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FACTOR IX

Adverse Events
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Factor Ix Adverse Events Reported to the FDA Over Time

How are Factor Ix adverse event reports trending over time?

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

Most Common Factor Ix Adverse Events Reported to the FDA

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

Adverse Event
1185 (33.51%)
Hiv Infection
224 (6.33%)
Hepatitis C
176 (4.98%)
Factor Ix Inhibition
121 (3.42%)
Hypersensitivity
82 (2.32%)
Drug Ineffective
69 (1.95%)
Acquired Immunodeficiency Syndrome
67 (1.89%)
Haemarthrosis
58 (1.64%)
Haemorrhage
46 (1.3%)
Urticaria
36 (1.02%)
Pyrexia
32 (.9%)
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Drug Effect Decreased
30 (.85%)
Hiv Test Positive
30 (.85%)
Nausea
29 (.82%)
Dizziness
27 (.76%)
Anaphylactic Reaction
26 (.74%)
Convulsion
26 (.74%)
Vomiting
26 (.74%)
Dyspnoea
23 (.65%)
Epistaxis
22 (.62%)
Rash
21 (.59%)
Coagulation Factor Ix Level Decreas...
16 (.45%)
Muscle Haemorrhage
16 (.45%)
Cough
15 (.42%)
Headache
13 (.37%)
Pruritus
13 (.37%)
Chest Discomfort
12 (.34%)
Chills
12 (.34%)
Hot Flush
12 (.34%)
Malaise
12 (.34%)
Rash Erythematous
12 (.34%)
Anaphylactoid Reaction
11 (.31%)
Anti Factor Ix Antibody Positive
11 (.31%)
Fatigue
11 (.31%)
Rash Pruritic
11 (.31%)
Back Pain
10 (.28%)
Cyanosis
10 (.28%)
Death
10 (.28%)
Hypotension
10 (.28%)
Local Swelling
10 (.28%)
Pain
10 (.28%)
Swelling Face
10 (.28%)
Tremor
10 (.28%)
Vertigo
10 (.28%)
Wrong Drug Administered
10 (.28%)
Angina Pectoris
9 (.25%)
Asthenia
9 (.25%)
Drug Hypersensitivity
9 (.25%)
Fall
9 (.25%)
Flushing
9 (.25%)
Anaphylactic Shock
8 (.23%)
Cerebral Haemorrhage
8 (.23%)
Cold Sweat
8 (.23%)
Dysgeusia
8 (.23%)
Ecchymosis
8 (.23%)
Formication
8 (.23%)
Injection Site Discomfort
8 (.23%)
Injection Site Pruritus
8 (.23%)
Medication Error
8 (.23%)
Tachycardia
8 (.23%)
Throat Tightness
8 (.23%)
Abdominal Pain
7 (.2%)
Catheter Site Haemorrhage
7 (.2%)
Catheter Site Pain
7 (.2%)
Chest Pain
7 (.2%)
Deep Vein Thrombosis
7 (.2%)
Hepatitis B
7 (.2%)
Hypertension
7 (.2%)
Indirect Infection Transmission
7 (.2%)
Pain In Extremity
7 (.2%)
Palpitations
7 (.2%)
Paraesthesia Oral
7 (.2%)
Vision Blurred
7 (.2%)
Acidosis
6 (.17%)
Arthritis Infective
6 (.17%)
Catheter Related Infection
6 (.17%)
Contusion
6 (.17%)
Drug Exposure During Pregnancy
6 (.17%)
Feeling Abnormal
6 (.17%)
Haematochezia
6 (.17%)
Hepatic Failure
6 (.17%)
Migraine With Aura
6 (.17%)
Mouth Haemorrhage
6 (.17%)
Myocardial Infarction
6 (.17%)
Paraesthesia
6 (.17%)
Respiratory Arrest
6 (.17%)
Respiratory Tract Congestion
6 (.17%)
Speech Disorder
6 (.17%)
Superior Vena Caval Occlusion
6 (.17%)
Bacteraemia
5 (.14%)
Injection Site Reaction
5 (.14%)
Ocular Hyperaemia
5 (.14%)
Pneumonia
5 (.14%)
Post Procedural Complication
5 (.14%)
Respiratory Failure
5 (.14%)
Road Traffic Accident
5 (.14%)
Serum Sickness
5 (.14%)
Skull Fracture
5 (.14%)
Tachypnoea
5 (.14%)
Unevaluable Event
5 (.14%)
Weight Decreased
5 (.14%)

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

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

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

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

Haemophilia
1625
Factor Ix Deficiency
360
Factor Viii Deficiency
40
Haemorrhage
18
Prophylaxis
14
Haemarthrosis
6
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Drug Use For Unknown Indication
6
Emphysema
5
Bronchitis
5
Surgery
5
Haemophilia B With Anti Factor Ix
4
Haemorrhage Prophylaxis
4
Rectal Haemorrhage
4
Orchidopexy
3
International Normalised Ratio Incr...
2
Dental Care
2
Coagulopathy
2
Renal Transplant
2
Procoagulant Therapy
2
Anti Factor Ix Antibody Positive
1
Hypocoagulable State
1
Joint Swelling
1
Off Label Use
1
Tooth Extraction
1
Product Used For Unknown Indication
1
Haematoma
1
Haemophilia B Without Inhibitors
1
Haemorrhage Intracranial
1

Drug Labels

LabelLabelerEffective
BebulinvhBaxter Healthcare Corporation16-MAR-11
BebulinBaxter Healthcare Corporation07-APR-11
Profilnine SdGrifols Biologicals Inc.31-AUG-11
MononineCSL Behring LLC23-NOV-11
Alphanine SdGrifols Biologicals Inc.31-DEC-11
BenefixWyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer07-MAR-12

Factor Ix Case Reports

What Factor Ix 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 Factor Ix. 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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