Medicine guide

Rosuvastatin Calcium

10 mg · Tablet, Film Coated

Prescription only
HMG-CoA Reductase Inhibitor

Active substance: Rosuvastatin Calcium
Used in: Heart, blood pressure and circulation
Made by: Aurobindo Pharma Limited
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-08-28

What it is

HMG-CoA Reductase Inhibitor

Used for

To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in

The label’s usual adult dose

( 2.1 ) Adults: Recommended dosage range is 5 to 40 mg once daily.

do not exceed 10 mg once daily.

Full directions ↓

Do not take it if

Rosuvastatin tablets are contraindicated in patients with:

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

130other products contain Rosuvastatin Calcium — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Rosuvastatin tablets are indicated:

To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in
adults at increased risk for CV events.
As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C):
in
adults with hypercholesterolemia. and slow the progression of atherosclerosis in
adults. in
adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). in
adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH).
As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.
Hypertriglyceridemia.
Rosuvastatin tablets are an HMG Co-A reductase inhibitor (statin) indicated:
( 1 ) To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in
adults at increased risk for CV events.
As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C):
in
adults with primary hypercholesterolemia. and slow the progression of atherosclerosis in
adults. in
adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). in
adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH).
As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.
Hypertriglyceridemia.

From the official label · 2026-08-28 · DailyMed

How it works

From this product’s own US prescribing label.

Rosuvastatin is an inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol.

Peak level after3–5 h

Half-life19 h

Mostly cleared after≈ 4 daysfive half-lives — our arithmetic

The shape is a standard model drawn from the two times above, not a measurement. How fast a medicine acts and wears off also depends on the dose, the form and the person.

How the body breaks it down

Rosuvastatin is not extensively metabolized; approximately 10% of a radiolabeled dose is recovered as metabolite.

How it leaves the body

Following oral administration, rosuvastatin and its metabolites are primarily excreted in the feces (90%).

With food

Effect of food Administration of rosuvastatin with food did not affect the AUC of rosuvastatin.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-08-28

Do not take it if

Rosuvastatin tablets are contraindicated in patients with:
Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3) ].
Hypersensitivity to rosuvastatin or any excipients in rosuvastatin tablets.
Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin [see Adverse Reactions (6.1) ] .
Acute liver failure or decompensated cirrhosis.
( 4 ) Hypersensitivity to rosuvastatin or any excipients in rosuvastatin tablets.
( 4 )

