Note: This document contains side effect information about lamivudine. Some dosage forms listed on this page may not apply to the brand name Epivir.

Applies to lamivudine: oral solution, oral tablet.

Serious side effects of Epivir

Along with its needed effects, lamivudine (the active ingredient contained in Epivir) 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 lamivudine:

Incidence not known

• Black, tarry stools
• bleeding gums
• bloating
• blood in the urine or stools
• blurred vision
• chills
• constipation
• cough
• dark urine
• decreased appetite
• diarrhea
• difficulty with swallowing
• dizziness
• dry mouth
• fast heartbeat
• fast, shallow breathing
• fever
• flushed, dry skin
• fruit-like breath odor
• general feeling of discomfort
• general tiredness and weakness
• increased hunger
• increased thirst
• increased urination
• indigestion
• light-colored stools
• loss of appetite
• muscle cramps, pain, stiffness, or spasms
• nausea
• 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
• stomach discomfort
• tightness in the chest
• troubled breathing with exertion
• unexplained weight loss
• unusual bleeding or bruising
• unusual tiredness or weakness
• upper right abdominal or stomach pain
• vomiting
• yellow eyes or skin

Other side effects of Epivir

Some side effects of lamivudine 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:

More common

• Belching
• burning, tingling, numbness or pain in the hands, arms, feet, or legs
• depression
• general feeling of discomfort or illness
• headache
• heartburn
• indigestion
• 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

• Hair loss or thinning of the hair
• pale skin
• sweating
• weight gain around your neck, upper back, breast, face, or waist

For Healthcare Professionals

Applies to lamivudine: oral solution, oral tablet.

General

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) monotherapy.^[Ref]

Gastrointestinal

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).^[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, pancreatitis^[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

Postmarketing reports: Peripheral neuropathy, paresthesia^[Ref]

Other

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, increased blood lipid levels

Combination antiretroviral therapy:

-Frequency not reported: Fat loss, fat gain^[Ref]

Hepatic

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]

Psychiatric

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]

Dermatologic

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, rash, pruritus, alopecia^[Ref]

Respiratory

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]

Hematologic

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.^[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, anemia (including pure red cell aplasia), thrombocytopenia^[Ref]

Musculoskeletal

Elevated CPK (at least 7 x baseline) has been reported in 9% of patients.^[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, elevated CPK, rhabdomyolysis, muscle disorders (including myalgia, cramps)^[Ref]

Metabolic

Very common (10% or more): Anorexia (up to 12%)

Common (1% to 10%): Anorexia and/or decreased appetite, hypertriglyceridemia, hyperamylasemia, abnormal enzyme levels

Uncommon (0.1% to 1%): Eating problems, disorders of thirst/fluid intake

Very rare (less than 0.01%): Lactic acidosis

Postmarketing reports: Hyperglycemia, redistribution/accumulation of body fat, hyperlactatemia, lactic acidosis

Antiretroviral therapy:

-Frequency not reported: Increased glucose levels^[Ref]

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

Hypersensitivity

Frequency not reported: Anaphylactoid reaction

Postmarketing reports: Anaphylaxis^[Ref]

Immunologic

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

Renal

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

Ocular

Frequency not reported: Eye redness^[Ref]