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).
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For the consumer For the professional
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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:
Seek medical attention right away if any of these SEVERE side effects occur 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:
Seek medical attention right away if any of these SEVERE side effects occur 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:
Seek medical attention right away if any of these SEVERE side effects occur when using Zidovudine Syrup:Headache; loss of appetite; nausea; tiredness; vomiting.
TopSevere 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.
For the professional
Zidovudine
Adults
The frequency and severity of adverse events associated with the use of Zidovudine are greater in patients with more advanced infection at the time of initiation of therapy.
Table 6 summarizes events reported at a statistically significant greater incidence for patients receiving Zidovudine in a monotherapy study:
| *Reported in ≥5% of study population. † Not statistically significant versus placebo. | ||
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Adverse Event |
Zidovudine 500 mg/day (n = 453) |
Placebo (n = 428) |
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Body as a whole Asthenia Headache Malaise |
8.6%† 62.5% 53.2% |
5.8% 52.6% 44.9% |
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Gastrointestinal Anorexia Constipation Nausea Vomiting |
20.1% 6.4%† 51.4% 17.2% |
10.5% 3.5% 29.9% 9.8% |
In addition to the adverse events listed in Table 6, other adverse events observed in clinical studies were abdominal cramps, abdominal pain, arthralgia, chills, dyspepsia, fatigue, hyperbilirubinemia, insomnia, musculoskeletal pain, myalgia, and neuropathy.
Selected laboratory abnormalities observed during a clinical study of monotherapy with Zidovudine are shown in Table 7.
| ULN = Upper limit of normal. | ||
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Adverse Event |
Zidovudine 500 mg/day (n = 453) |
Placebo (n = 428) |
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Anemia (Hgb<8 g/dL) Granulocytopenia (<750 cells/mm3) Thrombocytopenia (platelets<50,000/mm3) ALT (>5 x ULN) AST (>5 x ULN) Alkaline phosphatase (>5 x ULN) |
1.1% 1.8% 0% 3.1% 0.9% 0% |
0.2% 1.6% 0.5% 2.6% 1.6% 0% |
Pediatrics: Study ACTG300
Selected clinical adverse events and physical findings with a ≥5% frequency during therapy with lamivudine 4 mg/kg twice daily plus Zidovudine 160 mg/m2 3 times daily compared with didanosine in therapy-naive (≤56 days of antiretroviral therapy) pediatric patients are listed in Table 8.
| * Includes pain, discharge, erythema, or swelling of an ear. | ||
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Adverse Event |
Lamivudine plus Zidovudine (n = 236) |
Didanosine (n = 235) |
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Body as a whole Fever |
25% |
32% |
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Digestive Hepatomegaly Nausea & vomiting Diarrhea Stomatitis Splenomegaly |
11% 8% 8% 6% 5% |
11% 7% 6% 12% 8% |
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Respiratory Cough Abnormal breath sounds/wheezing |
15% 7% |
18% 9% |
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Ear, Nose, and Throat Signs or symptoms of ears* Nasal discharge or congestion |
7% 8% |
6% 11% |
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Other Skin rashes Lymphadenopathy |
12% 9% |
14% 11% |
Selected laboratory abnormalities experienced by therapy-naive (≤56 days of antiretroviral therapy) pediatric patients are listed in Table 9.
| ULN = Upper limit of normal. ANC = Absolute neutrophil count. | ||
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Test (Abnormal Level) |
Lamivudine plus Zidovudine |
Didanosine |
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Neutropenia (ANC<400 cells/mm3) Anemia (Hgb<7 g/dL) Thrombocytopenia (platelets<50,000/mm3) ALT (>10 x ULN) AST (>10 x ULN) Lipase (>2.5 x ULN) Total amylase (>2.5 x ULN) |
8% 4% 1% 1% 2% 3% 3% |
3% 2% 3% 3% 4% 3% 3% |
The clinical adverse events reported among adult recipients of Zidovudine may also occur in pediatric patients.
Use for the Prevention of Maternal-Fetal Transmission of HIV
In a randomized, double-blind, placebo-controlled trial in HIV-infected women and their neonates conducted to determine the utility of Zidovudine for the prevention of maternal-fetal HIV 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 experiences 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 to 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 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.
Observed During Clinical Practice
In addition to adverse events reported from clinical trials, the following events have been identified during use of Zidovudine in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, potential causal connection to Zidovudine, or a combination of these factors.
Body as a Whole: Back pain, chest pain, flu-like syndrome, generalized pain, redistribution/accumulation of body fat.
Cardiovascular: Cardiomyopathy, syncope.
Endocrine: Gynecomastia.
Eye: Macular edema.
Gastrointestinal: Constipation, 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 disease), rhabdomyolysis, tremor.
Nervous: Anxiety, confusion, depression, dizziness, loss of mental acuity, mania, paresthesia, seizures, somnolence, vertigo.
Respiratory: Cough, dyspnea, rhinitis, sinusitis.
Skin: Changes in skin and nail pigmentation, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, sweat, urticaria.
Special Senses: Amblyopia, hearing loss, photophobia, taste perversion.
Urogenital: Urinary frequency, urinary hesitancy. Top
More resources:
Zidovudine - Includes detailed dosage instructions.
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