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What the FDA labels say about taking them together

Nitric oxide and sapropterin

Sapropterin's FDA label of August 26, 2024 names nitric oxide in its drug interactions section; the nitric oxide labels PlainMeds reads (2) do not name sapropterin. The sapropterin label: “Drugs Affecting Nitric Oxide‑Mediated Vasorelaxation Clinical Impact Both sapropterin dihydrochloride and PDE-5 inhibitors may induce vasorelaxation. A reduction in blood pressure could occur; …”

Check it at the source: the nitric oxide FDA label on DailyMed (effective December 11, 2025, VERO BIOTECH, INC.); the sapropterin FDA label on DailyMed (effective August 26, 2024, BioMarin Pharmaceutical Inc.).

What does the nitric oxide label say about sapropterin?

Nitric oxide's label (effective December 11, 2025) and its 1 other brand-application label do not name sapropterin in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (GENOSYL), VERO BIOTECH, INC., effective December 11, 2025 (SPL set c9560c54-9e28-4039-a4e5-5000c41c6c85), via openFDA; the full label on DailyMed

What does the sapropterin label say about nitric oxide?

Sapropterin label, drug interactions

Drugs Affecting Nitric Oxide‑Mediated Vasorelaxation (e.g., PDE-5 inhibitors such as sildenafil, vardenafil, or tadalafil) Clinical Impact Both sapropterin dihydrochloride and PDE-5 inhibitors may induce vasorelaxation. A reduction in blood pressure could occur; however, the combined use of these medications has not been evaluated in humans. Intervention Monitor blood pressure. Inhibitors of Folate Synthesis (e.g., methotrexate, valproic acid, phenobarbital, trimethoprim):

Source: FDA drug label (Kuvan), BioMarin Pharmaceutical Inc., effective August 26, 2024 (SPL set af38711e-8873-4790-a92d-4d583e23fb89), 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

3Nitric oxide generic labelers
9Sapropterin generic labelers
Nitric oxideSapropterin
Labeled forn/an/a
Boxed warningNoNo
Pharmacy cost (NADAC)n/an/a
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)

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