Prescription medicine
Efavirenz and lamivudine and tenofovir disoproxil Brand names: Symfi; first approved as Symfi Lo
Efavirenz and lamivudine and tenofovir disoproxil (Symfi) is a prescription medicine with an FDA approval on record since 2018. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
- Boxed warning
Check it at the source: the efavirenz and lamivudine and tenofovir disoproxil FDA label on DailyMed (effective October 15, 2019, Viatris Specialty LLC); the NDA 208255 record on Drugs@FDA; every efavirenz and lamivudine and tenofovir disoproxil label on DailyMed.
Highlights of the record
FDA label of October 15, 2019; 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, two components of SYMFI. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment [see Warnings and Precautions (5.1) ]. 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 usageSYMFI ® (efavirenz, lamivudine and tenofovir disoproxil fumarate) is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.
Forms and strengths
- 400 mg / 300 mg / 300 mg
- 600 mg / 300 mg / 300 mg
Film-coated tablet.
On the market
- Earliest approval on file
- February 5, 2018 Symfi Lo, Mylan; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first May 14, 2020; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 1 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
- 30 through July 30, 2026
What is efavirenz and lamivudine and tenofovir disoproxil used for?
From the label: indications and usageSYMFI ® (efavirenz, lamivudine and tenofovir disoproxil fumarate) is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg. SYMFI is a three-drug combination of efavirenz (EFV), a non-nucleoside reverse transcriptase inhibitor, and lamivudine (3TC) and tenofovir disoproxil fumarate (TDF), both nucleo(t)side reverse transcriptase inhibitors and is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.
Conditions named in the indications of efavirenz and lamivudine and tenofovir disoproxil's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor, Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor and Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor.
Source: FDA drug label (SYMFI), NDA022142 (Mylan Labs Ltd), as published by Viatris Specialty LLC, effective October 15, 2019 (SPL set 81a55dd9-78a8-49c3-88ab-8f5bffafa359), via openFDA; the full label on DailyMed
What does the patient leaflet for efavirenz and 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 SYMFI?SYMFI can cause serious side effects, including: • Worsening of Hepatitis B virus 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 SYMFI. 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 SYMFI. o It is not known if SYMFI is safe and effective in people who have both HIV-1 and HBV infection. o Do not run out of SYMFI. Refill your prescription or talk to your healthcare provider before your SYMFI is all gone. o Do not stop SYMFI without first talking to your healthcare provider. If you stop taking SYMFI, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver. For more information about side effects, see “What are the possible side effects of SYMFI?”
From the patient leaflet: What should I avoid while taking SYMFI?You should avoid taking medicines that contain sorbitol during treatment with SYMFI.
From the patient leaflet: How should I store SYMFI?Store SYMFI tablets below 86°F (30°C). • Keep SYMFI tablets in the original container. Keep SYMFI and all medicines out of the reach of children.
Source: FDA drug label (SYMFI), NDA022142 (Mylan Labs Ltd), as published by Viatris Specialty LLC, effective October 15, 2019 (SPL set 81a55dd9-78a8-49c3-88ab-8f5bffafa359), via openFDA; the full label on DailyMed
Is there a generic for efavirenz and lamivudine and tenofovir disoproxil (Symfi)?
The FDA approved the first generic efavirenz and lamivudine and tenofovir disoproxil on May 14, 2020. 2 generic applications are approved; 2 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 3 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists efavirenz and lamivudine and tenofovir disoproxil from 1 labeler 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.
- 2018 earliest approval on file
- 2020 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the efavirenz and lamivudine and tenofovir disoproxil label say about other medicines?
