Busulfan Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 2, 2024.

Applies to busulfan: intravenous solution.

Important warnings This medicine can cause some serious health issues

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 busulfan

Along with its needed effects, busulfan 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 side effects

• black, tarry stools
• bloated abdomen or stomach
• blood in the urine or stools
• blurred vision
• chest pain
• cough or hoarseness
• dizziness
• fast or irregular breathing
• fast, pounding, or irregular heartbeat or pulse
• fever or chills
• headache
• lower back or side pain
• nervousness
• pain and fullness in the upper abdominal or stomach
• painful or difficult urination
• pinpoint red spots on the skin
• pounding in the ears
• skin rash or itching
• slow heartbeat
• swelling of the eyes or eyelids
• tightness in the chest
• trouble breathing
• unusual bleeding or bruising
• weight gain
• yellow eyes and skin

Incidence not known

• seizures

Other side effects of busulfan

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 side effects

• acid or sour stomach
• back pain
• belching
• bloody nose
• depression
• diarrhea
• difficulty having a bowel movement (stool)
• fear
• heartburn
• indigestion
• loss of appetite
• lack or loss of strength
• sneezing
• stomach discomfort or upset
• stuffy nose or runny nose
• swelling or inflammation of the mouth
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area
• trouble sleeping

For healthcare professionals

Applies to busulfan: intravenous solution, oral tablet.

Hematologic adverse events

• 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]

Respiratory

• 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]

Cardiovascular

• 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]

Ocular

• 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]

Dermatologic

• Very common (10% or more): Rash (57%), pruritus (28%)
• Common (1% to 10%): Alopecia^[Ref]

Metabolic

• 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]

Hepatic

• 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]

Oncologic

• Common (1% to 10%): Neoplasms benign, malignant, and unspecified (including cysts and polyps)
• Postmarketing reports: Tumor lysis syndrome, cellular dysplasia^[Ref]

Genitourinary

• Very rare (less than 0.01%): Gynecomastia
• Frequency not reported: Dysuria, oliguria, hematuria, hemorrhagic cystitis^[Ref]

Gastrointestinal

• 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]

Musculoskeletal

• Very common (10% or more): Chills (46%), back pain (23%)
• Frequency not reported: Myalgia, arthralgia^[Ref]

Immunologic

• Frequency not reported: Graft-versus-host disease
• Postmarketing reports: Severe bacterial, viral (e.g., cytomegalovirus viremia), fungal infections, sepsis^[Ref]

Hypersensitivity

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

Local

• Very common (10% or more): Injection site inflammation (25%)
• Frequency not reported: Injection site pain^[Ref]

Renal

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

Further information

Busulfan 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.

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