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AFLIBERCEPT

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Aflibercept Adverse Events Reported to the FDA Over Time

How are Aflibercept adverse event reports trending over time?

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

Most Common Aflibercept Adverse Events Reported to the FDA

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

Proteinuria
42 (5.8%)
Death
29 (4.01%)
Dyspnoea
19 (2.62%)
Leukopenia
18 (2.49%)
Intestinal Perforation
16 (2.21%)
Fatigue
15 (2.07%)
Adrenal Insufficiency
13 (1.8%)
Vomiting
13 (1.8%)
Neutrophil Count
12 (1.66%)
Febrile Neutropenia
11 (1.52%)
Hyperkalaemia
11 (1.52%)
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Pneumonia Necrotising
11 (1.52%)
Pneumothorax
11 (1.52%)
Neutropenia
10 (1.38%)
Femur Fracture
9 (1.24%)
Hyperthyroidism
9 (1.24%)
Pleural Effusion
9 (1.24%)
Sudden Death
9 (1.24%)
Hyponatraemia
8 (1.1%)
Hypotension
8 (1.1%)
Impaired Healing
8 (1.1%)
Pain
8 (1.1%)
Supraventricular Tachycardia
8 (1.1%)
Urinary Tract Infection
8 (1.1%)
Dehydration
7 (.97%)
Malaise
7 (.97%)
Pyrexia
7 (.97%)
Syncope
7 (.97%)
Bradycardia
6 (.83%)
Corneal Erosion
6 (.83%)
Diarrhoea
6 (.83%)
Large Intestine Perforation
6 (.83%)
Ventricular Arrhythmia
6 (.83%)
Ventricular Extrasystoles
6 (.83%)
Anal Fistula
5 (.69%)
Chest Pain
5 (.69%)
Cholecystitis Acute
5 (.69%)
Confusional State
5 (.69%)
Folliculitis
5 (.69%)
Hypocalcaemia
5 (.69%)
Peritonitis
5 (.69%)
Pneumonia
5 (.69%)
Pulmonary Embolism
5 (.69%)
Reversible Posterior Leukoencephalo...
5 (.69%)
Sinus Tachycardia
5 (.69%)
Urethral Stenosis
5 (.69%)
Vitreous Haemorrhage
5 (.69%)
Acute Respiratory Failure
4 (.55%)
Cardio-respiratory Arrest
4 (.55%)
Dermatitis Bullous
4 (.55%)
Disease Progression
4 (.55%)
Neutropenic Infection
4 (.55%)
Neutropenic Sepsis
4 (.55%)
Osteonecrosis
4 (.55%)
Pigmentary Glaucoma
4 (.55%)
Radiculopathy
4 (.55%)
Sinoatrial Block
4 (.55%)
Urinary Retention
4 (.55%)
Abdominal Distension
3 (.41%)
Anaemia
3 (.41%)
Asthenia
3 (.41%)
Convulsion
3 (.41%)
Decreased Appetite
3 (.41%)
Enterovesical Fistula
3 (.41%)
Gastric Ulcer
3 (.41%)
General Physical Health Deteriorati...
3 (.41%)
Haemangioma
3 (.41%)
Haemoglobin Decreased
3 (.41%)
Hypertension
3 (.41%)
Hypertensive Crisis
3 (.41%)
Interstitial Lung Disease
3 (.41%)
Macular Degeneration
3 (.41%)
Nausea
3 (.41%)
Peripheral Ischaemia
3 (.41%)
Pyoderma Gangrenosum
3 (.41%)
Rectal Ulcer
3 (.41%)
Sepsis
3 (.41%)
Septic Shock
3 (.41%)
Thrombosis
3 (.41%)
Abdominal Pain
2 (.28%)
Acute Myocardial Infarction
2 (.28%)
Anal Fissure
2 (.28%)
Anastomotic Leak
2 (.28%)
Atrial Fibrillation
2 (.28%)
Autoimmune Thrombocytopenia
2 (.28%)
Bladder Spasm
2 (.28%)
Cardiac Failure Congestive
2 (.28%)
Cerebral Infarction
2 (.28%)
Cerebrovascular Accident
2 (.28%)
Coagulopathy
2 (.28%)
Coccydynia
2 (.28%)
Contusion
2 (.28%)
Deep Vein Thrombosis
2 (.28%)
Disorientation
2 (.28%)
Diverticular Perforation
2 (.28%)
Drug Ineffective
2 (.28%)
Dysuria
2 (.28%)
Electrocardiogram Abnormal
2 (.28%)
Enterocolitis Haemorrhagic
2 (.28%)
Epistaxis
2 (.28%)
Face Injury
2 (.28%)

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

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

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

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

Non-small Cell Lung Cancer
29
Prostate Cancer Metastatic
29
Non-small Cell Lung Cancer Metastat...
18
Diabetic Retinal Oedema
6
Pseudomyxoma Peritonei
6
Age-related Macular Degeneration
3
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Macular Degeneration
3
Lung Neoplasm Malignant
2
Metastatic Gastric Cancer
2
Lung Adenocarcinoma
2
Pancreatic Carcinoma Stage Iv
1
Choroidal Neovascularisation
1
Ovarian Epithelial Cancer
1
Colon Cancer
1
Glioblastoma
1
Thymic Cancer Metastatic
1
Colorectal Cancer Metastatic
1
Thymoma Malignant
1

Drug Labels

LabelLabelerEffective
EyleaRegeneron Pharmaceuticals, Inc.28-FEB-13
Zaltrapsanofi-aventis U.S. LLC19-APR-13

Aflibercept Case Reports

What Aflibercept 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 Aflibercept. 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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