{
 "query": "metronidazole",
 "ingredient": "metronidazole",
 "slug": "metronidazole",
 "rxcui": "6922",
 "brands": [
  "Vandazole",
  "Noritate",
  "Nuvessa",
  "MetroGel",
  "Flagyl",
  "Likmez",
  "MetroCream",
  "MetroLotion",
  "Nydamax",
  "Rosadan"
 ],
 "names": [
  "metronidazole",
  "metronidazole benzoate",
  "metronidazole hydrochloride"
 ],
 "classes": [
  {
   "id": "P01AB",
   "name": "Nitroimidazole derivatives"
  },
  {
   "id": "A01AB",
   "name": "Antiinfectives and antiseptics for local oral treatment"
  },
  {
   "id": "G01AF",
   "name": "Imidazole derivatives"
  },
  {
   "id": "J01XD",
   "name": "Imidazole derivatives"
  }
 ],
 "alternatives": [
  "amphotericin b",
  "benzoxonium chloride",
  "butoconazole",
  "chlorhexidine",
  "chlortetracycline",
  "clotrimazole",
  "domiphen",
  "doxycycline",
  "econazole",
  "fenticonazole",
  "flutrimazole",
  "hexetidine",
  "hydrogen peroxide",
  "isoconazole",
  "ketoconazole",
  "miconazole",
  "minocycline",
  "natamycin",
  "neomycin",
  "nimorazole",
  "octenidine",
  "omoconazole",
  "ornidazole",
  "oxiconazole",
  "oxyquinoline",
  "oxytetracycline",
  "polynoxylin",
  "secnidazole",
  "sertaconazole",
  "sodium perborate",
  "tetracycline",
  "tibezonium iodide",
  "tinidazole",
  "tioconazole"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 101,
   "TOPICAL": 27,
   "VAGINAL": 16,
   "INTRAVENOUS": 8,
   "CUTANEOUS": 1
  },
  "boxed_warning": "WARNING: POTENTIAL FOR CARCINOGENICITY Metronidazole has been shown to be carcinogenic in mice and rats [ see Warnings and Precautions (5.1) ] . Avoid unnecessary use of LIKMEZ. Reserve LIKMEZ for use in the following indications: trichomoniasis [see Indications and Usage (1.1) ] , amebiasis [ see Indications and Usage (1.2) ] and anaerobic bacterial infections [ see Indications and Usage (1.3) ]. WARNING: POTENTIAL FOR CARCINOGENICITY See full prescribing information for complete boxed warning. Metronidazole has been shown to be carcinogenic in mice and rats ( 5.1 ). Avoid unnecessary use of LIKMEZ. Reserve LIKMEZ for use in the following indications: trichomoniasis ( 1.1 ), amebiasis ( 1.2 ) and anaerobic bacterial infections ( 1.3 ).",
  "indications_and_usage": "is a nitroimidazole antimicrobial indicated for Trichomoniasis in adults ( 1.1 ) Amebiasis in adults and pediatric patients ( 1.2 ) Anaerobic Bacterial Infections in adults ( 1.3 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of LIKMEZ and other antibacterial drugs, LIKMEZ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria ( 1.4 ). 1.1 Trichomoniasis LIKMEZ is indicated for the treatment of: Symptomatic trichomoniasis caused by Trichomonas vaginalis in adult females and males when the diagnosis is confirmed by appropriate laboratory procedures. Asymptomatic trichomoniasis caused by Trichomonas vaginalis in adult females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, treat sexual partners of patients simultaneously to prevent re-infection. 1.2 Amebiasis LIKMEZ is indicated for the treatment of acute intestinal amebiasis (amoebic dysentery) and amebic liver abscess in adults and pediatric patients. In amebic liver abscess, treatment with LIKMEZ does not o...",
  "contraindications": "Prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives ( 4.1 ) Patients who have used disulfiram within the last two weeks. ( 4.2 , 7.1 ) Patients who consume alcohol or products containing propylene glycol during and for at least three days after LIKMEZ therapy. ( 4.3 , 7.2 ) Patients with Cockayne syndrome ( 4.4 , 6.2 ) 4.1 Hypersensitivity Reactions LIKMEZ is contraindicated in patients with known hypersensitivity to metronidazole or other nitroimidazole derivatives [ see Adverse Reactions (6.1) ] . 4.2 Psychotic Reactions with Disulfiram LIKMEZ is contraindicated in patients who have used disulfiram within the last two weeks. Use of oral metronidazole is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently [ see Drug Interactions (7.1) ] . 4.3 Interaction with Alcohol LIKMEZ is contraindicated in patients who consume alcohol or products containing propylene glycol during and for at least three days after LIKMEZ therapy. Use of oral metronidazole is associated with a disulfiram-like reaction to alcohol, including abdominal cramps, nausea, vomiting, headaches, and flushing [ see Drug Interactions (7.2) ] ...",
