Diflunisal

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 reasons not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides. Use the lowest dose that works for your condition.

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

If you take diflunisal for a long time, you may need regular medical tests.

This medicine can change the results of some medical tests. Inform any doctor treating you that you are using diflunisal.

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

Diflunisal can raise your risk of a deadly heart attack or stroke. Do not use diflunisal right before or after heart bypass surgery (coronary artery bypass graft, or CABG). Diflunisal may also lead to stomach or intestinal bleeding, which can be life-threatening.

Diflunisal can increase your risk of a fatal heart attack or stroke, even if you have no 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 issues can happen without warning while you are taking 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.

Get emergency medical help if you notice signs of an allergic reaction (hives, runny or stuffy nose, wheezing, difficulty 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 notice 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 right away if you have:

• changes in your vision;
• any skin rash, no matter how mild;
• shortness of breath (even with mild activity);
• 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, feeling very tired, 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, feeling tired;
• 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.

Usual Adult Dose for Pain:

Initial dose: 1000 mg orally onceMaintenance dose: 500 mg every 12 hours; some patients may require 500 mg every 8 hoursMaximum dose: 1500 mg/dayComments: 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 dosesComments:-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 dosesComments:-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/dayComments: 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 dosesComments:-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 dosesComments:-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

Since diflunisal is taken as needed, you might not follow a regular dosing schedule. If you miss a dose and it's nearly time for your next dose, just skip the missed dose. Do not take two doses at the same 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.

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.

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.