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

Take orally with or without food, at any time of day.
( 2.1 ) Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating rosuvastatin tablets, and adjust dosage if necessary.
( 2.1 ) Adults: Recommended dosage range is 5 to 40 mg once daily.
( 2.2 ) Pediatric Patients with HeFH :
Recommended dosage range is 5 to 10 mg once daily for patients aged 8 to less than 10 years of age, and 5 to 20 mg once daily for patients aged 10 years and older.
( 2.3 ) Pediatric Patients with HoFH :
Recommended dosage is 20 mg once daily for patients aged 7 years and older.
( 2.3 ) Asian Patients: Initiate at 5 mg once daily.
Consider risks and benefits of treatment if not adequately controlled at dosages up to 20 mg once daily.
( 2.4 ) Patients with Severe Renal Impairment (not on hemodialysis):
Initiate at 5 mg once daily;
do not exceed 10 mg once daily.
( 2.5 ) See full prescribing information for rosuvastatin tablets dosage and administration modifications due to drug interactions.
( 2.6 )
2.1 General Dosage and Administration Information Administer rosuvastatin tablets orally as a single dose at any time of day, with or without food.
Swallow the tablets whole.
Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating rosuvastatin tablets, and adjust the dosage if necessary.
If a dose is missed, advise patients not to take an extra dose.
Resume treatment with the next dose.
When taking rosuvastatin tablets with an aluminum and magnesium hydroxide combination antacid, administer rosuvastatin tablets at least 2 hours before the antacid [see Drug Interactions (7.2) ].
2.2 Recommended Dosage in Adult Patients The dosage range for rosuvastatin tablets is 5 to 40 mg orally once daily.
The recommended dosage of rosuvastatin tablets depends on a patient’s indication for usage, LDL-C, and individual risk for CV events.
2.3 Recommended Dosage in Pediatric Patients Dosage in Pediatric Patients 8 Years of Age and Older with HeFH The recommended dosage range is 5 mg to 10 mg orally once daily in patients aged 8 years to less than 10 years and 5 mg to 20 mg orally once daily in patients aged 10 years and older.
Dosage in Pediatric Patients 7 Years of Age and Older with HoFH The recommended dosage is 20 mg orally once daily.
2.4 Recommended Dosage in Asian Patients Initiate rosuvastatin tablets at 5 mg orally once daily due to increased rosuvastatin plasma concentrations.
Consider the risks and benefits of rosuvastatin tablets when treating Asian patients not adequately controlled at dosages up to 20 mg orally once daily [see Warnings and Precautions (5.1) , Use in Specific Populations (8.8) , and Clinical Pharmacology (12.3) ].
2.5 Recommended Dosage in Patients with Renal Impairment In patients with severe renal impairment (CL cr less than 30 mL/min/1.73 m 2 ) not on hemodialysis, the recommended starting dosage is 5 mg orally once daily and should not exceed 10 mg orally once daily [see Warnings and Precautions (5.1) and Use in Specific Populations (8.6) ].
There are no dosage adjustment recommendations for patients with mild and moderate renal impairment.
2.6 Dosage Modifications Due to Drug Interactions Table 1 displays dosage modifications for rosuvastatin tablets due to drug interactions [see Warnings and Precautions (5.1) and Drug Interactions (7.1) ].
Table 1:
Rosuvastatin Tablets Dosage Modifications Due to Drug Interactions Concomitantly Used Drug Rosuvastatin Tablets Dosage Modifications Sofosbuvir/velpatasvir/voxilaprevir or Ledipasvir/sofosbuvir
Avoid concomitant use.
Gemfibrozil Avoid concomitant use.
If use is unavoidable, initiate at 5 mg once daily and do not exceed 10 mg once daily.
Tafamidis Avoid concomitant use.
If use is unavoidable, initiate at 5 mg once daily and do not exceed 20 mg once daily.
Belumosudil Do not exceed 5 mg once daily.
Cyclosporine Do not exceed 5 mg once daily.
Darolutamide Do not exceed 5 mg once daily.
Additional Antiviral Medications Simeprevir Dasabuvir/ombitasvir/paritaprevir/ritonavir Elbasvir/Grazoprevir Sofosbuvir/Velpatasvir Glecaprevir/Pibrentasvir Atazanavir/Ritonavir Lopinavir/Ritonavir Initiate at 5 mg once daily.
Do not exceed 10 mg once daily.
Capmatinib Do not exceed 10 mg once daily.
Enasidenib Do not exceed 10 mg once daily.
Momelotinib Do not exceed 10 mg once daily.
Regorafenib Do not exceed 10 mg once daily.
Teriflunomide Do not exceed 10 mg once daily.
Ticagrelor Do not exceed 20 mg once daily.
In patients at increased risk for rhabdomyolysis [ see Warnings and Precautions (5.1) ], consider dosages less than 20 mg per day.
Febuxostat Do not exceed 20 mg once daily.
Fostamatinib Do not exceed 20 mg once daily.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Myopathy and Rhabdomyolysis:
Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher rosuvastatin dosage.
Asian patients may be at higher risk for myopathy.
Discontinue rosuvastatin if markedly elevated CK levels occur or myopathy is diagnosed or suspected.
Temporarily discontinue rosuvastatin in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis.
Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing rosuvastatin dosage.
Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.
( 5.1 ) Immune-Mediated Necrotizing Myopathy (IMNM):
Rare reports of IMNM, an autoimmune myopathy, have been reported with statin use.
Discontinue rosuvastatin if IMNM is suspected.
( 5.2 ) Hepatic Dysfunction:
Increases in serum transaminases have occurred, some persistent.
Rare reports of fatal and non-fatal hepatic failure have occurred.
Consider testing liver enzymes before initiating therapy and as clinically indicated thereafter.
If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue rosuvastatin.
( 5.3 )
5.1 Myopathy and Rhabdomyolysis Rosuvastatin 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 with statins, including rosuvastatin.
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 rosuvastatin dosage.
Asian patients on rosuvastatin may be at higher risk for myopathy [ see Drug Interactions (7.1) and Use in Specific Populations (8.8) ].
The myopathy risk is greater in patients taking rosuvastatin 40 mg daily compared with lower rosuvastatin dosages.
Steps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis The concomitant use of rosuvastatin with cyclosporine or gemfibrozil is not recommended.
Rosuvastatin dosage modifications are recommended for patients taking certain antiviral medications, darolutamide, and regorafenib [ see Dosage and Administration (2.6) ].
Niacin, fibrates, and colchicine may also increase the risk of myopathy and rhabdomyolysis [see Drug Interactions (7.1) ].
Discontinue rosuvastatin if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected.
Muscle symptoms and CK elevations may resolve if rosuvastatin is discontinued.
Temporarily discontinue rosuvastatin 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 rosuvastatin dosage.
5.2 Immune-Mediated Necrotizing Myopathy 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 persist 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 rosuvastatin if IMNM is suspected.
5.3 Hepatic Dysfunction Increases in serum transaminases have been reported with use of rosuvastatin [ 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.
In a pooled analysis of placebo-controlled trials, increases in serum transaminases to more than three times the ULN occurred in 1.1% of patients taking rosuvastatin versus 0.5% of patients treated with placebo.
Marked persistent increases of hepatic transaminases have also occurred with rosuvastatin.
There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including rosuvastatin.
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 rosuvastatin initiation and when clinically indicated thereafter.
Rosuvastatin 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 rosuvastatin.
5.4 Proteinuria and Hematuria In the rosuvastatin clinical trial program, dipstick-positive proteinuria and microscopic hematuria were observed among rosuvastatin treated patients.
These findings were more frequent in patients taking rosuvastatin 40 mg, when compared to lower doses of rosuvastatin or comparator statins, though it was generally transient and was not associated with worsening renal function.
Although the clinical significance of this finding is unknown, consider a dose reduction for patients on rosuvastatin therapy with unexplained persistent proteinuria and/or hematuria during routine urinalysis testing.
5.5 Increases in HbA1c and Fasting Serum Glucose Levels Increases in HbA1c and fasting serum glucose levels have been reported with statins, including rosuvastatin.
Based on clinical trial data with rosuvastatin, in some instances these increases may exceed the threshold for the diagnosis of diabetes mellitus [ see Adverse Reactions (6.1) ] .

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Risk Summary Discontinue rosuvastatin when pregnancy is recognized.
Alternatively, consider the ongoing therapeutic needs of the individual patient.
Rosuvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, rosuvastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1) ].
In addition, treatment of hypercholesterolemia 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 hypercholesterolemia for most patients.
Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations.
Published data from prospective and retrospective observational cohort studies with rosuvastatin use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see Data) .
In animal reproduction studies, no adverse developmental effects were observed in pregnant rats or rabbits orally administered rosuvastatin during the period of organogenesis at doses that resulted in systemic exposures equivalent to human exposures at the maximum recommended human dose (MRHD) of 40 mg/day, based on AUC and body surface area (mg/m 2 ), respectively (see Data) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Human Data A Medicaid cohort linkage study of 1,152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders – including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity score-based methods.
The relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus.
There were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for confounders.
In the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified.
Study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for the use of a statin, and lack of information on non-live births.
Animal Data In female rats given 5, 15 and 50 mg/kg/day before mating and continuing through to gestation day 7 resulted in decreased fetal body weight (female pups) and delayed ossification at 50 mg/kg/day (10 times the human exposure at the MRHD of 40 mg/day based on AUC).
In pregnant rats given 2, 10 and 50 mg/kg/day of rosuvastatin from gestation day 7 through lactation day 21 (weaning), decreased pup survival occurred at 50 mg/kg/day (dose equivalent to 12 times the MRHD of 40 mg/day based body surface area).
In pregnant rabbits given 0.3, 1, and 3 mg/kg/day of rosuvastatin from gestation day 6 to day 18, decreased fetal viability and maternal mortality was observed at 3 mg/kg/day (dose equivalent to the MRHD of 40 mg/day based on body surface area).
Rosuvastatin crosses the placenta in rats and rabbits and is found in fetal tissue and amniotic fluid at 3% and 20%, respectively, of the maternal plasma concentration following a single 25 mg/kg oral gavage dose on gestation day 16 in rats.
In rabbits, fetal tissue distribution was 25% of maternal plasma concentration after a single oral gavage dose of 1 mg/kg on gestation day 18.
IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm.
( 8.1 ) Lactation: Breastfeeding not recommended during treatment with rosuvastatin.
( 8.2 )
8.1 Pregnancy Risk Summary Discontinue rosuvastatin when pregnancy is recognized.
Alternatively, consider the ongoing therapeutic needs of the individual patient.
Rosuvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, rosuvastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1) ].
In addition, treatment of hypercholesterolemia 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 hypercholesterolemia for most patients.
Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations.
Published data from prospective and retrospective observational cohort studies with rosuvastatin use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see Data) .
In animal reproduction studies, no adverse developmental effects were observed in pregnant rats or rabbits orally administered rosuvastatin during the period of organogenesis at doses that resulted in systemic exposures equivalent to human exposures at the maximum recommended human dose (MRHD) of 40 mg/day, based on AUC and body surface area (mg/m 2 ), respectively (see Data) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Human Data A Medicaid cohort linkage study of 1,152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders – including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity score-based methods.
The relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus.
There were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for confounders.
In the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified.
Study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for the use of a statin, and lack of information on non-live births.
Animal Data In female rats given 5, 15 and 50 mg/kg/day before mating and continuing through to gestation day 7 resulted in decreased fetal body weight (female pups) and delayed ossification at 50 mg/kg/day (10 times the human exposure at the MRHD of 40 mg/day based on AUC).
In pregnant rats given 2, 10 and 50 mg/kg/day of rosuvastatin from gestation day 7 through lactation day 21 (weaning), decreased pup survival occurred at 50 mg/kg/day (dose equivalent to 12 times the MRHD of 40 mg/day based body surface area).
In pregnant rabbits given 0.3, 1, and 3 mg/kg/day of rosuvastatin from gestation day 6 to day 18, decreased fetal viability and maternal mortality was observed at 3 mg/kg/day (dose equivalent to the MRHD of 40 mg/day based on body surface area).
Rosuvastatin crosses the placenta in rats and rabbits and is found in fetal tissue and amniotic fluid at 3% and 20%, respectively, of the maternal plasma concentration following a single 25 mg/kg oral gavage dose on gestation day 16 in rats.
In rabbits, fetal tissue distribution was 25% of maternal plasma concentration after a single oral gavage dose of 1 mg/kg on gestation day 18.
8.2 Lactation Risk Summary Limited data from case reports in published literature indicate that rosuvastatin is present in human milk.
There is no available information on the effects of the drug on the breastfed infant or the effects of the drug on milk production.
Statins, including rosuvastatin, 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 rosuvastatin [ see Use in Specific Populations (8.1) and Clinical Pharmacology (12.1) ] .
8.4 Pediatric Use The safety and effectiveness of rosuvastatin as an adjunct to diet to reduce LDL-C have been established in pediatric patients 8 years of age and older with HeFH.
Use of rosuvastatin for this indication is based on one 12-week controlled trial with a 40-week open-label extension period in 176 pediatric patients 10 years of age and older with HeFH and one 2-year open-label, uncontrolled trial in 175 pediatric patients 8 years of age and older with HeFH [ see Clinical Studies (14) ] .
In the 1-year trial with a 12-week controlled phase, there was no detectable effect of rosuvastatin on growth, weight, BMI (body mass index), or sexual maturation in patients aged 10 to 17 years.
The safety and effectiveness of rosuvastatin as an adjunct to other LDL-C-lowering therapies to reduce LDL-C have been established in pediatric patients 7 years of age and older with HoFH.
Use of rosuvastatin for this indication is based on a randomized, placebo-controlled, cross-over study in 14 pediatric patients 7 years of age and older with HoFH [ see Clinical Studies (14) ] .
The safety and effectiveness of rosuvastatin have not been established in pediatric patients younger than 8 years of age with HeFH, younger than 7 years of age with HoFH, or in pediatric patients with other types of hypercholesterolemia (other than HeFH or HoFH).
8.5 Geriatric Use Of the 10,275 patients in clinical studies with rosuvastatin, 3,159 (31%) were 65 years and older, and 698 (6.8%) were 75 years and older.
No overall differences in safety or effectiveness were observed between these subjects and younger subjects.
Advanced age (≥65 years) is a risk factor for rosuvastatin-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 rosuvastatin for the increased risk of myopathy [see Warnings and Precautions (5.1) ].
8.6 Renal Impairment Rosuvastatin exposure is not influenced by mild to moderate renal impairment (CL cr ≥30 mL/min/1.73 m 2 ).
Exposure to rosuvastatin is increased to a clinically significant extent in patients with severe renal impairment (CL cr <30 mL/min/1.73 m 2 ) who are not receiving hemodialysis [see Clinical Pharmacology (12.3) ] .
Renal impairment is a risk factor for myopathy and rhabdomyolysis.
Monitor all patients with renal impairment for development of myopathy.
In patients with severe renal impairment not on hemodialysis, the recommended starting dosage is 5 mg daily and should not exceed 10 mg daily [see Dosage and Administration (2.5) and Warnings and Precautions (5.1) ].
8.7 Hepatic Impairment Rosuvastatin is contraindicated in patients with acute liver failure or decompensated cirrhosis.
Chronic alcohol liver disease is known to increase rosuvastatin exposure.
Patients who consume substantial quantities of alcohol and/or have a history of liver disease may be at increased risk for hepatic injury [see Contraindications (4) , Warning and Precautions (5.3) and Clinical Pharmacology (12.3) ].
8.8 Asian Patients Pharmacokinetic studies have demonstrated an approximate 2-fold increase in median exposure to rosuvastatin in Asian subjects when compared with White controls.
Adjust the rosuvastatin dosage in Asian patients [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3) ] .

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

See full prescribing information for details regarding concomitant use of rosuvastatin with other drugs that increase the risk of myopathy and rhabdomyolysis.
( 7.1 ) Aluminum and Magnesium Hydroxide Combination Antacids :
Administer rosuvastatin at least 2 hours before the antacid.
( 7.2 ) Warfarin: Obtain INR prior to starting rosuvastatin.
Monitor INR frequently until stable upon initiation, dosage titration or discontinuation.
( 7.3 )
7.1 Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Rosuvastatin Rosuvastatin is a substrate of CYP2C9 and transporters (such as OATP1B1, BCRP).
Rosuvastatin plasma levels can be significantly increased with concomitant administration of inhibitors of CYP2C9 and transporters.
Table 5 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when used concomitantly with rosuvastatin and instructions for preventing or managing them [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ].
Table 5:
Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Rosuvastatin Sofosbuvir/velpatasvir/voxilaprevir or Ledipasvir/sofosbuvir Prevention or Management:
Avoid concomitant use with rosuvastatin.
Mechanism and Clinical Effect(s):
Rosuvastatin plasma levels were significantly increased with concomitant administration of many anti-viral drugs, which increases the risk of myopathy and rhabdomyolysis.
Gemfibrozil Prevention or Management:
Avoid concomitant use of gemfibrozil with rosuvastatin.
If use is unavoidable, initiate rosuvastatin at 5 mg once daily and
do not exceed a dosage of rosuvastatin 10 mg once daily.
Mechanism and Clinical Effect(s):
Gemfibrozil significantly increased rosuvastatin exposure and gemfibrozil may cause myopathy when given alone.
The risk of myopathy and rhabdomyolysis is increased with concomitant use.
Tafamidis Prevention or Management: Avoid concomitant use of tafamidis with rosuvastatin.
If use is unavoidable, initiate rosuvastatin at 5 mg once daily and
do not exceed a dosage of rosuvastatin 20 mg once daily.
Monitor for signs of myopathy and rhabdomyolysis if used concomitantly with rosuvastatin.
Mechanism and Clinical Effect(s):
Tafamidis significantly increased rosuvastatin exposure and tafamidis may cause myopathy when given alone.
The risk of myopathy and rhabdomyolysis is increased with concomitant use.
Belumosudil Prevention or Management:
In patients taking belumosudil,
do not exceed a dosage of rosuvastatin 5 mg once daily.
Mechanism and Clinical Effect(s):
Belumosudil increased rosuvastatin exposure more than 4.6-fold.
The risk of myopathy and rhabdomyolysis is increased with concomitant use.
Cyclosporine Prevention or Management:
In patients taking cyclosporine,
do not exceed a dosage of rosuvastatin 5 mg once daily.
Mechanism and Clinical Effect(s): Cyclosporine increased rosuvastatin exposure 7-fold.
The risk of myopathy and rhabdomyolysis is increased with concomitant use.
Darolutamide Prevention or Management:
In patients taking darolutamide,
do not exceed a dosage of rosuvastatin 5 mg once daily.
Mechanism and Clinical Effect(s):
Darolutamide increased rosuvastatin exposure more than 5-fold.
The risk of myopathy and rhabdomyolysis is increased with concomitant use.
Additional Anti-Viral Medications Prevention or Management:
Simeprevir Dasabuvir/ombitasvir/paritaprevir/ritonavir Elbasvir/grazoprevir Sofosbuvir/velpatasvir Glecaprevir/pibrentasvir Atazanavir/ritonavir Lopinavir/ritonavir Initiate with rosuvastatin 5 mg once daily, and
do not exceed a dosage of rosuvastatin 10 mg once daily.
Mechanism and Clinical Effect(s):
Rosuvastatin plasma levels were significantly increased with concomitant administration of many anti-viral drugs, which increases the risk of myopathy and rhabdomyolysis.
Capmatinib Prevention or Management:
In patients taking capmatinib,
do not exceed a dosage of rosuvastatin 10 mg once daily.
Mechanism and Clinical Effect(s):
Capmatinib increased rosuvastatin exposure more than 2.1-fold.
The risk of myopathy and rhabdomyolysis is increased with concomitant use.
Enasidenib Prevention or Management:
In patients taking enasidenib,
do not exceed a dosage of rosuvastatin 10 mg once daily.
Mechanism and Clinical Effect(s):
Enasidenib increased rosuvastatin exposure more than 3.4-fold.
