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Prescription tablet taken by moutha cholesterol-lowering medicine of the HMG-CoA reductase inhibitor type (often called a statin)

Simvastatin

Simvastatin · Say it: SIM-va-stat-in

A prescription cholesterol-lowering tablet, used along with diet to lower harmful cholesterol and fats in the blood and to help lower the risk of heart attack, stroke, and related procedures in certain people.

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Used for

Lowering the risk of death from heart disease, heart attacks, and strokes in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes who are at high risk of heart disease events

Comes as

5 mg tan, round, film-coated tablets; 10 mg peach, oval, film-coated tablets

Common side effects

Upper respiratory infection (such as a cold-type infection), Headache, Stomach (abdominal) pain

Key facts
Generic nameSimvastatin
Brand names—
Type of medicinea cholesterol-lowering medicine of the HMG-CoA reductase inhibitor type (often called a statin)
How it is soldPrescription tablet taken by mouth
Comes as5 mg tan, round, film-coated tablets; 10 mg peach, oval, film-coated tablets; 20 mg tan, oval, film-coated tablets; 40 mg brick red, round, film-coated tablets; 80 mg brick red, capsule-shaped, film-coated tablets
Routeoral
Boxed warningNo
Label date2026-02-26

💊 What is Simvastatin used for?

  • Lowering the risk of death from heart disease, heart attacks, and strokes in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes who are at high risk of heart disease events
  • Lowering LDL cholesterol ("bad" cholesterol) along with diet in adults with high levels of fat in the blood (hyperlipidemia)
  • Lowering LDL cholesterol along with diet in adults and children 10 years of age and older with heterozygous familial hypercholesterolemia, an inherited condition
  • Lowering LDL cholesterol in adults with homozygous familial hypercholesterolemia, used together with other cholesterol-lowering treatments
  • Treating adults with primary dysbetalipoproteinemia, a type of high cholesterol, along with diet
  • Lowering triglycerides (a type of fat in the blood) in adults, along with diet

How it works

The label says simvastatin decreases the body's production of cholesterol, and that it is a type of HMG-CoA reductase inhibitor.

How it is usually taken

  • The label says simvastatin is taken by mouth once a day, in the evening. It is used along with diet. Follow the instructions from your prescriber or pharmacist about how to take it.

Comes as

  • 5 mg tan, round, film-coated tablets
  • 10 mg peach, oval, film-coated tablets
  • 20 mg tan, oval, film-coated tablets
  • 40 mg brick red, round, film-coated tablets
  • 80 mg brick red, capsule-shaped, film-coated tablets

⚠️ Simvastatin side effects

Common side effects

  • Upper respiratory infection (such as a cold-type infection)
  • Headache
  • Stomach (abdominal) pain
  • Constipation
  • Nausea

Get medical help right away if

  • Get medical help right away if you have unexplained muscle pain, tenderness, or weakness, especially if it comes with feeling unwell (malaise) or fever. The label says these can be signs of myopathy or rhabdomyolysis, a serious muscle problem that can affect the kidneys.
  • Get medical help promptly if you have fatigue (unusual tiredness), loss of appetite, pain in the upper right side of the belly, dark urine, or yellowing of the skin or eyes (jaundice). The label says these can be signs of liver problems.
  • The label notes that rare cases of an autoimmune muscle condition called immune-mediated necrotizing myopathy have been reported. Tell your prescriber about any new or unusual muscle symptoms.

🛑 Who should not take Simvastatin, and who should be careful

The label says not to take it if

  • You take certain strong CYP3A4 inhibitor medicines, such as some antifungal medicines (itraconazole, ketoconazole, posaconazole, voriconazole), certain antibiotics (erythromycin, clarithromycin), certain HIV protease inhibitors, certain hepatitis C protease inhibitors (boceprevir, telaprevir), cobicistat-containing products, or the antidepressant nefazodone. The label says these are contraindicated.
  • You take cyclosporine, danazol, or gemfibrozil. The label says these are contraindicated.
  • You have acute liver failure or decompensated cirrhosis. The label says these are contraindicated.
  • You are allergic to simvastatin or any of its ingredients. The label notes that serious allergic reactions, including anaphylaxis, angioedema, and Stevens-Johnson syndrome, have been reported.

Tell your doctor before taking it if

  • Tell your prescriber about all your medical conditions, including unexplained muscle aches or weakness, myasthenia gravis or ocular myasthenia, kidney problems, liver problems, thyroid problems, and if you drink more than 2 glasses of alcohol daily.
  • Tell your prescriber if you are 65 years of age or older, or of Chinese descent. The label says these can affect the risk of muscle problems.
  • Tell your prescriber if you are pregnant or plan to become pregnant.
  • Tell every prescriber and pharmacist about all medicines you take, both prescription and over the counter. Tell other prescribers if you are taking simvastatin before they start or change a medicine.
  • The label says to read the Patient Information leaflet each time you get a refill, because there may be new information.

