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ENDARI [L-glutamine oral powder] is indicated to reduce the acute complications of sickle cell disease in adults and children 5 years 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 the hands or feet, back pain, and chest pain.
Side effects that led to a stop in treatment during the clinical studies were 1 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 younger than 5 years old with sickle cell disease.
Please see full Prescribing Information.
You are encouraged to report all possible negative side effects of ENDARI to Emmaus Medical, Inc. at 1-877-420-6493 or FDA at 1-800-FDA-1080 or www.fda.gov/medwatch.