Prescription medicine
Ezetimibe and simvastatin Brand names: Vytorin
Ezetimibe and simvastatin (Vytorin) is a prescription medicine with an FDA approval on record since 2004. FDA's NDC Directory lists it from 7 generic labelers, and pharmacies paid $0.285 per unit (Ezetimibe-simvastatin 10-80 mg) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the ezetimibe and simvastatin FDA label on DailyMed (effective January 21, 2026, Organon LLC); the NDA 21687 record on Drugs@FDA; every ezetimibe and simvastatin label on DailyMed.
Highlights of the record
FDA label of January 21, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageVYTORIN VYTORIN ® is a combination of simvastatin and ezetimibe indicated: As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia.
Forms and strengths
- 10 mg / 40 mg
- 10 mg / 80 mg
- 10 mg / 10 mg
- 10 mg / 20 mg
Tablet.
On the market
- Earliest approval on file
- July 23, 2004 Vytorin, Organon; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first April 26, 2017; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 8 of which 7 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.285 per unit Ezetimibe-simvastatin 10-80 mg
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 10 since 2019 0 Class I among all firms' recalls; latest May 19, 2025
- FAERS reports
- 15,110 through July 30, 2026
What is ezetimibe and simvastatin used for?
From the label: indications and usageVYTORIN VYTORIN ® is a combination of simvastatin and ezetimibe indicated: As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). […]
Conditions named in the indications of ezetimibe and simvastatin's FDA labels, with every medicine labeled for each:
From other ezetimibe and simvastatin labelsHeart attack and coronary artery disease: Simvastatin Simvastatin, when used as a component of VYTORIN, is indicated to reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and …
FDA pharmacologic class: Dietary Cholesterol Absorption Inhibitor and HMG-CoA Reductase Inhibitor.
Source: FDA drug label (VYTORIN), Organon LLC, effective January 21, 2026 (SPL set 89b860d2-de83-468e-b7e8-76aeec2edca2), via openFDA; the full label on DailyMed
Is there a generic for ezetimibe and simvastatin (Vytorin)?
The FDA approved the first generic ezetimibe and simvastatin on April 26, 2017. 9 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists ezetimibe and simvastatin from 7 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2004 earliest approval on file
- 2017 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ezetimibe and simvastatin (Vytorin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.285 per unit (Ezetimibe-simvastatin 10-80 mg), down 35% from $0.440 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Ezetimibe-simvastatin 10-80 mg (generic)
- Vytorin 10-20 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ezetimibe-simvastatin 10-10 mg | Generic | $0.274 per unit | n/a | -10% |
| Ezetimibe-simvastatin 10-20 mg | Generic | $0.199 per unit | n/a | -49% |
| Ezetimibe-simvastatin 10-40 mg | Generic | $0.183 per unit | n/a | -64% |
| Ezetimibe-simvastatin 10-80 mg | Generic | $0.285 per unit | n/a | -35% |
| Vytorin 10-20 mg tablet | Brand | $13.62 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $408.62 | +3% |
| Vytorin 10-40 mg tablet | Brand | $13.80 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $413.85 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has ezetimibe and simvastatin been recalled?
The FDA's Enforcement Report lists 10 recalls naming ezetimibe and simvastatin since 2019: 0 Class I (the most serious), 9 Class II, 1 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 19, 2025 | Class III | Glenmark Pharmaceuticals Inc., USA | Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during … |
| October 14, 2021 | Class II | Golden State Medical Supply Inc. | Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some … |
| October 14, 2021 | Class II | Golden State Medical Supply Inc. | Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity |
| October 5, 2021 | Class II | Dr. Reddy's Laboratories, Inc. | Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity |
| October 5, 2021 | Class II | Dr. Reddy's Laboratories, Inc. | Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some … |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| January 15, 2019 | Class II | Dr. Reddy's Laboratories, Inc. | Presence of Foreign Substance: Product complaint of black speckles observed on tablets. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ezetimibe and simvastatin label say about other medicines?
