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Metronidazole
Flagyl, Helidac, Metro, Metrocream, Metrogel, Metrolotion, Noritate, Nuvessa, Pylera, Vandazole (metronidazole) is a small molecule pharmaceutical. Metronidazole was first approved as Flagyl i.v. rtu in plastic container on 1982-01-01. It is used to treat abscess, amebiasis, bacterial endocarditis, bacterial infections, and bacterial meningitis amongst others in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
digestive system diseasesD004066
nervous system diseasesD009422
urogenital diseasesD000091642
cardiovascular diseasesD002318
skin and connective tissue diseasesD017437
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Flagyl, Metro, Metrocream, Metrogel, Metrolotion, Noritate, Nuvessa, Vandazole (generic drugs available since 1984-11-06, discontinued: Flagyl, Metromidol, Protostat, Satric)
Combinations
Pylera (generic drugs available since 1984-11-06, discontinued: Helidac)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Bismuth subcitrate potassium
+
Metronidazole
+
Tetracycline hydrochloride
Tradename
Company
Number
Date
Products
PYLERAAbbVieN-050786 RX2006-09-28
1 products, RLD, RS
Bismuth subsalicylate
+
Metronidazole
+
Tetracycline hydrochloride
Tradename
Company
Number
Date
Products
HELIDACCasper PharmaN-050719 DISCN1996-08-15
1 products, RLD
Hide discontinued
Metronidazole
Tradename
Company
Number
Date
Products
METRO I.V. IN PLASTIC CONTAINERB. Braun MedicalN-018900 RX1983-09-29
1 products, RLD, RS
METROGEL-VAGINALBausch Health CompaniesN-020208 RX1992-08-17
1 products, RLD, RS
NORITATEBausch Health CompaniesN-020743 RX1997-09-26
1 products, RLD, RS
FLAGYL I.V. RTU IN PLASTIC CONTAINERBaxterN-018657 RX1982-01-01
1 products, RLD, RS
NUVESSACHEMO ResearchN-205223 RX2014-03-24
1 products, RLD, RS
METROGELGaldermaN-019737 RX1988-11-22
1 products, RLD, RS
METROCREAMGaldermaN-020531 RX1995-09-20
1 products, RLD, RS
METROLOTIONGaldermaN-020901 RX1998-11-24
1 products, RLD, RS
METROGELGaldermaN-021789 RX2005-06-30
1 products, RLD, RS
METRONIDAZOLE IN PLASTIC CONTAINERHospiraN-018890 RX1983-11-18
1 products, RLD, RS
Show 3 marketed
Show 15 discontinued
Metronidazole hydrochloride
Tradename
Company
Number
Date
Products
FLAGYL I.V.MylanN-018353 DISCN1982-01-01
1 products
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
flagylNew Drug Application2021-03-17
helidac therapyANDA2020-06-17
metrocream New Drug Application2018-06-26
metrogelNew Drug Application2019-06-05
metrolotionNew Drug Application2018-06-27
metronidazoleANDA2023-05-30
noritateNew Drug Application2020-06-01
nuvessaNew Drug Application2021-01-15
pyleraNew Drug Application2021-12-15
vandazoleNew Drug Application2023-06-07
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
abscessEFO_0003030D000038—
amebiasisEFO_0007144D000562A06
bacterial endocarditisEFO_1000830D004697—
bacterial infections—D001424A49
bacterial meningitisEFO_1000831D016920G00
bacterial vaginosisEFO_0003932D016585—
bacteroides infectionsEFO_1000832D001442—
giardiasisDOID_10718D005873A07.1
helicobacter infectionsEFO_1000961D016481—
protozoan infections—D011528B50-B64
Show 4 more
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Metronidazole, Nuvessa, Chemo Research Sl
89462762032-06-28U-1664
91988582032-06-28U-1664
102386342032-06-28DP
105961552032-06-28DP
86586782028-06-27U-1682
78930972028-02-19DP
88777922028-02-02DP
Metronidazole, Vandazole, Teva Pharms
74562072024-09-22DP
ATC Codes
A: Alimentary tract and metabolism drugs
— A01: Stomatological preparations
— A01A: Stomatological preparations
— A01AB: Antiinfectives and antiseptics for local oral treatment
— A01AB17: Metronidazole
— A02: Drugs for acid related disorders
— A02B: Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)
— A02BD: Combinations for eradication of helicobacter pylori
— A02BD01: Omeprazole, amoxicillin and metronidazole
— A02BD02: Lansoprazole, tetracycline and metronidazole
— A02BD03: Lansoprazole, amoxicillin and metronidazole
— A02BD08: Bismuth subcitrate, tetracycline and metronidazole
— A02BD11: Pantoprazole, amoxicillin, clarithromycin and metronidazole
— A02BD13: Rabeprazole, amoxicillin and metronidazole
— A02BD15: Vonoprazan, amoxicillin and metronidazole
D: Dermatologicals
— D06: Antibiotics and chemotherapeutics for dermatological use
— D06B: Chemotherapeutics for topical use
— D06BX: Other chemotherapeutics in atc
— D06BX01: Metronidazole
G: Genito urinary system and sex hormones
— G01: Gynecological antiinfectives and antiseptics
— G01A: Antiinfectives and antiseptics, excl. combinations with corticosteroids
— G01AF: Imidazole derivatives, gyncological antiinfectives
— G01AF01: Metronidazole
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01R: Combinations of antibacterials
— J01RA: Combinations of antibacterials
— J01RA03: Cefuroxime and metronidazole
