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Tox | Related Drugs | 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value	Unit	Confidence	Similarity
azlogd74	LogD at pH 7.4	-1.100		Moderate	0.74
caco2-efflux	Caco-2 efflux ratio (BA/AB)	1.469		Moderate	0.74
caco2-intrinsic-papp	Caco-2 intrinsic apparent permeability	0.142	10^-6 cm/s	Moderate	0.74
dh-clint	Dog hepatocyte intrinsic clearance	0.733	uL/min/10^6 cells	Moderate	0.74
dppb	Dog plasma protein binding (% unbound)	89.810	%	Moderate	0.74
fcs-ppb	Fetal calf serum protein binding (% unbound)	77.090	%	Moderate	0.74
herg	hERG pIC50	3.869	pIC50	Moderate	0.74
hh-clint	Human hepatocyte intrinsic clearance	1.603	uL/min/10^6 cells	Moderate	0.74
hlm-clint	Human liver microsomal intrinsic clearance	3.499	uL/min/mg protein	Moderate	0.74
hppb	Human plasma protein binding (% unbound)	84.540	%	Moderate	0.74
kinase-safety-class	ACVR2B,EIF2AK3,GRK2,PDK1,PDK2,PRKDC	6
kinase-selectivity-class	AXL,CDK1,CDK16,CDK2,CDK3,CDK9,MAP3K21,PDK1	8
mdck-mdr1-bcrp-efflux	MDCK-MDR1-BCRP efflux ratio	0.828		Moderate	0.74
mdck-mdr1-efflux	MDCK-MDR1 efflux ratio	0.783		Moderate	0.74
mh-clint	Mouse hepatocyte intrinsic clearance	26.730		Moderate	0.74
mppb	Mouse plasma protein binding (% unbound)	90.020		Moderate	0.74
nih-mdck-mdr1-efflux	NIH MDCK-MDR1 efflux ratio	0.701		Moderate	0.74
pfas-class	PFAS structural alert (1 = True, 0 = False)	0
pld-class	Phospholipidosis risk class (1 = positive, 0 = negative)	0		High	1
pppb	Pig plasma protein binding (% unbound)	87.320	%	Moderate	0.74
rat-kpuu-brain	Rat brain Kpuu	0.006	%	Moderate	0.74
rh-clint	Rat hepatocyte intrinsic clearance	8.670	uL/min/10^6 cells	Moderate	0.74
rh-fuinc	Rat hepatocyte fraction unbound in incubation	93.570	%	Moderate	0.74
rppb	Rat plasma protein binding (% unbound)	75.550	%	Moderate	0.74
solubility-dd	Solubility at pH 7.4 in DMSO	905.733	uM	Moderate	0.74

Approvals:

