Retrovir Side Effects Center

Last updated on RxList: 4/26/2022
Retrovir Side Effects Center

What Is Retrovir?

Retrovir (zidovudine) is an antiviral medication used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Retrovir is also given during pregnancy to prevent an HIV-infected woman from passing the virus to her baby. Retrovir is not a cure for HIV or AIDS. Retrovir is available in generic form.

What Are Side Effects of Retrovir?

Common side effects of Retrovir include:

  • headache,
  • nausea,
  • vomiting,
  • constipation,
  • trouble sleeping (insomnia),
  • loss of appetite,
  • joint pain, and
  • 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 any serious side effects of Retrovir including:

  • unexplained weight loss,
  • persistent muscle aches or weakness,
  • joint pain,
  • numbness or tingling of the hands/feet/arms/legs,
  • severe tiredness,
  • vision changes,
  • severe or 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), or
  • signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech).

Dosage for Retrovir

The recommended adult oral dose of Retrovir is 600 mg/day in divided doses in combination with other antiretroviral agents. The pediatric dose of Retrovir is based on the child's weight.

What Drugs, Substances, or Supplements Interact with Retrovir?

Retrovir may interact with atovaquone, doxorubicin, fluconazole, ganciclovir, interferon-alfa, methadone, nelfinavir, phenytoin, probenecid, ribavirin, ritonavir, or stavudine.

Retrovir During Pregnancy and Breastfeeding

Tell your doctor all medications you use. During pregnancy, Retrovir should be used only when prescribed. However, HIV medicines are often given to pregnant women with HIV. Treatment decreases the risk of HIV transmission to the baby. This medication passes into breast milk. Because breast milk can transmit HIV, do not breastfeed.

Additional Information

Our Retrovir (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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Retrovir Consumer Information

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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 used 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.

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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 severe hepatomegaly with steatosis [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
  • Hepatic decompensation in patients co-infected with HIV-1 and hepatitis C [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 practice.

Adults

The frequency and severity of adverse reactions associated with the use of RETROVIR are greater in patients with more advanced infection at the time of initiation of therapy.

Table 3 summarizes adverse reactions reported at a statistically significant greater incidence for subjects receiving oral RETROVIR in a monotherapy trial.

Table 3: Percentage (%) of Subjects with Adverse Reactions (Greater than or Equal to 5% Frequency) in Asymptomatic HIV-1 Infection (ACTG 019)

Adverse ReactionRETROVIR 500 mg/day
(n = 453)
Placebo
(n = 428)
Body as a whole
Asthenia9%a6%
Headache63%53%
Malaise53%45%
Gastrointestinal
Anorexia20%11%
Constipation6%a4%
Nausea51%30%
Vomiting17%10%
a Not statistically significant versus placebo.

In addition to the adverse reactions listed in Table 3, adverse reactions observed at an incidence of greater than or equal to 5% in any treatment arm in clinical trials (NUCA3001, NUCA3002, NUCB3001, and NUCB3002) were abdominal cramps, abdominal pain, arthralgia, chills, dyspepsia, fatigue, insomnia, musculoskeletal pain, myalgia, and neuropathy. Additionally, in these trials hyperbilirubinemia was reported at an incidence of less than or equal to 0.8%.

Selected laboratory abnormalities observed during a clinical trial of monotherapy with oral RETROVIR are shown in Table 4.

Table 4: Frequencies of Selected (Grade 3/4) Laboratory Abnormalities in Subjects with Asymptomatic HIV-1 Infection (ACTG 019)

Test (Abnormal Level)RETROVIR 500 mg/day
(n = 453)
Placebo
(n = 428)
Anemia (Hgb <8 g/dL)1%<1%
Granulocytopenia (<750 cells/mm³)2%2%
Thrombocytopenia (platelets <50,000/mm³)0%<1%
ALT (>5 x ULN)3%3%
AST (>5 x ULN)1%2%
ULN = Upper limit of normal.

The adverse reactions reported during IV administration of RETROVIR injection are similar to those reported with oral administration; neutropenia and anemia were reported most frequently. Long-term IV administration beyond 2 to 4 weeks has not been studied in adults and may enhance hematologic adverse reactions. Local reaction, pain, and slight irritation during IV administration occur infrequently.

Pediatrics

The clinical adverse reactions reported among adult recipients of RETROVIR may also occur in pediatric patients.

Trial ACTG 300

Selected clinical adverse reactions and physical findings with a greater than or equal to 5% frequency during therapy with EPIVIR (lamivudine) oral suspension 4 mg per kg twice daily plus RETROVIR 160 mg per m 3 times daily compared with didanosine in therapy-naive (less than or equal to 56 days of antiretroviral therapy) pediatric subjects are listed in Table 5.

