Lamivudine Side Effects

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

For the Consumer

Applies to lamivudine: oral solution, oral tablet

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

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

Incidence not known
  • Abdominal or stomach discomfort
  • black, tarry stools
  • bleeding gums
  • bloating
  • blood in the urine or stools
  • chills
  • constipation
  • cough
  • darkened urine
  • decreased appetite
  • diarrhea
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • fast, shallow breathing
  • fever
  • general feeling of discomfort
  • general tiredness and weakness
  • indigestion
  • light-colored stools
  • loss of appetite
  • muscle cramps or spasms
  • muscle pain or stiffness
  • nausea and vomiting
  • 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
  • skin rash, hives, or itching
  • sleepiness
  • tightness in the chest
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal or stomach pain
  • yellow eyes or skin

Some of the side effects that can occur with lamivudine 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
  • Acid or sour stomach
  • belching
  • burning, tingling, numbness or pain in the hands, arms, feet, or legs
  • depression
  • general feeling of discomfort or illness
  • headache
  • heartburn
  • indigestion
  • muscle or joint pain
  • sensation of pins and needles
  • sore throat
  • stabbing pain
  • stomach discomfort, upset, or pain
  • stuffy or runny nose
  • trouble sleeping
  • weight loss
Incidence not known
  • Blurred vision
  • dry mouth
  • flushed, dry skin
  • fruit-like breath odor
  • hair loss or thinning of the hair
  • increased hunger
  • increased thirst
  • increased urination
  • pale skin
  • sweating
  • troubled breathing with exertion
  • unexplained weight loss
  • weight gain around your neck, upper back, breast, face, or waist

For Healthcare Professionals

Applies to lamivudine: oral solution, oral tablet


The most common side effects reported with lamivudine have included headache, nausea, malaise, fatigue, nasal signs and symptoms, diarrhea, and cough. During clinical studies, HIV-1-infected patients received lamivudine plus zidovudine. Patients with hepatitis B received lamivudine monotherapy.

Lamivudine side effects were sometimes difficult to distinguish from the symptomatology observed during the clinical course of AIDS, as well as from the possible side effects of other drugs used in the treatment of HIV-1 infection. Many of the side effects associated with nucleoside reverse transcriptase inhibitor therapy (myopathy, pancreatitis, liver failure, lactic acidosis, etc.) are attributable to their direct toxic effect on mitochondria which causes decreased mitochondrial energy generating capacity.[Ref]

Nervous system

Very common (10% or more): Headache (35%), neuropathy (12%), dizziness (10%)
Postmarketing reports: Peripheral neuropathy, paresthesia[Ref]


Pancreatitis has been reported infrequently in adults, but has been more common in pediatric patients (up to 18% in 2 limited studies).[Ref]

Very common (10% or more): Nausea (33%), diarrhea (up to 18%), nausea and vomiting (13%), increased serum lipase (at least 2.5 times upper limit of normal [ULN]: 10%)
Common (1% to 10%): Abdominal pain (9%), abdominal cramps (6%), dyspepsia (5%), increased amylase (greater than 2 times ULN: up to 4.2%)
Uncommon (0.1% to 1%): Pancreatitis (0.3%)
Frequency not reported: Abdominal discomfort and pain, increased amylase (greater than 3 times ULN), oral ulcerations, lesions
Postmarketing reports: Pancreatitis, stomatitis[Ref]


Common (1% to 10%): Elevated AST (greater than 5 times ULN: up to 4%), elevated ALT (greater than 5 times ULN: up to 3.8%)
Uncommon (0.1% to 1%): Elevated bilirubin (greater than 2.5 times ULN: 0.8%)
Frequency not reported: Elevated ALT (greater than 3 times ULN), severe hepatomegaly with steatosis, hepatic decompensation
Postmarketing reports: Lactic acidosis and hepatic steatosis, posttreatment exacerbation of hepatitis B[Ref]

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of lamivudine and other nucleoside analogs alone or in combination with other antiretroviral agents.

Severe acute exacerbations of hepatitis B, including fatalities, have been reported in patients with HBV (including those coinfected with HIV-1) who have discontinued lamivudine. The causal relationship to stopping lamivudine treatment was unknown.

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


Very common (10% or more): Malaise and fatigue (27%); ear, nose, and throat infections (25%); sore throat (13%)
Common (1% to 10%): Fever or chills (10%)
Postmarketing reports: Weakness[Ref]


Very common (10% or more): Nasal signs and symptoms (20%), cough (18%)
Postmarketing reports: Abnormal breath sounds/wheezing[Ref]


Very common (10% or more): Decreased absolute neutrophil count (less than 750/mm3: up to 15%)
Common (1% to 10%): Decreased platelets (less than 50,000/mm3: up to 4%), decreased hemoglobin (less than 8 g/dL: up to 2.9%)
Postmarketing reports: Anemia (including pure red cell aplasia and severe anemias progressing on therapy), lymphadenopathy, splenomegaly, thrombocytopenia[Ref]


Very common (10% or more): Musculoskeletal pain (12%)
Common (1% to 10%): Increased creatine phosphokinase (at least 7 times baseline: 9%), myalgia (8%), arthralgia (5%)
Postmarketing reports: Muscle weakness, elevated creatine phosphokinase, rhabdomyolysis, cramps[Ref]


Although progressive subcutaneous fat wasting has been attributed to the use of protease inhibitors, nucleoside reverse transcriptase inhibitors may have an independent contribution. This syndrome has been observed in patients naive to protease inhibitors, however, not to the same degree as in patients on a combination regimen that includes a protease inhibitor.[Ref]

Very common (10% or more): Anorexia and/or decreased appetite (10%)
Frequency not reported: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance"), progressive subcutaneous fat wasting
Postmarketing reports: Hyperglycemia, redistribution/accumulation of body fat[Ref]


Common (1% to 10%): Skin rashes (9%)
Frequency not reported: Paronychia, periungual pyogenic granulomata
Postmarketing reports: Alopecia, rash, pruritus[Ref]


Very common (10% or more): Insomnia and other sleep disorders (11%)
Common (1% to 10%): Depressive disorders (9%)[Ref]


Frequency not reported: Angioedema, anaphylactoid reaction
Postmarketing reports: Anaphylaxis, urticaria[Ref]


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


Rare (less than 0.1%): Fanconi syndrome (at least 1 case)[Ref]


Frequency not reported: Eye redness[Ref]


1. "Product Information. Epiver-HBV (lamivudine)" Glaxo Wellcome, Research Triangle Pk, NC.

2. Warnke D, Barreto J, Temesgen Z "Antiretroviral drugs." J Clin Pharmacol 47 (2007): 1570-9

3. Nelson M, Azwa A, Sokwala A, Harania RS, Stebbing J "Fanconi syndrome and lactic acidosis associated with stavudine and lamivudine therapy." AIDS 22 (2008): 1374-6

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

5. Rivkina A, Rybalov S "Chronic hepatitis B: current and future treatment options." Pharmacotherapy 22 (2002): 721-37

6. "Drugs for HIV infection." Med Lett Drugs Ther 43 (2001): 103-8

7. Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children. NIH. National Institutes of Health "Guidelines for the use of antiretroviral agents in pediatric HIV infection. Available from: URL:" ([2012 Nov 5]):

8. van Leeuwen R, Lange JM, Hussey EK, Donn KH, Hall ST, Harker AJ, Jonker P, Danner SA "The safety and pharmacokinetics of a reverse transcriptase inhibitor, 3TC, in patients with HIV infection: a phase I study." AIDS 6 (1992): 1471-5

9. van Leeuwen R, Katlama C, Kitchen V, Boucher CA, Tubiana R, McBride M, Ingrand D, Weber J, Hill A, McDade H, et al "Evaluation of safety and efficacy of 3TC (lamivudine) in patients with asymptomatic or mildly symptomatic human immunodeficiency virus infection: a phase I/II study." J Infect Dis 171 (1995): 1166-71

10. 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

11. Pluda JM, Cooley TP, Montaner JS, Shay LE, Reinhalter NE, Warthan SN, Ruedy J, Hirst HM, Vicary CA, Quinn JB, et al "A phase I/II study of 2'-deoxy-3'-thiacytidine (lamivudine) in patients with advanced human immunodeficiency virus infection." J Infect Dis 171 (1995): 1438-47

12. van Leeuwen R, Boucher C, Reiss P, Schuurman R, Nijhuis M, Danner S "Safety and efficacy of ZDV addition to 3TC monotherapy." Int Conf AIDS 10 (1994): 21(

13. Sims KA, Woodland AM "Entecavir: a new nucleoside analog for the treatment of chronic hepatitis B infection." Pharmacotherapy 26 (2006): 1745-57

14. Cupler EJ, Dalakas MC "Exacerbation of peripheral neuropathy by lamivudine." Lancet 345 (1995): 460-1

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

16. Asari A, Iles-Smith H, Chen YC, et al. "Pharmacokinetics of lamivudine in subjects receiving peritoneal dialysis in end-stage renal failure." Br J Clin Pharmacol 64 (2007): 738-44

17. Danner S, van Leeuwen R, Katlama C, Ingrand D, Weber J, Kitchen V "3TC in HIV positive, asymptomatic or mild ARC patients." Int Conf AIDS 9 (1993): 477(

18. HHS Panel on Antiretroviral Guidelines for Adults and Adolescents – A Working Group of the Office of AIDS Research Advisory Council (OARAC). NIH. National Institutes of Health "Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Available from: URL:" ([2011 Oct 14]):

19. Cameron DW, Becker S, King MS, et al. "Exploratory study comparing the metabolic toxicities of a lopinavir/ritonavir plus saquinavir dual protease inhibitor regimen versus a lopinavir/ritonavir plus zidovudine/lamivudine nucleoside regimen." J Antimicrob Chemother 59 (2007): 957-63

20. Ormseth EJ, Holtzmuller KC, Goodman ZD, Colonna JO, Batty DS, Sjogren MH "Hepatic decompensation associated with lamivudine: A case report and review of lamivudine-induced hepatotoxicity." Am J Gastroenterol 96 (2001): 1619-22

21. "Drugs for HIV infection." Treat Guidel Med Lett 7 (2009): 11-22

22. Bruno R, Sacchi P, Filice C, Filice G "Acute liver failure during lamivudine treatment in a hepatitis B cirrhotic patient." Am J Gastroenterol 96 (2001): 265

23. denBrinker M, Wit FWNM, WertheimvanDillen PME, Jurriaans S, Weel J, vanLeeuwen R, Pakker NG, Reiss P, Danner SA, Weverling G "Hepatitis B and C virus co-infection and the risk for hepatotoxicity of highly active antiretroviral therapy in HIV-1 infection." Aids 14 (2000): 2895-902

24. 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." Aids 14 (2000): 1309-16

25. Martinez E, Mocroft A, GarciaViejo MA, PerezCuevas JB, Blanco JL, Mallolas J, Bianchi L, Conget I, Blanch J, Phillips A, Gatell "Risk of lipodystrophy in HIV-1-infected patients treated with protease inhibitors: a prospective cohort study." Lancet 357 (2001): 592-8

26. 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

27. Weitzel T, Plettenberg A, Albrecht D, Lorenzen T, Stoehr A "Severe anaemia as a newly recognized side-effect caused by lamivudine." AIDS 13 (1999): 2309-11

28. Williams LH, Fleckman P "Painless periungual pyogenic granulomata associated with reverse transcriptase inhibitor therapy in a patient with human immunodeficiency virus infection." Br J Dermatol 156 (2007): 163-4

29. Fong IW "Hair loss associated with lamivudine." Lancet 344 (1994): 1702

30. Kainer MA, Mijch A "Anaphylactoid reaction, angioedema, and urticaria associated with lamivudine." Lancet 348 (1996): 1519

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 material does not endorse drugs, diagnose patients, or recommend therapy. This 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 combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials 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 substances you are taking, check with your doctor, nurse, or pharmacist.