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Aranesp Adverse Events Reported to the FDA Over Time

How are Aranesp adverse event reports trending over time?

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

Most Common Aranesp Adverse Events Reported to the FDA

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

Aplasia Pure Red Cell
1204 (5.71%)
Anaemia
880 (4.17%)
Therapeutic Response Decreased
762 (3.61%)
Haemoglobin Decreased
680 (3.22%)
Drug Ineffective
453 (2.15%)
Fatigue
330 (1.56%)
Anti-erythropoietin Antibody Positi...
325 (1.54%)
Death
262 (1.24%)
Dyspnoea
213 (1.01%)
Asthenia
195 (.92%)
Pain
167 (.79%)
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Pyrexia
155 (.73%)
Myelodysplastic Syndrome
148 (.7%)
Pleural Effusion
137 (.65%)
Oedema Peripheral
136 (.64%)
Nausea
133 (.63%)
Refractory Anaemia
132 (.63%)
Pruritus
131 (.62%)
Thrombocytopenia
131 (.62%)
Bone Marrow Failure
126 (.6%)
Rash
122 (.58%)
Malaise
120 (.57%)
Rectal Haemorrhage
120 (.57%)
Pancytopenia
117 (.55%)
Diarrhoea
116 (.55%)
Hospitalisation
113 (.54%)
Hypertension
111 (.53%)
Injection Site Pain
111 (.53%)
Haemorrhoids
108 (.51%)
Blood Pressure Increased
107 (.51%)
Gastritis Erosive
105 (.5%)
Headache
105 (.5%)
Neutralising Antibodies Positive
104 (.49%)
Colonic Polyp
103 (.49%)
Hypersensitivity
103 (.49%)
Cystitis
101 (.48%)
Left Ventricular Failure
101 (.48%)
Dizziness
100 (.47%)
Hypopnoea
100 (.47%)
Muscle Twitching
99 (.47%)
Anal Fissure
98 (.46%)
Cardioactive Drug Level Increased
98 (.46%)
Right Ventricular Failure
98 (.46%)
Vaginal Abscess
98 (.46%)
Varicose Vein
98 (.46%)
Pneumonia
97 (.46%)
Hepatic Enzyme Increased
93 (.44%)
Vomiting
88 (.42%)
Pulmonary Embolism
86 (.41%)
Weight Decreased
83 (.39%)
Hypotension
81 (.38%)
Renal Failure
77 (.36%)
Chest Pain
70 (.33%)
Deep Vein Thrombosis
69 (.33%)
Cerebrovascular Accident
68 (.32%)
Fall
68 (.32%)
Dehydration
67 (.32%)
Epistaxis
66 (.31%)
Urticaria
66 (.31%)
Convulsion
65 (.31%)
Infection
64 (.3%)
Haemorrhage
63 (.3%)
Platelet Count Decreased
62 (.29%)
Reticulocyte Count Decreased
60 (.28%)
Bone Pain
59 (.28%)
Back Pain
58 (.27%)
General Physical Health Deteriorati...
58 (.27%)
Cough
57 (.27%)
Thrombosis
57 (.27%)
Cardiac Failure
56 (.27%)
Myocardial Infarction
56 (.27%)
Sepsis
55 (.26%)
Arthralgia
54 (.26%)
Cardiac Failure Congestive
54 (.26%)
Erythema
54 (.26%)
Urinary Tract Infection
53 (.25%)
Chills
52 (.25%)
Loss Of Consciousness
52 (.25%)
Iron Deficiency
51 (.24%)
Pain In Extremity
51 (.24%)
Atrial Fibrillation
49 (.23%)
Eosinophilia
46 (.22%)
Haemoglobin Increased
46 (.22%)
Myalgia
46 (.22%)
Hyperkalaemia
45 (.21%)
Lethargy
45 (.21%)
Normochromic Normocytic Anaemia
44 (.21%)
White Blood Cell Count Decreased
43 (.2%)
Blood Creatinine Increased
42 (.2%)
Rash Generalised
42 (.2%)
Renal Failure Acute
41 (.19%)
Renal Impairment
41 (.19%)
Staphylococcal Infection
41 (.19%)
Condition Aggravated
39 (.18%)
Confusional State
39 (.18%)
Feeling Abnormal
39 (.18%)
Haematocrit Decreased
39 (.18%)
Syncope
38 (.18%)
Abdominal Pain
37 (.18%)
Aplastic Anaemia
37 (.18%)
Drug Hypersensitivity
37 (.18%)

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

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

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

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

Renal Failure Chronic
2140
Anaemia
1323
Anaemia Of Malignant Disease
806
Drug Use For Unknown Indication
801
Product Used For Unknown Indication
651
Dialysis
642
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Myelodysplastic Syndrome
322
Nephrogenic Anaemia
107
Renal Transplant
92
Renal Failure
41
Haemoglobin Decreased
39
Hepatitis C
23
Pre-existing Disease
20
Multiple Myeloma
19
Anaemia Of Chronic Disease
15
Prophylaxis
15
Anaemia Prophylaxis
14
Chemotherapy
14
Haemoglobin Abnormal
10
Red Blood Cell Count Decreased
10
Myelofibrosis
9
Blood Disorder
8
Iron Deficiency Anaemia
8
Renal Disorder
8
Breast Cancer Metastatic
7
Nephropathy
7
Aplastic Anaemia
7
Full Blood Count Decreased
6
Acute Myeloid Leukaemia
6
Breast Cancer
5
Paroxysmal Nocturnal Haemoglobinuri...
4
Anaemia Postoperative
4
Haemodialysis
4
Red Blood Cell Count Abnormal
4
Bone Marrow Transplant
4
Thalassaemia
4
Chronic Lymphocytic Leukaemia
4
Peritoneal Dialysis
4
Refractory Anaemia With An Excess O...
4
Red Blood Cell Count
4
Neoplasm Malignant
4
Crohns Disease
4
Lymphoma
4
Renal Impairment
3
Transplant Failure
3
Haemolytic Anaemia
3
Ovarian Cancer
3
Erythropenia
3
Liver Transplant
3
Sideroblastic Anaemia
3
Haemoglobin
3

Drug Labels

LabelLabelerEffective
AranespPhysicians Total Care, Inc.17-NOV-10
AranespAmgen Inc13-DEC-12

Aranesp Case Reports

What Aranesp 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 Aranesp. 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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