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
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:

    Constipation; headache; loss of appetite; nausea; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Zidovudine:

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

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
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:

    Constipation; headache; loss of appetite; nausea; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Zidovudine Capsules:

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

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
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:

    Constipation; headache; loss of appetite; nausea; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Zidovudine Syrup:

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

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
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Zidovudine Side Effects - for the Professional
Zidovudine
[b][b]Clinical Trials Experience

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 (5.1)].
    * Symptomatic myopathy [see Boxed Warning, Warnings and Precautions (5.2)].
    * Lactic acidosis and severe hepatomegaly with steatosis [see Boxed Warning, Warnings and Precautions (5.3)].
    * Hepatic decompensation in patients co-infected with HIV-1 and hepatitis C [see Warnings and Precautions (5.4)].


Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to 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 Zidovudine are greater in patients with more advanced infection at the time of initiation of therapy.

Table 2 summarizes events reported at a statistically significant greater incidence for patients receiving Zidovudine in a monotherapy study.
Table 2. Percentage (%) of Patients With Adverse Reactions* in Asymptomatic HIV-1 Infection (ACTG 019) Adverse Reaction Zidovudine 500 mg/day
(n = 453) Placebo
(n = 428)
*Reported in ≥5% of study population.
†Not statistically significant versus placebo.
Body as a whole


    Asthenia
9%†
6%
    Headache
63%
53%
    Malaise
53%
45%
Gastrointestinal


    Anorexia
20%
11%
    Constipation
6%†
4%
    Nausea
51%
30%
    Vomiting
17%
10%
In addition to the adverse reactions listed in Table 2, adverse reactions observed at an incidence of ≥5% in any treatment arm in clinical studies (NUCA3001, NUCA3002, NUCB3001, and NUCB3002) were abdominal cramps, abdominal pain, arthralgia, chills, dyspepsia, fatigue, insomnia, musculoskeletal pain, myalgia, and neuropathy. Additionally, in these studies hyperbilirubinemia was reported at an incidence of ≤0.8%.

Selected laboratory abnormalities observed during a clinical study of monotherapy with Zidovudine are shown in Table 3.
Table 3. Frequencies of Selected (Grade 3/4) Laboratory Abnormalities in Patients With Asymptomatic HIV-1 Infection (ACTG 019) Test
(Abnormal Level) Zidovudine 500 mg/day
(n = 453) Placebo
(n = 428)
ULN = Upper limit of normal.
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%
Pediatrics: The clinical adverse reactions reported among adult recipients of Zidovudine may also occur in pediatric patients.

Study ACTG 300: Selected clinical adverse reactions and physical findings with a ≥5% frequency during therapy with EPIVIR® (lamivudine) Oral Suspension 4 mg/kg twice daily plus Zidovudine160 mg/m2 3 times daily compared with didanosine in therapy-naive (≤56 days of antiretroviral therapy) pediatric patients are listed in Table 4.
Table 4. Selected Clinical Adverse Reactions and Physical Findings (≥5% Frequency) in Pediatric Patients in Study ACTG 300 Adverse Reaction EPIVIR plus Zidovudine
(n = 236) Didanosine
(n = 235)
*Includes pain, discharge, erythema, or swelling of an ear.
Body as a whole


    Fever
25%
32%
Digestive


    Hepatomegaly
11%
11%
    Nausea & vomiting
8%
7%
    Diarrhea
8%
6%
    Stomatitis
6%
12%
    Splenomegaly
5%
8%
Respiratory


    Cough
15%
18%
    Abnormal breath sounds/wheezing
7%
9%
Ear, Nose, and Throat


    Signs or symptoms of ears*
7%
6%
    Nasal discharge or congestion
8%
11%
Other


    Skin rashes
12%
14%
    Lymphadenopathy
9%
11%
Selected laboratory abnormalities experienced by therapy-naive (≤56 days of antiretroviral therapy) pediatric patients are listed in Table 5.
Table 5. Frequencies of Selected (Grade 3/4) Laboratory Abnormalities in Pediatric Patients in Study ACTG 300 Test (Abnormal Level) EPIVIR plus Zidovudine Didanosine
ULN = Upper limit of normal.
ANC = Absolute neutrophil count.
Neutropenia (ANC<400 cells/mm3)
8%
3%
Anemia (Hgb<7 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%
Macrocytosis was reported in the majority of pediatric patients receiving Zidovudine 180 mg/m2 every 6 hours in open-label studies. Additionally, adverse reactions reported at an incidence of <6% in these studies 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 Zidovudine for the prevention of maternal-fetal HIV-1 transmission, Zidovudine syrup at 2 mg/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 <9 g/dL) and neutropenia (<1,000 cells/mm3). Anemia occurred in 22% of the neonates who received Zidovudine and in 12% of the neonates who received placebo. The mean difference in hemoglobin values was less than 1 g/dL for neonates receiving Zidovudine 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 Zidovudine. Neutropenia in neonates was reported with similar frequency in the group that received Zidovudine (21%) and in the group that received placebo (27%). The long-term consequences of in utero and infant exposure to Zidovudine are unknown.
Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following reactions have been identified during postmarketing use of Zidovudine. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to Zidovudine.

Body as a Whole:  Back pain, chest pain, flu-like syndrome, generalized pain, redistribution/accumulation of body fat [see Warnings and Precautions (5.7)].

Cardiovascular:  Cardiomyopathy, syncope.

Endocrine:  Gynecomastia.

Eye:  Macular edema.

Gastrointestinal:  Dysphagia, flatulence, oral mucosa pigmentation, mouth ulcer.

General:  Sensitization reactions including anaphylaxis and angioedema, vasculitis.

Hemic and Lymphatic:  Aplastic anemia, hemolytic anemia, leukopenia, lymphadenopathy, pancytopenia with marrow hypoplasia, pure red cell aplasia.

Hepatobiliary Tract and Pancreas:  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.

Respiratory:  Dyspnea, rhinitis, sinusitis.

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

Special Senses:  Amblyopia, hearing loss, photophobia, taste perversion.

Urogenital:  Urinary frequency, urinary hesitancy. Top
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Side Effects by Body System - for Healthcare Professionals
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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