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Belatacept Adverse Events Reported to the FDA Over Time

How are Belatacept adverse event reports trending over time?

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

Most Common Belatacept Adverse Events Reported to the FDA

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

Urinary Tract Infection
44 (2.82%)
Sepsis
42 (2.69%)
Pyrexia
37 (2.37%)
Pneumonia
33 (2.11%)
Basal Cell Carcinoma
26 (1.67%)
Cardiac Arrest
23 (1.47%)
Graft Loss
21 (1.35%)
Hepatic Failure
21 (1.35%)
Renal Failure Acute
21 (1.35%)
Squamous Cell Carcinoma Of Skin
21 (1.35%)
Urosepsis
20 (1.28%)
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Epstein-barr Virus Associated Lymph...
18 (1.15%)
Diarrhoea
17 (1.09%)
Multi-organ Failure
17 (1.09%)
Anaemia
16 (1.02%)
Hypotension
16 (1.02%)
Kidney Transplant Rejection
15 (.96%)
Renal Failure
15 (.96%)
Respiratory Distress
15 (.96%)
Bronchopneumonia
14 (.9%)
Nausea
13 (.83%)
Abdominal Pain
12 (.77%)
Cellulitis
12 (.77%)
Pleural Effusion
12 (.77%)
Pulmonary Oedema
12 (.77%)
Deep Vein Thrombosis
11 (.7%)
Respiratory Failure
11 (.7%)
Cytomegalovirus Infection
10 (.64%)
Gastroenteritis
10 (.64%)
Graft Dysfunction
10 (.64%)
Hypoglycaemia
10 (.64%)
Myocardial Infarction
10 (.64%)
Vomiting
10 (.64%)
Weight Decreased
10 (.64%)
Complications Of Transplanted Liver
9 (.58%)
Localised Infection
9 (.58%)
Pulmonary Tuberculosis
9 (.58%)
Salivary Gland Mass
9 (.58%)
Septic Shock
9 (.58%)
Spinal Cord Compression
9 (.58%)
Chills
8 (.51%)
Headache
8 (.51%)
Transient Ischaemic Attack
8 (.51%)
Transplant Failure
8 (.51%)
Bacteraemia
7 (.45%)
Bronchopulmonary Aspergillosis
7 (.45%)
Candidiasis
7 (.45%)
Circulatory Collapse
7 (.45%)
Coagulopathy
7 (.45%)
Convulsion
7 (.45%)
Dehydration
7 (.45%)
Diabetic Foot
7 (.45%)
Escherichia Sepsis
7 (.45%)
Escherichia Urinary Tract Infection
7 (.45%)
Femur Fracture
7 (.45%)
Ileus
7 (.45%)
Non-small Cell Lung Cancer
7 (.45%)
Pancreatitis Acute
7 (.45%)
Pneumocystis Jiroveci Pneumonia
7 (.45%)
Pneumonia Aspiration
7 (.45%)
Radicular Syndrome
7 (.45%)
Respiratory Moniliasis
7 (.45%)
Vaginal Haemorrhage
7 (.45%)
Back Pain
6 (.38%)
Blood Creatinine Increased
6 (.38%)
Bradycardia
6 (.38%)
Cervical Myelopathy
6 (.38%)
Hepatitis C
6 (.38%)
Liver Abscess
6 (.38%)
Obstructive Uropathy
6 (.38%)
Platelet Count Decreased
6 (.38%)
Pneumothorax
6 (.38%)
Prostate Cancer
6 (.38%)
Pyelonephritis
6 (.38%)
Renal Cell Carcinoma
6 (.38%)
Skin Lesion
6 (.38%)
Squamous Cell Carcinoma
6 (.38%)
Transplant Rejection
6 (.38%)
Wound Infection
6 (.38%)
Acute Myocardial Infarction
5 (.32%)
Acute Respiratory Failure
5 (.32%)
Arrhythmia
5 (.32%)
Bronchial Carcinoma
5 (.32%)
Chronic Obstructive Pulmonary Disea...
5 (.32%)
Cryptococcosis
5 (.32%)
Death
5 (.32%)
Enterococcal Sepsis
5 (.32%)
Influenza
5 (.32%)
Metastases To Central Nervous Syste...
5 (.32%)
Metastases To Liver
5 (.32%)
Oedema Peripheral
5 (.32%)
Oesophageal Candidiasis
5 (.32%)
Oral Candidiasis
5 (.32%)
Pneumonitis
5 (.32%)
Tremor
5 (.32%)
Abdominal Adhesions
4 (.26%)
Anuria
4 (.26%)
Azotaemia
4 (.26%)
Bk Virus Infection
4 (.26%)
Cervical Vertebral Fracture
4 (.26%)
Chest Pain
4 (.26%)

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

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

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

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

Renal Transplant
275
Liver Transplant
35
Immunosuppression
29
Prophylaxis Against Transplant Reje...
11
Product Used For Unknown Indication
3
Immunosuppressant Drug Therapy
2
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Drug Labels

LabelLabelerEffective
NulojixE.R. Squibb & Sons, L.L.C.15-JUN-11
NulojixE.R. Squibb & Sons, L.L.C.08-APR-13

Belatacept Case Reports

What Belatacept 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 Belatacept. 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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