FDA approved Zyvox (linezolid) for Gram-Positive Infections Including MRSAFDA approved new antibiotic Zyvox for serious bacterial infections.

FDA From the archive Source published April 18, 2000 Summary added June 16, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider Zyvox for Gram-positive infections including MRSA and VRE, but not for Gram-negative coverage.

The FDA has approved Zyvox (linezolid), a new oxazolidinone-class antibacterial, for the treatment of serious Gram-positive infections in adults and children. The approval covers nosocomial pneumonia, community-acquired pneumonia (including cases with concurrent bacteremia), complicated skin and skin structure infections (including diabetic foot infections without osteomyelitis), uncomplicated skin and skin structure infections, and vancomycin-resistant Enterococcus faecium infections. Zyvox is available in both intravenous and oral formulations, offering flexibility for step-down therapy. Clinicians should note that Zyvox is not indicated for Gram-negative infections, and empiric Gram-negative coverage should be initiated if co-infection is suspected. The safety and efficacy of treatment beyond 28 days have not been evaluated in controlled trials.

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

Mechanism of Action

Linezolid is an oxazolidinone-class antibacterial. It inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, preventing formation of the initiation complex.

Indication & Patient Population

Zyvox is indicated for adults and children for the treatment of 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 S. pneumoniae or S. aureus [methicillin-susceptible only]); complicated skin and skin structure infections (caused by S. aureus [methicillin-susceptible and -resistant], Streptococcus pyogenes, or Streptococcus agalactiae); uncomplicated skin and skin structure infections (caused by S. aureus [methicillin-susceptible only] or S. pyogenes); and vancomycin-resistant Enterococcus faecium infections (including bacteremia). Limitations: not indicated for Gram-negative infections; safety and efficacy beyond 28 days not evaluated.

Dosing & Administration

For adults and adolescents (12 years and older): nosocomial pneumonia, community-acquired pneumonia, complicated skin infections, and VRE faecium infections: 600 mg IV or oral every 12 hours for 10-14 days (pneumonia) or 14-28 days (others). Uncomplicated skin infections: 400 mg oral every 12 hours for 10-14 days (adults) or 600 mg oral every 12 hours (adolescents). For pediatric patients (birth through 11 years): dosing is weight-based (10 mg/kg) with frequency depending on age and infection. Preterm neonates <7 days: start with 10 mg/kg every 12 hours; consider every 8 hours if suboptimal response; all neonates should receive every 8 hours by day 7 of life.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Zyvox is not indicated for Gram-negative infections. If Gram-negative pathogen is documented or suspected, specific Gram-negative therapy must be initiated immediately. Use only for proven or strongly suspected bacterial infections to reduce drug resistance. Safety and efficacy beyond 28 days not established.

Place in Therapy

Zyvox provides an oral and IV option for serious Gram-positive infections, including MRSA and VRE. It is a valuable alternative when resistance or intolerance limits other agents. However, it should not be used as monotherapy when Gram-negative infection is possible. Its role is limited to infections caused by susceptible Gram-positive bacteria.

The FDA has approved a new antibiotic called Zyvox (linezolid) for treating serious bacterial infections in adults and children. Zyvox works against Gram-positive bacteria, which are a common cause of infections like pneumonia and skin infections. It can be given as a pill or through an IV, making it easier for patients to switch from hospital to home treatment.

Zyvox is approved for several types of infections, including hospital-acquired pneumonia, community-acquired pneumonia (with or without bloodstream infection), complicated skin infections (including diabetic foot infections without bone infection), and uncomplicated skin infections. It is also approved for infections caused by vancomycin-resistant Enterococcus faecium, a hard-to-treat bacteria.

This approval gives doctors a new option for treating serious infections. However, Zyvox does not work against Gram-negative bacteria. If a Gram-negative infection is suspected, doctors will need to add other antibiotics. Also, the safety and effectiveness of using Zyvox for more than 28 days have not been studied.

If you or a loved one has a serious infection, talk to your doctor about whether Zyvox might be a good treatment option. Your doctor can help decide if this antibiotic is right for your specific situation.

What this means for you:

Zyvox is a new antibiotic for serious Gram-positive infections; talk to your doctor if it might be 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 Gram-Positive Infections Including MRSAFDA approved new antibiotic Zyvox for serious bacterial infections.

Study Details

Intrawound tobramycin plus vancomycin did not reduce deep infection risk compared with vancomycin alone in high-risk tibial fractures

Adding Antibiotics to Bone Surgery Didn't Lower Infection Risk

Clinical research that matters. Delivered to your inbox.

FDA approved Zyvox (linezolid) for Gram-Positive Infections Including MRSAFDA approved new antibiotic Zyvox for serious bacterial infections.

Study Details

Intrawound tobramycin plus vancomycin did not reduce deep infection risk compared with vancomycin alone in high-risk tibial fractures

Adding Antibiotics to Bone Surgery Didn't Lower Infection Risk

Clinical research that matters. Delivered to your inbox.

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