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What the FDA labels say about taking them together

Avanafil and cobicistat

Cobicistat's FDA label of February 10, 2026 names avanafil in its drug interactions section; the avanafil label PlainMeds reads does not name cobicistat. The cobicistat label: “Coadministration with avanafil is not recommended because a safe and effective avanafil dosage regimen has not been established. Coadministration with TYBOST coadministered with atazanavir or darunavir may result in an …”

Check it at the source: the avanafil FDA label on DailyMed (effective December 17, 2025, Camber Pharmaceuticals, Inc.); the cobicistat FDA label on DailyMed (effective February 10, 2026, Gilead Sciences, Inc.).

What does the avanafil label say about cobicistat?

Avanafil's label (effective December 17, 2025) does not name cobicistat in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (Avanafil), ANDA209266 (Hetero Labs Ltd V), as published by Camber Pharmaceuticals, Inc., effective December 17, 2025 (SPL set 1d04e17d-7399-430a-a8bb-fa1912b155e9), via openFDA; the full label on DailyMed

What does the cobicistat label say about avanafil?

Cobicistat label, drug interactions

Concomitant Drug Class/Drug Name: Phosphodiesterase-5 (PDE-5) Inhibitors: avanafil sildenafil tadalafil vardenafil; Potential Effect ↑ = Increase, ↓ = Decrease, ↔ = No change: ↑ PDE-5 inhibitors; Clinical Comment: Coadministration with avanafil is not recommended because a safe and effective avanafil dosage regimen has not been established. Coadministration with TYBOST coadministered with atazanavir or darunavir may result in an increase in PDE-5 inhibitor associated adverse events, including hypotension, syncope, visual disturbances, and priapism. …

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

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

1Avanafil generic labelers
0Cobicistat generic labelers
AvanafilCobicistat
Labeled forErectile dysfunctionHIV
Boxed warningNoNo
Pharmacy cost (NADAC)$50.00 per tablet 200 mg tabletn/a
Shortage nowNo current entryA presentation being discontinued

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

What next?