BARACLUDE (entecavir) side effects

All medicines have benefits and risks. BARACLUDE^® (entecavir) may cause the following serious side effects:

Your hepatitis B virus infection may get worse if you stop taking BARACLUDE. This usually happens within 6 months after stopping BARACLUDE.

• Take BARACLUDE exactly as prescribed.
• Do not run out of BARACLUDE.
• Do not stop BARACLUDE without talking to your healthcare provider.
• Your healthcare provider should monitor your health and do regular blood tests to check your liver if you stop taking BARACLUDE.

Tell your healthcare provider right away about any new or unusual symptoms that you notice after you stop taking BARACLUDE.

If you have or get HIV that is not being treated with medicines while taking BARACLUDE, the HIV virus may develop resistance to certain HIV medicines and become harder to treat. You should get an HIV test before you start taking BARACLUDE and anytime after that when there is a chance you were exposed to HIV.

BARACLUDE can cause serious side effects including:

Lactic acidosis (buildup of acid in the blood). Some people who have taken BARACLUDE or medicines like BARACLUDE (a nucleoside analogue) have developed a serious condition called lactic acidosis. Lactic acidosis is a serious medical emergency that can cause death. Lactic acidosis must be treated in the hospital. Reports of lactic acidosis with BARACLUDE generally involved patients who were seriously ill due to their liver disease or other medical condition.

Call your healthcare provider right away if you get any of the following signs or symptoms of lactic acidosis:

• You feel very weak or tired.
• You have unusual (not normal) muscle pain.
• You have trouble breathing.
• You have stomach pain with nausea and vomiting.
• You feel cold, especially in your arms and legs.
• You feel dizzy or light-headed.
• You have a fast or irregular heartbeat.

Serious liver problems. Some people who have taken medicines like BARACLUDE have developed serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Hepatomegaly with steatosis is a serious medical emergency that can cause death.

Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:

• Your skin or the white part of your eyes turns yellow (jaundice).
• Your urine turns dark.
• Your bowel movements (stools) turn light in color.
• You don’t feel like eating food for several days or longer.
• You feel sick to your stomach (nausea).
• You have lower stomach pain. You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight, or have been taking nucleoside analogue medicines, like BARACLUDE, for a long time.

The most common side effects of BARACLUDE include:

• headache
• tiredness
• dizziness
• nausea.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of BARACLUDE. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.