Last reviewed 2026-04-20 · How we verify

TENOFOVIR DISOPROXIL FUMARATE

TENOFOVIR DISOPROXIL FUMARATE is a drug. It is currently FDA-approved (first approved 2001) for HIV-1 Infection, Chronic Hepatitis B.

Tenofovir Disoproxil Fumarate is a marketed antiretroviral drug primarily indicated for HIV-1 infection. Its key strength lies in its established market presence and the protection of its key composition patent, which expires in 2028. The primary risk is the eventual loss of patent protection, which could lead to increased competition from generic alternatives.

At a glance

Approved indications

• HIV-1 Infection
• Chronic Hepatitis B

Boxed warnings

• BOXED WARNING WARNING: POSTTREATMENT EXACERBATION OF HEPATITIS Severe acute exacerbations of hepatitis have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including tenofovir disoproxil fumarate tablets. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including tenofovir disoproxil fumarate tablets. If appropriate, resumption of anti-hepatitis B therapy may be warranted [See Warnings and Precautions ( 5.1 )]. WARNING: POSTTREATMENT EXACERBATION OF HEPATITIS See full prescribing information for complete boxed warning. Severe acute exacerbations of hepatitis have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including tenofovir disoproxil fumarate tablets. Hepatic function should be monitored closely in these patients. If appropriate, resumption of anti-hepatitis B therapy may be warranted. (5.1)

Common side effects

• rash
• diarrhea
• headache
• pain
• fever
• abdominal pain
• back pain
• asthenia
• nausea
• dyspepsia
• vomiting
• lipodystrophy

Drug interactions

• didanosine
• atazanavir
• HIV-1 protease inhibitors or certain drugs to treat HCV
• drugs affecting renal function (e.g., acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, high-dose or multiple NSAIDs)
• HEPSERA (adefovir dipivoxil)

Key clinical trials

• ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention (NA)
• A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010) (PHASE3)
• Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2, PHASE3)
• A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011) (PHASE3)
• Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men (PHASE2, PHASE3)
• Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention
• A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
• Antiviral Clinical Trial for Long Covid-19 (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• TENOFOVIR DISOPROXIL FUMARATE CI brief — competitive landscape report
• TENOFOVIR DISOPROXIL FUMARATE updates RSS · CI watch RSS

Frequently asked questions about TENOFOVIR DISOPROXIL FUMARATE

Related

• Indication: Drugs for HIV-1 Infection
• Indication: Drugs for Chronic Hepatitis B
• Compare: TENOFOVIR DISOPROXIL FUMARATE vs similar drugs
• Pricing: TENOFOVIR DISOPROXIL FUMARATE cost, discount & access