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The following serious adverse reactions are discussed in greater detail in other sections of the label:

• Rhabdomyolysis with myoglobinuria and acute renal failure and myopathy (including myositis) [see WARNINGS AND PRECAUTIONS]
• Liver enzyme abnormalities [see WARNINGS AND PRECAUTIONS]

In the CRESTOR (rosuvastatin calcium) controlled clinical trials database (placebo or active-controlled) of 5394 patients with a mean treatment duration of 15 weeks, 1.4% of patients discontinued due to adverse reactions. The most common adverse reactions that led to treatment discontinuation were:

• myalgia
• abdominal pain
• nausea

The most commonly reported adverse reactions (incidence ≥ 2%) in the CRESTOR (rosuvastatin calcium) controlled clinical trial database of 5394 patients were:

• headache
• myalgia
• abdominal pain
• asthenia
• nausea

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.

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

Table 1: Adverse Reactions* Reported by ≥ 2% of Patients Treated with CRESTOR (rosuvastatin calcium) and > Placebo in Placebo-Controlled Trials (% of Patients)

Other adverse reactions reported in clinical studies were abdominal pain, dizziness, hypersensitivity (including rash, pruritus, urticaria, and angioedema) and pancreatitis. The following laboratory abnormalities have also been reported: dipstick-positive proteinuria and microscopic hematuria [see WARNINGS AND PRECAUTIONS]; elevated creatine phosphokinase, transaminases, glucose, glutamyl transpeptidase, alkaline phosphatase, and bilirubin; and thyroid function abnormalities.

In the METEOR study, involving 981 participants treated with rosuvastatin 40 mg (n=700) or placebo (n=281) with a mean treatment duration of 1.7 years, 5.6% of subjects treated with CRESTOR (rosuvastatin calcium) versus 2.8% of placebo-treated subjects discontinued due to adverse reactions. The most common adverse reactions that led to treatment discontinuation were: myalgia, hepatic enzyme increased, headache, and nausea [see Clinical Studies].

Adverse reactions reported in ≥ 2% of patients and at a rate greater than placebo are shown in Table 2.

Table 2: Adverse Reactions* Reported by ≥ 2% of Patients Treated with CRESTOR (rosuvastatin calcium) and > Placebo in the METEOR Trial (% of Patients)

In the JUPITER study, 17,802 participants were treated with rosuvastatin 20 mg (n=8901) or placebo (n=8901) for a mean duration of 2 years. A higher percentage of rosuvastatin-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 rosuvastatin (2.8%) versus patients taking placebo (2.3%). Mean HbAlc was significantly increased by 0.1% in rosuvastatin-treated patients compared to placebo-treated patients. The number of patients with a HbAlc > 6.5% at the end of the trial was significantly higher in rosuvastatin-treated versus placebotreated patients [see WARNINGS AND PRECAUTIONS and Clinical Studies].

Adverse reactions reported in ≥ 2% of patients and at a rate greater than placebo are shown in Table 3.

Table 3: Adverse Reactions* Reported by ≥ 2% of Patients Treated with CRESTOR (rosuvastatin calcium) and > Placebo in the JUPITER Trial (% of Patients)

Pediatric patients 10 to 17 years of age

In a 12-week controlled study in boys and postmenarchal girls, the safety and tolerability profile of CRESTOR (rosuvastatin calcium) 5 to 20 mg daily was generally similar to that of placebo [see Clinical Studies and Use in Special Populations, Pediatric Use].

However, elevations in serum creatine phosphokinase (CK) > 10 x ULN were observed more frequently in rosuvastatin compared with placebo-treated children. Four of 130 (3%) children treated with rosuvastatin (2 treated with 10 mg and 2 treated with 20 mg) had increased CK > 10 x ULN, compared to 0 of 46 children on placebo.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of CRESTOR (rosuvastatin calcium) : arthralgia, hepatic failure, hepatitis, jaundice, memory loss, depression, and sleep disorders (including insomnia and nightmares). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cyclosporine

Cyclpsporine significantly increased rosuvastatin exposure. Therefore, in patients taking cyclosporine, therapy should be limited to CRESTOR 5 mg once daily [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, and CLINICAL PHARMACOLOGY].

Gemfibrozil

Gemfibrozil significantly increased rosuvastatin exposure. Therefore, combination therapy with CRESTOR (rosuvastatin calcium) and gemfibrozil should be avoided. If used, do not exceed CRESTOR 10 mg once daily [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY].

Protease Inhibitors

Coadministration of rosuvastatin with certain protease inhibitors given in combination with ritonavir has differing effects on rosuvastatin exposure. The protease inhibitor combinations lopinavir/ritonavir and atazanavir/ritonavir increase rosuvastatin exposure (AUC) up to threefold [see Table 3 - CLINICAL PHARMACOLOGY]. For these combinations the dose of CRESTOR (rosuvastatin calcium) should be limited to 10 mg. The combinations of tipranavir/ritonavir or fosamprenavir/ritonavir produce little or no change in rosuvastatin exposure. Caution should be exercised when rosuvastatin is coadministered with protease inhibitors given in combination with ritonavir [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Coumarin Anticoagulants

CRESTOR (rosuvastatin calcium) significantly increased INR in patients receiving coumarin anticoagulants. Therefore, caution should be exercised when coumarin anticoagulants are given in conjunction with CRESTOR (rosuvastatin calcium) . In patients taking coumarin anticoagulants and CRESTOR (rosuvastatin calcium) concomitantly, INR should be determined before starting CRESTOR (rosuvastatin calcium) and frequently enough during early therapy to ensure that no significant alteration of INR occurs [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Niacin

The risk of skeletal muscle effects may be enhanced when CRESTOR (rosuvastatin calcium) is used in combination with niacin; a reduction in CRESTOR (rosuvastatin calcium) dosage should be considered in this setting [see WARNINGS AND PRECAUTIONS].

Fenofibrate

When CRESTOR (rosuvastatin calcium) was coadministered with fenofibrate, no clinically significant increase in the AUC of rosuvastatin or fenofibrate was observed. The benefit of further alterations in lipid levels by the combined use of CRESTOR (rosuvastatin calcium) with fibrates should be carefully weighed against the potential risks of this combination [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Last reviewed on RxList: 1/6/2011
This monograph has been modified to include the generic and brand name in many instances.