The risk of myopathy and rhabdomyolysis is increased with concomitant use.
Momelotinib Prevention or Management:
In patients taking momelotinib,
do not exceed a dosage of rosuvastatin 10 mg once daily.
Mechanism and Clinical Effect(s):
Momelotinib increased rosuvastatin exposure by 2.7-fold.
The risk of myopathy and rhabdomyolysis is increased with concomitant use.
Regorafenib Prevention or Management:
In patients taking regorafenib,
do not exceed a dosage of rosuvastatin 10 mg once daily.
Mechanism and Clinical Effect(s):
Regorafenib increased rosuvastatin exposure and may increase the risk of myopathy and rhabdomyolysis.
Teriflunomide Prevention or Management:
In patients taking teriflunomide,
do not exceed a dosage of rosuvastatin 10 mg once daily.
Mechanism and Clinical Effect(s):
Teriflunomide increased rosuvastatin exposure more than 2.5-fold.
The risk of myopathy and rhabdomyolysis is increased with concomitant use.
Ticagrelor Prevention or Management:
In patients taking ticagrelor,
do not exceed a dosage of rosuvastatin 20 mg once daily.
In patients at increased risk for rhabdomyolysis [ see Warnings and Precautions (5.1) ] , consider dosages less than 20 mg per day.
Mechanism and Clinical Effect(s): Ticagrelor increased rosuvastatin exposure by 2.3-fold.
The risk of myopathy and rhabdomyolysis is increased with concomitant use.
Febuxostat Prevention or Management:
In patients taking febuxostat,
do not exceed a dosage of rosuvastatin 20 mg once daily.
Mechanism and Clinical Effect(s):
Febuxostat increased rosuvastatin exposure more than 1.9-fold.
The risk of myopathy and rhabdomyolysis is increased with concomitant use.
Fostamatinib Prevention or Management:
In patients taking fostamatinib,
do not exceed a dosage of rosuvastatin 20 mg once daily.
Mechanism and Clinical Effect(s):
Fostamatinib increased rosuvastatin exposure more than 2.0-fold.
The risk of myopathy and rhabdomyolysis is increased with concomitant use.
Fenofibrates (e.g., fenofibrate and fenofibric acid) Prevention or Management:
Consider if the benefit of using fibrates concomitantly with rosuvastatin 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 dosage titration of either drug.
Mechanism and Clinical Effect(s): Fibrates may cause myopathy when given alone.
The risk of myopathy and rhabdomyolysis is increased with concomitant use.
Colchicine Prevention or Management:
Consider if the benefit of using colchicine concomitantly with rosuvastatin 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 dosage titration of either drug.
Mechanism and Clinical Effect(s):
Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with rosuvastatin.
Niacin Prevention or Management:
Consider if the benefit of using lipid-modifying dosages (≥1 g/day) of niacin concomitantly with rosuvastatin 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 dosage titration of either drug.
Mechanism and Clinical Effect(s):
Cases of myopathy and rhabdomyolysis have occurred with concomitant use of lipid-modifying dosages (≥1 g/day) of niacin with rosuvastatin.
7.2 Drug Interactions that Decrease the Efficacy of Rosuvastatin Table 6 presents drug interactions that may decrease the efficacy of rosuvastatin and instructions for preventing or managing them.
Table 6:
Drug Interactions that Decrease the Efficacy of Rosuvastatin Antacids Prevention or Management:
In patients taking an antacid, administer rosuvastatin at least 2 hours before the antacid .
Mechanism and Clinical Effect(s):
Concomitant aluminum and magnesium hydroxide combination antacid administration decreased the mean exposure of rosuvastatin 50% [see Clinical Pharmacology (12.3) ].
7.3 Rosuvastatin Effects on Other Drugs Table 7 presents rosuvastatin’s effect on other drugs and instructions for preventing or managing them.
Table 7:
Rosuvastatin Effects on Other Drugs Warfarin Prevention or Management:
In patients taking warfarin, obtain an INR before starting rosuvastatin and frequently enough after initiation, dosage titration or discontinuation to ensure that no significant alteration in INR occurs.
Once the INR is stable, monitor INR at regularly recommended intervals.
Mechanism and Clinical Effect(s):
Rosuvastatin significantly increased the INR in patients receiving warfarin [see Clinical Pharmacology (12.3) ].

