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

Stem definition	Drug id	CAS RN
antiparasitics, salicylanilides and analogues	1943	55981-09-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: nitazoxanide nitazode nitazoxanida nizonide	a 5-nitrothiazolyl derivative used for a broad range of intestinal parasitic infections including CRYPTOSPORIDIUM and GIARDIA; it is a redox-active nitrothiazolyl-salicylamide prodrug; structure given in first source. It was investigated as a potential treatment for COVID-19 based on its broad antiviral activity, including in vitro activity against SARS-CoV-2 and MERS-CoV; however, there are no data to support the use of nitazoxanide in the treatment of COVID-19. Molecular weight: 307.28 Formula: C12H9N3O5S CLOGP: 1.25 LIPINSKI: 0 HAC: 8 HDO: 1 TPSA: 114.11 ALOGS: -4.61 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

nitazoxanide
nitazode
nitazoxanida
nizonide

a 5-nitrothiazolyl derivative used for a broad range of intestinal parasitic infections including CRYPTOSPORIDIUM and GIARDIA; it is a redox-active nitrothiazolyl-salicylamide prodrug; structure given in first source. It was investigated as a potential treatment for COVID-19 based on its broad antiviral activity, including in vitro activity against SARS-CoV-2 and MERS-CoV; however, there are no data to support the use of nitazoxanide in the treatment of COVID-19.

Molecular weight: 307.28
Formula: C12H9N3O5S
CLOGP: 1.25
LIPINSKI: 0
HAC: 8
HDO: 1
TPSA: 114.11
ALOGS: -4.61
ROTB: 5

Status: OFP

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

Drug dosage:

Dose	Unit	Route
1	g	O

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	70 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
MRTD (Maximum Recommended Therapeutic Daily Dose)	46.49 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Bocci G, Oprea TI, Benet LZ
S (Water solubility)	0.01 mg/mL	Bocci G, Oprea TI, Benet LZ

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Approvals:

Date	Agency	Company	Orphan
Nov. 22, 2002	FDA	ROMARK

FDA Adverse Event Reporting System (Female)

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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
Therapy interrupted	341.57	39.47	89	1346	32366	63455221
Death	296.99	39.47	150	1285	374231	63113356
Therapy cessation	210.00	39.47	60	1375	30397	63457190
Hospitalisation	118.95	39.47	51	1384	85030	63402557
Surgery	113.34	39.47	39	1396	35873	63451714
Intentional dose omission	55.85	39.47	16	1419	8059	63479528
Anticholinergic syndrome	47.61	39.47	11	1424	2371	63485216
Chromaturia	44.40	39.47	16	1419	16701	63470886

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FDA Adverse Event Reporting System (Male)

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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
Death	351.45	39.83	175	709	397874	34558173
Therapy interrupted	190.36	39.83	48	836	13649	34942398
Therapy cessation	133.61	39.83	38	846	16935	34939112
Surgery	81.86	39.83	25	859	14132	34941915
Hospitalisation	56.96	39.83	28	856	56874	34899173

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FDA Adverse Event Reporting System (Geriatric)

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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
Death	654.93	33.41	320	2084	566194	79175790
Therapy interrupted	529.61	33.41	133	2271	31208	79710776
Therapy cessation	333.28	33.41	96	2308	37466	79704518
Surgery	200.59	33.41	63	2341	32703	79709281
Hospitalisation	177.75	33.41	76	2328	94160	79647824
Chromaturia	69.75	33.41	27	2377	25719	79716265
Intentional dose omission	62.46	33.41	19	2385	8798	79733186
Anticholinergic syndrome	39.91	33.41	11	2393	3600	79738384
Spinal operation	39.24	33.41	13	2391	7904	79734080

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	P01AX11	ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS ANTIPROTOZOALS AGENTS AGAINST AMOEBIASIS AND OTHER PROTOZOAL DISEASES Other agents against amoebiasis and other protozoal diseases
FDA EPC	N0000175485	Antiprotozoal
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D000977	Antiparasitic Agents

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

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Disease	Relation	SNOMED_ID	DOID
Giardiasis	indication	58265007	DOID:10718
Infection by Cryptosporidium	indication	58777003
Coronavirus infection	off-label use	186747009
Diabetes mellitus	contraindication	73211009	DOID:9351
Kidney disease	contraindication	90708001	DOID:557
Disease of liver	contraindication	235856003	DOID:409

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	6.29	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Aldose reductase	Enzyme	P15121	ALDR_HUMAN		IC50	5.09	CHEMBL
Anoctamin-1	Ion channel	Q5XXA6	ANO1_HUMAN		IC50	6.37	CHEMBL
Signal transducer and activator of transcription 3	Transcription factor	P40763	STAT3_HUMAN		IC50	5.01	CHEMBL
Pyruvate dehydrogenase [NADP(+)]	Enzyme		PNO_CRYPV	INHIBITOR			DRUGBANK	CHEMBL
Pyruvate:ferredoxin oxidoreductase	Enzyme		Q24982_GIAIN	INHIBITOR			CHEMBL	CHEMBL
Pyruvate-flavodoxin oxidoreductase	Enzyme		Q0P8E1_CAMJE		Ki	4.98	CHEMBL

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External reference:

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ID	Source
006303	NDDF
17040	MMSL
189467	MMSL
31819	RXNORM
4021365	VUID
4021365	VANDF
407148001	SNOMEDCT_US
407149009	SNOMEDCT_US
41684	PUBCHEM_CID
5007	INN_ID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Alinia	HUMAN PRESCRIPTION DRUG LABEL	1	67546-111	TABLET	500 mg	ORAL	NDA	24 sections
Alinia	HUMAN PRESCRIPTION DRUG LABEL	1	67546-212	POWDER, FOR SUSPENSION	100 mg	ORAL	NDA	24 sections
N/A	HUMAN PRESCRIPTION DRUG LABEL	1	43386-405	TABLET	500 mg	ORAL	NDA authorized generic	24 sections
Nitazoxanide	Human Prescription Drug Label	1	64980-526	TABLET, FILM COATED	500 mg	ORAL	ANDA	23 sections
Nitazoxanide	Human Prescription Drug Label	1	64980-526	TABLET, FILM COATED	500 mg	ORAL	ANDA	23 sections

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