What the FDA labels say about taking them together
Fluvoxamine and ketoconazole
Fluvoxamine's FDA label of June 27, 2026 names ketoconazole in its drug interactions section; the ketoconazole label PlainMeds reads does not name fluvoxamine. The fluvoxamine label: “Pimozide is metabolized by the CYP3A4 isozyme and it has been demonstrated that ketoconazole, a potent inhibitor of CYP3A4, blocks the metabolism of this drug, resulting in increased plasma concentrations of parent drug.”
Check it at the source: the fluvoxamine FDA label on DailyMed (effective June 27, 2026, Zydus Pharmaceuticals USA Inc.); the ketoconazole FDA label on DailyMed (effective January 28, 2026, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC).
What does the fluvoxamine label say about ketoconazole?
Fluvoxamine label, drug interactionsThe metabolism of fluvoxamine has not been fully characterized and the effects of potent cytochrome P450 isoenzyme inhibition, such as the ketoconazole inhibition of CYP3A4, on fluvoxamine metabolism have not been studied.
Fluvoxamine label, warnings and precautionsPimozide is metabolized by the CYP3A4 isozyme and it has been demonstrated that ketoconazole, a potent inhibitor of CYP3A4, blocks the metabolism of this drug, resulting in increased plasma concentrations of parent drug.
Source: FDA drug label (Fluvoxamine Maleate, NDA021519), ANI Pharmaceuticals, Inc., effective August 4, 2025 (SPL set 7ecd83ec-88f5-4f85-9cc2-9068375d8820), via openFDA
Source: FDA drug label (Fluvoxamine maleate extended-release), Zydus Pharmaceuticals USA Inc., effective June 27, 2026 (SPL set 6c71d4f6-54b5-4d3a-8d2f-b7773c92c32e), via openFDA; the full label on DailyMed
What does the ketoconazole label say about fluvoxamine?
Ketoconazole's label (effective January 28, 2026) does not name fluvoxamine 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
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
| Fluvoxamine | Ketoconazole | |
|---|---|---|
| Labeled for | n/a | Fungal infections |
| Boxed warning | Yes | No |
| Pharmacy cost (NADAC) | $4.08 per capsule 100 mg capsule | $0.249 per gram 2% cream |
| 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