BYDUREON BCise may cause serious side effects, including:
- POSSIBLE THYROID TUMORS, INCLUDING CANCER Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In animal studies, BYDUREON and medicines that work like it caused thyroid tumors, including thyroid cancer. It is not known if BYDUREON BCise will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people
- Do not use BYDUREON BCise if you or any of your family members have ever had MTC or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- Do not use BYDUREON BCise if you have had an allergic reaction to exenatide or any of the other ingredients in BYDUREON BCise
- Inflammation of the pancreas (pancreatitis) Stop using BYDUREON BCise and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back
- Low blood sugar (hypoglycemia) Your risk for getting low blood sugar may be higher if you use BYDUREON BCise with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Tell your healthcare provider if you take other diabetes medicines. Talk to your healthcare provider about managing low blood sugar. Signs and symptoms of low blood sugar include dizziness or lightheadedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery
- Kidney problems (kidney failure) Tell your healthcare provider if you have or had kidney problems. In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse
- Stomach problems Tell your healthcare provider if you have severe stomach problems, such as slowed emptying of your stomach (gastroparesis) or problems digesting food. Other medicines like BYDUREON BCise may cause severe stomach problems. It is not known if BYDUREON BCise causes or worsens stomach problems
- Serious allergic reactions Stop using BYDUREON BCise and get medical help right away if you have any symptoms of a serious allergic reaction, including itching, rash, or difficulty breathing
- Injection-site reactions Serious injection-site reactions, with or without bumps (nodules), have happened in some people who use BYDUREON BCise. Some of these injection-site reactions have required surgery. Call your healthcare provider if you have any symptoms of injection-site reactions, including severe pain, swelling, blisters, an open wound, or a dark scab
- Gallbladder problems have happened in some people who take BYDUREON or other medicines like it. Tell your healthcare provider right away if you get symptoms of gallbladder problems including pain in the right or middle upper stomach area, nausea and vomiting, fever, or your skin or the white part of your eyes turns yellow
The most common adverse reactions with BYDUREON BCise include a bump at the injection site and nausea. Other side effects that occur less often include headache, diarrhea, vomiting, injection site itching and redness, dizziness, and constipation.
These are not all the possible side effects of BYDUREON BCise. See the Important Safety Information for more information and talk to your healthcare provider if you have any side effects that bother you or do not go away.
Also, talk to your healthcare provider if you have any changes in your medical condition or the medicines you take.
For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.