Molecule
Tenofovir disoproxil is a hepatitis B virus nucleoside analog reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults, among other approved uses. MedsAcross supplies Tenofovir disoproxil for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
VIREAD 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. for the treatment of chronic hepatitis B in adults and pediatric patients 2 years and older weighing at least 10 kg.
Source: US FDA prescribing information
Tenofovir disoproxil fumarate is an antiviral drug.
Source: US FDA prescribing information
Testing: Prior to or when initiating VIREAD test for hepatitis B virus infection and HIV-1 infection. Prior to initiation and during use of VIREAD, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorous. Recommended tablet dosage in adults and pediatric patients weighing at least 35 kg: One VIREAD 300 mg tablet once daily taken orally without regard to food. Recommended dosage in pediatric patients at least 2 years of age and adults: Tablets: For patients weighing at least 17 kg who can swallow an intact tablet, one VIREAD tablet (150 mg, 200 mg, 250 mg, or 300 mg based on body weight) once daily taken orally without regard to food.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Boxed warning (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 VIREAD. 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 VIREAD. New onset or worsening renal impairment: Can include acute renal failure and Fanconi syndrome. Avoid administering VIREAD with concurrent or recent use of nephrotoxic drugs. HIV testing: HIV antibody testing should be offered to all HBV-infected patients before initiating therapy with VIREAD. VIREAD should only be used as part of an appropriate antiretroviral combination regimen in HIV-infected patients with or without HBV coinfection.
Source: US FDA prescribing information
The following adverse reactions are discussed in other sections of the labeling: Severe Acute Exacerbation of Hepatitis B in Patients with HBV Infection. New Onset or Worsening Renal Impairment. Immune Reconstitution Syndrome. Bone Loss and Mineralization Defects. Lactic Acidosis/Severe Hepatomegaly with Steatosis. In HIV-infected adult subjects: Most common adverse reactions (incidence greater than or equal to 10%, Grades 2–4) were rash, diarrhea, nausea, headache, pain, depression, and asthenia. In HBV-infected subjects with compensated liver disease: Most common adverse reaction (all grades) was nausea (9%). In HBV-infected subjects with decompensated liver disease: Most common adverse reactions (incidence greater than or equal to 10%, all grades) were abdominal pain, nausea, insomnia, pruritus, vomiting, dizziness, and pyrexia.
Source: US FDA prescribing information
Tenofovir disoproxil fumarate increases didanosine concentrations. Dose reduction and close monitoring for didanosine toxicity are warranted. Coadministration decreases atazanavir concentrations. When coadministered with VIREAD, use atazanavir given with ritonavir. Coadministration of VIREAD with certain HIV-1 protease inhibitors or certain drugs to treat HCV increases tenofovir concentrations. Monitor for evidence of tenofovir toxicity. Consult Full Prescribing Information prior to and during treatment for important drug interactions.
Source: US FDA prescribing information
Store VIREAD tablets and oral powder at 25 °C (77 °F), excursions permitted to 15–30 °C (59–86 °F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
9 presentations of Tenofovir disoproxil, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Tenofovir disoproxil 300 mg tabletOralGeneric name | — | US FDA | Available on request |
| Tenofovir disoproxil 150 mg tabletOralGeneric name | — | US FDA | Available on request |
| Tenofovir disoproxil 200 mg tabletOralGeneric name | — | US FDA | Available on request |
| Tenofovir disoproxil 250 mg tabletOralGeneric name | — | US FDA | Available on request |
| Viread 150 mg tabletOral | Gilead Sciences | US FDA | Available on request |
| Viread 200 mg tabletOral | Gilead Sciences | US FDA | Available on request |
| Viread 250 mg tabletOral | Gilead Sciences | US FDA | Available on request |
| Viread 300 mg tabletOral | Gilead Sciences | US FDA | Available on request |
| Viread 40 mg/g oral powderOral | Gilead Sciences | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Tenofovir disoproxil in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 9 presentations of Tenofovir disoproxil and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Tenofovir disoproxil, including Viread.
Yes. The US FDA first approved Tenofovir disoproxil on 26 October 2001, according to Drugs@FDA.
Yes. Tenofovir disoproxil has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Tenofovir disoproxil is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tenofovir disoproxil is classified under ATC code J05AF07 (Tenofovir disoproxil).
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