🔀 Simvastatin with other medicines, food and alcohol

The label says to discuss these with your doctor or pharmacist

  • Grapefruit juice: The label says it can increase the risk of myopathy and rhabdomyolysis with simvastatin.
  • Other medicines that raise the risk of muscle problems: the label lists strong CYP3A4 inhibitors, cyclosporine, danazol, gemfibrozil, and says dosage changes are recommended with lomitapide, verapamil, diltiazem, dronedarone, amiodarone, amlodipine, or ranolazine.
  • Coumarin anticoagulants (blood thinners): The label says to obtain an INR before starting simvastatin and to monitor INR during starting or dose changes.
  • Digoxin: The label says digoxin levels should be monitored during the start of simvastatin.
  • Other lipid-lowering therapies: The label lists these as a factor that can increase the risk of myopathy.

Alcohol and food

The label says to tell your prescriber if you drink more than 2 glasses of alcohol daily, since this is listed as a condition to report. The label also says grapefruit juice can increase the risk of muscle problems with simvastatin.

🤰 Simvastatin in pregnancy and breastfeeding

Pregnancy

The label says simvastatin should be discontinued when pregnancy is recognized, and that it may cause fetal harm. It also says treatment of high cholesterol is generally not necessary during pregnancy. Pregnant people and people who can become pregnant should discuss the potential risk with their healthcare provider.

Breastfeeding

The label says breastfeeding is not recommended during treatment with simvastatin.

🗓️ Storage, missed doses and taking too much

Storage

The label says to store between 20 and 25 degrees Celsius (68 to 77 degrees Fahrenheit) and to keep the tablets in a tight container.

If a dose is missed

The label says that if a dose is missed, take it as soon as possible. Do not double the next dose.

If too much is taken

The label says no specific antidote for simvastatin is known. Contact Poison Control at 1-800-222-1222 for the latest recommendations.

🗒️ Questions to ask about Simvastatin

🎯 Check what you understood

1. When does the label say simvastatin is usually taken?

2. According to the label, what can grapefruit juice do when taken with simvastatin?

3. What does the label say to do if a dose is missed?

❓ Simvastatin: frequently asked questions

Is simvastatin safe during pregnancy?

The label says simvastatin may cause fetal harm and should be discontinued when pregnancy is recognized. It also says treatment of high cholesterol is generally not necessary during pregnancy, so anyone who is pregnant or planning pregnancy should talk with their healthcare provider.

Can I breastfeed while taking simvastatin?

The label says breastfeeding is not recommended during treatment with simvastatin. Discuss this with your prescriber.

What muscle symptoms should I report?

The label says to promptly report unexplained muscle pain, tenderness, or weakness, especially if accompanied by feeling unwell or fever. Get medical help right away for these symptoms.

What should I do if I take too much simvastatin?

The label says there is no specific antidote for simvastatin. It advises contacting Poison Control at 1-800-222-1222 for the latest recommendations.

How should I store simvastatin tablets?

The label says to store the tablets between 20 and 25 degrees Celsius (68 to 77 degrees Fahrenheit) in a tight container.

🧪 Tests and reports linked to Simvastatin

The label text mentions these. If you have one of these reports, get every line of it explained.

📖 Medical words used on this page

  • Acute vs chronic

    Acute means something started recently or suddenly. Chronic means it has lasted a long time or keeps coming back.

  • Anaphylaxis

    Anaphylaxis is a severe, whole-body allergic reaction that comes on fast and is a medical emergency needing urgent help.

  • Angioedema

    Angioedema is swelling deep under the skin, often of the lips, face, tongue or throat. Swelling of the throat or tongue needs emergency help.

  • Antibiotic

    An antibiotic is a medicine that kills bacteria or stops them growing; it treats bacterial infections, not viral ones like colds or flu.

  • Anticoagulant

    An anticoagulant is a medicine that slows blood clotting, used to prevent or treat harmful clots. It raises the risk of bleeding.

  • Antidepressant

    An antidepressant is a medicine used to treat depression, and often anxiety, pain and other conditions, by acting on chemical messengers in the brain.

  • Antifungal

    An antifungal is a medicine that treats or prevents infections caused by fungi, such as yeast infections, athlete's foot and ringworm.

  • Cardiovascular mortality

    Cardiovascular mortality means deaths caused by heart and blood vessel disease, such as heart attacks, heart failure and strokes.

  • Cirrhosis

    Cirrhosis is long-term scarring of the liver, where healthy tissue is replaced by scar tissue so the liver cannot work as well.

  • Contraindication

    A contraindication is a reason not to use a particular medicine, test or procedure for a person because it could cause harm.

  • CYP3A

    CYP3A is a family of enzymes, mainly in the liver and gut, that break down a large share of commonly used medicines.

  • CYP3A Inhibitor

    A CYP3A inhibitor is a medicine or food that slows the liver enzyme CYP3A, which can make other medicines build up in the body.

  • CYP3A4

    CYP3A4 is a liver and gut enzyme that breaks down many medicines. Drugs or foods that block or boost it can change medicine levels.

  • Film-coated

    Film-coated means a tablet has a thin outer layer that makes it easier to swallow, masks taste, or protects the medicine inside.

📖 Medical words on this page

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🧩 Similar medicines

  • Atorvastatin · a statin, a cholesterol-lowering medicine of the HMG-CoA reductase inhibitor type
  • Rosuvastatin · a cholesterol-lowering medicine of the statin type (an HMG CoA reductase inhibitor)
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Source: official FDA drug label (label updated 2026-02-26). Read the full label on DailyMed

MedicDecode explains the official label in plain words. It is not medical advice and does not replace your doctor or pharmacist. Never start, stop or change a medicine because of what you read here.