Prescription medicine
Emtricitabine and tenofovir disoproxil Brand names: Truvada
Emtricitabine and tenofovir disoproxil (Truvada) is a prescription medicine with an FDA approval on record since 2004. FDA's NDC Directory lists it from 25 generic labelers, and pharmacies paid $0.529 per emtricitabine-tenofovir disoproxil fumarate 200-300 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $59.71 per Truvada 200 mg-300 mg tablet.
- Generic listed
- Boxed warning
Check it at the source: the emtricitabine and tenofovir disoproxil FDA label on DailyMed (effective July 16, 2025, Gilead Sciences, Inc); the NDA 21752 record on Drugs@FDA; every emtricitabine and tenofovir disoproxil label on DailyMed.
Highlights of the record
FDA label of July 16, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B.
and RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION Severe acute exacerbations of hepatitis B (HBV) have been reported in HBV-infected individuals who have discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in individuals who are infected with HBV and discontinue TRUVADA. If appropriate, anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1) ]. TRUVADA used for HIV-1 PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use. Drug-resistant HIV-1 variants have been identified with use of TRUVADA for HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate TRUVADA for HIV-1 PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed [see Warnings and Precautions (5.2) ]. WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION See full prescribing information for complete boxed warning. […]
Used for
From the label: indications and usageHIV-1 Treatment ( 1.1 ) TRUVADA is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg.
Forms and strengths
- 100 mg / 150 mg
- 133 mg / 200 mg
- 167 mg / 250 mg
- 200 mg / 300 mg
- 300 mg / 200 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- August 2, 2004 Truvada, Gilead; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 13 first June 8, 2017; 10 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 27 of which 25 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.529 per tablet Emtricitabine-tenofovir disoproxil fumarate 200-300 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2014 0 Class I among all firms' recalls; latest September 30, 2014
- FAERS reports
- 45,341 through July 30, 2026
What is emtricitabine and tenofovir disoproxil used for?
From the label: indications and usageHIV-1 Treatment ( 1.1 ) TRUVADA is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg. HIV-1 PrEP ( 1.2 ): TRUVADA is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. […]
Conditions named in the indications of emtricitabine 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 (Truvada), Gilead Sciences, Inc, effective July 16, 2025 (SPL set 54e82b13-a037-49ed-b4b3-030b37c0ecdd), via openFDA; the full label on DailyMed
What does the patient leaflet for emtricitabine 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 TRUVADA?TRUVADA can cause serious side effects, including: Worsening of hepatitis B virus infection (HBV). Your healthcare provider will test you for HBV before start or when you start treatment with TRUVADA. If you have HBV infection and take TRUVADA, your HBV may get worse (flare-up) if you stop taking TRUVADA. A "flare-up" is when your HBV infection suddenly returns in a worse way than before. Do not run out of TRUVADA. Refill your prescription or talk to your healthcare provider before your TRUVADA is all gone. Do not stop taking TRUVADA without first talking to your healthcare provider. If you stop taking TRUVADA, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection, or give you a medicine to treat hepatitis B. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking TRUVADA. For more information about side effects, see the section " What are the possible side effects of TRUVADA? ". Other important information for people who take TRUVADA to help reduce their risk of getting human immunodeficiency virus-1 (HIV-1) infection, also called pre-exposure prophylaxis or "PrEP": Before taking TRUVADA to reduce your risk of getting HIV-1: You must be HIV-1 negative to start TRUVADA. You must get tested to make sure that you do not already have HIV-1 infection. Do not take TRUVADA for HIV-1 PrEP unless you are confirmed to be HIV-1 negative. Some HIV-1 tests can miss HIV-1 infection in a person who has recently become infected. If you have flu-like symptoms, you could have recently become infected with HIV-1. Tell your healthcare provider if you had a flu-like illness within the last month before starting TRUVADA or at any time while taking TRUVADA. […]
From the patient leaflet: How should I store TRUVADA?Store TRUVADA at room temperature between 68°F to 77°F (20°C to 25°C). Keep TRUVADA in its original container. Keep the container tightly closed. Do not use TRUVADA if seal over bottle opening is broken or missing. Keep TRUVADA and all other medicines out of reach of children.
Source: FDA drug label (Truvada), Gilead Sciences, Inc, effective July 16, 2025 (SPL set 54e82b13-a037-49ed-b4b3-030b37c0ecdd), via openFDA; the full label on DailyMed
Is there a generic for emtricitabine and tenofovir disoproxil (Truvada)?