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

No specific antidotes for rosuvastatin are known.
Hemodialysis does not significantly enhance clearance of rosuvastatin.
In the event of overdose, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

Quoted from the official label, section “Overdosage”.

Use in children

The safety and effectiveness of rosuvastatin as an adjunct to diet to reduce LDL-C have been established in pediatric patients 8 years of age and older with HeFH.
Use of rosuvastatin for this indication is based on one 12-week controlled trial with a 40-week open-label extension period in 176 pediatric patients 10 years of age and older with HeFH and one 2-year open-label, uncontrolled trial in 175 pediatric patients 8 years of age and older with HeFH [ see Clinical Studies (14) ] .
In the 1-year trial with a 12-week controlled phase, there was no detectable effect of rosuvastatin on growth, weight, BMI (body mass index), or sexual maturation in patients aged 10 to 17 years.
The safety and effectiveness of rosuvastatin as an adjunct to other LDL-C-lowering therapies to reduce LDL-C have been established in pediatric patients 7 years of age and older with HoFH.
Use of rosuvastatin for this indication is based on a randomized, placebo-controlled, cross-over study in 14 pediatric patients 7 years of age and older with HoFH [ see Clinical Studies (14) ] .
The safety and effectiveness of rosuvastatin have not been established in pediatric patients younger than 8 years of age with HeFH, younger than 7 years of age with HoFH, or in pediatric patients with other types of hypercholesterolemia (other than HeFH or HoFH).

Quoted from the official label, section “Pediatric Use”.

Use in older people

Of the 10,275 patients in clinical studies with rosuvastatin, 3,159 (31%) were 65 years and older, and 698 (6.8%) were 75 years and older.
No overall differences in safety or effectiveness were observed between these subjects and younger subjects.
Advanced age (≥65 years) is a risk factor for rosuvastatin-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 rosuvastatin for the increased risk of myopathy [see Warnings and Precautions (5.1) ].

Quoted from the official label, section “Geriatric Use”.

