Thiotepa: adverse event reports filed with FDA

7,853

reports as suspect product

0% of all reports · about 350 a year

1,035

reports, 12 months to June 2026

879 in the 12 months before

98.8%

marked serious by the reporter

93.5% across the class

27.7%

record death among outcomes, as reported

2,172 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 Thiotepa reports recording the termmedian drug in alkylating drug

1. Off label useused for a purpose or in a way not on the label11.1%870
2. Febrile neutropeniafever with low white blood cells9.2%726
3. Mucosal inflammation8.9%698
4. Cytomegalovirus infection5.9%464
5. Product use in unapproved indicationused for a purpose not on the label5.4%426
6. Pyrexiafever5.3%420
7. Drug ineffectivethe medicine did not work as expected5.1%398
8. Cytomegalovirus infection reactivation4.9%388
9. Acute graft versus host disease in skin4.9%384
10. Infectionan infection, type not specified4.6%360
11. Acute graft versus host disease4.6%358
12. Venoocclusive liver disease4.6%358
13. Neutropenialow neutrophils, a type of white blood cell4.5%350
14. Sepsisa severe body-wide response to infection4.4%347
15. Thrombocytopenialow platelets4%316
16. Adenovirus infection3.7%290
17. Human herpesvirus 6 infection3.6%283
18. Haematotoxicity3.4%268
19. Graft versus host disease3.1%240
20. Thrombotic microangiopathy3%238
21. Multiple organ dysfunction syndromeseveral organs failing2.9%230
22. Diarrhoealoose or frequent stools2.9%225
23. Acute graft versus host disease in intestine2.8%221
24. Graft versus host disease in skin2.7%214
25. Chronic graft versus host disease2.6%203
26. Pneumonialung infection2.5%197
27. Graft versus host disease in gastrointestinal tract2.4%191
28. Respiratory failurethe lungs could not supply enough oxygen2.3%180
29. Epstein-Barr virus infection2.2%176
30. Disease progressionthe disease advanced2.2%175

Top 30 of 1,117 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. 20% 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 7,853 reports.

Drugs most often listed in the same reports

Other products listed in reports where Thiotepa 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 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 Thiotepa as a suspect or interacting product; reports listing it only as a concomitant medication (1,464) 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.