Prescription medicine
Atorvastatin Brand names: Lipitor, Atorvaliq
Atorvastatin (Lipitor) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 59 generic labelers, and pharmacies paid $0.0228 per atorvastatin 10 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $1.23 per mL (Atorvaliq 20 mg/5 mL suspension).
- Generic listed
Check it at the source: the atorvastatin FDA label on DailyMed (effective April 15, 2024, Viatris Specialty LLC); the NDA 20702 record on Drugs@FDA; every atorvastatin label on DailyMed.
Highlights of the record
FDA label of April 15, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageLIPITOR is indicated:
To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization p
Forms and strengths
- 10 mg
- 20 mg
- 40 mg
- 80 mg
- 20 mg/5ml
Film-coated tablet; tablet; coated tablet; suspension.
On the market
- Earliest approval on file
- December 17, 1996 Lipitor, Upjohn; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 33 first November 30, 2011; 24 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 61 of which 59 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- June 7, 2037 Atorvaliq oral suspension; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0228 per tablet Atorvastatin 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 53 since 2012 0 Class I among all firms' recalls; latest September 19, 2025
- FAERS reports
- 245,894 through July 30, 2026
What is atorvastatin used for?
From the label: indications and usageLIPITOR is indicated:
To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD
As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). […]
Conditions named in the indications of atorvastatin's FDA labels, with every medicine labeled for each:
From other atorvastatin labelsAngina: Reduce the risk of MI, stroke, revascularization procedures, and angina in adult patients without CHD, but with multiple risk factors ( 1.1 ).
High triglycerides: Reduce elevated TG in adult patients with hypertriglyceridemia and primary dysbetalipoproteinemia ( 1.2 ).
Heart attack and coronary artery disease: Reduce the risk of myocardial infarction
FDA pharmacologic class: HMG-CoA Reductase Inhibitor.
Source: FDA drug label (Lipitor), NDA020702 (Upjohn), as published by Viatris Specialty LLC, effective April 15, 2024 (SPL set a60cc18b-0631-4cf0-b021-9f52224ece65), via openFDA; the full label on DailyMed
What does the patient leaflet for atorvastatin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking LIPITOR?Avoid drinking more than 1.2 liters of grapefruit juice each day.
Source: FDA drug label (Lipitor), NDA020702 (Upjohn), as published by Viatris Specialty LLC, effective April 15, 2024 (SPL set a60cc18b-0631-4cf0-b021-9f52224ece65), via openFDA; the full label on DailyMed
Is there a generic for atorvastatin (Lipitor)?
The FDA approved the first generic atorvastatin on November 30, 2011. 33 generic applications are approved; 24 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists atorvastatin from 59 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Lipitor tablets; a patent listed only for Atorvaliq oral suspension runs to June 7, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1996 earliest approval on file
- 2011 first generic approved
- 2037 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for atorvastatin (Lipitor)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0228 per Atorvastatin 10 mg tablet, down 8% from $0.0248 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Atorvastatin 10 mg tablet (generic)
- Atorvaliq 20 mg/5 mL suspension (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Atorvastatin 10 mg tablet | Generic | $0.0228 per tablet | $0.685 | -8% |
| Atorvastatin 20 mg tablet | Generic | $0.0279 per tablet | $0.838 | -12% |
| Atorvastatin 40 mg tablet | Generic | $0.0374 per tablet | $1.12 | -12% |
| Atorvastatin 80 mg tablet | Generic | $0.0693 per tablet | $2.08 | -5% |
| Atorvaliq 20 mg/5 mL suspension | Brand | $1.23 per mL | n/a | +4% |
| Lipitor 10 mg tablet | Brand | $13.41 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $402.25 | +5% |
| Lipitor 20 mg tablet | Brand | $19.07 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $572.18 | +5% |
| Lipitor 40 mg tablet | Brand | $19.11 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $573.41 | +5% |
| Lipitor 80 mg tablet | Brand | $19.00 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $570.12 | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has atorvastatin been recalled?
The FDA's Enforcement Report lists 53 recalls naming atorvastatin since 2012: 0 Class I (the most serious), 37 Class II, 16 Class III; 8 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 19, 2025 | Class II | Ascend Laboratories, LLC | Failed Dissolution Specifications |
| March 17, 2025 | Class II | BIOCON PHARMA INC | Failed dissolution specifications: lower than specifications |
| September 24, 2024 | Class II | Nivagen Pharmaceuticals 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 … |
| March 23, 2023 | Class II | Preferred Pharmaceuticals, Inc. | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. |
| March 20, 2023 | Class II | RemedyRepack Inc. | cGMP Deviations |
| March 16, 2023 | Class II | Northwind Pharmaceuticals LLC | CGMP Deviations |
| February 7, 2023 | Class II | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. |
| March 16, 2022 | Class III | Dr. Reddy's Laboratories, Inc. | Failed Impurities/Degradation Specifications: Out of Specification results for related substance. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the atorvastatin label say about other medicines?
The atorvastatin label names 21 other medicines in its interaction, contraindication or warning sections. The labels of 50 other medicines name atorvastatin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Clarithromycin | drug interactions | Select Azole Antifungals or Macrolide Antibiotics Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of LIPITOR with select azole antifungals or macrolide antibiotics, due to inhibition of CYP3A4 and/or transporters. Intervention: In patients taking clarithromycin or itraconazole, do not exceed LIPITOR 20 mg [see ]. Consider the risk/benefit of concomitant use of other azole antifungals or macrolide antibiotics with LIPITOR. … |
| Colchicine | drug interactions | Colchicine Clinical Impact: Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with LIPITOR. Intervention: Consider the risk/benefit of concomitant use of colchicine with LIPITOR. If concomitant use is decided, monitor patients for signs and symptoms of myopathy particularly during initiation of therapy and … |
| Cyclosporine | drug interactions | Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with LIPITOR Cyclosporine or Gemfibrozil |
| Darunavir | drug interactions | Anti-Viral Medications Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of LIPITOR with many anti-viral medications, which are inhibitors of CYP3A4 and/or transporters (…). … concomitant use with atorvastatin. • In patients taking saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir or letermovir, do not exceed LIPITOR 20 … |
| Digoxin | drug interactions | May increase digoxin plasma levels; monitor patients appropriately ( 7.3 ). |
| Efavirenz | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Erythromycin | drug interactions | Select Azole Antifungals or Macrolide Antibiotics Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of LIPITOR with select azole antifungals or macrolide antibiotics, due to inhibition of CYP3A4 and/or transporters. … initiation of therapy and during upward dose titration of either drug. Examples: Erythromycin, clarithromycin, itraconazole, ketoconazole, posaconazole, and voriconazole. |
| Fenofibrate | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Fosamprenavir | drug interactions | Anti-Viral Medications Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of LIPITOR with many anti-viral medications, which are inhibitors of CYP3A4 and/or transporters (…). … • In patients taking saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir or letermovir, do not exceed LIPITOR 20 mg. … |
| Gemfibrozil | drug interactions | Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with LIPITOR Cyclosporine or Gemfibrozil |
| Itraconazole | drug interactions | Select Azole Antifungals or Macrolide Antibiotics Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of LIPITOR with select azole antifungals or macrolide antibiotics, due to inhibition of CYP3A4 and/or transporters. Intervention: In patients taking clarithromycin or itraconazole, do not exceed LIPITOR 20 mg [see ]. Consider the risk/benefit of concomitant use of other azole antifungals or macrolide antibiotics with LIPITOR. … |
| Ketoconazole | drug interactions | Select Azole Antifungals or Macrolide Antibiotics Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of LIPITOR with select azole antifungals or macrolide antibiotics, due to inhibition of CYP3A4 and/or transporters. … titration of either drug. Examples: Erythromycin, clarithromycin, itraconazole, ketoconazole, posaconazole, and voriconazole. |
| Letermovir | drug interactions | Anti-Viral Medications Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of LIPITOR with many anti-viral medications, which are inhibitors of CYP3A4 and/or transporters (…). … fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir or letermovir, do not exceed LIPITOR 20 mg. • In patients taking nelfinavir, do not exceed LIPITOR 40 mg [see ]. … |
| Nelfinavir | drug interactions | Anti-Viral Medications Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of LIPITOR with many anti-viral medications, which are inhibitors of CYP3A4 and/or transporters (…). … grazoprevir or letermovir, do not exceed LIPITOR 20 mg. • In patients taking nelfinavir, do not exceed LIPITOR 40 mg [see ]. • Consider the risk/benefit of concomitant use of ledipasvir plus sofosbuvir with LIPITOR. … |
Every other medicine the atorvastatin label names
| Medicine named | Section | What the label says |
|---|---|---|
| Niacin | drug interactions | Niacin Clinical Impact: Cases of myopathy and rhabdomyolysis have been observed with concomitant use of lipid modifying dosages of niacin (≥1 gram/day niacin) with LIPITOR. Intervention: Consider if the benefit of using lipid modifying dosages of niacin concomitantly with LIPITOR outweighs the increased risk of myopathy and rhabdomyolysis. … |
| Norethindrone | drug interactions | Oral Contraceptives: May increase plasma levels of norethindrone and ethinyl estradiol; consider this effect when selecting an oral contraceptive ( 7.3 ). |
| Posaconazole | drug interactions | Select Azole Antifungals or Macrolide Antibiotics Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of LIPITOR with select azole antifungals or macrolide antibiotics, due to inhibition of CYP3A4 and/or transporters. … drug. Examples: Erythromycin, clarithromycin, itraconazole, ketoconazole, posaconazole, and voriconazole. |
| Rifampin | drug interactions | Drug Interactions that may Decrease Exposure to LIPITOR Rifampin |
| Ritonavir | drug interactions | Anti-Viral Medications Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of LIPITOR with many anti-viral medications, which are inhibitors of CYP3A4 and/or transporters (…). … Intervention: • Concomitant use of tipranavir plus ritonavir or glecaprevir plus pibrentasvir with LIPITOR is not recommended. • In patients taking lopinavir plus ritonavir, or simeprevir, consider the risk/benefit of … |
| Sofosbuvir | drug interactions | Anti-Viral Medications Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of LIPITOR with many anti-viral medications, which are inhibitors of CYP3A4 and/or transporters (…). … [see ]. • Consider the risk/benefit of concomitant use of ledipasvir plus sofosbuvir with LIPITOR. • Monitor all patients for signs and symptoms of myopathy particularly during initiation of therapy and during upward … |
| Voriconazole | drug interactions | Select Azole Antifungals or Macrolide Antibiotics Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of LIPITOR with select azole antifungals or macrolide antibiotics, due to inhibition of CYP3A4 and/or transporters. … Erythromycin, clarithromycin, itraconazole, ketoconazole, posaconazole, and voriconazole. |
Other labels that name atorvastatin
- Amiodarone
- Atazanavir
- Cobicistat
- Danazol
- Drospirenone and ethinyl estradiol
- Drospirenone and ethinyl estradiol and levomefolate
- Elbasvir and grazoprevir
- Eltrombopag
- Ethinyl estradiol and etonogestrel
- Ethinyl estradiol and ferrous bisglycinate and levonorgestrel
- Ethinyl estradiol and ferrous fumarate and levonorgestrel
- Ethinyl estradiol and levonorgestrel
- Ethinyl estradiol and norelgestromin
- Ethinyl estradiol and norgestimate
- Ethinyl estradiol and segesterone
- Everolimus
- Fluconazole
- Fostemsavir
- Glecaprevir and pibrentasvir
- Isavuconazonium
- Leflunomide
- Levoketoconazole
- Lonafarnib
- Nefazodone
- Nirmatrelvir and ritonavir
- Quinine
- Resmetirom
- Sarilumab
- Siltuximab
- Sodium zirconium cyclosilicate
- Teriflunomide
- Tocilizumab
- Verapamil
- Voclosporin
Source: FDA drug label (Lipitor), NDA020702 (Upjohn), as published by Viatris Specialty LLC, effective April 15, 2024 (SPL set a60cc18b-0631-4cf0-b021-9f52224ece65), via openFDA; the full label on DailyMed
What do FAERS reports show for atorvastatin?
The FDA Adverse Event Reporting System holds 245,894 reports that list atorvastatin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 18,672 are coded as a death and 70,054 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as atorvastatin?
19 other medicines are given the same way (oral) and in the same FDA class as atorvastatin or labeled mainly for the same use (high cholesterol), the same class first. High cholesterol lists all 25 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Rosuvastatin | Heart attack and coronary artery disease, High cholesterol, High triglycerides | 46 labelers | $0.0692 per tablet 40 mg tablet | No current entry |
| Pravastatin | Heart attack and coronary artery disease, High cholesterol, High triglycerides | 37 labelers | $0.058 per tablet 20 mg tablet | No current entry |
| Simvastatin | Heart attack and coronary artery disease, High cholesterol, High triglycerides | 27 labelers | $0.0321 per tablet 20 mg tablet | No current entry |
| Lovastatin | Heart attack and coronary artery disease, High cholesterol | 19 labelers | $0.0436 per tablet 20 mg tablet | No current entry |
| Pitavastatin | High cholesterol | 12 labelers | $0.954 per tablet 2 mg tablet | No current entry |
| Ezetimibe and simvastatin | Heart attack and coronary artery disease, High cholesterol | 7 labelers | $0.285 per unit 10-80 mg | No current entry |
| Fluvastatin | High cholesterol | 4 labelers | $2.88 per tablet 80 mg tablet | A presentation being discontinued |
| Fenofibrate | High cholesterol, High triglycerides | 54 labelers | $0.103 per tablet 160 mg tablet | No current entry |
Every medicine labeled for the same conditions as atorvastatin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does atorvastatin compare with medicines for the same use?
17 side-by-side pages set atorvastatin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to atorvastatin
- 19 medicines for the same use
- Other statins
- the pharmacologic class, with prices and generics
- Atorvastatin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other