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Drug · FAERS side-effect profile with label screen

Vancomycin Hydrochloride side effects: what 65,527 FDA adverse event reports show

Vancomycin Hydrochloride · 1,330 reaction terms · 244,011 drug–reaction co-reports · data 2026-09-14

Drug class

Glycopeptide Antibacterial

FDA label (Established Pharmacologic Class)

Who reports

65,527 reports · 92% serious · 12,915 with death outcome · 46% female

openFDA FAERS counts, all years, deduplication not applied

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 .

FDA label, Indications and Usage

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 ).

FDA label, Description section

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.

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled — boxed warning 2Labeled adverse reaction 3Labeled (related wording) 4Likely indication confounding 8Reporting / coding artifact 1Lab value / disease marker 3Not in label — unassessed 19

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). 1,290 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Vancomycin infusion reaction	282	1,152.8 896.1–1,483.1ROR 1,157.8 · calibrated p 1e-17 ✓	244.0 EB05 221.0 · IC025 +7.2 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=271	not reported in cached trials
Red man syndrome	438	311.9 273.4–355.9ROR 314.0 · calibrated p 7e-12 ✓	156.1 EB05 144.2 · IC025 +6.9 3/3 methods agree	Labeled — boxed warning exact term	serious n=347	not reported in cached trials
Antibiotic level above therapeutic	165	225.8 184.9–275.8ROR 226.4 · calibrated p 2e-10 ✓	130.0 EB05 114.1 · IC025 +6.3 3/3 methods agree	Lab value / disease marker	serious n=153 · 91% clinician	not reported in cached trials
Linear iga disease	676	220.1 199.5–242.7ROR 222.3 · calibrated p 2e-10 ✓	129.5 EB05 121.5 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious n=670 · 100% clinician	not reported in cached trials
Geotrichum infection	64	138.0 102.9–185.1ROR 138.1 · calibrated p 2e-8 ✓	93.6 EB05 75.9 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious n=64 · 100% clinician	not reported in cached trials
Antimicrobial susceptibility test resistant	82	114.2 88.7–147.0ROR 114.4 · calibrated p 6e-8 ✓	82.5 EB05 68.6 · IC025 +5.4 3/3 methods agree	Labeled (related wording) related wording	serious n=81 · ♀ 0% (drug 46%) · 100% clinician	not reported in cached trials
Choroiditis	90	100.8 79.5–127.8ROR 101.0 · calibrated p 2e-7 ✓	75.4 EB05 63.2 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious n=90 · ♀ 0% (drug 46%)	not reported in cached trials
Retinal vasculitis	171	53.8 45.8–63.3ROR 54.0 · calibrated p 9e-6 ✓	45.9 EB05 40.4 · IC025 +5.1 3/3 methods agree	Labeled adverse reaction exact term	serious n=171 · ♀ 67% (drug 46%) · 100% clinician	not reported in cached trials
Trichosporon infection	57	53.7 40.6–71.1ROR 53.8 · calibrated p 1e-5 ✓	45.4 EB05 36.3 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=57 · ♀ 0% (drug 46%) · 100% clinician	not reported in cached trials
Disseminated mucormycosis	55	52.8 39.7–70.2ROR 52.8 · calibrated p 1e-5 ✓	44.7 EB05 35.6 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=55 · 100% clinician	not reported in cached trials
Rhinocerebral mucormycosis	46	49.6 36.3–67.7ROR 49.6 · calibrated p 2e-5 ✓	42.3 EB05 33.0 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=46 · ♀ 100% (drug 46%) · 100% clinician	not reported in cached trials
Enterococcus test positive	78	43.4 34.2–55.0ROR 43.4 · calibrated p 4e-5 ✓	37.9 EB05 31.4 · IC025 +4.6 3/3 methods agree	Lab value / disease marker	serious n=77	not reported in cached trials
Cardiac valve vegetation	56	42.1 31.8–55.6ROR 42.1 · calibrated p 5e-5 ✓	36.8 EB05 29.4 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=56 · ♀ 0% (drug 46%)	not reported in cached trials
Bacterial disease carrier	81	40.0 31.7–50.4ROR 40.0 · calibrated p 6e-5 ✓	35.3 EB05 29.3 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious n=81 · ♀ 100% (drug 46%)	not reported in cached trials
Fungaemia	171	39.2 33.4–46.0ROR 39.3 · calibrated p 6e-5 ✓	34.9 EB05 30.7 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=171 · 100% clinician	not reported in cached trials
Drug reaction with eosinophilia and systemic symptoms	2,695	37.7 36.2–39.2ROR 39.2 · calibrated p 6e-5 ✓	33.7 EB05 32.7 · IC025 +5.0 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 24.9 · serious PRR 21.0 · 97% clinician	not reported in cached trials
Intensive care unit acquired weakness	40	37.4 26.9–51.9ROR 37.4 · calibrated p 1e-4 ✓	33.0 EB05 25.3 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=40 · ♀ 100% (drug 46%)	not reported in cached trials
Acinetobacter infection	112	36.8 30.3–44.8ROR 36.9 · calibrated p 1e-4 ✓	32.9 EB05 28.1 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=110 · 100% clinician	not reported in cached trials
Dysbiosis	82	36.4 29.0–45.8ROR 36.5 · calibrated p 1e-4 ✓	32.5 EB05 27.0 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=81 · ♀ 72% (drug 46%) · 100% clinician	not reported in cached trials
Congestive hepatopathy	45	36.0 26.4–48.9ROR 36.0 · calibrated p 1e-4 ✓	32.0 EB05 24.9 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=45 · ♀ 100% (drug 46%)	not reported in cached trials
Septic embolus	79	33.4 26.5–42.1ROR 33.5 · calibrated p 2e-4 ✓	30.1 EB05 24.9 · IC025 +4.3 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=79 · 100% clinician	not reported in cached trials
Stenotrophomonas infection	126	33.2 27.6–39.8ROR 33.2 · calibrated p 2e-4 ✓	30.0 EB05 25.8 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=126 · 100% clinician	not reported in cached trials
Systemic candida	230	32.8 28.7–37.6ROR 32.9 · calibrated p 2e-4 ✓	29.8 EB05 26.7 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=228 · 92% clinician	not reported in cached trials
Renal tubular necrosis	889	31.7 29.6–34.0ROR 32.2 · calibrated p 2e-4 ✓	28.9 EB05 27.4 · IC025 +4.7 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 22.7 · serious PRR 17.9 · 97% clinician	not reported in cached trials
Enterococcal infection	423	30.6 27.7–33.8ROR 30.8 · calibrated p 2e-4 ✓	27.9 EB05 25.8 · IC025 +4.6 3/3 methods agree	Likely indication confounding term in indications	serious n=420 · 91% clinician	not reported in cached trials
Pseudomembranous colitis	190	29.5 25.5–34.3ROR 29.6 · calibrated p 3e-4 ✓	27.0 EB05 23.9 · IC025 +4.4 3/3 methods agree	Labeled adverse reaction exact term	serious n=190 · 92% clinician	not reported in cached trials
Pseudomonal bacteraemia	70	29.1 22.8–37.1ROR 29.1 · calibrated p 4e-4 ✓	26.5 EB05 21.7 · IC025 +4.1 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=70	not reported in cached trials
Nephropathy toxic	904	28.2 26.4–30.2ROR 28.6 · calibrated p 3e-4 ✓	26.0 EB05 24.6 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	age-adj. PRR 19.4 · serious PRR 16.1 · 97% clinician	not reported in cached trials
Rash morbilliform	225	28.2 24.6–32.3ROR 28.3 · calibrated p 4e-4 ✓	25.9 EB05 23.2 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=223 · 93% clinician	not reported in cached trials
Sepsis syndrome	41	28.2 20.5–38.8ROR 28.2 · calibrated p 5e-4 ✓	25.7 EB05 19.7 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=41 · ♀ 100% (drug 46%) · 100% clinician	not reported in cached trials
Clostridium test positive	173	27.5 23.5–32.1ROR 27.6 · calibrated p 4e-4 ✓	25.3 EB05 22.3 · IC025 +4.3 3/3 methods agree	Lab value / disease marker	serious n=171	not reported in cached trials
Fusarium infection	54	27.4 20.7–36.1ROR 27.4 · calibrated p 5e-4 ✓	25.1 EB05 19.9 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=54 · 100% clinician	not reported in cached trials
Staphylococcal bacteraemia	329	26.2 23.4–29.3ROR 26.4 · calibrated p 5e-4 ✓	24.3 EB05 22.1 · IC025 +4.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=328	not reported in cached trials
Corynebacterium infection	39	25.2 18.2–34.9ROR 25.2 · calibrated p 9e-4 ✓	23.2 EB05 17.7 · IC025 +3.7 3/3 methods agree	Likely indication confounding term in indications	serious n=39 · ♀ 0% (drug 46%) · 100% clinician	not reported in cached trials
Enterococcal sepsis	59	24.9 19.1–32.4ROR 24.9 · calibrated p 8e-4 ✓	23.0 EB05 18.5 · IC025 +3.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=59 · 100% clinician	not reported in cached trials
Enterococcal bacteraemia	75	24.4 19.3–30.9ROR 24.4 · calibrated p 9e-4 ✓	22.6 EB05 18.6 · IC025 +3.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=73 · 100% clinician	not reported in cached trials
Drug rash with eosinophilia and systemic symptoms	233	24.3 21.3–27.8ROR 24.4 · calibrated p 8e-4 ✓	22.6 EB05 20.3 · IC025 +4.2 3/3 methods agree	Labeled (related wording) related wording	serious n=228 · 90% clinician	not reported in cached trials
Clostridium difficile colitis	733	23.7 22.0–25.5ROR 23.9 · calibrated p 8e-4 ✓	22.1 EB05 20.8 · IC025 +4.3 3/3 methods agree	Labeled — boxed warning synonym match	age-adj. PRR 17.7 · serious PRR 13.7	not reported in cached trials
Clostridium difficile infection	1,466	23.2 22.0–24.4ROR 23.7 · calibrated p 9e-4 ✓	21.6 EB05 20.7 · IC025 +4.3 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 16.9 · serious PRR 13.8	not reported in cached trials
Pneumonia necrotising	43	22.9 16.8–31.2ROR 22.9 · calibrated p 0.001 ✓	21.2 EB05 16.4 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=41 · 100% clinician	not reported in cached trials

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

Concept	Reports	PRR 95% CI	Reading
Severe cutaneous reaction	4,393	20.019.4–20.6	signal
Kidney injury	10,079	7.27.1–7.3	signal
Neutropenia / agranulocytosis	3,329	4.34.2–4.5	signal
Thrombocytopenia	2,703	4.03.8–4.1	signal
Liver injury	3,146	3.43.2–3.5	signal
Serious infection	7,329	3.13.0–3.1	signal
Anaphylaxis / angioedema	1,103	2.82.7–3.0	signal
Rhabdomyolysis / myopathy	679	2.72.5–2.9	signal
Anaemia	2,370	2.52.4–2.6	signal
Arrhythmia / qt	1,391	2.32.2–2.4	signal
Hyponatraemia	558	2.22.0–2.4	signal
Opportunistic infection	926	2.22.0–2.3	signal
Gi bleeding	1,071	1.91.8–2.0	raised
Interstitial lung disease	556	1.91.7–2.0	raised
Pancreatitis	405	1.61.5–1.8	raised
Heart failure	868	1.61.5–1.7	raised

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)	7,279	1.8 1.7–1.8ROR 1.9 · calibrated p 0.871	1.8 EB05 1.7 · IC025 +0.8	Reporting / coding artifact	age-adj. PRR 2.2 · serious PRR 2.9 · 90% clinician	not reported in cached trials
Acute kidney injury (sudden kidney damage)	4,892	10.6 10.3–10.9ROR 11.4 · calibrated p 0.020 ✓	10.3 EB05 10.0 · IC025 +3.3 3/3 methods agree	Labeled — boxed warning exact term	age-adj. PRR 8.2 · serious PRR 6.4 · 94% clinician	not reported in cached trials
Off label use (used outside approved label)	4,721	1.7 1.7–1.8ROR 1.8 · calibrated p 0.831	1.7 EB05 1.7 · IC025 +0.8	Reporting / coding artifact	age-adj. PRR 1.6 · serious PRR 1.8	not reported in cached trials
Pyrexia (fever)	4,048	3.8 3.7–3.9ROR 4.0 · calibrated p 0.386	3.7 EB05 3.6 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 2.9 · serious PRR 2.9	not reported in cached trials
Drug reaction with eosinophilia and systemic symptoms	2,695	37.7 36.2–39.2ROR 39.2 · calibrated p 6e-5 ✓	33.7 EB05 32.7 · IC025 +5.0 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 24.9 · serious PRR 21.0 · 97% clinician	not reported in cached trials
Renal failure (kidney failure)	2,467	6.0 5.8–6.2ROR 6.2 · calibrated p 0.138	5.9 EB05 5.7 · IC025 +2.5 3/3 methods agree	Labeled — boxed warning exact term	age-adj. PRR 5.4 · serious PRR 3.7	not reported in cached trials
Diarrhoea (diarrhea)	2,392	1.2 1.1–1.2ROR 1.2 · calibrated p 0.439	1.2 EB05 1.2 · IC025 +0.2	Labeled — boxed warning exact term	age-adj. PRR 1.0 · serious PRR 1.2	not reported in cached trials
Sepsis (blood infection)	2,384	7.0 6.7–7.2ROR 7.2 · calibrated p 0.091	6.8 EB05 6.6 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	age-adj. PRR 5.8 · serious PRR 4.3	not reported in cached trials
Pneumonia (lung infection)	2,239	2.2 2.1–2.3ROR 2.3 · calibrated p 0.918	2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree	Labeled — boxed warning synonym match	age-adj. PRR 1.9 · serious PRR 1.4	not reported in cached trials
Rash	2,195	1.6 1.6–1.7ROR 1.6 · calibrated p 0.735	1.6 EB05 1.6 · IC025 +0.6	Labeled — boxed warning exact term	age-adj. PRR 1.5 · serious PRR 1.9	not reported in cached trials
Condition aggravated	2,168	2.3 2.2–2.4ROR 2.4 · calibrated p 0.879	2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 2.0 · serious PRR 2.1 · 91% clinician	not reported in cached trials
Hypotension (low blood pressure)	2,166	3.5 3.3–3.6ROR 3.6 · calibrated p 0.467	3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree	Labeled — boxed warning exact term	age-adj. PRR 2.9 · serious PRR 2.5	not reported in cached trials
Dyspnoea (shortness of breath)	1,866	1.1 1.0–1.1ROR 1.1 · calibrated p 0.344	1.1 EB05 1.0 · IC025 +0.0	Labeled — boxed warning exact term	age-adj. PRR 0.9 · serious PRR 0.9	not reported in cached trials
Septic shock	1,818	14.0 13.4–14.7ROR 14.4 · calibrated p 0.008 ✓	13.5 EB05 12.9 · IC025 +3.7 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	age-adj. PRR 10.9 · serious PRR 8.4 · 93% clinician	not reported in cached trials
Nausea	1,785	0.7 0.7–0.8ROR 0.7 · calibrated p 0.138	0.7 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC	Not in label — unassessed	age-adj. PRR 0.6 · 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=676, PRR 220.1
Geotrichum infection — n=64, PRR 138.0
Choroiditis — n=90, PRR 100.8
Trichosporon infection — n=57, PRR 53.7
Disseminated mucormycosis — n=55, PRR 52.8
Rhinocerebral mucormycosis — n=46, PRR 49.6
Cardiac valve vegetation — n=56, PRR 42.1
Fungaemia — n=171, PRR 39.2
Intensive care unit acquired weakness — n=40, PRR 37.4
Acinetobacter infection — n=112, PRR 36.8

✓ 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, field patient.drug.openfda.generic_name.exact, 1,330 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.