FDA approved Zyvox (linezolid) for Serious Gram-Positive Infections Including VRE and PneumoniaFDA approved Zyvox, a new antibiotic for serious Gram-positive infections

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 adults and children with infections caused by susceptible Gram-positive bacteria. Labeled indications include nosocomial pneumonia caused by methicillin-susceptible or methicillin-resistant Staphylococcus aureus or Streptococcus pneumoniae; community-acquired pneumonia caused by S. pneumoniae (including concurrent bacteremia) or methicillin-susceptible S. aureus; complicated skin and skin structure infections, including diabetic foot infections without concomitant osteomyelitis; uncomplicated skin and skin structure infections; and vancomycin-resistant Enterococcus faecium infections, including those with concurrent bacteremia.

The label carries explicit limitations. Zyvox is not indicated for Gram-negative infections, and specific Gram-negative therapy should be started immediately if a concomitant Gram-negative pathogen is documented or suspected. Safety and efficacy of Zyvox formulations given for longer than 28 days have not been evaluated in controlled clinical trials. Clinicians should reserve use for infections proven or strongly suspected to be bacterial, and should use culture and susceptibility data when available to guide therapy selection.

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

Mechanism of Action

Zyvox is an oxazolidinone-class antibacterial. The label identifies the drug class but does not describe the specific mechanism of action in the provided text.

Indication & Patient Population

Zyvox is indicated in adults and children for infections caused by susceptible Gram-positive bacteria: nosocomial pneumonia caused by S. aureus (methicillin-susceptible and resistant isolates) or S. pneumoniae; community-acquired pneumonia caused by S. pneumoniae, including cases with concurrent bacteremia, or S. aureus (methicillin-susceptible isolates only); complicated skin and skin structure infections, including diabetic foot infections without concomitant osteomyelitis, caused by S. aureus (methicillin-susceptible and resistant isolates), S. pyogenes, or S. agalactiae; uncomplicated skin and skin structure infections caused by S. aureus (methicillin-susceptible isolates only) or S. pyogenes; and vancomycin-resistant E. faecium infections, including cases with concurrent bacteremia. Zyvox has not been studied in decubitus ulcers. It is not indicated for Gram-negative infections.

Dosing & Administration

For nosocomial pneumonia, community-acquired pneumonia (including concurrent bacteremia), complicated skin and skin structure infections, and VRE faecium infections: pediatric patients (birth through 11 years) receive 10 mg/kg IV or oral every 8 hours; adults and adolescents (12 years and older) receive 600 mg IV or oral every 12 hours. Duration is 10 to 14 days for pneumonia and 14 to 28 days for the other indications. For uncomplicated skin and skin structure infections: children under 5 years receive 10 mg/kg oral every 8 hours; children 5 to 11 years receive 10 mg/kg oral every 12 hours; adults receive 400 mg oral every 12 hours; adolescents receive 600 mg oral every 12 hours; duration 10 to 14 days. Neonates under 7 days should start at 10 mg/kg every 12 hours, with 10 mg/kg every 8 hours considered for suboptimal response; all neonates should receive 10 mg/kg every 8 hours by 7 days of life.

Key Clinical Trial Data

Trial data not available in label. The label cross-references Clinical Studies (14) but does not provide outcome data in the provided text.

Warnings & Contraindications

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 of Zyvox formulations given for longer than 28 days have not been evaluated in controlled clinical trials. The label cross-references Warnings and Precautions (5.4) regarding Gram-negative coverage. Specific contraindications are not detailed in the provided text.

Place in Therapy

Zyvox should be used only to treat or prevent infections proven or strongly suspected to be caused by susceptible bacteria, to reduce development of drug-resistant bacteria and maintain effectiveness of Zyvox and other antibacterials. When culture and susceptibility information are available, they should guide selection or modification of therapy; in the absence of such data, local epidemiology and susceptibility patterns may inform empiric selection.

Zyvox, also known by its generic name linezolid, is a new antibiotic approved by the FDA. It treats adults and children with infections caused by certain Gram-positive bacteria. These include some hospital-acquired and community-acquired pneumonias, complicated and simple skin infections (including diabetic foot infections without bone infection), and a tough germ called vancomycin-resistant Enterococcus faecium.

The drug is for people whose infection is proven or strongly suspected to be bacterial. Doctors should use lab culture and susceptibility results when they are available to choose the right treatment. Zyvox is not meant for Gram-negative infections. If a Gram-negative germ is found or suspected, specific treatment for it should start right away.

This approval gives doctors another option for some serious infections, including ones that resist other antibiotics. It does not mean Zyvox is right for every infection or for mild illnesses. Safety and effectiveness beyond 28 days of use have not been studied in controlled trials.

If you or a family member are facing a serious infection, talk with your doctor about whether Zyvox is appropriate. Do not use it on your own. Your care team can weigh the benefits and risks for your situation.

What this means for you:

Zyvox is a new antibiotic for certain serious bacterial infections. Ask your doctor if it fits your case.

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 Infections Including VRE and PneumoniaFDA approved Zyvox, a new antibiotic for serious Gram-positive infections

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FDA approved Zyvox (linezolid) for Serious Gram-Positive Infections Including VRE and PneumoniaFDA approved Zyvox, a new antibiotic for serious Gram-positive infections

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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