Overview: Ezetimibe/simvastatin is used to lower bad cholesterol levels. It works by decreasing the amount of cholesterol made by the liver, increasing the breakdown of bad cholesterol, and reducing cholesterol absorption in the gut. Common side effects may include headache, muscle pain, and diarrhea. Tell your health care provider right away if you have unexplained muscle pain, weakness, or tenderness, dark-colored pee, a fever, or yellowing of your skin or the whites of your eyes. Ezetimibe/simvastatin is a tablet that is taken by mouth.
Uses
What is ezetimibe/simvastatin used for?
Ezetimibe/simvastatin is commonly used for the following conditions.
- To lower bad cholesterol levels (LDL-C) in people with high cholesterol levels
- To lower bad cholesterol levels (LDL-C) in people that are born with a genetic condition affecting how the body removes cholesterol from the blood (heterozygous familial hypercholesterolemia or homozygous familial hypercholesterolemia)
Ezetimibe/simvastatin may also be used for other conditions as determined by your health care provider.
How does ezetimibe/simvastatin work (mechanism of action)?
Ezetimibe/simvastatin contains two medicines: ezetimibe and simvastatin. These medicines work together to lower blood cholesterol levels in the following ways.
- Decreasing the amount of cholesterol made by your liver
- Increasing the breakdown of bad cholesterol
- Inhibiting the absorption of cholesterol by your intestines
How is ezetimibe/simvastatin supplied (dosage forms)?
Brands and other names
- Vytorin
Dosage forms and strengths
- 10 mg/10 mg oral tablets
- 10 mg/20 mg oral tablets
- 10 mg/40 mg oral tablets
- 10 mg/80 mg oral tablets
How should I store ezetimibe/simvastatin?
Ezetimibe/simvastatin should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. Protect from moisture.
Side Effects
What are the most common side effects of ezetimibe/simvastatin?
The most common side effects of ezetimibe/simvastatin are listed below. Tell your health care provider if you have any of these side effects that bother you.
- Headache
- Muscle pain
- Infection in the nose or throat, sore throat, or common cold symptoms
- Diarrhea
There may be other side effects of ezetimibe/simvastatin that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of ezetimibe/simvastatin?
While less common, the most serious side effects of ezetimibe/simvastatin are described below, along with what to do if they happen.
Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking ezetimibe/simvastatin. Keep all appointments to have your blood checked. Call your health care provider right away if you have any of the following symptoms of liver damage.
- Nausea or vomiting
- Stomach or belly pain
- Fever
- Weakness or unusual tiredness
- Itching
- Loss of appetite
- Light-colored poop
- Dark-colored urine (pee)
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
Muscle Problems. Ezetimibe/simvastatin can cause muscle problems, including muscle pain, weakness, and tenderness called myopathy. In some people, the muscle may break down (rhabdomyolysis), which can be serious and rarely lead to kidney damage and death. Stop taking ezetimibe/simvastatin and get help right away if you have any of the following symptoms of myopathy or rhabdomyolysis.
- Unexplained muscle pain, weakness, or tenderness
- Low energy levels or feeling easily tired, especially with activity
- Dark-colored urine (pee)
- Fever
- Muscle cramps
- Stomach pain
- Nausea or vomiting
Severe Allergic Reactions. Ezetimibe/simvastatin may cause allergic reactions, which can be serious. Stop taking ezetimibe/simvastatin and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching or skin rash
- Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Increased Blood Sugar. Ezetimibe/simvastatin may increase your blood sugar levels. Talk to your health care provider about how to maintain healthy blood sugar levels.
Warnings & Precautions
Who should not use ezetimibe/simvastatin?
Allergies to Ingredients. People who are allergic to any of the following should not take ezetimibe/simvastatin.
- Ezetimibe
- Simvastatin
- Vytorin
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in the specific ezetimibe/simvastatin products they stock.
Drug Interactions. Ezetimibe/simvastatin should not be taken along with certain other medicines. Before taking ezetimibe/simvastatin, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section below for more details.
Liver Problems. Ezetimibe/simvastatin should not be taken if your liver is not working as well as it should be. If there is a concern about the health of your liver, your health care provider may do tests to see if it is working well enough to take this medicine.
