Atorvastatin
Generic name: atorvastatin calcium · Brand names: Lipitor, Atorvaliq (oral suspension, not covered here), Caduet (combination with amlodipine, not covered), Lypqozet (combination with ezetimibe, not covered)
Quick facts
Drug class
Statin (HMG-CoA reductase inhibitor). openFDA pharmacologic class: HMG-CoA Reductase Inhibitor [EPC].
Source
DailyMed Macleods label Highlights; openFDA https://api.fda.gov/drug/label.json?search=openfda.generic_name.exact:%22ATORVASTATIN%20CALCIUM%22&count=openfda.pharm_class_epc.exact
Source text (exact source wording)
Atorvastatin calcium tablets is an HMG-CoA reductase inhibitor (statin) indicated (1):
Rx or otc
Rx (DailyMed label type: HUMAN PRESCRIPTION DRUG LABEL)
Forms and strengths
- Tablets, USP: 10 mg; 20 mg; 40 mg; 80 mg of atorvastatin (Macleods film-coated tablets debossed M35, M36, M37, M38). Source: Section 3, DailyMed Macleods label
- Other forms exist (Atorvaliq oral suspension per MedlinePlus); not covered in this record
Generic available
Value
Yes; many ANDA tablet labels on DailyMed (Macleods, Mylan, Dr. Reddy's, others)
Source
DailyMed list https://dailymed.nlm.nih.gov/dailymed/services/v2/spls.json?drug_name=atorvastatin
Common use one line
Lowers LDL cholesterol and the risk of heart attack and stroke (Section 1).
What it is used for
Atorvastatin is a statin. The label lists these uses: lowering the risk of heart attack, stroke and related problems in adults with risk factors for coronary heart disease, in adults with type 2 diabetes, and in adults with clinically evident coronary heart disease. It is also used with diet to lower LDL cholesterol in adults with primary hyperlipidemia, and in adults and children aged 10 years and older with heterozygous familial hypercholesterolemia. It is used with other treatments to lower LDL cholesterol in adults and children aged 10 years and older with homozygous familial hypercholesterolemia. It is used with diet in adults with primary dysbetalipoproteinemia or hypertriglyceridemia.
Section
1 INDICATIONS & USAGE
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
Atorvastatin calcium tablets 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). • As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). • As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia
How it works
Atorvastatin blocks an enzyme (HMG-CoA reductase) that the liver uses to make cholesterol. In animal models it lowers cholesterol by reducing cholesterol made in the liver and by increasing the number of LDL receptors on liver cells, so more LDL is taken up and broken down.
Section
12.1 Mechanism of Action
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
Atorvastatin calcium tablets is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3- methylglutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. In animal models, Atorvastatin calcium tablets lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and by increasing the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL; Atorvastatin calcium tablets also reduces LDL production and the number of LDL particles.
Dosage: adults
Take atorvastatin once a day, at any time of day, with or without food. The usual starting dose for adults is 10 mg to 20 mg once daily, and the dose range is 10 mg to 80 mg once daily. People who need LDL-C lowered by more than 45% may start at 40 mg once daily. LDL-C is assessed as early as 4 weeks after starting.
Section
2.1; 2.2
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
• Take atorvastatin calcium tablets orally once daily at any time of the day, with or without food. • Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating atorvastatin calcium tablets, and adjust the dosage if necessary. • If a dose is missed, advise patients not to take the missed dose and resume with the next scheduled dose. The recommended starting dosage of atorvastatin calcium tablets is 10 mg to 20 mg once daily. The dosage range is 10 mg to 80 mg once daily. Patients who require reduction in LDL-C greater than 45% may be started at 40 mg once daily.
Dosage: children
For children aged 10 years and older with HeFH, the starting dose is 10 mg once daily and the range is 10 mg to 20 mg once daily. For children aged 10 years and older with HoFH, the starting dose is 10 mg to 20 mg once daily and the range is 10 mg to 80 mg once daily.
Section
2.3; 2.4
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
2.3 Recommended Dosage in Pediatric Patients 10 Years of Age and Older with HeFH: The recommended starting dosage of atorvastatin calcium tablets is 10 mg once daily. The dosage range is 10 mg to 20 mg once daily. 2.4 Recommended Dosage in Pediatric Patients 10 Years of Age and Older with HoFH: The recommended starting dosage of atorvastatin calcium tablets is 10 mg to 20 mg once daily. The dosage range is 10 mg to 80 mg once daily.
Dosage adjustments
Drug interaction caps
With some antiviral medicines, the dose should not exceed 20 mg once daily (for example saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, elbasvir plus grazoprevir, or letermovir) or 40 mg once daily (nelfinavir). With clarithromycin or itraconazole, the dose should not exceed 20 mg once daily.
Section
2.5
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
Concomitant use of atorvastatin calcium tablets with the following drugs requires dosage modification of atorvastatin calcium tablets [see Warnings and Precautions (5.1) and Drug Interactions (7.1)]. Anti-Viral Medications • In patients taking saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir or letermovir, do not exceed atorvastatin calcium tablets 20 mg once daily. • In patients taking nelfinavir, do not exceed atorvastatin calcium tablets 40 mg once daily. Select Azole Antifungals or Macrolide Antibiotics • In patients taking clarithromycin or itraconazole, do not exceed atorvastatin calcium tablets 20 mg once daily. For additional recommendations regarding concomitant use of atorvastatin calcium tablets with other anti-viral medications, azole antifungals or macrolide antibiotics, see Drug Interactions (7.1).
Kidney
Kidney problems raise the risk of muscle problems, so patients are monitored. The label says there is no dose adjustment for kidney impairment.
Section
8.6 Renal Impairment
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
Renal impairment is a risk factor for myopathy and rhabdomyolysis. Monitor all patients with renal impairment for development of myopathy. Renal impairment does not affect the plasma concentrations of atorvastatin calcium tablets, therefore there is no dosage adjustment in patients with renal impairment [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)].
Liver
In chronic alcoholic liver disease, atorvastatin levels are markedly higher (4-fold in Childs-Pugh A, and approximately 16-fold and 11-fold for Cmax and AUC in Childs-Pugh B). The label says it must not be used in acute liver failure or decompensated cirrhosis. No specific liver dose adjustment is given in the sections read.
Section
8.7 Hepatic Impairment
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
In patients with chronic alcoholic liver disease, plasma concentrations of atorvastatin calcium tablets are markedly increased. Cmax and AUC are each 4-fold greater in patients with Childs-Pugh A disease. Cmax and AUC are approximately 16-fold and 11-fold increased, respectively, in patients with Childs-Pugh B disease. atorvastatin calcium tablets is contraindicated in patients with acute liver failure or decompensated cirrhosis [see Contraindications (4)].
Elderly
Of the people treated in trials, 40% were 65 or older. No overall differences in safety or effectiveness were seen, but age 65 years or older is a risk factor for muscle problems. Dose choice should be cautious and these patients are monitored.
Section
8.5 Geriatric Use
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
Of the total number of atorvastatin calcium tablets -treated patients in clinical trials, 15,813 (40%) were ≥65 years old and 2,800 (7%) were ≥75 years old. No overall differences in safety or effectiveness were observed between these patients and younger patients. Advanced age (≥65 years) is a risk factor for atorvastatin calcium tablets -associated myopathy and rhabdomyolysis. Dose selection for an elderly patient should be cautious, recognizing the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of myopathy. Monitor geriatric patients receiving atorvastatin calcium tablets for the increased risk of myopathy [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)].
Missed dose
Label
For the tablet, do not take the missed dose. Take the next dose at the usual time.
Section
2.1 Important Dosage Information
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
If a dose is missed, advise patients not to take the missed dose and resume with the next scheduled dose.
Medlineplus
MedlinePlus says to skip the missed tablet dose and not to double up.
Section
MedlinePlus: What should I do if I forget a dose?
Source
MedlinePlus Atorvastatin
Source url
https://medlineplus.gov/druginfo/meds/a600045.html
Source text (exact source wording)
If you miss a dose of the tablet, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Note
MedlinePlus also gives separate missed-dose wording for the Atorvaliq suspension; not covered (tablet only).
Overdose
Label
There is no known specific antidote. Call Poison Control at 1-800-222-1222 for the latest advice. Dialysis is not expected to help clear the drug much because it binds strongly to plasma proteins.
Section
10 OVERDOSAGE
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
No specific antidotes for atorvastatin calcium tablets are known. Contact Poison Control (1-800-222-1222) for latest recommendations. Due to extensive drug binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin calcium tablets clearance.
Medlineplus
For overdose call poison control at 1-800-222-1222. If the person has collapsed, had a seizure, has trouble breathing or can't be awakened, call 911.
Section
MedlinePlus: In case of emergency/overdose
Source
MedlinePlus Atorvastatin
Source url
https://medlineplus.gov/druginfo/meds/a600045.html
Source text (exact source wording)
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Storage
Label
Store at 20° to 25°C (68° to 77°F). Short trips to 15° to 30°C (59° to 86°F) are allowed.
Section
16 HOW SUPPLIED/STORAGE AND HANDLING (Macleods label; storage details are labeler-specific)
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
Store at 20° to 25°C (68° to77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]
Medlineplus
Keep it in the original container, tightly closed, out of reach of children, at room temperature and away from heat and moisture (not in the bathroom).
Section
MedlinePlus: storage and disposal
Source
MedlinePlus Atorvastatin
Source url
https://medlineplus.gov/druginfo/meds/a600045.html
Source text (exact source wording)
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Boxed warning
NONEContraindications
Do not use in acute liver failure or decompensated cirrhosis.
Section
4 CONTRAINDICATIONS
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3)]
Do not use if allergic to atorvastatin or any ingredient in the tablet. Serious allergic reactions have been reported.
