Applies to busulfan: intravenous solution.

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

• 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

• 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

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]