Gemfibrozil helps reduce cholesterol and triglycerides (fatty acids) in the blood. High levels of these types of fat in the blood are associated with an increased risk of atherosclerosis (clogged arteries).

Gemfibrozil is used together with diet to treat very high cholesterol and triglyceride levels in people with pancreatitis.

Gemfibrozil is also used to lower the risk of stroke, heart attack, or other heart complications in certain people with high cholesterol and triglycerides who have not been helped by other treatment methods.

You should not take gemfibrozil if you have severe liver or kidney disease, gallbladder disease, or if you are also taking repaglinide, dasabuvir, or simvastatin.

Take gemfibrozil exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Gemfibrozil is usually taken 30 minutes before breakfast and dinner. Follow your doctor's dosing instructions very carefully.

Gemfibrozil is only part of a complete treatment program that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

You may need frequent medical tests. Even if you have no symptoms, tests can help your doctor determine if this medicine is effective.

Store at room temperature away from moisture, heat, and light.

Usual Adult Dose of Gemfibrozil for Hyperlipidemia:

600 mg orally twice a day, 30 minutes before the morning and evening meals

Uses: As an adjunct to diet in the following situations: to treat hypertriglyceridemia in Types IV and V hyperlipidemia in patients who present at risk for pancreatitis and who do not respond adequately to diet; to reduce the risk for coronary heart disease (CHD) only in Type IIb patients without a history of or symptoms of existing CHD who have not responded adequately to other pharmacologic agents and nonpharmacologic interventions and who have low high density lipoprotein (HDL), elevated low density lipoprotein (LDL), and elevated triglycerides

Usual Adult Dose of Gemfibrozil for Hyperlipoproteinemia Type IIb (Elevated LDL + VLDL):

600 mg orally twice a day, 30 minutes before the morning and evening meals

Uses: As an adjunct to diet in the following situations: to treat hypertriglyceridemia in Types IV and V hyperlipidemia in patients who present at risk for pancreatitis and who do not respond adequately to diet; to reduce the risk for coronary heart disease (CHD) only in Type IIb patients without a history of or symptoms of existing CHD who have not responded adequately to other pharmacologic agents and nonpharmacologic interventions and who have low high density lipoprotein (HDL), elevated low density lipoprotein (LDL), and elevated triglycerides

Usual Adult Dose of Gemfibrozil for Hyperlipoproteinemia Type IV (Elevated VLDL):

600 mg orally twice a day, 30 minutes before the morning and evening meals

Uses: As an adjunct to diet in the following situations: to treat hypertriglyceridemia in Types IV and V hyperlipidemia in patients who present at risk for pancreatitis and who do not respond adequately to diet; to reduce the risk for coronary heart disease (CHD) only in Type IIb patients without a history of or symptoms of existing CHD who have not responded adequately to other pharmacologic agents and nonpharmacologic interventions and who have low high density lipoprotein (HDL), elevated low density lipoprotein (LDL), and elevated triglycerides

Usual Adult Dose for Hyperlipoproteinemia Type V (Elevated Chylomicrons + VLDL):

600 mg orally twice a day, 30 minutes before the morning and evening meals

Uses: As an adjunct to diet in the following situations: to treat hypertriglyceridemia in Types IV and V hyperlipidemia in patients who present at risk for pancreatitis and who do not respond adequately to diet; to reduce the risk for coronary heart disease (CHD) only in Type IIb patients without a history of or symptoms of existing CHD who have not responded adequately to other pharmacologic agents and nonpharmacologic interventions and who have low high density lipoprotein (HDL), elevated low density lipoprotein (LDL), and elevated triglycerides

Usual Adult Dose for Hypertriglyceridemia:

600 mg orally twice a day, 30 minutes before the morning and evening meals

Uses: As an adjunct to diet in the following situations: to treat hypertriglyceridemia in Types IV and V hyperlipidemia in patients who present at risk for pancreatitis and who do not respond adequately to diet; to reduce the risk for coronary heart disease (CHD) only in Type IIb patients without a history of or symptoms of existing CHD who have not responded adequately to other pharmacologic agents and nonpharmacologic interventions and who have low high density lipoprotein (HDL), elevated low density lipoprotein (LDL), and elevated triglycerides

Usual Adult Dose for Prevention of Cardiovascular Disease:

600 mg orally twice a day, 30 minutes before the morning and evening meals

Uses: As an adjunct to diet in the following situations: to treat hypertriglyceridemia in Types IV and V hyperlipidemia in patients who present at risk for pancreatitis and who do not respond adequately to diet; to reduce the risk for coronary heart disease (CHD) only in Type IIb patients without a history of or symptoms of existing CHD who have not responded adequately to other pharmacologic agents and nonpharmacologic interventions and who have low high density lipoprotein (HDL), elevated low density lipoprotein (LDL), and elevated triglycerides

You should not use gemfibrozil if you are allergic to it, if you have:

• severe liver disease;

• severe kidney disease;

• gallbladder disease; or

• if you are also taking repaglinide, dasabuvir, or simvastatin.

To make sure gemfibrozil is safe for you, tell your doctor if you have ever had::

• gallstones; or

• if you also take warfarin (Coumadin, Jantoven).

It is not known whether gemfibrozil will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Eat a low-fat, low-cholesterol diet. Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. You can also visit the National Cholesterol Education Program (NCEP) website for additional dietary information at http://www.nhlbi.nih.gov/health/public/heart/chol/chol_tlc.pdf.

Avoid eating foods high in fat or cholesterol, or gemfibrozil will not be as effective.

Avoid drinking alcohol. It may interfere with your treatment.

Get emergency medical help if you have signs of an allergic reaction to gemfibrozil: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, gemfibrozil can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Also call your doctor at once if you have:

• sharp pain in your upper stomach (especially after eating);

• jaundice (yellowing of your skin or eyes);

• pain or burning when you urinate;

• blurred vision, eye pain, or seeing halos around lights; or

• low blood cell counts - pale skin, easy bruising, unusual bleeding, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common gemfibrozil side effects may include:

• stomach pain, indigestion, diarrhea;

• numbness or tingly feeling;

• dizziness, drowsiness;

• blurred vision;

• muscle or joint pain; or

• loss of interest in sex, impotence.

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.

Using certain medicines together with gemfibrozil can increase your risk of serious muscle problems. It is very important to tell your doctor about all medicines you use, and those you start or stop using, especially:

• colchicine; or

• a "statin" cholesterol-lowering medicine - atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin, Crestor, Lipitor, Zocor, Vytorin, and others.

This list is not complete and many other drugs may interact with gemfibrozil. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to gemfibrozil.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.