Crestor Side Effects Center

SIDE EFFECTS

The following important adverse reactions are described below and elsewhere in the labeling:

• Myopathy and Rhabdomyolysis [see WARNINGS AND PRECAUTIONS]
• Immune-Mediated Necrotizing Myopathy [see WARNINGS AND PRECAUTIONS]
• Hepatic Dysfunction [see WARNINGS AND PRECAUTIONS]
• Proteinuria and Hematuria [see WARNINGS AND PRECAUTIONS]
• Increases in HbA1c and Fasting Serum Glucose Levels [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

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

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

Table 2: Adverse Reactions Reported in ≥2% of Patients Treated with CRESTOR and > Placebo in Placebo-Controlled Trials

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

In the METEOR study, patients were treated with CRESTOR 40 mg (n=700) or placebo (n=281) with a mean treatment duration of 1.7 years. Adverse reactions reported in ≥2% of patients and at a rate greater than placebo are shown in Table 3.

Table 3: Adverse Reactions Reported in ≥2% of Patients Treated with CRESTOR and > Placebo in the METEOR Trial

In the JUPITER study, patients were treated with CRESTOR 20 mg (n=8901) or placebo (n=8901) for a mean duration of 2 years. 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 a HbA1c >6.5% at the end of the trial was significantly higher in CRESTOR-treated versus placebo-treated 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 4.

Table 4: Adverse Reactions Reported in ≥2% of Patients Treated with CRESTOR and > Placebo in the JUPITER Trial

Pediatric Patients With HeFH

In a 12-week controlled study in pediatric patients 10 to 17 years of age with HeFH with CRESTOR 5 to 20 mg daily [see Use In Specific Populations and Clinical Studies], elevations in serum CK greater than 10 x ULN were observed more frequently in CRESTOR-treated patients compared with patients receiving placebo. Four of 130 (3%) patients treated with CRESTOR (2 treated with 10 mg and 2 treated with 20 mg) had increased CK greater than 10 x ULN, compared to 0 of 46 patients on placebo.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of CRESTOR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood Disorders: thrombocytopenia

Hepatobiliary Disorders: hepatitis, jaundice, fatal and non-fatal hepatic failure

Musculoskeletal Disorders: arthralgia, rare reports of immune-mediated necrotizing myopathy associated with statin use

Nervous System Disorders: peripheral neuropathy, rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, and confusion) associated with the use of all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).

Psychiatric Disorders: depression, sleep disorders (including insomnia and nightmares)

Reproductive System and Breast Disorders: gynecomastia

Respiratory Disorders: interstitial lung disease

Skin and Subcutaneous Tissue Disorders: drug reaction with eosinophilia and systemic symptoms (DRESS), lichenoid drug eruption

DRUG INTERACTIONS

Drug Interactions That Increase The Risk Of Myopathy And Rhabdomyolysis With CRESTOR

Rosuvastatin is a substrate of CYP2C9 and transporters (such as OATP1B1, BCRP). Rosuvastatin plasma levels can be significantly increased with concomitant administration of inhibitors of CYP2C9 and transporters. Table 5 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when used concomitantly with CRESTOR and instructions for preventing or managing them [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Table 5: Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with CRESTOR

Drug Interactions That Decrease The Efficacy Of CRESTOR

Table 6 presents drug interactions that may decrease the efficacy of CRESTOR and instructions for preventing or managing them.

Table 6: Drug Interactions that Decrease the Efficacy of CRESTOR

CRESTOR Effects On Other Drugs

Table 7 presents CRESTOR's effect on other drugs and instructions for preventing or managing them.

Table 7: CRESTOR Effects on Other Drugs

Read the entire FDA prescribing information for Crestor (Rosuvastatin Calcium)