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IMMUNE GLOBULIN INTRAVENOUS

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Immune Globulin Intravenous Adverse Events Reported to the FDA Over Time

How are Immune Globulin Intravenous adverse event reports trending over time?

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

Most Common Immune Globulin Intravenous Adverse Events Reported to the FDA

What are the most common Immune Globulin Intravenous adverse events reported to the FDA?

Neutropenia
120 (2.73%)
Pyrexia
96 (2.18%)
Drug Exposure During Pregnancy
77 (1.75%)
Chills
64 (1.45%)
Headache
58 (1.32%)
Nausea
58 (1.32%)
Drug Ineffective
55 (1.25%)
Infusion Related Reaction
48 (1.09%)
Vomiting
46 (1.04%)
Pulmonary Embolism
39 (.89%)
Haemoglobin Decreased
38 (.86%)
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Haemorrhage Intracranial
36 (.82%)
Dyspnoea
34 (.77%)
Abortion Spontaneous
33 (.75%)
Convulsion
33 (.75%)
Cerebrovascular Accident
29 (.66%)
Hypertension
27 (.61%)
Blood Pressure Increased
26 (.59%)
Rash
26 (.59%)
Renal Failure Acute
26 (.59%)
Thrombocytopenia
26 (.59%)
Renal Failure
25 (.57%)
Haemolysis
24 (.55%)
Anaphylactoid Reaction
23 (.52%)
Arthralgia
23 (.52%)
Off Label Use
23 (.52%)
Oxygen Saturation Decreased
23 (.52%)
Pulmonary Hypertension
23 (.52%)
Tachycardia
23 (.52%)
Hypotension
22 (.5%)
Purpura
22 (.5%)
Deep Vein Thrombosis
21 (.48%)
Haemolytic Anaemia
21 (.48%)
Meningitis Aseptic
21 (.48%)
Anaphylactic Reaction
20 (.45%)
Cough
20 (.45%)
Premature Baby
20 (.45%)
Premature Labour
20 (.45%)
Rash Maculo-papular
20 (.45%)
Tricuspid Valve Incompetence
20 (.45%)
Abdominal Pain
19 (.43%)
Asthenia
19 (.43%)
Depressed Level Of Consciousness
19 (.43%)
Malaise
19 (.43%)
Urinary Tract Infection
19 (.43%)
Cerebral Infarction
18 (.41%)
Drug Intolerance
18 (.41%)
Lymphoproliferative Disorder
18 (.41%)
Rash Erythematous
18 (.41%)
Rectal Haemorrhage
18 (.41%)
Respiratory Failure
18 (.41%)
Back Pain
17 (.39%)
Haemorrhage
17 (.39%)
Melaena
17 (.39%)
Peritonitis
17 (.39%)
Pneumonia
17 (.39%)
Respiratory Disorder
17 (.39%)
Dilatation Ventricular
16 (.36%)
Feeling Abnormal
16 (.36%)
Heart Rate Increased
16 (.36%)
Hypersensitivity
16 (.36%)
Vaginal Haemorrhage
16 (.36%)
Acute Respiratory Distress Syndrome
15 (.34%)
Condition Aggravated
15 (.34%)
Death Neonatal
15 (.34%)
Myocardial Infarction
15 (.34%)
Bacteraemia
14 (.32%)
Epistaxis
14 (.32%)
Multi-organ Failure
14 (.32%)
Diabetes Mellitus
13 (.3%)
No Therapeutic Response
13 (.3%)
Sepsis
13 (.3%)
Toxic Epidermal Necrolysis
13 (.3%)
Tremor
13 (.3%)
Anaemia Haemolytic Autoimmune
12 (.27%)
Caesarean Section
12 (.27%)
Chest Pain
12 (.27%)
Dermatitis Exfoliative
12 (.27%)
Fatigue
12 (.27%)
Intra-uterine Death
12 (.27%)
Reversible Posterior Leukoencephalo...
12 (.27%)
Skin Lesion
12 (.27%)
Staphylococcal Infection
12 (.27%)
Stillbirth
12 (.27%)
Unresponsive To Stimuli
12 (.27%)
Acute Myocardial Infarction
11 (.25%)
Blood Creatinine Increased
11 (.25%)
Cardiac Failure
11 (.25%)
Chest Discomfort
11 (.25%)
Confusional State
11 (.25%)
Cytomegalovirus Infection
11 (.25%)
Dizziness
11 (.25%)
Feeling Hot
11 (.25%)
Flank Pain
11 (.25%)
Hypoglycaemia
11 (.25%)
Leukoencephalopathy
11 (.25%)
Lung Disorder
11 (.25%)
Peptic Ulcer Perforation
11 (.25%)
Blister
10 (.23%)
Blood Pressure Decreased
10 (.23%)
Coronary Artery Aneurysm
10 (.23%)

