Prescription medicine
Metronidazole Brand names: Likmez, Nuvessa, Noritate, Flagyl, Vandazole
Metronidazole (Flagyl) is a prescription medicine with an FDA approval on record since 1963. FDA's NDC Directory lists it from 55 generic labelers, and pharmacies paid $0.102 per metronidazole 250 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $2.60 per mL (Likmez 500 mg/5 mL suspension).
- Generic listed
- In shortage
- Boxed warning
Check it at the source: the metronidazole FDA label on DailyMed (effective September 3, 2024, Aurobindo Pharma Limited); the NDA 12623 record on Drugs@FDA; every metronidazole label on DailyMed.
Highlights of the record
FDA label of September 3, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Metronidazole has been shown to be carcinogenic in mice and rats (see PRECAUTIONS ). Unnecessary use of the drug should be avoided. Its use should be reserved for the conditions described in the INDICATIONS AND USAGE section below.
Used for
From the label: indications and usageSymptomatic Trichomoniasis.
Forms and strengths
- 125 mg
- 250 mg
- 375 mg
- 500 mg
- 750 mg
- 5 mg/ml
- 7.5 mg/g
- 7.5 mg/ml
- 10 mg/g
- 10 mg/60g
- 65 mg/5g
- 100 mg/ml
Tablet; film-coated tablet; gel; cream; injection (solution).
On the market
- Earliest approval on file
- July 18, 1963 Flagyl, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 55 first December 6, 1984; 39 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 67 of which 55 under generic applications, 10 under brand applications, repackagers included
- Last listed patent
- October 4, 2039 Likmez oral suspension; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.102 per tablet Metronidazole 250 mg tablet
- Shortage (FDA)
- 3 of 4 presentations limited or unavailable updated October 6, 2026
- Recalls by its makers (FDA)
- 7 since 2011 1 Class I among all firms' recalls; latest April 13, 2022; 2 more by firms not listed as its makers
- FAERS reports
- 63,553 through July 30, 2026
What is metronidazole used for?
From the label: indications and usageSymptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. […]
Conditions named in the indications of metronidazole's FDA labels, with every medicine labeled for each:
From other metronidazole labelsBacterial infections: Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
FDA pharmacologic class: Nitroimidazole Antimicrobial.
Source: FDA drug label (Metronidazole), Aurobindo Pharma Limited, effective September 3, 2024 (SPL set f68397ee-67db-472e-8607-4300064e37df), via openFDA; the full label on DailyMed
Is there a generic for metronidazole (Flagyl)?
The FDA approved the first generic metronidazole on December 6, 1984. 55 generic applications are approved; 39 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists metronidazole from 55 labelers under a generic (ANDA) application and from 10 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Flagyl I.V. Rtu In Plastic Container injection; a patent listed only for Likmez oral suspension runs to October 4, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1963 earliest approval on file
- 1984 first generic approved
- 2039 last listed patent
- 2022 to now in shortage
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for metronidazole (Flagyl)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.102 per Metronidazole 250 mg tablet, up 10% from $0.0924 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Metronidazole 250 mg tablet (generic)
- Likmez 500 mg/5 mL suspension (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Metronidazole 0.75% cream | Generic | $0.257 per gram | n/a | -20% |
| Metronidazole 0.75% lotion | Generic | $1.82 per mL | n/a | -5% |
| Metronidazole 250 mg tablet | Generic | $0.102 per tablet | $3.05 | +10% |
| Metronidazole 375 mg capsule | Generic | $7.31 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $219.24 | -3% |
| Metronidazole 500 mg tablet | Generic | $0.104 per tablet | $3.13 | +1% |
| Metronidazole top 1% gel pump | Generic | $0.540 per gram | n/a | -27% |
| Metronidazole topical 0.75% gl | Generic | $0.179 per gram | n/a | -56% |
| Metronidazole topical 1% gel | Generic | $0.621 per gram | n/a | -22% |
| Metronidazole vaginal 0.75% gl | Generic | $0.141 per gram | n/a | -22% |
| Likmez 500 mg/5 mL suspension | Brand | $2.60 per mL | n/a | -0.2% |
| Nuvessa vaginal 1.3% gel | Brand | $43.03 per gram | n/a | +5% |
| Vandazole vaginal 0.75% gel | Brand | $0.334 per gram | n/a | -41% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is metronidazole in shortage?
The FDA Drug Shortage Database lists 3 of 4 metronidazole presentations as limited or unavailable (updated October 6, 2026); the first entry was posted on January 13, 2022. 1 more presentation is on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Flagyl I.v. Rtu In Plastic Container, Injection, 500 mg/100 mL (NDC 0338-1055-48) | Baxter Healthcare | Current | October 2, 2026 |
| Metronidazole In Plastic Container, Injection, 500 mg/100 mL (NDC 47335-993-01) | Gland Pharma Limited | Current | July 22, 2026 |
| Metronidazole in Flexible Container, Injection, 500 mg/100 mL (NDC 0409-0152-24) | InfoRLife SA | Current | October 6, 2026 |
| Metronidazole, Injection, 500 mg/100 mL (NDC 25021-131-82) | InfoRLife SA | Current | August 18, 2026 |
Every metronidazole presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has metronidazole been recalled?
The FDA's Enforcement Report lists 9 recalls naming metronidazole since 2011: 1 Class I (the most serious), 8 Class II, 0 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of metronidazole and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 27, 2022 | Class II | Sentara Infusion Services not a listed maker | Lack of sterility assurance |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| March 10, 2017 | Class II | Claris Lifesciences Inc | Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination … |
| February 10, 2017 | Class II | Hospira Inc., A Pfizer Company | Lack of Sterility Assurance: customer report of leaking bag |
| July 7, 2016 | Class II | Safecor Health, LLC not a listed maker | CGMP Deviations |
| January 21, 2016 | Class I | Baxter Healthcare Corp. | Presence of Particulate Matter: identified as a cloth fiber. |
| May 21, 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. … |
| February 15, 2013 | Class II | Hospira Inc. | Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the metronidazole label say about other medicines?
