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Stem definition	Drug id	CAS RN
systemic antifungal agents, miconazole derivatives	1513	84625-61-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: itraconazole canditral itrizole oriconazole traconal triasporin R-51211	A triazole antifungal agent that inhibits cytochrome P-450-dependent enzymes required for ERGOSTEROL synthesis. Molecular weight: 705.64 Formula: C35H38Cl2N8O4 CLOGP: 6.84 LIPINSKI: 3 HAC: 12 HDO: 0 TPSA: 100.79 ALOGS: -4.86 ROTB: 11 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

itraconazole
canditral
itrizole
oriconazole
traconal
triasporin
R-51211

A triazole antifungal agent that inhibits cytochrome P-450-dependent enzymes required for ERGOSTEROL synthesis.

Molecular weight: 705.64
Formula: C35H38Cl2N8O4
CLOGP: 6.84
LIPINSKI: 3
HAC: 12
HDO: 0
TPSA: 100.79
ALOGS: -4.86
ROTB: 11

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.20	g	O
0.20	g	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.00 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0.03 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	14.17 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	55 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	7.40 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	5.10 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.00 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	25 hours	Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value	Unit	Confidence	Similarity
azlogd74	LogD at pH 7.4	4.387		High	0.85
caco2-efflux	Caco-2 efflux ratio (BA/AB)	2.410		High	0.85
caco2-intrinsic-papp	Caco-2 intrinsic apparent permeability	5.689	10^-6 cm/s	High	0.85
dh-clint	Dog hepatocyte intrinsic clearance	5.200	uL/min/10^6 cells	High	0.85
dppb	Dog plasma protein binding (% unbound)	0.100	%	High	0.85
fcs-ppb	Fetal calf serum protein binding (% unbound)	0.550	%	High	0.85
herg	hERG pIC50	5.218	pIC50	High	0.85
hh-clint	Human hepatocyte intrinsic clearance	7.656	uL/min/10^6 cells	High	0.85
hlm-clint	Human liver microsomal intrinsic clearance	46.132	uL/min/mg protein	High	0.85
hppb	Human plasma protein binding (% unbound)	0.240	%	High	0.85
kinase-safety-class	ACVR2B,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,EGFR,EIF2AK3,ERBB2,GRK2,ITK,JAK3,MAPK10,MAPK7,MET,NTRK2,PDK1,PDK2,PDK4,PIM2,PRKDC,STK33,TEK	24
kinase-selectivity-class	AXL,EIF2AK3,GRK2	3
mdck-mdr1-efflux	MDCK-MDR1 efflux ratio	0.824		High	0.85
mh-clint	Mouse hepatocyte intrinsic clearance	13.677		High	0.85
mppb	Mouse plasma protein binding (% unbound)	0.140		High	0.85
nih-mdck-mdr1-efflux	NIH MDCK-MDR1 efflux ratio	10.889		High	0.85
pfas-class	PFAS structural alert (1 = True, 0 = False)	0
pld-class	Phospholipidosis risk class (1 = positive, 0 = negative)	1		High	1
pppb	Pig plasma protein binding (% unbound)	0.290	%	High	0.85
rh-clint	Rat hepatocyte intrinsic clearance	10.544	uL/min/10^6 cells	High	0.85
rh-fuinc	Rat hepatocyte fraction unbound in incubation	0.850	%	High	0.85
rppb	Rat plasma protein binding (% unbound)	0.170	%	High	0.85
solubility-dd	Solubility at pH 7.4 in DMSO	0.780	uM	High	0.85

Approvals:

Date	Agency	Company	Orphan
Sept. 11, 1992	FDA	JANSSEN PHARMS

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
Drug interaction	524.92	16.83	393	13665	276060	90338329
Aspergillus infection	185.53	16.83	68	13990	10755	90603634
Bronchopulmonary aspergillosis	178.45	16.83	67	13991	11331	90603058
Febrile neutropenia	139.32	16.83	146	13912	158203	90456186
Pseudoaldosteronism	115.43	16.83	20	14038	128	90614261
Pseudohyponatraemia	103.21	16.83	16	14042	44	90614345
Drug resistance	102.47	16.83	62	13996	30387	90584002
Rhabdomyolysis	99.19	16.83	74	13984	51182	90563207
Symmetrical drug-related intertriginous and flexural exanthema	82.68	16.83	21	14037	958	90613431
Hepatic function abnormal	78.95	16.83	62	13996	46226	90568163
Neutrophil count decreased	73.88	16.83	72	13986	71460	90542929
Myopathy	71.35	16.83	37	14021	13481	90600908
Cytomegalovirus test positive	66.89	16.83	24	14034	3567	90610822
Cytomegalovirus infection	66.70	16.83	45	14013	26557	90587832
Labelled drug-drug interaction medication error	63.17	16.83	35	14023	14547	90599842
Hypokalaemia	62.88	16.83	89	13969	131027	90483362
Platelet count decreased	62.80	16.83	91	13967	136878	90477511
Sepsis	62.29	16.83	105	13953	179709	90434680
Pathogen resistance	60.14	16.83	28	14030	8087	90606302
Mycotic endophthalmitis	59.65	16.83	12	14046	186	90614203
Acute myeloid leukaemia	59.25	16.83	38	14020	20602	90593787
Septic shock	59.05	16.83	69	13989	84091	90530298
Adrenal insufficiency	57.42	16.83	43	14015	29878	90584511
Adrenal suppression	53.60	16.83	15	14043	994	90613395
Drug level increased	53.50	16.83	40	14018	27722	90586667
Pain	52.02	16.83	47	14011	996294	89618095
Neutropenia	51.41	16.83	110	13948	224794	90389595
Acute graft versus host disease	50.49	16.83	22	14036	5446	90608943
Skin candida	49.59	16.83	16	14042	1725	90612664
Disseminated aspergillosis	48.73	16.83	12	14046	482	90613907
Neutropenic sepsis	48.66	16.83	32	14026	18098	90596291
Transplant rejection	48.19	16.83	28	14030	12730	90601659
Abdominal discomfort	46.23	16.83	9	14049	477319	90137070
Ileus paralytic	45.46	16.83	20	14038	5065	90609324
Electrocardiogram QT prolonged	45.24	16.83	56	14002	72400	90541989
Pneumonia fungal	45.20	16.83	22	14036	7009	90607380
Swelling	42.52	16.83	7	14051	419051	90195338
Fungal infection	42.28	16.83	42	14016	42619	90571770
Cerebral aspergillosis	42.06	16.83	11	14047	564	90613825
Joint swelling	41.92	16.83	13	14045	503287	90111102
Fungal endocarditis	41.75	16.83	10	14048	357	90614032
Systemic lupus erythematosus	41.67	16.83	4	14054	361892	90252497
Histoplasmosis disseminated	41.41	16.83	15	14043	2290	90612099
Trichosporon infection	41.37	16.83	10	14048	371	90614018
Corneal perforation	41.36	16.83	11	14047	602	90613787
Cytomegalovirus viraemia	40.71	16.83	21	14037	7565	90606824
Mucormycosis	40.66	16.83	17	14041	3804	90610585
Cardiotoxicity	40.40	16.83	24	14034	11365	90603024
Thrombotic microangiopathy	40.35	16.83	27	14031	15716	90598673
Pleural effusion	39.55	16.83	66	13992	111925	90502464
Immune reconstitution inflammatory syndrome associated tuberculosis	38.62	16.83	10	14048	493	90613896
Contraindicated product prescribed	38.54	16.83	13	14045	1609	90612780
White blood cell count decreased	38.47	16.83	82	13976	167027	90447362
Scedosporium infection	38.11	16.83	11	14047	815	90613574
Toxic epidermal necrolysis	37.87	16.83	35	14023	32493	90581896
Arthropathy	37.42	16.83	6	14052	366236	90248153
Acute graft versus host disease in skin	37.08	16.83	17	14041	4739	90609650
Multiple organ dysfunction syndrome	36.67	16.83	49	14009	68287	90546102
Thrombocytopenia	36.58	16.83	92	13966	208633	90405756
Lung transplant rejection	35.60	16.83	11	14047	1030	90613359
Respiratory failure	34.33	16.83	64	13994	118354	90496035
Posterior reversible encephalopathy syndrome	33.99	16.83	28	14030	22311	90592078
Infusion related reaction	32.54	16.83	12	14046	416768	90197621
Eye infection fungal	32.31	16.83	7	14051	158	90614231
Human herpesvirus 6 infection reactivation	31.75	16.83	9	14049	625	90613764
Disseminated varicella zoster vaccine virus infection	31.41	16.83	6	14052	70	90614319
Pneumonia	31.23	16.83	187	13871	637872	89976517
Pericarditis	31.05	16.83	3	14055	270148	90344241
Candida infection	30.95	16.83	32	14026	34025	90580364
Rheumatoid arthritis	30.83	16.83	9	14049	362605	90251784
Exposure during pregnancy	30.79	16.83	94	13964	238316	90376073
Pyrexia	30.08	16.83	190	13868	660295	89954094
Pseudomonas infection	29.94	16.83	22	14036	14843	90599546
Polyglandular disorder	29.87	16.83	7	14051	227	90614162
Pulmonary nocardiosis	29.71	16.83	9	14049	789	90613600
Liver function test abnormal	29.67	16.83	38	14020	50807	90563582
Diabetes mellitus	29.55	16.83	43	14015	64832	90549557
Torticollis	29.31	16.83	12	14046	2546	90611843
Staphylococcal sepsis	28.74	16.83	18	14040	9365	90605024
Disseminated intravascular coagulation	28.67	16.83	25	14033	21513	90592876
Blood lactate dehydrogenase increased	28.45	16.83	27	14031	25905	90588484
Anaemia	28.31	16.83	119	13939	352683	90261706
Mobility decreased	28.25	16.83	3	14055	250731	90363658
Immunosuppressant drug level increased	28.16	16.83	14	14044	4666	90609723
Fatigue	28.11	16.83	89	13969	1153934	89460455
Systemic mycosis	27.65	16.83	10	14048	1520	90612869
Therapeutic product effect decreased	27.34	16.83	5	14053	277566	90336823
Infective pulmonary exacerbation of cystic fibrosis	27.23	16.83	18	14040	10261	90604128
Klebsiella infection	27.21	16.83	18	14040	10279	90604110
Discomfort	26.90	16.83	5	14053	274330	90340059
Erythema multiforme	26.66	16.83	19	14039	12227	90602162
Cardiac failure	26.66	16.83	55	14003	109441	90504948
Graft versus host disease	25.89	16.83	16	14042	8128	90606261
Musculoskeletal stiffness	25.87	16.83	7	14051	296525	90317864
Product dispensing issue	25.03	16.83	7	14051	463	90613926
Acute myeloid leukaemia recurrent	24.77	16.83	10	14048	2047	90612342
Mucosal inflammation	24.53	16.83	37	14021	57588	90556801
Varicella zoster virus infection	24.53	16.83	12	14046	3865	90610524
Cystic fibrosis	24.34	16.83	12	14046	3929	90610460
Blast cell count increased	24.21	16.83	7	14051	522	90613867
Hypersensitivity	24.17	16.83	21	14037	454656	90159733
Haematoma	24.08	16.83	30	14028	39018	90575371
Anaemia folate deficiency	23.99	16.83	7	14051	539	90613850
Drug hypersensitivity	23.95	16.83	22	14036	463587	90150802
Labelled drug-drug interaction issue	23.87	16.83	10	14048	2248	90612141
Drug reaction with eosinophilia and systemic symptoms	23.46	16.83	31	14027	42727	90571662
Candida test positive	23.40	16.83	8	14050	1031	90613358
Duodenal atresia	23.32	16.83	3	14055	0	90614389
Renal failure	23.20	16.83	58	14000	130949	90483440
Disseminated sporotrichosis	23.03	16.83	4	14054	26	90614363
Duplicate therapy error	22.99	16.83	5	14053	115	90614274
Pancreatitis haemorrhagic	22.80	16.83	7	14051	642	90613747
Galactorrhoea	22.41	16.83	12	14046	4660	90609729
Coccidioidomycosis	22.32	16.83	8	14050	1185	90613204
Implant site hypersensitivity	22.30	16.83	4	14054	32	90614357
Blood prolactin increased	22.24	16.83	11	14047	3626	90610763
Plasmapheresis	22.24	16.83	6	14052	347	90614042
Stevens-Johnson syndrome	22.13	16.83	25	14033	29351	90585038
Fibromyalgia	21.93	16.83	3	14055	206266	90408123
Cardiac valve vegetation	21.81	16.83	6	14052	373	90614016
Cholestatic liver injury	21.79	16.83	11	14047	3786	90610603
Cross sensitivity reaction	21.61	16.83	10	14048	2847	90611542
Leukopenia	21.54	16.83	48	14010	100662	90513727
Streptococcal bacteraemia	20.69	16.83	9	14049	2218	90612171
Injury	20.67	16.83	3	14055	197346	90417043
Moraxella infection	20.49	16.83	6	14052	468	90613921
Immune reconstitution inflammatory syndrome	20.33	16.83	13	14045	7006	90607383
Endocrine disorder	20.10	16.83	7	14051	953	90613436
Hypoparathyroidism	19.82	16.83	7	14051	994	90613395
Liver disorder	19.72	16.83	52	14006	121217	90493172
Alopecia	19.63	16.83	29	14029	495042	90119347
Alanine aminotransferase increased	19.51	16.83	51	14007	118287	90496102
Respiratory distress	19.48	16.83	27	14031	38919	90575470
Trichophytosis	19.27	16.83	4	14054	73	90614316
Renal impairment	19.01	16.83	47	14011	105374	90509015
Chronic hepatitis	18.90	16.83	7	14051	1138	90613251
Cutaneous nocardiosis	18.87	16.83	4	14054	81	90614308
Cushing's syndrome	18.75	16.83	6	14052	630	90613759
Peripheral swelling	18.62	16.83	22	14036	413084	90201305
Cystitis haemorrhagic	17.96	16.83	11	14047	5502	90608887
Culture stool positive	17.90	16.83	5	14053	329	90614060
Impaired healing	17.83	16.83	7	14051	234192	90380197
Ecchymosis	17.82	16.83	15	14043	12308	90602081
Dizziness	17.63	16.83	41	14017	589243	90025146
Engraft failure	17.30	16.83	5	14053	372	90614017
Secondary adrenocortical insufficiency	17.18	16.83	8	14050	2310	90612079
Heart transplant rejection	17.08	16.83	6	14052	838	90613551
Torsade de pointes	17.02	16.83	16	14042	15166	90599223
General physical health deterioration	17.00	16.83	18	14040	355097	90259292

