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Drug – Busulfan
Office for Human Research Studies
DANA-FARBER / HARVARD CANCER CENTER
Busulfan
FDA Approved
Risks Associated with Busulfan
Frequent (Between a 10-50% chance that this will happen)
 A low number of white blood cells that may increase the risk of infection. It may
become life-threatening. Symptoms of infection may include fever, pain, redness,
and/or difficulty breathing
 Low number of red blood cells that can causes tiredness and shortness of breath.
May require a blood transfusion.
 Low number of platelets, which may cause bleeding and bruising. Bleeding may be
serious or life threatening and may required a blood transfusion.
 Loss of appetite and weight loss
 Any change from the normal heartbeat (abnormal heartbeat)
 Difficulty passing stool
 Skin irritation, rash
 Diarrhea, which is frequent, loose watery stools, which can cause dehydration and
may require hospitalization and treatment with intravenous fluids. Severe and
prolonged diarrhea can be life-threatening.
 Dizziness
 Heartburn
 Build up of fluid in the body or extremities causing swelling.
 Feeling tired, tiredness, weakness.
 Pain in the head
 High body temperature, a fever.
 High blood pressure
 Allergic reaction that may include a rash, hives, fever, difficulty breathing, and low
blood pressure. Although usually reversible with treatment, it can be severe or life
threatening.
 Difficulty sleeping or falling asleep; unable to sleep
 Liver damage which can cause fatigue, and jaundice (yellowing of the skin and
eyes). Although this is usually mild and reversible, this can be serious or life
threatening and may require hospitalization and surgery.
 Sores in the mouth and esophagus, which may be painful and cause difficulty
swallowing.
 Stuffy nose
 Feeling sick to the stomach, vomiting
CF Builder Generated Version: 05.27.2016
DFCI IRB Approved Version: 05.20.2016
Drug – Busulfan



Chills and shivering
Cough
Anxiety
Occasional (Between a 1-10% chance that this will happen)
 Condition in which the lens of the eye becomes cloudy. Surgical intervention may be
required.
 Abnormal sex hormone production. In pre-menopausal women, underproduction of
these hormones may cause menstrual periods to stop (amenorrhea), infertility and
vaginal dryness. In men, underproduction of these hormones may result in
decreased sperm production and consequent infertility.
 Blood in the urine
 Bleeding internally which may require hospitalization and surgery
 Scarring of the lungs that can affect your ability to breath and may make you short of
breath. This may be serious or life-threatening.
 Convulsion or seizure
 Vision loss or vision changes that may be reversible.
 Loss or absence of sperm
 Menopause
Rare (Less than a 1% chance that this will happen)
 Collection of fluid around the heart which may cause a life threatening condition
where the heart is unable to pump correctly due to the external pressure. This may
require medical intervention to drain the fluid and remove the pressure.
 The heart is not able to pump blood properly, which can cause weakness and
tiredness, fluid retention, and fluid build-up in the lungs, which can cause shortness
of breath.
 Low blood pressure, which may cause dizziness, lightheadedness or fainting.
 A second cancer related to the treatment of your first cancer. This usually occurs
years after treatment for the first cancer.
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