Combivir Side Effects
Generic Name: lamivudine / zidovudine
Note: This document contains side effect information about lamivudine / zidovudine. Some of the dosage forms listed on this page may not apply to the brand name Combivir.
Some side effects of Combivir 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 / zidovudine: oral tablet
Along with its needed effects, lamivudine / zidovudine 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 / zidovudine:More common
- pale skin
- sore throat
- unusual tiredness or weakness
- Abdominal or stomach pain (severe)
- burning, tingling, numbness, or pain in the hands, arms, feet, or legs
- muscle tenderness and weakness
- skin rash
- yellow eyes or skin
- Blistering, peeling, or loosening of the skin
- canker sores
- chest discomfort or pain
- dark urine
- decreased appetite
- difficulty with breathing
- difficulty with swallowing
- fast, irregular, or pounding heartbeat
- fast, shallow breathing
- feeling of fullness
- general feeling of discomfort
- general tiredness and weakness
- hives or welts
- 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
- 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
Some side effects of lamivudine / zidovudine 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
- Abdominal or stomach pain (mild)
- decreased appetite
- trouble in sleeping
- Abnormal breathing
- blurred vision
- body fat redistribution or accumulation
- darkening of the skin and mucous membranes
- dry mouth
- flushed, dry skin
- fruit-like breath odor
- hair loss
- increased hunger
- increased thirst
- increased urination
- 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
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 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 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.
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 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 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 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 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.
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.
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.
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.
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 side effects have included cardiomyopathy and vasculitis 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.
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.
Hypersensitivity side effects have included sensitization reactions (including anaphylaxis) and urticaria during postmarketing experience with lamivudine, zidovudine, and/or lamivudine-zidovudine.
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 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 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.
More about Combivir (lamivudine / zidovudine)
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