This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
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 ).
Listed on the WHO Model List of Essential Medicines (antibiotic stewardship group: KeyAccessGroup, AccessGroup): a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
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...
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) ] ...
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...
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 ...
Source: FDA SPL label for LIKMEZ (Kesin Pharma Corporation), effective 20241230. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 5,285 | 4,671 | 4,438 | 3,575 | 3,632 | 3,303 | 3,569 | 1,539 |
3,681 reports blaming this drug for every million Medicare prescriptions filled, which is 1.3× the typical drug on this site. (8,342 reports in 2024–2026, against 2,265,997 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 01/2016 | Class I | Baxter Healthcare Corp. | Presence of Particulate Matter: identified as a cloth fiber. |
| 05/2013 | Class II | Baxter Healthcare Corp. | 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 |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $2,871 in payments to US physicians and hospitals tied to this drug across 165 transactions (Nuvessa $2,871).
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Metronidazole | 2,260,622 | $25 |
| Vandazole | 3,115 | $69 |
| Noritate | 1,632 | $1,997 |
| Nuvessa | 534 | $243 |
| Metrogel | 83 | $485 |
| Flagyl | 11 | $90 |
4 drugs in the same class grade a letter or more higher than metronidazole on this site. Worth asking whether one of them would do the same job for you.
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.