Atorvastatin (Lipitor): Top 12 Drug Facts You Need to Know
1. What is atorvastatin (Lipitor)?
Atorvastatin calcium (brand name: Lipitor) is a medicine in a class of drugs called HMG CoA reductase inhibitors, also referred to as "statins." Pfizer’s Lipitor was first approved in 1996 and is considered one of the most successful selling drugs of all time. In 2006, Lipitor had the top U.S. drug sales of over $13 billion. Even today, after its patent loss in 2011, atorvastatin is still one of the most prescribed medications in the U.S.
As a drug class, statins are used by over 35 million people in the U.S. Statins are usually the first drug used to treat people with high cholesterol levels or heart disease. They help to reduce the risk of stroke and heart attacks, heart surgery, or chest pain (angina) due to coronary heart disease. If you have high cholesterol plus diabetes, high blood pressure, obesity, or a history of smoking, statins may be especially helpful for you.
A doctor might prescribe this drug for you if you are not able to lower your cholesterol after following a low-fat diet and a program of regular exercise. Atorvastatin can be used in adults and children over the age of 10 years.
Atorvastatin is considered a moderate- or high-intensity statin depending upon the dose:
- A dose of 10 to 20 mg per day is considered moderate-intensity therapy with an expected LDL (low density lipoprotein) reduction of 30% to 50%.
- A dose of 40 to 80 mg per day is considered high-intensity therapy with an expected LDL reduction of 50% or greater.
Atorvastatin is one of the many statin drugs on the market. If you and your doctor decide you should start a cholesterol-lowering medication, the choice of drug and your dose is based on many factors, like:
- your risk factors for heart disease, or if you currently have ongoing heart disease
- your cholesterol levels
- your previous treatments for high cholesterol, if any
- your family history for heart disease
- if you have diabetes
- other prescription drugs or medications you take
- adverse effects
2. What does atorvastatin do to the body?
Atorvastatin works by reducing your "bad" cholesterol (low density lipoprotein, or LDL cholesterol) and triglycerides in the blood, while increasing levels of “good" cholesterol (high density lipoprotein, or HDL cholesterol). It can lower the build-up of cholesterol plaque in your blood vessels and arteries that could lead to a heart attack.
It does this by blocking an enzyme known as 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase in the liver. Blocking this enzyme helps to lower the production and increase the removal of bad cholesterol from your body.
Statins typically start to lower your cholesterol levels in about 2 weeks. Roughly two months after you start statin therapy your doctor will check your cholesterol levels with a simple blood test to see how well the drug is working.
Related Information: Cholesterol Testing: What Do Your Results Mean?
3. How does atorvastatin come at the pharmacy?
Atorvastatin is an oral tablet you take by mouth once a day to help lower your cholesterol. It is a prescription drug and comes as a generic and brand name (Lipitor) product. Both products come in strengths of 10 mg, 20 mg, 40 mg, and 80 mg.
Atorvastatin can also be found in combination drugs, such as:
- amlodipine and atorvastatin (brand name: Caduet), a combination calcium channel blocker and statin drug used to help lower cholesterol and blood pressure.
- atorvastatin and ezetimibe (generic only), a combination of two drugs that help to lower cholesterol and triglycerides in people with an inherited form of high cholesterol.
Table 1. List of Brand and Generic Statins in the U.S.
|Generic name||Brand name(s)||Are Generics Available?|
|fluvastatin||Lescol, Lescol XL||yes|
|lovastatin ER (extended-release form)||Altoprev||no|
|pitavastatin||Livalo, Zypitamag||no (generic FDA approved but not yet on market)|
|simvastatin (oral suspension)||FloLipid||no|
What do atorvastatin tablets look like?
- There are many different generic manufacturers and tablets may look different: different shapes, colors or numbers on the pill.
- The best way to see a picture of an atorvastatin tablet is to look at the atorvastatin images in the Pill Identifier Wizard. Here you can search for any drug image by entering the drug name, the imprint code, the pill color, or the pill shape.
- You can also view an image of the brand name product Lipitor.
4. How much does atorvastatin cost?
Most of the drugs in the statin class are now available generically and are affordable for almost everyone. While prices differ between cities and pharmacies, atorvastatin usually costs about $10 to $20 for a month supply using an online coupon. Insurance will most likely pay for atorvastatin with a copay. Your cost may even be cheaper if you pay cash instead of a copay, so check with your pharmacist before you fill your prescription.
If you find you cannot afford your medication, talk to your doctor or pharmacist about ways you may be able to lower your costs. These medications can be life-saving and it is important that you take your medication as prescribed.
5. Should I take atorvastatin at night?
You can take atorvastatin at any time of the day because the amount of time the drug is active (known as the half-life) is long. This drug inhibits the HMG-CoA reductase enzyme for about 20 to 30 hours. This means you can take it at any time during the day or night, but you should take your dose at the same time each day. Some statins should be taken only at night, so be sure to follow the directions on your prescription bottle.
6. Does atorvastatin cause muscle pain?
Yes, muscle pain and weakness is one of the most common complaints with statins. The muscle pain can occur in several different ways.
- Mild to moderate muscle pain (myalgia) is the most commonly reported side effect with statins, and 1% to 10% (1 to 10 out of every 100 people) may report this effect.
- Myositis is a less common inflammation of your muscles that may be accompanied by an elevation in your creatine kinase (CK) which can be determined from a blood test.
- Rhabdomyolysis is a very rare but serious form of muscle pain, occurring in less than 0.1% of people. Severe effect leads to a rapid breakdown of muscle tissue, high elevation of creatine kinase (over 10 times higher), and possible kidney damage or kidney failure.
Severe muscle breakdown and kidney damage occurs more often in women, in older patients, or those with ongoing kidney disease or an underactive thyroid (hypothyroidism).
Drug interactions can also lead to muscle pain. Use of higher doses of atorvastatin with certain medications, such as cyclosporine, clarithromycin, itraconazole, and some HIV and hepatitis drugs can increase the risk of muscle pain. Always have your pharmacist run a drug interaction screen any time to start or stop a new medication.
If you notice symptoms of muscle toxicity or rhabdomyolysis such as fatigue, malaise, pain, tenderness, stiffness, cramping, weakness, bruising, low urine output, fever, or brown-colored urine you should call your doctor immediately. Your medication may need to be stopped, your dose adjusted or your medication changed completely.
7. How does atorvastatin cause type 2 diabetes?
The use of statins may lead to a small increased risk of higher blood sugar (glucose) levels and type 2 diabetes. In general, most doctors agree that the benefits of statins in lowering your heart risk clearly outweigh any risk from the development of diabetes.
A large review of 13 studies (called a meta-analysis) with over 90,000 patients found that use of statins does lead to a small but statistically significant increased risk of developing diabetes (9%). Statins appear to elevate diabetes risk by impairing insulin sensitivity and insulin secretion, although the exact causes are not fully known. One study suggested an immune response may stop insulin from doing its job properly.
Studies seems to suggest that pravastatin is the statin with the lowest risk of causing diabetes, and high-intensity therapy, such as atorvastatin, rosuvastatin or simvastatin may lead to a greater risk. A review from Lancet estimated that if 10,000 patients were treated for 5 years with atorvastatin 40 mg per day (high-intensity therapy), 50 to 100 new cases of type 2 diabetes might occur.
8. Will atorvastatin make me drowsy?
While atorvastatin won’t cause you to be drowsy or sleepy right after you take it, some people do experience a level of lower energy and tiredness (fatigue) throughout the day. Higher doses may worsen this effect, and women seem to be especially at risk. Fatigue or weakness may also be a sign of more serious effects, such as muscle problems or liver toxicity.
Research published in the journal Archives of Internal Medicine evaluated the side effect of fatigue with statins. Researchers looked at the effect of two other statins, pravastatin and simvastatin, compared to a placebo (sugar pill) in 1016 people. Forty percent, or about 4 out of 10 women reported fatigue and loss of energy after exertion. Older people between 70 and 75 years of age also experienced this effect.
9. Does atorvastatin cause liver problems?
Atorvastatin can cause liver damage. In clinical trials, liver toxicity was reported in less than 1% (1 out of 100) of patients overall, but was more common with higher doses. Statins are extensively metabolized (broken down) by the liver. Your doctor will check your liver enzymes with a simple blood test before you start treatment with statins.
Liver problems might first be noticed on a blood test ordered by your doctor or you might have symptoms of liver disease. Enzyme blood levels (known as transaminases, or AST and ALT) may be high in your lab report. If these levels get to be about 3 times higher than normal, your doctor may decide to stop your medication, lower your dose, or change your medication to a different class.
If you notice symptoms of liver disease, such as severe fatigue or weakness along with loss of appetite, stomach pain, dark-colored urine or yellowing of skin or eyes, contact your doctor for medical advice immediately.
Can I drink alcohol while taking atorvastatin?
There is no specific drug interaction between alcohol and atorvastatin; however, you may consider limiting your alcohol intake because statins plus excessive alcohol may raise your triglyceride levels and possibly lead to liver toxicity. If you drink more than 2 glasses of alcohol per day, discuss this with your doctor. High cholesterol and alcohol use can be linked if alcohol is consumed chronically and excessively.
Learn More: Cholesterol Medications and Alcohol Interactions
Other common side effects of atorvastatin
Statins are usually well-tolerated. If a side effect does occur, your doctor might lower your dose to see if the side effect will subside, or switch you to another statin.
In addition to muscle or joint pain, other common side effects include:
- upset stomach
- memory loss
These are not all the side effects that may occur with the use of atorvastatin. Ask your doctor or pharmacist for a complete list or view more atorvastatin side effects here.
Who should not use atorvastatin?
Do not use atorvastatin if:
- you have previously had a serious allergic reaction to Lipitor, atorvastatin or any inactive ingredient in the medication.
- you have active liver disease or elevated liver enzymes.
- you are pregnant.
- you are breastfeeding.
