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Epivir-HBV Side Effects

Generic Name: lamivudine

Note: This page contains information about the side effects of lamivudine. Some of the dosage forms included on this document may not apply to the brand name Epivir-HBV.

For the Consumer

Applies to lamivudine: oral solution, oral tablet

In addition to its needed effects, some unwanted effects may be caused by lamivudine (the active ingredient contained in Epivir-HBV). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

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

Incidence not known:
  • Abdominal or stomach discomfort
  • black, tarry stools
  • bleeding gums
  • bloating
  • blood in the urine or stools
  • chills
  • constipation
  • cough
  • darkened urine
  • decreased appetite
  • diarrhea
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • fast, shallow breathing
  • fever
  • general feeling of discomfort
  • general tiredness and weakness
  • indigestion
  • light-colored stools
  • loss of appetite
  • muscle cramps or spasms
  • muscle pain or stiffness
  • nausea and vomiting
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • right upper abdominal or stomach pain and fullness
  • skin rash, hives, or itching
  • sleepiness
  • tightness in the chest
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal or stomach pain
  • yellow eyes or skin

Minor Side Effects

Some of the side effects that can occur with lamivudine 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:

More common:
  • Acid or sour stomach
  • belching
  • burning, tingling, numbness or pain in the hands, arms, feet, or legs
  • depression
  • general feeling of discomfort or illness
  • headache
  • heartburn
  • indigestion
  • muscle or joint pain
  • sensation of pins and needles
  • sore throat
  • stabbing pain
  • stomach discomfort, upset, or pain
  • stuffy or runny nose
  • trouble sleeping
  • weight loss
Incidence not known:
  • Blurred vision
  • dry mouth
  • flushed, dry skin
  • fruit-like breath odor
  • hair loss or thinning of the hair
  • increased hunger
  • increased thirst
  • increased urination
  • pale skin
  • sweating
  • troubled breathing with exertion
  • unexplained weight loss
  • weight gain around your neck, upper back, breast, face, or waist

For Healthcare Professionals

Applies to lamivudine: oral solution, oral tablet


The most common side effects reported with this drug have included headache, nausea, malaise, fatigue, nasal signs and symptoms, respiratory tract infections, throat and tonsil discomfort, abdominal discomfort and pain, vomiting, diarrhea, and cough. During clinical studies in HIV-1-infected patients, this drug was used with zidovudine (with or without other antiretroviral agents). Patients with hepatitis B virus (HBV) infection received lamivudine (the active ingredient contained in Epivir-HBV) monotherapy.[Ref]


Increased serum lipase (at least 2.5 times the upper limit of normal [2.5 x ULN]) and amylase (greater than 2 x ULN) have been reported in 10% and up to 4.2% of patients, respectively. Amylase increases greater than 3 x ULN have also been reported.

Pancreatitis has been reported infrequently in adults, but has been more common in pediatric patients (up to 18% in 2 limited studies).

Pancreatitis has also been reported during postmarketing experience.[Ref]

Very common (10% or more): Nausea (up to 42%), diarrhea (up to 18%), vomiting (up to 15%), nausea and vomiting (up to 13%), abdominal discomfort and pain (up to 11.3%)
Common (1% to 10%): Abdominal pain, increased serum lipase, dyspeptic symptoms, abdominal cramps, taste disorders, abdominal discomfort, dyspepsia, increased amylase, upper abdominal pain, fungal gastrointestinal (GI) infection, GI discomfort and pain, gaseous symptoms
Uncommon (0.1% to 1%): Pancreatitis
Rare (0.01% to 0.1%): Abnormal pancreatic enzymes
Frequency not reported: Oral ulcerations, lesions
Postmarketing reports: Stomatitis[Ref]

Nervous system

Very common (10% or more): Headache (up to 35.1%), dizziness (up to 35%), neuropathy (12.4%)
Common (1% to 10%): Hypnagogic effects, peripheral paresthesia
Uncommon (0.1% to 1%): Paresthesia, hypoesthesia
Very rare (less than 0.01%): Peripheral neuropathy[Ref]

Peripheral neuropathy and paresthesia have also been reported during postmarketing experience.[Ref]


Very common (10% or more): Fatigue (up to 29%); malaise and fatigue (up to 27%); ear, nose, and throat infections (up to 25%)
Common (1% to 10%): Fever/chills; fever; malaise; viral ear, nose, and throat infection; viral infection
Postmarketing reports: Weakness

Antiretroviral therapy:
-Frequency not reported: Increased weight[Ref]


Very common (10% or more): Posttreatment ALT elevations (up to 27%), ALT elevations
Common (1% to 10%): Increased liver function tests, elevated AST, elevated ALT, abnormal liver function tests
Uncommon (0.1% to 1%): Elevated bilirubin, transient elevations in liver enzymes (AST, ALT)
Rare (0.01% to 0.1%): Hepatitis
Frequency not reported: Severe hepatomegaly with steatosis, hepatic decompensation, exacerbations of hepatitis/recurrent hepatitis
Postmarketing reports: Hepatic steatosis, posttreatment exacerbation of hepatitis B[Ref]

In HBV patients monitored for up to 16 weeks after discontinuing therapy, posttreatment ALT elevations occurred more often in those who had taken the HBV-specific product than subjects who had taken placebo.

Elevated AST (greater than 5 x ULN), ALT (greater than 5 x ULN), and bilirubin (greater than 2.5 x ULN) have been reported in up to 4%, up to 3.8%, and up to 0.8% of patients, respectively. ALT increases greater than 3 x ULN have also been reported.

Exacerbations of hepatitis (primarily detected by serum ALT elevations) have been reported during HBV therapy and after drug discontinuation. Most events were self-limited; however, fatalities were reported in some cases.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.

Hepatic decompensation (some fatal) has been reported in patients coinfected with HIV-1 and hepatitis C receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin.

Severe acute exacerbations of hepatitis B (including fatalities) have been reported in HBV-infected patients (including those coinfected with HIV-1) who have discontinued this drug. The causal relationship to stopping therapy was unknown.[Ref]


Very common (10% or more): Dreams (up to 26%), sleep disorders (up to 16%), insomnia and other sleep disorders (11%), mood disorders (up to 11%)
Common (1% to 10%): Depressive disorders, anxiety[Ref]


Rash, pruritus, and alopecia have also been reported during postmarketing experience.[Ref]

Very common (10% or more): Rash (up to 23%)
Common (1% to 10%): Alopecia, pruritus, sweating, fungal skin infections, acne and folliculitis, viral skin infection
Rare (0.01% to 0.1%): Angioedema
Frequency not reported: Paronychia, periungual pyogenic granulomata
Postmarketing reports: Urticaria[Ref]


Very common (10% or more): Nasal signs and symptoms (20%), cough (up to 18%), viral respiratory infections (up to 15%), sore throat (13%), throat and tonsil discomfort and pain (up to 11.6%)
Common (1% to 10%): Bronchitis, sinus disorders, sinusitis, throat signs and symptoms, upper respiratory inflammation, breathing disorders
Frequency not reported: Respiratory tract infections, throat and tonsil discomfort
Postmarketing reports: Abnormal breath sounds/wheezing[Ref]


Very common (10% or more): Decreased absolute neutrophil count (up to 15%)
Common (1% to 10%): Lymphatic signs and symptoms, neutropenia, decreased white cells, anemia, decreased platelets, decreased hemoglobin
Uncommon (0.1% to 1%): Thrombocytopenia
Very rare (less than 0.01%): Pure red cell aplasia
Postmarketing reports: Severe anemias progressing on therapy, lymphadenopathy, splenomegaly[Ref]

Decreased absolute neutrophil count (less than 750/mm3), platelets (less than 50,000/mm3), and hemoglobin (less than 8 g/dL) have been reported in up to 15%, up to 4%, and up to 2.9% of patients, respectively.

Severe neutropenia and severe anemia have been reported infrequently.

Anemia (including pure red cell aplasia) and thrombocytopenia have also been reported during postmarketing experience.[Ref]


Elevated CPK (at least 7 x baseline) has been reported in 9% of patients.

Elevated CPK, rhabdomyolysis, and muscle disorders (including myalgia and cramps) have also been reported during postmarketing experience.[Ref]

Very common (10% or more): Musculoskeletal pain (up to 13.5%)
Common (1% to 10%): Elevated creatine phosphokinase (CPK), myalgia, arthralgia, muscle disorders, cramps
Rare (0.01% to 0.1%): Rhabdomyolysis
Frequency not reported: Osteonecrosis
Postmarketing reports: Muscle weakness[Ref]


Very common (10% or more): Anorexia (up to 12%)
Common (1% to 10%): Anorexia and/or decreased appetite, hypertriglyceridemia, hyperamylasemia, hyperlactatemia, abnormal enzyme levels
Uncommon (0.1% to 1%): Eating problems, disorders of thirst/fluid intake
Rare (0.01% to 0.1%): Lactic acidosis
Postmarketing reports: Hyperglycemia, redistribution/accumulation of body fat

Antiretroviral therapy:
-Frequency not reported: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance"), increased blood lipid levels, increased glucose levels[Ref]

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.

Redistribution/accumulation of body fat has been reported with antiretroviral therapy; causality has not been established.[Ref]


Frequency not reported: Anaphylactoid reaction
Postmarketing reports: Anaphylaxis[Ref]


Frequency not reported: Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)[Ref]


Frequency not reported: Fanconi syndrome (at least 1 case)[Ref]


Frequency not reported: Eye redness[Ref]


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

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