Drugs › Glycopeptide antibacterial
Generic name
Vancomycin hydrochloride: adverse event reports filed with FDA
5,245 reports list it as a suspect or interacting product, 2004–2026. Class: Glycopeptide antibacterial. Also reported as Vancomycin Hydrochloride For Injection Usp, Vancomycin Hydrochloride Capsules Usp 250mg, Vancomycin Hydrochloride Capsules.
- 5,245
- reports as suspect product
- 0% of all reports · about 233 a year
- 388
- reports, 12 months to June 2026
- 518 in the 12 months before
- 87.5%
- marked serious by the reporter
- 91.2% across the class
- 14.9%
- record death among outcomes, as reported
- 783 reports · not verified by FDA
Between January 2004 and June 2026, 5,245 adverse event reports received by FDA list vancomycin hydrochloride, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (2,351) are left out of every figure here.
In the 12 months to June 2026, 388 reports listed it, down 25% from 518 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 233 reports a year and 0% of the 20,646,523 reports in the database, and 14.7% of the reports for the glycopeptide antibacterial class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are drug ineffective (13.9%), acute kidney injury (8.8%) and off label use (6.3%). A report can list several reactions, so shares add to more than 100%; 895 different terms appear across these reports. Drug ineffective is recorded in 13.9% of these reports, about the same share as in the median glycopeptide antibacterial drug (14.1%).
87.5% of the reports are marked serious by the reporter (91.2% across the class); 14.9% record death among the outcomes and 39.5% record hospitalisation, as reported. 48.4% of the reports came from other health professionals, and the largest patient age group is 45 to 64 (23.1%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Vancomycin hydrochloride reports recording the termmedian drug in glycopeptide antibacterial
- Drug ineffectivethe medicine did not work as expected13.9%728
- Acute kidney injurysudden loss of kidney function8.8%463
- Off label useused for a purpose or in a way not on the label6.3%333
- Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement6.1%319
- Drug hypersensitivityan allergic-type reaction to a medicine5.1%267
- Rashskin rash4.7%249
- Pyrexiafever4%210
- Condition aggravatedthe condition being treated got worse3.7%193
- Pruritusitching3.3%174
- Hypotensionlow blood pressure2.9%151
- Sepsisa severe body-wide response to infection2.6%137
- Anaphylactic reactiona severe, sudden allergic reaction2.5%130
- Renal failurekidney failure2.4%125
- Dyspnoeashortness of breath2.3%119
- Erythemaskin redness2.2%117
- Hypersensitivityan allergic-type reaction2.2%113
- Renal impairmentreduced kidney function2.1%110
- Septic shockshock arising from infection2%107
- Urticariahives2%107
- Diarrhoealoose or frequent stools2%104
- Eosinophilia2%104
- Linear IgA disease1.9%100
- Thrombocytopenialow platelets1.9%98
- Treatment failurethe treatment did not work1.8%94
- Multiple organ dysfunction syndromeseveral organs failing1.8%93
- Blood creatinine increasedraised creatinine, a kidney test1.7%89
- Neutropenialow neutrophils, a type of white blood cell1.6%83
- Pneumonialung infection1.5%81
Top 30 of 895 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 2 drugs in the glycopeptide antibacterial class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 35,654 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 48.9% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Staphylococcal infection | 251 | 4.8% |
| Clostridium difficile infection | 175 | 3.3% |
| Antibiotic therapy | 163 | 3.1% |
| Infection | 153 | 2.9% |
| Pneumonia | 118 | 2.2% |
| Sepsis | 104 | 2% |
The indication field is filled in by the reporter and is often blank; shares are of all 5,245 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Vancomycin hydrochloride reports |
|---|---|---|
| Meropenem | 721 | 13.7% |
| Metronidazole | 401 | 7.6% |
| Piperacillin and tazobactam | 391 | 7.5% |
| Ceftriaxone | 389 | 7.4% |
| Piperacillin sodium,tazobactam sodium | 320 | 6.1% |
| Cefepime | 257 | 4.9% |
| Ciprofloxacin | 255 | 4.9% |
| Acetaminophen | 253 | 4.8% |
| Fluconazole | 230 | 4.4% |
| Prednisone | 209 | 4% |
Other products listed in reports where Vancomycin hydrochloride is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Vancomycin hydrochloride | Glycopeptide antibacterial | All reports |
|---|---|---|---|
| Reports as suspect product | 5,245 | 35,654 | 20,646,523 |
| Share of that pool | — | 14.7% | 0% |
| Reports, latest 12 months | 388 | — | 1,332,454 |
| Marked serious | 87.5% | 91.2% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 149 | 161 | 91 |
| Hospitalisation recorded, per 1,000 reports | 395 | 489 | 213 |
| Consumer-filed share | 11.6% | 7.6% | 45.8% |
| Top term, share of reports | Drug ineffective 13.9% | median 14.1% | 6.3% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the glycopeptide antibacterial class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Vancomycin | generic | 30,409 | 2,400 | 91.8% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Vancomycin hydrochloride reports
How many adverse event reports has FDA received for Vancomycin hydrochloride?
5,245 reports list Vancomycin hydrochloride as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 388 of them arrived in the latest 12 months. Another 2,351 list it only as a concomitant medication.
What reactions are recorded in Vancomycin hydrochloride reports?
drug ineffective (13.9%), acute kidney injury (8.8%), off label use (6.3%), drug reaction with eosinophilia and systemic symptoms (6.1%) and drug hypersensitivity (5.1%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Vancomycin hydrochloride was responsible.
How serious are the reports?
87.5% are marked serious by the reporter. Among the outcomes recorded, 14.9% of reports include death and 39.5% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (48.4%), physician (23.6%) and pharmacist (12.4%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Vancomycin hydrochloride rising?
388 reports in the 12 months to June 2026, down 25% from 518 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Vancomycin hydrochloride was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Vancomycin hydrochloride?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Vancomycin hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (2,351) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.