10. Why does atorvastatin have a drug interaction with grapefruit juice?
Drinking grapefruit juice or eating grapefruit while taking atorvastatin (Lipitor) can increase the risk of some side effects, such as liver disease or muscle damage. Blood levels of the drug may increase leading to side effects.
Drug levels rise because grapefruit compounds block enzymes involved in the breakdown of atorvastatin (known as cytochrome P450 3A4 [CYP3A4] enzymes). These enzymes are involved in the metabolism of more than 50% of all drugs, and are needed to help eliminate drugs from the body.
Lovastatin and simvastatin also have drug interactions with grapefruit juice, and you should not drink grapefruit juice at all with these medications.
The drug maker of atorvastatin suggests that people taking this drug avoid large quantities of grapefruit juice (more than 1 quart per day). Always follow the directions on your prescription label.
If you drink grapefruit juice on a daily basis, tell your doctor. He or she may decide to change your statin to one that does not interact with grapefruit juice (such as pravastatin, fluvastatin, rosuvastatin, or pitavastatin). Some interactions are theoretical, based on their CYP3A4 enzymes, but a warning is still important.
Learn More: Common Grapefruit Juice Drug Interactions
11. Why was there an atorvastatin recall?
There have been several recalls of generic atorvastatin in the past. In general, generic drugs are extremely safe to use and recalls are not a common occurrence. However, they do happen. If there is a recall on a medication you were prescribed, contact your pharmacist to return the medication and get a safe substitute.
- In May 2018, Dr. Reddy’s Laboratories Inc. recalled close to 6,400 bottles of atorvastatin calcium tablets due to a report of an embedded object in one tablet.
- In March 2014, India-based Ranbaxy, the original generic pharmaceutical manufacturer of atorvastatin, recalled over 64,000 thousand bottles of the drug due to a possible tablet mix-up in their atorvastatin shipments. A pharmacist found a stray 20-milligram (mg) tablet in a sealed 10-mg bottle, according to the U.S. Food and Drug Administration (FDA).
- In addition, Ranbaxy also issued a recall in November 2012 due to glass particles found in atorvastatin bottles.
Although substandard quality control issues can be alarming for the public, most US generic manufacturers can be trusted to produce equivalent generic substitutions due to regulatory oversight from the FDA. In fact, it is the FDA inspections and regulatory action that halted the Ranbaxy shipments. In addition, many other manufacturers also make high-quality versions of generic atorvastatin.
To see if there is an FDA recall, visit: Drugs.com FDA Medwatch Alerts
12. Can I stop taking atorvastatin?
Do not stop taking any medication unless you have discussed this with your doctor. If your doctor has recommended that you take a statin drug, it is important that you continue this medication long-term to help protect you from a heart attack or stroke. Most people continue taking their statins as a lifelong medication. Some people who adhere to a strict diet and exercise routine may be able to stop their statin, but this is not the norm.
If you need to stop your atorvastatin because of a side effect, drug interaction, or other medical issue, your doctor will either choose another stain to use or prescribe another class of cholesterol-lowering medication. Be sure to contact your healthcare proivder to discuss your options.
- Cholesterol Overview: Know Your Risk
- Medications for High Cholesterol
- Side-by-Side Comparisons of Statins
- 2018 Guideline on the Management of Blood Cholesterol. A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. Nov 2018; DOI: 10.1016/j.jacc.2018.11.003 Updated June 2019.
- Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials.. Sattar N, Preiss D, Murray HM, et al. Lancet. 2010;375(9716):735. Epub 2010 Feb 16.
- Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. Ridker PM, Danielson E, Fonseca FA, et al. JUPITER Study Group. N Engl J Med. 2008;359(21):2195. Epub 2008 Nov 9.
- Interpretation of the evidence for the efficacy and safety of statin therapy. Collins R, Reith C, Emberson J, et al. Lancet. 2016;388(10059):2532. Epub 2016 Sep 8.
- Laakso M, Kuusisto J. Diabetes Secondary to Treatment with Statins. Curr Diab Rep. 2017 Feb;17(2):10. doi: 10.1007/s11892-017-0837-8.
- Golomb B, Evans M, Dimsdale J. Effects of Statins on Energy and Fatigue With Exertion: Results From a Randomized Controlled Trial. Arch Intern Med. 2012;172(15):1180-1182. doi:10.1001/archinternmed.2012.2171
- Worldwide revenue of Pfizer's Lipitor from 2003 to 2018 (in million U.S. dollars). Statista. https://www.statista.com/statistics/254341/pfizers-worldwide-viagra-revenues-since-2003/
- Rosenson R, et al. Patient education: High cholesterol and lipids (hyperlipidemia) (Beyond the Basics). https://www.uptodate.com/contents/high-cholesterol-and-lipids-hyperlipidemia-beyond-the-basics
- Rosenson R, et al. Patient Education: High cholesterol treatment options. Beyond the Basics. Up to Date. https://www.uptodate.com/contents/high-cholesterol-treatment-options-beyond-the-basics
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.