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Halaven Adverse Events Reported to the FDA Over Time

How are Halaven adverse event reports trending over time?

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

Most Common Halaven Adverse Events Reported to the FDA

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

Neutropenia
114 (8.18%)
Leukopenia
112 (8.04%)
Febrile Neutropenia
85 (6.1%)
Pneumonia
57 (4.09%)
Interstitial Lung Disease
56 (4.02%)
Pyrexia
41 (2.94%)
Thrombocytopenia
34 (2.44%)
Lymphopenia
32 (2.3%)
Nausea
32 (2.3%)
Stomatitis
32 (2.3%)
Neoplasm Malignant
25 (1.79%)
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Hepatic Function Abnormal
23 (1.65%)
Sepsis
22 (1.58%)
Pleural Effusion
20 (1.44%)
Fatigue
19 (1.36%)
Malaise
18 (1.29%)
Dyspnoea
15 (1.08%)
Alopecia
14 (1.01%)
Headache
14 (1.01%)
Vomiting
14 (1.01%)
Anaemia
13 (.93%)
Disseminated Intravascular Coagulat...
13 (.93%)
Dysgeusia
13 (.93%)
Mucosal Inflammation
13 (.93%)
Neuropathy Peripheral
12 (.86%)
Gait Disturbance
11 (.79%)
Respiratory Failure
11 (.79%)
Aspartate Aminotransferase Increase...
10 (.72%)
Pneumocystis Jiroveci Pneumonia
9 (.65%)
Decreased Appetite
8 (.57%)
Depressed Level Of Consciousness
8 (.57%)
Rash
8 (.57%)
Supraventricular Tachycardia
8 (.57%)
Wheezing
8 (.57%)
Convulsion
7 (.5%)
Cystitis Haemorrhagic
7 (.5%)
Hyperglycaemia
7 (.5%)
Lymphangiosis Carcinomatosa
7 (.5%)
Pulmonary Haemorrhage
7 (.5%)
Thrombotic Thrombocytopenic Purpura
7 (.5%)
Alanine Aminotransferase Increased
6 (.43%)
Asthenia
6 (.43%)
Blood Bilirubin Increased
6 (.43%)
Bone Marrow Failure
6 (.43%)
C-reactive Protein Increased
6 (.43%)
Dizziness
6 (.43%)
Feeling Hot
6 (.43%)
Malignant Pleural Effusion
6 (.43%)
Pain
6 (.43%)
Renal Failure Acute
6 (.43%)
Toxic Epidermal Necrolysis
6 (.43%)
Abdominal Pain
5 (.36%)
Hyperbilirubinaemia
5 (.36%)
Hypoxia
5 (.36%)
Oedema Peripheral
5 (.36%)
Pulmonary Embolism
5 (.36%)
Death
4 (.29%)
Deep Vein Thrombosis
4 (.29%)
Dehydration
4 (.29%)
Diarrhoea
4 (.29%)
Dysphonia
4 (.29%)
Enterocolitis Bacterial
4 (.29%)
Hepatic Cirrhosis
4 (.29%)
Herpes Zoster
4 (.29%)
Herpes Zoster Disseminated
4 (.29%)
Hyperthermia
4 (.29%)
Loss Of Consciousness
4 (.29%)
Lung Infection
4 (.29%)
Neurotoxicity
4 (.29%)
Neutrophilia
4 (.29%)
Pancreatitis
4 (.29%)
Platelet Count Decreased
4 (.29%)
Pulmonary Artery Thrombosis
4 (.29%)
Rectal Ulcer Haemorrhage
4 (.29%)
Rhabdomyolysis
4 (.29%)
Tachycardia
4 (.29%)
Tumour Lysis Syndrome
4 (.29%)
Uterine Prolapse
4 (.29%)
Abdominal Pain Upper
3 (.22%)
Chest Pain
3 (.22%)
Deafness Bilateral
3 (.22%)
Dysphagia
3 (.22%)
Epistaxis
3 (.22%)
Fall
3 (.22%)
Hip Fracture
3 (.22%)
Influenza
3 (.22%)
Liver Disorder
3 (.22%)
Metastases To Central Nervous Syste...
3 (.22%)
Oedema
3 (.22%)
Pain In Extremity
3 (.22%)
Palmar-plantar Erythrodysaesthesia ...
3 (.22%)
Palpitations
3 (.22%)
Pruritus
3 (.22%)
Renal Impairment
3 (.22%)
Respiratory Arrest
3 (.22%)
Altered State Of Consciousness
2 (.14%)
Alveolitis Allergic
2 (.14%)
Ascites
2 (.14%)
Balance Disorder
2 (.14%)
Bladder Tamponade
2 (.14%)
Blister
2 (.14%)

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

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

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

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

Breast Cancer Recurrent
174
Breast Cancer
83
Metastases To Liver
67
Metastases To Bone
60
Metastases To Lung
54
Metastases To Lymph Nodes
41
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Breast Cancer Metastatic
22
Metastases To Skin
17
Metastases To Breast
11
Non-small Cell Lung Cancer
9
Product Used For Unknown Indication
6
Recurrent Cancer
4
Metastases To Uterus
4
Metastases To Chest Wall
4
Pleural Disorder
3
Metastases To Muscle
3
Metastases To Gallbladder
3
Metastases To Peritoneum
3
Metastases To Kidney
3
Metastases To Pleura
2
Metastases To Ovary
2
Faecaloma
1
Pruritus
1
Metastases To Reproductive Organ
1

Drug Labels

LabelLabelerEffective
HalavenEisai, Inc28-FEB-12

Halaven Case Reports

What Halaven 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 Halaven. 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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