Sunitinib malate: adverse event reports filed with FDA

4,677

reports as suspect product

0% of all reports · about 230 a year

79

reports, 12 months to June 2026

74 in the 12 months before

97%

marked serious by the reporter

70.8% across the class

22.2%

record death among outcomes, as reported

1,040 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Sunitinib malate reports recording the termmedian drug in kinase inhibitor

1. Diarrhoealoose or frequent stools6.3%295
2. Disease progressionthe disease advanced5.9%274
3. Deaththe patient died; cause not stated by this term5.4%254
4. Vomitingbeing sick5.3%249
5. Fatiguetiredness5%233
6. Thrombocytopenialow platelets4.7%222
7. Platelet count decreasedlow platelet count4.7%219
8. Nauseafeeling sick4.5%212
9. Dehydrationdehydration4%188
10. Anaemialow red blood cells3.8%179
11. Hypertensionhigh blood pressure3.8%179
12. Astheniaweakness or lack of energy3.7%175
13. Pyrexiafever3.6%168
14. Hypothyroidismunderactive thyroid3.5%165
15. Neoplasm progression3.5%164
16. Dyspnoeashortness of breath3.1%145
17. Palmar-plantar erythrodysaesthesia syndrome2.8%131
18. Pneumonialung infection2.8%131
19. Neutropenialow neutrophils, a type of white blood cell2.8%129
20. General physical health deteriorationgeneral decline in health2.6%120
21. Decreased appetitereduced appetite2.4%113
22. Abdominal painstomach or belly pain2.4%112
23. Pleural effusionfluid around the lung2.4%112
24. Malaisegeneral feeling of being unwell2.3%106
25. Hypotensionlow blood pressure2.2%101
26. Renal failurekidney failure2%94
27. Confusional stateconfusion1.9%89
28. Renal cell carcinoma1.8%84
29. Hyponatraemialow blood sodium1.8%83
30. Mucosal inflammation1.7%80

Top 30 of 674 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 100 drugs in the kinase inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 849,161 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 23.2% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 4,677 reports.

Drugs most often listed in the same reports

Other products listed in reports where Sunitinib malate is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the kinase inhibitor class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Sunitinib malate as a suspect or interacting product; reports listing it only as a concomitant medication (295) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.