Abacavir, Lamivudine, and Zidovudine
Abacavir, Lamivudine, and Zidovudine is a three-in-one HIV medicine that treats HIV-1 infection, usually together with other HIV medicines.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
This medicine can cause a serious, sometimes fatal allergic reaction (from abacavir). Watch for fever, rash, stomach symptoms, tiredness or aches, and cough or shortness of breath. Stop the medicine and get medical help immediately if you suspect a reaction. Never restart it or any abacavir-containing medicine afterward.
People with the HLA-B*5701 gene are at higher risk and must not take it. Everyone should be tested before starting.
Other boxed risks:
- Low blood counts (neutropenia and anemia) from zidovudine, especially in advanced HIV disease.
- Muscle disease (myopathy) with long-term use.
- Lactic acidosis and severe liver enlargement with fat buildup, including fatal cases.
- Severe hepatitis B flare-ups in people with both HIV and hepatitis B who stop the medicine. Liver function needs close monitoring for at least several months.
📖 Abacavir, Lamivudine, and Zidovudine: Patient Information Guide
A plain-language walkthrough of Abacavir, Lamivudine, and Zidovudine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
What Abacavir, Lamivudine, and Zidovudine is used for
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This combination tablet is used for HIV-1 infection.
- Treatment of HIV-1 infection, together with other antiretroviral medicines.
- Treatment of HIV-1 infection alone, though data are limited in people with a viral load above 100,000 copies per mL.
How Abacavir, Lamivudine, and Zidovudine works
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All three ingredients are nucleoside analogue reverse transcriptase inhibitors. They block the enzyme HIV-1 uses to copy itself, which helps lower the amount of virus in the body.
How Abacavir, Lamivudine, and Zidovudine is taken (dosage)
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The tablet is taken by mouth, one tablet twice a day, with or without food. It is for adults and children who weigh at least 40 kg. Because it is a fixed-dose tablet, the dose cannot be adjusted. Follow your prescriber's directions and the label.
Abacavir, Lamivudine, and Zidovudine side effects in detail
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The most common side effects in clinical trials were:
- Nausea
- Headache
- Malaise and fatigue
- Nausea and vomiting
- Diarrhea
- Fever and/or chills
Seek medical help right away for signs of an allergic reaction, serious liver problems, lactic acidosis, or low blood counts.
Abacavir, Lamivudine, and Zidovudine warnings and precautions
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- Abacavir allergic reaction: can be fatal. Stop the medicine and never restart it if you suspect one.
- Low blood counts: zidovudine can cause neutropenia and anemia. Blood counts are checked regularly.
- Myopathy: muscle problems with long-term use.
- Lactic acidosis and liver enlargement: including fatal cases, more often reported in women.
- Hepatitis B flare: may occur after stopping if you also have hepatitis B.
- Immune reconstitution syndrome: inflammation from old infections as the immune system recovers.
- Lipoatrophy: fat loss in the face, limbs and buttocks.
- Heart attack: evidence of a link with abacavir is inconclusive.
Abacavir, Lamivudine, and Zidovudine interactions: what it interacts with
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Some medicines can change how this one works or raise its risks.
- Ribavirin: can worsen anemia, so combining is not advised.
- Interferon alfa, ganciclovir and other bone marrow suppressive drugs: may raise blood-count toxicity.
- Stavudine and doxorubicin: work against zidovudine.
- Methadone: dose may need to rise in some people.
- Riociguat: dose may need to be lowered.
- Sorbitol: can lower lamivudine levels.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
Before taking Abacavir, Lamivudine, and Zidovudine
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- Must not be used with the HLA-B*5701 gene or a prior reaction to abacavir, lamivudine or zidovudine.
- Must not be used with moderate or severe liver impairment.
- Not recommended with mild liver impairment, creatinine clearance below 50 mL per minute, or weight under 40 kg.
- Tell your doctor if you have hepatitis B or C.
- Women with HIV should not breastfeed.
- A pregnancy registry exists for use during pregnancy. Registry data showed no difference in overall birth defect risk compared with the background rate.