  "warnings_and_cautions": "Central and Peripheral Nervous System Effects: Encephalopathy, convulsive seizures, aseptic meningitis and peripheral neuropathy have been reported with metronidazole. Promptly evaluate the benefit/risk of continuation of LIKMEZ if abnormal neurological signs develop. ( 5.2 ) Blood Dyscrasias : Use LIKMEZ with care in patients with a history of blood dyscrasias. LIKMEZ may cause mild transient leukopenia. ( 5.4 ) 5.1 Potential for Carcinogenicity Metronidazole has been shown to be carcinogenic in mice and rats. Tumors affecting the liver, lungs, mammary, and lymphatic tissues have been detected in several studies of metronidazole in rats and mice, but not hamsters [ see Nonclinical Toxicology (13.1) ] . Avoid unnecessary use of LIKMEZ. Reserve LIKMEZ for use in the following indications: trichomoniasis [ see Indications and Usage (1.1) ] , amebiasis [ see Indications and Usage (1.2) ] and anaerobic bacterial infections [ see Indications and Usage (1.3) ]. 5.2 Central and Peripheral Nervous System Effects Encephalopathy, aseptic meningitis, peripheral neuropathy (including optic neuropathy) and convulsive seizures have been reported with metronidazole. Encephalopathy has been report...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: Central and Peripheral Nervous System Effects [ see Warnings and Precautions (5.2) ] Blood Dyscrasias [ see Warnings and Precautions (5.4 )] Common adverse reactions include nausea, headache, anorexia, vomiting, diarrhea, abdominal cramping, epigastric distress, and constipation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Saptalis Pharmaceuticals, LLC at 1-833-727-8254 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following reactions have been reported during treatment with metronidazole: Central and Peripheral Nervous System: The most serious adverse reactions reported in patients treated with metronidazole have been convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an ...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information). Administration Instructions Instruct the patients and caregivers to: Ensure the prescribed dose of LIKMEZ oral suspension is taken as directed [ see Dosage and Administration (2) ]. Use a calibrated oral dosing device to correctly measure the prescribed dose of medication. Do not use a household teaspoon or tablespoon to measure doses. Calibrated oral dosing devices may be obtained from the pharmacy. Shake LIKMEZ oral suspension well before use each time. Alcohol or Products Containing Propylene Glycol Advise patients to avoid consumption of alcoholic beverages and preparations containing ethanol or propylene glycol during LIKMEZ therapy and for 3 days afterward because abdominal cramps, nausea, vomiting, headaches, and flushing may occur [ see Contraindications (4.3) and Drug Interactions (7.2) ] . Lactation Advise lactating women that they may choose to pump and discard human milk for the duration of LIKMEZ therapy and for 48 hours after the last dose and feed her infant stored human milk or formula [ see Use in Specific Populations (8.2) ] . Central and Peripheral Nervous System Effects Inform pa...",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "LIKMEZ",
  "manufacturer": "Kesin Pharma Corporation",
  "application_number": "NDA216755",
  "pharm_class_epc": [
   "Nitroimidazole Antimicrobial [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20241230",
  "set_id": "23927a8b-1641-4104-aa85-d7b7bf4ebb9d",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 45787,
  "serious": 38612,
  "death": 4610,
  "hospitalization": 17777,
  "primary_suspect": 45639,
  "top_reactions": [
   [
    "Drug Ineffective",
    4882
   ],
   [
    "Off Label Use",
    3486
   ],
   [
    "Nausea",
    3308
   ],
   [
    "Diarrhoea",
    2542
   ],
   [
    "Headache",
    2299
   ],
   [
    "Vomiting",
    2093
   ],
   [
    "Fatigue",
    2070
   ],
   [
    "Pyrexia",
    2061
   ],
   [
    "Abdominal Pain",
    1950
   ],
   [
    "Pain",
    1944
   ],
   [
    "Condition Aggravated",
    1709
   ],
   [
    "Acute Kidney Injury",
    1630
   ],
   [
    "Dizziness",
    1622
   ],
   [
    "Malaise",
    1478
   ],
   [
    "Dyspnoea",
    1447
   ]
  ],
  "by_year": {
   "2019": 5285,
   "2020": 4671,
   "2021": 4438,
   "2022": 3575,
   "2023": 3632,
   "2024": 3303,
   "2025": 3569,
   "2026": 1539
  },
  "by_year_primary": {
   "2019": 5282,