— J01RA04: Spiramycin and metronidazole
— J01RA10: Ciprofloxacin and metronidazole
— J01RA14: Norfloxacin and metronidazole
— J01X: Other antibacterials in atc
— J01XD: Imidazole derivatives, antibacterial for systemic use
— J01XD01: Metronidazole
P: Antiparasitic products, insecticides and repellents
— P01: Antiprotozoals
— P01A: Agents against amoebiasis and other protozoal diseases
— P01AB: Nitroimidazole derivatives, antiprotozoal agents against amoebiasis and other protozoal diseases
— P01AB01: Metronidazole
— P01AB51: Metronidazole and furazolidone
— P01AB52: Metronidazole and diloxanide
HCPCS
Code
Description
S0030
Injection, metronidazole, 500 mg
Clinical
Clinical Trials
440 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_00005442—4411663
Bacterial vaginosisD016585EFO_00039328111313746
Intraabdominal infectionsD059413—6142—21
AppendicitisD001064EFO_0007149K37—3—7515
PeriodontitisD010518EFO_0000649K05.3—232512
Chronic periodontitisD055113EFO_0006343K05.3—317212
Periodontal diseasesD010510K05.6—3—4411
RosaceaD012393L711323211
Surgical wound infectionD013530312229
Healthy volunteers/patients—6——118
Show 49 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD015179331—29
NeoplasmsD009369C805—1——6
Trichomonas vaginitisD014247EFO_0007521—12—14
Type 2 diabetes mellitusD003924EFO_0001360E11—21—13
Clostridioides difficileD016360NCBITaxon_1496—31——3
LymphomaD008223C85.9—21——3
MalnutritionD044342EFO_0008572E40-E46—11——2
Bacterial pneumoniaD018410EFO_1001272J15.9——2——2
VaginitisD014627EFO_0005757N761—1——2
CandidiasisD002177B37—11——2
Show 15 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471C6149———12
Breast neoplasmsD001943EFO_0003869C5072———8
Ulcerative colitisD003093EFO_0000729K5113——15
Inflammatory bowel diseasesD015212EFO_000376711——13
Rectal neoplasmsD01200421———3
Fallopian tube neoplasmsD00518531———3
AdenocarcinomaD00023011———2
Non-small-cell lung carcinomaD00228911———2
Systemic inflammatory response syndromeD018746EFO_1001478R65.10—1——12
Ovarian epithelial carcinomaD00007721621———2
Show 19 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colonic neoplasmsD003110C182———13
Lung neoplasmsD008175C34.902———13
Ovarian neoplasmsD010051EFO_0003893C563————3
Stomach neoplasmsD013274EFO_0003897C163————3
Liver neoplasmsD008113EFO_1001513C22.02————2
Necrotizing enterocolitisD020345EFO_0003928K55.31———12
Male breast neoplasmsD0185672————2
Gallbladder neoplasmsD005706EFO_0004606C232————2
Therapeutic equivalencyD0138102————2
Sclerosing cholangitisD015209EFO_0004268K83.011———12
Show 13 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Peritonsillar abscessD000039EFO_0007429J36————22
ObesityD009765EFO_0001073E66.9————22
AbscessD000038EFO_0003030————22
Rectal fistulaD012003HP_0010447K60.3————22
StrokeD020521EFO_0000712I63.9————22
Hip osteoarthritisD015207EFO_1000786M16————22
Disease susceptibilityD004198————11
Periapical diseasesD010483EFO_0010688————11
Premature obstetric laborD007752O60————11
PancreatitisD010195EFO_0000278K85————11
Show 27 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMETRONIDAZOLE
INNmetronidazole
Description
Metronidazole is a member of the class of imidazoles substituted at C-1, -2 and -5 with 2-hydroxyethyl, nitro and methyl groups respectively. It has activity against anaerobic bacteria and protozoa, and has a radiosensitising effect on hypoxic tumour cells. It may be given by mouth in tablets, or as the benzoate in an oral suspension. The hydrochloride salt can be used in intravenous infusions. Metronidazole is a prodrug and is selective for anaerobic bacteria due to their ability to intracellularly reduce the nitro group of metronidazole to give nitroso-containing intermediates. These can covalently bind to DNA, disrupting its helical structure, inducing DNA strand breaks and inhibiting bacterial nucleic acid synthesis, ultimately resulting in bacterial cell death. It has a role as an antitrichomonal drug, a prodrug, an antibacterial drug, an antimicrobial agent, an antiparasitic agent, a xenobiotic, an environmental contaminant, a radiosensitizing agent and an antiamoebic agent. It is a member of imidazoles, a C-nitro compound and a primary alcohol. It is a conjugate base of a metronidazole(1+).
Classification
Small molecule
Drug classantiprotozoal substances (metronidazole type)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Cc1ncc([N+](=O)[O-])n1CCO
Identifiers
PDB—
CAS-ID443-48-1
RxCUI6922
ChEMBL IDCHEMBL137
ChEBI ID6909
PubChem CID4173
DrugBankDB00916
UNII ID140QMO216E (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 46,890 documents
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Safety
Black-box Warning
Black-box warning for: Flagyl, Helidac therapy, Pylera
Adverse Events
Top Adverse Reactions
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44,838 adverse events reported
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