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Combivir

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Combivir

Combivir

Combivir Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

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 include headache, dizziness, nausea, loss of appetite, diarrhea, or trouble sleeping.

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 should not be taken with other lamivudine and zidovudine combinations. Tell your doctor all medications you use. During pregnancy, Combivir should be used only when prescribed. This medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Combivir in Detail - Patient Information: Side Effects

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

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:

  • muscle pain or weakness;
  • numb or cold feeling in your arms and legs;
  • trouble breathing;
  • feeling dizzy, light-headed, tired, or very weak;
  • stomach pain, nausea with vomiting; or
  • slow or uneven heart rate.

Call your doctor at once if you have any of these other serious side effects:

  • fever, chills, body aches, flu symptoms;
  • pale skin, easy bruising or bleeding, unusual weakness;
  • trouble swallowing, trouble standing up or climbing stairs;
  • liver problems (stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes));
  • pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate); or
  • white patches or sores inside your mouth or on your lips.

Less serious side effects may include:

  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk);
  • mild nausea, vomiting, diarrhea;
  • numbness or tingling;
  • sleep problems (insomnia);
  • headache, dizziness, tired feeling; or
  • cough, runny or stuffy nose.

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Combivir Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Headache, tiredness, loss of appetite, nausea, vomiting, diarrhea, trouble sleeping, dizziness, or stuffy nose may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech).

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as depression), signs of pancreatitis (such as nausea, vomiting, stomach/abdominal/back pain, fever), easy bruising/bleeding, skin/nail color changes.

Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.

This medication can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, seek immediate medical attention if you develop any rash.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Combivir (Lamivudine, Zidovudine)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Combivir FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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

Hematologic toxicity, including neutropenia and anemia [see BOXED WARNING, WARNINGS AND PRECAUTIONS].

Symptomatic myopathy [see BOXED WARNING, WARNINGS AND PRECAUTIONS]. Lactic acidosis and hepatomegaly with steatosis [see BOXED WARNING, WARNINGS AND PRECAUTIONS].

Acute exacerbations of hepatitis B [see BOXED 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].

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 to rates in the clinical trials of another drug and may not reflect the rates observed in 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 (see Tables 1 and 2).

Table 1: Selected Clinical Adverse Reactions ( ≥ 5% Frequency) in 4 Controlled Clinical Trials With EPIVIR 300 mg/day and RETROVIR 600 mg/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 patients (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/day plus RETROVIR 600 mg/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 patients assessed.
a Frequencies of these laboratory abnormalities were higher in patients with mild laboratory abnormalities at baseline.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following reactions have been identified during post-approval use of EPIVIR, RETROVIR, and/or COMBIVIR. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to EPIVIR, RETROVIR, and/or COMBIVIR.

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 exacerbation of hepatitis B [see BOXED 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) »

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Combivir - User Reviews

Combivir User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Combivir sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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