Get medical help right away if you have any of the following serious symptoms, including: symptoms of liver problems (such as … HCPs who received occupational PEP with triple-drug regimen, AZT+3TC+Lpv/r, experienced different side effects, and the tolerability and safety of PEP regimen were good in this cohort. In this study, chills, influenza syndrome, and chest pain were reported in less than 5% of patients using zidovudine. Occasionally, neutropenia and anemia reported with lamivudine were severe. Data sources include IBM Watson Micromedex (updated 3 Mar 2021), Cerner Multum™ (updated 1 Mar 2021), ASHP (updated 3 Mar 2021) and others. 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. Arch Intern Med 151 (1991): 981-6, 17. Side effects may include trouble sleeping and weight gain. Glaxo Wellcome, Research Triangle Park, NC. Minor side effects may include nausea, fatigue, headaches, diarrhea, cough and nasal congestion. Rabaud C, Burty C, Grandidier M, et al. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Serious side effects and their symptoms can include the following: Lactic acidosis or severe liver enlargement. Side Effects . "Product Information. Commonly reported side effects of lamivudine/zidovudine include: nausea and nausea and vomiting. If you notice any other effects, check with your healthcare professional. You may report side effects to FDA at 1-800-FDA-1088. Clin Infect Dis 40 (2005): 303-5, 10. Drug information provided by: IBM Micromedex. Glaxo Wellcome, Research Triangle Park, NC. 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]. Advertising revenue supports our not-for-profit mission. Pharmacotherapy 26 (2006): 1111-33, 12. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Ann Intern Med 117 (1992): 487-501, 20. This content does not have an English version. 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. 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." These side effects may go away during treatment as your body adjusts to the medicine. 5. Incidence was higher in patients with mild laboratory abnormalities at baseline. Redistribution/accumulation of body fat has been reported with antiretroviral therapy; causality has not been established. This content does not have an Arabic version. "New once-daily HIV combination better tolerated." Am J Med 86 (1989): 469-70, 26. Description: Lamivudine, a synthetic nucleoside analogue, is phosphorylated into the body to the active 5'-triphosphate metabolite.It inhibits RNA- and DNA-dependent polymerase activities of reverse transcriptase via DNA chain termination. It is on the World Health Organization's List of Essential Medicines. [Ref], -Frequency not reported: Urinary hesitancy, dysuria, polyuria[Ref]. (4/8/2015): 6. Arch Intern Med 152 (1992): 850-1, 29. "Severe liver toxicity in postexposure prophylaxis for HIV infection with a zidovudine, lamivudine and fosamprenavir/ritonavir regimen." Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. muscle cramps, pain, stiffness, or spasms, pains in the stomach, side, or abdomen, possibly radiating to the back, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, right upper abdominal or stomach pain and fullness, burning, tingling, numbness or pain in the hands, arms, feet, or legs, weight gain around your neck, upper back, breast, face, or waist. A rare and potentially fatal condition called lactic acidosis can develop in patients taking lamivudine. Zidovudine has been associated with hematologic toxicity including neutropenia and severe anemia, particularly in patients with advanced Human Immunodeficiency Virus (HIV-1) disease.Prolonged use of zidovudine has been associated with symptomatic myopathy.Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including lamivudine and zidovudine. 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. For Healthcare Professionals General. Incidence was higher in patients with mild laboratory abnormalities at baseline. [Ref], In an advanced HIV disease study, vasodilation was reported in less than 5% of patients using zidovudine. Ann Intern Med 112 (1990): 145-6, 28. 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. One patient with preexisting hepatitis B developed acute hepatic failure 2 weeks after starting zidovudine therapy. Cerner Multum, Inc. "Australian Product Information." 