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What the FDA labels say about taking them together

Atorvastatin and ketoconazole

Atorvastatin's FDA label of April 15, 2024 names ketoconazole in its drug interactions section; the ketoconazole label PlainMeds reads does not name atorvastatin. The atorvastatin label: “Atorvastatin plasma levels were significantly increased with concomitant administration of LIPITOR with select azole antifungals or macrolide antibiotics, due to inhibition of CYP3A4 and/or transporters.”

Check it at the source: the atorvastatin FDA label on DailyMed (effective April 15, 2024, Viatris Specialty LLC); the ketoconazole FDA label on DailyMed (effective January 28, 2026, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC).

What does the atorvastatin label say about ketoconazole?

Atorvastatin label, drug interactions

Select Azole Antifungals or Macrolide Antibiotics Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of LIPITOR with select azole antifungals or macrolide antibiotics, due to inhibition of CYP3A4 and/or transporters. … and during upward dose titration of either drug. Examples: Erythromycin, clarithromycin, itraconazole, ketoconazole, posaconazole, and voriconazole.

Source: FDA drug label (Atorvaliq, NDA213260), CMP Pharma, Inc., effective April 27, 2024 (SPL set 41fca2d8-7f3f-45b9-8974-81b89accc211), via openFDA

Source: FDA drug label (Lipitor), NDA020702 (Upjohn), as published by Viatris Specialty LLC, effective April 15, 2024 (SPL set a60cc18b-0631-4cf0-b021-9f52224ece65), via openFDA; the full label on DailyMed

What does the ketoconazole label say about atorvastatin?

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

59Atorvastatin generic labelers
30Ketoconazole generic labelers
AtorvastatinKetoconazole
Labeled forHigh cholesterol, Angina, High triglycerides, Heart attack and coronary artery diseaseFungal infections
Boxed warningNoNo
Pharmacy cost (NADAC)$0.0228 per tablet 10 mg tablet$0.249 per gram 2% cream
Shortage nowNo current entryNo 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?