Vancomycin side effects: what 57,457 FDA adverse event reports show
Drug class
Glycopeptide Antibacterial
Who reports
57,457 reports · 92% serious · 11,333 with death outcome · 46% female
Used for
Vancomycin Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (1 month and older) for the treatment of: Septicemia ( 1.1 ) Infective Endocarditis ( 1.2 ) Skin and Skin Structure Infections ( 1.3 ) Bone Infections ( 1.4 .
What it is
Vancomycin Injection, USP, in single-dose flexible bags contain vancomycin as vancomycin hydrochloride. It is a tricyclic glycopeptide antibacterial drug derived from Amycolatopsis orientalis (formerly Nocardia orientalis ).
Boxed warning
POTENTIAL RISK OF EXPOSURE TO EXCIPIENTS DURING THE FIRST OR SECOND TRIMESTER OF PREGNANCY If use of vancomycin is needed during the first or second trimester of pregnancy, use other available formulations of vancomycin.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,272 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Vancomycin infusion reaction | 204 | 472.7 383.6–582.4ROR 474.3 · calibrated p 2e-13 ✓ | 200.8 EB05 178.7 · IC025 +6.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=201 · ♀ 69% (drug 46%) | not reported in cached trials |
| Red man syndrome | 393 | 289.8 253.8–330.9ROR 291.8 · calibrated p 1e-11 ✓ | 159.6 EB05 146.8 · IC025 +6.9 3/3 methods agree | Labeled — boxed warning exact term | serious n=313 | not reported in cached trials |
| Linear iga disease | 592 | 202.3 183.0–223.7ROR 204.4 · calibrated p 4e-10 ✓ | 129.2 EB05 120.7 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious n=586 · 100% clinician | not reported in cached trials |
| Antibiotic level above therapeutic | 135 | 186.5 151.5–229.5ROR 186.9 · calibrated p 1e-9 ✓ | 121.0 EB05 104.8 · IC025 +6.1 3/3 methods agree | Lab value / disease marker | serious n=124 · 93% clinician | not reported in cached trials |
| Geotrichum infection | 61 | 147.0 109.2–198.0ROR 147.2 · calibrated p 1e-8 ✓ | 101.4 EB05 81.8 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=61 · 100% clinician | not reported in cached trials |
| Antimicrobial susceptibility test resistant | 77 | 119.7 92.5–154.9ROR 119.9 · calibrated p 5e-8 ✓ | 88.1 EB05 72.8 · IC025 +5.5 3/3 methods agree | Labeled (related wording) related wording | serious n=76 · ♀ 0% (drug 46%) · 100% clinician | not reported in cached trials |
| Choroiditis | 67 | 79.2 60.8–103.1ROR 79.2 · calibrated p 9e-7 ✓ | 63.9 EB05 52.1 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=67 · ♀ 0% (drug 46%) | not reported in cached trials |
| Trichosporon infection | 55 | 58.8 44.2–78.2ROR 58.8 · calibrated p 7e-6 ✓ | 49.8 EB05 39.7 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=55 · 100% clinician | not reported in cached trials |
| Retinal vasculitis | 160 | 56.8 48.1–67.1ROR 57.0 · calibrated p 7e-6 ✓ | 48.9 EB05 42.9 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=160 · ♀ 67% (drug 46%) · 100% clinician | not reported in cached trials |
| Disseminated mucormycosis | 52 | 56.4 42.1–75.6ROR 56.5 · calibrated p 9e-6 ✓ | 48.1 EB05 38.1 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=52 · 100% clinician | not reported in cached trials |
| Rhinocerebral mucormycosis | 42 | 51.0 36.9–70.4ROR 51.0 · calibrated p 2e-5 ✓ | 43.9 EB05 33.9 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=42 · ♀ 100% (drug 46%) · 100% clinician | not reported in cached trials |
| Fungal endocarditis | 35 | 49.3 34.6–70.2ROR 49.3 · calibrated p 3e-5 ✓ | 42.5 EB05 32.0 · IC025 +4.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=35 · ♀ 0% (drug 46%) · 100% clinician | not reported in cached trials |
