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Rosuvastatin: Drug information

Rosuvastatin: Drug information
(For additional information see "Rosuvastatin: Patient drug information" and see "Rosuvastatin: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Special Alerts
Statin Pregnancy Contraindication Update July 2021

After a comprehensive review of all available data, the FDA is requesting all statin manufacturers to remove the contraindication in the prescribing information against using statins in pregnant patients. Although statin therapy should be discontinued in most pregnant patients, health care providers should consider the ongoing therapeutic needs of the individual patient, especially patients at very high risk of cardiovascular events during pregnancy, such as patients with homozygous familial hypercholesterolemia or those with established cardiovascular disease. Additionally, breastfeeding is still not recommended in patients taking a statin; health care providers should determine whether it is better to temporarily stop statin therapy while breastfeeding or to continue statin therapy and not have the patient breastfeed. If ongoing statin treatment is necessary, infant formula and other alternatives are available. The FDA expects that removing the contraindication will enable health care providers and patients to make individual decisions about benefit and risk, especially for those at very high risk of heart attack or stroke.

Further information is available at https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-removal-strongest-warning-against-using-cholesterol-lowering-statins-during-pregnancy.

Brand Names: US
  • Crestor;
  • Ezallor Sprinkle
Brand Names: Canada
  • ACH-Rosuvastatin;
  • AG-Rosuvastatin;
  • AG-Rosuvastatin Calcium;
  • APO-Rosuvastatin;
  • Auro-Rosuvastatin;
  • BIO-Rosuvastatin;
  • Crestor;
  • DOM-Rosuvastatin [DSC];
  • JAMP Rosuvastatin Calcium;
  • JAMP-Rosuvastatin;
  • M-Rosuvastatin;
  • Mar-Rosuvastatin;
  • MINT-Rosuvastatin;
  • NRA-Rosuvastatin;
  • PMS-Rosuvastatin;
  • Priva-Rosuvastatin [DSC];
  • PRZ-Rosuvastatin;
  • RIVA-Rosuvastatin;
  • SANDOZ Rosuvastatin;
  • TARO-Rosuvastatin;
  • TEVA-Rosuvastatin
Pharmacologic Category
  • Antilipemic Agent, HMG-CoA Reductase Inhibitor
Dosing: Adult

Dosage guidance:

Dosing: Rosuvastatin 20 to 40 mg/day is considered a high-intensity statin (generally reduces low-density lipoprotein cholesterol [LDL-C] by ≥50%). Rosuvastatin 5 to 10 mg/day is considered a moderate-intensity statin (generally reduces LDL-C by ~30% to 49%). Assess response ~1 to 3 months after therapy initiation or dose adjustment and every 3 to 12 months thereafter (Ref). In patients of East Asian descent, exposure can be ~2-fold higher compared to White patients; consider initial dosage reduction and risk versus benefit in East Asian patients not adequately controlled with rosuvastatin 20 mg once daily before increasing dose further (Ref).

Clinical considerations: Use in conjunction with lifestyle modification (eg, diet, exercise). When initiating therapy and selecting dose intensity, consider age, baseline LDL-C, 10-year atherosclerotic cardiovascular disease (ASCVD) risk, risk-enhancing factors, potential adverse effects, and drug interactions.

Heterozygous familial hypercholesterolemia

Heterozygous familial hypercholesterolemia:

Note: Multiple lipid-lowering therapies may be needed if statin monotherapy is not effective. Referral to a lipid specialist should be considered if treatment goals are not met (Ref).

High-intensity therapy: Oral: Initial: 20 or 40 mg once daily; if 20 mg once daily is initiated and tolerated, increase to 40 mg once daily (Ref).

Homozygous familial hypercholesterolemia

Homozygous familial hypercholesterolemia:

Note: Multiple lipid-lowering therapies are usually needed to achieve treatment goals; treatment should be guided by an experienced lipid specialist (Ref).

High-intensity therapy: Oral: 40 mg once daily (Ref).

Prevention of atherosclerotic cardiovascular disease

Prevention of atherosclerotic cardiovascular disease :

Note: If LDL-C goal (eg, percent reduction or absolute goal) is not met with the initial dose, may consider up-titration based on estimated 10-year ASCVD risk (see American College of Cardiology ASCVD Risk Estimator Plus online), LDL-C response, and tolerability. If LDL-C goal is not met with maximally tolerated dose, additional lipid-lowering therapy may be warranted (Ref).

Primary prevention:

Patients without diabetes, 40 to 75 years of age, and with LDL-C 70 to 189 mg/dL:

ASCVD 10-year risk 5% to <7.5%:

Note: Depending on baseline LDL-C and presence of risk-enhancing factors, consider statin therapy after shared decision-making with patient. Some experts suggest shared decision-making if ASCVD 10-year risk is 5% to 10%; however, in patients with a baseline LDL-C >160 mg/dL, statin therapy is usually recommended (Ref).

Moderate-intensity therapy: Oral: 5 to 10 mg once daily to reduce LDL-C by 30% to 49% (Ref).

ASCVD 10-year risk ≥7.5% to <20%:

Note: Depending on baseline LDL-C and presence of risk-enhancing factors, consider statin therapy after shared decision-making with patient. Some experts suggest initiating moderate-intensity statin therapy in most patients if ASCVD 10-year risk is >10% to <20% and LDL-C is >100 mg/dL (Ref).

Moderate-intensity therapy: Oral: 5 to 10 mg once daily to reduce LDL-C by 30% to 49%; higher risk patients with multiple risk-enhancing factors may benefit from higher doses to reduce LDL-C by ≥50% (Ref).

ASCVD 10-year risk ≥20%:

High-intensity therapy: Oral: 20 to 40 mg once daily to reduce LDL-C by ≥50%; if unable to tolerate due to adverse effects, may reduce dose to maximum tolerated (Ref).

Patients with diabetes:

40 to 75 years of age without additional ASCVD risk factors :

Moderate-intensity therapy: Oral: 5 to 10 mg once daily to reduce LDL-C by 30% to 49% (Ref).

ASCVD risk ≥7.5% or multiple ASCVD risk factors :

High-intensity therapy: Oral: 20 to 40 mg once daily to reduce LDL-C by ≥50%; if unable to tolerate due to adverse effects, may reduce dose to maximum tolerated (Ref).

Patients with LDL-C ≥190 mg/dL and 20 to 75 years of age:

Note: High-intensity therapy is indicated regardless of ASCVD risk calculation or coexisting diabetes mellitus.

High-intensity therapy: Oral: 20 to 40 mg once daily to reduce LDL-C by ≥50%; if unable to tolerate due to adverse effects, may reduce dose to maximum tolerated (Ref).

Secondary prevention in patients with established ASCVD (eg, coronary heart disease, cerebrovascular disease [ischemic stroke or transient ischemic attack], peripheral arterial disease):

Note: Patients with high-risk ASCVD may require additional therapies to achieve LDL-C goal (eg, <70 mg/dL or <50 mg/dL if very high risk) (Ref).

High-intensity therapy: Oral: 20 to 40 mg once daily to reduce LDL-C by ≥50%; if unable to tolerate due to adverse effects, may reduce dose to maximum tolerated (Ref).

Transplantation

Transplantation:

Note: Certain immunosuppressive drugs can induce or exacerbate hypercholesterolemia. Significant drug interactions between statins and immunosuppressant drugs are frequent; some interactions can increase statin serum concentrations and risk of toxicity (eg, myopathy) (Ref). Consult Drug Interactions Database for more detailed information.

Transplantation, post heart (off-label use): Oral: Initial: 5 to 10 mg once daily starting 1 to 2 weeks after transplant, regardless of baseline cholesterol levels; increase to the maximum tolerated dose within 4 to 8 weeks of transplantation based on response and use of concomitant medications up to 20 mg once daily (Ref).

Transplantation, post kidney (off-label use):

Note: The decision to initiate therapy for primary or secondary prevention is similar to the nontransplant population (see "Dosing: Prevention of Atherosclerotic Cardiovascular Disease"). However, in patients who are 30 to 39 years of age, some experts suggest statin therapy post kidney transplantation for primary prevention of ASCVD. For primary prevention of ASCVD in patients 18 to 29 years of age, use shared decision making while considering risks and benefits (Ref).

Oral: Initial: 5 mg once daily; increase dose based on response, tolerability, and use of concomitant medications up to 10 mg once daily (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult Drug Interactions Database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function:

CrCl ≥30 mL/minute/1.73 m2: No dosage adjustment necessary.

CrCl <30 mL/minute/1.73 m2: 5 to 10 mg once daily.

Hemodialysis, intermittent (thrice weekly): Not dialyzable: Maximum: 10 mg/day. Steady state concentrations are increased ~50% during chronic hemodialysis; however, accumulation is minimal, and rates of adverse effects are similar to placebo with a dose of 10 mg/day (Ref).

Peritoneal dialysis: Maximum: 10 mg/day; accumulation unlikely to occur at a dose of ≤10 mg/day (Ref).

CRRT: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Recommendations are based on high-flux dialyzers and effluent flow rates of 20 to 25 mL/kg/hour (or ~1,500 to 3,000 mL/hour) unless otherwise noted. Close monitoring of response and adverse reactions (eg, rhabdomyolysis) due to drug accumulation is important.

Maximum: 10 mg/day (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration): Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Close monitoring of response and adverse reactions (eg, rhabdomyolysis) due to drug accumulation is important.

Maximum: 10 mg/day (Ref).

Dosing: Hepatic Impairment: Adult

The hepatic dosing recommendations are based upon on the best available evidence and clinical expertise. Senior Editorial Team: Matt Harris, PharmD, MHS, BCPS, FAST; Jeong Park, PharmD, MS, BCPS, FCCP, FAST; Arun Jesudian, MD; Sasan Sakiani, MD.

Hepatic impairment prior to treatment initiation:

Note: Although use is contraindicated in patients with active liver failure or decompensated cirrhosis according to the manufacturer's labeling, baseline elevation in AST/ALT should not preclude use of statins for compelling indications in patients with chronic stable liver disease including compensated cirrhosis (Ref).

Child-Turcotte-Pugh class A: No dosage adjustment necessary (Ref).

Child-Turcotte-Pugh class B: Oral: Initial: 5 mg once daily; may increase to 10 mg once daily based on tolerability and response; maximum recommended dose: 10 mg once daily (Ref).

Child-Turcotte-Pugh class C: Oral: Use generally not recommended. If use deemed necessary (eg, patients with compelling indications): Initial: 5 mg once daily; a maximum dose of 5 mg once daily is recommended (Ref).

Acute hepatoxicity or worsening hepatic function (eg, progression from class A to B) during treatment:

Progression from baseline to Child-Turcotte-Pugh class A through C: Although use is contraindicated in patients with active liver failure or decompensated cirrhosis according to the manufacturer's labeling, if rosuvastatin-induced hepatoxicity has been ruled out, may continue rosuvastatin therapy with no dosage adjustment necessary; monitor closely for signs or symptoms of rhabdomyolysis (Ref).

Dosing: Adjustment for Toxicity: Adult

Severe muscle symptoms or fatigue: Promptly discontinue use; evaluate CPK, creatinine, and urinalysis for myoglobinuria (Ref).

Mild to moderate muscle symptoms: Discontinue use until symptoms can be evaluated; evaluate patient for conditions that may increase the risk for muscle symptoms (eg, hypothyroidism, reduced renal or hepatic function, rheumatologic disorders such as polymyalgia rheumatica, steroid myopathy, vitamin D deficiency, or primary muscle diseases). Upon resolution, resume the original or lower dose of rosuvastatin. If muscle symptoms recur, discontinue rosuvastatin use. After muscle symptom resolution, may then use a low dose of a different statin; gradually increase if tolerated. In the absence of continued statin use, if muscle symptoms or elevated CPK continues after 2 months, consider other causes of muscle symptoms. If determined to be due to another condition aside from statin use, may resume statin therapy at the original dose (Ref).

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Rosuvastatin: Pediatric drug information")

Dosage guidance:

Dosing: Doses should be individualized according to the baseline LDL-cholesterol levels, the recommended goal of therapy, and patient response; adjustments should be made at intervals of 4 weeks or more. A lower, conservative dosing regimen may be necessary in patient populations predisposed to myopathy, including patients of East Asian descent (Ref).

Heterozygous familial hypercholesterolemia

Heterozygous familial hypercholesterolemia:

Children 8 to <10 years: Oral: 5 to 10 mg once daily.

Children ≥10 years and Adolescents: Oral: 5 to 20 mg once daily.

Homozygous familial hypercholesterolemia

Homozygous familial hypercholesterolemia: Children ≥7 years and Adolescents: Oral: 20 mg once daily.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Children ≥7 years and Adolescents:

CrCl ≥30 mL/minute/1.73 m2: No dosage adjustment required.

CrCl <30 mL/minute/1.73 m2 and not receiving hemodialysis: Initial: 5 mg once daily; maximum daily dose: 10 mg/day

Dosing: Hepatic Impairment: Pediatric

Children ≥7 years and Adolescents: There are no dosage adjustments provided in the manufacturer's labeling; systemic exposure (increased AUC and Cmax) may be increased in patients with liver disease; monitor closely. Use is contraindicated in patients with active liver disease or decompensated cirrhosis.

