Adverse Reactions

Placebo-Controlled Trials

Adverse Events (AE) reported in CRESTOR diverse dose (5 mg - 40 mg) vs placebo
Adverse Reactions CRESTOR 5 mg N=291 CRESTOR 10 mg N=283 CRESTOR 20 mg N=64 CRESTOR 40 mg N=106 Total CRESTOR
5 mg-40 mg
N=744		 Placebo N=382
Headache 5.5 4.9 3.1 8.5 5.5 5.0
Nausea 3.8 3.5 6.3 0 3.4 3.1
Myalqia 3.1 2.1 6.3 1.9 2.8 1.3
Asthenia 2.4 3.2 4.7 0.9 2.7 2.6
Constipation 2.1 2.1 4.7 2.8 2.4 2.4
Adverse Events (AE) reported in CRESTOR diverse dose (5 mg – 40 mg) vs placebo
    • Adverse Reactions

      Headache

    • CRESTOR 5 mg, N=291

      5.5

    • CRESTOR 10 mg, N=283

      4.9

    • CRESTOR 20 mg, N=64

      3.1

    • CRESTOR 40 mg, N=106

      8.5

    • Total CRESTOR 5 mg - 40 mg, N=744

      5.5

    • Placebo, N=382

      5.0

    • Adverse Reactions

      Nausea

    • CRESTOR 5 mg, N=291

      3.8

    • CRESTOR 10 mg, N=283

      3.5

    • CRESTOR 20 mg, N=64

      6.3

    • CRESTOR 40 mg, N=106

      0

    • Total CRESTOR 5 mg - 40 mg, N=744

      3.4

    • Placebo, N=382

      3.1

    • Adverse Reactions

      Myalqia

    • CRESTOR 5 mg, N=291

      3.1

    • CRESTOR 10 mg, N=283

      2.1

    • CRESTOR 20 mg, N=64

      6.3

    • CRESTOR 40 mg, N=106

      1.9

    • Total CRESTOR 5 mg - 40 mg, N=744

      2.8

    • Placebo, N=382

      1.3

    • Adverse Reactions

      Asthenia

    • CRESTOR 5 mg, N=291

      2.4

    • CRESTOR 10 mg, N=283

      3.2

    • CRESTOR 20 mg, N=64

      4.7

    • CRESTOR 40 mg, N=106

      0.9

    • Total CRESTOR 5 mg - 40 mg, N=744

      2.7

    • Placebo, N=382

      2.6

    • Adverse Reactions

      Constipation

    • CRESTOR 5 mg, N=291

      2.1

    • CRESTOR 10 mg, N=283

      2.1

    • CRESTOR 20 mg, N=64

      4.7

    • CRESTOR 40 mg, N=106

      2.8

    • Total CRESTOR 5 mg - 40 mg, N=744

      2.4

    • Placebo, N=382

      2.4

* ^ Adverse reactions by COSTART preferred term.

Adverse reactions[*] reported in ≥2% of patients treated with CRESTOR in placebo-controlled clinical studies and at a rate greater than placebo. These studies had a treatment duration of up to 12 weeks.[1b]

METEOR Trials

Adverse reactions[*] reported in ≥2% of patients treated with CRESTOR and at a rate greater than placebo in the METEOR trial.[1c]

For more information concerning the METEOR trial, visit slowing atherosclerosis progression.

In the JUPITER study, 17,802 participants were treated with CRESTOR 20 mg (n=8901) or placebo (n=8901) for a mean duration of 2 years. A higher percentage of CRESTOR-treated patients versus placebo-treated patients, 6.6% and 6.2%, respectively, discontinued study medication due to an adverse event, irrespective of treatment causality. Myalgia was the most common adverse reaction that led to treatment discontinuation.

In JUPITER, there was a significantly higher frequency of diabetes mellitus reported in patients taking CRESTOR (2.8%) versus patients taking placebo (2.3%). Mean HbA1c was significantly increased by 0.1% in CRESTOR-treated patients compared to placebo-treated patients. The number of patients with an HbA1c >6.5% at the end of the trial was significantly higher in CRESTOR-treated versus placebo-treated patients.

Adverse Events(AE) reported in CRESTOR 40 mg vs Placebo 10 mg
Adverse
Reactions		 CRESTOR
40 mg

N=700		 Placebo 10 mg

N=281
Myalagia 12.7 12.1
Arthralgia 10.1 7.1
Headache 6.4 5.3
Dizziness 4.0 2.8
Increased CPK 2.6 0.7
Abdominal pain 2.4 1.8
[†]ALT>3x ULN 2.2 0.7
Adverse Events(AE) reported in CRESTOR 40 mg vs Placebo 10 mg
    • Adverse Reactions

      Myalagia

    • CRESTOR 20 mg N=8901

      12.7

    • Placebo N=8901

      12.1

    • Adverse Reactions

      Arthralgia

    • CRESTOR 20 mg N=8901

      10.1

    • Placebo N=8901

      7.1

    • Adverse Reactions

      Headache

    • CRESTOR 20 mg N=8901

      6.4

    • Placebo N=8901

      5.3

    • Adverse Reactions

      Dizziness

    • CRESTOR 20 mg N=8901

      4.0

    • Placebo N=8901

      2.8

    • Adverse Reactions

      Increased CPK

    • CRESTOR 20 mg N=8901

      2.6

    • Placebo N=8901

      0.7

    • Adverse Reactions

      Abdominal pain

    • CRESTOR 20 mg N=8901

      2.4

    • Placebo N=8901

      1.8

    • Adverse Reactions

      [†]ALT>3x ULN

    • CRESTOR 20 mg N=8901

      2.2

    • Placebo N=8901

      0.7

† ^ Frequency recorded as abnormal laboratory value.

* ^ Adverse reactions by MedDRA preferred term.

† ^ Frequency recorded as abnormal laboratory value.

Adverse Reactions[*] Reported by ≥2% of Patients Treated With CRESTOR and Greater Than Placebo in the METEOR Trial (% of Patients)[1d]

Adverse reactions reported in ≥2% of patients treated with CRESTOR and at a rate greater than placebo in the METEOR trial are shown below.[1e]

For more information concerning the METEOR trial, visit slowing atherosclerosis progression.

In the JUPITER study, 17,802 participants were treated with CRESTOR 20 mg (n=8901) or placebo (n=8901) for a mean duration of 2 years. A higher percentage of CRESTOR-treated patients versus placebo-treated patients, 6.6% and 6.2%, respectively, discontinued study medication due to an adverse event, irrespective of treatment causality. Myalgia was the most common adverse reaction that led to treatment discontinuation.

In JUPITER, there was a significantly higher frequency of diabetes mellitus reported in patients taking CRESTOR (2.8%) versus patients taking placebo (2.3%). Mean HbA1c was significantly increased by 0.1% in CRESTOR-treated patients compared to placebo-treated patients. The number of patients with an HbA1c >6.5% at the end of the trial was significantly higher in CRESTOR-treated versus placebo-treated patients.

JUPITER Trial

Adverse Events (AE) reported in CRESTOR 40 mg vs placebo
Adverse Reactions CRESTOR 40 mg N=8901 Placebo
N=8901
Myalagia 7.6 6.6
Arthralgia 3.8 3.2
Constipation 3.3 3.0
Diabetes mellitus 2.8 2.3
Nausea 2.4 2.3
Adverse Events (AE) reported in CRESTOR 40 mg vs placebo
    • Adverse Reactions

      Myalagia

    • CRESTOR 20 mg N=8901

      7.6

    • Placebo N=8901

      6.6

    • Adverse Reactions

      Arthralgia

    • CRESTOR 20 mg N=8901

      3.8

    • Placebo N=8901

      3.2

    • Adverse Reactions

      Constipation

    • CRESTOR 20 mg N=8901

      3.3

    • Placebo N=8901

      3.0

    • Adverse Reactions

      Diabetes mellitus

    • CRESTOR 20 mg N=8901

      2.8

    • Placebo N=8901

      2.3

    • Adverse Reactions

      Nausea

    • CRESTOR 20 mg N=8901

      2.4

    • Placebo N=8901

      2.3

* ^ Treatment-emergent adverse reactions by MedDRA preferred term.

Adverse reactions[*] reported in ≥2% of patients treated with CRESTOR and at a rate greater than or equal to placebo in the JUPITER trial.[1d]

For more information concerning the JUPITER trial, visit primary prevention of CVD indication

Next: CRESTOR Clinical Trials

SAVINGS ELIGIBILITY

Eligible patients MAY pay as low as $3 for a 30-, 60-, or 90-day supply.[*]

* ^ Subject to eligibility. Restrictions apply.

Learn About Savings Eligibility

HELP YOUR PATIENTS REACH LDL-C GOAL WITH CRESTOR

In the STELLAR trial, in patients with hyperlipidemia or mixed dyslipidemia, nearly 9 out of 10 met their LDL-C goal with CRESTOR 20 mg.

Learn about patients reaching LDL-C goal

Important Safety Information for CRESTOR® (rosuvastatin) Tablets

  • CRESTOR is contraindicated in patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels or a known hypersensitivity to any component of this product
  • Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with statins, including CRESTOR. These risks can occur at any dose level, but are increased at the highest dose (40 mg)
  • CRESTOR should be prescribed with caution in patients with predisposing factors for myopathy (eg, age ≥65 years, inadequately treated hypothyroidism, renal impairment). The risk of myopathy during treatment with CRESTOR may be increased in Asian patients and with concurrent administration of some other lipid-lowering therapies (fibrates or niacin), cyclosporine, teriflunomide, enasidenib, capmatinib, fostamatinib, febuxostat, gemfibrozil, tafamidis, darolutamide, regorafenib, atazanavir/ritonavir, lopinavir/ritonavir, simeprevir or combination of sofosbuvir/velpatasvir/voxilaprevir, dasabuvir/ombitasvir/paritaprevir/ritonavir, elbasvir/grazoprevir, sofosbuvir/velpatasvir, glecaprevir/pibrentasvir, all combinations with ledipasvir (including ledipasvir/sofosbuvir), colchicine or ticagrelor
  • Therapy with CRESTOR should be discontinued if markedly elevated CK levels occur or myopathy is diagnosed or suspected. All patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, and if muscle signs and symptoms persist after discontinuing CRESTOR
  • There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents. Treatment with immunosuppressive agents may be required. Discontinue CRESTOR if IMNM is suspected
  • Increases in serum transaminases have occurred, some persistent. Rare reports of fatal and non-fatal hepatic failure have occurred. Consider testing liver enzymes before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue CRESTOR
  • CRESTOR should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of chronic liver disease
  • CRESTOR significantly increased INR in patients receiving coumarin anticoagulants (eg, warfarin). In patients taking coumarin anticoagulants and CRESTOR concomitantly, INR should be determined before starting CRESTOR and frequently enough during early therapy to ensure that no significant alteration of INR occurs
  • Dipstick-positive proteinuria and microscopic hematuria were observed among patients treated with CRESTOR. These findings were more frequent in patients taking CRESTOR 40 mg, though it was generally transient and was not associated with worsening renal function. Although the clinical significance of this finding is unknown, dose reduction should be considered for patients on CRESTOR therapy with unexplained persistent proteinuria and/or hematuria during routine urinalysis testing
  • Increases in HbA1c and fasting serum glucose levels have been reported with statins, including CRESTOR. Based on clinical trial data with CRESTOR, in some instances these increases may exceed the threshold for the diagnosis of diabetes mellitus
  • In the controlled clinical trials database, the most common adverse reactions were headache (3.7%), myalgia (3.1%), abdominal pain (2.6%), asthenia (2.5%), and nausea (2.2%)
  • Rare post-marketing reports of cognitive impairment (eg, memory loss, forgetfulness, amnesia, memory impairment, confusion) have been associated with statin use, including CRESTOR. These reports are generally nonserious and reversible upon statin discontinuation
  • Discontinue CRESTOR when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient
  • CRESTOR 40 mg should be used only for those patients not achieving their LDL-C goal with 20 mg
  • Administer CRESTOR at least 2 hours before aluminum and magnesium hydroxide combination antacids

INDICATIONS

  • To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor
  • Adjunct to diet to:
    • reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia
    • reduce LDL-C and slow the progression of atherosclerosis in adults
    • reduce LDL-C in patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH)
  • Adjunct to other LDL-C lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH)
  • Adjunct to diet for the treatment of adults with primary dysbetalipoproteinemia or hypertriglyceridemia

Read full Prescribing Information.

You may report side effects related to AstraZeneca products.

References:

1a 1b 1c 1d 1e 1f 1g 1h 1i CRESTOR® (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.

  • 1a 1b 1c 1c 1d CRESTOR® (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.
  • ^ Falk, E; Aarhus University Hospital (Skejby). Pathogenesis of atherosclerosis. Am J Cardiol. 2006;47(8):C7-12.
  • ^ Nissen, S; Cleveland Clinic Foundation. Rationale for a postintervention continuum of care; insights from intravascular ultrasound. Am J Cardiol. 2000;86(4):H12-17.
  • ^ Lexcol® (fluvastatin sodium) [package insert]. East Hanover, New Jersey: Novartis; 2020
  • ^ Mevacor® (lovastatin) [package insert]. Whitehouse Station, New Jersey: Merck & Company, Inc. 2012
  • ^ Pravachol® (pravastatin) [package insert]. Princeton, New Jersey: Bristol-Myers Squibb Company, 2020.
  • ^ Lipitor® (atorvastatin) [package insert]. New York, New York: Pfizer, 2021
  • ^ Livalo® (pitavastatin) [package insert]. Montgomery, AL: Kowa group of companies, 2020.
  • ^ Zocor® (simvastatin) [package insert]. Jersey City, NJ: Organon & Company, 2022
  • ^ Vytorin® (ezetimibe/simvastatin) [package insert]. Jersey City, NJ: Organon & Company, 2022.
  • ^ Lexcol® (fluvastatin sodium) [package insert]. East Hanover, New Jersey: Novartis; 2020
  • ^ Mevacor® (lovastatin) [package insert]. Whitehouse Station, New Jersey: Merck & Company, Inc. 2012
  • ^ Pravachol® (pravastatin) [package insert]. Princeton, New Jersey: Bristol-Myers Squibb Company, 2020.
  • ^ Lipitor® (atorvastatin) [package insert]. New York, New York: Pfizer, 2021
  • ^ Livalo® (pitavastatin) [package insert]. Montgomery, AL: Kowa group of companies, 2020.
  • ^ Zocor® (simvastatin) [package insert]. Jersey City, NJ: Organon & Company, 2022
  • ^ Vytorin® (ezetimibe/simvastatin) [package insert]. Jersey City, NJ: Organon & Company, 2022.
  • ^ Faergeman O, Hill L, Windler E, et al; on behalf of the ECLIPSE Study Investigators. Efficacy and tolerability of rosuvastatin and atorvastatin when force-titrated in patients with primary hypercholesterolemia. Cardiology. 2008;111(4):219-228.
  • ^ Ballantyne CM, Bertolami M, Hernandez Garcia HR, et al. Achieving LDL cholesterol, non-HDL cholesterol, and apolipoprotein B target levels in high-risk patients: Measuring Effective Reductions in Cholesterol Using Rosuvastatin therapY (MERCURY) II. Am Heart J. 2006;151(5):975.e1-975.e9.
  • ^ Schuster H, Barter PJ, Stender S, et al. Effects of switching statins on achievement of lipid goals: Measuring Effective Reductions in Cholesterol Using Rosuvastatin therapY (MERCURY I) study. Am Heart J. 2004;147(4):705-713.
  • ^ Jones PH, Davidson MH, Stein EA, et al; STELLAR Study Group. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial). Am J Cardiol. 2003;92(2):152-160.
  • ^ CRESTOR® (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.
  • ^ Betteridge DJ, Gibson JM; ANDROMEDA Study Investigators. Effects of rosuvastatin on lipids, lipoproteins, and apolipoproteins in the dyslipidaemia of diabetes. Diabet Med. 2007;24(5):541-549.
  • ^ Berne C, Siewert-Delle A; URANUS Study Investigators. Comparison of rosuvastatin and atorvastatin for lipid lowering in patients with type 2 diabetes mellitus: results from the URANUS study. Cardiovasc Diabetol. 2005;4:7.
  • ^ Ferdinand KC, Clark LT, Watson KE, et al; ARIES Study Group. Comparison of efficacy and safety of rosuvastatin versus atorvastatin in African-American patients in a six-week trial. Am J Cardiol. 2006;97(2):229-235.
  • ^ Lloret R, Yčas J, Stein M, Haffner S; STARSHIP Study Group. Comparison of rosuvastatin versus atorvastatin in Hispanic-Americans with hypercholesterolemia (from the STARSHIP trial). Am J Cardiol. 2006;98(6):768-773.
  • ^ Data on File, REF-148952, AstraZeneca Pharmaceuticals LP.
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  • 1a 1b CRESTOR® (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.
  • ^ Lusis AJ. Atherosclerosis. Nature. 2000;407:233-241.
  • ^ Naghavi M, Falk E, Hecht HS, et al; for the SHAPE Task Force. From vulnerable plaque to vulnerable patient—part III: executive summary of the Screening for Heart Attack Prevention and Education (SHAPE) Task Force report. Am J Cardiol. 2006;98(suppl):2H-15H.
  • ^ Falk E. Pathogenesis of atherosclerosis. J Am Coll Cardiol. 2006;47(suppl):C7-C12.
  • ^ Crouse JR 3rd, Raichlen JS, Riley WA, et al; METEOR Study Group. Effect of rosuvastatin on progression of carotid intima-media thickness in low-risk individuals with subclinical atherosclerosis: the METEOR Trial. JAMA. 2007;297(12):1344-1353.
  • ^ Data on File, REF-148945, AstraZeneca Pharmaceuticals LP.
  • 1a 1b 1c CRESTOR® (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.
  • ^ Faergeman O, Hill L, Windler E, et al; ECLIPSE Study Investigators. Efficacy and tolerability of rosuvastatin and atorvastatin when force-titrated in patients with primary hypercholesterolemia: results from the ECLIPSE study. Cardiology. 2008;111(4):219-228.
  • 3a 3b Faergeman O, Sosef F, Duffield E; on behalf of the ECLIPSE study investigators. Efficacy and tolerability of rosuvastatin and atorvastatin when force titrated in high-risk patients: results from the ECLIPSE study. Poster presented at: 14th International Symposium on Atherosclerosis; June 18-22, 2006; Rome, Italy.
  • Grundy SM, Cleeman JI, Merz CNB, et al; for the Coordinating Committee of the National Cholesterol Education Program. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation. 2004;110:227-239.
  • ^ Jones PH, Davidson MH, Stein EA, et al; for the STELLAR Study Group. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial). Am J Cardiol. 2003;92:152-160.
  • 6a 6b 6c McKenney JM, Jones PH, Adamczyk MA, Cain VA, Bryzinski BS, Blasetto JW; STELLAR Study Group. Comparison of the efficacy of rosuvastatin versus atorvastatin, simvastatin, and pravastatin in achieving lipid goals: results from the STELLAR trial. Curr Med Res Opin. 2003;19(8):689-698.
  • ^ Data on File, REF-148955, AstraZeneca Pharmaceuticals LP
  • ^ Nicholls SJ, Brandrup-Wognsen G, Palmer N, et al. Meta-analysis of comparative efficacy of increasing dose of atorvastatin versus rosuvastatin versus simvastatin on lowering levels of atherogenic lipids (from VOYAGER). Am J Cardiol. 2010;105:69-76.

1a 1b 1c 1d 1e 1f 1g 1h 1i 1j 1k 1l 1m 1n 1o 1p 1q 1r CRESTOR® (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.

1a 1b 1c 1d1d CRESTOR® (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.

  • 1a CRESTOR® (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.
  • 2a Lipitor® (atorvastatin calcium) [prescribing information]. Morgantown, WV: Viatris Specialty LLC, 2024.
  • 3a Faergeman O, Hill L, Windler E, et al; on behalf of the ECLIPSE Study Investigators. Efficacy and tolerability of rosuvastatin and atorvastatin when force-titrated in patients with primary hypercholesterolemia. Cardiology. 2008;111(4):219-228.
  • 4a Jones PH, Davidson MH, Stein EA, et al; for the STELLAR Study Group. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial). Am J Cardiol. 2003;92:152-160.
  • 5a Crouse JR 3rd, Raichlen JS, Riley WA, et al; METEOR Study Group. Effect of rosuvastatin on progression of carotid intima-media thickness in low-risk individuals with subclinical atherosclerosis: the METEOR Trial. JAMA. 2007;297(12):1344-1353.

Lipitor is a registered trademark of Upjohn Manufacturing Ireland Unlimited Company, a Viatris Company.

1a 1b 1c 1d CRESTOR® (rosuvastatin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.

This product information is intended for US Health Care Professionals only.

IMPORTANT SAFETY INFORMATION FOR CRESTOR® (ROSUVASTATIN) TABLETS

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