Etodolac is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.

Etodolac is used to treat mild to moderate pain, osteoarthritis, or rheumatoid arthritis.

Etodolac may also be used for purposes not listed in this medication guide.

Etodolac can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Etodolac may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using etodolac, especially in older adults.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to etodolac (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen. Do not drink alcohol while taking this medicine. Alcohol can increase the risk of stomach bleeding caused by etodolac. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). This medicine can make your skin more sensitive to sunlight and sunburn may result.

Take etodolac exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides. Use the lowest dose that is effective in treating your condition.

Swallow the extended-release tablet whole and do not crush, chew, or break it.

It may take up to 2 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

If you use etodolac long-term, you may need frequent medical tests.

Etodolac can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Usual Adult Dose for Osteoarthritis:

Immediate Release:
-Initial dose: 300 mg orally 2 to 3 times a day or 400 mg to 500 mg orally twice a day
-Maintenance dose: A lower dose of 600 mg/day may suffice for long-term use
-Maximum dose: 1000 mg/day

Extended Release: 400 mg to 1000 mg orally once a day

Comments:
-Therapeutic response can be seen within 1 week of therapy, however, is most often observed by 2 weeks; doses should be adjusted accordingly after satisfactory response is achieved.

Uses: For acute and long-term use in the management of signs and symptoms of osteoarthritis and rheumatoid arthritis

Usual Adult Dose for Rheumatoid Arthritis:

Immediate Release:
-Initial dose: 300 mg orally 2 to 3 times a day or 400 mg to 500 mg orally twice a day
-Maintenance dose: A lower dose of 600 mg/day may suffice for long-term use
-Maximum dose: 1000 mg/day

Extended Release: 400 mg to 1000 mg orally once a day

Comments:
-Therapeutic response can be seen within 1 week of therapy, however, is most often observed by 2 weeks; doses should be adjusted accordingly after satisfactory response is achieved.

Uses: For acute and long-term use in the management of signs and symptoms of osteoarthritis and rheumatoid arthritis

Usual Adult Dose for Pain:

Immediate Release: 200 mg to 400 mg orally every 6 to 8 hours
-Maximum dose: 1000 mg/day

Use: For the management of acute pain

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis:

Extended Release:
6 to 16 years:
20 to 30 kg: 400 mg orally once a day
31 to 45 kg: 600 mg orally once a day
40 to 60 kg: 480 mg orally once a day
Greater than 60 kg: 1000 mg orally once a day

17 to 18 years: 400 mg to 1000 mg orally once a day

Use: For the relief of signs and symptoms of juvenile rheumatoid arthritis

Etodolac can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Etodolac may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using etodolac, especially in older adults.

You should not use etodolac if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

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

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;

• a heart attack, stroke, or blood clot;

• stomach ulcers or bleeding;

• asthma;

• fluid retention;

• liver or kidney disease; or

• if you take aspirin to prevent heart attack or stroke.

If you are pregnant, you should not take etodolac unless your doctor tells you to. Taking a NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

Etodolac is not approved for use by anyone younger than 18 years old.

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.

Overdose symptoms may include drowsiness, vomiting, stomach pain, or stomach bleeding.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Do not prepare doses of etodolac tablets in advance; keep the tablets in the original container until you are ready to take them. Store etodolac at room temperature and away from excess heat and moisture (not in the bathroom).

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

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.

Unless your doctor tells you otherwise, continue your normal diet.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to etodolac (such as ibuprofen, ketoprofen, or naproxen).

Avoid taking aspirin unless your doctor tells you to.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb etodolac.

Get emergency medical help if you have signs of an allergic reaction to etodolac: (hives, runny or stuffy nose, wheezing, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, swelling in your legs, feeling short of breath.

Stop using etodolac and call your doctor at once if you have:

• changes in your vision;

• any skin rash, no matter how mild;

• shortness of breath (even with mild exertion);

• swelling or rapid weight gain;

• signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• liver problems - nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• kidney problems - little or no urination, swelling in your feet or ankles, feeling tired; or

• low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed, cold hands and feet.

Common etodolac side effects include:

• nausea, vomiting, stomach pain, indigestion;

• diarrhea, constipation, gas;

• dizziness, headache, tired feeling;

• rash; or

• ringing in your ears.

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.

Ask your doctor before using etodolac if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.

Tell your doctor about all your other medicines, especially:

• cyclosporine;

• lithium;

• methotrexate;

• a blood thinner (warfarin, Coumadin, Jantoven);

• heart or blood pressure medication, including a diuretic or "water pill"; or

• steroid medicine (such as prednisone).

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

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking etodolac.

If you have diabetes and you test your urine for ketones, you should know that etodolac may interfere with the results of this type of test. Talk to your doctor about how you should monitor your diabetes while you are taking etodolac.

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.