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BASILIXIMAB

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Basiliximab Adverse Events Reported to the FDA Over Time

How are Basiliximab adverse event reports trending over time?

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

Most Common Basiliximab Adverse Events Reported to the FDA

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

Pyrexia
89 (2.44%)
Kidney Transplant Rejection
75 (2.06%)
Blood Creatinine Increased
61 (1.68%)
Multi-organ Failure
61 (1.68%)
Cytomegalovirus Infection
60 (1.65%)
Transplant Rejection
52 (1.43%)
Renal Impairment
40 (1.1%)
Sepsis
40 (1.1%)
Diarrhoea
39 (1.07%)
Renal Failure
37 (1.02%)
Haematuria
36 (.99%)
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Complications Of Transplanted Kidne...
34 (.93%)
Proteinuria
33 (.91%)
Pleural Effusion
25 (.69%)
Renal Failure Acute
25 (.69%)
Leukopenia
24 (.66%)
Anaemia
23 (.63%)
Lymphocytic Infiltration
23 (.63%)
Nephropathy Toxic
23 (.63%)
Respiratory Failure
23 (.63%)
Graft Loss
22 (.6%)
Pneumonia
21 (.58%)
Dysuria
20 (.55%)
C-reactive Protein Increased
18 (.49%)
Death
18 (.49%)
Hepatic Failure
18 (.49%)
Renal Tubular Necrosis
18 (.49%)
Thrombocytopenia
18 (.49%)
Adenoviral Haemorrhagic Cystitis
17 (.47%)
Graft Versus Host Disease
17 (.47%)
Haemodialysis
17 (.47%)
Haemorrhage
17 (.47%)
Polyomavirus-associated Nephropathy
17 (.47%)
Residual Urine
17 (.47%)
Ascites
16 (.44%)
Chronic Allograft Nephropathy
16 (.44%)
Urinary Tract Infection
16 (.44%)
Anuria
15 (.41%)
Bronchopulmonary Aspergillosis
14 (.38%)
Cytomegalovirus Viraemia
14 (.38%)
Oliguria
14 (.38%)
Pain
14 (.38%)
Nausea
13 (.36%)
Renal Tubular Disorder
13 (.36%)
Aspergillosis
12 (.33%)
Bone Marrow Failure
12 (.33%)
Bone Marrow Oedema
12 (.33%)
Epstein-barr Virus Associated Lymph...
12 (.33%)
Hypotension
12 (.33%)
Kidney Fibrosis
12 (.33%)
Lung Infiltration
12 (.33%)
Myocardial Infarction
12 (.33%)
Peritonitis
12 (.33%)
Pseudomonas Infection
12 (.33%)
Abdominal Pain
11 (.3%)
Aspartate Aminotransferase Increase...
11 (.3%)
Bk Virus Infection
11 (.3%)
Blood Lactate Dehydrogenase Increas...
11 (.3%)
Enterococcal Infection
11 (.3%)
Foot Fracture
11 (.3%)
Infection
11 (.3%)
Liver Function Test Abnormal
11 (.3%)
Staphylococcal Infection
11 (.3%)
Tubulointerstitial Nephritis
11 (.3%)
Acute Respiratory Distress Syndrome
10 (.27%)
Alanine Aminotransferase Increased
10 (.27%)
Complications Of Transplanted Liver
10 (.27%)
Diabetes Mellitus
10 (.27%)
Hepatic Enzyme Increased
10 (.27%)
Lymphadenopathy
10 (.27%)
Pancytopenia
10 (.27%)
Rash
10 (.27%)
Renal Tubular Atrophy
10 (.27%)
Wound Infection
10 (.27%)
Brain Oedema
9 (.25%)
Convulsion
9 (.25%)
Drug Ineffective
9 (.25%)
Dyspnoea
9 (.25%)
Gastrointestinal Haemorrhage
9 (.25%)
Glomerulonephritis
9 (.25%)
Graft Dysfunction
9 (.25%)
Herpes Zoster
9 (.25%)
Human Herpesvirus 6 Infection
9 (.25%)
Hydronephrosis
9 (.25%)
Hypoxia
9 (.25%)
Intestinal Perforation
9 (.25%)
Thrombotic Microangiopathy
9 (.25%)
Urine Output Decreased
9 (.25%)
Vomiting
9 (.25%)
Cardiac Failure
8 (.22%)
Debridement
8 (.22%)
Dehydration
8 (.22%)
Fatigue
8 (.22%)
Grand Mal Convulsion
8 (.22%)
Human Herpesvirus 8 Infection
8 (.22%)
Mechanical Ventilation
8 (.22%)
Myalgia
8 (.22%)
Nephrectomy
8 (.22%)
Off Label Use
8 (.22%)
Pneumocystis Jiroveci Pneumonia
8 (.22%)
Post Procedural Complication
8 (.22%)

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

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

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

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

Renal Transplant
238
Liver Transplant
92
Immunosuppression
76
Prophylaxis Against Transplant Reje...
52
Immunosuppressant Drug Therapy
35
Lung Transplant
18
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Heart Transplant
13
Product Used For Unknown Indication
11
Renal And Pancreas Transplant
11
Transplant
11
Drug Use For Unknown Indication
9
Graft Versus Host Disease
9
Intestinal Transplant
7
Stem Cell Transplant
7
Renal And Liver Transplant
6
Small Intestine Transplant
6
Liver And Small Intestine Transplan...
6
Prophylaxis Against Graft Versus Ho...
5
Prophylaxis
5
Pancreas Transplant
4
Acute Graft Versus Host Disease
3
Organ Transplant
3
Transplant Rejection
2
Nephrectomy
1
Crohns Disease
1
Ill-defined Disorder
1
Heart And Lung Transplant
1
Thrombotic Microangiopathy
1

Drug Labels

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SimulectNovartis Pharmaceuticals Corporation05-OCT-09

Basiliximab Case Reports

What Basiliximab 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 Basiliximab. 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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