What the label lists and what reports show

Vancomycin side effects

Vancomycin's FDA label lists its adverse reactions in its own words. FAERS holds 65,529 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is acute kidney injury (4,892 reports).

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Check it at the source: the vancomycin FDA label on DailyMed (effective June 7, 2024, Mylan Institutional LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: • Infusion Reactions [see Warnings and Precautions (5.1) ] • Nephrotoxicity [see Warnings and Precautions (5.2) ] • Ototoxicity [see Warnings and Precautions (5.3) ] • Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.5) ] • Hemorrhagic Occlusive Retinal Vasculitis [see Warnings and Precautions (5.6) ] • Neutropenia [see Warnings and Precautions (5.7) ] The common adverse reactions are anaphylaxis, “vancomycin infusion reaction”, acute kidney Injury, hearing loss, neutropenia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

A table the label prints in its adverse reactions section without a title; its column headings name the groups compared

This table is printed in the VANCOMYCIN HYDROCHLORIDE label published by HIKMA PHARMACEUTICALS USA INC. of August 13, 2025; the label quoted above does not print one.

Reaction	Vancomycin Hydrochloride Capsule % (N=260) 17 15 9 9 8 9 6 5
Urinary tract infection	8
Hypokalemia	13
Back pain	6
Headache	7

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

Source: FDA drug label, Mylan Institutional LLC, effective June 7, 2024 (SPL set caf22ccb-df75-45ea-a1d0-ccb2d37272fb), via openFDA; the full label on DailyMed

What do FAERS reports show?

65,529 reports list vancomycin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 12,915 are coded as a death and 34,805 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

Drug Ineffective (a use or a product term, not a reaction)7,279
Acute Kidney Injury (named in the label)4,892
Off Label Use (a use or a product term, not a reaction)4,721
Pyrexia4,050
Drug Reaction With Eosinophilia And Systemic Symptoms (named in the label)2,695
Renal Failure (named in the label)2,468
Diarrhoea (named in the label)2,393
Sepsis2,384
Pneumonia2,240
Rash (named in the label)2,194
Condition Aggravated (a use or a product term, not a reaction)2,168
Hypotension (named in the label)2,165
Dyspnoea (named in the label)1,864
Septic Shock1,817
Nausea1,786
Thrombocytopenia (named in the label)1,739
Pain1,618
Respiratory Failure1,569
Renal Impairment1,537
Drug Hypersensitivity1,502
Neutropenia (named in the label)1,502
Clostridium Difficile Infection1,466
Vomiting1,466
Death (an outcome recorded in the report)1,413
Febrile Neutropenia1,395

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Vancomycin: the full record: label, generics, price, shortages, recalls
Report a side effect to the FDA: MedWatch
Side effects hub: the most reported medicines and reactions