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
Drug interaction	326.31	14.96	470	17089	266529	42337247
Aspergillus infection	124.69	14.96	79	17480	15758	42588018
Drug resistance	122.11	14.96	106	17453	34142	42569634
Bronchopulmonary aspergillosis	112.32	14.96	80	17479	19349	42584427
Fungal infection	95.52	14.96	73	17486	19649	42584127
Pathogen resistance	92.33	14.96	58	17501	11392	42592384
Phaeohyphomycosis	81.88	14.96	27	17532	1157	42602619
Drug ineffective	81.10	14.96	488	17071	629709	41974067
Parathyroid gland enlargement	80.45	14.96	18	17541	167	42603609
Upper respiratory fungal infection	79.60	14.96	18	17541	176	42603600
Febrile neutropenia	78.05	14.96	209	17350	185494	42418282
Apparent mineralocorticoid excess	77.62	14.96	15	17544	61	42603715
Cardiotoxicity	76.31	14.96	44	17515	7401	42596375
Disseminated intravascular coagulation	73.12	14.96	69	17490	24725	42579051
Neutrophil count decreased	70.17	14.96	107	17452	63308	42540468
Drug level increased	69.90	14.96	69	17490	26131	42577645
Platelet count decreased	60.22	14.96	158	17401	138423	42465353
Forced expiratory volume	58.86	14.96	13	17546	113	42603663
Renal impairment	57.73	14.96	135	17424	110093	42493683
Cytomegalovirus test positive	53.74	14.96	29	17530	4290	42599486
Symmetrical drug-related intertriginous and flexural exanthema	52.90	14.96	18	17541	850	42602926
Adrenal insufficiency	48.92	14.96	49	17510	18875	42584901
Hepatic function abnormal	48.75	14.96	81	17478	51486	42552290
Mycobacterial infection	48.06	14.96	23	17536	2645	42601131
Bradyarrhythmia	44.98	14.96	22	17537	2653	42601123
Bronchial disorder	44.54	14.96	18	17541	1380	42602396
Cytomegalovirus infection	42.22	14.96	59	17500	32247	42571529
Hypokalaemia	42.15	14.96	92	17467	71629	42532147
Pseudoaldosteronism	41.90	14.96	10	17549	126	42603650
Bronchiectasis	41.76	14.96	44	17515	17975	42585801
Cutaneous vasculitis	41.37	14.96	29	17530	6831	42596945
Lip squamous cell carcinoma	40.73	14.96	10	17549	143	42603633
Acute myeloid leukaemia recurrent	39.34	14.96	22	17537	3490	42600286
Sinus congestion	38.62	14.96	28	17531	6952	42596824
Fluorosis	37.88	14.96	8	17551	55	42603721
Histoplasmosis disseminated	37.58	14.96	18	17541	2073	42601703
Tendon disorder	37.33	14.96	21	17538	3368	42600408
Blood lactate dehydrogenase increased	36.14	14.96	49	17510	26032	42577744
White blood cell count decreased	35.45	14.96	113	17446	110283	42493493
Hyperbilirubinaemia	35.24	14.96	43	17516	20592	42583184
Granulomatous rosacea	35.04	14.96	9	17550	156	42603620
Fatigue	34.31	14.96	81	17478	435560	42168216
Secretion discharge	34.21	14.96	27	17532	7608	42596168
Bronchopulmonary aspergillosis allergic	33.85	14.96	22	17537	4576	42599200
Obliterative bronchiolitis	33.84	14.96	15	17544	1446	42602330
Hyperventilation	33.12	14.96	19	17540	3163	42600613
Myopathy	30.82	14.96	33	17526	13728	42590048
Pyrexia	30.55	14.96	271	17288	393771	42210005
Pseudomonas infection	30.19	14.96	35	17524	15888	42587888
Death	30.09	14.96	97	17462	471088	42132688
Pneumonia fungal	29.96	14.96	27	17532	9119	42594657
Product dose omission issue	28.48	14.96	14	17545	154351	42449425
Ileus paralytic	27.91	14.96	24	17535	7617	42596159
Philadelphia positive acute lymphocytic leukaemia	26.98	14.96	6	17553	54	42603722
Haemoptysis	26.86	14.96	59	17500	46108	42557668
Neutrophil Pelger-Huet anomaly present	26.38	14.96	8	17551	260	42603516
Immunosuppressant drug level increased	25.67	14.96	23	17536	7708	42596068
Acute myeloid leukaemia	25.22	14.96	38	17521	22218	42581558
Fall	25.18	14.96	36	17523	234484	42369292
Lung transplant rejection	25.06	14.96	11	17548	1036	42602740
Cardiovascular insufficiency	24.80	14.96	13	17546	1813	42601963
Lymphadenopathy	24.56	14.96	47	17512	33318	42570458
Acute graft versus host disease	24.47	14.96	23	17536	8192	42595584
Folliculitis	23.50	14.96	19	17540	5539	42598237
Drug abuse	23.47	14.96	7	17552	104764	42499012
Liver disorder	23.44	14.96	51	17508	39593	42564183
Ocular surface squamous neoplasia	23.35	14.96	5	17554	37	42603739
Pneumonia	22.94	14.96	270	17289	421879	42181897
Treatment failure	22.79	14.96	67	17492	62557	42541219
Cerebrovascular accident	22.67	14.96	6	17553	97154	42506622
Histoplasmosis	22.23	14.96	12	17547	1775	42602001
Obstructive airways disorder	22.20	14.96	38	17521	24721	42579055
Graft versus host disease	22.17	14.96	27	17532	12898	42590878
Ubiquinone decreased	21.64	14.96	4	17555	12	42603764
Choriomeningitis lymphocytic	21.32	14.96	6	17553	149	42603627
Hypothalamic pituitary adrenal axis suppression	21.31	14.96	7	17552	296	42603480
Transplant rejection	21.09	14.96	27	17532	13561	42590215
Asthma-chronic obstructive pulmonary disease overlap syndrome	20.89	14.96	11	17548	1548	42602228
Acute graft versus host disease in skin	20.62	14.96	20	17539	7404	42596372
Sputum increased	20.55	14.96	14	17545	3149	42600627
Condition aggravated	20.49	14.96	180	17379	260574	42343202
CARD9 deficiency	20.02	14.96	4	17555	20	42603756
Alternaria infection	19.96	14.96	8	17551	600	42603176
Respiratory disorder	19.94	14.96	34	17525	22051	42581725
Pain	19.64	14.96	45	17514	244803	42358973
Trichosporon infection	19.59	14.96	9	17550	943	42602833
Blood alkaline phosphatase abnormal	19.54	14.96	8	17551	634	42603142
Epstein-Barr virus infection	19.50	14.96	22	17537	9696	42594080
Septic shock	19.40	14.96	82	17477	91590	42512186
Differentiation syndrome	19.34	14.96	11	17548	1802	42601974
Neutropenia	19.07	14.96	144	17415	199287	42404489
Cystitis haemorrhagic	18.98	14.96	19	17540	7310	42596466
Post transplant lymphoproliferative disorder	18.90	14.96	21	17538	9099	42594677
Blood immunoglobulin E increased	18.83	14.96	14	17545	3611	42600165
Hyperhidrosis	18.61	14.96	7	17552	90505	42513271
Bronchial polyp	18.31	14.96	3	17556	3	42603773
Myositis	17.73	14.96	26	17533	14840	42588936
Haemophagocytic lymphohistiocytosis	17.71	14.96	29	17530	18193	42585583
Dizziness	17.52	14.96	49	17510	249205	42354571
Squamous cell carcinoma of the oral cavity	17.34	14.96	6	17553	298	42603478
Overdose	17.31	14.96	11	17548	105253	42498523
Polyomavirus-associated nephropathy	17.26	14.96	16	17543	5599	42598177
Pneumonia cytomegaloviral	17.22	14.96	14	17545	4112	42599664
Immune reconstitution inflammatory syndrome	17.09	14.96	21	17538	10122	42593654
Feeling abnormal	16.88	14.96	4	17555	69782	42533994
Labelled drug-drug interaction medication error	16.80	14.96	26	17533	15556	42588220
Cytomegalovirus viraemia	16.71	14.96	21	17538	10356	42593420
Pulmonary haemorrhage	16.68	14.96	22	17537	11375	42592401
Pulmonary embolism	16.47	14.96	15	17544	119597	42484179
Sepsis	16.37	14.96	139	17420	199195	42404581
Weight decreased	16.04	14.96	39	17520	207909	42395867
Pneumaturia	15.99	14.96	4	17555	62	42603714
Acute graft versus host disease in liver	15.98	14.96	10	17549	1948	42601828
Back pain	15.97	14.96	21	17538	141755	42462021
Neurotoxicity	15.81	14.96	32	17527	23619	42580157
Drug level changed	15.68	14.96	6	17553	398	42603378
Acute graft versus host disease in intestine	15.64	14.96	13	17546	3938	42599838
Contraindicated product prescribed	15.63	14.96	7	17552	692	42603084
Oedema	15.56	14.96	52	17507	51949	42551827
Aspartate aminotransferase increased	15.53	14.96	68	17491	77095	42526681
Drug hypersensitivity	15.51	14.96	11	17548	99378	42504398
Therapeutic product effect incomplete	15.43	14.96	64	17495	70875	42532901
Corneal epithelium defect	15.42	14.96	6	17553	416	42603360
Candida infection	15.36	14.96	30	17529	21580	42582196
Aspergilloma	14.98	14.96	6	17553	449	42603327

