ganciclovir ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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) 6 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 91 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 78.36 ยตM/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

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 475.26 22.87 167 10190 17795 50576972
Drug resistance 421.32 22.87 155 10202 18834 50575933
Post transplant lymphoproliferative disorder 306.61 22.87 85 10272 4119 50590648
Pathogen resistance 298.49 22.87 89 10268 5600 50589167
Cytomegalovirus viraemia 279.21 22.87 81 10276 4628 50590139
Smooth muscle cell neoplasm 261.41 22.87 54 10303 717 50594050
Epstein-Barr virus infection 235.53 22.87 78 10279 6919 50587848
Encephalitis cytomegalovirus 213.48 22.87 43 10314 499 50594268
Multiple organ dysfunction syndrome 210.57 22.87 130 10227 50207 50544560
Graft versus host disease 157.80 22.87 56 10301 6110 50588657
Pancytopenia 142.70 22.87 126 10231 83904 50510863
Nephropathy toxic 136.36 22.87 54 10303 7975 50586792
Pneumonia cytomegaloviral 126.70 22.87 36 10321 1905 50592862
Off label use 126.23 22.87 290 10067 474136 50120631
Cytomegalovirus test positive 116.42 22.87 36 10321 2556 50592211
Neutropenia 114.60 22.87 146 10211 147819 50446948
Cystitis haemorrhagic 107.69 22.87 37 10320 3665 50591102
Haemophagocytic lymphohistiocytosis 105.80 22.87 46 10311 8587 50586180
Fatigue 101.33 22.87 13 10344 707588 49887179
Transplant rejection 101.07 22.87 46 10311 9563 50585204
Leukopenia 96.52 22.87 92 10265 67436 50527331
Cytomegalovirus colitis 96.07 22.87 29 10328 1898 50592869
Acute graft versus host disease 93.92 22.87 34 10323 3924 50590843
Cytomegalovirus chorioretinitis 89.63 22.87 26 10331 1481 50593286
Product use in unapproved indication 87.57 22.87 113 10244 115706 50479061
Cytomegalovirus infection reactivation 87.18 22.87 29 10328 2602 50592165
Epstein-Barr virus associated lymphoproliferative disorder 86.71 22.87 26 10331 1663 50593104
Haemorrhage intracranial 84.24 22.87 44 10313 12330 50582437
Pain 77.29 22.87 13 10344 578890 50015877
Septic shock 74.37 22.87 74 10283 57101 50537666
Sepsis 72.63 22.87 111 10246 132814 50461953
Transplant dysfunction 70.87 22.87 29 10328 4655 50590112
Acute graft versus host disease in skin 68.16 22.87 25 10332 2993 50591774
Renal failure 66.82 22.87 95 10262 106538 50488229
Bronchopulmonary aspergillosis 66.40 22.87 32 10325 7560 50587207
Renal impairment 65.42 22.87 79 10278 75582 50519185
Pneumocystis jirovecii pneumonia 64.08 22.87 39 10318 14624 50580143
Adenovirus infection 63.35 22.87 24 10333 3144 50591623
Bone marrow failure 62.56 22.87 49 10308 27575 50567192
Aspergillus infection 60.41 22.87 29 10328 6792 50587975
Respiratory failure 59.73 22.87 83 10274 91098 50503669
Thrombotic microangiopathy 59.09 22.87 31 10326 8760 50586007
Graft versus host disease in gastrointestinal tract 58.99 22.87 22 10335 2759 50592008
Kidney transplant rejection 58.00 22.87 24 10333 3963 50590804
Arthralgia 53.93 22.87 12 10345 438690 50156077
Graft versus host disease in skin 53.42 22.87 20 10337 2536 50592231
Cytomegalovirus enterocolitis 53.18 22.87 14 10343 555 50594212
Cytomegalovirus gastrointestinal infection 51.61 22.87 12 10345 282 50594485
Dyspnoea 51.47 22.87 24 10333 547584 50047183
Cytomegalovirus oesophagitis 49.99 22.87 11 10346 200 50594567
Posterior reversible encephalopathy syndrome 48.63 22.87 33 10324 14895 50579872
Mucormycosis 46.73 22.87 18 10339 2465 50592302
Parvovirus B19 infection 45.60 22.87 12 10345 475 50594292
Ureaplasma infection 44.86 22.87 12 10345 506 50594261
Epstein-Barr virus infection reactivation 44.55 22.87 12 10345 520 50594247
Chronic graft versus host disease 44.22 22.87 18 10339 2849 50591918
BK virus infection 44.14 22.87 18 10339 2863 50591904
