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Epzicom

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Epzicom

Epzicom

Epzicom Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Epzicom (abacavir sulfate and lamivudine) is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). It is not a cure for HIV or AIDS. It is a type of antiviral medication called a reverse transcriptase inhibitor. Common side effects include headache, nausea, diarrhea, dizziness, tiredness, or trouble sleeping.

The recommended oral dose of Epzicom for adults is one tablet daily, in combination with other antiretroviral agents. Epzicom may interact with methadone, ribavirin, interferon, or other medications that contain abacavir or lamivudine. Tell your doctor all medications and supplements you use. During pregnancy, Epzicom should be used only when prescribed. HIV medicines are usually given to pregnant women with HIV. Treatment has been shown to decrease the risk of HIV transmission to the baby. This drug may be part of that treatment. Consult your doctor. It is unknown if abacavir passes into breast milk. Lamivudine passes into breast milk. Because breast milk can transmit HIV, do not breastfeed.

Our Epzicom (abacavir sulfate and lamivudine) 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.

Epzicom in Detail - Patient Information: Side Effects

  • Group 1 - fever;
  • Group 2 - rash;
  • Group 3 - nausea, vomiting, diarrhea, stomach pain;
  • Group 4 - general tiredness, body aches;
  • Group 5 - shortness of breath, cough, sore throat.

Other serious side effects that may not be signs of an allergic reaction include:

  • stomach pain, low fever, lost appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • lactic acidosis - muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired;
  • fever, chills, body aches, flu symptoms; or
  • white patches or sores inside your mouth or on your lips.

Less serious side effects include:

  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk);
  • sleep problems or strange dreams;
  • headache, depression, anxiety; or
  • mild diarrhea.

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 Epzicom (Abacavir Sulfate and Lamivudine Tablets) »

What is Patient Information Overview?

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

Epzicom Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning and How to Use sections.

Headache, nausea, diarrhea, dizziness, tiredness, or trouble sleeping 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 right away if you have any serious side effects, including: mental/mood changes (such as depression, anxiety), easy bruising/bleeding, signs of anemia (such as unusual tiredness, fast breathing, pale skin, fast heartbeat).

Get medical help right away if you have any very serious side effects, including: signs of pancreatitis (such as nausea, vomiting, stomach/abdominal/back pain, fever).

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 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 Epzicom (Abacavir Sulfate and Lamivudine Tablets)»

What is Prescribing information?

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

Epzicom FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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

Serious and sometimes fatal hypersensitivity reaction. In one trial, once-daily dosing of abacavir was associated with more severe hypersensitivity reactions [see BOXED WARNING, 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 clinical practice.

Therapy-Naive Adults

Treatment-emergent clinical adverse reactions (rated by the investigator as moderate or severe) with a ≥ 5% frequency during therapy with ZIAGEN 600 mg once daily or ZIAGEN 300 mg twice daily, both in combination with lamivudine 300 mg once daily and efavirenz 600 mg once daily, are listed in Table 1.

Table 1: Treatment-Emergent (All Causality) Adverse Reactions of at Least Moderate Intensity (Grades 2-4, 5% Frequency) in Therapy-Naive Adults (CNA30021) Through 48 Weeks of Treatment

Adverse Event ZIAGEN 600 mg q.d. plus EPIVIR plus Efavirenz
(n = 384)
ZIAGEN 300 mg b.i.d. plus EPIVIR plus Efavirenz
(n = 386)
Drug hypersensitivitya,b 9% 7%
Insomnia 7% 9%
Depression/Depressed mood 7% 7%
Headache/Migraine 7% 6%
Fatigue/Malaise 6% 8%
Dizziness/Vertigo 6% 6%
Nausea 5% 6%
Diarrheaa 5% 6%
Rash 5% 5%
Pyrexia 5% 3%
Abdominal pain/gastritis 4% 5%
Abnormal dreams 4% 5%
Anxiety 3% 5%
a Subjects receiving ZIAGEN 600 mg once daily, experienced a significantly higher incidence of severe drug hypersensitivity reactions and severe diarrhea compared with subjects who received ZIAGEN 300 mg twice daily. Five percent (5%) of subjects receiving ZIAGEN 600 mg once daily had severe drug hypersensitivity reactions compared with 2% of subjects receiving ZIAGEN 300 mg twice daily. Two percent (2%) of subjects receiving ZIAGEN 600 mg once daily had severe diarrhea while none of the subjects receiving ZIAGEN 300 mg twice daily had this event.
b CNA30024 was a multi-center, double-blind, controlled trial in which 649 HIV-1-infected, therapy-naive adults were randomized and received either ZIAGEN (300 mg twice daily), EPIVIR (150 mg twice daily), and efavirenz (600 mg once daily); or zidovudine (300 mg twice daily), EPIVIR (150 mg twice daily), and efavirenz (600 mg once daily). CNA30024 used double-blind ascertainment of suspected hypersensitivity reactions. During the blinded portion of the trial, suspected hypersensitivity to abacavir was reported by investigators in 9% of 324 subjects in the abacavir group and 3% of 325 subjects in the zidovudine group.

Laboratory Abnormalities

Laboratory abnormalities observed in clinical trials of ZIAGEN were anemia, neutropenia, liver function test abnormalities, and elevations of CPK, blood glucose, and triglycerides. Additional laboratory abnormalities observed in clinical trials of EPIVIR were thrombocytopenia and elevated levels of bilirubin, amylase, and lipase.

The frequencies of treatment-emergent laboratory abnormalities were comparable between treatment groups in CNA30021.

Other Adverse Events

In addition to adverse reactions listed above, other adverse events observed in the expanded access program for abacavir were pancreatitis and increased GGT.

Postmarketing Experience

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

Abacavir

Cardiovascular: Myocardial infarction.

Skin: Suspected Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving abacavir primarily in combination with medications known to be associated with SJS and TEN, respectively. Because of the overlap of clinical signs and symptoms between hypersensitivity to abacavir and SJS and TEN, and the possibility of multiple drug sensitivities in some patients, abacavir should be discontinued and not restarted in such cases.

There have also been reports of erythema multiforme with abacavir use.

Abacavir and Lamivudine

Body as a Whole: Redistribution/accumulation of body fat [see WARNINGS AND PRECAUTIONS]

Digestive: Stomatitis.

Endocrine and Metabolic: Hyperglycemia.

General: Weakness.

Hemic and Lymphatic: Aplastic anemia, anemia (including pure red cell aplasia and severe anemias progressing on therapy), lymphadenopathy, splenomegaly.

Hepatic: Lactic acidosis and hepatic steatosis [see WARNINGS AND PRECAUTIONS], posttreatment exacerbation of hepatitis B [see 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 Epzicom (Abacavir Sulfate and Lamivudine Tablets) »

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Epzicom - User Reviews

Epzicom 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 Epzicom 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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