diflunisal

What is the most important information I should know about diflunisal?

This medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use diflunisal just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking diflunisal, especially in older adults.

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

If you drink more than three alcoholic beverages per day, do not take this medication without your doctor's advice.

What is diflunisal?

Diflunisal is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by reducing hormones that cause inflammation and pain in the body.

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

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

What should I discuss with my healthcare provider before taking diflunisal?

This medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking diflunisal, especially in older adults.

Do not use this medication if you are allergic to diflunisal, or if you have a history of allergic reaction to aspirin or other NSAIDs. Do not use diflunisal just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

If you have any of these other conditions, you may need a diflunisal dose adjustment or special tests:

• a history of heart attack, stroke, or blood clot;
• heart disease, congestive heart failure, high blood pressure;
• a history of stomach ulcers or bleeding;
• liver or kidney disease;
• asthma;
• polyps in your nose;
• a bleeding or blood clotting disorder; or
• if you smoke.

FDA pregnancy category C. It is not known whether diflunisal is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking diflunisal during the last 3 months of pregnancy may result in birth defects. Do not take diflunisal during pregnancy unless your doctor has told you to.

Diflunisal can pass into breast milk and could cause harm to a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medicine to a child younger than 12 years old without the advice of a doctor.

How should I take diflunisal?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Diflunisal is usually taken every 8 to 12 hours. Follow your doctor's instructions.

If you use this medication long-term, your blood may need to be tested often. Your blood pressure may also need to be checked. Visit your doctor regularly.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using diflunisal.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since diflunisal is sometimes taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

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

What should I avoid while taking diflunisal?

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

Avoid taking aspirin or other NSAIDs without your doctor's advice. This includes ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), sulindac (Clinoril), and others.

Ask a doctor or pharmacist before using any over-the-counter cold, allergy, or pain medicine. Many combination medicines contain aspirin or other medicines similar to diflunisal (such as ibuprofen, ketoprofen, or naproxen). Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen.

Avoid exposure to sunlight or tanning beds. Diflunisal can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 15 or higher) when you are outdoors.

Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends. Some antacids can make it harder for your body to absorb diflunisal.

What are the possible side effects of diflunisal?

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

Stop taking diflunisal and call your doctor at once if you have any of these serious side effects:

• chest pain, slurred speech, problems with vision or balance, and feeling weak or short of breath;
• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• fever, chills, body aches, flu symptoms;
• pale or yellowed skin, dark colored urine, confusion;
• swelling or rapid weight gain;
• urinating less than usual or not at all;
• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
• the first sign of any skin rash, no matter how mild.

Less serious side effects may include:

• mild nausea, stomach pain, vomiting, upset stomach;
• diarrhea, constipation, gas;
• dizziness, drowsiness, headache, tired feeling;
• sleep problems (insomnia); 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.

What other drugs will affect diflunisal?

Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with diflunisal may cause you to bruise or bleed easily.

Before taking diflunisal, tell your doctor if you are using any of the following drugs:

• acetaminophen (Tylenol);
• a blood thinner such as warfarin (Coumadin);
• cyclosporine (Gengraf, Neoral, Sandimmune);
• a diuretic (water pill);
• lithium (Eskalith, Lithobid);
• methotrexate (Rheumatrex, Trexall); or
• heart or blood pressure medication such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others.

This list is not complete and other drugs may interact with diflunisal. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about diflunisal.