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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.

Background

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
2025/02/04
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
2024/07/19
Not Applicable
Not yet recruiting
General Committee of Teaching Hospitals and Institutes, Egypt

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
Metronidazole Capsules
国药准字H32024845
化学药品
胶囊剂
8/11/2020
Metronidazole Capsules
国药准字H61021594
化学药品
胶囊剂
7/14/2022
Metronidazole Capsules
国药准字H33021102
化学药品
胶囊剂
4/22/2020
Metronidazole Capsules
国药准字H42020404
化学药品
胶囊剂
9/7/2020
Metronidazole Capsules
国药准字H23023215
化学药品
胶囊剂
3/9/2020
Metronidazole Capsules
国药准字H33020321
化学药品
胶囊剂
4/30/2020
Metronidazole Capsules
国药准字H32022757
化学药品
胶囊剂
8/13/2020
Metronidazole Capsules
国药准字H32021956
化学药品
胶囊剂
8/11/2020
Metronidazole Capsules
国药准字H22021046
化学药品
胶囊剂
5/25/2020
Metronidazole Capsules
国药准字H13022249
化学药品
胶囊剂
10/18/2020
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