The efavirenz and lamivudine and tenofovir disoproxil label names 48 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, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.4) ]. |
| Adefovir dipivoxil | drug interactions | Hepatitis B antiviral agents Adefovir dipivoxil Concomitant administration of adefovir dipivoxil is not recommended. |
| Artemether and lumefantrine | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Atorvastatin | drug interactions | Concomitant Drug/Class/Drug Name: HMG-CoA reductase inhibitors: Atorvastatin Pravastatin Simvastatin; Effect: ↓ atorvastatin ↓ pravastatin ↓ simvastatin; Clinical Comment: Plasma concentrations of atorvastatin, pravastatin, and simvastatin decreased. … |
| Atovaquone | drug interactions | Concomitant Drug/Class/Drug Name: Atovaquone/ proguanil; Effect: ↓ atovaquone ↓ proguanil; Clinical Comment: Concomitant administration is not recommended. |
| Atovaquone and proguanil | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Azithromycin | drug interactions | Drugs without Clinically Significant Interactions No dosage adjustment is recommended when SYMFI is administered with the following: aluminum/magnesium hydroxide antacids, azithromycin, cetirizine, famotidine, fluconazole, and lorazepam. |
| Bupropion | drug interactions | Concomitant Drug/Class/Drug Name: Antidepressants: Bupropion; Effect: ↓ bupropion; Clinical Comment: Increases in bupropion dosage should be guided by clinical response. Bupropion dose should not exceed the maximum recommended dose. |
| Carbamazepine | drug interactions | Concomitant Drug/Class/Drug Name: Anticonvulsants: Carbamazepine; Effect: ↓ carbamazepine The interaction between EFV and the drug was evaluated in a clinical study. All other drug interactions shown are predicted. ↓ EFV *; Clinical Comment: There are insufficient data to make a dose recommendation for EFV. … |
| Cetirizine | drug interactions | Drugs without Clinically Significant Interactions No dosage adjustment is recommended when SYMFI is administered with the following: aluminum/magnesium hydroxide antacids, azithromycin, cetirizine, famotidine, fluconazole, and lorazepam. |
| Cidofovir | drug interactions | Some examples include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.4) ]. |
| Clarithromycin | drug interactions | Concomitant Drug/Class/Drug Name: Anti-infective: Clarithromycin; Effect: ↓ clarithromycin ↑ 14-OH metabolite; Clinical Comment: Consider alternatives to macrolide antibiotics because of the risk of QT interval prolongation. |
| Cyclosporine | drug interactions | Concomitant Drug/Class/Drug Name: Immunosuppressants: Cyclosporine, tacrolimus, sirolimus, and others metabolized by CYP3A; Effect: ↓ immunosuppressant; Clinical Comment: Dose adjustments of the immunosuppressant may be required. … |
| Diltiazem | drug interactions | Concomitant Drug/Class/Drug Name: Calcium channel blockers: Diltiazem; Effect: ↓ diltiazem ↓ desacetyl diltiazem ↓ N-monodesmethyldiltiazem; Clinical Comment: Diltiazem dose adjustments should be guided by clinical response (refer to the full prescribing information for diltiazem). |
Every other medicine the efavirenz and lamivudine and tenofovir disoproxil label names
| Medicine named | Section | What the label says |
|---|---|---|
| Elbasvir and grazoprevir | contraindications | Coadministration with elbasvir/grazoprevir. |
| Etonogestrel | drug interactions | Concomitant Drug/Class/Drug Name: Implant Etonogestrel; Effect: ↓ etonogestrel; Clinical Comment: A reliable method of barrier contraception should be used in addition to hormonal contraceptives. … |
| Famotidine | drug interactions | … following: aluminum/magnesium hydroxide antacids, azithromycin, cetirizine, famotidine, fluconazole, and lorazepam. |
| Felodipine | drug interactions | Concomitant Drug/Class/Drug Name: Others (e.g., felodipine, nicardipine, nifedipine, verapamil); Effect: ↓ calcium channel blocker; … |
| Fluconazole | drug interactions | … aluminum/magnesium hydroxide antacids, azithromycin, cetirizine, famotidine, fluconazole, and lorazepam. |
| Ganciclovir | drug interactions | Some examples include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and … |
| Gentamicin | drug interactions | Some examples include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and … |
| Glecaprevir and pibrentasvir | drug interactions | Pibrentasvir/Glecaprevir ↓ pibrentasvir ↓ glecaprevir Coadministration of EFV is not recommended because it may lead to reduced therapeutic effect of pibrentasvir/glecaprevir. |
| Itraconazole | drug interactions | Concomitant Drug/Class/Drug Name: Antifungals: Itraconazole Ketoconazole; Effect: ↓ itraconazole ↓ hydroxy itraconazole ↓ ketoconazole; … |
| Ketoconazole | drug interactions | Concomitant Drug/Class/Drug Name: Antifungals: Itraconazole Ketoconazole; Effect: ↓ itraconazole ↓ hydroxy itraconazole ↓ ketoconazole; … |
| Ledipasvir and sofosbuvir | drug interactions | Ledipasvir/Sofosbuvir ↑ TDF Monitor for adverse reactions associated with TDF. |
| Lorazepam | drug interactions | … hydroxide antacids, azithromycin, cetirizine, famotidine, fluconazole, and lorazepam. |
| Magnesium hydroxide | drug interactions | … recommended when SYMFI is administered with the following: aluminum/magnesium hydroxide antacids, azithromycin, cetirizine, famotidine, fluconazole, and lorazepam. |