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

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	1421.85	19.50	442	22314	26160	90579531
Cytomegalovirus viraemia	705.68	19.50	194	22562	7392	90598299
Transplant rejection	689.36	19.50	214	22542	12544	90593147
Leukopenia	605.23	19.50	353	22403	100357	90505334
Off label use	507.31	19.50	949	21807	1101303	89504388
Drug resistance	497.60	19.50	211	22545	30238	90575453
Neutropenia	480.12	19.50	419	22337	224485	90381206
Pathogen resistance	429.35	19.50	134	22622	7981	90597710
Cytomegalovirus infection reactivation	371.99	19.50	119	22637	7681	90598010
Pancytopenia	292.84	19.50	242	22514	120021	90485670
Kidney transplant rejection	281.38	19.50	86	22670	4771	90600920
BK virus infection	257.84	19.50	79	22677	4419	90601272
Polyomavirus-associated nephropathy	256.29	19.50	69	22687	2421	90603270
Cytomegalovirus colitis	253.02	19.50	73	22683	3313	90602378
Epstein-Barr virus infection	249.73	19.50	95	22661	10249	90595442
Agranulocytosis	223.96	19.50	128	22628	34874	90570817
Post transplant lymphoproliferative disorder	220.28	19.50	78	22678	6871	90598820
Immunosuppressant drug level increased	209.23	19.50	68	22688	4612	90601079
Cytomegalovirus gastrointestinal infection	197.86	19.50	40	22716	378	90605313
Smooth muscle cell neoplasm	189.33	19.50	48	22708	1325	90604366
Nocardiosis	155.24	19.50	47	22709	2523	90603168
Acute kidney injury	154.33	19.50	283	22473	320104	90285587
Encephalitis cytomegalovirus	144.16	19.50	34	22722	688	90605003
Transplant dysfunction	143.85	19.50	53	22703	5229	90600462
Renal transplant failure	143.46	19.50	37	22719	1095	90604596
Thrombocytopenia	142.90	19.50	216	22540	208509	90397182
Enterococcal infection	142.66	19.50	63	22693	9928	90595763
Pneumocystis jirovecii pneumonia	140.79	19.50	80	22676	21536	90584155
Escherichia infection	134.60	19.50	70	22686	15825	90589866
Cytomegalovirus chorioretinitis	132.34	19.50	41	22715	2378	90603313
Thrombotic microangiopathy	126.67	19.50	67	22689	15676	90590015
Pulmonary nocardiosis	125.51	19.50	31	22725	767	90604924
Fatigue	122.83	19.50	69	22687	1153954	89451737
Blood creatinine increased	122.69	19.50	139	22617	101247	90504444
Arthralgia	121.79	19.50	24	22732	778498	89827193
Bronchopulmonary aspergillosis	119.45	19.50	58	22698	11340	90594351
Aspergillus infection	119.25	19.50	57	22699	10766	90594925
Complications of transplanted kidney	117.30	19.50	39	22717	2839	90602852
Klebsiella infection	115.80	19.50	55	22701	10242	90595449
Lymphopenia	113.36	19.50	71	22685	22810	90582881
Lung transplant rejection	112.57	19.50	30	22726	1011	90604680
Delayed graft function	112.17	19.50	32	22724	1393	90604298
Nephropathy toxic	107.78	19.50	56	22700	12632	90593059
Renal impairment	105.20	19.50	131	22625	105290	90500401
Adenovirus infection	102.79	19.50	40	22716	4582	90601109
Brain abscess	102.35	19.50	35	22721	2777	90602914
Cytomegalovirus oesophagitis	101.19	19.50	23	22733	393	90605298
Polyomavirus viraemia	101.09	19.50	29	22727	1288	90604403
Pain	101.07	19.50	63	22693	996278	89609413
Adrenal mass	100.27	19.50	28	22728	1127	90604564
Pneumonia cytomegaloviral	98.89	19.50	35	22721	3076	90602615
Graft versus host disease	96.20	19.50	45	22711	8099	90597592
Mucormycosis	95.48	19.50	36	22720	3785	90601906
Lymphocele	95.48	19.50	25	22731	786	90604905
Posterior reversible encephalopathy syndrome	95.06	19.50	63	22693	22276	90583415
Renal tubular necrosis	89.78	19.50	52	22704	14503	90591188
Strongyloidiasis	86.99	19.50	27	22729	1575	90604116
Joint swelling	86.41	19.50	12	22744	503288	90102403
Infusion related reaction	84.66	19.50	5	22751	416775	90188916
Renal transplant	81.47	19.50	26	22730	1662	90604029
Cytopenia	81.07	19.50	52	22704	17397	90588294
Epstein-Barr virus associated lymphoproliferative disorder	80.97	19.50	29	22727	2638	90603053
Peripheral swelling	80.84	19.50	6	22750	413100	90192591
Hypersensitivity	80.05	19.50	10	22746	454667	90151024
Toxoplasmosis	80.04	19.50	26	22730	1759	90603932
Myelosuppression	79.76	19.50	82	22674	53509	90552182
Cytomegalovirus test positive	79.58	19.50	31	22725	3560	90602131
Swelling	79.46	19.50	7	22749	419051	90186640
Rheumatoid arthritis	77.98	19.50	3	22753	362611	90243080
Renal graft infection	76.14	19.50	18	22738	368	90605323
Septic shock	75.16	19.50	99	22657	84061	90521630
Anaemia	74.67	19.50	226	22530	352576	90253115
Ureaplasma infection	74.29	19.50	21	22735	884	90604807
Sepsis	74.29	19.50	149	22607	179665	90426026
Haemophagocytic lymphohistiocytosis	74.14	19.50	47	22709	15412	90590279
Abdominal discomfort	73.92	19.50	15	22741	477313	90128378
Pseudomonas infection	70.80	19.50	45	22711	14820	90590871
Citrobacter infection	70.16	19.50	19	22737	681	90605010
Cholestasis	69.92	19.50	64	22692	36235	90569456
Multiple organ dysfunction syndrome	69.88	19.50	86	22670	68250	90537441
Human ehrlichiosis	69.82	19.50	15	22741	195	90605496
Congenital cytomegalovirus infection	68.90	19.50	14	22742	136	90605555
Intracranial infection	68.52	19.50	15	22741	214	90605477
Hyperammonaemia	67.99	19.50	33	22723	6442	90599249
Dizziness	67.26	19.50	32	22724	589252	90016439
Weight increased	67.11	19.50	12	22744	417915	90187776
Scedosporium infection	67.05	19.50	19	22737	807	90604884
Drug hypersensitivity	66.92	19.50	17	22739	463592	90142099
Alopecia	64.44	19.50	22	22734	495049	90110642
Systemic lupus erythematosus	63.58	19.50	8	22748	361888	90243803
Cytomegalovirus gastritis	62.45	19.50	15	22741	329	90605362
Viraemia	61.63	19.50	21	22735	1648	90604043
No adverse event	60.74	19.50	80	22676	67902	90537789
Neutrophil Pelger-Huet anomaly present	60.60	19.50	12	22744	101	90605590
Varicella zoster virus infection	60.40	19.50	26	22730	3851	90601840
Infection reactivation	58.54	19.50	21	22735	1919	90603772
Adenoviral hepatitis	58.38	19.50	15	22741	437	90605254
Graft loss	58.15	19.50	15	22741	444	90605247
Systemic candida	57.33	19.50	27	22729	4932	90600759
Hepatocellular injury	55.66	19.50	51	22705	28907	90576784
Oesophageal candidiasis	54.75	19.50	29	22727	6800	90598891
Transplant failure	54.51	19.50	20	22736	1949	90603742
Therapeutic product effect decreased	54.36	19.50	4	22752	277567	90328124
Retinitis viral	54.26	19.50	13	22743	282	90605409
Epstein-Barr virus infection reactivation	54.26	19.50	19	22737	1618	90604073
Fall	53.68	19.50	27	22729	481783	90123908
Urticaria	52.36	19.50	8	22748	312726	90292965
Epstein-Barr viraemia	52.34	19.50	18	22738	1452	90604239
Viral load increased	51.34	19.50	18	22738	1538	90604153
Pneumonia fungal	51.17	19.50	28	22728	7003	90598688
Pain in extremity	50.56	19.50	25	22731	450504	90155187
Cervicitis	50.36	19.50	14	22742	554	90605137
Haematotoxicity	50.08	19.50	34	22722	12501	90593190
Urosepsis	50.05	19.50	42	22714	21190	90584501
Pericarditis	49.88	19.50	5	22751	270146	90335545
Gastrointestinal stromal tumour	49.62	19.50	17	22739	1356	90604335
Venoocclusive liver disease	49.60	19.50	26	22730	5967	90599724
Liver transplant rejection	49.50	19.50	18	22738	1710	90603981
Asthma	48.85	19.50	3	22753	242157	90363534
Focal segmental glomerulosclerosis	48.29	19.50	18	22738	1833	90603858
Dyspnoea	47.98	19.50	93	22663	880862	89724829
Urinary tract infection	47.88	19.50	177	22579	305455	90300236
Pyelonephritis	47.86	19.50	41	22715	21275	90584416
Deafness congenital	47.52	19.50	10	22746	117	90605574
Bone marrow failure	47.38	19.50	49	22707	32172	90573519
SARS-CoV-2 RNA increased	47.36	19.50	10	22746	119	90605572
Product use in unapproved indication	47.17	19.50	188	22568	336048	90269643
Infected neoplasm	46.05	19.50	12	22744	370	90605321
Pruritus	44.83	19.50	42	22714	541483	90064208
Cryptococcosis	44.67	19.50	16	22740	1455	90604236
Rash	44.24	19.50	83	22673	796017	89809674
Proteus infection	44.10	19.50	16	22740	1510	90604181
Drug level increased	44.07	19.50	44	22712	27718	90577973
Disseminated cytomegaloviral infection	43.86	19.50	11	22745	290	90605401
Malaise	43.38	19.50	50	22706	585936	90019755
Hydronephrosis	43.37	19.50	31	22725	12371	90593320
Muscle spasms	43.19	19.50	6	22750	251877	90353814
Insomnia	43.04	19.50	15	22741	333459	90272232
Contusion	43.03	19.50	6	22750	251210	90354481
Mobility decreased	42.92	19.50	6	22750	250728	90354963
Respiratory failure	42.87	19.50	93	22663	118325	90487366
Wheezing	42.44	19.50	5	22751	238075	90367616
JC virus infection	41.59	19.50	18	22738	2701	90602990
Fusarium infection	41.47	19.50	14	22742	1068	90604623
Headache	41.21	19.50	98	22658	862648	89743043
Vitritis infective	40.85	19.50	7	22749	23	90605668
Drug intolerance	40.33	19.50	32	22724	447559	90158132
Fibromyalgia	40.30	19.50	3	22753	206266	90399425
Glomerulonephritis	39.91	19.50	17	22739	2453	90603238
Type 2 diabetes mellitus	39.58	19.50	3	22753	203241	90402450
Nasopharyngitis	39.40	19.50	27	22729	407077	90198614
Cardiac valve abscess	38.55	19.50	8	22748	87	90605604
Hypogammaglobulinaemia	38.06	19.50	27	22729	10647	90595044
Blood cholesterol increased	38.00	19.50	4	22752	208008	90397683
Depression	37.97	19.50	14	22742	300587	90305104
General physical health deterioration	37.90	19.50	21	22735	355094	90250597
Parainfluenzae virus infection	37.85	19.50	17	22739	2786	90602905
Intussusception	37.76	19.50	13	22743	1052	90604639
Cystitis haemorrhagic	37.50	19.50	21	22735	5492	90600199
Cytomegalovirus gastroenteritis	37.29	19.50	10	22746	345	90605346
Gastric ulcer	37.26	19.50	40	22716	27408	90578283
Bacterial infection	36.92	19.50	37	22719	23407	90582284
Cytomegalovirus enteritis	36.83	19.50	10	22746	362	90605329
Pericarditis constrictive	36.76	19.50	11	22745	567	90605124
Drug interaction	36.70	19.50	152	22604	276301	90329390
Bacteraemia	36.61	19.50	36	22720	22264	90583427
Migraine	36.54	19.50	3	22753	190389	90415302
Immune recovery uveitis	36.49	19.50	7	22749	49	90605642
Acinetobacter infection	36.40	19.50	15	22741	1993	90603698
Measles	36.29	19.50	10	22746	383	90605308
Hyperuricaemia	36.19	19.50	22	22734	6697	90598994
Brain oedema	36.13	19.50	32	22724	17353	90588338
Escherichia urinary tract infection	36.06	19.50	29	22727	13786	90591905
Hypoaesthesia	35.89	19.50	17	22739	314193	90291498
Graft thrombosis	35.83	19.50	9	22747	239	90605452
Cytomegalovirus myocarditis	35.55	19.50	7	22749	57	90605634
Memory impairment	35.51	19.50	4	22752	197240	90408451
Herpes simplex viraemia	35.40	19.50	10	22746	420	90605271
Renal artery stenosis	35.23	19.50	15	22741	2162	90603529
Pleural mesothelioma malignant	35.03	19.50	7	22749	62	90605629
Nephrogenic diabetes insipidus	35.01	19.50	12	22744	958	90604733
Parvovirus B19 infection	34.59	19.50	12	22744	994	90604697
Product dose omission issue	34.53	19.50	15	22741	291672	90314019
Superinfection bacterial	34.40	19.50	12	22744	1010	90604681
Sinusitis	34.21	19.50	22	22734	343066	90262625
Musculoskeletal stiffness	33.93	19.50	16	22740	296516	90309175
Septal panniculitis	33.91	19.50	7	22749	74	90605617
Venous haemorrhage	33.80	19.50	9	22747	302	90605389
Renal failure	33.55	19.50	90	22666	130917	90474774
Hepatic enzyme increased	33.49	19.50	25	22731	360711	90244980
Ascites	33.43	19.50	50	22706	47690	90558001
Oesophagitis ulcerative	33.02	19.50	11	22745	805	90604886
Imprisonment	32.96	19.50	9	22747	333	90605358
Stomatitis	32.72	19.50	14	22742	274684	90331007
Injection site pain	32.62	19.50	3	22753	173696	90431995
Dry mouth	32.47	19.50	4	22752	184055	90421636
Pyelonephritis acute	32.42	19.50	19	22737	5413	90600278
Bacterial endophthalmitis	32.19	19.50	8	22748	203	90605488
Febrile neutropenia	32.07	19.50	100	22656	158249	90447442
Human herpesvirus 8 infection	31.76	19.50	9	22747	382	90605309
Pneumonia bacterial	31.60	19.50	26	22730	12764	90592927
Haemolytic uraemic syndrome	31.56	19.50	15	22741	2796	90602895
Myocardial calcification	31.17	19.50	8	22748	232	90605459
COVID-19	30.91	19.50	103	22653	168740	90436951
Aplasia pure red cell	30.56	19.50	18	22738	5176	90600515
Blister	30.36	19.50	13	22743	254985	90350706
Mesothelioma malignant	29.94	19.50	6	22750	54	90605637
Gait disturbance	29.88	19.50	14	22742	260482	90345209
Chest pain	29.86	19.50	22	22734	319623	90286068
Guillain-Barre syndrome	29.83	19.50	17	22739	4595	90601096
Acute graft versus host disease	29.70	19.50	18	22738	5450	90600241
Viral uveitis	29.48	19.50	7	22749	146	90605545
Hepatic necrosis	29.44	19.50	19	22737	6419	90599272
Back pain	29.41	19.50	22	22734	317153	90288538
Cytomegalovirus duodenitis	29.37	19.50	6	22750	60	90605631
Urate nephropathy	29.30	19.50	7	22749	150	90605541
Immunosuppressant drug level decreased	29.09	19.50	11	22745	1165	90604526
Chorioretinitis	28.88	19.50	10	22746	823	90604868
Bacteriuria	28.82	19.50	11	22745	1195	90604496
Chronic graft versus host disease	28.79	19.50	16	22740	4123	90601568
Heart transplant rejection	28.76	19.50	10	22746	834	90604857
Pancreas transplant rejection	28.70	19.50	7	22749	164	90605527
Arthritis	28.64	19.50	4	22752	167311	90438380
Feeling abnormal	28.62	19.50	4	22752	167231	90438460
Kidney fibrosis	28.43	19.50	13	22743	2221	90603470
Cytomegalovirus enterocolitis	28.41	19.50	10	22746	864	90604827
Tonic clonic movements	28.32	19.50	12	22744	1710	90603981
Mycoplasma infection	28.15	19.50	10	22746	888	90604803
Vasogenic cerebral oedema	28.10	19.50	11	22745	1279	90604412
Herpes simplex	27.92	19.50	22	22734	10159	90595532
Graft versus host disease in gastrointestinal tract	27.92	19.50	16	22740	4372	90601319
Metapneumovirus infection	27.74	19.50	11	22745	1324	90604367
Complications of transplanted lung	27.70	19.50	8	22748	364	90605327
Complications of transplant surgery	27.68	19.50	7	22749	191	90605500
Urinary tract infection bacterial	27.40	19.50	18	22738	6267	90599424
Staphylococcal sepsis	27.30	19.50	21	22735	9362	90596329
Abdominal pain upper	27.26	19.50	26	22730	332648	90273043
Muscular weakness	27.17	19.50	9	22747	206657	90399034
Reticulocytopenia	27.00	19.50	6	22750	92	90605599
Injury	27.00	19.50	8	22748	197341	90408350
Cytomegalovirus hepatitis	26.95	19.50	8	22748	401	90605290
Pancreatic pseudoaneurysm	26.71	19.50	6	22750	97	90605594
Eye infection toxoplasmal	26.70	19.50	8	22748	414	90605277
Lower respiratory tract infection	26.48	19.50	15	22741	250644	90355047
Superinfection viral	26.32	19.50	5	22751	33	90605658
Clostridium difficile colitis	26.31	19.50	33	22723	26673	90579018
Pyrexia	26.22	19.50	267	22489	660218	89945473
Escherichia sepsis	26.19	19.50	17	22739	5799	90599892
Diabetes mellitus	25.85	19.50	53	22703	64822	90540869
Rhinovirus infection	25.81	19.50	17	22739	5946	90599745
Hyperkalaemia	25.80	19.50	53	22703	64911	90540780
Colon injury	25.50	19.50	7	22749	264	90605427
Perinephric collection	25.00	19.50	6	22750	131	90605560
Liver transplant	24.90	19.50	12	22744	2305	90603386
Intentional product use issue	24.75	19.50	114	22642	216778	90388913
Oral candidiasis	24.63	19.50	37	22719	35418	90570273
Gastrointestinal mucormycosis	24.48	19.50	7	22749	307	90605384
Ill-defined disorder	24.39	19.50	8	22748	184883	90420808
Central nervous system fungal infection	24.35	19.50	6	22750	147	90605544
Candida infection	24.32	19.50	36	22720	34021	90571670
Mixed liver injury	24.26	19.50	18	22738	7605	90598086
Pneumonia respiratory syncytial viral	24.18	19.50	10	22746	1341	90604350
Encephalitis viral	24.06	19.50	11	22745	1878	90603813
Escherichia bacteraemia	23.97	19.50	16	22740	5719	90599972
Pulmonary mucormycosis	23.93	19.50	8	22748	592	90605099
Microsporidia infection	23.81	19.50	7	22749	339	90605352
Sleep disorder	23.72	19.50	10	22746	198020	90407671
Bacterial sepsis	23.59	19.50	15	22741	4940	90600751
Human herpesvirus 6 infection reactivation	23.50	19.50	8	22748	626	90605065
Fungal infection	23.43	19.50	40	22716	42621	90563070
Splenomegaly	23.36	19.50	22	22734	12902	90592789
Calciphylaxis	23.34	19.50	13	22743	3363	90602328
Pulmonary alveolar haemorrhage	23.32	19.50	16	22740	5982	90599709
Renal lymphocele	23.27	19.50	5	22751	65	90605626
Pneumonia pneumococcal	23.16	19.50	12	22744	2690	90603001
Renal arteriosclerosis	23.15	19.50	6	22750	181	90605510
Colitis	23.13	19.50	53	22703	69889	90535802
Epstein-Barr virus test positive	22.71	19.50	8	22748	693	90604998
Trichodysplasia spinulosa	22.68	19.50	8	22748	696	90604995
Clostridium difficile infection	22.62	19.50	36	22720	36209	90569482
Human herpesvirus 6 encephalitis	22.59	19.50	7	22749	406	90605285
Inappropriate schedule of product administration	22.58	19.50	5	22751	149928	90455763
Herpes simplex oesophagitis	22.57	19.50	6	22750	200	90605491
Pneumonia influenzal	22.27	19.50	11	22745	2229	90603462
Diffuse large B-cell lymphoma	22.25	19.50	18	22738	8627	90597064
Staphylococcal infection	22.23	19.50	42	22714	48397	90557294
Apoptotic colonopathy	22.19	19.50	5	22751	82	90605609
Dyspepsia	22.19	19.50	11	22745	198149	90407542
Neutropenia neonatal	22.02	19.50	5	22751	85	90605606
Blastomycosis	21.83	19.50	7	22749	454	90605237
Gait inability	21.82	19.50	5	22751	146451	90459240
Anisocytosis	21.67	19.50	8	22748	793	90604898
Respiratory tract infection viral	21.62	19.50	12	22744	3084	90602607
Chronic allograft nephropathy	21.59	19.50	8	22748	801	90604890
Hepatic failure	21.49	19.50	37	22719	39691	90566000
Wound dehiscence	21.39	19.50	15	22741	5807	90599884
Thyroid tuberculosis	21.11	19.50	4	22752	26	90605665
Mycobacterium avium complex infection	21.01	19.50	13	22743	4085	90601606
Disseminated tuberculosis	20.91	19.50	12	22744	3287	90602404
Genital lesion	20.79	19.50	6	22750	272	90605419
Haemophilus infection	20.45	19.50	9	22747	1405	90604286
Renal tubular atrophy	20.42	19.50	8	22748	932	90604759
Anorexia nervosa	20.36	19.50	6	22750	293	90605398
Pre-eclampsia	20.34	19.50	19	22737	11029	90594662
Viral mutation identified	20.30	19.50	10	22746	2015	90603676
Somnolence	20.03	19.50	14	22742	209070	90396621
Delayed engraftment	20.00	19.50	5	22751	130	90605561
Hepatic cyst infection	19.97	19.50	5	22751	131	90605560
Acute lung injury	19.95	19.50	9	22747	1489	90604202
Pneumonia haemophilus	19.92	19.50	9	22747	1494	90604197
Herpes simplex reactivation	19.80	19.50	8	22748	1011	90604680
Coronavirus infection	19.78	19.50	14	22742	5501	90600190
Loss of personal independence in daily activities	19.58	19.50	5	22751	136100	90469591
Impaired healing	19.53	19.50	18	22738	234181	90371510