Section
4 CONTRAINDICATIONS
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
Hypersensitivity to atorvastatin or any excipients in atorvastatin calcium tablets. Hypersensitivity reactions, including anaphylaxis, angioneurotic edema, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported [see Adverse Reactions (6.2)].
Warnings and precautions
This medicine can cause muscle problems. Rarely, a serious muscle breakdown called rhabdomyolysis can happen and can hurt the kidneys. The risk is higher at age 65 years or greater, with an underactive thyroid that is not controlled, with kidney problems, with certain other drugs, and with a higher dose. The label says not to take large quantities (more than 1.2 liters daily) of grapefruit juice. Report unexplained muscle pain, tenderness or weakness, especially with fever or feeling unwell.
Heading
5.1 Myopathy and Rhabdomyolysis
Section
5.1
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
Atorvastatin calcium tablets may cause myopathy (muscle pain, tenderness, or weakness associated with elevated creatine kinase [CK]) and rhabdomyolysis. Acute kidney injury secondary to myoglobinuria and rare fatalities have occurred as a result of rhabdomyolysis in patients treated with statins, including atorvastatin calcium tablets. Risk Factors for Myopathy: Risk factors for myopathy include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs (including other lipid-lowering therapies), and higher atorvastatin calcium tablets dosage [see Drug Interactions (7.1) and Use in Specific Populations (8.5,8.6)]. Steps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis: Atorvastatin calcium tablets exposure may be increased by drug interactions due to inhibition of cytochrome P450 enzyme 3A4 (CYP3A4) and/or transporters (e.g., breast cancer resistant protein [BCRP], organic anion-transporting polypeptide [OATP1B1/OATP1B3] and P-glycoprotein [P-gp]), resulting in an increased risk of myopathy and rhabdomyolysis. Concomitant use of cyclosporine, gemfibrozil, tipranavir plus ritonavir, or glecaprevir plus pibrentasvir with atorvastatin calcium tablets is not recommended. atorvastatin calcium tablets dosage modifications are recommended for patients taking certain anti-viral, azole antifungals, or macrolide antibiotic medications [see Dosage and Administration (2.5)]. Cases of myopathy/rhabdomyolysis have been reported with atorvastatin co-administered with lipid modifying doses (>1 gram/day) of niacin, fibrates, colchicine, and ledipasvir plus sofosbuvir [see Adverse Reactions (6.1)]. Consider if the benefit of use of these products outweighs the increased risk of myopathy and rhabdomyolysis [see Drug Interactions (7.1)]. Concomitant intake of large quantities, more than 1.2 liters daily, of grapefruit juice is not recommended in patients taking atorvastatin calcium tablets [see Drug Interactions (7.1)]. Discontinue atorvastatin calcium tablets if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected. Muscle symptoms and CK elevations may resolve if atorvastatin calcium tablets is discontinued. Temporarily discontinue atorvastatin calcium tablets in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis (e.g., sepsis; shock; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy). Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the atorvastatin calcium tablets dosage. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
Rarely, statins have been linked to an autoimmune muscle disease in which muscle weakness continues even after the statin is stopped. The label says to stop this medicine if this condition is suspected.
Heading
5.2 Immune-Mediated Necrotizing Myopathy
Section
5.2
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use, including reports of recurrence when the same or a different statin was administered. IMNM is characterized by proximal muscle weakness and elevated serum creatine kinase that persists despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents. Additional neuromuscular and serologic testing may be necessary. Treatment with immunosuppressive agents may be required. Discontinue atorvastatin calcium tablets if IMNM is suspected.
Liver enzyme levels can rise. Persistent increases to more than three times the upper limit of normal happened in approximately 0.7% of patients in clinical trials. Rare cases of liver failure have been reported with statins. People who drink substantial quantities of alcohol or have a history of liver disease may be at higher risk. The label says to consider liver enzyme testing before starting and when clinically indicated, and to stop the medicine promptly if serious liver injury with symptoms or jaundice occurs.
Heading
5.3 Hepatic Dysfunction
Section
5.3
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
Increases in serum transaminases have been reported with use of atorvastatin calcium tablets [see Adverse Reactions (6.1)]. In most cases, these changes appeared soon after initiation, were transient, were not accompanied by symptoms, and resolved or improved on continued therapy or after a brief interruption in therapy. Persistent increases to more than three times the ULN in serum transaminases have occurred in approximately 0.7% of patients receiving atorvastatin calcium tablets in clinical trials. There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including atorvastatin calcium tablets. Patients who consume substantial quantities of alcohol and/or have a history of liver disease may be at increased risk for hepatic injury [see Use in Specific Populations (8.7)]. Consider liver enzyme testing before atorvastatin calcium tablets initiation and when clinically indicated thereafter. atorvastatin calcium tablets is contraindicated in patients with acute liver failure or decompensated cirrhosis [see Contraindications (4)]. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue atorvastatin calcium tablets.
Blood sugar measures (HbA1c and fasting glucose) can go up with statins. The label advises regular exercise, a healthy body weight, and healthy food choices.
