Abacavir / Lamivudine / Zidovudine Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 28, 2024.

Applies to abacavir / lamivudine / zidovudine: oral tablet.

Serious side effects

Along with its needed effects, abacavir/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 abacavir/lamivudine/zidovudine:

Other side effects

Some side effects of abacavir / 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:

Precautions

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not take any other medicine containing abacavir, emtricitabine, lamivudine, or zidovudine, such as Atripla®, Combivir®, Complera®, Emtriva®, Epivir®, Epivir-HBV®, Epzicom®, Retrovir®, Truvada®, or Ziagen®. Tell your doctor if you also use efavirenz (Sustiva®), rilpivirine (Edurant®), or tenofovir (Viread®).

This medicine may cause severe allergic reactions in some patients. These reactions usually occurs within 6 weeks after the medicine is started, but may occur at any time. If untreated, it can lead to severe low blood pressure and even death. Check with your doctor right away if you or your child notice abdominal or stomach pain, cough, diarrhea, fever, headache, nausea, numbness or tingling of the face, feet, or hands, pain in the joints, pain in the muscles, skin rash, sore throat, swelling of the feet or lower legs, unusual feeling of discomfort or illness, unusual tiredness or weakness, or vomiting.

When you or your child begin taking this medicine, you will be given a warning card which describes symptoms of severe allergic reactions that may be caused by abacavir, lamivudine, and zidovudine combination. The warning card also provides information about how to treat these allergic reactions. For your safety, you should carry the warning card with you at all times.

If you or your child must stop using abacavir because of an allergic reaction, you should never use the medicine again. Return the unused medicine to your doctor or pharmacist. A worse reaction, possibly even death, can occur if you use the medicine again. Tell your doctor right away if you have ever taken abacavir, especially if you have experienced an allergic reaction to it in the past.

Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you or your child have more than one of these symptoms: abdominal or stomach discomfort or cramping, dark urine, decreased appetite, diarrhea, general feeling of discomfort, light-colored stools, muscle cramping or pain, nausea, unusual tiredness or weakness, trouble breathing, vomiting, or yellow eyes or skin.

When you or your child start taking HIV medicines, your immune system may get stronger. If you have infections that are hidden in your body (eg, pneumonia or tuberculosis), you may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor right away.

This medicine may cause you or your child to have excess body fat. Tell your doctor right away if you notice changes in your body shape, including an increased amount of body fat in the neck or upper back, face, around the chest, or stomach area. You might also lose fat from your legs, arms, or face.

This medicine may increase your risk of having a heart attack. This is more likely to occur if you smoke or already have heart disease, high blood pressure, or high cholesterol or fats in the blood. Call your doctor right away if you have chest pain or discomfort, nausea, pain or discomfort in the arms, jaw, back or neck, sweating, or vomiting. These could be symptoms of a heart attack.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex, such as using latex condoms, even if your partner also has HIV. Do not share needles, toothbrushes, and razor blades with anyone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

For healthcare professionals

Applies to abacavir / lamivudine / zidovudine: oral tablet.

General adverse events

Many of the side effects listed occurred commonly in patients with abacavir hypersensitivity (e.g., nausea, vomiting, diarrhea, fever, lethargy, rash).^[Ref]

Hypersensitivity

• Common (1% to 10%): Hypersensitivity reaction

Abacavir, lamivudine, and/or zidovudine:

• Postmarketing reports: Sensitization reactions (including anaphylaxis)

Abacavir:

• Common (1% to 10%): Hypersensitivity reactions (including fever, rash [maculopapular, urticarial], fatigue, nausea, vomiting, diarrhea, abdominal pain, pharyngitis, malaise, achiness, dyspnea, cough, lethargy, headache, myalgia, arthralgia, myolysis, edema, abnormal chest X-ray findings [mainly localized infiltrates], paresthesia, anaphylaxis, hepatitis, liver failure, renal failure, hypotension, sore throat, adult respiratory distress syndrome, respiratory failure, death, lymphadenopathy, mucous membrane lesions [conjunctivitis, mouth ulceration], erythema multiforme, elevated liver function tests, elevated creatine phosphokinase, elevated creatinine, lymphopenia)^[Ref]

Serious and sometimes fatal hypersensitivity reactions have been reported with abacavir. Such reactions have included multi-organ failure and anaphylaxis and usually occurred within the first 6 weeks of abacavir therapy (median onset: 9 to 11 days); however, abacavir hypersensitivity reactions have occurred any time during therapy.

Patients with the human leukocyte antigen subtype B*5701 (HLA-B*5701) allele are at higher risk of abacavir hypersensitivity reactions; however, such reactions have occurred in patients without the HLA-B*5701 allele. Abacavir hypersensitivity was reported in about 8% of patients in 9 clinical trials with abacavir-containing products where patients were not screened for the HLA-B*5701 allele; incidence of suspected abacavir hypersensitivity reactions was 1% in clinical trials where HLA-B*5701 carriers were excluded.

