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RENAGEL

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Renagel Adverse Events Reported to the FDA Over Time

How are Renagel adverse event reports trending over time?

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

Most Common Renagel Adverse Events Reported to the FDA

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

Constipation
111 (2.13%)
Muscular Weakness
103 (1.98%)
Balance Disorder
87 (1.67%)
Diverticulitis
79 (1.52%)
Large Intestine Perforation
66 (1.27%)
Intestinal Perforation
63 (1.21%)
Haemodialysis
61 (1.17%)
Diarrhoea
60 (1.15%)
Death
58 (1.11%)
Peritonitis
56 (1.07%)
Hyperphosphataemia
54 (1.04%)
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Gastrointestinal Haemorrhage
53 (1.02%)
Pruritus
53 (1.02%)
Anaemia
49 (.94%)
Vomiting
47 (.9%)
Drug Interaction
45 (.86%)
Intestinal Obstruction
45 (.86%)
Abdominal Pain
44 (.84%)
Haemoglobin Decreased
43 (.83%)
Nausea
43 (.83%)
Condition Aggravated
42 (.81%)
Melaena
41 (.79%)
Blood Potassium Increased
39 (.75%)
Abdominal Distension
36 (.69%)
Pyrexia
35 (.67%)
Hypotension
32 (.61%)
Ileus
29 (.56%)
Blood Phosphorus Increased
28 (.54%)
Sepsis
28 (.54%)
Dialysis
27 (.52%)
Cerebrovascular Accident
26 (.5%)
Dizziness
25 (.48%)
Abdominal Pain Upper
24 (.46%)
Asthenia
24 (.46%)
Gastric Ulcer
24 (.46%)
Haematocrit Decreased
24 (.46%)
Blood Creatine Phosphokinase Increa...
23 (.44%)
Blood Pressure Decreased
23 (.44%)
Diverticular Perforation
23 (.44%)
Dyspnoea
23 (.44%)
Hypertension
23 (.44%)
Duodenal Ulcer
21 (.4%)
Rash
21 (.4%)
Dysphagia
20 (.38%)
Vascular Calcification
20 (.38%)
Drug Ineffective
19 (.36%)
Hepatic Function Abnormal
19 (.36%)
Ascites
18 (.35%)
Colitis Ischaemic
18 (.35%)
Diverticulum Intestinal
18 (.35%)
Gastric Ulcer Haemorrhage
17 (.33%)
General Physical Health Deteriorati...
17 (.33%)
Platelet Count Decreased
17 (.33%)
Septic Shock
17 (.33%)
Thrombocytopenia
17 (.33%)
Gastrointestinal Perforation
16 (.31%)
Malaise
16 (.31%)
Treatment Noncompliance
16 (.31%)
Acute Abdomen
15 (.29%)
Blood Alkaline Phosphatase Increase...
15 (.29%)
Blood Lactate Dehydrogenase Increas...
15 (.29%)
Blood Parathyroid Hormone Increased
15 (.29%)
Cardio-respiratory Arrest
15 (.29%)
Chest Pain
15 (.29%)
Drug Exposure During Pregnancy
15 (.29%)
Eosinophilia
15 (.29%)
Gangrene
15 (.29%)
Intestinal Ischaemia
15 (.29%)
Metabolic Acidosis
15 (.29%)
Procedural Complication
15 (.29%)
Renal Failure
15 (.29%)
Alanine Aminotransferase Increased
14 (.27%)
Cerebral Haemorrhage
14 (.27%)
Decreased Appetite
14 (.27%)
Gastrointestinal Disorder
14 (.27%)
Grip Strength Decreased
14 (.27%)
Hypothyroidism
14 (.27%)
Post Procedural Complication
14 (.27%)
Shock
14 (.27%)
Anorexia
13 (.25%)
Aspartate Aminotransferase Increase...
13 (.25%)
Cardiac Arrest
13 (.25%)
Foreign Body Trauma
13 (.25%)
Haematochezia
13 (.25%)
Hyperkalaemia
13 (.25%)
Proctalgia
13 (.25%)
Cardiac Murmur
12 (.23%)
Disseminated Intravascular Coagulat...
12 (.23%)
Epistaxis
12 (.23%)
Inflammation
12 (.23%)
Small Intestinal Obstruction
12 (.23%)
White Blood Cell Count Increased
12 (.23%)
Blood Creatinine Increased
11 (.21%)
Cachexia
11 (.21%)
Cardiac Failure
11 (.21%)
Convulsion
11 (.21%)
Faecaloma
11 (.21%)
Gastric Haemorrhage
11 (.21%)
Hypocalcaemia
11 (.21%)
Leg Amputation
11 (.21%)
Myocardial Infarction
11 (.21%)

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

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

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

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

Hyperphosphataemia
1461
Drug Use For Unknown Indication
723
Product Used For Unknown Indication
496
Blood Phosphorus Increased
69
Renal Failure Chronic
68
Hyperparathyroidism Secondary
52
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Renal Failure
37
Renal Disorder
25
Blood Phosphorus Abnormal
24
Dialysis
22
Prophylaxis
20
Blood Phosphorus
17
Haemodialysis
15
Mineral Supplementation
13
Phosphorus Metabolism Disorder
11
Supplementation Therapy
11
Hyperparathyroidism
10
Drug Therapy
8
Renal Impairment
7
Ill-defined Disorder
7
Blood Phosphorus Decreased
5
Renal Osteodystrophy
4
Hyperphosphatasaemia
3
Focal Glomerulosclerosis
3
Iron Deficiency Anaemia
3
Nephritis
3
Electrolyte Imbalance
3
Hypophosphataemia
3
Calcium Deficiency
3
Metastatic Renal Cell Carcinoma
3
Peritoneal Dialysis
3
Hypertension
3
Pruritus
3
Medical Diet
2
Hypocalcaemia
2
Hyperlipidaemia
2
Metabolic Disorder
2
Renal Failure Acute
2
Hyperkalaemia
2
Nephropathy
2
Melaena
2
Gastrointestinal Disorder
2
Congenital Cystic Kidney Disease
1
Glomerulonephritis Chronic
1
Prostatism
1
Calcium Metabolism Disorder
1
Hypercholesterolaemia
1
Renal Cell Carcinoma Stage Iv
1
Renal Tubular Disorder
1
Osteodystrophy
1
Vitamin Supplementation
1

Drug Labels

LabelLabelerEffective
RenagelState of Florida DOH Central Pharmacy01-JUN-10
RenagelCardinal Health10-AUG-11
RenagelGenzyme Corporation06-DEC-12

Renagel Case Reports

What Renagel 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 Renagel. 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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