Table 5: Selected Clinical Adverse Reactions and Physical Findings (Greater than or Equal to 5% Frequency) in Pediatric Subjects in Trial ACTG 300

Adverse ReactionEPIVIR plus RETROVIR
(n = 236)
Didanosine
(n = 235)
Body as a whole
Fever25%32%
Digestive
Hepatomegaly11%11%
Nausea & vomiting8%7%
Diarrhea8%6%
Stomatitis6%12%
Splenomegaly5%8%
Respiratory
Cough15%18%
Abnormal breath sounds/wheezing7%9%
Ear, Nose, and Throat
Signs or symptoms of earsa7%6%
Nasal discharge or congestion8%11%
Other
Skin rashes12%14%
Lymphadenopathy9%11%
a Includes pain, discharge, erythema, or swelling of an ear.

Selected laboratory abnormalities experienced by therapy-naive (less than or equal to 56 days of antiretroviral therapy) pediatric subjects are listed in Table 6.

Table 6: Frequencies of Selected (Grade 3/4) Laboratory Abnormalities in Pediatric Subjects in Trial ACTG 300

Test (Abnormal Level)EPIVIR plus RETROVIRDidanosine
Neutropenia (ANC <400 cells/mm³)8%3%
Anemia (Hgb <7.0 g/dL)4%2%
Thrombocytopenia (platelets <50,000/mm³)1%3%
ALT (>10 x ULN)1%3%
AST (>10 x ULN)2%4%
Lipase (>2.5 x ULN)3%3%
Total amylase (>2.5 x ULN)3%3%
ULN = Upper limit of normal.
ANC = Absolute neutrophil count.

Macrocytosis was reported in the majority of pediatric subjects receiving RETROVIR 180 mg per m² every 6 hours in openlabel trials. Additionally, adverse reactions reported at an incidence of less than 6% in these trials were congestive heart failure, decreased reflexes, ECG abnormality, edema, hematuria, left ventricular dilation, nervousness/irritability, and weight loss.

Use For The Prevention Of Maternal-Fetal Transmission Of HIV-1

In a randomized, double-blind, placebo-controlled trial in HIV-1-infected women and their neonates conducted to determine the utility of RETROVIR for the prevention of maternal-fetal HIV-1 transmission, RETROVIR oral solution at 2 mg per kg was administered every 6 hours for 6 weeks to neonates beginning within 12 hours following birth. The most commonly reported adverse reactions were anemia (hemoglobin less than 9.0 g per dL) and neutropenia (less than 1,000 cells per mm³).

Anemia occurred in 22% of the neonates who received RETROVIR and in 12% of the neonates who received placebo. The mean difference in hemoglobin values was less than 1.0 g per dL for neonates receiving RETROVIR compared with neonates receiving placebo. No neonates with anemia required transfusion and all hemoglobin values spontaneously returned to normal within 6 weeks after completion of therapy with RETROVIR. Neutropenia in neonates was reported with similar frequency in the group that received RETROVIR (21%) and in the group that received placebo (27%). The long-term consequences of in utero and infant exposure to RETROVIR are unknown.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of RETROVIR. 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

Back pain, chest pain, flu-like syndrome, generalized pain, redistribution/accumulation of body fat [see WARNINGS AND PRECAUTIONS].

Cardiovascular

Cardiomyopathy, syncope.

Eye

Macular edema.

Gastrointestinal

Constipation, dysphagia, flatulence, oral mucosa pigmentation, mouth ulcer.

General

Sensitization reactions including anaphylaxis and angioedema, vasculitis.

Hematologic

Aplastic anemia, hemolytic anemia, leukopenia, lymphadenopathy, pancytopenia with marrow hypoplasia, pure red cell aplasia.

Hepatobiliary

Hepatitis, hepatomegaly with steatosis, jaundice, lactic acidosis, pancreatitis.

Musculoskeletal

Increased CPK, increased LDH, muscle spasm, myopathy and myositis with pathological changes (similar to that produced by HIV-1 disease), rhabdomyolysis, tremor.

Nervous

Anxiety, confusion, depression, dizziness, loss of mental acuity, mania, paresthesia, seizures, somnolence, vertigo.

Reproductive System And Breast

Gynecomastia.

Respiratory

Dyspnea, rhinitis, sinusitis.

Skin And Subcutaneous Tissue

Changes in skin and nail pigmentation, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, sweating, urticaria.

Special Senses

Amblyopia, hearing loss, photophobia, taste perversion.

Renal And Urinary

Urinary frequency, urinary hesitancy.

Read the entire FDA prescribing information for Retrovir (Zidovudine)

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

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