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The safety profile for CRESTOR^® (rosuvastatin calcium) is in line with other leading statins, as demonstrated by preapproval clinical trials in 10,275 patients and postmarketing experience.^{1,2,3,4,5,6,7}

Supported by 4 completed studies of real-world use by more than 240,000 patients*^4,5,6,7

• There was no evidence of a difference between patients on CRESTOR and patients on other statins in the incidence of hospitalizations associated with rhabdomyolysis, myopathy, acute renal failure, or hepatic dysfunction in actual clinical practice^4,5,6,7
• Part of a completed 9-study pharmacoepidemiologic program⁸

*CRESTOR (n=42,069), other statins (n=206,634).^4,5,6,7

Long-term treatment and renal function from pooled data

• Glomerular filtration rate increases were seen after median of 8 weeks of treatment with CRESTOR 5 mg to 40 mg — and following long-term treatment^2,9
• Mean serum creatinine levels decreased with all doses of CRESTOR over long-term treatment²
• CRESTOR was not associated with worsening of renal function — even among patients with preexisting kidney disease²

Get more detailed information about the safety profile for CRESTOR by reviewing our clinical experience.

Side effects

The most commonly reported adverse reactions (incidence ≥2%) in the CRESTOR controlled clinical trial database of 5,394 patients were^1,10

• Headache: 3.7%
• Myalgia: 3.1%
• Abdominal pain: 2.6%
• Asthenia: 2.5%
• Nausea: 2.2%

Adverse reactions reported in ≥2% of patients in placebo-controlled clinical studies and at a rate greater than or equal to placebo are shown below. These studies had a treatment duration of up to 12 weeks.¹

Adverse reactions reported in ≥2% of patients and at a rate greater than or equal to placebo in the METEOR trial are shown below.¹

Consider our dosing and titration recommendations for at-risk patients.

• CRESTOR is indicated^# as an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, non-HDL-C, and triglycerides, and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia and to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower total-C and LDL-C to target levels

Important Safety Information for CRESTOR tablets

• CRESTOR is contraindicated^# in patients with a known hypersensitivity to any component of this product, in patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels, in women who are pregnant or may become pregnant, and in nursing mothers
• Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, 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 with concurrent administration of some other lipid-lowering therapies (fibrates or niacin), gemfibrozil, cyclosporine, lopinavir/ritonavir, or atazanavir/ritonavir
• 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
• It is recommended that liver enzyme tests be performed before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (eg, semiannually) thereafter. Should an increase in ALT or AST of >3 times ULN persist, reduction of dose or withdrawal of CRESTOR is recommended
• 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. 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 HMG-CoA reductase inhibitors, including CRESTOR
• 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%)^‡‡
• The dose range for CRESTOR is 5 mg to 40 mg orally once daily. The usual starting dose is 10 mg to 20 mg. Patients initiating CRESTOR therapy or switching from another statin should begin treatment with CRESTOR at the appropriate starting dose. After initiation or upon titration of CRESTOR, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly. CRESTOR 40 mg should be used only for those patients not achieving their LDL-C goal with 20 mg