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Metronidazole

Generic Name
Metronidazole
Brand Names
Flagyl, Flagystatin, Likmez, Metrocream, Metrogel, Metrolotion, Nidagel, Noritate, Nuvessa, Pylera, Rosadan, Vandazole
Drug Type
Small Molecule
Chemical Formula
C6H9N3O3
CAS Number
443-48-1
Unique Ingredient Identifier
140QMO216E

Overview

Metronidazole is a commonly used antibiotic, belonging to the nitroimidazole class of antibiotics. It is frequently used to treat gastrointestinal infections as well as trichomoniasis and giardiasis, and amebiasis which are parasitic infections. Metronidazole has been used as an antibiotic for several decades, with added antiparasitic properties that set it apart from many other antibacterial drugs, allowing it to treat a wide variety of infections. It is available in capsule form, tablet form, and topical form, and suppository preparations for the treatment of various infections.

Indication

Metronidazole is indicated for the treatment of confirmed trichomoniasis caused by Trichomonas vaginalis (except for in the first trimester of pregnancy) and the patient's sexual partners, bacterial vaginosis, certain types of amebiasis, and various anaerobic infections. The above anaerobic infections may occur on the skin and skin structures, the abdomen, the heart, reproductive organs, central nervous system, and the respiratory system. Some may also be present in the bloodstream in cases of septicemia. Common infections treated by metronidazole are Bacteroides species infections, Clostridium infections, and Fusobacterium infections, as well as Peptococcus and Peptostreptococcus infections. Topical formulations of metronidazole are indicated for the treatment of inflammatory lesions of rosacea. It is also used off-label in the treatment of Crohn's disease, as a prophylactic agent after surgery, and in the treatment of Helicobacter pylori infection. It has also been studied in the prevention of preterm births and to treat periodontal disease.

Associated Conditions

  • Abscess Brain
  • Abscess, Intra-Abdominal
  • Anaerobic Bacterial Infection
  • Bacterial Endocarditis
  • Bacterial Peritonitis
  • Bacterial Septicemia
  • Bacterial Vaginosis (BV)
  • Balantidiasis
  • Bone and Joint Infections
  • Central Nervous System Bacterial Infections
  • Empyema
  • Endometritis
  • Endomyometritis
  • Facial Rosacea
  • Giardiasis
  • Gynecological Infection
  • Helicobacter Pylori Infection
  • Inflammatory Papule
  • Inflammatory pustules
  • Liver Abscess, Amebic
  • Lower respiratory tract infection bacterial
  • Lung Abscess
  • Meningitis
  • Mixed Vaginal Infections
  • Mixed Vaginal Infections caused by Trichomonas Vaginalis, candida albicans
  • Periodontitis
  • Pneumonia
  • Postoperative Infections
  • Pouchitis
  • Skin and skin structure infections
  • Tetanus
  • Trichomonas Vaginitis
  • Tubo-ovarian abscess
  • Vaginal Candidiasis
  • Vaginitis Trichomonal
  • Vulvovaginitis
  • Acute Intestinal amebiasis
  • Asymptomatic Trichomoniasis
  • Entamoeba histolytica
  • Hepatic abscess
  • Intra-abdominal bacterial infections
  • Post-surgical vaginal cuff infection
  • Refractory Sinusitis
  • Symptomatic Trichomoniasis

Research Report

Published: May 1, 2025

Metronidazole: A Comprehensive Pharmacological and Clinical Review

I. Introduction

A. Overview

Metronidazole is a synthetic antimicrobial agent belonging to the nitroimidazole class, recognized for its potent activity against anaerobic bacteria and certain protozoa.[1] It has been a cornerstone of antimicrobial therapy for several decades, employed in the treatment of a diverse array of infections.[1] Its clinical applications span various body systems, including the gastrointestinal tract, reproductive system, skin and soft tissues, central nervous system (CNS), and bloodstream, as well as specific parasitic diseases like trichomoniasis, amebiasis, and giardiasis.[1] Metronidazole functions as a prodrug, requiring activation under low-oxygen conditions, which confers selectivity towards anaerobic and microaerophilic microorganisms.[2]

B. Historical Context & Significance

Developed in the late 1950s, metronidazole initially gained prominence for treating Trichomonas vaginalis infections.[8] Its therapeutic spectrum rapidly expanded upon discovery of its efficacy against anaerobic bacteria. Metronidazole has maintained its clinical relevance over many years, remaining a first-line or essential component of treatment regimens for numerous conditions.[8] Its distinctive profile, combining potent antibacterial effects against anaerobes with significant antiparasitic activity, sets it apart from many other antimicrobial agents and allows for its broad utility.[1]

