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TENOFOVIR DISOPROXIL
TENOFOVIR DISOPROXIL is a drug. It is currently FDA-approved (first approved 2001).
At a glance
| Generic name | TENOFOVIR DISOPROXIL |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2001 |
Approved indications
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
- Nausea
- Depression
- Asthenia
- Dizziness
- Fever
- Abdominal pain
- Back pain
- Fatigue
Key clinical trials
- Spotting Syphilis: A Dual Point-of-Care Syphilis Screening Initiative in a Low-Resource Healthcare Setting (NA)
- A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062) (PHASE2, PHASE3)
- Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018) (PHASE3)
- Early Metabolic Effects of Dolutegravir or Tenofovir Alefenamide in Healthy Volunteers (PHASE2)
- ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention (NA)
- Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1 (PHASE2, PHASE3)
- 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)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- TENOFOVIR DISOPROXIL CI brief — competitive landscape report
- TENOFOVIR DISOPROXIL updates RSS · CI watch RSS
Frequently asked questions about TENOFOVIR DISOPROXIL
What is TENOFOVIR DISOPROXIL?
TENOFOVIR DISOPROXIL is a Small molecule drug.
When was TENOFOVIR DISOPROXIL approved?
TENOFOVIR DISOPROXIL was first approved on 2001.
What development phase is TENOFOVIR DISOPROXIL in?
TENOFOVIR DISOPROXIL is FDA-approved (marketed).
What are the side effects of TENOFOVIR DISOPROXIL?
Common side effects of TENOFOVIR DISOPROXIL include Rash, Diarrhea, Headache, Pain, Nausea, Depression.