Entecavir Side Effects

Not all side effects for entecavir may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to entecavir: oral solution, oral tablet

In addition to its needed effects, some unwanted effects may be caused by entecavir. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking entecavir:

Incidence not known
  • Abdominal or stomach discomfort
  • cough
  • decreased appetite
  • diarrhea
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • fast, shallow breathing
  • general feeling of discomfort
  • hives, itching, or rash
  • muscle pain or cramping
  • nausea
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • right upper abdominal or stomach pain and fullness
  • sleepiness
  • tightness in the chest
  • unusual tiredness or weakness

Some of the side effects that can occur with entecavir may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common
  • Acid or sour stomach
  • belching
  • headache
  • heartburn
  • indigestion
  • stomach discomfort, upset, or pain
Rare
  • Trouble sleeping
  • Unusual drowsiness
Incidence not known
  • Hair loss
  • thinning of the hair

For Healthcare Professionals

Applies to entecavir: oral solution, oral tablet

General

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 failure

Respiratory

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, somnolence

Psychiatric

Common (1% to 10%): Insomnia

Hypersensitivity

Postmarketing reports: Anaphylactoid reaction

Dermatologic

Frequency not reported: Erythema, photosensitivity with lethargy
Postmarketing reports: Rash, alopecia

Musculoskeletal

Frequency not reported: Arthralgia, myalgia, back pain

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