[Ref], Very common (10% or more): Musculoskeletal pain (up to 13.5%), Postmarketing reports: Muscle weakness, elevated creatine phosphokinase (CPK), rhabdomyolysis, -Common (1% to 10%): Arthralgia, muscle disorders, -Common (1% to 10%): Musculoskeletal pain, myalgia, -Frequency not reported: Symptomatic myopathy, myositis, back pain, arthralgia, muscle spasm, twitch, -Frequency not reported: Osteonecrosis[Ref]. It is either used by itself or along with other antiretrovirals. Although not all of these side effects may occur, if they do occur they may need medical attention. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. 1. Piacenti FJ "An update and review of antiretroviral therapy." Cerner Multum, Inc. "UK Summary of Product Characteristics." It contains lamivudine, nevirapine, and stavudine. "Tolerability of postexposure prophylaxis with the combination of zidovudine-lamivudine and lopinavir-ritonavir for HIV infection." 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]. 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." See below for a comprehensive list of adverse effects. AIDS 21 (2007): 268-269, 11. Gallant JE, DeJesus E, Arribas JR, et al "Tenofovir DF, emtricitabine, and efavirenz vs. zidovudine, lamivudine, and efavirenz for HIV." Panel on Antiretroviral Guidelines for Adults and Adolescents "Guidelines for the use of antiretroviral Available for Android and iOS devices. Before using Tenofovir/lamivudine/efavirenz Tablet, inform your doctor about your current list of medications, over the counter products (e.g. Ann Intern Med 117 (1992): 487-501, 20. Merenich JA, Hannon RN, Gentry RH, Harrison SM "Azidothymidine-induced hyperpigmentation mimicking primary adrenal insufficiency." 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. 2014;127(14):2632-6. Severe acute exacerbations of hepatitis have been reported in patients with hepatitis B after discontinuation of lamivudine. 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. 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. Serious side effects can occur with lamivudine use. Ann Intern Med 116 (1992): 311-3. Ann Intern Med 112 (1990): 145-6, 28. O 0, 4. In an advanced HIV disease study, headache (42%), somnolence (8%), dizziness (6%), paresthesia … Tell your doctor if … "New once-daily HIV combination better tolerated." AIDS 12 (1998): 1735-44. (4/8/2015): 6. 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." 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. ).Some health conditions may make you more susceptible to the side-effects of the drug. 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. Expert Rev Anti Infect Ther 2 (2004): 826, 24. [Ref], Postmarketing reports: Cardiomyopathy, vasculitis, -Frequency not reported: Vasodilation[Ref], Frequency not reported: Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome), Frequency not reported: Disturbances of vision, -Frequency not reported: Amblyopia, photophobia, macular edema[Ref]. In an advanced HIV disease study, lymphadenopathy was reported in less than 5% of patients using zidovudine.[Ref]. Some side effects may occur that usually do not need medical attention. McLeod GX, Hammer SM "Zidovudine: five years later." "Product Information. AIDS 13 (1999): 1659-67, 14. hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia, hyperlactataemia), osteonecrosis; … All rights reserved. [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, -Rare (0.01% to 0.1%): Peripheral neuropathy/neuropathy, paresthesia, -Very common (10% or more): Headache, dizziness, -Common (1% to 10%): Neuropathy, paresthesia, somnolence, taste perversion, -Frequency not reported: Generalized seizures, status epilepticus, vertigo, Wernicke's syndrome, hearing loss, hyperalgesia, tremor, syncope[Ref], 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, Postmarketing reports: Oral mucosal pigmentation, stomatitis, pancreatitis, -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, -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, -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]. In this study, chills, influenza syndrome, and chest pain were reported in less than 5% 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. Clin Infect Dis 40 (2005): 303-5, 10. Along with its needed effects, a medicine may cause some unwanted effects. Call your doctor for medical advice about side effects. Rarely, lamivudine and zidovudine have caused severe (sometimes fatal) liver problems and a certain metabolic problem (lactic acidosis). Take efavirenz, lamivudine, and tenofovir exactly as directed. Side effects have been reported with lamivudine and zidovudine, administered separately or together. Tell your doctor if you have: signs of a new infection --fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss; © 1998-2021 Mayo Foundation for Medical Education and Research (MFMER). Many people using this medication do not have serious side effects. 7. It is much better tolerated than interferon. Truvada, tenofovir, lamivudine, emtricitabine, Atripla, Stribild, Complera, Epzicom. Combivir (lamivudine-zidovudine)" Glaxo Wellcome, Research Triangle PK, NC. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. 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. Portions of this document last updated: Feb. 01, 2021. Puro V, Soldani F, De Carli G, Lazarevic Z, Mattioli F, Ippolito G "Drug-induced aminotransferase alterations during antiretroviral HIV post-exposure prophylaxis." [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. Pharmacotherapy 26 (2006): 1111-33, 12. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. These serious side effects may occur more often in women and obese patients. Advertising revenue supports our not-for-profit mission. Zidovudine has been associated with hematologic toxicity (including neutropenia and severe anemia), particularly in patients with advanced HIV-1 disease. 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. Lamivudine (3tc) (Epivir; Epivir HBV) is a drug prescribed for the treatment of HIV infection and hepatitis B infection. O'Dowd MA, McKegney FP "Manic syndrome associated with zidovudine." Other side effects include: neutropenia. You may report them to the FDA. O 0, 3. Lamivudine Side Effects See also Warning section. 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. Mayo Clinic does not endorse companies or products. Rarely, lamivudine has caused severe (sometimes fatal) liver problems and a buildup of lactic acid in the blood (lactic acidosis). It is on the World Health Organization's List of Essential Medicines. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic. Aids 14 (2000): 1309-16, 13. In an advanced HIV disease study, amblyopia and photophobia were reported in less than 5% of patients using zidovudine. Call your doctor for medical advice about side effects. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Gastro-intestinal disorders: Pancreatitis, upper abdominal pain, … Side effects: 77. 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. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. 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. Headache, dizziness, nausea, diarrhea, or trouble sleeping may occur. In this study, redistribution/accumulation of body fat was reported in less than 5% of patients using zidovudine. Incidence of neutropenia increased in patients with low neutrophil counts, hemoglobin levels, and serum vitamin B12 levels at baseline. Get medical help right away if you have any of the following serious symptoms, including: symptoms of liver problems (such as … A rare and potentially fatal condition called lactic acidosis can develop in patients taking lamivudine. 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. J Am Acad Dermatol 21 (1989): 192-3, 27. In the early symptomatic HIV disease study, asthenia was reported in 69% of patients using zidovudine. 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. Our general interest e-newsletter keeps you up to date on a wide variety of health topics. Data sources include IBM Watson Micromedex (updated 3 Mar 2021), Cerner Multum™ (updated 1 Mar 2021), ASHP (updated 3 Mar 2021) and others. Serious side effects and their symptoms can include the following: Lactic acidosis or severe liver enlargement. You may report side effects to FDA at 1-800-FDA-1088. The most serious side include muscle pain, liver failure, pancreatitis, and liver failure. pregnancy, upcoming surgery, etc. Redistribution/accumulation of body fat has been reported with antiretroviral therapy; causality has not been established. Glaxo Wellcome, Research Triangle Park, NC. Side Effects . [Ref], Very common (10% or more): Insomnia and other sleep disorders (up to 11.6%), -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]. Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs. [Ref], In an advanced HIV disease study, insomnia (5%) was reported with zidovudine at a significantly greater rate than placebo. [Ref], -Frequency not reported: Urinary hesitancy, dysuria, polyuria[Ref]. [Ref], 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, -Uncommon (0.1% to 1%): Elevated liver enzymes (AST, ALT), -Rare (0.01% to 0.1%): Hepatitis, abnormal liver function tests, -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], Common (1% to 10%): Neutropenia, anemia, lymphatic signs/symptoms, decreased white cells, Postmarketing reports: Anemia (including pure red cell aplasia and anemias progressing on therapy), lymphadenopathy, splenomegaly, -Uncommon (0.1% to 1%): Neutropenia, anemia, thrombocytopenia, decreased white cells, -Very rare (less than 0.01%): Pure red cell aplasia, -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]. 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. agents in HIV-1-infected adults and adolescents. Taking efavirenz, lamivudine, and tenofovir at bedtime may make certain side effects less bothersome. Anders KH, Abele DC "Development of nail pigmentation during zidovudine therapy." Although not all of these side effects may occur, if they do occur they may need medical attention. In an advanced HIV disease study, myalgia (8%) was reported with zidovudine at a significantly greater rate than placebo. Torres RA, Lin RY, Lee M, Barr MR "Zidovudine-induced leukocytoclastic vasculitis." It is taken by mouth twice a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Schedule your appointment now for safe in-person care. 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. 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. 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 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. Some side effects may not be reported. 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. Headache, tiredness, loss of appetite, nausea, vomiting, diarrhea, trouble sleeping, dizziness, or stuffy nose may occur. Discoloration has occurred as longitudinal streaks or transverse bands. 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. Arch Intern Med 152 (1992): 850-1, 29. [Ref], In an advanced HIV disease study, vasodilation was reported in less than 5% of patients using zidovudine. [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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