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What the FDA labels say about taking them together

Sepiapterin and vardenafil

Sepiapterin's FDA label of April 24, 2026 names vardenafil in its drug interactions section; the vardenafil label PlainMeds reads does not name sepiapterin. The sepiapterin label: “Monitor for signs and symptoms of hypotension with concomitant use of SEPHIENCE with drugs that affect nitric oxide-mediated vasorelaxation.”

Check it at the source: the sepiapterin FDA label on DailyMed (effective April 24, 2026, PTC Therapeutics Inc.); the vardenafil FDA label on DailyMed (effective January 5, 2026, Zydus Pharmaceuticals USA Inc.).

What does the sepiapterin label say about vardenafil?

Sepiapterin label, drug interactions

Monitor for signs and symptoms of hypotension with concomitant use of SEPHIENCE with drugs that affect nitric oxide-mediated vasorelaxation (e.g., PDE-5 inhibitors such as sildenafil, vardenafil, or tadalafil).

Source: FDA drug label (Sephience), PTC Therapeutics Inc., effective April 24, 2026 (SPL set 32ac719c-49f0-4105-9c46-18c19583a5c2), via openFDA; the full label on DailyMed

What does the vardenafil label say about sepiapterin?

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

0Sepiapterin generic labelers
11Vardenafil generic labelers
SepiapterinVardenafil
Labeled forn/aErectile 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?