Treosulfan Side Effects

Medically reviewed by Drugs.com. Last updated on May 10, 2025.

Applies to treosulfan: intravenous powder for injection.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• swelling, pain, burning, irritation, or skin changes where the injection was given;

• severe itching, rash, or dryness of the skin;

• unusual bruising or bleeding, new signs of infection (fever, weakness, cough, diarrhea, burning when you urinate); or

• seizures.

Common side effects may include:

• infections, fever;

• mouth sores;

• muscle, bone, or joint pain;

• nausea or vomiting;

• swelling; or

• abnormal lab results.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

See also:

For healthcare professionals

Applies to treosulfan: intravenous powder for injection.

General adverse events

The most common adverse reactions observed were abdominal pain, decreased appetite, diarrhea, edema, fatigue, febrile neutropenia, gastrointestinal disorders, headache, hepatotoxicity, infections, increased alanine transaminase, aspartate transaminase, and bilirubin levels, maculopapular rash, musculoskeletal pain, myelosuppression, nausea, pyrexia, stomatitis, and vomiting. In addition, alopecia and pruritus occurred in pediatric patients.^[Ref]

Cardiovascular

• Very common (10% or more): Hypertension (up to 14%), tachycardia (up to 10%)
• Common (1% to 10%): Atrial fibrillation, cardiac arrhythmias, flushing, hypotension, sinus tachycardia
• Uncommon (0.1% to 1%): Hematoma, pericardial effusion, supraventricular tachycardia, ventricular extrasystole
• Very rare (less than 0.01%): Cardiomyopathy
• Frequency not reported: Cardiac arrest, cardiac failure, capillary leak syndrome, embolism, myocardial infarction^[Ref]

Cardiac arrhythmias included atrial fibrillation and sinus arrhythmia.^[Ref]

Dermatologic

• Very common (10% or more): Alopecia, bronze skin pigmentation, maculopapular eruption (up to 11.9%), rash (up to 17%)
• Common (1% to 10%): Dermatitis, erythema, exfoliative, maculopapular rash, pruritus, purpura, palmar plantar erythrodysesthesia syndrome, pain of skin, rash, urticaria
• Uncommon (0.1% to 1%): Dermatitis acneiform, dry skin, erythema multiforme, hyperhidrosis, skin hyperpigmentation
• Very rare (less than 0.01%): Scleroderma, triggering of psoriasis
• Frequency not reported: Bullous dermatitis, diaper dermatitis, dermatitis, generalized erythema, skin necrosis or ulcer, scrotal erythema^[Ref]

Endocrine

• Very rare (less than 0.01%): Addison's disease^[Ref]

Gastrointestinal

• Very common (10% or more): Abdominal pain (up to 15%), constipation (up to 12%), diarrhea (up to 17%), gastrointestinal disorders (up to 39%), nausea (up to 39%), stomatitis or oral mucositis (up to 38%), vomiting (up to 23%)
• Common (1% to 10%): Dyspepsia, dysphagia, gastritis, oral pain
• Uncommon (0.1% to 1%): Abdominal distension, dry mouth, esophageal pain, gastrointestinal hemorrhage, gastrointestinal pain, mouth hemorrhage
• Frequency not reported: Anal inflammation, esophagitis, gingival pain, mouth ulceration, neutropenic colitis, proctitis^[Ref]

Genitourinary

• Common (1% to 10%): Hematuria, urinary tract pain
• Frequency not reported: Dysuria, penile pain, scrotal erythema^[Ref]

Hematologic

• Very common (10% or more): Anemia, febrile neutropenia (15%), hemorrhage (14%), leukocytopenia, myelosuppression, neutropenia, pancytopenia, thrombocytopenia
• Common (1% to 10%): Flushing
• Frequency not reported: Graft failure^[Ref]

Hepatic

• Very common (10% or more): Hepatotoxicity (up to 10%), increased GGT (up to 16%), increased blood bilirubin, increased ALT
• Common (1% to 10%): Increased AST, increase of C-reactive protein, transaminase elevations
• Uncommon (0.1% to 1%): Veno-occlusive liver disease
• Very rare (less than 0.01%): Increased liver function values, jaundice
• Frequency not reported: Hepatic failure, hepatomegaly, hepatic pain^[Ref]

Hypersensitivity

• Common (1% to 10%): Allergic reactions, hypersensitivity^[Ref]

Local

• Uncommon (0.1% to 1%): Non-cardiac chest pain
• Very rare (less than 0.01%): Local painful inflammatory reactions (in case of extravasation)
• Frequency not reported: Injection site reaction

Metabolic

• Common (1% to 10%): Anorexia, decreased appetite, hypomagnesemia
• Uncommon (0.1% to 1%): Decreased weight, hyperglycemia
• Very rare (less than 0.01%): Hypoglycemia
• Frequency not reported: Alkalosis, decreased appetite, electrolyte imbalance, impaired glucose tolerance
• Postmarketing reports: Acidosis^[Ref]

Musculoskeletal

• Very common (10% or more): Arthralgia (up to 10%), back pain (up to 14.8%), bone pain (up to 13.7%), musculoskeletal pain (up to 39%),
• Common (1% to 10%): Myalgia, pain in extremity
• Uncommon (0.1% to 1%): Muscular weakness
• Frequency not reported: Increased blood lactate dehydrogenase^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 16%)
• Common (1% to 10%): Dizziness, vertigo
• Uncommon (0.1% to 1%): Intracranial hemorrhage, peripheral sensory neuropathy
• Frequency not reported: Paresthesia
• Postmarketing reports: Encephalopathy, extrapyramidal disorder, syncope, seizure^[Ref]

Ocular

• Frequency not reported: Dry eye, conjunctival hemorrhage^[Ref]

Oncologic

• Common (1% to 10%): Acute myeloid leukemia
• Uncommon (0.1% to 1%): Acute non-lymphocytic leukemia, breast cancer, myeloma, myeloproliferative disorder
• Frequency not reported: Acute lymphoblastic leukemia, Ewing's sarcoma, myelodysplastic syndrome, treatment related secondary malignancy^[Ref]

Other

• Very common (10% or more): Asthenia, edema (up to 29%), fatigue (up to 13%), infection (bacterial, viral, fungal) (up to 23%), lethargy, pyrexia (up to 34%)
• Common (1% to 10%): Blood alkaline phosphatase increased, chills (feeling cold), decreased weight, pain, sepsis, weight gain
• Very rare (less than 0.01%): Flu-like complaints
• Frequency not reported: Septic shock

Infections included fatalities.

Psychiatric

• Common (1% to 10%): Insomnia
• Uncommon (0.1% to 1%): Confessional state
• Frequency not reported: Agitation^[Ref]

Renal

• Common (1% to 10%): Acute kidney injury, increased blood creatinine
• Very rare (less than 0.01%): Hemorrhagic cystitis
• Frequency not reported: Non-infective cystitis
• Postmarketing reports: Renal failure^[Ref]

Respiratory

• Very common (10% or more): Lung infection (15.2%)
• Common (1% to 10%): Dyspnea, epistaxis
• Uncommon (0.1% to 1%): Cough, hiccups, laryngeal inflammation, laryngeal or oropharyngeal pain, pneumonitis, pleural effusion, pharyngeal
• Very rare (less than 0.01%): Allergic alveolitis, pulmonary fibrosis, pneumonia
• Frequency not reported: Dysphonia, hypoxia^[Ref]

Further information

Treosulfan side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer