Do not take LIPITOR if you:

• have liver problems (acute liver failure or decompensated cirrhosis)
• are allergic to atorvastatin or any of the ingredients in LIPITOR. Stop using LIPITOR and get medical help right away if you have symptoms of a serious allergic reaction including:
  • swelling of your face, lips, tongue, or throat
  • problems breathing or swallowing
  • fainting or feeling dizzy
  • very rapid heartbeat
  • severe skin rash or itching
  • flu-like symptoms, including fever, sore throat, cough, tiredness, and joint pain

Before you take LIPITOR, tell your doctor about all of your medical conditions, including if you:

• have unexplained muscle aches or weakness
• drink more than 2 glasses of alcohol daily
• have diabetes
• have thyroid problems
• have kidney problems
• had a stroke
• are pregnant or plan to become pregnant. LIPITOR may harm your unborn baby. If you become pregnant, stop taking LIPITOR and call your doctor right away.
• are breastfeeding or plan to breastfeed. You and your doctor should decide if you will take LIPITOR or breastfeed. You should not do both. Talk to your doctor about the best way to feed your baby if you take LIPITOR.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LIPITOR and certain other medicines can increase the risk of muscle problems or other side effects.

What are the possible side effects of LIPITOR?
LIPITOR 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 doctor right away if you have:
  • unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or feel more tired than usual while you take LIPITOR.
  • muscle problems that do not go away after your doctor has told you to stop taking LIPITOR. Your doctor 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 LIPITOR
  • drink large amounts of grapefruit juice
  • are 65 years of age or older
  • have thyroid problems (hypothyroidism) that are not controlled
  • have kidney problems
  • are taking higher doses of LIPITOR
• Liver problems. Your doctor should do blood tests to check your liver before you start taking LIPITOR and if you have symptoms of liver problems while you take LIPITOR. Call your doctor right away if you have the following symptoms of liver problems:
  • feel tired or weak
  • nausea or vomiting
  • loss of appetite
  • upper belly pain
  • dark amber colored urine
  • yellowing of your skin or the whites of your eyes
• Increase in blood sugar level. Your blood sugar level may increase while you are taking LIPITOR. Exercise regularly and make healthy food choices to maintain healthy body weight.

The most common side effects of LIPITOR include:

• nasal congestion, sore throat, runny nose
• muscle and joint pain
• diarrhea
• pain in extremity
• urinary tract infection
• upset stomach
• nause
• musculoskeletal pain
• muscle spasms
• trouble sleeping
• throat pain

Talk to your doctor or pharmacist if you have side effects that bother you or that will not go away. These are not all the side effects of LIPITOR. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Indications
LIPITOR is a prescription medicine that contains a cholesterol lowering medicine (statin) called atorvastatin. LIPITOR is used:

• to reduce the risk of:
  • heart attack, stroke, certain types of heart surgery and chest pain in adults who do not have heart disease but have other multiple risk factors for heart disease.
  • heart attack and stroke in adults with type 2 diabetes mellitus who do not have heart disease but have other multiple risk factors.
  • heart attack that does not cause death, stroke, certain types of heart surgery, hospitalization for congestive heart failure, and chest pain in adults with heart disease.
• along with diet to reduce low density lipoprotein cholesterol (LDL-C) or bad cholesterol:
  • in adults with primary hyperlipidemia.
  • in adults and children aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). This is an inherited condition that causes high levels of bad cholesterol.
• along with other cholesterol lowering treatments or alone if such treatments are unavailable in adults and children aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). This is an inherited condition that causes high levels of bad cholesterol.
• along with diet for the treatment of adults with:
  • primary dysbetalipoproteinemia (an inherited condition that causes high levels of cholesterol and fat).
  • hypertriglyceridemia.

It is not known if LIPITOR is safe and effective in children younger than 10 years of age with HeFH or HoFH or in children with other types of hyperlipidemias (other than HeFH or HoFH).

LIPITOR is available by prescription only in 10 mg, 20 mg, 40 mg, and 80 mg tablets.

Please see Full Prescribing Information and Patient Information.