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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, Metronidazole, Noritate, Nuvessa, Vandazole (discontinued: Flagyl, Metro, Metrogel, Metronidazole, Protostat, Satric)
Combinations
Bismuth subcitrate potassium, metronidazole tetracycline, Bismuth subsalicylate, metronidazole tetracycline (discontinued: Helidac)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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
METROCREAMGaldermaN-020531 RX1995-09-20
1 products, RLD, RS
METROGELGaldermaN-021789 RX2005-06-30
1 products, RLD, RS
METROLOTIONGaldermaN-020901 RX1998-11-24
1 products, RLD, RS
METRONIDAZOLE IN PLASTIC CONTAINERHospiraN-018890 RX1983-11-18
1 products, RLD, RS
FLAGYLPfizerN-020334 RX1995-05-03
1 products, RLD, RS
Show 2 marketed
Show 17 discontinued
Metronidazole hydrochloride
Tradename
Company
Number
Date
Products
FLAGYL I.V.PfizerN-018353 DISCN1982-01-01
1 products
Hide discontinued
Bismuth subsalicylate
+
Metronidazole
+
Tetracycline hydrochloride
Tradename
Company
Number
Date
Products
HELIDACCasper PharmaN-050719 DISCN1996-08-15
1 products, RLD
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
171083 ivermectin 1% / metronidazole 1% / niacinamide 4%unapproved drug other2020-07-02
aceast clear concealer sunscreen liquid foundation spf50 paC2002632024-10-10
acnilunapproved drug other2025-02-17
bismuth subcitrate potassium, metronidazole and tetracycline hydrochlorideANDA2024-12-27
bismuth subcitrate potassium, metronidazole, and tetracycline hydrochlorideNew Drug Application2024-07-25
bismuth subcitrate potassium, metronidazole, tetracycline hydrochlorideANDA2024-10-22
bismuth subsalicylate/metronidazole/tetracycline hydrochlorideANDA2019-11-24
brimonidine tartrate 0.25% / ivermectin 1% / metronidazole 1% / niacinamide 4%unapproved drug other2019-05-15
flagylNew Drug Application2024-12-26
helidac therapyANDA2020-06-17
Show 22 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
rosacea—D012393L71
bacterial infections—D001424A49
giardiasisDOID_10718D005873A07.1
helicobacter infectionsEFO_1000961D016481—
surgical wound infection—D013530—
abscessEFO_0003030D000038—
bacterial vaginosisEFO_0003932D016585—
bacterial endocarditisEFO_1000830D004697—
bacterial meningitisEFO_1000831D016920G00
protozoan infections—D011528B50-B64
Show 28 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
1149 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bacterial vaginosisD016585EFO_0003932—11———1
Vaginal diseasesD014623——11———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.9————11
Lung diseasesD008171EFO_0003818J98.4————11
Obstructive lung diseasesD008173——————11
Multiple sclerosisD009103EFO_0003885G35————11
Relapsing-remitting multiple sclerosisD020529EFO_0003929—————11
SclerosisD012598——————11
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 66,213 documents
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Safety
Black-box Warning
Black-box warning for: Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride, Bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride, Bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride, Bismuth subsalicylate/metronidazole/tetracycline hydrochloride, Flagyl, Helidac therapy, Likmez, Metronidazole, Metronidazole250 mg, Metronidazole500 mg, Pylera
Adverse Events
Top Adverse Reactions
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35,896 adverse events reported
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