Heading
5.4 Increases in HbA1c and Fasting Serum Glucose Levels
Section
5.4
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
Increases in HbA1c and fasting serum glucose levels have been reported with statins, including atorvastatin calcium tablets. Optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices.
In one study of adults who had a recent stroke or TIA, bleeding strokes (hemorrhagic stroke) were more common with the 80 mg dose than with placebo (2.3% vs. 1.4%). The label says to consider the risks and benefits of the 80 mg dose in people with a recent hemorrhagic stroke.
Heading
5.5 Increased Risk of Hemorrhagic Stroke in Patients on atorvastatin calcium tablets 80 mg with Recent Hemorrhagic Stroke
Section
5.5
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
In a post-hoc analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial where 2,365 adult patients, without CHD who had a stroke or TIA within the preceding 6 months, were treated with atorvastatin calcium tablets 80 mg, a higher incidence of hemorrhagic stroke was seen in the atorvastatin calcium tablets 80 mg group compared to placebo (55, 2.3% atorvastatin calcium tablets vs. 33, 1.4% placebo; HR: 1.68, 95% CI: 1.09, 2.59; p=0.0168). The incidence of fatal hemorrhagic stroke was similar across treatment groups (17 vs. 18 for the atorvastatin and placebo groups, respectively). The incidence of non-fatal hemorrhagic stroke was significantly higher in the atorvastatin calcium tablets group (38, 1.6%) as compared to the placebo group (16, 0.7%). Some baseline characteristics, including hemorrhagic and lacunar stroke on study entry, were associated with a higher incidence of hemorrhagic stroke in the atorvastatin calcium tablets group [see Adverse Reactions (6.1)]. Consider the risk/benefit of use of atorvastatin calcium tablets 80 mg in patients with recent hemorrhagic stroke.
Pregnancy and breastfeeding
Label
The label says to stop atorvastatin when pregnancy is recognized, or to consider the ongoing therapeutic needs of the patient, because it may cause fetal harm. Breastfeeding is not recommended during treatment, because it may cause harm to a breastfed infant.
Section
8.1 Pregnancy (Risk Summary); 8.2 Lactation (Risk Summary)
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
Discontinue atorvastatin calcium tablets when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. atorvastatin calcium tablets decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, atorvastatin calcium tablets may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1)]. In addition, treatment of hyperlipidemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. (Section 8.1 Risk Summary) || There is no information about the presence of atorvastatin in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production. However, it has been shown that another drug in this class passes into human milk. Studies in rats have shown that atorvastatin and/or its metabolites are present in the breast milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk (see Data). Statins, including atorvastatin calcium tablets, decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol and may cause harm to the breastfed infant. Because of the potential for serious adverse reactions in a breastfed infant, based on the mechanism of action, advise patients that breastfeeding is not recommended during treatment with atorvastatin calcium tablets [see Use in Specific Populations (8.1), Clinical Pharmacology (12.1)]. (Section 8.2 Lactation Risk Summary)
Medlineplus
MedlinePlus says to tell your doctor if you are pregnant or plan to be, to stop atorvastatin and call your doctor right away if you become pregnant, and not to breastfeed while taking it.
Section
MedlinePlus: special precautions
Source
MedlinePlus Atorvastatin
Source url
https://medlineplus.gov/druginfo/meds/a600045.html
Source text (exact source wording)
tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking atorvastatin, stop taking atorvastatin and call your doctor immediately. Atorvastatin may harm the fetus. tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while you are taking this medication.
Side effects
Common
The label lists these as most common (incidence 5% or more): nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection.
Section
Highlights: Adverse Reactions; 6.1
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Threshold
incidence ≥5%
Source text (exact source wording)
Most common adverse reactions (incidence ≥5%) are nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection (6.1).
Common medlineplus
MedlinePlus lists side effects to report if severe or not going away: diarrhea, heartburn, gas, joint pain, forgetfulness or memory loss, and confusion.
Section
MedlinePlus: side effects
Source
MedlinePlus Atorvastatin
Source url
https://medlineplus.gov/druginfo/meds/a600045.html
Source text (exact source wording)
Atorvastatin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: diarrhea heartburn gas joint pain forgetfulness or memory loss confusion
Less common
In placebo-controlled trials, these reactions were reported in at least 2% of patients and more often than with placebo, but below the 5% most-common threshold: dyspepsia (4.7%), nausea (4.0%), musculoskeletal pain (3.8%), muscle spasms (3.6%), myalgia (3.5%), insomnia (3.0%), and pharyngolaryngeal pain (2.3%).
Section
6.1 Table 1
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
Table 1 (Section 6.1) lists adverse reactions reported in ≥ 2% and at a rate greater than placebo in patients treated with atorvastatin calcium tablets (n=8,755), from seventeen placebo-controlled trials. Rows below the ≥5% most-common threshold (% any dose N=8,755 vs % placebo N=7,311): Dyspepsia 4.7 vs 4.3; Nausea 4.0 vs 3.5; Musculoskeletal pain 3.8 vs 3.6; Muscle spasms 3.6 vs 3.0; Myalgia 3.5 vs 3.1; Insomnia 3.0 vs 2.9; Pharyngolaryngeal pain 2.3 vs 2.1.
Serious
Label postmarketing
Reports after approval include pancreatitis, fatal and non-fatal liver failure, anaphylaxis, tendon rupture, rhabdomyolysis, myositis, peripheral neuropathy, depression, interstitial lung disease, angioneurotic edema and serious skin reactions. Rare reports of memory problems and of myasthenia gravis have been made.
Section
6.2 Postmarketing Experience
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
The following adverse reactions have been identified during post-approval use of atorvastatin calcium tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal Disorders: pancreatitis General Disorders: fatigue Hepatobiliary Disorders: fatal and non-fatal hepatic failure Immune System Disorders: anaphylaxis Injury: tendon rupture Musculoskeletal and Connective Tissue Disorders: rhabdomyolysis, myositis. There have been rare reports of immune-mediated necrotizing myopathy associated with statin use. Nervous System Disorders: dizziness, peripheral neuropathy. There have been rare reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with the use of all statins. Cognitive impairment was generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks). There have been rare reports of new-onset or exacerbation of myasthenia gravis, including ocular myasthenia, and reports of recurrence when the same or a different statin was administered. Psychiatric Disorders: depression Respiratory Disorders: interstitial lung disease Skin and Subcutaneous Tissue Disorders: angioneurotic edema, bullous rashes (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis)
Label warnings
See warnings_and_precautions (5.1 myopathy and rhabdomyolysis, 5.2 immune-mediated necrotizing myopathy, 5.3 hepatic dysfunction, 5.4 HbA1c and glucose increases, 5.5 hemorrhagic stroke with 80 mg).
Medlineplus
MedlinePlus lists symptoms that need a call to the doctor or emergency help: muscle pain, tenderness or weakness; extreme tiredness; fever; flu-like symptoms; nausea; unusual bleeding or bruising; loss of appetite; upper right stomach pain; dark urine; yellow skin or eyes; rash, itching, hives, trouble breathing or swallowing; swelling; hoarseness; chest pain.
Section
MedlinePlus: side effects
Source
MedlinePlus Atorvastatin
Source url
https://medlineplus.gov/druginfo/meds/a600045.html
Source text (exact source wording)
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor or get emergency medical help immediately: muscle pain, tenderness, or weakness; lack of energy, extreme tiredness or weakness; fever; flu-like symptoms nausea; unusual bleeding or bruising; loss of appetite; pain in the upper right part of the stomach; dark-colored urine; yellowing of the skin or eyes rash, itching, hives, difficulty breathing or swallowing; swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs; hoarseness chest pain
Led to discontinuation
In the trial database, the most common reactions that led to stopping the medicine and occurred more than with placebo were myalgia (0.7%), diarrhea (0.5%), nausea (0.4%), alanine aminotransferase increase (0.4%), and hepatic enzyme increase (0.4%).
Section
6.1 Clinical Trials Experience
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
In the atorvastatin calcium tablets placebo-controlled clinical trial database of 16,066 patients (8,755 atorvastatin calcium tablets vs. 7,311 placebo; age range 10-93 years, 39% female, 91% White, 3% Black or African American, 2% Asian, 4% other) with a median treatment duration of 53 weeks, the most common adverse reactions in patients treated with atorvastatin calcium tablets that led to treatment discontinuation and occurred at a rate greater than placebo were: myalgia (0.7%), diarrhea (0.5%), nausea (0.4%), alanine aminotransferase increase (0.4%), and hepatic enzyme increase (0.4%).
Interactions
Drugs
The label says using atorvastatin with cyclosporine or gemfibrozil is not recommended because the risk of muscle problems goes up.
Name
Cyclosporine or Gemfibrozil
Section
7.1 Table 2
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin calcium tablets and cyclosporine, an inhibitor of CYP3A4 and OATP1B1 [see Clinical Pharmacology (12.3)]. Gemfibrozil may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of cyclosporine or gemfibrozil with atorvastatin calcium tablets. Concomitant use of cyclosporine or gemfibrozil with atorvastatin calcium tablets is not recommended.
Many antiviral medicines raise atorvastatin levels. The label says some combinations are not recommended, and others have a dose limit of 20 mg or 40 mg of atorvastatin. Anyone taking antiviral medicines should have the dose set by their prescriber.
