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NEULASTA

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Neulasta Adverse Events Reported to the FDA Over Time

How are Neulasta adverse event reports trending over time?

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

Most Common Neulasta Adverse Events Reported to the FDA

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

Febrile Neutropenia
817 (4.29%)
Neutropenia
530 (2.78%)
Bone Pain
510 (2.68%)
Drug Ineffective
501 (2.63%)
Pyrexia
483 (2.54%)
Dyspnoea
412 (2.16%)
Nausea
267 (1.4%)
White Blood Cell Count Decreased
258 (1.35%)
Vomiting
211 (1.11%)
Fatigue
203 (1.07%)
Diarrhoea
200 (1.05%)
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Back Pain
199 (1.04%)
Thrombocytopenia
192 (1.01%)
Pain
190 (1%)
Malaise
188 (.99%)
Chest Pain
186 (.98%)
Leukocytosis
177 (.93%)
Death
175 (.92%)
Asthenia
172 (.9%)
White Blood Cell Count Increased
168 (.88%)
Headache
147 (.77%)
Hypotension
143 (.75%)
Anaemia
141 (.74%)
Hypersensitivity
141 (.74%)
Arthralgia
139 (.73%)
Haemoglobin Decreased
139 (.73%)
Neutrophil Count Decreased
139 (.73%)
Pneumonia
134 (.7%)
Dehydration
127 (.67%)
Myalgia
127 (.67%)
Sepsis
127 (.67%)
Neutropenic Sepsis
121 (.64%)
Platelet Count Decreased
121 (.64%)
Infection
119 (.62%)
Leukopenia
113 (.59%)
Rash
113 (.59%)
Therapeutic Response Decreased
110 (.58%)
Abdominal Pain
103 (.54%)
Dizziness
102 (.54%)
Urticaria
100 (.52%)
Syncope
92 (.48%)
Pruritus
91 (.48%)
Pain In Extremity
87 (.46%)
Pancytopenia
87 (.46%)
Erythema
86 (.45%)
Pulmonary Embolism
76 (.4%)
Body Temperature Increased
72 (.38%)
Palmar-plantar Erythrodysaesthesia ...
72 (.38%)
Confusional State
71 (.37%)
Chest Discomfort
68 (.36%)
Cough
68 (.36%)
Influenza Like Illness
68 (.36%)
Deep Vein Thrombosis
67 (.35%)
Chills
64 (.34%)
General Physical Health Deteriorati...
64 (.34%)
Tachycardia
64 (.34%)
Oedema Peripheral
62 (.33%)
Fall
60 (.31%)
Palpitations
60 (.31%)
Septic Shock
59 (.31%)
Heart Rate Increased
58 (.3%)
Anaphylactic Reaction
57 (.3%)
Abdominal Pain Upper
55 (.29%)
Mucosal Inflammation
55 (.29%)
Musculoskeletal Pain
55 (.29%)
Pleural Effusion
55 (.29%)
Neutrophil Count Increased
54 (.28%)
Hyperhidrosis
53 (.28%)
Loss Of Consciousness
53 (.28%)
Renal Failure Acute
53 (.28%)
Pneumonitis
52 (.27%)
Swelling Face
51 (.27%)
Acute Respiratory Distress Syndrome
49 (.26%)
Respiratory Failure
49 (.26%)
Feeling Abnormal
48 (.25%)
Haematocrit Decreased
47 (.25%)
Lung Infiltration
46 (.24%)
Febrile Bone Marrow Aplasia
45 (.24%)
Insomnia
45 (.24%)
Muscle Spasms
45 (.24%)
Constipation
42 (.22%)
Paraesthesia
42 (.22%)
Petechiae
42 (.22%)
Splenic Rupture
42 (.22%)
Dermatitis Allergic
41 (.22%)
Injection Site Pain
41 (.22%)
Blood Pressure Decreased
40 (.21%)
Stomatitis
39 (.2%)
Delirium
38 (.2%)
Weight Decreased
38 (.2%)
Medication Error
37 (.19%)
Anxiety
36 (.19%)
Ejection Fraction Decreased
36 (.19%)
Hypokalaemia
36 (.19%)
Pharyngeal Oedema
36 (.19%)
Tremor
36 (.19%)
Angioedema
35 (.18%)
Flushing
35 (.18%)
No Therapeutic Response
35 (.18%)
Splenomegaly
35 (.18%)
Staphylococcal Infection
35 (.18%)

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

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

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

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

Chemotherapy
3657
Drug Use For Unknown Indication
514
Neutropenia
373
Product Used For Unknown Indication
352
Prophylaxis
216
Breast Cancer
179
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Diffuse Large B-cell Lymphoma
76
Non-hodgkins Lymphoma
54
B-cell Lymphoma
54
Mantle Cell Lymphoma
40
Myelodysplastic Syndrome
28
Agranulocytosis
23
White Blood Cell Count Decreased
22
Febrile Neutropenia
20
Chronic Lymphocytic Leukaemia
18
Premedication
15
Prostate Cancer
15
Colony Stimulating Factor Prophylax...
14
Peripheral Blood Stem Cell Apheresi...
13
Granulocytopenia
13
Lymphoma
12
Leukopenia
12
Anaemia
10
Hodgkins Disease
10
Malignant Lymphoid Neoplasm
10
Infection Prophylaxis
8
Pre-existing Disease
8
Acute Myeloid Leukaemia
8
Supportive Care
6
Blood Stem Cell Harvest
6
Neoplasm Malignant
6
Ovarian Cancer
5
Bone Sarcoma
4
Colony Stimulating Factor Therapy
4
Acute Lymphocytic Leukaemia
3
Gastrointestinal Carcinoma
3
Breast Cancer In Situ
3
Infection
3
Sarcoma Uterus
3
Bone Marrow Failure
3
White Blood Cell Count
3
Small Cell Lung Cancer Stage Unspec...
3
Neutrophil Count Decreased
3
Paroxysmal Nocturnal Haemoglobinuri...
3
Anaplastic Large Cell Lymphoma T- A...
2
Small Cell Lung Cancer Metastatic
2
Aplasia
2
Autoimmune Neutropenia
2
Hodgkins Disease Nodular Sclerosis ...
2
Bladder Cancer
2
Non-small Cell Lung Cancer
2

Drug Labels

LabelLabelerEffective
NeulastaPhysicians Total Care, Inc.17-FEB-10
NeulastaAMGEN INC17-JUN-11

Neulasta Case Reports

What Neulasta 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 Neulasta. 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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