Rosuvastatin is used together with a proper diet to lower bad cholesterol (LDL) and triglycerides (fats) in the blood, and to increase your good cholesterol (HDL). It is also used to treat adults who cannot control their cholesterol levels by diet and exercise alone. Rosuvastatin may help prevent or slow down medical problems, like atherosclerosis (hardening of the arteries), that are caused by fats clogging the blood vessels. It may also be used to prevent certain types of heart and blood vessel problems in patients with risk factors for heart problems.

Rosuvastatin belongs to a group of medicines called HMG-CoA reductase inhibitors, or statins. It works by blocking an enzyme that is needed by the body to make cholesterol, so this reduces the amount of cholesterol in the blood.

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

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, or do not use it for a longer time than your doctor ordered. Also, this medicine works best if there is a constant amount in the blood. To help keep this amount constant, do not miss any doses and take the medicine at the same time each day.

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.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Swallow the tablet whole. Do not break, crush, or chew it.

To use the capsule:

• Swallow the capsule whole. Do not crush or chew it. If you have trouble swallowing, you may open it and mix the contents with 1 teaspoon of applesauce. Take this mixture right away. Do not save the mixture for later use. Throw away any unused mixture.
• You may also take the capsule using a nasogastric tube. To use:
  • Open the capsule and empty the contents into a 60-milliliter (mL) catheter syringe. Add 40 mL of water. Do not use any other liquid.
  • Replace the plunger and shake the syringe for 15 seconds. The granules may start dissolving.
  • Attach the syringe to a nasogastric tube and deliver the contents into the stomach.
  • Flush the tube with an additional 20 mL of water to get all of the medicine.
  • Throw away any unused mixture.

    If you need to take an antacid that contains aluminum and magnesium (eg, Maalox®), take the antacid at least 2 hours after using rosuvastatin.

    Do not drink large amounts of alcohol while using rosuvastatin. This could cause side 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

Difficulty in moving

joint pain or swelling

muscle pain, cramps, spasms, or stiffness

Less common

Blurred vision

chest pain or discomfort

chest tightness or heaviness

difficult, burning, or painful urination

dry mouth

fast, irregular, pounding, or racing heartbeat or pulse

flushed, dry skin

fruit-like breath odor

increased hunger

increased thirst

increased urination

loss of consciousness

muscle tension or tightness

nausea

slow heartbeat

stomachache

sweating

troubled breathing

unexplained weight loss

unusual tiredness or weakness

vomiting

Rare

Dark urine

fever

Incidence not known

Black, tarry stools

bleeding gums

bloating

bloody urine

chills

clay-colored stools

constipation

cough

general feeling of tiredness or weakness

headache

hives, itching, skin rash

hoarseness

indigestion

irritation

joint swelling

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

light-colored stools

loss of appetite

muscular tenderness, wasting, or weakness

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

pinpoint red spots on the skin

redness of the skin

stomach pain, continuing swelling of the eyelids, face, lips, hands, or feet

tightness in the chest

trouble swallowing

unpleasant breath odor

unusual bleeding or bruising

upper right abdominal pain

vomiting of blood

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:

More common

Body aches or pain

congestion

dry or sore throat

runny nose

tender, swollen glands in the neck

voice changes

Less common

Accidental injury

accumulation of pus, swollen, red, or tender area of infection near a tooth

arm, back, or jaw pain

belching

bladder pain

burning feeling in the chest or stomach

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

diarrhea

discouragement

dizziness

excess air or gas in the stomach or bowels

excessive muscle tone

fear

feeling faint

feeling of constant movement of self or surroundings

feeling of warmth or heat

feeling sad or empty

flushing or redness of the skin, especially on the face and neck

general feeling of discomfort or illness

heartburn

lack of appetite

lack or loss of strength

lightheadedness

loss of interest or pleasure

neck pain

nerve pain

nervousness

pain or swelling in the arms or legs without any injury

pain or tenderness around the eyes and cheekbones

passing gas

pounding in the ears

sensation of spinning

shivering

sneezing

stomach discomfort, tenderness, or upset

stuffy nose

trouble concentrating

trouble sleeping

Incidence not known

Confusion

forgetfulness

memory loss

nightmares

swelling of the breasts or breast soreness in both females and males

unsteadiness or awkwardness

weakness in the arms, hands, legs, or feet

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 to lower your cholesterol and triglyceride levels and to decide if you should continue to take it. Blood and urine 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.

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 a major surgery, major injury, or if you develop other serious health problems.

Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness, even after stopping the medicine. These could be symptoms of serious muscle problems such as myopathy or immune-mediated necrotizing myopathy (IMNM).

Call your doctor right away if you have dark urine, fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness or weakness. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Do not stop or change your dose without checking first with your doctor, even if you are feeling well.

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.