C. Scope of Report

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/07/25
Not Applicable
Completed
Muhammad Aamir Latif
2025/02/04
Phase 1
Recruiting
2025/01/29
Phase 2
Recruiting
Hayder Adnan Fawzi
2025/01/27
Phase 2
Recruiting
AC Camargo Cancer Center
2024/12/12
N/A
Not yet recruiting
Xiuli Zuo
2024/10/09
Phase 3
Not yet recruiting
2024/10/04
Phase 2
Not yet recruiting
2024/09/27
Phase 2
Recruiting
2024/09/04
Not Applicable
Completed
2024/08/26
Phase 2
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Bryant Ranch Prepack
72162-2468
ORAL
125 mg in 1 1
4/28/2025
NuCare Pharmaceuticals,Inc.
68071-2809
ORAL
250 mg in 1 1
9/16/2022
RedPharm Drug, Inc.
67296-1418
ORAL
500 mg in 1 1
2/15/2021
AMICI PHARMACEUTICALS LLC
69292-206
ORAL
500 mg in 1 1
3/13/2021
Pharmasource Meds, LLC
82982-072
ORAL
500 mg in 1 1
11/3/2023
A-S Medication Solutions
50090-5249
ORAL
500 mg in 1 1
12/20/2021
A-S Medication Solutions
50090-0212
ORAL
500 mg in 1 1
1/7/2022
Aidarex Pharmaceuticals LLC
33261-786
VAGINAL
7.5 mg in 1 g
1/14/2014
Rebel Distributors Corp
42254-069
TOPICAL
7.5 mg in 1 g
9/21/2009
Encube Ethicals Private Limited
21922-046
VAGINAL
65 mg in 5 g
3/19/2024

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
AA PHARMA METRONIDAZOLE TABLET 250 mg
SIN03741P
TABLET
250 mg
8/13/1989
ROZEX CREAM 0.75%
SIN11198P
CREAM
0.75%
9/24/1999
TRINAZOLE TABLETS 200 mg
SIN00141P
TABLET
200 mg
3/21/1988
METRONIDAZOLE FRESENIUS SOLUTION FOR INFUSION 500 mg/100 ml
SIN11737P
INJECTION
500 mg/100 ml
11/27/2001
MEDAZOLE TABLETS 200 mg
SIN02391P
TABLET
200 mg
11/23/1988
FLAGYSTATIN VAGINAL OVULE
SIN03798P
SUPPOSITORY
500 mg
2/1/1990
NIZOLE TABLET 200 mg
SIN08077P
TABLET
200MG
3/18/1995
ROZEX GEL 0.75%
SIN08453P
GEL
0.75%
11/30/1995
METRONIDAZOLE INTRAVENOUS INFUSION 500 mg/100 ml
SIN01260P
INJECTION
5.000g/1000ml
5/14/1988
AXCEL METRONIDAZOLE-200 TABLETS 200 mg
SIN10509P
TABLET
200 mg
12/5/1998

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
PMS-METRONIDAZOLE 250MG/TAB
00584339
Tablet - Oral
250 MG
12/31/1984
METRONIDAZOLE
sanis health inc
02534592
Capsule - Oral
500 MG
12/21/2023
APO-METRONIDAZOLE
02406470
Tablet - Oral
250 MG
N/A
NIDAGEL
bausch health, canada inc.
02125226
Gel - Vaginal
0.75 % / W/W
12/31/1994
APO-METRONIDAZOLE
02406489
Capsule - Oral
500 MG
N/A
ROSASOL
02242919
Cream - Topical
1.0 %
3/28/2001
APO-METRONIDAZOLE
02248562
Capsule - Oral
500 MG
11/27/2003
M-METRONIDAZOLE
mantra pharma inc
02519755
Capsule - Oral
500 MG
3/4/2022
AURO-METRONIDAZOLE
auro pharma inc
02470284
Capsule - Oral
500 MG
4/3/2018
FLAGYL
sanofi-aventis canada inc
01926853
Capsule - Oral
500 MG
12/31/1979

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
METRONIDAZOL ALTAN 5 MG/ML SOLUCION PARA PERFUSION EFG
Altan Pharmaceuticals Sa
68091
SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
FLAGYL 500 mg SOLUCION PARA PERFUSION
Sanofi Aventis S.A.
55233
SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Not Commercialized
BLASGINA OVULOS VAGINALES
50441
ÓVULO
Medicamento Sujeto A Prescripción Médica
Commercialized
METRONIDAZOL NORMON 5 MG/ML SOLUCIÓN PARA PERFUSIÓN EFG
Laboratorios Normon S.A.
62224
SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
FLAGYL 1500 mg SOLUCION PARA PERFUSION
Sanofi Aventis S.A.
59325
SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Not Commercialized
METRONIDAZOL/ESPIRAMICINA FARMALIDER 250 MG/1,5 MUI COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Farmalider S.A.
86717
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica
Not Commercialized
INTIZOL VAGINAL 1.000 MG OVULOS
Seid S.A.
89284
ÓVULO
Medicamento Sujeto A Prescripción Médica
Not Commercialized
METRONIDAZOL AUROVITAS 250 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Aurovitas Spain, S.A.U.
84614
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica
Commercialized
ZIDOVAL 7,5 mg/g GEL VAGINAL
Meda Pharma S.L.
63692
GEL VAGINAL
Medicamento Sujeto A Prescripción Médica
Not Commercialized
METRONIDAZOL NORMON 250 mg COMPRIMIDOS EFG
Laboratorios Normon S.A.
62223
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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