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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Trade Name
FDA
EMA
Flagyl, Metro, Metrocream, Metrogel, Metrolotion, Noritate, Nuvessa, Vandazole (generic drugs available since 1984-11-06, discontinued: Flagyl, Metromidol, Protostat, Satric)
CombinationsPylera (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 |
---|---|---|---|---|
PYLERA | AbbVie | N-050786 RX | 2006-09-28 | 1 products, RLD, RS |
Bismuth subsalicylate
+
Metronidazole
+
Tetracycline hydrochloride
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
HELIDAC | Casper Pharma | N-050719 DISCN | 1996-08-15 | 1 products, RLD |
Hide discontinued
Metronidazole
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
METRO I.V. IN PLASTIC CONTAINER | B. Braun Medical | N-018900 RX | 1983-09-29 | 1 products, RLD, RS |
METROGEL-VAGINAL | Bausch Health Companies | N-020208 RX | 1992-08-17 | 1 products, RLD, RS |
NORITATE | Bausch Health Companies | N-020743 RX | 1997-09-26 | 1 products, RLD, RS |
FLAGYL I.V. RTU IN PLASTIC CONTAINER | Baxter | N-018657 RX | 1982-01-01 | 1 products, RLD, RS |
NUVESSA | CHEMO Research | N-205223 RX | 2014-03-24 | 1 products, RLD, RS |
METROGEL | Galderma | N-019737 RX | 1988-11-22 | 1 products, RLD, RS |
METROCREAM | Galderma | N-020531 RX | 1995-09-20 | 1 products, RLD, RS |
METROLOTION | Galderma | N-020901 RX | 1998-11-24 | 1 products, RLD, RS |
METROGEL | Galderma | N-021789 RX | 2005-06-30 | 1 products, RLD, RS |
METRONIDAZOLE IN PLASTIC CONTAINER | Hospira | N-018890 RX | 1983-11-18 | 1 products, RLD, RS |
Show 3 marketed
Show 15 discontinued
Metronidazole hydrochloride
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
FLAGYL I.V. | Mylan | N-018353 DISCN | 1982-01-01 | 1 products |
Hide discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
flagyl | New Drug Application | 2021-03-17 |
helidac therapy | ANDA | 2020-06-17 |
metrocream | New Drug Application | 2018-06-26 |
metrogel | New Drug Application | 2019-06-05 |
metrolotion | New Drug Application | 2018-06-27 |
metronidazole | ANDA | 2023-05-30 |
noritate | New Drug Application | 2020-06-01 |
nuvessa | New Drug Application | 2021-01-15 |
pylera | New Drug Application | 2021-12-15 |
vandazole | New Drug Application | 2023-06-07 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
abscess | EFO_0003030 | D000038 | — |
amebiasis | EFO_0007144 | D000562 | A06 |
bacterial endocarditis | EFO_1000830 | D004697 | — |
bacterial infections | — | D001424 | A49 |
bacterial meningitis | EFO_1000831 | D016920 | G00 |
bacterial vaginosis | EFO_0003932 | D016585 | — |
bacteroides infections | EFO_1000832 | D001442 | — |
giardiasis | DOID_10718 | D005873 | A07.1 |
helicobacter infections | EFO_1000961 | D016481 | — |
protozoan infections | — | D011528 | B50-B64 |
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Agency Specific
FDA
EMA
No data
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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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Infections | D007239 | EFO_0000544 | 2 | — | 4 | 41 | 16 | 63 | |
Bacterial vaginosis | D016585 | EFO_0003932 | 8 | 11 | 13 | 13 | 7 | 46 | |
Intraabdominal infections | D059413 | — | 6 | 14 | 2 | — | 21 | ||
Appendicitis | D001064 | EFO_0007149 | K37 | — | 3 | — | 7 | 5 | 15 |
Periodontitis | D010518 | EFO_0000649 | K05.3 | — | 2 | 3 | 2 | 5 | 12 |
Chronic periodontitis | D055113 | EFO_0006343 | K05.3 | — | 3 | 1 | 7 | 2 | 12 |
Periodontal diseases | D010510 | K05.6 | — | 3 | — | 4 | 4 | 11 | |
Rosacea | D012393 | L71 | 1 | 3 | 2 | 3 | 2 | 11 | |
Surgical wound infection | D013530 | 3 | 1 | 2 | 2 | 2 | 9 | ||
