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XIGRIS

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Xigris Adverse Events Reported to the FDA Over Time

How are Xigris adverse event reports trending over time?

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

Most Common Xigris Adverse Events Reported to the FDA

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

Death
356 (5.97%)
Platelet Count Decreased
267 (4.47%)
Thrombocytopenia
264 (4.42%)
Multi-organ Failure
209 (3.5%)
Activated Partial Thromboplastin Ti...
172 (2.88%)
Haemorrhage
166 (2.78%)
International Normalised Ratio Incr...
154 (2.58%)
Sepsis
148 (2.48%)
Haemorrhage Intracranial
140 (2.35%)
Septic Shock
108 (1.81%)
Cerebral Haemorrhage
97 (1.63%)
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Haemoglobin Decreased
96 (1.61%)
Cardiac Arrest
87 (1.46%)
Gastrointestinal Haemorrhage
80 (1.34%)
Disseminated Intravascular Coagulat...
76 (1.27%)
Prothrombin Time Prolonged
75 (1.26%)
Hypotension
72 (1.21%)
Haematocrit Decreased
60 (1.01%)
Renal Failure
59 (.99%)
Condition Aggravated
57 (.96%)
Respiratory Failure
57 (.96%)
General Physical Health Deteriorati...
56 (.94%)
Pneumonia
51 (.85%)
Epistaxis
40 (.67%)
Subarachnoid Haemorrhage
40 (.67%)
Brain Oedema
38 (.64%)
Coagulopathy
36 (.6%)
Medication Error
35 (.59%)
Haemodialysis
34 (.57%)
Acute Respiratory Distress Syndrome
33 (.55%)
Brain Death
32 (.54%)
Catheter Site Haemorrhage
32 (.54%)
Pulmonary Haemorrhage
32 (.54%)
Mouth Haemorrhage
31 (.52%)
Cardio-respiratory Arrest
30 (.5%)
Mydriasis
30 (.5%)
Convulsion
29 (.49%)
Hepatic Failure
28 (.47%)
Post Procedural Haemorrhage
25 (.42%)
Renal Failure Acute
24 (.4%)
Nervous System Disorder
23 (.39%)
Cardiac Failure
22 (.37%)
Myocardial Infarction
22 (.37%)
Bradycardia
21 (.35%)
Deep Vein Thrombosis
21 (.35%)
Dialysis
21 (.35%)
Pyrexia
21 (.35%)
Accidental Overdose
20 (.34%)
Shock
20 (.34%)
Blood Fibrinogen Increased
19 (.32%)
Coma
19 (.32%)
International Normalised Ratio Decr...
19 (.32%)
Thrombosis
19 (.32%)
White Blood Cell Count Increased
19 (.32%)
Drug Exposure During Pregnancy
18 (.3%)
Rhabdomyolysis
18 (.3%)
Alanine Aminotransferase Increased
17 (.28%)
Anaemia
17 (.28%)
Blood Creatinine Increased
17 (.28%)
Disease Recurrence
17 (.28%)
Pulmonary Embolism
17 (.28%)
Blood Pressure Decreased
16 (.27%)
Cardiovascular Disorder
16 (.27%)
Pupil Fixed
16 (.27%)
Wound Haemorrhage
16 (.27%)
Drug Ineffective
15 (.25%)
Intraventricular Haemorrhage
15 (.25%)
Metabolic Acidosis
15 (.25%)
Respiratory Disorder
15 (.25%)
Blood Bilirubin Increased
14 (.23%)
Depressed Level Of Consciousness
14 (.23%)
Haematuria
14 (.23%)
Loss Of Consciousness
14 (.23%)
Brain Herniation
13 (.22%)
Post Procedural Complication
13 (.22%)
Rectal Haemorrhage
13 (.22%)
Upper Gastrointestinal Haemorrhage
13 (.22%)
Acute Myocardial Infarction
12 (.2%)
Aspartate Aminotransferase Increase...
12 (.2%)
Disease Progression
12 (.2%)
Fibrin D Dimer Increased
12 (.2%)
Haematemesis
12 (.2%)
Haemodynamic Instability
12 (.2%)
Off Label Use
12 (.2%)
Peritonitis
12 (.2%)
Atrial Fibrillation
11 (.18%)
Hypoxia
11 (.18%)
Multi-organ Disorder
11 (.18%)
Tachycardia
11 (.18%)
Acidosis
10 (.17%)
Cerebral Haematoma
10 (.17%)
Circulatory Collapse
10 (.17%)
Haematoma
10 (.17%)
Intra-abdominal Haemorrhage
10 (.17%)
Melaena
10 (.17%)
Blood Urea Increased
9 (.15%)
Electrocardiogram St Segment Elevat...
9 (.15%)
Haemorrhagic Cerebral Infarction
9 (.15%)
Incision Site Haemorrhage
9 (.15%)
Intracranial Pressure Increased
9 (.15%)
Petechiae
9 (.15%)

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

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

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

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

Sepsis
1188
Septic Shock
267
Multi-organ Failure
95
Urosepsis
29
Pneumonia
28
Abdominal Sepsis
25
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Meningococcal Sepsis
19
Staphylococcal Sepsis
9
Organ Failure
7
Acute Respiratory Distress Syndrome
6
Post Procedural Sepsis
6
Sepsis Syndrome
6
Infection
6
Pneumonia Staphylococcal
5
Streptococcal Sepsis
5
Drug Use For Unknown Indication
5
Systemic Inflammatory Response Synd...
5
Disseminated Intravascular Coagulat...
5
Pneumococcal Sepsis
4
Pneumonia Streptococcal
4
Meningitis
4
Lung Injury
4
Shock
4
Bacterial Sepsis
4
Intestinal Perforation
4
Pulmonary Sepsis
3
Peritonitis
3
Meningitis Meningococcal
3
Klebsiella Sepsis
3
Localised Infection
2
Pneumonia Pneumococcal
2
Product Used For Unknown Indication
2
Ischaemic Stroke
2
Multi-organ Disorder
2
Toxic Shock Syndrome Streptococcal
2
Urinary Tract Infection
2
Acinetobacter Bacteraemia
2
Bronchopulmonary Aspergillosis
2
Staphylococcal Infection
2
Cerebrovascular Accident
2
Renal Failure
2
Clostridial Infection
2
Post Procedural Complication
2
Candida Sepsis
1
Nosocomial Infection
1
Endocarditis
1
Ill-defined Disorder
1
H1n1 Influenza
1
Biliary Sepsis
1
Lung Disorder
1
Malaria
1

Xigris Case Reports

What Xigris 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 Xigris. 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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