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Myleran Side Effects

Generic name: busulfan

Medically reviewed by Last updated on Mar 16, 2024.

Note: This document contains side effect information about busulfan. Some dosage forms listed on this page may not apply to the brand name Myleran.

Applies to busulfan: intravenous solution.


Intravenous route (Solution)

Busulfan causes severe or prolonged myelosuppression at recommended doses. Hematopoietic progenitor cell transplantation is required to prevent life-threatening or fatal complications of severe or prolonged myelosuppression.

Serious side effects of Myleran

Along with its needed effects, busulfan (the active ingredient contained in Myleran) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking busulfan:

More common

Incidence not known

Other side effects of Myleran

Some side effects of busulfan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

For Healthcare Professionals

Applies to busulfan: intravenous solution, oral tablet.


Very common (10% or more): Prolonged myelosuppression (i.e., severe granulocytopenia, leukopenia, thrombocytopenia, anemia, or any combination thereof) (100%)

Rare (less than 0.1%): Aplastic anemia

Frequency not reported: Prolonged prothrombin time

Postmarketing reports: Febrile neutropenia[Ref]


Very common (10% or more): Rhinitis (44%), lung disorder (34%), cough (28%), epistaxis (25%), dyspnea (25%)

Rare (less than 0.1%): Bronchopulmonary dysplasia

Frequency not reported: Pneumonia, hyperventilation, alveolar hemorrhage, pharyngitis, hiccup, asthma, atelectasis, pleural effusion, hypoxia, hemoptysis, sinusitis, interstitial fibrosis[Ref]


Very common (10% or more): Tachycardia (44%), hypertension (36%), chest pain (26%), vasodilation (25%)

Common (1% to 10%): Cardiac tamponade in patients with thalassemia (at high doses)

Frequency not reported: Arrhythmia, atrial fibrillation, ventricular extrasystoles, third degree heart block, thrombosis (all episodes were associated with the central venous catheter), hypotension, flushing and hot flashes, cardiomegaly, ECG abnormality, left-sided heart failure, pericardial effusion, cardiac tamponade

Postmarketing reports: Thrombotic microangiopathy (TMA)[Ref]


Rare (less than 0.1%): Lens disorder and cataract (which may be bilateral), corneal thinning (reported after bone marrow transplantation preceded by high-dose therapy)[Ref]


Very common (10% or more): Rash (57%), pruritus (28%)

Common (1% to 10%): Alopecia[Ref]


Very common (10% or more): Hypomagnesemia (77%), hyperglycemia (66%), hypokalemia (64%), hypocalcemia (49%), hyperbilirubinemia (49%), edema (36%), serum glutamic pyruvic transaminase (SGPT) elevation (31%), creatinine increased (21%)

Frequency not reported: Hypervolemia, hypophosphatemia, hyponatremia[Ref]


Very common (10% or more): SGPT Elevation

Common (1% to 10%): Hepatic veno-occlusive disease (HVOD)

Rare (less than 0.1%): Jaundice, abnormal hepatic function, biliary fibrosis

Frequency not reported: Alkaline phosphatase increase, jaundice, hepatomegaly[Ref]

Nervous system

Very common (10% or more): Headache (69%), asthenia (51%), dizziness (30%)

Common (1% to 10%): Seizures

Very rare (less than 0.01%): Myasthenia gravis

Frequency not reported: Cerebral hemorrhage, coma, delirium, agitation, encephalopathy, confusion, hallucinations, lethargy, somnolence[Ref]


Common (1% to 10%): Neoplasms benign, malignant, and unspecified (including cysts and polyps)

Postmarketing reports: Tumor lysis syndrome, cellular dysplasia[Ref]


Very rare (less than 0.01%): Gynecomastia

Frequency not reported: Dysuria, oliguria, hematuria, hemorrhagic cystitis[Ref]


Very common (10% or more): Nausea (98%), stomatitis (mucositis) (97%), vomiting (95%), anorexia (85%), diarrhea (84%), abdominal pain (72%), dyspepsia (44%), dry mouth (26%), rectal disorder (25%), abdominal enlargement (23%)

Frequency not reported: Esophagitis, ileus, hematemesis, pancreatitis, rectal discomfort

Postmarketing reports: Tooth hypoplasia[Ref]


Very common (10% or more): Chills (46%), back pain (23%)

Frequency not reported: Myalgia, arthralgia[Ref]


Frequency not reported: Graft-versus-host disease

Postmarketing reports: Severe bacterial, viral (e.g., cytomegalovirus viremia), fungal infections, sepsis[Ref]


Very common (10% or more): Allergic reaction (26%)[Ref]


Very common (10% or more): Injection site inflammation (25%)

Frequency not reported: Injection site pain[Ref]


Frequency not reported: Blood urea nitrogen (BUN) increased[Ref]


1. (2001) "Product Information. Myleran (busulfan)." Prasco Laboratories

2. (2004) "Product Information. Busulfex (busulfan)." ESP Pharma Inc

3. (2018) "Product Information. Busulfan (busulfan)." Amneal Pharmaceuticals

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.