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Combivir Side Effects

Generic Name: lamivudine / zidovudine

Note: This page contains information about the side effects of lamivudine / zidovudine. Some of the dosage forms included on this document may not apply to the brand name Combivir.

In Summary

Common side effects of Combivir include: nausea and vomiting and nausea. Other side effects include: neutropenia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to lamivudine / zidovudine: oral tablet

In addition to its needed effects, some unwanted effects may be caused by lamivudine / zidovudine. In the event that any of these side effects do occur, they may require medical attention.

Severity: Major

You should check with your doctor immediately if any of these side effects occur when taking lamivudine / zidovudine:

More common:
  • Chills
  • fever
  • pale skin
  • sore throat
  • unusual tiredness or weakness
Less common:
  • Abdominal or stomach pain (severe)
  • burning, tingling, numbness, or pain in the hands, arms, feet, or legs
  • muscle tenderness and weakness
  • nausea
  • skin rash
  • vomiting
  • yellow eyes or skin
Incidence not known:
  • Blistering, peeling, or loosening of the skin
  • canker sores
  • chest discomfort or pain
  • chills
  • convulsions
  • dark urine
  • decreased appetite
  • difficulty with breathing
  • difficulty with swallowing
  • dizziness
  • faintness
  • fast, irregular, or pounding heartbeat
  • fast, shallow breathing
  • feeling of fullness
  • general feeling of discomfort
  • general tiredness and weakness
  • hives or welts
  • itching
  • itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
  • jerking of all extremities
  • joint or muscle pain
  • light-colored stools
  • loss of bladder control
  • muscle pain, spasms, stiffness, or cramping
  • red skin lesions often with a purple center
  • red, irritated eyes
  • redness, soreness, or itching skin
  • sensation of pins and needles
  • shortness of breath
  • sleepiness
  • sores, ulcers, or white spots in the mouth or on the lips or tongue
  • sores, welting or blisters
  • stabbing pain
  • sudden loss of consciousness
  • swelling of the feet or lower legs
  • tingling, burning, numbness, or pain in the hands, arms, feet, or legs
  • tightness in the chest
  • troubled with breathing
  • unsteadiness or awkwardness
  • wheezing

Severity: Minor

Some of the side effects that can occur with lamivudine / zidovudine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Headache
Less common:
  • Abdominal or stomach pain (mild)
  • coughing
  • decreased appetite
  • diarrhea
  • dizziness
  • trouble in sleeping
Incidence not known:
  • Abnormal breathing
  • blurred vision
  • body fat redistribution or accumulation
  • darkening of the skin and mucous membranes
  • dry mouth
  • fatigue
  • flushed, dry skin
  • fruit-like breath odor
  • hair loss
  • increased hunger
  • increased thirst
  • increased urination
  • sweating
  • swelling of the breasts or breast soreness in both females and males
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • thinning of the hair
  • troubled breathing, unexplained

For Healthcare Professionals

Applies to lamivudine / zidovudine: oral tablet

General

Side effects have been reported with lamivudine and zidovudine, administered separately or together. For many of these side effects, it was not clear if they were due to lamivudine, zidovudine, the other drugs used to treat HIV infection, or the underlying disease process.[Ref]

Nervous system

In an advanced HIV disease study, headache (42%), somnolence (8%), dizziness (6%), paresthesia (6%), and taste perversion (5%) were reported with zidovudine; only headache was reported at a significantly greater rate than placebo. In this study, seizures, vertigo, hearing loss, hyperalgesia, tremor, and syncope were reported in less than 5% of patients using zidovudine.

In an asymptomatic HIV infection study, headache and dizziness were reported in 58% and 20.8% (using 1500 mg) and 62.5% and 17.9% (using 500 mg) of patients using zidovudine, respectively.[Ref]

Very common (10% or more): Headache (up to 35.1%), neuropathy (up to 12.4%), dizziness (up to 10.4%)
Frequency not reported: Syncope, taste perversion
Postmarketing reports: Paresthesia, peripheral neuropathy, seizures

Lamivudine:
-Common (1% to 10%): Headache
-Rare (0.01% to 0.1%): Peripheral neuropathy/neuropathy, paresthesia

Zidovudine:
-Very common (10% or more): Headache, dizziness
-Common (1% to 10%): Neuropathy, paresthesia, somnolence, taste perversion
-Rare (0.01% to 0.1%): Convulsions
-Frequency not reported: Generalized seizures, status epilepticus, vertigo, Wernicke's syndrome, hearing loss, hyperalgesia, tremor, syncope[Ref]

Gastrointestinal

Very common (10% or more): Nausea (33%), diarrhea (18%), nausea and vomiting (13%), abdominal discomfort and pain (up to 11.3%)
Common (1% to 10%): Abdominal cramps, dyspepsia, elevated amylase, fungal gastrointestinal (GI) infection, GI discomfort and pain, gaseous symptoms, vomiting
Uncommon (0.1% to 1%): Pancreatitis
Frequency not reported: Flatulence
Postmarketing reports: Oral mucosal pigmentation, stomatitis, pancreatitis

Lamivudine:
-Common (1% to 10%): Nausea, vomiting, abdominal discomfort and pain or cramps, diarrhea
-Uncommon (0.1% to 1%): Pancreatitis, abnormal pancreatic enzymes
-Rare (0.01% to 0.1%): Elevated serum amylase

Zidovudine:
-Very common (10% or more): Nausea, GI pain, diarrhea, vomiting
-Common (1% to 10%): Abdominal discomfort and pain, fungal GI infection, GI discomfort and pain, gaseous symptoms, elevated amylase, dyspepsia
-Uncommon (0.1% to 1%): Flatulence
-Rare (0.01% to 0.1%): Oral mucosa pigmentation, pancreatitis
-Frequency not reported: Constipation, dysphagia, tongue edema, eructation, bleeding gums, rectal hemorrhage, lip edema, mouth ulcer[Ref]

Elevated amylase (greater than 2 times the upper limit of normal [2 x ULN]) has been reported in 4.2% of patients using lamivudine plus zidovudine and 1.5% of patients using zidovudine. Incidence was higher in patients with mild laboratory abnormalities at baseline.

In an advanced HIV disease study, nausea (46%), GI pain (20%), diarrhea (12%), vomiting (6%), and dyspepsia (5%) were reported with zidovudine; only nausea was reported at a significantly greater rate than placebo. In this study, constipation, dysphagia, tongue edema, eructation, flatulence, bleeding gums, rectal hemorrhage, lip edema, and mouth ulcer were reported in less than 5% of patients using zidovudine.

In the early symptomatic HIV disease study, nausea (61%), vomiting (25%), and dyspepsia (6%) were reported with zidovudine. In an asymptomatic HIV infection study, nausea, vomiting, and constipation were reported in 57.3%, 16.4%, and 8.1% (using 1500 mg) and 51.4%, 17.2%, and 6.4% (using 500 mg) of patients using zidovudine, respectively.[Ref]

Other

In an advanced HIV disease study, asthenia (19%), fever (16%), and malaise (8%) were reported with zidovudine. In this study, chills, influenza syndrome, and chest pain were reported in less than 5% of patients using zidovudine.

In the early symptomatic HIV disease study, asthenia was reported in 69% of patients using zidovudine. In an asymptomatic HIV infection study, asthenia and malaise were reported in 10.1% and 55.6% (using 1500 mg) and 8.6% and 53.2% (using 500 mg) of patients using zidovudine, respectively.[Ref]

Very common (10% or more): Malaise and fatigue (27%); ear, nose, and throat infection (up to 11.3%)
Common (1% to 10%): Fever or chills; viral ear, nose, and throat infection; viral infection
Postmarketing reports: Weakness

Lamivudine:
-Common (1% to 10%): Fatigue, malaise, fever

Zidovudine:
-Very common (10% or more): Asthenia, fever, malaise
-Common (1% to 10%): Ear, nose, and throat infection; viral ear, nose, and throat infection; viral infection
-Uncommon (0.1% to 1%): Generalized pain
-Rare (0.01% to 0.1%): Chills, chest pain, influenza-like syndrome
-Frequency not reported: Influenza syndrome

Antiretroviral therapy:
-Frequency not reported: Increased weight[Ref]

Respiratory

Very common (10% or more): Nasal signs and symptoms (20%), cough (18%), throat and tonsil discomfort and pain (up to 11.6%)
Common (1% to 10%): Bronchitis, sinusitis, breathing disorders, upper respiratory inflammation
Frequency not reported: Dyspnea, rhinitis
Postmarketing reports: Abnormal breath sounds/wheezing

Lamivudine:
-Common (1% to 10%): Cough, nasal symptoms

Zidovudine:
-Common (1% to 10%): Throat and tonsil discomfort and pain, sinusitis, bronchitis, breathing disorders, upper respiratory inflammation, dyspnea
-Rare (0.01% to 0.1%): Cough
-Frequency not reported: Epistaxis, pharyngitis, rhinitis, hoarseness[Ref]

In an advanced HIV disease study, dyspnea (5%) was reported with zidovudine. In this study, cough, epistaxis, pharyngitis, rhinitis, sinusitis, and hoarseness were reported in less than 5% of patients using zidovudine.[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (up to 13.5%)
Common (1% to 10%): Myalgia, arthralgia
Postmarketing reports: Muscle weakness, elevated creatine phosphokinase (CPK), rhabdomyolysis

Lamivudine:
-Common (1% to 10%): Arthralgia, muscle disorders
-Rare (0.01% to 0.1%): Rhabdomyolysis

Zidovudine:
-Common (1% to 10%): Musculoskeletal pain, myalgia
-Uncommon (0.1% to 1%): Myopathy
-Frequency not reported: Symptomatic myopathy, myositis, back pain, arthralgia, muscle spasm, twitch

Combination antiretroviral therapy:
-Frequency not reported: Osteonecrosis[Ref]

Myopathy and myositis (with pathological changes similar to that produced by HIV-1 disease) have been associated with prolonged zidovudine use.

In an advanced HIV disease study, myalgia (8%) was reported with zidovudine at a significantly greater rate than placebo. In this study, back pain, arthralgia, muscle spasm, twitch, and myopathy were reported in less than 5% of patients using zidovudine.

In 1 zidovudine study, myalgias and elevated CPK occurred in 8% of treated patients with a CD4 cell count less than 200/mm3, and in none of the patients with higher CD4 cell counts. Dose reduction has not affected the course of myopathy, although drug discontinuation sometimes resulted in improvement of symptoms, generally within a month. Muscle biopsy has shown atrophic and sometimes necrotic fibers, ragged-red fibers, and large accumulations of mitochondrial and fibrillar sarcoplasmic inclusions.[Ref]

Psychiatric

In an advanced HIV disease study, insomnia (5%) was reported with zidovudine at a significantly greater rate than placebo. In this study, anxiety, confusion, depression, emotional lability, nervousness, and loss of mental acuity were reported in less than 5% of patients using zidovudine.[Ref]

Very common (10% or more): Insomnia and other sleep disorders (up to 11.6%)
Common (1% to 10%): Depressive disorders

Lamivudine:
-Common (1% to 10%): Insomnia

Zidovudine:
-Common (1% to 10%): Sleep disorders, insomnia
-Rare (0.01% to 0.1%): Anxiety, depression, loss of mental acuity
-Frequency not reported: Mania, confusion, grandiosity, emotional lability, nervousness[Ref]

Hepatic

Common (1% to 10%): Elevated ALT, elevated AST, abnormal liver function tests
Uncommon (0.1% to 1%): Elevated bilirubin
Frequency not reported: Severe hepatomegaly with steatosis, hepatic decompensation
Postmarketing reports: Hepatic steatosis, posttreatment exacerbation of hepatitis B

Lamivudine:
-Uncommon (0.1% to 1%): Elevated liver enzymes (AST, ALT)
-Rare (0.01% to 0.1%): Hepatitis, abnormal liver function tests

Zidovudine:
-Common (1% to 10%): Elevated liver enzyme levels in blood (including ALT, AST), elevated bilirubin levels in blood
-Rare (0.01% to 0.1%): Liver disorders (e.g., severe hepatomegaly with steatosis)
-Frequency not reported: Changes in liver function tests (including increased AST levels), acute hepatic failure[Ref]

Elevated ALT (greater than 5 x ULN), AST (greater than 5 x ULN), and bilirubin (greater than 2.5 x ULN) have been reported in 3.7%, 1.7%, and 0.8% of patients using lamivudine plus zidovudine, respectively, and 3.6%, 1.8%, and 0.4% of patients using zidovudine, respectively. Incidence was higher in patients with mild laboratory abnormalities at baseline.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.

Hepatic decompensation (some fatal) has been reported in patients coinfected with HIV-1 and hepatitis C virus (HCV) receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin.

Severe acute exacerbations of hepatitis have been reported in patients with hepatitis B after discontinuation of lamivudine.

In an advanced HIV disease study, changes in liver function tests (including increased AST levels) was reported in less than 5% of patients using zidovudine.

One patient with preexisting hepatitis B developed acute hepatic failure 2 weeks after starting zidovudine therapy.[Ref]

Hematologic

Common (1% to 10%): Neutropenia, anemia, lymphatic signs/symptoms, decreased white cells
Uncommon (0.1% to 1%): Thrombocytopenia
Postmarketing reports: Anemia (including pure red cell aplasia and anemias progressing on therapy), lymphadenopathy, splenomegaly

Lamivudine:
-Uncommon (0.1% to 1%): Neutropenia, anemia, thrombocytopenia, decreased white cells
-Very rare (less than 0.01%): Pure red cell aplasia

Zidovudine:
-Very common (10% or more): Granulocytopenia, anemia
-Common (1% to 10%): Neutropenia, leukopenia, lymphatic signs/symptoms, decreased white cells, thrombocytopenia
-Uncommon (0.1% to 1%): Pancytopenia (with marrow hypoplasia)
-Rare (0.01% to 0.1%): Pure red cell aplasia
-Very rare (less than 0.01%): Aplastic anemia
-Frequency not reported: Exacerbation of anemia, hemolytic anemia, hematologic toxicity (including neutropenia, severe anemia), lymphadenopathy[Ref]

Neutropenia (absolute neutrophil count less than 750/mm3), anemia (hemoglobin less than 8 g/dL), and thrombocytopenia (platelets less than 50,000/mm3) have been reported in 7.2%, 2.9%, and 0.4% of patients using lamivudine plus zidovudine, respectively, and 5.4%, 1.8%, and 1.3% of patients using zidovudine, respectively. Incidence was higher in patients with mild laboratory abnormalities at baseline.

Occasionally, neutropenia and anemia reported with lamivudine were severe.

Granulocytopenia (less than 750/mm3) has been reported in 6.4% (CD4 up to 500 using 1500 mg), 1.8% (CD4 up to 500 using 500 mg), 4% (CD4 greater than 200 using 1200 mg), 10% (CD4 greater than 200 using 1500 mg), and 47% (CD4 less than 200 using 1500 mg) of patients using zidovudine. Anemia (hemoglobin less than 8 g/dL) has been reported in 6.4% (CD4 up to 500 using 1500 mg), 1.1% (CD4 up to 500 using 500 mg), 4% (CD4 greater than 200 using 1200 mg), 3% (CD4 greater than 200 using 1500 mg), and 29% (CD4 less than 200 using 1500 mg) of patients using zidovudine.

Zidovudine has been associated with hematologic toxicity (including neutropenia and severe anemia), particularly in patients with advanced HIV-1 disease. Anemia, neutropenia, and leukopenia were reported more often with higher doses (1200 to 1500 mg/day) and in patients with advanced HIV disease (especially with poor bone marrow reserve at baseline) and particularly in those with CD4 cell counts less than 100/mm3. These hematological effects were generally observed after 4 to 6 weeks of therapy. Incidence of neutropenia increased in patients with low neutrophil counts, hemoglobin levels, and serum vitamin B12 levels at baseline.

Exacerbation of anemia has been reported in HIV-1/HCV-coinfected patients using zidovudine and ribavirin.

In an advanced HIV disease study, lymphadenopathy was reported in less than 5% of patients using zidovudine.[Ref]

Metabolic

Common (1% to 10%): Anorexia and/or decreased appetite
Postmarketing reports: Hyperglycemia, redistribution/accumulation of body fat, lactic acidosis

Lamivudine:
-Very rare (less than 0.01%): Lactic acidosis
-Postmarketing reports: Hyperlactatemia (common), lactic acidosis (rare), redistribution/accumulation of body fat

Zidovudine:
-Very common (10% or more): Anorexia
-Rare (0.01% to 0.1%): Lactic acidosis (without hypoxemia)
-Frequency not reported: Redistribution/accumulation of body fat, hyperlactatemia

Antiretroviral therapy:
-Frequency not reported: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance"), increased blood lipid levels, increased glucose levels[Ref]

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.

In an advanced HIV disease study, anorexia (11%) was reported with zidovudine. In this study, redistribution/accumulation of body fat was reported in less than 5% of patients using zidovudine.

In an asymptomatic HIV infection study, anorexia was reported in 19.3% (using 1500 mg) and 20.1% (using 500 mg) of patients using zidovudine.

Redistribution/accumulation of body fat has been reported with antiretroviral therapy; causality has not been established.[Ref]

Dermatologic

In an advanced HIV disease study, rash (17%) and diaphoresis (5%) were reported with zidovudine. In this study, acne, pruritus, urticaria, nail pigmentation, and body odor were reported in less than 5% of patients using zidovudine.

Bluish or brownish-black discoloration of nails has developed during the first 1 or 2 months of zidovudine therapy and usually disappeared within 2 months if the drug is discontinued. Discoloration has occurred as longitudinal streaks or transverse bands.[Ref]

Common (1% to 10%): Skin rashes, sweating, fungal skin infection, acne and folliculitis, viral skin infection
Frequency not reported: Pruritus
Postmarketing reports: Alopecia, erythema multiforme, Stevens-Johnson syndrome, urticaria

Lamivudine:
-Common (1% to 10%): Rash, alopecia
-Rare (0.01% to 0.1%): Angioedema

Zidovudine:
-Very common (10% or more): Rash
-Common (1% to 10%): Sweating/diaphoresis, fungal skin infection, acne and folliculitis, viral skin infection
-Uncommon (0.1% to 1%): Pruritus
-Rare (0.01% to 0.1%): Nail and skin pigmentation, urticaria
-Frequency not reported: Lipoatrophy, skin and nailbed pigmentation changes, toxic epidermal necrolysis, leukocytoclastic vasculitis (with eosinophilia and fever), nail hyperpigmentation (rarely accompanied by mucocutaneous pigmentation or hypertrichosis), body odor[Ref]

Cardiovascular

Frequency not reported: Phlebitis
Postmarketing reports: Cardiomyopathy, vasculitis

Zidovudine:
-Rare (0.01% to 0.1%): Cardiomyopathy
-Frequency not reported: Vasodilation[Ref]

In an advanced HIV disease study, vasodilation was reported in less than 5% of patients using zidovudine.[Ref]

Immunologic

Frequency not reported: Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)

Ocular

Frequency not reported: Disturbances of vision

Zidovudine:
-Frequency not reported: Amblyopia, photophobia, macular edema[Ref]

In an advanced HIV disease study, amblyopia and photophobia were reported in less than 5% of patients using zidovudine.

At least 1 case of macular edema was deemed definitively associated with zidovudine in a patient with history of anterior uveitis secondary to syphilis.[Ref]

Hypersensitivity

Postmarketing reports: Sensitization reactions (including anaphylaxis)

Zidovudine:
-Frequency not reported: Sensitization reactions (including anaphylaxis)[Ref]

Endocrine

Postmarketing reports: Gynecomastia

Zidovudine:
-Rare (0.01% to 0.1%): Gynecomastia[Ref]

Genitourinary

In an advanced HIV disease study, urinary frequency, urinary hesitancy, dysuria, and polyuria were reported in less than 5% of patients using zidovudine.[Ref]

Zidovudine:
-Rare (0.01% to 0.1%): Urinary frequency
-Frequency not reported: Urinary hesitancy, dysuria, polyuria[Ref]

References

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2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. Brinkman K, terHofstede HJM, Burger DM, Smeitinkt JAM, Koopmans PP "Adverse effects of reverse transcriptase inhibitors: mitochondrial toxicity as common pathway." AIDS 12 (1998): 1735-44

5. Panel on Antiretroviral Guidelines for Adults and Adolescents "Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. Available from: URL: https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf." (4/8/2015):

6. "Product Information. Retrovir (zidovudine)." Glaxo Wellcome, Research Triangle Park, NC.

7. Gallant JE, DeJesus E, Arribas JR, et al "Tenofovir DF, emtricitabine, and efavirenz vs. zidovudine, lamivudine, and efavirenz for HIV." N Engl J Med 354 (2006): 251-60

8. "Product Information. Epivir (lamivudine)." Glaxo Wellcome, Research Triangle Park, NC.

9. Rabaud C, Burty C, Grandidier M, et al. "Tolerability of postexposure prophylaxis with the combination of zidovudine-lamivudine and lopinavir-ritonavir for HIV infection." Clin Infect Dis 40 (2005): 303-5

10. Pavel S, Burty C, Alcaraz I, et al. "Severe liver toxicity in postexposure prophylaxis for HIV infection with a zidovudine, lamivudine and fosamprenavir/ritonavir regimen." AIDS 21 (2007): 268-269

11. Piacenti FJ "An update and review of antiretroviral therapy." Pharmacotherapy 26 (2006): 1111-33

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13. SaintMarc T, Partisani M, PoizotMartin I, Bruno F, Rouviere O, Lang JM, Gastaut JA, Touraine JL "A syndrome of peripheral fat wasting (Lipodystrophy) in patients receiving long-term nucleoside analogue therapy." AIDS 13 (1999): 1659-67

14. Gertner E, Thurn JR, Williams DN, et al "Zidovudine-associated myopathy." Am J Med 86 (1989): 814-8

15. Dalakas MC, Illa I, Pezeshkpour GH, et al "Mitochondrial myopathy caused by long-term zidovudine therapy." N Engl J Med 322 (1990): 1098-105

16. Moore RD, Creagh-Kirk T, Keruly J, et al "Long-term safety and efficacy of zidovudine in patients with advanced human immunodefiency virus disease." Arch Intern Med 151 (1991): 981-6

17. O'Dowd MA, McKegney FP "Manic syndrome associated with zidovudine." JAMA 260 (1988): 3587-8

18. Wright JM, Sachdev PS, Perkins RJ, Rodriguez P "Zidovudine-related mania." Med J Aust 150 (1989): 339-40

19. McLeod GX, Hammer SM "Zidovudine: five years later." Ann Intern Med 117 (1992): 487-501

20. Gradon JD, Chapnick EK, Sepkowitz DV "Zidovudine-induced hepatitis." J Intern Med 231 (1992): 317-8

21. Puro V, Soldani F, De Carli G, Lazarevic Z, Mattioli F, Ippolito G "Drug-induced aminotransferase alterations during antiretroviral HIV post-exposure prophylaxis." AIDS 17 (2003): 1988-90

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23. "New once-daily HIV combination better tolerated." Expert Rev Anti Infect Ther 2 (2004): 826

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27. Don P, Fusco F, Fried P, et al "Nail dyschromia associated with zidovudine." Ann Intern Med 112 (1990): 145-6

28. Anders KH, Abele DC "Development of nail pigmentation during zidovudine therapy." J Am Acad Dermatol 21 (1989): 192-3

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Not all side effects for Combivir may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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