Prescription medicine
Tenofovir disoproxil Brand names: Viread
Tenofovir disoproxil (Viread) is a prescription medicine with an FDA approval on record since 2001. FDA's NDC Directory lists it from 15 generic labelers, and pharmacies paid $0.294 per tenofovir disoproxil fumarate 300 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the tenofovir disoproxil FDA label on DailyMed (effective June 7, 2024, Aurobindo Pharma Limited); the NDA 21356 record on Drugs@FDA; every tenofovir disoproxil label on DailyMed.
Highlights of the record
FDA label of June 7, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B.
Severe acute exacerbations of hepatitis B virus (HBV) have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including t enofovir disoproxil fumarate. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in HBV-infected patients who discontinue anti-hepatitis B therapy, including tenofovir disoproxil fumarate. If appropriate, resumption of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1) ]. WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B See full prescribing information for complete boxed warning. Severe acute exacerbations of hepatitis B virus (HBV) have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including tenofovir disoproxil fumarate. Hepatic function should be monitored closely in HBV-infected patients who discontinue tenofov ir disoproxil fumarate. If appropriate, resumption of anti-hepatitis B therapy may be warranted.
Used for
From the label: indications and usageTenofovir disoproxil fumarate is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg.
Forms and strengths
- 150 mg
- 200 mg
- 250 mg
- 300 mg
- 40 mg/g
Film-coated tablet; coated tablet; tablet; powder.
On the market
- Earliest approval on file
- October 26, 2001 Viread, Gilead Sciences Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 13 first March 18, 2015; 11 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 16 of which 15 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.294 per tablet Tenofovir disoproxil fumarate 300 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 32,864 through July 30, 2026
What is tenofovir disoproxil used for?
From the label: indications and usageTenofovir disoproxil fumarate is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. (1.1) for the treatment of chronic hepatitis B in adults and pediatric patients 2 years and older weighing at least 10 kg. […]
Conditions named in the indications of 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 (Tenofovir Disoproxil Fumarate), Aurobindo Pharma Limited, effective June 7, 2024 (SPL set a75c6be8-3719-4bb3-8a9e-06e5254d2a82), via openFDA; the full label on DailyMed
What does the patient leaflet for 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 tenofovir disoproxil fumarate tablets?Tenofovir disoproxil fumarate tablets can cause serious side effects, including: Worsening of Hepatitis B virus infection (HBV). Your healthcare provider will test you for HBV and HIV before starting treatment with tenofovir disoproxil fumarate tablets. If you have HBV infection and take tenofovir disoproxil fumarate tablets your HBV may get worse (flare-up) if you stop taking tenofovir disoproxil fumarate tablets. A “flare-up” is when your HBV infection suddenly returns in a worse way than before. Do not run out of tenofovir disoproxil fumarate tablets. Refill your prescription or talk to your healthcare provider before your tenofovir disoproxil fumarate tablets are all gone. Do not stop taking tenofovir disoproxil fumarate tablets without first talking to your healthcare provider. If you stop taking tenofovir disoproxil fumarate tablets, your healthcare provider will need to check your health often and do blood tests regularly to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking tenofovir disoproxil fumarate tablets. For more information about side effects, see “What are the possible side effects of tenofovir disoproxil fumarate tablets?”
From the patient leaflet: How should I store tenofovir disoproxil fumarate tablets?Store tenofovir disoproxil fumarate tablets at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59° to 86°F). Keep tenofovir disoproxil fumarate tablets in the original container. Keep the bottle tightly closed. Do not use tenofovir disoproxil fumarate tablets if the seal over the bottle opening is broken or missing. Keep tenofovir disoproxil fumarate tablets and all medicines out of the reach of children.
Source: FDA drug label (Tenofovir Disoproxil Fumarate), Aurobindo Pharma Limited, effective June 7, 2024 (SPL set a75c6be8-3719-4bb3-8a9e-06e5254d2a82), via openFDA; the full label on DailyMed
Is there a generic for tenofovir disoproxil (Viread)?
The FDA approved the first generic tenofovir disoproxil on March 18, 2015. 13 generic applications are approved; 11 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 tenofovir disoproxil from 15 labelers 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.
- 2001 earliest approval on file
- 2015 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for tenofovir disoproxil (Viread)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.294 per Tenofovir disoproxil fumarate 300 mg tablet, down 21% from $0.372 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.
- Tenofovir disoproxil fumarate 300 mg tablet (generic)
- Viread 300 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tenofovir disoproxil fumarate 300 mg tablet | Generic | $0.294 per tablet | $8.81 | -21% |
| Viread 300 mg tablet | Brand | $40.69 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $1,220.60 | +0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the tenofovir disoproxil label say about other medicines?
The tenofovir disoproxil label names 15 other medicines in its interaction, contraindication or warning sections. The labels of 23 other medicines name tenofovir disoproxil. 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 (5.2) ]. |
| Adefovir dipivoxil | drug interactions | In the treatment of chronic hepatitis B, tenofovir disoproxil fumarate should not be administered in combination with HEPSERA (adefovir dipivoxil). |
| 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, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.2) ]. |
| Cobicistat | drug interactions | … HARVONI ® (ledipasvir/sofosbuvir) without an HIV-1 protease inhibitor/ritonavir or an HIV-1 protease inhibitor/cobicistat combination, for adverse reactions associated with TDF. In patients receiving tenofovir disoproxil fumarate concomitantly with HARVONI and an HIV-1 protease inhibitor/ritonavir or an HIV-1 protease … |
| Darunavir | drug interactions | Concomitant Drug Class/Drug Name: HIV-1 Protease Inhibitors: atazanavir lopinavir/ritonavir atazanavir/ritonavir darunavir/ritonavir; Effect on Concentration b: ↓ atazanavir ↑ tenofovir; Clinical Comment: When coadministered with tenofovir disoproxil fumarate, atazanavir 300 mg should be given with ritonavir 100 mg. … |
| 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 Precautions (5.2) ]. |
| 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 Precautions (5.2) ]. |
| Ledipasvir and sofosbuvir | drug interactions | Hepatitis C Antiviral Agents: sofosbuvir/velpatasvir sofosbuvir/velpatasvir/ voxilaprevir ledipasvir/sofosbuvir ↑ tenofovir Monitor patients receiving tenofovir disoproxil fumarate concomitantly with EPCLUSA ® (sofosbuvir/velpatasvir) for adverse reactions associated with TDF. |
| 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 tenofovir disoproxil fumarate, use atazanavir given with ritonavir. ( 7.2 ) Coadministration of tenofovir disoproxil fumarate with certain HIV-1 protease inhibitors or certain drugs to treat HCV increases tenofovir concentrations. |
| Sofosbuvir and velpatasvir | drug interactions | Hepatitis C Antiviral Agents: sofosbuvir/velpatasvir sofosbuvir/velpatasvir/ voxilaprevir ledipasvir/sofosbuvir ↑ tenofovir Monitor patients receiving tenofovir disoproxil fumarate concomitantly with EPCLUSA ® (sofosbuvir/velpatasvir) for adverse reactions associated with TDF. |
| Sofosbuvir and velpatasvir and voxilaprevir | drug interactions | Hepatitis C Antiviral Agents: sofosbuvir/velpatasvir sofosbuvir/velpatasvir/ voxilaprevir ledipasvir/sofosbuvir ↑ tenofovir Monitor patients receiving tenofovir disoproxil fumarate concomitantly with EPCLUSA ® (sofosbuvir/velpatasvir) for adverse reactions associated with TDF. |
| 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 Precautions (5.2) ]. |
Every other medicine the tenofovir disoproxil label names
| Medicine named | Section | What the label says |
|---|---|---|
| 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 … |
Other labels that name tenofovir disoproxil
Source: FDA drug label (Tenofovir Disoproxil Fumarate), Aurobindo Pharma Limited, effective June 7, 2024 (SPL set a75c6be8-3719-4bb3-8a9e-06e5254d2a82), via openFDA; the full label on DailyMed
What do FAERS reports show for tenofovir disoproxil?
The FDA Adverse Event Reporting System holds 32,864 reports that list tenofovir disoproxil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,940 are coded as a death and 6,381 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 (12,182, against a median of 1,322 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 tenofovir disoproxil?
40 other medicines are given the same way (oral) and in the same FDA class as 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 |
|---|---|---|---|---|
| Entecavir | Hepatitis B | 16 labelers | $0.219 per tablet 0.5 mg tablet | No current entry |
| Lamivudine | HIV, Hepatitis B | 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 |
| 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 |
Every medicine labeled for the same conditions as tenofovir disoproxil
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to tenofovir disoproxil
- 40 medicines for the same use
- Other hepatitis b virus nucleoside analog reverse transcriptase inhibitors
- the pharmacologic class, with prices and generics
- Tenofovir disoproxil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other