Retrovir Side Effects
Generic Name: Zidovudine
Please note - some side effects for Retrovir 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 Retrovir - for the consumer
Retrovir
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 Retrovir:
Seek medical attention right away if any of these SEVERE side effects occur when using Retrovir: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.
Retrovir 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 Retrovir Capsules:
Seek medical attention right away if any of these SEVERE side effects occur when using Retrovir 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.
Retrovir 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 Retrovir Syrup:
Seek medical attention right away if any of these SEVERE side effects occur when using Retrovir 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
Retrovir
Adults
The frequency and severity of adverse events associated with the use of Retrovir 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 Retrovir in a monotherapy study:
Adverse Event |
Retrovir 500 mg/day (n = 453) |
Placebo (n = 428) |
Body as a whole |
||
Asthenia |
8.6%† |
5.8% |
Headache |
62.5% |
52.6% |
Malaise |
53.2% |
44.9% |
Gastrointestinal |
||
Anorexia |
20.1% |
10.5% |
Constipation |
6.4%† |
3.5% |
Nausea |
51.4% |
29.9% |
Vomiting |
17.2% |
9.8% |
*Reported in ≥5% of study population.
†Not statistically significant versus placebo.
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 Retrovir are shown in Table 7.
Adverse Event |
Retrovir 500 mg/day (n = 453) |
Placebo (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.
Pediatrics
Study ACTG300Selected clinical adverse events and physical findings with a ≥5% frequency during therapy with EPIVIR 4 mg/kg twice daily plus Retrovir 160 mg/m2 3 times daily compared with didanosine in therapy-naive (≤56 days of antiRetroviral therapy) pediatric patients are listed in Table 8.
Adverse Event |
EPIVIR plus Retrovir (n = 236) |
Didanosine (n = 235) |
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% |
*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 9.
|
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 uteroand 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.
Body as a WholeBack pain, chest pain, flu-like syndrome, generalized pain, redistribution/accumulation of body fat.
CardiovascularCardiomyopathy, syncope.
EndocrineGynecomastia.
EyeMacular edema.
GastrointestinalConstipation, dysphagia, flatulence, oral mucosa pigmentation, mouth ulcer.
GeneralSensitization reactions including anaphylaxis and angioedema, vasculitis.
Hemic and LymphaticAplastic anemia, hemolytic anemia, leukopenia, lymphadenopathy, pancytopenia with marrow hypoplasia, pure red cell aplasia.
Hepatobiliary Tract and PancreasHepatitis, hepatomegaly with steatosis, jaundice, lactic acidosis, pancreatitis.
MusculoskeletalIncreased CPK, increased LDH, muscle spasm, myopathy and myositis with pathological changes (similar to that produced by HIV disease), rhabdomyolysis, tremor.
NervousAnxiety, confusion, depression, dizziness, loss of mental acuity, mania, paresthesia, seizures, somnolence, vertigo.
RespiratoryCough, dyspnea, rhinitis, sinusitis.
SkinChanges in skin and nail pigmentation, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, sweat, urticaria.
Special SensesAmblyopia, hearing loss, photophobia, taste perversion.
UrogenitalUrinary frequency, urinary hesitancy.
TopRetrovir Infusion
The adverse events reported during intravenous administration of Retrovir IV 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.
Adults
The frequency and severity of adverse events associated with the use of Retrovir are greater in patients with more advanced infection at the time of initiation of therapy.
Table 5 summarizes events reported at a statistically significantly greater incidence for patients receiving Retrovir orally in a monotherapy study:
Adverse Event |
Retrovir 500 mg/day (n = 453) |
Placebo (n = 428) |
Body as a whole |
||
Asthenia |
8.6%† |
5.8% |
Headache |
62.5% |
52.6% |
Malaise |
53.2% |
44.9% |
Gastrointestinal |
||
Anorexia |
20.1% |
10.5% |
Constipation |
6.4%† |
3.5% |
Nausea |
51.4% |
29.9% |
Vomiting |
17.2% |
9.8% |
*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.
Adverse Event |
Retrovir 500 mg/day (n = 453) |
Placebo (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.
Pediatrics
Study ACTG300Selected 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.
Adverse Event |
EPIVIR plus Retrovir (n = 236) |
Didanosine (n = 235) |
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% |
*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.
|
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 uteroand 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.
Body as a WholeBack pain, chest pain, flu-like syndrome, generalized pain.
CardiovascularCardiomyopathy, syncope.
EndocrineGynecomastia.
EyeMacular edema.
GastrointestinalConstipation, dysphagia, flatulence, oral mucosal pigmentation, mouth ulcer.
GeneralSensitization reactions including anaphylaxis and angioedema, vasculitis.
Hemic and LymphaticAplastic anemia, hemolytic anemia, leukopenia,lymphadenopathy, pancytopenia with marrow hypoplasia, pure red cell aplasia.
Hepatobiliary Tract and PancreasHepatitis, hepatomegaly with steatosis, jaundice, lactic acidosis, pancreatitis.
MusculoskeletalIncreased CPK, increased LDH, muscle spasm, myopathy and myositis with pathological changes (similar to that produced by HIV disease), rhabdomyolysis, tremor.
NervousAnxiety, confusion, depression, dizziness, loss of mental acuity, mania, paresthesia, seizures, somnolence, vertigo.
RespiratoryCough, dyspnea, rhinitis, sinusitis.
SkinChanges in skin and nail pigmentation, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, sweat, urticaria.
Special SensesAmblyopia, hearing loss, photophobia, taste perversion.
UrogenitalUrinary frequency, urinary hesitancy.
TopMore resources:
Retrovir - Includes detailed dosage instructions.
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