Nausea 43.97 22.87 48 10309 705350 49889417
Pyrexia 42.67 22.87 172 10185 380031 50214736
Gastric ulcer 42.30 22.87 35 10322 21270 50573497
Myelosuppression 41.94 22.87 29 10328 13488 50581279
Intentional product use issue 41.62 22.87 64 10293 76854 50517913
Lung transplant rejection 40.17 22.87 12 10345 757 50594010
Cytomegalovirus gastritis 40.14 22.87 9 10348 179 50594588
Hepatic function abnormal 40.09 22.87 41 10316 32640 50562127
Headache 39.30 22.87 28 10329 506507 50088260
Alopecia 38.81 22.87 3 10354 245044 50349723
Epstein-Barr viraemia 38.63 22.87 12 10345 864 50593903
Product use issue 37.88 22.87 90 10267 149385 50445382
Abdominal discomfort 36.22 22.87 3 10354 231638 50363129
Thrombocytopenia 35.79 22.87 80 10277 127593 50467174
Hyperammonaemia 35.62 22.87 18 10339 4706 50590061
Polyomavirus-associated nephropathy 35.58 22.87 13 10344 1539 50593228
Pulmonary haemorrhage 35.58 22.87 20 10337 6472 50588295
Brain oedema 34.81 22.87 25 10332 12345 50582422
Enterococcal infection 34.45 22.87 20 10337 6878 50587889
Fall 34.08 22.87 13 10344 334919 50259848
Pseudomonas infection 33.49 22.87 22 10335 9408 50585359
Hyperlactacidaemia 33.22 22.87 14 10343 2419 50592348
Transplant failure 32.84 22.87 12 10345 1421 50593346
Hydrocephalus 32.50 22.87 17 10340 4771 50589996
Hypogammaglobulinaemia 32.44 22.87 18 10339 5681 50589086
Aplasia pure red cell 31.60 22.87 16 10341 4199 50590568
Hypersensitivity 30.52 22.87 4 10353 215157 50379610
Swelling 30.33 22.87 3 10354 200869 50393898
Immune reconstitution inflammatory syndrome 30.24 22.87 17 10340 5499 50589268
Liver transplant rejection 30.13 22.87 11 10346 1299 50593468
Cytomegalovirus nephritis 30.07 22.87 5 10352 17 50594750
Dizziness 29.76 22.87 17 10340 346352 50248415
Acute respiratory distress syndrome 28.69 22.87 28 10329 21071 50573696
Drug hypersensitivity 28.59 22.87 8 10349 251002 50343765
Venoocclusive liver disease 28.56 22.87 15 10342 4246 50590521
Klebsiella infection 28.55 22.87 18 10339 7176 50587591
Viral haemorrhagic cystitis 28.50 22.87 9 10348 684 50594083
Bacterial sepsis 27.92 22.87 14 10343 3598 50591169
Acute graft versus host disease in intestine 27.73 22.87 11 10346 1628 50593139
Pruritus 27.23 22.87 12 10345 283556 50311211
Pain in extremity 27.07 22.87 11 10346 272854 50321913
Immunosuppressant drug level increased 26.97 22.87 13 10344 3069 50591698
Confabulation 26.31 22.87 7 10350 289 50594478
Central nervous system necrosis 26.14 22.87 6 10351 133 50594634
Renal transplant failure 25.37 22.87 8 10349 605 50594162
Red blood cells urine positive 25.18 22.87 12 10345 2763 50592004
Incision site pain 25.17 22.87 9 10348 1002 50593765
Renal tubular necrosis 25.12 22.87 19 10338 10149 50584618
Complications of transplanted kidney 24.74 22.87 11 10346 2162 50592605
Agranulocytosis 24.69 22.87 26 10331 21395 50573372
Systemic mycosis 24.45 22.87 9 10348 1088 50593679
Genital lesion 23.37 22.87 6 10351 215 50594552
Leukaemia recurrent 23.28 22.87 9 10348 1245 50593522
Back pain 23.28 22.87 8 10349 220022 50374745
Cytomegalovirus enteritis 23.19 22.87 6 10351 222 50594545
Hypomagnesaemia 23.02 22.87 26 10331 23130 50571637
Malaise 22.90 22.87 21 10336 335511 50259256
Cytomegalovirus syndrome 22.88 22.87 5 10352 88 50594679

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 665.68 19.34 295 14916 22920 29536396
Drug resistance 456.03 19.34 222 14989 21318 29537998
Cytomegalovirus viraemia 386.89 19.34 139 15072 6181 29553135
Pathogen resistance 321.71 19.34 130 15081 7986 29551330
Pneumonia cytomegaloviral 198.58 19.34 68 15143 2614 29556702
Leukopenia 156.15 19.34 166 15045 55037 29504279
End stage renal disease 150.05 19.34 75 15136 7589 29551727
Pancytopenia 141.32 19.34 193 15018 82975 29476341
Transplant rejection 134.28 19.34 74 15137 9138 29550178
