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ENDARI is indicated to reduce the acute complications of sickle cell disease in adults and children 5 years of age and older.
IMPORTANT SAFETY INFORMATION
The most common side effects in clinical studies were constipation, nausea, headache, pain in the stomach area, cough, pain in hands or feet, back pain, and chest pain.
Side effects that lead to a stop in treatment during the clinical study were, one case each of overactive spleen (an organ that helps filter your blood), pain in the stomach area, indigestion, burning sensation, and hot flash.
It is not known whether ENDARI is safe and effective in children with sickle cell disease younger than 5 years old.
Talk to your doctor to determine if prescription ENDARI is right for you. You may report side effects to the FDA. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088. You can also call Emmaus Medical, Inc. at 1-855-725-0900.
For more information, please read the full Prescribing Information, including Instructions for Use, for ENDARI.