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Brand Name: Ziagen®
Active Ingredient:   abacavir sulfate
Strength(s): 300mg oral tablets or 20mg/ml oral solution
Dosage Form(s):   Tablets and solution
Company Name:    GlaxoSmithKline
Prescription only
*Date Approved by the FDA:   December 17, 2021
*Approval by FDA does not mean that the drug is
available for consumers at this time.

What is Ziagen used for? Ziagen is used to treat HIV-1 infection in
combination with other antiretroviral medications. Ziagen is only proven to work when
taken in combination with other antiretroviral medications. Ziagen belongs to the class of
drugs known as nucleoside reverse transcriptase inhibitors.

long-term effects of treatment with Ziagen are not known at this time.

Special Warning(s) with Ziagen:

If you experience signs or symptoms of a hypersensitivity reaction, (severe
allergic reaction) at any time while you are taking Ziagen, you must stop taking Ziagen
and contact your health care provider immediately. If you have a skin rash or two or more
of the following symptoms you may be having a hypersensitivity reaction:

  • Fever
  • Nausea, vomiting, diarrhea, or stomach pain
  • Severe tiredness, achiness, or a general ill feeling
  • Sore throat, cough, or shortness of breath

If you experience a hypersensitivity reaction, at any time while taking Ziagen
you must never take Ziagen again. If you take Ziagen again, more severe symptoms will
reappear within hours, which may include life-threatening low blood pressure and death.

A medication guide for patients comes with every Ziagen prescription. Read the
medication guide carefully. In addition, your pharmacist will give you a warning card
listing the symptoms of a Ziagen allergy. Carry this card with you.

Ziagen can cause a condition called lactic acidosis (accumulation of lactic acid
in the body) together with an enlarged liver, which can be a serious and sometimes fatal.

If you have a history of liver problems, your health care provider will evaluate
and decide if Ziagen is right for you.

General Precautions with Ziagen:

  • Because resistance to the HIV virus can occur quickly with single-drug treatment,
    Ziagen should always be taken in combination with other antiretroviral medications. Ziagen
    should not be taken alone to treat HIV. If your current treatment is failing, Ziagen
    should not be added as a single agent.

  • Ziagen is not a cure for HIV infection. At present, there are no results from
    studies evaluating long term suppression of HIV or disease progression. You may continue
    to experience illnesses associated with HIV infection, including opportunistic infections.

  • You should remain under the care of a physician when using Ziagen. If you stopped taking Ziagen for
    reasons other than a severe allergic reaction, it is possible to begin taking Ziagen again
    with continued monitoring by your doctor for such a reaction.
  • Ziagen has not been shown to reduce the risk of transmission to others through
    sexual contact or blood contamination.

What should I tell my doctor or health care provider?

Tell your health care provider if you are:

  • trying to become pregnant, or are pregnant.
  • breast-feeding or thinking about breast-feeding while taking Ziagen.

What are some possible side effects of Ziagen? (This is NOT
a complete list of side effects reported with Ziagen. Your health care provider can
discuss with you a more complete list of side effects.
)   Carry the
warning card of Ziagen allergy symptoms with you. Tell your health care provider
immediately about any side effects you experience while taking Ziagen. Serious and life
threatening allergic reactions have been associated with Ziagen (See "Special

Side effects of Ziagen include:

  • Fever
  • Rash
  • Nausea
  • Vomiting
  • Feeling tired
  • Diarrhea
  • Loss of appetite
  • Trouble sleeping
  • Joint pain
  • Swelling
  • Shortness of breath

For more detailed information about Ziagen, ask your health care provider.

http://www.fda.gov/cder/foi/label/1998/20978lbl.pdf    Link to Ziagen’s approved label and patient information 

Date Posted: 2/23/99

Updated: 3/20/01, 4/18/00, 4/16/01

Revised: 7/25/00


Back to Drug Side Effects

source: FDA

last update: December 2004

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