What Is Vancomycin Used For? Approved Uses, Per the Label

Vancomycin is a prescription medicine, a glycopeptide antibacterial that has been marketed in the United States for decades and is available in multiple approved forms from multiple manufacturers. It is not an investigational agent awaiting approval. This page summarises what the United States prescribing information describes vancomycin as being indicated for, how those indications are split between injectable and oral products, and what the published literature in the reference list below reported about monitoring and safety. It does not provide dosing information and it does not tell any reader what to do.

This page is for educational purposes only and is not medical advice; consult a licensed physician or the prescribing clinician about whether any medicine, including vancomycin, is appropriate in a particular situation.

The short answer: two product families, two sets of indications

Vancomycin labeling is not a single document. The indications depend on the route of administration, because the drug behaves very differently depending on whether it is delivered into the bloodstream or into the gut lumen.

• Vancomycin hydrochloride for injection (including lyophilised vials, premixed frozen or ready-to-use bags, and pharmacy bulk packages, marketed by several manufacturers under the generic name and under brand names): indicated for serious or severe infections caused by susceptible Gram-positive organisms.
• Oral vancomycin hydrochloride (capsules, and an oral solution supplied as a kit for reconstitution): indicated for specific intestinal infections.

Because revision dates differ between manufacturers and between presentations, the current prescribing information for the specific product dispensed is the authoritative source for exact wording.

US label versions on DailyMed: Vancomycin hydrochloride injection (Baxter), DailyMed label version June 2026; Vancocin (vancomycin hydrochloride) capsules, DailyMed label version December 2025. The current label for the specific product governs.

Indications in the injectable label

The prescribing information for vancomycin hydrochloride for injection describes the drug as indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci. The labeling further frames its place in therapy: it is described as indicated for patients who are allergic to penicillins, for patients who cannot receive or who have failed to respond to other drugs including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial agents.

The specific infection types named in the injectable labeling include:

• Endocarditis, including staphylococcal endocarditis; the labeling also addresses endocarditis caused by viridans group streptococci and Streptococcus bovis, enterococcal endocarditis in combination with an aminoglycoside, and diphtheroid endocarditis.
• Septicemia.
• Bone infections.
• Lower respiratory tract infections.
• Skin and skin structure infections.

Injectable labeling also carries the standard antibacterial stewardship statement that the product should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria, and that culture and susceptibility information should be considered when selecting or modifying therapy.

Indications in the oral label

Oral vancomycin is poorly absorbed from the gastrointestinal tract, which is why it carries its own distinct indications aimed at infections inside the bowel. The prescribing information for vancomycin hydrochloride capsules and for vancomycin hydrochloride oral solution describes the product as indicated for the treatment of Clostridioides difficile-associated diarrhea (older labeling used the name Clostridium difficile), and for the treatment of enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains, in adults and in pediatric patients less than 18 years of age.

Summary table of label indications by route

Regulatory history of the indications

Vancomycin entered United States clinical use in the 1950s, before the Kefauver-Harris Drug Amendments of 1962 established the modern requirement for substantial evidence of effectiveness from adequate and well-controlled trials. Its original indications therefore rest on the clinical experience and approval standards of that era rather than on a modern registration programme with named pivotal trials, and the peer-reviewed sources verified for this page do not contain a pivotal trial dossier for the original indications. Later approvals added new presentations, including oral capsules, premixed and ready-to-use injectable bags, and an oral solution kit, each reviewed under the applicable pathway, with generic versions approved through abbreviated applications referencing the listed drug.

Labeling has continued to evolve in areas other than the indication list, including microbiology sections, pediatric information, and language on therapeutic monitoring. A 2020 commentary in the Journal of the Pediatric Infectious Diseases Society described vancomycin therapeutic monitoring as a moving target and discussed how exposure targets used in practice have shifted over time (PMID 32716487). A 2025 review of therapeutic drug monitoring of antineoplastic and antimicrobial agents in children reported that vancomycin is among the antimicrobials for which concentration monitoring is routinely applied in pediatric settings (PMID 40348442).

Why susceptibility and resistance appear throughout the label

The indication wording repeatedly ties vancomycin to susceptible organisms, and resistance is the reason. A 2014 review in Current Opinion in Infectious Diseases addressed optimising therapy for vancomycin-resistant enterococcal bacteremia in children and reported that vancomycin resistance in enterococci drives the use of alternative agents (PMID 25313503). Development of other Gram-positive agents has continued in parallel: a 2021 Drugs review reported the first approval of contezolid, an oxazolidinone approved in China for complicated skin and soft tissue infections (PMID 34365606). Approval-update summaries in formulary journals track such additions to the anti-infective landscape (PMID 29719365).

