Lamivudine / zidovudine Side Effects

Not all side effects for lamivudine / zidovudine 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 / zidovudine: oral tablet

In addition to its needed effects, some unwanted effects may be caused by lamivudine / zidovudine. 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 / zidovudine:

More common
  • Chills
  • fever
  • pale skin
  • sore throat
  • unusual tiredness or weakness
Less common
  • Abdominal or stomach pain (severe)
  • burning, tingling, numbness, or pain in the hands, arms, feet, or legs
  • muscle tenderness and weakness
  • nausea
  • skin rash
  • vomiting
  • yellow eyes or skin
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • canker sores
  • chest discomfort or pain
  • chills
  • convulsions
  • dark urine
  • decreased appetite
  • difficulty with breathing
  • difficulty with swallowing
  • dizziness
  • faintness
  • fast, irregular, or pounding heartbeat
  • fast, shallow breathing
  • feeling of fullness
  • general feeling of discomfort
  • general tiredness and weakness
  • hives or welts
  • itching
  • itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
  • jerking of all extremities
  • joint or muscle pain
  • light-colored stools
  • loss of bladder control
  • muscle pain, spasms, stiffness, or cramping
  • red skin lesions often with a purple center
  • red, irritated eyes
  • redness, soreness, or itching skin
  • sensation of pins and needles
  • shortness of breath
  • sleepiness
  • sores, ulcers, or white spots in the mouth or on the lips or tongue
  • sores, welting or blisters
  • stabbing pain
  • sudden loss of consciousness
  • swelling of the feet or lower legs
  • tingling, burning, numbness, or pain in the hands, arms, feet, or legs
  • tightness in the chest
  • troubled with breathing
  • unsteadiness or awkwardness
  • wheezing

Some of the side effects that can occur with lamivudine / zidovudine 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
  • Headache
Less common
  • Abdominal or stomach pain (mild)
  • coughing
  • decreased appetite
  • diarrhea
  • dizziness
  • trouble in sleeping
Incidence not known
  • Abnormal breathing
  • blurred vision
  • body fat redistribution or accumulation
  • darkening of the skin and mucous membranes
  • dry mouth
  • fatigue
  • flushed, dry skin
  • fruit-like breath odor
  • hair loss
  • increased hunger
  • increased thirst
  • increased urination
  • sweating
  • swelling of the breasts or breast soreness in both females and males
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • thinning of the hair
  • troubled breathing, unexplained

For Healthcare Professionals

Applies to lamivudine / zidovudine: oral tablet

General

The adverse effects of lamivudine plus zidovudine are sometimes difficult to distinguish from the symptomatology observed during the clinical course of AIDS, as well as from the possible adverse effects of other drugs used in the treatment of HIV 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.

Gastrointestinal

Gastrointestinal side effects have included nausea (33%), diarrhea (18%), nausea and vomiting (13%), anorexia and/or decreased appetite (10%), abdominal pain (9%), abdominal cramps (6%), and dyspepsia (5%) during clinical studies of lamivudine plus zidovudine administered as separate formulations. Pancreatitis has been reported in 0.3% of patients receiving lamivudine during clinical studies. Taste perversion and flatulence have also been reported. Oral mucosal pigmentation, stomatitis, and pancreatitis have been reported during postmarketing experience with lamivudine, zidovudine, and/or lamivudine-zidovudine.

Hepatic

Hepatic side effects have included elevated ALT (greater than 5 times ULN; 3.7%), AST (greater than 5 times ULN; 1.7%), and bilirubin (greater than 2.5 times ULN; 0.8%) during clinical studies of lamivudine plus zidovudine administered as separate formulations. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination, including lamivudine, zidovudine, and other antiretrovirals. One patient with preexisting hepatitis B developed acute hepatic failure two weeks after starting zidovudine therapy. 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 is 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. Lactic acidosis and hepatic steatosis and posttreatment exacerbation of hepatitis B have been reported during postmarketing experience with lamivudine, zidovudine, and/or lamivudine-zidovudine.

Hematologic

Zidovudine should be used with extreme caution in patients with bone marrow suppression indicated by a granulocyte count below 1000 cells/mm3 or hemoglobin less than 9.5 g/dL. Routine blood counts are recommended, and generally should occur more frequently in patients with advanced HIV disease. If bone marrow toxicity occurs, an interruption or discontinuation of zidovudine therapy may be necessary.

Hematologic side effects have included neutropenia (absolute neutrophil count less than 750/mm3; 7.2%), anemia (hemoglobin less than 8 g/dL; 2.9%), and thrombocytopenia (platelets less than 50,000/mm3; 0.4%) during clinical studies of lamivudine plus zidovudine administered as separate formulations. Exacerbation of anemia has been reported in HIV-1/HCV coinfected patients receiving ribavirin and zidovudine. Aplastic anemia, hemolytic anemia, leukopenia, and pancytopenia with marrow hypoplasia have been associated with zidovudine. Anemia (including pure red cell aplasia and anemias progressing on therapy), lymphadenopathy, and splenomegaly have been reported during postmarketing experience with lamivudine, zidovudine, and/or lamivudine-zidovudine.

