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Vancomycin Adverse Events Reported to the FDA Over Time

How are Vancomycin adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Vancomycin, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Vancomycin is flagged as the suspect drug causing the adverse event.

Most Common Vancomycin Adverse Events Reported to the FDA

What are the most common Vancomycin adverse events reported to the FDA?

Renal Failure Acute
665 (2.72%)
Pyrexia
532 (2.17%)
Drug Rash With Eosinophilia And Sys...
400 (1.63%)
Rash
386 (1.58%)
Renal Failure
274 (1.12%)
Pruritus
266 (1.09%)
Toxic Epidermal Necrolysis
264 (1.08%)
Thrombocytopenia
242 (.99%)
Blood Creatinine Increased
235 (.96%)
Hypotension
217 (.89%)
Sepsis
199 (.81%)
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Stevens-johnson Syndrome
197 (.8%)
Erythema
176 (.72%)
Neutropenia
176 (.72%)
Diarrhoea
170 (.69%)
Dyspnoea
168 (.69%)
Renal Impairment
168 (.69%)
Septic Shock
165 (.67%)
Drug Hypersensitivity
159 (.65%)
Eosinophilia
159 (.65%)
Rash Erythematous
153 (.62%)
Anaemia
148 (.6%)
Pneumonia
145 (.59%)
Red Man Syndrome
142 (.58%)
Tachycardia
131 (.54%)
Multi-organ Failure
124 (.51%)
Staphylococcal Infection
123 (.5%)
Alanine Aminotransferase Increased
122 (.5%)
Aspartate Aminotransferase Increase...
121 (.49%)
Platelet Count Decreased
121 (.49%)
Rash Generalised
121 (.49%)
Rash Maculo-papular
119 (.49%)
Nausea
118 (.48%)
Chills
117 (.48%)
Dermatitis Exfoliative
117 (.48%)
Leukopenia
117 (.48%)
Infusion Related Reaction
116 (.47%)
Respiratory Failure
115 (.47%)
Nephropathy Toxic
114 (.47%)
White Blood Cell Count Decreased
114 (.47%)
Drug Ineffective
111 (.45%)
Vomiting
110 (.45%)
Pancytopenia
109 (.45%)
Condition Aggravated
105 (.43%)
Toxic Skin Eruption
105 (.43%)
Haemodialysis
101 (.41%)
General Physical Health Deteriorati...
100 (.41%)
Urticaria
99 (.4%)
Hepatic Function Abnormal
97 (.4%)
Drug Interaction
95 (.39%)
Drug Level Increased
95 (.39%)
Hypersensitivity
95 (.39%)
Oedema Peripheral
94 (.38%)
Tubulointerstitial Nephritis
90 (.37%)
Liver Disorder
88 (.36%)
Skin Exfoliation
87 (.36%)
Dialysis
85 (.35%)
Disseminated Intravascular Coagulat...
85 (.35%)
Renal Tubular Necrosis
85 (.35%)
Haemoglobin Decreased
84 (.34%)
Headache
81 (.33%)
Confusional State
78 (.32%)
Metabolic Acidosis
78 (.32%)
Agranulocytosis
76 (.31%)
Linear Iga Disease
76 (.31%)
Purpura
74 (.3%)
Drug Eruption
73 (.3%)
Hypokalaemia
73 (.3%)
Rash Pruritic
73 (.3%)
Anaphylactic Reaction
71 (.29%)
Face Oedema
71 (.29%)
Infection
71 (.29%)
Lymphadenopathy
71 (.29%)
Pleural Effusion
71 (.29%)
Acute Respiratory Distress Syndrome
70 (.29%)
Cytolytic Hepatitis
70 (.29%)
Dehydration
70 (.29%)
Cardiac Arrest
69 (.28%)
Respiratory Distress
69 (.28%)
Hypoxia
68 (.28%)
Blister
67 (.27%)
Febrile Neutropenia
67 (.27%)
Acute Generalised Exanthematous Pus...
66 (.27%)
Asthenia
66 (.27%)
Death
63 (.26%)
Hypertension
63 (.26%)
Blood Alkaline Phosphatase Increase...
62 (.25%)
Pain
61 (.25%)
Dizziness
59 (.24%)
Flushing
59 (.24%)
Gamma-glutamyltransferase Increased
59 (.24%)
Haemorrhage
58 (.24%)
Dermatitis Bullous
57 (.23%)
Deafness
56 (.23%)
Blood Urea Increased
54 (.22%)
Cholestasis
54 (.22%)
Cellulitis
53 (.22%)
Convulsion
53 (.22%)
Inflammation
52 (.21%)
Cardio-respiratory Arrest
51 (.21%)
Disorientation
51 (.21%)

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This graph shows the top adverse events submitted to the FDA for Vancomycin, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Vancomycin is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Vancomycin

What are the most common Vancomycin adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Vancomycin, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Vancomycin is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Vancomycin According to Those Reporting Adverse Events

Why are people taking Vancomycin, according to those reporting adverse events to the FDA?

