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NEXAVAR

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Nexavar Adverse Events Reported to the FDA Over Time

How are Nexavar adverse event reports trending over time?

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

Most Common Nexavar Adverse Events Reported to the FDA

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

Palmar-plantar Erythrodysaesthesia ...
3738 (4.75%)
Diarrhoea
3094 (3.93%)
Hepatic Function Abnormal
2122 (2.7%)
Rash
2005 (2.55%)
Hypertension
1847 (2.35%)
Fatigue
1389 (1.77%)
Pyrexia
1311 (1.67%)
Alopecia
1292 (1.64%)
Decreased Appetite
1251 (1.59%)
Nausea
1166 (1.48%)
Hepatic Neoplasm Malignant
1118 (1.42%)
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Pain In Extremity
935 (1.19%)
Platelet Count Decreased
893 (1.13%)
Malaise
828 (1.05%)
Hepatic Encephalopathy
763 (.97%)
Vomiting
752 (.96%)
Ascites
746 (.95%)
Blister
742 (.94%)
Erythema
698 (.89%)
Abdominal Pain
683 (.87%)
Stomatitis
675 (.86%)
Blood Pressure Increased
673 (.86%)
Asthenia
654 (.83%)
Death
650 (.83%)
Dysphonia
645 (.82%)
Weight Decreased
633 (.8%)
Dyspnoea
593 (.75%)
Pruritus
581 (.74%)
Hepatic Failure
566 (.72%)
Constipation
552 (.7%)
Blood Amylase Increased
501 (.64%)
Oedema Peripheral
486 (.62%)
Lipase Increased
452 (.57%)
Liver Disorder
443 (.56%)
Renal Cell Carcinoma
402 (.51%)
Jaundice
398 (.51%)
Skin Exfoliation
396 (.5%)
Anaemia
386 (.49%)
Aspartate Aminotransferase Increase...
384 (.49%)
Dry Skin
379 (.48%)
Abdominal Pain Upper
376 (.48%)
Pleural Effusion
360 (.46%)
Dehydration
354 (.45%)
Anorexia
350 (.44%)
Blood Bilirubin Increased
330 (.42%)
Arthralgia
329 (.42%)
Dizziness
328 (.42%)
Rash Generalised
327 (.42%)
Alanine Aminotransferase Increased
321 (.41%)
Headache
320 (.41%)
Confusional State
319 (.41%)
C-reactive Protein Increased
305 (.39%)
White Blood Cell Count Decreased
302 (.38%)
Pain
298 (.38%)
Epistaxis
283 (.36%)
Hypophosphataemia
281 (.36%)
Pneumonia
273 (.35%)
Cough
266 (.34%)
Gastrointestinal Haemorrhage
258 (.33%)
Interstitial Lung Disease
250 (.32%)
Glossodynia
243 (.31%)
Gait Disturbance
235 (.3%)
Chest Pain
219 (.28%)
Muscle Spasms
218 (.28%)
Renal Failure
218 (.28%)
Cerebral Infarction
217 (.28%)
Haemoglobin Decreased
214 (.27%)
Sepsis
214 (.27%)
Hyperkeratosis
213 (.27%)
Hypothyroidism
211 (.27%)
Back Pain
210 (.27%)
Abasia
209 (.27%)
Gastric Ulcer
209 (.27%)
Erythema Multiforme
207 (.26%)
Thrombocytopenia
205 (.26%)
Pain Of Skin
204 (.26%)
Oral Pain
200 (.25%)
Melaena
198 (.25%)
Paraesthesia
192 (.24%)
General Physical Health Deteriorati...
191 (.24%)
Insomnia
182 (.23%)
Renal Impairment
179 (.23%)
Hypoglycaemia
175 (.22%)
Hypoaesthesia
165 (.21%)
Ammonia Increased
163 (.21%)
Chest Discomfort
162 (.21%)
Encephalopathy
159 (.2%)
Blood Lactate Dehydrogenase Increas...
158 (.2%)
Rash Macular
158 (.2%)
Dysgeusia
154 (.2%)
Atrial Fibrillation
151 (.19%)
Hypotension
149 (.19%)
Myocardial Infarction
149 (.19%)
Disseminated Intravascular Coagulat...
148 (.19%)
Hyperkalaemia
146 (.19%)
Hyponatraemia
145 (.18%)
Blood Alkaline Phosphatase Increase...
143 (.18%)
Muscular Weakness
143 (.18%)
Skin Ulcer
143 (.18%)
Abdominal Distension
142 (.18%)
Burning Sensation
139 (.18%)

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

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

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

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

Hepatic Neoplasm Malignant
5010
Renal Cell Carcinoma
1775
Renal Cell Carcinoma Stage Unspecif...
926
Renal Cell Carcinoma Stage Iv
918
Drug Use For Unknown Indication
640
Metastatic Renal Cell Carcinoma
500
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Renal Cancer
167
Thyroid Cancer
150
Hepatic Neoplasm Malignant Non-rese...
113
Product Used For Unknown Indication
102
Malignant Melanoma
84
Neoplasm Malignant
74
Metastases To Lung
68
Renal Cancer Metastatic
58
Gastrointestinal Stromal Tumour
57
Hepatic Cancer Metastatic
55
Lung Neoplasm Malignant
45
Hepatic Cancer Stage Iv
30
Thyroid Cancer Metastatic
29
Hepatic Neoplasm Malignant Recurren...
26
Acute Myeloid Leukaemia
25
Renal Cell Carcinoma Stage Iii
24
Non-small Cell Lung Cancer
23
Sarcoma
22
Pancreatic Carcinoma
21
Metastatic Malignant Melanoma
21
Angiosarcoma
19
Metastases To Liver
19
Renal Neoplasm
16
Metastases To Bone
15
Ovarian Cancer
14
Hepatic Neoplasm
14
Prostate Cancer
14
Unevaluable Event
13
Renal Cell Carcinoma Stage Ii
12
Gastric Cancer
11
Colon Cancer
10
Bile Duct Cancer
10
Soft Tissue Neoplasm
10
Metastases To Lymph Nodes
10
Renal Cell Carcinoma Stage I
9
Metastasis
9
Gastrointestinal Carcinoma
8
Breast Cancer
7
Head And Neck Cancer
7
Breast Cancer Metastatic
7
Renal Cancer Stage Iv
7
Hepatic Neoplasm Malignant Resectab...
6
Bone Neoplasm Malignant
6
Clear Cell Carcinoma Of The Kidney
6
Lung Cancer Metastatic
6

Drug Labels

LabelLabelerEffective
NexavarBayer HealthCare Pharmaceuticals Inc.11-DEC-12

Nexavar Case Reports

What Nexavar 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 Nexavar. 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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