The ezetimibe and simvastatin label names 27 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | drug interactions | Amiodarone, Dronedarone, Ranolazine, or Calcium Channel Blockers Clinical Impact: The risk of myopathy and rhabdomyolysis is increased by concomitant use of amiodarone, dronedarone, ranolazine, or calcium channel blockers with VYTORIN. Intervention: For patients taking verapamil, diltiazem, or dronedarone, do not exceed VYTORIN 10/10 mg daily. For patients taking amiodarone, amlodipine, or ranolazine, do not exceed VYTORIN 10/20 mg daily [see ]. |
| Amlodipine | drug interactions | For patients taking amiodarone, amlodipine, or ranolazine, do not exceed VYTORIN 10/20 mg daily [see Dosage and Administration (2.3) ]. |
| Cholestyramine | drug interactions | Bile Acid Sequestrants Clinical Impact: Concomitant cholestyramine administration decreased the mean exposure of total ezetimibe approximately 55%. The incremental LDL-C reduction due to adding VYTORIN to cholestyramine may be reduced by this interaction. Intervention: In patients taking a bile acid sequestrant, administer VYTORIN at least 2 hours before or at least 4 hours after cholestyramine [see ]. |
| Clarithromycin | drug interactions | Strong CYP3A4 inhibitors Clinical Impact: Simvastatin is a substrate of CYP3A4. Concomitant use of strong CYP3A4 inhibitors with VYTORIN increases simvastatin exposure and increases the risk of myopathy and rhabdomyolysis, particularly with higher VYTORIN dosages. … posaconazole, and voriconazole), select macrolide antibiotics (e.g., erythromycin and clarithromycin, telithromycin), select HIV protease inhibitors (e.g., nelfinavir, ritonavir, and darunavir/ritonavir), select HCV … |
| Colchicine | drug interactions | Colchicine Clinical Impact: Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with VYTORIN. Intervention: Consider if the benefit of using colchicine concomitantly with VYTORIN outweighs the increased risk of myopathy and rhabdomyolysis. … |
| Cyclosporine | contraindications | Concomitant use of strong CYP3A4 inhibitors (select azole anti-fungals, macrolide antibiotics, anti-viral medications and nefazodone). ( 4 ) Concomitant use of cyclosporine, danazol or gemfibrozil. ( 4 ) Acute liver failure or decompensated cirrhosis. … |
| Danazol | contraindications | Concomitant use of strong CYP3A4 inhibitors (select azole anti-fungals, macrolide antibiotics, anti-viral medications and nefazodone). ( 4 ) Concomitant use of cyclosporine, danazol or gemfibrozil. ( 4 ) Acute liver failure or decompensated cirrhosis. … |
| Daptomycin | drug interactions | Clinical Impact: Cases of rhabdomyolysis have been reported with simvastatin administered with daptomycin. Both VYTORIN and daptomycin can cause myopathy and rhabdomyolysis when given alone and the risk of myopathy and rhabdomyolysis may be increased by … Intervention: If treatment with daptomycin is required, consider temporarily suspending VYTORIN during the course of daptomycin treatment. |
| Darunavir | drug interactions | Strong CYP3A4 inhibitors Clinical Impact: Simvastatin is a substrate of CYP3A4. Concomitant use of strong CYP3A4 inhibitors with VYTORIN increases simvastatin exposure and increases the risk of myopathy and rhabdomyolysis, particularly with higher VYTORIN dosages. … telithromycin), select HIV protease inhibitors (e.g., nelfinavir, ritonavir, and darunavir/ritonavir), select HCV protease inhibitors (e.g., boceprevir and telaprevir), cobicistat-containing products, and nefazodone. |
| Digoxin | drug interactions | Digoxin Clinical Impact: Concomitant use of digoxin with VYTORIN may result in elevated plasma digoxin concentrations. Intervention: Monitor digoxin levels in patients taking digoxin when VYTORIN is initiated. |
| Diltiazem | drug interactions | Amiodarone, Dronedarone, Ranolazine, or Calcium Channel Blockers Clinical Impact: The risk of myopathy and rhabdomyolysis is increased by concomitant use of amiodarone, dronedarone, ranolazine, or calcium channel blockers with VYTORIN. Intervention: For patients taking verapamil, diltiazem, or dronedarone, do not exceed VYTORIN 10/10 mg daily. For patients taking amiodarone, amlodipine, or ranolazine, do not exceed VYTORIN 10/20 mg daily [see ]. |
| Dronedarone | drug interactions | Amiodarone, Dronedarone, Ranolazine, or Calcium Channel Blockers Clinical Impact: The risk of myopathy and rhabdomyolysis is increased by concomitant use of amiodarone, dronedarone, ranolazine, or calcium channel blockers with VYTORIN. Intervention: For patients taking verapamil, diltiazem, or dronedarone, do not exceed VYTORIN 10/10 mg daily. For patients taking amiodarone, amlodipine, or ranolazine, do not exceed VYTORIN 10/20 mg daily [see ]. |
| Erythromycin | drug interactions | Strong CYP3A4 inhibitors Clinical Impact: Simvastatin is a substrate of CYP3A4. Concomitant use of strong CYP3A4 inhibitors with VYTORIN increases simvastatin exposure and increases the risk of myopathy and rhabdomyolysis, particularly with higher VYTORIN dosages. … ketoconazole, posaconazole, and voriconazole), select macrolide antibiotics (e.g., erythromycin and clarithromycin, telithromycin), select HIV protease inhibitors (e.g., nelfinavir, ritonavir, and darunavir/ritonavir) … |
| Fenofibrate | drug interactions | If cholelithiasis is suspected in a patient receiving ezetimibe and a fenofibrate, gallbladder studies are indicated and alternative lipid-lowering therapy should be considered. |
Every other medicine the ezetimibe and simvastatin label names
| Medicine named | Section | What the label says |
|---|---|---|
| Fenofibric acid | drug interactions | Clinical Impact: Both ezetimibe and fenofibrates may increase cholesterol excretion into the bile, leading to cholelithiasis. … therapy should be considered [see the product labeling for fenofibrate and fenofibric acid]. |
| Gemfibrozil | contraindications | … and nefazodone). ( 4 ) Concomitant use of cyclosporine, danazol or gemfibrozil. ( 4 ) Acute liver failure or decompensated cirrhosis. … |
| Itraconazole | drug interactions | Strong CYP3A4 inhibitors Clinical Impact: Simvastatin is a substrate of CYP3A4. Concomitant use of strong CYP3A4 inhibitors with VYTORIN increases simvastatin exposure and increases the risk of myopathy and rhabdomyolysis, particularly with higher VYTORIN 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 … |
| Ketoconazole | drug interactions | Strong CYP3A4 inhibitors Clinical Impact: Simvastatin is a substrate of CYP3A4. Concomitant use of strong CYP3A4 inhibitors with VYTORIN increases simvastatin exposure and increases the risk of myopathy and rhabdomyolysis, particularly with higher VYTORIN dosages. … inhibitor treatment. Examples: Select azole anti-fungals (e.g., itraconazole, ketoconazole, posaconazole, and voriconazole), select macrolide antibiotics (e.g., erythromycin and clarithromycin, telithromycin), select … |
| Lomitapide | drug interactions | Clinical Impact: Simvastatin exposure is approximately doubled with concomitant use of lomitapide and the risk of myopathy and rhabdomyolysis is increased. Intervention: Reduce the dose of VYTORIN by 50% if initiating lomitapide. Do not exceed VYTORIN 10/20 mg daily (or VYTORIN 10/40 mg daily for patients who have previously taken VYTORIN 10/80 mg daily chronically) while … |
| Nefazodone | contraindications | … azole anti-fungals, macrolide antibiotics, anti-viral medications, and nefazodone) [see Drug Interactions (7.1) ]. |
| Nelfinavir | drug interactions | Strong CYP3A4 inhibitors Clinical Impact: Simvastatin is a substrate of CYP3A4. Concomitant use of strong CYP3A4 inhibitors with VYTORIN increases simvastatin exposure and increases the risk of myopathy and rhabdomyolysis, particularly with higher VYTORIN dosages. … and clarithromycin, telithromycin), select HIV protease inhibitors (e.g., nelfinavir, ritonavir, and darunavir/ritonavir), select HCV protease inhibitors (e.g., boceprevir and telaprevir), cobicistat-containing … |
| Niacin | drug interactions | Niacin 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 VYTORIN. The risk of myopathy is greater in Chinese patients. … Intervention: Concomitant use of VYTORIN 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 … |
| Posaconazole | drug interactions | Strong CYP3A4 inhibitors Clinical Impact: Simvastatin is a substrate of CYP3A4. Concomitant use of strong CYP3A4 inhibitors with VYTORIN increases simvastatin exposure and increases the risk of myopathy and rhabdomyolysis, particularly with higher VYTORIN dosages. … treatment. Examples: Select azole anti-fungals (e.g., itraconazole, ketoconazole, posaconazole, and voriconazole), select macrolide antibiotics (e.g., erythromycin and clarithromycin, telithromycin), select HIV protease … |
