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LEUKINE

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Leukine Adverse Events Reported to the FDA Over Time

How are Leukine adverse event reports trending over time?

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

Most Common Leukine Adverse Events Reported to the FDA

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

Nausea
106 (2.7%)
Dyspnoea
99 (2.52%)
Syncope
79 (2.01%)
Dizziness
78 (1.99%)
Hypotension
78 (1.99%)
Vomiting
76 (1.93%)
Pyrexia
70 (1.78%)
Diarrhoea
67 (1.71%)
Dehydration
60 (1.53%)
Fatigue
59 (1.5%)
Abdominal Pain
51 (1.3%)
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Hyperhidrosis
50 (1.27%)
Chills
49 (1.25%)
Chest Pain
44 (1.12%)
Pulmonary Embolism
41 (1.04%)
Back Pain
38 (.97%)
Headache
34 (.87%)
Loss Of Consciousness
33 (.84%)
Rash
31 (.79%)
Chest Discomfort
30 (.76%)
Flushing
30 (.76%)
Injection Site Reaction
28 (.71%)
Anaemia
25 (.64%)
Injection Site Erythema
25 (.64%)
Pain
25 (.64%)
Bone Pain
24 (.61%)
Asthenia
23 (.59%)
Atrial Fibrillation
23 (.59%)
Urticaria
23 (.59%)
White Blood Cell Count Decreased
23 (.59%)
Adrenal Insufficiency
22 (.56%)
Weight Decreased
21 (.53%)
Cough
20 (.51%)
White Blood Cell Count Increased
20 (.51%)
Decreased Appetite
18 (.46%)
Hyponatraemia
18 (.46%)
Malaise
18 (.46%)
Oedema Peripheral
18 (.46%)
Pain In Extremity
18 (.46%)
Pruritus
18 (.46%)
Renal Failure Acute
18 (.46%)
Confusional State
17 (.43%)
Fall
17 (.43%)
Neutropenia
17 (.43%)
Presyncope
17 (.43%)
Renal Failure
17 (.43%)
Sepsis
17 (.43%)
Thrombocytopenia
17 (.43%)
Myocardial Infarction
16 (.41%)
Tachycardia
16 (.41%)
Anaphylactic Reaction
15 (.38%)
Convulsion
15 (.38%)
Febrile Neutropenia
15 (.38%)
Myalgia
15 (.38%)
Deep Vein Thrombosis
14 (.36%)
Feeling Hot
13 (.33%)
Heart Rate Increased
13 (.33%)
Hypoxia
13 (.33%)
Mucosal Inflammation
13 (.33%)
Muscular Weakness
13 (.33%)
Pallor
13 (.33%)
Tremor
13 (.33%)
Blood Glucose Increased
12 (.31%)
Death
12 (.31%)
Injection Site Pain
12 (.31%)
Injection Site Pruritus
12 (.31%)
Malignant Neoplasm Progression
12 (.31%)
Neoplasm Malignant
12 (.31%)
Oxygen Saturation Decreased
12 (.31%)
Pneumonia
12 (.31%)
Unevaluable Event
12 (.31%)
Arthralgia
11 (.28%)
Blood Pressure Decreased
11 (.28%)
Embolism
11 (.28%)
Hypokalaemia
11 (.28%)
Injection Site Inflammation
11 (.28%)
Injection Site Irritation
11 (.28%)
Injection Site Swelling
11 (.28%)
Melanoma Recurrent
11 (.28%)
Sinus Tachycardia
11 (.28%)
Abdominal Pain Upper
10 (.25%)
Adverse Event
10 (.25%)
Alanine Aminotransferase Increased
10 (.25%)
Aspartate Aminotransferase Increase...
10 (.25%)
Blood Pressure Increased
10 (.25%)
Haematocrit Decreased
10 (.25%)
Haemoglobin Decreased
10 (.25%)
Metastatic Malignant Melanoma
10 (.25%)
Pleural Effusion
10 (.25%)
Transaminases Increased
10 (.25%)
Cardiac Failure Congestive
9 (.23%)
Cholecystitis
9 (.23%)
Colitis
9 (.23%)
Dyspepsia
9 (.23%)
Erythema
9 (.23%)
Gastritis
9 (.23%)
Lethargy
9 (.23%)
Pancytopenia
9 (.23%)
Platelet Count Decreased
9 (.23%)
Transient Ischaemic Attack
9 (.23%)
Acute Myocardial Infarction
8 (.2%)

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

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

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

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

Malignant Melanoma
159
Drug Use For Unknown Indication
135
Neutropenia
71
Crohns Disease
61
Prostate Cancer
47
Product Used For Unknown Indication
29
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Colony Stimulating Factor Prophylax...
22
Breast Cancer
20
Colony Stimulating Factor Therapy
18
Myelodysplastic Syndrome
16
Metastatic Malignant Melanoma
12
Diffuse Large B-cell Lymphoma
11
Lung Neoplasm Malignant
10
Glioblastoma Multiforme
10
Prophylaxis
9
White Blood Cell Count Decreased
8
Prostate Cancer Metastatic
8
Leukopenia
8
Non-hodgkins Lymphoma
8
Chronic Lymphocytic Leukaemia
8
Acute Myeloid Leukaemia
7
Melanoma Recurrent
7
Renal Cell Carcinoma Stage Unspecif...
6
Alveolar Proteinosis
6
Chemotherapy Cytokine Prophylaxis
6
Haematopoietic Stem Cell Mobilisati...
5
Small Cell Lung Cancer Stage Unspec...
5
Chemotherapy
5
B-cell Lymphoma
5
Neoplasm Malignant
5
Stem Cell Transplant
4
Hodgkins Disease
4
Inflammatory Bowel Disease
4
Cervix Carcinoma
3
Lymphoma
3
Ovarian Cancer Recurrent
3
Pancreatic Carcinoma
3
Ovarian Cancer Metastatic
3
Metastatic Renal Cell Carcinoma
3
Autoimmune Disorder
2
Breast Cancer Metastatic
2
Agranulocytosis
2
Immunodeficiency
2
Secondary Immunodeficiency
2
Ill-defined Disorder
2
Skin Cancer
2
Anal Cancer
2
Multiple Myeloma
2
Colon Cancer
2
Glioblastoma
2
Bone Marrow Conditioning Regimen
2

Drug Labels

LabelLabelerEffective
LeukineGenzyme Corporation01-JUL-09
Leukinesanofi-aventis U.S. LLC21-MAR-13

Leukine Case Reports

What Leukine 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 Leukine. 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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