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
1Diarrhoea*1754
2Palmar-plantar erythrodysaesthesia syndrome1463
3Rash*1058
4Fatigue996
5Decreased appetite946
6Nausea833
7Death813
8Hypertension800
9Pyrexia730
10Asthenia643
11Hepatic function abnormal632
12Vomiting623
13Pain in extremity587
14Abdominal pain544
15Dyspnoea541
16Hepatic neoplasm malignant505
17Alopecia503
18Weight decreased484
19Ascites458
20Blister430

* 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
1Hepatic neoplasm malignant15259
2Renal cell carcinoma9189
3Metastatic renal cell carcinoma4243
4Renal cell carcinoma stage iv2204
5Product used for unknown indication1509
6Thyroid cancer1327
7Renal cancer1068
8Non-small cell lung cancer1051
9Metastatic malignant melanoma659
10Acute myeloid leukaemia620

*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.

Click to go back to search results and NEXAVAR Reviews and Review Summary .

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.

Visit   DrugInformer.com more on NEXAVAR's side effects.