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	1071.38	15.92	526	34748	31780	42554281
Cytomegalovirus viraemia	840.46	15.92	318	34956	10059	42576002
Transplant rejection	590.84	15.92	267	35007	13321	42572740
Leukopenia	571.95	15.92	482	34792	74264	42511797
Drug resistance	490.07	15.92	322	34952	33926	42552135
Off label use	373.94	15.92	1263	34011	637072	41948989
Encephalitis cytomegalovirus	354.59	15.92	99	35175	1140	42584921
BK virus infection	345.33	15.92	161	35113	8623	42577438
Neutropenia	300.10	15.92	567	34707	198864	42387197
Polyomavirus-associated nephropathy	278.25	15.92	121	35153	5494	42580567
Cytomegalovirus colitis	275.85	15.92	109	35165	3872	42582189
Pancytopenia	260.78	15.92	398	34876	117345	42468716
Pathogen resistance	246.72	15.92	140	35134	11310	42574751
Kidney transplant rejection	236.55	15.92	124	35150	8559	42577502
Nocardiosis	225.51	15.92	102	35172	5088	42580973
Cytomegalovirus infection reactivation	223.02	15.92	130	35144	11048	42575013
Delayed graft function	203.27	15.92	78	35196	2557	42583504
Cytomegalovirus chorioretinitis	201.54	15.92	91	35183	4520	42581541
Complications of transplanted kidney	197.75	15.92	94	35180	5256	42580805
Nephropathy toxic	185.71	15.92	135	35139	16703	42569358
Pseudoaneurysm infection	182.81	15.92	41	35233	171	42585890
Transplant dysfunction	181.96	15.92	77	35197	3266	42582795
Pneumonia cytomegaloviral	178.97	15.92	81	35193	4045	42582016
Epstein-Barr viraemia	170.30	15.92	66	35208	2223	42583838
Vascular pseudoaneurysm ruptured	167.99	15.92	45	35229	438	42585623
Epstein-Barr virus infection	165.27	15.92	102	35172	9616	42576445
Aspergillus infection	161.21	15.92	121	35153	15716	42570345
Thrombotic microangiopathy	157.32	15.92	116	35158	14666	42571395
Cystitis haemorrhagic	153.54	15.92	88	35186	7241	42578820
Immunosuppressant drug level increased	151.80	15.92	89	35185	7642	42578419
Myelosuppression	151.49	15.92	177	35097	40284	42545777
Post transplant lymphoproliferative disorder	150.73	15.92	94	35180	9026	42577035
Agranulocytosis	142.32	15.92	150	35124	30462	42555599
Polyomavirus viraemia	136.48	15.92	55	35219	2057	42584004
Candida infection	132.22	15.92	123	35151	21487	42564574
Cytomegalovirus enteritis	127.97	15.92	39	35235	622	42585439
Cytomegalovirus gastrointestinal infection	123.11	15.92	33	35241	322	42585739
Pulmonary nocardiosis	119.90	15.92	48	35226	1764	42584297
Escherichia infection	118.05	15.92	88	35186	11308	42574753
Enterococcal infection	115.94	15.92	89	35185	11950	42574111
Immune reconstitution inflammatory syndrome	111.09	15.92	81	35193	10062	42575999
Septic shock	110.34	15.92	238	35036	91434	42494627
Fatigue	108.25	15.92	121	35153	435520	42150541
Human ehrlichiosis	107.07	15.92	32	35242	476	42585585
Lung transplant rejection	106.56	15.92	38	35236	1009	42585052
Cytomegalovirus syndrome	106.27	15.92	24	35250	104	42585957
Mucormycosis	104.06	15.92	68	35206	7075	42578986
Cytomegalovirus test positive	101.70	15.92	56	35218	4263	42581798
Lymphopenia	100.81	15.92	106	35168	21457	42564604
Pseudomonas infection	90.46	15.92	87	35187	15836	42570225
Renal impairment	89.60	15.92	246	35028	109982	42476079
Fall	88.13	15.92	42	35232	234478	42351583
Pneumocystis jirovecii pneumonia	87.36	15.92	106	35168	25075	42560986
Parvovirus B19 infection	84.69	15.92	37	35237	1697	42584364
Klebsiella infection	84.19	15.92	72	35202	11260	42574801
Pain	83.00	15.92	50	35224	244798	42341263
Infection reactivation	82.45	15.92	39	35235	2155	42583906
Malacoplakia	80.86	15.92	30	35244	894	42585167
Focal segmental glomerulosclerosis	79.84	15.92	40	35234	2508	42583553
Haemophagocytic lymphohistiocytosis	78.87	15.92	86	35188	18136	42567925
Enterovirus infection	77.82	15.92	32	35242	1261	42584800
Liver transplant rejection	77.42	15.92	39	35235	2474	42583587
Somnolence	75.39	15.92	13	35261	141092	42444969
Product dose omission issue	70.83	15.92	20	35254	154345	42431716
Arterial haemorrhage	69.19	15.92	29	35245	1200	42584861
Thrombocytopenia	66.90	15.92	323	34951	189956	42396105
Pain in extremity	66.40	15.92	21	35253	150583	42435478
Cryptococcosis	65.76	15.92	38	35236	3173	42582888
Dyspnoea	65.59	15.92	171	35103	442450	42143611
Dizziness	65.35	15.92	66	35208	249188	42336873
Graft versus host disease	64.84	15.92	66	35208	12859	42573202
Toxoplasmosis	64.82	15.92	30	35244	1577	42584484
Rash	64.27	15.92	81	35193	276873	42309188
Myocardial infarction	62.89	15.92	13	35261	123996	42462065
Mycobacterium avium complex infection	62.47	15.92	36	35238	2991	42583070
Cytomegalovirus oesophagitis	62.45	15.92	22	35252	563	42585498
Multiple organ dysfunction syndrome	62.09	15.92	199	35075	96836	42489225
Choriomeningitis lymphocytic	61.35	15.92	16	35258	139	42585922
Nausea	61.31	15.92	150	35124	396649	42189412
Cytopenia	61.24	15.92	74	35200	17423	42568638
Renal artery stenosis	60	15.92	32	35242	2285	42583776
Drug ineffective	59.35	15.92	787	34487	629410	41956651
Rectal prolapse	59.26	15.92	21	35253	547	42585514
Dermatophytosis	59.18	15.92	18	35256	285	42585776
Renal cyst haemorrhage	58.91	15.92	22	35252	668	42585393
Strongyloidiasis	58.29	15.92	36	35238	3395	42582666
Trichophytosis	58.10	15.92	19	35255	385	42585676
Glomerulosclerosis	57.30	15.92	23	35251	851	42585210
Bone marrow failure	56.97	15.92	100	35174	32993	42553068
Arthralgia	56.50	15.92	52	35222	205186	42380875
Constipation	55.14	15.92	33	35241	162258	42423803
Viral load increased	54.90	15.92	33	35241	2964	42583097
Pericarditis fungal	54.76	15.92	16	35258	219	42585842
Bronchopulmonary aspergillosis	53.57	15.92	73	35201	19356	42566705
Cutaneous mucormycosis	53.01	15.92	20	35254	625	42585436
Fungal skin infection	51.60	15.92	33	35241	3308	42582753
Cutaneous nocardiosis	51.49	15.92	15	35259	203	42585858
Acute kidney injury	49.86	15.92	493	34781	366844	42219217
Syncope	49.21	15.92	11	35263	99395	42486666
Generalised oedema	49.07	15.92	62	35212	15274	42570787
Vena cava injury	48.75	15.92	16	35258	328	42585733
Brain abscess	48.70	15.92	35	35239	4249	42581812
Pyelonephritis fungal	48.42	15.92	12	35262	83	42585978
Subcapsular renal haematoma	48.03	15.92	18	35256	552	42585509
Renal tubular necrosis	47.66	15.92	67	35207	18287	42567774
Headache	47.61	15.92	78	35196	239291	42346770
Large intestinal ulcer	47.41	15.92	28	35246	2435	42583626
Gastritis fungal	47.25	15.92	13	35261	141	42585920
Infective aneurysm	46.59	15.92	21	35253	1038	42585023
Pulmonary mucormycosis	46.05	15.92	23	35251	1432	42584629
Abdominal wall haemorrhage	46.00	15.92	17	35257	501	42585560
Monkeypox	45.85	15.92	16	35258	398	42585663
Progressive multifocal leukoencephalopathy	45.71	15.92	52	35222	11484	42574577
Depression	44.85	15.92	18	35256	111345	42474716
Malaise	44.20	15.92	67	35207	212089	42373972
Retroperitoneal abscess	44.04	15.92	15	35259	346	42585715
Anxiety	43.31	15.92	22	35252	118538	42467523
Pruritus	42.92	15.92	56	35218	188715	42397346
Back pain	42.58	15.92	33	35241	141743	42444318
SARS-CoV-2 antibody test positive	42.39	15.92	15	35259	389	42585672
Aplasia pure red cell	42.30	15.92	40	35234	7126	42578935
JC virus infection	42.30	15.92	28	35246	2976	42583085
Vascular anastomotic haemorrhage	42.12	15.92	14	35260	299	42585762
Penile ulceration	42.07	15.92	18	35256	784	42585277
Asthenia	41.85	15.92	108	35166	280685	42305376
Stenotrophomonas infection	41.51	15.92	30	35244	3674	42582387
Disseminated mycobacterium avium complex infection	41.19	15.92	13	35261	234	42585827
Fungal infection	41.18	15.92	65	35209	19657	42566404
Splenic infection viral	40.43	15.92	9	35265	36	42586025
Graft ischaemia	40.23	15.92	9	35265	37	42586024
Kidney fibrosis	39.86	15.92	26	35248	2696	42583365
Hyperhidrosis	39.20	15.92	13	35261	90499	42495562
Lymphocele	39.03	15.92	21	35253	1526	42584535
Actinic keratosis	38.67	15.92	33	35241	5143	42580918
Intentional product use issue	38.60	15.92	139	35135	71694	42514367
Malignant neoplasm progression	38.29	15.92	21	35253	108379	42477682
New onset diabetes after transplantation	38.28	15.92	12	35262	211	42585850
Feeling abnormal	38.21	15.92	6	35268	69780	42516281
Granulomatous dermatitis	37.92	15.92	13	35261	306	42585755
Rhinovirus infection	37.60	15.92	36	35238	6512	42579549
Peripheral swelling	37.32	15.92	14	35260	90256	42495805
Staphylococcal infection	36.68	15.92	90	35184	37553	42548508
Muscle spasms	36.15	15.92	13	35261	86031	42500030
Cardiac infection	36.11	15.92	12	35262	256	42585805
Disseminated varicella zoster virus infection	35.99	15.92	16	35258	765	42585296
Intraductal papillary mucinous neoplasm	35.96	15.92	14	35260	477	42585584
Drug hypersensitivity	35.47	15.92	19	35255	99370	42486691
Liver transplant	35.29	15.92	24	35250	2667	42583394
Vascular compression	35.24	15.92	13	35261	381	42585680
Urticaria	35.05	15.92	9	35265	74027	42512034
Escherichia urinary tract infection	35.04	15.92	29	35245	4334	42581727
Inappropriate schedule of product administration	34.72	15.92	18	35256	95884	42490177
Cytomegalovirus gastritis	34.63	15.92	12	35262	292	42585769
Cytomegalovirus nephritis	34.49	15.92	10	35264	133	42585928
Immune recovery uveitis	34.33	15.92	9	35265	80	42585981
Botulism	34.20	15.92	11	35263	211	42585850
Cardiac failure congestive	34.19	15.92	14	35260	85588	42500473
Squamous cell carcinoma of skin	33.85	15.92	47	35227	12679	42573382
Latent autoimmune diabetes in adults	33.76	15.92	10	35264	144	42585917
Respiratory distress	33.58	15.92	93	35181	41727	42544334
Carotid arteriosclerosis	33.47	15.92	22	35252	2310	42583751
Shock haemorrhagic	33.18	15.92	53	35221	16189	42569872
Fungal endocarditis	33.17	15.92	13	35261	451	42585610
Nasopharyngitis	33.13	15.92	14	35260	83982	42502079
Trench fever	33.12	15.92	8	35266	49	42586012
Perineal cyst	33.05	15.92	11	35263	236	42585825
Hyperparathyroidism secondary	33.01	15.92	20	35254	1822	42584239
Oesophageal infection	32.95	15.92	12	35262	339	42585722
Staphylococcal mediastinitis	32.84	15.92	8	35266	51	42586010
Death	32.81	15.92	242	35032	470943	42115118
Transplant failure	32.73	15.92	27	35247	4017	42582044
Abdominal discomfort	32.25	15.92	11	35263	75244	42510817
Retinal scar	31.99	15.92	12	35262	369	42585692
Hepatic artery thrombosis	31.93	15.92	11	35263	263	42585798
Hydronephrosis	31.83	15.92	44	35230	11821	42574240
Pneumocystis jirovecii infection	31.67	15.92	23	35251	2837	42583224
Disseminated cytomegaloviral infection	31.50	15.92	11	35263	274	42585787
Acute respiratory distress syndrome	31.50	15.92	74	35200	30034	42556027
Cytomegalovirus hepatitis	31.43	15.92	13	35261	520	42585541
Renal transplant failure	31.32	15.92	18	35256	1487	42584574
Hypocomplementaemia	31.15	15.92	8	35266	65	42585996
Gene mutation	31.05	15.92	19	35255	1762	42584299
Heart transplant rejection	31.00	15.92	18	35256	1516	42584545
Meningitis viral	30.71	15.92	16	35258	1089	42584972
Meningitis fungal	30.65	15.92	10	35264	201	42585860
Klebsiella sepsis	30.55	15.92	22	35252	2679	42583382
