Prescription medicine
Lamivudine Brand names: Epivir
Lamivudine (Epivir) is a prescription medicine with an FDA approval on record since 1995. FDA's NDC Directory lists it from 14 generic labelers, and pharmacies paid $0.489 per lamivudine 150 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the lamivudine FDA label on DailyMed (effective January 5, 2026, Strides Pharma Science Limited); the NDA 20564 record on Drugs@FDA; every lamivudine label on DailyMed.
Highlights of the record
FDA label of January 5, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
EXACERBATIONS OF HEPATITIS B, AND DIFFERENT FORMULATIONS OF LAMIVUDINE.
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. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue lamivudine and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1)]. Important Differences among Lamivudine-Containing Products Lamivudine tablets (used to treat HIV-1 infection) contain a higher dose of the active ingredient (lamivudine) than EPIVIR-HBV tablets and oral solution (used to treat chronic HBV infection). Patients with HIV-1 infection should receive only dosage forms appropriate for treatment of HIV-1 [see Warnings and Precautions (5.1)]. […]
Used for
From the label: indications and usageLamivudine is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
Forms and strengths
- 100 mg
- 150 mg
- 300 mg
- 10 mg/ml
Film-coated tablet; solution; tablet.
On the market
- Earliest approval on file
- November 17, 1995 Epivir, Viiv Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 19 first November 17, 2011; 13 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 15 of which 14 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.489 per tablet Lamivudine 150 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2015 0 Class I among all firms' recalls; latest August 27, 2019
- FAERS reports
- 25,152 through July 30, 2026
What is lamivudine used for?
From the label: indications and usageLamivudine is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Limitations of Use: The dosage of this product is for HIV-1 and not for HBV. Lamivudine is a nucleoside analogue reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Limitations of Use: The dosage of this product is for HIV-1 and not for HBV.
Conditions named in the indications of lamivudine's FDA labels, with every medicine labeled for each:
From other lamivudine labelsHepatitis B: Lamivudine tablets (HBV) are indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation [see Clinical Studies ( 14.1 , 14.2 )].
FDA pharmacologic class: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor and Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor.
Source: FDA drug label (Lamivudine), Strides Pharma Science Limited, effective January 5, 2026 (SPL set ac824c7e-9c9f-487b-ad2f-d50eaef5cbda), via openFDA; the full label on DailyMed
What does the patient leaflet for lamivudine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: 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 tablet. 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.
Source: FDA drug label (Lamivudine), Strides Pharma Science Limited, effective January 5, 2026 (SPL set ac824c7e-9c9f-487b-ad2f-d50eaef5cbda), via openFDA; the full label on DailyMed
Is there a generic for lamivudine (Epivir)?
The FDA approved the first generic lamivudine on November 17, 2011. 19 generic applications are approved; 13 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 6 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists lamivudine from 14 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1995 earliest approval on file
- 2011 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for lamivudine (Epivir)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.489 per Lamivudine 150 mg tablet, up 13% from $0.434 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Lamivudine 150 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Lamivudine 10 mg/mL oral solution | Generic | $0.218 per mL | n/a | -12% |
| Lamivudine 150 mg tablet | Generic | $0.489 per tablet | $14.66 | +13% |
| Lamivudine 300 mg tablet | Generic | $1.40 per tablet | $42.04 | +12% |
| Lamivudine hbv 100 mg tablet | Generic | $9.48 per tablet | $284.29 | +9% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has lamivudine been recalled?
The FDA's Enforcement Report lists 2 recalls naming lamivudine since 2015: 0 Class I (the most serious), 0 Class II, 2 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 27, 2019 | Class III | American Health Packaging | Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths section of the insert that incorrectly lists the tablet description … |
| August 21, 2015 | Class III | Silarx Pharmaceutical, Inc. | Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the lamivudine label say about other medicines?
The lamivudine label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 20 other medicines name lamivudine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Trimethoprim | drug interactions | The possibility of interactions with other drugs administered concurrently should be considered, particularly when their main route of elimination is active renal secretion via the organic cationic transport system (e.g., trimethoprim) [see Pharmacokinetics (12.3)]. |
Other labels that name lamivudine
Source: FDA drug label (Lamivudine), Strides Pharma Science Limited, effective January 5, 2026 (SPL set ac824c7e-9c9f-487b-ad2f-d50eaef5cbda), via openFDA; the full label on DailyMed
What do FAERS reports show for lamivudine?
The FDA Adverse Event Reporting System holds 25,152 reports that list lamivudine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,540 are coded as a death and 6,944 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as lamivudine?
39 other medicines are given the same way (oral) and in the same FDA class as lamivudine or labeled mainly for the same use (HIV), the same class first. HIV lists all 47 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Emtricitabine and tenofovir disoproxil | HIV | 25 labelers | $0.529 per tablet 200-300 mg tablet | No current entry |
| Entecavir | Hepatitis B | 16 labelers | $0.219 per tablet 0.5 mg tablet | No current entry |
| Tenofovir disoproxil | HIV, Hepatitis B | 15 labelers | $0.294 per tablet 300 mg tablet | No current entry |
| Abacavir | HIV | 12 labelers | $0.546 per tablet 300 mg tablet | No current entry |
| Efavirenz and emtricitabine and tenofovir disoproxil | HIV | 7 labelers | $1.12 per tablet 600-200-300 mg tablet | No current entry |
| Zidovudine | HIV | 3 labelers | $0.464 per tablet 300 mg tablet | No current entry |
| Bictegravir and emtricitabine and tenofovir alafenamide | HIV | none listed | $136.73 per tablet 50-200-25 mg tablet | No current entry |
| Emtricitabine | HIV | 2 labelers | $12.69 per capsule 200 mg capsule | A presentation being discontinued |
Every medicine labeled for the same conditions as lamivudine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to lamivudine
- 39 medicines for the same use
- Other hepatitis b virus nucleoside analog reverse transcriptase inhibitors
- the pharmacologic class, with prices and generics
- Lamivudine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other