BARACLUDE side effects

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

Some people who have taken medicines like BARACLUDE (a nucleoside analogue) have developed a serious condition called lactic acidosis (buildup of acid in the blood). Lactic acidosis is a medical emergency and must be treated in the hospital. Call your healthcare provider right away if you get any of the following signs 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.

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). Call your healthcare provider right away if you get any of the following signs 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.

Your hepatitis B infection may get worse or become very serious if you stop BARACLUDE.

• Take BARACLUDE exactly as prescribed.
• Do not run out of BARACLUDE.
• Do NOT STOP taking BARACLUDE without talking to your healthcare provider.

Your healthcare provider will need to monitor your health and do regular blood tests to check your liver if you stop 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 (human immunodeficiency virus) infection, be sure to discuss your treatment with your doctor. If you are taking BARACLUDE to treat chronic hepatitis B and are not taking medicines for your HIV at the same time, some HIV treatments that you take in the future may be less likely to work. You are advised to get an HIV test before you start taking BARACLUDE and anytime after that when there is a chance you were exposed to HIV. BARACLUDE will not help your HIV infection.

The most common side effects of BARACLUDE are:

• Headache
• Tiredness
• Dizziness
• Nausea

Less common side effects include diarrhea, indigestion, vomiting, sleepiness, and trouble sleeping. There have also been occasional reports of rash. In some patients, the results of blood tests that measure how the liver or pancreas is working may worsen.

These are not all the side effects of BARACLUDE. The list of side effects is not complete at this time because BARACLUDE is still under study. Report any new or continuing symptoms to your healthcare provider. If you have any questions about side effects, ask your healthcare provider. Your healthcare provider may be able to help you manage these side effects or change your therapy.