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Drug – Bicalutamide Office for Human Research Studies DANA-FARBER / HARVARD CANCER CENTER Bicalutamide FDA Approved Risks Associated with Bicalutamide Frequent (Between a 10-50% chance that this will happen) Difficulty passing stool Feeling tired, tiredness, weakness. Hot flashes Pain Occasional (Between a 1-10% chance that this will happen) 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. Build up of fluid in the body or extremities causing swelling. 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. Blood in the urine Increased urination at night A low number of white blood cells may increase the risk of infection. It may become life-threatening. Symptoms of infection may include fever, pain, redness, and/or difficulty breathing. 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. Feeling sick to the stomach Inflammation of the liver caused by a virus CF Builder Generated Version: 05.12.2016 DFCI IRB Approved Version: 05.20.2016