Hypersensitivity	30.29	15.92	11	35263	72359	42513702
Hypogammaglobulinaemia	30.27	15.92	43	35231	11848	42574213
Blood pressure increased	30.24	15.92	24	35250	101904	42484157
Cell-mediated cytotoxicity	30.01	15.92	7	35267	36	42586025
Gastroenteritis Escherichia coli	30.00	15.92	15	35259	936	42585125
Cytomegalovirus gastroenteritis	29.83	15.92	11	35263	322	42585739
Chest discomfort	29.60	15.92	8	35266	63608	42522453
No adverse event	29.59	15.92	85	35189	38936	42547125
Blood 25-hydroxycholecalciferol decreased	29.51	15.92	11	35263	332	42585729
Bicytopenia	29.47	15.92	23	35251	3161	42582900
Musculoskeletal stiffness	29.38	15.92	6	35268	57759	42528302
Odynophagia	29.37	15.92	32	35242	6738	42579323
Drug level increased	29.18	15.92	66	35208	26134	42559927
Metastases to salivary gland	29.14	15.92	8	35266	86	42585975
Gastrointestinal haemorrhage	29.01	15.92	23	35251	97703	42488358
Disseminated aspergillosis	29.00	15.92	18	35256	1712	42584349
Granulomatous rosacea	28.83	15.92	9	35265	156	42585905
Clostridium difficile colitis	28.82	15.92	58	35216	21194	42564867
Central nervous system viral infection	28.67	15.92	9	35265	159	42585902
Viraemia	28.62	15.92	18	35256	1752	42584309
Renal tubular injury	28.54	15.92	18	35256	1761	42584300
Encephalitis viral	28.44	15.92	17	35257	1511	42584550
Muscular weakness	28.30	15.92	17	35257	83481	42502580
Cerebral toxoplasmosis	28.20	15.92	19	35255	2079	42583982
Product use in unapproved indication	28.12	15.92	254	35020	184202	42401859
Gait disturbance	27.93	15.92	24	35250	97976	42488085
Anaemia	27.82	15.92	354	34920	279924	42306137
Blood pressure decreased	27.78	15.92	7	35267	58325	42527736
Pneumonia fungal	27.72	15.92	36	35238	9110	42576951
Therapeutic product effect incomplete	27.69	15.92	12	35262	70927	42515134
Joint swelling	27.37	15.92	11	35263	68011	42518050
Proteus infection	27.27	15.92	16	35258	1374	42584687
Chronic papillomatous dermatitis	27.13	15.92	7	35267	58	42586003
Anal ulcer	27.06	15.92	15	35259	1156	42584905
Aortic dilatation	27.06	15.92	17	35257	1652	42584409
Graft versus host disease in skin	26.84	15.92	27	35247	5185	42580876
Dry skin	26.81	15.92	4	35270	48334	42537727
Neutropenic colitis	26.47	15.92	25	35249	4445	42581616
Bacillary angiomatosis	26.29	15.92	9	35265	211	42585850
Lymph gland infection	26.21	15.92	9	35265	213	42585848
Hepatitis viral	25.93	15.92	13	35261	816	42585245
Staphylococcal skin infection	25.77	15.92	14	35260	1037	42585024
Hyperparathyroidism	25.61	15.92	15	35259	1284	42584777
Hepatosplenomegaly	25.59	15.92	25	35249	4635	42581426
Glomerulonephropathy	25.56	15.92	9	35265	230	42585831
American trypanosomiasis	25.54	15.92	10	35264	346	42585715
Scrotal ulcer	25.48	15.92	11	35263	490	42585571
Pyrexia	25.30	15.92	462	34812	393580	42192481
Suicide attempt	25.15	15.92	4	35270	46096	42539965
Blood glucose increased	24.98	15.92	15	35259	73684	42512377
Blastomycosis	24.89	15.92	12	35262	692	42585369
Brain herniation	24.87	15.92	25	35249	4798	42581263
Encephalopathy	24.81	15.92	83	35191	41250	42544811
Intervertebral disc space narrowing	24.65	15.92	14	35260	1131	42584930
Pneumonia pseudomonal	24.49	15.92	25	35249	4884	42581177
Sleep disorder	24.45	15.92	5	35269	48090	42537971
Electrocardiogram QT prolonged	24.34	15.92	5	35269	47940	42538121
Fibrin D dimer increased	24.17	15.92	25	35249	4960	42581101
Disseminated trichosporonosis	23.94	15.92	7	35267	96	42585965
Injection site pain	23.82	15.92	9	35265	57789	42528272
Meningoencephalitis viral	23.80	15.92	8	35266	177	42585884
Chest pain	23.69	15.92	50	35224	139480	42446581
Renal tubular acidosis	23.60	15.92	19	35255	2731	42583330
Hypoglycaemia	23.56	15.92	10	35264	59844	42526217
Graft versus host disease in gastrointestinal tract	23.52	15.92	25	35249	5118	42580943
Paraesthesia	23.47	15.92	16	35258	73443	42512618
Mean cell volume increased	23.35	15.92	22	35252	3901	42582160
Intentional product misuse	23.33	15.92	11	35263	61889	42524172
Seizure	23.27	15.92	40	35234	120521	42465540
Haemolytic uraemic syndrome	23.15	15.92	18	35256	2461	42583600
Meningitis histoplasma	23.10	15.92	5	35269	17	42586044
Steroid diabetes	22.99	15.92	19	35255	2833	42583228
Infection in an immunocompromised host	22.96	15.92	13	35261	1044	42585017
Sepsis	22.92	15.92	259	35015	199075	42386986
Eye infection toxoplasmal	22.78	15.92	9	35265	319	42585742
Blood creatine phosphokinase increased	22.64	15.92	6	35268	48332	42537729
Isosporiasis	22.61	15.92	7	35267	118	42585943
Palpitations	22.51	15.92	7	35267	50790	42535271
Blood creatinine increased	22.47	15.92	162	35112	109841	42476220
Pneumonia necrotising	22.46	15.92	13	35261	1089	42584972
Oesophagopleural fistula	22.43	15.92	6	35268	58	42586003
Myocarditis toxoplasmal	22.43	15.92	6	35268	58	42586003
Disease progression	22.33	15.92	54	35220	143602	42442459
Confusional state	22.30	15.92	68	35206	167529	42418532
Therapeutic product effect decreased	22.28	15.92	3	35271	39147	42546914
Epstein-Barr virus infection reactivation	22.23	15.92	18	35256	2609	42583452
Cerebral ventricle collapse	22.13	15.92	7	35267	127	42585934
Prostate cancer	21.96	15.92	5	35269	44638	42541423
Graft loss	21.91	15.92	12	35262	903	42585158
Diverticulum intestinal	21.89	15.92	24	35250	5089	42580972
Retroperitoneal haematoma	21.87	15.92	19	35255	3032	42583029
Aortic arteriosclerosis	21.86	15.92	24	35250	5096	42580965
Organising pneumonia	21.82	15.92	29	35245	7503	42578558
Varicella virus test positive	21.61	15.92	8	35266	237	42585824
Protothecosis	21.57	15.92	6	35268	68	42585993
Optic discs blurred	21.57	15.92	6	35268	68	42585993
Bacterial toxaemia	21.49	15.92	7	35267	140	42585921
Drug intolerance	21.36	15.92	21	35253	80403	42505658
Posterior reversible encephalopathy syndrome	21.10	15.92	38	35236	12783	42573278
Disseminated tuberculosis	21.09	15.92	18	35256	2806	42583255
Renal tubular disorder	20.94	15.92	23	35251	4886	42581175
Respiratory failure	20.83	15.92	179	35095	127953	42458108
Cryptosporidiosis infection	20.75	15.92	11	35263	776	42585285
Viral haemorrhagic cystitis	20.74	15.92	15	35259	1839	42584222
Pyelonephritis	20.71	15.92	29	35245	7885	42578176
Anaphylactic reaction	20.61	15.92	5	35269	42738	42543323
Agitation	20.55	15.92	14	35260	64300	42521761
Toxic optic neuropathy	20.48	15.92	12	35262	1028	42585033
Hirsutism	20.46	15.92	8	35266	276	42585785
Human polyomavirus infection	20.44	15.92	13	35261	1290	42584771
General physical health deterioration	20.38	15.92	61	35213	151185	42434876
Erythrophagocytosis	20.38	15.92	5	35269	33	42586028
T-cell lymphoma stage IV	20.33	15.92	7	35267	167	42585894
Heart rate decreased	20.31	15.92	3	35271	36529	42549532
Wheezing	20.24	15.92	10	35264	54771	42531290
Encephalitis brain stem	20.18	15.92	7	35267	171	42585890
Enterobacter infection	20.12	15.92	18	35256	2986	42583075
Cardiac disorder	19.54	15.92	8	35266	48924	42537137
Lung transplant	19.45	15.92	16	35258	2370	42583691
Erythema	19.30	15.92	38	35236	108755	42477306
Abdominal pain upper	19.27	15.92	24	35250	82585	42503476
Renal transplant	19.23	15.92	16	35258	2409	42583652
Deafness congenital	19.06	15.92	6	35268	107	42585954
Cerebrovascular accident	18.96	15.92	32	35242	97128	42488933
Cytokine release syndrome	18.89	15.92	80	35194	44447	42541614
Pneumonia cryptococcal	18.71	15.92	13	35261	1495	42584566
Genitourinary tract infection	18.71	15.92	6	35268	114	42585947
Immunosuppressant drug level decreased	18.69	15.92	14	35260	1810	42584251
Osteomyelitis chronic	18.69	15.92	8	35266	349	42585712
Oliguria	18.48	15.92	30	35244	9283	42576778
Colitis	18.48	15.92	82	35192	46490	42539571
Biloma	18.47	15.92	6	35268	119	42585942
Bacteraemia	18.46	15.92	54	35220	24986	42561075
Loss of consciousness	18.41	15.92	30	35244	92324	42493737
Retinal artery occlusion	18.37	15.92	15	35259	2200	42583861
Scedosporium infection	18.33	15.92	13	35261	1545	42584516
Periorbital cellulitis	18.33	15.92	8	35266	366	42585695
Trichophytic granuloma	18.28	15.92	5	35269	53	42586008
Mycotic endophthalmitis	18.25	15.92	7	35267	229	42585832
Contusion	18.22	15.92	6	35268	41979	42544082
Vertebral lesion	18.16	15.92	7	35267	232	42585829
Prophylaxis against transplant rejection	18.11	15.92	5	35269	55	42586006
Drug ineffective for unapproved indication	18.10	15.92	81	35193	46082	42539979
Vision blurred	18.10	15.92	11	35263	53688	42532373
Guillain-Barre syndrome	18.09	15.92	26	35248	7237	42578824
Skin exfoliation	17.93	15.92	6	35268	41547	42544514
Oedematous kidney	17.87	15.92	5	35269	58	42586003
Melaena	17.79	15.92	5	35269	38741	42547320
Bronchial anastomosis complication	17.77	15.92	4	35270	17	42586044
Urogenital infection bacterial	17.64	15.92	5	35269	61	42586000
Campylobacter gastroenteritis	17.46	15.92	11	35263	1074	42584987
Metabolic acidosis	17.42	15.92	87	35187	51771	42534290
Anastomotic stenosis	17.42	15.92	8	35266	413	42585648
Transmission of an infectious agent via transplant	17.41	15.92	4	35270	19	42586042
Urinoma	17.39	15.92	7	35267	261	42585800
Granuloma	17.35	15.92	19	35255	4022	42582039
Morganella infection	17.31	15.92	9	35265	610	42585451
Infusion related reaction	17.19	15.92	15	35259	60791	42525270
Haemoperitoneum	17.15	15.92	14	35260	2052	42584009
Abscess	17.11	15.92	37	35237	14211	42571850
Bronchostenosis	17.10	15.92	8	35266	431	42585630
Loss of personal independence in daily activities	17.08	15.92	10	35264	49806	42536255
Corynebacterium infection	16.89	15.92	10	35264	873	42585188
Tubulointerstitial nephritis	16.89	15.92	61	35213	31487	42554574
Adverse drug reaction	16.87	15.92	5	35269	37429	42548632
Graft infection	16.84	15.92	8	35266	446	42585615
Cerebral aspergillosis	16.80	15.92	13	35261	1764	42584297
Renal tubular atrophy	16.80	15.92	12	35262	1443	42584618
Swelling of eyelid	16.79	15.92	14	35260	2114	42583947
Viral mutation identified	16.69	15.92	17	35257	3314	42582747
Arthritis	16.60	15.92	7	35267	42058	42544003
Neurological decompensation	16.59	15.92	18	35256	3771	42582290
Phaeohyphomycosis	16.58	15.92	11	35263	1173	42584888
End stage renal disease	16.56	15.92	40	35234	16518	42569543
Thrombotic thrombocytopenic purpura	16.54	15.92	18	35256	3786	42582275
Lymphorrhoea	16.45	15.92	5	35269	79	42585982
Hypoaesthesia	16.42	15.92	21	35253	71442	42514619
Iris neovascularisation	16.35	15.92	4	35270	26	42586035
Post procedural bile leak	16.25	15.92	7	35267	310	42585751
Acinetobacter infection	16.25	15.92	12	35262	1519	42584542
Serum sickness	16.24	15.92	14	35260	2211	42583850
Renal vein thrombosis	16.23	15.92	8	35266	484	42585577
Transient ischaemic attack	16.16	15.92	4	35270	33735	42552326
Dyspepsia	16.13	15.92	7	35267	41345	42544716
Paraspinal abscess	16.11	15.92	5	35269	85	42585976
Orchitis	16.10	15.92	14	35260	2237	42583824
Suicidal ideation	16.04	15.92	10	35264	48151	42537910
Vomiting	15.97	15.92	158	35116	289565	42296496
Perinephric collection	15.95	15.92	6	35268	186	42585875

