Report new muscle symptoms promptly.
Unexplained muscle pain, tenderness, or weakness—especially with fever or feeling unwell—needs prompt assessment. Interacting medicines and higher doses increase the risk of muscle injury.
Warnings and precautionsIndications
Lipid lowering and cardiovascular risk reduction.
Labeled oral indications
In adults with multiple coronary risk factors but no evident coronary heart disease (CHD), reduces myocardial infarction, stroke, revascularization, and angina risk. In adults with type 2 diabetes and multiple CHD risk factors but no evident CHD, reduces myocardial infarction and stroke risk. In established CHD, reduces nonfatal myocardial infarction, fatal and nonfatal stroke, revascularization, heart-failure hospitalization, and angina risk.
As an adjunct to diet, lowers LDL-C in adults with primary hyperlipidemia and in patients aged 10 years or older with heterozygous familial hypercholesterolemia (HeFH). Also treats adult hypertriglyceridemia and primary dysbetalipoproteinemia. For homozygous familial hypercholesterolemia (HoFH) from age 10, use with other LDL-lowering treatment, or alone if those treatments are unavailable.
Reference scope
This profile summarizes Lipitor tablets. Other brands, generic labels, combination medicines, and alternative dosage forms may have different labeled uses or instructions. It does not provide an exhaustive off-label treatment guide.
Dosage and administration
Once-daily dosing with population and interaction limits.
Oral tablets · Recommended dosage
| Population | Selected product directions |
|---|---|
| Adults | Start 10–20 mg once daily; range 10–80 mg once daily. A 40 mg start may be used when LDL-C reduction greater than 45% is needed. |
| HeFH · age ≥10 years | Start 10 mg once daily; range 10–20 mg once daily. |
| HoFH · age ≥10 years | Start 10–20 mg once daily; range 10–80 mg once daily. |
Administration and dose adjustment
Take tablets once daily at any time, with or without food. Skip a missed dose and resume the next scheduled dose.
Assess LDL-C as clinically appropriate, as early as 4 weeks after starting, and adjust to response. Interaction-related limits may be lower than the usual maximum.
Hepatic and renal impairment
Renal impairment does not require a dose adjustment, but increases muscle-injury risk. Chronic alcohol-associated liver disease markedly increases exposure. Acute liver failure and decompensated cirrhosis are contraindications; assess other hepatic disease individually rather than applying a universal dose reduction.
Other oral formulation
Atorvaliq is a 20 mg/5 mL (4 mg/mL) suspension taken on an empty stomach, 1 hour before or 2 hours after a meal. Shake well before each use. Measure with a calibrated oral device in mL. Its missed-dose directions allow taking a dose as soon as possible unless more than 12 hours late; then skip it. Follow its own storage instructions. Lipitor tablet directions do not apply.
Safety
Muscle injury, liver injury, and metabolic effects.
Warnings and precautions
Myopathy and rhabdomyolysis can cause acute kidney injury and rarely death. Risk increases with age ≥65, uncontrolled hypothyroidism, renal impairment, interacting medicines, and higher doses.
Discontinue when myopathy is diagnosed or suspected or CK is markedly elevated. Temporarily interrupt during serious acute illness with high risk of renal failure from rhabdomyolysis. Persistent weakness and elevated CK after stopping may indicate immune-mediated necrotizing myopathy, requiring further evaluation.
Consider liver enzymes before treatment and when clinically indicated. Promptly discontinue for serious liver injury with symptoms, jaundice, or hyperbilirubinemia. Glucose and HbA1c can rise.
The 80 mg dose warrants individualized benefit–risk review after a recent hemorrhagic stroke. The label reports an increased hemorrhagic-stroke signal in a post-hoc analysis of SPARCL; do not generalize it to every patient or dose.
Contraindications
Acute liver failure, decompensated cirrhosis, or hypersensitivity to atorvastatin or product ingredients. Pregnancy is no longer listed as an absolute contraindication; see population-specific guidance.
Boxed warning status
The selected Lipitor tablet label has no boxed warning. Its warnings and precautions still require attention to muscle injury, hepatic injury, and relevant population and interaction risks.
Adverse reactions
Common trial reports included nasopharyngitis, joint pain, diarrhea, extremity pain, and urinary tract infection.
Serious reactions include muscle injury, hepatic injury, and hypersensitivity. Trial frequencies depend on study design and are not comparative risk estimates across statins.
Drug interactions
Reconcile prescription, nonprescription, and supplement use.
