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LINEZOLID

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Linezolid Adverse Events Reported to the FDA Over Time

How are Linezolid adverse event reports trending over time?

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

Most Common Linezolid Adverse Events Reported to the FDA

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

Thrombocytopenia
178 (3.79%)
Serotonin Syndrome
155 (3.3%)
Drug Interaction
154 (3.28%)
Anaemia
99 (2.11%)
Pancytopenia
85 (1.81%)
Platelet Count Decreased
74 (1.58%)
Nausea
48 (1.02%)
Pyrexia
45 (.96%)
Lactic Acidosis
43 (.92%)
Tachycardia
43 (.92%)
Renal Failure Acute
42 (.89%)
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Confusional State
41 (.87%)
Tremor
41 (.87%)
Death
40 (.85%)
Hypertension
39 (.83%)
Vomiting
39 (.83%)
Enterococcal Infection
38 (.81%)
Drug Ineffective
37 (.79%)
Sepsis
37 (.79%)
Renal Failure
36 (.77%)
Septic Shock
36 (.77%)
Respiratory Failure
35 (.75%)
Staphylococcal Infection
35 (.75%)
Multi-organ Failure
33 (.7%)
Neuropathy Peripheral
33 (.7%)
Agitation
32 (.68%)
Drug Toxicity
30 (.64%)
Haemoglobin Decreased
29 (.62%)
Rash
26 (.55%)
Paraesthesia
25 (.53%)
Asthenia
24 (.51%)
Mental Status Changes
24 (.51%)
Condition Aggravated
23 (.49%)
Diarrhoea
23 (.49%)
Renal Impairment
23 (.49%)
Pathogen Resistance
22 (.47%)
Pneumonia
22 (.47%)
Alanine Aminotransferase Increased
21 (.45%)
Convulsion
21 (.45%)
Leukopenia
21 (.45%)
Metabolic Acidosis
21 (.45%)
White Blood Cell Count Decreased
21 (.45%)
Bone Marrow Failure
20 (.43%)
Hyperhidrosis
20 (.43%)
Optic Neuropathy
20 (.43%)
Blood Bilirubin Increased
19 (.4%)
Blood Pressure Increased
19 (.4%)
General Physical Health Deteriorati...
19 (.4%)
Neutropenia
19 (.4%)
Aggression
18 (.38%)
Blood Alkaline Phosphatase Increase...
18 (.38%)
Dyspnoea
18 (.38%)
Optic Neuritis
18 (.38%)
Delirium
17 (.36%)
Hypotension
17 (.36%)
Liver Function Test Abnormal
17 (.36%)
Aspartate Aminotransferase Increase...
16 (.34%)
Blood Creatinine Increased
16 (.34%)
Malaise
16 (.34%)
Disorientation
15 (.32%)
Heart Rate Increased
15 (.32%)
Hepatic Failure
15 (.32%)
Multiple-drug Resistance
15 (.32%)
Anxiety
14 (.3%)
Chills
14 (.3%)
Hyponatraemia
14 (.3%)
Depression
13 (.28%)
Hepatic Function Abnormal
13 (.28%)
Hypoglycaemia
13 (.28%)
Mydriasis
13 (.28%)
Candidiasis
12 (.26%)
Cardio-respiratory Arrest
12 (.26%)
Dizziness
12 (.26%)
Grand Mal Convulsion
12 (.26%)
Myoclonus
12 (.26%)
Pneumonia Aspiration
12 (.26%)
Rhabdomyolysis
12 (.26%)
Stevens-johnson Syndrome
12 (.26%)
Toxic Epidermal Necrolysis
12 (.26%)
Urinary Tract Infection
12 (.26%)
Visual Acuity Reduced
12 (.26%)
Abdominal Pain
11 (.23%)
Disease Progression
11 (.23%)
Hallucination
11 (.23%)
Headache
11 (.23%)
Urinary Tract Infection Enterococca...
11 (.23%)
Vision Blurred
11 (.23%)
Blood Culture Positive
10 (.21%)
Cardiac Arrest
10 (.21%)
Clostridial Infection
10 (.21%)
Disseminated Intravascular Coagulat...
10 (.21%)
Drug Resistance
10 (.21%)
Gastrointestinal Haemorrhage
10 (.21%)
Hallucination, Visual
10 (.21%)
Hypoxia
10 (.21%)
Overdose
10 (.21%)
Pain
10 (.21%)
Paranoia
10 (.21%)
Polyneuropathy
10 (.21%)
Psychotic Disorder
10 (.21%)
Restlessness
10 (.21%)

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This graph shows the top adverse events submitted to the FDA for Linezolid, 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 Linezolid 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 Linezolid

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

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This graph shows the top categories of adverse events submitted to the FDA for Linezolid, 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 Linezolid 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 Linezolid According to Those Reporting Adverse Events

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

Staphylococcal Infection
201
Infection
115
Pneumonia
94
Product Used For Unknown Indication
83
Enterococcal Infection
82
Osteomyelitis
69
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Tuberculosis
66
Sepsis
56
Drug Use For Unknown Indication
50
Pneumonia Staphylococcal
46
Ill-defined Disorder
42
Device Related Infection
24
Bacterial Infection
22
Endocarditis
22
Cellulitis
21
Urinary Tract Infection
19
Staphylococcal Sepsis
16
Nocardiosis
14
Septic Shock
14
Catheter Related Infection
14
Wound Infection
13
Enterococcal Bacteraemia
12
Infection Prophylaxis
12
Arthritis Bacterial
11
Urinary Tract Infection Enterococca...
11
Antibiotic Prophylaxis
10
Abscess
10
Glycopeptide Antibiotic Resistant E...
9
Bacteraemia
9
Wound Infection Staphylococcal
9
Nosocomial Infection
9
Antibiotic Therapy
8
Pyrexia
8
Fungal Infection
8
Urinary Tract Infection Staphylococ...
8
Graft Infection
8
Staphylococcal Bacteraemia
7
Pulmonary Tuberculosis
7
Enterococcal Sepsis
7
Pathogen Resistance
7
Peritonitis
7
Staphylococcal Osteomyelitis
7
Septic Embolus
6
Postoperative Wound Infection
6
Prophylaxis
6
Intervertebral Discitis
6
Arthritis Infective
5
Evidence Based Treatment
5
Diabetic Foot Infection
4
Cellulitis Staphylococcal
4
Pneumonia Klebsiella
4

Drug Labels

LabelLabelerEffective
ZyvoxRebel Distributors Corp22-DEC-10
ZyvoxCardinal Health07-JUN-11
ZyvoxPharmacia and Upjohn Company18-MAY-12
ZyvoxREMEDYREPACK INC. 03-APR-13
ZyvoxREMEDYREPACK INC. 03-APR-13

Linezolid Case Reports

What Linezolid 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 Linezolid. 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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