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Patient-friendly FDA guidance and safety information.

Last updated · May 16, 2026Source: DailyMed ↗
Boxed Warning

Exacerbations of Hepatitis B
Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine tablets. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue lamivudine tablets and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted .

Important Differences among Lamivudine-Containing Products
Lamivudine tablets (used to treat HIV-1 infection) contain a higher dose of the active ingredient (lamivudine) than lamivudine-HBV tablets (used to treat chronic HBV infection). Patients with HIV-1 infection should receive only dosage forms appropriate for treatment of HIV-1 .

WARNING: EXACERBATIONS OF HEPATITIS B, and DIFFERENT FORMULATIONS OF LAMIVUDINE TABLETS

See full prescribing information for complete boxed warning.

  • Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine tablets. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment. ( 5.1)
  • Patients with HIV-1 infection should receive only dosage forms of lamivudine tablets appropriate for treatment of HIV-1. ( 5.1)

Poison Help

If you suspect an overdose or accidental ingestion, call Poison Control: 1-800-222-1222 (free, 24/7, U.S.). For life-threatening symptoms, call 911.

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PATIENT INFORMATION

Revised: May 2019

Lamivudine Tablets, USP

(la miv' ue deen)

What is the most important information I should know about lamivudine tablets?

Lamivudine tablets can cause serious side effects, including:

  • Worsening of hepatitis B virus in people who have HIV-1 infection.If you have HIV-1 (Human Immunodeficiency Virus type 1) and hepatitis B virus (HBV) infection, your HBV may get worse (flare-up) if you stop taking lamivudine tablets. A “flare-up” is when your HBV infection suddenly returns in a worse way than before. Worsening liver disease can be serious and may lead to death.
    • Do not run out of lamivudine tablets. Refill your prescription or talk to your healthcare provider before your lamivudine tablets is all gone.
    • Do not stop lamivudine tablets without first talking to your healthcare provider.
    • If you stop taking lamivudine tablets, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver.
  • Resistant Hepatitis B Virus (HBV).If you have HIV-1 and hepatitis B, the hepatitis B virus can change (mutate) during your treatment with lamivudine tablets and become harder to treat (resistant).

What is lamivudine?
Lamivudine is a prescription medicine used together with other antiretroviral medicines to treat Human Immunodeficiency Virus (HIV-1) infection.

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

Lamivudine tablets (used to treat HIV-1 infection) contain a higher dose of the same active ingredient (lamivudine) than is in the medicine lamivudine -HBV tablets (used to treat HBV). If you have both HIV-1 and HBV, you should not use lamivudine -HBV to treat your infections.

The safety and effectiveness of lamivudine tablets have not been established in children under 3 months of age.

Who should not take lamivudine tablets?
Do not take lamivudine tabletsif you are allergic to lamivudine or any of the ingredients in lamivudine tablets. Seethe end of this Patient Information leaflet for a complete list of ingredients in lamivudine tablets.

What should I tell my healthcare provider before taking lamivudine tablets?

Before you take lamivudine tablets, tell your healthcare provider if you:

  • have or have had liver problems, including hepatitis B or C virus infection.
  • have kidney problems.
  • have diabetes.
  • are pregnant or plan to become pregnant. Taking lamivudine tablets during pregnancy has not been associated with an increased risk of birth defects. Talk to your healthcare provider if you are pregnant or plan to become pregnant. Pregnancy Registry.There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
  • are breastfeeding or plan to breastfeed. Do not breastfeed if you take lamivudine tablets.
    • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some medications interact with lamivudine. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. You can ask your healthcare provider or pharmacist for a list of medicines that interact with lamivudine.

Do not start taking a new medicine without telling your healthcare provider.Your healthcare provider can tell you if it is safe to take lamivudine tablets with other medicines.

How should I take lamivudine tablets?