Name
Anti-viral medications
Section
7.1 Table 2; 2.5
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin calcium tablets with many anti-viral medications, which are inhibitors of CYP3A4 and/or transporters (e.g., BCRP, OATP1B1/1B3, P-gp, MRP2, and/or OAT2) [see Clinical Pharmacology (12.3)]. Cases of myopathy and rhabdomyolysis have been reported with concomitant use of ledipasvir plus sofosbuvir with atorvastatin calcium tablets. • Concomitant use of tipranavir plus ritonavir or glecaprevir plus pibrentasvir with atorvastatin calcium tablets is not recommended. • In patients taking lopinavir plus ritonavir, or simeprevir, consider the risk/benefit of 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 atorvastatin calcium tablets 20 mg. • In patients taking nelfinavir, do not exceed atorvastatin calcium tablets 40 mg [see Dosage and Administration (2.5)]. • Consider the risk/benefit of concomitant use of ledipasvir plus sofosbuvir with atorvastatin calcium tablets. • Monitor all patients for signs and symptoms of myopathy particularly during initiation of therapy and during upward dose titration of either drug.
Some antifungal and macrolide antibiotic medicines raise atorvastatin levels. With clarithromycin or itraconazole, the dose should not exceed 20 mg.
Name
Select azole antifungals or macrolide antibiotics
Section
7.1 Table 2
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin calcium tablets with select azole antifungals or macrolide antibiotics, due to inhibition of CYP3A4 and/or transporters [see Clinical Pharmacology (12.3)]. In patients taking clarithromycin or itraconazole, do not exceed atorvastatin calcium tablets 20 mg [see Dosage and Administration (2.5)]. Consider the risk/benefit of concomitant use of other azole antifungals or macrolide antibiotics with atorvastatin calcium tablets. Monitor all patients for signs and symptoms of myopathy particularly during initiation of therapy and during upward dose titration of either drug. Examples: Erythromycin, clarithromycin, itraconazole, ketoconazole, posaconazole, and voriconazole.
Muscle problems have been seen when niacin is used at cholesterol-lowering doses (more than 1 gram/day) with atorvastatin. The prescriber weighs the benefit against the risk.
Name
Niacin
Section
7.1 Table 2
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
Cases of myopathy and rhabdomyolysis have been observed with concomitant use of lipid modifying dosages of niacin (>1 gram/day niacin) with atorvastatin calcium tablets. Consider if the benefit of using lipid modifying dosages of niacin concomitantly with atorvastatin calcium tablets outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy particularly during initiation of therapy and during upward dose titration of either drug.
Fibrates can raise the risk of muscle problems when combined with atorvastatin. The prescriber weighs the benefit against the risk.
Name
Fibrates (other than gemfibrozil)
Section
7.1 Table 2
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
Fibrates may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of fibrates with atorvastatin calcium tablets. Consider if the benefit of using fibrates concomitantly with atorvastatin calcium tablets outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy particularly during initiation of therapy and during upward dose titration of either drug.
Muscle problems have been reported when colchicine is used with atorvastatin. The prescriber weighs the benefit against the risk.
Name
Colchicine
Section
7.1 Table 2
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with atorvastatin calcium tablets. Consider the risk/benefit of concomitant use of colchicine with atorvastatin calcium tablets. If concomitant use is decided, monitor patients for signs and symptoms of myopathy particularly during initiation of therapy and during upward dose titration of either drug.
Rifampin can lower atorvastatin levels. The label says to give the two medicines at the same time.
Name
Rifampin
Section
7.2 Table 3
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
Concomitant administration of atorvastatin calcium tablets with rifampin, an inducer of cytochrome P450 3A4 and inhibitor of OATP1B1, can lead to variable reductions in plasma concentrations of atorvastatin. Due to the dual interaction mechanism of rifampin, delayed administration of atorvastatin calcium tablets after administration of rifampin has been associated with a significant reduction in atorvastatin plasma concentrations. Administer atorvastatin calcium tablets and rifampin simultaneously.
Atorvastatin can raise the levels of hormones in some birth control pills. This should be considered when choosing a birth control pill.
Name
Oral contraceptives
Section
7.3 Table 4
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
Co-administration of atorvastatin calcium tablets and an oral contraceptive increased plasma concentrations of norethindrone and ethinyl estradiol [see Clinical Pharmacology (12.3)]. Consider this when selecting an oral contraceptive for patients taking atorvastatin calcium tablets.
Atorvastatin can raise digoxin levels, so people taking digoxin should be monitored.
Name
Digoxin
Section
7.3 Table 4
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
When multiple doses of atorvastatin calcium tablets and digoxin were co-administered, steady state plasma digoxin concentrations increased [see Clinical Pharmacology (12.3)]. Monitor patients taking digoxin appropriately.
Food and alcohol
Large amounts of grapefruit juice (more than 1.2 liters daily) can raise atorvastatin levels and the risk of muscle problems, so the label says to avoid them.
Name
Grapefruit juice
Section
7.1 Table 2
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
Grapefruit juice consumption, especially excessive consumption, more than 1.2 liters/daily, can raise the plasma levels of atorvastatin and may increase the risk of myopathy and rhabdomyolysis. Avoid intake of large quantities of grapefruit juice, more than 1.2 liters daily, when taking atorvastatin calcium tablets.
People who drink substantial quantities of alcohol may be at higher risk of liver injury.
Name
Alcohol (label)
Section
5.3
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
Patients who consume substantial quantities of alcohol and/or have a history of liver disease may be at increased risk for hepatic injury [see Use in Specific Populations (8.7)].