Product Used For Unknown Indication
824
Drug Use For Unknown Indication
680
Staphylococcal Infection
560
Infection
473
Sepsis
350
Pneumonia
326
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Cellulitis
274
Osteomyelitis
227
Pyrexia
182
Endocarditis
171
Infection Prophylaxis
151
Antibiotic Prophylaxis
125
Pneumonia Staphylococcal
114
Antibiotic Therapy
113
Prophylaxis
108
Febrile Neutropenia
106
Bacteraemia
97
Bacterial Infection
86
Clostridial Infection
86
Wound Infection
83
Staphylococcal Bacteraemia
78
Device Related Infection
78
Meningitis
74
Staphylococcal Sepsis
60
Abscess
56
Arthritis Bacterial
54
Anti-infective Therapy
54
Ill-defined Disorder
49
Urinary Tract Infection
49
Clostridium Difficile Colitis
40
Wound Infection Staphylococcal
40
Arthritis Infective
38
Peritonitis
37
Septic Shock
37
Pseudomembranous Colitis
35
Surgery
34
Evidence Based Treatment
33
Osteitis
33
Preoperative Care
31
Post Procedural Infection
28
Brain Abscess
27
Pseudomonas Infection
26
Eye Irrigation
24
Lung Disorder
24
Enterococcal Infection
23
Localised Infection
23
Postoperative Wound Infection
23
Catheter Related Infection
21
Meningitis Bacterial
20
Intervertebral Discitis
19
Lung Infection
18

Drug Labels

LabelLabelerEffective
Vancomycin HydrochlorideSandoz Inc27-APR-10
Vancomycin HydrochloridePrasco Laboratories28-JUN-10
Sterile Vancomycin Hydrochloride Akorn - Strides LLC 18-AUG-10
Sterile Vancomycin Hydrochloride Akorn - Strides LLC 19-AUG-10
Vancomycin HydrochlorideMylan Institutional LLC04-OCT-10
Sterile Vancomycin HydrochlorideRebel Distributors Corp22-DEC-10
Vancomycin HydrochlorideHospira, Inc.28-FEB-11
VancocinCardinal Health07-JUN-11
Sterile Vancomycin HydrochloridePfizer Laboratories Div Pfizer Inc14-SEP-11
VancocinViroPharma13-DEC-11
Vancomycin HydrochlorideAkorn, Inc. 15-FEB-12
Vancomycin HydrochlorideBaxter Healthcare Corporation17-FEB-12
Vancomycin HydrochlorideHospira, Inc.02-APR-12
Vancomycin HydrochlorideHospira, Inc.02-APR-12
Vancomycin HydrochlorideHospira, Inc.03-APR-12
Vancomycin HydrochlorideWatson Laboratories, Inc.10-APR-12
Vancomycin HydrochlorideAlvogen, Inc.12-APR-12
Vancomycin HydrochlorideCardinal Health27-APR-12
VancomycinSagent Pharmaceuticals15-JUN-12
Sterile Vancomycin HydrochlorideGeneral Injectables & Vaccines, Inc25-JUN-12
Vancomycin HydrochlorideAPP Pharmaceuticals, LLC25-JUN-12
Vancomycin HydrochlorideAPP Pharmaceuticals, LLC31-AUG-12
Vancomycin HydrochlorideAPP Pharmaceuticals, LLC31-AUG-12
Vancomycin HydrochloridePfizer Laboratories Div Pfizer Inc.20-NOV-12
Vancomycin HydrochlorideAGILA SPECIALTIES PRIVATE LIMITED29-NOV-12
Vancomycin HclCantrell Drug Company03-DEC-12
Vancomycin HclCantrell Drug Company03-DEC-12
Vancomycin HydrochloridePfizer Laboratories Div Pfizer Inc08-FEB-13
Vancomycin HydrochloridePfizer Laboratories Div Pfizer Inc12-FEB-13
Vancomycin HydrochlorideMylan Institutional LLC28-FEB-13
Vancomycin HydrochlorideCardinal Health02-APR-13
Vancomycin HclCantrell Drug Company30-APR-13

Vancomycin Case Reports

What Vancomycin safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Vancomycin. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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