valganciclovir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
antivirals bicyclic heterocycle compounds	2801	175865-59-5

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
0.90	g	O

ADMET properties:

Property	Value	Reference
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 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	61 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
March 29, 2001	FDA	HOFFMANN LA ROCHE
Nov. 5, 2004	PMDA	Tanabe Seiyaku Co., Ltd.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
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

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
DNA polymerase catalytic subunit	Enzyme		DPOL_HHV11	INHIBITOR				DRUGBANK	CHEMBL

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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