Skip to main content

What the FDA labels say about taking them together

Cobicistat and tenofovir disoproxil

Cobicistat's FDA label of February 10, 2026 names tenofovir disoproxil in its warnings and precautions section, and tenofovir disoproxil's label names cobicistat too. The tenofovir disoproxil label: “… without an HIV-1 protease inhibitor/ritonavir or an HIV-1 protease inhibitor/cobicistat combination, for adverse reactions associated with TDF. …”

Check it at the source: the cobicistat FDA label on DailyMed (effective February 10, 2026, Gilead Sciences, Inc.); the tenofovir disoproxil FDA label on DailyMed (effective June 7, 2024, Aurobindo Pharma Limited).

What does the cobicistat label say about tenofovir disoproxil?

Cobicistat label, warnings and precautions

Onset or Worsening Renal Impairment When Used with Tenofovir Disoproxil Fumarate Renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported when TYBOST was used in an antiretroviral regimen that contained TDF.

Source: FDA drug label (Tybost), Gilead Sciences, Inc., effective February 10, 2026 (SPL set 3784c35c-e87f-410c-900b-8fd6313c6010), via openFDA; the full label on DailyMed

What does the tenofovir disoproxil label say about cobicistat?

Tenofovir disoproxil label, drug interactions

Concomitant Drug Class/Drug Name: Hepatitis C Antiviral Agents: sofosbuvir/velpatasvir sofosbuvir/velpatasvir/ voxilaprevir ledipasvir/sofosbuvir; Effect on Concentration b: ↑ tenofovir; Clinical Comment: Monitor patients receiving tenofovir disoproxil fumarate concomitantly with EPCLUSA ® (sofosbuvir/velpatasvir) for adverse reactions associated with TDF. Monitor patients receiving tenofovir disoproxil fumarate concomitantly with HARVONI ® (ledipasvir/sofosbuvir) without an HIV-1 protease inhibitor/ritonavir or an HIV-1 protease inhibitor/cobicistat combination, for adverse reactions associated with TDF. …

Viread label (Gilead Sciences, Inc., February 18, 2025), drug interactions

Concomitant Drug Class/Drug Name: ledipasvir/sofosbuvir; Effect on Concentration ↑=Increase, ↓=Decrease: Monitor patients receiving VIREAD concomitantly with 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 VIREAD concomitantly with HARVONI and an HIV-1 protease inhibitor/ritonavir or an HIV-1 protease inhibitor/cobicistat combination, consider an alternative HCV or antiretroviral therapy, as the safety of increased tenofovir concentrations in this setting has not been established. …

Source: FDA drug label (Viread, NDA021356), Gilead Sciences, Inc., effective February 18, 2025 (SPL set 33fd6418-fbdc-42ca-a50d-ce2a476a5418), via openFDA

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

These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.

Both medicines on the record

0Cobicistat generic labelers
15Tenofovir disoproxil generic labelers
CobicistatTenofovir disoproxil
Labeled forHIVHIV, Hepatitis B
Boxed warningNoYes
Pharmacy cost (NADAC)n/a$0.294 per tablet 300 mg tablet
Shortage nowA presentation being discontinuedNo current entry

Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)

What next?