Heart & blood Glycopeptide antibiotic
Vancomycin
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Vancomycin (sold as a generic injection and, for oral use, as Vancocin and Firvanq) is a glycopeptide antibiotic that has been a mainstay against serious Gram-positive infections, including MRSA, for decades. It kills bacteria by blocking construction of their cell wall, and the same drug, taken by mouth, treats intestinal C. difficile infection. It has been FDA-approved in the U.S. since 1958 and is given intravenously for most infections or orally for gut infections.
At a glance
- What it is
- A glycopeptide antibiotic active against Gram-positive bacteria
- Approved for
- Serious MRSA and other Gram-positive infections (intravenous); C. difficile-associated diarrhea (oral)
- Key fact
- It remains the standard comparator against which newer anti-MRSA drugs are measured
- Route
- Intravenous for systemic infection; oral (not absorbed) for intestinal infection
- Evidence strength
- FDA approved
Summary
Vancomycin is an FDA-approved antibiotic for serious Gram-positive infections, including MRSA and C. difficile. Learn how it works, its uses, and side effects.
What is vancomycin?
Vancomycin, sold as a generic injection and as the oral products Vancocin (capsules) and Firvanq (oral solution), is a glycopeptide antibiotic, a large, complex molecule that bacteria have found relatively hard to resist. It is used for serious infections caused by Gram-positive bacteria, especially methicillin-resistant Staphylococcus aureus (MRSA), and it has a distinct second role: taken orally, where it stays in the gut, it treats Clostridioides difficile infection. It was approved in the United States in 1958.
The history of vancomycin
Vancomycin came from a soil bacterium collected in the 1950s, at a time when penicillin resistance in staphylococci was becoming a serious problem. The earliest preparations were impure and brown, earning the nickname "Mississippi mud," and early formulations were associated with more side effects than the purified drug used today. For years it was held in reserve, but with the spread of MRSA it became one of the most important last-resort antibiotics in the hospital, a role it still holds more than six decades after approval.
How does vancomycin work?
Vancomycin blocks bacterial cell-wall synthesis. It binds tightly to the building blocks of peptidoglycan, the mesh that gives the bacterial wall its strength, specifically the D-alanyl-D-alanine end of those precursors. By capping that site, it prevents the cross-linking that would complete the wall, so the growing bacterium cannot maintain its structure and dies. This is a different target from the penicillins, which is why vancomycin works against many penicillin-resistant organisms.
Where it acts depends on the form given:
| Form | Where it acts | Infections treated |
|---|---|---|
| Intravenous | Distributes through the body | Bloodstream, bone, skin, and other serious Gram-positive infections |
| Oral | Barely absorbed, so it acts locally in the intestine | C. difficile, where local action is exactly what is wanted |
Dosing is guided by blood levels, because too little risks treatment failure and resistance while too much raises the risk of kidney injury. Vancomycin is established enough that newer drugs are tested against it. In a 2006 trial in Staphylococcus aureus bloodstream infection, daptomycin was compared with standard therapy that included vancomycin.
Is it FDA-approved?
Editor’s note
Status: Yes. Vancomycin has been FDA-approved since 1958 and is available as intravenous formulations and an oral form. Its approved uses span serious Gram-positive infections systemically and C. difficile infection and staphylococcal enterocolitis when given orally.
Category: FDA-approved · Primary body area: Heart & blood
Yes. Vancomycin has been FDA-approved since 1958 and is available as intravenous formulations and an oral form. Its approved uses span serious Gram-positive infections systemically and C. difficile infection and staphylococcal enterocolitis when given orally.
What is vancomycin prescribed for?
Intravenous vancomycin is prescribed for serious Gram-positive infections such as MRSA bloodstream infections, endocarditis, bone and joint infections, skin and soft-tissue infections, and pneumonia. Oral vancomycin is prescribed for C. difficile-associated diarrhea, where it acts within the gut.
What are the side effects?
According to the prescribing information, common side effects of intravenous vancomycin include:
- Kidney injury
- Hearing loss
- Low white-cell counts
- Allergic reactions
- Vancomycin infusion reaction, a flushing reaction related to fast infusion (formerly called "red man syndrome")
Common side effects of oral vancomycin include:
- Nausea
- Abdominal pain
- Low potassium
More serious considerations include:
- Severe skin reactions
- Lasting kidney or hearing damage, more likely at high blood levels or with other drugs that stress the kidneys
Sources: FDA prescribing information for vancomycin injection, Vancocin, and Firvanq; a trial of daptomycin versus standard therapy that included vancomycin (Fowler et al., The New England Journal of Medicine, 2006, DOI: 10.1056/NEJMoa053783), indexed on PubMed. This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
approved (PDF)
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