Drug Safety Information for SUTENT (Sunitinib malate)

Safety-related Labeling Changes for SUTENT (SUNITINIB MALATE) Rx Drug: FDA Link

Adverse Drug Reactions for SUTENT* (Sunitinib malate)

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 SUTENT
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Death4191
2Disease progression3112
3Diarrhoea1998
4Fatigue1904
5Nausea1575
6Vomiting1217
7Asthenia1190
8Decreased appetite1115
9Hypertension*948
10Renal cell carcinoma907
11Platelet count decreased817
12Dysgeusia796
13Neoplasm malignant787
14Dyspnoea782
15Thrombocytopenia752
16Palmar-plantar erythrodysaesthesia syndrome736
17Stomatitis721
18Pyrexia701
19Dehydration666
20Weight decreased665

* This side effect also appears in "Top 10 Side Effects of SUTENT " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking SUTENT
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Renal cell carcinoma20442
2Metastatic renal cell carcinoma16992
3Renal cancer8831
4Gastrointestinal stromal tumour5773
5Renal cancer metastatic3750
6Neoplasm malignant1610
7Product used for unknown indication1045
8Pancreatic neuroendocrine tumour1033
9Breast cancer689
10Non-small cell lung cancer555

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for SUTENT

Total Reports Filed with FDA: 85139


Number of FDA Adverse Event Reports by Patient Age for SUTENT

Total Reports Filed with FDA: 85139*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Sunitinib malate (Sunitinib maleate, Sunitinib, Sunitinib malate, Su11248, Su011248, Su 11248, Sutent)

Charts are based on 85139 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 SUTENT 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 SUTENT's side effects.