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	2235.21	15.78	880	52982	53564	110481873
Cytomegalovirus viraemia	1490.67	15.78	488	53374	17276	110518161
Transplant rejection	1156.16	15.78	439	53423	24128	110511309
Leukopenia	1136.23	15.78	774	53088	148017	110387420
Drug resistance	1053.93	15.78	525	53337	55849	110479588
Neutropenia	721.96	15.78	899	52963	373721	110161716
Pathogen resistance	638.72	15.78	261	53601	17411	110518026
BK virus infection	597.68	15.78	229	53633	12877	110522560
Off label use	565.29	15.78	1801	52061	1498384	109037053
Pancytopenia	558.16	15.78	595	53267	209018	110326419
Cytomegalovirus infection reactivation	549.48	15.78	237	53625	18096	110517341
Cytomegalovirus colitis	536.13	15.78	180	53682	6881	110528556
Polyomavirus-associated nephropathy	525.03	15.78	184	53678	8017	110527420
Encephalitis cytomegalovirus	518.21	15.78	131	53731	1779	110533658
Kidney transplant rejection	505.90	15.78	198	53664	11789	110523648
Epstein-Barr virus infection	408.44	15.78	194	53668	18544	110516893
Nocardiosis	378.19	15.78	141	53721	7345	110528092
Immunosuppressant drug level increased	346.16	15.78	150	53712	11574	110523863
Post transplant lymphoproliferative disorder	344.43	15.78	163	53699	15450	110519987
Agranulocytosis	342.20	15.78	265	53597	61495	110473942
Nephropathy toxic	335.74	15.78	193	53669	27285	110508152
Cytomegalovirus chorioretinitis	330.16	15.78	126	53736	7002	110528435
Delayed graft function	325.06	15.78	109	53753	4148	110531289
Complications of transplanted kidney	321.33	15.78	125	53737	7317	110528120
Aspergillus infection	318.54	15.78	182	53680	25434	110510003
Transplant dysfunction	300.86	15.78	123	53739	8205	110527232
Cytomegalovirus gastrointestinal infection	300.76	15.78	70	53792	654	110534783
Pneumonia cytomegaloviral	276.35	15.78	110	53752	6844	110528593
Enterococcal infection	270.25	15.78	151	53711	20215	110515222
Thrombotic microangiopathy	266.49	15.78	170	53692	28979	110506458
Escherichia infection	258.62	15.78	155	53707	23661	110511776
Mucormycosis	249.99	15.78	116	53746	10512	110524925
Pulmonary nocardiosis	247.99	15.78	79	53783	2550	110532887
Polyomavirus viraemia	245.77	15.78	84	53778	3390	110532047
Epstein-Barr viraemia	235.59	15.78	82	53780	3497	110531940
Cytomegalovirus syndrome	232.50	15.78	49	53813	274	110535163
Fatigue	231.24	15.78	155	53707	1215803	109319634
Pneumocystis jirovecii pneumonia	227.21	15.78	179	53683	42556	110492881
Pain	225.32	15.78	92	53770	954863	109580574
Myelosuppression	214.75	15.78	247	53615	94093	110441344
Renal impairment	213.58	15.78	352	53510	188093	110347344
Acute kidney injury	211.93	15.78	735	53127	634695	109900742
Cystitis haemorrhagic	211.17	15.78	108	53754	12101	110523336
Klebsiella infection	208.93	15.78	127	53735	19882	110515555
Arthralgia	204.49	15.78	63	53799	779569	109755868
Lymphopenia	204.45	15.78	164	53698	40006	110495431
Septic shock	204.32	15.78	313	53549	157215	110378222
Pseudoaneurysm infection	203.70	15.78	41	53821	175	110535262
Thrombocytopenia	189.27	15.78	480	53382	348405	110187032
Pseudomonas infection	184.31	15.78	133	53729	27720	110507717
Human ehrlichiosis	183.90	15.78	47	53815	668	110534769
Vascular pseudoaneurysm ruptured	183.80	15.78	45	53817	531	110534906
Lung transplant rejection	182.04	15.78	58	53804	1873	110533564
Graft versus host disease	170.20	15.78	109	53753	18697	110516740
Bronchopulmonary aspergillosis	169.41	15.78	130	53732	29733	110505704
Smooth muscle cell neoplasm	160.58	15.78	49	53813	1368	110534069
Cytomegalovirus enteritis	155.84	15.78	45	53817	1033	110534404
Haemophagocytic lymphohistiocytosis	154.57	15.78	126	53736	31433	110504004
Candida infection	154.19	15.78	151	53711	47858	110487579
Strongyloidiasis	147.85	15.78	64	53798	4922	110530515
Cytomegalovirus test positive	147.67	15.78	71	53791	6965	110528472
Joint swelling	146.12	15.78	21	53841	442824	110092613
Toxoplasmosis	145.50	15.78	56	53806	3183	110532254
Renal transplant failure	144.64	15.78	53	53809	2627	110532810
Brain abscess	144.13	15.78	69	53793	6705	110528732
Dizziness	143.47	15.78	81	53781	698112	109837325
Infection reactivation	143.06	15.78	59	53803	4022	110531415
Multiple organ dysfunction syndrome	142.58	15.78	261	53601	151449	110383988
Hypersensitivity	138.44	15.78	17	53845	403981	110131456
Cytomegalovirus oesophagitis	137.39	15.78	40	53822	946	110534491
Peripheral swelling	136.03	15.78	18	53844	404016	110131421
Fall	134.39	15.78	63	53799	603419	109932018
Infusion related reaction	130.69	15.78	16	53846	381146	110154291
Drug ineffective	129.72	15.78	1216	52646	1519324	109016113
Cryptococcosis	129.38	15.78	57	53805	4574	110530863
Renal tubular necrosis	129.28	15.78	112	53750	30363	110505074
Focal segmental glomerulosclerosis	128.81	15.78	55	53807	4090	110531347
Cytopenia	128.40	15.78	111	53751	30005	110505432
Headache	126.89	15.78	146	53716	882231	109653206
Parvovirus B19 infection	126.53	15.78	49	53813	2832	110532605
Pain in extremity	126.40	15.78	40	53822	487078	110048359
Drug hypersensitivity	123.82	15.78	34	53828	454056	110081381
Immune reconstitution inflammatory syndrome	122.50	15.78	84	53778	16142	110519295
Abdominal discomfort	122.45	15.78	22	53840	393836	110141601
Malaise	121.56	15.78	90	53772	671729	109863708
Dyspnoea	119.30	15.78	224	53638	1106648	109428789
Blood creatinine increased	114.38	15.78	266	53596	182623	110352814
Rash	112.51	15.78	141	53721	820823	109714614
Nasopharyngitis	110.40	15.78	28	53834	394333	110141104
Graft loss	109.35	15.78	36	53826	1292	110534145
Contraindicated product administered	106.96	15.78	3	53859	248264	110287173
Alopecia	105.83	15.78	24	53838	364729	110170708
Liver transplant rejection	105.51	15.78	47	53815	3871	110531566
Urticaria	105.42	15.78	15	53847	318842	110216595
Bone marrow failure	104.81	15.78	135	53727	57713	110477724
Nausea	104.74	15.78	285	53577	1235405	109300032
Renal artery stenosis	104.54	15.78	46	53816	3680	110531757
Completed suicide	104.16	15.78	3	53859	242378	110293059
Asthma	101.06	15.78	5	53857	250286	110285151
Sepsis	97.15	15.78	365	53497	326981	110208456
Cytomegalovirus gastritis	96.26	15.78	28	53834	660	110534777
Hydronephrosis	95.95	15.78	80	53782	20585	110514852
Musculoskeletal stiffness	95.27	15.78	12	53850	279810	110255627
Adenovirus infection	95.23	15.78	62	53800	10932	110524505
Systemic lupus erythematosus	94.08	15.78	8	53854	254330	110281107
Pruritus	93.91	15.78	87	53775	581473	109953964
Lymphocele	93.61	15.78	35	53827	1836	110533601
Anaemia	93.40	15.78	518	53344	546568	109988869
Viral load increased	92.36	15.78	41	53821	3349	110532088
Therapeutic product effect decreased	92.28	15.78	7	53855	244309	110291128
Depression	91.81	15.78	21	53841	317314	110218123
Mycobacterium avium complex infection	90.22	15.78	48	53814	5829	110529608
Product dose omission issue	89.75	15.78	23	53839	321759	110213678
Posterior reversible encephalopathy syndrome	89.65	15.78	96	53766	33765	110501672
Drug intolerance	89.55	15.78	43	53819	406469	110128968
Muscle spasms	87.60	15.78	15	53847	278142	110257295
Malacoplakia	87.49	15.78	30	53832	1222	110534215
Swelling	87.22	15.78	31	53831	351010	110184427
Mobility decreased	86.38	15.78	8	53854	237414	110298023
Pneumonia fungal	85.37	15.78	65	53797	14689	110520748
Weight increased	84.21	15.78	50	53812	419594	110115843
JC virus infection	83.45	15.78	44	53818	5246	110530191
Aplasia pure red cell	82.93	15.78	54	53808	9524	110525913
Wheezing	82.07	15.78	13	53849	255217	110280220
Contusion	81.94	15.78	9	53853	233352	110302085
Anxiety	79.90	15.78	34	53828	345044	110190393
Drug level increased	79.69	15.78	107	53755	47612	110487825
Staphylococcal infection	79.60	15.78	131	53731	69813	110465624
Hypogammaglobulinaemia	79.57	15.78	71	53791	20005	110515432
Renal transplant	78.20	15.78	36	53826	3202	110532235
Dry mouth	77.62	15.78	5	53857	199943	110335494
Respiratory failure	77.54	15.78	256	53606	215076	110320361
Back pain	76.14	15.78	43	53819	370953	110164484
Discomfort	76.10	15.78	8	53854	214699	110320738
Pulmonary mucormycosis	75.18	15.78	31	53831	2112	110533325
Scedosporium infection	74.35	15.78	32	53830	2426	110533011
Somnolence	74.34	15.78	26	53836	297423	110238014
Ureaplasma infection	74.01	15.78	28	53834	1518	110533919
Fungal skin infection	73.08	15.78	45	53817	7204	110528233
Fungal infection	73.02	15.78	106	53756	50700	110484737
Viraemia	73.01	15.78	37	53825	4065	110531372
Pyelonephritis	72.94	15.78	75	53787	25175	110510262
Pericarditis fungal	72.78	15.78	19	53843	295	110535142
Transplant failure	72.62	15.78	41	53821	5594	110529843
Osteoarthritis	72.61	15.78	4	53858	182619	110352818
Cutaneous nocardiosis	72.54	15.78	19	53843	299	110535138
Disseminated cytomegaloviral infection	72.38	15.78	22	53840	606	110534831
Renal graft infection	71.79	15.78	23	53839	756	110534681
Migraine	70.68	15.78	3	53859	171649	110363788
Immune recovery uveitis	70.30	15.78	16	53846	134	110535303
Epstein-Barr virus infection reactivation	70.25	15.78	36	53826	4048	110531389
Proteus infection	70.04	15.78	32	53830	2796	110532641
Adrenal mass	69.47	15.78	27	53835	1575	110533862
Trichophytosis	69.06	15.78	20	53842	464	110534973
Feeling abnormal	68.74	15.78	5	53857	180706	110354731
Product use in unapproved indication	68.70	15.78	412	53450	446965	110088472
Renal cyst haemorrhage	68.21	15.78	22	53840	739	110534698
Blister	67.88	15.78	14	53848	227362	110308075
Enterovirus infection	67.53	15.78	31	53831	2739	110532698
Pyelonephritis fungal	67.31	15.78	18	53844	308	110535129
Choriomeningitis lymphocytic	66.88	15.78	16	53846	170	110535267
Stomatitis	65.20	15.78	25	53837	270217	110265220
Hypoaesthesia	65.07	15.78	36	53826	314187	110221250
Cutaneous mucormycosis	65.01	15.78	21	53841	709	110534728
Kidney fibrosis	64.97	15.78	35	53827	4357	110531080
Rhinovirus infection	63.97	15.78	50	53812	11739	110523698
Shock haemorrhagic	61.38	15.78	71	53791	27176	110508261
Cytomegalovirus gastroenteritis	61.06	15.78	20	53842	706	110534731
Arterial haemorrhage	60.91	15.78	32	53830	3787	110531650
Glomerulosclerosis	60.67	15.78	23	53839	1254	110534183
Respiratory distress	60.29	15.78	115	53747	68759	110466678
General physical health deterioration	60.29	15.78	71	53791	425224	110110213
Abdominal pain upper	60.21	15.78	49	53813	349062	110186375
Muscular weakness	59.92	15.78	23	53839	248445	110286992
Hepatic enzyme increased	59.22	15.78	42	53820	320850	110214587
Helicobacter infection	59.06	15.78	9	53853	181868	110353569
Squamous cell carcinoma of skin	58.78	15.78	56	53806	17147	110518290
Escherichia urinary tract infection	57.88	15.78	54	53808	16108	110519329
Varicella zoster virus infection	57.84	15.78	37	53825	6331	110529106
Sleep disorder	57.72	15.78	13	53849	198631	110336806
Arthritis	57.48	15.78	7	53855	167579	110367858
Dermatophytosis	57.07	15.78	18	53844	562	110534875
Actinic keratosis	56.98	15.78	38	53824	6975	110528462
Vena cava injury	56.75	15.78	16	53846	336	110535101
Cytomegalovirus hepatitis	56.72	15.78	20	53842	886	110534551
Monkeypox	55.84	15.78	16	53846	357	110535080
Subcapsular renal haematoma	55.47	15.78	20	53842	946	110534491
Ill-defined disorder	55.18	15.78	6	53856	156847	110378590
Memory impairment	55.04	15.78	14	53848	196930	110338507
Pericarditis	55.00	15.78	19	53843	219095	110316342
No adverse event	54.70	15.78	115	53747	73724	110461713
Maternal exposure during pregnancy	54.53	15.78	28	53834	254855	110280582
Progressive multifocal leukoencephalopathy	54.49	15.78	64	53798	24892	110510545
Dyspepsia	54.49	15.78	13	53849	190952	110344485
Cardiac infection	54.38	15.78	18	53844	657	110534780
Acinetobacter infection	54.33	15.78	29	53833	3544	110531893
Epstein-Barr virus associated lymphoproliferative disorder	54.06	15.78	32	53830	4770	110530667
Infective aneurysm	53.76	15.78	22	53840	1470	110533967
Penile ulceration	53.69	15.78	18	53844	684	110534753
Heart transplant rejection	53.64	15.78	24	53838	1997	110533440
Pyrexia	53.56	15.78	670	53192	897595	109637842
Gait disturbance	53.22	15.78	35	53827	278173	110257264
Encephalitis viral	53.16	15.78	27	53835	2980	110532457
Stenotrophomonas infection	53.11	15.78	34	53828	5824	110529613
Injection site pain	53.01	15.78	11	53851	177911	110357526
Graft versus host disease in gastrointestinal tract	52.96	15.78	40	53822	8928	110526509
Psoriasis	52.88	15.78	4	53858	139989	110395448
Liver transplant	52.76	15.78	31	53831	4558	110530879
Injury	52.73	15.78	11	53851	177254	110358183
Paraesthesia	52.61	15.78	35	53827	276486	110258951
Intracranial infection	52.42	15.78	15	53847	333	110535104
Intentional overdose	52.36	15.78	3	53859	132498	110402939
Fusarium infection	52.27	15.78	26	53836	2745	110532692
Oesophageal candidiasis	52.20	15.78	44	53818	11490	110523947
Blood cholesterol increased	51.90	15.78	13	53849	184772	110350665
Chest pain	51.05	15.78	65	53797	376310	110159127
Guillain-Barre syndrome	50.72	15.78	42	53820	10702	110524735
Odynophagia	50.28	15.78	47	53815	14054	110521383
Insomnia	50.24	15.78	61	53801	360529	110174908
Clostridium difficile colitis	49.81	15.78	82	53780	43696	110491741
SARS-CoV-2 antibody test positive	49.81	15.78	15	53847	400	110535037
Vascular anastomotic haemorrhage	49.43	15.78	14	53848	299	110535138
Cervicitis	49.26	15.78	14	53848	303	110535134
Cerebral toxoplasmosis	49.18	15.78	26	53836	3116	110532321
Granulomatous rosacea	49.14	15.78	13	53849	213	110535224
Blastomycosis	48.76	15.78	19	53843	1116	110534321
Blood pressure increased	48.75	15.78	33	53829	258340	110277097
Abdominal wall haemorrhage	48.59	15.78	17	53845	736	110534701
Eye infection toxoplasmal	48.43	15.78	17	53845	743	110534694
Sinusitis	48.27	15.78	44	53818	296644	110238793
Haemolytic uraemic syndrome	47.86	15.78	30	53832	4955	110530482
Myocardial infarction	47.62	15.78	17	53845	192066	110343371
Chest discomfort	47.36	15.78	13	53849	173835	110361602
Disseminated tuberculosis	46.99	15.78	30	53832	5116	110530321
Graft versus host disease in skin	46.95	15.78	36	53826	8218	110527219
Type 2 diabetes mellitus	46.90	15.78	14	53848	177218	110358219
Gait inability	46.03	15.78	6	53856	136370	110399067
Lower respiratory tract infection	45.93	15.78	31	53831	243075	110292362
Citrobacter infection	45.41	15.78	19	53843	1343	110534094
New onset diabetes after transplantation	45.34	15.78	14	53848	407	110535030
Splenic infection viral	45.18	15.78	9	53853	36	110535401
Bacteraemia	45.03	15.78	77	53785	42313	110493124
Colitis	44.54	15.78	130	53732	102193	110433244
Acute respiratory distress syndrome	44.33	15.78	87	53775	53111	110482326
Gene mutation	44.33	15.78	25	53837	3404	110532033
Constipation	44.29	15.78	66	53796	357720	110177717
Gastritis fungal	44.27	15.78	13	53849	317	110535120
Retroperitoneal abscess	44.22	15.78	15	53847	591	110534846
Inappropriate schedule of product administration	44.11	15.78	22	53840	203615	110331822
Herpes simplex	44.05	15.78	46	53816	15718	110519719
Generalised oedema	44.03	15.78	64	53798	30640	110504797
Meningitis viral	43.75	15.78	22	53840	2377	110533060
Syncope	43.69	15.78	22	53840	202514	110332923
Adenoviral hepatitis	43.69	15.78	17	53845	995	110534442
Obesity	43.50	15.78	3	53859	113348	110422089
Viral mutation identified	43.45	15.78	27	53835	4392	110531045
Disseminated varicella zoster virus infection	43.15	15.78	18	53844	1263	110534174
Pneumonia pseudomonal	43.12	15.78	33	53829	7513	110527924
Musculoskeletal pain	42.39	15.78	18	53844	183005	110352432
Oesophageal atresia	41.99	15.78	10	53852	104	110535333
Bicytopenia	41.96	15.78	31	53831	6693	110528744
Neutrophil Pelger-Huet anomaly present	41.90	15.78	13	53849	384	110535053
Confusional state	41.87	15.78	105	53757	468575	110066862
Hyperammonaemia	41.87	15.78	42	53820	13690	110521747
Asthenia	41.83	15.78	183	53679	688816	109846621
Glomerulonephritis	41.77	15.78	27	53835	4703	110530734
Chronic obstructive pulmonary disease	41.56	15.78	3	53859	109155	110426282
Febrile neutropenia	41.31	15.78	280	53582	316487	110218950
Systemic candida	40.97	15.78	36	53826	9938	110525499
Hyperhidrosis	40.92	15.78	20	53842	187278	110348159
Organising pneumonia	40.58	15.78	42	53820	14201	110521236
Disseminated aspergillosis	40.18	15.78	21	53841	2459	110532978
Retinitis viral	40.05	15.78	13	53849	446	110534991
Hyperkalaemia	39.86	15.78	151	53711	135645	110399792
Pericarditis constrictive	39.83	15.78	16	53846	1019	110534418
Death	39.81	15.78	190	53672	698679	109836758
Folliculitis	39.62	15.78	16	53846	167637	110367800
Joint range of motion decreased	39.62	15.78	6	53856	121826	110413611
Rectal prolapse	39.53	15.78	21	53841	2542	110532895
Fungal endocarditis	39.51	15.78	15	53847	821	110534616
Therapeutic product effect incomplete	39.08	15.78	31	53831	223774	110311663
Renal tubular atrophy	38.97	15.78	20	53842	2256	110533181
Perineal cyst	38.93	15.78	11	53851	233	110535204
Carotid arteriosclerosis	38.74	15.78	22	53840	3035	110532402
Cytomegalovirus myocarditis	38.67	15.78	9	53853	84	110535353
Pneumocystis jirovecii infection	38.57	15.78	25	53837	4375	110531062
Disseminated mycobacterium avium complex infection	38.50	15.78	13	53849	505	110534932
Granulomatous dermatitis	38.31	15.78	13	53849	513	110534924
Cytokine release syndrome	38.28	15.78	97	53765	70209	110465228
Road traffic accident	38.05	15.78	4	53858	107394	110428043
Cytomegalovirus nephritis	37.97	15.78	10	53852	161	110535276
Neck pain	37.96	15.78	7	53855	123123	110412314
Vitritis infective	37.77	15.78	8	53854	46	110535391
Hepatic artery thrombosis	37.76	15.78	12	53850	384	110535053
Brain oedema	37.76	15.78	60	53802	31038	110504399
Drug ineffective for unapproved indication	37.64	15.78	123	53739	102715	110432722
Perinephric collection	37.27	15.78	12	53850	401	110535036
Latent autoimmune diabetes in adults	37.19	15.78	10	53852	175	110535262
Large intestinal ulcer	36.94	15.78	27	53835	5734	110529703
Trench fever	36.93	15.78	8	53854	52	110535385
Staphylococcal mediastinitis	36.93	15.78	8	53854	52	110535385
Steroid diabetes	36.85	15.78	26	53836	5228	110530209
SARS-CoV-2 RNA increased	36.51	15.78	10	53852	188	110535249
Granuloma	36.50	15.78	33	53829	9457	110525980
Brain herniation	36.43	15.78	32	53830	8831	110526606
Drug interaction	36.39	15.78	388	53474	499795	110035642
Haematotoxicity	36.31	15.78	48	53814	21034	110514403
Serum sickness	36.10	15.78	24	53838	4382	110531055
Toxic optic neuropathy	35.98	15.78	16	53846	1312	110534125
Loss of personal independence in daily activities	35.97	15.78	14	53848	150006	110385431
Intraductal papillary mucinous neoplasm	35.57	15.78	14	53848	845	110534592
Retinal scar	35.52	15.78	12	53850	467	110534970
Haemolytic anaemia	35.06	15.78	47	53815	20873	110514564
Acute graft versus host disease	34.94	15.78	37	53825	12844	110522593
Palpitations	34.78	15.78	17	53845	159195	110376242
Hyperuricaemia	34.65	15.78	39	53823	14492	110520945
Hyperparathyroidism secondary	34.56	15.78	21	53841	3283	110532154
Graft ischaemia	34.40	15.78	9	53853	141	110535296
Teratogenicity	34.25	15.78	10	53852	239	110535198
Anaphylactic reaction	34.18	15.78	7	53855	114293	110421144
Left ventricular hypertrophy	34.09	15.78	37	53825	13207	110522230
Suicide attempt	33.83	15.78	5	53857	103389	110432048
Metastases to salivary gland	33.35	15.78	8	53854	86	110535351
Oesophageal infection	33.34	15.78	13	53849	765	110534672
Vascular compression	33.29	15.78	13	53849	768	110534669
Renal tubular injury	33.14	15.78	20	53842	3088	110532349
Urosepsis	32.95	15.78	56	53806	30619	110504818
Gastroenteritis Escherichia coli	32.93	15.78	15	53847	1302	110534135
Immunosuppressant drug level decreased	32.60	15.78	19	53843	2752	110532685
Central nervous system fungal infection	32.47	15.78	12	53850	609	110534828
Superinfection bacterial	32.38	15.78	18	53844	2383	110533054
Scrotal ulcer	32.29	15.78	11	53851	439	110534998
COVID-19	32.17	15.78	217	53645	244843	110290594
Bacterial sepsis	31.99	15.78	32	53830	10394	110525043
Hepatocellular injury	31.99	15.78	74	53788	50568	110484869
Blood 25-hydroxycholecalciferol decreased	31.69	15.78	11	53851	465	110534972
Viral uveitis	31.66	15.78	9	53853	195	110535242
Chronic allograft nephropathy	31.61	15.78	17	53845	2109	110533328
Night sweats	31.31	15.78	13	53849	133970	110401467
Pneumonia pneumococcal	31.23	15.78	23	53839	4942	110530495
Meningitis fungal	31.20	15.78	10	53852	329	110535108
Oral candidiasis	31.18	15.78	68	53794	44692	110490745
Complications of transplanted lung	31.12	15.78	12	53850	685	110534752
Renal tubular disorder	30.89	15.78	27	53835	7402	110528035
Aortic dilatation	30.74	15.78	17	53845	2229	110533208
Anal ulcer	30.72	15.78	16	53846	1860	110533577
Hypercholesterolaemia	30.64	15.78	4	53858	90833	110444604
Blood pressure decreased	30.61	15.78	9	53853	115082	110420355
Adverse drug reaction	30.47	15.78	7	53855	105552	110429885
Gastrointestinal mucormycosis	30.41	15.78	12	53850	729	110534708
Botulism	30.39	15.78	11	53851	526	110534911
Medication error	30.39	15.78	7	53855	105359	110430078
Epilepsy	30.25	15.78	6	53856	100203	110435234
Pancreas transplant rejection	30.19	15.78	10	53852	366	110535071
Klebsiella sepsis	30.17	15.78	21	53841	4132	110531305
Electrocardiogram QT prolonged	29.95	15.78	8	53854	108952	110426485
Cardiac valve abscess	29.80	15.78	8	53854	139	110535298
Cell-mediated cytotoxicity	29.73	15.78	7	53855	69	110535368
Tubulointerstitial nephritis	29.66	15.78	75	53787	54209	110481228
Varicella virus test positive	29.53	15.78	10	53852	392	110535045
Renal failure	29.36	15.78	200	53662	226374	110309063
Cytomegalovirus duodenitis	29.33	15.78	8	53854	148	110535289
Infected neoplasm	29.29	15.78	11	53851	584	110534853
Neutropenic colitis	28.98	15.78	27	53835	8038	110527399
Cardiac failure congestive	28.86	15.78	19	53843	150981	110384456
Gastrointestinal stromal tumour	28.81	15.78	16	53846	2115	110533322
Impaired healing	28.76	15.78	32	53830	196685	110338752
Chronic papillomatous dermatitis	28.64	15.78	7	53855	82	110535355
Diffuse large B-cell lymphoma	28.62	15.78	37	53825	15861	110519576
Hepatosplenomegaly	28.47	15.78	25	53837	6894	110528543
Clostridium difficile infection	28.46	15.78	72	53790	52057	110483380
Hepatitis viral	28.30	15.78	14	53848	1461	110533976
Flushing	28.21	15.78	8	53854	104728	110430709
Cerebrovascular accident	28.17	15.78	28	53834	181256	110354181
Herpes simplex viraemia	28.04	15.78	11	53851	658	110534779
Encephalopathy	27.93	15.78	95	53767	80960	110454477
Human herpesvirus 8 infection	27.93	15.78	15	53847	1856	110533581
Intentional product misuse	27.82	15.78	15	53847	132889	110402548
Vomiting	27.63	15.78	297	53565	910378	109625059
Pyelonephritis acute	27.58	15.78	25	53837	7188	110528249
Infection in an immunocompromised host	27.51	15.78	15	53847	1912	110533525
Prostatitis	27.44	15.78	21	53841	4780	110530657
Central nervous system viral infection	27.28	15.78	9	53853	325	110535112
Escherichia bacteraemia	27.22	15.78	29	53833	10135	110525302
Chronic graft versus host disease	27.15	15.78	28	53834	9429	110526008
Prophylaxis against transplant rejection	27.10	15.78	7	53855	104	110535333
Graft thrombosis	27.05	15.78	10	53852	508	110534929
Pneumonia bacterial	26.97	15.78	47	53815	26214	110509223
Retroperitoneal haematoma	26.95	15.78	23	53839	6108	110529329
Sciatica	26.93	15.78	6	53856	92393	110443044
Wrong technique in product usage process	26.85	15.78	5	53857	87343	110448094
Venoocclusive liver disease	26.77	15.78	35	53827	15172	110520265
