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GAMIMUNE N

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Gamimune N Adverse Events Reported to the FDA Over Time

How are Gamimune N adverse event reports trending over time?

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

Most Common Gamimune N Adverse Events Reported to the FDA

What are the most common Gamimune N adverse events reported to the FDA?

Pyrexia
20 (3.23%)
Nausea
18 (2.91%)
Hepatitis B
16 (2.58%)
Chills
15 (2.42%)
Headache
14 (2.26%)
Hepatitis C
14 (2.26%)
Haemolytic Anaemia
12 (1.94%)
Infusion Related Reaction
12 (1.94%)
Pulmonary Embolism
12 (1.94%)
Liver Disorder
11 (1.78%)
Blood Pressure Decreased
10 (1.62%)
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Deep Vein Thrombosis
9 (1.45%)
Haemolysis
9 (1.45%)
Meningitis Aseptic
9 (1.45%)
Pain In Extremity
9 (1.45%)
Anaphylactic Reaction
8 (1.29%)
Alanine Aminotransferase Increased
7 (1.13%)
Aspartate Aminotransferase Increase...
7 (1.13%)
Hepatitis B Positive
7 (1.13%)
Vomiting
7 (1.13%)
C-reactive Protein Increased
6 (.97%)
Cardiac Failure
6 (.97%)
Cardiomegaly
6 (.97%)
Dyspnoea
6 (.97%)
Gallop Rhythm Present
6 (.97%)
Haemoglobin Decreased
6 (.97%)
Lethargy
6 (.97%)
Platelet Count Decreased
6 (.97%)
Thrombosis
6 (.97%)
Arthritis
5 (.81%)
Cerebrovascular Accident
5 (.81%)
Drug Intolerance
5 (.81%)
Hypersensitivity
5 (.81%)
Hypotension
5 (.81%)
Multi-organ Failure
5 (.81%)
Oedema Peripheral
5 (.81%)
Pallor
5 (.81%)
Skin Necrosis
5 (.81%)
Body Temperature Decreased
4 (.65%)
Body Temperature Increased
4 (.65%)
Caesarean Section
4 (.65%)
Cardio-respiratory Arrest
4 (.65%)
Chest Discomfort
4 (.65%)
Drug Hypersensitivity
4 (.65%)
Drug Ineffective
4 (.65%)
Dysstasia
4 (.65%)
Electrocardiogram St Segment Elevat...
4 (.65%)
Epistaxis
4 (.65%)
Fatigue
4 (.65%)
Heart Rate Decreased
4 (.65%)
Hepatic Function Abnormal
4 (.65%)
Hepatitis C Positive
4 (.65%)
Hypertension
4 (.65%)
Hypothermia
4 (.65%)
Injection Site Discolouration
4 (.65%)
Injection Site Ulcer
4 (.65%)
Overdose
4 (.65%)
Sepsis
4 (.65%)
Vascular Occlusion
4 (.65%)
White Blood Cell Count Decreased
4 (.65%)
Anal Fissure
3 (.48%)
Anaphylactoid Reaction
3 (.48%)
Blood Pressure Increased
3 (.48%)
Blood Pressure Systolic Increased
3 (.48%)
Bronchial Disorder
3 (.48%)
Bronchospasm
3 (.48%)
Death
3 (.48%)
Eye Rolling
3 (.48%)
Factor Viii Inhibition
3 (.48%)
Hepatitis B Surface Antigen Positiv...
3 (.48%)
Idiopathic Thrombocytopenic Purpura
3 (.48%)
Ill-defined Disorder
3 (.48%)
Injection Site Extravasation
3 (.48%)
Injection Site Vesicles
3 (.48%)
Joint Swelling
3 (.48%)
Loss Of Consciousness
3 (.48%)
Pulmonary Infarction
3 (.48%)
Shock
3 (.48%)
Tachycardia
3 (.48%)
Throat Tightness
3 (.48%)
Transfusion Reaction
3 (.48%)
Urticaria
3 (.48%)
Abdominal Pain
2 (.32%)
Anaemia
2 (.32%)
Anaphylactic Shock
2 (.32%)
Atrial Fibrillation
2 (.32%)
Bradycardia
2 (.32%)
Cerebral Infarction
2 (.32%)
Coma
2 (.32%)
Condition Aggravated
2 (.32%)
Convulsion
2 (.32%)
Cyanosis
2 (.32%)
Device Malfunction
2 (.32%)
Diarrhoea
2 (.32%)
Dizziness
2 (.32%)
False Positive Laboratory Result
2 (.32%)
Feeling Abnormal
2 (.32%)
Heart Rate Increased
2 (.32%)
Hepatitis A Antibody Positive
2 (.32%)
Hepatitis B Antibody Positive
2 (.32%)
Hepatitis B Dna Assay Positive
2 (.32%)

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

What are the most common Gamimune N adverse events reported to the FDA?

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

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

Kawasakis Disease
65
Immunodeficiency Common Variable
17
Hypogammaglobulinaemia
16
Infection
6
Drug Use For Unknown Indication
6
Demyelinating Polyneuropathy
6
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Pemphigus
5
Gammopathy
5
Ataxia
5
Acquired Epileptic Aphasia
5
Neuropathy Peripheral
5
Wegeners Granulomatosis
4
Acute Lymphocytic Leukaemia
4
Guillain-barre Syndrome
4
Idiopathic Thrombocytopenic Purpura
4
Bronchospasm
3
Multiple Myeloma
3
Thrombocytopenia Neonatal
3
Infection Prophylaxis
3
Immunodeficiency
2
Pneumonia
2
Systemic Lupus Erythematosus
2
Platelet Count Decreased
2
Vasculitis
2
Autoimmune Disorder
2
Primary Immunodeficiency Syndrome
2
Protein-losing Gastroenteropathy
2
Nervous System Disorder
2
Multiple Sclerosis
2
Selective Igg Subclass Deficiency
2
Thrombocytopenia
1
Chronic Inflammatory Demyelinating ...
1
Bone Marrow Transplant
1
Hepatitis B
1
Disease Recurrence
1
Peritoneal Dialysis
1
Hepatitis E
1
Stem Cell Transplant
1
Myasthenia Gravis
1
Prophylaxis
1
Drug Resistance
1
Antiviral Prophylaxis
1
Blood Immunoglobulin G Decreased
1
Secondary Immunodeficiency
1
Hepatitis C
1

Gamimune N Case Reports

What Gamimune N 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 Gamimune N. 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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