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
Drug interaction	811.31	14.29	810	27880	499373	110061236
Bronchopulmonary aspergillosis	273.25	14.29	140	28550	29723	110530886
Aspergillus infection	266.46	14.29	131	28559	25485	110535124
Drug resistance	216.47	14.29	151	28539	56223	110504386
Pathogen resistance	173.76	14.29	87	28603	17585	110543024
Febrile neutropenia	170.18	14.29	299	28391	316468	110244141
Pseudoaldosteronism	146.24	14.29	30	28660	296	110560313
Symmetrical drug-related intertriginous and flexural exanthema	132.05	14.29	39	28651	1858	110558751
Drug level increased	127.75	14.29	103	28587	47616	110512993
Ileus paralytic	124.95	14.29	61	28629	11676	110548933
Drug ineffective	118.94	14.29	735	27955	1519805	109040804
Neutrophil count decreased	117.89	14.29	151	28539	120790	110439819
Cardiotoxicity	117.49	14.29	66	28624	16815	110543794
Fungal infection	111.92	14.29	98	28592	50708	110509901
Platelet count decreased	107.77	14.29	205	28485	230238	110330371
Phaeohyphomycosis	105.30	14.29	32	28658	1682	110558927
Myopathy	100.81	14.29	69	28621	24891	110535718
Adrenal insufficiency	91.82	14.29	81	28609	42309	110518300
Hepatic function abnormal	90.97	14.29	114	28576	89181	110471428
Apparent mineralocorticoid excess	90.39	14.29	16	28674	64	110560545
Hypokalaemia	88.62	14.29	165	28525	182283	110378326
Parathyroid gland enlargement	85.63	14.29	18	28672	202	110560407
Cytomegalovirus test positive	82.26	14.29	39	28651	6997	110553612
Cytomegalovirus infection	79.98	14.29	84	28606	54360	110506249
Disseminated intravascular coagulation	77.88	14.29	73	28617	41213	110519396
Renal impairment	76.44	14.29	158	28532	188287	110372322
Pseudohyponatraemia	75.13	14.29	16	28674	192	110560417
Upper respiratory fungal infection	73.75	14.29	18	28672	409	110560200
Labelled drug-drug interaction medication error	73.68	14.29	61	28629	29241	110531368
Pain	72.28	14.29	85	28605	954870	109605739
Pneumonia fungal	72.23	14.29	46	28644	14708	110545901
Rhabdomyolysis	71.54	14.29	119	28571	120282	110440327
Fatigue	67.31	14.29	134	28556	1215824	109344785
Septic shock	66.15	14.29	134	28556	157394	110403215
Transplant rejection	65.67	14.29	53	28637	24514	110536095
Acute myeloid leukaemia	65.47	14.29	64	28626	38046	110522563
White blood cell count decreased	60.94	14.29	163	28527	229227	110331382
Forced expiratory volume	60.64	14.29	12	28678	97	110560512
Histoplasmosis disseminated	59.44	14.29	26	28664	3873	110556736
Acute myeloid leukaemia recurrent	58.60	14.29	28	28662	5111	110555498
Lung transplant rejection	57.96	14.29	21	28669	1910	110558699
Blood lactate dehydrogenase increased	57.40	14.29	64	28626	44270	110516339
Granulomatous rosacea	57.28	14.29	13	28677	213	110560396
Adrenal suppression	56.78	14.29	20	28670	1676	110558933
Abdominal discomfort	56.64	14.29	16	28674	393842	110166767
Arthropathy	56.16	14.29	5	28685	287517	110273092
Drug hypersensitivity	54.20	14.29	25	28665	454065	110106544
Pseudomonas infection	53.98	14.29	50	28640	27803	110532806
Rheumatoid arthritis	53.96	14.29	7	28683	299606	110261003
Trichosporon infection	53.93	14.29	18	28672	1282	110559327
Systemic lupus erythematosus	53.78	14.29	3	28687	254335	110306274
Bradyarrhythmia	53.58	14.29	26	28664	4908	110555701
Immunosuppressant drug level increased	53.56	14.29	35	28655	11689	110548920
Joint swelling	53.45	14.29	24	28666	442821	110117788
Pleural effusion	53.09	14.29	132	28558	177577	110383032
Neurotoxicity	53.05	14.29	60	28630	42147	110518462
Fungal endocarditis	53.04	14.29	16	28674	820	110559789
Swelling	52.87	14.29	13	28677	351028	110209581
Bronchiectasis	51.28	14.29	55	28635	36438	110524171
Contraindicated product prescribed	50.90	14.29	20	28670	2273	110558336
Completed suicide	50.82	14.29	3	28687	242378	110318231
Sepsis	50.57	14.29	193	28497	327153	110233456
Infusion related reaction	50.33	14.29	18	28672	381144	110179465
Mycobacterial infection	50.16	14.29	24	28666	4393	110556216
Pneumonia	49.31	14.29	392	28298	876322	109684287
Musculoskeletal stiffness	49.30	14.29	7	28683	279815	110280794
Wound	48.85	14.29	3	28687	234434	110326175
Mycotic endophthalmitis	48.50	14.29	13	28677	433	110560176
Respiratory failure	48.35	14.29	144	28546	215188	110345421
Bronchopulmonary aspergillosis allergic	48.17	14.29	29	28661	8397	110552212
Bronchial disorder	47.21	14.29	20	28670	2756	110557853
Skin candida	47.14	14.29	19	28671	2309	110558300
Pyrexia	44.82	14.29	391	28299	897874	109662735
Acute graft versus host disease in skin	44.09	14.29	30	28660	10710	110549899
Graft versus host disease	42.86	14.29	37	28653	18769	110541840
Cytomegalovirus viraemia	42.63	14.29	36	28654	17728	110542881
Fluorosis	41.50	14.29	10	28680	215	110560394
Acute graft versus host disease	41.41	14.29	31	28659	12850	110547759
Immune reconstitution inflammatory syndrome	41.25	14.29	34	28656	16192	110544417
Neutropenia	40.99	14.29	199	28491	374421	110186188
Hyperbilirubinaemia	40.95	14.29	45	28645	30626	110529983
Cardiac failure	39.79	14.29	123	28567	187503	110373106
Mucormycosis	39.67	14.29	28	28662	10600	110550009
Blast cell count increased	38.90	14.29	15	28675	1622	110558987
Dizziness	38.45	14.29	77	28613	698116	109862493
Headache	37.81	14.29	111	28579	882266	109678343
Lip squamous cell carcinoma	37.75	14.29	10	28680	318	110560291