MedlinePlus says to ask your doctor about alcohol and about grapefruit while taking atorvastatin.
Name
Alcohol and grapefruit (MedlinePlus)
Section
MedlinePlus: special precautions; special dietary instructions
Source
MedlinePlus (Atorvastatin, Last Revised 02/15/2026)
Source url
https://medlineplus.gov/druginfo/meds/a600045.html
Source text (exact source wording)
ask your doctor about the safe use of alcoholic beverages while you are taking atorvastatin. Alcohol can increase the risk of serious side effects. Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.
Other
In the label's drug-interaction study table, cimetidine is listed with an AUC ratio of 1.00 and a Cmax ratio of 0.89. The label does not list cimetidine as needing a dose change.
Name
Cimetidine (label pharmacokinetic table)
Section
12.3 Table 5
Source
DailyMed Macleods atorvastatin label (set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631f), Revised: 7/2026
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
Cimetidine 300 mg QIDe, 2 weeks | 10 mg QDa for 2 weeks | 1.00 | 0.89 (Table 5 columns: co-administered drug and dosage regimen | atorvastatin dosage | ratio of AUC | ratio of Cmax)
MedlinePlus says cimetidine and niacin may interact with atorvastatin and to talk with a doctor before starting either one.
Name
Cimetidine and niacin (MedlinePlus)
Section
MedlinePlus: special precautions
Source
MedlinePlus (Atorvastatin, Last Revised 02/15/2026)
Source url
https://medlineplus.gov/druginfo/meds/a600045.html
Source text (exact source wording)
the following nonprescription products may interact with atorvastatin: cimetidine and niacin. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking atorvastatin. Do not start any of these medications while taking atorvastatin without discussing with your healthcare provider.
Patient tips
Label section 17
The label tells prescribers to counsel patients to report unexplained muscle pain, tenderness or weakness, and to report tiredness, loss of appetite, pain in the upper right belly, dark urine or yellowing of the skin or eyes.
Source
DailyMed Macleods label, Section 17 (first two items captured)
Source url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
Source text (exact source wording)
Advise the patient to read the FDA-approved patient labeling (Patient Information). Myopathy and Rhabdomyolysis: Advise patients that atorvastatin calcium tablets may cause myopathy and rhabdomyolysis. Inform patients that the risk is also increased when taking certain types of medication or consuming large quantities of grapefruit juice and they should discuss all medication, both prescription and over the counter, with their healthcare provider. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever [see Warnings and Precautions (5.1), Drug Interactions (7.1)]. Hepatic Dysfunction: Inform patients that atorvastatin calcium tablets may cause liver enzyme elevations and possibly liver failure. Advise patients to promptly report fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice [see Warnings and Precautions (5.3)].
Medlineplus how to take
Take the tablet once a day, with or without food, at around the same time every day. Take it exactly as directed. Keep taking it even if you feel well, and do not stop without talking to your doctor.
Source
MedlinePlus Atorvastatin
Source url
https://medlineplus.gov/druginfo/meds/a600045.html
Source text (exact source wording)
Atorvastatin comes as a tablet and suspension (liquid) to take by mouth. Take the tablet once a day with or without food. Take atorvastatin at around the same time every day. Take atorvastatin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Continue to take atorvastatin even if you feel well. Do not stop taking atorvastatin without talking to your doctor.
Medlineplus avoid
Follow a low-fat, low-cholesterol diet and your doctor's exercise advice. Ask your doctor about grapefruit, grapefruit juice and alcohol.
Source
MedlinePlus Atorvastatin
Source url
https://medlineplus.gov/druginfo/meds/a600045.html
Source text (exact source wording)
Eat a low-fat, low-cholesterol diet. Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication. ask your doctor about the safe use of alcoholic beverages while you are taking atorvastatin. Alcohol can increase the risk of serious side effects.
Medlineplus when to call
Call your doctor or get emergency help right away for muscle pain, tenderness or weakness; extreme tiredness; fever; signs of liver trouble such as dark urine or yellow skin or eyes; allergic signs such as rash, hives, trouble breathing or swelling; or chest pain.
Source
MedlinePlus Atorvastatin
Source url
https://medlineplus.gov/druginfo/meds/a600045.html
Source text (exact source wording)
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor or get emergency medical help immediately: muscle pain, tenderness, or weakness; lack of energy, extreme tiredness or weakness; fever; flu-like symptoms nausea; unusual bleeding or bruising; loss of appetite; pain in the upper right part of the stomach; dark-colored urine; yellowing of the skin or eyes rash, itching, hives, difficulty breathing or swallowing; swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs; hoarseness chest pain
Alternatives
Class source
Label Section 1 (HMG-CoA reductase inhibitor (statin)); openFDA openfda.pharm_class_epc: HMG-CoA Reductase Inhibitor [EPC]
Class source urls
- https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7bd0f0ec-f7a3-4403-9a1a-11f18213631f&type=display
- https://api.fda.gov/drug/label.json?search=openfda.pharm_class_epc.exact:%22HMG-CoA%20Reductase%20Inhibitor%20[EPC]%22&count=openfda.generic_name.exact&limit=20
Candidates same class
- simvastatin
- lovastatin
- rosuvastatin
- pitavastatin magnesium
Frequently asked questions
Question
What is atorvastatin used for?