Abacavir hypersensitivity reactions have been characterized by at least 2 of the following key signs/symptoms: (1) fever; (2) rash; (3) gastrointestinal symptoms (including nausea, vomiting, diarrhea, abdominal pain); (4) constitutional symptoms (including generalized malaise, fatigue, achiness); (5) respiratory symptoms (including dyspnea, cough, pharyngitis). Almost all reactions have included fever and/or rash (usually maculopapular or urticarial); however, reactions also reported without fever or rash. Signs/symptoms reported in at least 10% of patients with hypersensitivity reaction have included rash, nausea, vomiting, diarrhea, abdominal pain, dyspnea, cough, fever, fatigue/lethargy, malaise, headache, elevated liver function tests, and myalgia. Other signs/symptoms of hypersensitivity have included mouth ulceration, sore throat, adult respiratory distress syndrome, respiratory failure, edema, lymphadenopathy, hypotension, conjunctivitis, anaphylaxis, paresthesia, lymphopenia, hepatitis, liver failure, myolysis, arthralgia, elevated creatine phosphokinase, elevated creatinine, renal failure, abnormal chest x-ray findings (mainly infiltrates, which were localized), and death.

Symptoms of abacavir hypersensitivity reaction worsened with continued therapy and generally resolved when abacavir was discontinued. Restarting abacavir after a hypersensitivity reaction has resulted in more severe symptoms within hours and included life-threatening hypotension and death. Rarely, life-threatening reactions have occurred within hours after restarting abacavir in patients who stopped it for reasons other than symptoms of hypersensitivity (or who stopped it with only 1 key symptom of hypersensitivity).^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (up to 52%), nausea and vomiting (up to 22%), diarrhea (up to 15%)
• Common (1% to 10%): Abdominal distension, abdominal discomfort and pain, gaseous symptoms, dyspeptic symptoms, constipation
• Uncommon (0.1% to 1%): Dry mouth/hyposalivation
• Frequency not reported: Abdominal cramps

Abacavir, lamivudine, and/or zidovudine:

• Postmarketing reports: Abdominal pain, oral mucosal pigmentation, stomatitis, dyspepsia

Abacavir:

• Common (1% to 10%): Nausea, vomiting, diarrhea
• Rare (0.01% to 0.1%): Pancreatitis

Lamivudine:

• Common (1% to 10%): Nausea, vomiting, diarrhea, abdominal pain, upper abdominal pain
• Rare (0.01% to 0.1%): Elevated serum amylase, pancreatitis
• Frequency not reported: Oral ulcerations and lesions

Zidovudine:

• Very common (10% or more): Nausea
• Common (1% to 10%): Vomiting, abdominal pain, diarrhea
• Uncommon (0.1% to 1%): Flatulence
• Rare (0.01% to 0.1%): Oral mucosa pigmentation, dyspepsia, pancreatitis^[Ref]

Pancreatitis was observed in the expanded access program for abacavir.^[Ref]

Other

• Very common (10% or more): Malaise and fatigue (up to 29%)
• Common (1% to 10%): Temperature regulation disturbance (fever and/or chills), pain, ear/nose/throat infections

Abacavir, lamivudine, and/or zidovudine:

• Postmarketing reports: Weakness

Abacavir:

• Common (1% to 10%): Fever, lethargy, fatigue

Lamivudine:

• Common (1% to 10%): Fatigue, malaise, fever
• Frequency not reported: Drug-resistant hepatitis B virus (HBV)

Zidovudine:

• Common (1% to 10%): Malaise
• Uncommon (0.1% to 1%): Fever, generalized pain, asthenia
• Rare (0.01% to 0.1%): Chills, chest pain, influenza-like syndrome

The emergence of lamivudine-resistant HBV has been reported in HIV-1/HBV-coinfected patients using lamivudine-containing antiretroviral regimens.

Dermatologic

• Very common (10% or more): Disorders of sweat and sebum (primarily dry skin; up to 19%)
• Common (1% to 10%): Skin rashes, pruritus

Abacavir, lamivudine, and/or zidovudine:

• Postmarketing reports: Alopecia, erythema multiforme, Stevens-Johnson syndrome, urticaria

Abacavir:

• Common (1% to 10%): Rash (without systemic symptoms)
• Very rare (less than 0.01%): Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme
• Frequency not reported: Sweet's syndrome

Lamivudine:

• Common (1% to 10%): Rash, alopecia

Zidovudine:

• Uncommon (0.1% to 1%): Rash, pruritus
• Rare (0.01% to 0.1%): Nail and skin pigmentation, urticaria, sweating
• Frequency not reported: Nail discoloration, nailbed hyperpigmentation, leukocytoclastic vasculitis (with eosinophilia and fever)^[Ref]

Suspected Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients using abacavir primarily in combination with agents known to be associated with SJS and TEN, respectively.