| Ranolazine | drug interactions | Amiodarone, Dronedarone, Ranolazine, or Calcium Channel Blockers Clinical Impact: The risk of myopathy and rhabdomyolysis is increased by concomitant use of amiodarone, dronedarone, ranolazine, or calcium channel blockers with VYTORIN. Intervention: For patients taking verapamil, diltiazem, or dronedarone, do not exceed VYTORIN 10/10 mg daily. For patients taking amiodarone, amlodipine, or ranolazine, do not exceed VYTORIN 10/20 mg daily [see ]. |
| Ritonavir | drug interactions | Strong CYP3A4 inhibitors Clinical Impact: Simvastatin is a substrate of CYP3A4. Concomitant use of strong CYP3A4 inhibitors with VYTORIN increases simvastatin exposure and increases the risk of myopathy and rhabdomyolysis, particularly with higher VYTORIN dosages. … clarithromycin, telithromycin), select HIV protease inhibitors (e.g., nelfinavir, ritonavir, and darunavir/ritonavir), select HCV protease inhibitors (e.g., boceprevir and telaprevir), cobicistat-containing products … |
| Verapamil | drug interactions | Amiodarone, Dronedarone, Ranolazine, or Calcium Channel Blockers Clinical Impact: The risk of myopathy and rhabdomyolysis is increased by concomitant use of amiodarone, dronedarone, ranolazine, or calcium channel blockers with VYTORIN. Intervention: For patients taking verapamil, diltiazem, or dronedarone, do not exceed VYTORIN 10/10 mg daily. For patients taking amiodarone, amlodipine, or ranolazine, do not exceed VYTORIN 10/20 mg daily [see ]. |
| Voriconazole | drug interactions | Strong CYP3A4 inhibitors Clinical Impact: Simvastatin is a substrate of CYP3A4. Concomitant use of strong CYP3A4 inhibitors with VYTORIN increases simvastatin exposure and increases the risk of myopathy and rhabdomyolysis, particularly with higher VYTORIN dosages. … Select azole anti-fungals (e.g., itraconazole, ketoconazole, posaconazole, and voriconazole), select macrolide antibiotics (e.g., erythromycin and clarithromycin, telithromycin), select HIV protease inhibitors (e.g. … |
Source: FDA drug label (VYTORIN), Organon LLC, effective January 21, 2026 (SPL set 89b860d2-de83-468e-b7e8-76aeec2edca2), via openFDA; the full label on DailyMed
What do FAERS reports show for ezetimibe and simvastatin?
The FDA Adverse Event Reporting System holds 15,110 reports that list ezetimibe and simvastatin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 856 are coded as a death and 4,779 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ezetimibe and simvastatin?
17 other medicines are given the same way (oral) and in the same FDA class as ezetimibe and simvastatin or labeled mainly for the same use (high cholesterol), the same class first. High cholesterol lists all 25 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Atorvastatin | Heart attack and coronary artery disease, High cholesterol | 61 labelers | $0.0228 per tablet 10 mg tablet | No current entry |
| Rosuvastatin | Heart attack and coronary artery disease, High cholesterol | 46 labelers | $0.0692 per tablet 40 mg tablet | No current entry |
| Pravastatin | Heart attack and coronary artery disease, High cholesterol | 37 labelers | $0.058 per tablet 20 mg tablet | No current entry |
| Amlodipine and atorvastatin | Heart attack and coronary artery disease, High cholesterol | 6 labelers | $1.34 per unit 10-40 mg | No current entry |
| Lovastatin | Heart attack and coronary artery disease, High cholesterol | 19 labelers | $0.0436 per tablet 20 mg tablet | No current entry |
| Pitavastatin | High cholesterol | 12 labelers | $0.954 per tablet 2 mg tablet | No current entry |
| Fluvastatin | High cholesterol | 4 labelers | $2.88 per tablet 80 mg tablet | A presentation being discontinued |
| Fenofibrate | High cholesterol | 54 labelers | $0.103 per tablet 160 mg tablet | No current entry |
Every medicine labeled for the same conditions as ezetimibe and simvastatin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does ezetimibe and simvastatin compare with medicines for the same use?
1 side-by-side page set ezetimibe and simvastatin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to ezetimibe and simvastatin
- 17 medicines for the same use
- Other dietary cholesterol absorption inhibitors
- the pharmacologic class, with prices and generics
- Ezetimibe and simvastatin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other