Adverse Reactions (Significant): Considerations
Hepatic effects

Statins are associated with increased serum transaminases and hepatotoxicity (Ref). Asymptomatic transient or persistent increases both <3 or >3 times the ULN in serum transaminases may occur with all statins; the increased serum alanine aminotransferase (ALT) is typically greater than the increase in aspartate aminotransferase (AST) (Ref). One case report of increased liver function tests has also been reported as part of drug rash eosinophilia with systemic symptoms (Ref). Acute hepatotoxicity, often presenting as a drug-induced autoimmune hepatitis, has been documented (Ref).

Upon dose reduction or discontinuation, transaminase levels return to or near pretreatment levels; although, mild elevations resolve with continued use in some cases (Ref). Chronic liver injury (defined as liver biochemical or histological abnormalities that persisted for 6 months or more after onset) have been reported (Ref).

Mechanism: Unknown; rosuvastatin undergoes minimal hepatic metabolism. Acute liver injury may be caused by immune-mediated mechanisms (Ref). Changes in the lipid components of the hepatocyte membrane may lead to increased permeability and leakage of liver enzymes (Ref).

Onset: Varied; most cases occur within the first 3 months of initiation or dose escalation (Ref). Duration of rosuvastatin prior to development of hepatotoxicity has been reported from approximately 2 months to 2 years (Ref).

Risk factors:

• Higher doses may increase the risk of liver injury (Ref)

• Concurrent medications with statin drug-drug interactions or hepatotoxic properties (Ref)

• Hepatotoxicity is more commonly associated with atorvastatin than pravastatin, rosuvastatin, and simvastatin (Ref). Fluvastatin is associated with the greatest risk of developing hepatotoxicity (Ref).

• Cross-reactivity between different statins and the susceptibility to hepatotoxicity is unknown, as data have shown conflicting results (Ref).

• Chronic hepatitis B and alcohol consumption are independent risk factors for hepatic aminotransferase elevation associated with statins in patients 80 years of age or older (Ref).

Muscle-related effects

Statins are associated with several muscle-related effects, including:

• Myalgia (muscle symptoms without significant creatine kinase [CK] elevations; also known as statin-associated muscle symptoms) (Ref)

• Myopathy (defined as unexplained muscle pain or weakness accompanied by a CK concentration >10 times the ULN) (Ref)

• Rhabdomyolysis (CK >40 times the ULN) (Ref) often with acute renal failure secondary to myoglobinuria (Ref)

• Immune-mediated necrotizing myopathy (IMNM) (elevated CK plus the presence of antibodies against HMG-CoA) (Ref)

Mechanism: Uncertain; alterations in the mevalonate pathway and changes in the electrical and structural characteristics of the sarcolemma related to calcium ion flux possibly contribute (Ref). Decreased ubiquinone, which is essential for energy production in skeletal muscle, may also contribute (Ref). Myopathy/rhabdomyolysis risk is related to circulating active drug concentrations (Ref). IMNM is considered an immune-mediated process; autoantibodies against HMG-CoA reductase (anti-HMG-CoA) have been identified (Ref).

Onset: Delayed; often presents within a few months after starting therapy (highest risk within first year of use), when the dose of the statin is increased, or when introducing an interacting drug (Ref). Muscle symptoms often appear more promptly when patients are reexposed to the same statin (Ref). Duration of statin use prior to development of IMNM is ~2 to 3 years (Ref).

Risk factors:

• First year of therapy (Ref)

• Dose increase (for myopathy and rhabdomyolysis, but not IMNM) (Ref)

• Addition of an interacting drug (eg, concurrent use of medications associated with myopathy [eg, gemfibrozil]) (Ref); since there is minimal metabolism of rosuvastatin by CYP3A4, low risk for clinically significant drug interactions with CYP3A4 inhibitors (Ref)

• Older patients (Ref)

• Hypothyroidism (Ref)

• Preexisting muscle disease (Ref)

• Kidney impairment (Ref)

• Females (Ref)

• Low body mass index (Ref)

• Heavy exercise (Ref)

• Surgery (Ref)

• Higher HMG-COA reductase inhibitory activity (Ref), rosuvastatin > atorvastatin > simvastatin > pravastatin ≈ lovastatin (Ref)

• East Asian population: Increased plasma concentrations (up to ≈ twofold with rosuvastatin) may result in increased risk of myopathy (Ref)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Neuromuscular & skeletal: Myalgia (2% to 13%) (table 1)

Rosuvastatin: Adverse Reaction: Myalgia

Drug (Rosuvastatin)

Placebo

Dose

Number of Patients (Rosuvastatin)

Number of Patients (Placebo)

13%

12%

40 mg once daily

700

281

8%

7%

20 mg once daily

8,901

8,901

6%

1%

20 mg once daily

64

382

3%

1%

5 mg once daily

291

382

2%

1%

10 mg once daily

283

382

2%

1%

40 mg once daily

106

382

1% to 10%:

Endocrine & metabolic: Diabetes mellitus (new onset: 3%)

Gastrointestinal: Constipation (3% to 5%), nausea (4% to 6%)

Hepatic: Increased serum transaminases (>3 × ULN; including increased serum alanine aminotransferase [2%] (table 2), increased serum alkaline phosphatase, increased serum bilirubin)

Rosuvastatin: Adverse Reaction: Increased Serum Alanine Aminotransferase

Drug (Rosuvastatin)

Placebo

Dose

Number of Patients (Rosuvastatin)

Number of Patients (Placebo)

Comments

2%

0.7%

40 mg once daily

700

281

>3 x ULN

Nervous system: Asthenia (5%) (table 3), dizziness (4%), headache (6% to 9%)

Rosuvastatin: Adverse Reaction: Asthenia

Drug (Rosuvastatin)

Placebo

Dose

Number of Patients (Rosuvastatin)

Number of Patients (Placebo)

5%

3%

20 mg once daily

64

382

3%

3%

10 mg once daily

283

382

2%

3%

5 mg once daily

291

382

0.9%

3%

40 mg once daily

106

382

Neuromuscular & skeletal: Arthralgia (4% to 10%) (table 4), increased creatine phosphokinase in blood specimen (3%) (table 5)

Rosuvastatin: Adverse Reaction: Arthralgia

Drug (Rosuvastatin)

Placebo

Dose

Number of Patients (Rosuvastatin)

Number of Patients (Placebo)

10%

7%

40 mg once daily

700

281

4%

3%

20 mg once daily

8,901

8,901

Rosuvastatin: Adverse Reaction: Increased Creatine Phosphokinase in Blood Specimen

Drug (Rosuvastatin)

Placebo

Population

Dose

Number of Patients (Rosuvastatin)

Number of Patients (Placebo)

Comments

3%

0%

Children and adolescents

10 mg to 20 mg once daily

130

46

>10 x ULN

3%

0.7%

Adults

40 mg once daily

700

281

N/A

Frequency not defined:

Endocrine & metabolic: Abnormal thyroid function test, elevated glycosylated hemoglobin, increased serum glucose

Gastrointestinal: Abdominal pain

Hepatic: Increased gamma-glutamyl transferase

Hypersensitivity: Hypersensitivity reaction

Postmarketing:

Dermatologic: Lichenoid eruption (Vesza 2018), maculopapular rash (Mancano 2018), pemphigoid (Murad 2012), pruritus (Malik 2022), purpuric rash (photolocalized) (Thabouti 2022)

Endocrine & metabolic: Gynecomastia (Roberto 2012)

Gastrointestinal: Oral mucosa ulcer (Algeffari 2022), pancreatitis (Chintanabonia 2012)

Genitourinary: Cystitis (interstitial) (Huang 2015), microscopic hematuria (Shin 2022), proteinuria (Shin 2022)

Hematologic & oncologic: Thrombocytopenia (Vrettos 2010)

Hepatic: Autoimmune hepatitis (Russo 2014), hepatic failure, hepatitis (Oteri 2008), jaundice (Oteri 2008)

Hypersensitivity: Angioedema (Shahbaz 2018), drug reaction with eosinophilia and systemic symptoms (Mustafa 2020)

Nervous system: Cognitive dysfunction (reversible; includes amnesia, confusion, memory impairment) (Tuccori 2014), depression, myasthenia (myonecrosis) (Hassan 2022), myasthenia gravis (including exacerbation of myasthenia gravis and ocular myasthenia gravis) (Purvin 2006), peripheral neuropathy (Özdemir 2019), sleep disorder (including insomnia, nightmares)

Neuromuscular & skeletal: Immune-mediated necrotizing myopathy (Essers 2019), myoglobinuria (Hilton-Jones 2018), myopathy (Newman 2019), myositis, rhabdomyolysis (Kariyanna 2019)

Renal: Acute interstitial nephritis (Londrino 2013), acute kidney injury (Wagner 2021), kidney failure (Hilton-Jones 2018)

Respiratory: Interstitial lung disease (including interstitial pneumonitis) (Kim 2015)

Contraindications

Hypersensitivity (eg, angioedema, pruritus, rash, urticaria) to rosuvastatin or any component of the formulation; active liver failure or decompensated cirrhosis.

Canadian labeling: Additional contraindications (not in US labeling): Concomitant administration of cyclosporine or sofosbuvir/velpatasvir/voxilaprevir; patients with active liver disease or unexplained persistent elevations of serum transaminases (>3 times ULN); pregnancy; breastfeeding; use of 40 mg dose in East Asian patients or patients with predisposing risk factors for myopathy/rhabdomyolysis.

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Warnings/Precautions

Concerns related to adverse effects:

• Diabetes mellitus: Small increases in HbA1c (mean: ~0.1%) and fasting blood glucose have been reported with rosuvastatin; however, the benefits of statin therapy far outweigh the risk of dysglycemia.

• Hematuria/proteinuria: Hematuria (microscopic) and proteinuria have been observed; more commonly reported in adults receiving rosuvastatin 40 mg daily. Typically, transient and not associated with a decrease in renal function. Consider dosage reduction if unexplained hematuria and proteinuria persists.

Disease-related concerns:

• Hepatic impairment: Use with caution in patients who consume large amounts of ethanol and/or have a history of liver disease; may require dosage adjustment in some patients with hepatic impairment.

• Myasthenia gravis: May rarely worsen or precipitate myasthenia gravis (MG); monitor for worsening MG if treatment is initiated (AAN [Narayanaswami 2021]).

• Renal impairment: Dosage adjustment may be required in patients with renal impairment.

Special populations:

• East Asian population: Dosage adjustment should be considered for patients of East Asian descent.

• Older adult: Use with caution in patients with advanced age; these patients are more predisposed to myopathy.

• Surgical patients: Based on current research and clinical guidelines, HMG-CoA reductase inhibitors should be continued in the perioperative period for noncardiac and cardiac surgery (ACC/AHA [Fleisher 2014]; ACC/AHA [Hillis 2011]). Perioperative discontinuation of statin therapy is associated with an increased risk of cardiac morbidity and mortality.

Other warnings/precautions:

• Appropriate use: Rosuvastatin has not been studied when the primary lipid abnormality is chylomicron elevation (Fredrickson types I and V).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule Sprinkle, Oral:

Ezallor Sprinkle: 5 mg [contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye)]

Ezallor Sprinkle: 10 mg, 20 mg [contains fd&c blue #1 (brilliant blue)]

Ezallor Sprinkle: 40 mg

Tablet, Oral:

Crestor: 5 mg, 10 mg, 20 mg, 40 mg

Generic: 5 mg, 10 mg, 20 mg, 40 mg

Generic Equivalent Available: US

May be product dependent

Pricing: US

Capsule, sprinkles (Ezallor Sprinkle Oral)

5 mg (per each): $3.97

10 mg (per each): $3.97

20 mg (per each): $3.97

40 mg (per each): $3.97

Tablets (Crestor Oral)

5 mg (per each): $11.06

10 mg (per each): $11.06

20 mg (per each): $11.06

40 mg (per each): $11.06

Tablets (Rosuvastatin Calcium Oral)

5 mg (per each): $0.19 - $8.95

10 mg (per each): $0.19 - $8.95

20 mg (per each): $8.61 - $8.95

40 mg (per each): $8.61 - $8.95

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Crestor: 5 mg, 10 mg, 20 mg, 40 mg

Generic: 5 mg, 10 mg, 20 mg, 40 mg

Administration: Adult

Capsule:

Oral: Administer with or without food. May be taken at any time of the day. Swallow capsule whole; do not crush or chew. Capsule may be opened and contents sprinkled over a small amount (teaspoonful) of soft food (eg, applesauce, chocolate/vanilla flavored pudding); stir mixture for 10 to 15 seconds. Swallow mixture within 60 minutes without chewing.

Nasogastric tube: Capsule may be opened and contents emptied into a 60 mL catheter tipped syringe. Add 40 mL of water (do not use other liquids), then replace plunger and shake syringe vigorously for 15 seconds. Attach syringe to a ≥16-French NG tube and administer contents; flush NG tube with additional 20 mL of water. Mixture must be used immediately after preparation.

Tablet: Administer with or without food. May be taken at any time of the day; swallow tablet whole.

Administration: Pediatric

Oral: May be taken with or without food; may be taken at any time of the day; swallow tablet whole.

Missed dose: Do not take an extra dose; resume treatment with next scheduled dose.

Use: Labeled Indications

Familial hypercholesterolemia:

Pediatric: Adjunct to diet to reduce total cholesterol, LDL-C, and apoB levels in children and adolescents 8 to 17 years of age with heterozygous familial hypercholesterolemia (HeFH) if after an adequate trial of diet therapy the following findings are present: LDL-C greater than 190 mg/dL or greater than 160 mg/dL and there is a positive family history of premature cardiovascular disease or 2 or more other cardiovascular disease risk factors; adjunct to diet to reduce LDL-C, total cholesterol, nonHDL-C, and apoB in children and adolescents 7 to 17 years of age with homozygous familial hypercholesterolemia (HoFH), either alone or with other lipid-lowering treatments (eg, LDL apheresis).

Adult: To reduce LDL-C, total cholesterol, and apoB in adults with familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) or alone if such treatments are unavailable.

Prevention of cardiovascular disease:

Primary prevention of atherosclerotic cardiovascular disease: To reduce the risk of myocardial infarction (MI), stroke, revascularization procedures, and angina in adults without a history of coronary heart disease (CHD) but who have multiple CHD risk factors.

Secondary prevention in patients with established atherosclerotic cardiovascular disease (Crestor only): To reduce the risk of MI, stroke, revascularization procedures, and angina in adults with a history of CHD.

Use: Off-Label: Adult

Transplantation, post heart; Transplantation, post kidney

Medication Safety Issues
Sound-alike/look-alike issues:

HMG-CoA reductase inhibitors (when referred to as "statins") may be confused with nystatin.

Rosuvastatin may be confused with atorvastatin, nystatin, pitavastatin

Metabolism/Transport Effects

Substrate of BCRP/ABCG2, CYP2C9 (minor), CYP3A4 (minor), OATP1B1/1B3 (SLCO1B1/1B3); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Abiraterone Acetate: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy

Acipimox: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy

Antacids: May decrease the serum concentration of Rosuvastatin. Risk C: Monitor therapy

Apalutamide: May decrease the serum concentration of Rosuvastatin. Risk C: Monitor therapy

Asciminib: May increase the serum concentration of Rosuvastatin. Risk X: Avoid combination

Asunaprevir: May increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy

Atazanavir: May increase the serum concentration of Rosuvastatin. Rosuvastatin may increase the serum concentration of Atazanavir. Management: Initiate rosuvastatin at 5 mg daily and do not exceed rosuvastatin 10 mg daily if coadministered with atazanavir/ritonavir. If combined, monitor for signs and symptoms of myopathy and rhabdomyolysis and for increased atazanavir toxicities. Risk D: Consider therapy modification

BCRP/ABCG2 Inhibitors: May increase the serum concentration of Rosuvastatin. Risk C: Monitor therapy

Bezafibrate: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). Bezafibrate may increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). More specifically, bezafibrate may increase the serum concentration of fluvastatin Management: Avoid use of bezafibrate and HMG-CoA reductase inhibitors (statins) unless strictly indicated due to the increased of muscle toxicity (including rhabdomyolysis). In patients who may be predisposed to myopathy, concomitant use is contraindicated. Risk D: Consider therapy modification

Capmatinib: May increase the serum concentration of Rosuvastatin. Management: Limit the dose of rosuvastatin to 10 mg daily when combined with capmatinib. Monitor closely for increased rosuvastatin effects/toxicities (eg, myalgias, rhabdomyolysis) when these agents are combined. Risk D: Consider therapy modification

CarBAMazepine: May decrease the serum concentration of Rosuvastatin. Risk C: Monitor therapy

Ciprofibrate: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). Management: Avoid the use of HMG-CoA reductase inhibitors and ciprofibrate if possible. If concomitant therapy is considered, benefits should be carefully weighed against the risks, and patients should be monitored closely for signs/symptoms of muscle toxicity. Risk D: Consider therapy modification

Cobicistat: May increase the serum concentration of Rosuvastatin. Management: If coadministeed with cobicistat/atazanavir or cobicistat/darunavir, initiate rosuvastatin at the lowest dose. Do not exceed rosuvastatin 10 mg/day with concurrent use of atazanavir/cobicistat or 20 mg/day with concurrent use of darunavir/cobicistat. Risk D: Consider therapy modification

Colchicine: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). Colchicine may increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). HMG-CoA Reductase Inhibitors (Statins) may increase the serum concentration of Colchicine. Risk C: Monitor therapy

CycloSPORINE (Systemic): May increase the serum concentration of Rosuvastatin. Management: Limit rosuvastatin to 5 mg daily in patients who are also receiving cyclosporine, and monitor patients for increased rosuvastatin toxicities. Canadian labeling contraindicates concomitant use of rosuvastatin with cyclosporine. Risk D: Consider therapy modification

Daclatasvir: May increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy

DAPTOmycin: HMG-CoA Reductase Inhibitors (Statins) may enhance the adverse/toxic effect of DAPTOmycin. Specifically, the risk of skeletal muscle toxicity may be increased. Management: Consider temporarily stopping statin (HMG-CoA reductase inhibitor) therapy prior to daptomycin. If daptomycin is used with a statin, creatine phosphokinase (CPK) monitoring could be considered. Risk D: Consider therapy modification

Darolutamide: May increase the serum concentration of Rosuvastatin. Management: Limit the dose of rosuvastatin to 5 mg daily when combined with darolutamide. Monitor closely for increased rosuvastatin effects/toxicities (eg, myalgias, rhabdomyolysis) when these agents are combined. Risk D: Consider therapy modification

Dasabuvir: May increase the serum concentration of Rosuvastatin. Management: Limit the rosuvastatin dose to a maximum of 10 mg per day when used with the ombitasvir/paritaprevir/ritonavir/dasabuvir combination product. Labeling outside of the US recommends limiting the rosuvastatin dose to 5 mg per day. Risk D: Consider therapy modification

Dronedarone: May increase the serum concentration of Rosuvastatin. Risk C: Monitor therapy

Elacestrant: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Elagolix: May decrease the serum concentration of Rosuvastatin. Risk C: Monitor therapy

Elagolix, Estradiol, and Norethindrone: May decrease the serum concentration of Rosuvastatin. Risk C: Monitor therapy

Elbasvir and Grazoprevir: May increase the serum concentration of Rosuvastatin. Management: Initiate rosuvastatin at 5 mg daily and limit the rosuvastatin dose to a maximum of 10 mg per day during coadministration with elbasvir/grazoprevir. Monitor closely for evidence of rosuvastatin toxicities (eg, myopathy, rhabdomyolysis). Risk D: Consider therapy modification

Eltrombopag: May increase the serum concentration of Rosuvastatin. Management: Consideration a preventive 50% reduction in rosuvastatin adult dose when starting this combination. Risk D: Consider therapy modification

Enasidenib: May increase the serum concentration of Rosuvastatin. Management: Limit the dose of rosuvastatin to 10 mg once daily when combined with enasidenib. Risk D: Consider therapy modification

Eslicarbazepine: May decrease the serum concentration of Rosuvastatin. Risk C: Monitor therapy

Febuxostat: May increase the serum concentration of Rosuvastatin. Management: Limit the dose of rosuvastatin to 20 mg daily when combined with febuxostat. Monitor closely for increased rosuvastatin effects/toxicities (eg, myalgias, rhabdomyolysis) when these agents are combined. Risk D: Consider therapy modification

Fenofibrate and Derivatives: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy

Fostamatinib: May increase the serum concentration of Rosuvastatin. Management: Limit the dose of rosuvastatin to 20 mg daily when combined with fostamatinib. Monitor closely for increased rosuvastatin effects/toxicities (eg, myalgias, rhabdomyolysis) when these agents are combined. Risk D: Consider therapy modification

Fostemsavir: May increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Management: Use the lowest possible starting statin dose and monitor patients closely for statin-related adverse effects (eg, muscle aches and pains) during coadministration with fostemsavir. Risk D: Consider therapy modification

Fusidic Acid (Systemic): May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). Specifically, the risk for muscle toxicities, including rhabdomyolysis may be significantly increased. Management: Avoid concurrent use whenever possible. Use is listed as contraindicated in product characteristic summaries in several countries, although UK labeling suggests that use could be considered under exceptional circumstances and with close supervision. Risk X: Avoid combination

Futibatinib: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Gemfibrozil: May enhance the myopathic (rhabdomyolysis) effect of Rosuvastatin. Gemfibrozil may increase the serum concentration of Rosuvastatin. Management: Avoid combination if possible. If combination cannot be avoided, initiate rosuvastatin at 5 mg/day and limit rosuvastatin to 10 mg/day. Monitor for signs/symptoms of rhabdomyolysis. Risk D: Consider therapy modification

Gilteritinib: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Glecaprevir and Pibrentasvir: May increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Management: Use the lowest statin dose possible if combined with glecaprevir/pibrentasvir and monitor for increased statin effects/toxicities. Avoid concomitant use with atorva-, simva-, or lovastatin. Limit rosuvastatin to 10 mg daily and reduce pravastatin dose 50% Risk D: Consider therapy modification

Itraconazole: May increase the serum concentration of Rosuvastatin. Risk C: Monitor therapy

Lanthanum: May decrease the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Management: Administer HMG-CoA reductase inhibitors (eg, statins) at least two hours before or after lanthanum. Risk D: Consider therapy modification

Ledipasvir: May increase the serum concentration of Rosuvastatin. Risk X: Avoid combination

Leflunomide: May increase the serum concentration of Rosuvastatin. Management: Limit the maximum adult rosuvastatin dose to 10 mg/day in patients receiving leflunomide, and monitor for evidence of rosuvastatin toxicity (eg, muscle toxicity, elevated transaminase concentrations). Risk D: Consider therapy modification

Leniolisib: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid combination

Letermovir: May increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy

Lopinavir: May increase the serum concentration of Rosuvastatin. Management: Initiate rosuvastatin at 5 mg daily and limit the rosuvastatin dose to a maximum of 10 mg per day when used with lopinavir/ritonavir. Monitor patients closely for evidence of rosuvastatin toxicities (eg, myopathy, rhabdomyolysis). Risk D: Consider therapy modification

Maribavir: May increase the serum concentration of Rosuvastatin. Risk C: Monitor therapy

Momelotinib: May increase the serum concentration of Rosuvastatin. Management: In patients who are receiving momelotinib, initiate rosuvastatin at a dose of 5 mg once daily and limit the rosuvastatin dose to a maximum of 10 mg once daily. Risk D: Consider therapy modification

Niacin: May enhance the myopathic (rhabdomyolysis) effect of Rosuvastatin. Risk C: Monitor therapy

Nirmatrelvir and Ritonavir: May increase the serum concentration of Rosuvastatin. Management: Consider temporarily discontinuing rosuvastatin during treatment with nirmatrelvir/ritonavir. It is not necessary to hold rosuvastatin either prior to or after completion of nirmatrelvir/ritonavir treatment. Risk D: Consider therapy modification

Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir: May increase the serum concentration of Rosuvastatin. Management: Initiate rosuvastatin at 5 mg daily and limit the rosuvastatin dose to a maximum of 10 mg per day when used with the ombitasvir/paritaprevir/ritonavir/dasabuvir combination product. Monitor for rosuvastatin toxicities (eg, myopathy, rhabdomyolysis). Risk D: Consider therapy modification

Pacritinib: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid combination

Pretomanid: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Protease Inhibitors: May increase the serum concentration of Rosuvastatin. Risk C: Monitor therapy

Raltegravir: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy

Red Yeast Rice: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). Risk X: Avoid combination

Regorafenib: May increase the serum concentration of Rosuvastatin. Management: Limit the dose of rosuvastatin to 10 mg daily when combined with regorafenib. Monitor closely for increased rosuvastatin effects/toxicities (eg, myalgias, rhabdomyolysis) when these agents are combined. Risk D: Consider therapy modification

Repaglinide: HMG-CoA Reductase Inhibitors (Statins) may increase the serum concentration of Repaglinide. Risk C: Monitor therapy

RifAMPin: May decrease the serum concentration of Rosuvastatin. Risk C: Monitor therapy

Rupatadine: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). Specifically, the risk for increased CPK and/or other muscle toxicities may be increased. Risk C: Monitor therapy

Simeprevir: May increase the serum concentration of Rosuvastatin. Management: Limit initial rosuvastatin dose to 5 mg/day when being started in a patient who is also being treated with simeprevir. The maximum rosuvastatin dose should not exceed 10 mg/day with concurrent use of simeprevir. Risk D: Consider therapy modification

Sparsentan: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid combination

Tafamidis: May enhance the myopathic (rhabdomyolysis) effect of Rosuvastatin. Tafamidis may increase the serum concentration of Rosuvastatin. Management: Avoid this combination if possible. If combined, initiate rosuvastatin at a dose of 5 mg once daily and do not exceed a dose of rosuvastatin 20 mg daily. Monitor for signs of myopathy and rhabdomyolysis. Risk D: Consider therapy modification

Taurursodiol: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid combination

Tedizolid: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Teriflunomide: May increase the serum concentration of Rosuvastatin. Management: Limit the maximum adult rosuvastatin dose to 10 mg/day in patients receiving teriflunomide, and monitor for evidence of rosuvastatin toxicity (eg, muscle toxicity, elevated transaminase concentrations). Risk D: Consider therapy modification

Ticagrelor: May enhance the myopathic (rhabdomyolysis) effect of Rosuvastatin. Ticagrelor may increase the serum concentration of Rosuvastatin. Risk C: Monitor therapy

Trabectedin: HMG-CoA Reductase Inhibitors (Statins) may enhance the myopathic (rhabdomyolysis) effect of Trabectedin. Risk C: Monitor therapy

Trofinetide: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Management: Avoid concurrent use with OATP1B1/1B3 substrates for which small changes in exposure may be associated with serious toxicities. Monitor for evidence of an altered response to any OATP1B1/1B3 substrate if used together with trofinetide. Risk D: Consider therapy modification

Velpatasvir: May increase the serum concentration of Rosuvastatin. Management: Initiate rosuvastatin at 5 mg daily and limit the rosuvastatin dose to a maximum of 10 mg per day during coadministration with sofosbuvir/velpatasvir. Monitor closely for evidence of rosuvastatin toxicities (eg, myopathy, rhabdomyolysis). Risk D: Consider therapy modification

Vitamin K Antagonists (eg, warfarin): HMG-CoA Reductase Inhibitors (Statins) may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy

Voclosporin: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Voxilaprevir: May increase the serum concentration of Rosuvastatin. Risk X: Avoid combination

Reproductive Considerations

Adequate contraception is recommended if an HMG-CoA reductase inhibitor (statin) is required in patients who may become pregnant (AHA/ACC [Grundy 2019]; CCS [Pearson 2021]). Patients planning to become pregnant should discuss their lifetime risk of cardiovascular disease, as well as risks and benefits of statin therapy with their health care team (CCS [Pearson 2021]). When appropriate, statins can be discontinued 1 to 2 months prior to conception (AHA/ACC [Grundy 2019]).

When a statin is needed in a patient of reproductive potential, a more hydrophilic option (eg, pravastatin, rosuvastatin) may be preferred to limit placental transfer (CCS [Pearson 2021]).

Pregnancy Considerations

In healthy pregnancies, changes in lipid synthesis occur that are required for normal placental and fetal growth. Low-density lipoprotein cholesterol and triglycerides increase as pregnancy progresses and decline postpartum. HMG-CoA reductase inhibitors (statins) decrease the synthesis of cholesterol and substances derived from cholesterol. Therefore, based on the mechanism of action, in utero exposure may cause fetal harm (Lecarpentier 2012); however, data from available studies have not shown an increased risk of major congenital anomalies following first trimester exposure (Bateman 2015; Chang 2021; Vahedian-Azimi 2021a). Additional data are needed to evaluate other pregnancy outcomes, such as miscarriage (Vahedian-Azimi 2021b).

Because there is potential for fetal harm, statins should be discontinued once pregnancy is recognized (AHA/ACC [Grundy 2019]; Brunham 2018). If lipid-lowering therapy during pregnancy is required, it should be individualized based on the therapeutic needs of the patient, considering the lifetime risk of untreated disease, use of nonstatin therapies, as well as the known risks and benefits of statins. Based on limited data, when a statin is needed in a pregnant patient, a more hydrophilic option (eg, pravastatin, rosuvastatin) may be preferred. Lipophilic statins (eg, atorvastatin, fluvastatin, lovastatin, simvastatin, pitavastatin) may be more likely to cross the placenta and increase the risk of congenital malformations (AHA/ACC [Grundy 2019]; CCS [Pearson 2021]; Lecarpentier 2012).

Additional data are needed to clarify the role of statins for the prevention of atherosclerotic cardiovascular disease in at-risk pregnant patients (AHA/ACC [Grundy 2019]; CCS [Pearson 2021]; Parikh 2021).

Breastfeeding Considerations

Rosuvastatin is present in breast milk.

Data related to the presence of rosuvastatin in breast milk are available from case reports (Lwin 2018; Schutte 2013).

• Rosuvastatin 40 mg daily was re-initiated in a lactating patient 33 days postpartum. Rosuvastatin breast milk concentrations were 15.2 ng/mL (1 hour after the oral dose) and increased to 29.4 ng/mL (7 hours after the dose). Additional breast milk concentrations of rosuvastatin were between 21.9 ng/mL and 22.8 ng/mL (3 samples obtained at random times between 4 and 80 days of treatment). Maternal serum concentrations of rosuvastatin on day 25 of therapy were 18 ng/mL, 23 hours after the dose (Schutte 2013).

• Rosuvastatin 20 mg once daily was initiated in a lactating patient 13 months postpartum. Breast milk samples were obtained over 24 hours after the patient had received at least 5 doses. Rosuvastatin breast milk concentrations ranged from 16.58 ng/mL to 58.59 ng/mL with the highest concentration occurring ~17 hours after the dose. Maternal plasma concentrations of rosuvastatin were 2.47 ng/mL (~14 hours after the dose). Authors of the study calculated the estimated exposure of rosuvastatin to a breastfeeding infant to be 4.63 mcg/kg/day (relative infant dose [RID] 1.5% based on the weight adjusted maternal dose). The infant was not breastfed in this study (Lwin 2018).

• In general, breastfeeding is considered acceptable when the RID of a medication is <10% (Anderson 2016; Ito 2000); however, authors of one study suggest monitoring growth and development of infants exposed to rosuvastatin via breast milk until additional data are available (Lwin 2018).

HMG-CoA reductase inhibitors (statins) decrease the synthesis of cholesterol and substances derived from cholesterol. Normal concentrations of cholesterol in breast milk are required for infant development (Holmsen 2017; Lecarpentier 2012). Due to the potential for adverse events in the breastfed infant, breastfeeding is not recommended by the manufacturer. Available guidelines recommend resuming statin therapy once breastfeeding is completed (AHA/ACC [Grundy 2019]; CCS [Pearson 2021]).

Dietary Considerations

Red yeast rice contains variable amounts of several compounds that are structurally similar to HMG-CoA reductase inhibitors, primarily monacolin K (or mevinolin) which is structurally identical to lovastatin; concurrent use of red yeast rice with HMG-CoA reductase inhibitors may increase the incidence of adverse and toxic effects (Lapi 2008; Smith 2003).

Monitoring Parameters

ACC/AHA Blood Cholesterol Guideline recommendations (ACC/AHA [Grundy 2019 ]):

Lipid panel (total cholesterol, HDL, LDL, triglycerides): Lipid profile (fasting or nonfasting) before initiating treatment. Fasting lipid profile should be rechecked 4 to 12 weeks after starting therapy and every 3 to 12 months thereafter. If 2 consecutive LDL levels are <40 mg/dL, consider decreasing the dose.

Hepatic transaminase levels: Baseline measurement of hepatic transaminase levels (ie, AST and ALT); measure AST, ALT, total bilirubin, and alkaline phosphatase if symptoms suggest rosuvastatin-induced hepatotoxicity (eg, unusual fatigue or weakness, loss of appetite, abdominal pain, dark-colored urine or yellowing of skin or sclera) during therapy.

CPK: CPK should not be routinely measured. Baseline CPK measurement is reasonable for some individuals (eg, family history of statin intolerance or muscle disease, clinical presentation, concomitant drug therapy that may increase risk of myopathy). May measure CPK in any patient with symptoms suggestive of myopathy (pain, tenderness, stiffness, cramping, weakness, or generalized fatigue).

Evaluate for new-onset diabetes mellitus during therapy; if diabetes develops, continue statin therapy and encourage adherence to a heart-healthy diet, physical activity, a healthy body weight, and tobacco cessation. Monitor for signs and symptoms of myopathy or rhabdomyolysis.

If patient develops a confusional state or memory impairment, may evaluate patient for nonstatin causes (eg, exposure to other drugs), systemic and neuropsychiatric causes, and the possibility of adverse effects associated with statin therapy.

Manufacturer's labeling: Consider neuromuscular and serologic testing if immune-mediated necrotizing myopathy is suspected.

Mechanism of Action

Inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, the rate-limiting enzyme in cholesterol synthesis (reduces the production of mevalonic acid from HMG-CoA); this then results in a compensatory increase in the expression of LDL receptors on hepatocyte membranes and a stimulation of LDL catabolism. In addition to the ability of HMG-CoA reductase inhibitors to decrease levels of high-sensitivity C-reactive protein (hsCRP), they also possess pleiotropic properties including improved endothelial function, reduced inflammation at the site of the coronary plaque, inhibition of platelet aggregation, and anticoagulant effects (de Denus 2002; Ray 2005).

Pharmacokinetics (Adult Data Unless Noted)

Note: In pediatric patients (10 to 17 years of age), maximum serum concentration and AUC have been shown to be similar to adult values

Onset of action: Within 1 week; maximal at 4 weeks

Distribution: Vd: 134 L

Protein binding: 88%

Metabolism: Hepatic (10%), via CYP2C9 (1 active metabolite identified: N-desmethyl rosuvastatin, one-sixth to one-half the HMG-CoA reductase activity of the parent compound)

Bioavailability: 20% (high first-pass extraction by liver)

Half-life elimination: 19 hours

Time to peak, plasma: 3 to 5 hours

Excretion: Feces (90%), primarily as unchanged drug

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: Plasma concentrations increase about 3-fold in patients with severe renal impairment (CrCl <30 mL/minute/1.73 m2) not requiring hemodialysis. Steady-state plasma concentrations in patients on chronic hemodialysis are ~50% higher compared with patients with normal renal function.

Hepatic function impairment: Cmax and AUC are increased in patients with Child-Pugh class A or Child-Pugh class B hepatic impairment.

Race/ethnicity: East Asian patients have ~2-fold elevation in exposure (AUC and Cmax).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Caroza | Crestor | Ivarin | Kolros | Medystatin | Rofast | Rosalus | Rosatin | Rostagen | Rosuvas | Rosval | Rovista | Roxardio | Rozat | Rozavel | Rozavi | Rozbio | Rozinor | Rustat | Xolstat | Zyrosa;
  • (AR) Argentina: Astende | Ateronova | Bilip | Colerragin | Crestor | Mesoterol | Nodis | Parasul | Rosimol | Rosucol | Rosufec | Rosufen | Rosustatin | Rosuvast | Rosuvastatina | Rosux | Rovartal | Rovastane | Sinlip | Tialipol;
  • (AT) Austria: Arosuva | Crestor | Rosuvalan | Rosuvastatin +pharma | Rosuvastatin 1A Pharma | Rosuvastatin accord | Rosuvastatin actavis | Rosuvastatin aristo | Rosuvastatin G.L. | Rosuvastatin Genericon | Rosuvastatin hexal | Rosuvastatin krka | Rosuvastatin mylan | Rosuvastatin ratiopharm | Rosuvastatin sandoz | Rosuvastatin stada;
  • (AU) Australia: Affora | Apo rosuvastatin | APX Rosuvastatin | Blooms the chemist rosuvastatin | Cavstat | Chemmart rosuvastatin | Crestor | Crosuva | Noumed rosuvastatin | Pharmacor rosuvastatin | Rostor | Rosuvastatin actavis | Rosuvastatin amneal | Rosuvastatin an | Rosuvastatin APOTEX | Rosuvastatin drla | Rosuvastatin generichealth | Rosuvastatin Lupin | Rosuvastatin rbx | Rosuvastatin sandoz | Terry white chemists rosuvastatin | Visacor;
  • (BD) Bangladesh: Bestcol | Cholcut | Corestin | Creston | Creva | Nestor | Restat | Rocovas | Rolip | Ropitor | Rostab | Rostatin | Rosu | Rosugen | Rosutin | Rosuva | Rovast | Rovator | Rovex | Rovius | Rozavel | Rozenon | Rtv | Ruvastin | Sb rostin;
  • (BE) Belgium: Crestor | Rosuvastatin ab | Rosuvastatin krka | Rosuvastatin sandoz | Rosuvastatine apotex | Rosuvastatine eg | Rosuvastatine mylan | Rosuvastatine teva;
  • (BF) Burkina Faso: Pms rosuvastatin | Robestar | Rosukaa | Rosumac | Rosuvas | Rozan;
  • (BG) Bulgaria: Aterostad | Crestor | Neoroso | Romazic | Ropuido | Rosistat | Rossta | Rosucard | Rosuvanor | Rosuvastatin accord | Rosuvastatin mylan | Rosuvistat | Roswera | Rovasta | Rusocon | Suzastor | Tintaros | Ultravas | Vosustat | Zaranta;
  • (BR) Brazil: Creslip | Crestor | Elpenzo | Rostatin | Rosucor | Rosulib | Rosustatin | Rosuvast | Rosuvastatina calcica | Rox | Rusovas | Ruva | Ruvascor | Sancol | Trezor | Vivacor | Zinpass;
  • (CH) Switzerland: Crestastatin | Crestor | Rosuvastatin axapharm | Rosuvastatin mepha lactab | Rosuvastatin nobel | Rosuvastatin sandoz | Rosuvastatin spirig HC | Rosuvastatin viatris | Rosuvastatin zentiva | Rosuvastax;
  • (CI) Côte d'Ivoire: Crestor | Pms rosuvastatin | Robestar | Rosukaa | Rosumac | Statinpro | Superstat;
  • (CL) Chile: Crestor | Pravalip | Redistatin | Rosuvitae | Rovartal | Rux | Simcor;
  • (CN) China: Crestor | Hai shu yan | Jing nuo | Ke Ding | Rui zhi | Tuo tuo;
  • (CO) Colombia: Biotor | Brosteril | Cardiomax | Crestor | Garmisch rosuvax | Rosucol | Rosudex | Rosumax | Rosustar | Rosutor ldl | Rosuvastatina | Rosuvastatina MK | Rosuvastin | Rosuvax | Rosuverol | Rosuvitae | Rotavin | Rovaril | Rozavel | Rustatina | Rux | Vusorex | Xineba | Xuniro;
  • (CZ) Czech Republic: Apo rosuvastatin | Corvapro | Cresagen | Crestor | Mertenil | Rosi | Rosucard | Rosumop | Rosuvastatin accord | Rosuvastatin aurobindo | Rosuvastatin krka | Rosuvastatin msn | Rosuvastatin mylan | Rosuvastatin polpharma | Rosuvastatin teva | Rovasyn | Roxilip | Sorvasta | Tintaros | Zahron;
  • (DE) Germany: Crestor | Rosu 1 a pharma | Rosuhexal | Rosustar | Rosuvador | Rosuvastatin 1A Pharma | Rosuvastatin accord | Rosuvastatin aristo | Rosuvastatin Astra | Rosuvastatin aurobindo | Rosuvastatin axcount | Rosuvastatin axiromed | Rosuvastatin denk | Rosuvastatin elpen | Rosuvastatin Generinobel | Rosuvastatin hec pharm | Rosuvastatin heumann | Rosuvastatin q pharm | Rosuvastatin ratiopharm | Rosuvastatin vivanta;
  • (DO) Dominican Republic: Blokimax | Cora ros | Crestatin | Crestor | Etistatin | Lesterol | Limacol | Liponor | Lustatin | Praxia | Quiralex | Regutol | Rex | Rosalta | Rosustar | Rosutin | Rosuvast | Rosuvastatina | Rosuvastatina ethical | Rosuvastatina Feltrex | Rosuvastatina Lam | Rosuvastatina MK | Rosuvastatina normon | Rosuvastatina sandoz | Rosuvina | Rovaril | Rovartal | Rovascol | Rovasta | Rucol | Rusarte 20 | Rusarte 40 | Ruxicol | Sincolex | Sinlip | Skorlat | Suvasroi | Triglicol;
  • (EC) Ecuador: Astende | Colesta | Coroval | Cresadex | Crestor | Cresvax | Deplet | Hibolipid | Roslipid | Rosumax | Rusovas | Rux;
  • (EE) Estonia: Crestor | Rosuvacard | Rosuvastatin | Rosuvastatin accord | Rosuvastatin krka | Rosuvastatin tad | Rosuvastatin teva | Roswera | Rovasyn | Roxardio | Zaranta;
  • (EG) Egypt: Advochol | Bemastrim | Cemicresto | Cholerose | Crestatin | Crestolip | Crestor | Deconadal | Epirovastin | Estero Map | Frositor | Justechol | Merosatin | Naplema | Nexirozova | Novistoric | Pentastatin | Rositor | Rosumop | Rosuvast | Rosuvastatin | Statirose | Suvikan | Vastasiero;
  • (ES) Spain: Abemax | Alzil | Arrox | Crestor | Kastia | Provisacor | Rosuvastatina almus | Rosuvastatina alter | Rosuvastatina apotex | Rosuvastatina aristo | Rosuvastatina aurovitas | Rosuvastatina cinfa | Rosuvastatina combix | Rosuvastatina kern | Rosuvastatina krka | Rosuvastatina mabo-farma | Rosuvastatina mylan | Rosuvastatina normon | Rosuvastatina Pensa | Rosuvastatina qualigen | Rosuvastatina ranbaxy | Rosuvastatina Ratiopharm | Rosuvastatina sandoz | Rosuvastatina stada | Rosuvastatina tarbis | Rosuvastatina tecnigen | Rosuvastatina teva | Rosuvastatina viso | Rosuvastatina Vivanta | Roxera | Vaxar;
  • (ET) Ethiopia: Crestor | Ivarin | Robestar | Rofast | Rosumac | Rosuvas | Rosuvastatin | Rosuvastatin atb | Turbovas;
  • (FI) Finland: Crestor | Rosuvastatin accord | Rosuvastatin actavis | Rosuvastatin krka | Rosuvastatin mylan | Rosuvastatin orion | Rosuvastatin ratiopharm | Rosuvastatin sandoz | Rosuvastatin stada | Rosuvastatin teva | Rosuvastatin xiromed;
  • (FR) France: Crestor | Rosuvastatine | Rosuvastatine accord | Rosuvastatine almus | Rosuvastatine arrow | Rosuvastatine biogaran | Rosuvastatine cristers | Rosuvastatine eg | Rosuvastatine evolugen | Rosuvastatine krka | Rosuvastatine mylan | Rosuvastatine polfa pabianice | Rosuvastatine ranbaxy | Rosuvastatine sandoz | Rosuvastatine teva | Rosuvastatine zentiva | Rosuvastatine zydus;
  • (GB) United Kingdom: Crestor | Rosuvastatin | Rosuvastatin glenmark;
  • (GR) Greece: Celmantin | Crestilen | Crestor | Extrator S | Grosera | Holestatin | Platorel | Rosartia | Rossta | Rosuben | Rosuvador | Rosuval heremco | Rosuvastatin win medica | Rosuvastatin/mylan | Rosuvastatin/pharmazac | Rosuvastatin/sandoz | Rovastine | Sterocardin | Venex | Zircos | Zirus;
  • (HK) Hong Kong: Apo rosuvastatin | Crestor | Eurovastin | Hovid Rosuvastatin | Myungmoon rosuvastatin | Neusator | Pms rosuvastatin | Rosetor | Rosukaa | Rosuvas | Rosuvastatin actavis | Rosuvastatin sandoz | Rosuvastatin stella | Vickrostor;
  • (HR) Croatia: Coupet | Crestor | Epri | Rosacol | Rosix | Rosuvex | Roswera;
  • (HU) Hungary: Cresagen | Delipid | Rosucard | Rosutec | Rosuvastatin pharma regist | Rosuvastatin sandoz | Rosuvastatin teva | Roxera | Rozuva teva | Xeter;
  • (ID) Indonesia: Crestor | Giventor | Nistrol | Pyfaros | Recansa | Robestar | Rostin | Rosuvastatin | Rovascol | Rovastar | Rovator;
  • (IE) Ireland: Crestor | Rosuva | Rosuvastatin | Rosuvastatin actavis | Rosuvastatin krka | Rosuvastatin rowa | Rosuvastatin teva;
  • (IL) Israel: Crestor;
  • (IN) India: Aboros | Acmerose | Adipostat | Advastat | Akroz | Alfastat | Alviroz | Arostat | Arvast | Ateros | Athrovas | Bakolip | Bestor | Cardiorostin | Cardirose | Coltro | Consivas | Creolip | Cresov | Crestor | Crevast | Exeroz | Favros | Fliptor | Fortius | Glihypo Plus | Gloristat | Glyvas | Herocin | Ibstatin | Jprest | Jubira | Jupiros | Ldnil | Lipigo | Lipirose | Lipitas | Lipitrack | Lodens | Mahastat | Multistat | Newsta | Novastat | Osutin | R2 | Rastrol | Razel | Restolip | Retroser | Revostat | Rezara | Rolip | Roliptin | Rolistat | Ropiless | Rosact | Rosadil | Rosat | Rosave | Rosbest | Roseday | Rosepil | Rosevast | Rosidoc | Roslaren | Rosloy | Rosmi | Rost | Rosta | Rostar | Rosubest | Rosucad | Rosuchol | Rosucia | Rosufit | Rosuflo | Rosugraf | Rosuhop | Rosukaa | Rosukem | Rosular | Rosuless | Rosulex | Rosuline | Rosulip | Rosumac | Rosumerc | Rosunova | Rosupack | Rosupil | Rosur | Rosuson | Rosutec | Rosutero | Rosuvas | Rosuvastat | Rosuvel | Rosuvotin | Rosvera | Rosvin | Rosycap | Rosys | Rosytab | Rotin | Rovastat | Rovax | Rovustin | Rozanex | Rozat | Rozavel | Rozfirst | Roznova | Roznyle | Rozstyl | Rozucor | Rozudoc | Rozugus | Rozuone | Rozustat | Rozuxia 10 | Rozuxia 20 | Rozuxia 5 | Rvs | Rxtor | Saanvas r | Statpure | Statset | Suvalip | Turbovas | Unizuva | Vitastat | Wyteros | Xoten | Z Stat | Zyrova;
  • (IQ) Iraq: Crestosam | Rosatin awa | Rosuvastatin mdi | Rosva | Rouvastatin kindi | Zerotin;
  • (IT) Italy: Borghes | Cirantan | Colcardiol | Colfri | Crativ | Crestor | Dilivas | Exorta | Koleros | Lipidover | Miastina | Provisacor | Rosastin | Rosuvastatina accord | Rosuvastatina adamed | Rosuvastatina almus | Rosuvastatina alter | Rosuvastatina aristo | Rosuvastatina Aurobindo | Rosuvastatina doc | Rosuvastatina eg | Rosuvastatina mylan | Rosuvastatina Pensa | Rosuvastatina sandoz | Rosuvastatina tecnigen | Rosuvastatina Teva Italia | Rosuvastatina zentiva | Simestat | Snaptag | Staros | Tekvas;
  • (JO) Jordan: Crestor | Cresuva | Cristaram | Eveness | Rosakit | Rosalus | Rosatin | Rostar | Rovasta | Roxardio | Stage | Zerova | Zyrosa;
  • (JP) Japan: Crestor | Rosuvastatin | Rosuvastatin amel | Rosuvastatin calcium kaken | Rosuvastatin chemiphar | Rosuvastatin dsep | Rosuvastatin ee | Rosuvastatin jg | Rosuvastatin kyorin | Rosuvastatin meek | Rosuvastatin nichiiko | Rosuvastatin nipro | Rosuvastatin nissin | Rosuvastatin ohara | Rosuvastatin pfizer | Rosuvastatin sandoz | Rosuvastatin sanwa | Rosuvastatin sawai | Rosuvastatin takata | Rosuvastatin takeda teva | Rosuvastatin tck | Rosuvastatin towa | Rosuvastatin tsuruhara | Rosuvastatin yd | Rosuvastatin zeria;
  • (KE) Kenya: Aurora | Bestor | Crestat | Creston | Crestor | Easetec | Jupiros | Ld berg r | Ldnil | Lipecos | Robestar | Rosave | Rostat | Rosuat | Rosucip | Rosucor | Rosugard | Rosulip | Rosumac | Rosuna | Rosuva | Rosuvas | Rosuvitae | Rovas | Rovast | Rovastin | Roviros | Rovista | Rozar | Rozatin | Rozavel | Statinor | Turbovas | X Plended | Xovat | Zoruva | Zyrova;
  • (KR) Korea, Republic of: Allstatin | Aprogen rosuvastatin calcium | Austatin | Cholesdin | Cholestop | Cholostar | Ciustar | Clestin | Clow | Cmg rosuvastatin | Cratin | Creazin | Crecheck | Crego | Crerato | Creros | Crerosue | Crerova | Cres | Cresante | Cresba | Cresno | Cresnon | Crestan | Crestar | Crestin | Crestor | Cresvan | Cretor | Crevas | Crevatin | Crevato | Crezin | Crezy | Crosta | Crostin | Crovatin | Crystal rosuvastatin | Cuistar | Cvastin | Daewoong rosuvastatin | Dongkwang rosuvastatin calcium | Dongsung rosuvastatin | Dongwha rosuvastatin | Elosuva | Elrosuva | Esrotin | Etex rosuvastatin calcium | Hanall rosuvastatin calcium | High l | Huresto | Irosta | J rosu | K rotin | Liposto | Loresto | Lovastar | Merova | Monorova | Myungmoon rosuvastatin calcium | Neustatin r | Newrostin | Newsto | Newsuvatin | Pavist | Pms rosuvastatin | Rerostar | Restar | Rojustin | Roresto | Roshuta | Rosta | Rostagen | Rostin | Rosto | Roston | Rosu v | Rosuco | Rosucor | Rosugreen | Rosulord | Rosumax | Rosumedi | Rosumin | Rosunex | Rosuridin | Rosusta | Rosustin | Rosustor | Rosuta | Rosutan | Rosutatin | Rosuterol | Rosutin | Rosutin m | Rosuto | Rosutop | Rosuva | Rosuva m | Rosuvan | Rosuvasin | Rosuvastaqual | Rosuvastatin bkw | Rosuvastin | Rosuvat | Rosuvatin | Rosuvato | Rosvatan | Rotatin | Rotrovan | Rovaid | Rovasro | Rovasto | Rovat | Rovatan | Rovaterol | Rovetin | Rovitan | Roxtan | Roxva | Samsung rosuvastatin | Shuvasta | Shuvastin | Starova | Stavastor | Sustar | Suvast | Suvastatin | Suvastin | Suvatan | Suvatin | Td rosu | Topstatin | Unirova | Vivacor | Yoorostor | Yurostin | Yurostor;
  • (KW) Kuwait: Crestor | Ivarin | Rosatin | Roztor;
  • (LB) Lebanon: Apo rosuvastatin | Cresotab | Crestor | Cresulip | Kolros | Lipirose obp | Pms rosuvastatin | Rostat | Rosucor | Rosuvas | Rovastin | Roxardio | Sinlip | Superstat;
  • (LT) Lithuania: Crestor | Nisatlex | Romazic | Rosuvacard | Rosuvastatin accord | Rosuvastatin actavis | Rosuvastatin krka | Rosuvastatin teva | Rosuvastatin zentiva | Roswera | Roxardio | Zaranta;
  • (LU) Luxembourg: Crestor | Rosuvastatin ratiopharm | Rosuvastatine eg | Rosuvastatine mylan;
  • (LV) Latvia: Crestor | Romazic | Rosuvacard | Rosuvastatin accord | Rosuvastatin actavis | Rosuvastatin krka | Rosuvastatin tad | Rosuvastatin teva | Rosuvastatin zentiva | Roswera | Rovasyn | Sorvasta | Zaranta;
  • (MA) Morocco: Bestor | Crestor | Decrestin | Ictaves | Rosustar | Rosuvas | Rozat;
  • (MX) Mexico: Colsulix | Cresabella | Crestor | Crisvi | Crostox | Divotran | Equistat | Forcoco | Gantena | Isostal | Orenda | Relastrol | Robotek | Rosuvastatin | Rosuvastatin sandoz | Rosuvastatina | Rosvaden | Rovartal nf | Rupilip | Tordia | Traustabindo | Vibrent | Zathelo;
  • (MY) Malaysia: Apo rosuvastatin | Crestor | Hovid Rosuvastatin | Rosucor | Rosuvastatin | Rosuvastatin stada | Rosuvor | Rovastin | Roxatin | Starez | Vasticure | Vastinor | Vivacor | Xolstat;
  • (NG) Nigeria: Ajacin | Crestor | Filroxy | Lipiros | Ocestat | Prevesta | Razel | Restoday | Rolip | Rosuglob | Rosulad | Rosunorm | Rosutor | Rosuvastatin | Rosuvastatin sandoz | Rovista | Rozcard | Sai rosuvastatin | Scolta | Statinor | X Plended;
  • (NL) Netherlands: Crestor | Rosuvastatin AstraZeneca | Rosuvastatine | Rosuvastatine accord | Rosuvastatine aristo | Rosuvastatine Aurobindo | Rosuvastatine CF | Rosuvastatine glenmark | Rosuvastatine mylan | Rosuvastatine sandoz | Rosuvastatine SUN | Rosuvastatine teva | Rosuvastatine xiromed;
  • (NO) Norway: Crestor | Rosuvastatin glenmark | Rosuvastatin sandoz | Rosuvastatin xiromed;
  • (NZ) New Zealand: Crestor | Noumed rosuvastatin | Rosuvastatin calcium generic | Rosuvastatin viatris;
  • (PE) Peru: Aurovas | Cresadex | Crestor | Dismigras | Rostatin | Rosucol | Rosuvastor | Rovastane | Rux;
  • (PH) Philippines: Arvast | Athero | Controld | Crestor | Gostatin | Ldnil | Lipichek | Lowas | Lustatin | Preventa | Rainsuvast | Robestar | Rosadoc | Rosalta | Roselion | Rosett | Rost | Rosubolic | Rosucare | Rosucol | Rosulip | Rosumond | Rosuphil | Rosuple | Rosustat | Rosutin | Rosuvastatin | Rosuvaz | Rosuvin | Rosvascal | Roswin | Rovex | Rovista | Roztin | Ruchol | Torros | Torus | Turbovas | Vaptor | Wilovast | Zenrosu | Zyrova;
  • (PK) Pakistan: Amro | Atistatin | Aurora | Cougar | Crescor | Easetec | Exilip | Fortius | Kestore | Kovastin | Loster | Neomycodox | Neostat | Nevastatin | Omnitor | Pasage | Prevlip | Qazzo | R vastin | Rast | Ravitin | Raystatin | Regulip | Restore | Ricoda | Rolip | Ropitor | Rortos | Rosan | Rosatin | Rosca | Roscard | Roscor | Rosera | Rosimol | Rosir | Rosocard | Rostat | Rostaten | Rostatin | Rostin | Rostor | Rosubar | Rosucal | Rosugen | Rosulin | Rosulite | Rosun | Rosunext | Rosusid | Rosustar | Rosutrol | Rosuva | Rosuvast | Rosuvasure | Rosuvax | Rosuwim | Rosva | Rosvital | Rova | Rovator | Rovin | Rovip | Roviros | Rovustat | Rozavel | Rudra | Rusiam | Ruvastat | Rvastine | Savuros | Signova | Simrose | Staars | Suvet | Tri ase | Vastec | Vegarose | Vesonor | Vistin | Welrus | X Plended | Xell | Xenecor | Xovat | Xstatin | Zyrova;
  • (PL) Poland: Actarosin | Astrium | Crestor | Crosuvo | Ivirosina | Ridlip | Romazic | Rosucard | Rosugen | Rosutrox | Rosuvastatin aurovitas | Rosuvastatin krka | Rosuvastatin ranbaxy | Rosuvastatin ratiopharm | Rosuvastatin teva | Roswera | Suvardio | Zahron | Zaranta;
  • (PR) Puerto Rico: Crestor | Ezallor | Rosuvastatin;
  • (PT) Portugal: Crestor | Rosuvastatin bisten | Rosuvastatina alter | Rosuvastatina aristo | Rosuvastatina aurovitas | Rosuvastatina azevedos | Rosuvastatina bluepharma | Rosuvastatina ciclum | Rosuvastatina generis | Rosuvastatina mylan | Rosuvastatina Pharmakern | Rosuvastatina Ratiopharm | Rosuvastatina sandoz | Rosuvastatina tecnigen | Rosuvastatina tecnilor | Rosuvastatina teva | Rosuvastatina toLife | Rosuvastatina zentiva | Visacor;
  • (PY) Paraguay: Crestor | Rosulip | Rosuvastatina sandoz | Roxicam | Rux | Sinlip;
  • (QA) Qatar: Corteza | Crestor | Ivarin | Rofast | Rosakit | Rosatin | Rostatin | Rosuvas | Rosvacor | Rovalex | Rovasta | Roxardio | Rozitta | Roztor | Scolta | Stage | Vazatin | Vironta | Zyrosa;
  • (RO) Romania: Astrium | Crestor | Rosi | Rostat | Rosuvastatina atb | Rosuvastatina krka | Rosuvastatina mylan | Rosuvastatina teva | Roswera | Rovastamed | Rozucor;
  • (RU) Russian Federation: Akorta | Cardiolip | Crestor | Lipoprime | Mertenil | Reddistatine | Ro-statin | Rosart | Rosucard | Rosufast | Rosulip | Rosuvastatin | Rosuvastatin canon | Rosuvastatin FT | Rosuvastatin medisorb | Rosuvastatin sz | Rosuvastatin teva | Rosuvastatin vial | Rosuvastatin xantis | Roxera | Rozart | Rozistark | Rozucard | Rozulip | Rustor | Suvardio | Tevastor | Yogaros;
  • (SA) Saudi Arabia: Apo rosuvastatin | Corteza | Creschol | Crestor | Crevast | Pms rosuvastatin | Rost | Rovasta | Rozavi | Rozitta | Vironta | Zyrosa;
  • (SE) Sweden: Crestor | Rosuvastatin accord | Rosuvastatin glenmark | Rosuvastatin krka | Rosuvastatin Medical Valley | Rosuvastatin mylan | Rosuvastatin orion | Rosuvastatin sandoz | Rosuvastatin stada | Rosuvastatin teva | Rosuvastatin xiromed | Rosuvastatin zentiva | Visacor;
  • (SG) Singapore: Apo rosuvastatin | Celmantin | Crestor | Rofast | Rostat | Rosucard | Rosuvastatin sandoz;
  • (SI) Slovenia: Coupet | Crestor | Ropuido | Rosuvastatin actavis | Rosuvastatin teva | Rustavo | Sorvasta | Vosustat;
  • (SK) Slovakia: Crestor | Rosucard | Rosuvastatin actavis | Rosuvastatin krka | Rosuvastatin msn | Rosuvastatin mylan | Rosuvastatin ratiopharm | Rosuvastatin sandoz | Rosuvastatin teva | Sorvasta | Zahron | Zaranta;
  • (TH) Thailand: Cholestor | Crestor | K zuva | Rosucor | Rosugrix | Rosuvastatin | Rosuvastatin gpo | Rosuvastatin sandoz | Rovastor | Surotin | Vivacor;
  • (TN) Tunisia: Crestor | Neacrest | Rocor | Rosulip | Rosuvans | Rosuvascor | Rosuvast | Rosuvast 20 | Rosuvast 5 | Rosuvastatine zentiva | Rozuvie 10 | Rozuvie 20 | Rozuvie 5 | Superstat | Vissen;
  • (TR) Turkey: Colnar | Crelix | Crestor | Kolros | Livercol | Reakt | Rosucor | Rosufix | Rosugen | Rosuvas | Stage | Stata | Ultrox;
  • (TW) Taiwan: Alvostat | Apo rosuvastatin | Crestor | Kolros | Pms rosuvastatin | Robestar | Rolipostatin | Ropicin | Rostatin | Rosu | Rosulator | Rosulip | Rosutor | Rosuvastatin mylan | Rotlip | Roty | Rovastin | Rozinin | Zyrova;
  • (UA) Ukraine: Cholrest | Clivas | Mertenil | Ozalex | Preventor | Redistatin | Romazic | Romestin | Romestin 10 | Rosart | Rosastin | Rosufast | Rosulip | Rosustar | Rosuvastatin | Rosuvastatin ananta | Rosuvastatin darnitsa | Rosuvastatin ic | Rosvator | Rovamed | Rovix | Roxera | Rozister | Rozucard | Rozusta;
  • (UG) Uganda: Crestor | Ldnil | Robestar | Rofast | Rosucor | Rosumac | Rosutab | Rosuvax | Rovas | Statinor | Zyrova;
  • (UY) Uruguay: Artomey | Brytar | Lesterol | Novostatin 10 | Novostatin 20 | Reovex | Rosulip | Rosustat;
  • (VE) Venezuela, Bolivarian Republic of: Crestor | Lodal | Racor | Regulip | Robotek | Rosulip | Rosuvastatina | Rosuvastatina genven | Rovaril | Rovartal | Rozat | Triglival;
  • (VN) Viet Nam: Auritz | Bonzacim | Carhurol | Colarosu | Devastin | Eftirosu | Intoras | Merovast | Nafelof | Richstatin | Rossuwell | Rosuvagen | Rotinvast | Rotorlip | Ruvasan | Sterolow | Sunbakant | Surotadina | Vacoros;
  • (ZA) South Africa: Cresagen | Crestor | Crevas | Kolestor | Lupovas | Rocrest | Rostat | Rostor | Rosuvastatin adco | Rosuvastatin cipla | Rosuvastatin PharmC | Rosuvastatin unicorn | Rosvator | Storwin | Torolar | Trinchol | Vasrov | Vusor | Xartigen | Zuvamor;
  • (ZM) Zambia: Ldnil | Rosuvas | Rozatin;
  • (ZW) Zimbabwe: Crestor | Ldnil | Rosucor | Rovas
  1. Akimoto H, Negishi A, Oshima S, et al. Onset timing of statin-induced musculoskeletal adverse events and concomitant drug-associated shift in onset timing of MAEs. Pharmacol Res Perspect. 2018;6(6):e00439. doi:10.1002/prp2.439 [PubMed 30443347]
  2. Algeffari M, Alsharidah M. Rosuvastatin-induced oral ulcer: a case report and review of literature. Case Rep Dent. 2022;2022:7960513. doi:10.1155/2022/7960513 [PubMed 35392489]
  3. Anderson PO, Sauberan JB. Modeling drug passage into human milk. Clin Pharmacol Ther. 2016;100(1):42-52. doi:10.1002/cpt.377 [PubMed 27060684]
  4. Balla S, Ekpo EP, Wilemon KA, Knowles JW, Rodriguez F. Women living with familial hypercholesterolemia: challenges and considerations surrounding their care. Curr Atheroscler Rep. 2020;22(10):60. doi:10.1007/s11883-020-00881-5 [PubMed 32816232]
  5. Bang UC, Benfield T, Bendtsen F. Reduced risk of decompensation and death associated with use of statins in patients with alcoholic cirrhosis. A nationwide case-cohort study. Aliment Pharmacol Ther. 2017;46(7):673-680. doi:10.1111/apt.14243 [PubMed 28880449]
  6. Bateman BT, Hernandez-Diaz S, Fischer MA, et al. Statins and congenital malformations: cohort study. BMJ. 2015;350:h1035. doi:10.1136/bmj.h1035 [PubMed 25784688]
  7. Bays H. Statin safety: an overview and assessment of the data--2005. Am J Cardiol. 2006;97(8A):6C-26C. doi:10.1016/j.amjcard.2005.12.006 [PubMed 16581330]
  8. Bellosta S, Paoletti R, Corsini A. Safety of statins: focus on clinical pharmacokinetics and drug interactions. Circulation. 2004;109(23 suppl 1):III50-III57. doi:10.1161/01.CIR.0000131519.15067.1f [PubMed 15198967]
  9. Birmingham BK, Swan SK, Puchalski T, et al. Pharmacokinetic and pharmacodynamic profile of rosuvastatin in patients with end-stage renal disease on chronic haemodialysis. Clin Drug Investig. 2013;33(4):233-241. doi:10.1007/s40261-013-0071-3 [PubMed 23494963]
  10. Björnsson E, Jacobsen EI, Kalaitzakis E. Hepatotoxicity associated with statins: reports of idiosyncratic liver injury post-marketing. J Hepatol. 2012;56(2):374-380. doi:10.1016/j.jhep.2011.07.023 [PubMed 21889469]
  11. Björnsson ES. Hepatotoxicity of statins and other lipid-lowering agents. Liver Int. 2017;37(2):173-178. doi:10.1111/liv.13308 [PubMed 27860156]
  12. Bologa R, Levine D, Parker T, et al. Pharmacokinetics of rosuvastatin in patients with end-stage kidney disease undergoing peritoneal dialysis. Clin Nephrol. 2009;72(6):437-441. doi:10.5414/cnp72437 [PubMed 19954720]
  13. Bosch J, Gracia-Sancho J, Abraldes JG. Cirrhosis as new indication for statins. Gut. 2020;69(5):953-962. doi:10.1136/gutjnl-2019-318237 [PubMed 32139553]
  14. Brunham LR, Ruel I, Aljenedil S, et al. Canadian Cardiovascular Society position statement on familial hypercholesterolemia: update 2018. Can J Cardiol. 2018;34(12):1553-1563. doi:10.1016/j.cjca.2018.09.005 [PubMed 30527143]
  15. Calderon RM, Cubeddu LX, Goldberg RB, Schiff ER. Statins in the treatment of dyslipidemia in the presence of elevated liver aminotransferase levels: a therapeutic dilemma. Mayo Clin Proc. 2010;85(4):349-356. doi:10.4065/mcp.2009.0365 [PubMed 20360293]
  16. Canadian Diabetes Association Clinical Practice Guidelines Expert Committee. Canadian Diabetes Association 2013 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada. Can J Diabetes. 2013;35(suppl 1):1-212.
  17. Chalasani N, Aljadhey H, Kesterson J, Murray MD, Hall SD. Patients with elevated liver enzymes are not at higher risk for statin hepatotoxicity. Gastroenterology. 2004;126(5):1287-1292. doi:10.1053/j.gastro.2004.02.015 [PubMed 15131789]
  18. Chalasani N, Bonkovsky HL, Fontana R, et al. Features and outcomes of 899 patients with drug-induced liver injury: the DILIN prospective study. Gastroenterology. 2015;148(7):1340-52.e7. doi:10.1053/j.gastro.2015.03.006 [PubMed 25754159]
  19. Chang JC, Chen YJ, Chen IC, Lin WS, Chen YM, Lin CH. Perinatal outcomes after statin exposure during pregnancy. JAMA Netw Open. 2021;4(12):e2141321. doi:10.1001/jamanetworkopen.2021.41321 [PubMed 34967881]
  20. Chen GL, Hsiao FY, Dong YH, Shen LJ, Wu FL. Statins and the risk of liver injury: a population-based case-control study. Pharmacoepidemiol Drug Saf. 2014;23(7):719-725. doi:10.1002/pds.3646 [PubMed 24829162]
  21. Chintanaboina J, Gopavaram D. Recurrent acute pancreatitis probably induced by rosuvastatin therapy: a case report. Case Rep Med. 2012;2012:973279. doi:10.1155/2012/973279 [PubMed 22536267]
  22. Costanzo MR, Dipchand A, Starling R, et al. The International Society of Heart and Lung Transplantation guidelines for the care of heart transplant recipients. J Heart Lung Transplant. 2010;29(8):914-956. doi:10.1016/j.healun.2010.05.034 [PubMed 20643330]
  23. Crestor (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; January 2023.
  24. Crestor (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; July 2023.
  25. Crestor (rosuvastatin) [product monograph]. Mississauga, Ontario, Canada: AstraZeneca Canada Inc; July 2023.
  26. de Denus S, Spinler SA. Early statin therapy for acute coronary syndromes. Ann Pharmacother. 2002;36(11):1749-1758. doi:10.1345/aph.1A413. [PubMed 12398573]
  27. Eisen HJ, Rosenson RS, Johnson S. Heart transplantation: hyperlipidemia after transplantation. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed October 26, 2022.
  28. Essers D, Schäublin M, Kullak-Ublick GA, Weiler S. Statin-associated immune-mediated necrotizing myopathy: a retrospective analysis of individual case safety reports from VigiBase. Eur J Clin Pharmacol. 2019;75(3):409-416. doi:10.1007/s00228-018-2589-z [PubMed 30430215]
  29. Expert opinion. Senior Hepatic Editorial Team: Matt Harris, PharmD, MHS, BCPS, FAST; Jeong Park, PharmD, MS, BCTXP, FCCP, FAST; Arun Jesudian, MD; Sasan Sakiani, MD.
  30. Expert opinion. Senior Renal Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
  31. Ezallor Sprinkle (rosuvastatin) [prescribing information]. Cranbury, NJ: Sun Pharmaceutical Industries Inc; August 2023.
  32. Famularo G, Miele L, Minisola G, Grieco A. Liver toxicity of rosuvastatin therapy. World J Gastroenterol. 2007;13(8):1286-1288. doi:10.3748/wjg.v13.i8.1286 [PubMed 17451217]
  33. Fellström BC, Jardine AG, Schmieder RE, et al. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis. N Engl J Med. 2009;360(14):1395-1407. doi:10.1056/NEJMoa0810177 [PubMed 19332456]
  34. Fleisher LA, Fleischmann KE, Auerbach AD, et al. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;130(24):e278-e333. [PubMed 25085961]
  35. Godfrey LM, Erramouspe J, Cleveland KW. Teratogenic risk of statins in pregnancy. Ann Pharmacother. 2012;46(10):1419-1424. doi:10.1345/aph.1R202. [PubMed 23032657]
  36. Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;139(25):e1082-e1143. doi:10.1161/CIR.0000000000000625 [PubMed 30586774]
  37. Guo M, Zhao J, Zhai Y, Zang P, Lv Q, Shang D. A prospective study of hepatic safety of statins used in very elderly patients. BMC Geriatr. 2019;19(1):352. doi:10.1186/s12877-019-1361-2 [PubMed 31842780]
  38. Harper CR, Jacobson TA. Evidence-based management of statin myopathy. Curr Atheroscler Rep. 2010;12(5):322-330. doi:10.1007/s11883-010-0120-9 [PubMed 20628837]
  39. Hassan M, Nguyen B, Helmsdoerfer K, Nadella S, Chang Lopez A. High-intensity statin with severe consequences: a case of non-autoimmune rosuvastatin-induced myonecrosis. Cureus. 2022;14(10):e30080. doi:10.7759/cureus.30080 [PubMed 36381879]
  40. Hillis LD, Smith PK, Anderson JL, et al. 2011 ACCF/AHA guideline for coronary artery bypass graft surgery: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011;124(23):e652-735. [PubMed 22064599]
  41. Hilton-Jones D. Statin-related myopathies. Pract Neurol. 2018;18(2):97-105. doi:10.1136/practneurol-2017-001738 [PubMed 29496886]
  42. Hoffman KB, Kraus C, Dimbil M, Golomb BA. A survey of the FDA's AERS database regarding muscle and tendon adverse events linked to the statin drug class. PLoS One. 2012;7(8):e42866. doi:10.1371/journal.pone.0042866 [PubMed 22936996]
  43. Holmsen ST, Bakkebø T, Seferowicz M, Retterstøl K. Statins and breastfeeding in familial hypercholesterolaemia. Tidsskr Nor Laegeforen. 2017;137(10):686-687. doi:10.4045/tidsskr.16.0838 [PubMed 28551957]
  44. Huang CY, Chung SD, Kao LT, Lin HC, Wang LH. Statin use is associated with bladder pain syndrome/interstitial cystitis: a population-based case-control study. Urol Int. 2015;95(2):227-232. [PubMed 26184102]
  45. Ito S. Drug therapy for breast-feeding women. NEJM. 2000;343(2):118-126. doi:10.1056/NEJM200007133430208 [PubMed 10891521]
  46. January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society [published online March 28, 2014]. Circulation. [PubMed 24682347]
  47. Kariyanna PT, Haseeb S, Chowdhury YS, et al. Ticagrelor and statin interaction induces rhabdomyolysis and acute renal failure: case reports and scoping review. Am J Med Case Rep. 2019;7(12):337-341. doi:10.12691/ajmcr-7-12-9 [PubMed 31745500]
  48. Kim SY, Kim SJ, Yoon D, Hong SW, Park S, Ock CY. A case of statin-induced interstitial pneumonitis due to rosuvastatin. Tuberc Respir Dis (Seoul). 2015;78(3):281-285. doi:10.4046/trd.2015.78.3.281 [PubMed 26175786]
  49. Kostapanos MS, Milionis HJ, Elisaf MS. Rosuvastatin-associated adverse effects and drug-drug interactions in the clinical setting of dyslipidemia. Am J Cardiovasc Drugs. 2010;10(1):11-28. doi:10.2165/13168600-000000000-00000 [PubMed 20104931]
  50. Kulik A, Ruel M, Jneid H, et al; American Heart Association Council on Cardiovascular Surgery and Anesthesia. Secondary prevention after coronary artery bypass graft surgery: a scientific statement from the American Heart Association. Circulation. 2015;131(10):927-964. [PubMed 25679302]
  51. Lapi F, Gallo E, Bernasconi S, et al. Myopathies associated with red yeast rice and liquorice: spontaneous reports from the Italian Surveillance System of Natural Health Products. Br J Clin Pharmacol. 2008;66(4):572-574. [PubMed 18637891]
  52. Law M, Rudnicka AR. Statin safety: a systematic review. Am J Cardiol. 2006;97(8A):52C-60C. doi:10.1016/j.amjcard.2005.12.010 [PubMed 16581329]
  53. Lecarpentier E, Morel O, Fournier T, Elefant E, Chavatte-Palmer P, Tsatsaris V. Statins and pregnancy: between supposed risks and theoretical benefits. Drugs. 2012;72(6):773-788. doi:10.2165/11632010-000000000-00000. [PubMed 22480340]
  54. Lentine KL, Brennan DC. Kidney transplantation in adults: lipid abnormalities after kidney transplantation. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed May 24, 2022.
  55. Lloyd-Jones DM, Morris PB, Ballantyne CM, et al. 2022 ACC expert consensus decision pathway on the role of nonstatin therapies for LDL-cholesterol lowering in the management of atherosclerotic cardiovascular disease risk: a report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2022;80(14):1366-1418. doi:10.1016/j.jacc.2022.07.006 [PubMed 36031461]
  56. Londrino F, Zattera T, Falqui V, et al. Rosuvastatin-induced acute interstitial nephritis. Case Rep Nephrol Urol. 2013;3(1):87-90. doi:10.1159/000353175 [PubMed 24167517]
  57. Lwin EMP, Leggett C, Ritchie U, et al. Transfer of rosuvastatin into breast milk: liquid chromatography-mass spectrometry methodology and clinical recommendations. Drug Des Devel Ther. 2018;12:3645-3651. doi:10.2147/DDDT.S184053 [PubMed 30464396]
  58. Malik S, Cohen PR. Rosuvastatin-induced dizziness and pruritus: a case report and summary of statin-associated dizziness and pruritus. Cureus. 2022;14(9):e29014. doi:10.7759/cureus.29014 [PubMed 36237799]
  59. Mammen AL. Statin-associated autoimmune myopathy. N Engl J Med. 2016;374(7):664-669. doi:10.1056/NEJMra1515161 [PubMed 26886523]
  60. Mancano MA. ISMP Adverse Drug Reactions: Influenza vaccine-induced Stevens-Johnson syndrome; vilazodone-induced nightmares; dabigatran-induced pustular eruptions; neurotoxic and cardiotoxic symptoms after cannabis concentrate exposure; rosuvastatin-induced skin eruption. Hosp Pharm. 2018;53(1):15-17. doi:10.1177/0018578717739727 [PubMed 29434381]
  61. McKenney JM, Ganz P, Wiggins B, Saseen JS. Statins. In: Ballantyne CM, ed. Clinical Lipidology: A Companion to Braunwald’s Heart Disease. Philadelphia, PA: Saunders Elsevier; 2009:253-280.
  62. Murad AA, Connolly M, Tobin AM. Rosuvastatin-induced pemphigoid. BMJ Case Rep. 2012;2012:bcr1120115180. doi:10.1136/bcr.11.2011.5180 [PubMed 22605857]
