Drug
Treosulfan
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Cytomegalovirus Infection | 262 | 127.1 | 141.0 | signal |
| 2 | Mucosal Inflammation | 234 | 72.0 | 78.9 | signal |
| 3 | Posterior Reversible Encephalopathy Syndrome | 66 | 55.5 | 56.8 | signal |
| 4 | Thrombotic Microangiopathy | 57 | 47.0 | 48.0 | signal |
| 5 | Multiple Organ Dysfunction Syndrome | 127 | 36.3 | 38.1 | signal |
| 6 | Acute Respiratory Distress Syndrome | 44 | 19.8 | 20.1 | signal |
| 7 | Lymphopenia | 31 | 17.5 | 17.7 | signal |
| 8 | Pneumonitis | 58 | 17.1 | 17.4 | signal |
| 9 | Bacteraemia | 25 | 16.9 | 17.1 | signal |
| 10 | Staphylococcal Infection | 66 | 15.9 | 16.2 | signal |
| 11 | Myelodysplastic Syndrome | 26 | 14.3 | 14.4 | signal |
| 12 | Acute Myeloid Leukaemia | 26 | 13.3 | 13.4 | signal |
| 13 | Hyperbilirubinaemia | 16 | 12.4 | 12.4 | signal |
| 14 | Febrile Neutropenia | 96 | 11.5 | 11.9 | signal |
| 15 | Pericardial Effusion | 33 | 11.4 | 11.5 | signal |
| 16 | Haematotoxicity | 13 | 11.2 | 11.2 | signal |
| 17 | Viral Infection | 46 | 11.0 | 11.2 | signal |
| 18 | Candida Infection | 23 | 11.0 | 11.0 | signal |
| 19 | Drug Resistance | 35 | 10.8 | 11.0 | signal |
| 20 | Neurotoxicity | 23 | 10.5 | 10.6 | signal |
| 21 | Nephropathy Toxic | 14 | 10.0 | 10.0 | signal |
| 22 | Impaired Gastric Emptying | 16 | 10.0 | 10.0 | signal |
| 23 | Clostridium Difficile Colitis | 13 | 9.7 | 9.8 | signal |
| 24 | Ascites | 34 | 9.2 | 9.3 | signal |
| 25 | Acute Respiratory Failure | 22 | 9.1 | 9.2 | signal |
| 26 | Fungal Infection | 38 | 9.1 | 9.2 | signal |
| 27 | Toxic Epidermal Necrolysis | 17 | 9.0 | 9.0 | signal |
| 28 | Hepatic Failure | 34 | 8.9 | 9.0 | signal |
| 29 | Multi-organ Failure | 19 | 8.6 | 8.7 | signal |
| 30 | Hepatotoxicity | 24 | 8.6 | 8.7 | signal |
| 31 | Encephalopathy | 25 | 8.1 | 8.2 | signal |
| 32 | Product Use In Unapproved Indication | 225 | 7.3 | 7.9 | signal |
| 33 | Sepsis | 99 | 7.1 | 7.3 | signal |
| 34 | Gastroenteritis Viral | 16 | 7.0 | 7.1 | signal |
| 35 | Drug Ineffective For Unapproved Indication | 48 | 6.8 | 7.0 | signal |
| 36 | Neutropenia | 116 | 6.8 | 7.1 | signal |
| 37 | Therapy Non-responder | 38 | 6.8 | 6.9 | signal |
| 38 | Cytopenia | 10 | 6.7 | 6.7 | signal |
| 39 | Hyperthyroidism | 12 | 6.6 | 6.6 | signal |
| 40 | Vitreous Floaters | 8 | 6.5 | 6.5 | signal |
| 41 | Intentional Product Use Issue | 72 | 6.5 | 6.7 | signal |
| 42 | Ileus | 10 | 6.5 | 6.5 | signal |
| 43 | Respiratory Failure | 59 | 6.4 | 6.5 | signal |
| 44 | Bacterial Infection | 15 | 6.4 | 6.4 | signal |
| 45 | Thrombocytopenia | 88 | 6.3 | 6.5 | signal |
| 46 | Cytokine Release Syndrome | 15 | 6.3 | 6.3 | signal |
| 47 | Cholestasis | 15 | 6.2 | 6.3 | signal |
| 48 | Lymphoma | 12 | 6.2 | 6.2 | signal |
| 49 | Leukopenia | 38 | 6.1 | 6.1 | signal |
| 50 | Agranulocytosis | 14 | 6.0 | 6.0 | signal |
| 51 | Covid-19 Pneumonia | 9 | 6.0 | 6.0 | signal |
| 52 | Off Label Use | 637 | 5.8 | 7.4 | signal |
| 53 | Haemorrhage Intracranial | 11 | 5.8 | 5.8 | signal |
| 54 | Respiratory Distress | 20 | 5.8 | 5.8 | signal |
| 55 | Pancreatitis Acute | 16 | 5.7 | 5.7 | signal |
| 56 | Pneumocystis Jirovecii Pneumonia | 7 | 5.6 | 5.6 | signal |
| 57 | Disease Recurrence | 33 | 5.5 | 5.6 | signal |
| 58 | Ataxia | 8 | 5.3 | 5.3 | signal |
| 59 | Device Related Infection | 10 | 5.1 | 5.2 | signal |
| 60 | Hypocalcaemia | 12 | 5.1 | 5.1 | signal |
| 61 | Brain Oedema | 8 | 5.0 | 5.0 | signal |
| 62 | Septic Shock | 27 | 5.0 | 5.0 | signal |
| 63 | Renal Impairment | 50 | 4.7 | 4.8 | signal |
| 64 | Therapy Partial Responder | 9 | 4.7 | 4.8 | signal |
| 65 | Quality Of Life Decreased | 8 | 4.7 | 4.7 | signal |
| 66 | Polyneuropathy | 7 | 4.7 | 4.7 | signal |
| 67 | Skin Lesion | 16 | 4.7 | 4.7 | signal |
| 68 | Disseminated Intravascular Coagulation | 8 | 4.5 | 4.5 | signal |
| 69 | Stomatitis | 34 | 4.5 | 4.5 | signal |
| 70 | Pancytopenia | 30 | 4.3 | 4.3 | signal |
| 71 | Diarrhoea Haemorrhagic | 5 | 4.2 | 4.2 | signal |
| 72 | Metastases To Lung | 6 | 4.1 | 4.1 | signal |
| 73 | Toxic Skin Eruption | 5 | 3.9 | 3.9 | signal |
| 74 | Disease Progression | 58 | 3.9 | 4.0 | signal |
| 75 | Herpes Zoster | 28 | 3.9 | 3.9 | signal |
| 76 | Skin Haemorrhage | 7 | 3.9 | 3.9 | signal |
| 77 | Pulmonary Arterial Hypertension | 7 | 3.8 | 3.8 | signal |
| 78 | Hepatitis | 12 | 3.7 | 3.7 | signal |
| 79 | Anaphylactic Shock | 12 | 3.7 | 3.7 | signal |
| 80 | Oral Herpes | 9 | 3.7 | 3.7 | signal |
| 81 | Drug Eruption | 8 | 3.6 | 3.6 | signal |
| 82 | Bone Marrow Failure | 9 | 3.5 | 3.5 | signal |
| 83 | Central Nervous System Lesion | 6 | 3.4 | 3.5 | signal |
| 84 | Impaired Quality Of Life | 6 | 3.3 | 3.3 | signal |
| 85 | Product Use Issue | 76 | 3.2 | 3.3 | signal |
| 86 | Ischaemic Stroke | 7 | 3.1 | 3.1 | signal |
| 87 | Peritonitis | 8 | 3.1 | 3.1 | signal |
| 88 | Convulsion | 22 | 3.0 | 3.0 | signal |
| 89 | Colitis Ulcerative | 16 | 2.8 | 2.9 | signal |
| 90 | Myelosuppression | 10 | 2.3 | 2.3 | signal |
| 91 | Plasma Cell Myeloma | 10 | 2.0 | 2.0 | signal |
| 92 | Osteonecrosis | 8 | 1.9 | 1.9 | no signal |
| 93 | Drug Effective For Unapproved Indication | 7 | 1.9 | 1.9 | no signal |