Skip to main content

What the FDA labels say about taking them together

Fluvastatin and ketoconazole

Fluvastatin's FDA label of April 21, 2025 names ketoconazole in its warnings and precautions section; the ketoconazole label PlainMeds reads does not name fluvastatin. The fluvastatin label: “Caution should be exercised if a statin or other agent used to lower cholesterol levels is administered to patients receiving other drugs that may decrease the levels of endogenous steroid hormones.”

Check it at the source: the fluvastatin FDA label on DailyMed (effective April 21, 2025, Teva 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 fluvastatin label say about ketoconazole?

Fluvastatin label, warnings and precautions

Caution should be exercised if a statin or other agent used to lower cholesterol levels is administered to patients receiving other drugs (e.g., ketoconazole, spironolactone, cimetidine) that may decrease the levels of endogenous steroid hormones.

Source: FDA drug label (Fluvastatin), Teva Pharmaceuticals USA, Inc., effective April 21, 2025 (SPL set aad8b373-0aec-4efb-8e61-3d8114b31127), via openFDA; the full label on DailyMed

What does the ketoconazole label say about fluvastatin?

Ketoconazole's label (effective January 28, 2026) does not name fluvastatin 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

4Fluvastatin generic labelers
30Ketoconazole generic labelers
FluvastatinKetoconazole
Labeled forHigh cholesterolFungal infections
Boxed warningNoNo
Pharmacy cost (NADAC)$2.88 per tablet 80 mg tablet$0.249 per gram 2% cream
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?