Single Patient IND
Leuprolide
FDA Approved
Risks Associated with Leuprolide
Frequent (Between a 10-50% chance that this will happen)
• Feeling tired, tiredness, weakness.
• Sudden reddening of the face and/or neck
• Difficulty sleeping or falling asleep; unable to sleep
• Feeling sick to the stomach
• Vomiting
• Painful or difficult urination
• Depression
• Pain
• Vaginal discharge
• A reaction at the site where an injection (shot) was given, which may cause some redness and swelling.
Occasional (Between a 1-10% chance that this will happen)
• Build up of fluid in the body or extremities causing swelling.
• Low number of red blood cells that can causes tiredness and shortness of breath. May require a blood transfusion.
• Acne; pimples
• Blood clots can form leading to swelling in the arms and legs. These clots can travel to the lungs causing shortness of breath or to the brain causing a stroke. This may be serious or life threatening.
• Weight gain
• Thoughts of suicide
• Shrinkage of the testis
• Breast tenderness, pain, or changing breast size
• Difficulty passing stool
• Skin irritation, rash
• Dizziness
• A broken bone
• Pain in the head
• 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.
• High blood pressure
• 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.
• Cough
Rare (Less than a 1% chance that this will happen)
• 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.
• Convulsion or seizure
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DANA-FARBER / HARVARD CANCER CENTER
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