.76 20.52 7 35557 197 110553538
Platelet count decreased 25.17 20.52 143 35421 230300 110323435
Hydrocephalus 24.75 20.52 23 35541 10352 110543383
Drug reaction with eosinophilia and systemic symptoms 24.69 20.52 70 35494 82025 110471710
Retinal ischaemia 24.63 20.52 10 35554 997 110552738
Pseudomonal bacteraemia 24.32 20.52 16 35548 4355 110549380
Hypoproteinaemia 24.28 20.52 18 35546 5927 110547808
Macular fibrosis 24.13 20.52 9 35555 715 110553020
Enterococcal bacteraemia 24.03 20.52 16 35548 4445 110549290
Colitis 24.01 20.52 80 35484 102243 110451492
Adenovirus reactivation 23.93 20.52 9 35555 731 110553004
Folliculitis 23.91 20.52 12 35552 167641 110386094
Tractional retinal detachment 23.80 20.52 6 35558 125 110553610
Imprisonment 23.71 20.52 9 35555 750 110552985
Splenomegaly 23.61 20.52 34 35530 24464 110529271
Flavobacterium infection 23.57 20.52 6 35558 130 110553605
Interstitial lung disease 23.54 20.52 98 35466 139236 110414499
Vitreous haemorrhage 23.52 20.52 16 35548 4604 110549131
Product administered to patient of inappropriate age 23.51 20.52 20 35544 8016 110545719
Flushing 23.44 20.52 3 35561 104733 110449002
Hypoalbuminaemia 23.35 20.52 37 35527 28937 110524798
Intentional product misuse 23.09 20.52 7 35557 132897 110420838
Blood creatinine increased 23.03 20.52 118 35446 182771 110370964
Oesophagopleural fistula 22.98 20.52 5 35559 53 110553682
Cerebrovascular accident 22.96 20.52 15 35549 181269 110372466
Squamous cell carcinoma of skin 22.94 20.52 28 35536 17175 110536560
BK polyomavirus test positive 22.82 20.52 7 35557 305 110553430
Lymphadenopathy 22.79 20.52 58 35506 63777 110489958
Hyperammonaemia 22.76 20.52 25 35539 13707 110540028
Cytomegalovirus duodenitis 22.76 20.52 6 35558 150 110553585
Chimerism 22.62 20.52 7 35557 314 110553421
Muscular weakness 22.58 20.52 28 35536 248440 110305295
Heart rate increased 22.54 20.52 9 35555 143825 110409910
Pneumonia klebsiella 22.53 20.52 18 35546 6614 110547121
Pharyngeal abscess 22.49 20.52 9 35555 864 110552871
Adverse event 22.33 20.52 4 35560 108805 110444930
Gait inability 22.26 20.52 8 35556 136368 110417367
Mycobacterium avium complex infection 22.24 20.52 17 35547 5860 110547875
Cerebral aspergillosis 22.17 20.52 12 35552 2290 110551445
Myocarditis toxoplasmal 22.11 20.52 5 35559 64 110553671
Bacterial toxaemia 22.11 20.52 6 35558 168 110553567
Lung infiltration 22.02 20.52 33 35531 24595 110529140
Organising pneumonia 22.01 20.52 25 35539 14218 110539517
Human polyomavirus infection 21.96 20.52 11 35553 1791 110551944
Scopulariopsis infection 21.81 20.52 6 35558 177 110553558
Encephalitis Japanese B 21.76 20.52 5 35559 69 110553666
Actinic keratosis 21.65 20.52 18 35546 6995 110546740
Night sweats 21.63 20.52 8 35556 133975 110419760
Shock 21.58 20.52 51 35513 53537 110500198
Nasal congestion 21.55 20.52 3 35561 98279 110455456
Nephrogenic diabetes insipidus 21.49 20.52 12 35552 2433 110551302
Haematotoxicity 21.41 20.52 30 35534 21052 110532683
Encephalopathy 21.40 20.52 66 35498 80989 110472746
Loss of consciousness 21.34 20.52 19 35545 196287 110357448
Bronchitis 21.28 20.52 12 35552 157020 110396715
Leukaemia recurrent 21.26 20.52 13 35551 3118 110550617
Adenoviral hepatitis 21.21 20.52 9 35555 1003 110552732
Pneumonia cryptococcal 21.06 20.52 12 35552 2530 110551205
Exposure during pregnancy 21.01 20.52 14 35550 167410 110386325
Haemodynamic instability 20.94 20.52 31 35533 22857 110530878
Iris neovascularisation 20.79 20.52 5 35559 85 110553650
Hyperplasia 20.69 20.52 10 35554 1508 110552227
Retinal vasculitis 20.63 20.52 11 35553 2038 110551697
Organ failure 20.61 20.52 15 35549 4802 110548933
Diffuse alveolar damage 20.56 20.52 14 35550 4033 110549702

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J05AB06 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Nucleosides and nucleotides excl. reverse transcriptase inhibitors
ATC S01AD09 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFECTIVES
Antivirals
FDA MoA N0000020060 DNA Polymerase Inhibitors
FDA EXT N0000175459 Nucleoside Analog
FDA EPC N0000175461 Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor
FDA EPC N0000175466 Nucleoside Analog Antiviral
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000998 Antiviral Agents
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:36044 antiviral drug
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:66981 ophthalmology drug
CHEBI has role CHEBI:231911 renoprotective agent
CHEBI has role CHEBI:67079 anti-inflammatory agent

Related Drugs by ATC class:

J05AB Nucleosides and nucleotides excl. reverse transcriptase inhibitors 11 drugs
acyclovirbrivudinecidofovirfamcicloviridoxuridinemolnupiravirpenciclovirremdesivirvalaciclovirvalganciclovirvidarabine
S01AD Antivirals 6 drugs
acyclovirfamciclovirfomivirsenidoxuridinetrifluridinevidarabine

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

DiseaseRelationSNOMED_IDDOID
Cytomegaloviral retinitis indication 22455005
Herpes simplex dendritic keratitis indication 29943008
Paroxysmal supraventricular tachycardia indication 67198005
CMV Retinitis in AIDS Patients indication
Prevention of CMV Disease After Kidney-Pancreas Transplantation indication
CMV Retinitis in Immunocompromised Patients indication
Prevention of CMV Disease After Organ Transplant indication
Prevention of CMV Disease After Kidney Transplantation indication
Myocardial Perfusion Imaging Adjunct indication
Prevention of CMV Disease in Advanced HIV Patients indication
Prevention of CMV Disease After Cardiac Transplantation indication
Supraventricular tachycardia off-label use 6456007
Cytomegalovirus infection off-label use 28944009
CMV-Related Polyradiculopathy in AIDS Patients off-label use
Prevention of Cytomegalovirus Disease off-label use
Endophthalmitis contraindication 1847009 DOID:4692
Pericarditis contraindication 3238004 DOID:1787
Reduced visual acuity contraindication 13164000
Chronic obstructive lung disease contraindication 13645005 DOID:3083
Disorder of autonomic nervous system contraindication 15241006
Complete atrioventricular block contraindication 27885002
Hypovolemia contraindication 28560003
Acute cerebrovascular insufficiency contraindication 29322000
Vitreous hemorrhage contraindication 31341008
Transplantation of heart contraindication 32413006
Dehydration contraindication 34095006
Sick sinus syndrome contraindication 36083008 DOID:13884
Retinal detachment contraindication 42059000 DOID:5327
Low blood pressure contraindication 45007003
Acute nephropathy contraindication 58574008
Aortic valve stenosis contraindication 60573004 DOID:1712
Left to right cardiovascular shunt contraindication 66130006
Mitral valve stenosis contraindication 79619009 DOID:1754
Pulmonary emphysema contraindication 87433001
Kidney disease contraindication 90708001 DOID:557
Bilateral cataracts contraindication 95722004
Respiratory alkalosis contraindication 111378004
Eye infection contraindication 128351009
Uveitis contraindication 128473001 DOID:13141
Second degree atrioventricular block contraindication 195042002
Asthma contraindication 195967001 DOID:2841
Anemia contraindication 271737000 DOID:2355
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Aplastic anemia contraindication 306058006 DOID:12449
Left main coronary artery disease contraindication 371804009
Acute coronary syndrome contraindication 394659003
Respiratory insufficiency contraindication 409623005
Breastfeeding (mother) contraindication 413712001
Granulocytopenic disorder contraindication 417672002
Severe Bone Marrow Depression contraindication
Syncope due to Bradycardia contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.97 acidic
pKa2 12.38 acidic
pKa3 12.98 acidic
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
Metabotropic glutamate receptor 1 GPCR Ki 6.05 WOMBAT-PK
Metabotropic glutamate receptor 5 GPCR Ki 5.41 WOMBAT-PK
Transitional endoplasmic reticulum ATPase Enzyme IC50 5.89 CHEMBL
DNA polymerase catalytic subunit Enzyme INHIBITOR WOMBAT-PK CHEMBL
Thymidine kinase Kinase WOMBAT-PK
Capsid scaffolding protein Enzyme EC50 6.07 WOMBAT-PK
Purine nucleoside phosphorylase Enzyme Kd 4.80 CHEMBL

