Diflunisal is a nonsteroidal anti-inflammatory drug (NSAID) that is used to treat mild to moderate pain, osteoarthritis, or rheumatoid arthritis.

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

Diflunisal can increase your risk of fatal heart attack or stroke. Do not use diflunisal just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Diflunisal may also cause stomach or intestinal bleeding, which can be fatal.

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 tablet whole and do not crush, chew, or break it.

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

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

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

Usual Adult Dose for Pain:

Initial dose: 1000 mg orally once
Maintenance dose: 500 mg every 12 hours; some patients may require 500 mg every 8 hours
Maximum dose: 1500 mg/day

Comments: A lower dose may be appropriate depending on such factors as pain severity, patient response, weight, or advanced age; for example, 500 mg initially, followed by 250 mg every 8 to 12 hours.

Use: For the treatment of mild to moderate pain

Usual Adult Dose for Osteoarthritis:

500 to 1000 mg orally per day in 2 divided doses

Comments:
-Dosage may be increased or decreased based on patient response.
-Not to exceed 1500 mg/day.

Uses: For the treatment of osteoarthritis and rheumatoid arthritis

Usual Adult Dose for Rheumatoid Arthritis:

500 to 1000 mg orally per day in 2 divided doses

Comments:
-Dosage may be increased or decreased based on patient response.
-Not to exceed 1500 mg/day.

Uses: For the treatment of osteoarthritis and rheumatoid arthritis

Usual Pediatric Dose for Pain:

12 years or older:
-Initial dose: 1000 mg orally once
-Maintenance dose: 500 mg every 12 hours; some patients may require 500 mg every 8 hours
-Maximum dose: 1500 mg/day

Comments: A lower dose may be appropriate depending on such factors as pain severity, patient response, weight, or advanced age; for example, 500 mg initially, followed by 250 mg every 8 to 12 hours.

Use: For the treatment of mild to moderate pain

Usual Pediatric Dose for Osteoarthritis:

12 years or older: 500 to 1000 mg orally per day in 2 divided doses

Comments:
-Dosage may be increased or decreased based on patient response.
-Not to exceed 1500 mg/day.

Uses: For the treatment of osteoarthritis and rheumatoid arthritis

Usual Pediatric Dose for Rheumatoid Arthritis:

12 years or older: 500 to 1000 mg orally per day in 2 divided doses

Comments:
-Dosage may be increased or decreased based on patient response.
-Not to exceed 1500 mg/day.

Uses: For the treatment of osteoarthritis and rheumatoid arthritis

Diflunisal 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).

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

You should not use diflunisal 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.

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 diflunisal unless your doctor tells you to. Taking an 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.

You should not breastfeed while using diflunisal.

Diflunisal is not approved for use by anyone younger than 12 years old. Ask a doctor before giving this medicine to a child or teenager with a fever, flu symptoms, or chicken pox.

Since diflunisal is used when needed, you may not be on a dosing schedule. Skip any missed dose if it's almost time for your next dose. Do not use two doses at one time.

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

Overdose symptoms may include vomiting, diarrhea, gasping for breath, fast heart rate, sweating, confusion, extreme drowsiness, and fainting.

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 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 diflunisal (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 diflunisal.

Get emergency medical help if you have signs of an allergic reaction (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.

Diflunisal may cause serious side effects. Stop using diflunisal 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 side effects of diflunisal may include:

• nausea, vomiting, stomach pain, indigestion;

• diarrhea, constipation, gas;

• dizziness, drowsiness, 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 diflunisal 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:

• acetaminophen (Tylenol);

• 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 affect diflunisal, 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 diflunisal.

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.