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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Atorvastatin

What is ATORVALIQ?

ATORVALIQ is a prescription medicine that contains a cholesterol lowering medicine (statin) called atorvastatin. ATORVALIQ 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 ATORVALIQ 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 ATORVALIQ if you:

  • have liver problems (acute liver failure or decompensated cirrhosis).

  • are allergic to atorvastatin or any of the ingredients in ATORVALIQ. Stop using ATORVALIQ 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

See the end of this Patient Information leaflet for a complete list of ingredients in ATORVALIQ.

Before you take ATORVALIQ, 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. ATORVALIQ may harm your unborn baby. If you become pregnant, stop taking ATORVALIQ and call your healthcare provider right away.

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

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements . ATORVALIQ 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)
  • tipranavir plus ritonavir
  • ledipasvir plus sofosbuvir
  • saquinavir plus ritonavir
  • fosamprenavir
  • elbasvir plus grazoprevir
  • nelfinavir
  • glecaprevir plus pibrentasvir
  • simeprevir
  • darunavir plus ritonavir
  • fosamprenavir plus ritonavir
  • letermovir

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 ATORVALIQ?

  • Take ATORVALIQ exactly as your healthcare provider tells you to take it.
  • Do not change your dose or stop ATORVALIQ without talking to your healthcare provider.
  • Your healthcare provider may do blood tests to check your cholesterol levels during your treatment with ATORVALIQ. Your dose of ATORVALIQ may be changed based on these blood test results.

  • Take ATORVALIQ each day at any time of day. ATORVALIQ should be taken on an empty stomach (1 hour before or 2 hours after a meal).

  • Your healthcare provider should start you on a cholesterol lowering diet before giving you ATORVALIQ. Stay on this cholesterol lowering diet when you take ATORVALIQ.
  • Use an oral dosing syringe to correctly measure your dose of ATORVALIQ. Ask your pharmacist for an oral dosing syringe if you do not have one.
  • If you miss a dose of ATORVALIQ, take it as soon as you remember. Do not take ATORVALIQ if it has been more than 12 hours since you missed your last dose. Wait and take the next dose at your regular time. Do not take 2 doses of ATORVALIQ at the same time.
  • If you take too much ATORVALIQ 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 ATORVALIQ?

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

What are the possible side effects of ATORVALIQ?

ATORVALIQ 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:

    • unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or feel more tired than usual while you take ATORVALIQ.
    • muscle problems that do not go away after your healthcare provider has told you to stop taking ATORVALIQ. 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. o are taking certain other medicines while you take ATORVALIQ
    2. o drink large amounts of grapefruit juice
    3. o are 65 years of age or older
    4. o have thyroid problems (hypothyroidism) that are not controlled
    5. o have kidney problems
    6. o are taking higher doses of ATORVALIQ

  • Liver problems. Your healthcare provider should do blood tests to check your liver before you start taking ATORVALIQ and if you have symptoms of liver problems while you take ATORVALIQ. Call your healthcare provider 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 ATORVALIQ.

    Exercise regularly and make healthy food choices to maintain healthy body weight.

The most common side effects of ATORVALIQ 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

These are not all the possible side effects of ATORVALIQ. For more information, ask you healthcare provider or pharmacist. 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 ATORVALIQ?

  • Store ATORVALIQ at room temperature between 68°F to 77°F (20°C to 25°C) in the original bottle.
  • Throw away (discard) any unused portion of ATORVALIQ in the household trash after 60 days of first opening the bottle.
  • Do not keep medicine that is out of date or that you no longer need.
  • Keep ATORVALIQ and all medicines out of the reach of children.

General information about the safe and effective use of ATORVALIQ.

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

What are the ingredients in ATORVALIQ?

Active Ingredient: atorvastatin calcium

Inactive Ingredients: carboxymethylcellulose sodium, magnesium aluminum silicate, methylparaben, ethylparaben, propylparaben, sucralose, acesulfame potassium, orange flavor, water.

Distributed by:

CMP Pharma Inc.

Farmville, NC 27828 U.S.A

For more information, go to the ATORVALIQ website at www.atorvaliq.com

This Patient Information has been approved by the U.S. Food and Drug Administration Issued: 02/2023

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 213260 · View the label on DailyMed

Revision date stated in the text: February 2023

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Atorvastatin

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class HMG-CoA Reductase Inhibitor
Active ingredient Atorvastatin calcium trihydrate 20 mg/5 mL
Dosage form Suspension
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) CMP DEV LLC
FDA approval NDA 213260New Drug Application (NDA) Approved February 1, 2023
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 38 labelers list this drug on DailyMed
Recalls
  • September 19, 2025: Class II recall: Failed Dissolution Specifications
  • September 19, 2025: Class II recall: Failed Dissolution Specifications
  • September 19, 2025: Class II recall: Failed Dissolution Specifications
Show more recalls (2)+
  • September 19, 2025: Class II recall: Failed Dissolution Specifications
  • March 17, 2025: Class II recall: Failed dissolution specifications: lower than specifications
Packages (NDC)
Package
20 mg/5 mL – 150 ml in 1 bottle NDC 46287-030-01

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.