The product information provided in this site is intended for residents of the United States.

Can EnteraGam® Cause Side Effects?

In the study of patients with IBS who had loose or frequent stools, side effects of EnteraGam® were about the same as those in patients taking placebo.1 In accumulated patient studies of multiple conditions including IBS, 2%-5% of patients had mild nausea, constipation, stomach cramps, headache, and increased urination.

There have been no serious side effects reported among patients in EnteraGam® clinical trials. The main ingredient, SBI, has been manufactured since 2001, with no serious side effects reported to the manufacturer.

References
  1. Wilson D et al. Evaluation of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects with Diarrhea-Predominant Irritable Bowel Syndrome. Clin MedInsights: Gastroenterol 2013: 6:49-60.

Intended Use

EnteraGam® is a medical food product intended for the dietary management of chronic diarrhea and loose stools. EnteraGam® must be administered under medical supervision.

Important Safety Information:

EnteraGam® contains beef protein: therefore, patients who have an allergy to beef or any other component of EnteraGam® should not take this product. EnteraGam® has not been studied in pregnant women, in women during labor and delivery, or in nursing mothers. The choice to administer EnteraGam® during pregnancy, labor and delivery, or to nursing mothers is at the clinical discretion of the prescribing physician.

EnteraGam® does not contain any milk-derived ingredients such as lactose, casein, or whey. EnteraGam® is gluten-free, dye-free, and soy-free.

Please see full Product Information

To report suspected adverse reactions, contact Entera Health, Inc. at 1-855-4ENTERA (1-855-436-8372), or the FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.