Simvastatin is used together with a proper diet to treat high cholesterol and triglyceride (fat) levels in the blood. This medicine may help prevent medical problems (eg, heart attacks, strokes) caused by clogged blood vessels. Simvastatin may also be used to prevent certain types of heart problems in patients with risk factors for heart problems.

Simvastatin belongs to the group of medicines called HMG-CoA reductase inhibitors, or statins. It works to reduce the amount of cholesterol in the blood by blocking an enzyme that is needed to make cholesterol.

This medicine is available only with your doctor's prescription.

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

If you are using the oral suspension:

• Take this medicine on the evening, on an empty stomach.
• Shake the oral suspension well for at least 20 seconds before using it. Use a marked measuring spoon, oral syringe, or medicine cup to measure the right dose.

In addition to this medicine, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. Carefully follow your doctor's orders about any special diet.

If you are taking diltiazem (Cardizem®), dronedarone (Multaq®), or verapamil (Calan®, Isoptin®, Verelan®) together with simvastatin, your simvastatin dose should not be higher than 10 milligrams (mg) per day, unless otherwise directed by your doctor. Do not use more than 20 mg per day of simvastatin together with amiodarone (Cordarone®), amlodipine (Norvasc®), lomitapide (Juxtapid™), or ranolazine (Ranexa®). When used together with higher doses of simvastatin, these medicines may increase your risk of muscle injury and could result in kidney problems.

Tell your doctor if you regularly drink grapefruit juice. Drinking large amounts of grapefruit juice (more than 1 quart each day) while taking this medicine may increase your risk of muscle injury and could result in kidney problems.

Do not drink large amounts of alcohol with simvastatin. This could cause unwanted effects on the liver.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Dizziness

fainting

fast or irregular heartbeat

Less common

Bladder pain

bloody or cloudy urine

blurred vision

body aches or pain

chills

cough

dark-colored urine

difficult, burning, or painful urination

difficulty with breathing

difficulty with moving

dry mouth

ear congestion

fever

flushed, dry skin

frequent urge to urinate

fruit-like breath odor

headache

increased hunger

increased thirst

increased urination

joint pain

loss of consciousness

lower back or side pain

muscle cramps, spasms, or stiffness

muscular pain, tenderness, wasting, or weakness

nasal congestion

nausea

runny nose

sneezing

sore throat

stomachache

sweating

swelling

swollen joints

troubled breathing

unexplained weight loss

unusual tiredness or weakness

vomiting

Incidence not known

Blistering, peeling, or loosening of the skin

bloating

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

constipation

diarrhea

difficulty with swallowing

general tiredness and weakness

indigestion

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

light-colored stools

loss of appetite

pains in the stomach, side, or abdomen, possibly radiating to the back

pale skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red skin lesions, often with a purple center

red, irritated eyes

skin rash, hives, or itching

sores, ulcers, or white spots in the mouth or on the lips

tightness in the chest

troubled breathing with exertion

unusual bleeding or bruising

upper right abdominal or stomach pain

weakness in the arms, hands, legs, or feet

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Acid or sour stomach

belching

burning feeling in the chest or stomach

dizziness or lightheadedness

excess air or gas in the stomach or intestines

feeling of constant movement of self or surroundings

full feeling

heartburn

lack or loss of strength

pain or tenderness around the eyes and cheekbones

passing gas

sensation of spinning

skin rash, encrusted, scaly, and oozing

stomach discomfort, upset, or pain

tenderness in the stomach area

trouble sleeping

Incidence not known

Being forgetful

depression

discoloration of the skin

hair loss or thinning of the hair

inability to have or keep an erection

loss in sexual ability, desire, drive, or performance

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Do not use simvastatin if you are also taking any of the following medicines: boceprevir (Victrelis®), cobicistat-containing products (Stribild®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), danazol (Danocrine®), gemfibrozil (Lopid®), nefazodone (Serzone®), telaprevir (Incivek®), certain antibiotics (such as clarithromycin, erythromycin, itraconazole, ketoconazole, posaconazole, telithromycin, voriconazole, Nizoral®), or medicines to treat HIV/AIDS (such as atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, Crixivan®, Kaletra®, Lexiva®, Norvir®, Prezista®, Reyataz®). Using these medicines together with simvastatin may increase your risk of muscle injury and could result in kidney problems.

Chinese patients who are taking large amounts of niacin (greater than or equal to 1 gram or 1000 milligrams per day) together with this medicine may have an increased risk for muscle injury. Talk to your doctor if you are Chinese or have Chinese ancestry and take large amounts of niacin (Niacor®, Niaspan®). You may need a different dose of this medicine.

Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever. These could be symptoms of serious muscle problems, such as myopathy or immune-mediated necrotizing myopathy (IMNM). Myopathy is more common when high doses of simvastatin (eg, 80 milligrams) are used, but some people get myopathy with lower doses.

Call your doctor right away if you have dark-colored urine, diarrhea, a fever, muscle cramps or spasms, muscle pain or stiffness, or feel very tired or weak. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.

Call your doctor right away if you get a headache, stomach pain, vomiting, dark-colored urine, loss of appetite, weight loss, general feeling of tiredness or weakness, light-colored stools, upper right stomach pain, or yellow eyes or skin. These could be symptoms of liver damage.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine if you have major surgery, a major injury, or you develop other serious health problems.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.