Tpharm.info


Side Effects of Crestor (Rosuvastatin Calcium) Drug Center - RxList

Openmedi.orgCrestor side effects


8/8/2014
02:28 | Author: David Perry

Crestor side effects
Side Effects of Crestor (Rosuvastatin Calcium) Drug Center - RxList

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

What is Patient Information in Detail?

What is Prescribing information?

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

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.

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

Less serious side effects may include:

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.

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

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

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.

Read the Crestor User Reviews » Share this Article:

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

Medical Editor: Charles Patrick Davis, MD, PhD.

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).

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.

There have been rare reports of immune-mediated necrotizing myopathy associated with statin use.

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.

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.

Lipitor's generic name is atorvastatin. Two generic drugmakers, Ra".

FAQ: Generic Lipitor »

A very small number of people taking rosuvastatin may have mild memory problems or confusion. If these rare effects occur, talk to your doctor. l 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). l 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, l 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. Read the entire patient information overview for Crestor (Rosuvastatin Calcium) »

Read the FAQ: Generic Lipitor article »

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.

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.

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.

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

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

What is Patient Information Overview?

"Nov. 29, 2011 -- The cholesterol-lowering drug Lipitor -- the best-selling prescription drug in world history -- will be available as a generic drug beginning Nov. 30.

Tips to keep it under control.

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.

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

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.

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

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 ]

Report Problems to the Food and Drug Administration.

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.

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

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:

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 ]

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

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.

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 side effects