Drug Safety Information for NEXAVAR (Sorafenib tosylate)
Safety-related Labeling Changes for NEXAVAR (SORAFENIB TOSYLATE) Rx Drug: FDA Link
Adverse Drug Reactions for NEXAVAR* (Sorafenib tosylate)
These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).
Top 20 Adverse Effects Associated with NEXAVAR
(reported in FDA Medwatch/FAERS Reports)
|Side Effect||# of FDA Reports|
|2||Palmar-plantar erythrodysaesthesia syndrome||1463|
|11||Hepatic function abnormal||632|
|13||Pain in extremity||587|
|16||Hepatic neoplasm malignant||505|
* This side effect also appears in "Top 10 Side Effects of NEXAVAR " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking NEXAVAR
(associated with FDA Medwatch/FAERS Reports)
|Reason||# of FDA Reports|
|1||Hepatic neoplasm malignant||15259|
|2||Renal cell carcinoma||9189|
|3||Metastatic renal cell carcinoma||4243|
|4||Renal cell carcinoma stage iv||2204|
|5||Product used for unknown indication||1509|
|8||Non-small cell lung cancer||1051|
|9||Metastatic malignant melanoma||659|
|10||Acute myeloid leukaemia||620|
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for NEXAVAR
Total Reports Filed with FDA: 56596
Number of FDA Adverse Event Reports by Patient Age for NEXAVAR
Total Reports Filed with FDA: 56596*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Sorafenib tosylate (Bay 43-9006 tosylate, Sorafenib, Bay 43-9006, Sorafenib tosylate, Nexavar)
Charts are based on 56596 reports filed with the FDA between 2004 and June 2015.
Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.
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Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.