Prescription medicine
Linezolid Brand names: Zyvox
Linezolid (Zyvox) is a prescription medicine with an FDA approval on record since 2000. FDA's NDC Directory lists it from 24 generic labelers, and pharmacies paid $1.44 per linezolid 600 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the linezolid FDA label on DailyMed (effective June 19, 2026, Hospira, Inc.); the NDA 21131 record on Drugs@FDA; every linezolid label on DailyMed.
Highlights of the record
FDA label of June 19, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageLinezolid injection is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia ( 1.1 );
Forms and strengths
- 600 mg
- 2 mg/ml
- 100 mg/5ml
- 200 mg/100ml
- 600 mg/300ml
Injection (solution); film-coated tablet; tablet; granule for suspension; injection.
On the market
- Earliest approval on file
- April 18, 2000 Zyvox, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 25 first June 27, 2012; 20 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 27 of which 24 under generic applications, 3 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $1.44 per tablet Linezolid 600 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2016 1 Class I among all firms' recalls; latest March 27, 2018
- FAERS reports
- 29,594 through July 30, 2026
What is linezolid used for?
From the label: indications and usageLinezolid injection is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia ( 1.1 ); Community-acquired pneumonia ( 1.2 ); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis ( 1.3 ); Vancomycin-resistant Enterococcus faecium infections. ( 1.4 ) Limitations of Use: ( 1.5 )
Linezolid injection is not indicated for the treatment of Gram-negative infections.
The safety and efficacy of Linezolid formulations given for longer than 28 days have not been evaluated in controlled clinical trials. […]
Conditions named in the indications of linezolid's FDA labels, with every medicine labeled for each:
From other linezolid labelsBacterial infections: Linezolid injection is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below.
FDA pharmacologic class: Oxazolidinone Antibacterial.
Source: FDA drug label (Linezolid), Hospira, Inc., effective June 19, 2026 (SPL set c401f1a8-cc37-461b-bfef-f2e156629bf8), via openFDA; the full label on DailyMed
Is there a generic for linezolid (Zyvox)?
The FDA approved the first generic linezolid on June 27, 2012. 25 generic applications are approved; 20 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 linezolid from 24 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2000 earliest approval on file
- 2012 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for linezolid (Zyvox)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.44 per Linezolid 600 mg tablet, down 2% from $1.47 on October 8, 2025. 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.
- Linezolid 600 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Linezolid 100 mg/5 mL suspension | Generic | $2.74 per mL | n/a | +13% |
| Linezolid 600 mg tablet | Generic | $1.44 per tablet | $43.23 | -2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has linezolid been recalled?
The FDA's Enforcement Report lists 4 recalls naming linezolid since 2016: 1 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 27, 2018 | Class II | AuroMedics Pharma LLC | Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap |
| December 20, 2017 | Class I | AuroMedics Pharma LLC | Presence of Particulate Matter; white particulate matter identified as mold was found in one bag |
| June 17, 2016 | Class II | Teva North America | CGMP Deviations |
| April 27, 2016 | Class II | Teva North America | Lack of Assurance of Sterility: Due to potential for leaking bags. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the linezolid label say about other medicines?
The linezolid label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 30 other medicines name linezolid. 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 |
|---|---|---|
| Buspirone | warnings and precautions | Commonly used serotonergic agents include serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, buspirone, serotonin 5-HT1 receptor agonists (triptans), and opioids, including meperidine. |
| Dicloxacillin | warnings and precautions | Imbalance in an Investigational Study in Patients With Catheter-Related Bloodstream Infections, Including Those With Catheter-Site Infections An imbalance in mortality was seen in patients treated with linezolid relative to vancomycin/dicloxacillin/oxacillin in an open-label study in seriously ill patients with … |
| Dobutamine | warnings and precautions | … pseudoephedrine), vasopressive agents (e.g., epinephrine, norepinephrine), dopaminergic agents (e.g., dopamine, dobutamine) [ see Drug Interactions (7) and Clinical Pharmacology (12.3) ]. |
| Epinephrine | warnings and precautions | … directly and indirectly acting sympathomimetic agents (e.g., pseudoephedrine), vasopressive agents (e.g., epinephrine, norepinephrine), dopaminergic agents (e.g., dopamine, dobutamine) [ see Drug Interactions (7) and Clinical Pharmacology (12.3) ]. |
| Isocarboxazid | contraindications | Linezolid should not be used in patients taking any medicinal product which inhibits monoamine oxidases A or B (e.g., phenelzine, isocarboxazid) or within two weeks of taking any such medicinal product. |
| Meperidine | warnings and precautions | Commonly used serotonergic agents include serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, buspirone, serotonin 5-HT1 receptor agonists (triptans), and opioids, including meperidine. |
| Oxacillin | warnings and precautions | Imbalance in an Investigational Study in Patients With Catheter-Related Bloodstream Infections, Including Those With Catheter-Site Infections An imbalance in mortality was seen in patients treated with linezolid relative to vancomycin/dicloxacillin/oxacillin in an open-label study in seriously ill patients with … |
| Phenelzine | contraindications | Linezolid should not be used in patients taking any medicinal product which inhibits monoamine oxidases A or B (e.g., phenelzine, isocarboxazid) or within two weeks of taking any such medicinal product. |
| Pseudoephedrine | warnings and precautions | … taking any of the following types of medications: directly and indirectly acting sympathomimetic agents (e.g., pseudoephedrine), vasopressive agents (e.g., epinephrine, norepinephrine), dopaminergic agents (e.g., dopamine, dobutamine) [ see Drug Interactions (7) and Clinical Pharmacology (12.3) ]. |
| Vancomycin | warnings and precautions | Imbalance in an Investigational Study in Patients With Catheter-Related Bloodstream Infections, Including Those With Catheter-Site Infections An imbalance in mortality was seen in patients treated with linezolid relative to vancomycin/dicloxacillin/oxacillin in an open-label study in seriously ill patients with … |
Other labels that name linezolid
- Acetaminophen and benzhydrocodone
- Amphetamine
- Atomoxetine
- Buprenorphine
- Bupropion
- Butorphanol
- Carbidopa and levodopa
- Citalopram
- Clomipramine
- Codeine
- Desipramine
- Desvenlafaxine
- Dextroamphetamine
- Dopamine
- Droxidopa
- Duloxetine
- Escitalopram
- Fentanyl
- Fluoxetine
- Fluvoxamine
- Gepirone
- Hydrocodone
- Hydromorphone
- Levomilnacipran
- Levorphanol
- Lisdexamfetamine
- Metaxalone
- Methadone
- Methamphetamine
- Methylene blue
- Milnacipran
- Mirtazapine
- Morphine
- Nalbuphine
- Naloxone and pentazocine
- Norepinephrine
- Nortriptyline
- Oliceridine
- Oxycodone
- Ozanimod
- Paroxetine
- Pretomanid
- Remifentanil
- Selegiline
- Sertraline
- Sufentanil
- Tapentadol
- Tramadol
- Trazodone
- Trimipramine
- Venlafaxine
- Vilazodone
- Vortioxetine
- Ziprasidone
Source: FDA drug label (Linezolid), Hospira, Inc., effective June 19, 2026 (SPL set c401f1a8-cc37-461b-bfef-f2e156629bf8), via openFDA; the full label on DailyMed
What do FAERS reports show for linezolid?
The FDA Adverse Event Reporting System holds 29,594 reports that list linezolid among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,443 are coded as a death and 12,213 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 linezolid?
23 other medicines are given the same way (oral) and in the same FDA class as linezolid 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 |
| Metronidazole | Bacterial infections | 40 labelers | $0.102 per tablet 250 mg tablet | In shortage |
| 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 |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does linezolid compare with medicines for the same use?
11 side-by-side pages set linezolid beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to linezolid
- 23 medicines for the same use
- Other oxazolidinone antibacterials
- the pharmacologic class, with prices and generics
- Linezolid side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other