Multiple organ dysfunction syndrome 128.22 19.34 160 15051 62956 29496360
Cytomegalovirus test positive 125.90 19.34 52 15159 3371 29555945
Graft versus host disease 125.84 19.34 72 15139 9556 29549760
Aspergillus infection 124.73 19.34 74 15137 10507 29548809
Encephalitis cytomegalovirus 123.03 19.34 32 15179 462 29558854
Product use in unapproved indication 113.30 19.34 178 15033 86697 29472619
Bone marrow failure 112.10 19.34 101 15110 27348 29531968
Cytomegalovirus infection reactivation 109.99 19.34 47 15164 3317 29555999
Cytomegalovirus colitis 109.79 19.34 43 15168 2426 29556890
Pneumocystis jirovecii pneumonia 98.12 19.34 76 15135 16703 29542613
Cystitis haemorrhagic 93.63 19.34 47 15164 4795 29554521
Fatigue 93.62 19.34 24 15187 316797 29242519
Cytomegalovirus chorioretinitis 92.06 19.34 41 15170 3197 29556119
Respiratory failure 88.62 19.34 170 15041 96961 29462355
Off label use 88.42 19.34 346 14865 300454 29258862
Acute graft versus host disease 88.22 19.34 48 15163 5776 29553540
Post transplant lymphoproliferative disorder 79.69 19.34 44 15167 5449 29553867
Kidney transplant rejection 72.28 19.34 45 15166 6960 29552356
Thrombotic microangiopathy 70.53 19.34 48 15163 8633 29550683
Chronic graft versus host disease 68.89 19.34 36 15175 3993 29555323
Incision site pain 68.67 19.34 28 15183 1755 29557561
Glomerulosclerosis 68.24 19.34 22 15189 698 29558618
Parvovirus B19 infection 68.12 19.34 22 15189 702 29558614
Nephropathy toxic 65.67 19.34 50 15161 10706 29548610
Dizziness 65.03 19.34 10 15201 189674 29369642
Haemophagocytic lymphohistiocytosis 64.51 19.34 49 15162 10455 29548861
Fall 63.89 19.34 8 15203 177170 29382146
Acute graft versus host disease in intestine 58.20 19.34 27 15184 2314 29557002
Encephalitis 58.12 19.34 38 15173 6392 29552924
Renal impairment 57.23 19.34 128 15083 81205 29478111
Neutropenia 56.37 19.34 172 15039 131539 29427777
Acute graft versus host disease in skin 55.94 19.34 33 15178 4631 29554685
Klebsiella infection 53.52 19.34 38 15173 7311 29552005
Drug ineffective 53.06 19.34 343 14868 362827 29196489
Adenovirus infection 52.12 19.34 31 15180 4416 29554900
Neutrophil Pelger-Huet anomaly present 51.91 19.34 14 15197 234 29559082
Cytomegalovirus syndrome 51.61 19.34 12 15199 105 29559211
Epstein-Barr virus infection 49.95 19.34 35 15176 6594 29552722
Immune reconstitution inflammatory syndrome 49.24 19.34 37 15174 7765 29551551
Septic shock 48.02 19.34 102 15109 62458 29496858
Myelosuppression 47.94 19.34 44 15167 12183 29547133
Necrotising retinitis 47.36 19.34 17 15194 751 29558565
Aplastic anaemia 46.04 19.34 35 15176 7475 29551841
Product use issue 45.55 19.34 89 15122 51355 29507961
Bronchopulmonary aspergillosis 43.75 19.34 42 15169 12302 29547014
Asthenia 43.08 19.34 29 15182 215221 29344095
BK virus infection 42.99 19.34 28 15183 4679 29554637
Enterococcal infection 40.96 19.34 34 15177 8234 29551082
Lymphocyte count decreased 40.88 19.34 50 15161 19221 29540095
Death 40.88 19.34 71 15140 342013 29217303
Graft versus host disease in skin 40.76 19.34 24 15187 3355 29555961
Acanthamoeba infection 40.55 19.34 13 15198 405 29558911
Viral load increased 39.93 19.34 20 15191 2029 29557287
Epstein-Barr viraemia 39.87 19.34 16 15195 962 29558354
Aplasia pure red cell 39.08 19.34 28 15183 5463 29553853
Pyrexia 39.07 19.34 267 14944 287355 29271961
Human herpesvirus 8 infection 38.53 19.34 15 15196 832 29558484
Product dose omission issue 38.23 19.34 3 15208 96380 29462936
Macular fibrosis 37.83 19.34 12 15199 361 29558955
Botulism 37.49 19.34 10 15201 160 29559156
Pneumocystis jirovecii infection 36.93 19.34 17 15194 1431 29557885
Brain herniation 36.62 19.34 23 15188 3610 29555706
Cytomegalovirus oesophagitis 36.54 19.34 12 15199 404 29558912
Pain 35.78 19.34 22 15189 171410 29387906
Pseudomonas infection 34.87 19.34 35 15176 10817 29548499