1. In this study, redistribution/accumulation of body fat was reported in less than 5% of patients using zidovudine. Panel on Antiretroviral Guidelines for Adults and Adolescents "Guidelines for the use of antiretroviral Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue lamivudine / zidovudine and are co-infected with HIV-1 and HBV. In the early symptomatic HIV disease study, nausea (61%), vomiting (25%), and dyspepsia (6%) were reported with zidovudine. … ).Some health conditions may make you more susceptible to the side-effects of the drug. Lamivudine and zidovudine affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). 2. AIDS 5 (1991): 1395-6, 25. See "Lamivudine Precautions" section. Abdominal pain, nausea, vomiting, diarrhoea, headache, fever, rash, alopecia, malaise, insomnia, cough, nasal symptoms, arthralgia, musculoskeletal pain, pancreatitis, anaemia, neutropenia, thrombocytopenia, immune reconstitution syndrome, lipodystrophy, metabolic abnormalities (e.g. [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, -Common (1% to 10%): Fatigue, malaise, fever, -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, -Rare (0.01% to 0.1%): Chills, chest pain, influenza-like syndrome, -Frequency not reported: Influenza syndrome, -Frequency not reported: Increased weight[Ref], 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, -Common (1% to 10%): Cough, nasal symptoms, -Common (1% to 10%): Throat and tonsil discomfort and pain, sinusitis, bronchitis, breathing disorders, upper respiratory inflammation, dyspnea, -Frequency not reported: Epistaxis, pharyngitis, rhinitis, hoarseness[Ref], In an advanced HIV disease study, dyspnea (5%) was reported with zidovudine. In an advanced HIV disease study, asthenia (19%), fever (16%), and malaise (8%) were reported with zidovudine. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Applies to lamivudine / zidovudine: oral tablet, Side effects have been reported with lamivudine and zidovudine, administered separately or together. O'Dowd MA, McKegney FP "Manic syndrome associated with zidovudine." Available from: URL: https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf." If any of these effects persist or worsen, notify your doctor or pharmacist promptly. ), allergies, pre-existing diseases, and current health conditions (e.g. In this study, back pain, arthralgia, muscle spasm, twitch, and myopathy were reported in less than 5% of patients using zidovudine. The most serious side include muscle pain, liver failure, pancreatitis, and liver failure. Tell your doctor if … You may report them to the FDA. 2014;127(14):2632-6. Serious side effects can occur with lamivudine use. All rights reserved. Headache, tiredness, loss of appetite, nausea, vomiting, diarrhea, trouble sleeping, dizziness, or stuffy nose may occur. Side effects and tolerability of post-exposure prophylaxis with zidovudine, lamivudine, and lopinavir/ritonavir: a comparative study with HIV/AIDS patients Chin Med J (Engl). Department of Health and Am J Med 86 (1989): 814-8, 15. side-effects and special precautions Side-effects: The following side-effects have been reposed during therapy of HIV disease with LAMIVUDINE alone, and in combination with other anti-retrovirals. Zidovudine has been associated with hematologic toxicity (including neutropenia and severe anemia), particularly in patients with advanced HIV-1 disease. It contains lamivudine, nevirapine, and stavudine. 7. Lamivudine/Zidovudine Side Effects See also Warning section. Tell your doctor if you have unlikely but serious side effects of Combivir including: mental/mood changes (such as depression), signs of pancreatitis (such as vomiting, stomach/abdominal/ back pain, fever), easy bruising or bleeding, or pains in the stomach, side, or abdomen, possibly radiating to the back pinpoint red spots on the skin puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue right upper abdominal or stomach pain and fullness Rarely, lamivudine has caused severe (sometimes fatal) liver problems and a buildup of lactic acid in the blood (lactic acidosis). Gertner E, Thurn JR, Williams DN, et al "Zidovudine-associated myopathy." Although rare, they may require the immediate termination of the drug and, in some cases, emergency medical intervention. Gallant JE, DeJesus E, Arribas JR, et al "Tenofovir DF, emtricitabine, and efavirenz vs. zidovudine, lamivudine, and efavirenz for HIV." Rarely, lamivudine and zidovudine have caused severe (sometimes fatal) liver problems and a certain metabolic problem (lactic acidosis). vitamins, herbal supplements, etc. 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. Exacerbation of anemia has been reported in HIV-1/HCV-coinfected patients using zidovudine and ribavirin. 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. epivir. In an advanced HIV disease study, anorexia (11%) was reported with zidovudine. Discontinue lamivudine / zidovudine if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur.Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and HIV-1 and have discontinued lamivudine. Epivir (lamivudine)." Call your doctor for medical advice about side effects. 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. Muscle biopsy has shown atrophic and sometimes necrotic fibers, ragged-red fibers, and large accumulations of mitochondrial and fibrillar sarcoplasmic inclusions. "Tolerability of postexposure prophylaxis with the combination of zidovudine-lamivudine and lopinavir-ritonavir for HIV infection." Check out these best-sellers and special offers on books and newsletters from Mayo Clinic. Take efavirenz, lamivudine, and tenofovir exactly as directed. Drug interactions, and dosage, and pregnancy and breastfeeding safety information should be reviewed prior to taking this medication. Some side effects may not be reported. Taking efavirenz, lamivudine, and tenofovir at bedtime may make certain side effects less bothersome. 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. JAMA 260 (1988): 3587-8, 18. It is much better tolerated than interferon. Lamivudine / zidovudine systemic 150 mg / 300 mg (TV TV L2 L2), We comply with the HONcode standard for trustworthy health information -, Blistering, peeling, or loosening of the skin, itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue, muscle pain, spasms, stiffness, or cramping, red skin lesions often with a purple center, sores, ulcers, or white spots in the mouth or on the lips or tongue, tingling, burning, numbness, or pain in the hands, arms, feet, or legs, darkening of the skin and mucous membranes, swelling of the breasts or breast soreness in both females and males, swollen, painful, or tender lymph glands in the neck, armpit, or groin. Many people using this medication do not have serious side effects. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. 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. Mayo Clinic does not endorse companies or products. In an advanced HIV disease study, amblyopia and photophobia were reported in less than 5% of patients using zidovudine. 1. Don P, Fusco F, Fried P, et al "Nail dyschromia associated with zidovudine." Med J Aust 150 (1989): 339-40, 19. Anders KH, Abele DC "Development of nail pigmentation during zidovudine therapy." Medical uses. Serious side effects of lamivudine include a buildup of lactic acid in the blood (lactic acidosis), severe liver problems, and inflammation of the pancreas (pancreatitis) in children at risk for developing pancreatitis. Our general interest e-newsletter keeps you up to date on a wide variety of health topics. In an advanced HIV disease study, headache (42%), somnolence (8%), dizziness (6%), paresthesia … These side effects may go away during treatment as your body adjusts to the medicine. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Call your doctor for medical advice about side effects. Brinkman K, terHofstede HJM, Burger DM, Smeitinkt JAM, Koopmans PP "Adverse effects of reverse transcriptase inhibitors: mitochondrial toxicity as common pathway." 9. 8. Medically reviewed by Drugs.com. Incidence of neutropenia increased in patients with low neutrophil counts, hemoglobin levels, and serum vitamin B12 levels at baseline. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Other side effects not listed may also occur in some patients. hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia, hyperlactataemia), osteonecrosis; … AIDS 13 (1999): 1659-67, 14. Before using Tenofovir/lamivudine/efavirenz Tablet, inform your doctor about your current list of medications, over the counter products (e.g. It may be used in people with both HIV and tuberculosis, however if the person is on rifampicin a larger dose of dolutegravir is needed.. Side effects. Ann Intern Med 110 (1989): 85-6, 22. Incidence was higher in patients with mild laboratory abnormalities at baseline. Along with its needed effects, lamivudine / zidovudine may cause some unwanted effects. Dalakas MC, Illa I, Pezeshkpour GH, et al "Mitochondrial myopathy caused by long-term zidovudine therapy." 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. Aids 14 (2000): 1309-16, 13. 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 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. "Product Information. Expert Rev Anti Infect Ther 2 (2004): 826, 24. Sahai J, Conway B, Cameron D, Garber G "Zidovudine-associated hypertrichosis and nail pigmentation in an HIV-infected patient." Gastro-intestinal disorders: Pancreatitis, upper abdominal pain, … McLeod GX, Hammer SM "Zidovudine: five years later." Learn more about Dolutegravir & Abacavir & Lamivudine agents in HIV-1-infected adults and adolescents. Lamivudine side effects. "Product Information. It is either used by itself or along with other antiretrovirals. Retrovir (zidovudine)." Check with your doctor immediately if any of the following side effects occur: Some side effects may occur that usually do not need medical attention. Pharmacokinetics: Absorption: Rapidly absorbed from the GI tract.Delayed absorption by ingestion w/ food. Wright JM, Sachdev PS, Perkins RJ, Rodriguez P "Zidovudine-related mania." Herskowitz A, Willoughby SB, Baughman KL, et al "Cardiomyopathy associated with antiretroviral therapy in patients with HIV infection: a report of six cases." Abacavir and lamivudine can also cause serious or fatal side effects on the liver. Human Services. All rights reserved. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Common Questions and Answers about Lamivudine side effects. Combivir (lamivudine-zidovudine)" Glaxo Wellcome, Research Triangle PK, NC. Severe acute exacerbations of hepatitis have been reported in patients with hepatitis B after discontinuation of lamivudine. Many people using this medication do not have serious side effects. Many other medications may also interact with lamivudine and zidovudine, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. These hematological effects were generally observed after 4 to 6 weeks of therapy. At least 1 case of macular edema was deemed definitively associated with zidovudine in a patient with history of anterior uveitis secondary to syphilis. In this study, cough, epistaxis, pharyngitis, rhinitis, sinusitis, and hoarseness were reported in less than 5% of patients using zidovudine. Although not all of these side effects may occur, if they do occur they may need medical attention. O 0, 3. Lamivudine (3tc) (Epivir; Epivir HBV) is a drug prescribed for the treatment of HIV infection and hepatitis B infection. Some side effects may occur that usually do not need medical attention. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education, FREE book offer — Mayo Clinic Health Letter, Time running out - 40% off Online Mayo Clinic Diet ends soon. Side effects have been reported with lamivudine and zidovudine, administered separately or together. In the early symptomatic HIV disease study, asthenia was reported in 69% of patients using zidovudine. The most common side effects of DOVATO include: headache; nausea; diarrhea; trouble sleeping; tiredness; anxiety; These are not all the possible side effects of DOVATO. In this study, anxiety, confusion, depression, emotional lability, nervousness, and loss of mental acuity were reported in less than 5% of patients using zidovudine. pains in the stomach, side, or abdomen, possibly radiating to the back pinpoint red spots on the skin puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue right upper abdominal or stomach pain and fullness Lamivudine / 3TC TABLETS AND ORAL SOLUTION. Ann Intern Med 116 (1992): 311-3. Mallal SA, John M, Moore CB, James IR, McKinnon EJ "Contribution of nucleoside analogue reverse transcriptase inhibitors to subcutaneous fat wasting in patients with HIV infection." Truvada, tenofovir, lamivudine, emtricitabine, Atripla, Stribild, Complera, Epzicom. Moore RD, Creagh-Kirk T, Keruly J, et al "Long-term safety and efficacy of zidovudine in patients with advanced human immunodefiency virus disease." [Ref], Common (1% to 10%): Anorexia and/or decreased appetite, Postmarketing reports: Hyperglycemia, redistribution/accumulation of body fat, lactic acidosis, -Very rare (less than 0.01%): Lactic acidosis, -Postmarketing reports: Hyperlactatemia (common), lactic acidosis (rare), redistribution/accumulation of body fat, -Rare (0.01% to 0.1%): Lactic acidosis (without hypoxemia), -Frequency not reported: Redistribution/accumulation of body fat, hyperlactatemia, -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], Common (1% to 10%): Skin rashes, sweating, fungal skin infection, acne and folliculitis, viral skin infection, Postmarketing reports: Alopecia, erythema multiforme, Stevens-Johnson syndrome, urticaria, -Common (1% to 10%): Sweating/diaphoresis, fungal skin infection, acne and folliculitis, viral skin infection, -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].
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