Vancomycin Adverse Events: What Studies Report

Adverse effects are described in the Warnings, Precautions and Adverse Reactions sections of the labeling rather than in the indications, and they are also the subject of a substantial published literature.

Kidney effects

A 2017 review in Clinical Pharmacology and Therapeutics examined the nephrotoxicity of vancomycin and reported on acute kidney injury associated with vancomycin exposure, the proposed mechanisms of tubular injury, and the patient and treatment factors linked to higher risk (PMID 28474732). The same review discussed the relationship between drug exposure and renal outcomes, which is part of the rationale for concentration monitoring described by researchers in the pediatric monitoring literature (PMID 32716487).

Cutaneous and hypersensitivity reactions

A 2011 case report in Case Reports in Infectious Diseases described leukocytoclastic vasculitis that the authors attributed to vancomycin therapy, with the reaction reported in association with the drug and discussed alongside other vancomycin-related cutaneous reactions (PMID 22567469). Single case reports describe individual patients and do not establish frequency.

Monitoring as a safety practice

The 2025 review of therapeutic drug monitoring in children reported that monitoring of antimicrobials including vancomycin is used to keep exposures within targeted ranges in pediatric populations (PMID 40348442). Decisions about monitoring, laboratory testing and any adjustment of therapy sit with the prescribing clinician and the treating team.

One note on uses that are not approved indications

Published reports also describe vancomycin administered in ways or settings that are outside the approved labeling, and these are not approved uses. A 2019 report in Surgical Infections described vancomycin given by enema in patients with Clostridium difficile infection, a route not listed in the prescribing information (PMID 30716016); a 2025 case report in Clinical Case Reports described intravenous vancomycin administration in a patient on peritoneal dialysis with peritonitis (PMID 41341563); and laboratory work has reported on experimental formulations that are not approved products, including a liposomal nanocarrier for the vancomycin derivative FU002 reported in 2024 (PMID 38158147), folate-functionalised lipid nanoparticles studied against methicillin-resistant Staphylococcus aureus (PMID 34834208), and responsive chitosan-based hydrogels developed for pathogen-induced skin infections (PMID 35926673). These are investigational or non-label contexts described in the literature, not indications.

Where questions about individual use belong

Whether vancomycin is appropriate for a particular infection, which product form applies, how therapy should be monitored, and how any adverse effect should be handled are clinical decisions. Those questions belong with a prescribing clinician, a pharmacist, or an infectious diseases specialist who has access to the patient's culture results, kidney function and full medication list. This page describes published labeling categories and peer-reviewed findings for educational purposes and provides no dosing information.

References

• The Nephrotoxicity of Vancomycin (Clinical Pharmacology and Therapeutics, 2017)
• A Moving Target: Vancomycin Therapeutic Monitoring (Journal of the Pediatric Infectious Diseases Society, 2020)
• Recent Advances in Therapeutic Drug Monitoring of Antineoplastic and Antimicrobial Agents in Children (Clinics in Laboratory Medicine, 2025)
• Vancomycin-associated leukocytoclastic vasculitis (Case Reports in Infectious Diseases, 2011)
• Optimizing therapy for vancomycin-resistant enterococcal bacteremia in children (Current Opinion in Infectious Diseases, 2014)
• Contezolid: First Approval (Drugs, 2021)
• Pharmaceutical Approval Update (P&T, 2018)
• Vancomycin Enema in the Treatment of Clostridium difficile Infection (Surgical Infections, 2019)
• Effects of Intravenous Administration of Vancomycin on Peritonitis in a Patient on Peritoneal Dialysis (Clinical Case Reports, 2025)
• Improved pharmacokinetics and enhanced efficacy of the vancomycin derivative FU002 using a liposomal nanocarrier (Nanomedicine, 2024)
• Folate Functionalized Lipid Nanoparticles for Targeted Therapy of Methicillin-Resistant Staphylococcus aureus (Pharmaceutics, 2021)
• Development of responsive chitosan-based hydrogels for the treatment of pathogen-induced skin infections (International Journal of Biological Macromolecules, 2022)