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DARBEPOETIN ALFA

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Darbepoetin Alfa Adverse Events Reported to the FDA Over Time

How are Darbepoetin Alfa adverse event reports trending over time?

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

Most Common Darbepoetin Alfa Adverse Events Reported to the FDA

What are the most common Darbepoetin Alfa adverse events reported to the FDA?

Cardiac Failure
35 (1.87%)
Myocardial Infarction
31 (1.65%)
Anaemia
29 (1.55%)
Hypertension
29 (1.55%)
Dyspnoea
26 (1.39%)
Pulmonary Embolism
26 (1.39%)
Cardiac Failure Congestive
25 (1.33%)
Diarrhoea
23 (1.23%)
Haemoglobin Decreased
21 (1.12%)
Angina Pectoris
18 (.96%)
Thrombocytopenia
18 (.96%)
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International Normalised Ratio Incr...
17 (.91%)
Drug Interaction
16 (.85%)
Atrial Fibrillation
15 (.8%)
Febrile Neutropenia
15 (.8%)
Myocardial Ischaemia
15 (.8%)
Renal Failure Chronic
15 (.8%)
Chronic Myeloid Leukaemia
14 (.75%)
Haematoma
14 (.75%)
Contusion
13 (.69%)
Death
13 (.69%)
Hyperkalaemia
13 (.69%)
Pancytopenia
13 (.69%)
Rash
13 (.69%)
Renal Impairment
13 (.69%)
Disease Progression
12 (.64%)
Pneumonia
12 (.64%)
Pyrexia
12 (.64%)
Respiratory Failure
12 (.64%)
Swelling
12 (.64%)
Confusional State
11 (.59%)
Nausea
11 (.59%)
Urinary Tract Infection
11 (.59%)
Blood Creatinine Increased
10 (.53%)
Cerebral Ischaemia
10 (.53%)
Chest Pain
10 (.53%)
Deep Vein Thrombosis
10 (.53%)
Loss Of Consciousness
10 (.53%)
Sepsis
10 (.53%)
Spinal Compression Fracture
10 (.53%)
Therapeutic Response Decreased
10 (.53%)
Vomiting
10 (.53%)
Aplasia Pure Red Cell
9 (.48%)
Hypertensive Crisis
9 (.48%)
Hypotension
9 (.48%)
Lethargy
9 (.48%)
Peripheral Ischaemia
9 (.48%)
Renal Failure
9 (.48%)
Renal Failure Acute
9 (.48%)
Sudden Death
9 (.48%)
Asthenia
8 (.43%)
Cardio-respiratory Arrest
8 (.43%)
Cerebrovascular Accident
8 (.43%)
Colitis Ischaemic
8 (.43%)
Fatigue
8 (.43%)
Haematuria
8 (.43%)
Haemolytic Anaemia
8 (.43%)
Headache
8 (.43%)
Hypoglycaemia
8 (.43%)
Oedema Peripheral
8 (.43%)
Palmar-plantar Erythrodysaesthesia ...
8 (.43%)
Pleural Effusion
8 (.43%)
Arrhythmia
7 (.37%)
Arthralgia
7 (.37%)
Ascites
7 (.37%)
Cerebral Infarction
7 (.37%)
Fall
7 (.37%)
Hepatic Neoplasm Malignant
7 (.37%)
Infection
7 (.37%)
Ischaemic Stroke
7 (.37%)
Pain In Extremity
7 (.37%)
Blindness
6 (.32%)
Blood Pressure Increased
6 (.32%)
Bronchopneumonia
6 (.32%)
Gastroenteritis
6 (.32%)
Haemolysis
6 (.32%)
Intracardiac Thrombus
6 (.32%)
Phlebitis
6 (.32%)
Premature Baby
6 (.32%)
White Blood Cell Count Decreased
6 (.32%)
Acute Lymphocytic Leukaemia
5 (.27%)
Acute Myeloid Leukaemia
5 (.27%)
Cellulitis
5 (.27%)
Cerebral Circulatory Failure
5 (.27%)
Cerebral Haemorrhage
5 (.27%)
Circulatory Collapse
5 (.27%)
Condition Aggravated
5 (.27%)
Cough
5 (.27%)
Dehydration
5 (.27%)
Delirium
5 (.27%)
Gastrointestinal Haemorrhage
5 (.27%)
Haemodialysis
5 (.27%)
Hla Marker Study
5 (.27%)
Liver Disorder
5 (.27%)
Malignant Neoplasm Progression
5 (.27%)
Metabolic Acidosis
5 (.27%)
Metastases To Liver
5 (.27%)
Neutropenia
5 (.27%)
Non-cardiac Chest Pain
5 (.27%)
Pallor
5 (.27%)
Respiratory Alkalosis
5 (.27%)

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

What are the most common Darbepoetin Alfa adverse events reported to the FDA?

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

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

Anaemia
186
Renal Failure Chronic
143
Drug Use For Unknown Indication
95
Anaemia Of Malignant Disease
89
Cardiac Failure
87
Product Used For Unknown Indication
74
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Nephrogenic Anaemia
53
Dialysis
31
Myelodysplastic Syndrome
12
Renal Failure
8
Renal Disorder
6
Acute Myeloid Leukaemia
5
Neutropenia
5
Nutritional Support
4
Anaemia Prophylaxis
3
Prophylaxis
3
Haemoglobin Decreased
3
Anaemia Of Chronic Disease
3
Cardiac Failure Congestive
3
Breast Cancer
2
Chronic Myelomonocytic Leukaemia
2
Hypertension
2
Cardiac Failure Chronic
2
Diffuse Large B-cell Lymphoma
2
Prophylactic Chemotherapy
1
Breast Cancer Metastatic
1
Drug Exposure During Pregnancy
1
Premedication
1
Cervix Carcinoma
1
Normochromic Normocytic Anaemia
1
Blood Bicarbonate Decreased
1
Pre-existing Disease
1
Hodgkins Disease
1
Ill-defined Disorder
1
Chemotherapy
1
Hepatitis C
1
Multiple Myeloma
1
Maternal Exposure Timing Unspecifie...
1
Platelet Count Decreased
1
Renal Failure Acute
1

Drug Labels

LabelLabelerEffective
AranespAmgen Inc13-DEC-12

Darbepoetin Alfa Case Reports

What Darbepoetin Alfa 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 Darbepoetin Alfa. 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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