Lamivudine and Tenofovir
Lamivudine and tenofovir is a two-drug HIV-1 medicine that, taken with other antiretroviral drugs, treats HIV-1 infection in adults and children weighing at least 35 kg.
🧬 Where this information comes from
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 →
Lamivudine and tenofovir pairs two long-familiar HIV medicines in one once-daily tablet, on the U.S. market since about 2018. Both block reverse transcriptase, the enzyme HIV uses to copy itself, by stopping the virus’s DNA chain as it builds, and together they are a common core pairing in HIV treatment, always taken with at least one other HIV-1 medicine. Most people tolerate it well, and headache, nausea or diarrhea are what people notice most. Its boxed warning is that stopping it can set off a severe hepatitis B flare in people who also have hepatitis B, so get tested before starting and never stop or run out on your own.
Clinical pearls
- Kidney function, urine glucose and urine protein are checked before and during treatment, because tenofovir can damage the kidneys.
- Tell every prescriber you take it, since high-dose or combined NSAIDs such as ibuprofen can harm kidneys alongside tenofovir.
- Sorbitol-containing liquid medicines can lower lamivudine levels, so avoid using them regularly.
- Report bone pain, muscle weakness or a fracture, since these can signal tenofovir-related kidney tubule damage or bone thinning.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Stopping this medicine can cause a severe flare-up of hepatitis B in people who have both HIV-1 and hepatitis B. This is the key risk of the boxed warning.
If you have both infections and stop treatment, your doctor should closely monitor your liver with exams and blood tests, for at least several months. Hepatitis B treatment may need to be restarted. Do not stop taking it without talking to your prescriber.
Patient Information Guide A plain-language walkthrough of Lamivudine and Tenofovir, written from its FDA label.
What Lamivudine and Tenofovir Is Used For
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Lamivudine and tenofovir is used to treat HIV-1 infection.
- Cimduo is used with other antiretroviral drugs to treat HIV-1 infection in adults and children weighing at least 35 kg.
How Lamivudine and Tenofovir Works
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Lamivudine and tenofovir are both nucleoside or nucleotide reverse transcriptase inhibitors. They block reverse transcriptase, an enzyme HIV uses to copy its genetic material.
Once inside cells, each drug is converted to an active form and built into the growing viral DNA. This stops the chain from lengthening and slows the virus from multiplying.
Lamivudine and Tenofovir Dosage
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Cimduo is one tablet taken by mouth once a day, with or without food. Follow your prescriber's directions and the label.
- Before and during treatment, expect testing for hepatitis B and kidney checks.
- It is not recommended if kidney function is reduced or you are on hemodialysis.
Dosing details from the FDA-approved label
From the Lamivudine and Tenofovir prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- HIV-1-infected adult and pediatric patients weighing at least 35 kg
- One tablet (300 mg lamivudine and 300 mg tenofovir disoproxil fumarate) taken orally once daily with or without food
- With or without food
- Renal impairment (creatinine clearance less than 50 mL/min) or end-stage renal disease requiring hemodialysis
- Not recommended because CIMDUO is a fixed-dose combination tablet and cannot be dose adjusted
- Not recommended with CrCL less than 50 mL/min or ESRD requiring hemodialysis
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION • Testing: Prior to initiation and during treatment with CIMDUO, patients should be tested for hepatitis B virus infection, and estimated creatinine clearance, urine glucose, and urine protein should be obtained. ( 2.1 ) • Recommended dose: One tablet taken orally once daily with or without food. ( 2.2 ) • Renal Impairment: Not recommended in patients with CrCL less than 50 mL/min or patients with end-stage renal disease requiring hemodialysis. ( 2.3 ) 2.1 Testing Prior to Initiation and During Treatment with CIMDUO Prior to initiation of CIMDUO, test patients for hepatitis B virus infection [see Warnings and Precautions (5.2) ] . It is recommended that serum creatinine, serum phosphorus, estimated creatinine clearance, urine glucose, and urine protein be assessed before initiating CIMDUO and during therapy in all patients as clinically appropriate [see Warnings and Precautions (5.3) ]. 2.2 Recommended Dosage for Adult and Pediatric Patients Weighing at Least 35 kg CIMDUO is a two-drug fixed-dose combination product containing 300 mg of lamivudine (3TC) and 300 mg of tenofovir disoproxil fumarate (TDF). The recommended dosage of CIMDUO in HIV-1-infected adult and pediatric patients weighing at least 35 kg is one tablet taken orally once daily with or without food. 2.3 Not Recommended in Renal Impairment Because CIMDUO is a fixed-dose combination tablet and cannot be dose adjusted, it is not recommended for patients with impaired renal function (creatinine clearance less than 50 mL/min) or patients with end-stage renal disease (ESRD) requiring hemodialysis [see Use in Specific Populations (8.6) ] .
Read the full Dosage and Administration section on DailyMed →
Lamivudine and Tenofovir Side Effects
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The most common side effects with Cimduo are:
Common side effects
- Headache
- Pain
- Depression
- Diarrhea
- Rash
- Nausea
- Dizziness
- Fever
When to get medical help
- Call your doctor if you have a stomach-area ache, yellow skin or eyes, or unusual tiredness after stopping this medicine, especially if you also have hepatitis B.
- Get help if you have symptoms of lactic acidosis (too much acid in the blood) or serious liver problems. Your doctor may need to stop the medicine.
- Tell your doctor about bone pain, pain in your arms or legs, fractures, or muscle pain or weakness. These can be signs of kidney tubule damage.
- Report signs of kidney problems right away.
- Call your doctor about signs of pancreatitis (inflammation of the pancreas), which can be serious. Children with a history of it are at higher risk.
- Tell your doctor if new symptoms of infection or inflammation appear soon after you start HIV treatment. This can happen as your immune system recovers.
- Seek urgent care for an allergic reaction such as swelling of the face or lips, hives, or trouble breathing.
Also reported were nausea, dizziness and fever. Contact your doctor promptly about kidney, liver, pancreas or bone symptoms, or a hepatitis B flare after stopping.
Lamivudine and Tenofovir Warnings and Precautions
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- Hepatitis B flare after stopping (boxed warning) in people who also have hepatitis B.
- Kidney problems, including kidney failure and Fanconi syndrome (kidney tubule injury).
- Lactic acidosis and severe liver enlargement with fat buildup.
- Liver decompensation in people with HIV-1 and hepatitis C who also take interferon and ribavirin.
- Pancreatitis, especially in children with risk factors.
- Decreased bone mineral density and bone softening.
- Immune reconstitution syndrome and body fat changes.
- Early treatment failure if used in certain triple nucleoside-only regimens.
Lamivudine and Tenofovir Interactions
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Several medicines can change drug levels or stress the kidneys.
- NSAIDs in high doses or several at once, and other kidney-affecting drugs (such as acyclovir, valacyclovir, ganciclovir, cidofovir, gentamicin), can harm the kidneys or raise tenofovir levels.
- Atazanavir needs ritonavir with it. Atazanavir, darunavir or lopinavir with ritonavir raise tenofovir levels.
- Epclusa and Harvoni can raise tenofovir levels.
- Sorbitol lowers lamivudine levels, so avoid regular use.
- Trimethoprim is cleared in a similar way to lamivudine.
- Interferon and ribavirin can increase liver risks.
Interactions listed in the FDA-approved label
From the Lamivudine and Tenofovir prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Drugs affecting renal function (cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir, aminoglycosides e.g. gentamicin, high-dose or multiple NSAIDs): Drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of tenofovir and/or increase concentrations of other renally eliminated drugs.
- Atazanavir: TDF decreases the AUC and Cmin of atazanavir. Atazanavir 300 mg should be given with ritonavir 100 mg when coadministered with CIMDUO; TDF should not be coadministered with atazanavir without ritonavir.
- Lopinavir/ritonavir, atazanavir with ritonavir, darunavir with ritonavir: These have been shown to increase tenofovir concentrations. Monitor for tenofovir-associated adverse reactions; discontinue CIMDUO in patients who develop tenofovir-associated adverse reactions.
- Sofosbuvir/velpatasvir (EPCLUSA): Coadministration with TDF has been shown to increase tenofovir exposure. Monitor for adverse reactions associated with TDF.
- Ledipasvir/sofosbuvir (HARVONI) without an HIV-1 protease inhibitor/ritonavir or protease inhibitor/cobicistat: Coadministration with TDF has been shown to increase tenofovir exposure. Monitor for adverse reactions associated with tenofovir.
- Ledipasvir/sofosbuvir with an HIV-1 protease inhibitor/ritonavir or protease inhibitor/cobicistat combination: Safety of increased tenofovir concentrations in this setting has not been established. Consider an alternative HCV or antiretroviral therapy; if coadministration is necessary, monitor for adverse reactions associated with tenofovir.
- Drugs eliminated by active organic cationic secretion (e.g., trimethoprim): 3TC is predominantly eliminated in the urine by active organic cationic secretion, so interactions are possible with drugs whose main elimination route is active renal secretion via the organic cationic transport system. The possibility of interactions should be considered.
- Sorbitol: Coadministration of single doses of 3TC and sorbitol resulted in a sorbitol dose-dependent reduction in 3TC exposures. Avoid chronic administration of sorbitol with CIMDUO; when possible, avoid sorbitol-containing medicines with 3TC.