Candida infection	37.70	14.29	54	28636	47955	110512654
Pericarditis	37.40	14.29	6	28684	219108	110341501
Peripheral swelling	37.39	14.29	30	28660	404004	110156605
Multiple organ dysfunction syndrome	36.49	14.29	104	28586	151606	110409003
Fall	36.36	14.29	63	28627	603419	109957190
Electrocardiogram QT prolonged	35.81	14.29	84	28606	108876	110451733
Obliterative bronchiolitis	35.62	14.29	18	28672	3705	110556904
Drug level decreased	35.37	14.29	33	28657	18515	110542094
Myositis	35.36	14.29	42	28648	31074	110529535
Haemoptysis	35.19	14.29	65	28625	71289	110489320
Discomfort	34.22	14.29	7	28683	214700	110345909
Cystitis haemorrhagic	34.04	14.29	27	28663	12182	110548427
Cerebral aspergillosis	33.95	14.29	15	28675	2287	110558322
Candida pneumonia	33.78	14.29	12	28678	1031	110559578
Sputum increased	33.41	14.29	20	28670	5731	110554878
Therapeutic product effect decreased	33.17	14.29	11	28679	244305	110316304
Scedosporium infection	33.01	14.29	15	28675	2443	110558166
Neuropathy peripheral	31.27	14.29	110	28580	179167	110381442
Tendon disorder	31.20	14.29	22	28668	8315	110552294
Corneal perforation	30.96	14.29	11	28679	945	110559664
Alanine aminotransferase increased	30.55	14.29	111	28579	183662	110376947
Liver function test abnormal	30.53	14.29	60	28630	68890	110491719
Histoplasmosis	30.39	14.29	15	28675	2938	110557671
Alternaria infection	30.35	14.29	11	28679	1001	110559608
Haemophagocytic lymphohistiocytosis	30.08	14.29	39	28651	31520	110529089
Injury	29.92	14.29	5	28685	177260	110383349
Product dose omission issue	29.62	14.29	24	28666	321758	110238851
Systemic mycosis	29.47	14.29	16	28674	3813	110556796
Aspergilloma	28.97	14.29	10	28680	789	110559820
Disseminated varicella zoster vaccine virus infection	28.68	14.29	7	28683	159	110560450
Acute graft versus host disease in intestine	28.65	14.29	18	28672	5621	110554988
Hypersensitivity	28.33	14.29	38	28652	403960	110156649
Post transplant lymphoproliferative disorder	28.28	14.29	27	28663	15586	110545023
Philadelphia positive acute lymphocytic leukaemia	28.25	14.29	6	28684	71	110560538
Ocular surface squamous neoplasia	27.68	14.29	5	28685	23	110560586
Infective pulmonary exacerbation of cystic fibrosis	27.62	14.29	26	28664	14745	110545864
Pneumonia cytomegaloviral	27.54	14.29	19	28671	6935	110553674
Eye infection fungal	27.31	14.29	9	28681	616	110559993
Arthralgia	27.29	14.29	107	28583	779525	109781084
Dry mouth	27.14	14.29	9	28681	199939	110360670
Neutrophil Pelger-Huet anomaly present	26.92	14.29	8	28682	389	110560220
Cutaneous vasculitis	26.91	14.29	24	28666	12705	110547904
Disseminated aspergillosis	26.72	14.29	13	28677	2467	110558142
Migraine	26.53	14.29	6	28684	171646	110388963
Nocardiosis	26.28	14.29	19	28671	7467	110553142
Immune reconstitution inflammatory syndrome associated tuberculosis	26.27	14.29	10	28680	1044	110559565
Contusion	26.08	14.29	14	28676	233347	110327262
Muscle injury	26.05	14.29	3	28687	140804	110419805
Injection site pain	25.98	14.29	7	28683	177915	110382694
Polyglandular disorder	25.95	14.29	7	28683	239	110560370
Secretion discharge	25.81	14.29	29	28661	20215	110540394
Staphylococcal sepsis	25.75	14.29	27	28663	17427	110543182
Mobility decreased	25.44	14.29	15	28675	237407	110323202
Osteoarthritis	25.18	14.29	8	28682	182615	110377994
Irritable bowel syndrome	24.87	14.29	6	28684	164209	110396400
Endophthalmitis	24.76	14.29	19	28671	8168	110552441
Drug level below therapeutic	24.66	14.29	22	28668	11651	110548958
Cushingoid	24.60	14.29	22	28668	11690	110548919
Lower respiratory tract infection fungal	24.53	14.29	9	28681	848	110559761
Pneumonia bacterial	24.33	14.29	32	28658	26229	110534380
Pulmonary alveolar haemorrhage	24.23	14.29	28	28662	20122	110540487
Differentiation syndrome	24.21	14.29	13	28677	3031	110557578
Blood immunoglobulin E increased	24.03	14.29	18	28672	7464	110553145
Corneal epithelium defect	23.99	14.29	9	28681	903	110559706
Alopecia	23.90	14.29	36	28654	364717	110195892
Arthritis	23.72	14.29	7	28683	167579	110393030
Blood creatine phosphokinase increased	23.64	14.29	56	28634	73021	110487588
Aspartate aminotransferase increased	23.60	14.29	93	28597	159843	110400766
Bursitis	23.46	14.29	3	28687	129915	110430694
Hyperventilation	23.27	14.29	19	28671	8928	110551681
Cardiovascular insufficiency	23.27	14.29	13	28677	3275	110557334
Tumour lysis syndrome	23.24	14.29	34	28656	30767	110529842
Impaired healing	23.18	14.29	11	28679	196706	110363903
Choriomeningitis lymphocytic	22.99	14.29	6	28684	180	110560429
Disseminated sporotrichosis	22.97	14.29	5	28685	67	110560542
Lymphadenopathy	22.95	14.29	51	28639	63784	110496825
Thrombocytopenia	22.91	14.29	162	28528	348723	110211886
Hyperhidrosis	22.81	14.29	10	28680	187288	110373321
Hypothalamic pituitary adrenal axis suppression	22.67	14.29	8	28682	674	110559935
Human herpesvirus 6 infection reactivation	22.12	14.29	9	28681	1120	110559489
Liver disorder	22.04	14.29	84	28606	142159	110418450
Varicella zoster virus infection	21.99	14.29	16	28674	6352	110554257
CARD9 deficiency	21.87	14.29	4	28686	20	110560589
Memory impairment	21.74	14.29	12	28678	196932	110363677
Pulmonary haemorrhage	21.72	14.29	24	28666	16432	110544177
Anaemia	21.66	14.29	227	28463	546859	110013750