The metronidazole label names 14 other medicines in its interaction, contraindication or warning sections. The labels of 24 other medicines name metronidazole. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | drug interactions | Cytochrome P450 3A4 (CYP3A4) substrates Concomitant use of Metronidazole Injection and CYP3A4 substrates (e.g., amiodarone, tacrolimus, cyclosporine, carbamazepine, phenytoin, and quinidine) may increase respective CYP3A4-substrate plasma levels. |
| Busulfan | drug interactions | Busulfan Metronidazole has been reported to increase plasma concentrations of busulfan, which can result in an increased risk for serious busulfan toxicity. |
| Carbamazepine | drug interactions | Cytochrome P450 3A4 (CYP3A4) substrates Concomitant use of Metronidazole Injection and CYP3A4 substrates (e.g., amiodarone, tacrolimus, cyclosporine, carbamazepine, phenytoin, and quinidine) may increase respective CYP3A4-substrate plasma levels. |
| Cimetidine | drug interactions | Drugs that Inhibit CYP450 Enzymes The simultaneous administration of drugs that decrease microsomal liver enzyme activity, such as cimetidine, may prolong the half-life and decrease plasma clearance of metronidazole. |
| Cyclosporine | drug interactions | Cytochrome P450 3A4 (CYP3A4) substrates Concomitant use of Metronidazole Injection and CYP3A4 substrates (e.g., amiodarone, tacrolimus, cyclosporine, carbamazepine, phenytoin, and quinidine) may increase respective CYP3A4-substrate plasma levels. |
| Disulfiram | contraindications | Psychotic Reaction with Disulfiram Use of oral metronidazole is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently. |
| Fluorouracil | drug interactions | Fluorouracil Metronidazole Injection decreases the clearance of 5-fluorouracil and may therefore cause 5-fluorouracil toxicity. |
| Lithium | drug interactions | Lithium In patients stabilized on relatively high doses of lithium, short-term metronidazole therapy has been associated with elevation of serum lithium and, in a few cases, signs of lithium toxicity. |
| Phenobarbital | drug interactions | Drugs that Induce CYP450 Enzymes The simultaneous administration of drugs that induce microsomal liver enzymes, such as phenytoin or phenobarbital, may accelerate the elimination of metronidazole, resulting in reduced plasma levels; impaired clearance of phenytoin has also been reported. |
| Phenytoin | drug interactions | Drugs that Induce CYP450 Enzymes The simultaneous administration of drugs that induce microsomal liver enzymes, such as phenytoin or phenobarbital, may accelerate the elimination of metronidazole, resulting in reduced plasma levels; impaired clearance of phenytoin has also been reported. |
| Quinidine | drug interactions | Cytochrome P450 3A4 (CYP3A4) substrates Concomitant use of Metronidazole Injection and CYP3A4 substrates (e.g., amiodarone, tacrolimus, cyclosporine, carbamazepine, phenytoin, and quinidine) may increase respective CYP3A4-substrate plasma levels. |
| Tacrolimus | drug interactions | Cytochrome P450 3A4 (CYP3A4) substrates Concomitant use of Metronidazole Injection and CYP3A4 substrates (e.g., amiodarone, tacrolimus, cyclosporine, carbamazepine, phenytoin, and quinidine) may increase respective CYP3A4-substrate plasma levels. |
| Vecuronium | drug interactions | Vecuronium Metronidazole Injection may potentiate the effects of vecuronium. |
| Warfarin | drug interactions | Warfarin and other Oral Anticoagulants Metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time. |
Other labels that name metronidazole
Source: FDA drug label (Metronidazole), Aurobindo Pharma Limited, effective September 3, 2024 (SPL set f68397ee-67db-472e-8607-4300064e37df), via openFDA; the full label on DailyMed
What do FAERS reports show for metronidazole?
The FDA Adverse Event Reporting System holds 63,553 reports that list metronidazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6,852 are coded as a death and 27,061 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as metronidazole?
23 other medicines are given the same way (oral) and in the same FDA class as metronidazole or labeled mainly for the same use (bacterial infections), the same class first. Bacterial infections lists all 51 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Amoxicillin | Bacterial infections | 38 labelers | $0.0788 per capsule 500 mg capsule | No current entry |
| Azithromycin | Bacterial infections | 47 labelers | $0.266 per tablet 250 mg tablet | A presentation being discontinued |
| Cephalexin | Bacterial infections | 36 labelers | $0.120 per capsule 500 mg capsule | No current entry |
| Clindamycin | Bacterial infections | 40 labelers | $0.103 per capsule 150 mg capsule | In shortage |
| Sulfamethoxazole and trimethoprim | Bacterial infections | 42 labelers | $0.0448 per tablet Sulfamethoxazole-tmp ds tablet | No current entry |
| Levofloxacin | Bacterial infections | 35 labelers | $0.259 per tablet 750 mg tablet | No current entry |
| Cefdinir | Bacterial infections | 26 labelers | $0.458 per capsule 300 mg capsule | No current entry |
| Erythromycin | Bacterial infections | 22 labelers | $1.96 per tablet 250 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does metronidazole compare with medicines for the same use?
15 side-by-side pages set metronidazole beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other nitroimidazole antimicrobials
- the pharmacologic class, with prices and generics
- Metronidazole side effects
- the label's list beside FAERS reports
- Metronidazole shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other