Adenoviral hepatitis 34.75 19.34 10 15201 214 29559102
Red blood cells urine positive 34.59 19.34 17 15194 1656 29557660
Intentional product use issue 34.58 19.34 71 15140 42427 29516889
Nausea 34.55 19.34 60 15151 289195 29270121
Pneumonia bacterial 33.50 19.34 32 15179 9311 29550005
Candida infection 33.10 19.34 40 15171 15185 29544131
Retinal scar 32.41 19.34 10 15201 274 29559042
Retinitis 32.21 19.34 10 15201 280 29559036
Kidney fibrosis 31.35 19.34 17 15194 2030 29557286
Retinal detachment 31.31 19.34 23 15188 4663 29554653
Myocardial infarction 31.23 19.34 9 15202 110287 29449029
Pneumonia pseudomonal 31.12 19.34 20 15191 3267 29556049
Epstein-Barr virus associated lymphoproliferative disorder 31.06 19.34 16 15195 1722 29557594
Toxoplasmosis 30.70 19.34 14 15197 1153 29558163
Cytomegalovirus gastritis 30.58 19.34 9 15202 209 29559107
Renal tubular disorder 30.53 19.34 22 15189 4330 29554986
Pruritus 30.50 19.34 11 15200 116838 29442478
Dyspnoea 30.45 19.34 78 15133 326654 29232662
Arthralgia 30.41 19.34 17 15194 139600 29419716
Scedosporium infection 29.11 19.34 12 15199 773 29558543
Infection reactivation 28.47 19.34 13 15198 1074 29558242
Cytopenia 28.42 19.34 30 15181 9829 29549487
Headache 27.94 19.34 29 15182 173978 29385338
Cytomegalovirus gastrointestinal infection 27.22 19.34 8 15203 185 29559131
Glomerulonephropathy 26.98 19.34 8 15203 191 29559125
Disseminated cytomegaloviral infection 26.59 19.34 8 15203 201 29559115
Malaise 26.30 19.34 26 15185 159576 29399740
Back pain 26.07 19.34 10 15201 102274 29457042
Meningoencephalitis herpetic 25.98 19.34 11 15200 758 29558558
Epstein-Barr virus infection reactivation 25.90 19.34 10 15201 542 29558774
Renal failure 25.82 19.34 125 15086 118474 29440842
Septic embolus 25.76 19.34 12 15199 1038 29558278
Fungal sepsis 25.44 19.34 11 15200 798 29558518
Red blood cell schistocytes present 25.43 19.34 8 15203 234 29559082
Cytomegalovirus enterocolitis 25.39 19.34 11 15200 802 29558514
Oesophagopleural fistula 25.27 19.34 6 15205 58 29559258
Cerebral toxoplasmosis 25.20 19.34 13 15198 1403 29557913
Pharyngeal abscess 25.11 19.34 9 15202 396 29558920
Procedural pain 24.31 19.34 19 15192 4225 29555091
Cytomegalovirus hepatitis 23.54 19.34 8 15203 300 29559016
Flavobacterium infection 23.51 19.34 6 15205 80 29559236
Brain compression 23.45 19.34 7 15204 171 29559145
ADAMTS13 activity decreased 23.44 19.34 6 15205 81 29559235
Viral mutation identified 23.21 19.34 15 15196 2473 29556843
Hyperhidrosis 23.01 19.34 3 15208 64537 29494779
Large intestinal ulcer 22.91 19.34 13 15198 1696 29557620
Protein urine present 22.62 19.34 19 15192 4675 29554641
Lymphadenopathy mediastinal 22.54 19.34 14 15197 2155 29557161
Cardiac failure congestive 22.13 19.34 6 15205 76575 29482741
Scopulariopsis infection 22.10 19.34 6 15205 103 29559213
Fungal infection 22.02 19.34 31 15180 13654 29545662
Pain in extremity 21.88 19.34 15 15196 110418 29448898
Graft versus host disease in gastrointestinal tract 21.78 19.34 16 15195 3242 29556074
Chimerism 21.65 19.34 7 15204 224 29559092
Enterococcal bacteraemia 21.46 19.34 12 15199 1521 29557795
Organising pneumonia 21.42 19.34 19 15192 5029 29554287
Bone marrow disorder 21.33 19.34 12 15199 1540 29557776
Complications of transplanted kidney 21.14 19.34 17 15194 3937 29555379
Drug ineffective for unapproved indication 21.11 19.34 31 15180 14183 29545133
Malnutrition 20.98 19.34 27 15184 10914 29548402
Blood pressure increased 20.92 19.34 6 15205 73797 29485519
Diffuse alveolar damage 20.76 19.34 13 15198 2030 29557286
Hypogammaglobulinaemia 20.74 19.34 20 15191 5887 29553429
Depression 20.59 19.34 9 15202 85138 29474178
Myocarditis toxoplasmal 20.39 19.34 5 15206 56 29559260
Bacterial toxaemia 20.08 19.34 6 15205 147 29559169
Cerebral aspergillosis 20.04 19.34 11 15200 1345 29557971
