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More frequently reported side effects include: glycosuria, hematuria, increased serum aspartate aminotransferase, and increased serum lipase. See below for a comprehensive list of adverse effects.For the Consumer
Applies to entecavir: oral solution, oral tablet
Oral route (Tablet; Solution)
Severe acute exacerbations of hepatitis B have been reported upon discontinuation of anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely for at least several months in patients who discontinue therapy and reinitiation of anti-hepatitis B therapy may be warranted. Entecavir is not recommended in HIV/HBV co-infected patients not treated with highly active antiretroviral therapy because there is potential for the development of resistance to HIV nucleoside reverse transcriptase inhibitors. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogue inhibitors.
Along with its needed effects, entecavir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking entecavir:
Incidence not known
Some side effects of entecavir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
For Healthcare Professionals
Applies to entecavir: oral solution, oral tabletGeneral
The most common side effects reported in patients with chronic hepatitis B virus (HBV) infection and compensated liver disease during clinical trials have included headache, fatigue, dizziness, and nausea. One percent of patients discontinued therapy due to side effects or laboratory abnormalities (compared to 4% of lamivudine-treated patients).
The most common side effects reported in patients with chronic HBV infection and evidence of hepatic decompensation (n=102) through Week 48 of a study have included peripheral edema, ascites, pyrexia, hepatic encephalopathy, and upper respiratory infection. The cumulative death rate was 23% with entecavir during the first 48 weeks of therapy (compared to 33% with adefovir). The majority of deaths were due to liver-related causes such as hepatic failure, hepatic encephalopathy, hepatorenal syndrome, and upper gastrointestinal hemorrhage. Through Week 48, up to 7% of patients discontinued this drug due to a side effect.Hepatic
Very common (10% or more): Elevated ALT (up to 12%), posttreatment exacerbation of hepatitis/ALT flare (up to 12%), deaths due to liver-related causes (e.g., hepatic failure, hepatic encephalopathy, hepatorenal syndrome, upper gastrointestinal hemorrhage; 11%), hepatic encephalopathy (10%)
Common (1% to 10%): On-treatment exacerbation of hepatitis/ALT flares
Frequency not reported: Elevated AST, lactic acidosis and severe hepatomegaly with steatosis (including fatal cases), severe acute exacerbations of hepatitis B (after discontinuation of therapy)
Postmarketing reports: Increased transaminases
Elevated ALT (greater than 10 times ULN and greater than 2 times baseline: up to 2%; greater than 5 times ULN: up to 12%; greater than 3 times baseline: up to 5%; greater than 2 times baseline [with total bilirubin greater than 2 times ULN and greater than 2 times baseline]: up to 1%) and total bilirubin (greater than 2.5 times ULN; up to 3%) have been reported.
Posttreatment exacerbations of hepatitis or ALT flare, as defined by ALT greater than 10 times ULN and greater than 2 times baseline, have been reported in patients who discontinued therapy 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 this drug without regard to treatment response.
Hepatic encephalopathy and deaths due to liver-related causes (such as hepatic failure, hepatic encephalopathy, hepatorenal syndrome, and upper gastrointestinal hemorrhage) were reported in patients with hepatic decompensation.Hematologic
Decreased albumin (less than 2.5 g/dL) and platelets (less than 50,000/mm3) were reported in 30% and 20% of patients with hepatic decompensation, respectively.
Very common (10% or more): Decreased albumin (up to 30%), decreased platelets (up to 20%)Gastrointestinal
Very common (10% or more): Elevated lipase (up to 18%)
Common (1% to 10%): Diarrhea, dyspepsia, nausea, vomiting, elevated amylase
Frequency not reported: Abdominal pain (unspecified), upper abdominal pain, upper gastrointestinal hemorrhage
Elevated lipase (greater than 3 times baseline: up to 18%; at least 2.1 times upper limit of normal [ULN]: 7%) and amylase (greater than 3 times baseline: 2%) have been reported.Other
Very common (10% or more): Peripheral edema (16%), ascites (15%), pyrexia/fever (14%)
Common (1% to 10%): Fatigue
Frequency not reported: Accidental injury, influenza
Peripheral edema, ascites, and pyrexia were reported in patients with hepatic decompensation.Oncologic
Very common (10% or more): Hepatocellular carcinoma (up to 12%)
Frequency not reported: Malignant neoplasms
Hepatocellular carcinoma was reported in patients with hepatic decompensation.
Malignant neoplasms, occurring at a rate of 8.4 per 1000 patient-years, have been reported.Renal
Confirmed creatinine increase of at least 0.5 mg/dL was reported in up to 2% of patients with compensated liver disease. Confirmed increase in serum creatinine of 0.5 mg/dL (11%) and renal failure were reported in patients with hepatic decompensation.
Very common (10% or more): Increased serum creatinine (up to 11%)
Uncommon (0.1% to 1%): Renal failureRespiratory
Very common (10% or more): Upper respiratory infection (10%)
Frequency not reported: Cough, nasopharyngitis, rhinitis
Upper respiratory infection was reported in patients with hepatic decompensation.Metabolic
Common (1% to 10%): Elevated fasting hyperglycemia, decreased blood bicarbonate
Frequency not reported: Elevated alkaline phosphatase
Postmarketing reports: Lactic acidosis
Elevated fasting hyperglycemia (greater than 250 mg/dL) was reported in up to 3% of patients.
Decreased blood bicarbonate was reported in patients with hepatic decompensation.
Lactic acidosis was often associated with hepatic decompensation, other serious medical conditions, or drug exposures.Genitourinary
Common (1% to 10%): Hematuria, glycosuria
Frequency not reported: Dysuria
Grade 3 to 4 hematuria (9%) and glycosuria (4%) were reported.Nervous system
Common (1% to 10%): Headache, dizziness, somnolencePsychiatric
Common (1% to 10%): InsomniaHypersensitivity
Postmarketing reports: Anaphylactoid reactionDermatologic
Frequency not reported: Erythema, photosensitivity with lethargy
Postmarketing reports: Rash, alopeciaMusculoskeletal
Frequency not reported: Arthralgia, myalgia, back pain
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