Answer
Atorvastatin is a statin. The label lists uses that include lowering the risk of heart attack and stroke in certain adults, and lowering LDL cholesterol as an add-on to diet. It is also used in adults with primary dysbetalipoproteinemia or hypertriglyceridemia, and in children aged 10 years and older with certain inherited high cholesterol conditions.
Source section
1 INDICATIONS & USAGE
Source
DailyMed Macleods label
Question
Can I take atorvastatin with food?
Answer
Yes. The label says to take it once daily at any time of the day, with or without food.
Source section
2.1 Important Dosage Information
Source
DailyMed Macleods label
Question
What should I do if I miss a dose?
Answer
For the tablet, the label says not to take the missed dose and to resume with the next scheduled dose. MedlinePlus also says not to take a double dose.
Source section
2.1; MedlinePlus: forget a dose
Source
DailyMed Macleods label; MedlinePlus
Question
Can I drink grapefruit juice or alcohol with atorvastatin?
Answer
The label says to avoid large quantities of grapefruit juice, more than 1.2 liters daily. It also says people who consume substantial quantities of alcohol may be at higher risk of liver injury. MedlinePlus says to ask your doctor about both.
Source section
7.1 Table 2; 5.3; MedlinePlus
Source
DailyMed Macleods label; MedlinePlus
Question
What are the most common side effects?
Answer
The label lists these as most common (incidence 5% or more): nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection.
Source section
Highlights: Adverse Reactions; 6.1
Source
DailyMed Macleods label
Question
Is atorvastatin safe in pregnancy or while breastfeeding?
Answer
The label says to discontinue it when pregnancy is recognized, or to consider the ongoing therapeutic needs of the patient, and that it may cause fetal harm. Breastfeeding is not recommended during treatment. Talk to your doctor if you are pregnant, plan to be, or are breastfeeding.
Source section
8.1; 8.2
Source
DailyMed Macleods label
Question
What medicines should I not combine with atorvastatin?
Answer
The label says combining it with cyclosporine, gemfibrozil, tipranavir plus ritonavir, or glecaprevir plus pibrentasvir is not recommended. Several other medicines, including some antivirals, clarithromycin and itraconazole, need a dose limit. Tell your prescriber about every medicine you take.
Source section
7.1 Table 2; 2.5
Source
DailyMed Macleods label
Question
Should I stop atorvastatin when I feel well?
Answer
MedlinePlus says to continue taking atorvastatin even if you feel well, and not to stop without talking to your doctor.
Source section
MedlinePlus: how should this medicine be used
Source
MedlinePlus
Sources
- DailyMed atorvastatin calcium tablets, Macleods Pharmaceuticals Limited (chosen primary)
Set id: 7bd0f0ec-f7a3-4403-9a1a-11f18213631f · Label effective or revised date: Revised: 7/2026 · Dailymed version date: Updated July 15, 2026 (drugInfo page); list publish Jul 16, 2026 · Fetched at: 2026-11-02 · Sections used: Highlights, 1-8, 10, 12.1-12.3 (Table 5 cimetidine row), 16 Storage, 17 (partial) - Alternate 1: Mylan Pharmaceuticals Inc. atorvastatin
Set id: d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d · Label effective or revised date: Revised: 6/2026 · Dailymed version date: Updated June 15, 2026 · Fetched at: 2026-11-02 · Sections used: Revised line only (not used for text) - Alternate 2: Dr. Reddy's Laboratories Inc atorvastatin
Set id: aaf960d1-8bf9-64c6-1e70-8aa33b0ce549 · Label effective or revised date: Revised: 4/2026 · Dailymed version date: Updated April 30, 2026 · Fetched at: 2026-11-02 · Sections used: Revised line only (not used for text) - DailyMed Lipitor (Viatris Specialty LLC), brand label
Set id: a60cc18b-0631-4cf0-b021-9f52224ece65 · Label effective or revised date: Revised: 4/2024 · Dailymed version date: list publish Jul 15, 2026 · Fetched at: 2026-11-02 · Sections used: Highlights excerpts and phrase checks only - MedlinePlus Atorvastatin
Set id: n/a · Label effective or revised date: Last Revised - 02/15/2026 · Fetched at: 2026-11-02 · Sections used: all patient sections - openFDA drug label API (pharmacologic class)
Set id: n/a · Label effective or revised date: n/a (openFDA last_updated 2026-10-30) · Fetched at: 2026-11-02 · Sections used: pharm_class_epc - Drugs@FDA
Label effective or revised date: NOT FOUND (not searched) · Fetched at: 2026-11-02 · Sections used: none
Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug