FDA approved Zyvox (linezolid) for Serious Gram-Positive InfectionsFDA approved Zyvox to treat serious bacterial infections in adults and children

FDA From the archive Source published April 18, 2000 Summary added October 27, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Note: Zyvox is not indicated for Gram-negative infections; add specific Gram-negative coverage if suspected.

The FDA has approved Zyvox (linezolid), an oxazolidinone-class antibacterial, for the treatment of several serious infections caused by susceptible Gram-positive bacteria in adults and children. The approved indications include nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant) or Streptococcus pneumoniae; community-acquired pneumonia caused by Streptococcus pneumoniae (including bacteremia) or methicillin-susceptible S. aureus; complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis, caused by S. aureus (methicillin-susceptible and -resistant), Streptococcus pyogenes, or Streptococcus agalactiae; uncomplicated skin infections caused by methicillin-susceptible S. aureus or S. pyogenes; and vancomycin-resistant Enterococcus faecium infections, including bacteremia.

Clinicians should note that Zyvox is not indicated for Gram-negative infections, and specific Gram-negative therapy should be initiated immediately if such a pathogen is documented or suspected. The safety and efficacy of Zyvox formulations given for longer than 28 days have not been evaluated in controlled clinical trials. To reduce the development of drug-resistant bacteria, Zyvox should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Zyvox is an oxazolidinone-class antibacterial. The label does not provide a detailed mechanism of action.

Indication & Patient Population

Zyvox is indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae; community-acquired pneumonia caused by Streptococcus pneumoniae (including cases with concurrent bacteremia) or Staphylococcus aureus (methicillin-susceptible isolates only); complicated skin and skin structure infections, including diabetic foot infections without concomitant osteomyelitis, caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, or Streptococcus agalactiae; uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes; and vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteremia. Zyvox has not been studied in the treatment of decubitus ulcers. Zyvox is not indicated for the treatment of Gram-negative infections. The safety and efficacy of Zyvox formulations given for longer than 28 days have not been evaluated in controlled clinical trials.

Dosing & Administration

For nosocomial pneumonia, community-acquired pneumonia (including concurrent bacteremia), complicated skin and skin structure infections, and vancomycin-resistant Enterococcus faecium infections (including concurrent bacteremia): pediatric patients (birth through 11 years) receive 10 mg/kg intravenously or orally every 8 hours; adults and adolescents (12 years and older) receive 600 mg intravenously or orally every 12 hours. Duration is 10 to 14 days for nosocomial pneumonia and 14 to 28 days for the other indications. For uncomplicated skin and skin structure infections: pediatric patients less than 5 years receive 10 mg/kg orally every 8 hours; those 5 to 11 years receive 10 mg/kg orally every 12 hours; adults receive 400 mg orally every 12 hours; adolescents receive 600 mg orally every 12 hours. Duration is 10 to 14 days. Neonates less than 7 days: most pre-term neonates (gestational age less than 34 weeks) have lower linezolid clearance and larger AUC; initiate with 10 mg/kg every 12 hours. Consider 10 mg/kg every 8 hours in neonates with sub-optimal clinical response. All neonatal patients should receive 10 mg/kg every 8 hours by 7 days of life.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

The label does not list contraindications. Warnings and precautions are referenced but not detailed in the provided text. Zyvox is not indicated for Gram-negative infections; specific Gram-negative therapy should be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected. Safety and efficacy beyond 28 days have not been evaluated.

Place in Therapy

Zyvox is an antibacterial indicated for serious Gram-positive infections, including those caused by methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus faecium. It should be used only to treat or prevent infections proven or strongly suspected to be caused by susceptible bacteria, and culture and susceptibility information should guide therapy selection when available.

Zyvox is an antibiotic that treats serious infections caused by certain bacteria called Gram-positive bacteria. These include pneumonia caught in the hospital or in the community, complicated skin infections such as diabetic foot infections without bone involvement, simpler skin infections, and a tough gut infection caused by enterococcus that resists the drug vancomycin. It comes in forms that can be given by mouth or by vein.

The approval covers adults and children. It is meant for infections that are proven or strongly suspected to be caused by bacteria the drug can kill. Zyvox does not work on Gram-negative bacteria, so doctors are told to start a different treatment right away if those germs are found or suspected. It has not been tested in controlled trials for use longer than 28 days.

For patients, this means another treatment choice for some hard-to-treat infections, including ones that resist other antibiotics. It does not mean Zyvox is right for every infection or that people should seek it out on their own.

Antibiotics like this one are watched closely because overuse can lead to resistant germs. If you or a family member has a serious infection, talk with your doctor about whether Zyvox is a good fit and about the risks and benefits.

What this means for you:

Zyvox is a new FDA-approved antibiotic for certain serious infections; ask your doctor if it is right for you.

Study Details

Study typeFda approval

PublishedApr 2000

View Original Abstract ↓

1 INDICATIONS AND USAGE ZYVOX 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 ); Uncomplicated skin and skin structure infections ( 1.4 ); Vancomycin-resistant Enterococcus faecium infections. ( 1.5 ) Limitations of Use ( 1.6 ) : • ZYVOX is not indicated for the treatment of Gram-negative infections. • The safety and efficacy of ZYVOX formulations given for longer than 28 days have not been evaluated in controlled clinical trials. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZYVOX formulations and other antibacterial drugs, ZYVOX should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.7 ) 1.1 Nosocomial Pneumonia ZYVOX is indicated for the treatment of nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae [ see Clinical Studies (14) ]. 1.2 Community-acquired Pneumonia ZYVOX is indicated for the treatment of community-acquired pneumonia caused by Streptococcus pneumoniae , including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible isolates only) [ see Clinical Studies (14) ]. 1.3 Complicated Skin and Skin Structure Infections ZYVOX is indicated for the treatment of complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus pyogenes , or Streptococcus agalactiae . ZYVOX has not been studied in the treatment of decubitus ulcers [ see Clinical Studies (14) ]. 1.4 Uncomplicated Skin and Skin Structure Infections ZYVOX is indicated for the treatment of uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes [ see Clinical Studies (14) ]. 1.5 Vancomycin-resistant Enterococcus faecium Infections ZYVOX is indicated for the treatment of vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteremia [ see Clinical Studies (14) ]. 1.6 Limitations of Use • ZYVOX is not indicated for the treatment of Gram-negative infections. It is critical that specific Gram-negative therapy be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected [ see Warnings and Precautions (5.4) ]. • The safety and efficacy of ZYVOX formulations given for longer than 28 days have not been evaluated in controlled clinical trials [ see Clinical Studies (14) ]. 1.7 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZYVOX and other antibacterial drugs, ZYVOX should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

FDA approved Zyvox (linezolid) for Serious Gram-Positive InfectionsFDA approved Zyvox to treat serious bacterial infections in adults and children

Study Details

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FDA approved Zyvox (linezolid) for Serious Gram-Positive InfectionsFDA approved Zyvox to treat serious bacterial infections in adults and children

Study Details

Candidiasis prevalence of 13.46% and Cryptococcal meningitis of 3.15% among HIV-positive individuals

New data shows prevalence of fungal infections in HIV patients

Clinical research that matters. Delivered to your inbox.

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