Medications and Drugs

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Brand Names: Baraclude

Generic Name: entecavir (Pronunciation: en TEK a vir)

• What is entecavir (Baraclude)?
• What are the possible side effects of entecavir (Baraclude)?
• What is the most important information I should know about entecavir (Baraclude)?
• What should I discuss with my healthcare provider before taking entecavir (Baraclude)?
• How should I take entecavir (Baraclude)?
• What happens if I miss a dose (Baraclude)?
• What happens if I overdose (Baraclude)?
• What should I avoid while taking entecavir (Baraclude)?
• What other drugs will affect entecavir (Baraclude)?
• Where can I get more information?

What is entecavir (Baraclude)?

Entecavir is an antiviral medication. Entecavir prevents certain virus cells from multiplying in your body

Entecavir is used to treat chronic hepatitis B.

Entecavir may also be used for other purposes not listed in this medication guide.

Baraclude 0.5 mg

triangular, white, imprinted with BMS, 1611

Baraclude 1 mg

triangular, pink, imprinted with BMS, 1612

What are the possible side effects of entecavir (Baraclude)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:

• muscle pain or weakness;
• numb or cold feeling in your arms and legs;
• trouble breathing;
• feeling dizzy, light-headed, tired, or very weak;
• stomach pain, nausea with vomiting; or
• slow or uneven heart rate.

Entecavir may also cause severe liver symptoms. Call your doctor at once if you have any of these liver symptoms:

• low fever;
• nausea, stomach pain, loss of appetite;
• dark urine, clay-colored stools; or
• jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• mild nausea, vomiting, diarrhea, upset stomach;
• temporary hair loss;
• headache;
• skin rash; or
• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about entecavir (Baraclude)?

You should not take this medication if you are allergic to entecavir, or if you also have HIV (human immunodeficiency virus) that is not being treated.

Some people have developed a life-threatening condition called lactic acidosis while taking enteavir. Early signs of lactic acidosis generally get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

Entecavir may also cause severe liver symptoms such as nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Call your doctor at once if you have any of these symptoms.

Some people with hepatitis B develop liver symptoms after they stop taking entecavir, even months after stopping. Your doctor may want to check your liver function on a regular basis for several months after you stop using this medication. Do not miss any scheduled visits.