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Drug ReportsMetronidazole
Metronidazole
Bismuth / Metronidazole / Tetracycline, Flagyl, Likmez, Metro, Metrocream, Metrogel, Metrolotion, Metronidazole, 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, Likmez, 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
PYLERALABS JUVISEN-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 16 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
bismuth subsalicylate/metronidazole/tetracycline hydrochlorideANDA2019-11-24
brimonidine tartrate 0.25% / ivermectin 1% / metronidazole 1% / niacinamide 4%unapproved drug other2019-05-15
helidac therapyANDA2020-06-17
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, Likmez, Saptalis Pharms
115410352039-10-04DP
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
1033 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_0000544—2—96139111
Bacterial vaginosisD016585EFO_0003932—91113151456
AppendicitisD001064EFO_0007149K37—4—101529
Intraabdominal infectionsD059413———6152—22
PeriodontitisD010518EFO_0000649K05.3—354920
Chronic periodontitisD055113EFO_0006343K05.3—318718
Surgical wound infectionD013530——3233615
Colorectal neoplasmsD015179——3411615
Periodontal diseasesD010510—K05.6—324514
RosaceaD012393—L712324213
Show 71 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471—C61591—216
NeoplasmsD009369—C80731—414
Type 2 diabetes mellitusD003924EFO_0001360E11—21—79
Diabetes mellitusD003920HP_0000819E08-E13——1—78
Clostridium infectionsD003015EFO_1000874A05.2—35—17
HypertensionD006973EFO_0000537I10——1—67
MalnutritionD044342EFO_0008572E40-E46—11—35
VaginitisD014627EFO_0005757N76114——5
Clostridioides difficileD016360NCBITaxon_1496——41—15
Autism spectrum disorderD000067877HP_0000729F84.0—11—34
Show 29 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C5073——413
Inflammatory bowel diseasesD015212EFO_0003767—11——35
Non-small-cell lung carcinomaD002289——11——24
AdenocarcinomaD000230——12——14
Anastomotic leakD057868———1——34
Urinary bladder neoplasmsD001749—C6711——24
TuberculosisD014376EFO_0000774A15-A1911——13
Fallopian tube neoplasmsD005185——31———3
MelanomaD008545——11——13
OsteomyelitisD010019EFO_0003102M8611———2
Show 23 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colonic neoplasmsD003110—C183———25
Head and neck neoplasmsD006258——2———35
Lung neoplasmsD008175HP_0100526C34.902———24
Liver neoplasmsD008113EFO_1001513C22.02———13
Ovarian neoplasmsD010051EFO_0003893C563————3
Male breast neoplasmsD018567——2———13
GlioblastomaD005909EFO_0000515—1———12
Necrotizing enterocolitisD020345EFO_0003928K55.31———12
Hepatocellular carcinomaD006528—C22.01———12
Gallbladder neoplasmsD005706EFO_0004606C232————2
Show 18 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
StrokeD020521EFO_0000712I63.9————1010
ObesityD009765EFO_0001073E66.9————55
DepressionD003863—F33.9————55
Covid-19D000086382—U07.1————44
Cardiovascular diseasesD002318HP_0001626—————44
Cystic fibrosisD003550EFO_0000390E84————44
Heart failureD006333HP_0001635I50————44
Obstructive sleep apneaD020181EFO_0003918G47.33————44
Multiple sclerosisD009103EFO_0003885G35————44
Peritonsillar abscessD000039EFO_0007429J36————33
Show 218 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)Loading
Structure (InChI/SMILES or Protein Sequence)
Cc1ncc([N+](=O)[O-])n1CCO
Identifiers
PDB—
CAS-ID443-48-1
RxCUI—
ChEMBL IDCHEMBL137
ChEBI ID6909
PubChem CID4173
DrugBankDB00916
UNII ID140QMO216E (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
No data
Estimated US medical usage
Metronidazole
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 60,036 documents
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Safety
Black-box Warning
Black-box warning for: Bismuth subsalicylate/metronidazole/tetracycline hydrochloride, Helidac therapy
Adverse Events
Top Adverse Reactions
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27,615 adverse events reported
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