Zidovudine Side Effects

Brand Names: Retrovir

Please note - some side effects for Zidovudine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Zidovudine - for the Consumer

Zidovudine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zidovudine:

Headache; loss of appetite; nausea; tiredness; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills; dark urine; drowsiness; fast breathing; fever; muscle pain or aches; red, swollen, or blistered skin; seizures; shortness of breath; sore throat; stomach pain; unusual tiredness or weakness; yellowing of the skin or eyes.

Zidovudine Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zidovudine Capsules:

Headache; loss of appetite; nausea; tiredness; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills; dark urine; drowsiness; fast breathing; fever; muscle pain or aches; red, swollen, or blistered skin; seizures; shortness of breath; sore throat; stomach pain; unusual tiredness or weakness; yellowing of the skin or eyes.

Zidovudine Syrup

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zidovudine Syrup:

Headache; loss of appetite; nausea; tiredness; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills; dark urine; drowsiness; fast breathing; fever; muscle pain or aches; red, swollen, or blistered skin; seizures; shortness of breath; sore throat; stomach pain; unusual tiredness or weakness; yellowing of the skin or eyes.

Zidovudine Side Effects - for the Professional

Zidovudine

• The most commonly reported adverse reactions (incidence ≥15%) in adult HIV-1 clinical studies were headache, malaise, nausea, anorexia, and vomiting. (6.1)
• The most commonly reported adverse reactions (incidence ≥15%) in pediatric HIV-1 clinical studies were fever, cough, and digestive disorders.  (6.1)
• The most commonly reported adverse reactions in neonates (incidence ≥15%) in the prevention of maternal-fetal transmission of HIV-1 clinical trial were anemia and neutropenia. (6.1)

Side Effects by Body System

General

The adverse effects of zidovudine are sometimes difficult to distinguish from the symptomatology observed during the clinical course of AIDS, as well as from the possible adverse effects of other drugs used in the treatment of HIV infection. Many of the side effects associated with nucleoside reverse transcriptase inhibitor therapy (myopathy, pancreatitis, liver failure, lactic acidosis, etc.) are attributable to their direct toxic effect on mitochondria which causes decreased mitochondrial energy-generating capacity.

Hematologic

Bone marrow suppression, the most common reason for cessation of zidovudine therapy, appears to be dose-dependent and may be seen as early as 2 to 6 weeks after initiation of therapy. Recombinant GM-CSF (sargramostim), G-CSF (filgrastim), and erythropoietin (epoetin alfa) have been used to control the hematologic toxicity of zidovudine.

Zidovudine should be used with extreme caution in patients with bone marrow suppression indicated by a granulocyte count below 1000 cells/mm3 or hemoglobin less than 9.5 g/dL. Routine blood counts are recommended, and generally should occur more frequently in patients with advanced disease. If bone marrow toxicity occurs, an interruption or discontinuation of zidovudine therapy may be necessary.

Hematologic side effects are the major dose-limiting adverse effects of zidovudine and occur in up to 45% of patients. Zidovudine-induced bone marrow suppression results in neutropenia, granulocytopenia, anemia, and less frequently, thrombocytopenia. Increased hemoglobin A2 percentage has been reported. Aplastic anemia, hemolytic anemia, leukopenia, pancytopenia with marrow hypoplasia, and pure red cell aplasia have been reported during postmarketing experience.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, anorexia, dyspepsia, flatulence, constipation, diarrhea, abdominal cramps, abdominal pain, stomatitis, and splenomegaly. Dysphagia, oral mucosa pigmentation, mouth ulcer, and pancreatitis have been reported during postmarketing experience.

Hepatic

Hepatic side effects have included increases in liver function tests (ALT and AST), severe or fatal hepatomegaly with steatosis and lactic acidosis, fulminate hepatitis, and hepatic failure. Hepatic decompensation has been reported in patients coinfected with HIV-1 and hepatitis C. Hepatitis and jaundice have been reported during postmarketing experience.

One patient with preexisting hepatitis B developed acute hepatic failure two weeks after starting zidovudine therapy.

Patients with a history of liver disease should be monitored for further deterioration in liver function.

Musculoskeletal

In one study, myalgias and elevated CK 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. Dosage 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.

Musculoskeletal side effects have included myopathy, myositis, muscle tenderness, arthralgia, myalgias, musculoskeletal pain, and weakness in the arms and legs, and are generally associated with an elevation in serum creatine kinase. Zidovudine-related myopathy may occur after several weeks of therapy and may be difficult to distinguish from that associated with the natural progression of HIV disease. Increased lactate dehydrogenase, muscle spasm, rhabdomyolysis, and tremor have been reported during postmarketing experience.

Nervous system

Nervous system side effects have included headache (common), dizziness, insomnia, numbness, and neuropathy. Generalized seizures, status epilepticus, confusion, paresthesia, somnolence, vertigo, and Wernicke's syndrome have been rarely reported. Loss of mental acuity has been reported during postmarketing experience.

Other

Other side effects have included asthenia, malaise, fatigue, chills, fever, and lymphadenopathy. Back pain, chest pain, flu-like syndrome, generalized pain, hearing loss, and taste perversion have been reported during postmarketing experience.

In one case of zidovudine-associated fever, no source of infection was found after an extensive evaluation, but an anti-zidovudine immunoglobulin was isolated, indicating a possible hypersensitivity reaction.

Psychiatric

Psychiatric side effects have included sleep disturbances and isolated cases of depression, mania, anxiety, and grandiosity.

Dermatologic

Dermatologic side effects have included case reports of nailbed hyperpigmentation, particularly in black people. Rarely, nail hyperpigmentation has been accompanied by mucocutaneous pigmentation or hypertrichosis. Skin rashes and leukocytoclastic vasculitis with eosinophilia and fever have also been reported. Changes in skin and nail pigmentation, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, sweat, and urticaria have been reported during postmarketing experience.

Bluish or brownish-black discoloration of nails may develop during the first month or two of zidovudine therapy and usually disappears within 2 months if the drug is discontinued. Discoloration may occur as longitudinal streaks or transverse bands.

Other

Zidovudine therapy may be associated with lower levels of vitamins B2 and C, folate, and zinc despite adequate dietary intake. The use of multivitamins with zidovudine is recommended.

Cardiovascular

Cardiovascular side effects have included rare cases of reversible congestive heart failure, syncope, and vasodilation. Cardiomyopathy and vasculitis have been reported during postmarketing experience.

Ocular

Ocular side effects have included a case of macular edema in a patient with a history of anterior uveitis secondary to syphilis. Amblyopia and photophobia have been reported during postmarketing experience.

Hypersensitivity

Hypersensitivity reactions have included allergic skin rash. Sensitization reactions including anaphylaxis and angioedema have been reported during postmarketing experience.

Metabolic

Metabolic side effects have included hyperbilirubinemia, hyperlipidemia, and redistribution and/or accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement and cushingoid appearance.

Respiratory

Respiratory side effects have included cough, wheezing/abnormal breath sounds, nasal discharge, and congestion in pediatric patients. Dyspnea, rhinitis, and sinusitis have been reported during postmarketing experience.

Genitourinary

Genitourinary side effects have included urinary frequency and urinary hesitancy during postmarketing experience.

Endocrine

Endocrine side effects have included gynecomastia during postmarketing experience.

Other

Ear pain, discharge, erythema, and swelling have been reported in pediatric patients.

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