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SUNITINIB MALATE

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Sunitinib Malate Adverse Events Reported to the FDA Over Time

How are Sunitinib Malate adverse event reports trending over time?

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

Most Common Sunitinib Malate Adverse Events Reported to the FDA

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

Death
3076 (3.94%)
Disease Progression
1950 (2.5%)
Diarrhoea
1571 (2.01%)
Fatigue
1368 (1.75%)
Nausea
1325 (1.7%)
Vomiting
1196 (1.53%)
Platelet Count Decreased
1104 (1.41%)
Hypertension
1058 (1.36%)
Asthenia
987 (1.26%)
Thrombocytopenia
920 (1.18%)
Dehydration
874 (1.12%)
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Dyspnoea
870 (1.11%)
Pyrexia
762 (.98%)
Decreased Appetite
712 (.91%)
Anaemia
683 (.88%)
Palmar-plantar Erythrodysaesthesia ...
683 (.88%)
Pleural Effusion
626 (.8%)
Pneumonia
600 (.77%)
Renal Cell Carcinoma
596 (.76%)
Malaise
524 (.67%)
White Blood Cell Count Decreased
505 (.65%)
Renal Failure
496 (.64%)
Weight Decreased
487 (.62%)
Stomatitis
484 (.62%)
Confusional State
477 (.61%)
Dysgeusia
475 (.61%)
Abdominal Pain
467 (.6%)
Blood Pressure Increased
435 (.56%)
Hypothyroidism
433 (.55%)
General Physical Health Deteriorati...
428 (.55%)
Pain
422 (.54%)
Renal Failure Acute
420 (.54%)
Constipation
378 (.48%)
Haemoglobin Decreased
373 (.48%)
Rash
370 (.47%)
Headache
366 (.47%)
Hypotension
360 (.46%)
Pain In Extremity
340 (.44%)
Oedema Peripheral
335 (.43%)
Oral Pain
335 (.43%)
Neutropenia
332 (.43%)
Drug Toxicity
331 (.42%)
Blood Creatinine Increased
326 (.42%)
Sepsis
324 (.42%)
Ascites
323 (.41%)
Metastatic Renal Cell Carcinoma
321 (.41%)
Myocardial Infarction
321 (.41%)
Epistaxis
314 (.4%)
Hyponatraemia
311 (.4%)
Mucosal Inflammation
300 (.38%)
Convulsion
290 (.37%)
Dizziness
289 (.37%)
Neoplasm Malignant
277 (.35%)
Chest Pain
272 (.35%)
Yellow Skin
272 (.35%)
Pulmonary Embolism
269 (.34%)
Jaundice
266 (.34%)
Gastrointestinal Haemorrhage
262 (.34%)
Syncope
258 (.33%)
Urinary Tract Infection
256 (.33%)
Cardiac Failure
247 (.32%)
Skin Exfoliation
246 (.32%)
Haemorrhage
239 (.31%)
Loss Of Consciousness
238 (.3%)
Disseminated Intravascular Coagulat...
235 (.3%)
Anorexia
232 (.3%)
Gastrointestinal Stromal Tumour
231 (.3%)
Leukopenia
229 (.29%)
Cerebrovascular Accident
224 (.29%)
Cough
223 (.29%)
Pancytopenia
223 (.29%)
Dyspepsia
222 (.28%)
Respiratory Failure
220 (.28%)
Renal Cancer
218 (.28%)
Fall
217 (.28%)
Aspartate Aminotransferase Increase...
215 (.28%)
Renal Impairment
211 (.27%)
Hepatic Failure
199 (.26%)
Abdominal Pain Upper
198 (.25%)
Hepatic Function Abnormal
198 (.25%)
Alanine Aminotransferase Increased
190 (.24%)
Muscular Weakness
188 (.24%)
Ageusia
187 (.24%)
Blister
185 (.24%)
Haematuria
182 (.23%)
Multi-organ Failure
182 (.23%)
Cerebral Haemorrhage
180 (.23%)
Back Pain
176 (.23%)
Interstitial Lung Disease
176 (.23%)
Infection
174 (.22%)
Mental Status Changes
172 (.22%)
Gait Disturbance
169 (.22%)
Haematemesis
166 (.21%)
Malignant Neoplasm Progression
166 (.21%)
Arthralgia
165 (.21%)
Mouth Ulceration
165 (.21%)
Lethargy
162 (.21%)
Cardiac Failure Congestive
160 (.21%)
Pruritus
157 (.2%)
Skin Discolouration
157 (.2%)
Somnolence
156 (.2%)

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

What are the most common Sunitinib Malate 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 Malate, 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 Malate 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 Malate According to Those Reporting Adverse Events

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

Renal Cell Carcinoma
4928
Metastatic Renal Cell Carcinoma
4915
Gastrointestinal Stromal Tumour
1699
Renal Cancer
1510
Renal Cell Carcinoma Stage Unspecif...
1201
Renal Cancer Metastatic
682
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Prostate Cancer
637
Breast Cancer
362
Hepatic Neoplasm Malignant
296
Non-small Cell Lung Cancer
294
Colorectal Cancer
218
Neoplasm Malignant
165
Thyroid Cancer
144
Breast Cancer Metastatic
124
Transitional Cell Carcinoma
117
Lung Neoplasm Malignant
105
Pancreatic Neuroendocrine Tumour
98
Metastases To Lung
88
Colorectal Cancer Metastatic
87
Drug Use For Unknown Indication
73
Pancreatic Carcinoma
69
Metastatic Gastric Cancer
58
Malignant Melanoma
54
Bladder Cancer
49
Neuroendocrine Tumour
49
Renal Cancer Stage Iv
47
Gastric Cancer
45
Neoplasm
44
Metastatic Malignant Melanoma
39
Renal Neoplasm
38
Oesophageal Carcinoma
38
Neuroendocrine Carcinoma
38
Angiosarcoma
36
Prostate Cancer Metastatic
36
Thyroid Cancer Metastatic
35
Malignant Neoplasm Of Islets Of Lan...
35
Renal Cell Carcinoma Stage Iv
33
Metastases To Central Nervous Syste...
31
Metastasis
31
Ovarian Cancer
29
Hepatic Neoplasm Malignant Recurren...
28
Bladder Transitional Cell Carcinoma
27
Metastatic Neoplasm
26
Glioblastoma
26
Metastases To Bone
26
Malignant Urinary Tract Neoplasm
25
Bone Neoplasm Malignant
24
Sarcoma
24
Carcinoid Tumour
22
Breast Cancer Recurrent
21
Product Used For Unknown Indication
20

Drug Labels

LabelLabelerEffective
SutentPfizer Laboratories Div Pfizer Inc30-NOV-12

Sunitinib Malate Case Reports

What Sunitinib Malate 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 Malate. 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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