Exposure and muscle-toxicity interactions
| Label instruction | Concomitant medicines |
|---|---|
| Not recommended | Cyclosporine; gemfibrozil; tipranavir/ritonavir; glecaprevir/pibrentasvir. |
| Maximum 20 mg daily | Clarithromycin; itraconazole; saquinavir/ritonavir; darunavir/ritonavir; fosamprenavir with or without ritonavir; elbasvir/grazoprevir; letermovir. |
| Maximum 40 mg daily | Nelfinavir. |
| Individual benefit–risk assessment | Lopinavir/ritonavir; simeprevir; ledipasvir/sofosbuvir; other azole antifungals or macrolides. Monitor for muscle toxicity. |
Other clinically relevant interactions
Fibrates other than gemfibrozil, lipid-modifying niacin (≥1 g/day), and colchicine add muscle risk; weigh benefit and monitor if combined. Avoid large grapefruit-juice quantities (>1.2 L/day). Give rifampin simultaneously with Lipitor because delayed dosing can reduce atorvastatin exposure. Monitor digoxin appropriately; atorvastatin can raise norethindrone and ethinyl estradiol concentrations.
These are the selected label’s interaction instructions, not a complete screen for every newly prescribed medicine. Check both drug labels before adding treatment.
Use in specific populations
Consider pregnancy, lactation, age, and organ function.
Pregnancy
Stop treatment when pregnancy is recognized in most patients; the label permits consideration of ongoing therapeutic needs. FDA removed the class-wide pregnancy contraindication in 2021 to allow individualized decisions, particularly for very high-risk patients. Notify the prescriber promptly about a known or suspected pregnancy. Observational data have not established an increase in major birth defects; this does not establish safety for every pregnancy.
Lactation
Breastfeeding is not recommended during treatment. Discuss temporary treatment interruption versus continued statin therapy with alternative infant feeding based on the patient’s cardiovascular needs.
Pediatric and geriatric considerations
Lipitor HeFH and HoFH uses are established from age 10; safety and effectiveness below 10 or for other pediatric hyperlipidemias are not established.
Choose doses cautiously in older adults and monitor for muscle symptoms. Organ impairment and polypharmacy increase risk; see dosing for the relevant renal and hepatic distinctions.
Clinical pharmacology
Hepatic cholesterol synthesis and LDL clearance.
Mechanism of action and pharmacodynamics
Inhibits HMG-CoA reductase, reducing cholesterol synthesis and increasing hepatic LDL-receptor-mediated clearance. LDL-C response guides dosing; plasma concentration alone is not the treatment target.
Pharmacokinetics
- Absorption
- Peak concentration in approximately 1–2 hours; parent-drug bioavailability about 14%.
- Metabolism
- CYP3A4; active metabolites contribute substantially to enzyme inhibition.
- Elimination
- Mainly biliary; less than 2% of a dose recovered in urine.
- Half-life
- Parent drug about 14 hours; inhibitory activity 20–30 hours with active metabolites.
Monitoring and counseling
Assess LDL response, interaction exposure, and warning symptoms.
Monitoring parameters
- Reassess LDL-C as early as 4 weeks after starting and adjust to the individualized plan.
- Consider liver enzymes before treatment and thereafter when clinically indicated. Evaluate jaundice, dark urine, appetite loss, fatigue, or right-upper-abdominal discomfort.
- Investigate unexplained muscle symptoms; CK and renal assessment are appropriate when muscle injury is suspected. Persistent weakness after stopping warrants assessment for immune-mediated myopathy.
- Review glucose risk and reinforce healthy diet, activity, and weight management.
Patient counseling information
- Use the prescribed once-daily schedule and avoid doubling missed doses.
- Maintain diet and activity measures alongside drug treatment. Review all new medicines and supplements with the prescriber or pharmacist.
- Promptly report unexplained muscle symptoms, especially with fever or feeling unwell. Seek urgent care for a severe allergic reaction.
- Discuss pregnancy or breastfeeding promptly with the treating clinician.
- For overdose, contact U.S. Poison Control at 1-800-222-1222; emergency symptoms require emergency care.
Product identification
Verify formulation, strength, and original packaging.
Representative oral product · Lipitor
Other strengths and manufacturers have different appearances and package identifiers. Verify the exact imprint and original packaging with a pharmacist.
- Dosage form / strengths
- Film-coated oral tablets · 10, 20, 40, 80 mg
- Label distributor
- Viatris Specialty LLC
- Representative appearance
- 10 mg: white, elliptical tablet
- Imprint
- 10 on one side · VLE 155 on the other
- Example package NDC
- 58151-155-77 · 90 tablets
Dosage forms and strengths
- Selected tablets
- 10, 20, 40, 80 mg
- Additional formulation
- Atorvaliq oral suspension · 20 mg/5 mL; separate label applies.
- Other products
- Generic and combination products require their own labeling.
Storage and handling
Lipitor: store at 20–25°C (68–77°F).
Follow the exact formulation’s storage instructions and retain packaging to identify the medicine.
References
Original sources for the clinical and product information.
- DailyMed / Viatris Specialty LLCLipitor · Prescribing information
Current selected label, revised April 2024. Sections 1–8, 10–12, 16–17 and patient labeling.
- U.S. Food and Drug AdministrationStatins · Pregnancy safety communication
July 20, 2021 removal of the class pregnancy contraindication; most pregnant patients should stop therapy, with individualized exceptions.
- DailyMed / CMP PharmaAtorvaliq · Oral suspension
Separate formulation label, revised April 2024. Administration and concentration differ from tablets.