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What the FDA labels say about taking them together

Darunavir and vardenafil

Darunavir's FDA label of August 29, 2025 names vardenafil in its drug interactions section; the vardenafil label PlainMeds reads does not name darunavir. The darunavir label: “… dysfunction: Sildenafil at a single dose not exceeding 25 mg in 48 hours, vardenafil at a single dose not exceeding 2.5 mg dose in 72 hours, or tadalafil at a single dose not exceeding 10 mg dose in 72 hours can be used …”

Check it at the source: the darunavir FDA label on DailyMed (effective August 29, 2025, Janssen Products LP); the vardenafil FDA label on DailyMed (effective January 5, 2026, Zydus Pharmaceuticals USA Inc.).

What does the darunavir label say about vardenafil?

Darunavir label, drug interactions

Concomitant Drug Class Drug Name Examples: PDE-5 inhibitors: e.g. avanafil, sildenafil, tadalafil, vardenafil; Effect on Concentration of Darunavir Or Concomitant Drug: ↑ PDE-5 inhibitors (only the use of sildenafil at doses used for treatment of erectile dysfunction has been studied with PREZISTA/ritonavir); Clinical Comment: Co-administration with PREZISTA/ritonavir may result in an increase in PDE-5 inhibitor-associated adverse events, including hypotension, syncope, visual disturbances and priapism. …

Source: FDA drug label (PREZISTA), Janssen Products LP, effective August 29, 2025 (SPL set 814301f9-c990-46a5-b481-2879a521a16f), via openFDA; the full label on DailyMed

What does the vardenafil label say about darunavir?

Vardenafil's label (effective January 5, 2026) does not name darunavir in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (VARDENAFIL), Zydus Pharmaceuticals USA Inc., effective January 5, 2026 (SPL set 5876e062-e604-42a7-99c3-5da30b8dac06), 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

13Darunavir generic labelers
11Vardenafil generic labelers
DarunavirVardenafil
Labeled forHIVErectile dysfunction
Boxed warningNoNo
Pharmacy cost (NADAC)$1.16 per tablet 600 mg tablet$2.79 per tablet 20 mg tablet
Shortage nowNo current entryNo 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?