November 1, 2014
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Drug Factsheets

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Apo-Atorvastatin

(atorvastatin)


What side effects are possible with Apo-Atorvastatin?

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.

  • constipation
  • diarrhea
  • gas
  • headache
  • rash
  • sexual problems
  • stomach pain or upset
  • vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • confusion
  • memory loss
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
  • 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)
  • trouble sleeping

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 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)
  • 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 Apo-Atorvastatin?

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 atorvastatin. 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.

Cardiovascular: There is an increased risk of hemorrhagic stroke if atorvastatin is started within 6 months of having a stroke or transient ischemic attack (TIA). If you have a history of stroke or have had a recent stroke, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Diabetes: Atorvastatin may cause an increase in blood sugar levels and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Diet: Atorvastatin is not intended to be used alone to reduce high cholesterol levels. It is important that a cholesterol-reducing diet along with appropriate exercise be attempted before taking any medication and continued while taking medication.

Grapefruit Juice: Tell your pharmacist or doctor if you regularly drink grapefruit juice, because grapefruit juice may interact with atorvastatin.

Kidney function: If you have decreased kidney function or a history of kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Atorvastatin may reduce liver function and can cause liver failure. This medication should not be used by people with active liver disease or by people whose liver function tests are higher than normal. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Muscle effects: In rare cases, serious muscle pain, cramps, and weakness have been associated with the use of statin medications (i.e., cholesterol-lowering medications whose names end in "-statin," such as atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, or simvastatin), especially at higher doses. Before taking this medication, tell your doctor or pharmacist if you:

  • have kidney or liver problems
  • are taking niacin or a fibrate medication (such as gemfibrozil, fenofibrate)
  • have an underactive thyroid gland (hypothyroidism)
  • regularly drink more than 3 alcoholic drinks per day
  • have had any past problems with muscles (pain, tenderness) after taking a statin such as atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, or simvastatin
  • have a personal or family history of inherited muscle problems
  • are more than 65 years old
  • have undergone surgery or suffered any traumatic injury
  • are frail
  • do excessive physical exercise
  • have diabetes

Report any unexplained muscle pain, tenderness, weakness, or 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: Cholesterol is necessary for the development of an unborn baby. Taking atorvastatin during pregnancy reduces the amount of cholesterol reaching the developing baby and may cause harm to the baby. Atorvastatin should not be taken by pregnant women. If you become pregnant while taking this medication, stop taking it immediately and contact your doctor.

Breast-feeding: It is not known if atorvastatin passes into breast milk. If you are a breast-feeding mother and are taking this medication, it 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. Atorvastatin has only been studied for use by children aged 10 to 17 years who have inherited cholesterol disorders (also known as familial hypercholesterolemia).

Seniors: If you are more than 70 years old, you may experience more side effects. Your doctor will monitor you closely while you are taking this medication.

What other drugs could interact with Apo-Atorvastatin?

There may be an interaction between atorvastatin and any of the following:

  • aliskiren
  • amiodarone
  • antacids
  • antifungal medications (e.g., itraconazole, ketoconazole)
  • aprepitant
  • aripiprazole
  • birth control pills
  • boceprevir
  • bosentan
  • bosutinib
  • carbamazepine
  • carvedilol
  • cholestyramine
  • colchicines
  • colestipol
  • conivaptan
  • corticosteroids (e.g., dexamethasone, prednisone, prednisolone)
  • cyclosporine
  • cyproterone
  • dabigatran
  • dasatinib
  • deferasirox
  • desipramine
  • digoxin
  • diltiazem
  • dipyridamole
  • doxorubicin
  • efavirenz
  • fibrates (e.g., bezafibrate, gemfibrozil, fenofibrate)
  • fosphenytoin
  • grapefruit juice
  • haloperidol
  • imatinib
  • macrolide antibiotics (e.g., azithromycin, erythromycin, clarithromycin)
  • midazolam
  • mifepristone
  • nefazodone
  • niacin (nicotinic acid)
  • niacinamide
  • norfloxacin
  • pazopanib
  • phenobarbital
  • phenytoin
  • pimozide
  • prazosin
  • primidone
  • propranolol
  • protease inhibitors (e.g., nelfinavir, ritonavir, saquinavir)
  • proton pump inhibitors (PPIs; e.g., lansoprazole, omeprazole, pantoprazole)
  • quinidine
  • quinine
  • rifabutin
  • rifampin
  • rifamycin
  • ribaroxaban
  • sertraline
  • sildenafil
  • silodosin
  • St. John's wort
  • tamoxifen
  • telithromycin
  • tetracycline
  • tocilizumab
  • topotecan
  • trabectidine
  • trazodone
  • verapamil
  • vinblastine
  • vincristine

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 that 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.

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