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Vytorin: Uses, Side Effects and Dosage

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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Vytorin

What is VYTORIN?

VYTORIN is a prescription medicine that contains the cholesterol lowering medicines, simvastatin and ezetimibe:

  • VYTORIN is used along with diet to lower elevated low-density lipoprotein cholesterol (LDL-C) or bad cholesterol in:

    • adults with primary hyperlipidemia (high level of fats in your blood).
    • adults and children 10 years of age and older with heterozygous familial hypercholesterolemia (HeFH). HeFH is an inherited condition that causes high levels of bad cholesterol.
  • VYTORIN is also used with other cholesterol lowering treatments to lower elevated LDL-C levels in adults with homozygous familial hypercholesterolemia (HoFH). HoFH is an inherited condition that causes high levels of bad cholesterol.

  • Simvastatin when used as a component of VYTORIN is used to lower:

    • the risk of death by lowering the risk of heart disease death.
    • the risk of heart attacks and strokes.
    • the need for certain types of heart and blood vessel procedures to improve blood flow called arterial revascularization in people with known heart, cerebrovascular disease (conditions that affect blood flow and the blood vessels in the brain), peripheral vascular disease (a blood circulation disorder that causes the blood vessels outside of your heart and brain to narrow, block, or spasm), and diabetes, who are at high risk for heart disease problems.

The safety and effectiveness of VYTORIN has not been established in children younger than 10 years of age with inherited heterozygous familial hypercholesterolemia (HeFH) or other types of hyperlipidemia.

Do not take VYTORIN if you:

  • take certain medicines called CYP3A4 inhibitors such as:

    • certain antifungal medicines (such as itraconazole, ketoconazole, posaconazole, voriconazole).
    • certain antibiotics (including erythromycin, clarithromycin, telithromycin).
    • HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir, saquinavir, tipranavir, or atazanavir and cobicistat-containing products such as (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate).
    • certain hepatitis C virus protease inhibitors (such as boceprevir or telaprevir).
    • the antidepressant nefazodone.
  • take medicines called cyclosporine, danazol, or gemfibrozil.
  • have liver problems.
  • are allergic to simvastatin, ezetimibe, or any of the ingredients in VYTORIN. See the end of this Patient Information leaflet for a complete list of ingredients in VYTORIN.

Ask your healthcare provider or pharmacist if you are not sure if your medicine is listed above.

Before you take VYTORIN, tell your healthcare provider about all of your medical conditions, including if you:

  • have unexplained muscle aches or weakness.
  • have or have had myasthenia gravis (a disease causing general muscle weakness including in some cases muscles used for breathing), ocular myasthenia (a disease causing eye muscle weakness).
  • have kidney problems.
  • have liver problems or drink more than 2 glasses of alcohol daily.
  • have thyroid problems.
  • are 65 years of age or older.
  • are of Chinese descent.

  • are pregnant or plan to become pregnant. If you become pregnant while taking VYTORIN, call your healthcare provider right away to discuss stopping VYTORIN.

  • are breastfeeding or plan to breastfeed. It is not known if VYTORIN passes into your breast milk. Do not breastfeed while taking VYTORIN.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Talk to your healthcare provider before you start taking any new medicines.

Tell your healthcare provider who prescribes VYTORIN if another healthcare provider increases the dose of another medicine you are taking.

VYTORIN may affect the way other medicines work, and other medicines may affect how VYTORIN works. Especially tell your healthcare provider if you take:

  • digoxin (a drug used to treat irregular heartbeat).
  • coumarin anticoagulants (drugs that prevent blood clots, such as warfarin).
  • fibric acid derivatives (such as fenofibrate).

Taking VYTORIN with certain substances can also increase the risk of muscle problems. Especially tell your healthcare provider if you take:

  • amiodarone or dronedarone (medicines used to treat an irregular heartbeat).
  • verapamil, diltiazem, amlodipine, or ranolazine (medicines used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions).
  • lomitapide (a medicine used to treat a serious and rare genetic cholesterol condition).
  • daptomycin (a drug used to treat complicated skin and bloodstream infections).
  • large doses of niacin or nicotinic acid, especially if you are of Chinese descent.
  • colchicine (a medicine used to treat gout).

  • grapefruit juice.

