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PEGFILGRASTIM

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Pegfilgrastim Adverse Events Reported to the FDA Over Time

How are Pegfilgrastim adverse event reports trending over time?

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

Most Common Pegfilgrastim Adverse Events Reported to the FDA

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

Febrile Neutropenia
147 (5.66%)
Dyspnoea
70 (2.69%)
Pyrexia
65 (2.5%)
Anaemia
50 (1.92%)
Diarrhoea
46 (1.77%)
Fatigue
46 (1.77%)
Neutropenia
44 (1.69%)
Chest Pain
38 (1.46%)
Nausea
35 (1.35%)
Dehydration
34 (1.31%)
Platelet Count Decreased
34 (1.31%)
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Infection
32 (1.23%)
White Blood Cell Count Decreased
29 (1.12%)
Pneumonia
28 (1.08%)
Vomiting
28 (1.08%)
Chest Discomfort
27 (1.04%)
Pancytopenia
26 (1%)
Haemoglobin Decreased
24 (.92%)
Pleural Effusion
23 (.88%)
Headache
22 (.85%)
Pulmonary Embolism
22 (.85%)
Abdominal Pain
21 (.81%)
Syncope
21 (.81%)
Pneumonitis
20 (.77%)
Multi-organ Failure
19 (.73%)
Septic Shock
19 (.73%)
Left Ventricular Dysfunction
18 (.69%)
Leukopenia
18 (.69%)
Asthenia
17 (.65%)
Sepsis
17 (.65%)
Urinary Tract Infection
17 (.65%)
Bacteraemia
16 (.62%)
C-reactive Protein Increased
16 (.62%)
Renal Failure
16 (.62%)
Thrombocytopenia
16 (.62%)
Back Pain
14 (.54%)
Chills
14 (.54%)
Cough
14 (.54%)
Dizziness
14 (.54%)
Neutrophil Count Decreased
14 (.54%)
Respiratory Failure
14 (.54%)
Stomatitis
14 (.54%)
Atrial Fibrillation
13 (.5%)
Cardiac Failure Congestive
13 (.5%)
Malaise
13 (.5%)
Device Related Infection
12 (.46%)
Ejection Fraction Decreased
12 (.46%)
Mucosal Inflammation
12 (.46%)
Myelodysplastic Syndrome
12 (.46%)
Neutropenic Sepsis
12 (.46%)
Oral Candidiasis
12 (.46%)
Weight Decreased
12 (.46%)
Deep Vein Thrombosis
11 (.42%)
Pain
11 (.42%)
Death
10 (.38%)
Drug Ineffective
10 (.38%)
General Physical Health Deteriorati...
10 (.38%)
Hypertension
10 (.38%)
Acute Myocardial Infarction
9 (.35%)
Alveolitis Allergic
9 (.35%)
Epistaxis
9 (.35%)
Hypotension
9 (.35%)
Musculoskeletal Stiffness
9 (.35%)
Neutropenic Infection
9 (.35%)
Pulmonary Hypertension
9 (.35%)
Supraventricular Tachycardia
9 (.35%)
Acute Myeloid Leukaemia
8 (.31%)
Arthralgia
8 (.31%)
Bone Pain
8 (.31%)
Coronary Artery Occlusion
8 (.31%)
Cystitis
8 (.31%)
Decreased Appetite
8 (.31%)
Hepatic Failure
8 (.31%)
Leukocytosis
8 (.31%)
Lung Disorder
8 (.31%)
Photosensitivity Reaction
8 (.31%)
Pseudomonal Sepsis
8 (.31%)
Respiratory Depth Decreased
8 (.31%)
Thrombosis
8 (.31%)
White Blood Cell Count Increased
8 (.31%)
Blood Potassium Decreased
7 (.27%)
Cardiac Arrest
7 (.27%)
Cardiac Disorder
7 (.27%)
Cardiac Failure
7 (.27%)
Cellulitis
7 (.27%)
Disease Progression
7 (.27%)
Dysgeusia
7 (.27%)
Embolism
7 (.27%)
Hypokalaemia
7 (.27%)
Hyponatraemia
7 (.27%)
Neoplasm Malignant
7 (.27%)
Peripheral Sensory Neuropathy
7 (.27%)
Pneumocystis Jiroveci Pneumonia
7 (.27%)
Sinus Tachycardia
7 (.27%)
Venoocclusive Liver Disease
7 (.27%)
Adenovirus Infection
6 (.23%)
Alanine Aminotransferase Increased
6 (.23%)
Bronchopneumonia
6 (.23%)
Cerebrovascular Accident
6 (.23%)
Clostridial Infection
6 (.23%)
Computerised Tomogram Abnormal
6 (.23%)

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

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

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

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

Breast Cancer
196
Prophylaxis
129
Diffuse Large B-cell Lymphoma
96
Product Used For Unknown Indication
91
Chemotherapy
87
Neutropenia
83
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Drug Use For Unknown Indication
60
B-cell Lymphoma
26
T-cell Lymphoma
25
Acute Myeloid Leukaemia
24
Malignant Lymphoid Neoplasm
17
Non-hodgkins Lymphoma
17
Lymphoma
17
Bone Marrow Conditioning Regimen
16
Chronic Lymphocytic Leukaemia
15
Uterine Leiomyosarcoma
9
Colorectal Cancer Metastatic
7
Multiple Myeloma
6
Palliative Care
6
Febrile Neutropenia
5
Hodgkins Disease
3
Neoplasm Malignant
3
Ill-defined Disorder
2
Gastrointestinal Carcinoma
2
Leukopenia
2
Peripheral T-cell Lymphoma Unspecif...
2
Non-small Cell Lung Cancer Stage Iv
2
Mantle Cell Lymphoma
2
Breast Cancer Stage Ii
2
Germ Cell Cancer
2
Neutrophil Count Decreased
2
Colony Stimulating Factor Therapy
2
Transitional Cell Carcinoma
2
Sarcoma
2
Chemotherapy Cytokine Prophylaxis
2
Prostate Cancer
2
Premedication
2
Lung Neoplasm Malignant
2
White Blood Cell Disorder
2
Immunosuppressant Drug Therapy
1
Genital Neoplasm Malignant Female
1
Renal Cell Carcinoma Stage Unspecif...
1
Bone Sarcoma
1
Gallbladder Cancer Stage Iv
1
Pre-existing Disease
1
Plasmablastic Lymphoma
1
Neoplasm
1
Infection
1
White Blood Cell Count Decreased
1
Metastases To Liver
1
Diffuse Large B-cell Lymphoma Stage...
1

Drug Labels

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

Pegfilgrastim Case Reports

What Pegfilgrastim 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 Pegfilgrastim. 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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