Lamivudine Side Effects

Some side effects of lamivudine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to lamivudine: oral solution, oral tablet

Along with its needed effects, lamivudine 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:

More common—especially in children
  • Abdominal or stomach pain (severe)
  • feeling of fullness
  • nausea
  • sensation or pins and needles
  • skin rash
  • stabbing pain
  • tingling, burning, numbness, or pain in the hands, arms, feet, or legs
  • unsteadiness or awkwardness
  • vomiting
Rare
  • Abdominal discomfort
  • decreased appetite
  • diarrhea
  • fast, shallow breathing
  • feeling of fullness
  • fever, chills, or sore throat
  • general feeling of discomfort
  • muscle pain or cramping
  • nausea
  • shortness of breath
  • sleepiness
  • unusual tiredness or weakness
Incidence not determined
  • Cough
  • dark urine
  • difficulty swallowing
  • dizziness
  • fast heartbeat
  • fever
  • hives or welts
  • itching
  • light-colored stools
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness of skin
  • tightness in chest
  • upper right abdominal pain
  • wheezing
  • yellow eyes and skin

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
  • Canker sores
  • difficulty in moving
  • discouragement
  • ear discharge
  • ear swelling
  • feeling sad or empty
  • general feeling of discomfort or illness
  • irritability
  • loss of appetite
  • loss of interest or pleasure
  • nasal discharge or congestion
  • pain in joints
  • sores, ulcers, or white spots on lips or tongue or inside the mouth
  • stomach pain or cramps
  • swollen and painful spots on neck, armpit, or groin
  • swollen joints
  • trouble concentrating
  • trouble sleeping
  • unusually warm skin
  • weight loss
Less common
  • Acid or sour stomach
  • belching
  • cough
  • heartburn
  • indigestion
  • stomach discomfort or upset

For Healthcare Professionals

Applies to lamivudine: oral solution, oral tablet

General

The most common side effects reported with lamivudine 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.

Nervous system

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

Gastrointestinal

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

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

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

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.

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

Respiratory

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

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

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

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.

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

Dermatologic

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

Psychiatric

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

Hypersensitivity

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

Immunologic

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

Renal

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

Ocular

Frequency not reported: Eye redness

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web2)