Patient Information

LIPITOR (LIP-ih-tore)
(atorvastatin calcium)
tablets, for oral use

What is LIPITOR?

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

• •to reduce the risk of:
  • oheart 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.
  • oheart attack and stroke in adults with type 2 diabetes mellitus who do not have heart disease but have other multiple risk factors.
  • oheart 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:
  • oin adults with primary hyperlipidemia.
  • oin 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:
  • oprimary dysbetalipoproteinemia (an inherited condition that causes high levels of cholesterol and fat).
  • ohypertriglyceridemia.

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).

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:
  • oswelling of your face, lips, tongue or throat
  • oproblems breathing or swallowing
  • ofainting or feeling dizzy
  • overy rapid heartbeat
  • osevere skin rash or itching
  • oflu-like symptoms including fever, sore throat, cough, tiredness, and joint pain

See the end of this leaflet for a complete list of ingredients in LIPITOR.

Before you take LIPITOR, tell your healthcare provider 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 healthcare provider right away.
• •are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take LIPITOR or breastfeed. You should not do both. Talk to your healthcare provider about the best way to feed your baby if you take LIPITOR.

Tell your healthcare provider 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. Especially tell your healthcare provider if you take medicines for:

• •your immune system (cyclosporine)
• •cholesterol (gemfibrozil)
• •infections (erythromycin, clarithromycin, itraconazole, ketoconazole, posaconazole, and voriconazole)
• •birth control pills
• •heart failure (digoxin)
• •gout (colchicine)
• •niacin
• •fibrates
• •treating HIV, AIDS, or hepatitis C (anti-virals)

• otipranavir plus ritonavir
• oledipasvir plus sofosbuvir
• osaquinavir plus ritonavir
• ofosamprenavir
• oelbasvir plus grazoprevir
• onelfinavir

• oglecaprevir plus pibrentasvir
• osimeprevir
• odarunavir plus ritonavir
• ofosamprenavir plus ritonavir
• oletermovir

Ask your healthcare provider or pharmacist for a list of medicines if you are not sure. Know all the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take LIPITOR?

• •Take LIPITOR exactly as your healthcare provider tells you to take it.
• •Do not change your dose or stop LIPITOR without talking to your healthcare provider.
• •Your healthcare provider may do blood tests to check your cholesterol levels during your treatment with LIPITOR. Your dose of LIPITOR may be changed based on these blood test results.
• •Take LIPITOR each day at any time of day. LIPITOR can be taken with or without food.
• •Your healthcare provider may start you on a cholesterol lowering diet before giving you LIPITOR. Stay on this low-fat diet when you take LIPITOR.
• •If you miss a dose of LIPITOR, wait and take the next dose at your regular time. Do not take 2 doses of LIPITOR at the same time.
• •If you take too much LIPITOR or overdose, call your healthcare provider or Poison Control Center at 1-800-222-1222 or go to the nearest emergency room right away.

What should I avoid while taking LIPITOR?

• •Avoid drinking more than 1.2 liters of grapefruit juice each day.

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 healthcare provider right away if you have:
  • ounexplained muscle pain, tenderness, or weakness, especially if you also have a fever or feel more tired than usual while you take LIPITOR.
  • omuscle problems that do not go away after your healthcare provider has told you to stop taking LIPITOR. Your healthcare provider may do further tests to diagnose the cause of your muscle problems.
• Your chances of getting muscle problems are higher if you:
  1. oare taking certain other medicines while you take LIPITOR
  2. odrink large amounts of grapefruit juice
  3. oare 65 years of age or older
  4. ohave thyroid problems (hypothyroidism) that are not controlled
  5. ohave kidney problems
  6. oare taking higher doses of LIPITOR
• • Liver problems. Your healthcare provider 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 healthcare provider right away if you have the following symptoms of liver problems:
  • ofeel tired or weak
  • onausea or vomiting
  • oloss of appetite
  • oupper belly pain
  • odark amber colored urine
  • oyellowing 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
• •diarrhea
• •urinary tract infection
• •nausea
• •muscle spasms
• •throat pain

• •muscle and joint pain
• •pain in extremity
• •upset stomach
• •musculoskeletal pain
• •trouble sleeping

Talk to your healthcare provider 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 healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How do I store LIPITOR?

• •Store LIPITOR at room temperature between 68°F to 77°F (20 C to 25°C).
• •Do not keep medicine that is out of date or that you no longer need.
• • Keep LIPITOR and all medicines out of the reach of children.

General information about the safe and effective use of LIPITOR.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use LIPITOR for a condition for which it was not prescribed. Do not give LIPITOR to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information about LIPITOR, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about LIPITOR that is written for health professionals.

What are the ingredients in LIPITOR?

Active Ingredient: atorvastatin calcium

Inactive Ingredients: calcium carbonate, USP; candelilla wax, FCC; croscarmellose sodium, NF; hydroxypropyl cellulose, NF; lactose monohydrate, NF; magnesium stearate, NF; microcrystalline cellulose, NF; Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide); polysorbate 80, NF; simethicone emulsion.

Distributed by:

Viatris Specialty LLC

Morgantown, WV 26505 U.S.A.

© 2024 Viatris Inc.

LIPITOR is a registered trademark of Upjohn Manufacturing Ireland Unlimited Company, a Viatris Company.

For more information, call Viatris at 1-877-446-3679 (1-877-4-INFO-RX).

This Patient Package Information has been approved by the U.S. Food and Drug Administration              Revised: 4/2024

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