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Retrovir Side Effects

Generic name: zidovudine

Medically reviewed by Last updated on Nov 9, 2023.

Note: This document contains side effect information about zidovudine. Some dosage forms listed on this page may not apply to the brand name Retrovir.

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.

Serious side effects of Retrovir

Along with its needed effects, zidovudine (the active ingredient contained in Retrovir) 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


Incidence not known

Other side effects of Retrovir

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

For Healthcare Professionals

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.[Ref]


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[Ref]

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.[Ref]

Nervous system

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[Ref]


In 1 case of drug-associated fever, no source of infection was found after an extensive evaluation, but an anti-zidovudine (the active ingredient contained in Retrovir) 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.[Ref]

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[Ref]


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[Ref]


Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.[Ref]

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[Ref]


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[Ref]

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.[Ref]


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.[Ref]

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[Ref]


Common (1% to 10%): Insomnia

Frequency not reported: Nervousness/irritability, emotional lability, grandiosity

Postmarketing reports: Anxiety, confusion, depression, mania[Ref]


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.[Ref]

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[Ref]


Frequency not reported: Congestive heart failure ECG abnormality, left ventricular dilation, vasodilation

Postmarketing reports: Cardiomyopathy, vasculitis[Ref]


Frequency not reported: Allergic skin rash

Postmarketing reports: Sensitization reactions (including anaphylaxis, angioedema)[Ref]


Frequency not reported: Cough, abnormal breath sounds/wheezing, nasal discharge/congestions, flu syndrome, epistaxis, pharyngitis, hoarseness

Postmarketing reports: Dyspnea, rhinitis, sinusitis[Ref]


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.[Ref]

Postmarketing reports: Amblyopia, macular edema, photophobia[Ref]


Frequency not reported: Hematuria, dysuria, polyuria

Postmarketing reports: Urinary frequency, urinary hesitancy[Ref]


Postmarketing reports: Gynecomastia[Ref]


Frequency not reported: Local reaction, pain, slight irritation

Local reaction, pain, and slight irritation were reported infrequently during IV administration.


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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.