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ENZASTAURIN

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Enzastaurin Adverse Events Reported to the FDA Over Time

How are Enzastaurin adverse event reports trending over time?

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

Most Common Enzastaurin Adverse Events Reported to the FDA

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

Neutropenia
42 (4.28%)
Hypotension
38 (3.87%)
Fatigue
31 (3.16%)
Febrile Neutropenia
26 (2.65%)
Dehydration
25 (2.55%)
Anaemia
24 (2.44%)
Diarrhoea
24 (2.44%)
Pneumonia
23 (2.34%)
Abdominal Pain
21 (2.14%)
Dyspnoea
18 (1.83%)
Pleural Effusion
16 (1.63%)
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Sepsis
13 (1.32%)
Septic Shock
13 (1.32%)
Weight Decreased
13 (1.32%)
Nausea
12 (1.22%)
Acute Respiratory Distress Syndrome
11 (1.12%)
Dizziness
11 (1.12%)
Lobar Pneumonia
11 (1.12%)
Cardiomegaly
10 (1.02%)
Fall
10 (1.02%)
Ileus
10 (1.02%)
Intestinal Obstruction
10 (1.02%)
Intestinal Perforation
10 (1.02%)
Tachycardia
10 (1.02%)
Atelectasis
9 (.92%)
Convulsion
9 (.92%)
Oral Candidiasis
9 (.92%)
Pericardial Effusion
9 (.92%)
Platelet Count Decreased
9 (.92%)
Pulmonary Embolism
9 (.92%)
Supraventricular Tachycardia
9 (.92%)
Thrombocytopenia
9 (.92%)
Abdominal Abscess
8 (.81%)
Anorexia
8 (.81%)
Colonic Stenosis
8 (.81%)
Diverticulitis
8 (.81%)
Neutropenic Sepsis
8 (.81%)
Escherichia Infection
7 (.71%)
Haemoglobin Decreased
7 (.71%)
Heart Rate Increased
7 (.71%)
Pain
7 (.71%)
Aspartate Aminotransferase Increase...
6 (.61%)
Asthenia
6 (.61%)
Constipation
6 (.61%)
Death
6 (.61%)
Disease Progression
6 (.61%)
Hypokalaemia
6 (.61%)
Renal Failure
6 (.61%)
Renal Haemorrhage
6 (.61%)
Stomatitis
6 (.61%)
Urinary Tract Infection
6 (.61%)
Blood Creatinine Increased
5 (.51%)
Blood Potassium Decreased
5 (.51%)
Deep Vein Thrombosis
5 (.51%)
Femoral Neck Fracture
5 (.51%)
Gastrointestinal Necrosis
5 (.51%)
Hyperglycaemia
5 (.51%)
Hypocalcaemia
5 (.51%)
Hyponatraemia
5 (.51%)
Mucosal Inflammation
5 (.51%)
Multi-organ Failure
5 (.51%)
Peritonitis
5 (.51%)
Alanine Aminotransferase Increased
4 (.41%)
Arrhythmia
4 (.41%)
Back Pain
4 (.41%)
Cardiac Arrest
4 (.41%)
Decreased Appetite
4 (.41%)
General Physical Health Deteriorati...
4 (.41%)
Haematocrit Decreased
4 (.41%)
Infection
4 (.41%)
Muscular Weakness
4 (.41%)
Pancytopenia
4 (.41%)
Pyrexia
4 (.41%)
Thrombosis
4 (.41%)
Vomiting
4 (.41%)
Abdominal Pain Upper
3 (.31%)
Acute Myocardial Infarction
3 (.31%)
Blood Bilirubin Increased
3 (.31%)
Blood Sodium Decreased
3 (.31%)
Cardio-respiratory Arrest
3 (.31%)
Cerebrovascular Accident
3 (.31%)
Dysaesthesia
3 (.31%)
Haematemesis
3 (.31%)
Hepatic Enzyme Increased
3 (.31%)
Hypertension
3 (.31%)
Hypoaesthesia
3 (.31%)
Hypoaesthesia Oral
3 (.31%)
International Normalised Ratio Incr...
3 (.31%)
Leukopenia
3 (.31%)
Malaise
3 (.31%)
Malignant Neoplasm Progression
3 (.31%)
Melaena
3 (.31%)
Neuropathy Peripheral
3 (.31%)
Pneumocystis Jiroveci Pneumonia
3 (.31%)
Pulmonary Fibrosis
3 (.31%)
Renal Failure Acute
3 (.31%)
Respiratory Arrest
3 (.31%)
Sensory Loss
3 (.31%)
Trigger Finger
3 (.31%)
Urinary Retention
3 (.31%)
Abdominal Distension
2 (.2%)

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

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

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

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

Diffuse Large B-cell Lymphoma
109
Non-small Cell Lung Cancer
28
Glioma
10
Prostate Cancer Metastatic
9
Glioblastoma
7
Prostate Cancer
7
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Multiple Myeloma
6
Colon Cancer
5
B-cell Lymphoma
5
Diffuse Large B-cell Lymphoma Recur...
4
Breast Cancer
4
Glioblastoma Multiforme
4
Bile Duct Cancer
3
Colorectal Cancer
3
Ovarian Cancer
2
Astrocytoma
2
Neoplasm Recurrence
2
Colon Cancer Metastatic
2
Peritoneal Carcinoma
2
Gastric Cancer
2
Product Used For Unknown Indication
1
Drug Use For Unknown Indication
1
Ovarian Epithelial Cancer
1
Waldenstroms Macroglobulinaemia
1
Lymphoma
1
Colorectal Cancer Metastatic
1
Pancreatic Carcinoma
1

Enzastaurin Case Reports

What Enzastaurin 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 Enzastaurin. 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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