  63. Mustafa SF, Zafar MR, Miller TW. Rosuvastatin use implicated in the drug reaction with eosinophilia and systemic symptoms. Cureus. 2020;12(2):e7098. doi:10.7759/cureus.7098 [PubMed 32231894]
  64. Narayanaswami P, Sanders DB, Wolfe G, et al. International consensus guidance for management of myasthenia gravis: 2020 update. Neurology. 2021;96(3):114-122. doi:10.1212/WNL.0000000000011124 [PubMed 33144515]
  65. National Heart, Lung, and Blood Institute, "Expert Panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents," Clinical Practice Guidelines, 2011, National Institutes of Health. Available at http://www.nhlbi.nih.gov/guidelines/cvd_ped/peds_guidelines_full.pdf
  66. Navarro Pérez MP, Sanabria Sanchinel AA, Alfaro Torres J, Marquina Ibañez I, Larrodé Pellicer P. Autoimmune necrotising myopathy: a case report. Article in English and Spanish. Neurologia. 2019;34(1):67-68. doi:10.1016/j.nrl.2017.04.002 [PubMed 28647134]
  67. Nazir S, Lohani S, Tachamo N, Poudel D, Donato A. Statin-associated autoimmune myopathy: a systematic review of 100 cases. J Clin Rheumatol. 2017;23(3):149-154. doi:10.1097/RHU.0000000000000497 [PubMed 28277343]
  68. Newman CB, Preiss D, Tobert JA, et al. Statin safety and associated adverse events: a scientific statement from the American Heart Association. Arterioscler Thromb Vasc Biol. 2019;39(2):e38-e81. doi:10.1161/ATV.0000000000000073 [PubMed 30580575]
  69. Oteri A, Catania MA, Russo A, et al. Reversible acute hepatitis induced by rosuvastatin. South Med J. 2008;101(7):768. doi:10.1097/SMJ.0b013e3181778d75 [PubMed 19209117]
  70. Özdemir IH, Copkiran Ö, Tıkız H, Tıkız C. Peripheral polyneuropathy in patients receiving long-term statin therapy. Turk Kardiyol Dern Ars. 2019;47(7):554-563. doi:10.5543/tkda.2019.78379 [PubMed 31582682]
  71. Parikh NI, Gonzalez JM, Anderson CAM, et al; American Heart Association Council on Epidemiology and Prevention; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular and Stroke Nursing; and the Stroke Council. Adverse pregnancy outcomes and cardiovascular disease risk: unique opportunities for cardiovascular disease prevention in women: a scientific statement from the American Heart Association. Circulation. 2021;143(18):e902-e916. doi:10.1161/CIR.0000000000000961 [PubMed 33779213]
  72. Pearson GJ, Thanassoulis G, Anderson TJ, et al. 2021 Canadian Cardiovascular Society guidelines for the management of dyslipidemia for the prevention of cardiovascular disease in adults. Can J Cardiol. 2021:S0828-282X(21)00165-3. doi:10.1016/j.cjca.2021.03.016 [PubMed 33781847]
  73. Pignone M. Low-density lipoprotein cholesterol-lowering therapy in the primary prevention of cardiovascular disease. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed December 20, 2022.
  74. Purvin V, Kawasaki A, Smith KH, Kesler A. Statin-associated myasthenia gravis: report of 4 cases and review of the literature. Medicine (Baltimore). 2006;85(2):82-85. doi:10.1097/01.md.0000209337.59874.aa [PubMed 16609346]
  75. Ray KK, Cannon CP. The potential relevance of the multiple lipid-independent (pleiotropic) effects of statins in the management of acute coronary syndromes. J Am Coll Cardiol. 2005;46(8):1425-1433. [PubMed 16226165]
  76. Refer to the manufacturer's labeling.
  77. Roberto G, Biagi C, Montanaro N, Koci A, Moretti U, Motola D. Statin-associated gynecomastia: evidence coming from the Italian spontaneous ADR reporting database and literature. Eur J Clin Pharmacol. 2012;68(6):1007-1011. doi:10.1007/s00228-012-1218-5 [PubMed 22286160]
  78. Rosenson RS. Statins: Actions, side effects, and administration. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed October 13, 2021.
  79. Rosenson RS, Durrington P, Lopez-Sendon J. Familial hypercholesterolemia in adults: treatment. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed June 3, 2020a.
  80. Rosenson RS, Hayward RA. Management of low density lipoprotein cholesterol (LDL-C) in the secondary prevention of cardiovascular disease. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed June 3, 2020b.
  81. Russo MW, Hoofnagle JH, Gu J, et al. Spectrum of statin hepatotoxicity: experience of the drug-induced liver injury network. Hepatology. 2014;60(2):679-686. doi:10.1002/hep.27157 [PubMed 24700436]
  82. Russo MW, Scobey M, Bonkovsky HL. Drug-induced liver injury associated with statins. Semin Liver Dis. 2009;29(4):412-422. doi:10.1055/s-0029-1240010 [PubMed 19826975]
  83. Schutte AE, Symington EA, du Preez JL. Rosuvastatin is transferred into human breast milk: a case report. Am J Med. 2013;126(9):e7-e8. doi:10.1016/j.amjmed.2013.02.032 [PubMed 23968910]
  84. Selva-O'Callaghan A, Alvarado-Cardenas M, Pinal-Fernández I, et al. Statin-induced myalgia and myositis: an update on pathogenesis and clinical recommendations. Expert Rev Clin Immunol. 2018;14(3):215-224. doi:10.1080/1744666X.2018.1440206 [PubMed 29473763]
  85. Sever PS, Dahlöf B, Poulter NR, et al; ASCOT investigators. Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial--Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial. Lancet. 2003;361(9364):1149-1158. doi:10.1016/S0140-6736(03)12948-0. [PubMed 12686036]
  86. Sewright KA, Clarkson PM, Thompson PD. Statin myopathy: incidence, risk factors, and pathophysiology. Curr Atheroscler Rep. 2007;9(5):389-396. doi:10.1007/s11883-007-0050-3 [PubMed 18001622]
  87. Shah J, Lingiah V, Pyrsopoulos N, Galan M. Acute liver injury in a patient treated with rosuvastatin: a rare adverse effect. Gastroenterology Res. 2019;12(5):263-266. doi:10.14740/gr1212 [PubMed 31636777]
  88. Shahbaz A, Mahendhar R, Fransawy Alkomos M, Zarghamravanbakhsh P, Sachmechi I. Drug-induced angioedema: a rare side effect of rosuvastatin. Cureus. 2018;10(7):e2965. Published 2018 Jul 11. doi:10.7759/cureus.2965 [PubMed 30210953]
  89. Shin JI, Fine DM, Sang Y, et al. Association of rosuvastatin use with risk of hematuria and proteinuria. J Am Soc Nephrol. 2022;33(9):1767-1777. doi:10.1681/ASN.2022020135 [PubMed 35853713]
  90. Simonson SG, Martin PD, Mitchell P, et al. Pharmacokinetics and pharmacodynamics of rosuvastatin in subjects with hepatic impairment. Eur J Clin Pharmacol. 2003;58(10):669-675. doi:10.1007/s00228-002-0541-7 [PubMed 12610743]
  91. Singh KN, Perez LKM, Singh A, Carey W. Safety of statins in decompensated cirrhosis in patients listed for liver transplantation. Am J Gastroenterol. 2019;114:S561–562
  92. Skilving I, Eriksson M, Rane A, Ovesjö ML. Statin-induced myopathy in a usual care setting-a prospective observational study of gender differences. Eur J Clin Pharmacol. 2016;72(10):1171-1176. doi:10.1007/s00228-016-2105-2 [PubMed 27484241]
  93. Smith DJ, Olive KE. Chinese red rice-induced myopathy. South Med J. 2003;96(12):1265-1267. doi:10.1097/01.SMJ.0000100117.79718.DC. [PubMed 14696880]
  94. Speliotes EK, Balakrishnan M, Friedman LS, Corey KE. Treatment of dyslipidemia in common liver diseases. Clin Gastroenterol Hepatol. 2018;16(8):1189-1196. doi:10.1016/j.cgh.2018.04.023 [PubMed 29684459]
  95. Stein EA, Strutt K, Southworth H, Diggle PJ, Miller E; HeFH Study Group. Comparison of rosuvastatin versus atorvastatin in patients with heterozygous familial hypercholesterolemia. Am J Cardiol. 2003;92(11):1287-1293. doi:10.1016/j.amjcard.2003.08.009 [PubMed 14636905]
  96. Stroes ES, Thompson PD, Corsini A, et al. Statin-associated muscle symptoms: impact on statin therapy-European Atherosclerosis Society Consensus Panel statement on assessment, aetiology and management. Eur Heart J. 2015;36(17):1012-1022. doi:10.1093/eurheartj/ehv043 [PubMed 25694464]
  97. Sung S, Al-Karaghouli M, Kalainy S, Cabrera Garcia L, Abraldes JG. A systematic review on pharmacokinetics, cardiovascular outcomes and safety profiles of statins in cirrhosis. BMC Gastroenterol. 2021;21(1):120. doi:10.1186/s12876-021-01704-w [PubMed 33726685]
  98. Thabouti M, Gahriani Fetoui N, Manaa L, et al. Rosuvastatin induced photolocalized purpura. Clin Case Rep. 2022;10(9):e6375. doi:10.1002/ccr3.6375 [PubMed 36188032]
  99. Thapar M, Russo MW, Bonkovsky HL. Statins and liver injury. Gastroenterol Hepatol (N Y). 2013;9(9):605-606. [PubMed 24729773]
  100. Thompson PD, Clarkson PM, Rosenson RS; National Lipid Association Statin Safety Task Force Muscle Safety Expert Panel. An assessment of statin safety by muscle experts. Am J Cardiol. 2006;97(8A):69C-76C. doi:10.1016/j.amjcard.2005.12.013 [PubMed 16581332]
  101. Tonelli M, Wanner C; Kidney Disease: Improving Global Outcomes Lipid Guideline Development Work Group Members. Lipid management in chronic kidney disease: synopsis of the Kidney Disease: Improving Global Outcomes 2013 clinical practice guideline. Ann Intern Med. 2014;160(3):182. doi:10.7326/M13-2453 [PubMed 24323134]
  102. Tuccori M, Montagnani S, Mantarro S, et al. Neuropsychiatric adverse events associated with statins: epidemiology, pathophysiology, prevention and management. CNS Drugs. 2014;28(3):249-272. doi:10.1007/s40263-013-0135-1 [PubMed 24435290]
  103. Vahedian-Azimi A, Bianconi V, Makvandi S, et al. A systematic review and meta-analysis on the effects of statins on pregnancy outcomes. Atherosclerosis. 2021b;336:1-11. doi:10.1016/j.atherosclerosis.2021.09.010 [PubMed 34601188]
  104. Vahedian-Azimi A, Makvandi S, Banach M, Reiner Ž, Sahebkar A. Fetal toxicity associated with statins: a systematic review and meta-analysis. Atherosclerosis. 2021a;327:59-67. doi:10.1016/j.atherosclerosis.2021.05.006 [PubMed 34044205]
  105. Vesza Z, Pires C, da Silva PM. Statin-related lichenoid dermatosis: an uncommon adverse reaction to a common treatment. Eur J Case Rep Intern Med. 2018;5(5):000844. doi:10.12890/2018_000844 [PubMed 30756034]
  106. Vrettos I, Papageorgiou S, Economopoulou C, et al. Rosuvastatin-induced thrombocytopenia. South Med J. 2010;103(7):676-678. doi:10.1097/SMJ.0b013e3181e170f5 [PubMed 20531065]
  107. Wagner B, Escobar GP, Jackson DB, DeAguero J. Rosuvastatin-induced rhabdomyolysis, pancreatitis, transaminitis, and acute kidney injury. Fed Pract. 2021;38(Suppl 4):S18-S22. doi:10.12788/fp.0199 [PubMed 35136340]
  108. Wiggins BS, Saseen JJ, Page RL 2nd, et al. Recommendations for management of clinically significant drug-drug interactions with statins and select agents used in patients with cardiovascular disease: a scientific statement from the American Heart Association. Circulation. 2016;134(21):e468-e495. doi:10.1161/CIR.0000000000000456 [PubMed 27754879]
  109. Wolters LM, Van Buuren HR. Rosuvastatin-associated hepatitis with autoimmune features. Eur J Gastroenterol Hepatol. 2005;17(5):589-590. doi:10.1097/00042737-200505000-00019 [PubMed 15827453]
  110. Zaleski AL, Taylor BA, Thompson PD. Coenzyme Q10 as treatment for statin-associated muscle symptoms-a good idea, but…. Adv Nutr. 2018;9(4):519S-523S. doi:10.1093/advances/nmy010 [PubMed 30032220]
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