Side Effects > Combivir

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).

For the consumer Combivir For the professional Combivir Combivir Tablets

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:

Appetite loss; changes in body fat; cough; diarrhea; dizziness; fatigue; headache; indigestion; nasal problems; sleeplessness or other sleep problems; tiredness; weakness.

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

Severe 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.

Top

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.

Table 4. Selected Clinical Adverse Events (≥5% Frequency) in 4 Controlled Clinical Trials With EPIVIR 300 mg/day and RETROVIR 600 mg/day

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.

Table 5. Frequencies of Selected Laboratory Abnormalities Among Adults in 4 Controlled Clinical Trials of EPIVIR 300 mg/day plus RETROVIR 600 mg/day*

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 Whole

Redistribution/accumulation of body fat.

Cardiovascular

Cardiomyopathy.

Endocrine and Metabolic

Gynecomastia, hyperglycemia.

Gastrointestinal

Oral mucosal pigmentation, stomatitis.

General

Vasculitis, weakness.

Hemic and Lymphatic

Anemia, (including pure red cell aplasia and severe anemias progressing on therapy), lymphadenopathy, splenomegaly.

Hepatic and Pancreatic

Lactic acidosis and hepatic steatosis, pancreatitis, posttreatment exacerbation of hepatitis B.

Hypersensitivity

Sensitization reactions (including anaphylaxis), urticaria.

Musculoskeletal

Muscle weakness, CPK elevation, rhabdomyolysis.

Nervous

Paresthesia, peripheral neuropathy, seizures.

Respiratory

Abnormal breath sounds/wheezing.

Skin

Alopecia, erythema multiforme, Stevens-Johnson syndrome.

Top

Combivir 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.

Table 4. Selected Clinical Adverse Events (≥5% Frequency) in 4 Controlled Clinical Trials With EPIVIR 300 mg/day and RETROVIR 600 mg/day

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 Whole

Redistribution/accumulation of body fat.

Cardiovascular

Cardiomyopathy.

Endocrine and Metabolic

Gynecomastia, hyperglycemia.

Gastrointestinal

Oral mucosal pigmentation, stomatitis.

General

Vasculitis, weakness.

Hemic and Lymphatic

Anemia, (including pure red cell aplasia and severe anemias progressing on therapy), lymphadenopathy, splenomegaly.

Hepatic and Pancreatic

Lactic acidosis and hepatic steatosis, pancreatitis, posttreatment exacerbation of hepatitis B.

Hypersensitivity

Sensitization reactions (including anaphylaxis), urticaria.

Musculoskeletal

Muscle weakness, CPK elevation, rhabdomyolysis.

Nervous

Paresthesia, peripheral neuropathy, seizures.

Respiratory

Abnormal breath sounds/wheezing.

Skin

Alopecia, erythema multiforme, Stevens-Johnson syndrome.

Top

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.