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This graph shows the top adverse events submitted to the FDA for Immune Globulin Intravenous, 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 Immune Globulin Intravenous 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 Immune Globulin Intravenous

What are the most common Immune Globulin Intravenous adverse events reported to the FDA?

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

Why are people taking Immune Globulin Intravenous, according to those reporting adverse events to the FDA?

Idiopathic Thrombocytopenic Purpura
388
Drug Use For Unknown Indication
184
Off Label Use
87
Kawasakis Disease
75
Product Used For Unknown Indication
65
Chronic Inflammatory Demyelinating ...
42
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Hypogammaglobulinaemia
40
Immunodeficiency Common Variable
39
Demyelinating Polyneuropathy
36
Guillain-barre Syndrome
34
Thrombocytopenia
32
Evans Syndrome
27
Infection Prophylaxis
22
Primary Immunodeficiency Syndrome
21
Multiple Sclerosis
21
Systemic Lupus Erythematosus
21
Immunodeficiency
20
Infection
18
Histiocytosis Haematophagic
17
Prophylaxis
16
Multifocal Motor Neuropathy
15
Chronic Lymphocytic Leukaemia
15
Immunosuppression
14
Prophylaxis Of Abortion
13
Pyoderma Gangrenosum
13
Sepsis
13
Autoimmune Disorder
12
Pneumonia
11
Pemphigus
11
Foetal Exposure Timing Unspecified
10
Transplant Rejection
10
Sneddons Syndrome
9
Thrombocytopenia Neonatal
9
Miller Fisher Syndrome
9
Toxic Shock Syndrome Streptococcal
9
Prophylaxis Against Rh Isoimmunisat...
8
Cardiomyopathy Neonatal
8
Myasthenia Gravis
8
Multiple Myeloma
7
Drug Exposure During Pregnancy
7
Thrombocytopenic Purpura
6
Renal Transplant
6
Blood Immunoglobulin G Decreased
6
Autoimmune Thrombocytopenia
6
Rheumatoid Arthritis
6
Secondary Immunodeficiency
5
Combined Immunodeficiency
5
Myasthenic Syndrome
5
Neuropathy
5
Dermatomyositis
5
Pemphigoid
5

Drug Labels

LabelLabelerEffective
FlebogammaInstituto Grifols, S.A.01-SEP-04
Octagam Immune Globulin (human)Octapharma AB09-SEP-09
Octagam Immune Globulin (human)Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.09-SEP-09
Hepagam BCangene bioPharma Inc.14-JUN-10
GammaplexBioProducts Laboratory24-JUN-10
Gammagard S/dBaxter Healthcare Corporation17-JUN-11
Gammagards/dBaxter Healthcare Corporation16-DEC-11
Gammagards/dBaxter Healthcare Corporation16-DEC-11
Gammagards/dBaxter Healthcare Corporation16-DEC-11
Flebogammadif Instituto Grifols, S.A. 31-DEC-11
Flebogamma DifInstituto Grifols, S.A.31-DEC-11
Hepagam BCangene bioPharma Inc.13-JAN-12
Carimune NanofilteredCSL Behring AG13-JUL-12
CytogamCSL Behring AG22-AUG-12
Gammagards/dBaxter Healthcare Corporation03-SEP-12
Gammagards/dBaxter Healthcare Corporation03-SEP-12
RhophylacCSL Behring AG17-OCT-12
BabybigCALIFORNIA DEPARTMENT OF PUBLIC HEALTH28-JAN-13
PrivigenCSL Behring AG14-FEB-13

Immune Globulin Intravenous Case Reports

What Immune Globulin Intravenous 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 Immune Globulin Intravenous. 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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