   "2020": 4671,
   "2021": 4408,
   "2022": 3556,
   "2023": 3611,
   "2024": 3284,
   "2025": 3541,
   "2026": 1517
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class I",
   "date": "20160121",
   "reason": "Presence of Particulate Matter: identified as a cloth fiber.",
   "firm": "Baxter Healthcare Corp.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20130521",
   "reason": "Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the",
   "firm": "Baxter Healthcare Corp.",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 93,
  "nda": 29,
  "anda": 55,
  "first_approval": "19630718",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 197,
  "labeling_recent": 55,
  "sponsors": [
   "ABBOTT",
   "ABLE",
   "ABRAXIS PHARM",
   "ALEMBIC",
   "ALEMBIC PHARMS LTD",
   "ALEMBIC THERAP",
   "AMNEAL",
   "AMVIKA"
  ],
  "unapproved": false,
  "first_approval_fmt": "07/18/1963"
 },
 "trials": {
  "total": 1410,
  "completed": 727,
  "terminated": 103,
  "with_results": 174,
  "industry": 260,
  "phase3": 138,
  "results_share": 0.2393397524071527,
  "terminated_share": 0.07304964539007092
 },
 "pubmed": {
  "rct": 861,
  "meta": 76,
  "recent_rct": 56,
  "cochrane": [
   {
    "pmid": "41631546",
    "title": "Aminoglycosides, vancomycin, and metronidazole for people with cirrhosis and hepatic encephalopathy",
    "year": "2026"
   },
   {
    "pmid": "19160244",
    "title": "Image-guided percutaneous procedure plus metronidazole versus metronidazole alone for uncomplicated amoebic liver abscess",
    "year": "2009"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 2871.1,
  "records": 165,
  "by_name": [
   [
    "Nuvessa",
    2871.1
   ]
  ],
  "names_checked": [
   "metronidazole",
   "Vandazole",
   "Noritate",
   "Nuvessa",
   "MetroGel",
   "Flagyl",
   "Likmez",
   "MetroCream",
   "MetroLotion",
   "Nydamax",
   "Rosadan"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2265997,
  "beneficiaries": 1633328,
  "spend": 60051535.87,
  "by_brand": [
   {
    "brand": "Metronidazole",
    "claims": 2260622,
    "per_claim": 24.951678189,
    "is_generic": true
   },
   {
    "brand": "Vandazole",
    "claims": 3115,
    "per_claim": 69.093707865,
    "is_generic": false
   },
   {
    "brand": "Noritate",
    "claims": 1632,
    "per_claim": 1997.0148407,
    "is_generic": false
   },
   {
    "brand": "Nuvessa",
    "claims": 534,
    "per_claim": 242.75220974,
    "is_generic": false
   },
   {
    "brand": "Metrogel",
    "claims": 83,
    "per_claim": 484.8773494,
    "is_generic": false
   },
   {
    "brand": "Flagyl",
    "claims": 11,
    "per_claim": 90.327272727,
    "is_generic": false
   }
  ],
  "per_claim": 26.501154180698386
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "metronidazole",
  "matched": "metronidazole",
  "stewardship": [
   "KeyAccessGroup",
   "AccessGroup"
  ]
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 8342,
  "fills": 2265997,
  "per_million": 3681.3817494021396,
  "ratio": 1.3295227709938262,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 53,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "3,681 FDA reports naming it as the suspect drug per million Medicare fills, 1.3x the median drug on this site (-2)",
    "Death share in reports is near or below the FAERS average (1.1x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)",
    "1 Class I recall(s): reasonable probability of serious harm (-10)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 69,
   "letter": "C",
   "why": [
    "861 randomized trials and 76 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "2 independent Cochrane review(s) exist",
    "Only 24% of completed registered trials posted results (-15)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 77,
   "letter": "B",
   "why": [
    "Recalls since 2016: 1 Class I, 0 Class II, 0 Class III across 55 generic makers (-15)",
    "55 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $2,871 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (55 applications)",
    "34 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 72,
 "grade": "C",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are nausea, diarrhoea. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over amphotericin b, benzoxonium chloride, butoconazole? What would make you pick one of those instead?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}