85/100 · Critical
Manufactured by Hikma Pharmaceuticals USA Inc.
High Safety Concerns with Vancomycin, Particularly Acute Kidney Injury and Sepsis
102,861 FDA adverse event reports analyzed
Last updated: 2026-05-12
VANCOMYCIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Hikma Pharmaceuticals USA Inc.. Based on analysis of 102,861 FDA adverse event reports, VANCOMYCIN has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for VANCOMYCIN include DRUG INEFFECTIVE, ACUTE KIDNEY INJURY, OFF LABEL USE, PYREXIA, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for VANCOMYCIN.
Vancomycin has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 102,861 adverse event reports for this medication, which is primarily manufactured by Hikma Pharmaceuticals Usa Inc..
The most commonly reported adverse events include Drug Ineffective, Acute Kidney Injury, Off Label Use. Of classified reports, 92.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Acute kidney injury and sepsis are the most frequently reported serious adverse events.
A high number of reports involve drug interactions and hypersensitivity reactions. Renal impairment and failure are significant safety concerns, especially in elderly patients.
Patients taking Vancomycin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Vancomycin can interact with other antibiotics and may cause drug hypersensitivity reactions. Close monitoring is advised, especially in patients with pre-existing renal or hepatic impairment. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Vancomycin received a safety concern score of 85/100 (high concern). This is based on a 92.4% serious event ratio across 55,548 classified reports. The score accounts for 102,861 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 27,010, Female: 22,834, Unknown: 278. The most frequently reported age groups are age 62 (1,042 reports), age 69 (969 reports), age 63 (959 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 55,548 classified reports for VANCOMYCIN:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Vancomycin can interact with other antibiotics and may cause drug hypersensitivity reactions. Close monitoring is advised, especially in patients with pre-existing renal or hepatic impairment.
If you are taking Vancomycin, here are important things to know. The most commonly reported side effects include drug ineffective, acute kidney injury, off label use, pyrexia, drug reaction with eosinophilia and systemic symptoms. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor renal function closely, especially in elderly patients and those with pre-existing renal impairment. Be aware of potential drug interactions and hypersensitivity reactions. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulatory oversight includes monitoring for severe renal and hepatic toxicity, as well as drug interactions. Regular monitoring of renal function is recommended, particularly in elderly patients.
The FDA has received approximately 102,861 adverse event reports associated with Vancomycin. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Vancomycin include Drug Ineffective, Acute Kidney Injury, Off Label Use, Pyrexia, Drug Reaction With Eosinophilia And Systemic Symptoms. By volume, the top reported reactions are: Drug Ineffective (6,107 reports), Acute Kidney Injury (4,178 reports), Off Label Use (3,965 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Vancomycin.
Out of 55,548 classified reports, 51,317 (92.4%) were classified as serious and 4,231 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Vancomycin break down by patient sex as follows: Male: 27,010, Female: 22,834, Unknown: 278. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Vancomycin adverse events are: age 62: 1,042 reports, age 69: 969 reports, age 63: 959 reports, age 67: 959 reports, age 65: 933 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Vancomycin adverse event reports is Hikma Pharmaceuticals Usa Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Vancomycin include: Renal Failure, Sepsis, Diarrhoea, Pneumonia, Hypotension. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Vancomycin to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Vancomycin has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Acute kidney injury and sepsis are the most frequently reported serious adverse events.
Key safety signals identified in Vancomycin's adverse event data include: Acute kidney injury and renal failure. Sepsis and septic shock. Drug hypersensitivity reactions. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Vancomycin can interact with other antibiotics and may cause drug hypersensitivity reactions. Close monitoring is advised, especially in patients with pre-existing renal or hepatic impairment. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Vancomycin.
Monitor renal function closely, especially in elderly patients and those with pre-existing renal impairment. Be aware of potential drug interactions and hypersensitivity reactions.
Vancomycin has 102,861 adverse event reports on file with the FDA. A high number of reports involve drug interactions and hypersensitivity reactions. The volume of reports for Vancomycin reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight includes monitoring for severe renal and hepatic toxicity, as well as drug interactions. Regular monitoring of renal function is recommended, particularly in elderly patients. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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