| Cardiac valve vegetation | 51 | 43.2 32.3–57.8ROR 43.2 · calibrated p 5e-5 ✓ | 38.2 EB05 30.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=51 · ♀ 0% (drug 46%) | not reported in cached trials |
| Acinetobacter infection | 109 | 40.8 33.5–49.7ROR 40.9 · calibrated p 5e-5 ✓ | 36.5 EB05 31.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=107 · 100% clinician | not reported in cached trials |
| Fungaemia | 157 | 40.7 34.5–47.9ROR 40.8 · calibrated p 5e-5 ✓ | 36.5 EB05 31.9 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=157 · 100% clinician | not reported in cached trials |
| Bacterial disease carrier | 71 | 39.3 30.8–50.3ROR 39.4 · calibrated p 7e-5 ✓ | 35.3 EB05 28.9 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious n=71 · ♀ 100% (drug 46%) | not reported in cached trials |
| Enterococcus test positive | 63 | 38.9 30.0–50.5ROR 39.0 · calibrated p 8e-5 ✓ | 34.9 EB05 28.2 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=62 | not reported in cached trials |
| Drug reaction with eosinophilia and systemic symptoms | 2,386 | 37.5 36.0–39.1ROR 39.1 · calibrated p 6e-5 ✓ | 34.1 EB05 32.9 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.2 · 97% clinician | not reported in cached trials |
| Dysbiosis | 72 | 36.0 28.2–45.8ROR 36.0 · calibrated p 1e-4 ✓ | 32.5 EB05 26.7 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=72 · ♀ 73% (drug 46%) · 100% clinician | not reported in cached trials |
| Stenotrophomonas infection | 117 | 34.9 28.8–42.2ROR 34.9 · calibrated p 1e-4 ✓ | 31.7 EB05 27.2 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=117 · 94% clinician | not reported in cached trials |
| Systemic candida | 212 | 34.2 29.7–39.4ROR 34.4 · calibrated p 1e-4 ✓ | 31.3 EB05 27.9 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=212 · 92% clinician | not reported in cached trials |
| Septic embolus | 68 | 32.3 25.2–41.5ROR 32.4 · calibrated p 2e-4 ✓ | 29.5 EB05 24.1 · IC025 +4.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=68 · 100% clinician | not reported in cached trials |
| Renal tubular necrosis | 800 | 32.3 30.0–34.7ROR 32.7 · calibrated p 2e-4 ✓ | 29.7 EB05 28.0 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 18.2 · 97% clinician | not reported in cached trials |
| Sepsis syndrome | 40 | 31.3 22.7–43.2ROR 31.3 · calibrated p 3e-4 ✓ | 28.5 EB05 21.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=40 · 100% clinician | not reported in cached trials |
| Fusarium infection | 54 | 31.2 23.7–41.2ROR 31.3 · calibrated p 3e-4 ✓ | 28.6 EB05 22.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=54 | not reported in cached trials |
| Enterococcal infection | 376 | 30.7 27.6–34.1ROR 30.9 · calibrated p 2e-4 ✓ | 28.3 EB05 26.0 · IC025 +4.6 3/3 methods agree | Likely indication confounding term in indications | serious n=373 · 91% clinician | not reported in cached trials |
| Nephropathy toxic | 818 | 28.9 26.9–31.0ROR 29.3 · calibrated p 3e-4 ✓ | 26.8 EB05 25.3 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 16.6 · 98% clinician | not reported in cached trials |
| Clostridium test positive | 160 | 28.8 24.5–33.9ROR 28.9 · calibrated p 3e-4 ✓ | 26.7 EB05 23.4 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=158 | not reported in cached trials |
| Corynebacterium infection | 36 | 26.4 18.8–37.0ROR 26.4 · calibrated p 7e-4 ✓ | 24.4 EB05 18.4 · IC025 +3.7 3/3 methods agree | Likely indication confounding term in indications | serious n=36 · ♀ 0% (drug 46%) · 100% clinician | not reported in cached trials |
| Rash morbilliform | 186 | 26.2 22.6–30.4ROR 26.3 · calibrated p 6e-4 ✓ | 24.4 EB05 21.6 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=184 · 95% clinician | not reported in cached trials |
| Drug rash with eosinophilia and systemic symptoms | 219 | 26.0 22.6–29.8ROR 26.1 · calibrated p 6e-4 ✓ | 24.2 EB05 21.7 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious n=216 | not reported in cached trials |
| Enterococcal sepsis | 54 | 25.8 19.6–34.0ROR 25.8 · calibrated p 7e-4 ✓ | 24.0 EB05 19.1 · IC025 +3.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=54 · 100% clinician | not reported in cached trials |
| Pseudomembranous colitis | 145 | 25.2 21.3–29.8ROR 25.2 · calibrated p 7e-4 ✓ | 23.5 EB05 20.5 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=145 · 92% clinician | not reported in cached trials |
| Pseudomonal bacteraemia | 53 | 24.6 18.6–32.4ROR 24.6 · calibrated p 9e-4 ✓ | 22.9 EB05 18.2 · IC025 +3.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=53 · 100% clinician | not reported in cached trials |
| Megacolon | 98 | 24.3 19.8–29.8ROR 24.4 · calibrated p 9e-4 ✓ | 22.8 EB05 19.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=98 · 100% clinician | not reported in cached trials |
| Enterococcal bacteraemia | 66 | 24.3 18.9–31.2ROR 24.3 · calibrated p 9e-4 ✓ | 22.7 EB05 18.4 · IC025 +3.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=64 | not reported in cached trials |
| Clostridium difficile colitis | 662 | 24.2 22.4–26.2ROR 24.5 · calibrated p 8e-4 ✓ | 22.7 EB05 21.3 · IC025 +4.4 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 14.0 | not reported in cached trials |
| Staphylococcal bacteraemia | 269 | 24.1 21.3–27.3ROR 24.2 · calibrated p 8e-4 ✓ | 22.6 EB05 20.4 · IC025 +4.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=268 | not reported in cached trials |
| Crystal nephropathy | 36 | 23.8 17.0–33.4ROR 23.8 · calibrated p 0.001 ✓ | 22.2 EB05 16.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=36 · ♀ 100% (drug 46%) · 100% clinician | not reported in cached trials |
| Pneumonia necrotising | 39 | 23.5 17.0–32.5ROR 23.6 · calibrated p 0.001 ✓ | 21.9 EB05 16.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=37 · 100% clinician | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Vancomycin as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT04075526 — Vancomycin Powder and Dilute Povidone Iodine Lavage for Infection Prophylaxis in High Risk Total Joint Arthrop (N=2129, PHASE1; 7 AE terms posted; arms: Povidone Iodine and Vancomycin Powder; Povidone Iodine Alone; Vancomycin Powder Alone; Conventional)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 6,443 | 1.8 1.7–1.8ROR 1.9 · calibrated p 0.882 | 1.8 EB05 1.7 · IC025 +0.8 | Reporting / coding artifact | serious PRR 3.0 · 91% clinician | not reported in cached trials |
| Acute kidney injury (sudden kidney damage) | 4,344 | 10.7 10.4–11.0ROR 11.5 · calibrated p 0.020 ✓ | 10.4 EB05 10.1 · IC025 +3.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.5 · 94% clinician | not reported in cached trials |
| Off label use (used outside approved label) | 4,234 | 1.8 1.7–1.8ROR 1.8 · calibrated p 0.857 | 1.8 EB05 1.7 · IC025 +0.8 | Reporting / coding artifact | serious PRR 1.8 · 91% clinician | not reported in cached trials |
| Pyrexia (fever) | 3,592 | 3.8 3.7–3.9ROR 4.0 · calibrated p 0.377 | 3.8 EB05 3.7 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.9 | not reported in cached trials |
