Sancuso: adverse event reports filed with FDA

1,167

reports as suspect product

0% of all reports · about 67 a year

0

reports, 12 months to June 2026

1 in the 12 months before

33.5%

marked serious by the reporter

86.9% across the class

21.3%

record death among outcomes, as reported

248 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

Reactions recorded in the reports

share of Sancuso reports recording the termmedian drug in serotonin-3 receptor antagonist

1. Product adhesion issue21.5%251
2. Deaththe patient died; cause not stated by this term18.9%220
3. Nauseafeeling sick14.5%169
4. Wrong technique in product usage processthe product was used in the wrong way9.9%115
5. Drug ineffectivethe medicine did not work as expected8.2%96
6. Application site pruritusitching where the product was applied4.7%55
7. Product use in unapproved indicationused for a purpose not on the label4.7%55
8. Application site erythemaredness where the product was applied4.4%51
9. Inappropriate schedule of product administrationthe product was taken at the wrong times4.2%49
10. Vomitingbeing sick4.1%48
11. No adverse eventno adverse event was reported3.9%45
12. Application site rash3.7%43
13. Constipationconstipation3.7%43
14. Hospitalisationadmission to hospital3%35
15. Inappropriate schedule of drug administrationthe medicine was taken at the wrong times3%35
16. Malaisegeneral feeling of being unwell3%35
17. Drug administered at inappropriate site2.9%34
18. Headachehead pain2.8%33
19. Product use issuea problem in how the product was used2.6%30
20. Application site irritation2.2%26
21. Rashskin rash2.1%25
22. Exposure during pregnancythe medicine was taken during pregnancy2%23
23. Pruritusitching1.8%21
24. Dizzinesslight-headedness or unsteadiness1.6%19
25. Feeling abnormalfeeling odd or not right1.6%19
26. Intentional product misusedeliberate use not as intended1.6%19
27. Diarrhoealoose or frequent stools1.3%15
28. Skin irritationirritated skin1.3%15
29. Product quality issuea problem with the product itself1.2%14
30. Illness1%12

Top 30 of 122 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 4 drugs in the serotonin-3 receptor antagonist 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 22,267 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. 97.3% 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 1,167 reports.

Drugs most often listed in the same reports

Other products listed in reports where Sancuso 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 serotonin-3 receptor antagonist 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 Sancuso as a suspect or interacting product; reports listing it only as a concomitant medication (467) 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.