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TIGECYCLINE

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Tigecycline Adverse Events Reported to the FDA Over Time

How are Tigecycline adverse event reports trending over time?

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

Most Common Tigecycline Adverse Events Reported to the FDA

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

Drug Ineffective
83 (5.62%)
Death
52 (3.52%)
Multi-organ Failure
38 (2.57%)
Septic Shock
38 (2.57%)
Nausea
30 (2.03%)
Pancreatitis
29 (1.96%)
Acinetobacter Infection
27 (1.83%)
Sepsis
24 (1.62%)
Pathogen Resistance
23 (1.56%)
Renal Failure Acute
23 (1.56%)
Vomiting
23 (1.56%)
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Condition Aggravated
22 (1.49%)
Infection
22 (1.49%)
Thrombocytopenia
21 (1.42%)
Respiratory Failure
19 (1.29%)
Blood Bilirubin Increased
16 (1.08%)
Alanine Aminotransferase Increased
14 (.95%)
Clostridial Infection
14 (.95%)
Jaundice
14 (.95%)
Pyrexia
14 (.95%)
Pancreatitis Necrotising
13 (.88%)
Abdominal Pain
11 (.74%)
Blood Alkaline Phosphatase Increase...
11 (.74%)
Diarrhoea
11 (.74%)
Lipase Increased
11 (.74%)
Pancreatitis Haemorrhagic
11 (.74%)
Hepatic Failure
10 (.68%)
Renal Failure
10 (.68%)
Aspartate Aminotransferase Increase...
9 (.61%)
Bacteraemia
9 (.61%)
Drug Resistance
9 (.61%)
Fungaemia
9 (.61%)
Pseudomonas Infection
9 (.61%)
Staphylococcal Infection
9 (.61%)
Abdominal Abscess
8 (.54%)
Anaemia
8 (.54%)
Chills
8 (.54%)
Dehydration
8 (.54%)
Drug Interaction
8 (.54%)
Liver Abscess
8 (.54%)
Pallor
8 (.54%)
Pneumonia Klebsiella
8 (.54%)
Atrial Fibrillation
7 (.47%)
Gastrointestinal Haemorrhage
7 (.47%)
Hypovolaemic Shock
7 (.47%)
Peritonitis
7 (.47%)
Rash Macular
7 (.47%)
Asthenia
6 (.41%)
Cardiac Failure
6 (.41%)
Device Related Infection
6 (.41%)
Disease Progression
6 (.41%)
Dyspnoea
6 (.41%)
Endocarditis
6 (.41%)
Hepatic Infarction
6 (.41%)
Intestinal Ischaemia
6 (.41%)
Klebsiella Infection
6 (.41%)
Pancreatitis Acute
6 (.41%)
Renal Abscess
6 (.41%)
Renal Infarct
6 (.41%)
Renal Tubular Necrosis
6 (.41%)
Splenic Abscess
6 (.41%)
Splenic Infarction
6 (.41%)
Stevens-johnson Syndrome
6 (.41%)
Trichosporon Infection
6 (.41%)
Wound Infection
6 (.41%)
Blood Urea Increased
5 (.34%)
Cardiac Arrest
5 (.34%)
Cholestasis
5 (.34%)
Coma
5 (.34%)
Confusional State
5 (.34%)
Eosinophil Count Increased
5 (.34%)
Hypoglycaemia
5 (.34%)
Klebsiella Bacteraemia
5 (.34%)
Leukopenia
5 (.34%)
Lung Infection Pseudomonal
5 (.34%)
Palpitations
5 (.34%)
Platelet Count Decreased
5 (.34%)
Urticaria
5 (.34%)
Bradycardia
4 (.27%)
Cardiogenic Shock
4 (.27%)
Convulsion
4 (.27%)
Cytolytic Hepatitis
4 (.27%)
Cytomegalovirus Infection
4 (.27%)
Disseminated Intravascular Coagulat...
4 (.27%)
Drug Toxicity
4 (.27%)
Endotracheal Intubation
4 (.27%)
Enterococcal Sepsis
4 (.27%)
Erythema
4 (.27%)
Haematocrit Decreased
4 (.27%)
Haemoptysis
4 (.27%)
Hepatitis
4 (.27%)
Hepatitis Cholestatic
4 (.27%)
Histiocytosis Haematophagic
4 (.27%)
Hypotension
4 (.27%)
Hypoxia
4 (.27%)
Idiopathic Pulmonary Fibrosis
4 (.27%)
Infusion Site Irritation
4 (.27%)
Jaundice Cholestatic
4 (.27%)
Lung Infiltration
4 (.27%)
Mouth Ulceration
4 (.27%)
Multi-organ Disorder
4 (.27%)

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

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

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

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

Pneumonia
74
Acinetobacter Infection
37
Abdominal Infection
27
Sepsis
25
Pathogen Resistance
23
Infection
20
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Osteomyelitis
18
Cellulitis
18
Product Used For Unknown Indication
18
Staphylococcal Infection
17
Peritonitis
14
Drug Use For Unknown Indication
12
Bacteraemia
12
Klebsiella Infection
11
Multiple-drug Resistance
11
Soft Tissue Infection
10
Abdominal Abscess
8
Enterobacter Infection
7
Enterococcal Infection
7
Mycobacterium Chelonei Infection
6
Wound Infection
6
Antibiotic Therapy
6
Acinetobacter Bacteraemia
6
Urinary Tract Infection
6
Stenotrophomonas Infection
6
Skin Infection
5
Escherichia Infection
5
Diabetic Foot Infection
5
Peritonitis Bacterial
5
Post Procedural Infection
5
Empyema
4
Pneumonia Klebsiella
4
Mycobacterium Abscessus Infection
4
Pneumonia Bacterial
4
Antibiotic Prophylaxis
4
Endocarditis
3
Febrile Neutropenia
3
Abscess
3
Atypical Mycobacterial Infection
3
Diverticulitis
3
Clostridial Infection
3
Bronchopneumonia
3
Septic Shock
3
Device Related Infection
3
Pyrexia
3
Mediastinitis
3
Renal Failure
2
Infectious Peritonitis
2
Appendicitis Perforated
2
Enterococcal Bacteraemia
2
Wound Infection Staphylococcal
2

Drug Labels

LabelLabelerEffective
TygacilWyeth Pharmaceuticals Company, a subsidiary of Pfizer Inc.15-NOV-12

Tigecycline Case Reports

What Tigecycline 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 Tigecycline. 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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