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DIANEAL

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Dianeal Adverse Events Reported to the FDA Over Time

How are Dianeal adverse event reports trending over time?

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

Most Common Dianeal Adverse Events Reported to the FDA

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

Death
7589 (8.61%)
Myocardial Infarction
2733 (3.1%)
Peritonitis Bacterial
2572 (2.92%)
Cardiac Arrest
2373 (2.69%)
Peritonitis
2249 (2.55%)
Pneumonia
1946 (2.21%)
Sepsis
1945 (2.21%)
Cardiac Disorder
1773 (2.01%)
Cardiac Failure
1752 (1.99%)
Cerebrovascular Accident
1604 (1.82%)
Peritoneal Dialysis Complication
1577 (1.79%)
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Vomiting
1453 (1.65%)
Hypotension
1419 (1.61%)
Dyspnoea
1333 (1.51%)
Infection
1099 (1.25%)
Fall
1088 (1.23%)
Asthenia
1002 (1.14%)
Dehydration
1000 (1.13%)
Nausea
963 (1.09%)
Fungal Peritonitis
941 (1.07%)
Chest Pain
923 (1.05%)
Malaise
769 (.87%)
Cardiac Failure Congestive
764 (.87%)
Pyrexia
763 (.87%)
Diarrhoea
681 (.77%)
Hernia
652 (.74%)
Abdominal Pain
638 (.72%)
Fluid Overload
631 (.72%)
Hypertension
547 (.62%)
Respiratory Failure
530 (.6%)
Abdominal Distension
529 (.6%)
Gastrointestinal Haemorrhage
504 (.57%)
Constipation
487 (.55%)
Anaemia
457 (.52%)
Convulsion
456 (.52%)
Gangrene
446 (.51%)
Urinary Tract Infection
409 (.46%)
Pancreatitis
397 (.45%)
Pulmonary Oedema
386 (.44%)
Localised Infection
363 (.41%)
Failure To Thrive
352 (.4%)
Catheter Related Complication
341 (.39%)
Renal Failure
335 (.38%)
Cardio-respiratory Arrest
333 (.38%)
Pain
332 (.38%)
Therapy Cessation
327 (.37%)
Cardiovascular Disorder
320 (.36%)
Hip Fracture
314 (.36%)
Confusional State
303 (.34%)
Pleural Effusion
302 (.34%)
Thrombosis
290 (.33%)
Cellulitis
288 (.33%)
Renal Failure Chronic
280 (.32%)
Loss Of Consciousness
278 (.32%)
Mental Status Changes
275 (.31%)
Neoplasm Malignant
267 (.3%)
Staphylococcal Infection
250 (.28%)
Blood Potassium Decreased
238 (.27%)
Procedural Complication
234 (.27%)
Hypoglycaemia
230 (.26%)
Syncope
225 (.26%)
Refusal Of Treatment By Patient
224 (.25%)
Blood Glucose Decreased
221 (.25%)
Decreased Appetite
221 (.25%)
General Physical Health Deteriorati...
221 (.25%)
Skin Ulcer
221 (.25%)
Haemorrhage
220 (.25%)
Dizziness
218 (.25%)
Catheter Site Infection
217 (.25%)
Fluid Retention
217 (.25%)
Multi-organ Failure
216 (.25%)
Peripheral Vascular Disorder
216 (.25%)
Diabetes Mellitus
199 (.23%)
Muscle Spasms
197 (.22%)
Pain In Extremity
197 (.22%)
Cerebral Haemorrhage
194 (.22%)
Atrial Fibrillation
192 (.22%)
Back Pain
192 (.22%)
Treatment Noncompliance
192 (.22%)
Azotaemia
190 (.22%)
Procedural Pain
189 (.21%)
Discomfort
188 (.21%)
Blood Glucose Increased
186 (.21%)
Calciphylaxis
184 (.21%)
Arrhythmia
182 (.21%)
Haemoglobin Decreased
180 (.2%)
Intestinal Perforation
180 (.2%)
Intestinal Obstruction
179 (.2%)
Wound
176 (.2%)
Malnutrition
174 (.2%)
Septic Shock
174 (.2%)
Cholelithiasis
172 (.2%)
Bloody Peritoneal Effluent
170 (.19%)
Clostridial Infection
170 (.19%)
Lung Neoplasm Malignant
166 (.19%)
Gastrointestinal Disorder
165 (.19%)
Device Related Infection
163 (.18%)
Post Procedural Complication
161 (.18%)
Blood Pressure Decreased
152 (.17%)
Peritoneal Cloudy Effluent
150 (.17%)
Medical Device Complication
146 (.17%)

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

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

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

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

Peritoneal Dialysis
33599
Renal Failure Chronic
2919
Renal Failure
143
Dialysis
121
Drug Use For Unknown Indication
75
Diabetic Nephropathy
46
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Renal Disorder
46
Product Used For Unknown Indication
43
Diarrhoea
23
Prophylaxis
21
Crohns Disease
17
Glomerulonephritis Chronic
16
Diabetes Mellitus
13
Hypertension
11
Congenital Cystic Kidney Disease
11
Enterocolitis
10
Ill-defined Disorder
10
Fluid Replacement
9
Diabetic End Stage Renal Disease
8
Nephrosclerosis
7
Azotaemia
7
Glomerulonephritis
7
Fluid Overload
7
Osteoporosis
6
Haemodialysis
6
Pruritus
5
Cardiac Failure Congestive
5
Diabetic Neuropathy
5
Gastrointestinal Disorder
4
Off Label Use
4
Drug Therapy
4
Renal Cyst
4
Enteritis
4
Drug Exposure During Pregnancy
4
Dyspnoea
4
Intravenous Catheter Management
4
Renal Failure Acute
3
Disbacteriosis
3
Surgery
3
Tubulointerstitial Nephritis
3
Migraine
3
Otitis Media Acute
3
Adverse Event
3
Peritoneal Lavage
2
Perianal Abscess
2
Exposure During Breast Feeding
2
Gastroenteritis
2
Bronchitis Acute
2
Mineral Supplementation
2
Constipation
2
Ascites
2

Drug Labels

LabelLabelerEffective
Dianeal Pd-2 With DextroseBaxter Healthcare Corporation02-FEB-02
Dianeal Low Calcium With DextroseBaxter Healthcare Corporation12-FEB-02
Dianeal Pd-2 Peritoneal Dialysis Solution With DextroseBaxter Healthcare Corporation07-JUN-10
Dianeal Low Calcium Peritoneal Dialysis Solution With DextroseBAXTER HEALTHCARE CORPORATION20-OCT-10

Dianeal Case Reports

What Dianeal 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 Dianeal. 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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