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What the FDA labels say about taking them together

Itraconazole and riociguat

Itraconazole's FDA label of July 13, 2026 names riociguat in its drug interactions section, and riociguat's label names itraconazole too. The itraconazole label: “Aliskiren Riociguat Sildenafil Tadalafil Not recommended during and 2 weeks after TOLSURA treatment.”

Check it at the source: the itraconazole FDA label on DailyMed (effective July 13, 2026, Janssen Pharmaceuticals, Inc.); the riociguat FDA label on DailyMed (effective August 13, 2026, Bayer HealthCare Pharmaceuticals Inc.).

What does the itraconazole label say about riociguat?

Itraconazole label, drug interactions

Aliskiren Riociguat Sildenafil (for pulmonary hypertension) Tadalafil (for pulmonary hypertension) Not recommended during and 2 weeks after SPORANOX ® treatment.

Source: FDA drug label (Tolsura, NDA208901), Mayne Pharma Commercial LLC, effective April 23, 2025 (SPL set 306352d1-9d5a-49ad-b72d-893b99546861), via openFDA

Source: FDA drug label (SPORANOX), Janssen Pharmaceuticals, Inc., effective July 13, 2026 (SPL set a4d555fa-787c-40fb-bb7d-b0d4f7318fd0), via openFDA; the full label on DailyMed

What does the riociguat label say about itraconazole?

Riociguat label, drug interactions

Strong CYP and P-gp/BCRP inhibitors: Concomitant use of riociguat with strong cytochrome CYP inhibitors and P-gp/BCRP inhibitors such as azole antimycotics (for example, ketoconazole, itraconazole) or HIV protease inhibitors (such as ritonavir) increase riociguat exposure and may result in hypotension.

Source: FDA drug label (Adempas), Bayer HealthCare Pharmaceuticals Inc., effective August 13, 2026 (SPL set 7b57509a-3d5d-41d4-8fed-1471e26372a3), 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

11Itraconazole generic labelers
1Riociguat generic labelers
ItraconazoleRiociguat
Labeled forFungal infectionsPulmonary arterial hypertension
Boxed warningYesYes
Pharmacy cost (NADAC)$0.910 per capsule 100 mg capsulen/a
Shortage nowA presentation being discontinuedNo 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?