Cases of erythema multiforme, SJS, or TEN have been reported very rarely when abacavir hypersensitivity could not be ruled out.

Bluish or brownish-black discoloration of nails has developed during the first 1 or 2 months of zidovudine therapy and usually disappeared within 2 months if the drug was discontinued. Discoloration has occurred as longitudinal streaks or transverse bands.^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 18%)
• Common (1% to 10%): Dizziness, taste impairment

Abacavir, lamivudine, and/or zidovudine:

• Postmarketing reports: Paresthesia, peripheral neuropathy, seizures, dizziness

Abacavir:

• Common (1% to 10%): Headache

Lamivudine:

• Common (1% to 10%): Headache
• Very rare (less than 0.01%): Peripheral neuropathy, paresthesia

Zidovudine:

• Very common (10% or more): Headache
• Common (1% to 10%): Dizziness
• Rare (0.01% to 0.1%): Paresthesia, somnolence, convulsions, taste disturbance, syncope
• Frequency not reported: Generalized seizures, status epilepticus, vertigo, Wernicke's syndrome^[Ref]

Hepatic

• Common (1% to 10%): Elevated ALT, abnormal liver function tests

Abacavir, lamivudine, and/or zidovudine:

• Postmarketing reports: Hepatic steatosis, elevated bilirubin, elevated transaminases, posttreatment exacerbations of hepatitis B

Abacavir:

• Frequency not reported: Elevated GGT

Lamivudine:

• Uncommon (0.1% to 1%): Elevated liver enzymes (AST, ALT)
• Rare (0.01% to 0.1%): Hepatitis
• Frequency not reported: Hepatic decompensation

Zidovudine:

• Common (1% to 10%): Elevated liver enzyme levels in blood, elevated bilirubin levels in blood
• Rare (0.01% to 0.1%): Liver disorders (e.g., severe hepatomegaly with steatosis)
• Frequency not reported: Acute hepatic failure^[Ref]

Elevated ALT (greater than 5 times the upper limit of normal [5 x ULN]) has been reported in 6% of patients.

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

Elevated GGT was observed in the expanded access program for abacavir.

Hepatic decompensation (some fatal) has been reported in patients coinfected with HIV-1 and hepatitis C virus (HCV) receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin.

Severe acute exacerbations of hepatitis have been reported in patients with hepatitis B after discontinuation of lamivudine.

One patient with preexisting hepatitis B developed acute hepatic failure 2 weeks after starting zidovudine therapy.^[Ref]

Hematologic

• Common (1% to 10%): Neutropenia, decreased WBCs

Abacavir, lamivudine, and/or zidovudine:

• Postmarketing reports: Aplastic anemia, anemia (including pure red cell aplasia and severe anemias progressing on therapy), lymphadenopathy, thrombocytopenia, splenomegaly

Abacavir:

• Frequency not reported: Agranulocytosis

Lamivudine:

• Uncommon (0.1% to 1%): Neutropenia, anemia, thrombocytopenia
• Very rare (less than 0.01%): Pure red cell aplasia

Zidovudine:

• Common (1% to 10%): Anemia, neutropenia, leukopenia
• Uncommon (0.1% to 1%): Thrombocytopenia, pancytopenia (with marrow hypoplasia)
• Rare (0.01% to 0.1%): Pure red cell aplasia
• Very rare (less than 0.01%): Aplastic anemia
• Frequency not reported: Hematologic toxicity (including neutropenia, severe anemia), exacerbation of anemia^[Ref]

Neutropenia (less than 750/mm3) has been reported in 5% of patients.

Agranulocytosis has been reported after the addition of abacavir to a multi-drug regimen.

Occasionally, neutropenia and anemia reported with lamivudine were severe.

Zidovudine has been associated with hematologic toxicity (including neutropenia and severe anemia), particularly in patients with advanced HIV-1 disease. Anemia, neutropenia, and leukopenia were reported more often with higher doses (1200 to 1500 mg/day) and in patients with advanced HIV disease (especially with poor bone marrow reserve at baseline) and particularly in those with CD4 cell counts less than 100/mm3. These hematological effects were generally observed after 4 to 6 weeks of therapy. Incidence of neutropenia increased in patients with low neutrophil counts, hemoglobin levels, and serum vitamin B12 levels at baseline.

