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What the FDA labels say about taking them together

Leflunomide and rosuvastatin

Leflunomide's FDA label of June 4, 2025 names rosuvastatin in its drug interactions section; the rosuvastatin labels PlainMeds reads (2) do not name leflunomide. The leflunomide label: “The dose of rosuvastatin should not exceed 10 mg once daily in patients taking ARAVA. Effect of Potent CYP and Transporter Inducers Leflunomide is metabolized by CYP450 metabolizing enzymes.”

Check it at the source: the leflunomide FDA label on DailyMed (effective June 4, 2025, sanofi-aventis U.S. LLC); the rosuvastatin FDA label on DailyMed (effective September 4, 2026, ScieGen Pharmaceuticals, Inc.).

What does the leflunomide label say about rosuvastatin?

Leflunomide label, drug interactions

The dose of rosuvastatin should not exceed 10 mg once daily in patients taking ARAVA. ( 7 ) Effect of Potent CYP and Transporter Inducers Leflunomide is metabolized by CYP450 metabolizing enzymes.

Source: FDA drug label (Arava), sanofi-aventis U.S. LLC, effective June 4, 2025 (SPL set 320f63f2-fac3-4aee-aff8-85724e00ef52), via openFDA; the full label on DailyMed

What does the rosuvastatin label say about leflunomide?

Rosuvastatin's label (effective September 4, 2026) and its 1 other brand-application label do not name leflunomide in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (Rosuvastatin), ScieGen Pharmaceuticals, Inc., effective September 4, 2026 (SPL set ee4933c5-0d97-494d-ac0f-2083e0100836), 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

16Leflunomide generic labelers
45Rosuvastatin generic labelers
LeflunomideRosuvastatin
Labeled forRheumatoid arthritisHeart attack and coronary artery disease, High cholesterol, High triglycerides, Stroke prevention
Boxed warningYesNo
Pharmacy cost (NADAC)$0.324 per tablet 10 mg tablet$0.0692 per tablet 40 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?