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Drug – Dactinomycin Office for Human Research Studies DANA-FARBER / HARVARD CANCER CENTER Dactinomycin FDA Approved Risks Associated with Dactinomycin Frequent (Between a 10-50% chance that this will happen) Feeling sick to the stomach, vomiting Hairloss 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. Occasional (Between a 1-10% chance that this will happen) Condition in which the number of white blood cells called neutrophils is abnormally low. This increases the risk of infection, which may be serious or life threatening. Low number of platelets, which may cause bleeding and bruising. Bleeding may be serious or life threatening and may required a blood transfusion. Low number of red blood cells that can causes tiredness and shortness of breath. May require a blood transfusion. Skin irritation, rash Difficulty swallowing A reaction at the site where an injection (shot) was given, which may cause some redness and swelling 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. Severe skin rash with blisters and can involve inside of mouth and other parts of the body. CF Builder Generated Version: 05.27.2016 DFCI IRB Approved Version: 05.20.2016