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ZAVESCA

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Zavesca Adverse Events Reported to the FDA Over Time

How are Zavesca adverse event reports trending over time?

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

Most Common Zavesca Adverse Events Reported to the FDA

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

Diarrhoea
104 (5.28%)
Weight Decreased
79 (4.01%)
Tremor
57 (2.89%)
Condition Aggravated
45 (2.28%)
Convulsion
42 (2.13%)
Niemann-pick Disease
39 (1.98%)
Disease Progression
32 (1.62%)
Dysphagia
30 (1.52%)
Pneumonia
28 (1.42%)
Asthenia
26 (1.32%)
Abdominal Pain
25 (1.27%)
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Gait Disturbance
25 (1.27%)
Epilepsy
23 (1.17%)
Pyrexia
22 (1.12%)
Gastrointestinal Disorder
21 (1.07%)
General Physical Health Deteriorati...
21 (1.07%)
Memory Impairment
21 (1.07%)
Growth Retardation
20 (1.01%)
Headache
20 (1.01%)
Death
18 (.91%)
Drug Ineffective
18 (.91%)
Fatigue
17 (.86%)
Bone Pain
16 (.81%)
Decreased Appetite
16 (.81%)
Platelet Count Decreased
15 (.76%)
Depression
14 (.71%)
Neurological Decompensation
14 (.71%)
Concomitant Disease Aggravated
13 (.66%)
Epistaxis
13 (.66%)
Respiratory Failure
13 (.66%)
Constipation
12 (.61%)
Flatulence
12 (.61%)
Aphasia
11 (.56%)
Ataxia
11 (.56%)
Thrombocytopenia
11 (.56%)
Abnormal Behaviour
10 (.51%)
Aspartate Aminotransferase Increase...
10 (.51%)
Confusional State
10 (.51%)
Aggression
9 (.46%)
Malaise
9 (.46%)
Off Label Use
9 (.46%)
Pain
9 (.46%)
Renal Failure
9 (.46%)
Respiratory Tract Infection
9 (.46%)
Speech Disorder
9 (.46%)
Vomiting
9 (.46%)
Abdominal Distension
8 (.41%)
Activities Of Daily Living Impaired
8 (.41%)
Alanine Aminotransferase Increased
8 (.41%)
Anxiety
8 (.41%)
Bone Lesion
8 (.41%)
Disorientation
8 (.41%)
Guillain-barre Syndrome
8 (.41%)
Hallucination
8 (.41%)
Mood Altered
8 (.41%)
Neuropathy Peripheral
8 (.41%)
Pancytopenia
8 (.41%)
Peripheral Sensory Neuropathy
8 (.41%)
Back Pain
7 (.36%)
Chitotriosidase Increased
7 (.36%)
Cognitive Disorder
7 (.36%)
Demyelinating Polyneuropathy
7 (.36%)
Gastrostomy
7 (.36%)
Mental Disorder
7 (.36%)
Muscular Weakness
7 (.36%)
Nausea
7 (.36%)
No Therapeutic Response
7 (.36%)
Osteopenia
7 (.36%)
Polyneuropathy
7 (.36%)
Refusal Of Treatment By Patient
7 (.36%)
Sleep Disorder
7 (.36%)
Status Epilepticus
7 (.36%)
Amenorrhoea
6 (.3%)
Apathy
6 (.3%)
Balance Disorder
6 (.3%)
Cardiac Arrest
6 (.3%)
Coagulation Factor Decreased
6 (.3%)
Dizziness
6 (.3%)
Dyspnoea
6 (.3%)
Ear Haemorrhage
6 (.3%)
Factor X Deficiency
6 (.3%)
Fall
6 (.3%)
Gastrostomy Tube Insertion
6 (.3%)
Insomnia
6 (.3%)
Mental Status Changes
6 (.3%)
Neurological Symptom
6 (.3%)
Paradoxical Drug Reaction
6 (.3%)
Sepsis
6 (.3%)
Splenomegaly
6 (.3%)
Urinary Incontinence
6 (.3%)
Wheelchair User
6 (.3%)
C-reactive Protein Increased
5 (.25%)
Cachexia
5 (.25%)
Chest X-ray Abnormal
5 (.25%)
Decreased Activity
5 (.25%)
Dehydration
5 (.25%)
Dementia
5 (.25%)
Dysarthria
5 (.25%)
Enteral Nutrition
5 (.25%)
Grand Mal Convulsion
5 (.25%)
Loss Of Consciousness
5 (.25%)

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

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

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

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

Niemann-pick Disease
163
Gauchers Disease
132
Tay-sachs Disease
20
Product Used For Unknown Indication
12
Glycogen Storage Disease Type Ii
6
Lipidosis
4
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Interferon Gamma Receptor Deficienc...
2
Dyspepsia
2
Leukodystrophy
2
Dementia
1
Electroneurography
1
Accidental Exposure
1
Mucopolysaccharidosis
1

Drug Labels

LabelLabelerEffective
ZavescaActelion Pharmaceuticals US, Inc.30-NOV-10

Zavesca Case Reports

What Zavesca 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 Zavesca. 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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