What the FDA labels say about taking them together
Fluvastatin and gemfibrozil
Fluvastatin's FDA label of April 21, 2025 names gemfibrozil in its drug interactions section, and gemfibrozil's label names fluvastatin too. The gemfibrozil label: “(D) OATP1B1 substrates: Gemfibrozil is an inhibitor of OATP1B1 transporter and may increase exposure of drugs that are substrates of OATP1B1.”
Check it at the source: the fluvastatin FDA label on DailyMed (effective April 21, 2025, Teva Pharmaceuticals USA, Inc.); the gemfibrozil FDA label on DailyMed (effective April 10, 2026, Northstar RxLLC).
What does the fluvastatin label say about gemfibrozil?
Fluvastatin label, drug interactionsDue to an increased risk of myopathy/rhabdomyolysis when HMG-CoA reductase inhibitors are coadministered with gemfibrozil, concomitant administration of fluvastatin sodium with gemfibrozil should be avoided.
Fluvastatin label, warnings and precautionsWARNINGS AND PRECAUTIONS Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with advanced age (≥ 65), uncontrolled hypothyroidism, renal impairment, and combination use with cyclosporine, or gemfibrozil.
Fluvastatin Sodium Er label (Sandoz Inc, January 31, 2024), drug interactionsClinical impact; There is an increased risk of myopathy/rhabdomyolysis when fluvastatin sodium extended-release tablets are administered with gemfibrozil
Fluvastatin Sodium Er label (Sandoz Inc, January 31, 2024), warnings and precautionsSteps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis Avoid concomitant use of fluvastatin sodium extended-release tablets with gemfibrozil, cyclosporin, and fluconazole.
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 gemfibrozil label say about fluvastatin?
Gemfibrozil label, drug interactions(D) OATP1B1 substrates: Gemfibrozil is an inhibitor of OATP1B1 transporter and may increase exposure of drugs that are substrates of OATP1B1 (e.g., atrasentan, atorvastatin, bosentan, ezetimibe, fluvastatin, glyburide, SN-38 [active metabolite of irinotecan], rosuvastatin, pitavastatin, pravastatin, rifampin, valsartan, olmesartan).
Source: FDA drug label (Gemfibrozil), Northstar RxLLC, effective April 10, 2026 (SPL set 75cac02c-56e3-4dfe-b1e2-4ce166b28833), 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
| Fluvastatin | Gemfibrozil | |
|---|---|---|
| Labeled for | High cholesterol | High cholesterol, Heart attack and coronary artery disease |
| Boxed warning | No | Yes |
| Pharmacy cost (NADAC) | $2.88 per tablet 80 mg tablet | $0.104 per tablet 600 mg tablet |
| Shortage now | A presentation being discontinued | A presentation being discontinued |
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