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 →
NADAC price trail: ATORVASTATIN 10 MG TABLET
Same CMS presentation as the headline generic unit price above (4 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -13.1% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| July 17, 2024 | $0.0234/EA | - | 2 |
| September 18, 2024 | $0.0302/EA | +28.7% | 1 |
| October 23, 2024 | $0.0296/EA | -1.9% | 2 |
| December 18, 2024 | $0.0257/EA | -13.1% | 59 |
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.
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
- Fatigue
Fatigue
13,812 reports
- Nausea
Nausea
12,425 reports
- Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus
11,244 reports
- Diarrhoea
Diarrhoea
11,037 reports
- Dyspnoea
Dyspnoea
11,029 reports
- Pain
Pain
10,041 reports
- Myalgia
Myalgia
9,801 reports
- Dizziness
Dizziness
9,713 reports
- Headache
Headache
9,650 reports
- Asthenia
Asthenia
8,837 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) 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.
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.
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for atorvastatin?
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
Related Medications in HMG-CoA Reductase Inhibitor (Statin)
Other drugs grouped near atorvastatin - same-class peers and common alternatives.
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Nexlizet
Nexlizet is a combination medicine that helps lower cholesterol.
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cholestyramine
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Cholestyramine is a medicine that helps lower high cholesterol levels in your blood.
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colestipol
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Colestipol is a drug that helps lower cholesterol levels in your blood.
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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for atorvastatin: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 240,204.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 7.65%.
- risperidone Δ 0.01 pts · 129,958 reports · Atypical Antipsychotic 7.66%death share
- misoprostol Δ 0.01 pts · 9,536 reports · Prostaglandin E1 Analog 7.64%death share
- tizanidine Δ 0.01 pts · 22,750 reports · Central Alpha-2 Agonist (Muscle Relaxant) 7.64%death share
- felodipine Δ 0.03 pts · 11,019 reports · Calcium Channel Blocker 7.62%death share
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
FDA bioequivalence and label-record context for narrow therapeutic index medicines
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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: August 28, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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