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Crestor

Last reviewed on RxList: 9/1/2016
Crestor Side Effects Center

Last reviewed on RxList 8/30/2016

Crestor (rosuvastatin calcium) is a statin drug, that works by slowing the production of cholesterol by the body, used to lower cholesterol and fats (triglycerides) in the blood and is used to reduce the chances of developing problems like heart disease and strokes that can be caused, in part, by high cholesterol levels. It is often recommended to use Crestor in conjunction with a diet low in fats and cholesterol, and exercise (about 30 min. per day). Crestor is available in generic form. Side effects of Crestor include

Infrequent but serious side effects of Crestor include rhabdomyolysis (muscle damage or destruction) that can lead to acute renal failure and liver damage.

Crestor is available in tablets of 5, 10, 20 and 40 mg strengths. Usual dose ranges from 5 to 20 mg per day. Crestor should be taken with water once a day at the same time of day, with or without food. Dosage may be adjusted depending on what medicines the patient is already taking. Crestor may interact with birth control pills, cimetidine, blood thinners, spironolactone, niacin, or other "statin" medications. Tell your doctor all medications and supplements you use. Crestor should not be taken during pregnancy or during breastfeeding because of potential birth defects.

Our Crestor Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Crestor Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking rosuvastatin and call your doctor at once if you have any of these serious side effects:

  • unexplained muscle pain, tenderness, or weakness;
  • confusion, memory problems;
  • fever, unusual tiredness, and dark colored urine;
  • swelling, weight gain, urinating less than usual or not at all;
  • increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • headache, depressed mood;
  • mild muscle pain;
  • joint pain;
  • sleep problems (insomnia), nightmares;
  • constipation;
  • mild nausea; or
  • stomach pain or indigestion.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Crestor (Rosuvastatin Calcium)

Crestor Professional Information

SIDE EFFECTS

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

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:

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 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 mg D40 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
*Adverse reactions by COSTART preferred term.

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 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 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† 2.2 0.7
*Adverse reactions by MedDRA preferred term.
†Frequency recorded as abnormal laboratory value

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 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 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
* Treatment-emergent adverse reactions by MedDRA preferred term.

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 and Clinical Studies], 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 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].

There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, 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).

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

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