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Feiba Adverse Events Reported to the FDA Over Time

How are Feiba adverse event reports trending over time?

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

Most Common Feiba Adverse Events Reported to the FDA

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

Factor Viii Inhibition
43 (3.9%)
Disseminated Intravascular Coagulat...
41 (3.72%)
Drug Ineffective
40 (3.63%)
Pneumonia
33 (2.99%)
Haemorrhage
31 (2.81%)
Renal Failure
26 (2.36%)
Condition Aggravated
21 (1.9%)
Myocardial Infarction
21 (1.9%)
Thrombosis
19 (1.72%)
Oedema Peripheral
17 (1.54%)
Pulmonary Embolism
17 (1.54%)
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Fall
16 (1.45%)
Dyspnoea
14 (1.27%)
Multi-organ Failure
14 (1.27%)
Urticaria
14 (1.27%)
Vomiting
14 (1.27%)
Blood Fibrinogen Decreased
13 (1.18%)
Cerebral Haemorrhage
12 (1.09%)
Pyrexia
12 (1.09%)
Chills
11 (1%)
Death
11 (1%)
Anaphylactic Reaction
10 (.91%)
Device Related Infection
10 (.91%)
Hepatitis B Antibody Positive
10 (.91%)
Capillary Leak Syndrome
9 (.82%)
Cerebrovascular Accident
9 (.82%)
Haemarthrosis
9 (.82%)
Haemoglobin Decreased
9 (.82%)
Haemorrhage Subcutaneous
9 (.82%)
Hypersensitivity
9 (.82%)
Anaphylactic Shock
8 (.73%)
Chest Pain
8 (.73%)
Deep Vein Thrombosis
8 (.73%)
Oedema
8 (.73%)
Cough
7 (.63%)
Haemolytic Uraemic Syndrome
7 (.63%)
Infusion Site Swelling
7 (.63%)
Thrombophlebitis Superficial
7 (.63%)
Abdominal Pain
6 (.54%)
Acute Hepatic Failure
6 (.54%)
Drug Effect Decreased
6 (.54%)
Enterobacter Infection
6 (.54%)
Haemorrhage Intracranial
6 (.54%)
Hepatitis C
6 (.54%)
Hip Fracture
6 (.54%)
Leukocytosis
6 (.54%)
Metabolic Acidosis
6 (.54%)
Nausea
6 (.54%)
Oxygen Saturation Decreased
6 (.54%)
Post Procedural Haemorrhage
6 (.54%)
Respiratory Failure
6 (.54%)
Sepsis
6 (.54%)
Treatment Failure
6 (.54%)
Weight Increased
6 (.54%)
Erythema
5 (.45%)
Haematoma
5 (.45%)
Haemothorax
5 (.45%)
Headache
5 (.45%)
Muscle Haemorrhage
5 (.45%)
Platelet Count Decreased
5 (.45%)
Renal Impairment
5 (.45%)
Screaming
5 (.45%)
Acute Myocardial Infarction
4 (.36%)
Arthralgia
4 (.36%)
Bone Disorder
4 (.36%)
Cardiopulmonary Failure
4 (.36%)
Catheter Site Haematoma
4 (.36%)
Catheter Site Haemorrhage
4 (.36%)
Cholecystitis
4 (.36%)
Circulatory Collapse
4 (.36%)
Crying
4 (.36%)
Drooling
4 (.36%)
Dysphonia
4 (.36%)
Emotional Distress
4 (.36%)
Erysipelas
4 (.36%)
Face Injury
4 (.36%)
Facial Bones Fracture
4 (.36%)
Febrile Convulsion
4 (.36%)
Femur Fracture
4 (.36%)
Fibrin D Dimer Increased
4 (.36%)
Haemolytic Anaemia
4 (.36%)
Head Injury
4 (.36%)
Ileus Paralytic
4 (.36%)
Loss Of Consciousness
4 (.36%)
Mass
4 (.36%)
Necrosis Ischaemic
4 (.36%)
Pain In Extremity
4 (.36%)
Pallor
4 (.36%)
Pulmonary Haemorrhage
4 (.36%)
Pulmonary Sepsis
4 (.36%)
Throat Tightness
4 (.36%)
Upper Airway Obstruction
4 (.36%)
Back Pain
3 (.27%)
Cardio-respiratory Arrest
3 (.27%)
Chest Discomfort
3 (.27%)
Decreased Appetite
3 (.27%)
Gastrointestinal Haemorrhage
3 (.27%)
Hypotension
3 (.27%)
Infusion Related Reaction
3 (.27%)
Oliguria
3 (.27%)
Post Procedural Complication
3 (.27%)

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

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

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

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

Factor Viii Inhibition
65
Factor Viii Deficiency
62
Acquired Haemophilia
55
Haemostasis
50
Haemorrhage
33
Haemophilia
30
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Prophylaxis
26
Off Label Use
25
Post Procedural Haemorrhage
21
Haemophilia A With Anti Factor Viii
20
Haemarthrosis
19
Drug Use For Unknown Indication
12
Product Used For Unknown Indication
11
Haemophilia B With Anti Factor Ix
10
Haematuria
8
Haematoma
8
Haemorrhage Prophylaxis
7
Joint Surgery
6
Gastrointestinal Haemorrhage
6
Factor Ix Inhibition
4
Haemorrhage Control
3
Muscle Haemorrhage
3
Rectal Haemorrhage
2
Factor Vii Deficiency
2
Abnormal Clotting Factor
2
Adverse Event
2
Factor Ix Deficiency
2
Haemophilia B Without Inhibitors
2
Acquired Haemophilia With Anti Fvii...
2
Anti Factor Viii Antibody Test
2
Von Willebrands Disease
2
Wrong Drug Administered
1
Soft Tissue Haemorrhage
1
Fracture
1
Haemorrhage Subcutaneous
1
Haematemesis
1
Retroperitoneal Haematoma
1
Nervous System Disorder
1
Wound Haemorrhage
1
Procoagulant Therapy
1
Haemophilia A Without Inhibitors
1
Tongue Haemorrhage
1
Surgery
1
Bite
1
Sigmoidectomy
1
Mouth Haemorrhage
1
Pulmonary Haemorrhage
1
Melaena
1
Drug Administration Error
1
Epistaxis
1
Haemoptysis
1

Drug Labels

LabelLabelerEffective
FeibanfBaxter Healthcare Corporation29-JUL-10
FeibanfBaxter Healthcare Corporation23-JUN-11

Feiba Case Reports

What Feiba 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 Feiba. 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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