Combivir Side Effects
Please note - some side effects for Combivir 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 Combivir - for the consumer
Combivir
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 Combivir:
Seek medical attention right away if any of these SEVERE side effects occur when using Combivir:Appetite loss; changes in body fat; cough; diarrhea; dizziness; fatigue; headache; indigestion; nasal problems; sleeplessness or other sleep problems; tiredness; weakness.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; depression; fast or irregular heartbeat; infection (fever, chills, sore throat); inflammation of the pancreas (severe stomach pain, nausea, vomiting); joint pain; mental/mood changes; muscle pain; nausea; numbness, tingling, or weakness in arms or legs; seizures; shortness of breath; stomach tenderness or pain; swelling or soreness of the mouth or tongue; unusual bleeding or bruising; unusual tiredness; unusual weakness or exhaustion; vomiting; yellowing of the skin or eyes.
For the professional
Combivir
Lamivudine Plus Zidovudine Administered As Separate Formulations
In 4 randomized, controlled trials of EPIVIR 300 mg per day plus RETROVIR 600 mg per day, the following selected clinical and laboratory adverse events were observed.
Adverse Event |
EPIVIR plus RETROVIR (n = 251) |
Body as a whole |
|
Headache |
35% |
Malaise & fatigue |
27% |
Fever or chills |
10% |
Digestive |
|
Nausea |
33% |
Diarrhea |
18% |
Nausea & vomiting |
13% |
Anorexia and/or decreased appetite |
10% |
Abdominal pain |
9% |
Abdominal cramps |
6% |
Dyspepsia |
5% |
Nervous system |
|
Neuropathy |
12% |
Insomnia & other sleep disorders |
11% |
Dizziness |
10% |
Depressive disorders |
9% |
Respiratory |
|
Nasal signs & symptoms |
20% |
Cough |
18% |
Skin |
|
Skin rashes |
9% |
Musculoskeletal |
|
Musculoskeletal pain |
12% |
Myalgia |
8% |
Arthralgia |
5% |
Pancreatitis was observed in 3 of the 656 adult patients (<0.5%) who received EPIVIR in controlled clinical trials.
Selected laboratory abnormalities observed during therapy are listed in Table 5.
|
Test (Abnormal Level) |
EPIVIR plus RETROVIR % (n) |
Neutropenia (ANC<750/mm3) |
7.2% (237) |
Anemia (Hgb<8.0 g/dL) |
2.9% (241) |
Thrombocytopenia (platelets<50,000/mm3) |
0.4% (240) |
ALT (>5.0 x ULN) |
3.7% (241) |
AST (>5.0 x ULN) |
1.7% (241) |
Bilirubin (>2.5 x ULN) |
0.8% (241) |
Amylase (>2.0 x ULN) |
4.2% (72) |
ULN = Upper limit of normal.
ANC = Absolute neutrophil count.
n = Number of patients assessed.
* Frequencies of these laboratory abnormalities were higher in patients with mild laboratory abnormalities at baseline.
Observed During Clinical Practice
In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of EPIVIR, RETROVIR, and/or Combivir. 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 a combination of their seriousness, frequency of reporting, or potential causal connection to EPIVIR, RETROVIR, and/or Combivir.
Body as a WholeRedistribution/accumulation of body fat.
CardiovascularCardiomyopathy.
Endocrine and MetabolicGynecomastia, hyperglycemia.
GastrointestinalOral mucosal pigmentation, stomatitis.
GeneralVasculitis, weakness.
Hemic and LymphaticAnemia, (including pure red cell aplasia and severe anemias progressing on therapy), lymphadenopathy, splenomegaly.
Hepatic and PancreaticLactic acidosis and hepatic steatosis, pancreatitis, posttreatment exacerbation of hepatitis B.
HypersensitivitySensitization reactions (including anaphylaxis), urticaria.
MusculoskeletalMuscle weakness, CPK elevation, rhabdomyolysis.
NervousParesthesia, peripheral neuropathy, seizures.
RespiratoryAbnormal breath sounds/wheezing.
SkinAlopecia, erythema multiforme, Stevens-Johnson syndrome.
TopCombivir Tablets
Lamivudine Plus Zidovudine Administered As Separate Formulations
In 4 randomized, controlled trials of EPIVIR 300 mg per day plus RETROVIR 600 mg per day, the following selected clinical and laboratory adverse events were observed.
Adverse Event |
EPIVIR plus RETROVIR (n = 251) |
Body as a whole |
|
Headache |
35% |
Malaise & fatigue |
27% |
Fever or chills |
10% |
Digestive |
|
Nausea |
33% |
Diarrhea |
18% |
Nausea & vomiting |
13% |
Anorexia and/or decreased appetite |
10% |
Abdominal pain |
9% |
Abdominal cramps |
6% |
Dyspepsia |
5% |
Nervous system |
|
Neuropathy |
12% |
Insomnia & other sleep disorders |
11% |
Dizziness |
10% |
Depressive disorders |
9% |
Respiratory |
|
Nasal signs & symptoms |
20% |
Cough |
18% |
Skin |
|
Skin rashes |
9% |
Musculoskeletal |
|
Musculoskeletal pain |
12% |
Myalgia |
8% |
Arthralgia |
5% |
Pancreatitis was observed in 3 of the 656 adult patients (<0.5%) who received EPIVIR in controlled clinical trials.
Selected laboratory abnormalities observed during therapy are listed in Table 5.
|
Test (Abnormal Level) |
EPIVIR plus RETROVIR % (n) |
Neutropenia (ANC<750/mm3) |
7.2% (237) |
Anemia (Hgb<8.0 g/dL) |
2.9% (241) |
Thrombocytopenia (platelets<50,000/mm3) |
0.4% (240) |
ALT (>5.0 x ULN) |
3.7% (241) |
AST (>5.0 x ULN) |
1.7% (241) |
Bilirubin (>2.5 x ULN) |
0.8% (241) |
Amylase (>2.0 x ULN) |
4.2% (72) |
ULN = Upper limit of normal.
ANC = Absolute neutrophil count.
n = Number of patients assessed.
* Frequencies of these laboratory abnormalities were higher in patients with mild laboratory abnormalities at baseline.
Observed During Clinical Practice
In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of EPIVIR, RETROVIR, and/or Combivir. 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 a combination of their seriousness, frequency of reporting, or potential causal connection to EPIVIR, RETROVIR, and/or Combivir.
Body as a WholeRedistribution/accumulation of body fat.
CardiovascularCardiomyopathy.
Endocrine and MetabolicGynecomastia, hyperglycemia.
GastrointestinalOral mucosal pigmentation, stomatitis.
GeneralVasculitis, weakness.
Hemic and LymphaticAnemia, (including pure red cell aplasia and severe anemias progressing on therapy), lymphadenopathy, splenomegaly.
Hepatic and PancreaticLactic acidosis and hepatic steatosis, pancreatitis, posttreatment exacerbation of hepatitis B.
HypersensitivitySensitization reactions (including anaphylaxis), urticaria.
MusculoskeletalMuscle weakness, CPK elevation, rhabdomyolysis.
NervousParesthesia, peripheral neuropathy, seizures.
RespiratoryAbnormal breath sounds/wheezing.
SkinAlopecia, erythema multiforme, Stevens-Johnson syndrome.
TopMore resources:
Combivir - Includes detailed dosage instructions.
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