External reference:

IDSource
4019764 VUID
N0000147855 NUI
D00333 KEGG_DRUG
107910-75-8 SECONDARY_CAS_RN
4019457 VANDF
4019764 VANDF
C0017066 UMLSCUI
CHEBI:465284 CHEBI
GA2 PDB_CHEM_ID
CHEMBL182 ChEMBL_ID
CHEMBL1200850 ChEMBL_ID
DB01004 DRUGBANK_ID
D015774 MESH_DESCRIPTOR_UI
135398740 PUBCHEM_CID
6023 INN_ID
P9G3CKZ4P5 UNII
4678 RXNORM
177021 MMSL
33722 MMSL
34097 MMSL
47373 MMSL
4775 MMSL
4776 MMSL
d00066 MMSL
003444 NDDF
003445 NDDF
372848001 SNOMEDCT_US
76587005 SNOMEDCT_US
78025001 SNOMEDCT_US
P9G3CKZ4P5 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ganciclovir HUMAN PRESCRIPTION DRUG LABEL 1 0143-9299 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 mg INTRAVENOUS ANDA 29 sections
Ganciclovir HUMAN PRESCRIPTION DRUG LABEL 1 14335-030 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 mg INTRAVENTRICULAR ANDA 30 sections
ZIRGAN HUMAN PRESCRIPTION DRUG LABEL 1 24208-535 GEL 1.50 mg OPHTHALMIC NDA 25 sections
ganciclovir HUMAN PRESCRIPTION DRUG LABEL 1 25021-185 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 28 sections
Ganciclovir HUMAN PRESCRIPTION DRUG LABEL 1 42023-173 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS ANDA 29 sections
GANCICLOVIR HUMAN PRESCRIPTION DRUG LABEL 1 51754-2500 INJECTION, SOLUTION 2 mg INTRAVENOUS NDA 18 sections
Ganciclovir HUMAN PRESCRIPTION DRUG LABEL 1 51817-171 INJECTION, SOLUTION 500 mg INTRAVENOUS ANDA 29 sections
GANCICLOVIR HUMAN PRESCRIPTION DRUG LABEL 1 63304-636 CAPSULE 250 mg ORAL ANDA 23 sections
GANCICLOVIR HUMAN PRESCRIPTION DRUG LABEL 1 63304-637 CAPSULE 500 mg ORAL ANDA 23 sections
Ganciclovir HUMAN PRESCRIPTION DRUG LABEL 1 63323-315 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS ANDA 31 sections
Ganciclovir HUMAN PRESCRIPTION DRUG LABEL 1 63323-315 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS ANDA 31 sections
ganciclovir HUMAN PRESCRIPTION DRUG LABEL 1 70436-089 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS ANDA 29 sections
ganciclovir sodium HUMAN PRESCRIPTION DRUG LABEL 1 70436-231 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS ANDA 29 sections