Amnesia	26.68	15.78	9	53853	105399	110430038
COVID-19 pneumonia	26.52	15.78	57	53805	37086	110498351
Glomerulonephropathy	26.45	15.78	9	53853	358	110535079
Trichodysplasia spinulosa	26.38	15.78	12	53850	1038	110534399
Parainfluenzae virus infection	26.33	15.78	24	53838	6950	110528487
Bacillary angiomatosis	26.24	15.78	9	53853	367	110535070
Venous haemorrhage	26.21	15.78	9	53853	368	110535069
Cholestasis	26.20	15.78	80	53782	64438	110470999
Urinary tract infection	26.03	15.78	258	53604	326024	110209413
Enterobacter infection	25.95	15.78	22	53840	5789	110529648
Pneumonia necrotising	25.85	15.78	14	53848	1761	110533676
Bacterial pyelonephritis	25.81	15.78	11	53851	814	110534623
Trichophytic granuloma	25.69	15.78	6	53856	57	110535380
Bacteriuria	25.68	15.78	13	53849	1425	110534012
Angioedema	25.66	15.78	8	53854	98492	110436945
Colon injury	25.63	15.78	9	53853	394	110535043
Donor specific antibody present	25.56	15.78	9	53853	397	110535040
Disseminated cryptococcosis	25.53	15.78	16	53846	2641	110532796
Escherichia sepsis	25.23	15.78	28	53834	10244	110525193
Orchitis	25.22	15.78	14	53848	1848	110533589
Shock	25.18	15.78	70	53792	53518	110481919
Cytomegalovirus enterocolitis	25.16	15.78	15	53847	2266	110533171
Myocarditis toxoplasmal	25.14	15.78	6	53856	63	110535374
Myocardial calcification	25.12	15.78	8	53854	258	110535179
American trypanosomiasis	25.09	15.78	10	53852	624	110534813
Staphylococcal skin infection	25.06	15.78	14	53848	1871	110533566
Septal panniculitis	25.06	15.78	7	53855	142	110535295
Pneumonia respiratory syncytial viral	25.03	15.78	16	53846	2733	110532704
Intervertebral disc space narrowing	24.99	15.78	14	53848	1882	110533555
Malignant neoplasm progression	24.86	15.78	29	53833	174538	110360899
Hyperparathyroidism	24.76	15.78	18	53844	3792	110531645
Adverse event	24.72	15.78	11	53851	108798	110426639
Erythema	24.70	15.78	67	53795	291380	110244057
Optic discs blurred	24.57	15.78	6	53856	70	110535367
Measles	24.54	15.78	10	53852	661	110534776
Parvovirus infection	24.31	15.78	11	53851	940	110534497
Corynebacterium infection	24.29	15.78	14	53848	1986	110533451
Viral haemorrhagic cystitis	24.25	15.78	17	53845	3382	110532055
End stage renal disease	24.13	15.78	40	53822	21433	110514004
Oliguria	24.05	15.78	37	53825	18620	110516817
Bacterial toxaemia	23.98	15.78	7	53855	167	110535270
Drug level fluctuating	23.92	15.78	11	53851	976	110534461
Thyroid tuberculosis	23.87	15.78	5	53857	27	110535410
Terminal ileitis	23.74	15.78	13	53849	1671	110533766
Mycobacterium fortuitum infection	23.73	15.78	9	53853	491	110534946
Epstein-Barr virus test positive	23.71	15.78	12	53850	1314	110534123
Pleural mesothelioma malignant	23.67	15.78	7	53855	175	110535262
Pneumonia cryptococcal	23.66	15.78	15	53847	2527	110532910
T-cell lymphoma stage IV	23.64	15.78	7	53855	176	110535261
Cerebral ventricle collapse	23.49	15.78	7	53855	180	110535257
Retinal detachment	23.46	15.78	28	53834	11072	110524365
Immunosuppressant drug level	23.28	15.78	5	53857	31	110535406
Hypocomplementaemia	23.26	15.78	8	53854	329	110535108
Isosporiasis	23.23	15.78	7	53855	187	110535250
Balance disorder	23.19	15.78	14	53848	116546	110418891
Bacterial endophthalmitis	23.14	15.78	8	53854	334	110535103
Complications of transplant surgery	23.10	15.78	10	53852	769	110534668
Prescribed overdose	23.02	15.78	7	53855	87574	110447863
Meningitis histoplasma	23.01	15.78	5	53857	33	110535404
Graft infection	22.99	15.78	10	53852	778	110534659
Meningoencephalitis viral	22.98	15.78	9	53853	536	110534901
Condition aggravated	22.93	15.78	238	53624	734598	109800839
Human polyomavirus infection	22.92	15.78	13	53849	1789	110533648
Infectious pleural effusion	22.84	15.78	19	53843	4872	110530565
Pancreatic pseudoaneurysm	22.81	15.78	6	53856	96	110535341
Splenomegaly	22.80	15.78	42	53820	24456	110510981
Microsporidia infection	22.79	15.78	12	53850	1427	110534010
Erythrophagocytosis	22.76	15.78	5	53857	35	110535402
Urate nephropathy	22.18	15.78	7	53855	219	110535218
Suicidal ideation	22.13	15.78	9	53853	93928	110441509
Disseminated trichosporonosis	22.03	15.78	7	53855	224	110535213
Enterocolitis viral	21.92	15.78	10	53852	871	110534566
Urogenital infection bacterial	21.75	15.78	6	53856	116	110535321
Loss of consciousness	21.67	15.78	39	53823	196267	110339170
Necrotising retinitis	21.62	15.78	12	53850	1584	110533853
Urinary tract infection bacterial	21.58	15.78	23	53839	8044	110527393
Oesophagitis ulcerative	21.56	15.78	12	53850	1593	110533844
Lung transplant	21.55	15.78	19	53843	5267	110530170
Metabolic acidosis	21.53	15.78	101	53761	99643	110435794
Oropharyngeal candidiasis	21.51	15.78	13	53849	2013	110533424
Intussusception	21.45	15.78	12	53850	1609	110533828
Staphylococcal bacteraemia	21.37	15.78	33	53829	16655	110518782
Lymph gland infection	21.35	15.78	9	53853	648	110534789
Meningitis cryptococcal	21.21	15.78	18	53844	4744	110530693
Renal lymphocele	21.19	15.78	6	53856	128	110535309
Incorrect route of product administration	21.18	15.78	3	53859	64058	110471379
Alpha haemolytic streptococcal infection	21.16	15.78	16	53846	3577	110531860
Fibrin D dimer increased	21.08	15.78	25	53837	9820	110525617
Disseminated mucormycosis	21.06	15.78	13	53849	2089	110533348
Red blood cell sedimentation rate increased	21.05	15.78	6	53856	78296	110457141
Hepatic infection	21.05	15.78	11	53851	1288	110534149
Mean cell volume increased	20.97	15.78	23	53839	8307	110527130
Drug level above therapeutic	20.91	15.78	27	53835	11561	110523876
Oesophagopleural fistula	20.91	15.78	5	53857	53	110535384
Neurological decompensation	20.89	15.78	21	53841	6862	110528575
Adenoviral haemorrhagic cystitis	20.88	15.78	9	53853	685	110534752
Obliterative bronchiolitis	20.65	15.78	16	53846	3707	110531730
Abscess	20.59	15.78	43	53819	27426	110508011
Gastroenteritis	20.57	15.78	53	53809	38747	110496690
Eczema	20.46	15.78	5	53857	72288	110463149
Delayed engraftment	20.42	15.78	7	53855	285	110535152
Oxygen saturation decreased	20.35	15.78	28	53834	156954	110378483
Mycoplasma infection	20.29	15.78	11	53851	1387	110534050
Disturbance in attention	20.27	15.78	3	53859	61992	110473445
Vasogenic cerebral oedema	20.21	15.78	13	53849	2245	110533192
Renal and pancreas transplant rejection	20.19	15.78	5	53857	62	110535375
Chorioretinitis	20.16	15.78	11	53851	1404	110534033
Post procedural urine leak	20.14	15.78	6	53856	154	110535283
Imprisonment	20.10	15.78	9	53853	750	110534687
Cerebral aspergillosis	19.98	15.78	13	53849	2289	110533148
Blood glucose increased	19.97	15.78	21	53841	132475	110402962
Cytomegalovirus test negative	19.88	15.78	3	53859	0	110535437
Normochromic normocytic anaemia	19.87	15.78	28	53834	13029	110522408
Renal arteriosclerosis	19.82	15.78	8	53854	516	110534921
Herpes simplex hepatitis	19.77	15.78	9	53853	780	110534657
Superinfection viral	19.77	15.78	5	53857	68	110535369
Depressed mood	19.75	15.78	3	53859	60806	110474631
Blindness	19.62	15.78	50	53812	36309	110499128
Renal vein thrombosis	19.59	15.78	10	53852	1115	110534322
Human herpesvirus 6 infection reactivation	19.56	15.78	10	53852	1119	110534318
Reticulocytopenia	19.52	15.78	7	53855	326	110535111
Kaposi sarcoma inflammatory cytokine syndrome	19.48	15.78	6	53856	173	110535264
Cryptosporidiosis infection	19.44	15.78	10	53852	1133	110534304
Ascites	19.32	15.78	93	53769	92715	110442722
Hepatic necrosis	19.30	15.78	24	53838	9898	110525539
Metapneumovirus infection	19.27	15.78	13	53849	2431	110533006
Burning sensation	19.18	15.78	5	53857	69207	110466230
Encephalitis brain stem	19.14	15.78	7	53855	345	110535092
Diverticulum intestinal	19.14	15.78	26	53836	11693	110523744
Pulmonary interstitial emphysema syndrome	19.10	15.78	8	53854	567	110534870
Hypercalcaemia	19.08	15.78	58	53804	46599	110488838
Transmission of an infectious agent via transplant	18.88	15.78	4	53858	23	110535414
Gastric ulcer	18.68	15.78	52	53810	39775	110495662
Disseminated strongyloidiasis	18.66	15.78	8	53854	601	110534836
Bacterial infection	18.62	15.78	57	53805	45979	110489458
Coronavirus infection	18.43	15.78	23	53839	9522	110525915
Dysphonia	18.34	15.78	7	53855	75922	110459515
Bronchostenosis	18.28	15.78	9	53853	929	110534508
Mycobacterial infection	18.26	15.78	16	53846	4401	110531036
Phaeohyphomycosis	18.20	15.78	11	53851	1703	110533734
Diabetes mellitus	18.16	15.78	96	53766	99285	110436152
Agitation	18.10	15.78	17	53845	113034	110422403
Feeling hot	18.04	15.78	11	53851	91095	110444342
Oesophageal stenosis	18	15.78	17	53845	5148	110530289
Hypoglycaemia	17.96	15.78	18	53844	116086	110419351
Speech disorder	17.94	15.78	4	53858	61565	110473872
Congenital dyskeratosis	17.81	15.78	3	53859	3	110535434
Nephropathy	17.77	15.78	27	53835	13440	110521997
Vision blurred	17.77	15.78	22	53840	129000	110406437
Bronchiolitis obliterans syndrome	17.70	15.78	8	53854	682	110534755
Post procedural bile leak	17.68	15.78	7	53855	429	110535008
Haemophilus infection	17.68	15.78	13	53849	2787	110532650
Alternaria infection	17.64	15.78	9	53853	1003	110534434
Biliary tract disorder	17.56	15.78	11	53851	1815	110533622
Mycotic endophthalmitis	17.53	15.78	7	53855	439	110534998
Biloma	17.46	15.78	6	53856	246	110535191
Renal tubular acidosis	17.36	15.78	16	53846	4699	110530738
Heart rate increased	17.33	15.78	27	53835	143807	110391630
Azoospermia	17.32	15.78	6	53856	252	110535185
Transplantation complication	17.24	15.78	7	53855	458	110534979
Urinoma	17.16	15.78	6	53856	259	110535178
Type 3 diabetes mellitus	17.10	15.78	5	53857	120	110535317
Vascular graft thrombosis	17.10	15.78	6	53856	262	110535175
Hypervolaemia	17.06	15.78	58	53804	49402	110486035
Tonic clonic movements	17.06	15.78	13	53849	2939	110532498
Transient ischaemic attack	17.02	15.78	5	53857	63977	110471460
Campylobacter gastroenteritis	17.00	15.78	11	53851	1918	110533519
Periorbital cellulitis	16.99	15.78	9	53853	1083	110534354
Mesothelioma malignant	16.97	15.78	6	53856	268	110535169
Nephrogenic diabetes insipidus	16.92	15.78	12	53850	2433	110533004
Blood potassium decreased	16.84	15.78	3	53859	54111	110481326
Retinal artery occlusion	16.78	15.78	15	53847	4234	110531203
Cognitive disorder	16.73	15.78	11	53851	87500	110447937
Oesophageal ulcer	16.69	15.78	20	53842	7944	110527493
Nasal congestion	16.67	15.78	14	53848	98268	110437169
Neutrophilic dermatosis	16.64	15.78	8	53854	784	110534653
Abdominal abscess	16.63	15.78	21	53841	8798	110526639
Osteomyelitis chronic	16.60	15.78	8	53854	789	110534648
Oesophagogastroscopy normal	16.59	15.78	3	53859	6	110535431
Iliac artery perforation	16.59	15.78	3	53859	6	110535431
Endocarditis	16.51	15.78	26	53836	13345	110522092
Ear infection	16.51	15.78	5	53857	62727	110472710
Urinary tract infection enterococcal	16.50	15.78	14	53848	3688	110531749
Periostitis	16.35	15.78	8	53854	815	110534622
Gastrooesophageal reflux disease	16.30	15.78	40	53822	179936	110355501
Acute graft versus host disease in skin	16.30	15.78	23	53839	10717	110524720
Aeromonas infection	16.27	15.78	7	53855	530	110534907
Human herpesvirus 6 infection	16.27	15.78	18	53844	6563	110528874
Anorexia nervosa	16.23	15.78	6	53856	305	110535132
Pneumonia influenzal	16.17	15.78	14	53848	3791	110531646
Illness	16.16	15.78	10	53852	82161	110453276
Pneumonia klebsiella	16.15	15.78	18	53844	6614	110528823
Exposure during pregnancy	16.13	15.78	36	53826	167388	110368049
Hot flush	16.10	15.78	6	53856	66030	110469407
Pulmonary tuberculosis	16.03	15.78	21	53841	9118	110526319
Flatulence	16.00	15.78	3	53859	52146	110483291
Aortic arteriosclerosis	15.97	15.78	23	53839	10915	110524522
Abdominal distension	15.79	15.78	39	53823	175064	110360373