Side effects

The following important adverse reactions are described below and elsewhere in the labeling:
Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1) ] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2) ] Hepatic Dysfunction [see Warnings and Precautions (5.3) ] Proteinuria and Hematuria [see Warnings and Precautions (5.4) ] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.5) ] Most frequent adverse reactions (rate ≥2%) are headache, nausea, myalgia, asthenia, and constipation.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Adverse reactions reported in ≥2% of patients in placebo-controlled clinical studies and at a rate greater than placebo are shown in Table 2.
These studies had a treatment duration of up to 12 weeks.
Table 2:
Adverse Reactions Reported in ≥2% of Patients Treated with Rosuvastatin and > Placebo in Placebo-Controlled Trials Adverse Reactions Placebo N=382 % Rosuvastatin 5 mg N=291 % Rosuvastatin 10 mg N=283 % Rosuvastatin 20 mg N=64 % Rosuvastatin 40 mg N=106 % Total Rosuvastatin 5 mg to 40 mg N=744 % Headache 5.0 5.5 4.9 3.1 8.5
5.5 Nausea 3.1 3.8 3.5 6.3 0
3.4 Myalgia 1.3 3.1 2.1 6.3 1.9
2.8 Asthenia 2.6 2.4 3.2 4.7 0.9
2.7 Constipation 2.4 2.1 2.1 4.7 2.8
2.4 Other adverse reactions reported in clinical studies were abdominal pain, dizziness, hypersensitivity (including rash, pruritus, urticaria, and angioedema) and pancreatitis.
The following laboratory abnormalities have also been reported:
dipstick-positive proteinuria and microscopic hematuria; elevated creatine phosphokinase, transaminases, glucose, glutamyl transpeptidase, alkaline phosphatase, and bilirubin; and thyroid function abnormalities.
In the METEOR study, patients were treated with rosuvastatin 40 mg (n=700) or placebo (n=281) with a mean treatment duration of 1.7 years.
Adverse reactions reported in ≥2% of patients and at a rate greater than placebo are shown in Table 3.
Table 3:
Adverse Reactions Reported in ≥2% of Patients Treated with Rosuvastatin and > Placebo in the METEOR Trial 1 Frequency recorded as abnormal laboratory value.
Adverse Reactions Placebo N=281 % Rosuvastatin 40 mg N=700 % Myalgia 12.1
12.7 Arthralgia 7.1
10.1 Headache 5.3
6.4 Dizziness 2.8
4.0 Increased CPK 0.7
2.6 Abdominal pain 1.8
2.4 ALT greater than 3x ULN 1 0.7
2.2 In the JUPITER study, patients were treated with rosuvastatin 20 mg (n=8,901) or placebo (n=8,901) for a mean duration of 2 years.
In JUPITER, there was a significantly higher frequency of diabetes mellitus reported in patients taking rosuvastatin (2.8%) versus patients taking placebo (2.3%).
Mean HbA1c was significantly increased by 0.1% in rosuvastatin-treated patients compared to placebo-treated patients.
The number of patients with a HbA1c >6.5% at the end of the trial was significantly higher in rosuvastatin-treated versus placebo-treated patients [see Clinical Studies (14) ] .
Adverse reactions reported in ≥ 2% of patients and at a rate greater than placebo are shown in Table 4.
Table 4:
Adverse Reactions Reported in ≥2% of Patients Treated with Rosuvastatin and > Placebo in the JUPITER Trial Adverse Reactions Placebo N=8,901 % Rosuvastatin 20 mg N=8,901 % Myalgia 6.6
7.6 Arthralgia 3.2
3.8 Constipation 3.0
3.3 Diabetes mellitus 2.3
2.8 Nausea 2.3
2.4 Pediatric Patients with HeFH In a 12-week controlled study in pediatric patients 10 to 17 years of age with HeFH with rosuvastatin 5 mg to 20 mg daily [see Use in Specific Populations (8.4) and Clinical Studies (14) ] , elevations in serum CK greater than 10 x ULN were observed more frequently in rosuvastatin-treated patients compared with patients receiving placebo.
Four of 130 (3%) patients treated with rosuvastatin (2 treated with 10 mg and 2 treated with 20 mg) had increased CK greater than 10 x ULN, compared to 0 of 46 patients on placebo.
6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of rosuvastatin.
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.
Blood Disorders:
thrombocytopenia Hepatobiliary Disorders:
hepatitis, jaundice, fatal and non-fatal hepatic failure Musculoskeletal Disorders:
arthralgia, rare reports of immune-mediated necrotizing myopathy associated with statin use Nervous System Disorders:
peripheral neuropathy, rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, and confusion) associated with the use of all statins.
The reports are 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, sleep disorders (including insomnia and nightmares) Reproductive System and Breast Disorders:
gynecomastia Respiratory Disorders:
interstitial lung disease Skin and Subcutaneous Tissue Disorders:
drug reaction with eosinophilia and systemic symptoms (DRESS), lichenoid drug eruption

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

Advise the patient to read the FDA-approved patient labeling ( Patient Information ).
Myopathy and Rhabdomyolysis Advise patients that rosuvastatin tablets may cause myopathy and rhabdomyolysis.
Inform patients that the risk is also increased when taking certain types of medication 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) , and Drug Interactions (7.1) ].
Hepatic Dysfunction Inform patients that rosuvastatin 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) ].
Increases in HbA1c and Fasting Serum Glucose Levels Inform patients that increases in HbA1c and fasting serum glucose levels may occur with rosuvastatin tablets.
Encourage patients to optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices [see Warnings and Precautions (5.5) ].
Pregnancy Advise pregnant patients and patients who can become pregnant of the potential risk to a fetus.
Advise patients to inform their healthcare provider of a known or suspected pregnancy to discuss if rosuvastatin tablets should be discontinued [see Use in Specific Populations (8.1) ] .
Lactation Advise patients that breastfeeding during treatment with rosuvastatin tablets is not recommended [see Use in Specific Populations (8.2) ].
Concomitant Use of Antacids When taking rosuvastatin tablets with an aluminum and magnesium hydroxide combination antacid, administer rosuvastatin tablets at least 2 hours before the antacid [see Drug Interactions (7.2) ] .
Missed Doses If a dose is missed, advise patients not to take an extra dose.
Just resume the usual schedule [see Dosage and Administration (2.1) ] .
Distributed by:
Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by:
Aurobindo Pharma Limited Hyderabad-500 032, India Revised:
08/2026

