Prescription medication · HMG-CoA Reductase Inhibitor (Statin)
atorvastatin
Also sold as Lipitor. Atorvastatin is used to lower bad cholesterol (LDL) and triglycerides in your blood.
Data updated 2026-05-15
- 240,204
- FDA reportsHeavily reported
- 36
- InteractionsSeveral interactions
- 99% less
- Generic vs brandHuge savings
- 7
- Recall records
What the data shows
atorvastatin (Lipitor) is a prescription HMG-CoA Reductase Inhibitor (Statin), in the top 5% of tracked drugs by FAERS report volume (240,204 FDA reports), whose generic costs a fraction of the brand (about 99% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
atorvastatin (Lipitor) is a prescription HMG-CoA Reductase Inhibitor (Statin). Atorvastatin is used to lower bad cholesterol (LDL) and triglycerides in your blood.
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.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$12.43/unit
Generic Price
$0.03/unit
Generic Savings
99%
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.
The sections below are summarized in plain English from atorvastatin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
This is a plain-language summary of atorvastatin's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of atorvastatin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
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.
This is a plain-language summary of atorvastatin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at room temperature, between 68º to 77ºF (20º to 25ºC).
Side Effects (from patient reports)
Based on 240,204 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for atorvastatin, by number of reports
- Tiredness
Tiredness
13,809 reports
- Feeling sick to your stomach
Feeling sick to your stomach
12,421 reports
- Type 2 diabetes
Type 2 diabetes
11,243 reports
- Diarrhea
Diarrhea
11,034 reports
- Difficulty breathing
Difficulty breathing
11,029 reports
- Pain
Pain
10,044 reports
- Muscle pain
Muscle pain
9,798 reports
- Feeling lightheaded
Feeling lightheaded
9,713 reports
- Headache
Headache
9,651 reports
- Weakness
Weakness
8,831 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for atorvastatin each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where atorvastatin sits
atorvastatin has more FDA adverse-event reports than 96% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is atorvastatin; the line is the median (50th percentile).
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
Reports Mentioning Death
18,385
7.7% of reports — not proof of cause
Hospitalization Reports
68,513
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | FATIGUE | 13,812 |
| 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 |
| 17 | MALAISE | 6,892 |
Reactions in Death Reports
Reactions in Hospitalization Reports
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.
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.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I take atorvastatin with food?
What should I do if I experience muscle pain while taking atorvastatin?
How often will my cholesterol be checked?
Can I drink alcohol while taking atorvastatin?
Are there any other medications I should avoid while taking atorvastatin?
How long will I need to take atorvastatin?
What if I have side effects from atorvastatin?
Can children take atorvastatin?
What happens if I stop taking atorvastatin?
Does atorvastatin cure high cholesterol?
What are the common side effects of atorvastatin?
Does atorvastatin interact with other medications?
What drug class is atorvastatin?
Is there a generic version of atorvastatin?
Is atorvastatin safe during pregnancy?
Has atorvastatin been recalled?
Active Recalls
Failed Dissolution Specifications
Ascend Laboratories, LLC
Failed Dissolution Specifications
Ascend Laboratories, LLC
Failed dissolution specifications: lower than specifications
BIOCON PHARMA INC
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
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Preferred Pharmaceuticals, Inc.
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Preferred Pharmaceuticals, Inc.
CGMP Deviations
Northwind Pharmaceuticals LLC
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 240,204 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 99% 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
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages