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PRIVIGEN

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Privigen Adverse Events Reported to the FDA Over Time

How are Privigen adverse event reports trending over time?

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

Most Common Privigen Adverse Events Reported to the FDA

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

Off Label Use
104 (4.49%)
Nausea
64 (2.77%)
Headache
63 (2.72%)
Haemoglobin Decreased
59 (2.55%)
Haemolysis
58 (2.51%)
Haemolytic Anaemia
48 (2.07%)
Chills
47 (2.03%)
Pyrexia
45 (1.94%)
Vomiting
42 (1.82%)
Infusion Related Reaction
38 (1.64%)
Dyspnoea
37 (1.6%)
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Anaemia
32 (1.38%)
Meningitis Aseptic
32 (1.38%)
Asthenia
31 (1.34%)
Tachycardia
28 (1.21%)
Dizziness
24 (1.04%)
Chest Pain
23 (.99%)
Hypotension
22 (.95%)
Fatigue
20 (.86%)
Malaise
20 (.86%)
Anti-erythrocyte Antibody Positive
16 (.69%)
Respiratory Failure
15 (.65%)
General Physical Health Deteriorati...
14 (.61%)
Hypertension
14 (.61%)
Hypoxia
14 (.61%)
Neutropenia
14 (.61%)
Pneumonia
14 (.61%)
Transmission Of An Infectious Agent...
14 (.61%)
Chest Discomfort
13 (.56%)
Haematuria
13 (.56%)
Intravascular Haemolysis
13 (.56%)
Photophobia
13 (.56%)
Pruritus
13 (.56%)
Rash
13 (.56%)
Thrombocytopenia
13 (.56%)
Blood Bilirubin Increased
12 (.52%)
Blood Lactate Dehydrogenase Increas...
12 (.52%)
Oxygen Saturation Decreased
12 (.52%)
Abdominal Pain
11 (.48%)
Blood Pressure Decreased
11 (.48%)
Pain
11 (.48%)
Renal Failure
11 (.48%)
Urticaria
11 (.48%)
Anaemia Haemolytic Autoimmune
10 (.43%)
Blood Culture Positive
10 (.43%)
Chromaturia
10 (.43%)
Diarrhoea
10 (.43%)
Drug Ineffective
10 (.43%)
Haemoglobinuria
10 (.43%)
Haemolytic Transfusion Reaction
10 (.43%)
Sepsis
10 (.43%)
Septic Shock
10 (.43%)
Acute Respiratory Distress Syndrome
9 (.39%)
Back Pain
9 (.39%)
Blood Pressure Increased
9 (.39%)
Leukocytosis
9 (.39%)
Migraine
9 (.39%)
Musculoskeletal Stiffness
9 (.39%)
White Blood Cell Count Decreased
9 (.39%)
Bradycardia
8 (.35%)
Dysuria
8 (.35%)
Hyperhidrosis
8 (.35%)
International Normalised Ratio Incr...
8 (.35%)
Jaundice
8 (.35%)
Lung Infection
8 (.35%)
Rectal Haemorrhage
8 (.35%)
Renal Failure Acute
8 (.35%)
Weight Decreased
8 (.35%)
Anuria
7 (.3%)
Coombs Direct Test Positive
7 (.3%)
Drug Hypersensitivity
7 (.3%)
Encephalopathy
7 (.3%)
Influenza Like Illness
7 (.3%)
Rash Generalised
7 (.3%)
Transplant Rejection
7 (.3%)
Agitation
6 (.26%)
Altered State Of Consciousness
6 (.26%)
Antibody Test Positive
6 (.26%)
Blood Pressure Systolic Increased
6 (.26%)
Cardiac Failure
6 (.26%)
Confusional State
6 (.26%)
Cough
6 (.26%)
Death
6 (.26%)
Hot Flush
6 (.26%)
Hypoaesthesia
6 (.26%)
Myocardial Infarction
6 (.26%)
Neck Pain
6 (.26%)
Pancytopenia
6 (.26%)
Platelet Count Decreased
6 (.26%)
Sinusitis
6 (.26%)
Aspartate Aminotransferase Increase...
5 (.22%)
Bronchospasm
5 (.22%)
C-reactive Protein Increased
5 (.22%)
Convulsion
5 (.22%)
Cyanosis
5 (.22%)
Dysstasia
5 (.22%)
Feeling Abnormal
5 (.22%)
Fluid Overload
5 (.22%)
Haematocrit Decreased
5 (.22%)
Htlv-1 Test Positive
5 (.22%)
Htlv-2 Test Positive
5 (.22%)

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

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

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

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

Idiopathic Thrombocytopenic Purpura
29
Chronic Inflammatory Demyelinating ...
24
Immunodeficiency Common Variable
22
Chronic Lymphocytic Leukaemia
18
Myasthenia Gravis
18
Immunodeficiency
18
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Hypogammaglobulinaemia
16
Thrombocytopenia
15
Guillain-barre Syndrome
15
Secondary Immunodeficiency
14
Kawasakis Disease
12
Multiple Sclerosis
9
Polyneuropathy
9
Demyelinating Polyneuropathy
8
Dermatomyositis
7
Polymyositis
5
Myasthenia Gravis Crisis
5
Non-hodgkins Lymphoma
5
Chronic Graft Versus Host Disease
5
Selective Igg Subclass Deficiency
5
Anaemia Haemolytic Autoimmune
4
Off Label Use
4
Transplant Rejection
4
Systemic Lupus Erythematosus
3
B-cell Lymphoma
3
Muscular Weakness
3
Immune Tolerance Induction
3
Humoral Immune Defect
3
Pseudomembranous Colitis
3
Renal And Pancreas Transplant Rejec...
3
Primary Immunodeficiency Syndrome
3
Multifocal Motor Neuropathy
3
Immunoglobulins Abnormal
3
Optic Neuritis
3
Acquired Immunodeficiency Syndrome
2
Autoimmune Disorder
2
Encephalitis
2
Condition Aggravated
2
Urosepsis
2
Bk Virus Infection
2
Neuropathy Peripheral
2
Antibody Test Positive
2
Susacs Syndrome
2
Kidney Transplant Rejection
2
Infection Prophylaxis
2
Immunosuppression
2
Thrombocytopenic Purpura
2
Blood Immunoglobulin G Decreased
2
Infection
2
Lymphoma
2
Plasmapheresis
2

Drug Labels

LabelLabelerEffective
PrivigenCSL Behring AG14-FEB-13

Privigen Case Reports

What Privigen 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 Privigen. 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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