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Ontak Adverse Events Reported to the FDA Over Time

How are Ontak adverse event reports trending over time?

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

Most Common Ontak Adverse Events Reported to the FDA

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

Capillary Leak Syndrome
28 (2.76%)
Pain
22 (2.17%)
Pyrexia
18 (1.77%)
Vomiting
18 (1.77%)
Nausea
17 (1.67%)
Hypotension
16 (1.58%)
Dyspnoea
14 (1.38%)
Asthenia
13 (1.28%)
Cardio-respiratory Arrest
12 (1.18%)
Blindness
11 (1.08%)
Colour Blindness
11 (1.08%)
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Disease Progression
11 (1.08%)
Infection
11 (1.08%)
Oedema
11 (1.08%)
Atrial Fibrillation
10 (.99%)
Fatigue
10 (.99%)
Febrile Neutropenia
10 (.99%)
Thrombocytopenia
10 (.99%)
Unresponsive To Stimuli
10 (.99%)
Blood Albumin Decreased
9 (.89%)
Blood Lactate Dehydrogenase Increas...
9 (.89%)
Generalised Oedema
9 (.89%)
Hypoxia
9 (.89%)
Cardiac Arrest
8 (.79%)
Cellulitis
8 (.79%)
Dizziness
8 (.79%)
Drug Toxicity
8 (.79%)
Mental Status Changes
8 (.79%)
Sepsis
8 (.79%)
Blood Alkaline Phosphatase Increase...
7 (.69%)
Bradycardia
7 (.69%)
Csf Protein Increased
7 (.69%)
Dehydration
7 (.69%)
Malaise
7 (.69%)
Myalgia
7 (.69%)
Oxygen Saturation Decreased
7 (.69%)
Pruritus
7 (.69%)
Retinopathy
7 (.69%)
Rhabdomyolysis
7 (.69%)
Weight Increased
7 (.69%)
Blood Creatine Phosphokinase Increa...
6 (.59%)
Cachexia
6 (.59%)
Death
6 (.59%)
Gastrointestinal Disorder
6 (.59%)
Lymphadenopathy
6 (.59%)
Neoplasm Malignant
6 (.59%)
Pericardial Effusion
6 (.59%)
Pleural Effusion
6 (.59%)
Rash
6 (.59%)
Respiratory Failure
6 (.59%)
Retinitis
6 (.59%)
Syncope
6 (.59%)
Abdominal Pain
5 (.49%)
Arthralgia
5 (.49%)
Cardiomegaly
5 (.49%)
Deep Vein Thrombosis
5 (.49%)
Infusion Related Reaction
5 (.49%)
Insomnia
5 (.49%)
Liver Function Test Abnormal
5 (.49%)
Musculoskeletal Pain
5 (.49%)
Neutropenia
5 (.49%)
Oedema Peripheral
5 (.49%)
Pain In Extremity
5 (.49%)
Palpitations
5 (.49%)
Pulmonary Fibrosis
5 (.49%)
Sinus Tachycardia
5 (.49%)
Tachycardia
5 (.49%)
Tumour Lysis Syndrome
5 (.49%)
Angiopathy
4 (.39%)
Application Site Oedema
4 (.39%)
Back Pain
4 (.39%)
Blood Bilirubin Increased
4 (.39%)
Cardiac Tamponade
4 (.39%)
Cataract Nuclear
4 (.39%)
Diarrhoea
4 (.39%)
Electromechanical Dissociation
4 (.39%)
Hypertension
4 (.39%)
Hypothermia
4 (.39%)
Lymphopenia
4 (.39%)
Macular Degeneration
4 (.39%)
Maculopathy
4 (.39%)
Myocardial Infarction
4 (.39%)
Myositis
4 (.39%)
Pneumonia
4 (.39%)
Pneumonitis Chemical
4 (.39%)
Retinal Disorder
4 (.39%)
Retinopathy Hypertensive
4 (.39%)
Visual Acuity Reduced
4 (.39%)
Abasia
3 (.3%)
Acute Myocardial Infarction
3 (.3%)
Alanine Aminotransferase Abnormal
3 (.3%)
Alanine Aminotransferase Increased
3 (.3%)
Aspartate Aminotransferase Abnormal
3 (.3%)
Blood Albumin Abnormal
3 (.3%)
Blood Creatinine Increased
3 (.3%)
Blood Pressure Immeasurable
3 (.3%)
Blood Pressure Increased
3 (.3%)
Chest Pain
3 (.3%)
Csf Lactate Dehydrogenase Increased
3 (.3%)
Cytokine Release Syndrome
3 (.3%)
Hyperthyroidism
3 (.3%)

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

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

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

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

Peripheral T-cell Lymphoma Unspecif...
40
Mycosis Fungoides
26
T-cell Lymphoma
19
Lymphoma
12
Non-small Cell Lung Cancer
9
Graft Versus Host Disease
8
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Chronic Lymphocytic Leukaemia
8
Non-hodgkins Lymphoma
5
B-cell Lymphoma
4
Peripheral T-cell Lymphoma Unspecif...
3
Mycosis Fungoides Stage Iii
3
Angioimmunoblastic T-cell Lymphoma
3
Dermatomyositis
3
Ovarian Cancer Metastatic
3
Malignant Melanoma Stage Iv
2
Neoplasm
2
Lymphadenopathy
2
Panniculitis
2
Adult T-cell Lymphoma/leukaemia
2
Hypertension
2
Lymphocytic Leukaemia
1
Intestinal T-cell Lymphoma
1
Non-small Cell Lung Cancer Recurren...
1
Chronic Leukaemia
1
Hepatosplenic T-cell Lymphoma
1
Human T-cell Lymphotropic Virus Typ...
1
Follicle Centre Lymphoma, Follicula...
1
B-cell Small Lymphocytic Lymphoma
1
Malignant Lymphoid Neoplasm
1
Pancreatic Carcinoma Metastatic
1
Ovarian Cancer
1
Myeloproliferative Disorder
1
Non-small Cell Lung Cancer Stage Iv
1
Renal Cell Carcinoma Stage Iv
1

Drug Labels

LabelLabelerEffective
OntakEisai Inc.01-AUG-11

Ontak Case Reports

What Ontak 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 Ontak. 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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