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ETANERCEPT

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Etanercept Adverse Events Reported to the FDA Over Time

How are Etanercept adverse event reports trending over time?

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

Most Common Etanercept Adverse Events Reported to the FDA

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

Pneumonia
122 (1.45%)
Drug Ineffective
90 (1.07%)
Pyrexia
80 (.95%)
Condition Aggravated
77 (.92%)
Rheumatoid Arthritis
75 (.89%)
Weight Decreased
74 (.88%)
Diarrhoea
65 (.77%)
Sepsis
59 (.7%)
Dyspnoea
57 (.68%)
Renal Failure
52 (.62%)
Interstitial Lung Disease
48 (.57%)
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Breast Cancer
47 (.56%)
Cough
46 (.55%)
Diverticulitis
45 (.54%)
Cellulitis
44 (.52%)
Nausea
41 (.49%)
Abdominal Pain
40 (.48%)
Hypersensitivity
38 (.45%)
Respiratory Failure
38 (.45%)
Multi-organ Failure
37 (.44%)
Vomiting
36 (.43%)
Myocardial Infarction
35 (.42%)
Rectal Haemorrhage
34 (.4%)
Renal Failure Acute
34 (.4%)
Arthralgia
33 (.39%)
Headache
33 (.39%)
Neutropenia
33 (.39%)
Sarcoidosis
33 (.39%)
Death
32 (.38%)
Dizziness
32 (.38%)
Atrial Fibrillation
31 (.37%)
Lung Neoplasm Malignant
31 (.37%)
Septic Shock
31 (.37%)
Staphylococcal Infection
31 (.37%)
Pulmonary Embolism
30 (.36%)
Demyelination
29 (.35%)
Hepatic Steatosis
29 (.35%)
Urinary Tract Infection
29 (.35%)
Cardiac Failure
28 (.33%)
Fatigue
28 (.33%)
Herpes Zoster
28 (.33%)
Infection
28 (.33%)
Metastases To Liver
28 (.33%)
Pain
28 (.33%)
Squamous Cell Carcinoma
28 (.33%)
Dehydration
27 (.32%)
Fall
27 (.32%)
Pulmonary Fibrosis
27 (.32%)
Pleural Effusion
26 (.31%)
Thrombocytopenia
26 (.31%)
Anaemia
25 (.3%)
Back Pain
25 (.3%)
Hypoxia
25 (.3%)
Pancytopenia
25 (.3%)
Basal Cell Carcinoma
24 (.29%)
Chest Pain
24 (.29%)
Malaise
24 (.29%)
Asthenia
23 (.27%)
Granuloma
23 (.27%)
Histiocytosis Haematophagic
23 (.27%)
Impaired Healing
23 (.27%)
Oedema Peripheral
23 (.27%)
Tuberculosis
23 (.27%)
Immunosuppression
22 (.26%)
Lung Infiltration
22 (.26%)
Rash
22 (.26%)
Renal Cell Carcinoma
22 (.26%)
Bacteraemia
21 (.25%)
Organising Pneumonia
21 (.25%)
Hypotension
20 (.24%)
Thyroid Cancer
20 (.24%)
Eczema
19 (.23%)
Erythema
19 (.23%)
Lymphoma
19 (.23%)
Syncope
19 (.23%)
Abortion Spontaneous
18 (.21%)
Arthritis
18 (.21%)
Bronchitis
18 (.21%)
Deep Vein Thrombosis
18 (.21%)
General Physical Health Deteriorati...
18 (.21%)
Haemoglobin Decreased
18 (.21%)
Hepatic Failure
18 (.21%)
Pericardial Effusion
18 (.21%)
Pleurisy
18 (.21%)
White Blood Cell Count Decreased
18 (.21%)
Arthritis Bacterial
17 (.2%)
Cyanosis
17 (.2%)
Depression
17 (.2%)
Diverticular Perforation
17 (.2%)
Liver Function Test Abnormal
17 (.2%)
Drug Exposure During Pregnancy
16 (.19%)
Gastrointestinal Disorder
16 (.19%)
Influenza
16 (.19%)
Leukopenia
16 (.19%)
Lung Disorder
16 (.19%)
Lung Neoplasm
16 (.19%)
Ovarian Cancer
16 (.19%)
Psoriasis
16 (.19%)
Cardiac Failure Congestive
15 (.18%)
Convulsion
15 (.18%)
Iridocyclitis
15 (.18%)

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

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

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

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

Rheumatoid Arthritis
1682
Psoriasis
318
Product Used For Unknown Indication
223
Psoriatic Arthropathy
212
Drug Use For Unknown Indication
188
Ankylosing Spondylitis
175
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Juvenile Arthritis
166
Graft Versus Host Disease
33
Wegeners Granulomatosis
28
Polyarthritis
20
Arthritis
18
Spondylitis
17
Ill-defined Disorder
17
Immunosuppression
10
Pulmonary Fibrosis
9
Hepatitis Alcoholic
8
Chronic Lymphocytic Leukaemia
6
Spondyloarthropathy
6
Polychondritis
5
Pustular Psoriasis
5
Myositis
5
Systemic Lupus Erythematosus
5
Prophylaxis Against Transplant Reje...
5
Idiopathic Pneumonia Syndrome
5
Behcets Syndrome
5
Diffuse Vasculitis
4
Hidradenitis
4
Pain
4
Juvenile Chronic Myelomonocytic Leu...
4
Renal Failure Chronic
4
Crohns Disease
4
Pancreatic Carcinoma
3
Uveitis
3
Erythrodermic Psoriasis
3
Arthropathy
3
Drug Exposure During Pregnancy
3
Prophylaxis
2
Idiopathic Thrombocytopenic Purpura
2
Autoimmune Disorder
2
Erdheim-chester Disease
2
Seronegative Arthritis
2
Lung Disorder
2
Sleep Disorder
2
Pyoderma Gangrenosum
2
Musculoskeletal Pain
2
Tuberculosis
2
Off Label Use
2
Amyloidosis
2
Hypertension
2
Renal Transplant
2
Nail Psoriasis
2

Drug Labels

LabelLabelerEffective
EnbrelImmunex Corporation10-DEC-12

Etanercept Case Reports

What Etanercept 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 Etanercept. 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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