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What the FDA labels say about taking them together

Posaconazole and simvastatin

Posaconazole's FDA label of August 3, 2026 names simvastatin in its contraindications section, and simvastatin's label names posaconazole 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 posaconazole FDA label on DailyMed (effective August 3, 2026, Aurobindo Pharma Limited); the simvastatin FDA label on DailyMed (effective March 28, 2025, Organon LLC).

What does the posaconazole label say about simvastatin?

Posaconazole label, contraindications

Coadministration with the HMG-CoA reductase inhibitors that are primarily metabolized through CYP3A4 (e.g., atorvastatin, lovastatin, and simvastatin) is contraindicated since increased plasma concentration of these drugs can lead to rhabdomyolysis [see Drug Interactions (7.2) and Clinical Pharmacology (12.3) ].

Posaconazole label, drug interactions

Mechanism and Clinical Effect (s); Concomitant use of posaconazole with simvastatin increased simvastatin plasma concentrations which can lead to rhabdomyolysis [see ].

Source: FDA drug label (POSACONAZOLE), Aurobindo Pharma Limited, effective August 3, 2026 (SPL set f8a26673-261c-4e8e-b1e1-9e23aaf7f285), via openFDA; the full label on DailyMed

What does the simvastatin label say about posaconazole?

Simvastatin label, drug interactions

Strong 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. … 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 darunavir/ritonavir), select HCV …

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

27Posaconazole generic labelers
27Simvastatin generic labelers
PosaconazoleSimvastatin
Labeled forFungal infectionsHeart attack and coronary artery disease, High cholesterol, High triglycerides
Boxed warningNoNo
Pharmacy cost (NADAC)$2.03 per tablet 100 mg tablet$0.0321 per tablet 20 mg tablet
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?