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FILGRASTIM

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Filgrastim Adverse Events Reported to the FDA Over Time

How are Filgrastim adverse event reports trending over time?

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

Most Common Filgrastim Adverse Events Reported to the FDA

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

Febrile Neutropenia
138 (2.62%)
Pyrexia
130 (2.47%)
Neutropenia
113 (2.15%)
Nausea
70 (1.33%)
Diarrhoea
68 (1.29%)
Vomiting
68 (1.29%)
Dehydration
67 (1.27%)
Hypotension
66 (1.25%)
Thrombocytopenia
65 (1.24%)
Haemoglobin Decreased
59 (1.12%)
Dyspnoea
58 (1.1%)
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Anaemia
51 (.97%)
Platelet Count Decreased
50 (.95%)
White Blood Cell Count Decreased
48 (.91%)
Fatigue
45 (.86%)
Mucosal Inflammation
44 (.84%)
Sepsis
44 (.84%)
Pneumonia
43 (.82%)
Neutrophil Count Decreased
37 (.7%)
Renal Failure
37 (.7%)
Pleural Effusion
35 (.67%)
Tachycardia
35 (.67%)
Infection
31 (.59%)
Leukopenia
31 (.59%)
Hypoxia
28 (.53%)
Rash
28 (.53%)
Septic Shock
28 (.53%)
Stomatitis
28 (.53%)
Abdominal Pain
27 (.51%)
Pulmonary Embolism
27 (.51%)
Respiratory Distress
27 (.51%)
Pancytopenia
26 (.49%)
Chills
25 (.48%)
Hypertension
25 (.48%)
Respiratory Failure
25 (.48%)
Asthenia
22 (.42%)
Hypokalaemia
22 (.42%)
Multi-organ Failure
22 (.42%)
Pulmonary Oedema
22 (.42%)
Pain
21 (.4%)
Staphylococcal Infection
21 (.4%)
White Blood Cell Count Increased
21 (.4%)
Arthralgia
20 (.38%)
Atrial Fibrillation
20 (.38%)
Drug Ineffective
20 (.38%)
General Physical Health Deteriorati...
20 (.38%)
Syncope
20 (.38%)
Acute Myeloid Leukaemia
19 (.36%)
Ascites
19 (.36%)
Bone Pain
19 (.36%)
Confusional State
19 (.36%)
Device Related Infection
19 (.36%)
Dizziness
19 (.36%)
Renal Failure Acute
19 (.36%)
Blood Culture Positive
18 (.34%)
Cardiac Arrest
18 (.34%)
Disseminated Intravascular Coagulat...
18 (.34%)
Left Ventricular Dysfunction
18 (.34%)
Abdominal Distension
17 (.32%)
Chest Pain
17 (.32%)
Deep Vein Thrombosis
17 (.32%)
Drug Toxicity
17 (.32%)
Fall
17 (.32%)
Atelectasis
16 (.3%)
Haematocrit Decreased
16 (.3%)
Interstitial Lung Disease
16 (.3%)
Pneumonitis
16 (.3%)
Weight Decreased
16 (.3%)
Bacterial Infection
15 (.29%)
Dysphagia
15 (.29%)
Pericardial Effusion
15 (.29%)
Acute Respiratory Distress Syndrome
14 (.27%)
Back Pain
14 (.27%)
Constipation
14 (.27%)
Death
14 (.27%)
Oral Candidiasis
14 (.27%)
Blood Creatinine Increased
13 (.25%)
Candidiasis
13 (.25%)
Clostridial Infection
13 (.25%)
Colitis
13 (.25%)
Convulsion
13 (.25%)
Fluid Overload
13 (.25%)
Headache
13 (.25%)
Hepatic Function Abnormal
13 (.25%)
Lung Infiltration
13 (.25%)
Neutrophil Pelger-huet Anomaly Pres...
13 (.25%)
Oxygen Saturation Decreased
13 (.25%)
C-reactive Protein Increased
12 (.23%)
Cardiac Failure Congestive
12 (.23%)
Cardio-respiratory Arrest
12 (.23%)
Cardiomyopathy
12 (.23%)
Condition Aggravated
12 (.23%)
Disease Progression
12 (.23%)
Electrolyte Imbalance
12 (.23%)
Escherichia Infection
12 (.23%)
Blood Pressure Decreased
11 (.21%)
C-reactive Protein Decreased
11 (.21%)
Cough
11 (.21%)
Ejection Fraction Decreased
11 (.21%)
Enterococcal Infection
11 (.21%)
Hyperhidrosis
11 (.21%)

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

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

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

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

Neutropenia
198
Product Used For Unknown Indication
137
Prophylaxis
92
Diffuse Large B-cell Lymphoma
92
Drug Use For Unknown Indication
91
Breast Cancer
87
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Aplastic Anaemia
74
Infection Prophylaxis
54
Acute Myeloid Leukaemia
34
Haematopoietic Stem Cell Mobilisati...
34
Chemotherapy
29
Non-hodgkins Lymphoma
26
Neutrophil Count Decreased
25
Colony Stimulating Factor Prophylax...
25
B-cell Lymphoma
21
Febrile Neutropenia
20
Leukopenia
19
Hodgkins Disease
16
Colony Stimulating Factor Therapy
16
Blood Stem Cell Harvest
14
Pancytopenia
14
Ill-defined Disorder
13
White Blood Cell Count Increased
12
White Blood Cell Count
11
White Blood Cell Count Decreased
10
Supportive Care
10
Burkitts Lymphoma
10
Peripheral Blood Stem Cell Apheresi...
9
Uterine Leiomyosarcoma
9
Crohns Disease
8
T-cell Lymphoma
8
Blood Count Abnormal
8
Malignant Lymphoid Neoplasm
8
Bone Marrow Failure
8
Myelodysplastic Syndrome
8
Stem Cell Transplant
8
Burkitts Leukaemia
7
Multiple Myeloma
6
Endometrial Cancer
6
Granulocytopenia
5
Acute Lymphocytic Leukaemia
5
Peripheral T-cell Lymphoma Unspecif...
4
Precursor T-lymphoblastic Lymphoma/...
4
Burkitts Lymphoma Stage Iv
4
Ewings Sarcoma
4
Sepsis
4
Granulocyte Count Decreased
4
Pyoderma Gangrenosum
4
Sarcoma
4
Breast Cancer Metastatic
4
Aplasia
3

Drug Labels

LabelLabelerEffective
NeupogenAmgen Inc05-MAR-13

Filgrastim Case Reports

What Filgrastim 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 Filgrastim. 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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