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
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
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. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| TOLIZOLE CAPSULES 250MG | N/A | N/A | N/A | 9/4/2017 | |
| ROSAMED GEL 0.75% W/W | N/A | N/A | N/A | 7/17/2019 | |
| METRONIDAZOLE COOPER SOLUTION FOR INFUSION 500MG/100ML | N/A | N/A | N/A | 12/9/2024 | |
| METRONIDAZOLE CAP 200MG | N/A | N/A | N/A | 2/20/1990 | |
| METOLE TAB 200MG | N/A | N/A | N/A | 3/24/1999 | |
| SYNEODALIN TAB 200MG | N/A | N/A | N/A | 5/19/1987 | |
| METRONIDAZOLE TAB 200MG | N/A | N/A | N/A | 5/5/1983 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| METROGYL 400 metronidazole 400mg tablet bottle | 17655 | Medicine | A | 9/20/1991 | |
| METRONIDAZOLE JUNO metronidazole 500mg/100mL solution for injection bag | 129476 | Medicine | A | 5/10/2007 | |
| METRONIDAZOLE MEDSURGE metronidazole 200 mg tablet blister pack | 407005 | Medicine | A | 7/11/2024 | |
| METROGYL 200 metronidazole 200mg tablet bottlet | 17654 | Medicine | A | 9/20/1991 | |
| METRONIDAZOLE NORIDEM, metronidazole 500mg/100mL solution for injection bottle | 384574 | Medicine | A | 3/27/2023 | |
| METRONIDAMED metronidazole 200 mg tablet blister pack | 407007 | Medicine | A | 7/11/2024 | |
| METRONIDAZOLE MEDICIANZ metronidazole 400 mg tablet blister pack | 407009 | Medicine | A | 7/11/2024 | |
| Metronidazole Intravenous Infusion (metronidazole) 5mg/mL (0.5%) injection vial | 12728 | Medicine | A | 8/13/1991 | |
| ROZEX GEL | 15211 | Medicine | A | 9/9/1991 | |
| FLAGYL metronidazole 400 mg tablet blister pack | 160174 | Medicine | A | 6/22/2009 |
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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