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What the FDA labels say about taking them together

Fosamprenavir and vardenafil

Fosamprenavir's FDA label of September 15, 2023 names vardenafil in its drug interactions section; the vardenafil label PlainMeds reads does not name fosamprenavir. The fosamprenavir label: “… Sildenafil: 25 mg every 48 hours. Tadalafil: no more than 10 mg every 72 hours. Vardenafil: no more than 2.5 mg every 24 hours. Fosamprenavir/ritonavir: Sildenafil: 25 mg every 48 hours. …”

Check it at the source: the fosamprenavir FDA label on DailyMed (effective September 15, 2023, Mylan Pharmaceuticals Inc.); the vardenafil FDA label on DailyMed (effective January 5, 2026, Zydus Pharmaceuticals USA Inc.).

What does the fosamprenavir label say about vardenafil?

Fosamprenavir label, drug interactions

Concomitant Drug Class/Drug Name: PDE5 inhibitors: Sildenafil, tadalafil, vardenafil; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Sildenafil ↑ Tadalafil ↑ Vardenafil; Clinical Comment: May result in an increase in PDE5 inhibitor-associated adverse events, including hypotension, syncope, visual disturbances, and priapism. Use of PDE5 inhibitors for pulmonary arterial hypertension (PAH): Use of sildenafil (REVATIO) is contraindicated when used for the treatment of PAH. A safe and effective dose has not been established when used with fosamprenavir. …

Source: FDA drug label (Fosamprenavir Calcium), Mylan Pharmaceuticals Inc., effective September 15, 2023 (SPL set 3a1424d8-844c-4e24-9ebd-b2c2b61b61a3), via openFDA; the full label on DailyMed

What does the vardenafil label say about fosamprenavir?

Vardenafil's label (effective January 5, 2026) does not name fosamprenavir 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

2Fosamprenavir generic labelers
11Vardenafil generic labelers
FosamprenavirVardenafil
Labeled forHIVErectile dysfunction
Boxed warningNoNo
Pharmacy cost (NADAC)n/a$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?