CRESTOR - Side Effects Rosuvastatin calcium

Side Effects for CRESTOR (rosuvastatin calcium tablet, film coated) are also known as adverse reactions. Below is a summary of known side effects for CRESTOR. If you experience side effects when taking CRESTOR, be sure to tell your doctor.

Adverse Reactions

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

Most frequent adverse reactions (rate >2%) are headache, myalgia, abdominal pain, asthenia, and nausea. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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.

In the CRESTOR 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 controlled clinical trial database of 5394 patients were:

  • headache
  • myalgia
  • abdominal pain
  • asthenia
  • nausea

Adverse reactions reported in ≥2% of patients in placebo-controlled 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
Adverse reactions by COSTART preferred term.

Reported in ≥2% of Patients Treated with CRESTOR and > Placebo in Placebo-Controlled Trials (% of Patients)

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 mg40 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

Myalgia

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

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 (5.4)]; 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 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 (14.8)].

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

Table 2. Adverse Reactions
Adverse reactions by MedDRA preferred term.

Reported in ≥2% of Patients Treated with CRESTOR and > Placebo in the METEOR Trial (% of Patients)

Adverse Reactions CRESTOR 40 mg
N=700
Placebo
N=281

Myalgia

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

Frequency recorded as abnormal laboratory value.

2.2

0.7

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 HbA1c was significantly increased by 0.1% in rosuvastatin-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 rosuvastatin-treated versus placebo-treated patients [see Warnings and Precautions (5.5) and Clinical Studies (14.9)].

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

Table 3. Adverse Reactions
Treatment-emergent adverse reactions by MedDRA preferred term.

Reported in ≥2% of Patients Treated with CRESTOR and > Placebo in the JUPITER Trial (% of Patients)

Adverse Reactions

CRESTOR 20 mg

N=8901

Placebo

N=8901

Myalgia

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

Pediatric Patients with Heterozygous Familial Hypercholesterolemia

In a 12-week controlled study in boys and postmenarcheal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia with CRESTOR 5 to 20 mg daily [see Use in Specific Populations (8.4) and Clinical Studies (14.7)], 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: arthralgia, fatal and non-fatal hepatic failure, hepatitis, jaundice, thrombocytopenia, depression, sleep disorders (including insomnia and nightmares), peripheral neuropathy, interstitial lung disease and gynecomastia. 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.

There have been rare reports of immune-mediated necrotizing myopathy associated with statin use [see Warnings and Precautions (5.1)].

There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, and confusion) associated with statin use. These cognitive issues have been reported for 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).

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Search Drugs and Medication

Or Browse by Name