What the FDA labels say about taking them together
Itraconazole and simvastatin
Itraconazole's FDA label of July 13, 2026 names simvastatin in its boxed warning section, and simvastatin's label names itraconazole too. The simvastatin label: “Simvastatin is a substrate of CYP3A4. Concomitant use of strong CYP3A4 inhibitors with ZOCOR increases simvastatin exposure and increases the risk of myopathy and rhabdomyolysis, particularly with higher ZOCOR dosages.”
Check it at the source: the itraconazole FDA label on DailyMed (effective July 13, 2026, Janssen Pharmaceuticals, Inc.); the simvastatin FDA label on DailyMed (effective March 28, 2025, Organon LLC).
What does the itraconazole label say about simvastatin?
Itraconazole label, boxed warningSome examples of drugs that are contraindicated for coadministration with SPORANOX ® Capsules are: methadone, disopyramide, dofetilide, dronedarone, quinidine, isavuconazole, ergot alkaloids (such as dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine)), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ivabradine, ranolazine, eplerenone, cisapride, naloxegol, lomitapide, lovastatin, simvastatin, avanafil, ticagrelor, finerenone, voclosporin.
Itraconazole label, drug interactionsLipid-Lowering Drugs Lomitapide Lovastatin Simvastatin Contraindicated during and 2 weeks after SPORANOX ® treatment. Atorvastatin Monitor for drug adverse reactions.
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 simvastatin label say about itraconazole?
Simvastatin label, drug interactionsStrong CYP3A4 inhibitors Clinical Impact: Simvastatin is a substrate of CYP3A4. Concomitant use of strong CYP3A4 inhibitors with ZOCOR increases simvastatin exposure and increases the risk of myopathy and rhabdomyolysis, particularly with higher ZOCOR dosages. … ZOCOR during the course of strong CYP3A4 inhibitor treatment. Examples: Select azole anti-fungals (e.g., itraconazole, ketoconazole, posaconazole, and voriconazole), select macrolide antibiotics (e.g., erythromycin and clarithromycin), select HIV protease inhibitors (e.g., nelfinavir, ritonavir, and …
Source: FDA drug label (ZOCOR), Organon LLC, effective March 28, 2025 (SPL set 8f55d5de-5a4f-4a39-8c84-c53976dd6af9), 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
| Itraconazole | Simvastatin | |
|---|---|---|
| Labeled for | Fungal infections | Heart attack and coronary artery disease, High cholesterol, High triglycerides |
| Boxed warning | Yes | No |
| Pharmacy cost (NADAC) | $0.910 per capsule 100 mg capsule | $0.0321 per tablet 20 mg tablet |
| Shortage now | A presentation being discontinued | 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