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

FORMS AND STRENGTHS Rosuvastatin tablets, USP:
5 mg of rosuvastatin:
Pink, oval shaped, biconvex film-coated tablets debossed with ‘I’ on one side and ‘29’ on the other side. 10 mg of rosuvastatin:
Pink, round, biconvex film-coated tablets debossed with ‘I’ on one side and ‘30’ on the other side. 20 mg of rosuvastatin:
Pink, round, biconvex film-coated tablets debossed with ‘I’ on one side and ‘31’ on the other side. 40 mg of rosuvastatin:
Pink, oval shaped, biconvex film-coated tablets debossed with ‘I’ on one side and ‘32’ on the other side.
Tablets: 5 mg, 10 mg, 20 mg, and 40 mg of rosuvastatin.
( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

Rosuvastatin tablets USP 5 mg are pink, oval shaped, biconvex film-coated tablets debossed with ‘I’ on one side and ‘29’ on the other side.
Bottles of 30 NDC 65862-293-30 Bottles of 90 NDC 65862-293-90 Bottles of 500 NDC 65862-293-05 Bottles of 1,000 NDC 65862-293-99 10 x 6 Unit-dose Tablets NDC 65862-293-06 Rosuvastatin tablets USP 10 mg are pink, round, biconvex film-coated tablets debossed with ‘I’ on one side and ‘30’ on the other side.
Bottles of 30 NDC 65862-294-30 Bottles of 90 NDC 65862-294-90 Bottles of 500 NDC 65862-294-05 Bottles of 1,000 NDC 65862-294-99 10 x 6 Unit-dose Tablets NDC 65862-294-06 Rosuvastatin tablets USP 20 mg are pink, round, biconvex film-coated tablets debossed with ‘I’ on one side and ‘31’ on the other side.
Bottles of 30 NDC 65862-295-30 Bottles of 90 NDC 65862-295-90 Bottles of 500 NDC 65862-295-05 Bottles of 1,000 NDC 65862-295-99 10 x 6 Unit-dose Tablets NDC 65862-295-06 Rosuvastatin tablets USP 40 mg are pink, oval shaped, biconvex film-coated tablets debossed with ‘I’ on one side and ‘32’ on the other side.
Bottles of 30 NDC 65862-296-30 Bottles of 90 NDC 65862-296-90 Bottles of 500 NDC 65862-296-05 Bottles of 1,000 NDC 65862-296-99 10 x 10 Unit-dose Tablets NDC 65862-296-10 Storage
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Protect from moisture.

Quoted from the official label, section “How Supplied”.

What is in it

Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor.
The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula:
The empirical formula for rosuvastatin calcium is (C 22 H 27 FN 3 O 6 S) 2 Ca and the molecular weight is 1,001.14.
Rosuvastatin calcium USP is a white to off-white powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol.
Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0.
Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients:
crospovidone, dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.
Meets USP Dissolution Test-2.
Chemical Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Lactoselactose monohydrateMilk sugar: matters with lactose intolerance or a milk allergy.
Titanium dioxidetitanium dioxideA whitening agent no longer allowed in food in the EU (E171).

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (53)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 53 of 53

Details

Made by	Aurobindo Pharma Limited
Active substance	Rosuvastatin Calcium
Used in	Heart, blood pressure and circulation
Strength	10 mg
Form	Tablet, Film Coated
Route	Oral
Packs	500 TABLET, FILM COATED in 1 BOTTLE · 10 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED in 1 BLISTER PACK
NDC	65862-294

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

131 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Tablet, Film Coated98 products
- 5 mg23
  5 mg · 23 companies
  +15 more
- 10 mg28
  10 mg · 28 companies
  - A-S Medication Solutions
  - American Health Packaging
  - Aphena Pharma Solutions - Tennessee, LLC
  - Ascend Laboratories, LLC
  - Aurobindo Pharma Limited · this page
  - Biocon Pharma Inc
  - Bryant Ranch Prepack
  - Cadila Pharmaceuticals Limited
  +20 more
- 20 mg26
  20 mg · 26 companies
  +18 more
- 40 mg21
  40 mg · 21 companies
  +13 more
Tablet27 products
Tablet, Coated6 products
- 5 mg3
  5 mg · 3 companies
- 10 mg
- 20 mg
- 40 mg

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Rosuvastatin Calcium5 mgPrescription onlyTablet, Film Coated NCS HealthCare of KY, LLC dba Vangard Labs · Rosuvastatin Calcium Rosuvastatin Calcium10 mgPrescription onlyTablet, Film Coated NCS HealthCare of KY, LLC dba Vangard Labs · Rosuvastatin Calcium Rosuvastatin Calcium20 mgPrescription onlyTablet, Film Coated NCS HealthCare of KY, LLC dba Vangard Labs · Rosuvastatin Calcium Rosuvastatin Calcium40 mgPrescription onlyTablet, Film Coated NCS HealthCare of KY, LLC dba Vangard Labs · Rosuvastatin Calcium Rosuvastatin Calcium5 mgPrescription onlyTablet, Coated Torrent Pharmaceuticals Limited · Rosuvastatin Calcium Rosuvastatin Calcium10 mgPrescription onlyTablet, Coated Torrent Pharmaceuticals Limited · Rosuvastatin Calcium

See every product with Rosuvastatin Calcium