VIBERZI can cause serious side effects, including: • Inflammation of the pancreas (pancreatitis). Pancreatitis has happened most often in people who do not have a gallbladder and can lead to hospitalization. Pancreatitis has led to death in some people who do not have a gallbladder. Pancreatitis usually happens within the first week of treatment with VIBERZI, but can happen after 1 to 2 doses of VIBERZI. Your risk of getting pancreatitis is increased if you drink more than 3 alcoholic drinks a day. Limit your use of alcoholic drinks while you are taking VIBERZI. • A spasm in a muscle of the digestive system (called the sphincter of Oddi), which may cause new or worsening abdominal pain. Sphincter of Oddi spasm has happened most often in people who do not have a gallbladder and can lead to hospitalization. This spasm usually happens within the first week of treatment, but can happen after 1 to 2 doses of VIBERZI. Stop taking VIBERZI right away and get emergency medical care if you have new or worsening stomach-area (abdomen) pain or pain in the upper right side of your stomach-area (abdomen) that may move to your back or shoulder, with or without nausea and vomiting. • Serious allergic reactions have happened in some people after taking 1 or 2 doses of VIBERZI. Stop taking VIBERZI right away and get emergency medical care if you have signs or symptoms of an allergic reaction, including: swelling of your face, lips, mouth or tongue; shortness of breath or other breathing problems; itching, rash, or hives. Do not take VIBERZI if you: • Do not have a gallbladder • Have or may have had a blockage in your gallbladder or a sphincter of Oddi problem • Have or had problems with alcohol abuse, alcohol addiction, or drink more than 3 alcoholic drinks a day • Have had pancreatitis or other pancreas problems, including if you have had or may have had a blockage in your pancreas • Have had an allergic reaction to VIBERZI • Have severe liver problems • Have had long-lasting (chronic) or severe constipation, or problems caused by constipation • Have or may have had a bowel blockage (intestinal obstruction)
