Yondelis: adverse event reports filed with FDA

1,099

reports as suspect product

0% of all reports · about 57 a year

57

reports, 12 months to June 2026

53 in the 12 months before

84.8%

marked serious by the reporter

93.5% across the class

18.1%

record death among outcomes, as reported

199 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 Yondelis reports recording the termmedian drug in alkylating drug

1. Pancytopenialow counts of all blood cells8.3%91
2. Nauseafeeling sick8%88
3. Neutropenialow neutrophils, a type of white blood cell7.6%83
4. Rhabdomyolysismuscle breakdown7%77
5. Anaemialow red blood cells6.9%76
6. Alanine aminotransferase increasedraised liver enzyme (ALT)6.1%67
7. Thrombocytopenialow platelets5.8%64
8. Aspartate aminotransferase increasedraised liver enzyme (AST)5.7%63
9. Off label useused for a purpose or in a way not on the label5.6%62
10. Acute kidney injurysudden loss of kidney function4.8%53
11. Vomitingbeing sick4.8%53
12. Neutrophil count decreased4.5%50
13. Platelet count decreasedlow platelet count4.5%49
14. White blood cell count decreasedlow white cell count4.2%46
15. Febrile neutropeniafever with low white blood cells4%44
16. Pyrexiafever3.6%40
17. Deaththe patient died; cause not stated by this term3.1%34
18. Diarrhoealoose or frequent stools3.1%34
19. Blood creatine phosphokinase increased3%33
20. Astheniaweakness or lack of energy2.6%29
21. Hepatic function abnormal2.5%28
22. Sepsisa severe body-wide response to infection2.5%28
23. Fatiguetiredness2.5%27
24. Haematotoxicity2.5%27
25. Decreased appetitereduced appetite2.4%26
26. Hepatotoxicityliver injury2.4%26
27. Blood alkaline phosphatase increased2.3%25
28. Blood bilirubin increased2.3%25
29. Interstitial lung diseasescarring or inflammation of lung tissue2.3%25
30. Bone marrow failure2.2%24

Top 30 of 243 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 23 drugs in the alkylating drug 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 253,205 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. 29.6% 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 1,099 reports.

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 alkylating drug 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 Yondelis as a suspect or interacting product; reports listing it only as a concomitant medication (28) 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.