Abacavir, Lamivudine, and Zidovudine overdose: if you take too much
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There is no known specific treatment for overdose. You would be monitored and given standard supportive care. In zidovudine overdoses, symptoms were mostly fatigue, headache, vomiting and occasional blood changes, and patients recovered.
Pharmacokinetics: how your body processes Abacavir, Lamivudine, and Zidovudine
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All three ingredients are absorbed quickly after swallowing. Abacavir is broken down by the liver, lamivudine is mostly cleared unchanged in the urine, and zidovudine is mainly processed by the liver. None are significantly handled by CYP enzymes. Eating lowers peak levels somewhat but does not change the total amount absorbed.
How to store Abacavir, Lamivudine, and Zidovudine
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Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) .
📄 Written from Abacavir, Lamivudine, and Zidovudine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Abacavir, Lamivudine, and Zidovudine: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Abacavir, Lamivudine, and Zidovudine — the kind of thing our pharmacy team would talk through with you at the counter.
What is this medicine for?
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How do I take it?
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What side effects might I notice?
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What is the allergic reaction I keep hearing about?
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Why do I need blood tests?
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What if I also have hepatitis B?
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Is Abacavir, Lamivudine, and Zidovudine available over the counter?
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When was Abacavir, Lamivudine, and Zidovudine first available?
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Who makes Abacavir, Lamivudine, and Zidovudine?
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💬 Answers drafted from Abacavir, Lamivudine, and Zidovudine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 More about Abacavir, Lamivudine, and Zidovudine on HelloPharmacist
💊 Abacavir, Lamivudine, and Zidovudine forms and strengths (how it comes)
Abacavir, Lamivudine, and Zidovudine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Abacavir, lamivudine and zidovudine tablets treat HIV-1 infection, with other antiretrovirals or alone.
- Abacavir, lamivudine and zidovudine tablets are taken by mouth, one tablet twice daily, with or without food.
- Abacavir, lamivudine and zidovudine tablets are for adults and children weighing at least 40 kg.
- Abacavir, lamivudine and zidovudine tablets are a fixed-dose product and cannot be dose adjusted.
📊 Abacavir, Lamivudine, and Zidovudine on the U.S. market: products, makers and brands
How Abacavir, Lamivudine, and Zidovudine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 Compare Abacavir, Lamivudine, and Zidovudine products
A representative set of FDA-listed product records for Abacavir, Lamivudine, and Zidovudine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| LAMIVUDINE 150 mg/1; ZIDOVUDINE 300 mg/1; ABACAVIR SULFATE 300 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 300; 150; 300 mg/1; mg/1; mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 300; 150; 300 mg/1; mg/1; mg | Oral | ViiV Healthcare Company × 2 listings | NDA | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Abacavir, Lamivudine, and Zidovudine NDCs →
📈 Abacavir, Lamivudine, and Zidovudine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Abacavir, Lamivudine, and Zidovudine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Abacavir, Lamivudine, and Zidovudine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ Abacavir, Lamivudine, and Zidovudine FDA approval history
How Abacavir, Lamivudine, and Zidovudine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Abacavir, Lamivudine, and Zidovudine recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.
RxCUI 284620 1 dose form · 1 strength
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Dose form (SCDF) Oral Tablet RxCUI 374813In current FDA listingsClinical drug / strength (SCD) abacavir 300 MG / lamivudine 150 MG / zidovudine 300 MGRxCUI 307650
Look up RxCUI 284620 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Abacavir, Lamivudine, and Zidovudine supply and shortage status
Whether Abacavir, Lamivudine, and Zidovudine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Abacavir, Lamivudine, and Zidovudine brand names
🏭 Who makes Abacavir, Lamivudine, and Zidovudine: manufacturers and labelers
Abacavir, Lamivudine, and Zidovudine drug class (RxNorm)
Abacavir, Lamivudine, and Zidovudine belongs to the Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Sources for this Abacavir, Lamivudine, and Zidovudine page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Lupin Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.