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

Stem definition	Drug id	CAS RN
antiprotozoals and radiosensitizers, metronidazole derivatives	1790	443-48-1

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: metronidazole anagiardil metronidazol metropol metrotab mexibol nidazole trichazol trichobrol metronidazole hydrochloride metronidazole phosphate metronidazole benzoate metronidazole HCl rozex	A nitroimidazole used to treat AMEBIASIS; VAGINITIS; TRICHOMONAS INFECTIONS; GIARDIASIS; ANAEROBIC BACTERIA; and TREPONEMAL INFECTIONS. Molecular weight: 171.16 Formula: C6H9N3O3 CLOGP: -0.46 LIPINSKI: 0 HAC: 6 HDO: 1 TPSA: 81.19 ALOGS: -1.46 ROTB: 3 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

metronidazole
anagiardil
metronidazol
metropol
metrotab
mexibol
nidazole
trichazol
trichobrol
metronidazole hydrochloride
metronidazole phosphate
metronidazole benzoate
metronidazole HCl
rozex

A nitroimidazole used to treat AMEBIASIS; VAGINITIS; TRICHOMONAS INFECTIONS; GIARDIASIS; ANAEROBIC BACTERIA; and TREPONEMAL INFECTIONS.

Molecular weight: 171.16
Formula: C6H9N3O3
CLOGP: -0.46
LIPINSKI: 0
HAC: 6
HDO: 1
TPSA: 81.19
ALOGS: -1.46
ROTB: 3

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.50	g	V
1.50	g	P
2	g	O
2	g	R

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	99 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
t_half (Half-life)	7.10 hours	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	194.56 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
S (Water solubility)	10 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	10 %	Benet LZ, Broccatelli F, Oprea TI
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
fu (Fraction unbound in plasma)	0.96 %	Lombardo F, Berellini G, Obach RS
CL (Clearance)	0.85 mL/min/kg	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.40 L/kg	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
July 18, 1963	FDA	GD SEARLE LLC
July 4, 2014	PMDA	Pfizer Japan Inc.

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
Macular degeneration	445.04	10.27	307	75730	24069	63388916
Abortion spontaneous	371.10	10.27	364	75673	46831	63366154
Clostridium difficile infection	369.50	10.27	298	75739	29624	63383361
Toxic encephalopathy	305.88	10.27	152	75885	6427	63406558
Abortion incomplete	299.73	10.27	120	75917	3011	63409974
Clostridium difficile colitis	260.60	10.27	208	75829	20361	63392624
Contraindicated product administered	209.09	10.27	13	76024	217635	63195350
Drug reaction with eosinophilia and systemic symptoms	201.45	10.27	225	75812	33611	63379374
Neurotoxicity	192.50	10.27	161	75876	16829	63396156
Acute generalised exanthematous pustulosis	189.01	10.27	134	75903	10965	63402020

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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
Toxic encephalopathy	499.44	10.86	212	50949	5037	34900733
Appendicolith	236.94	10.86	151	51010	8450	34897320
Neurotoxicity	233.99	10.86	201	50960	17809	34887961
Appendicitis	233.65	10.86	185	50976	14622	34891148
Multiple organ dysfunction syndrome	209.20	10.86	390	50771	76176	34829594
Drug reaction with eosinophilia and systemic symptoms	179.08	10.86	231	50930	32781	34872989
Clostridium difficile colitis	156.19	10.86	151	51010	15579	34890191
Cerebellar syndrome	155.45	10.86	74	51087	2314	34903456
Abdominal distension	147.41	10.86	288	50873	58204	34847566
Ascites	143.39	10.86	250	50911	46321	34859449

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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
Toxic encephalopathy	799.94	9.77	365	108978	11075	79623970
Clostridium difficile infection	455.04	9.77	414	108929	42271	79592774
Neurotoxicity	436.96	9.77	360	108983	32158	79602887
Drug reaction with eosinophilia and systemic symptoms	367.70	9.77	447	108896	63797	79571248
Clostridium difficile colitis	353.66	9.77	318	109025	31965	79603080
Abortion incomplete	286.52	9.77	120	109223	2944	79632101
Multiple organ dysfunction syndrome	279.36	9.77	551	108792	119695	79515350
Pseudomembranous colitis	273.79	9.77	138	109205	5236	79629809
Cerebellar syndrome	245.33	9.77	129	109214	5351	79629694
Appendicolith	244.15	9.77	150	109193	8401	79626644