Ask your healthcare provider or pharmacist for a list of medicines if you are not sure. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take VYTORIN?

  • Take VYTORIN exactly as your healthcare provider tells you to take it.
  • Do not change your dose or stop taking VYTORIN without talking to your healthcare provider.
  • Take VYTORIN 1 time each day in the evening.
  • If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take 2 doses of VYTORIN at the same time. Talk with your healthcare provider if you have questions about a missed dose.
  • While taking VYTORIN, continue to follow your cholesterol-lowering diet and to exercise as your healthcare provider told you to.
  • Your healthcare provider may do blood tests to check your cholesterol while you take VYTORIN. Your healthcare provider may change your dose of VYTORIN if needed.

If you take too much VYTORIN, call your healthcare provider or Poison Help Line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What are the possible side effects of VYTORIN?

VYTORIN may cause serious side effects including:

  • Muscle pain, tenderness, and weakness (myopathy). Muscle problems, including muscle breakdown, can be serious in some people and rarely cause kidney damage that can lead to death.

    Tell your healthcare provider right away if:

    • you have unexplained muscle pain, tenderness, or weakness, especially if you have a fever or feel more tired than usual, while you take VYTORIN.

    • you have muscle problems that do not go away even after your healthcare provider has advised you to stop taking VYTORIN. Your healthcare provider may do further tests to diagnose the cause of your muscle problems.

      Your chances of getting muscle problems are higher if you:

    • are taking certain other medicines while you take VYTORIN.
    • are 65 years of age or older.
    • are female.
    • have thyroid problems (hypothyroidism) that are not controlled.
    • have kidney problems.
    • are taking higher doses of VYTORIN.
    • are Chinese.

  • Liver problems. Your healthcare provider should do blood tests to check your liver before you start taking VYTORIN and if you have any symptoms of liver problems while you take VYTORIN. Call your healthcare provider right away if you have the following symptoms of liver problems:

    • feeling tired or weak
    • loss of appetite
    • right-sided upper belly pain
    • dark urine
    • yellowing of your skin or the whites of your eyes
  • increase in blood sugar (glucose) levels). VYTORIN may cause an increase in your blood sugar levels.

The most common side effects of VYTORIN include:

  • headache
  • increased liver enzyme levels
  • muscle pain
  • upper respiratory infection
  • diarrhea

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of VYTORIN.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store VYTORIN?

  • Store VYTORIN at room temperature between 68ºF to 77ºF (20ºC to 25ºC).
  • Keep VYTORIN in its original container until you use it.
  • Keep VYTORIN in a tightly closed container.

Keep VYTORIN and all medicines out of the reach of children.

General information about safe and effective use of VYTORIN.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use VYTORIN for a condition for which it was not prescribed. Do not give VYTORIN to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about VYTORIN that is written for health professionals.

What are the ingredients in VYTORIN?

Active Ingredients: ezetimibe and simvastatin.

Inactive Ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.

Distributed by: Organon LLC, a subsidiary of

ORGANON & Co.,

Jersey City, NJ 07302, USA

For patent information: www.organon.com/our-solutions/patent/

© 2024 Organon group of companies. All rights reserved.

For more information, go to www.organon.com/our-focus/products-list/ or call 1-844-674-3200.

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About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 021687 · View the label on DailyMed

Revision date stated in the text: February 2024

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Vytorin

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Dietary Cholesterol Absorption Inhibitor, HMG-CoA Reductase Inhibitor
Active ingredients Ezetimibe 10 mg, Simvastatin
Dosage form Tablet
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) ORGANON
FDA approval NDA 021687New Drug Application (NDA) Approved July 23, 2004
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Ezetimibe and Simvastatin with the same TE code
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
10 mg, 10 mg – 30 in 1 bottle NDC 78206-174-01
10 mg, 10 mg – 90 in 1 bottle NDC 78206-174-02
10 mg, 20 mg – 30 in 1 bottle NDC 78206-175-01
10 mg, 20 mg – 90 in 1 bottle NDC 78206-175-02
10 mg, 40 mg – 30 in 1 bottle NDC 78206-176-01
10 mg, 40 mg – 90 in 1 bottle NDC 78206-176-02
10 mg, 80 mg – 30 in 1 bottle NDC 78206-177-01
10 mg, 80 mg – 90 in 1 bottle NDC 78206-177-02

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.