Epivir 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.

Not all side effects for Epivir 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 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). 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 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 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

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

General

The most common side effects reported with lamivudine (the active ingredient contained in Epivir) have included headache, nausea, malaise, fatigue, nasal signs and symptoms, diarrhea, and cough. During clinical studies, HIV-1-infected patients received lamivudine plus zidovudine. Patients with hepatitis B received lamivudine monotherapy.

Lamivudine side effects were sometimes difficult to distinguish from the symptomatology observed during the clinical course of AIDS, as well as from the possible side effects of other drugs used in the treatment of HIV-1 infection. Many of the side effects associated with nucleoside reverse transcriptase inhibitor therapy (myopathy, pancreatitis, liver failure, lactic acidosis, etc.) are attributable to their direct toxic effect on mitochondria which causes decreased mitochondrial energy generating capacity.[Ref]

Nervous system

Very common (10% or more): Headache (35%), neuropathy (12%), dizziness (10%)
Postmarketing reports: Peripheral neuropathy, paresthesia[Ref]

Gastrointestinal

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 (33%), diarrhea (up to 18%), nausea and vomiting (13%), increased serum lipase (at least 2.5 times upper limit of normal [ULN]: 10%)
Common (1% to 10%): Abdominal pain (9%), abdominal cramps (6%), dyspepsia (5%), increased amylase (greater than 2 times ULN: up to 4.2%)
Uncommon (0.1% to 1%): Pancreatitis (0.3%)
Frequency not reported: Abdominal discomfort and pain, increased amylase (greater than 3 times ULN), oral ulcerations, lesions
Postmarketing reports: Pancreatitis, stomatitis[Ref]

Hepatic

Common (1% to 10%): Elevated AST (greater than 5 times ULN: up to 4%), elevated ALT (greater than 5 times ULN: up to 3.8%)
Uncommon (0.1% to 1%): Elevated bilirubin (greater than 2.5 times ULN: 0.8%)
Frequency not reported: Elevated ALT (greater than 3 times ULN), severe hepatomegaly with steatosis, hepatic decompensation
Postmarketing reports: Lactic acidosis and hepatic steatosis, posttreatment exacerbation of hepatitis B[Ref]

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of lamivudine and other nucleoside analogs alone or in combination with other antiretroviral agents.

Severe acute exacerbations of hepatitis B, including fatalities, have been reported in patients with HBV (including those coinfected with HIV-1) who have discontinued lamivudine. The causal relationship to stopping lamivudine treatment was unknown.

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.[Ref]

Other

Very common (10% or more): Malaise and fatigue (27%); ear, nose, and throat infections (25%); sore throat (13%)
Common (1% to 10%): Fever or chills (10%)
Postmarketing reports: Weakness[Ref]

Respiratory

Very common (10% or more): Nasal signs and symptoms (20%), cough (18%)
Postmarketing reports: Abnormal breath sounds/wheezing[Ref]

Hematologic

Very common (10% or more): Decreased absolute neutrophil count (less than 750/mm3: up to 15%)
Common (1% to 10%): Decreased platelets (less than 50,000/mm3: up to 4%), decreased hemoglobin (less than 8 g/dL: up to 2.9%)
Postmarketing reports: Anemia (including pure red cell aplasia and severe anemias progressing on therapy), lymphadenopathy, splenomegaly, thrombocytopenia[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (12%)
Common (1% to 10%): Increased creatine phosphokinase (at least 7 times baseline: 9%), myalgia (8%), arthralgia (5%)
Postmarketing reports: Muscle weakness, elevated creatine phosphokinase, rhabdomyolysis, cramps[Ref]

Metabolic

Although progressive subcutaneous fat wasting has been attributed to the use of protease inhibitors, nucleoside reverse transcriptase inhibitors may have an independent contribution. This syndrome has been observed in patients naive to protease inhibitors, however, not to the same degree as in patients on a combination regimen that includes a protease inhibitor.[Ref]

Very common (10% or more): Anorexia and/or decreased appetite (10%)
Frequency not reported: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance"), progressive subcutaneous fat wasting
Postmarketing reports: Hyperglycemia, redistribution/accumulation of body fat[Ref]

Dermatologic

Common (1% to 10%): Skin rashes (9%)
Frequency not reported: Paronychia, periungual pyogenic granulomata
Postmarketing reports: Alopecia, rash, pruritus[Ref]

Psychiatric

Very common (10% or more): Insomnia and other sleep disorders (11%)
Common (1% to 10%): Depressive disorders (9%)[Ref]

Hypersensitivity

Frequency not reported: Angioedema, anaphylactoid reaction
Postmarketing reports: Anaphylaxis, urticaria[Ref]

Immunologic

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

Renal

Rare (less than 0.1%): Fanconi syndrome (at least 1 case)[Ref]

Ocular

Frequency not reported: Eye redness[Ref]

References

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2. Rivkina A, Rybalov S "Chronic hepatitis B: current and future treatment options." Pharmacotherapy 22 (2002): 721-37

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16. Asari A, Iles-Smith H, Chen YC, et al. "Pharmacokinetics of lamivudine in subjects receiving peritoneal dialysis in end-stage renal failure." Br J Clin Pharmacol 64 (2007): 738-44

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