Ill-defined disorder	21.39	14.29	7	28683	156846	110403763
Trichophytosis	21.27	14.29	7	28683	477	110560132
Lung infiltration	21.27	14.29	29	28661	24599	110536010
Acute lymphocytic leukaemia	21.08	14.29	15	28675	5750	110554859
Jaundice	20.93	14.29	47	28643	59189	110501420
Torticollis	20.81	14.29	12	28678	3209	110557400
Confusional state	20.73	14.29	58	28632	468622	110091987
Implant site hypersensitivity	20.60	14.29	4	28686	29	110560580
Ubiquinone decreased	20.60	14.29	4	28686	29	110560580
Polyomavirus-associated nephropathy	20.46	14.29	17	28673	8184	110552425
Musculoskeletal pain	20.42	14.29	11	28679	183012	110377597
Thrombotic microangiopathy	20.31	14.29	31	28659	29118	110531491
Cushing's syndrome	20.25	14.29	8	28682	922	110559687
Myelosuppression	20.13	14.29	62	28628	94278	110466331
Atypical mycobacterial infection	19.93	14.29	11	28679	2707	110557902
Fusarium infection	19.73	14.29	11	28679	2760	110557849
Secondary adrenocortical insufficiency	19.68	14.29	13	28677	4421	110556188
Nasopharyngitis	19.59	14.29	46	28644	394315	110166294
Psoriasis	19.53	14.29	6	28684	139987	110420622
Klebsiella infection	19.50	14.29	25	28665	19984	110540625
Cardiac valve vegetation	19.39	14.29	8	28682	1032	110559577
Sinus congestion	19.29	14.29	31	28659	30428	110530181
Cross sensitivity reaction	19.25	14.29	14	28676	5553	110555056
Pulmonary cavitation	19.23	14.29	10	28680	2184	110558425
Product dispensing issue	19.21	14.29	7	28683	647	110559962
Ileus	19.08	14.29	31	28659	30698	110529911
Obstructive airways disorder	19.04	14.29	39	28651	46110	110514499
Contraindicated product administered	18.81	14.29	22	28668	248245	110312364
Anaemia folate deficiency	18.74	14.29	7	28683	694	110559915
Splenic infection fungal	18.73	14.29	5	28685	164	110560445
Acute graft versus host disease in liver	18.55	14.29	10	28680	2349	110558260
Chronic granulomatous disease	18.49	14.29	4	28686	52	110560557
Pain in extremity	18.22	14.29	65	28625	487053	110073556
Pneumaturia	18.21	14.29	4	28686	56	110560553
Anterior chamber inflammation	18.05	14.29	7	28683	768	110559841
Fungal skin infection	18.03	14.29	15	28675	7234	110553375
Back pain	17.86	14.29	44	28646	370952	110189657
Urticaria	17.66	14.29	35	28655	318822	110241787
Periostitis	17.64	14.29	7	28683	816	110559793
Epstein-Barr virus infection	17.61	14.29	23	28667	18715	110541894
Pulmonary nocardiosis	17.54	14.29	10	28680	2619	110557990
Candida test positive	17.35	14.29	8	28682	1347	110559262
Bone marrow failure	17.29	14.29	43	28647	57805	110502804
Condition aggravated	17.27	14.29	277	28413	734559	109826050
Burkholderia cepacia complex infection	17.27	14.29	6	28684	483	110560126
Pneumonia klebsiella	17.07	14.29	14	28676	6618	110553991
Forced expiratory volume decreased	17.01	14.29	19	28671	13157	110547452
Disease progression	17.00	14.29	115	28575	243919	110316690
Disease recurrence	16.93	14.29	44	28646	60740	110499869
Inappropriate antidiuretic hormone secretion	16.89	14.29	31	28659	33820	110526789
Maternal exposure during pregnancy	16.84	14.29	25	28665	254858	110305751
Cortisol decreased	16.83	14.29	10	28680	2826	110557783
Gait disturbance	16.77	14.29	29	28661	278179	110282430
Intentional product use issue	16.69	14.29	24	28666	247882	110312727
Cystic fibrosis	16.59	14.29	12	28678	4719	110555890
Chronic graft versus host disease	16.46	14.29	16	28674	9441	110551168
Overdose	16.37	14.29	22	28668	233772	110326837
Fungal sepsis	16.25	14.29	9	28681	2228	110558381
Pancreatitis haemorrhagic	16.22	14.29	7	28683	1009	110559600
Paracoccidioides infection	16.14	14.29	4	28686	97	110560512
Cerebrovascular accident	16.09	14.29	14	28676	181270	110379339
Pancytopenia	15.95	14.29	101	28589	209512	110351097
Septic embolus	15.93	14.29	9	28681	2317	110558292
Drug level changed	15.88	14.29	6	28684	614	110559995
Labelled drug-drug interaction issue	15.76	14.29	11	28679	4090	110556519
General physical health deterioration	15.74	14.29	57	28633	425238	110135371
Galactorrhoea	15.63	14.29	11	28679	4144	110556465
Endocrine disorder	15.54	14.29	7	28683	1117	110559492
BK virus infection	15.40	14.29	18	28672	13088	110547521
Blood bilirubin increased	15.35	14.29	49	28641	75923	110484686
Chronic hepatitis	15.31	14.29	8	28682	1764	110558845
Oedema	15.26	14.29	100	28590	209876	110350733
Pseudomonal sepsis	15.18	14.29	15	28675	9031	110551578
Bacterial sepsis	15.15	14.29	16	28674	10410	110550199
Neutropenic sepsis	15.14	14.29	28	28662	30718	110529891
Depression	14.98	14.29	38	28652	317297	110243312
Cytomegalovirus infection reactivation	14.95	14.29	21	28669	18312	110542297
Squamous cell carcinoma of the oral cavity	14.86	14.29	6	28684	732	110559877
Nephropathy toxic	14.78	14.29	26	28664	27452	110533157
Myelodysplastic syndrome	14.67	14.29	31	28659	37453	110523156
Blood alkaline phosphatase abnormal	14.64	14.29	7	28683	1280	110559329
Neuropsychiatric symptoms	14.63	14.29	7	28683	1281	110559328
Moraxella infection	14.62	14.29	6	28684	764	110559845
Blood alkaline phosphatase increased	14.56	14.29	46	28644	70889	110489720
Drug ineffective for unapproved indication	14.52	14.29	59	28631	102779	110457830
Asthenia	14.47	14.29	112	28578	688887	109871722
Graft versus host disease in skin	14.43	14.29	14	28676	8240	110552369
Ecchymosis	14.34	14.29	20	28670	17318	110543291

