Pravachol

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 Pravachol (Pravastatin). If you are concerned about side effects, discuss the risks and benefits of Pravachol (Pravastatin) with your doctor.

The following side effects have been reported by at least 1% of people taking Pravachol (Pravastatin). 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.

• abdominal pain
• Constipation
• cough
• Diarrhea
• dizziness
• headache
• heartburn
• nausea
• nightmares
• rash
• sexual problems
• trouble sleeping

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:

• anxiety or nervousness
• chest pain
• confusion
• cough or shortness of breath
• memory loss or forgetfulness
• 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 problems (e.g., 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)
• vision problems (i.e., blurred vision)

Stop taking the medication and seek medical attention immediately if any of the following occur:

• severe skin rash, including skin blistering and peeling (possibly with headache, fever, sore throat or mouth, coughing, or aching)
• 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 Pravachol (Pravastatin).

20 mg
Each yellow, rounded, rectangular-shaped, biconvex tablet, with a "P" embossed on one side and "PRAVACHOL 20" engraved on the other, contains 20 mg of Pravachol (Pravastatin) sodium. Nonmedicinal ingredients: croscarmellose sodium, D&C Yellow No. 10 (40 mg tablets), FD&C Blue No. 1 (40 mg tablets), lactose, magnesium oxide, magnesium stearate, microcrystalline cellulose, povidone, and yellow ferric oxide (20 mg tablets).

40 mg
Each green, rounded, rectangular-shaped, biconvex tablet, with a "P" embossed on one side and "PRAVACHOL 40" engraved on the other, contains 40 mg of Pravachol (Pravastatin) sodium. Nonmedicinal ingredients: croscarmellose sodium, D&C Yellow No. 10, FD&C Blue No. 1, lactose, magnesium oxide, magnesium stearate, microcrystalline cellulose, and povidone.

Do not take Pravachol (Pravastatin) if you:

• are allergic to Pravachol (Pravastatin) or any ingredients of Pravachol (Pravastatin)
• are breast-feeding
• are pregnant or plan to become pregnant
• have active liver disease or unexplained increases in liver function tests

There may be an interaction between Pravachol (Pravastatin) and any of the following:

• "azole" antifungal medications (e.g., ketoconazole, itraconazole)
• Carbamazepine
• certain HIV protease inhibitors (e.g., darunavir, letermovir, nelfinavir, saquinavir)
• Cholestyramine
• Colchicine
• Colesevelam
• Colestipol
• Cyclosporine
• daptomycin
• efavirenz
• Eltrombopag
• fibrates (e.g., Bezafibrate, gemfibrozil, fenofibrate)
• Hepatitis C antiviral medications (e.g., asunaprevir, daclatasvir, glecavir, ledipasvir, pibrentasvir, sofosbuvir, voxilaprevir)
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• niacin (nicotinic acid)
• niacinamide
• Paroxetine
• Phenytoin
• raltegravir
• Repaglinide
• rifabutin
• rifampin
• rupatadine
• Teriflunomide
• Tolvaptan
• Warfarin

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 Pravachol (Pravastatin). 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.

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 Pravachol (Pravastatin).

Alcohol: People who drink large quantities of alcohol should be closely monitored by their doctor while they are taking Pravachol (Pravastatin). Alcohol can increase the risk of developing liver problems with Pravachol (Pravastatin). Tell your doctor if you drink more than 3 alcoholic drinks per day.

Diabetes: Pravachol (Pravastatin) 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 Pravachol (Pravastatin).

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

Diet: Pravachol (Pravastatin) is not intended for use 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 Pravachol (Pravastatin).

Kidney problems: If you have decreased kidney function or a history of Kidney Disease, discuss with your doctor how Pravachol (Pravastatin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Pravachol (Pravastatin), and whether any special monitoring is needed.

Liver function: Pravachol (Pravastatin) may reduce liver function and can cause liver failure. Laboratory signs of harmful effects to the liver occur in about 0.5% of adults who take Pravachol (Pravastatin) for extended periods. When the medication is stopped, the laboratory tests usually slowly return to normal.

Your doctor may want to test your liver function regularly with blood tests while you are taking Pravachol (Pravastatin). Pravachol (Pravastatin) should not be used by people with active liver disease or by people whose liver function tests are higher than normal. If you have a history of liver disease, discuss with your doctor how Pravachol (Pravastatin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Pravachol (Pravastatin), and whether any special monitoring is needed.

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.

Lung inflammation: Lung inflammation (interstitial lung disease), causing difficulty breathing has occurred rarely in some people taking Pravachol (Pravastatin). This complication can be serious and sometimes fatal. If you experience new or worsening shortness of breath or cough (with or without fever) at any time while you are taking Pravachol (Pravastatin), contact your doctor immediately.

Muscle effects: In rare cases, serious muscle damage has been associated with the use of statin medications (i.e., cholesterol-lowering medications whose names end in "-statin," such as Atorvastatin, Fluvastatin, Lovastatin, Pravachol (Pravastatin), Rosuvastatin, or Simvastatin), especially at higher doses. Before taking Pravachol (Pravastatin), tell your doctor or pharmacist if you:

• are over the age of 65
• are taking other medications, including prescription, non-prescription and natural health products, as drug interactions are possible
• are taking other cholesterol-lowering medication such as fibrates (Gemfibrozil, Fenofibrate) or Niacin
• are physically frail
• do excessive physical exercise
• have diabetes
• have a family history of muscular disorders
• have kidney or liver problems
• have uncontrolled Thyroid problems
• have undergone surgery or other tissue injury
• have had any past problems with the muscles (pain, tenderness), after using a statin
• regularly drink three 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: Pravachol (Pravastatin) should not be taken during pregnancy, as it may cause harm to the developing baby. If you become pregnant while taking Pravachol (Pravastatin), stop taking it immediately and contact your doctor.

Pravachol (Pravastatin) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Pravachol (Pravastatin), stop taking it immediately and contact your doctor.

Breast-feeding: Pravachol (Pravastatin) passes into breast milk. If you are a breast-feeding mother and are taking Pravachol (Pravastatin), 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 Pravachol (Pravastatin) by children. The safety and effectiveness of using Pravachol (Pravastatin) have not been established for children under 16 years old.

Seniors: If you are over 65 years old, your doctor will likely monitor you closely for muscle-related side effects.