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Benefix Adverse Events Reported to the FDA Over Time

How are Benefix adverse event reports trending over time?

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

Most Common Benefix Adverse Events Reported to the FDA

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

Factor Ix Inhibition
119 (6.89%)
Hypersensitivity
82 (4.75%)
Drug Ineffective
69 (4%)
Haemarthrosis
58 (3.36%)
Haemorrhage
45 (2.61%)
Urticaria
36 (2.09%)
Pyrexia
32 (1.85%)
Drug Effect Decreased
30 (1.74%)
Dizziness
27 (1.56%)
Nausea
27 (1.56%)
Anaphylactic Reaction
26 (1.51%)
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Convulsion
26 (1.51%)
Vomiting
26 (1.51%)
Dyspnoea
22 (1.27%)
Epistaxis
22 (1.27%)
Rash
21 (1.22%)
Coagulation Factor Ix Level Decreas...
16 (.93%)
Cough
15 (.87%)
Muscle Haemorrhage
15 (.87%)
Headache
13 (.75%)
Pruritus
13 (.75%)
Chest Discomfort
12 (.7%)
Chills
12 (.7%)
Hot Flush
12 (.7%)
Malaise
12 (.7%)
Rash Erythematous
12 (.7%)
Anaphylactoid Reaction
11 (.64%)
Anti Factor Ix Antibody Positive
11 (.64%)
Fatigue
11 (.64%)
Rash Pruritic
11 (.64%)
Back Pain
10 (.58%)
Cyanosis
10 (.58%)
Death
10 (.58%)
Local Swelling
10 (.58%)
Swelling Face
10 (.58%)
Tremor
10 (.58%)
Vertigo
10 (.58%)
Angina Pectoris
9 (.52%)
Asthenia
9 (.52%)
Drug Hypersensitivity
9 (.52%)
Fall
9 (.52%)
Wrong Drug Administered
9 (.52%)
Cerebral Haemorrhage
8 (.46%)
Cold Sweat
8 (.46%)
Dysgeusia
8 (.46%)
Ecchymosis
8 (.46%)
Flushing
8 (.46%)
Formication
8 (.46%)
Hypotension
8 (.46%)
Injection Site Discomfort
8 (.46%)
Injection Site Pruritus
8 (.46%)
Medication Error
8 (.46%)
Pain
8 (.46%)
Throat Tightness
8 (.46%)
Abdominal Pain
7 (.41%)
Catheter Site Haemorrhage
7 (.41%)
Catheter Site Pain
7 (.41%)
Chest Pain
7 (.41%)
Hypertension
7 (.41%)
Pain In Extremity
7 (.41%)
Palpitations
7 (.41%)
Paraesthesia Oral
7 (.41%)
Tachycardia
7 (.41%)
Vision Blurred
7 (.41%)
Acidosis
6 (.35%)
Anaphylactic Shock
6 (.35%)
Arthritis Infective
6 (.35%)
Catheter Related Infection
6 (.35%)
Contusion
6 (.35%)
Deep Vein Thrombosis
6 (.35%)
Drug Exposure During Pregnancy
6 (.35%)
Feeling Abnormal
6 (.35%)
Haematochezia
6 (.35%)
Hepatic Failure
6 (.35%)
Migraine With Aura
6 (.35%)
Mouth Haemorrhage
6 (.35%)
Paraesthesia
6 (.35%)
Respiratory Arrest
6 (.35%)
Respiratory Tract Congestion
6 (.35%)
Speech Disorder
6 (.35%)
Superior Vena Caval Occlusion
6 (.35%)
Bacteraemia
5 (.29%)
Injection Site Reaction
5 (.29%)
Myocardial Infarction
5 (.29%)
Ocular Hyperaemia
5 (.29%)
Post Procedural Complication
5 (.29%)
Road Traffic Accident
5 (.29%)
Skull Fracture
5 (.29%)
Tachypnoea
5 (.29%)
Weight Decreased
5 (.29%)
Wrong Technique In Drug Usage Proce...
5 (.29%)
Abnormal Sensation In Eye
4 (.23%)
Appendicitis Perforated
4 (.23%)
Bronchospasm
4 (.23%)
Chylothorax
4 (.23%)
Dental Caries
4 (.23%)
Device Related Infection
4 (.23%)
Disseminated Intravascular Coagulat...
4 (.23%)
Erythema Multiforme
4 (.23%)
Extradural Haematoma
4 (.23%)
Eye Movement Disorder
4 (.23%)

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

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

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

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

Factor Ix Deficiency
317
Haemophilia
33
Haemorrhage
14
Prophylaxis
13
Factor Viii Deficiency
7
Emphysema
5
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Surgery
5
Bronchitis
5
Rectal Haemorrhage
4
Haemophilia B With Anti Factor Ix
4
Haemorrhage Prophylaxis
4
Orchidopexy
3
Drug Use For Unknown Indication
2
Haemarthrosis
2
Dental Care
2
Haemophilia B Without Inhibitors
1
Joint Swelling
1
Haematoma
1
Tooth Extraction
1
Anti Factor Ix Antibody Positive
1
Off Label Use
1

Drug Labels

LabelLabelerEffective
BenefixWyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer07-MAR-12

Benefix Case Reports

What Benefix 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 Benefix. 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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