Recommended Topic Related To:

Crestor

"Nov. 5, 2012 (Los Angeles) -- An IV infusion of "good" HDL cholesterol seems to rapidly remove cholesterol out of plaque-clogged arteries following a heart attack, a small, early study suggests.

The goal of the new treatment is to red"...

Crestor

Crestor Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Crestor (rosuvastatin calcium) is a synthetic drug that belongs to a class of medications termed statins. Crestor slows the production of cholesterol by the body. Crestor is now available as a generic termed rosuvastatin or rosuvastatin calcium. Crestor is 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). Infrequent side effects that may occur (about 2% of patients) are headache, muscle aches, diarrhea, and abdominal discomfort.

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 should not be taken during pregnancy or during breastfeeding because of potential birth defects. Infrequent but serious side effects include rhabdomyolysis (muscle damage or destruction) that can lead to acute renal failure and liver damage. Patients on Crestor should have liver function tests done routinely to determine if any damage is occurring. Patients with liver damage should not take Crestor. Patients that drink large amounts of alcohol and patients with renal problems may be advised not to take Crestor. In some patients, the muscle pain, abdominal pain and diarrhea may become severe. If these symptoms or allergic symptoms (hives, short of breath, tissue swelling) develop, the person should seek medical attention quickly.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Crestor in Detail - Patient Information: Side Effects

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;
  • fever, unusual tiredness, and dark colored urine;
  • swelling, weight gain, urinating less than usual or not at all; 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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Crestor Overview - Patient Information: Side Effects

SIDE EFFECTS: Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very small number of people taking rosuvastatin may have mild memory problems or confusion. If these rare effects occur, talk to your doctor.

Tell your doctor right away if this unlikely but serious side effect occurs: foamy urine.

This drug may infrequently cause muscle problems (which can rarely lead to very serious conditions called rhabdomyolysis and autoimmune myopathy). Tell your doctor right away if you develop any of these symptoms during treatment and if these symptoms persist after your doctor stops this drug: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), change in the amount of urine.

This medication may rarely cause liver problems. If you notice any of the following rare but serious side effects, tell your doctor right away: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Crestor (Rosuvastatin Calcium)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Crestor FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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

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:

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 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 - 40 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 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 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 10 to 17 years of age

In a 12-week controlled study in boys and postmenarchal girls, the safety and tolerability profile of CRESTOR 5 to 20 mg daily was generally similar to that of placebo [see Clinical Studies and Use in Specific 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: arthralgia, fatal and non-fatal hepatic failure, hepatitis, jaundice, thrombocytopenia, depression, sleep disorders (including insomnia and nightmares) 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) »

A A A

Crestor - User Reviews

Crestor User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Crestor sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

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.


Cholesterol Management

Tips to keep it under control.