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EXTRANEAL

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Extraneal Adverse Events Reported to the FDA Over Time

How are Extraneal adverse event reports trending over time?

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

Most Common Extraneal Adverse Events Reported to the FDA

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

Death
1925 (12.54%)
Peritonitis Bacterial
473 (3.08%)
Peritonitis
429 (2.79%)
Sepsis
371 (2.42%)
Myocardial Infarction
286 (1.86%)
Pneumonia
264 (1.72%)
Cardiac Failure
233 (1.52%)
Cardiac Disorder
201 (1.31%)
Peritoneal Dialysis Complication
201 (1.31%)
Cardiac Arrest
199 (1.3%)
Vomiting
191 (1.24%)
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Pyrexia
184 (1.2%)
Device Interaction
182 (1.19%)
Fungal Peritonitis
176 (1.15%)
Hypotension
174 (1.13%)
Hypoglycaemia
166 (1.08%)
Cerebrovascular Accident
160 (1.04%)
Nausea
156 (1.02%)
Abdominal Pain
147 (.96%)
Infection
144 (.94%)
Dyspnoea
142 (.92%)
Asthenia
130 (.85%)
Fall
130 (.85%)
Malaise
128 (.83%)
Sclerosing Encapsulating Peritoniti...
119 (.77%)
Dehydration
111 (.72%)
Diarrhoea
105 (.68%)
Chest Pain
101 (.66%)
Fluid Overload
98 (.64%)
Cardiovascular Disorder
84 (.55%)
Abdominal Distension
83 (.54%)
Respiratory Failure
76 (.49%)
Gangrene
75 (.49%)
Hypertension
75 (.49%)
Constipation
71 (.46%)
Fluid Retention
68 (.44%)
Peritonitis Sclerosing
67 (.44%)
Convulsion
61 (.4%)
Pulmonary Oedema
61 (.4%)
Cardiac Failure Congestive
58 (.38%)
Peritoneal Cloudy Effluent
57 (.37%)
Urinary Tract Infection
57 (.37%)
Cerebral Haemorrhage
56 (.36%)
Gastrointestinal Haemorrhage
56 (.36%)
Anaemia
54 (.35%)
Decreased Appetite
54 (.35%)
Loss Of Consciousness
54 (.35%)
Staphylococcal Infection
54 (.35%)
Acute Myocardial Infarction
53 (.35%)
Pancreatitis
52 (.34%)
Localised Infection
49 (.32%)
General Physical Health Deteriorati...
47 (.31%)
Pruritus
47 (.31%)
Depressed Level Of Consciousness
45 (.29%)
Hernia
45 (.29%)
Multi-organ Failure
45 (.29%)
Procedural Complication
45 (.29%)
Septic Shock
45 (.29%)
Catheter Site Infection
44 (.29%)
Intestinal Obstruction
43 (.28%)
Pain
41 (.27%)
Renal Failure Chronic
41 (.27%)
Blood Glucose False Positive
40 (.26%)
Pleural Effusion
39 (.25%)
Blood Glucose Increased
38 (.25%)
Cellulitis
38 (.25%)
Cerebral Infarction
38 (.25%)
Ileus
38 (.25%)
Rash
37 (.24%)
Malnutrition
34 (.22%)
Ascites
32 (.21%)
Catheter Related Complication
32 (.21%)
Fatigue
32 (.21%)
Weight Decreased
32 (.21%)
Blood Glucose Decreased
31 (.2%)
Bloody Peritoneal Effluent
31 (.2%)
Confusional State
31 (.2%)
Haemorrhage
31 (.2%)
Muscle Spasms
31 (.2%)
Atrial Fibrillation
30 (.2%)
Therapy Cessation
30 (.2%)
Cardio-respiratory Arrest
29 (.19%)
Coma
29 (.19%)
Haemoglobin Decreased
29 (.19%)
Oedema Peripheral
29 (.19%)
Blood Pressure Increased
28 (.18%)
Chills
28 (.18%)
Unresponsive To Stimuli
28 (.18%)
Abdominal Pain Upper
27 (.18%)
Discomfort
27 (.18%)
Haemodialysis
27 (.18%)
Intestinal Perforation
27 (.18%)
Oedema
27 (.18%)
Skin Exfoliation
27 (.18%)
Weight Increased
27 (.18%)
Blood Potassium Decreased
26 (.17%)
Blood Pressure Decreased
26 (.17%)
Haemorrhagic Anaemia
26 (.17%)
Hyperkalaemia
26 (.17%)
Mental Status Changes
26 (.17%)
Peritoneal Disorder
26 (.17%)

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

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

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

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

Peritoneal Dialysis
6050
Renal Failure Chronic
921
Renal Failure
77
Diabetic Nephropathy
49
Drug Use For Unknown Indication
32
Dialysis
23
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Fluid Overload
15
Product Used For Unknown Indication
14
Off Label Use
10
Fluid Replacement
10
Glomerulonephritis Chronic
9
Diabetes Mellitus
9
Diabetic End Stage Renal Disease
9
Nephrosclerosis
7
Ill-defined Disorder
7
Cardiac Failure
6
Wegeners Granulomatosis
6
Osteoporosis
6
Glomerulonephritis
6
Hypertension
5
Azotaemia
4
Congenital Cystic Kidney Disease
4
Intravenous Catheter Management
4
Tubulointerstitial Nephritis
4
Cardiac Failure Congestive
3
Drug Exposure During Pregnancy
3
Migraine
3
Prophylaxis
3
Surgery
3
Vascular Access Complication
3
Kidney Transplant Rejection
3
Renal Disorder
2
Type 2 Diabetes Mellitus
2
Renal Cyst
2
Indwelling Catheter Management
2
Cardiorenal Syndrome
2
Dehydration
2
Diabetic Neuropathy
2
Iga Nephropathy
2
Haemodialysis
2
Mineral Supplementation
2
Fluid Imbalance
2
Therapeutic Procedure
2
Blood Electrolytes Decreased
1
Multiple Myeloma
1
Cardiac Hypertrophy
1
Cows Milk Intolerance
1
Hypertensive Nephropathy
1
Hypotension
1
Cerebral Infarction
1
Complications Of Transplanted Kidne...
1

Drug Labels

LabelLabelerEffective
ExtranealBaxter Healthcare Corporation18-OCT-10

Extraneal Case Reports

What Extraneal 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 Extraneal. 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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