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GAMUNEX

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Gamunex Adverse Events Reported to the FDA Over Time

How are Gamunex adverse event reports trending over time?

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

Most Common Gamunex Adverse Events Reported to the FDA

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

Haemolysis
129 (2.74%)
Dyspnoea
113 (2.4%)
Haemolytic Anaemia
106 (2.25%)
Infusion Related Reaction
105 (2.23%)
Headache
99 (2.1%)
Nausea
85 (1.81%)
Haemoglobin Decreased
81 (1.72%)
Pyrexia
72 (1.53%)
Vomiting
65 (1.38%)
Chills
63 (1.34%)
Chest Pain
56 (1.19%)
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Meningitis Aseptic
56 (1.19%)
Hypertension
49 (1.04%)
Back Pain
46 (.98%)
Hypersensitivity
41 (.87%)
Coombs Direct Test Positive
40 (.85%)
Blood Lactate Dehydrogenase Increas...
39 (.83%)
Fatigue
39 (.83%)
Hypotension
37 (.79%)
Pruritus
36 (.77%)
Body Temperature Increased
35 (.74%)
Chest Discomfort
35 (.74%)
Blood Bilirubin Increased
34 (.72%)
Urticaria
34 (.72%)
Tachycardia
33 (.7%)
Asthenia
32 (.68%)
Condition Aggravated
30 (.64%)
Blood Pressure Increased
29 (.62%)
Drug Ineffective
29 (.62%)
Pneumonia
29 (.62%)
Rash
29 (.62%)
Pain
28 (.6%)
Tremor
28 (.6%)
Arthralgia
27 (.57%)
Hyperhidrosis
27 (.57%)
Renal Failure
27 (.57%)
Anaphylactoid Reaction
26 (.55%)
Oxygen Saturation Decreased
26 (.55%)
Dizziness
25 (.53%)
Respiratory Rate Increased
24 (.51%)
Wheezing
24 (.51%)
Diarrhoea
23 (.49%)
Hepatitis B
23 (.49%)
Pain In Extremity
22 (.47%)
Pulmonary Embolism
22 (.47%)
Drug Intolerance
21 (.45%)
Haemoglobinuria
21 (.45%)
Erythema
20 (.43%)
Laboratory Test Abnormal
20 (.43%)
Myalgia
20 (.43%)
Renal Failure Acute
20 (.43%)
Aspartate Aminotransferase Increase...
19 (.4%)
Flushing
19 (.4%)
Haematuria
19 (.4%)
Malaise
19 (.4%)
Red Blood Cell Spherocytes Present
19 (.4%)
Anxiety
18 (.38%)
Cough
18 (.38%)
Hepatitis B Surface Antigen Positiv...
18 (.38%)
Platelet Count Decreased
18 (.38%)
Alanine Aminotransferase Increased
17 (.36%)
Blood Pressure Decreased
17 (.36%)
Deep Vein Thrombosis
17 (.36%)
Influenza Like Illness
17 (.36%)
Palpitations
17 (.36%)
Drug Hypersensitivity
16 (.34%)
Feeling Abnormal
16 (.34%)
Haematocrit Decreased
16 (.34%)
Neutropenia
16 (.34%)
Anti-hbc Igg Antibody Positive
15 (.32%)
Fall
15 (.32%)
Haemorrhage Intracranial
15 (.32%)
Heart Rate Increased
15 (.32%)
Infection
15 (.32%)
Abdominal Pain Upper
14 (.3%)
Anaemia
14 (.3%)
Anaphylactic Reaction
14 (.3%)
Anti-erythrocyte Antibody Positive
14 (.3%)
Loss Of Consciousness
14 (.3%)
Musculoskeletal Stiffness
14 (.3%)
Oedema Peripheral
14 (.3%)
Sepsis
14 (.3%)
Transfusion Reaction
14 (.3%)
Anti-hbc Antibody Positive
13 (.28%)
Medication Error
13 (.28%)
Antibody Test Positive
12 (.26%)
Bundle Branch Block Left
12 (.26%)
Burning Sensation
12 (.26%)
Rash Generalised
12 (.26%)
Staphylococcal Infection
12 (.26%)
Thrombosis
12 (.26%)
Transfusion-related Acute Lung Inju...
12 (.26%)
Viral Infection
12 (.26%)
Chromaturia
11 (.23%)
Convulsion
11 (.23%)
Dehydration
11 (.23%)
Drug Administration Error
11 (.23%)
Dysphagia
11 (.23%)
Hypokalaemia
11 (.23%)
Pulmonary Oedema
11 (.23%)
Anti-hbs Antibody Positive
10 (.21%)

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

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

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

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

Immunodeficiency Common Variable
80
Idiopathic Thrombocytopenic Purpura
61
Chronic Inflammatory Demyelinating ...
60
Hypogammaglobulinaemia
55
Myasthenia Gravis
42
Guillain-barre Syndrome
36
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Primary Immunodeficiency Syndrome
25
Kawasakis Disease
24
Immunodeficiency
24
Product Used For Unknown Indication
20
Neuropathy Peripheral
17
Thrombocytopenia
17
Blood Immunoglobulin G Decreased
16
Dermatomyositis
15
Demyelinating Polyneuropathy
14
Polymyositis
14
Polyneuropathy
11
Selective Igg Subclass Deficiency
10
Pancytopenia
10
Autoimmune Disorder
10
Drug Use For Unknown Indication
10
Chronic Lymphocytic Leukaemia
9
Toxic Epidermal Necrolysis
8
Relapsing-remitting Multiple Sclero...
7
Multiple Sclerosis
7
Renal Transplant
7
Amyotrophic Lateral Sclerosis
6
Combined Immunodeficiency
6
Humoral Immune Defect
6
Epistaxis
6
Multiple Myeloma
5
Muscular Weakness
5
Immune System Disorder
5
Allergenic Desensitisation Procedur...
5
Immunoglobulins Decreased
5
Multifocal Motor Neuropathy
5
Systemic Lupus Erythematosus
4
Protein-losing Gastroenteropathy
4
Transplant Rejection
4
Myelitis Transverse
4
Sepsis
4
Toxic Shock Syndrome
4
Cellulitis
4
Infertility
4
Asthma
4
Lymphadenitis
3
Necrotising Fasciitis
3
Stiff-man Syndrome
3
Amyotrophy
3
Neuropathy
3
Burkitts Lymphoma
3

Drug Labels

LabelLabelerEffective
Gamunex-c Grifols Therapeutics Inc.01-JUN-12

Gamunex Case Reports

What Gamunex 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 Gamunex. 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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