Prescription medicine
Abacavir and lamivudine and zidovudine First approved as Trizivir
Abacavir and lamivudine and zidovudine (Trizivir) is a prescription medicine with an FDA approval on record since 2000. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
- Boxed warning
Check it at the source: the abacavir and lamivudine and zidovudine FDA label on DailyMed (effective October 31, 2023, Lupin Pharmaceuticals, Inc.); the NDA 21205 record on Drugs@FDA; every abacavir and lamivudine and zidovudine label on DailyMed.
Highlights of the record
FDA label of October 31, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
HYPERSENSITIVITY REACTIONS, HEMATOLOGIC TOXICITY, MYOPATHY, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS,.
and EXACERBATIONS OF HEPATITIS B WARNING: HYPERSENSITIVITY REACTIONS, HEMATOLOGIC TOXICITY, MYOPATHY, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, and EXACERBATIONS OF HEPATITIS B See full prescribing information for complete boxed warning. Hypersensitivity Reactions Serious and sometimes fatal hypersensitivity reactions have occurred with abacavir-containing products. ( 5.1 ) Hypersensitivity to abacavir is a multi-organ clinical syndrome. ( 5.1 ) Patients who carry the HLA-B*5701 allele are at a higher risk of experiencing a hypersensitivity reaction to abacavir. ( 5.1 ) Abacavir, lamivudine and zidovudine tablets are contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients. ( 4 ) Discontinue abacavir, lamivudine and zidovudine tablets as soon as a hypersensitivity reaction is suspected. Regardless of HLA-B*5701 status, permanently discontinue abacavir, lamivudine and zidovudine tablets if hypersensitivity cannot be ruled out, even when other diagnoses are possible. ( 5.1 ) Following a hypersensitivity reaction to abacavir, lamivudine and zidovudine tablets NEVER restart abacavir, lamivudine and zidovudine tablets or any other abacavir-containing product. […]
Used for
From the label: indications and usageAbacavir, lamivudine and zidovudine tablet, a combination of abacavir, lamivudine, and zidovudine, each nucleoside analogue HIV-1 reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.( 1 ) Abacavir, lamivudine and zidovudine tablet is indicated in combination with other antiretrovirals or alone for the treatment of human immunodeficiency v
Forms and strengths
- 150 mg / 300 mg / 300 mg
Tablet.
On the market
- Earliest approval on file
- November 14, 2000 Trizivir, Viiv Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first December 5, 2013; 0 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 10 through July 30, 2026
What is abacavir and lamivudine and zidovudine used for?
From the label: indications and usageAbacavir, lamivudine and zidovudine tablet, a combination of abacavir, lamivudine, and zidovudine, each nucleoside analogue HIV-1 reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.( 1 ) Abacavir, lamivudine and zidovudine tablet is indicated in combination with other antiretrovirals or alone for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Limitations of Use: Limited data exist on the use of abacavir, lamivudine and zidovudine tablets alone in patients with higher baseline viral load levels (greater than 100,000 copies per mL) [see CLINICAL STUDIES ( 14 )].
Conditions named in the indications of abacavir and lamivudine and zidovudine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor and Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor.
Source: FDA drug label (ABACAVIR, LAMIVUDINE AND ZIDOVUDINE), Lupin Pharmaceuticals, Inc., effective October 31, 2023 (SPL set f5f7c0d9-a247-4308-8269-32accc490ea6), via openFDA; the full label on DailyMed
What does the patient leaflet for abacavir and lamivudine and zidovudine 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 abacavir, lamivudine and zidovudine tablets?Abacavir, lamivudine and zidovudine tablets can cause serious side effects, including: Serious allergic reactions (hypersensitivity reaction) that can cause death have happened with abacavir, lamivudine and zidovudine tablets and other abacavir-containing products. Your risk of this allergic reaction is much higher if you have a gene variation called HLA-B*5701. Your healthcare provider can determine with a blood test if you have this gene variation. If you get a symptom from 2 or more of the following groups while taking abacavir, lamivudine and zidovudine tablets, call your healthcare provider right away to find out if you should stop taking abacavir, lamivudine and zidovudine tablets. Symptom ( s ) Group 1 Fever Group 2 Rash Group 3 Nausea, vomiting, diarrhea, abdominal ( stomach area ) pain Group 4 Generally ill feeling, extreme tiredness, or achiness Group 5 Shortness of breath, cough, sore throat A list of these symptoms is on the Warning Card your pharmacist gives you. […] 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). Worsening of hepatitis B virus (HBV) infection. HBV infection and take abacavir, lamivudine and zidovudine tablets your HBV may get worse (flare-up) if you stop taking abacavir, lamivudine and zidovudine tablets. […]
From the patient leaflet: How should I store abacavir, lamivudine and zidovudine tablets?Store abacavir, lamivudine and zidovudine tablets at room temperature. Keep abacavir, lamivudine and zidovudine tablets and all medicines out of the reach of children. General information for safe and effective use of abacavir, lamivudine and zidovudine tablets. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use abacavir, lamivudine and zidovudine tablets for a condition for which it was not prescribed. Do not give abacavir, lamivudine and zidovudine 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 the information about abacavir, lamivudine and zidovudine tablets that is written for health professionals.
Source: FDA drug label (ABACAVIR, LAMIVUDINE AND ZIDOVUDINE), Lupin Pharmaceuticals, Inc., effective October 31, 2023 (SPL set f5f7c0d9-a247-4308-8269-32accc490ea6), via openFDA; the full label on DailyMed
Is there a generic for abacavir and lamivudine and zidovudine (Trizivir)?
The FDA approved the first generic abacavir and lamivudine and zidovudine on December 5, 2013. 1 generic application is approved; 0 of it 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 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists abacavir and lamivudine and zidovudine from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2000 earliest approval on file
- 2013 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the abacavir and lamivudine and zidovudine label say about other medicines?
The abacavir and lamivudine and zidovudine label names 5 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Doxorubicin | drug interactions | Stavudine Doxorubicin Nucleoside analogues, e.g., ribavirin Hematologic/Bone Marrow Suppressive/Cytotoxic Agents Coadministration with the following drugs may increase the hematologic toxicity of zidovudine: |
| Ganciclovir | drug interactions | Ganciclovir Interferon alfa Ribavirin Other bone marrow suppressive or cytotoxic agents |
| Methadone | drug interactions | DRUG INTERACTIONS Methadone: An increased methadone dose may be required in a small number of patients. |
| Ribavirin | drug interactions | Stavudine Doxorubicin Nucleoside analogues, e.g., ribavirin Hematologic/Bone Marrow Suppressive/Cytotoxic Agents Coadministration with the following drugs may increase the hematologic toxicity of zidovudine: |
| Riociguat | drug interactions | The riociguat dose may need to be reduced. ( 7.1 ) Sorbitol: Coadministration of lamivudine and sorbitol may decrease lamivudine concentrations; when possible, avoid chronic coadministration. ( 7.2 ) Agents antagonistic with zidovudine: |
Check abacavir and lamivudine and zidovudine against other medicines
Source: FDA drug label (ABACAVIR, LAMIVUDINE AND ZIDOVUDINE), Lupin Pharmaceuticals, Inc., effective October 31, 2023 (SPL set f5f7c0d9-a247-4308-8269-32accc490ea6), via openFDA; the full label on DailyMed
What do FAERS reports show for abacavir and lamivudine and zidovudine?
The FDA Adverse Event Reporting System holds 10 reports that list abacavir and lamivudine and zidovudine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 2 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.
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 abacavir and lamivudine and zidovudine?
34 other medicines are given the same way (oral) and in the same FDA class as abacavir and lamivudine and zidovudine 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 |
| Tenofovir disoproxil | HIV | 15 labelers | $0.294 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 |
| 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 |
| Emtricitabine and rilpivirine and tenofovir disoproxil | HIV | 2 labelers | $114.50 per tablet 200-25-300 mg tablet | No current entry |
| Emtricitabine and tenofovir alafenamide | HIV | none listed | $74.94 per tablet 200-25 mg tablet | No current entry |
| Cobicistat, darunavir, emtricitabine and tenofovir alafenamide | HIV | none listed | $152.87 per tablet 800-150-200-10 mg tablet | No current entry |
Every medicine labeled for the same conditions as abacavir and lamivudine and zidovudine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to abacavir and lamivudine and zidovudine
- 34 medicines for the same use
- Other hepatitis b virus nucleoside analog reverse transcriptase inhibitors
- the pharmacologic class, with prices and generics
- Abacavir and lamivudine and zidovudine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other