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SORAFENIB

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Sorafenib Adverse Events Reported to the FDA Over Time

How are Sorafenib adverse event reports trending over time?

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

Most Common Sorafenib Adverse Events Reported to the FDA

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

Palmar-plantar Erythrodysaesthesia ...
4192 (3.73%)
Diarrhoea
4000 (3.56%)
Rash
2408 (2.14%)
Hepatic Function Abnormal
2286 (2.03%)
Hypertension
2145 (1.91%)
Fatigue
2011 (1.79%)
Pyrexia
1755 (1.56%)
Nausea
1637 (1.46%)
Decreased Appetite
1503 (1.34%)
Alopecia
1481 (1.32%)
Hepatic Neoplasm Malignant
1303 (1.16%)
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Vomiting
1170 (1.04%)
Abdominal Pain
1154 (1.03%)
Pain In Extremity
1116 (.99%)
Dyspnoea
1098 (.98%)
Ascites
1097 (.98%)
Platelet Count Decreased
1023 (.91%)
Hepatic Encephalopathy
1021 (.91%)
Asthenia
992 (.88%)
Malaise
937 (.83%)
Death
896 (.8%)
Hepatic Failure
826 (.73%)
Blister
807 (.72%)
Blood Pressure Increased
795 (.71%)
Stomatitis
792 (.7%)
Erythema
790 (.7%)
Weight Decreased
787 (.7%)
Dehydration
769 (.68%)
Constipation
748 (.67%)
Dysphonia
720 (.64%)
Oedema Peripheral
695 (.62%)
Anaemia
661 (.59%)
Pruritus
656 (.58%)
General Physical Health Deteriorati...
586 (.52%)
Confusional State
564 (.5%)
Pleural Effusion
554 (.49%)
Blood Amylase Increased
547 (.49%)
Aspartate Aminotransferase Increase...
543 (.48%)
Pneumonia
535 (.48%)
Lipase Increased
517 (.46%)
Anorexia
489 (.43%)
Renal Failure
489 (.43%)
Jaundice
488 (.43%)
Abdominal Pain Upper
483 (.43%)
Liver Disorder
468 (.42%)
Dizziness
455 (.4%)
Headache
452 (.4%)
Pain
451 (.4%)
Skin Exfoliation
450 (.4%)
Alanine Aminotransferase Increased
448 (.4%)
Blood Bilirubin Increased
441 (.39%)
Gastrointestinal Haemorrhage
440 (.39%)
Renal Cell Carcinoma
433 (.39%)
Thrombocytopenia
433 (.39%)
Arthralgia
429 (.38%)
Dry Skin
419 (.37%)
Haemoglobin Decreased
416 (.37%)
Sepsis
407 (.36%)
Pulmonary Embolism
400 (.36%)
C-reactive Protein Increased
389 (.35%)
Hypophosphataemia
374 (.33%)
Rash Generalised
373 (.33%)
Chest Pain
371 (.33%)
White Blood Cell Count Decreased
368 (.33%)
Epistaxis
347 (.31%)
Atrial Fibrillation
346 (.31%)
Cough
346 (.31%)
Hypotension
346 (.31%)
Hyponatraemia
321 (.29%)
Back Pain
310 (.28%)
Malignant Neoplasm Progression
304 (.27%)
Interstitial Lung Disease
297 (.26%)
Gait Disturbance
296 (.26%)
Deep Vein Thrombosis
286 (.25%)
Gastric Ulcer
286 (.25%)
Disease Progression
278 (.25%)
Renal Failure Acute
277 (.25%)
Respiratory Failure
268 (.24%)
Abasia
263 (.23%)
Muscle Spasms
260 (.23%)
Cerebral Infarction
255 (.23%)
Glossodynia
255 (.23%)
Paraesthesia
253 (.23%)
Convulsion
252 (.22%)
Blood Alkaline Phosphatase Increase...
251 (.22%)
Hypothyroidism
251 (.22%)
Erythema Multiforme
250 (.22%)
Hypoglycaemia
249 (.22%)
Renal Impairment
247 (.22%)
Myocardial Infarction
245 (.22%)
Blood Creatinine Increased
241 (.21%)
Hyperkeratosis
239 (.21%)
Hypokalaemia
233 (.21%)
Insomnia
227 (.2%)
Skin Ulcer
227 (.2%)
Melaena
226 (.2%)
Oral Pain
226 (.2%)
Encephalopathy
225 (.2%)
Cerebrovascular Accident
223 (.2%)
Hyperkalaemia
223 (.2%)
Fall
221 (.2%)

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

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

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

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

Hepatic Neoplasm Malignant
6821
Renal Cell Carcinoma
2364
Renal Cell Carcinoma Stage Unspecif...
1347
Metastatic Renal Cell Carcinoma
1258
Renal Cell Carcinoma Stage Iv
923
Drug Use For Unknown Indication
747
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Non-small Cell Lung Cancer
571
Thyroid Cancer
274
Metastatic Malignant Melanoma
245
Renal Cancer
216
Malignant Melanoma
179
Hepatic Neoplasm Malignant Non-rese...
140
Product Used For Unknown Indication
127
Pancreatic Carcinoma
123
Breast Cancer Metastatic
122
Thyroid Cancer Metastatic
103
Acute Myeloid Leukaemia
103
Neoplasm Malignant
96
Renal Cancer Metastatic
94
Prostate Cancer
92
Metastases To Lung
80
Hepatic Cancer Metastatic
76
Lung Neoplasm Malignant
74
Gastrointestinal Stromal Tumour
63
Breast Cancer
61
Bile Duct Cancer
58
Neoplasm
52
Sarcoma
49
Colorectal Cancer Metastatic
43
Gastric Cancer
41
Hepatic Neoplasm Malignant Recurren...
38
Non-small Cell Lung Cancer Stage Iv
32
Hepatic Cancer Stage Iv
31
Angiosarcoma
29
Unevaluable Event
28
Ovarian Cancer
27
Pancreatic Carcinoma Metastatic
24
Non-small Cell Lung Cancer Metastat...
24
Renal Cell Carcinoma Stage Iii
24
Prostate Cancer Metastatic
22
Metastases To Liver
22
Metastatic Neoplasm
21
Metastases To Central Nervous Syste...
21
Mesothelioma
20
Glioblastoma Multiforme
19
Hepatic Neoplasm Malignant Resectab...
18
Renal Neoplasm
18
Adenocarcinoma Pancreas
18
Hepatic Neoplasm
17
Neuroendocrine Carcinoma
17
Oesophageal Carcinoma
17

Drug Labels

LabelLabelerEffective
NexavarBayer HealthCare Pharmaceuticals Inc.11-DEC-12

Sorafenib Case Reports

What Sorafenib 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 Sorafenib. 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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