What the FDA labels say about taking them together
Avanafil and hydralazine/isosorbide dinitrate
Hydralazine/isosorbide dinitrate's FDA label of November 30, 2025 names avanafil in its contraindications section; avanafil's label does not name hydralazine/isosorbide dinitrate itself but warns about its class (nitrate vasodilators). The hydralazine/isosorbide dinitrate label: “Do not use BiDil in patients who are taking PDE-5 inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil.”
Check it at the source: the avanafil FDA label on DailyMed (effective December 17, 2025, Camber Pharmaceuticals, Inc.); the hydralazine/isosorbide dinitrate FDA label on DailyMed (effective November 30, 2025, Azurity Pharmaceuticals, Inc.).
What does the avanafil label say about hydralazine/isosorbide dinitrate?
Avanafil's label does not name hydralazine/isosorbide dinitrate itself; it warns about its class (nitrate vasodilators):
Avanafil label, contraindicationsAdministration of avanafil tablet to patients using any form of organic nitrate is contraindicated
Avanafil label, contraindicationsAdministration of avanafil tablets with any form of organic nitrates, either regularly and/or intermittently, is contraindicated.
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 hydralazine/isosorbide dinitrate label say about avanafil?
Hydralazine/isosorbide dinitrate label, contraindicationsDo not use BiDil in patients who are taking PDE-5 inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil.
Hydralazine/isosorbide dinitrate label, drug interactionsDRUG INTERACTIONS 7.1 Phosphodiesterase Inhibitors BiDil is contraindicated in patients who are using a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5), PDE5 inhibitors such as avanafil, sildenafil, vardenafil, and tadalafil have been shown to potentiate the hypotensive effects of organic nitrates.
Source: FDA drug label (BiDil), Azurity Pharmaceuticals, Inc., effective November 30, 2025 (SPL set e1e63cd5-d1e4-4af5-bad5-1ad41ea46b00), 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
| Avanafil | Hydralazine/isosorbide dinitrate | |
|---|---|---|
| Labeled for | Erectile dysfunction | Heart failure |
| Boxed warning | No | No |
| Pharmacy cost (NADAC) | $50.00 per tablet 200 mg tablet | $0.714 per tablet 20-37.5 mg tablet |
| Shortage now | No current entry | No 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?
- Check more medicines together
- up to five at once