Exacerbation of anemia has been reported in HIV-1/HCV-coinfected patients using zidovudine and ribavirin.^[Ref]

Metabolic

• Common (1% to 10%): Feeding problems (primarily anorexia/loss of appetite), hypertriglyceridemia, hyperamylasemia
• Frequency not reported: Hyperglycemia

Abacavir, lamivudine, and/or zidovudine:

• Postmarketing reports: Hyperlactatemia (common), lactic acidosis (rare), anorexia/decreased appetite, redistribution/accumulation of body fat

Abacavir:

• Common (1% to 10%): Anorexia
• Frequency not reported: Lactic acidosis, hyperlactatemia, redistribution/accumulation of body fat

Lamivudine:

• Frequency not reported: Lactic acidosis, hyperlactatemia, redistribution/accumulation of body fat

Zidovudine:

• Common (1% to 10%): Anorexia
• Rare (0.01% to 0.1%): Lactic acidosis (without hypoxemia)
• Frequency not reported: Lactic acidosis, hyperlactatemia, redistribution/accumulation of body fat

Combination antiretroviral therapy:

• Frequency not reported: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance"), metabolic abnormalities (e.g., hypertriglyceridemia, hypercholesterolemia, insulin resistance, hyperglycemia, hyperlactatemia)^[Ref]

Hypertriglyceridemia (greater than 750 mg/dL), hyperamylasemia (greater than 2 x ULN), and hyperglycemia (greater than 13.9 mmol/L) have been reported in 2%, 2%, and less than 1% of patients, respectively.

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

Redistribution/accumulation of body fat has been reported with antiretroviral therapy; causality has not been established.^[Ref]

Musculoskeletal

• Common (1% to 10%): Elevated creatine phosphokinase (CPK), musculoskeletal pain, muscle pain

Abacavir, lamivudine, and/or zidovudine:

• Postmarketing reports: Myalgia, arthralgia, muscle weakness, rhabdomyolysis

Lamivudine:

• Common (1% to 10%): Arthralgia, muscle disorders
• Rare (0.01% to 0.1%): Rhabdomyolysis

Zidovudine:

• Common (1% to 10%): Myalgia
• Uncommon (0.1% to 1%): Myopathy
• Frequency not reported: Symptomatic myopathy, myositis

Combination antiretroviral therapy:

• Frequency not reported: Osteonecrosis^[Ref]

Elevated CPK (greater than 4 x ULN) has been reported in 7% of patients.

Myopathy and myositis (with pathological changes similar to that produced by HIV-1 disease) have been associated with prolonged zidovudine use.

In 1 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. Dose 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.^[Ref]

Psychiatric

• Common (1% to 10%): Sleep disorders, depressive disorders, anxiety
• Frequency not reported: Worsening of preexisting depression

Abacavir, lamivudine, and/or zidovudine:

• Postmarketing reports: Insomnia, other sleep disorders

Lamivudine:

• Common (1% to 10%): Insomnia

Zidovudine:

• Common (1% to 10%): Insomnia
• Rare (0.01% to 0.1%): Anxiety, depression, loss of mental acuity
• Frequency not reported: Confusion, mania, grandiosity^[Ref]

Respiratory

• Common (1% to 10%): Viral respiratory infections

Abacavir, lamivudine, and/or zidovudine:

• Postmarketing reports: Abnormal breath sounds/wheezing

Lamivudine:

• Common (1% to 10%): Nasal symptoms, cough

Zidovudine:

• Uncommon (0.1% to 1%): Dyspnea
• Rare (0.01% to 0.1%): Cough

Immunologic

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

Renal

• Frequency not reported: Renal signs/symptoms

Genitourinary

• Frequency not reported: Dysuria

Zidovudine:

• Rare (0.01% to 0.1%): Urinary frequency

Cardiovascular

Abacavir, lamivudine, and/or zidovudine:

• Postmarketing reports: Cardiomyopathy, vasculitis

Abacavir:

• Postmarketing reports: Myocardial infarction (MI)

Zidovudine:

• Rare (0.01% to 0.1%): Cardiomyopathy, reversible congestive heart failure, vasodilation^[Ref]

An observational study investigating the rate of MI in patients on combination antiretroviral therapy showed an increased risk of MI with the use of abacavir within the previous 6 months. A sponsor-conducted pooled analysis of clinical trials showed no excess risk of MI in abacavir-treated patients as compared with control subjects. Overall, available data from the observational cohort and from clinical trials were inconclusive.^[Ref]

Endocrine

Abacavir, lamivudine, and/or zidovudine:

• Postmarketing reports: Gynecomastia

Zidovudine:

• Rare (0.01% to 0.1%): Gynecomastia^[Ref]

Ocular

Zidovudine:

• Frequency not reported: Macular edema

At least 1 case of macular edema was deemed definitively associated with zidovudine in a patient with history of anterior uveitis secondary to syphilis.

See also:

Further information

Abacavir/lamivudine/zidovudine side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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