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RECOMBINATE

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Recombinate Adverse Events Reported to the FDA Over Time

How are Recombinate adverse event reports trending over time?

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

Most Common Recombinate Adverse Events Reported to the FDA

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

Adverse Event
730 (27.3%)
Hiv Infection
243 (9.09%)
Hepatitis C
109 (4.08%)
Factor Viii Inhibition
107 (4%)
Acquired Immunodeficiency Syndrome
65 (2.43%)
Haemorrhage
37 (1.38%)
Pyrexia
29 (1.08%)
Hiv Test Positive
26 (.97%)
Anti Factor Viii Antibody Positive
22 (.82%)
Drug Ineffective
22 (.82%)
Cyanosis
21 (.79%)
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Pneumonia
19 (.71%)
Tremor
17 (.64%)
General Physical Health Deteriorati...
16 (.6%)
Infusion Related Reaction
15 (.56%)
Atelectasis
14 (.52%)
Tachycardia
14 (.52%)
Anaphylactic Reaction
13 (.49%)
Death
13 (.49%)
Haematoma
13 (.49%)
Hypotension
13 (.49%)
Loss Of Consciousness
12 (.45%)
Dyspnoea
11 (.41%)
Alanine Aminotransferase Increased
10 (.37%)
Diarrhoea
10 (.37%)
Haemarthrosis
10 (.37%)
Hepatitis B
10 (.37%)
Hypertension
10 (.37%)
Respiratory Distress
10 (.37%)
Aspartate Aminotransferase Increase...
9 (.34%)
Headache
9 (.34%)
Muscular Weakness
9 (.34%)
Nausea
9 (.34%)
Pseudomonas Infection
9 (.34%)
Type Iii Immune Complex Mediated Re...
9 (.34%)
Urticaria
9 (.34%)
Condition Aggravated
8 (.3%)
Disease Progression
8 (.3%)
Flushing
8 (.3%)
Hyperhidrosis
8 (.3%)
Hypoxia
8 (.3%)
Impaired Healing
8 (.3%)
Lower Respiratory Tract Infection
8 (.3%)
Muscle Haemorrhage
8 (.3%)
Pruritus
8 (.3%)
Viral Infection
8 (.3%)
Chest Pain
7 (.26%)
Chills
7 (.26%)
Decubitus Ulcer
7 (.26%)
Hiv Test False Positive
7 (.26%)
Oxygen Saturation Decreased
7 (.26%)
Respiratory Failure
7 (.26%)
Therapeutic Response Decreased
7 (.26%)
Urinary Tract Infection
7 (.26%)
Antibody Test Positive
6 (.22%)
Aspiration
6 (.22%)
Asthenia
6 (.22%)
Blood Pressure Increased
6 (.22%)
Cardiac Arrest
6 (.22%)
Cardio-respiratory Arrest
6 (.22%)
Convulsion
6 (.22%)
Disease Recurrence
6 (.22%)
Dysphagia
6 (.22%)
Eczema
6 (.22%)
Haemoglobin Decreased
6 (.22%)
Hepatitis B Dna Assay Positive
6 (.22%)
Hepatitis B Surface Antigen Positiv...
6 (.22%)
Hypersensitivity
6 (.22%)
Inhibiting Antibodies
6 (.22%)
Lobar Pneumonia
6 (.22%)
Sepsis
6 (.22%)
Upper Respiratory Tract Infection
6 (.22%)
Activated Partial Thromboplastin Ti...
5 (.19%)
Acute Respiratory Distress Syndrome
5 (.19%)
Arthropod Bite
5 (.19%)
Blood Immunoglobulin G Increased
5 (.19%)
Bone Density Decreased
5 (.19%)
Cardiac Failure
5 (.19%)
Fall
5 (.19%)
Glycogen Storage Disease Type Ii
5 (.19%)
Heart Rate Increased
5 (.19%)
Hypertonia
5 (.19%)
Hypotonia
5 (.19%)
No Adverse Event
5 (.19%)
Respiratory Syncytial Virus Infecti...
5 (.19%)
Shock
5 (.19%)
Unevaluable Event
5 (.19%)
Ventricular Hypertrophy
5 (.19%)
Vomiting
5 (.19%)
Wheezing
5 (.19%)
Abasia
4 (.15%)
Abdominal Infection
4 (.15%)
Abdominal Pain
4 (.15%)
Anaemia
4 (.15%)
Blood Lactate Dehydrogenase Increas...
4 (.15%)
Body Temperature Increased
4 (.15%)
Bronchospasm
4 (.15%)
Circumstance Or Information Capable...
4 (.15%)
Device Related Infection
4 (.15%)
Dizziness
4 (.15%)
Face Oedema
4 (.15%)

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

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

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

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

Haemophilia
1010
Factor Viii Deficiency
282
Glycogen Storage Disease Type Ii
78
Drug Use For Unknown Indication
19
Prophylaxis
19
Von Willebrands Disease
14
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Haemarthrosis
13
Surgery
13
Product Used For Unknown Indication
8
Haemorrhage
7
Traumatic Haemorrhage
6
Haematuria
4
Factor Viii Inhibition
4
Joint Sprain
3
Haematoma
3
Haemophilia A With Anti Factor Viii
3
Coagulation Factor Viii Level Abnor...
2
Coagulation Factor
2
Haemorrhage Prophylaxis
2
Coagulation Factor Viii Level Decre...
2
Immunosuppressant Drug Therapy
2
Haemostasis
2
Allergy Test
1
Benign Tumour Excision
1
Subdural Haematoma
1
Ankle Fracture
1
Retinal Detachment
1
Factor V Deficiency
1
Immune Tolerance Induction
1
Laceration
1
Splenic Rupture
1
Polypectomy
1
Bacteraemia
1
Hiv Infection
1
Acute Myocardial Infarction
1
Knee Operation
1
Colon Polypectomy
1
Acinetobacter Infection
1
Haemorrhage Intracranial
1
Pulmonary Haemorrhage
1
Coagulation Factor Viii Level
1
Activated Partial Thromboplastin Ti...
1
Ill-defined Disorder
1
Epistaxis
1

Drug Labels

LabelLabelerEffective
RecombinateBaxter Healthcare Corporation26-MAY-10
RecombinateBaxter Healthcare Corporation26-MAY-10
RecombinateBaxter Healthcare Corporation26-MAY-10
RecombinateBaxter Healthcare Corporation01-DEC-10

Recombinate Case Reports

What Recombinate 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 Recombinate. 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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