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BYDUREON Side Effects

It is important to not only understand how BYDUREON works, but also to understand the risks associated with BYDUREON. Explore the links below to learn more about the safety considerations of BYDUREON.

Possible thyroid tumors, including cancer

During the drug testing process, the medicine in BYDUREON caused rats to develop tumors of the thyroid gland. Some of these tumors were cancer. It is not known if BYDUREON will cause thyroid tumors or a type of thyroid cancer called medullary thyroid cancer in people.

  • Before you start using BYDUREON, tell your healthcare provider if you or any of your family members have had thyroid cancer, especially medullary thyroid cancer, or Multiple Endocrine Neoplasia syndrome type 2. Do not use BYDUREON if you or any of your family members have medullary thyroid cancer, or if you have Multiple Endocrine Neoplasia syndrome type 2. People with these conditions already have a higher chance of developing medullary thyroid cancer in general and should not use BYDUREON
  • While using BYDUREON, 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

Allergic reaction

Do not use BYDUREON if you have had an allergic reaction to exenatide or any of the other ingredients in BYDUREON. Severe allergic reactions can happen with BYDUREON. Symptoms of a severe allergic reaction to BYDUREON are severe rash or itching, swelling of your face, lips, and throat that may cause difficulty breathing or swallowing, feeling faint or dizzy, and very rapid heartbeat. If you have any symptoms of a severe allergic reaction, stop using BYDUREON and call your healthcare provider right away.

Pancreatitis

Inflammation of the pancreas (pancreatitis) may happen, which may be severe and lead to death.

Before using BYDUREON, tell your healthcare provider if you have had:

  • pancreatitis
  • stones in your gallbladder (gallstones)
  • a history of alcoholism
  • high blood triglyceride levels

These medical conditions can make you more likely to get pancreatitis. It is not known if having these conditions will lead to a higher chance of getting pancreatitis while using BYDUREON.

Stop using BYDUREON and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may happen with or without vomiting. The pain may be felt going from your abdomen through to your back. This type of pain may be a symptom of pancreatitis.

Hypoglycemia

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar is higher if you use BYDUREON with another medicine that can cause low blood sugar, such as a sulfonylurea. The dose of your sulfonylurea medicine may need to be lowered while you use BYDUREON. Signs and symptoms of low blood sugar may include:

  • shakiness
  • sweating
  • headache
  • drowsiness
  • weakness
  • dizziness
  • confusion
  • irritability
  • hunger
  • fast heartbeat
  • feeling jittery

Talk with your healthcare provider about how to recognize and treat low blood sugar. Make sure that your family and other people around you a lot know how to recognize and treat low blood sugar.

Kidney and stomach problems

Kidney problems (kidney failure). BYDUREON may cause nausea, vomiting, or diarrhea leading to loss of fluids (dehydration). Dehydration may cause kidney failure, which can lead to the need for dialysis. This can happen in people who have never had kidney problems before. Drinking plenty of fluids may reduce your chance of dehydration. Call your healthcare provider right away if you have nausea, vomiting, or diarrhea that will not go away, or if you cannot drink liquids by mouth.

Stomach problems. Tell your healthcare provider if you have severe problems with your stomach, such as delayed emptying of your stomach (gastroparesis) or problems with digesting food.

Injection-site reactions

Serious injection-site reactions, with or without bumps (nodules), have happened in some people who use BYDUREON. Some of these injection-site reactions have required surgical intervention. Call your healthcare provider right away if you have severe pain, swelling, blisters, an open wound, or a dark scab at your injection site.

Most common side effects

The most common side effects of BYDUREON include:

  • nausea
  • diarrhea
  • headache
  • vomiting
  • constipation
  • itching at the injection site
  • a small bump (nodule) at the injection site
  • indigestion

Nausea is most common when you first start using BYDUREON, but decreases over time in most people as their body gets used to the medicine.

Talk to your healthcare provider about any side effect that bothers you or does not go away.

These are not all the side effects of BYDUREON. 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 or visit www.fda.gov/medwatch.

Drug interactions, pregnancy, and breastfeeding

Drug interactions. Before using BYDUREON, tell your doctor about all the medicines you use, as using them with BYDUREON may affect how each medicine works. Tell your healthcare provider if you use other diabetes medicines, especially insulin or a sulfonylurea, or warfarin sodium (Coumadin® or Jantoven®).

Pregnancy and breastfeeding. Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if BYDUREON will harm your unborn baby. Talk to your healthcare provider first if you are breastfeeding or plan to breastfeed.

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