Read the label’s full interactions text
7 DRUG INTERACTIONS • Atazanavir: Atazanavir should be coadministered with ritonavir when coadministered with CIMDUO. ( 7.2 ) • HIV-1 Protease Inhibitors: Monitor for evidence of tenofovir toxicity when CIMDUO is coadministrated with atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir. ( 7.2 ) • Sorbitol: Avoid chronic administration of sorbitol with CIMDUO.( 7.5 ) 7.1 Drugs Affecting Renal Function Since tenofovir is primarily eliminated by the kidneys [see Clinical Pharmacology (12.3) ] , coadministration of CIMDUO with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of tenofovir and/or increase the concentrations of other renally eliminated drugs. Some examples include, but are not limited to cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.3) ] . 7.2 HIV-1 Protease Inhibitors TDF decreases the AUC and C min of atazanavir [see Clinical Pharmacology (12.3) ] . When coadministered with CIMDUO, it is recommended that atazanavir 300 mg is given with ritonavir 100 mg. TDF should not be coadministered with atazanavir without ritonavir. Lopinavir/ritonavir, atazanavir coadministered with ritonavir, and darunavir coadministered with ritonavir have been shown to increase tenofovir concentrations [see Clinical Pharmacology (12.3) ] . Patients receiving CIMDUO concomitantly with lopinavir/ritonavir, atazanavir and ritonavir, or darunavir and ritonavir should be monitored for tenofovir-associated adverse reactions. CIMDUO should be discontinued in patients who develop tenofovir-associated adverse reactions. 7.3 Hepatitis C Antiviral Agents Coadministration of TDF, a component of CIMDUO, and EPCLUSA ® (sofosbuvir/velpatasvir) or HARVONI ® (ledipasvir/sofosbuvir) has been shown to increase tenofovir exposure [see Clinical Pharmacology (12.3) ] .
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before Taking Lamivudine and Tenofovir
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- Do not use with a past allergic reaction to any ingredient.
- Get tested for hepatitis B first.
- Not recommended with reduced kidney function or hemodialysis.
- Tell your doctor about a history of pancreatitis, bone loss or fractures.
- Pregnancy: tenofovir should be used only if clearly needed. A pregnancy registry monitors outcomes.
- Breastfeeding is not recommended with HIV-1.
- Older adults: use with caution.
- Children must weigh at least 35 kg.
Lamivudine and Tenofovir Overdose
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There is no known specific treatment for a lamivudine overdose. The person should be monitored and given standard supportive care. Tenofovir can be removed by hemodialysis, but lamivudine is removed only negligibly.
What Lamivudine and Tenofovir Does in the Body
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Both drugs have activity against HIV-1. Lamivudine and tenofovir also act on hepatitis B virus, which is why stopping them can lead to a hepatitis B flare in people with both infections.
How Your Body Processes Lamivudine and Tenofovir
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Lamivudine is well absorbed from the tablet and is mostly cleared unchanged by the kidneys, with a half-life of about 5 to 7 hours. Tenofovir from tenofovir disoproxil fumarate peaks in about an hour, is mostly cleared by the kidneys and has a half-life of about 17 hours. Reduced kidney function raises levels of both drugs.
How to Store Lamivudine and Tenofovir
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Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Dispense in original container.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Lamivudine and Tenofovir: Pharmacist Answers to Common Questions
Quick, plain-English answers to the questions patients ask most about Lamivudine and Tenofovir — 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 should I expect?
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Can I stop it if I feel fine?
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Are there pain relievers or other medicines I should avoid?
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Is it safe in pregnancy or while breastfeeding?
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Is Lamivudine and Tenofovir available over the counter?
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When was Lamivudine and Tenofovir first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More About Lamivudine and Tenofovir on HelloPharmacist
Lamivudine and Tenofovir Forms and Strengths (How It Comes)
Lamivudine and Tenofovir 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.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Lamivudine and Tenofovir inactive ingredients by manufacturer.
Tablet
How this form is used
- Cimduo is used with other antiretroviral drugs to treat HIV-1 infection in adults and children weighing at least 35 kg.
- Cimduo is taken as one tablet by mouth once daily, with or without food.
- Cimduo is a fixed-dose tablet that cannot be dose-adjusted, so it is not recommended with reduced kidney function or hemodialysis.
Lamivudine and Tenofovir on the U.S. Market: Products, Makers and Brands
How Lamivudine and Tenofovir 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.
1 company lists 1 Lamivudine and Tenofovir product record with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2018. Brand names on the directory include Cimduo; the rest are generics.
Compare Lamivudine and Tenofovir Products
A representative set of FDA-listed product records for Lamivudine and Tenofovir — 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 300 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg | Oral | Viatris Specialty LLC | NDA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Lamivudine and Tenofovir NDCs →
Lamivudine and Tenofovir 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 Lamivudine and Tenofovir — 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 Lamivudine and Tenofovir 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.
Lamivudine and Tenofovir FDA Approval History
How Lamivudine and Tenofovir went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Lamivudine and Tenofovir 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.
The FDA’s enforcement reports list no Lamivudine and Tenofovir recalls since July 2021.
✅No Lamivudine and Tenofovir recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Oct 8, 2026.
Lamivudine and Tenofovir Supply and Shortage Status
Whether Lamivudine and Tenofovir 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.
Lamivudine and Tenofovir Brand Names
Lamivudine and Tenofovir is sold under one brand name in the FDA directory — Cimduo. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who Makes Lamivudine and Tenofovir: Manufacturers and Labelers
One company lists Lamivudine and Tenofovir products with the FDA. By number of product records, the largest are Viatris Specialty LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Lamivudine and Tenofovir Drug Class (RxNorm)
Lamivudine and Tenofovir belongs to the Nucleoside and nucleotide reverse transcriptase inhibitors 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 Lamivudine and Tenofovir 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 this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Mylan Specialty L.P. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →