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TRACRIUM

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Tracrium Adverse Events Reported to the FDA Over Time

How are Tracrium adverse event reports trending over time?

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

Most Common Tracrium Adverse Events Reported to the FDA

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

Anaphylactic Shock
65 (3.67%)
Hypotension
61 (3.45%)
Bronchospasm
46 (2.6%)
Tachycardia
31 (1.75%)
Anaphylactic Reaction
30 (1.69%)
Circulatory Collapse
30 (1.69%)
Bradycardia
26 (1.47%)
Erythema
25 (1.41%)
Oxygen Saturation Decreased
20 (1.13%)
Cardiac Arrest
19 (1.07%)
Generalised Erythema
17 (.96%)
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Shock
17 (.96%)
Renal Failure
16 (.9%)
Toxic Skin Eruption
16 (.9%)
Drug Ineffective
15 (.85%)
Hypoxia
15 (.85%)
Stevens-johnson Syndrome
15 (.85%)
Rash
14 (.79%)
Respiratory Failure
14 (.79%)
Ventricular Fibrillation
14 (.79%)
Asthenia
13 (.73%)
Cyanosis
13 (.73%)
Urticaria
13 (.73%)
Alanine Aminotransferase Increased
12 (.68%)
Anaesthetic Complication
12 (.68%)
Hypertension
12 (.68%)
Respiratory Distress
12 (.68%)
Drug Interaction
11 (.62%)
Pallor
11 (.62%)
Pleural Effusion
11 (.62%)
Respiratory Acidosis
11 (.62%)
Rhabdomyolysis
11 (.62%)
Supraventricular Tachycardia
11 (.62%)
Dysphagia
10 (.56%)
Face Oedema
10 (.56%)
Gamma-glutamyltransferase Increased
10 (.56%)
Pruritus
10 (.56%)
Sepsis
10 (.56%)
Septic Shock
10 (.56%)
Anaemia
9 (.51%)
Cytolytic Hepatitis
9 (.51%)
Dyspnoea
9 (.51%)
Neutropenia
9 (.51%)
Pneumonia
9 (.51%)
Pyrexia
9 (.51%)
Abdominal Pain
8 (.45%)
Cardio-respiratory Arrest
8 (.45%)
Convulsion
8 (.45%)
Lung Disorder
8 (.45%)
Oedema Peripheral
8 (.45%)
Rash Generalised
8 (.45%)
Acute Pulmonary Oedema
7 (.4%)
Anaphylactoid Reaction
7 (.4%)
Angioedema
7 (.4%)
Anuria
7 (.4%)
Blood Pressure Decreased
7 (.4%)
Cardiac Failure
7 (.4%)
Coma
7 (.4%)
Drug Rash With Eosinophilia And Sys...
7 (.4%)
Dyskinesia
7 (.4%)
Electrocardiogram Qrs Complex Prolo...
7 (.4%)
Electromechanical Dissociation
7 (.4%)
Haematuria
7 (.4%)
Hepatic Enzyme Increased
7 (.4%)
Rash Vesicular
7 (.4%)
Respiration Abnormal
7 (.4%)
Respiratory Arrest
7 (.4%)
Ventricular Arrhythmia
7 (.4%)
Ventricular Tachycardia
7 (.4%)
Weight Decreased
7 (.4%)
Wheezing
7 (.4%)
Agitation
6 (.34%)
Blood Alkaline Phosphatase Increase...
6 (.34%)
Blood Bilirubin Increased
6 (.34%)
Enterobacter Infection
6 (.34%)
Eosinophilia
6 (.34%)
Lymphopenia
6 (.34%)
Neutropenic Colitis
6 (.34%)
Oliguria
6 (.34%)
Pancytopenia
6 (.34%)
Post Procedural Complication
6 (.34%)
Rales
6 (.34%)
Renal Failure Acute
6 (.34%)
Aspartate Aminotransferase Increase...
5 (.28%)
Aspiration
5 (.28%)
Conversion Disorder
5 (.28%)
Dermatitis Bullous
5 (.28%)
Drug Hypersensitivity
5 (.28%)
Electrocardiogram St Segment Depres...
5 (.28%)
Gastrointestinal Haemorrhage
5 (.28%)
Haemoglobin Decreased
5 (.28%)
Hyperthermia
5 (.28%)
Muscle Necrosis
5 (.28%)
Muscular Weakness
5 (.28%)
Myocardial Infarction
5 (.28%)
Overdose
5 (.28%)
Peripheral Ischaemia
5 (.28%)
Pityriasis
5 (.28%)
Procedural Complication
5 (.28%)
Proteinuria
5 (.28%)
Prothrombin Level Decreased
5 (.28%)

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

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

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

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

Anaesthesia
118
Induction Of Anaesthesia
61
General Anaesthesia
54
Drug Use For Unknown Indication
36
Acute Myeloid Leukaemia
32
Endotracheal Intubation
16
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Neuromuscular Blockade
15
Muscle Relaxant Therapy
13
Intubation
12
Acute Promyelocytic Leukaemia
12
Product Used For Unknown Indication
11
Maintenance Of Anaesthesia
9
Hypotonia
8
Wrong Drug Administered
7
Myelodysplastic Syndrome
7
Surgery
6
Paralysis
6
Sensory Disturbance
6
Neuromuscular Blocking Therapy
5
Scoliosis Surgery
4
Sedation
2
Therapeutic Procedure
2
Ileostomy
1
Appendicitis
1
Osteotomy
1
Premedication
1
Anaesthesia Procedure
1
Thyroid Neoplasm
1
Therapeutic Embolisation
1
Vascular Operation
1
Foetal Exposure During Pregnancy
1
Analgesic Therapy
1
Leukaemia
1
Tumour Excision
1
Back Pain
1
Ill-defined Disorder
1

Tracrium Case Reports

What Tracrium 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 Tracrium. 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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