What should I know about ezetimibe/simvastatin before using it?
Do not take ezetimibe/simvastatin unless it has been prescribed to you by a health care provider. Take it as prescribed.
Do not share ezetimibe/simvastatin with other people, even if they have the same condition as you. It may harm them.
Keep ezetimibe/simvastatin out of the reach of children.
People age 65 years and older can be at a greater risk for some side effects of ezetimibe/simvastatin, including muscle pain, weakness, and injury. Talk to your health care provider about your risks if you are in this age group.
What should I tell my health care provider before using ezetimibe/simvastatin?
Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if ezetimibe/simvastatin is right for you.
In particular, make sure that you discuss any of the following.
Current and Past Health Conditions. Tell your health care provider if you have any of the following.
- Muscle weakness or pain that cannot be explained
- Kidney problems
- Liver problems
- Thyroid problems
- Diabetes
- Myasthenia gravis
Chinese Descent. Tell your health care provider if you are of Chinese descent. You may have a higher risk of having serious muscle problems while taking ezetimibe/simvastatin.
Pregnancy. Ezetimibe/simvastatin may cause harm to a fetus. Tell your health care provider if you are pregnant or plan to become pregnant. Your health care provider will let you know if you should take ezetimibe/simvastatin while you are pregnant or trying to get pregnant.
Breastfeeding. Do not take ezetimibe/simvastatin while you are breastfeeding. It is not known if ezetimibe/simvastatin passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should take ezetimibe/simvastatin or breastfeed.
Interactions
Does ezetimibe/simvastatin interact with foods or drinks?
Do not drink grapefruit juice while taking ezetimibe/simvastatin. Grapefruit juice can increase your risk of having serious muscle problems while taking this medicine.
Limit the amount of alcohol you drink while taking ezetimibe/simvastatin. The risk of liver damage may be increased if you drink large amounts of alcohol. Tell your health care provider if you drink more than 2 glasses of alcohol per day before taking ezetimibe/simvastatin.
Does ezetimibe/simvastatin interact with other medicines (drug interactions)?
Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before taking ezetimibe/simvastatin.
- A medicine used for HIV, AIDS, or hepatitis C
- Itraconazole (Sporanox, Tolsura), ketoconazole, posaconazole (Noxafil), or voriconazole (Vfend), which is a medicine used for fungal infections
- Certain antibiotics, such as clarithromycin, erythromycin, or telithromycin
- Colchicine, which is a medicine commonly used for gout
- Cyclosporine (Gengraf, Neoral, Sandimmune, and others), which is a medicine that suppresses your immune system
- Digoxin (Lanoxin), which is a medicine used to treat irregular heartbeat and some types of heart failure
- Nefazodone, which is commonly used for depression
- Niacin or fibrate, such as fenofibrate (Tricor), fenofibric acid (Fibricor, Trilipix), or gemfibrozil (Lopid), which is a medicine for high cholesterol
- A bile acid sequestrant, such as cholestyramine (Prevalite), colestipol (Colestid), or colesevelam (Welchol), which is a medicine to lower cholesterol
- Lomitapide (Juxtapid), which is a medicine used to treat a genetic cholesterol condition
- Danazol
- Warfarin (Coumadin, Jantoven), which is a blood thinner
- Amiodarone (Cordarone, Pacerone) or dronedarone (Multaq), which are commonly used to treat an irregular heartbeat
- Amlodipine, diltiazem, ranolazine, or verapamil, which are medicines used to treat high blood pressure, chest pain, or other heart conditions
- Daptomycin (Cubicin), which is a medicine used to treat certain infections
Some other medicines may alter the blood levels of ezetimibe/simvastatin. Tell your health care provider about all medicines that you take or have recently taken.
This may not be a complete list of medicines that can interact with ezetimibe/simvastatin. Always check with your health care provider.
Overdose/Missed Dose
What should I do if I accidentally use too much ezetimibe/simvastatin?
If you or someone else has used too much ezetimibe/simvastatin, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of ezetimibe/simvastatin?
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.
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