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ANTIHEMOPHILIC FACTOR

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Antihemophilic Factor Adverse Events Reported to the FDA Over Time

How are Antihemophilic Factor adverse event reports trending over time?

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

Most Common Antihemophilic Factor Adverse Events Reported to the FDA

What are the most common Antihemophilic Factor adverse events reported to the FDA?

Adverse Event
1329 (4.57%)
Factor Viii Inhibition
975 (3.35%)
Hiv Infection
513 (1.76%)
Pyrexia
418 (1.44%)
Hepatitis C
413 (1.42%)
Drug Exposure During Pregnancy
411 (1.41%)
Drug Ineffective
403 (1.38%)
Haemorrhage
343 (1.18%)
Metal Poisoning
256 (.88%)
Neurotoxicity
241 (.83%)
Nausea
232 (.8%)
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Headache
216 (.74%)
Dyspnoea
212 (.73%)
Haemarthrosis
207 (.71%)
Anti Factor Viii Antibody Positive
203 (.7%)
Vomiting
200 (.69%)
Chills
182 (.63%)
Hypoglycaemia
175 (.6%)
Infection
172 (.59%)
Post Procedural Infection
170 (.58%)
Haematoma
152 (.52%)
Arthralgia
149 (.51%)
Convulsion
145 (.5%)
Neutropenia
145 (.5%)
Staphylococcal Infection
144 (.49%)
Infusion Related Reaction
138 (.47%)
Coagulation Factor Viii Level Decre...
133 (.46%)
Haemoglobin Decreased
129 (.44%)
Pneumonia
127 (.44%)
Hypotension
124 (.43%)
Blood Glucose Increased
119 (.41%)
Graft Infection
113 (.39%)
Pain
111 (.38%)
Hypersensitivity
110 (.38%)
Loss Of Consciousness
110 (.38%)
Graft Complication
108 (.37%)
Chest Pain
105 (.36%)
Erythema
105 (.36%)
Post Procedural Complication
103 (.35%)
Rash
103 (.35%)
Sepsis
102 (.35%)
Death
101 (.35%)
Diarrhoea
100 (.34%)
Hypertension
99 (.34%)
Tremor
99 (.34%)
Tachycardia
97 (.33%)
Condition Aggravated
95 (.33%)
Fatigue
93 (.32%)
Muscle Haemorrhage
93 (.32%)
Malaise
91 (.31%)
Renal Failure Acute
91 (.31%)
Product Quality Issue
90 (.31%)
Urticaria
90 (.31%)
Dizziness
87 (.3%)
Transmission Of An Infectious Agent...
86 (.3%)
Fall
85 (.29%)
Renal Failure
84 (.29%)
Acquired Immunodeficiency Syndrome
81 (.28%)
Asthenia
81 (.28%)
Pulmonary Oedema
81 (.28%)
Anaphylactic Reaction
80 (.27%)
Pruritus
80 (.27%)
Hyperhidrosis
77 (.26%)
Multi-organ Failure
76 (.26%)
Thrombocytopenia
76 (.26%)
Rash Maculo-papular
74 (.25%)
Abdominal Pain
72 (.25%)
Drug Interaction
72 (.25%)
Melaena
72 (.25%)
Respiratory Failure
71 (.24%)
Drug Effect Decreased
70 (.24%)
Hepatitis B
70 (.24%)
Pain In Extremity
68 (.23%)
Pulmonary Embolism
68 (.23%)
Rash Erythematous
68 (.23%)
Blood Pressure Increased
67 (.23%)
Postoperative Wound Infection
67 (.23%)
Anaemia
66 (.23%)
Medication Error
66 (.23%)
Rectal Haemorrhage
66 (.23%)
Cardiac Arrest
65 (.22%)
Device Related Infection
65 (.22%)
Purpura
65 (.22%)
Cerebrovascular Accident
64 (.22%)
Oedema Peripheral
64 (.22%)
Blood Pressure Decreased
63 (.22%)
General Physical Health Deteriorati...
63 (.22%)
Aspartate Aminotransferase Increase...
61 (.21%)
Blood Glucose Decreased
61 (.21%)
Haematuria
61 (.21%)
Heart Rate Increased
61 (.21%)
Vaginal Haemorrhage
60 (.21%)
Acute Respiratory Distress Syndrome
59 (.2%)
Depressed Level Of Consciousness
57 (.2%)
Oxygen Saturation Decreased
57 (.2%)
Poor Quality Drug Administered
57 (.2%)
Pseudomonas Infection
56 (.19%)
Swelling
56 (.19%)
Myocardial Infarction
55 (.19%)
Urinary Tract Infection
55 (.19%)
Feeling Abnormal
54 (.19%)

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

What are the most common Antihemophilic Factor adverse events reported to the FDA?

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

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

Haemophilia
2208
Factor Viii Deficiency
1368
Diabetes Mellitus
1018
Drug Use For Unknown Indication
798
Product Used For Unknown Indication
554
Idiopathic Thrombocytopenic Purpura
441
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Soft Tissue Disorder
270
Type 2 Diabetes Mellitus
246
Prophylaxis
224
Hypoalbuminaemia
177
Off Label Use
144
Diabetes Mellitus Insulin-dependent
141
Surgery
129
Kawasakis Disease
92
Diabetes Mellitus Non-insulin-depen...
84
Glycogen Storage Disease Type Ii
83
Haemorrhage
80
Type 1 Diabetes Mellitus
79
Hypogammaglobulinaemia
79
Immunodeficiency Common Variable
76
Pregnancy
66
Infection Prophylaxis
65
Therapeutic Procedure
65
Anaemia
61
Ill-defined Disorder
55
Chronic Inflammatory Demyelinating ...
54
Guillain-barre Syndrome
53
Thrombocytopenia
50
Insulin-requiring Type Ii Diabetes ...
50
Hepatic Cirrhosis
41
Demyelinating Polyneuropathy
40
Aplastic Anaemia
38
Haemarthrosis
37
Systemic Lupus Erythematosus
35
Hyperglycaemia
35
Immunodeficiency
34
Evans Syndrome
34
Corneal Dystrophy
33
Multiple Sclerosis
32
Primary Immunodeficiency Syndrome
30
Ascites
30
Myasthenia Gravis
29
Accidental Exposure
29
Hypoproteinaemia
28
Haemorrhage Prophylaxis
28
Transplant
28
Histiocytosis Haematophagic
27
Von Willebrands Disease
25
Infection
25
Infertility
24
Blood Albumin Decreased
24

Drug Labels

LabelLabelerEffective
RecombinateBaxter Healthcare Corporation26-MAY-10
RecombinateBaxter Healthcare Corporation26-MAY-10
RecombinateBaxter Healthcare Corporation26-MAY-10
RecombinateBaxter Healthcare Corporation01-DEC-10
Monoclate-pCSL Behring LLC29-APR-11
Alphanate Grifols Biologicals Inc. 30-JUN-11
Hemofil MBaxter Healthcare Corporation20-APR-12
XynthaWyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer01-JUL-12
Humate-pCSL Behring GmbH11-JUL-12
AdvateBaxter Healthcare Corporation12-JUL-12
Xynthaplasma/albumin-freeWyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer31-JUL-12
Koate -dviKEDRION BIOPHARMA, INC31-AUG-12
Kogenate FsBayer HealthCare LLC18-JAN-13
Kogenate FsBayer HealthCare LLC18-JAN-13
Helixate FsCSL Behring LLC18-JAN-13

Antihemophilic Factor Case Reports

What Antihemophilic Factor 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 Antihemophilic Factor. 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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