Nervous system

Nervous system side effects have included headache (35%), neuropathy (12%), insomnia and other sleep disorders (11%), and dizziness (10%) during clinical studies of lamivudine plus zidovudine administered as separate formulations. Syncope has been reported. Generalized seizures, status epilepticus, confusion, somnolence, vertigo, and Wernicke's syndrome have been reported, although rarely, with the use of zidovudine. Zidovudine has been associated with hearing loss. Paresthesia, peripheral neuropathy, and seizures have been reported during postmarketing experience with lamivudine, zidovudine, and/or lamivudine-zidovudine.

Other

Other side effects have included malaise and fatigue (27%) and fever or chills (10%) during clinical studies of lamivudine plus zidovudine administered as separate formulations. Weakness has been reported during postmarketing experience with lamivudine, zidovudine, and/or lamivudine-zidovudine.

Respiratory

Respiratory side effects have included nasal signs and symptoms (20%) and cough (18%) during clinical studies of lamivudine plus zidovudine administered as separate formulations. Dyspnea, rhinitis, and sinusitis have been reported. Abnormal breath sounds/wheezing have been reported during postmarketing experience with lamivudine, zidovudine, and/or lamivudine-zidovudine.

Musculoskeletal

In one zidovudine study, myalgias and elevated CPK occurred in 8% of treated patients with a CD4 cell count less than 200/mm3, and in none of the patients with higher CD4 cell counts. Dosage reduction has not affected the course of myopathy, although drug discontinuation sometimes resulted in improvement of symptoms, generally within a month. Muscle biopsy has shown atrophic and sometimes necrotic fibers, ragged-red fibers, and large accumulations of mitochondrial and fibrillar sarcoplasmic inclusions.

Musculoskeletal side effects have included musculoskeletal pain (12%), myalgia (8%), and arthralgia (5%) during clinical studies of lamivudine plus zidovudine administered as separate formulations. Zidovudine-related myopathy may occur after prolonged use. Muscle weakness, elevated creatine phosphokinase (CPK), and rhabdomyolysis have been reported during postmarketing experience with lamivudine, zidovudine, and/or lamivudine-zidovudine.

Dermatologic

Dermatologic side effects have included skin rashes (9%) during clinical studies of lamivudine plus zidovudine administered as separate formulations. Pruritus has also been reported. Skin and nailbed pigmentation changes, toxic epidermal necrolysis, increased sweating, urticaria, and leukocytoclastic vasculitis with eosinophilia and fever have been associated with zidovudine. Rarely, nail hyperpigmentation has been accompanied by mucocutaneous pigmentation or hypertrichosis. Alopecia, erythema multiforme, and Stevens-Johnson syndrome have been reported during postmarketing experience with lamivudine, zidovudine, and/or lamivudine-zidovudine.

Bluish or brownish-black discoloration of nails may develop during the first month or two of zidovudine therapy and usually disappears within 2 months if the drug is discontinued. Discoloration may occur as longitudinal streaks or transverse bands.

Psychiatric

Psychiatric side effects have included depressive disorders (9%) during clinical studies of lamivudine plus zidovudine administered as separate formulations. Other psychiatric side effects reported with the use of zidovudine have included isolated cases of mania, anxiety, confusion, loss of mental acuity, and grandiosity.

Cardiovascular

Cardiovascular side effects have included cardiomyopathy and vasculitis during postmarketing experience with lamivudine, zidovudine, and/or lamivudine-zidovudine.

Metabolic

Metabolic side effects have included elevated amylase (greater than 2 times ULN; 4.2%) during clinical studies of lamivudine plus zidovudine administered as separate formulations. Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving antiretroviral agents. Progressive subcutaneous fat wasting has been reported. Hyperglycemia and redistribution/accumulation of body fat have been reported during postmarketing experience with lamivudine, zidovudine, and/or lamivudine-zidovudine.

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.

Hypersensitivity

Hypersensitivity side effects have included sensitization reactions (including anaphylaxis) and urticaria during postmarketing experience with lamivudine, zidovudine, and/or lamivudine-zidovudine.

Immunologic

Immunologic side effects have included immune reconstitution syndrome. Autoimmune disorders (e.g., Graves' disease, polymyositis, and Guillain-Barre syndrome) have been reported in the setting of immune reconstitution.

Genitourinary

Genitourinary side effects associated with zidovudine have included urinary frequency and urinary hesitancy. Gynecomastia has been reported during postmarketing experience with lamivudine, zidovudine, and/or lamivudine-zidovudine.

Ocular

Ocular side effects have included amblyopia, photophobia, and at least one case of macular edema.

A case of macular edema deemed definitively associated with zidovudine occurred in a patient with a history of anterior uveitis secondary to syphilis.

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