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SUNITINIB

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Sunitinib Adverse Events Reported to the FDA Over Time

How are Sunitinib adverse event reports trending over time?

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

Most Common Sunitinib Adverse Events Reported to the FDA

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

Death
3087 (3.86%)
Disease Progression
1985 (2.48%)
Diarrhoea
1626 (2.03%)
Fatigue
1409 (1.76%)
Nausea
1369 (1.71%)
Vomiting
1237 (1.55%)
Platelet Count Decreased
1118 (1.4%)
Hypertension
1076 (1.35%)
Asthenia
1007 (1.26%)
Thrombocytopenia
938 (1.17%)
Dehydration
912 (1.14%)
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Dyspnoea
906 (1.13%)
Pyrexia
781 (.98%)
Decreased Appetite
727 (.91%)
Anaemia
709 (.89%)
Palmar-plantar Erythrodysaesthesia ...
692 (.87%)
Pleural Effusion
640 (.8%)
Pneumonia
613 (.77%)
Renal Cell Carcinoma
598 (.75%)
Malaise
539 (.67%)
White Blood Cell Count Decreased
512 (.64%)
Confusional State
504 (.63%)
Weight Decreased
501 (.63%)
Renal Failure
499 (.62%)
Abdominal Pain
486 (.61%)
Stomatitis
486 (.61%)
Dysgeusia
478 (.6%)
General Physical Health Deteriorati...
443 (.55%)
Blood Pressure Increased
437 (.55%)
Hypothyroidism
435 (.54%)
Pain
435 (.54%)
Renal Failure Acute
434 (.54%)
Constipation
400 (.5%)
Haemoglobin Decreased
394 (.49%)
Rash
384 (.48%)
Hypotension
378 (.47%)
Headache
372 (.47%)
Neutropenia
354 (.44%)
Oedema Peripheral
344 (.43%)
Blood Creatinine Increased
341 (.43%)
Pain In Extremity
340 (.43%)
Oral Pain
336 (.42%)
Drug Toxicity
335 (.42%)
Hyponatraemia
332 (.42%)
Sepsis
332 (.42%)
Ascites
331 (.41%)
Metastatic Renal Cell Carcinoma
322 (.4%)
Myocardial Infarction
321 (.4%)
Epistaxis
317 (.4%)
Mucosal Inflammation
310 (.39%)
Dizziness
306 (.38%)
Convulsion
296 (.37%)
Pulmonary Embolism
294 (.37%)
Neoplasm Malignant
279 (.35%)
Chest Pain
272 (.34%)
Yellow Skin
272 (.34%)
Gastrointestinal Haemorrhage
266 (.33%)
Jaundice
266 (.33%)
Syncope
266 (.33%)
Urinary Tract Infection
259 (.32%)
Cardiac Failure
255 (.32%)
Skin Exfoliation
247 (.31%)
Haemorrhage
243 (.3%)
Loss Of Consciousness
243 (.3%)
Anorexia
240 (.3%)
Disseminated Intravascular Coagulat...
235 (.29%)
Leukopenia
235 (.29%)
Gastrointestinal Stromal Tumour
232 (.29%)
Cough
229 (.29%)
Pancytopenia
229 (.29%)
Respiratory Failure
227 (.28%)
Cerebrovascular Accident
226 (.28%)
Aspartate Aminotransferase Increase...
225 (.28%)
Dyspepsia
223 (.28%)
Fall
222 (.28%)
Renal Cancer
220 (.28%)
Renal Impairment
214 (.27%)
Hepatic Failure
206 (.26%)
Abdominal Pain Upper
200 (.25%)
Hepatic Function Abnormal
199 (.25%)
Alanine Aminotransferase Increased
195 (.24%)
Haematuria
191 (.24%)
Muscular Weakness
190 (.24%)
Malignant Neoplasm Progression
188 (.24%)
Ageusia
187 (.23%)
Multi-organ Failure
186 (.23%)
Blister
185 (.23%)
Cerebral Haemorrhage
183 (.23%)
Mental Status Changes
183 (.23%)
Infection
178 (.22%)
Back Pain
176 (.22%)
Interstitial Lung Disease
176 (.22%)
Gait Disturbance
172 (.22%)
Mouth Ulceration
172 (.22%)
Arthralgia
169 (.21%)
Haematemesis
167 (.21%)
Lethargy
167 (.21%)
Somnolence
163 (.2%)
Cardiac Failure Congestive
162 (.2%)
Skin Discolouration
158 (.2%)
Pruritus
157 (.2%)

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

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

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

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

Renal Cell Carcinoma
4993
Metastatic Renal Cell Carcinoma
4939
Gastrointestinal Stromal Tumour
1716
Renal Cancer
1517
Renal Cell Carcinoma Stage Unspecif...
1213
Renal Cancer Metastatic
715
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Prostate Cancer
652
Breast Cancer
380
Non-small Cell Lung Cancer
359
Hepatic Neoplasm Malignant
297
Colorectal Cancer
246
Neoplasm Malignant
178
Thyroid Cancer
144
Breast Cancer Metastatic
125
Transitional Cell Carcinoma
121
Lung Neoplasm Malignant
109
Colorectal Cancer Metastatic
98
Pancreatic Neuroendocrine Tumour
98
Metastases To Lung
89
Drug Use For Unknown Indication
83
Pancreatic Carcinoma
69
Malignant Melanoma
58
Metastatic Gastric Cancer
58
Bladder Cancer
55
Neuroendocrine Tumour
49
Gastric Cancer
48
Renal Cancer Stage Iv
47
Neoplasm
44
Metastatic Malignant Melanoma
43
Renal Neoplasm
38
Oesophageal Carcinoma
38
Neuroendocrine Carcinoma
38
Prostate Cancer Metastatic
36
Angiosarcoma
36
Thyroid Cancer Metastatic
35
Malignant Neoplasm Of Islets Of Lan...
35
Metastases To Central Nervous Syste...
34
Renal Cell Carcinoma Stage Iv
33
Metastasis
31
Glioblastoma
30
Ovarian Cancer
29
Bladder Transitional Cell Carcinoma
29
Metastatic Neoplasm
28
Hepatic Neoplasm Malignant Recurren...
28
Malignant Urinary Tract Neoplasm
26
Metastases To Bone
26
Bone Neoplasm Malignant
24
Sarcoma
24
Carcinoid Tumour
22
Breast Cancer Recurrent
21
Colon Cancer
21

Drug Labels

LabelLabelerEffective
SutentPfizer Laboratories Div Pfizer Inc30-NOV-12

Sunitinib Case Reports

What Sunitinib 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 Sunitinib. 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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