Drug Safety Information for VIBERZI (Eluxadoline)

FDA Safety-related Labeling Changes for VIBERZI (ELUXADOLINE) Rx Drug: Safety Information Link

Required post-approval safety study:

Conduct a dose ranging study to determine the safety and effectiveness of eluxadoline in pediatric patients 6 through 17 years with diarrhea-predominant irritable bowel syndrome (IBS-D). The pharmacokinetics of eluxadoline in these pediatric patients should also be characterized. Due Date: 2020-01-15

Original FDA Drug Approval Date for VIBERZI: 2015-05-27

FDA Adverse Event Summary for VIBERZI (Eluxadoline) Unavailable


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Eluxadoline (Viberzi)

Charts are based on reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

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Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.