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Thiotepa Side Effects

The most commonly reported side effects of thiotepa include off label use, febrile neutropenia, and mucosal inflammation, based on 9,014 FDA adverse event reports from 2004 to 2025. 5.6% of reports found the drug to be ineffective.

Thiotepa side effects

Percentages show how often each reaction appears relative to total reports for thiotepa.

1
Off Label Use11.7%1,052
2
Febrile Neutropenia8.2%739
3
Mucosal Inflammation7.5%676
4
Product Use In Unapproved Indication6.4%574
5
Drug Ineffective5.6%501
6
Cytomegalovirus Infection5.5%499
7
Pyrexia4.8%435
8
Acute Graft Versus Host Disease In Skin4.6%413
9
Acute Graft Versus Host Disease4.5%406
10
Infection4.1%374
11
Cytomegalovirus Infection Reactivation4.1%372
12
Thrombocytopenia4.0%359
13
Neutropenia3.8%342
14
Venoocclusive Liver Disease3.8%340
15
Sepsis3.3%300

These are voluntary reports and do not establish that thiotepa caused these reactions.

Report severity

97.9%Serious8,824 reports
18.9%Hospitalizations1,702 reports
28.5%Fatal2,572 reports

Seriousness is determined by the reporter, not by OpenClaim.

Thiotepa drug interactions

Other drugs that appear in adverse event reports alongside thiotepa. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Fludarabine-phosphate46.4%4,182
2
Cyclophosphamide37.1%3,342
3
Busulfan27.3%2,463
4
Methotrexate24.6%2,213
5
Cyclosporine22.0%1,984
6
Mycophenolate20.2%1,817
7
Etoposide18.6%1,674
8
Rituximab17.6%1,587
9
Melphalan15.4%1,388
10
Carboplatin14.4%1,299
11
Cytarabine14.2%1,279
12
Vincristine-sulfate13.1%1,184
13
Treosulfan11.8%1,064
14
Tacrolimus10.4%937
15
Cisplatin7.3%660

Taken alongside

1
Fludarabine-phosphate7.8%705
2
Cyclophosphamide6.8%612
3
Cyclosporine6.0%544
4
Acyclovir5.1%456
5
Mycophenolate4.8%431
6
Busulfan4.6%416
7
Methotrexate4.2%377
8
Fluconazole3.3%300
9
Melphalan3.0%273
10
Etoposide2.9%258
11
Dexamethasone2.6%236
12
Ondansetron2.3%211
13
Tacrolimus2.3%208
14
Methylprednisolone2.2%194
15
Cytarabine2.1%192

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports thiotepa side effects

31.4% of thiotepa adverse event reports involve female patients and 38.6% involve male patients. The largest age group is adult at 44%. These figures reflect who reports side effects, not underlying risk.

Sex

Female31.4%
Male38.6%
Unknown30.0%

Age group

< 212.1%
2–1128.8%
12–1710.2%
18–6444.1%
65+4.8%

What is thiotepa used for

Conditions and purposes for which patients were taking thiotepa when the adverse event was reported.

Activated Pi3 Kinase Delta SyndromeAcute Biphenotypic LeukaemiaAcute LeukaemiaAcute Lymphocytic LeukaemiaAcute Lymphocytic Leukaemia RecurrentAcute Lymphocytic Leukaemia RefractoryAcute Myeloid LeukaemiaAcute Myeloid Leukaemia RecurrentAcute Myeloid Leukaemia RefractoryAcute Myelomonocytic LeukaemiaAcute Promyelocytic LeukaemiaAdjuvant TherapyAdult T-cell Lymphoma/leukaemiaAllogenic Bone Marrow Transplantation TherapyAllogenic Stem Cell Transplantation

Showing 15 of 412 indications

Thiotepa brand names and reporting trend

Thiotepa is sold under the brand name Thioplex.

Brand names

Thioplex10,660

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking thiotepa with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.