| Methadone | drug interactions | Concomitant Drug/Class/Drug Name: Narcotic analgesic: Methadone; Effect: ↓ methadone; Clinical Comment: Monitor for signs of methadone withdrawal and increase methadone dose if required to alleviate … |
| Nicardipine | drug interactions | Concomitant Drug/Class/Drug Name: Others (e.g., felodipine, nicardipine, nifedipine, verapamil); Effect: ↓ calcium channel blocker; … |
| Nifedipine | drug interactions | Concomitant Drug/Class/Drug Name: Others (e.g., felodipine, nicardipine, nifedipine, verapamil); Effect: ↓ calcium channel blocker; … |
| Phenobarbital | drug interactions | Drugs that induce CYP3A activity (e.g., phenobarbital, rifampin, rifabutin) would be expected to increase the clearance of EFV resulting in lowered plasma concentrations. |
| Phenytoin | drug interactions | Concomitant Drug/Class/Drug Name: Phenytoin Phenobarbital; Effect: ↓ anticonvulsant ↓ EFV; Clinical Comment: Monitor anticonvulsant plasma levels periodically because of potential for reduction in … |
| Posaconazole | drug interactions | Concomitant Drug/Class/Drug Name: Posaconazole; Effect: ↓ posaconazole; Clinical Comment: Avoid concomitant use unless the benefit outweighs the risks. |
| Pravastatin | drug interactions | Concomitant Drug/Class/Drug Name: HMG-CoA reductase inhibitors: Atorvastatin Pravastatin Simvastatin; Effect: ↓ atorvastatin ↓ pravastatin ↓ simvastatin; … |
| Rifabutin | drug interactions | Drugs that induce CYP3A activity (e.g., phenobarbital, rifampin, rifabutin) would be expected to increase the clearance of EFV resulting in lowered plasma concentrations. |
| Rifampin | drug interactions | Drugs that induce CYP3A activity (e.g., phenobarbital, rifampin, rifabutin) would be expected to increase the clearance of EFV resulting in lowered plasma concentrations. |
| Sertraline | drug interactions | Concomitant Drug/Class/Drug Name: Sertraline; Effect: ↓ sertraline; Clinical Comment: Increases in sertraline dosage should be guided by clinical response. |
| Simvastatin | drug interactions | Concomitant Drug/Class/Drug Name: HMG-CoA reductase inhibitors: Atorvastatin Pravastatin Simvastatin; Effect: ↓ atorvastatin ↓ pravastatin ↓ simvastatin; … |
| Sirolimus | drug interactions | Concomitant Drug/Class/Drug Name: Immunosuppressants: Cyclosporine, tacrolimus, sirolimus, and others metabolized by CYP3A; Effect: ↓ immunosuppressant; … |
| Sofosbuvir and velpatasvir | drug interactions | Velpatasvir/Sofosbuvir ↓ velpatasvir Coadministration of EFV and sofosbuvir/velpatasvir is not recommended because it may result in loss of therapeutic effect of sofosbuvir/velpatasvir. |
| Sofosbuvir and velpatasvir and voxilaprevir | drug interactions | Velpatasvir/Sofosbuvir/ Voxilaprevir ↓ velpatasvir ↓ voxilaprevir Coadministration of EFV and sofosbuvir/velpatasvir/voxilaprevir is not recommended because it may result in loss of therapeutic … |
| Tacrolimus | drug interactions | Concomitant Drug/Class/Drug Name: Immunosuppressants: Cyclosporine, tacrolimus, sirolimus, and others metabolized by CYP3A; Effect: ↓ immunosuppressant; … |
| 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 … |
| Trimethoprim | drug interactions | … active renal secretion via the organic cationic transport system (e.g., trimethoprim) [see Clinical Pharmacology (12.3) ]. |
| Valacyclovir | drug interactions | Some examples include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, 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, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and … |
| Verapamil | drug interactions | Concomitant Drug/Class/Drug Name: Others (e.g., felodipine, nicardipine, nifedipine, verapamil); Effect: ↓ calcium channel blocker; … |
| Warfarin | drug interactions | Concomitant Drug/Class/Drug Name: Anticoagulant: Warfarin; Effect: ↑ or ↓ warfarin; Clinical Comment: Monitor INR and adjust warfarin dosage if necessary. |
Check efavirenz and lamivudine and tenofovir disoproxil against other medicines
Source: FDA drug label (SYMFI), NDA022142 (Mylan Labs Ltd), as published by Viatris Specialty LLC, effective October 15, 2019 (SPL set 81a55dd9-78a8-49c3-88ab-8f5bffafa359), via openFDA; the full label on DailyMed
What do FAERS reports show for efavirenz and lamivudine and tenofovir disoproxil?
The FDA Adverse Event Reporting System holds 30 reports that list efavirenz and 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; 1 are coded as a death and 3 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 efavirenz and lamivudine and tenofovir disoproxil?
30 other medicines are given the same way (oral) and in the same FDA class as efavirenz and 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 |
|---|---|---|---|---|
| Etravirine | HIV | 5 labelers | $9.94 per tablet 200 mg tablet | A presentation being discontinued |
| Abacavir | HIV | 12 labelers | $0.546 per tablet 300 mg tablet | No current entry |
| Nevirapine | HIV | 6 labelers | $0.147 per tablet 200 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 |
| Rilpivirine | HIV | 2 labelers | $48.04 per tablet 25 mg tablet | No current entry |
| Doravirine | HIV | none listed | $60.79 per tablet 100 mg tablet | No current entry |
Every medicine labeled for the same conditions as efavirenz and 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 efavirenz and lamivudine and tenofovir disoproxil
- 30 medicines for the same use
- Other hepatitis b virus nucleoside analog reverse transcriptase inhibitors
- the pharmacologic class, with prices and generics
- Efavirenz and 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