FDA label
What is linezolid used for?
The FDA-approved uses of linezolid, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for linezolid (tablet, film coated) lists 6 uses: Nosocomial Pneumonia; Community-acquired Pneumonia; Complicated Skin and Skin Structure Infections; Uncomplicated Skin and Skin Structure Infections; and 2 more.
Run it in Rivvi
Which 2027 plans near you dropped or restricted linezolid?
Tier changes and new prior auth, step therapy or quantity limits, plan by plan.
Free to start. Opens Rivvi, the AI workspace for healthcare teams.
Linezolid, tablet, film coated
Indications and Usage, quoted from the label by Camber Pharmaceuticals, Inc. (ANDA204239). Cross-references to other label sections are left out.
Nosocomial Pneumonia
Linezolid tablets are indicated for the treatment of nosocomial pneumonia caused by Staphylococcus aureus(methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae.
Community-acquired Pneumonia
Linezolid tablets are indicated for the treatment of 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
Linezolid tablets are 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. linezolid tablets have not been studied in the treatment of decubitus ulcers.
Uncomplicated Skin and Skin Structure Infections
Linezolid tablets are indicated for the treatment of uncomplicated skin and skin structure infections caused by Staphylococcus aureus(methicillin-susceptible isolates only) or Streptococcus pyogenes.
Vancomycin-resistant Enterococcus faeciumInfections
Linezolid tablets are indicated for the treatment of vancomycin-resistant Enterococcus faeciuminfections, including cases with concurrent bacteremia.
Limitations of Use
- Linezolid tablets are 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. • The safety and efficacy of linezolid formulations given for longer than 28 days have not been evaluated in controlled clinical trials.
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid tablets and other antibacterial drugs, linezolid tablets 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.
Source: DailyMed label, set id b239458e-9a3e-49ac-9ac7-a4badc53dff6, version 5, effective January 9, 2025. NDC 31722-749, one of 12 listings for this product.
Linezolid, injection, solution
Indications and Usage, quoted from the label by Sun Pharmaceutical Industries, Inc. (ANDA207354). Cross-references to other label sections are left out.
Nosocomial Pneumonia
Linezolid injection is indicated for the treatment of nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae.
Community-acquired Pneumonia
Linezolid injection 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).
Complicated Skin and Skin Structure Infections
Linezolid injection 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. Linezolid injection has not been studied in the treatment of decubitus ulcers.
Uncomplicated Skin and Skin Structure Infections
Linezolid injection is indicated for the treatment of uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes.
Vancomycin-resistant Enterococcus faecium Infections
Linezolid injection is indicated for the treatment of vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteremia.
Limitations of Use
- Linezolid injection 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.
- The safety and efficacy of linezolid injection formulations given for longer than 28 days have not been evaluated in controlled clinical trials.
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid injection and other antibacterial drugs, linezolid injection 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.
Source: DailyMed label, set id 870c9600-04d5-4b44-a5b5-02252a310f22, version 20, effective July 31, 2026. NDC 57664-682, one of 10 listings for this product.
Questions
What is linezolid used for?
The FDA label for linezolid (tablet, film coated) lists 6 uses: Nosocomial Pneumonia; Community-acquired Pneumonia; Complicated Skin and Skin Structure Infections; Uncomplicated Skin and Skin Structure Infections; and 2 more.
What drug class is linezolid?
FDA lists linezolid in the Oxazolidinone Antibacterial established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.