Healthy volunteers/patients | — | 6 | — | — | 1 | 1 | 8 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Colorectal neoplasms | D015179 | 3 | 3 | 1 | — | 2 | 9 | ||
Neoplasms | D009369 | C80 | 5 | — | 1 | — | — | 6 | |
Trichomonas vaginitis | D014247 | EFO_0007521 | — | 1 | 2 | — | 1 | 4 | |
Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 2 | 1 | — | 1 | 3 |
Clostridioides difficile | D016360 | NCBITaxon_1496 | — | 3 | 1 | — | — | 3 | |
Lymphoma | D008223 | C85.9 | — | 2 | 1 | — | — | 3 | |
Malnutrition | D044342 | EFO_0008572 | E40-E46 | — | 1 | 1 | — | — | 2 |
Bacterial pneumonia | D018410 | EFO_1001272 | J15.9 | — | — | 2 | — | — | 2 |
Vaginitis | D014627 | EFO_0005757 | N76 | 1 | — | 1 | — | — | 2 |
Candidiasis | D002177 | B37 | — | 1 | 1 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Prostatic neoplasms | D011471 | C61 | 4 | 9 | — | — | — | 12 | |
Breast neoplasms | D001943 | EFO_0003869 | C50 | 7 | 2 | — | — | — | 8 |
Ulcerative colitis | D003093 | EFO_0000729 | K51 | 1 | 3 | — | — | 1 | 5 |
Inflammatory bowel diseases | D015212 | EFO_0003767 | 1 | 1 | — | — | 1 | 3 | |
Rectal neoplasms | D012004 | 2 | 1 | — | — | — | 3 | ||
Fallopian tube neoplasms | D005185 | 3 | 1 | — | — | — | 3 | ||
Adenocarcinoma | D000230 | 1 | 1 | — | — | — | 2 | ||
Non-small-cell lung carcinoma | D002289 | 1 | 1 | — | — | — | 2 | ||
Systemic inflammatory response syndrome | D018746 | EFO_1001478 | R65.10 | — | 1 | — | — | 1 | 2 |
Ovarian epithelial carcinoma | D000077216 | 2 | 1 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Colonic neoplasms | D003110 | C18 | 2 | — | — | — | 1 | 3 | |
Lung neoplasms | D008175 | C34.90 | 2 | — | — | — | 1 | 3 | |
Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 3 | — | — | — | — | 3 |
Stomach neoplasms | D013274 | EFO_0003897 | C16 | 3 | — | — | — | — | 3 |
Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 2 | — | — | — | — | 2 |
Necrotizing enterocolitis | D020345 | EFO_0003928 | K55.3 | 1 | — | — | — | 1 | 2 |
Male breast neoplasms | D018567 | 2 | — | — | — | — | 2 | ||
Gallbladder neoplasms | D005706 | EFO_0004606 | C23 | 2 | — | — | — | — | 2 |
Therapeutic equivalency | D013810 | 2 | — | — | — | — | 2 | ||
Sclerosing cholangitis | D015209 | EFO_0004268 | K83.01 | 1 | — | — | — | 1 | 2 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Peritonsillar abscess | D000039 | EFO_0007429 | J36 | — | — | — | — | 2 | 2 |
Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 2 | 2 |
Abscess | D000038 | EFO_0003030 | — | — | — | — | 2 | 2 | |
Rectal fistula | D012003 | HP_0010447 | K60.3 | — | — | — | — | 2 | 2 |
Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 2 | 2 |
Hip osteoarthritis | D015207 | EFO_1000786 | M16 | — | — | — | — | 2 | 2 |
Disease susceptibility | D004198 | — | — | — | — | 1 | 1 | ||
Periapical diseases | D010483 | EFO_0010688 | — | — | — | — | 1 | 1 | |
Premature obstetric labor | D007752 | O60 | — | — | — | — | 1 | 1 | |
Pancreatitis | D010195 | EFO_0000278 | K85 | — | — | — | — | 1 | 1 |
Show 27 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | METRONIDAZOLE |
INN | metronidazole |
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 class | antiprotozoal substances (metronidazole type) |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | Cc1ncc([N+](=O)[O-])n1CCO |
Identifiers
PDB | — |
CAS-ID | 443-48-1 |
RxCUI | 6922 |
ChEMBL ID | CHEMBL137 |
ChEBI ID | 6909 |
PubChem CID | 4173 |
DrugBank | DB00916 |
UNII ID | 140QMO216E (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
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Financial
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Trends
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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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