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Zidovudine is an antiviral medicine used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Zidovudine is also given during pregnancy to prevent an HIV-infected woman from passing the virus to her baby. Zidovudine is not a cure for HIV or AIDS.
Zidovudine may also be used for purposes not listed in this medication guide.
You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.
Zidovudine can lower blood cells that help your body fight infections and help circulate oxygen in your body. Zidovudine can also cause severe or life-threatening effects on your liver.
Call your doctor if you have symptoms such as: fever, flu symptoms, unusual tiredness, mouth sores, pale skin, cold hands and feet, upper stomach pain, dark urine, or jaundice (yellowing of the skin or eyes).
You should not use zidovudine if you are allergic to it. Do not take Retrovir with any other medicine that contains zidovudine or stavudine, including: Combivir, Trizivir, or Zerit.
You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, if you've taken HIV medication for a long time, or if you are a woman. Ask your doctor about your risk.
Zidovudine can also cause severe or life-threatening effects on your liver. Tell your doctor if you have liver disease, especially hepatitis C.
Tell your doctor if you have ever had:
kidney disease;
muscle problems;
a latex allergy (if you receive zidovudine injection);
bone marrow suppression;
anemia (low red blood cells); or
if you drink large amounts of alcohol.
Tell your doctor if you are pregnant, and use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.
Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Zidovudine injection is given as an infusion into a vein. A healthcare provider will give you this injection if you are unable to take the medicine by mouth.
Zidovudine oral can be taken with or without food.
Measure liquid medicine carefully, especially when giving zidovudine to a baby. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).
Zidovudine doses are based on weight in children. Your child's dose needs may change if the child gains or loses weight.
Zidovudine can lower blood cells that help your body fight infections and help circulate oxygen in your body. You may get an infection or feel more tired than usual. Your blood will need to be tested often.
Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with HIV should remain under the care of a doctor.
Store at room temperature away from moisture and heat.
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Because you will receive zidovudine injection in a clinical setting, you are not likely to miss a dose.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Avoid drinking alcohol. It may increase your risk of liver damage or lactic acidosis.
Using zidovudine will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).
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:
low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
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).
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;
fever, general ill feeling;
cough;
nausea, vomiting, loss of appetite; 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.
Other drugs may affect zidovudine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Zidovudine (www.drugs.com/mtm/zidovudine-oral-injection.html).
Commonly reported side effects of zidovudine include: headache, nausea, neutropenia, vomiting, anemia, anorexia, and malaise. See below for a comprehensive list of adverse effects.
Applies to zidovudine: oral capsule, oral syrup, oral tablet
Other dosage forms:
Oral route (Capsule; Tablet; Syrup)
Zidovudine has been associated with hematologic toxicity, including neutropenia and severe anemia, particularly in patients with advanced HIV disease. Prolonged use of zidovudine has been associated with symptomatic myopathy. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur.
Along with its needed effects, 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 zidovudine:
More common
Rare
Incidence not known
Some side effects of 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:
More common
Less common
Incidence not known
Applies to zidovudine: intravenous solution, oral capsule, oral syrup, oral tablet
The most common side effects reported during adult clinical trials were headache, malaise, nausea, anorexia, and vomiting; side effects reported most often with IV administration were anemia and neutropenia. The most common side effects reported during pediatric clinical trials were fever and cough. In the prevention of maternal-fetal transmission clinical trial, the most common side effects reported in neonates were anemia and neutropenia.
Hematologic toxicity (including neutropenia and severe anemia) has been reported, mostly in patients with advanced HIV-1 disease.
Exacerbation of anemia due to ribavirin has been reported when this drug was part of the HIV-1 regimen.
Common (1% to 10%): Granulocytopenia (less than 750 cells/mm3)
Uncommon (0.1% to 1%): Anemia (hemoglobin less than 8 g/dL)
Frequency not reported: Neutropenia, hematologic toxicity/bone marrow suppression, exacerbation of anemia, increased hemoglobin A2 percentage, thrombocytopenia, macrocytosis
Postmarketing reports: Aplastic anemia, hemolytic anemia, leukopenia, lymphadenopathy, pancytopenia with marrow hypoplasia, pure red cell aplasia
Very common (10% or more): Headache (up to 63%)
Common (1% to 10%): Neuropathy
Frequency not reported: Decreased reflexes, hyperalgesia, numbness, status epilepticus, Wernicke's syndrome
Postmarketing reports: Seizures, dizziness, paresthesia, somnolence, vertigo, hearing loss, loss of mental acuity, syncope, taste perversion, tremor
In 1 case of drug-associated fever, no source of infection was found after an extensive evaluation, but an anti-zidovudine immunoglobulin was isolated, indicating a possible hypersensitivity reaction.
This drug has been associated with lower levels of vitamins B2 and C, folate, and zinc despite adequate dietary intake.
Very common (10% or more): Malaise (up to 53%)
Common (1% to 10%): Asthenia, fatigue, chills
Frequency not reported: Fever, signs/symptoms of ears (included pain, discharge, erythema, swelling of ear), edema, weight loss, rigors, increased lactate dehydrogenase, lower levels of vitamins B2/C/folate/zinc
Postmarketing reports: Chest pain, influenza-like syndrome, generalized pain
Antiretroviral therapy:
-Frequency not reported: Increased weight
Very common (10% or more): Nausea (up to 51%), vomiting (up to 17%)
Common (1% to 10%): Constipation, dyspepsia, abdominal cramps, abdominal pain, gastrointestinal pain
Frequency not reported: Diarrhea, stomatitis, splenomegaly, elevated lipase, elevated total amylase, lip edema, tongue edema, eructation, bleeding gums, rectal hemorrhage
Postmarketing reports: Dysphagia, constipation, flatulence, oral mucosa pigmentation, mouth ulcer, pancreatitis
Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.
Very common (10% or more): Anorexia (up to 20%)
Rare (0.01% to 0.1%): Lactic acidosis without hypoxemia
Frequency not reported: Hyperlipidemia
Postmarketing reports: Redistribution/accumulation of body fat, lactic acidosis, hyperlactatemia
Antiretroviral therapy:
-Frequency not reported: Increased blood lipid levels, increased glucose levels
A patient with preexisting hepatitis B developed acute hepatic failure 2 weeks after starting this drug.
Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.
Hepatic decompensation (some fatal) has been reported in patients coinfected with HIV-1 and hepatitis C receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin.
Common (1% to 10%): Elevated ALT (greater than 5 times the upper limit of normal [5 x ULN]), raised blood levels of liver enzymes and bilirubin
Uncommon (0.1% to 1%): Elevated AST (greater than 5 x ULN), hyperbilirubinemia
Rare (0.01% to 0.1%): Liver disorders (e.g., severe hepatomegaly with steatosis)
Frequency not reported: Fulminate hepatitis, hepatic failure, hepatomegaly, hepatic decompensation, changes in liver function tests
Postmarketing reports: Hepatitis, hepatomegaly with steatosis, jaundice
Myopathy, myositis, muscle tenderness, and weakness in the arms and legs have been reported and were generally associated with an elevation in serum creatine kinase.
In 1 study, myalgias and elevated creatine kinase 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.
Myopathy and myositis with pathological changes, similar to that produced by HIV-1 disease, have been associated with prolonged use of this drug.
Common (1% to 10%): Arthralgia, myalgia, musculoskeletal pain
Frequency not reported: Myopathy, myositis, muscle tenderness, weakness in the arms and legs, osteonecrosis, twitch
Postmarketing reports: Increased creatine phosphokinase, muscle spasm, myopathy and myositis with pathological changes (similar to that produced by HIV-1 disease), rhabdomyolysis, back pain
Common (1% to 10%): Insomnia
Frequency not reported: Nervousness/irritability, emotional lability, grandiosity
Postmarketing reports: Anxiety, confusion, depression, mania
Bluish or brownish-black discoloration of nails has developed during the first month or 2 of therapy and usually disappeared within 2 months if the drug was discontinued. Discoloration has occurred as longitudinal streaks or transverse bands.
Frequency not reported: Skin rashes, lipoatrophy/loss of subcutaneous fat, body odor, acne, nailbed hyperpigmentation (rarely accompanied by mucocutaneous pigmentation or hypertrichosis), leukocytoclastic vasculitis (with eosinophilia and fever)
Postmarketing reports: Changes in skin and nail pigmentation, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, sweat, urticaria
Frequency not reported: Congestive heart failure ECG abnormality, left ventricular dilation, vasodilation
Postmarketing reports: Cardiomyopathy, vasculitis
Frequency not reported: Allergic skin rash
Postmarketing reports: Sensitization reactions (including anaphylaxis, angioedema)
Frequency not reported: Cough, abnormal breath sounds/wheezing, nasal discharge/congestions, flu syndrome, epistaxis, pharyngitis, hoarseness
Postmarketing reports: Dyspnea, rhinitis, sinusitis
Frequency not reported: Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)
A case of macular edema in a patient with a history of anterior uveitis secondary to syphilis has been reported.
Postmarketing reports: Amblyopia, macular edema, photophobia
Frequency not reported: Hematuria, dysuria, polyuria
Postmarketing reports: Urinary frequency, urinary hesitancy
Postmarketing reports: Gynecomastia
Local reaction, pain, and slight irritation were reported infrequently during IV administration.
Frequency not reported: Local reaction, pain, slight irritation
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Zidovudine (www.drugs.com/mtm/zidovudine-oral-injection.html).
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