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REFACTO

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Refacto Adverse Events Reported to the FDA Over Time

How are Refacto adverse event reports trending over time?

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

Most Common Refacto Adverse Events Reported to the FDA

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

Adverse Event
730 (19.2%)
Factor Viii Inhibition
435 (11.44%)
Hiv Infection
256 (6.73%)
Drug Ineffective
136 (3.58%)
Haemorrhage
112 (2.95%)
Coagulation Factor Viii Level Decre...
110 (2.89%)
Anti Factor Viii Antibody Positive
109 (2.87%)
Hepatitis C
108 (2.84%)
Haemarthrosis
99 (2.6%)
Acquired Immunodeficiency Syndrome
78 (2.05%)
Muscle Haemorrhage
47 (1.24%)
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Haematoma
46 (1.21%)
Drug Effect Decreased
43 (1.13%)
Arthralgia
36 (.95%)
Pain In Extremity
29 (.76%)
Hiv Test Positive
25 (.66%)
Atelectasis
22 (.58%)
Post Procedural Haemorrhage
20 (.53%)
Epistaxis
18 (.47%)
Infusion Site Haematoma
18 (.47%)
Pneumonia
18 (.47%)
Hypersensitivity
17 (.45%)
Spontaneous Haematoma
17 (.45%)
Activated Partial Thromboplastin Ti...
16 (.42%)
Infection
16 (.42%)
General Physical Health Deteriorati...
14 (.37%)
No Therapeutic Response
14 (.37%)
Pyrexia
14 (.37%)
Tachycardia
14 (.37%)
Anaphylactic Reaction
12 (.32%)
Catheter Related Complication
11 (.29%)
Alanine Aminotransferase Increased
10 (.26%)
Diarrhoea
10 (.26%)
Hepatitis B
10 (.26%)
Hypertension
10 (.26%)
Inflammation
10 (.26%)
Aspartate Aminotransferase Increase...
9 (.24%)
Contusion
9 (.24%)
Cyanosis
9 (.24%)
Death
9 (.24%)
Infusion Related Reaction
9 (.24%)
Muscular Weakness
9 (.24%)
Pseudomonas Infection
9 (.24%)
Therapeutic Response Decreased
9 (.24%)
Type Iii Immune Complex Mediated Re...
9 (.24%)
Varicella
9 (.24%)
Condition Aggravated
8 (.21%)
Disease Progression
8 (.21%)
Flushing
8 (.21%)
Hyperhidrosis
8 (.21%)
Hypoxia
8 (.21%)
Impaired Healing
8 (.21%)
Lower Respiratory Tract Infection
8 (.21%)
Muscle Strain
8 (.21%)
Pleurisy
8 (.21%)
Urticaria
8 (.21%)
Viral Infection
8 (.21%)
Antibody Test Positive
7 (.18%)
Chills
7 (.18%)
Decubitus Ulcer
7 (.18%)
Dyspnoea
7 (.18%)
Haematology Test Abnormal
7 (.18%)
Headache
7 (.18%)
Oxygen Saturation Decreased
7 (.18%)
Retroperitoneal Haematoma
7 (.18%)
Synovitis
7 (.18%)
Urinary Tract Infection
7 (.18%)
Weight Increased
7 (.18%)
Aspiration
6 (.16%)
Asthenia
6 (.16%)
Blood Pressure Increased
6 (.16%)
Cardiac Failure
6 (.16%)
Disease Recurrence
6 (.16%)
Drug Half-life Reduced
6 (.16%)
Dysphagia
6 (.16%)
Eczema
6 (.16%)
Fatigue
6 (.16%)
Haematocrit Decreased
6 (.16%)
Haemoglobin Decreased
6 (.16%)
Hepatic Failure
6 (.16%)
Inhibiting Antibodies
6 (.16%)
Lobar Pneumonia
6 (.16%)
Oesophageal Varices Haemorrhage
6 (.16%)
Post Procedural Complication
6 (.16%)
Pruritus
6 (.16%)
Respiratory Distress
6 (.16%)
Respiratory Failure
6 (.16%)
Somnolence
6 (.16%)
Upper Respiratory Tract Infection
6 (.16%)
Accident
5 (.13%)
Arthropod Bite
5 (.13%)
Blood Immunoglobulin G Increased
5 (.13%)
Bone Density Decreased
5 (.13%)
Cardio-respiratory Arrest
5 (.13%)
Drug Ineffective For Unapproved Ind...
5 (.13%)
Ecchymosis
5 (.13%)
Fall
5 (.13%)
Glycogen Storage Disease Type Ii
5 (.13%)
Heart Rate Increased
5 (.13%)
Hypertonia
5 (.13%)
Hypotonia
5 (.13%)

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

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

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

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

Haemophilia
1041
Factor Viii Deficiency
561
Glycogen Storage Disease Type Ii
78
Prophylaxis
47
Haemorrhage
16
Von Willebrands Disease
16
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Surgery
11
Drug Use For Unknown Indication
10
Knee Arthroplasty
9
Haemorrhage Prophylaxis
9
Anti Factor Viii Antibody Positive
7
Off Label Use
5
Cerebral Haemorrhage
4
Haematuria
4
Central Venous Catheterisation
4
Haematoma
3
Joint Sprain
3
Haemophilia A With Anti Factor Viii
3
Traumatic Haemorrhage
3
Immunosuppressant Drug Therapy
2
Haemorrhage Intracranial
2
Coagulation Factor
2
Haemostasis
2
Subdural Haematoma
1
Factor V Deficiency
1
Immune Tolerance Induction
1
Laceration
1
Pulmonary Haemorrhage
1
Polypectomy
1
Product Used For Unknown Indication
1
Knee Operation
1
Factor Viii Inhibition
1
Intervertebral Disc Protrusion
1
Coagulation Factor Viii Level
1
Epistaxis
1
Drug Ineffective For Unapproved Ind...
1
Activated Partial Thromboplastin Ti...
1
Coagulation Factor Viii Level Abnor...
1
Colon Polypectomy
1
Acquired Haemophilia
1
Factor Vii Deficiency
1
Splenic Rupture
1
Injury
1

Refacto Case Reports

What Refacto 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 Refacto. 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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