Burkholderia cepacia complex infection 19.67 19.34 6 15205 158 29559158
Sepsis 19.59 19.34 133 15078 142549 29416767

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 1077.93 18.23 433 23422 36766 64438111
Drug resistance 898.61 18.23 374 23481 34728 64440149
Pathogen resistance 607.66 18.23 213 23642 12330 64462547
Cytomegalovirus viraemia 606.64 18.23 205 23650 10623 64464254
Post transplant lymphoproliferative disorder 328.30 18.23 126 23729 9418 64465459
Encephalitis cytomegalovirus 318.22 18.23 74 23781 931 64473946
Multiple organ dysfunction syndrome 315.57 18.23 277 23578 101136 64373741
Pneumonia cytomegaloviral 302.66 18.23 97 23758 4242 64470635
Pancytopenia 283.08 18.23 305 23550 143004 64331873
Graft versus host disease 239.15 18.23 112 23743 13701 64461176
Epstein-Barr virus infection 237.26 18.23 108 23747 12380 64462497
Leukopenia 236.74 18.23 236 23619 101006 64373871
Smooth muscle cell neoplasm 223.27 18.23 54 23801 812 64474065
Cytomegalovirus test positive 221.14 18.23 80 23775 5064 64469813
Transplant rejection 208.91 18.23 110 23745 17291 64457586
Product use in unapproved indication 193.82 18.23 280 23575 176338 64298539
Nephropathy toxic 188.61 18.23 103 23752 17411 64457466
Cytomegalovirus colitis 187.41 18.23 66 23789 3862 64471015
Cytomegalovirus infection reactivation 183.75 18.23 72 23783 5684 64469193
Off label use 182.95 18.23 580 23275 632226 63842651
Aspergillus infection 181.03 18.23 98 23757 16281 64458596
Cystitis haemorrhagic 180.70 18.23 78 23777 7878 64466999
Fatigue 177.13 18.23 32 23823 748698 63726179
Cytomegalovirus syndrome 166.76 18.23 35 23820 263 64474614
Bone marrow failure 161.12 18.23 137 23718 47815 64427062
Cytomegalovirus chorioretinitis 158.76 18.23 62 23793 4850 64470027
Acute graft versus host disease 152.12 18.23 72 23783 9012 64465865
End stage renal disease 148.26 18.23 74 23781 10401 64464476
Haemophagocytic lymphohistiocytosis 147.77 18.23 88 23767 17521 64457356
Neutropenia 129.19 18.23 278 23577 239346 64235531
Pneumocystis jirovecii pneumonia 127.17 18.23 95 23760 27539 64447338
Renal impairment 121.02 18.23 195 23660 134822 64340055
Pain 115.84 18.23 31 23824 553480 63921397
Septic shock 115.25 18.23 167 23688 105270 64369607
Parvovirus B19 infection 112.91 18.23 34 23821 1205 64473672
Respiratory failure 112.01 18.23 208 23647 160975 64313902
Kidney transplant rejection 110.95 18.23 59 23796 9452 64465425
Adenovirus infection 104.87 18.23 52 23803 7203 64467674
Thrombotic microangiopathy 101.54 18.23 68 23787 16587 64458290
BK virus infection 100.88 18.23 51 23804 7361 64467516
Incision site pain 98.30 18.23 37 23818 2617 64472260
Epstein-Barr virus associated lymphoproliferative disorder 95.98 18.23 38 23817 3081 64471796
Fall 95.77 18.23 19 23836 416807 64058070
Nausea 94.81 18.23 91 23764 785709 63689168
Dizziness 93.97 18.23 22 23833 430141 64044736
Arthralgia 93.92 18.23 24 23831 442236 64032641
Chronic graft versus host disease 93.74 18.23 46 23809 6230 64468647
Graft versus host disease in skin 91.42 18.23 43 23812 5304 64469573
Acute graft versus host disease in skin 89.90 18.23 46 23809 6809 64468068
Dyspnoea 82.31 18.23 87 23768 718587 63756290
Klebsiella infection 80.42 18.23 54 23801 13227 64461650
Aplasia pure red cell 80.37 18.23 43 23812 6971 64467906
Bronchopulmonary aspergillosis 79.84 18.23 62 23793 19023 64455854
Cytomegalovirus oesophagitis 79.00 18.23 22 23833 588 64474289
Myelosuppression 77.79 18.23 67 23788 23763 64451114
Epstein-Barr viraemia 77.42 18.23 28 23827 1769 64473108
Product use issue 74.82 18.23 170 23685 151545 64323332
Headache 73.99 18.23 53 23802 529414 63945463
Pyrexia 73.67 18.23 403 23452 558241 63916636
Enterococcal infection 73.63 18.23 52 23803 13814 64461063
Cytomegalovirus gastritis 72.44 18.23 19 23836 402 64474475
Renal failure 71.89 18.23 187 23668 181501 64293376