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	J02AC02	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOTICS FOR SYSTEMIC USE ANTIMYCOTICS FOR SYSTEMIC USE Triazole and tetrazole derivatives
FDA CS	M0002083	Azoles
FDA EPC	N0000175487	Azole Antifungal
CHEBI has role	CHEBI:22587	antiviral agent
CHEBI has role	CHEBI:33282	antibacterial agent
CHEBI has role	CHEBI:35441	antiinfective agent
CHEBI has role	CHEBI:35480	analgesic
CHEBI has role	CHEBI:35554	cardiovascular drug
CHEBI has role	CHEBI:35610	antineoplastic agent
CHEBI has role	CHEBI:35620	vasodilator agent
CHEBI has role	CHEBI:38068	antimalarial
CHEBI has role	CHEBI:50183	P450 inhibitor
CHEBI has role	CHEBI:50249	anticoagulant
CHEBI has role	CHEBI:64951	anti-HBV agent
CHEBI has role	CHEBI:65023	anti-asthmatic agent
CHEBI has role	CHEBI:67079	anti-inflammatory agent
CHEBI has role	CHEBI:74518	anti-obesity agent
CHEBI has role	CHEBI:77748	EC 3.6.3.44 (xenobiotic-transporting ATPase) inhibitor
CHEBI has role	CHEBI:140921	Hedgehog signaling pathway inhibitor
CHEBI has role	CHEBI:233423	antifibrotic agent
FDA MoA	N0000182141	Cytochrome P450 3A4 Inhibitors
FDA MoA	N0000185503	P-Glycoprotein Inhibitors
FDA MoA	N0000190113	Breast Cancer Resistance Protein Inhibitors
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D000935	Antifungal Agents
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D006727	Hormone Antagonists
MeSH PA	D058888	14-alpha Demethylase Inhibitors
MeSH PA	D065088	Steroid Synthesis Inhibitors
MeSH PA	D065607	Cytochrome P-450 Enzyme Inhibitors
MeSH PA	D065692	Cytochrome P-450 CYP3A Inhibitors

Related Drugs by ATC class:

J02AC Triazole and tetrazole derivatives 5 drugs

fluconazole isavuconazonium oteseconazole posaconazole voriconazole

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

Disease	Relation	SNOMED_ID	DOID
Invasive pulmonary aspergillosis	indication	3214003
Histoplasmosis	indication	12962009	DOID:1731
Candidiasis of the esophagus	indication	20639004	DOID:13146
Fusarium infection	indication	64250002
Aspergillosis	indication	65553006	DOID:13564
Blastomycosis	indication	69996000	DOID:12663
Disseminated candidiasis	indication	70572005
Onychomycosis of fingernails	indication	403058003
Onychomycosis of toenails	indication	403059006
Candidemia	indication	432261003
Fungal Infection due to Scedosporium Apiospermum	indication
Fungal Infection due to Fusarium Solani	indication
Oropharyngeal Candidiasis	indication
Coccidioidomycosis	off-label use	60826002	DOID:13450
Chromoblastomycosis	off-label use	187079000
Infection due to Penicillium marneffei	off-label use	372936000
Onychomycosis due to dermatophyte	off-label use	402134005
Heart valve disorder	contraindication	368009	DOID:4079
Hypocalcemia	contraindication	5291005
Chronic obstructive lung disease	contraindication	13645005	DOID:3083
Hearing loss	contraindication	15188001
Torsades de pointes	contraindication	31722008
Hypokalemia	contraindication	43339004
Ventricular arrhythmia	contraindication	44103008
Achlorhydria	contraindication	47481007
Chronic heart failure	contraindication	48447003
Hypochlorhydria	contraindication	55961006
Heart failure	contraindication	84114007	DOID:6000
Cardiomyopathy	contraindication	85898001	DOID:0050700
Kidney disease	contraindication	90708001	DOID:557
Prolonged QT interval	contraindication	111975006
Liver function tests abnormal	contraindication	166603001
Hypomagnesemia	contraindication	190855004
Impaired renal function disorder	contraindication	197663003
Disease of liver	contraindication	235856003	DOID:409
Drug-induced hepatitis	contraindication	235876009
Edema	contraindication	267038008
Pregnancy, function	contraindication	289908002
Peripheral nerve disease	contraindication	302226006
Visual impairment	contraindication	397540003
Breastfeeding (mother)	contraindication	413712001
Myocardial ischemia	contraindication	414795007	DOID:3393
Poor metabolizer due to cytochrome p450 CYP2C19 variant	contraindication	424500005
Congenital long QT syndrome	contraindication	442917000

🐶 Veterinary Drug Use

Species	Use	Relation
Cats	Dermatophytosis caused by Microsporum canis	Indication

🐶 Veterinary products

Product	Applicant	Ingredients
Itrafungol	Virbac AH Inc.	1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	5.12	Basic
pKa2	5.0	Basic
pKa3	3.04	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
200MG	ONMEL	SEBELA IRELAND LTD	N022484	April 29, 2010	DISCN	TABLET	ORAL	8486456	Oct. 3, 2028	ONYCHOMYCOSIS OF THE TOENAIL CAUSED BY TRICOPHYTON RUBRUM OR TRICHOPHYTON MENTAGROPHYTES, ONCE DAILY USE FOR 12 CONSECUTIVE WEEKS
65MG	TOLSURA	MAYNE PHARMA	N208901	Dec. 11, 2018	RX	CAPSULE	ORAL	10463740	June 21, 2033	TREATMENT OF FUNGAL INFECTIONS, INCLUDING BLASTOMYCOSIS, HISTOPLASMOSIS, AND ASPERGILLOSIS
65MG	TOLSURA	MAYNE PHARMA	N208901	Dec. 11, 2018	RX	CAPSULE	ORAL	9713642	June 21, 2033	TREATMENT OF FUNGAL INFECTIONS, INCLUDING BLASTOMYCOSIS, HISTOPLASMOSIS, AND ASPERGILLOSIS

Orange Book exclusivity data (new drug applications)