Skip to main content

What the FDA labels say about taking them together

Fluvastatin and warfarin

Fluvastatin's FDA label of April 21, 2025 names warfarin in its drug interactions section, and warfarin's label names fluvastatin too. The fluvastatin label: “Monitor plasma phenytoin levels when fluvastatin treatment is initiated or when the dosage is changed Warfarin and coumarin derivates:”

Check it at the source: the fluvastatin FDA label on DailyMed (effective April 21, 2025, Teva Pharmaceuticals USA, Inc.); the warfarin FDA label on DailyMed (effective May 29, 2026, Amneal Pharmaceuticals LLC).

What does the fluvastatin label say about warfarin?

Fluvastatin label, drug interactions

Monitor plasma phenytoin levels when fluvastatin treatment is initiated or when the dosage is changed ( 7 ) Warfarin and coumarin derivates:

Fluvastatin Sodium Er label (Sandoz Inc, January 31, 2024), drug interactions

Clinical impact; There are postmarketing reports of clinically evident bleeding and/or increased INR in patients taking concomitant statins and warfarin.

Source: FDA drug label (Fluvastatin Sodium Er, NDA021192), Sandoz Inc, effective January 31, 2024 (SPL set 5ab4296c-87c2-4c64-b218-d620eef51310), via openFDA

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 warfarin label say about fluvastatin?

Warfarin label, drug interactions

Closely monitor INR if a concomitant drug is a CYP2C9, 1A2, and/or 3A4 inhibitor or inducer. Examples of CYP450 Interactions with Warfarin Enzyme Inhibitors Inducers CYP2C9 amiodarone, capecitabine, cotrimoxazole, etravirine, fluconazole, fluvastatin, fluvoxamine, metronidazole, miconazole, oxandrolone, sulfinpyrazone, tigecycline, voriconazole, zafirlukast aprepitant, bosentan, carbamazepine, phenobarbital, rifampin CYP1A2 acyclovir, allopurinol, caffeine, cimetidine, ciprofloxacin, disulfiram, enoxacin, famotidine, fluvoxamine, methoxsalen, mexiletine, norfloxacin, oral contraceptives, phenylpropanolamine, propafenone, propranolol, terbinafine, thiabendazole, ticlopidine, verapamil …

Source: FDA drug label (Warfarin Sodium), Amneal Pharmaceuticals LLC, effective May 29, 2026 (SPL set 558b7a0d-5490-4c1b-802e-3ab3f1efe760), 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
19Warfarin generic labelers
FluvastatinWarfarin
Labeled forHigh cholesterolBlood clots (DVT and PE), Atrial fibrillation
Boxed warningNoYes
Pharmacy cost (NADAC)$2.88 per tablet 80 mg tablet$0.093 per tablet 2 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?