Sorafenib: adverse event reports filed with FDA

5,594

reports as suspect product

0% of all reports · about 263 a year

137

reports, 12 months to June 2026

320 in the 12 months before

95.2%

marked serious by the reporter

70.8% across the class

23%

record death among outcomes, as reported

1,289 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 Sorafenib reports recording the termmedian drug in kinase inhibitor

1. Diarrhoealoose or frequent stools10.4%583
2. Off label useused for a purpose or in a way not on the label9.2%512
3. Palmar-plantar erythrodysaesthesia syndrome7.1%397
4. Fatiguetiredness6.7%377
5. Nauseafeeling sick5.1%288
6. Anaemialow red blood cells4.8%268
7. Thrombocytopenialow platelets4.8%266
8. Vomitingbeing sick4.7%262
9. Pyrexiafever4.5%250
10. Rashskin rash4.5%249
11. Hypertensionhigh blood pressure4.1%230
12. Product use in unapproved indicationused for a purpose not on the label4.1%229
13. Dyspnoeashortness of breath4%226
14. Abdominal painstomach or belly pain4%225
15. Deaththe patient died; cause not stated by this term3.9%218
16. Disease progressionthe disease advanced3.7%206
17. Astheniaweakness or lack of energy3.6%204
18. Malignant neoplasm progression3.6%204
19. Decreased appetitereduced appetite3.4%191
20. Drug ineffectivethe medicine did not work as expected3.3%184
21. General physical health deteriorationgeneral decline in health3.3%182
22. Pneumonialung infection3.2%177
23. Ascitesfluid in the abdomen3.1%174
24. Hepatocellular carcinoma3.1%173
25. Febrile neutropeniafever with low white blood cells2.9%164
26. Neutropenialow neutrophils, a type of white blood cell2.9%164
27. Dehydrationdehydration2.8%155
28. Pulmonary embolisma blood clot in the lung2.4%134
29. Hepatic failureliver failure2.3%128
30. Headachehead pain2.1%116

Top 30 of 894 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. 41.8% 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 5,594 reports.

Drugs most often listed in the same reports

Other products listed in reports where Sorafenib 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 Sorafenib as a suspect or interacting product; reports listing it only as a concomitant medication (658) 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.