The FDA approved the first generic emtricitabine and tenofovir disoproxil on June 8, 2017. 13 generic applications are approved; 10 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 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists emtricitabine and tenofovir disoproxil from 25 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2004 earliest approval on file
- 2017 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for emtricitabine and tenofovir disoproxil (Truvada)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.529 per Emtricitabine-tenofovir disoproxil fumarate 200-300 mg tablet, down 10% from $0.587 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Emtricitabine-tenofovir disoproxil fumarate 200-300 mg tablet (generic)
- Truvada 200 mg-300 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Emtricitabine-tenofovir disoproxil fumarate 100-150 mg tablet | Generic | $10.19 per tablet | $305.83 | -4% |
| Emtricitabine-tenofovir disoproxil fumarate 200-300 mg tablet | Generic | $0.529 per tablet | $15.87 | -10% |
| Truvada 200 mg-300 mg tablet | Brand | $59.71 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $1,791.29 | +0.2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has emtricitabine and tenofovir disoproxil been recalled?
The FDA's Enforcement Report lists 1 recall naming emtricitabine and tenofovir disoproxil since 2014: 0 Class I (the most serious), 0 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 30, 2014 | Class III | Gilead Sciences, Inc. | Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the emtricitabine and tenofovir disoproxil label say about other medicines?
The emtricitabine and tenofovir disoproxil label names 15 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, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.3) ]. |
| Adefovir dipivoxil | drug interactions | Some examples include, but are not limited to, acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.3) ]. |
| Atazanavir | drug interactions | Dose reduction and close monitoring for didanosine toxicity are warranted. ( 7.2 ) Coadministration decreases atazanavir concentrations. |
| Cidofovir | drug interactions | Some examples include, but are not limited to, acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.3) ]. |
| Cobicistat | drug interactions | Concomitant Drug Class/Drug Name: ledipasvir/sofosbuvir; Effect on Concentration ↑=Increase, ↓=Decrease: Monitor patients receiving TRUVADA concomitantly with HARVONI ® (ledipasvir/sofosbuvir) without an HIV-1 protease inhibitor/ritonavir or an HIV-1 protease inhibitor/cobicistat combination for adverse reactions … |
| Darunavir | drug interactions | Concomitant Drug Class/Drug Name: lopinavir/ritonavir atazanavir/ritonavir darunavir/ritonavir; Effect on Concentration ↑=Increase, ↓=Decrease: ↑ tenofovir; Clinical Comment: Monitor patients receiving TRUVADA concomitantly with lopinavir/ritonavir, ritonavir-boosted atazanavir, or ritonavir-boosted darunavir for … |
| Ganciclovir | drug interactions | Some examples include, but are not limited to, acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, 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, acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.3) ]. |
| Ledipasvir and sofosbuvir | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Lopinavir and ritonavir | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Ritonavir | drug interactions | When coadministered with TRUVADA, use atazanavir given with ritonavir. ( 7.2 ) Coadministration of TRUVADA with certain HIV-1 protease inhibitors or certain drugs to treat HCV increases tenofovir concentrations. |
| Sofosbuvir and velpatasvir | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Sofosbuvir and velpatasvir and voxilaprevir | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Valacyclovir | drug interactions | Some examples include, but are not limited to, acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.3) ]. |
Every other medicine the emtricitabine and tenofovir disoproxil label names
| Medicine named | Section | What the label says |
|---|---|---|
| Valganciclovir | drug interactions | Some examples include, but are not limited to, acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple … |
Check emtricitabine and tenofovir disoproxil against other medicines
Source: FDA drug label (Truvada), Gilead Sciences, Inc, effective July 16, 2025 (SPL set 54e82b13-a037-49ed-b4b3-030b37c0ecdd), via openFDA; the full label on DailyMed
What do FAERS reports show for emtricitabine and tenofovir disoproxil?
The FDA Adverse Event Reporting System holds 45,341 reports that list emtricitabine and tenofovir disoproxil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,830 are coded as a death and 7,631 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. Reports rose sharply in 2020 (14,654, against a median of 1,589 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
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 emtricitabine and tenofovir disoproxil?
31 other medicines are given the same way (oral) and in the same FDA class as emtricitabine 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 |
|---|---|---|---|---|
| Lamivudine | HIV | 14 labelers | $0.489 per tablet 150 mg tablet | No current entry |
| Abacavir | HIV | 12 labelers | $0.546 per tablet 300 mg tablet | No current entry |
| Lamivudine and zidovudine | HIV | 7 labelers | $0.771 per tablet Lamivudine-zidovudine tablet | No current entry |
| Zidovudine | HIV | 3 labelers | $0.464 per tablet 300 mg tablet | No current entry |
| Abacavir and lamivudine | HIV | 6 labelers | $1.48 per unit 600-300 mg | No current entry |
| Abacavir and dolutegravir and lamivudine | HIV | none listed | $130.01 per tablet 600-50-300 mg tablet | No current entry |
| Abacavir and lamivudine and zidovudine | HIV | 1 labeler | n/a | No current entry |
| Dolutegravir and lamivudine | HIV | none listed | $105.22 per tablet 50-300 mg tablet | No current entry |
Every medicine labeled for the same conditions as emtricitabine and tenofovir disoproxil
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to emtricitabine 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
- Emtricitabine and tenofovir disoproxil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other