Immune reconstitution inflammatory syndrome 71.45 18.23 49 23806 12421 64462456
Sepsis 68.65 18.23 214 23641 230127 64244750
Transplant dysfunction 68.21 18.23 38 23817 6670 64468207
Drug ineffective 67.46 18.23 535 23320 839712 63635165
Pruritus 66.17 18.23 17 23838 312383 64162494
Graft versus host disease in gastrointestinal tract 65.98 18.23 35 23820 5577 64469300
Epstein-Barr virus infection reactivation 64.95 18.23 22 23833 1144 64473733
Intentional product use issue 64.83 18.23 122 23733 95242 64379635
Necrotising retinitis 62.94 18.23 21 23834 1042 64473835
Cytomegalovirus enterocolitis 61.71 18.23 22 23833 1333 64473544
Glomerulosclerosis 60.89 18.23 20 23835 945 64473932
Pseudomonas infection 59.83 18.23 51 23804 17832 64457045
Encephalitis 59.57 18.23 44 23811 12527 64462350
Aplastic anaemia 57.74 18.23 45 23810 13875 64461002
Cytomegalovirus gastrointestinal infection 57.01 18.23 16 23839 440 64474437
Product dose omission issue 56.56 18.23 4 23851 194743 64280134
Peripheral swelling 56.12 18.23 6 23849 209147 64265730
Red blood cells urine positive 55.69 18.23 29 23826 4449 64470428
Acute graft versus host disease in intestine 55.54 18.23 27 23828 3582 64471295
Viral load increased 55.21 18.23 24 23831 2463 64472414
Anxiety 53.90 18.23 6 23849 202643 64272234
Hypogammaglobulinaemia 53.24 18.23 38 23817 10261 64464616
Lymphocyte count decreased 52.70 18.23 70 23785 40629 64434248
Malaise 52.30 18.23 42 23813 396205 64078672
Asthenia 52.10 18.23 49 23806 427995 64046882
Neutrophil Pelger-Huet anomaly present 51.59 18.23 14 23841 339 64474538
Pain in extremity 51.27 18.23 24 23831 303061 64171816
Brain herniation 50.54 18.23 31 23824 6502 64468375
Back pain 50.36 18.23 15 23840 250156 64224721
Liver transplant rejection 47.85 18.23 23 23832 2976 64471901
Mucormycosis 47.22 18.23 31 23824 7310 64467567
Acanthamoeba infection 47.16 18.23 14 23841 472 64474405
Gait disturbance 46.02 18.23 5 23850 172150 64302727
Complications of transplanted kidney 45.16 18.23 27 23828 5408 64469469
Pneumonia pseudomonal 45.06 18.23 26 23829 4877 64470000
Abdominal discomfort 44.65 18.23 7 23848 182315 64292562
Alopecia 43.82 18.23 5 23850 165685 64309192
Haemorrhage intracranial 43.82 18.23 49 23806 23835 64451042
Viral haemorrhagic cystitis 43.69 18.23 18 23837 1617 64473260
Human herpesvirus 8 infection 43.55 18.23 16 23839 1057 64473820
Vomiting 43.05 18.23 87 23768 551030 63923847
Retinal detachment 42.55 18.23 30 23825 7946 64466931
Polyomavirus-associated nephropathy 42.49 18.23 25 23830 4863 64470014
Candida infection 42.16 18.23 55 23800 31364 64443513
Swelling 41.96 18.23 5 23850 160213 64314664
Blood pressure increased 41.42 18.23 7 23848 172545 64302332
Ureaplasma infection 41.40 18.23 14 23841 724 64474153
Scedosporium infection 41.12 18.23 16 23839 1238 64473639
Pneumonia bacterial 40.61 18.23 38 23817 14997 64459880
Immunosuppressant drug level increased 40.35 18.23 28 23827 7231 64467646
Drug intolerance 40.21 18.23 10 23845 187982 64286895
Cytomegalovirus hepatitis 39.99 18.23 13 23842 594 64474283
Cytopenia 39.69 18.23 38 23817 15433 64459444
Bacterial sepsis 39.67 18.23 28 23827 7429 64467448
Nasopharyngitis 39.01 18.23 12 23843 196061 64278816
Muscle spasms 37.93 18.23 4 23851 141019 64333858
Urticaria 37.59 18.23 5 23850 147312 64327565
Weight increased 37.46 18.23 16 23839 213332 64261545
Hypersensitivity 37.36 18.23 13 23842 196439 64278438
Pneumocystis jirovecii infection 37.35 18.23 18 23837 2343 64472534
Pulmonary haemorrhage 37.09 18.23 34 23821 13075 64461802
Drug hypersensitivity 36.97 18.23 21 23834 237794 64237083
Viral mutation identified 36.90 18.23 20 23835 3326 64471551
Lung transplant rejection 36.74 18.23 15 23840 1317 64473560
Gastric ulcer 36.10 18.23 50 23805 30184 64444693
Human herpesvirus 6 infection 35.79 18.23 22 23833 4632 64470245
