Prescription medicine
Lamivudine and tenofovir disoproxil Brand names: Cimduo
Lamivudine and tenofovir disoproxil (Cimduo) is a prescription medicine with an FDA approval on record since 2018. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the lamivudine and tenofovir disoproxil FDA label on DailyMed (effective February 15, 2021, Viatris Specialty LLC); the NDA 22141 record on Drugs@FDA; every lamivudine and tenofovir disoproxil label on DailyMed.
Highlights of the record
FDA label of February 15, 2021; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
POST TREATMENT ACUTE 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 or tenofovir disoproxil fumarate, components of CIMDUO. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment [see Warnings and Precautions (5.2) ]. WARNING: POST TREATMENT ACUTE EXACERBATIONS OF HEPATITIS B See full prescribing information for complete boxed warning.
Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with HBV and human immunodeficiency virus (HIV-1) and have discontinued lamivudine and tenofovir disoproxil fumarate. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment.
Used for
From the label: indications and usageCIMDUO ® (lamivudine and tenofovir disoproxil fumarate) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.
Forms and strengths
- 300 mg / 300 mg
Film-coated tablet.
On the market
- Earliest approval on file
- February 28, 2018 Cimduo, Mylan Labs Ltd; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 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
- 42 through July 30, 2026
What is lamivudine and tenofovir disoproxil used for?
From the label: indications and usageCIMDUO ® (lamivudine and tenofovir disoproxil fumarate) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg. CIMDUO is a two-drug combination of lamivudine (3TC) and tenofovir disoproxil fumarate (TDF), both nucleo(t)side reverse transcriptase inhibitors and is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.
Conditions named in the indications of lamivudine and tenofovir disoproxil'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 (CIMDUO), NDA022141 (Mylan Labs Ltd), as published by Viatris Specialty LLC, effective February 15, 2021 (SPL set a300f04d-118f-4136-aaf3-ddfd00197f86), via openFDA; the full label on DailyMed
What does the patient leaflet for lamivudine and tenofovir disoproxil 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 CIMDUO?CIMDUO can cause serious side effects, including: • Too much lactic acid in your blood (lactic acidosis). Lactic acidosis is a serious medical emergency that can lead to death. Tell your healthcare provider right away if you get any of the following symptoms that could be signs of lactic acidosis: o feel very weak or tired o unusual (not normal) muscle pain o trouble breathing o stomach pain with nausea or vomiting o feel cold, especially in your arms and legs o feel dizzy or lightheaded o have a fast or irregular heartbeat • Severe liver problems. In some cases, severe 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: o your skin or the white part of your eyes turns yellow (jaundice) o dark or “tea-colored” urine o light-colored stools (bowel movements) o loss of appetite for several days or longer o nausea and vomiting o pain, aching, or tenderness on the right side of your stomach-area • Worsening of hepatitis B infection. If you have Human Immunodeficiency Virus type 1 (HIV-1) and hepatitis B Virus (HBV) infection, your HBV may get worse (flare-up) if you stop taking CIMDUO. A “flare-up” is when your HBV infection suddenly returns in a worse way than before. Your healthcare provider will test you for HBV infection before you start treatment with CIMDUO. o It is not known if CIMDUO is safe and effective in people who have both HIV-1 and HBV infection. o Do not run out of CIMDUO. Refill your prescription or talk to your healthcare provider before your CIMDUO is all gone. o Do not stop CIMDUO without first talking to your healthcare provider. […]
From the patient leaflet: What should I avoid while taking CIMDUO?You should avoid taking medicines that contain sorbitol during treatment with CIMDUO.
From the patient leaflet: How should I store CIMDUO?Store CIMDUO tablets at room temperature between 68°F to 77°F (20°C to 25°C). • Keep CIMDUO tablets in the original container. Keep CIMDUO and all medicines out of the reach of children.
Source: FDA drug label (CIMDUO), NDA022141 (Mylan Labs Ltd), as published by Viatris Specialty LLC, effective February 15, 2021 (SPL set a300f04d-118f-4136-aaf3-ddfd00197f86), via openFDA; the full label on DailyMed
Is there a generic for lamivudine and tenofovir disoproxil (Cimduo)?
No generic lamivudine and tenofovir disoproxil is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 4 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
- 2018 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the lamivudine and tenofovir disoproxil label say about other medicines?
The lamivudine and tenofovir disoproxil label names 16 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 |
|---|---|---|
| Acyclovir | drug interactions | 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) ]. |
| Atazanavir | drug interactions | Atazanavir should be coadministered with ritonavir when coadministered with CIMDUO. |
| Cidofovir | drug interactions | 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) ]. |
| Cobicistat | drug interactions | In patients receiving CIMDUO concomitantly with ledipasvir/sofosbuvir without an HIV-1 protease inhibitor/ritonavir or an HIV-1 protease inhibitor/cobicistat combination, monitor for adverse reactions associated with tenofovir. |
| Darunavir | drug interactions | HIV-1 Protease Inhibitors: Monitor for evidence of tenofovir toxicity when CIMDUO is coadministrated with atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir. |
| Ganciclovir | drug interactions | 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) ]. |
| Gentamicin | drug interactions | 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) ]. |
| Ledipasvir and sofosbuvir | drug interactions | 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) ]. |
| Lopinavir and ritonavir | drug interactions | HIV-1 Protease Inhibitors: Monitor for evidence of tenofovir toxicity when CIMDUO is coadministrated with atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir. |
| Ribavirin | warnings and precautions | Discontinue CIMDUO, as medically appropriate, and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both. |
| Ritonavir | drug interactions | Atazanavir should be coadministered with ritonavir when coadministered with CIMDUO. |
| Sofosbuvir and velpatasvir | drug interactions | 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) ]. |
| Tenofovir alafenamide | warnings and precautions | If treatment with EPIVIR-HBV, TDF, or a tenofovir alafenamide (TAF)-containing product is prescribed for chronic hepatitis B for a patient with unrecognized or untreated HIV-1 infection, rapid emergence of HIV-1 resistance is likely to result because of the subtherapeutic dose and the inappropriateness of monotherapy … |
| 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 Clinical Pharmacology (12.3) ]. |
Every other medicine the lamivudine and tenofovir disoproxil label names
| Medicine named | Section | What the label says |
|---|---|---|
| Valacyclovir | drug interactions | 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 … |
| Valganciclovir | drug interactions | 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 … |
Check lamivudine and tenofovir disoproxil against other medicines
Source: FDA drug label (CIMDUO), NDA022141 (Mylan Labs Ltd), as published by Viatris Specialty LLC, effective February 15, 2021 (SPL set a300f04d-118f-4136-aaf3-ddfd00197f86), via openFDA; the full label on DailyMed
What do FAERS reports show for lamivudine and tenofovir disoproxil?
The FDA Adverse Event Reporting System holds 42 reports that list lamivudine and tenofovir disoproxil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 5 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 lamivudine and tenofovir disoproxil?
31 other medicines are given the same way (oral) and in the same FDA class as lamivudine and tenofovir disoproxil 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 |
|---|---|---|---|---|
| Abacavir | HIV | 12 labelers | $0.546 per tablet 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 |
| 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 |
| Cobicistat, elvitegravir, emtricitabine and tenofovir alafenamide | HIV | none listed | $143.35 per tablet Genvoya tablet | No current entry |
| Emtricitabine and rilpivirine and tenofovir alafenamide | HIV | none listed | $130.49 per tablet Odefsey tablet | No current entry |
Every medicine labeled for the same conditions as lamivudine and tenofovir disoproxil
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to lamivudine and tenofovir disoproxil
- 31 medicines for the same use
- Other hepatitis b virus nucleoside analog reverse transcriptase inhibitors
- the pharmacologic class, with prices and generics
- Lamivudine and tenofovir disoproxil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other