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A01AB17	ALIMENTARY TRACT AND METABOLISM STOMATOLOGICAL PREPARATIONS STOMATOLOGICAL PREPARATIONS Antiinfectives and antiseptics for local oral treatment
ATC	A02BD01	ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Combinations for eradication of Helicobacter pylori
ATC	A02BD02	ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Combinations for eradication of Helicobacter pylori
ATC	A02BD03	ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Combinations for eradication of Helicobacter pylori
ATC	A02BD08	ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Combinations for eradication of Helicobacter pylori
ATC	A02BD11	ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Combinations for eradication of Helicobacter pylori
ATC	A02BD13	ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Combinations for eradication of Helicobacter pylori
ATC	A02BD15	ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Combinations for eradication of Helicobacter pylori
ATC	D06BX01	DERMATOLOGICALS ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE CHEMOTHERAPEUTICS FOR TOPICAL USE Other chemotherapeutics
ATC	G01AF01	GENITO URINARY SYSTEM AND SEX HORMONES GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS Imidazole derivatives

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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
Bacterial septicemia	indication	10001005	DOID:0040085
Infection of skin AND/OR subcutaneous tissue	indication	19824006
Abscess of liver	indication	27916005
Acute amebiasis	indication	39224005
Peritonitis	indication	48661000
Lower respiratory tract infection	indication	50417007
Infectious inflammation of intestine	indication	55184003
Infection by Trichomonas	indication	56335008	DOID:1947
Giardiasis	indication	58265007	DOID:10718
Tubo-ovarian abscess	indication	58949002

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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	10.4	acidic
pKa2	2.68	Basic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
1.3%	NUVESSA	CHEMO RESEARCH SL	N205223	March 24, 2014	RX	GEL	VAGINAL	8658678	June 27, 2028	TREATMENT OF BACTERIAL VAGINOSIS
1.3%	NUVESSA	CHEMO RESEARCH SL	N205223	March 24, 2014	RX	GEL	VAGINAL	8946276	June 28, 2032	TREATMENT OF BACTERIAL VAGINOSIS WITH METRONIDAZOLE GEL
1.3%	NUVESSA	CHEMO RESEARCH SL	N205223	March 24, 2014	RX	GEL	VAGINAL	9198858	June 28, 2032	TREATMENT OF BACTERIAL VAGINOSIS WITH METRONIDAZOLE GEL

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
140MG;125MG;125MG	BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	RICONPHARMA LLC	A217511	July 3, 2023	RX	CAPSULE	ORAL	Dec. 29, 2023	COMPETITIVE GENERIC THERAPY

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Thioredoxin reductase	Enzyme		C4LW95_ENTHI		Ki	5.48		CHEMBL

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External reference:

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ID	Source
2MN	PDB_CHEM_ID
002958	NDDF
002959	NDDF
005129	NDDF
1032	INN_ID
103866	RXNORM
10914	IUPHAR_LIGAND_ID
1222004	SNOMEDCT_US
13182-89-3	SECONDARY_CAS_RN
14032	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Flagyl	HUMAN PRESCRIPTION DRUG LABEL	1	0025-1942	CAPSULE	375 mg	ORAL	NDA	25 sections
Flagyl	HUMAN PRESCRIPTION DRUG LABEL	1	0025-1942	CAPSULE	375 mg	ORAL	NDA	25 sections
MetroCream	HUMAN PRESCRIPTION DRUG LABEL	1	0299-3836	CREAM	7.50 mg	TOPICAL	NDA	9 sections
METROGEL	HUMAN PRESCRIPTION DRUG LABEL	1	0299-3820	GEL	10 mg	TOPICAL	NDA	27 sections
METROGEL	HUMAN PRESCRIPTION DRUG LABEL	1	0299-3820	GEL	10 mg	TOPICAL	NDA	27 sections
MetroLotion	HUMAN PRESCRIPTION DRUG LABEL	1	0299-3838	LOTION	7.50 mg	TOPICAL	NDA	10 sections
Metronidazole	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1474	GEL	7.50 mg	TOPICAL	ANDA	16 sections
Metronidazole	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9772	INJECTION, SOLUTION	500 mg	INTRAVENOUS	ANDA	24 sections
Metronidazole	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0275	GEL	7.50 mg	TOPICAL	ANDA	17 sections
Metronidazole	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0323	CREAM	7.50 mg	TOPICAL	ANDA	18 sections

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