Cerebral toxoplasmosis 35.32 18.23 16 23839 1810 64473067
Thrombocytopenia 35.28 18.23 170 23685 223631 64251246
Protein urine present 35.09 18.23 28 23827 8928 64465949
Hepatic function abnormal 34.97 18.23 75 23780 64238 64410639
Cytomegalovirus enteritis 34.50 18.23 12 23843 676 64474201
Macular fibrosis 34.06 18.23 12 23843 702 64474175
Botulism 33.30 18.23 10 23845 351 64474526
Myocardial infarction 33.25 18.23 10 23845 165811 64309066
Acute respiratory distress syndrome 33.14 18.23 55 23800 38880 64435997
Renal tubular disorder 33.06 18.23 23 23832 5964 64468913
Fungal infection 32.73 18.23 51 23804 34200 64440677
Kidney fibrosis 32.71 18.23 18 23837 3083 64471794
Retinal scar 32.38 18.23 10 23845 386 64474491
Death 32.15 18.23 83 23772 482622 63992255
Neutrophil count increased 32.13 18.23 43 23812 25131 64449746
Transplant failure 31.92 18.23 19 23836 3775 64471102
Hepatic failure 31.74 18.23 66 23789 55328 64419549
Contusion 31.25 18.23 3 23852 113962 64360915
Respiratory distress 30.75 18.23 63 23792 52268 64422609
Disseminated intravascular coagulation 30.68 18.23 48 23807 32300 64442577
Posterior reversible encephalopathy syndrome 30.52 18.23 40 23815 22906 64451971
Injection site pain 30.38 18.23 3 23852 111405 64363472
Depression 30.22 18.23 15 23840 183276 64291601
Somnolence 30.22 18.23 19 23836 203626 64271251
Hyperhidrosis 30.12 18.23 5 23850 124915 64349962
Insomnia 29.99 18.23 18 23837 197818 64277059
Cardiac failure congestive 29.82 18.23 6 23849 130574 64344303
Abdominal pain upper 29.35 18.23 14 23841 175016 64299861
Therapeutic product effect decreased 29.23 18.23 4 23851 115347 64359530
Neurological decompensation 29.18 18.23 19 23836 4417 64470460
Lymphoproliferative disorder 29.11 18.23 20 23835 5083 64469794
Syncope 29.00 18.23 11 23844 157624 64317253
Complications of transplanted liver 28.98 18.23 9 23846 354 64474523
Organising pneumonia 28.61 18.23 25 23830 9030 64465847
Lymphopenia 28.51 18.23 41 23814 25616 64449261
Blood urea increased 28.15 18.23 55 23800 44098 64430779
Toxoplasmosis 28.04 18.23 15 23840 2429 64472448
Complications of transplanted lung 27.86 18.23 9 23846 403 64474474
Enterococcal bacteraemia 27.70 18.23 15 23840 2490 64472387
Disseminated cytomegaloviral infection 27.59 18.23 9 23846 416 64474461
Rash 27.44 18.23 83 23772 458466 64016411
Strongyloidiasis 27.37 18.23 16 23839 3074 64471803
Retinitis 27.36 18.23 14 23841 2071 64472806
Fungal sepsis 27.32 18.23 13 23842 1645 64473232
Toxic epidermal necrolysis 27.06 18.23 49 23806 37117 64437760
Constipation 26.98 18.23 27 23828 229310 64245567
Adenoviral hepatitis 26.74 18.23 9 23846 459 64474418
Meningoencephalitis herpetic 26.57 18.23 13 23842 1748 64473129
Septic embolus 26.57 18.23 13 23842 1749 64473128
Glomerulonephropathy 26.34 18.23 8 23847 292 64474585
Hypoproteinaemia 26.04 18.23 16 23839 3366 64471511
Systemic mycosis 25.94 18.23 14 23841 2309 64472568
Sinusitis 25.51 18.23 11 23844 145917 64328960
Musculoskeletal stiffness 25.49 18.23 7 23848 123199 64351678
Chest pain 25.31 18.23 30 23825 235950 64238927
Escherichia sepsis 25.13 18.23 21 23834 7144 64467733
Infection reactivation 24.82 18.23 13 23842 2017 64472860
Flavobacterium infection 24.75 18.23 6 23849 91 64474786
Cerebrovascular accident 24.65 18.23 10 23845 137573 64337304
Myalgia 24.65 18.23 14 23841 158603 64316274
Lower respiratory tract infection 24.65 18.23 3 23852 94611 64380266
Venoocclusive liver disease 24.56 18.23 24 23831 9991 64464886
Pharyngeal abscess 24.18 18.23 9 23846 617 64474260
Drug ineffective for unapproved indication 23.88 18.23 42 23813 31091 64443786
Scopulariopsis infection 23.54 18.23 6 23849 113 64474764
Malnutrition 23.39 18.23 32 23823 19093 64455784
Squamous cell carcinoma of skin 22.88 18.23 25 23830 11851 64463026