  • Take lamivudine tablets exactly as your healthcare provider tells you to take it.
  • If you miss a dose of lamivudine tablets, take it as soon as you remember. Do not take 2 doses at the same time or take more than what your healthcare provider tells you to take.
  • Stay under the care of a healthcare provider during treatment with lamivudine tablets.
  • Lamivudine tablets may be taken with or without food.
  • For children 3 months and older, your healthcare provider will prescribe a dose of lamivudine tablets based on your child’s body weight.
  • Tell your healthcare provider if you or your child has trouble swallowing tablets.
  • Do not run out of lamivudine tablets. The virus in your blood may increase and the virus may become harder to treat. When your supply starts to run low, get more from your healthcare provider or pharmacy.
  • If you take too much lamivudine tablets, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of lamivudine tablets?

  • Lamivudine tablets can cause serious side effects including:
  • See "What is the most important information I should know about lamivudine tablets?"
  • Build-up of an acid in your blood (lactic acidosis).Lactic acidosis can happen in some people who take lamivudine tablets. Lactic acidosis is a serious medical emergency that can cause death. Call your healthcare provider right away if you get any of the following symptoms that could be signs of lactic acidosis:

• feel very weak or tired


• unusual (not normal) muscle pain


• trouble breathing


• stomach pain with nausea and vomiting

• feel cold, especially in your arms and legs


• feel dizzy or light-headed


• have a fast or irregular heartbeat

  • Serious liver problemscan happen in people who take lamivudine tablets. In some cases these serious liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:

• your skin or the white part of your eyes turns yellow (jaundice)


• dark or “tea-colored” urine


• light-colored stools (bowel movements)

• loss of appetite for several days or longer


• nausea


• pain, aching, or tenderness on the right side of your stomach area

You may be more likely to get lactic acidosis or serious liver problems if you are female or very overweight (obese).

  • Risk of inflammation of the pancreas (pancreatitis).Children may be at risk for developing pancreatitis during treatment with lamivudine tablets if they:

• have taken nucleoside analogue medicines in the past

• have a history of pancreatitis

• have other risk factors for pancreatitis

Call your healthcare provider right away if your child develops signs and symptoms of pancreatitis including severe upper stomach-area pain, with or without nausea and vomiting.Your healthcare provider may tell you to stop giving lamivudine tablets to your child if their symptoms and blood test results show that your child may have pancreatitis.

  • Changes in your immune system (Immune Reconstitution Syndrome)can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after you start taking lamivudine tablets.

The most common side effects of lamivudine tablets in adults include:

• headache

• nasal signs and symptoms

• nausea

• diarrhea

• generally not feeling well

• cough

• tiredness

The most common side effects of lamivudine tablets in children include fever and cough.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of lamivudine tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store lamivudine tablets?

  • Store lamivudine tablets at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Keep lamivudine tablets and all medicines out of the reach of children.

General information about the safe and effective use of lamivudine tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use lamivudine tablets for a condition for which it was not prescribed. Do not give lamivudine tablets to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your healthcare provider or pharmacist for information about lamivudine tablets that is written for health professionals.

To report Suspected Adverse Reactions, contact Apotex Corp., at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What are the ingredients in lamivudine tablets?
Active ingredient: lamivudine

Inactive ingredients:
colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hydroxypropyl methylcellulose, iron oxide black, lactose anhydrous, magnesium stearate, polyethylene glycol, and titanium dioxide.

This Patient Information has been approved by the U.S. Food and Drug Administration.

All registered trademarks in this document are the property of their respective owners.

APOTEX INC.
LAMIVUDINE TABLETS, USP
150 mg and 300 mg

Manufactured by

Manufactured for

Apotex Inc.

Apotex Corp.

Toronto, Ontario

Weston, Florida

Canada M9L 1T9

USA 33326

Rev. 13

Marketed by:
GSMS, Inc.
Camarillo, CA 93012 USA

Sources

RxCUI: 349491

NDC: 604290354

Last fetched: May 16, 2026

Source: DailyMed ↗

⚠️ Disclaimer

This information is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.