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atorvastatin

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Brand names: Lipitor

HMG-CoA Reductase Inhibitor (Statin) Rx

Atorvastatin is a drug that lowers cholesterol and reduces the risk of heart problems and stroke. It belongs to a class of drugs called statins.

Drug Pricing (NADAC)

Brand Price

$12.43/unit

Generic Price

$0.03/unit

Generic Savings

100%

Generic Available

Yes (24 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

Atorvastatin is used to lower bad cholesterol (LDL) and triglycerides in your blood.

Common side effects

Common cold symptoms, Joint pain, Diarrhea

Key warnings

Atorvastatin can cause muscle problems, including muscle pain, tenderness, or weakness.

How It Works

Atorvastatin works by blocking a substance your body needs to make cholesterol. This helps to lower the amount of cholesterol in your blood. Lowering cholesterol can help prevent heart disease.

How to Take It

Take atorvastatin once a day, at any time of day, with or without food. Your doctor may start you on 10 mg to 20 mg daily. The dose can range from 10 mg to 80 mg per day. Your doctor may check your cholesterol levels after 4 weeks and adjust your dose if needed.

Pregnancy & Breastfeeding

Atorvastatin can harm an unborn baby. You should not take atorvastatin if you are pregnant or planning to become pregnant. It is also not recommended to breastfeed while taking atorvastatin.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.

Storage

Store at room temperature, between 68º to 77ºF (20º to 25ºC).

Side Effects (from patient reports)

Based on 111,603 FDA adverse event reports.

Tiredness
13,809
The medicine is not working
12,861
Feeling sick to your stomach
12,421
Type 2 diabetes
11,243
Diarrhea
11,034
Difficulty breathing
11,029
Pain
10,044
Muscle pain
9,798
Feeling lightheaded
9,713
Headache
9,651

FDA Adverse Event Report Analysis

Detailed analysis of 240,204 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2000–2025.

Total Reports

240,204

Death-Related Reports

18,385

Hospitalization Reports

68,513

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 121,275 (54%)
Male 102,566 (45%)

Age Distribution

0–17 569
18–44 7,262
45–64 56,931
65–74 44,581
75+ 38,431

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 FATIGUE 13,812
2 DRUG INEFFECTIVE 12,860
3 NAUSEA 12,425
4 TYPE 2 DIABETES MELLITUS 11,244
5 DIARRHOEA 11,037
6 DYSPNOEA 11,029
7 PAIN 10,041
8 MYALGIA 9,801
9 DIZZINESS 9,713
10 HEADACHE 9,650
11 ASTHENIA 8,837
12 ARTHRALGIA 8,510
13 PAIN IN EXTREMITY 8,172
14 FALL 7,836
15 DEATH 7,428

Reactions in Death Reports

DEATH 7,408
MYOCARDIAL INFARCTION 1,271
PNEUMONIA 1,099
RENAL FAILURE 1,015
DYSPNOEA 1,012
SEPSIS 792
DIARRHOEA 788
ASTHENIA 763
CARDIAC ARREST 763
FALL 762

Reactions in Hospitalization Reports

DYSPNOEA 5,530
PNEUMONIA 4,694
FALL 4,618
NAUSEA 4,471
MYOCARDIAL INFARCTION 4,368
FATIGUE 4,074
DIARRHOEA 3,997
ASTHENIA 3,897
PAIN 3,470
CEREBROVASCULAR ACCIDENT 3,390

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Atorvastatin can cause muscle problems, including muscle pain, tenderness, or weakness. In rare cases, this can lead to serious kidney damage. Tell your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or feel sick. Atorvastatin can also cause liver problems. Your doctor may do blood tests to check your liver before you start taking atorvastatin and while you are taking it.

Known Drug Interactions

Intervention: In patients taking clarithromycin or itraconazole, do not exceed atorvastatin 20 mg [see Dosage and Administration (2.5) ]. Examples: Erythromycin, clarithromycin, itraconazole, ketoconazole, posaconazole, and voriconazole.

Mechanism: Clarithromycin slows down how fast your body processes atorvastatin, which can cause the statin levels to rise too high.

What to do: If you must take both, your doctor should limit your atorvastatin dose to no more than 20 mg per day.

In patients taking saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir or letermovir, do not exceed atorvastatin 20 mg. Examples: Tipranavir plus ritonavir, glecaprevir plus pibrentasvir, lopinavir plus ritonavir, simeprevir, saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir, letermovir, nelfinavir, and ledipasvir plus sofosbuvir.

Mechanism: Darunavir interferes with the enzymes that clear atorvastatin from your system, potentially leading to side effects from too much medicine.

What to do: Your doctor should keep your atorvastatin dose at or below 20 mg daily while you are taking this combination.

Intervention: In patients taking clarithromycin or itraconazole, do not exceed atorvastatin 20 mg [see Dosage and Administration (2.5) ]. Examples: Erythromycin, clarithromycin, itraconazole, ketoconazole, posaconazole, and voriconazole.

Mechanism: Itraconazole prevents your body from breaking down atorvastatin normally, which increases the amount of medicine in your bloodstream.

What to do: Do not take more than 20 mg of atorvastatin each day if you are also using itraconazole.

Table 2: Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with Atorvastatin Cyclosporine or Gemfibrozil Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin and cyclosporine, an inhibitor of CYP3A4 and OATP1B1 [see Clinical Pharmacology (12.3) ]. The risk of myopathy and rhabdomyolysis is increased with concomitant use of cyclosporine or gemfibrozil with atorvastatin. Intervention: Concomitant use of cyclosporine or gemfibrozil with atorvastatin is not recommended.

Mechanism: Cyclosporine stops your body from breaking down and removing atorvastatin, which can lead to very high levels of the drug in your blood. This increases the risk of severe muscle breakdown.

What to do: You should not take these two medications together. Your doctor will likely prescribe a different medicine to avoid the risk of muscle damage.

moderate colchicine

Colchicine Clinical Impact: Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with atorvastatin. Intervention: Consider the risk/benefit of concomitant use of colchicine with atorvastatin.

Mechanism: Both drugs can cause muscle damage, and taking them together increases the risk of a severe muscle breakdown.

What to do: Your doctor should carefully weigh the risks and benefits before prescribing these two drugs together.

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Common Questions

Can I take atorvastatin with food?
Yes, you can take atorvastatin with or without food.
What should I do if I experience muscle pain while taking atorvastatin?
Tell your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or feel sick.
How often will my cholesterol be checked?
Your doctor may check your cholesterol levels about 4 weeks after you start taking atorvastatin and then periodically after that.
Can I drink alcohol while taking atorvastatin?
Talk to your doctor about drinking alcohol while taking atorvastatin, as it may increase your risk of liver problems.
Are there any other medications I should avoid while taking atorvastatin?
Yes, some medications can interact with atorvastatin. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How long will I need to take atorvastatin?
You may need to take atorvastatin long-term to manage your cholesterol levels and reduce your risk of heart problems.
What if I have side effects from atorvastatin?
Talk to your doctor if you have any side effects that bother you or do not go away.
Can children take atorvastatin?
Atorvastatin can be used in children 10 years and older with certain inherited cholesterol problems.
What happens if I stop taking atorvastatin?
If you stop taking atorvastatin, your cholesterol levels may increase.
Does atorvastatin cure high cholesterol?
No, atorvastatin does not cure high cholesterol. It helps to manage it.
What are the common side effects of atorvastatin?
The most commonly reported side effects of atorvastatin include Common cold symptoms, Joint pain, Diarrhea, Pain in arms or legs, Urinary tract infection. Based on 111,603 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does atorvastatin interact with other medications?
Yes, atorvastatin has 36 known drug interactions. Notable interactions include clarithromycin, darunavir, itraconazole. Always inform your doctor about all medications you are taking.
What drug class is atorvastatin?
atorvastatin belongs to the HMG-CoA Reductase Inhibitor (Statin) drug class. It requires a prescription (Rx). Atorvastatin is used to lower bad cholesterol (LDL) and triglycerides in your blood.
Is there a generic version of atorvastatin?
Yes, generic atorvastatin is available from 24 manufacturers. The generic costs $0.03 per unit compared to $12.43 for the brand version, saving approximately 100%. Pricing is based on NADAC (National Average Drug Acquisition Cost) data from CMS.
Is atorvastatin safe during pregnancy?
Atorvastatin can harm an unborn baby. You should not take atorvastatin if you are pregnant or planning to become pregnant. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has atorvastatin been recalled?
There are 7 recalls associated with atorvastatin products. Failed Dissolution Specifications. Check the recalls section below for full details and affected products.

Active Recalls

Class II September 19, 2025

Failed Dissolution Specifications

Ascend Laboratories, LLC

Class II September 19, 2025

Failed Dissolution Specifications

Ascend Laboratories, LLC

Class II March 17, 2025

Failed dissolution specifications: lower than specifications

BIOCON PHARMA INC

Class II September 24, 2024

Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.

Nivagen Pharmaceuticals Inc

Class II March 23, 2023

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc.

Class II March 23, 2023

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc.

Class II March 16, 2023

CGMP Deviations

Northwind Pharmaceuticals LLC

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What the FDA Data Shows for atorvastatin

The FDA label for atorvastatin (sold under brand names such as Lipitor) classifies it as a prescription-only medication in the HMG-CoA Reductase Inhibitor (Statin) class. Atorvastatin is used to lower bad cholesterol (LDL) and triglycerides in your blood. Official labeling lists 9 commonly reported side effects, including Common cold symptoms, Joint pain, Diarrhea.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 111,603 voluntary reports. The database also lists 36 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.03 versus $12.43 for the brand — a 100% generic savings.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 7 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: August 28, 2025

All federal data sources used on this page