What the FDA labels say about taking them together
Ezetimibe and simvastatin
Simvastatin's FDA label of March 28, 2025 names ezetimibe in its drug interactions section; ezetimibe's label does not name simvastatin itself but warns about its class (Statins). The simvastatin label: “… with well-controlled LDL-C levels on simvastatin 40 mg/day with or without ezetimibe 10 mg/day, there was no incremental benefit on cardiovascular outcomes with the addition of lipid-modifying doses of niacin.”
Check it at the source: the ezetimibe FDA label on DailyMed (effective November 25, 2025, Organon LLC); the simvastatin FDA label on DailyMed (effective March 28, 2025, Organon LLC).
What does the ezetimibe label say about simvastatin?
Ezetimibe's label does not name simvastatin itself; it warns about its class (Statins):
Ezetimibe label, contraindicationsWhen used in combination with a statin, fenofibrate, or other LDL-C lowering therapy, ZETIA is contraindicated in patients for whom a statin, fenofibrate, or other LDL-C lowering therapy are contraindicated.
Ezetimibe label, warnings and precautionsAssociated with Combination Treatment with a Statin, Fenofibrate, or Other LDL-C Lowering Therapies If ZETIA is administered with a statin, fenofibrate, or other LDL-C lowering therapies, refer to the Prescribing Information of these products for a description of their risks including, but not limited to, the warnings and precautions [see Contraindications (4) ].
Source: FDA drug label (Zetia), Organon LLC, effective November 25, 2025 (SPL set 174e45e0-45bb-48b7-9e60-8f6cfc1d22bb), via openFDA; the full label on DailyMed
What does the simvastatin label say about ezetimibe?
Simvastatin label, drug interactionsNiacin Clinical Impact: Cases of myopathy and rhabdomyolysis have been observed with concomitant use of lipid modifying dosages of niacin-containing products (≥1 gram/day niacin) with ZOCOR. The risk of myopathy is greater in Chinese patients. … Intervention: Concomitant use of ZOCOR with lipid-modifying dosages of niacin is not recommended in Chinese patients [see ]. For non-Chinese patients, consider if the benefit of using lipid-modifying doses of niacin concomitantly with ZOCOR outweighs the increased risk of myopathy and rhabdomyolysis. …
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
| Ezetimibe | Simvastatin | |
|---|---|---|
| Labeled for | High cholesterol | Heart attack and coronary artery disease, High cholesterol, High triglycerides |
| Boxed warning | No | No |
| Pharmacy cost (NADAC) | $0.0667 per tablet 10 mg tablet | $0.0321 per tablet 20 mg tablet |
| Shortage now | No current entry | 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