October 9, 2015
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Side Effects


The following adverse reactions are discussed in other sections of the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

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 adverse reactions and laboratory abnormalities were observed (see Tables 1 and 2).

Table 1: Selected Clinical Adverse Reactions (Greater than or Equal to 5% Frequency) in 4 Controlled Clinical Trials with EPIVIR 300 mg per day and RETROVIR 600 mg per day

Adverse Reaction EPIVIR plus RETROVIR
(n = 251)
Body as a whole
  Headache 35%
  Malaise & fatigue 27%
  Fever or chills 10%
  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%
  Nasal signs & symptoms 20%
  Cough 18%
  Skin rashes 9%
  Musculoskeletal pain 12%
  Myalgia 8%
  Arthralgia 5%

Pancreatitis was observed in 9 of the 2,613 adult subjects (0.3%) who received EPIVIR in controlled clinical trials [see WARNINGS AND PRECAUTIONS].

Selected laboratory abnormalities observed during therapy are listed in Table 2.

Table 2: Frequencies of Selected Laboratory Abnormalities among Adults in 4 Controlled Clinical Trials of EPIVIR 300 mg per day plus RETROVIR 600 mg per daya

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/mm ) 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 subjects assessed.
aFrequencies of these laboratory abnormalities were higher in subjects with mild laboratory abnormalities at baseline.

Postmarketing Experience

The following adverse reactions have been identified during postmarketing use. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a Whole

Redistribution/accumulation of body fat [see WARNINGS AND PRECAUTIONS].



Endocrine and Metabolic

Gynecomastia, hyperglycemia.


Oral mucosal pigmentation, stomatitis.


Vasculitis, weakness.

Hemic and Lymphatic

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

Hepatic and Pancreatic

Lactic acidosis and hepatic steatosis, pancreatitis, posttreatment exacerbations of hepatitis B [see BOXED WARNING, WARNINGS AND PRECAUTIONS].


Sensitization reactions (including anaphylaxis), urticaria.


Muscle weakness, CPK elevation, rhabdomyolysis.


Paresthesia, peripheral neuropathy, seizures.


Abnormal breath sounds/wheezing.


Alopecia, erythema multiforme, Stevens-Johnson syndrome.

Read the Combivir (lamivudine, zidovudine) Side Effects Center for a complete guide to possible side effects



Agents Antagonistic with Zidovudine

Concomitant use of zidovudine with the following drugs should be avoided since an antagonistic relationship has been demonstrated in vitro:

  • Stavudine
  • Doxorubicine
  • Nucleoside analogues e.g., ribavirin
Hematologic/Bone Marrow Suppressive/Cytotoxic Agents

Coadministration with the following drugs may increase the hematologic toxicity of zidovudine:

  • Ganciclovir
  • Interferon alfa
  • Ribavirin
  • Other bone marrow suppressive or cytotoxic agents

Read the Combivir Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 10/8/2015
This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Combivir - User Reviews

Combivir User Reviews

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Here is a collection of user reviews for the medication Combivir sorted by most helpful. Patient Discussions FAQs

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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