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VIVAGLOBIN

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Vivaglobin Adverse Events Reported to the FDA Over Time

How are Vivaglobin adverse event reports trending over time?

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

Most Common Vivaglobin Adverse Events Reported to the FDA

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

Headache
61 (2.71%)
Infusion Related Reaction
35 (1.55%)
Infusion Site Swelling
35 (1.55%)
Nausea
34 (1.51%)
Migraine
33 (1.46%)
Urticaria
32 (1.42%)
Infusion Site Erythema
29 (1.29%)
Swelling
28 (1.24%)
Cerebrovascular Accident
26 (1.15%)
Dyspnoea
25 (1.11%)
Meningitis Aseptic
25 (1.11%)
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Pain
25 (1.11%)
Erythema
20 (.89%)
Malaise
20 (.89%)
Oedema Peripheral
20 (.89%)
Pain In Extremity
20 (.89%)
Chest Pain
19 (.84%)
Pruritus
19 (.84%)
Vomiting
19 (.84%)
Arthralgia
18 (.8%)
Infusion Site Pain
18 (.8%)
Injection Site Erythema
18 (.8%)
Transmission Of An Infectious Agent...
18 (.8%)
Chills
17 (.75%)
Fatigue
17 (.75%)
Infusion Site Pruritus
15 (.67%)
Vision Blurred
15 (.67%)
Weight Decreased
15 (.67%)
Abnormal Behaviour
14 (.62%)
Cognitive Disorder
14 (.62%)
Injection Site Swelling
14 (.62%)
Agitation
13 (.58%)
Influenza Like Illness
13 (.58%)
Asthma
12 (.53%)
Diarrhoea
12 (.53%)
Dizziness
12 (.53%)
Hepatitis B Surface Antigen Positiv...
12 (.53%)
Hypersensitivity
12 (.53%)
Injection Site Reaction
12 (.53%)
Pyrexia
12 (.53%)
Back Pain
11 (.49%)
Cough
11 (.49%)
Death
11 (.49%)
Drug Ineffective
11 (.49%)
False Positive Laboratory Result
11 (.49%)
Paraesthesia
11 (.49%)
Abdominal Pain Upper
10 (.44%)
Blood Glucose Increased
10 (.44%)
Blood Pressure Decreased
10 (.44%)
Bronchitis
10 (.44%)
Contusion
10 (.44%)
Dehydration
10 (.44%)
Hypoaesthesia
10 (.44%)
Infusion Site Rash
10 (.44%)
Neck Pain
10 (.44%)
Vasculitis
10 (.44%)
Arrhythmia
9 (.4%)
Asthenia
9 (.4%)
Cellulitis
9 (.4%)
Escherichia Sepsis
9 (.4%)
Infusion Site Reaction
9 (.4%)
Infusion Site Urticaria
9 (.4%)
Injection Site Infection
9 (.4%)
Muscle Spasms
9 (.4%)
Myositis
9 (.4%)
Staphylococcal Infection
9 (.4%)
Tinnitus
9 (.4%)
Wrong Technique In Drug Usage Proce...
9 (.4%)
Abdominal Distension
8 (.35%)
Abortion Spontaneous
8 (.35%)
Anxiety
8 (.35%)
Cardiac Flutter
8 (.35%)
Convulsion
8 (.35%)
Decreased Appetite
8 (.35%)
Deep Vein Thrombosis
8 (.35%)
Drug Exposure During Pregnancy
8 (.35%)
Infection
8 (.35%)
Inflammation
8 (.35%)
Injection Site Pain
8 (.35%)
Intracranial Venous Sinus Thrombosi...
8 (.35%)
Nervous System Disorder
8 (.35%)
Rash
8 (.35%)
Rash Erythematous
8 (.35%)
Sinusitis
8 (.35%)
Skin Exfoliation
8 (.35%)
Subcutaneous Abscess
8 (.35%)
Wheezing
8 (.35%)
Blood Pressure Increased
7 (.31%)
Complex Regional Pain Syndrome
7 (.31%)
Erysipelas
7 (.31%)
Feeling Abnormal
7 (.31%)
Haemorrhage
7 (.31%)
Liver Function Test Abnormal
7 (.31%)
Myalgia
7 (.31%)
Product Contamination Microbial
7 (.31%)
Product Quality Issue
7 (.31%)
Thrombosis
7 (.31%)
Weight Increased
7 (.31%)
Burning Sensation
6 (.27%)
Cardiac Failure
6 (.27%)
Cerebral Infarction
6 (.27%)

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

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

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

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

Immunodeficiency Common Variable
129
Hypogammaglobulinaemia
58
Immunodeficiency
31
Primary Immunodeficiency Syndrome
16
Blood Immunoglobulin G Decreased
11
Selective Igg Subclass Deficiency
11
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Combined Immunodeficiency
8
Immune System Disorder
5
Humoral Immune Defect
4
Chronic Inflammatory Demyelinating ...
4
Hypoglobulinaemia
3
Epstein-barr Virus Infection
3
Immunosuppression
3
Selective Polysaccharide Antibody D...
3
Chronic Lymphocytic Leukaemia
3
Polyneuropathy
3
Infection
3
Respiratory Tract Infection
2
Transfusion-related Immunomodulatio...
2
Hypergammaglobulinaemia
2
Waldenstroms Macroglobulinaemia
2
Hypoproteinaemia
2
Immunoglobulins Decreased
2
Immunoglobulins
1
Multiple Myeloma
1
Axonal Neuropathy
1
Antibody Test Negative
1
Lymphopenia
1
Myopathy
1
Congenital Hypogammaglobulinaemia
1
Amyloidosis
1
Developmental Delay
1
Prophylaxis
1
Antibody Test Abnormal
1
Digeorges Syndrome
1

Drug Labels

LabelLabelerEffective
VivaglobinCSL Behring LLC15-JUL-10

Vivaglobin Case Reports

What Vivaglobin 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 Vivaglobin. 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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