Focal segmental glomerulosclerosis 22.85 18.23 14 23841 2930 64471947
Tubulointerstitial nephritis 22.81 18.23 41 23814 30868 64444009
Chimerism 22.70 18.23 7 23848 269 64474608
Asthma 22.54 18.23 4 23851 95221 64379656
Oesophagopleural fistula 22.28 18.23 5 23850 53 64474824
Infusion related reaction 22.20 18.23 17 23838 164450 64310427
Actinic keratosis 22.08 18.23 17 23838 5148 64469729
ADAMTS13 activity decreased 21.74 18.23 6 23849 155 64474722
Bacterial toxaemia 21.66 18.23 6 23849 157 64474720
Ascites 21.64 18.23 61 23794 61940 64412937
Myocarditis toxoplasmal 21.64 18.23 5 23850 61 64474816
Diffuse alveolar damage 21.64 18.23 14 23841 3221 64471656
Idiopathic pneumonia syndrome 21.59 18.23 8 23847 541 64474336
Opportunistic infection 21.53 18.23 13 23842 2649 64472228
Haematotoxicity 21.19 18.23 25 23830 12871 64462006
Acute graft versus host disease in liver 21.19 18.23 11 23844 1676 64473201
Cerebral aspergillosis 21.16 18.23 11 23844 1682 64473195
Balance disorder 21.05 18.23 3 23852 83923 64390954
Meningitis viral 20.88 18.23 11 23844 1727 64473150
Hyperlactacidaemia 20.83 18.23 16 23839 4828 64470049
Macular oedema 20.76 18.23 16 23839 4851 64470026
Contraindicated product administered 20.72 18.23 7 23848 107822 64367055
Paraesthesia 20.72 18.23 12 23843 134510 64340367
Platelet count decreased 20.63 18.23 119 23736 167592 64307285
Retinal haemorrhage 20.56 18.23 19 23836 7379 64467498
Loss of consciousness 20.45 18.23 15 23840 148350 64326527
Oliguria 20.31 18.23 26 23829 14550 64460327
Cytomegalovirus duodenitis 20.21 18.23 5 23850 83 64474794
Hydrocephalus 20.14 18.23 19 23836 7572 64467305
Epstein-Barr virus test positive 20.12 18.23 9 23846 989 64473888
Tractional retinal detachment 20.09 18.23 5 23850 85 64474792
Wheezing 19.93 18.23 3 23852 80576 64394301
Chronic allograft nephropathy 19.34 18.23 10 23845 1511 64473366
Lymphadenopathy mediastinal 19.34 18.23 14 23841 3862 64471015
Eye infection fungal 19.33 18.23 7 23848 444 64474433
Varicella zoster oesophagitis 19.30 18.23 4 23851 28 64474849
Hypoalbuminaemia 19.28 18.23 28 23827 17646 64457231
Confabulation 19.21 18.23 7 23848 452 64474425
Engraftment syndrome 19.18 18.23 9 23846 1104 64473773
Mycobacterium avium complex infection 19.14 18.23 14 23841 3926 64470951
Varicella zoster gastritis 18.73 18.23 4 23851 33 64474844
Renal transplant failure 18.63 18.23 10 23845 1630 64473247
Disease recurrence 18.58 18.23 38 23817 31472 64443405
Necrotising herpetic retinopathy 18.46 18.23 5 23850 120 64474757
Blood creatinine increased 18.46 18.23 99 23756 135683 64339194
CD4 lymphocytes increased 18.44 18.23 6 23849 275 64474602
Pleural effusion 18.40 18.23 94 23761 126465 64348412
Central nervous system necrosis 18.38 18.23 6 23849 278 64474599
Brain compression 18.34 18.23 7 23848 514 64474363
Bone marrow disorder 18.34 18.23 12 23843 2813 64472064

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
CHEBI has role CHEBI:35441 antiinfective agents
CHEBI has role CHEBI:36044 antiviral drugs
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000998 Antiviral Agents

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




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 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
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

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 22 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
CytoveneIV HUMAN PRESCRIPTION DRUG LABEL 1 61269-450 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS NDA 31 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 29 sections
Ganciclovir HUMAN PRESCRIPTION DRUG LABEL 1 63323-315 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS ANDA 29 sections
Ganciclovir HUMAN PRESCRIPTION DRUG LABEL 1 70436-089 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENTRICULAR ANDA 29 sections