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Advate Adverse Events Reported to the FDA Over Time

How are Advate adverse event reports trending over time?

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

Most Common Advate Adverse Events Reported to the FDA

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

Adverse Event
730 (19.61%)
Factor Viii Inhibition
284 (7.63%)
Hiv Infection
243 (6.53%)
Hepatitis C
113 (3.04%)
Haemorrhage
83 (2.23%)
Acquired Immunodeficiency Syndrome
65 (1.75%)
Haemarthrosis
57 (1.53%)
Drug Ineffective
51 (1.37%)
Pyrexia
36 (.97%)
Muscle Haemorrhage
33 (.89%)
Headache
28 (.75%)
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Anti Factor Viii Antibody Positive
25 (.67%)
Anaphylactic Reaction
24 (.64%)
Hiv Test Positive
24 (.64%)
Haematoma
23 (.62%)
Coagulation Factor Viii Level Decre...
21 (.56%)
Device Related Infection
21 (.56%)
Dyspnoea
21 (.56%)
Cyanosis
20 (.54%)
Vomiting
20 (.54%)
Central Venous Catheterisation
19 (.51%)
Flushing
19 (.51%)
Pneumonia
18 (.48%)
Condition Aggravated
17 (.46%)
Fall
17 (.46%)
Hypersensitivity
17 (.46%)
Death
16 (.43%)
General Physical Health Deteriorati...
16 (.43%)
Nausea
15 (.4%)
Alanine Aminotransferase Increased
14 (.38%)
Atelectasis
14 (.38%)
Chills
14 (.38%)
Diarrhoea
14 (.38%)
Haemoglobin Decreased
14 (.38%)
Hyperhidrosis
14 (.38%)
Urticaria
14 (.38%)
Infusion Related Reaction
13 (.35%)
Tachycardia
13 (.35%)
Arthralgia
12 (.32%)
Cerebral Haemorrhage
12 (.32%)
Loss Of Consciousness
12 (.32%)
Malaise
12 (.32%)
Aspartate Aminotransferase Increase...
11 (.3%)
Chest Pain
11 (.3%)
Hypertension
11 (.3%)
Inhibiting Antibodies
11 (.3%)
Joint Swelling
11 (.3%)
Pruritus
11 (.3%)
Subdural Haematoma
11 (.3%)
Asthenia
10 (.27%)
Bacteraemia
10 (.27%)
Hepatitis B
10 (.27%)
Liver Function Test Abnormal
10 (.27%)
Antibody Test Positive
9 (.24%)
Drug Level Below Therapeutic
9 (.24%)
Fatigue
9 (.24%)
Haemorrhage Intracranial
9 (.24%)
Head Injury
9 (.24%)
Impaired Healing
9 (.24%)
Muscular Weakness
9 (.24%)
Pseudomonas Infection
9 (.24%)
Rash
9 (.24%)
Type Iii Immune Complex Mediated Re...
9 (.24%)
Anaemia
8 (.21%)
Back Pain
8 (.21%)
Coagulation Factor Viii Level Incre...
8 (.21%)
Contusion
8 (.21%)
Disease Progression
8 (.21%)
Drug Administration Error
8 (.21%)
Drug Dispensing Error
8 (.21%)
Drug Effect Decreased
8 (.21%)
Haematocrit Decreased
8 (.21%)
Hypoaesthesia
8 (.21%)
Hypoxia
8 (.21%)
Lower Respiratory Tract Infection
8 (.21%)
Post Procedural Haemorrhage
8 (.21%)
Respiratory Failure
8 (.21%)
Therapeutic Response Decreased
8 (.21%)
Tremor
8 (.21%)
Urinary Tract Infection
8 (.21%)
Viral Infection
8 (.21%)
Bacterial Infection
7 (.19%)
Convulsion
7 (.19%)
Decubitus Ulcer
7 (.19%)
Feeling Hot
7 (.19%)
Heart Rate Increased
7 (.19%)
Oxygen Saturation Decreased
7 (.19%)
Pain
7 (.19%)
Paraesthesia
7 (.19%)
Respiratory Distress
7 (.19%)
Abdominal Pain
6 (.16%)
Aspiration
6 (.16%)
Blood Pressure Increased
6 (.16%)
Bronchospasm
6 (.16%)
Catheter Related Infection
6 (.16%)
Chest Discomfort
6 (.16%)
Decreased Appetite
6 (.16%)
Disease Recurrence
6 (.16%)
Dysphagia
6 (.16%)
Eczema
6 (.16%)
Hepatitis B Surface Antigen Positiv...
6 (.16%)

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

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

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

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

Haemophilia
1083
Factor Viii Deficiency
371
Glycogen Storage Disease Type Ii
78
Prophylaxis
43
Drug Use For Unknown Indication
33
Haemorrhage
31
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Product Used For Unknown Indication
26
Von Willebrands Disease
14
Surgery
13
Haemarthrosis
12
Immunomodulatory Therapy
12
Haemostasis
10
Factor Viii Inhibition
9
Haemorrhage Prophylaxis
8
Immune Tolerance Induction
7
Haemorrhage Intracranial
7
Haematoma
6
Immune Enhancement Therapy
6
Coagulation Factor Viii Level Abnor...
5
Subdural Haematoma
5
Haematuria
4
Joint Sprain
3
Haemophilic Arthropathy
3
Acquired Haemophilia
3
Coagulation Factor
2
Retroperitoneal Haemorrhage
2
Back Pain
2
Central Venous Catheterisation
2
Immunosuppressant Drug Therapy
2
Coagulation Factor Viii Level
2
Arthralgia
2
Haemophilia A With Anti Factor Viii
2
Knee Operation
2
Laceration
2
Rotator Cuff Repair
2
Factor V Deficiency
1
Knee Meniscectomy
1
Off Label Use
1
Polypectomy
1
Splenic Rupture
1
Subgaleal Haematoma
1
Dental Care
1
Head Injury
1
Polycythaemia
1
Pulmonary Haemorrhage
1
Arterial Bypass Operation
1
Gastrointestinal Haemorrhage
1
Epistaxis
1
Colon Polypectomy
1
Post Procedural Haemorrhage
1
Activated Partial Thromboplastin Ti...
1

Drug Labels

LabelLabelerEffective
AdvateBaxter Healthcare Corporation12-JUL-12

Advate Case Reports

What Advate 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 Advate. 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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