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

Stem definition	Drug id	CAS RN
testosterone reductase inhibitors	973	164656-23-9

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: dutasteride veltride avodart avolve GG745 GG-745	A 5-ALPHA-REDUCTASE INHIBITOR that is reported to inhibit both type-1 and type2 isoforms of the enzyme and is used to treat BENIGN PROSTATIC HYPERPLASIA. Molecular weight: 528.54 Formula: C27H30F6N2O2 CLOGP: 4.94 LIPINSKI: 1 HAC: 4 HDO: 2 TPSA: 58.20 ALOGS: -5.77 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

dutasteride
veltride
avodart
avolve
GG745
GG-745

A 5-ALPHA-REDUCTASE INHIBITOR that is reported to inhibit both type-1 and type2 isoforms of the enzyme and is used to treat BENIGN PROSTATIC HYPERPLASIA.

Molecular weight: 528.54
Formula: C27H30F6N2O2
CLOGP: 4.94
LIPINSKI: 1
HAC: 4
HDO: 2
TPSA: 58.20
ALOGS: -5.77
ROTB: 4

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.50	mg	O

ADMET properties:

Show entries

Search:

Property	Value	Reference
BA (Bioavailability)	60 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0.50 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.01 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Showing 1 to 4 of 4 entries

Previous1Next

Approvals:

Date	Agency	Company	Orphan
Nov. 20, 2001	FDA	GLAXOSMITHKLINE

FDA Adverse Event Reporting System (Female)

Show entries

Search:

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
Accidental exposure to product	39.95	38.02	10	153	27395	63461464

Showing 1 to 1 of 1 entries

Previous1Next

FDA Adverse Event Reporting System (Male)

Show entries

Search:

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 dispensed to wrong patient	168.02	12.26	45	26613	479	34929794
Conjunctivitis allergic	124.56	12.26	43	26615	1127	34929146
Mycotic allergy	116.82	12.26	35	26623	573	34929700
Spirometry abnormal	114.97	12.26	36	26622	688	34929585
Sleep disorder due to a general medical condition	112.26	12.26	62	26596	5159	34925114
Mite allergy	111.87	12.26	35	26623	667	34929606
Dust allergy	107.03	12.26	36	26622	870	34929403
Antimicrobial susceptibility test resistant	105.33	12.26	29	26629	345	34929928
Orthostatic hypotension	102.20	12.26	112	26546	25807	34904466
Minimum inhibitory concentration	94.69	12.26	23	26635	159	34930114

Showing 1 to 10 of 130 entries

Previous1 2 3 4 5…13Next

FDA Adverse Event Reporting System (Geriatric)

Show entries

Search:

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
Conjunctivitis allergic	142.68	13.08	41	21774	1679	79720894
Spirometry abnormal	131.68	13.08	34	21781	925	79721648
Antimicrobial susceptibility test resistant	128.23	13.08	28	21787	360	79722213
Mite allergy	123.29	13.08	34	21781	1196	79721377
Drug dispensed to wrong patient	121.58	13.08	30	21785	676	79721897
Dust allergy	120.23	13.08	35	21780	1501	79721072
Minimum inhibitory concentration	118.43	13.08	23	21792	157	79722416
Mycotic allergy	116.20	13.08	34	21781	1485	79721088
Sleep disorder due to a general medical condition	107.89	13.08	60	21755	14217	79708356
Orthostatic hypotension	102.84	13.08	100	21715	56064	79666509

Showing 1 to 10 of 137 entries

Previous1 2 3 4 5…14Next

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Show entries

Search:

Source	Code	Description
ATC	G04CA52	GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY Alpha-adrenoreceptor antagonists
ATC	G04CB02	GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY Testosterone-5-alpha reductase inhibitors
FDA EPC	N0000175836	5-alpha Reductase Inhibitor
FDA MoA	N0000000126	5-alpha Reductase Inhibitors
MeSH PA	D058891	5-alpha Reductase Inhibitors
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D006727	Hormone Antagonists
MeSH PA	D065088	Steroid Synthesis Inhibitors

Showing 1 to 8 of 8 entries

Previous1Next

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

Show entries

Search:

Disease	Relation	SNOMED_ID	DOID
Benign prostatic hyperplasia	indication	266569009
Priapism	contraindication	6273006	DOID:9286
Orthostatic hypotension	contraindication	28651003
Oligozoospermia	contraindication	88311004
Cataract surgery	contraindication	110473004
Disease of liver	contraindication	235856003	DOID:409
Syncope	contraindication	271594007
Pregnancy, function	contraindication	289908002
Dizziness	contraindication	404640003
Breastfeeding (mother)	contraindication	413712001

Showing 1 to 10 of 12 entries

Previous1 2Next

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	12.41	acidic
pKa2	13.26	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Show entries

Search:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
3-oxo-5-alpha-steroid 4-dehydrogenase 2	Enzyme	P31213	S5A2_HUMAN	INHIBITOR	IC50	9.20	WOMBAT-PK	CHEMBL
3-oxo-5-alpha-steroid 4-dehydrogenase 1	Enzyme	P18405	S5A1_HUMAN	INHIBITOR	IC50	8.49	WOMBAT-PK	CHEMBL
Glycine receptor subunit alpha-1	Ion channel	P23415	GLRA1_HUMAN		EC50	6.48	CHEMBL

Showing 1 to 3 of 3 entries

Previous1Next

External reference:

Show entries

Search:

ID	Source
009824	NDDF
16302	MMSL
228246	MMSL
228790	RXNORM
385570006	SNOMEDCT_US
385572003	SNOMEDCT_US
4021371	VUID
4021371	VANDF
42738	MMSL
6918296	PUBCHEM_CID

Showing 1 to 10 of 20 entries

Previous1 2Next

Pharmaceutical products:

Show entries

Search:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
AVODART	HUMAN PRESCRIPTION DRUG LABEL	1	0173-0712	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	NDA	27 sections
Avodart	HUMAN PRESCRIPTION DRUG LABEL	1	54868-5114	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	NDA	27 sections
Dutasteride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1438	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	28 sections
Dutasteride	HUMAN PRESCRIPTION DRUG LABEL	1	0173-7077	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	Export only	2 sections
Dutasteride	Human Prescription Drug Label	1	25000-011	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	29 sections
Dutasteride	HUMAN PRESCRIPTION DRUG LABEL	1	31722-131	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	18 sections
Dutasteride	HUMAN PRESCRIPTION DRUG LABEL	1	42806-549	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	28 sections
Dutasteride	HUMAN PRESCRIPTION DRUG LABEL	1	50090-4010	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	18 sections
Dutasteride	HUMAN PRESCRIPTION DRUG LABEL	1	51013-190	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	28 sections
Dutasteride	HUMAN PRESCRIPTION DRUG LABEL	1	51407-157	CAPSULE, LIQUID FILLED	0.50 mg	ORAL	ANDA	18 sections

Showing 1 to 10 of 30 entries

Previous1 2 3Next