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AFINITOR

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Afinitor Adverse Events Reported to the FDA Over Time

How are Afinitor adverse event reports trending over time?

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

Most Common Afinitor Adverse Events Reported to the FDA

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

Neoplasm Malignant
965 (2.72%)
Dyspnoea
816 (2.3%)
Death
759 (2.14%)
Pyrexia
718 (2.02%)
Fatigue
590 (1.66%)
Neoplasm Progression
581 (1.64%)
Diarrhoea
527 (1.48%)
Anaemia
501 (1.41%)
Cough
469 (1.32%)
Nausea
462 (1.3%)
Malignant Neoplasm Progression
413 (1.16%)
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Asthenia
402 (1.13%)
Vomiting
392 (1.1%)
Malaise
378 (1.06%)
Pneumonia
377 (1.06%)
Decreased Appetite
369 (1.04%)
Pleural Effusion
369 (1.04%)
Stomatitis
367 (1.03%)
C-reactive Protein Increased
351 (.99%)
Haemoglobin Decreased
330 (.93%)
Oedema Peripheral
325 (.92%)
Interstitial Lung Disease
318 (.9%)
Dehydration
277 (.78%)
Abdominal Pain
275 (.77%)
General Physical Health Deteriorati...
268 (.76%)
Pneumonitis
254 (.72%)
Platelet Count Decreased
234 (.66%)
Blood Creatinine Increased
225 (.63%)
Thrombocytopenia
219 (.62%)
Rash
213 (.6%)
Lung Disorder
206 (.58%)
Hyperglycaemia
201 (.57%)
Pain
187 (.53%)
Weight Decreased
186 (.52%)
Blood Glucose Increased
183 (.52%)
Renal Failure
172 (.48%)
Drug Ineffective
170 (.48%)
Lymphocyte Count Decreased
158 (.45%)
Febrile Neutropenia
157 (.44%)
Gamma-glutamyltransferase Increased
150 (.42%)
Convulsion
149 (.42%)
Hypotension
147 (.41%)
Mucosal Inflammation
147 (.41%)
Renal Failure Acute
146 (.41%)
Epistaxis
134 (.38%)
Back Pain
133 (.37%)
Metastases To Lung
133 (.37%)
Renal Impairment
132 (.37%)
Headache
131 (.37%)
Ascites
129 (.36%)
Sepsis
124 (.35%)
Blood Lactate Dehydrogenase Increas...
122 (.34%)
Pain In Extremity
122 (.34%)
Chest Pain
121 (.34%)
Dizziness
121 (.34%)
Urinary Tract Infection
120 (.34%)
Pulmonary Embolism
118 (.33%)
Fall
117 (.33%)
Blood Alkaline Phosphatase Increase...
116 (.33%)
Oral Pain
115 (.32%)
Hypophagia
113 (.32%)
Mouth Ulceration
112 (.32%)
Lung Infiltration
111 (.31%)
Chills
109 (.31%)
Confusional State
108 (.3%)
White Blood Cell Count Decreased
107 (.3%)
Aspartate Aminotransferase Increase...
105 (.3%)
Dysphagia
102 (.29%)
Somnolence
101 (.28%)
Hypoxia
100 (.28%)
Metastases To Bone
99 (.28%)
Oedema
99 (.28%)
Gastrointestinal Haemorrhage
97 (.27%)
Metastases To Liver
97 (.27%)
Abdominal Pain Upper
95 (.27%)
Respiratory Failure
95 (.27%)
Blood Urea Increased
93 (.26%)
Diabetes Mellitus
93 (.26%)
Infection
93 (.26%)
Neutropenia
92 (.26%)
Deep Vein Thrombosis
86 (.24%)
Arthralgia
84 (.24%)
Abdominal Distension
83 (.23%)
Neutrophil Count Decreased
83 (.23%)
Constipation
79 (.22%)
Pericardial Effusion
79 (.22%)
Cardiac Failure
78 (.22%)
Inflammation
76 (.21%)
Respiratory Distress
76 (.21%)
Hypertension
75 (.21%)
Tachycardia
75 (.21%)
Alanine Aminotransferase Increased
73 (.21%)
Disease Progression
73 (.21%)
Hyponatraemia
73 (.21%)
Atelectasis
72 (.2%)
Hypokalaemia
71 (.2%)
Pulmonary Oedema
71 (.2%)
Concomitant Disease Progression
70 (.2%)
Metastases To Central Nervous Syste...
70 (.2%)
Lethargy
68 (.19%)
Multi-organ Failure
67 (.19%)

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

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

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

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

Metastatic Renal Cell Carcinoma
1442
Renal Cell Carcinoma
997
Renal Cancer
308
Tuberous Sclerosis
230
Neuroendocrine Tumour
214
Pancreatic Neuroendocrine Tumour
195
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Breast Cancer Metastatic
168
Carcinoid Tumour
130
Renal Cancer Metastatic
123
Astrocytoma
98
Malignant Urinary Tract Neoplasm
82
Breast Cancer
76
Neoplasm Malignant
66
Astrocytoma, Low Grade
65
Acute Myeloid Leukaemia
64
Metastatic Gastric Cancer
57
Malignant Neoplasm Of Islets Of Lan...
50
Metastatic Malignant Melanoma
45
Neoplasm
44
Glioblastoma Multiforme
38
Gastric Cancer
38
Colorectal Cancer Metastatic
36
Neuroendocrine Carcinoma
34
Glioblastoma
29
Thyroid Cancer
29
Hepatic Neoplasm Malignant
26
Colorectal Cancer
25
Prostate Cancer
25
Head And Neck Cancer
25
Pancreatic Neuroendocrine Tumour Me...
24
Pancreatic Carcinoma
23
Sarcoma
22
Carcinoid Syndrome
21
Endometrial Cancer Metastatic
20
T-cell Lymphoma
20
Metastatic Carcinoid Tumour
19
Non-small Cell Lung Cancer
18
Mantle Cell Lymphoma Refractory
16
Hodgkins Disease
16
Diffuse Large B-cell Lymphoma
15
Metastatic Neoplasm
13
Renal Neoplasm
12
Metastases To Liver
11
Lymphangioleiomyomatosis
11
Neuroendocrine Carcinoma Metastatic
10
Small Intestine Carcinoma
9
Transitional Cell Carcinoma
9
Renal Cell Carcinoma Stage Iv
9
Phaeochromocytoma
9
Hepatic Cancer Metastatic
9
Non-hodgkins Lymphoma
8

Drug Labels

LabelLabelerEffective
AfinitorNovartis Pharmaceuticals Corporation29-AUG-12

Afinitor Case Reports

What Afinitor 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 Afinitor. 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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