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Retrovir IV Side Effects Center
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Retrovir IV in Detail - Patient Information: Side Effects
Stop using this medication and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these other serious side effects:
- liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- lactic acidosis - muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, nausea with vomiting, and fast or uneven heart rate;
- easy bruising or bleeding, unusual weakness, pale skin;
- white patches or sores inside your mouth or on your lips;
- fever, chills, body aches, flu symptoms; or
- any other signs of new infection.
Less serious side effects may be more likely to occur, such as:
- mild nausea, vomiting, constipation;
- sleep problems (insomnia);
- muscle or joint pain;
- headache, tired feeling;
- skin rash;
- pain or irritation where the medicine was injected; or
- changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Retrovir IV (Zidovudine Injection) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Retrovir IV FDA Prescribing Information: Side Effects
The adverse events reported during intravenous administration of RETROVIR IV (zidovudine injection) Infusion are similar to those reported with oral administration; neutropenia and anemia were reported most frequently. Long-term intravenous administration beyond 2 to 4 weeks has not been studied in adults and may enhance hematologic adverse events. Local reaction, pain, and slight irritation during intravenous administration occur infrequently.
Table 5 summarizes events reported at a statistically significantly greater incidence for patients receiving RETROVIR orally in a monotherapy study:
Table 5. Percentage (%) of Patients with Adverse Events*
in Asymptomatic HIV Infection (ACTG 019)
|Adverse Event|| RETROVIR 500 mg/day
(n = 453)
(n = 428)
|Body as a whole|
| *Reported in ≥ 5% of study population.
† Not statistically significant versus placebo.
In addition to the adverse events listed in Table 5, 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 oral RETROVIR are shown in Table 6.
Table 6. Frequencies of Selected (Grade 3/4) Laboratory Abnormalities
in Patients with Asymptomatic HIV Infection (ACTG 019)
|Adverse Event|| RETROVIR 500 mg/day
(n = 453)
(n = 428)
|Anemia (Hgb < 8 g/dL)||1.1%||0.2%|
|Granulocytopenia ( < 750 cells/mm3)||1.8%||1.6%|
|Thrombocytopenia (platelets < 50,000/mm3)||0%||0.5%|
|ALT ( > 5 x ULN)||3.1%||2.6%|
|AST ( > 5 x ULN)||0.9%||1.6%|
|Alkaline phosphatase ( > 5 x ULN)||0%||0%|
|ULN = Upper limit of normal.|
Study ACTG300: Selected clinical adverse events and physical findings with a ≥ 5% frequency during therapy with EPIVIR 4 mg/kg twice daily plus RETROVIR 160 mg/m2 orally 3 times daily compared with didanosine in therapy-naive ( ≤ 56 days of antiretroviral therapy) pediatric patients are listed in Table 7.
Table 7. Selected Clinical Adverse Events and Physical Findings
( ≥ 5% Frequency) in Pediatric Patients in Study ACTG300
|Adverse Event|| EPIVIR plus RETROVIR
(n = 236)
(n = 235)
|Body as a Whole|
|Nausea & vomiting||8%||7%|
|Abnormal breath sounds/wheezing||7%||9%|
|Ear, Nose, and Throat|
|Signs or symptoms of ears*||7%||6%|
|Nasal discharge or congestion||8%||11%|
|*Includes pain, discharge, erythema, or swelling of an ear.|
Selected laboratory abnormalities experienced by therapy-naive ( ≤ 56 days of antiretroviral therapy) pediatric patients are listed in Table 8.
Table 8. Frequencies of Selected (Grade 3/4) Laboratory Abnormalities
in Pediatric Patients in Study ACTG300
|Test (Abnormal Level)||EPIVIR plus RETROVIR||Didanosine|
|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.
Additional adverse events reported in open-label studies in pediatric patients receiving RETROVIR 180 mg/m2 every 6 hours were congestive heart failure, decreased reflexes, ECG abnormality, edema, hematuria, left ventricular dilation, macrocytosis, nervousness/irritability, and weight loss.
The clinical adverse events reported among adult recipients of RETROVIR 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 RETROVIR for the prevention of maternal-fetal HIV transmission, RETROVIR 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 < 9.0 g/dL) and neutropenia ( < 1,000 cells/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/dL for neonates receiving RETROVIR 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 RETROVIR. Neutropenia 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.
Observed During Clinical Practice
In addition to adverse events reported from clinical trials, the following events have been identified during use of RETROVIR 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 RETROVIR, or a combination of these factors.
Eye: Macular edema.
Urogenital:Urinary frequency, urinary hesitancy.
Read the entire FDA prescribing information for Retrovir IV (Zidovudine Injection) »
Additional Retrovir IV Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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