OpenClaim

Treosulfan Side Effects

The most commonly reported side effects of treosulfan include off label use, cytomegalovirus infection, and cytomegalovirus infection reactivation, based on 2,465 FDA adverse event reports from 2004 to 2025. 9.0% of reports found the drug to be ineffective.

Treosulfan side effects

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

1
Off Label Use22.1%544
2
Cytomegalovirus Infection9.7%239
3
Cytomegalovirus Infection Reactivation9.2%228
4
Product Use In Unapproved Indication9.1%224
5
Drug Ineffective9.0%221
6
Mucosal Inflammation8.9%219
7
Acute Graft Versus Host Disease In Skin7.7%190
8
Adenovirus Infection7.5%184
9
Graft Versus Host Disease In Skin5.7%140
10
Pyrexia4.9%120
11
Graft Versus Host Disease In Gastrointestinal Tract4.8%119
12
Multiple Organ Dysfunction Syndrome4.8%119
13
Neutropenia4.6%113
14
Human Herpesvirus 6 Infection4.6%113
15
Acute Graft Versus Host Disease4.4%109

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

Report severity

97.9%Serious2,413 reports
16.9%Hospitalizations417 reports
21.7%Fatal534 reports

Seriousness is determined by the reporter, not by OpenClaim.

Treosulfan drug interactions

Other drugs that appear in adverse event reports alongside treosulfan. 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-phosphate71.2%1,754
2
Thiotepa43.0%1,061
3
Cyclosporine34.3%846
4
Mycophenolate31.2%768
5
Cyclophosphamide24.5%603
6
Rituximab21.1%521
7
Alemtuzumab18.7%462
8
Methotrexate18.4%453
9
Tacrolimus17.5%431
10
Melphalan7.5%186
11
Methylprednisolone6.0%148
12
Etoposide4.9%122
13
Busulfan4.8%119
14
Cytarabine4.8%118
15
Abatacept4.3%107

Taken alongside

1
Fludarabine-phosphate16.6%408
2
Cyclosporine8.9%219
3
Thiotepa6.3%156
4
Mycophenolate6.3%155
5
Acyclovir5.4%134
6
Methotrexate4.9%120
7
Cyclophosphamide4.6%113
8
Tacrolimus4.3%106
9
Methylprednisolone3.9%96
10
Alemtuzumab3.8%94
11
Fluconazole2.9%72
12
Rituximab2.8%69
13
Posaconazole2.8%69
14
Amphotericin-b2.7%67
15
Levetiracetam2.7%67

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 treosulfan side effects

30.8% of treosulfan adverse event reports involve female patients and 39.1% involve male patients. The largest age group is child at 38%. These figures reflect who reports side effects, not underlying risk.

Sex

Female30.8%
Male39.1%
Unknown30.0%

Age group

< 220.7%
2–1138.0%
12–1711.5%
18–6425.5%
65+4.3%

What is treosulfan used for

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

Activated Pi3 Kinase Delta SyndromeAcute Lymphocytic LeukaemiaAcute Myeloid LeukaemiaAcute Myeloid LeukemiaAllogenic Bone Marrow Transplantation TherapyAllogenic Stem Cell TransplantationAutoimmune Lymphoproliferative SyndromeAutologous Haematopoietic Stem Cell TransplantAcute Lymphocytic LeukaemiaAcute Myeloid LeukaemiaAcute Myeloid Leukaemia RefractoryAdrenoleukodystrophyAllogenic Bone Marrow Transplantation TherapyAllogenic Stem Cell TransplantationAntifungal Prophylaxis

Showing 15 of 157 indications

Treosulfan brand names and reporting trend

Treosulfan is sold under the brand name Grafapex.

Brand names

Grafapex3,050

Quarterly reports (20042025)

20052010201520202025

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

Taking treosulfan with another medication?

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