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Combivir

Last reviewed on RxList: 5/11/2018
Combivir Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 5/11/2018

Combivir (lamivudine and zidovudine) is combination antiviral medication used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Combivir is not a cure for HIV or AIDS. Common side effects of Combivir include:

  • headache,
  • dizziness,
  • nausea,
  • loss of appetite,
  • diarrhea,
  • trouble sleeping,
  • cold symptoms (stuffy nose, sneezing, sinus pain, cough), or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

Tell your doctor if you have unlikely but serious side effects of Combivir including:

  • mental/mood changes (such as depression),
  • signs of pancreatitis (such as vomiting, stomach/abdominal/back pain, fever),
  • easy bruising or bleeding, or
  • skin or nail color changes.

The recommended oral dose of Combivir in HIV-1-infected adults and adolescents weighing more than 66 lbs (30 kg) is 1 tablet (containing 150 mg of lamivudine and 300 mg of zidovudine) twice daily. Combivir may interact with cancer treatments, other drugs to treat HIV/AIDS, antiviral medications, interferon, or sulfa drugs. Tell your doctor all medciations and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Combivir. Take all of your HIV medicines as directed to control your infection. It is unknown if Combivir will harm an unborn baby. HIV can be passed to your baby if you are not properly treated during pregnancy. If you are pregnant, your name may be listed on a pregnancy registry to track the outcome of the pregnancy and to evaluate any effects of Combivir on the baby. Combivir passes into breast milk. Because breast milk can transmit HIV, do not breastfeed.

Our Combivir (lamivudine and zidovudine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Combivir Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired.

Call your doctor at once if you have:

  • liver problems--swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;
  • low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing; or
  • pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting.

Lamivudine and zidovudine affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
  • trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects may include:

  • headache;
  • nausea, diarrhea;
  • tiredness, general ill feeling;
  • cold symptoms such as stuffy nose, sneezing, sinus pain, cough; or
  • loss of body fat (especially in your arms, legs, face, and buttocks).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Combivir (Lamivudine, Zidovudine)

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Combivir Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in other sections of the labeling:

  • Hematologic toxicity, including neutropenia and anemia [see BOX WARNING, WARNINGS AND PRECAUTIONS].
  • Symptomatic myopathy [see BOX WARNING, WARNINGS AND PRECAUTIONS].
  • Lactic acidosis and severe hepatomegaly with steatosis [see BOX WARNING, WARNINGS AND PRECAUTIONS].
  • Exacerbations of hepatitis B [see BOX WARNING, WARNINGS AND PRECAUTIONS]
  • Hepatic decompensation in patients co-infected with HIV-1 and hepatitis C [see WARNINGS AND PRECAUTIONS].
  • Exacerbation of anemia in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine [see WARNINGS AND PRECAUTIONS].
  • Pancreatitis [see WARNINGS AND PRECAUTIONS].
  • Immune reconstitution syndrome [see WARNINGS AND PRECAUTIONS].
  • Lipoatrophy [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Lamivudine Plus Zidovudine Administered As Separate Formulations

In 4 randomized, controlled trials of EPIVIR 300 mg per day plus RETROVIR 600 mg per day, the following selected adverse reactions and laboratory abnormalities were observed (Tables 1 and 2).

Table 1. Selected Clinical Adverse Reactions (Greater than or Equal to 5% Frequency) in 4 Controlled Clinical Trials with EPIVIR 300 mg per day and RETROVIR 600 mg per day

Adverse Reaction EPIVIR plus RETROVIR
(n = 251)
Body as a whole
  Headache 35%
  Malaise & fatigue 27%
  Fever or chills 10%
Digestive
  Nausea 33%
  Diarrhea 18%
  Nausea & vomiting 13%
  Anorexia and/or decreased appetite 10%
  Abdominal pain 9%
  Abdominal cramps 6%
  Dyspepsia 5%
Nervous system
  Neuropathy 12%
  Insomnia & other sleep disorders 11%
  Dizziness 10%
  Depressive disorders 9%
Respiratory
  Nasal signs & symptoms 20%
  Cough 18%
Skin
  Skin rashes 9%
Musculoskeletal
  Musculoskeletal pain 12%
  Myalgia 8%
  Arthralgia 5%

Pancreatitis was observed in 9 of the 2,613 adult subjects (0.3%) who received EPIVIR in controlled clinical trials [see WARNINGS AND PRECAUTIONS].

Selected laboratory abnormalities observed during therapy are listed in Table 2.

Table 2. Frequencies of Selected Laboratory Abnormalities among Adults in 4 Controlled Clinical Trials of EPIVIR 300 mg per day plus RETROVIR 600 mg per daya

Test
(Abnormal Level)
EPIVIR plus RETROVIR
% (n)
Neutropenia (ANC <750/mm3) 7.2% (237)
Anemia (Hgb <8.0 g/dL) 2.9% (241)
Thrombocytopenia (platelets <50,000/mm3) 0.4% (240)
ALT (>5.0 x ULN) 3.7% (241)
AST (>5.0 x ULN) 1.7% (241)
Bilirubin (>2.5 x ULN) 0.8% (241)
Amylase (>2.0 x ULN) 4.2% (72)
ULN = Upper limit of normal.
ANC = Absolute neutrophil count.
n = Number of subjects assessed.
a Frequencies of these laboratory abnormalities were higher in subjects with mild laboratory abnormalities at baseline.

Postmarketing Experience

The following adverse reactions have been identified during postmarketing use. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body As A Whole

Redistribution/accumulation of body fat [see WARNINGS AND PRECAUTIONS].

Cardiovascular

Cardiomyopathy.

Endocrine And Metabolic

Gynecomastia, hyperglycemia.

Gastrointestinal

Oral mucosal pigmentation, stomatitis.

General

Vasculitis, weakness.

Hemic And Lymphatic

Anemia, (including pure red cell aplasia and anemias progressing on therapy), lymphadenopathy, splenomegaly.

Hepatic And Pancreatic

Lactic acidosis and hepatic steatosis, pancreatitis, posttreatment exacerbations of hepatitis B [see BOX WARNING, WARNINGS AND PRECAUTIONS].

Hypersensitivity

Sensitization reactions (including anaphylaxis), urticaria.

Musculoskeletal

Muscle weakness, CPK elevation, rhabdomyolysis.

Nervous

Paresthesia, peripheral neuropathy, seizures.

Respiratory

Abnormal breath sounds/wheezing.

Skin

Alopecia, erythema multiforme, Stevens-Johnson syndrome.

Read the entire FDA prescribing information for Combivir (Lamivudine, Zidovudine)

Related Resources for Combivir

Read the Combivir User Reviews »

© Combivir Patient Information is supplied by Cerner Multum, Inc. and Combivir Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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