What the FDA labels say about taking them together
Ketoconazole and tolvaptan
Tolvaptan's FDA label of May 7, 2026 names ketoconazole in its drug interactions section; the ketoconazole label PlainMeds reads does not name tolvaptan. The tolvaptan label: “Inhibitors of CYP3A Concomitant use of JYNARQUE with drugs that are moderate or strong CYP3A inhibitors increases tolvaptan exposure.”
Check it at the source: the ketoconazole FDA label on DailyMed (effective January 28, 2026, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC); the tolvaptan FDA label on DailyMed (effective May 7, 2026, Otsuka America Pharmaceutical, Inc.).
What does the ketoconazole label say about tolvaptan?
Ketoconazole's label (effective January 28, 2026) does not name tolvaptan in these sections. A label lists what its studies and reports found; it is not a complete list.
Source: FDA drug label (ketoconazole), E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective January 28, 2026 (SPL set cad7c647-34a9-4e4e-83b3-8d78e58f588f), via openFDA; the full label on DailyMed
What does the tolvaptan label say about ketoconazole?
Tolvaptan label, drug interactionsAngiotensin receptor blockers Angiotensin converting enzyme inhibitors Potassium sparing diuretics 7.1 CYP3A Inhibitors and Inducers Strong CYP3A Inhibitors Tolvaptan's AUC was 5.4 times as large and C max was 3.5 times as large after co-administration of tolvaptan and 200 mg ketoconazole [see Warnings and Precautions (5.5) and Clinical Pharmacology (12.3) ].
Jynarque label (Otsuka America Pharmaceutical, Inc., November 6, 2025), drug interactionsInhibitors and Inducers CYP3A Inhibitors Tolvaptan's AUC was 5.4 times as large and Cmax was 3.5 times as large after co-administration of tolvaptan and 200 mg ketoconazole [see Warnings and Precautions (5.4) and Clinical Pharmacology (12.3) ].
Jynarque label (Otsuka America Pharmaceutical, Inc., November 6, 2025), warnings and precautionsInhibitors of CYP3A Concomitant use of JYNARQUE with drugs that are moderate or strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, lopinavir/ritonavir, indinavir/ritonavir, ritonavir, and conivaptan) increases tolvaptan exposure [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ].
Source: FDA drug label (Jynarque, NDA204441), Otsuka America Pharmaceutical, Inc., effective November 6, 2025 (SPL set 3febc0a1-9e5a-4ce0-843d-210f21d862c4), via openFDA
Source: FDA drug label (SAMSCA), Otsuka America Pharmaceutical, Inc., effective May 7, 2026 (SPL set 5526617c-c7b9-4556-886d-729bbabbc566), 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
| Ketoconazole | Tolvaptan | |
|---|---|---|
| Labeled for | Fungal infections | n/a |
| Boxed warning | No | Yes |
| Pharmacy cost (NADAC) | $0.249 per gram 2% cream | $14.57 per tablet 15 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