Baraclude Side Effects

Generic Name: entecavir

Please note - some side effects for Baraclude may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Baraclude - for the Consumer

Baraclude

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Baraclude:

Diarrhea; dizziness; drowsiness; headache; indigestion; nausea; tiredness; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark-colored urine; difficulty breathing; fast or irregular heartbeat; feeling cold, especially in the arms or legs; light-colored bowel movements; loss of appetite for several days; muscle pain; severe dizziness or lightheadedness; severe or prolonged nausea or vomiting; severe tiredness; stomach pain (with or without nausea or vomiting); weakness; yellowing of the skin or eyes.

Baraclude Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Baraclude Solution:

Diarrhea; dizziness; drowsiness; headache; indigestion; nausea; tiredness; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark-colored urine; difficulty breathing; fast or irregular heartbeat; feeling cold, especially in the arms or legs; light-colored bowel movements; loss of appetite for several days; muscle pain; severe dizziness or lightheadedness; severe or prolonged nausea or vomiting; severe tiredness; stomach pain (with or without nausea or vomiting); weakness; yellowing of the skin or eyes.

Baraclude Side Effects - for the Professional

Baraclude

• Most common adverse reactions (≥3%, all severity grades) are headache, fatigue, dizziness, and nausea. (6.1)

Side Effects by Body System

General

The most common side effects reported during clinical trials have included headache, fatigue, dizziness, and nausea. One percent of patients discontinued treatment due to side effects or laboratory abnormalities (compared to 4% of lamivudine-treated patients).

Hepatic

Hepatic side effects have included elevations in ALT (greater than 10 times ULN, 2%; greater than 5 times ULN, 5%), AST (greater than 5 times ULN, 5%), bilirubin (greater than 2.5 g/dL, 2% to 3%), amylase (greater than or equal to 2.1 times ULN, 2% to 3%), lipase (greater than or equal to 2.1 times ULN, 7%), ALT flares (2%), and alkaline phosphatase (greater than or equal to 5.1 times ULN, less than 1%). Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside/nucleotide analogs alone or in combination with other antiretroviral agents. Severe acute exacerbations of hepatitis have been reported in patients with hepatitis B after discontinuation of entecavir.

Posttreatment exacerbations of hepatitis, as defined by ALT greater than 10 times ULN and greater than 2 times baseline, have been reported in patients who discontinued treatment at or after 52 weeks after achieving a defined treatment response (nucleoside-naive HBeAg-positive, 2%; nucleoside-naive HBeAg-negative, 8%; lamivudine-refractory, 12%). The median time to exacerbation was 23 to 24 weeks. The rate may be higher in patients who discontinue entecavir without regard to treatment response.

Genitourinary

Genitourinary side effects have included hematuria (9%), glycosuria (4%), and dysuria.

Nervous system

Nervous system side effects have included headache (2% to 4%), dizziness, and somnolence.

Other

Other side effects have included fatigue (1% to 3%), fever, accidental injury, influenza, and back pain.

Hematologic

Hematologic side effects have included decreased platelets (less than 1%).

Metabolic

Metabolic side effects have included fasting hyperglycemia greater than 250 mg/dL (2% to 3%) and decreased serum albumin.

Renal

Renal side effects have included serum creatinine increases of 0.5 mg/dL or more (1% to 2%).

Gastrointestinal

Gastrointestinal side effects have included upper abdominal pain and Grade 2 to 4 diarrhea (1% or less), dyspepsia (1% or less), nausea (less than 1%), and vomiting (less than 1%). Abdominal pain (unspecified) has also been reported.

Oncologic

Oncologic side effects have included malignant neoplasms occurring at a rate of 8.4 per 1000 patient-years.

Respiratory

Respiratory side effects have included upper respiratory tract infection, cough, nasopharyngitis, and rhinitis.

Psychiatric

Psychiatric side effects have rarely included insomnia.

Dermatologic

Dermatologic side effects have included erythema. Rash and alopecia have been reported during postmarketing experience.

Hypersensitivity

Hypersensitivity side effects have included photosensitivity with lethargy in at least one patient, which resolved after stopping entecavir.

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