| Drug reaction with eosinophilia and systemic symptoms | 2,386 | 37.5 36.0–39.1ROR 39.1 · calibrated p 6e-5 ✓ | 34.1 EB05 32.9 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.2 · 97% clinician | not reported in cached trials |
| Renal failure (kidney failure) | 2,228 | 6.2 5.9–6.4ROR 6.4 · calibrated p 0.128 | 6.1 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.8 | not reported in cached trials |
| Diarrhoea (diarrhea) | 2,101 | 1.2 1.1–1.2ROR 1.2 · calibrated p 0.440 | 1.2 EB05 1.1 · IC025 +0.2 | Labeled — boxed warning exact term | serious PRR 1.2 | not reported in cached trials |
| Sepsis (blood infection) | 2,093 | 7.0 6.7–7.3ROR 7.2 · calibrated p 0.092 | 6.8 EB05 6.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | not reported in cached trials |
| Pneumonia (lung infection) | 1,943 | 2.2 2.1–2.3ROR 2.2 · calibrated p 0.930 | 2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 1.4 | not reported in cached trials |
| Hypotension (low blood pressure) | 1,922 | 3.5 3.4–3.7ROR 3.6 · calibrated p 0.458 | 3.5 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 2.5 | not reported in cached trials |
| Condition aggravated | 1,906 | 2.3 2.2–2.4ROR 2.4 · calibrated p 0.876 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.1 · 92% clinician | not reported in cached trials |
| Rash | 1,864 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.700 | 1.6 EB05 1.5 · IC025 +0.6 | Labeled — boxed warning exact term | serious PRR 1.8 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 1,640 | 1.1 1.0–1.1ROR 1.1 · calibrated p 0.346 | 1.1 EB05 1.0 · IC025 +0.0 | Labeled — boxed warning exact term | serious PRR 0.9 | not reported in cached trials |
| Septic shock | 1,613 | 14.1 13.4–14.8ROR 14.5 · calibrated p 0.008 ✓ | 13.6 EB05 13.1 · IC025 +3.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 8.4 · 94% clinician | not reported in cached trials |
| Nausea | 1,576 | 0.7 0.7–0.8ROR 0.7 · calibrated p 0.141 | 0.7 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 0.8 | not reported in cached trials |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Linear iga disease — n=592, PRR 202.3
- Geotrichum infection — n=61, PRR 147.0
- Choroiditis — n=67, PRR 79.2
- Trichosporon infection — n=55, PRR 58.8
- Disseminated mucormycosis — n=52, PRR 56.4
- Rhinocerebral mucormycosis — n=42, PRR 51.0
- Cardiac valve vegetation — n=51, PRR 43.2
- Acinetobacter infection — n=109, PRR 40.8
- Fungaemia — n=157, PRR 40.7
- Dysbiosis — n=72, PRR 36.0
✓ A hand-written Bradford Hill causality assessment exists for this drug: Vancomycin ↔ Acute kidney injury.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Vancomycin?
In FDA FAERS, the most frequently co-reported reaction terms for Vancomycin are acute kidney injury, pyrexia, drug reaction with eosinophilia and systemic symptoms, renal failure, diarrhoea, sepsis. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Vancomycin have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: POTENTIAL RISK OF EXPOSURE TO EXCIPIENTS DURING THE FIRST OR SECOND TRIMESTER OF PREGNANCY If use of vancomycin is needed during the first or second trimester of pregnancy, use other available formulations of vancomycin.
Do FAERS signals prove that Vancomycin causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 60bee69b-be70-412c-9e83-a24a0a8a5e7b, effective 20230323; matched on
openfda.generic_name.exact:"VANCOMYCIN") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,312 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
VANCOMYCIN, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.