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EVEROLIMUS

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Everolimus Adverse Events Reported to the FDA Over Time

How are Everolimus adverse event reports trending over time?

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

Most Common Everolimus Adverse Events Reported to the FDA

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

Pyrexia
186 (2.73%)
Dyspnoea
106 (1.56%)
Diarrhoea
98 (1.44%)
Anaemia
94 (1.38%)
Blood Creatinine Increased
76 (1.12%)
Neoplasm Malignant
75 (1.1%)
Pleural Effusion
65 (.95%)
Renal Failure
65 (.95%)
Concomitant Disease Progression
62 (.91%)
Abdominal Pain
61 (.9%)
Vomiting
61 (.9%)
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Cough
60 (.88%)
Fatigue
59 (.87%)
Dehydration
54 (.79%)
Pneumonia
52 (.76%)
Thrombocytopenia
51 (.75%)
Neoplasm Progression
50 (.73%)
Renal Failure Acute
50 (.73%)
Oedema Peripheral
49 (.72%)
Death
48 (.7%)
Interstitial Lung Disease
48 (.7%)
Transplant Rejection
47 (.69%)
Sepsis
46 (.68%)
Neutropenia
45 (.66%)
Asthenia
44 (.65%)
Febrile Neutropenia
44 (.65%)
Nausea
42 (.62%)
Disease Progression
41 (.6%)
Infection
41 (.6%)
Respiratory Failure
41 (.6%)
Ascites
38 (.56%)
Haemoglobin Decreased
38 (.56%)
General Physical Health Deteriorati...
37 (.54%)
Renal Impairment
37 (.54%)
Urinary Tract Infection
35 (.51%)
Lung Disorder
34 (.5%)
C-reactive Protein Increased
33 (.48%)
Gastrointestinal Haemorrhage
33 (.48%)
Lung Infiltration
33 (.48%)
Pneumonitis
33 (.48%)
Hypotension
32 (.47%)
Aspartate Aminotransferase Increase...
31 (.46%)
Cardiac Failure
31 (.46%)
Hyperglycaemia
31 (.46%)
Leukopenia
31 (.46%)
Alanine Aminotransferase Increased
30 (.44%)
Diabetes Mellitus
30 (.44%)
Septic Shock
30 (.44%)
Deep Vein Thrombosis
29 (.43%)
Proteinuria
29 (.43%)
Hypertension
28 (.41%)
Impaired Healing
28 (.41%)
Malaise
28 (.41%)
Confusional State
27 (.4%)
Headache
27 (.4%)
Stomatitis
27 (.4%)
Blood Alkaline Phosphatase Increase...
25 (.37%)
Drug Interaction
25 (.37%)
Pulmonary Embolism
25 (.37%)
Gamma-glutamyltransferase Increased
24 (.35%)
Liver Function Test Abnormal
24 (.35%)
Pulmonary Oedema
23 (.34%)
Tachycardia
23 (.34%)
Cholestasis
22 (.32%)
Decreased Appetite
22 (.32%)
Inflammation
22 (.32%)
Pericardial Effusion
22 (.32%)
Pneumocystis Jiroveci Pneumonia
22 (.32%)
Lung Infection
21 (.31%)
Rash
21 (.31%)
Drug Ineffective
20 (.29%)
Cholangitis
19 (.28%)
Cytomegalovirus Infection
19 (.28%)
Hepatic Failure
19 (.28%)
Kidney Transplant Rejection
19 (.28%)
Liver Transplant Rejection
19 (.28%)
Erysipelas
18 (.26%)
Hyponatraemia
18 (.26%)
Hypoxia
18 (.26%)
Blood Bilirubin Increased
17 (.25%)
Dizziness
17 (.25%)
Melaena
17 (.25%)
Chills
16 (.23%)
Complications Of Transplanted Liver
16 (.23%)
Hepatic Lesion
16 (.23%)
Hepatitis B
16 (.23%)
Lymphocele
16 (.23%)
Metastases To Lung
16 (.23%)
Pain
16 (.23%)
Pancytopenia
16 (.23%)
Skin Ulcer
16 (.23%)
Small Intestinal Obstruction
16 (.23%)
Bile Duct Stenosis
15 (.22%)
Blood Creatine Phosphokinase Increa...
15 (.22%)
Chest Pain
15 (.22%)
Dyspnoea Exertional
15 (.22%)
Hepatic Artery Stenosis
15 (.22%)
Hypophosphataemia
15 (.22%)
Nephropathy Toxic
15 (.22%)
Platelet Count Decreased
15 (.22%)
Pulmonary Fibrosis
15 (.22%)

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

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

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

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

Renal Transplant
169
Liver Transplant
137
Metastatic Renal Cell Carcinoma
111
Heart Transplant
73
Renal Cell Carcinoma
46
Renal Cancer Metastatic
39
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Colorectal Cancer
36
Breast Cancer
36
Hepatic Neoplasm Malignant
35
Transplant Rejection
32
Acute Myeloid Leukaemia
31
Immunosuppression
27
Breast Cancer Metastatic
24
Glioblastoma Multiforme
20
Product Used For Unknown Indication
19
Pancreatic Neuroendocrine Tumour
17
Renal Cancer
16
Lung Transplant
16
Prophylaxis Against Transplant Reje...
13
Thyroid Cancer
12
Neuroendocrine Tumour
11
Diffuse Large B-cell Lymphoma
11
Ovarian Epithelial Cancer
11
Pancreatic Carcinoma
10
Hepatic Neoplasm Malignant Recurren...
10
Immunosuppressant Drug Therapy
10
Neoplasm
9
Transplant
9
Renal Cell Carcinoma Stage Unspecif...
7
Organ Transplant
7
Prostate Cancer
7
Tuberous Sclerosis
7
Stem Cell Transplant
7
Glioblastoma
6
Pancreatic Carcinoma Metastatic
6
Non-small Cell Lung Cancer
6
Hepatic Neoplasm Malignant Non-rese...
6
Multiple Myeloma
6
Gastric Cancer
5
Neuroendocrine Carcinoma
5
Meningioma
5
Colon Cancer
5
Metastatic Malignant Melanoma
4
Bladder Cancer
4
Waldenstroms Macroglobulinaemia
4
Lymphangioleiomyomatosis
4
Carcinoid Tumour
4
Metastatic Gastric Cancer
4
Thymoma
4
Heart And Lung Transplant
3
Non-hodgkins Lymphoma
3

Drug Labels

LabelLabelerEffective
AfinitorNovartis Pharmaceuticals Corporation29-AUG-12
ZortressNovartis Pharmaceuticals Corporation15-FEB-13

Everolimus Case Reports

What Everolimus 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 Everolimus. 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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