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:22587	antiviral agent
CHEBI has role	CHEBI:35441	antiinfective agent
CHEBI has role	CHEBI:35469	antidepressant
CHEBI has role	CHEBI:35610	antineoplastic agent
CHEBI has role	CHEBI:36044	antiviral drug
CHEBI has role	CHEBI:50266	prodrug
CHEBI has role	CHEBI:67079	anti-inflammatory agent
CHEBI has role	CHEBI:231911	renoprotective agent
CHEBI has role	CHEBI:233423	antifibrotic agent

Related Drugs by ATC class:

J05AB Nucleosides and nucleotides excl. reverse transcriptase inhibitors 11 drugs

acyclovir brivudine cidofovir famciclovir ganciclovir idoxuridine molnupiravir penciclovir remdesivir valaciclovir vidarabine

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

Disease	Relation	SNOMED_ID	DOID
Congenital cytomegalovirus infection	indication	59527008
CMV Retinitis in AIDS Patients	indication
Prevention of CMV Disease After Kidney-Pancreas Transplantation	indication
Prevention of CMV Disease After Cardiac Transplantation	indication
Prevention of CMV Disease After Kidney 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
175865-60-8	SECONDARY_CAS_RN
4021263	VANDF
4021264	VANDF
4030204	VANDF
C0909381	UMLSCUI
CHEBI:63635	CHEBI
CHEMBL1201314	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
GCU97FKN3R	INXIGHT DRUGS

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Valganciclovir hydrochloride for Oral	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2579	POWDER, FOR SOLUTION	50 mg	ORAL	ANDA	27 sections
Valganciclovir	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6796	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	31722-837	POWDER, FOR SOLUTION	50 mg	ORAL	ANDA	27 sections
Valganciclovir hydrochloride for Oral	HUMAN PRESCRIPTION DRUG LABEL	1	42291-972	POWDER, FOR SOLUTION	50 mg	ORAL	ANDA	27 sections
Valganciclovir	HUMAN PRESCRIPTION DRUG LABEL	1	42291-973	TABLET, FILM COATED	450 mg	ORAL	ANDA	27 sections
VALGANCICLOVIR	HUMAN PRESCRIPTION DRUG LABEL	1	42571-477	POWDER, FOR SOLUTION	50 mg	ORAL	ANDA	28 sections
valganciclovir hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	43598-356	TABLET	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	25 sections
Valganciclovir	Human Prescription Drug Label	1	59651-444	FOR SOLUTION	50 mg	ORAL	ANDA	28 sections
Valganciclovir	HUMAN PRESCRIPTION DRUG LABEL	1	60429-846	TABLET, FILM COATED	450 mg	ORAL	ANDA	25 sections
Valganciclovir	HUMAN PRESCRIPTION DRUG LABEL	1	60687-765	POWDER, FOR SOLUTION	50 mg	ORAL	ANDA	29 sections
Valcyte	HUMAN PRESCRIPTION DRUG LABEL	1	61269-480	TABLET, FILM COATED	450 mg	ORAL	NDA	31 sections
Valcyte	HUMAN PRESCRIPTION DRUG LABEL	1	61269-485	POWDER, FOR SOLUTION	50 mg	ORAL	NDA	31 sections
Valganciclovir	HUMAN PRESCRIPTION DRUG LABEL	1	64380-153	TABLET, FILM COATED	450 mg	ORAL	ANDA	26 sections
Valganciclovir	HUMAN PRESCRIPTION DRUG LABEL	1	64380-161	TABLET, FILM COATED	450 mg	ORAL	ANDA	26 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	28 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	27 sections
VALGANCICLOVIR	HUMAN PRESCRIPTION DRUG LABEL	1	71151-003	FOR SOLUTION	50 mg	ORAL	ANDA	30 sections
Valganciclovir	Human Prescription Drug Label	1	71921-210	POWDER, FOR SOLUTION	50 mg	ORAL	ANDA	27 sections
valganciclovir hydrochloride	Human Prescription Drug Label	1	72205-019	FOR SOLUTION	50 mg	ORAL	ANDA	26 sections
VALGANCICLOVIR	HUMAN PRESCRIPTION DRUG LABEL	1	72603-174	POWDER, FOR SOLUTION	50 mg	ORAL	ANDA	27 sections
VALGANCICLOVIR HYDROCHLORIDE	Human Prescription Drug Label	1	72603-750	TABLET	450 mg	ORAL	ANDA	28 sections

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

Description:

Drug dosage:

ADMET properties:

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Approvals:

FDA Adverse Event Reporting System (Female)

FDA Adverse Event Reporting System (Male)

FDA Adverse Event Reporting System (Geriatric)

FDA Adverse Event Reporting System (Pediatric)

Pharmacologic Action:

Related Drugs by ATC class:

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

🐶 Veterinary Drug Use

🐶 Veterinary products

Acid dissociation constants calculated using MoKa v3.0.0

Orange Book patent data (new drug applications)

Orange Book exclusivity data (new drug applications)

Bioactivity Summary:

External reference:

Pharmaceutical products: