In this drug factsheet:
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- stomach pain
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- symptoms of liver damage (such as yellow skin or eyes, abdominal pain, dark urine, clay-coloured stools, loss of appetite, nausea and vomiting, or itching)
- symptoms of muscle damage (unexplained muscle pain, tenderness or weakness, or brown or discoloured urine - especially if you also have a fever or a general feeling of being unwell)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- severe skin rash, including skin blistering and peeling (possibly with headache, fever, coughing, or aching before the rash begins)
- symptoms of a serious allergic reaction (such as swelling of the face or throat, hives, or difficulty breathing)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
January 24, 2013
Health Canada has issued new restrictions concerning the use of rosuvastatin. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Alcohol: People who drink large quantities of alcohol should be closely monitored by their doctor while they are taking this medication.
Kidney problems: People with decreased kidney function should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver function: Your doctor will perform regular tests to check your liver function. This medication should not be used by people with active liver disease or by people whose liver function tests are higher than normal. People with a history of liver disease should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Muscle damage: In rare cases, serious muscle damage been associated with the use of statin medications, especially at higher doses. Before taking this medication, tell your doctor or pharmacist if you:
- are of Asian ancestry (Chinese, Filipino, Japanese, Korean, Vietnamese, or Asian-Indian origin)
- are over the age of 70
- are taking other cholesterol-lowering medication such as fibrates (e.g., gemfibrozil, fenofibrate) or niacin
- are taking other medications (as drug interactions are possible), including prescription, non-prescription, and natural health products
- do excessive physical exercise
- have diabetes
- have a family history of muscular disorders
- have had any past problems with muscles (pain, tenderness) after taking a statin
- have kidney or liver problems
- have thyroid problems
- have undergone surgery or other tissue injury
- regularly drink 3 or more alcoholic drinks daily
Report any unexplained muscle pain, tenderness, weakness, cramps, or any brown or discoloured urine to your doctor immediately, particularly if you are also experiencing malaise (a general feeling of being unwell) or fever.
Pregnancy: This medication should not be taken during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if rosuvastatin passes into breast milk. If you are a breast-feeding mother and are taking this medication, if may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: There is limited experience with the use of this medication by children. Its safety and effectiveness have not been established for this age group. If rosuvastatin is to be used by a child, the treatment should be supervised by a specialist.
Seniors: If you are older than 70 years of age, your doctor will likely monitor you closely for muscle-related side effects.
What other drugs could interact with this medication?
There may be an interaction between rosuvastatin and any of the following:
- antacids (if taken within 2 hours of taking rosuvastatin)
- anticoagulants (e.g., warfarin)
- antifungal agents (e.g.,, itraconazole, ketoconazole)
- birth control pills
- lopinavir - ritonavir
- macrolide antibiotics (e.g., erythromycin, clarithromycin)
- niacin (nicotinic acid)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.